Food Safety in the 111th Congress
Renée Johnson
Specialist in Agricultural Policy
September 23, 2010
Congressional Research Service
7-5700
www.crs.gov
R40443
CRS Report for Congress
P
repared for Members and Committees of Congress
Food Safety in the 111th Congress
Summary
The combined efforts of the food industry and government regulatory agencies often are credited
with making the U.S. food supply among the safest in the world. Nonetheless, public health
officials have estimated that each year in the United States, many millions of people become sick,
and thousands die from foodborne illnesses caused by any one of a number of microbial
pathogens and other contaminants. At issue is whether the current food safety system has the
resources, authority, and structural organization to safeguard the health of American consumers,
who spend more than $1 trillion on food each year. Also at issue is whether federal food safety
laws, first enacted in the early 1900s, have kept pace with the significant changes that have
occurred in the food production, processing, and marketing sectors since then.
In the 111th Congress, several food safety bills have been introduced, and wide-ranging legislation
(H.R. 2749) has passed the House. The Senate also has reported a comprehensive bill (S. 510).
Both of these bills mainly focus on the U.S. Food and Drug Administration’s (FDA’s) food
regulation rather than that of the U.S. Department of Agriculture (USDA, which has oversight of
most meat and poultry). The bills would use the agency and its existing FDA authorities rather
than create a new food safety structure or authorities. H.R. 2749 is a revised version of H.R. 759,
and was amended and approved by a House Energy and Commerce subcommittee on June 10,
2009. The full committee further amended and approved H.R. 2749 on June 17, 2009, and the full
House approved the bill on July 30, 2009, with a number of additional amendments intended to
satisfy the concerns of agricultural interests. The Senate Health, Education, Labor, and Pensions
Committee amended and approved S. 510, and later reported it in December 2009. In mid-July
2010, potential amendments to the bill were being discussed, aimed at addressing issues of
continued interest to various Senators. In August 2010, a group of Senate leaders released a
manager’s amendment to S. 510. Senate floor action has been held up by objections about the
projected cost of the bill, as well as attempts to further amend it.
Food safety legislation is a response to a number of perceived problems with the current food
safety system. For example, a growing consensus is that the FDA’s current programs are not
proactively designed to emphasize prevention, evaluate hazards, and focus inspection resources
on areas of greatest risk to public health. Given its widely acknowledged funding and staffing
constraints, and no explicit requirement on the frequency of inspections, the agency rarely visits
food manufacturing and other facilities to check sanitary and other conditions. In response, the
bills would require (although in different ways) food processing, manufacturing, shipping, and
other regulated facilities to conduct an analysis of the most likely safety hazards and to design
and implement risk-based controls to prevent them. The bills envision establishment of science-
based “performance standards” for the most significant food contaminants. To help determine
such risks and hazards, the bills propose improvement of foodborne illness surveillance systems.
The bills seek to increase frequency of inspections, tighten record-keeping requirements, extend
more oversight to certain farms, and mandate product recalls if a firm fails to do so voluntarily.
Major portions of the bills are devoted to more scrutiny of food imports, which account for an
increasing share of U.S. consumption; food import shipments would have to be accompanied by
documentation that they can meet safety standards that are at least equivalent to U.S. standards.
Such certifications might be provided by foreign governments or other so-called third parties
accredited in advance. The House and Senate bills differ in how to accomplish these objectives.
The bills have provisions for certifying or accrediting laboratories, including private laboratories,
to conduct sampling and testing of food for various oversight purposes.
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Contents
Introduction ................................................................................................................................ 1
Food Safety Incidents............................................................................................................ 1
Administration Views............................................................................................................ 2
Congressional Response........................................................................................................ 4
Leading House and Senate Bills ...................................................................................... 4
Overview of Major Provisions......................................................................................... 6
Selected Issues ............................................................................................................................ 8
Registration .......................................................................................................................... 9
Record-Keeping.................................................................................................................. 10
Hazard Analysis and Risk-Based Preventive Controls.......................................................... 11
Performance Standards........................................................................................................ 12
On-Farm Safety Standards; Safety of Produce ..................................................................... 13
Targeting of Inspections ...................................................................................................... 16
Use of Third Parties for Imports and for Laboratory Accreditation....................................... 19
Mandatory Recall Authority ................................................................................................ 21
Notification of Contaminated Products, and Product Tracing ............................................... 23
Foodborne Illness Surveillance and Outbreak Response ...................................................... 25
Food Imports ...................................................................................................................... 26
Bisphenol A (BPA).............................................................................................................. 28
Paying for Food Safety with User Fees................................................................................ 29
Organization of Food Safety Responsibilities ...................................................................... 32
Tables
Table 1. Crosswalk of Food Safety Provisions in H.R. 2749 (House-Passed) and S. 510
(Manager’s Amendment of August 12, 2010) ........................................................................... 7
Table 2. FDA Food-Related Inspection Data, FY2004-FY2011.................................................. 17
Table 3. FDA Direct Appropriations for Foods, FY2005-FY2011 .............................................. 30
Table 4. Types of Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment to
S. 510 .................................................................................................................................... 32
Table 5. Comparison of Annual Fees in House-Passed H.R. 2749 and Senate Manager’s
Amendment to S. 510............................................................................................................. 34
Table 6. Comparison of Periodic Fees in House-Passed H.R. 2749 and Senate Manager’s
Amendment to S. 510............................................................................................................. 35
Appendixes
Appendix. Comparison of Provisions in H.R. 2749 (House-Passed) and S. 510 (Senate
Manager’s Amendment) with Current Law............................................................................. 37
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Contacts
Author Contact Information ...................................................................................................... 79
Acknowledgments .................................................................................................................... 79
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Introduction
The combined efforts of the food industry and government regulatory agencies often are credited
with making the U.S. food supply among the safest in the world. Nonetheless, public health
officials have estimated that each year in the United States, many millions of people become sick,
and thousands die from foodborne illnesses caused by any one of a number of microbial
pathogens and other contaminants.1 At issue is whether the current food safety system has the
resources, authority, and structural organization to safeguard the health of American consumers,
who spend more than $1 trillion on food each year.2 Also at issue is whether federal food safety
laws, first enacted in the early 1900s, have kept pace with the significant changes that have
occurred in the food production, processing, and marketing sectors since then.
In 2007 and again in 2009, the Government Accountability Office (GAO) added food safety to its
biennially published list of high risk areas, one of 29 needing concerted attention by Congress and
the Administration.3 GAO has identified 15 federal agencies collectively administering at least 30
laws related to food safety. The majority of both total funding and total staffing, however, is with
the Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture (USDA),
which regulates most meat and poultry, and the Food and Drug Administration (FDA) at the U.S.
Department of Health and Human Services (HHS), which regulates virtually all other foods.
FSIS’s annual budget in FY2010 was approximately $1.1 billion in appropriated funds plus an
estimated $131 million in industry-paid user fees. FDA’s annual budget for its human foods
program was $784 million for FY2010, all of it appropriated.4
Food Safety Incidents
Food safety-related incidents frequently heighten public and media scrutiny of the U.S. food
safety system.5 Large recalls of FSIS-regulated meat and poultry products (including ground beef)
due to findings of E. coli O157:H7, Listeria, and other problems continue to occur each year.6 In
addition, in recent years, several large multi-state foodborne outbreaks have been linked to FDA-
regulated foods. For example, in 2006 more than 200 confirmed illnesses and three deaths were
1 According to the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 76
million people become sick, 325,000 are hospitalized, and 5,000 die from foodborne illnesses each year (“Foodborne
Illness: Frequently Asked Questions,” accessed at http://www.cdc.gov/foodsafety/). However, this estimate appears to
be based primarily on 1997 and earlier data in a report by Paul S. Mead et al., “Food-related Illness and Death in the
United States,” Emerging Infectious Diseases, vol. 5, pp. 607-625, 1999.
2 Nearly half of U.S. food spending is now in restaurants and other places outside the home. Roughly two-thirds of the
$1 trillion is for domestically produced farm foods; imports and seafood account for the balance. Data source: U.S.
Department of Agriculture (USDA), Economic Research Service.
3 GAO, High Risk Series: An Update (GAO-07-310), January 31, 2007. Food safety remains on GAO’s 2009 high-risk
list.
4 Source: USDA and HHS budget materials for FY2011. The FDA figure does not include some food safety activities
carried out by the Center for Veterinary Medicine and National Center for Toxicological Research. For more
information on current food safety authorities and agencies, with sources, see CRS Report RS22600, The Federal Food
Safety System: A Primer. Also see CRS Report R40721, Agriculture and Related Agencies: FY2010 Appropriations.
5 Three recent multi-state foodborne outbreaks and their implications for the nation’s food safety system are discussed
in more depth in CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
6 For updates on meat and poultry recalls and alerts, see the USDA website: http://www.fsis.usda.gov/fsis_recalls/
index.asp.
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linked to bagged fresh spinach grown in California and contaminated with the bacterium E. coli
O157:H7. In 2008, more than 1,300 persons in 43 states, the District of Columbia, and Canada
were found to be infected with the same unusual strain of bacteria, Salmonella Saintpaul.
Officials first suspected fresh tomatoes as the vehicle, but later tests confirmed the pathogen in
serrano peppers and irrigation water from a farm in Mexico. These incidents raised public
concerns about the safety of all fresh produce and stimulated a number of industry and
government initiatives to limit future contamination incidents.
Attention shifted to the safety of food imports in 2007, when pet food ingredients imported from
China, contaminated with the chemical melamine, sickened or killed an unknown number of dogs
and cats, and subsequently were found in some hog, chicken, and fish feeds. In 2008, melamine
contamination of infant formula in China sickened thousands of children and raised concerns
about the safety of infant formula in the United States. The melamine incidents highlighted the
limited reach of FDA’s oversight of imports, the difficulty in tracing the many pathways taken by
a common food ingredient, and the frequent confluence of human and animal food ingredients.
In late 2008 and early 2009, a multi-state outbreak of Salmonella Typhimurium was linked to an
institutional brand of peanut butter and other peanut-based ingredients from a single firm.
According to the U.S. Centers for Disease Control and Prevention (CDC), the outbreak sickened
more than 700 people in 46 states, and may have contributed to the deaths of nine people. A series
of expanding recalls was announced by FDA in early 2009, involving thousands of peanut-
containing products from more than 200 companies. Again, the incident highlighted the broad
reach of a common contaminated ingredient, and the resultant challenges in rapidly tracing
products and removing them from commerce.
In July 2010, CDC noticed a spike in cases of infection with Salmonella Enteritidis, a strain
commonly associated with shell eggs, which are regulated by FDA.7 In August, FDA found the
same pathogen on two egg farms in Iowa, leading to the nationwide recall by the companies of
more than 500 million eggs.8 In July 2009, FDA had published a long-awaited egg safety
regulation, which became effective in July 2010 as the outbreak was well underway.9 Although
most observers believe that the rule, if enforced, will help to prevent shell egg contamination and
outbreaks in the future, many remain concerned with the apparent lack of coordination between
USDA’s egg quality inspection activities and FDA’s food safety activities.10
Administration Views
The George W. Bush Administration issued several reports and studies calling for major changes
in the food safety system. Two Bush Administration initiatives were unveiled in November 2007
and were critiqued and debated extensively during the 110th Congress. They were the FDA’s Food
7 USDA regulates processed egg products, and grades shell eggs for quality (such as grade and size), but does not
oversee the safety of shell eggs.
8 FDA, “Salmonella Enteritidis Outbreak in Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/
ucm222684.htm.
9 FDA, “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Final
Rule,” 74 Federal Register 33029, July 9, 2009. See also FDA, “Egg Safety Final Rule,” http://www.fda.gov/Food/
FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm.
10 Alicia Mundy and Bill Tomson, “Egg Inspectors Failed to Raise Alarms,” The Wall Street Journal, September 10,
2010.
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Protection Plan: An Integrated Strategy for Protecting the Nation’s Food Supply, and the
Interagency Working Group on Import Safety’s Action Plan for Import Safety: A Roadmap for
Continual Improvement, part of which dealt extensively with food product imports.11 Both reports
generally called for a more preventive risk-based approach to food safety oversight, including
more attention to imported foods, among numerous other recommendations.
President Obama, in a March 14, 2009, weekly radio address, called the food safety system a
“hazard to public health.” He announced a Food Safety Working Group (FSWG) of Cabinet
secretaries and senior officials “to advise me on how we can upgrade our food safety laws for the
21st century; foster coordination throughout government; and ensure that we are not just
designing laws that will keep the American people safe, but enforcing them.”12 In July 2009, the
FSWG announced a number of steps the Administration was taking, under existing authorities, to
improve government safeguards.13 The group released a one-year progress report in July 2010.
Also, the Administration announced that it had “taken steps to reduce the prevalence of E. coli,
implemented new standards to reduce exposure to Campylobacter, and issued a rule to control
Salmonella contamination,” and that “FDA has conducted a pilot study on a tracing system, and
HHS, in collaboration with USDA, has rolled out an enhanced and updated www.foodsafety.gov
site to provide consumers rapid access to information on food recalls.”14
To date, the Obama Administration has not provided recommended language for changes in
authorizing statutes. The Administration declared its support for H.R. 2749 in its official
Statement of Administration Policy on the bill.15 In a July 2010 statement, the Administration
further urged the Senate to complete its work on S. 510.16 In addition, Administration officials
have testified on aspects of the legislation. Testimony regarding specific provisions of the House
bill was given by FDA Commissioner Dr. Margaret Hamburg to the House Energy and
Commerce Subcommittee on Health on June 3, 2009, and by FDA Senior Advisor Michael R.
Taylor to the House Agriculture Committee on July 16, 2009.17
In October 2009 testimony on the Senate bill, FDA Commissioner Margaret Hamburg called S.
510 a “major step in the right direction.” Provisions in the bill address a key policy concern by
refocusing FDA’s food safety system on prevention, the Commissioner stated. She added that the
bill also generally meets another key policy concern, the need for adequate FDA legal tools to
11 FDA, “An integrated strategy for protecting the nation’s food supply,” November 2007, http://www.fda.gov/Food/
FoodSafety/FoodSafetyPrograms/FoodProtectionPlan2007/ucm132565.htm; and the Interagency Working Group on
Import Safety, “Action Plan for Import Safety: A roadmap for continual improvement,” November 2007,
http://archive.hhs.gov/importsafety/report/actionplan.pdf.
12 The working group established a public website at http://foodsafetyworkinggroup.gov/, where the full text of these
remarks may be viewed.
13 FSWG, “Food Safety Working Group: Key Findings,” July 7, 2009, http://www.foodsafetyworkinggroup.gov/
FSWG_Key_Findings.pdf.
14 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
15 The White House, Statement by the President on House Passage of the Food Safety Enhancement Act of 2009, July
30, 2009, http://www.whitehouse.gov/the-press-office/statement-president-house-passage-food-safety-enhancement-
act-2009.
16 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
17 Dr. Hamburg’s comments were based on an earlier version of H.R. 2749, i.e., prior to markup by the subcommittee;
Mr. Taylor’s were based on the version reported by the full Energy and Commerce Committee (H.Rept. 111-234).
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implement the new requirements, although some additional provisions, such as effective
enforcement mechanisms, should be added. Finally, the Commissioner stated, the legislation must
provide or anticipate adequate resources, but it “does not provide a guaranteed consistent funding
source to help FDA fulfill its new responsibilities.” The Commissioner recommended the
inclusion of registration fees, flexibility to adjust facility inspection frequencies, and use of
accredited third parties to ensure adequate resources.18 (These issues are among those discussed
later in this report.)
Congressional Response
These and other developments have made food safety a top issue for many lawmakers. Several
have called for major changes in the U.S. food safety system and/or funding increases that they
assert are needed to meet current obligations to protect consumers from unsafe food. Perceived
gaps in federal safeguards have been explored at more than two dozen congressional hearings
since 2007.19 The 110th Congress adopted some amendments to current programs and increased
funding for the primary food safety agencies, but more comprehensive food safety legislation was
not enacted.
In the House, U.S. food safety laws variously fall under the purview of the Energy and
Commerce Committee, which claims jurisdiction over all FDA-regulated products, including
foods, and the Agriculture Committee, which claims the lead on USDA’s meat and poultry
inspection programs. Similarly, in the Senate, the Committee on Health, Education, Labor, and
Pensions has jurisdiction over FDA-regulated foods and other products, while the Agriculture
Committee has jurisdiction over USDA inspection programs. In contrast with the split in
jurisdictions among the authorizing committees, within each of the House and Senate
Appropriations Committees, one subcommittee (Agriculture) is responsible for funding and
oversight of both FDA and USDA.
Leading House and Senate Bills
In the 111th Congress, nearly a dozen food safety bills, several of them comprehensive, have been
introduced. However, the major vehicle in the House has been H.R. 2749 by Representative
Dingell. This bill was amended and approved by the Subcommittee on Health of the House
Energy and Commerce Committee on June 10, 2009; by the full committee on June 17 (H.Rept.
111-234, July 29, 2009); and by the full House on July 30, 2009.20
18 October 22, 2009, testimony of FDA Commissioner Margaret Hamburg before the Senate Committee on Health,
Education, Labor, and Pensions.
19 This includes hearings conducted by the House and Senate Agriculture Committees, House Committee on Energy
and Commerce, Senate Committee on Health, Education, Labor, and Pensions (HELP), House Committee on Small
Business, House Committee on Oversight and Government Reform, House Committee on Homeland Security, House
Committee on Ways and Means, Senate Appropriations Committee, and Senate Committee on Commerce, Science, and
Transportation.
20 Two other comprehensive House bills have been H.R. 875 by Representative DeLauro, a blueprint for a new,
independent Food Safety Administration (FSA), separated from the current FDA but still within HHS, which would
operate a comprehensive new food safety program (but would not include the meat and poultry inspection programs
operated by FSIS); and H.R. 1332 by Representative Costa, which is similar in design to the version of the Senate bill
originally introduced by Senator Durbin (S. 510).
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In the Senate, the principal bill was originally introduced as S. 510 by Senator Durbin. The
Senate Health, Education, Labor, and Pensions (HELP) Committee amended and approved the
bill on November 18, and reported it (without a written report) on December 18, 2009. During the
summer of 2010, potential amendments to the bill were being discussed, aimed at addressing
issues of continued interest to various Senators. These include a proposal by Senator Tester to
exempt facilities with less than $500,000 in annual sales from certain requirements,21 and a
proposal by Senator Feinstein to phase out the use of bisphenol-A (BPA) in food packaging.22
On August 12, 2010, several members of the Senate HELP Committee, including its chairman,
Senator Harkin, and ranking member, Mike Enzi, along with the bill’s original sponsor, Senator
Richard Durbin, released a manager’s amendment to S. 510, as a substitute to the Senate
committee bill.23 Following the release of the amendment of S. 510, Senate floor action was
widely anticipated. However, as of September 2010, further action on the bill has been stalled.
There have been objections about the projected cost of the bill,24 as well as continued attempts to
further amend the bill.
In general, the overall structure of H.R. 2749 and S. 510 is very similar; however, a key
difference between the House and Senate bills is how the proposed program changes would be
funded. Specifically, H.R. 2749 would institute a new $500 facility registration fee that would
help offset various reforms and FDA activities in the bill; a similar fee is not included in S. 510.
The Congressional Budget Office (CBO) estimates that implementing H.R. 2749 would increase
net spending subject to appropriation by about $2.0 billion (FY2010-FY2014); federal revenues
from civil penalties for food-related violations under the Federal Food, Drug, and Cosmetic Act
(FFDCA) would increase by $10 million over the same period.25 CBO estimates that spending
under S. 510, incorporating changes in the August 2010 manager’s amendment, would increase
net appropriations by about $1.4 billion (FY2011-FY2015); collections from possible revenue
and direct spending increases from new criminal penalties would be “insignificant, yielding a
negligible net impact in each year.”26
There has also been continued negotiation regarding further amendments to the bill. Although the
amendment of S. 510 does not include either of the proposed changes by Senators Tester and
Feinstein, versions of these and other proposals could be offered as amendments to the bill if it is
considered by the full Senate.
21 Seth Freedland, “Food Safety Bill Compromise on Small Farm Visits in Works,” FDA Week, April 30, 2010. See
also CRS Report RL34612, Food Safety on the Farm: Federal Programs and Legislative Action.
22 Alan K. Ota, “Food Safety Bill Held Up By Split Over Fine Lining,” CQ Today Online News, July 21, 2010. See also
CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible Human Health Effects.
23 The manager’s amendment is available at U.S. Senate Committee on Health, Education, Labor, and Pensions,
“Senate Leaders Release Manager’s Package of the FDA Food Safety Modernization Act,” press release, August 12,
2010, http://help.senate.gov/newsroom/press/.
24 See, for example, Ellyn Ferguson, “Food Safety Measure Faces Objection from Coburn Over Lack of Spending
Offsets,” CQ Today Online News, September 14, 2010.
25 CBO, Cost Estimate, H.R. 2749, Food Safety Enhancement Act of 2009, July 24, 2009, http://cbo.gov/ftpdocs/
104xx/doc10478/hr2749.pdf.
26 CBO, Cost Estimate, S. 510, Food Safety Modernization Act, August 12, 2010, http://cbo.gov/ftpdocs/117xx/
doc11794/s510.pdf.
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Overview of Major Provisions
Both H.R. 2749 and S. 510 focus primarily on FDA-regulated foods, and would achieve their
proposed reforms through the agency’s existing structure and authorities, in particular the Federal
Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. 301 et seq.).
In the House, U.S. food safety laws variously fall under the purview of the Energy and
Commerce Committee, which claims jurisdiction over all FDA-regulated products, including
foods, and the Agriculture Committee, which claims the lead on USDA’s meat and poultry
inspection programs. In the Senate, the Committee on Health, Education, Labor, and Pensions
likely would play the lead role in initiating legislation on FDA-regulated foods and other
products, while the Committee on Agriculture likely would initiate any legislation on changes in
USDA inspection programs. In contrast with the split in jurisdictions among the authorizing
committees, within each of the House and Senate Appropriations Committees, one subcommittee
(Agriculture) is responsible for funding and oversight of both FDA and USDA.
Although differing somewhat in approach, both the House and Senate bills seek to address many
of the same perceived problems with the current food safety system. For example, a growing
consensus is that the FDA’s current programs are not proactively designed to emphasize
prevention, evaluate hazards, and focus inspection resources on areas of greatest risk to public
health. Rather, FDA generally has been reactive, usually stepping in when adulterated or
misbranded products are found in commerce or an illness outbreak leads them to a problem.
Given its widely acknowledged funding and staffing constraints, and no explicit requirement for
the frequency of inspections, the agency rarely visits food manufacturing and other facilities to
check sanitary and other conditions.
Both bills would require (although in different ways) food processing, manufacturing, shipping,
and other regulated facilities to conduct an analysis of the most likely food safety hazards and to
design and implement risk-based controls to prevent them. (These are similar conceptually to the
so-called HACCP, or hazard analysis and critical control point, plans required of meat and poultry
establishments.) The bills envision the establishment of science-based “performance standards”
for the most significant food contaminants. To aid in determining such risks and hazards, both
bills propose the improvement of foodborne illness surveillance systems aimed at better data
reporting, analysis, and usefulness, with the CDC playing a lead role.
The bills seek to increase the frequency of plant inspections, taking into account risk factors. To
aid in such inspections, and to improve the ability to rapidly trace food products through the
production and marketing chain in the event of a foodborne illness outbreak, suspected
contamination, or other problems, the bills generally seek to strengthen record-keeping
requirements and food traceability systems. Industry participants would be required to maintain
records for certain time periods and in formats to be prescribed by FDA. The importance of
adequate records has been demonstrated in recent food safety incidents, particularly in the case of
outbreaks eventually linked to fresh produce. Food establishments, which are already subject to a
one-time registration requirement under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (P.L. 107-188; 21 U.S.C. 350d), would have to re-
register more frequently under the bills, which ask for additional registration information. Also,
the House bill requires a $500-per-facility registration fee.
The bills also appear to agree on the need to give FDA the authority to mandate product recalls if
a firm with suspect products fails to do so voluntarily. Currently FDA lacks such authority for
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food, except for infant formula. However, the bills differ somewhat on how such authority might
be applied, and on related requirements for notification when adulterated food threatens public
health.
The bills contain extensive provisions for heightened scrutiny of imports, which have comprised
an increasing share of U.S. food consumption. Food import shipments might newly have to be
accompanied by documentation that they are from facilities and establishments certified as
meeting safety standards that are at least equivalent to U.S. standards. Such certifications might
be provided by foreign governments or other so-called third parties accredited in advance by FDA
and/or an approved accrediting body; again, the House and Senate bills differ in detail on how to
accomplish these objectives. The bills also address the need for certifying or accrediting
laboratories, including private laboratories, to conduct sampling and testing of food for various
oversight purposes.
Provisions in the bills seek, in differing ways, to extend safeguards to the farm level, generally
calling for new, science-based regulations for safe production mainly of fruits, vegetables, and
related products, and expanding enforcement and record-keeping authorities.
Table 1 provides a crosswalk of the House and Senate provisions. A comparison of key
provisions in the major House and Senate bills with current law is provided in the Appendix at
the end of this report.
Table 1. Crosswalk of Food Safety Provisions in H.R. 2749 (House-Passed) and S. 510
(Manager’s Amendment of August 12, 2010)
Sections in H.R. 2749
Sections in S. 510 (Senate
Topic
(House-passed)
manager’s amendment)
Food Facility Registration
101 102
Requirements (not including
imported foods)
Recordkeeping; Records Access
106, 107, 205
101
and Inspection
Hazard Analysis and Risk-Based
102 103,
114
Preventive Controls and Food
Safety Plans
Performance Standards
103
104
Standards for Produce, other
104 105
Raw Agricultural Commodities
Targeting of Inspection
105 201
Resources
Third Party Accreditation
307
109
Laboratory Accreditation,
110, 209
202, 203
Testing
Food Traceability 107, 206
204
Foodborne Illness Surveillance
121, 122
205
and Education
Notification and Mandatory
111, 112
206, 211
Recall Authority; Reportable
Food Registry
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Sections in H.R. 2749
Sections in S. 510 (Senate
Topic
(House-passed)
manager’s amendment)
Administrative Detention of
132 207
Food
Intentional Adulteration and
102
106, 108, 109, 110
Domestic Food Defense
State and Local Food Safety
214 209,
210
Roles and Training
Whistleblower Protection
212
402
Other Enforcement Provisions
131 (Procedures for seizure), 133
208 (Decontamination and disposal
(including provisions not
(Authority to prohibit or restrict the
standards and plans)
comparable between House
movement of food), 134 (Criminal
and Senate bills)
penalties), 135 (Civil penalties), 210 (False
or Misleading Reporting to FDA), 211
(Subpoena Authority)
Import Certification
109
303
Inspection of Foreign Facilities
105, 207
306
Foreign Supplier Verification
204, 205, 206, 136
301
Expedited Imports
113
302
FDA Foreign Offices
208
308
Other importer provisions
202 (Country of Origin Labeling)
304 (Prior Notice of Imported Food
(including provisions not
Shipments), 305 (Building Capacity of
comparable between House
Foreign Governments with Respect
and Senate bills)
to Food), 115 (Port Shopping), 309
(Smuggled Food)
HHS-USDA Jurisdiction
4, 5, 6, 213
403, 116, 404
Funding and Fees
101, 108, 203, 204
107, 401
Research
123
210
Miscellaneous provisions
114 (Infant Formula), 201 (Food
111 (Sanitary Transportation of
(including provisions not
substances general y recognized as safe),
Food), 112 (Food Al ergy and
comparable between House
215 (Bisphenol A in Food and Beverage
Anaphylaxis Management), 113 (New
and Senate bills)
Containers), 216 (Lead Content Labeling
Dietary Ingredients)
Requirement for Ceramic Tableware and
Cookware)
Source: Table prepared by the Congressional Research Service based on the text of H.R. 2749, as passed by the
House, and the August 2010 manager’s amendment to S. 510 in the Senate.
Selected Issues
The following sections provide a discussion of the key provisions in H.R. 2749 as passed by the
House and the Senate manager’s amendment to S. 510. Unless otherwise noted, the House bill
provisions discussed in this section refer to provisions in the House-passed H.R. 2749, and the
Senate provisions refer to provisions in the Senate manager’s amendment (“amendment”) to S.
510, released August 12, 2010.
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Registration
Keeping Track of Food Facilities
The FFDCA already requires domestic and foreign food facilities to register with FDA, pursuant
to provisions in P.L. 107-188, the Bioterrorism Act (FFDCA Section 415; 21 U.S.C. 350d).
Excepted are farms, retailers, and certain types of nonprofit food establishments and fishing
vessels. Renewal is not required on any periodic basis, but registrants must notify the HHS
Secretary in a timely manner of relevant changes in their status. The FFDCA (Section 801(l); 21
U.S.C. 381(l)) provides that imported food may not be delivered to the importer, owner, or
consignee of the article unless the foreign facility is registered. FDA does not have explicit
authority to require a registration fee from domestic or foreign facilities.
Some assert that registration requirements should be strengthened so that authorities will be
notified when a firm moves, undertakes a new food business, or changes product lines.
Otherwise, FDA’s records of facilities that are manufacturing and marketing food are continually
out of date, it is argued. Others have argued that additional registration requirements would be
needlessly intrusive and costly for industry.
Legislative Proposals
The House-passed bill (Section 101) would require annual registration, and would deem foods
from unregistered facilities to be misbranded, which therefore would prohibit such food from
being introduced into, or delivered or received in, commerce. (The FDA has authority to seize
such food that is introduced into commerce, seek an injunction to prevent misbranding violations,
and assess criminal penalties against individuals and organizations.) The bill would amend
FFDCA Section 415 to clarify the types of facilities that would remain exempt from the
registration requirement, explicitly defining “retail food establishment” and “farm.” It also would
spell out additional types of information to be required of registrants. The bill also would provide
procedures for the suspension of registration for “a violation of [the FFDCA] that could result in
serious adverse health consequences or death to humans or animals,” and procedures for vacating
such a suspension. Registration fees would be imposed (discussed later in this report).
The Senate amendment (Section 102) would require domestic and foreign facilities to register
every two years, and to provide some additional types of contact information, with an abbreviated
renewal process available to facilities with no change in status. The amendment would provide
procedures for the suspension of registration if the HHS Secretary “determines that food
manufactured, processed, packed, received, or held by a facility registered under this section has a
reasonable probability of causing serious adverse health consequences or death to humans or
animals.” It also would provide procedures, somewhat different from those in the House-passed
bill, for vacating such a suspension. Facilities with suspended registrations would be barred from
importing or introducing food into commerce. Importing or introducing such food into commerce
would be prohibited, and subject to possible civil and criminal penalties and other enforcement
actions. The amendment would not change the current exemption of farms, retailers, and certain
types of nonprofit food establishments and fishing vessels from the registration requirement. The
amendment would not impose registration fees.
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Record-Keeping
Should Documentation Requirements and Access to Records Be Strengthened?
Pursuant to provisions in P.L. 107-188, the Bioterrorism Act (FFDCA Section 414; 21 U.S.C.
350c), the FFDCA authorizes the HHS Secretary to impose record-keeping requirements on
domestic and foreign food facilities (except farms and restaurants), and to inspect and copy such
records “[i]f the Secretary has a reasonable belief that an article of food is adulterated and
presents a threat of serious adverse health consequences or death to humans or animals.” The
Secretary must take appropriate measures to ensure that unauthorized disclosure of any trade
secret or confidential information is prevented. Through rulemaking, the Secretary has required
facilities to maintain records that allow for the identification of the immediate previous sources
and immediate subsequent recipients of food.27
Advocates of food safety reform often argue that record-keeping requirements must be
strengthened to help regulators determine whether firms are complying with the law, and to
facilitate outbreak investigations and product recalls. Among their concerns is that records do not
have to be maintained in electronic format, which, these advocates assert, delays outbreak
response. Related concerns include the types and level of detail of records to be kept, how long
they should be retained, and access to and use of these records by authorities. For example, is the
current “trigger” for accessing records (quoted above) too stringent to assure food safety, too
permissive to protect industry interests, or appropriately balanced between the two? Concerns
about increased record-keeping requirements and access authority often involve concerns about
the intrusiveness of government, as well as about privacy and the protection of sensitive
commercial information (trade secrets), for example.
Legislative Proposals
The House-passed bill (Section 106) would expand the Secretary’s authority to inspect and copy
relevant records of a food company in order to determine whether a food is adulterated or
misbranded, by removing the requirement that the Secretary have “a reasonable belief that an
article of food is adulterated and presents a threat of serious adverse health consequences or death
to humans or animals.” (Drafters of the bill view this as authority to access records during routine
inspections.) The bill also would remove the requirement to provide written notice before having
such access, and would authorize the Secretary to require that records be kept for up to three
years and be maintained in a standardized electronic format. Farms would generally remain
exempt from the requirement to provide access to records unless the Secretary determined, with
respect to specified commodities, that such commodities posed a risk to public or animal health,
or were the subject of an active investigation of a foodborne illness outbreak. Restaurants would
be required to provide access to records, but would only have to keep records regarding their
suppliers and any subsequent distribution other than to consumers.
The Senate amendment (Section 101) would expand the Secretary’s authority to inspect and copy
relevant records of a food company in two ways, but would not appear to authorize access during
routine inspections, as would the House-passed bill. The amendment would require that access be
27 FDA, “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002,” 69 Federal Register 71561, December 9, 2004.
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provided to the HHS Secretary if he or she “has a reasonable belief that an article of food, and
any other article of food that the Secretary reasonably believes is likely to be affected in a similar
manner, is adulterated and presents a threat of serious adverse health consequences or death to
humans or animals,” or if the Secretary “believes that there is a reasonable probability that the use
of or exposure to an article of food, and any other article of food that the Secretary reasonably
believes is likely to be affected in a similar manner, will cause serious adverse health
consequences or death to humans or animals.” The Secretary would no longer be required to have
a reasonable belief that the food is adulterated, and would be allowed access to records regarding
foods that are likely to be affected in a similar manner, but would need to believe that there is at
least a risk of harm. Unlike the House bill, farms and restaurants would (as under current law) be
fully exempt from this provision. For other facilities, written notification would still be required
to gain access.
(See also the subsequent section on “Notification .”)
Hazard Analysis and Risk-Based Preventive Controls
Reactive vs. Preventive Intervention
A broad consensus of policymakers agrees that FDA’s system of safeguards, which is based on a
law first written early the last century, is primarily reactive. By and large, the agency’s statute and
regulations spell out the reasons a food article is to be considered adulterated or misbranded and
therefore unfit for consumption. In effect, industry players are expected to abide by the rules;
generally it is only when a problem is detected—often after an illness outbreak is reported or
testing finds a contaminant in a product—that officials step in to correct it, or order the industry
to do so.
A recurring theme now in discussions of food safety modernization is prevention. Virtually all
stakeholders, including regulators, the regulated industries, consumer advocates, and food safety
scientists agree that the foundations of any new program should be an understanding of what, and
how, hazards can enter the food supply, followed by implementation of measures to prevent these
hazards. A popular version of this approach is the so-called Hazard Analysis and Critical Control
Point (HACCP) system, which many private companies already use, and which was incorporated
in the 1990s by FSIS as a regulatory requirement for all meat and poultry slaughtering and
processing establishments. Variations of the HACCP system also are required by FDA in the
processing of seafood, juices, and low-acid canned foods, but not other product categories.
Committees of the National Academy of Sciences’ National Research Council (NRC) have, in a
number of reports, recommended the HACCP approach for food safety. For example, its
Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe
Food stated at the outset of a 2003 report:
The balance of progress in reduction of certain human foodborne illnesses following
implementation of [HACCP] in various areas of the food industry is decidedly favorable.... The
committee believes that the emphasis of food safety regulatory agencies must continue to be on
prevention, reduction, or elimination of foodborne hazards along the food continuum.28
28 Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, National
(continued...)
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The National Advisory Committee on Microbiological Criteria for Foods, established to offer
ongoing advice to the FDA and USDA, agreed with the NAS recommendations, which have dated
at least to the early 1990s. The advisory committee also noted that HACCP principles should be
standardized to provide uniformity in training and applicability, but also must be developed by
each food establishment so they can be tailored to individual products, processing, and
distribution conditions.29
Legislative Proposals
The House-passed bill and Senate amendment (Sections 102 and 103, respectively) contain
somewhat similar provisions requiring each owner, operator, or agent of a facility to evaluate the
hazards that could affect food manufactured, processed, packed, transported, or held there;
identify and implement preventive controls to significantly minimize, prevent, or eliminate such
hazards; and monitor and maintain records on these controls once they are in place. The bills
further specify types of hazards that should be evaluated, and they require facilities to conduct a
re-analysis at specified intervals, and to maintain at least two years of records to document and
verify their control measures, among other details (which differ somewhat between the bills, with
the House version appearing to be somewhat more prescriptive). Written HACCP-type and/or
broader written food safety plans containing HACCP requirements are also elements of the bills.
Under the House-passed bill, higher-risk facilities must submit test results when finished products
are found to contain contaminants “posing a risk of severe adverse health consequences or death”
(although there are some limitations on the extent of the Secretary’s authority). The Senate
amendment contains additional requirements regarding available FDA guidance documents for
seafood (Section 114).
Performance Standards
Can Safety Be Better Measured?
Performance standards typically are specific, quantitative measurements of a property of, or a
substance in, food that are selected to serve as benchmarks for whether the food is safe in a
broader sense. For example, a microbial performance standard could be used to determine
whether a product is contaminated with microbes in general, and whether a problem with the
product’s processing should be investigated and corrected. The NAS-NRC standards committee
reported that a common theme of regulatory performance standards is “to provide clear
articulation of what is and is not acceptable in the process or system being regulated.”30 The
committee added that regulators like the FDA, USDA, and the Environmental Protection Agency
(EPA) have employed specific standards for diverse reasons and conditions and based on
numerous scientific, legal and practical constraints, including:
(...continued)
Research Council. Scientific Criteria to Ensure Safe Food, National Academies Press, 2003.
29 National Advisory Committee on Microbiological Criteria for Foods, Hazard Analysis and Critical Control Point
Principles and Application Guidelines, adopted August 14, 1997.
30 Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, National
Research Council, Scientific Criteria to Ensure Safe Food, National Academies Press, 2003, p. 16.
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tolerances (which set legal limits) on the presence of chemicals in food, prohibitions on specific
microbial pathogens in specific foods, standards for process control, and standards defining the
acceptable outcome of a food process for reducing pathogenic contamination. All of these are
performance standards in the sense that they define what must be achieved in controlling risk
factors for food safety.31
The FFDCA does authorize FDA to promulgate standards for certain hazards, such as tolerances
for pesticide or drug residues in foods, but does not grant explicit authority to develop standards
solely as a means to verify that processing is done in a manner that ensures safe food.32
Legislative Proposals
The House bill and Senate amendment both include language on performance standards (Sections
103 and 104, respectively). Although differing in detail, the House-passed and Senate bills amend
the FFDCA to require the Secretary of the U.S. Department of Health and Human Services (HHS)
to, at least every two years, review and evaluate epidemiological data, health data, or other
information to identify the most significant hazards and to issue guidance or regulations on
science-based performance standards to significantly minimize, prevent, or eliminate such
hazards. Such standards must be specific to products or product classes, not individual facilities.
The Senate amendment conditions the issuance of standards, requiring them “[b]ased on such
review and evaluation, and when appropriate to reduce the risk of serious illness or death to
humans or animals or to prevent the adulteration of food” under the FFDCA. The Senate bill
further requires that this review and evaluation be conducted in coordination with USDA. The
House-passed bill says such issuance shall be “as soon as practicable” and “as appropriate, to
minimize to an acceptable level, prevent, or eliminate the occurrence of such hazards.”
On-Farm Safety Standards; Safety of Produce
Should Agricultural Producers Get More Scrutiny?
Food safety experts agree that an effective, comprehensive food safety system should include
consideration of potential hazards at the farm level. From this point, viewpoints diverge. Should
farmers and ranchers be subject to mandatory safety standards, enforced through certification of
their practices, periodic inspections, and penalties for noncompliance? Or, should public policy
continue to encourage voluntary strategies for producing safe foods on farms and ranches,
through education, cooperation, and market-based incentives? Historically, the federal and state
governments have relied on the latter “carrot” approach that, in the view of some critics, is no
longer effective. It also could be argued that numerous existing laws and regulations already
impose restrictions, both direct and indirect, on producers of food commodities, which effectively
meet food safety objectives—and also involve significant compliance costs. These restrictions
include requirements on the use of animal drugs, feed additives, and pesticides.
31 Ibid, p. 17.
32 FSIS in 1996 had established two performance standards to verify the microbial safety of meat and poultry products
as part of its HACCP regulation. FSIS’s efforts to take enforcement action for violations of its standard upper limit for
Salmonella contamination were constrained by a successful legal challenge, but it still interprets noncompliant
Salmonella test results as a HACCP violation rather than a specific violation of the standard. For more information see
CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
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FDA’s “current good manufacturing practice” (CGMP) requirements (at 21 C.F.R. Part 110) apply
to manufacturing, packing, or holding human food, but establishments engaged solely in
harvesting, storing, or distributing raw agricultural commodities generally are excluded.33 Farms
are among those exempted from a requirement that food facilities be registered with FDA,
pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of
2002.34 Further, the FFDCA specifically exempts farms (and restaurants) from requirements to
maintain records for up to two years for purposes of identifying “immediate previous sources and
the immediate subsequent recipients of food, including its packaging, in order to address credible
threats of serious adverse health consequences or death to humans or animals,” and to permit
officials access to these records if a food is suspected of being adulterated and presenting a
serious health threat.35 Such requirements pertain to anyone who “manufactures, processes, packs,
distributes, receives, holds, or imports.”
FDA’s general approach has been not to impose mandatory on-farm safety standards or
inspections of agricultural facilities.36 Rather, the agency relies on farmers’ adoption of so-called
good agricultural practices to reduce hazards prior to harvest. Such practices are issued as FDA
guidance, not regulations; they are advisory and not legally enforceable responsibilities.37 In July
2009, the Obama Administration released new draft guidances on three specific types of produce:
tomatoes, melons, and leafy greens.38
Legislative Proposals
Several provisions in the House-passed and Senate bills could potentially affect agricultural
producers, including smaller farms and food processors, as well as organic, direct-to-market, and
sustainable farming operations. The provisions in the House-passed and Senate bills that could
have the most direct effect on on-farm activity, especially produce growers, would be the
establishment of new standards for produce safety (Sections 104 and 105, respectively).
The House-passed bill would require the Secretary to publish a notice of proposed rulemaking,
and within three years after such date, final rules, establishing scientific and risk-based standards
for the safe growing, harvesting, processing, packing, sorting, transporting, and holding of those
types of raw agricultural commodities that are a fruit, vegetable, nut, or fungus, and for which the
Secretary has determined such standards are reasonably necessary to minimize the risk of serious
33 21 C.F.R. 110.19(b). The FFDCA at 21 U.S.C. § 321(r) defines a “raw agricultural commodity” as “any food in its
raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form
prior to marketing.”
34 P.L. 107-188; 21 U.S.C. 350(d).
35 21 U.S.C. 350c and 21 U.S.C. § 374. FDA has observed that produce farms generally do pack and hold food for
introduction into interstate commerce, so it can and does inspect them periodically, usually in areas associated with
illness outbreaks or to conduct surveillance sampling. Source: U.S. Congress, House Appropriations Subcommittee on
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Appropriations for 2008,
Hearings, Part 5, p. 479.
36 The FDA advisory panel acknowledged that the agency “conducts only limited inspections of food-producing farms,
except in emergencies.” FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology.
37 Sources: FDA, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, October 26,
1998, at http://www.cfsan.fda.gov/~dms/prodguid.html; and Guide to Minimize Microbial Food Safety Hazards of
Fresh-cut Fruits and Vegetables, February 2008, at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm064458.htm.
38 74 Federal Register pp. 38437-38440.
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adverse health consequences or death to humans or animals. These regulations could set forth
procedures and practices that the Secretary determines to be reasonable to prevent known or
reasonably foreseeable biological, chemical, and physical hazards, including natural ones, that
may be intentionally or unintentionally introduced. The regulations could include minimum
safety standards, and address manure use, water quality, employee hygiene, sanitation and animal
control, and temperature controls, as the Secretary determines to be reasonably necessary. They
may provide for coordination of education and enforcement activities and must provide a
reasonable time for compliance, taking into account the needs of small businesses for additional
time, among other permitted activities. The Secretary would be required to take into consideration
(consistent with public health) “the impact on small-scale and diversified farms, and on wildlife
habitat, conservation practices, watershed-protection efforts, and organic production methods.”
The Senate amendment also focuses on fresh produce, by requiring within one year proposed
regulations for the safe production, harvesting, handling and packing of those fruits and
vegetables (that are raw agricultural commodities) for which the HHS Secretary has determined
that such standards minimize the risk of serious adverse health consequences or death. Required
contents of the regulations do not appear to be as prescriptive as in the House-passed bill. The
Senate amendment would encourage coordination with USDA and would require, as appropriate,
coordination with state agricultural agencies when enforcing standards. Enforcement may be in
the form of audit-based verification systems or other inspection methods. The amendment
includes language to enable a state or foreign government to request a variance from HHS if
needed to account for local growing conditions. It would also require that any standards address
growing, harvesting, sorting, and storage, soil amendments, hygiene, packaging, temperature
controls, animal encroachment and water; and that the Secretary convene at least three public
meetings to seek input on the proposals.
In addition, both bills would require the issuance of updated good agricultural practices, among
other bill provisions that could potentially affect small businesses and farming operations. These
include facility registration requirements (Section 101 of the House-passed bill; Section 102 of
the Senate amendment); records access and/or inspection requirements (Section 106 of H.R.
2749; Sections 101 and 204 of S. 510); food traceability requirements (Section 107 of H.R. 2749;
Section 204 of S. 510); hazard analysis and risk-based preventive controls (Section 103, S. 510);
targeting of inspection resources (Section 201, S. 510); and changes in the reportable food
registry (Section 112, H.R. 2749). For more information, see CRS Report RL34612, Food Safety
on the Farm: Federal Programs and Legislative Action.
The extent to which these other provisions might actually affect small business and farming
operations remains unclear, since the specific business requirements under these provisions would
be subject to agency rulemaking, as well as the discretion of the HHS Secretary.
Mitigating Effects on Small Businesses and Other Farming Operations
Although both the House-passed bill and the Senate amendment contain requirements that might
affect small business and farming operations, both bills also seek to take into account the needs of
small businesses and provide for coordination of enforcement and education activities with others
such as USDA and state authorities.
The House-passed bill contains additional provisions that are intended to address potential effects
of the food safety requirements on small, organic, direct-to-market, and sustainable farming
operations, among other related provisions. In particular, it would exempt from the facility
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registration requirements most commodity producers that sell directly to consumers, including an
“operation that sells food directly to consumers if the annual monetary value of sales of the food
products from the farm or by an agent of the farm to consumers exceeds the annual monetary
value of sales of the food products to all other buyers” (Section 101(b)(1)). The House-passed bill
also would require that any regulations governing performance standards “take into consideration,
consistent with ensuring enforceable public health protection, the impact on small-scale and
diversified farms, and on wildlife habitat, conservation practices, watershed-protection efforts,
and organic production methods” (Section 104(b)).
Initially, S. 510 was modified by the HELP Committee to require that the HHS Secretary
“provide sufficient flexibility to be applicable to various types of entities engaged in the
production and harvesting of raw agricultural commodities, including small businesses and
entities that sell directly to consumers, and be appropriate to the scale and diversity of the
production and harvesting of such commodities” (Sections 103 and 105, among others). Other
committee modifications require consideration of federal conservation and environmental
standards and policies including wildlife conservation, and assurances that these provisions will
not conflict with or duplicate those of the national Organic Foods Production Act (section 105).
The Senate amendment includes additional provisions intended to address the potential effects of
the food safety requirements on small business and other farming operations. These include the
requirement that HHS publish a “small entity compliance policy guide” to assist small entities in
complying with many of the bill’s requirements (for example, added to Sections 102, 103, 105,
204); allowances for HHS to exempt or limit compliance requirements for certain types of
farming operations and food processors, along with provisions that will allow the HHS Secretary
the discretion to exclude certain operations, if it is determined that these are low risk and/or do
not present a risk of “serious adverse health consequences or death”; and assurances that any new
regulations do not conflict with or duplicate other federal policies and standards, and that they
minimize regulatory burden and unnecessary paperwork and the number of separate standards
imposed on the facility (for example, Sections 101, 103, 105, and 204). There also would be
delayed implementation for small and very small businesses (as defined by the Secretary) for the
facility requirements and produce standards (Sections 103 and 105), as well as assurances of
“sufficient flexibility” for producers, including small businesses and entities that sell directly to
consumers (for example, Sections 103, 105, and 204).
Targeting of Inspections
How Often Should Plants Be Visited?
Reform advocates argue that many of the recent problems that have led to illness outbreaks and
recalls might have been avoided if inspectors were more frequently present in plants to monitor
sanitary conditions and processes. Due to the differing laws and circumstances that apply to FSIS,
for example, that agency’s inspectors are in meat and poultry slaughter and processing plants
every day, where they must organoleptically (by the senses) examine every live animal and every
carcass for defects, and must pass every item before it can enter commerce. FDA’s enabling law
authorizes but does not require it to inspect food facilities. Therefore, no periodic inspection
frequency is currently stipulated. On the other hand, nothing in current law appears to prohibit
FDA from prioritizing inspections based on risk.
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Some, including former and current FDA officials, have argued that the agency lacks sufficient
resources to conduct the number of inspections required to ensure the safety of the food supply,
particularly in light of the increasing number of registered food facilities.39 (See Table 2.) While
the number of facilities has increased each year since FY2004, the number of food inspectors
decreased by roughly one-fifth from FY2004 to FY2008. Due in part to arguments for increased
funding, appropriations for the agency’s field activities and full time equivalents (FTEs) have
risen each fiscal year since FY2007. (In FDA budget documents, inspection-related items appear
under the field heading, and employees are counted as FTEs.) According to the same documents,
the number of inspections of food facilities has increased each year since FY2008, yet is only
projected to surpass FY2004 levels in FY2011.
Table 2. FDA Food-Related Inspection Data, FY2004-FY2011
(budget for Field Salaries and Expenses (S&E), Number of Field Full Time Equivalents (FTEs), Total
Number of FDA and State Inspections, and Cumulative Number of Domestic and Foreign Facilities
Registered under FFDCA Section 415)
FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011
Field S&E (in
thousands)a
$299,341 $283,257 $285,251 $298,009 $340,608 $479,850 $547,497 $705,157
Field FTEsa 2,172 2,059 1,962 1,806 1,861 2,166 2,505 2,902
Inspectionsb 21,876 19,774 17,730 17,038 16,277 17,972 20,542 22,205
Domestic
Facilitiesc
121,534 148,451 172,190 194,245 214,584 236,398 252,433d N/A
Foreign
Facilitiesc
92,719 104,555 115,902 129,345 141,703 154,883 164,805d N/A
Source: Compiled by CRS from FDA annual budget documents for FY2006-FY2011.
a. Food field S&E and FTE data are from the FY2007-FY2011 annual Food and Drug Administration, President’s
Budget Request “All Purpose Table—Total Program Level,” except that the FY2004 numbers are from the
FY2006 annual Food and Drug Administration, President’s Budget Request, “Narrative by Activity, Foods—
Center for Food Safety and Applied Nutrition.” Numbers for FY2010 are appropriated; for FY2011 are
requested; al others are actual.
b. Inspection data are the reported Total FDA and State Contract Inspections, from the FY2006-FY2011
annual Food and Drug Administration, President’s Budget Request, Field Activities—Office of Regulatory
Affairs (ORA), “Foods Field Program Outputs—Domestic Inspections.” Numbers for FY2010 are
appropriated; for FY2011 are requested; al others are actual.
c. Source, FDA Office of Legislation on September 22, 2010.
d. Number of registrants as of September 22, 2010.
39 See, e.g., Hubbard, William, Former FDA Associate Commissioner for Policy and Planning, and Advisor, Alliance
for a Stronger FDA, March 11, 2009, testimony before the House Energy and Commerce Subcommittee on Health;
FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology,
November 2007; and “Science and Mission at Risk: FDA’s Self-Assessment,” January 29, 2008 Testimony of Peter
Barton Hutt before the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce.
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One additional issue is how FDA can best target its available inspection resources to protect
the public health. All facilities may not merit the same frequency of inspection. For example,
facilities that process and package food may create a greater opportunity for contamination than
warehouses that merely store foods. Companies and facilities that have a record of meeting all
FDA requirements may present less of a risk than those that do not. Foods produced in countries
with food processing and handling standards at least as rigorous as those of the U.S. may present
less of a health risk than those with less rigorous standards.
Legislative Proposals
The major proposals seek to improve both the targeting and frequency of in-plant inspections, but
in diverging ways. Relevant sections in the House-passed bill are 207 and 105, and in the Senate
amendment are 201 and 306. The House bill would require the HHS Secretary to establish, within
18 months, a risk-based schedule for inspecting each foreign and domestic food facility,
following these prescribed categories and frequencies: category 1, a high-risk food facility that
manufactures or processes food, must be inspected at least every 6-12 months; category 2, a low-
risk facility that manufactures or processes food or a facility that packs or labels food, must be
inspected at least every 18 months to three years; and category 3, a food facility that holds food,
must be inspected at least every five years.
The House bill would authorize the Secretary to modify the types of food facilities within each
category, and to alter inspection frequencies if needed to respond to illness outbreaks and recalls.
In doing so, the Secretary would be required to consider the type of food at the facility, its
compliance history, whether an importing facility is certified (under the new certification
requirements the bill would set; see below), and other factors determined relevant by the
Secretary.
The House bill would authorize the Secretary to recognize a federal, state, or local official to
conduct domestic facility inspections and an agency or representative of a foreign government to
conduct foreign facility inspections. Foods would be deemed to be adulterated if inspection were
delayed, limited, or refused by either the owner, operator, or agent of an establishment in which
the foods were held, or by any agent of a governmental authority of a foreign country within
which an establishment that held the food were located.
The House bill would require the Secretary to submit to Congress (1) annually, a report
containing the number and cost of risk-based inspections; and (2) within three years of enactment,
a report containing recommendations about the risk-based inspection schedule.
The Senate amendment would require the HHS Secretary to increase the inspection rate for any
food facility required to register under FFDCA Section 415. In addition, the Secretary would be
required to identify high-risk facilities and to allocate resources to inspect facilities according to
known safety risks. Risks would include the type of food, the facility’s history of food recalls, the
facility’s hazard analysis and preventive controls, and so forth. The Secretary would be required
to inspect domestic high-risk facilities not less than once in the five-year period following
enactment, and not less than once every three years thereafter. The Secretary would be required to
inspect domestic non-high-risk facilities not less than once in the seven-year period following
enactment, and not less than once every five years thereafter. The Secretary would be required to
inspect at least 600 foreign facilities in the year following enactment, and in each of the
subsequent five years to double the number of foreign facilities inspected. In meeting the
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inspection requirements, the Secretary would be authorized to rely on inspections conducted by
other federal, state, or local agencies.
For foreign food facilities registered under FFDCA Section 415, the Senate amendment would
permit the Secretary to enter into arrangements and agreements with foreign governments to
facilitate the inspection of those facilities. The Secretary would be required to direct resources for
inspection of such foreign facilities, suppliers, and food types, particularly those identified as
high-risk, to help ensure the safety of the U.S. food supply. Notwithstanding any other provision
of law, foreign foods would be refused entry into the U.S. if inspectors or other duly designated
individuals were refused (for more than 24 hours following a request) entry to a facility,
warehouse, or other establishment by the owner, operator, or agent in charge, or the government
of the foreign country. The Senate amendment would also require the Secretary to allocate
resources to identify and inspect imported foods at ports of entry, according to the known safety
risks of the article of food, based on certain factors.
Regarding seafood, the Senate amendment would permit the heads of various agencies to enter
into specified types of agreements as may be necessary or appropriate to improve seafood safety.
In order to target food inspection resources, the Secretary would be required to coordinate and
cooperate with the Secretaries of Agriculture and Homeland Security, and would be permitted to
consult with any relevant HHS advisory committee, as appropriate. For foreign seafood, the
Senate amendment would permit the Secretary of Commerce to send inspector(s) to a country or
facility of an exporter from which seafood imported into the U.S. originates. Such inspector(s)
would conduct a specified assessment of practices and processes used in connection with the
farming, cultivation, harvesting of such seafood. Based on each assessment, the Secretary of
HHS, in coordination with the Secretary of Commerce, would be required to prepare and
inspection report, provide it to the relevant country or exporter, and provide a 30-day period for
rebuttal.
The Senate amendment would require the Secretary to submit to Congress not later than February
1 of each year, and to make available to the public via FDA’s website, a report including certain
information about food facilities, food imports, and FDA foreign offices.
Use of Third Parties for Imports and for Laboratory Accreditation
Can Non-FDA Entities Help Ensure Safety?
Although FDA regulates importers and imported products, the agency does not have express
statutory authority to regulate private laboratories that sample or test imported foods, nor does
FDA accredit food laboratories or use others to certify the safety of imported foods. Presently,
laboratory accreditation is voluntary, and several domestic and international accreditation
organizations accredit laboratories.40 FDA may conduct voluntary, on-site assessments of private
accredited laboratories.41 FDA’s own laboratories are accredited and, according to FDA, “the
laboratory industry favors accreditation.”42 Industry participation in third-party certification
40 FDA, Draft Guidance, Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories (Jan.
2009), hereinafter Draft Guidance.
41 Ibid.
42 Ibid.
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programs, such as those that help foreign and domestic producers meet FDA requirements
through certification, is also voluntary, although FDA has indicated that participation in such
programs may “be beneficial.”43 The FDA has also indicated that “there is extensive support for
certification programs that audit to determine compliance with internationally recognized
criteria,” and that domestic suppliers use third-party certification programs “in part because of
customer demand.”44
The Government Accountability Office testified in 2008 that private laboratory accreditation
“could leverage outside resources while providing FDA greater assurance about the quality of the
laboratories importers use to demonstrate that their products are safe.”45 In January 2009, FDA
issued a draft guidance on accreditation standards for private laboratories and the test data that
such labs should submit to the agency for imported FDA-regulated products that were either
detained or subject to an FDA Import Alert.46 The guidance document encouraged importers to
notify the FDA in advance of their submission of a sample to an accredited laboratory, so as “to
discourage importers from withholding bad test results, re-testing, or re-sampling.”47 In January
2009, FDA also issued a final guidance document on voluntary third-party certification programs
for foods and animal feeds, which set forth attributes for third-party certification programs and
procedures for preventing conflicts of interest.
The use of third parties has been promoted as a method for helping the FDA to carry out its
responsibilities and target enforcement and inspections while better using existing personnel.
Concerns have been expressed regarding testing and certification by third parties, and there has
been criticism regarding the autonomy given to the importers and private laboratories. Such
criticism varies from the manner in which the samples are collected for testing, to the reporting of
test results by the importers to the FDA, to whether test results accurately reflect all information
obtained, such as evidence of FFDCA violations, to potential or actual conflicts of interest.
Additionally, critics contend that although third-party certification may be useful as a commercial
marketing tool, it does not necessarily ensure safety, as manufacturers involved in recent
foodborne illness outbreaks have passed private third-party and state inspections. For example, in
two of the most publicized recalls over the last two years—the recall of 380 million eggs by a
single company and the recall of over 3,900 peanut products from another—both companies had
used outside labs and reportedly knew of positive test results for Salmonella in their products
prior to the recalls.48
House and Senate legislative proposals address various ways to curb the potential for such abuses
through laboratory accreditation and third-party certification programs. The question remains as
to whether industry will opt to use third parties.
43 FDA, Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds (Jan. 2009).
44 Ibid.
45 Draft Guidance, supra note 40 (citing GAO, Federal Oversight of Food Safety—FDA’s Food Protection Plan
Proposes Positive First Steps, but Capacity to Carry Them Out is Critical, GAO-08-435T, at 7).
46 Draft Guidance.
47 Ibid.
48 FDA, Update on the Salmonella Typhimurium Investigation, FDA/CDC Joint Media Teleconference, (Jan. 28,
2009), at 9, http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM169176.pdf; Gardiner
Harris and William Neuman, Salmonella Found in ’08 at Egg Farm, N.Y. Times, (Sept. 15, 2010), at B1.
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Legislative Proposals
Under the House-passed bill, qualified certifying entities are to be accredited and given the
responsibility to provide import certifications when the Secretary determines such certifications
are needed; generally, the specifics of that certification, including its format, would be left to the
Secretary’s regulatory discretion. The bill defines “qualified certifying entity” as “an agency or a
representative of the government from which the article originated, as designated by such
government or the Secretary; or an individual or entity determined by the Secretary or an
accredited body recognized by the Secretary to be qualified to provide a certification.” The House
bill would require the Secretary to issue regulations to ensure that certifying entities and their
auditors are free from conflicts of interest, and it contains extensive language on what these
regulations are to cover. The Secretary would have to require that, to the extent applicable, any
certification provided by a certifying entity be renewed whenever the Secretary deems it
appropriate; and the Secretary would have to refuse to accept any certification determined to be
no longer valid or reliable. The House-passed bill also contains requirements for new laboratory
accreditation programs, testing of imported food by accredited laboratories, recognition of
laboratory accreditation bodies, advance notice to the Secretary prior to sample collection for
testing, and direct submission to the Secretary of laboratory analyses for certain analytical testing
of food.
The Senate amendment includes provisions that would require the Secretary to establish a
program for testing of food by accredited laboratories and the recognition of accreditation bodies
to accredit laboratories, including laboratories of states and localities. The Senate amendment
would require the development of model accreditation standards, re-evaluation of accreditation
bodies at least every five years, and a requirement that laboratory test results be sent to the FDA
unless the Secretary exempts the submission of test results after making a determination that the
results “do not contribute to the protection of public health.” It also would create a system of
accreditation of third-party auditors and audit agents, who would certify that importing entities
are meeting applicable FDA requirements. After an accreditation body performs certain reviews,
foreign governments, foreign agricultural cooperatives, and other third parties may be accredited
by the accreditation body to be a third-party auditor. Accreditation bodies could not accredit a
third-party auditor unless it agrees to issue a written food or facility certification to accompany
each food shipment for import into the United States from an eligible entity. Accredited third-
party auditors or audit agents must issue audit reports and are required to immediately notify the
Secretary of discoveries during an audit of “a condition that could cause or contribute to a serious
risk to the public health.” The Senate amendment also contains language regarding revocation of
accreditation and avoidance of conflicts of interest.
Mandatory Recall Authority
Removing Unsafe Foods from Commerce
Currently, neither FDA nor FSIS has explicit statutory authority to mandate a recall of most
adulterated foods, or to impose penalties if recall requirements are violated. (FDA can order food
recalls only for infant formula. It can also order recalls of unsafe medical devices such as
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pacemakers.) GAO and others have contended that these gaps increase the possibility that unsafe
food will not be recovered, and will be consumed.49
Defenders of the current system counter that the agencies already have sufficient authority to
keep tainted products from reaching consumers. FSIS’s statutory authority enables it to detain
meat and poultry products of concern for up to 20 days, and FDA’s authority enables it to detain
the foods it regulates for up to 30 days. Both agencies can, with a court’s permission, seize,
condemn, and destroy unsafe food.50 FDA notes, however, that its authority to seize adulterated or
misbranded food may not be practical or effective once a product is in wide distribution. Private
companies rarely fail to order a voluntary recall when problems arise, and some contend that
providing FDA with mandatory recall authority might foster a counterproductive adversarial
relationship between industry and government, slowing response times. Nonetheless, a number of
Members of Congress have supported GAO’s recommendation that legislation be considered to
strengthen the notification and recall authorities of both agencies.
The Bush Administration’s November 2007 strategy for food safety called for mandatory recall
authority (for FDA, not FSIS) in cases where firms (whether foreign or domestic) are unwilling to
do so voluntarily or expeditiously. Similarly, President Obama’s Food Safety Working Group
recommends granting FDA the authority to mandate food recalls.51 Significantly, reversing their
earlier opposition, many major food industry groups now endorse legislative proposals to grant
FDA mandatory recall authority.
Legislative Proposals
The House-passed bill (Section 111) would authorize the Secretary to request a voluntary recall
by any person who distributes an article of food that the Secretary has reason to believe is
adulterated, misbranded, or otherwise in violation of the FFDCA. It would further authorize the
Secretary to issue an order to cease distribution of any article of food if he/she has reason to
believe that the use or consumption of, or exposure to, that article of food may cause adverse
health consequences or death to humans or animals. An appeal process and other administrative
matters are specified. The Secretary would be required to issue a mandatory recall order if he/she
determined that problems were not adequately addressed through the procedures described above.
The bill would authorize the Secretary to proceed directly to a mandatory recall order if he/she
has credible evidence that an article of food subject to an order to cease distribution presents an
imminent threat of serious adverse health consequences or death to humans or animals. In such
case, the person would have to immediately recall the food while stipulated appeal procedures
were carried out.
The Senate amendment (Section 206) would require the HHS Secretary, if he/she has information
“that there is a reasonable probability that an article of food (other than infant formula) is
49 See, for example, GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of
Potentially Unsafe Food (GAO-05-51), October 2004. See also CRS Report RL34167, The FDA’s Authority to Recall
Products; and CRS Report RL34313, The USDA’s Authority to Recall Meat and Poultry Products.
50 A court’s permission may not be needed in all cases; for example, the FFDCA [§ 801(j)(1)] empowers officials to
hold an import for up to 24 hours if there is “credible evidence or information indicating that an article of food presents
a threat of serious adverse health consequences or death to humans or animals.”
51 President’s Food Safety Working Group, “Key Findings,” March 14, 2009, http://www.foodsafetyworkinggroup.gov/
.
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adulterated ... or misbranded ... and the use of or exposure to such article will cause serious
adverse health consequences or death to humans or animals,” to provide an opportunity to the
responsible party to cease distribution and recall the food. If the party did not do so “within the
time and in the manner prescribed by the Secretary,” authority would be provided to require such
person to cease distribution, or to immediately notify everyone involved in handling or receiving
the food. The Secretary would be required to provide specified notifications to the public of any
recall orders, and to establish an incident command or similar operation within the department to
assure coordinated communications during a recall. The amendment provides for the assessment
of civil penalties as well as criminal penalties with regard to failure to comply with or follow a
recall order. The assessment of civil penalties for failure to comply with a recall order may
preclude the assessment of criminal penalties. If the FDA assesses a civil penalty, the agency
would not be able to seek seizures or injunctions for the adulterated food.
Notification of Contaminated Products, and Product Tracing
Improving Notification and Traceability Capabilities
Notification and traceability are viewed as tools to make recalls more effective. Some have
argued that improved notification and traceability capabilities would enable either FSIS (in the
case of meat and poultry products) or FDA (in the case of other foods) to determine more quickly
a product’s source and whereabouts, in order to prevent or contain foodborne outbreaks.
Traceability has also been debated in connection with defense against agroterrorism, and for
verifying the origin of live animals and their products for marketing, trade, and/or animal health
purposes, for example. In some recent highly publicized outbreaks (such as the melamine
contamination of pet food), it appears that food company representatives were aware of a food
safety problem for a prolonged period of time before notifying FDA.
The 110th Congress responded to some of these concerns by including a provision in the Food and
Drug Administration Amendments Act of 2007 (P.L. 110-85) that requires the responsible party
for a food facility (i.e., registered under FFDCA Section 415) to notify the Secretary of any food
“for which there is a reasonable probability that the use of, or exposure to, such article of food
will cause serious adverse health consequences or death to humans or animals,” and that requires
the Secretary to establish a Reportable Food Registry of such reports.52 Also, the enacted 2008
farm bill (P.L. 110-246) amends the meat and poultry laws to require that an establishment notify
USDA if it has reason to believe that an adulterated or misbranded product has entered
commerce. (See also the earlier discussion of current record-keeping requirements under FFDCA
Section 414.)
Legislative Proposals
The House-passed bill (Section 112) would amend current authority for the Reportable Food
Registry to expand the definition of who must report about problem foods. In addition to persons
who register facilities under FFDCA Section 415, persons who own or operate farms and retail
establishments would also have to report, as would persons who register importing facilities
under FFDCA Section 801. In addition, the bill would require the submission of results of any
52 FFDCA § 417; 21 U.S.C. 350f. After some delays, the Reportable Food Registry was implemented in September
2009. See the FDA website at http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm.
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sampling or testing of a reported food, including tests conducted pursuant to the bill’s proposed
hazard analysis and preventive controls provisions, food safety plans, performance standards, or
testing by accredited laboratories.
The House-passed bill (Section 107) also would require the Secretary to establish by regulation a
tracing system for food in, or to be imported into, the United States, in order to enable the
Secretary “to identify each person who grows, produces, manufactures, processes, packs,
transports, holds, or sells such food in as short a timeframe as practicable but no longer than 2
business days.” Before promulgating regulations, the Secretary would be required to first identify
tracing technologies and methodologies that can enable each of the food industry sectors to
maintain the full pedigree of the food from source through subsequent distribution, to make
traceback interoperable with other systems, and to use a unique identifier for each facility. Also
prior to proposing regulations, the Secretary would first have to, as practicable, assess costs,
benefits, and feasibility of adopting such technologies; conduct at least two public meetings; and
conduct one or more pilots.
The House-passed bill’s traceback requirements would apply to agricultural producers, fisheries
(both wild and aquaculture), and retailers, but there is extensive language intended to limit the
applicability to farms. For example, the bill would exempt food produced on a farm or fishery and
sold directly to a consumer, restaurant, or grocery store. However, restaurants and grocery stores
would be required to keep records documenting the farm or fishery source. Farms or fisheries
would have to keep records for at least six months documenting the restaurants and groceries to
which they sold their food. The Secretary could also exempt a food or a type of facility, farm, or
restaurant from the regulations, or modify the requirements for these entities, if he/she
“determines that a tracing system for such food ... is not necessary to protect the public health.”
For this latter category of exemptions, each person who produces, manufactures, processes,
packs, transports, or holds such food still would have to maintain records that identify the
immediate previous sources of the food and its ingredients and the immediate subsequent
recipients. The Secretary would be required to coordinate with USDA, and tracing authority
would be constrained with regard to growers of grains or similarly handled commodities.
The Senate amendment (Section 211) would amend current authority for the Reportable Food
Registry to allow the Secretary to require the submission by a responsible party of additional
types of information about a reportable food in order to improve consumers’ ability to identify it.
The amendment also would require grocery stores to conspicuously post one-page information
sheets about reportable foods, to be developed by FDA and made available for copying on the
agency’s website. A store’s failure to comply would be prohibited.
The Senate amendment (Section 204) proposes a food tracing system that is generally similar to
the one proposed by the House-passed bill, although different in numerous details. Rather than
calling for a tracing system for all foods, from which low-risk foods may be exempted, it would
require the Secretary, through rulemaking, to impose enhanced recordkeeping requirements
(under FFDCA Section 414) for foods that the Secretary determines to pose a higher food safety
risk. A number of limitations of such requirements are stipulated, especially with respect to farms
and agricultural commodities. Effective dates for the record-keeping requirements would be
delayed for small businesses. The amendment also would require the Secretary to conduct pilot
studies and assessments of food tracing systems to inform the rulemaking process.
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Foodborne Illness Surveillance and Outbreak Response
How Might Data Collection and Use Be Strengthened?
Foodborne illness surveillance is carried out by the states, with assistance from CDC. States also
investigate foodborne disease outbreaks, in coordination with CDC, either or both FDA or FSIS
(depending on implicated or suspected foods), and other federal agencies, if appropriate. FDA is
authorized to carry out such investigations, or to coordinate with states in doing so, under broad,
permanent authorities in the FFDCA and in Title III of the Public Health Service (PHS) Act,
among other authorities.53 A foodborne disease outbreak is not defined in law or in regulations. In
public health practice, a foodborne disease outbreak is “the occurrence of two or more cases of a
similar illness resulting from the ingestion of a common food.”54 As a practical matter,
particularly for less serious hazards, outbreak investigations are rarely launched when only two
people are affected. (There are exceptions for serious illnesses such as botulism.)
The nation’s public health capacity for foodborne illness surveillance and outbreak response is a
mix of significant strengths and significant gaps.55 In the last decade or so, the linkage of
previously unrelated illnesses through genetic “fingerprinting” has revolutionized the ability to
identify large multistate outbreaks and mount an urgent response. However, the epidemiological
tools used to identify the food associated with an outbreak can be cumbersome. Also, especially
for FDA-regulated foods, information about common contaminants that may be present in foods
during production and in commerce, as well as how to test for them, is limited. As a result,
“attribution”—identifying the types of foods that cause foodborne illnesses—remains a
significant challenge. The daunting outbreaks of the past few years underscore the problem, but
are not the only evidence. Based on data from its active surveillance system, FoodNet, CDC
reported that as of 2009, the incidence of several of the foodborne diseases under surveillance had
reached a plateau, instead of declining, and that national 2010 health targets for three out of four
targeted pathogens—Campylobacter, Listeria, and Salmonella—may not be met.56
Because regulators regulate foods, rather than food contaminants, many contend that closing the
attribution gap is paramount in order to target preventive strategies efficiently and mount a more
nimble response to outbreaks. The President’s Food Safety Working Group stated one of its three
core food safety principles as follows: “High-quality information will help leading agencies know
which foods are at risk; which solutions should be put into place; and who should be
responsible.”57 Achieving this goal is a challenge, raising concerns about available technologies,
scientific soundness, intellectual property, “trade secret” protections, liability, and other issues.
Stakeholders discussed these issues at an FDA-sponsored public workshop in March 2010.58
53 FFDCA at 21 U.S.C. 372 and 21 U.S.C. 399; Public Health Service Act at 42 U.S.C. 241, 42 U.S.C. 243 42 U.S.C.
247b, 42 U.S.C. 247b-20, and 42 U.S.C. 264.
54 CDC, “Surveillance for Foodborne-Disease Outbreaks: United States, 1998–2002,” Morbidity and Mortality Weekly
Report (MMWR), vol. 55 (Surveillance Summary 10), pp. 1-34, November 10, 2006.
55 See CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
56 CDC, “Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through
Food–10 States, 2009,” MMWR, vol. 59, no. 14 (April 16, 2010), pp. 418-422, http://www.cdc.gov/foodnet/. CDC
reported that the target for harmful strains of E. coli had been met.
57 President’s Food Safety Working Group, “Key Findings,” March 2009, http://www.foodsafetyworkinggroup.gov/
ContentKeyFindings/HomeKeyFindings.htm.
58 FDA, “Measuring Progress on Food Safety: Current Status and Future Directions; Public Workshop,” 75 Federal
(continued...)
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Legislative Proposals
The House-passed bill (Section 121) would, for purposes of surveillance, define a foodborne
illness outbreak as two or more cases of a similar illness resulting from the ingestion of a food.
The bill would require the Secretary, acting through the CDC, to enhance foodborne surveillance
systems, including by coordinating federal, state, and local systems; facilitating timely sharing of
agency findings; ensuring early notification of the food industry when a particular food is
suspected in an outbreak; developing improved epidemiological tools; and other prescribed
methods. The bill also would mandate a review of and strategies to enhance the food safety and
defense capabilities of state and local agencies.
The Senate amendment (Section 205) contains provisions that generally mirror the House bill. It
contains additional provisions that would establish a working group to improve foodborne illness
surveillance and outbreak investigations, and would reauthorize food safety capacity-building
grants to states and Indian tribes under the PHS Act. It also would authorize the appropriation of
$24 million for each fiscal year for FY2011 through FY2015 for efforts to enhance foodborne
illness surveillance.
Food Imports
Concerns About Import Oversight
A steady increase in food imports, a result of globalization and consumer desire for a wider
variety of foods year-round, has generated growing concerns about whether current federal
programs sufficiently ensure the safety of these imports. FDA import alerts in 2007 and 2008
targeting adulterated pet food ingredients, farmed seafood, and dairy products and ingredients, all
from China, have been among the incidents that have heightened interest in this issue. Most of the
recent debate has included extensive discussion about how to improve current import safeguards,
within resource constraints, and without unduly restraining free trade.59
The FFDCA [at 21 U.S.C. 381(a)] empowers the FDA to refuse entry to any food import if it
“appears,” based on a physical examination or otherwise, to be adulterated, misbranded, or in
violation of the law. In exercising its oversight, the agency relies on a system of prior
notifications by importers and document reviews at ports of entry. Importers must have an entry
bond and file a notification for every shipment. An FDA database, the Operational and
Administrative System for Import Support (OASIS), is to help inspectors to determine a
shipment’s relative risk and whether it needs closer scrutiny (i.e., a physical examination, and/or
testing). In practice, import inspections are relatively infrequent. The agency recorded more than
8.2 million imported food “lines” in FY2007 (compared with fewer than 2.8 million entry lines in
FY1997), of which approximately 1% were physically examined and/or tested.60 In 2007
(...continued)
Register 9232, March 1, 2010.
59 Additional information is available in CRS Report RL34198, U.S. Food and Agricultural Imports: Safeguards and
Selected Issues.
60 Source: FDA briefing for Senate staff, February 8, 2008. FDA FY2009 budget materials state that 94,743 import
food field exams were conducted in FY2007.
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congressional hearings, witnesses testified that 450 inspectors must cover more than 300 ports of
entry.61
Current law does not explicitly authorize, or require, import verification, and whether FDA has
what is often called “equivalence authority” has been a matter of debate. Regardless, FDA does
not have a program like that of FSIS. Under the FMIA and PPIA, no foreign establishment can
ship its products to the United States until FSIS has determined that the establishment’s country
has a meat and/or poultry safety program that provides a level of protection that is at least
equivalent to the U.S. system. FSIS visits the exporting country to review its rules and
regulations, meets with foreign officials, and accompanies them on visits to establishments. In
addition, FSIS operates a reinspection program at 150 import houses located near approximately
35 border entry points. Some have suggested that the FDA program should operate more like that
of FSIS, although they acknowledge the difficulties and resource demands of attempting to
regulate many more different types of foods from many countries of origin.
Legislative Proposals
The House-passed bill and Senate amendment seek tighter controls over imports, and both would
use certification or verification systems involving so-called third parties. More specifically, under
the House-passed bill, the Secretary would have to require, as a condition of granting admission
for an imported food article, that a “qualified certifying entity provide a certification that the
article complies with specified requirements” of the FFDCA (Section 109). This requirement
would take effect on or after three years from the date of enactment. However, such certification
would apply only in the following situations:
• for food imported from a particular country or region, based on the adequacy of
government controls there or other relevant information, if such certification
would assist in determining the admissibility of the food;
• for a food type that could pose a significant risk to health, if such certification
would assist in determining whether the article poses such risk; or
• for an article imported from a particular country, if the Secretary has an
agreement with that government providing for such certification.
Another section of the House-passed bill would require a food importer to register annually with
the Secretary, to submit an appropriate unique facility identification as a condition of such
registration, and to meet “good importer practices” (Section 204); the latter to include verification
of good manufacturing practices and preventive controls of the importer’s foreign suppliers, as
applicable, among other things. A provision in this section would require every person importing,
or brokering for import of, a food to permit an officer or employee of the Secretary to “inspect the
facilities of such person and have access to, and to copy and verify, any related records.” Any
food offered for import that is not from a duly registered person would be misbranded. (Fees are
to be charged and are discussed later in this report.)
The Senate amendment contains a provision that would authorize the HHS Secretary, based on
public health considerations, including risks associated with food or its place of origin, to require
61 See for example hearings held before subcommittees of the House Committee on Energy and Commerce, July 17,
September 26, and October 11, 2007.
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food imports to be accompanied by “certification or such other assurances as the Secretary
determines appropriate” that the food complies with some or all requirements of the act (Section
303). Among other provisions, certifications would be used for designated food imported from
countries where FDA has an agreement for a certification program. Certifying entities would be
an agency or representative from the originating country or such other persons as accredited
elsewhere (see section titled “Use of Third Parties for Imports and for Laboratory Accreditation”).
Among separate but related provisions in both bills is specific authorization for the Secretary to
review the equivalence of a foreign country’s safety standards, regulations, statutes, and controls
and to conduct audits to verify their implementation; and to enter into arrangements with foreign
countries to facilitate inspection of foreign facilities.
The Senate amendment also would authorize a “Foreign Supplier Verification Program” (Section
301), generally requiring each importer to perform foreign supplier verification activities in
accordance with regulations the Secretary must issue to ensure compliance with relevant FFDCA
provisions. Each importer’s program would be able to assure that each of its foreign suppliers
produces the imported food employing processes and procedures, “including reasonably
appropriate risk-based preventive controls” that are documented in a written plan and equivalent
in preventing adulteration and reducing hazards as required by other relevant provisions of the
FFDCA. Verification activities may include monitoring records, lot-by-lot certification of
compliance, annual on-site inspections, checking the preventive control plan of the foreign
supplier, and periodically testing and sampling shipments. Importers must maintain import
verification program records for at least two years and make them available to the Secretary upon
request. The House bill also contains provisions regarding foreign supplier verification (including
provisions in Sections 204, 205, 206, and 136).
A feature of both the House bill and the Senate amendment would require the establishment of a
program to expedite imports from those who voluntarily agree to certain higher safety standards.
This program is called a “Safe and Secure Food Importation Program” in the House-passed bill
(Section 113) and a “Voluntary Qualified Importer Program” in the Senate bill (Section 302).
Bisphenol A (BPA)
Are Food Containers with BPA Safe? Are Alternatives Available?
Bisphenol A (BPA) is a component of certain plastics. When used in food containers, such as
plastic bottles or metal can liners, BPA is regulated by the FDA. Scientific disagreement about
possible human health effects that may result from BPA exposure has led to conflicting regulatory
decisions regarding the safety of these food containers, especially when intended for use by
infants and children.62 FDA’s conclusion in 2008 that BPA use is safe conflicted with findings of
advisory panels. This prompted some to question FDA’s risk assessment process, and its ability to
conduct such assessments competently. Recently, FDA expressed concern about possible health
effects from BPA exposure, and announced that it was conducting new studies on the matter,
pending possible changes in its regulatory approach.
62 For additional background information, see CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible
Human Health Effects.
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Food Safety in the 111th Congress
In March 2009, several manufacturers of baby bottles announced that they would stop selling
BPA-containing bottles in the United States, partly in response to growing numbers of retailers
that would no longer carry the products.63 However, manufacturers of cans maintain that suitable
alternatives to BPA are not available and are not likely to become available in the immediate
future. Until alternatives for all uses are developed, they argue that BPA-containing liners will be
necessary to ensure a tight seal on cans and lids, and thus to prevent food spoilage and food
poisoning risks to consumers. Manufacturers are seeking alternatives to meet consumer demand,
trade representatives report, but development will take time as new containers are produced and
tested for diverse foods with different properties.64
Legislative Proposals
The House-passed bill (Section 215) would require FDA to determine whether there was “a
reasonable certainty of no harm for infants, young children, pregnant women, and adults, for
approved uses of polycarbonate plastic and epoxy resin made with bisphenol A in food and
beverage containers ... under the conditions of use prescribed in current [FDA] regulations.” FDA
would be required to notify Congress about any uses of BPA for which a determination of safety
could not be made, and how the agency would regulate such uses to protect public health.
The Senate amendment does not contain a provision regarding BPA. It is reported that Senator
Dianne Feinstein had sought to include in it a provision that would ban BPA in FDA-regulated
food containers, and may instead offer a separate amendment restricting BPA if the manager’s
amendment is considered by the Senate before the end of the 111th Congress.65 A proposed BPA
amendment has not been made public. It could require a ban on BPA in FDA-regulated food
containers (as does S. 593, a bill sponsored by Senator Feinstein), or a phased elimination of the
chemical, or elimination of the chemical from only some types of food containers, or some other
approach.
Paying for Food Safety with User Fees
How Much Is Needed and Who Should Pay?
Many critics have argued that—irrespective of the need, if any, to reform food safety statutes and
organization—a fundamental problem has been the lack of sufficient funding and staff to carry
out congressionally mandated (and existing) responsibilities to ensure a safe food supply.66
Responding to a request from Democratic leaders of the House Energy and Commerce
Committee, a Science Board subcommittee estimated that, in order to address these deficiencies,
the food-related portion of FDA’s appropriation should be increased by $128 million in FY2009,
63 Lyndsey Layton, “No BPA for Baby Bottles in U.S.,” The Washington Post, March 6, 2009.
64 John Rost and Kathleen Roberts, personal communication, April 15, 2010. See also Lyndsey Layton, “Replacing
BPA in Cans Gives Foodmakers Fits; FDA Safety Concerns Prompt Scramble to Remove the Chemical,” The
Washington Post, February 23, 2010.
65 Denise Grady, “In Feast of Data on BPA Plastic, No Final Answer ,” The New York Times, September 7, 2010; and
Ellyn Ferguson, “Egg Recall Helps Spur Efforts to Find Consensus on Food Safety Legislation,” CQ Today Online
News, September 10, 2010.
66 See, e.g., FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and
Technology, November 2007.
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Food Safety in the 111th Congress
$283 million in FY2010, $441 million in 2011, $598 million in FY2012, and $755 million in
2013.67 In fact, congressional appropriators have increased funding for FDA food activities in
recent years.68 (See Table 3.)
Table 3. FDA Direct Appropriations for Foods, FY2005-FY2011
(dollars in thousands)
FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011
Appropriations
$435,517 $438,721 $457,104 $507,797 $712,769 $784,115 $1,041,940
Source: Compiled by CRS from FDA annual budget documents. Data are from the FY2007-FY2011 annual Food
and Drug Administration, President’s Budget Request “All Purpose Table—Total Program Level.” Numbers for
FY2010 are appropriated; for FY2011 are requested; al others are actual.
Proposed increases in program spending raise a variety of policy issues. Requests for higher
appropriations always compete with other priorities throughout the federal discretionary budget
(the programs do not operate, like farm support programs, for example, as mandatory
authorizations), and currently are being made during a period of budget deficits.
An alternative approach to direct appropriations that has been used in some other areas of FDA is
to fill perceived shortfalls through new user fees on the regulated industry. User fees related to
foods have been proposed in legislation and in budget requests over time. The FY2011
President’s budget request proposed $6.467 million for reinspection fees, $4.307 million for
export certification fees, and $182.783 million in inspection and registration fees. To date, no
such user fees for foods have been authorized or collected.
Currently, FDA’s authority to collect user fees extends to human and animal prescription drugs
and human medical devices (21 U.S.C. 379g - 379j-12);69 human biologics (42 U.S.C. 262 note);
and tobacco products (21 U.S.C. 387s). Some of these user fees are paid annually, and some are
paid when submitting certain applications to FDA. The fees collected are intended to be used to
fund approval-related activities; with the exception tobacco fees, they can not be used to fund
enforcement or inspection activities for products on the market, except to a very limited extent, if
at all. (Unlike foods and some food additives, prescription drugs, medical devices, and animal
drugs require FDA’s advance permission before they can be legally marketed.) The user fee
programs have generally been authorized in five-year increments (except for tobacco fees, which
are permanently authorized). Each authorization specifies the fee amounts FDA may collect
annually, among other legislative direction.
FDA is also authorized to collect export certification fees for drugs, animal drugs, medical
devices and biological products [21 U.S.C. 381(e)(4)]. A person who exports a human drug,
animal drug, or device may request that the Secretary certify in writing that the product meets
FFDCA requirements. If the Secretary issues a written export certification, a fee of up to $175
may be charged.
67 Estimated Resources Required for Implementation, report of the Science Board’s Subcommittee on Science and
Technology in response to the request of Representatives Dingell, Waxman, Stupak, and Pallone, February 25, 2008.
68 See CRS Report R40792, Food and Drug Administration Appropriations for FY2010.
69 See CRS Report RL34571, Medical Device User Fees and User Fee Acts; CRS Report RL33914, The Prescription
Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and Effect on FDA; and CRS Report RL34459,
Animal Drug User Fee Programs.
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The introduction of user fees in other areas of FDA has raised the following four issues, among
others, which are applicable to policy discussions about food fees. First, proposals for new user
fees typically meet with resistance, both from the companies that would have to absorb such costs
and from consumer advocates, who argue that industry funds might cause conflicts of interest in
by having industry pay the salaries of some of its regulators. (Certain types of fees, such as for
facility registration, have not been as vociferously opposed by some consumer advocates.) To
help address the issues that underlie this resistance, clear conflict-of-interest guidelines as well as
certain restrictions on how funds may be expended have been created in other areas.
Second, concerns are sometimes expressed that user fees, once authorized, comprise an ever-
increasing proportion of the budget, and may supplant rather than supplement funding for the
agency. For that reason, certain fees carry the requirement that direct appropriations meet a certain
threshold for user fees to be collected.70
Third, the funding generated by some types of fees—those that are periodic and associated with
external events such as the submission of marketing applications—can be difficult to predict.
However, FDA’s highly trained staff can not easily be increased or trimmed to conform to short-
term activity levels and associated available funds. One example of the dilemma of unpredictable
fee funding comes from the area of medical device user fees. In FY2002, when they were initially
authorized, the fees were all periodic. In FY2007, in order to make user fee funding more
consistent and reliable, certain annual fees (such as annual registration fees) were enacted.71
A fourth set of concerns has been raised by small businesses. In the area of drugs and devices,
small businesses claim to be drivers of innovation, and caution that fees imposed on them have a
disproportionate and chilling effect on their work. For that reason, many of the drug- and device-
related used fees have reductions for small businesses.
Legislative Proposals
Each proposal would fund some FDA food safety activities through the collection of user fees,
though the types of fees and details differ. (See Table 4.) The Congressional Budget Office
(CBO) estimates that over five years, the House bill would collect $1.4 billion in fees and the
Senate amendment would collect $241 million.72 CBO also estimates that that covering the five-
year cost of new requirements, including more inspections, would require additional outlays of
$2.2 billion under the House bill, and, for the five years beginning in 2011, $1.1 billion under the
Senate amendment.
The House-passed bill would establish two annual fees (a facility registration fee and an importer
registration fee), and two fees related to periodic activities (a reinspection and recall fee, and an
export certification fee). The Senate amendment would establish one annual fee (for participants
in the voluntary qualified importer program (VICP)), and three fees for periodic activities (a
70 See CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007.
71 See CRS Report RL34571, Medical Device User Fees and User Fee Acts; and CRS Report RL34465, FDA
Amendments Act of 2007 (P.L. 110-85).
72 Ellen Werble, Rebecca Yip, and Zachary Epstein, et al., H.R. 2749: Food Safety Enhancement Act of 2009,
Congressional Budget Office, July 24, 2009, p. 5, http://www.cbo.gov/ftpdocs/104xx/doc10478/hr2749.pdf. Ellen
Werble, Stephanie Cameron, and Susanne Mehlman, et al., S. 510: Food Safety Modernization Act, Congressional
Budget Office, August 12, 2010, p. 6, http://www.cbo.gov/ftpdocs/117xx/doc11794/s510.pdf.
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Food Safety in the 111th Congress
reinspection fee, a recall fee, and an export certification fee). Details of these fees are presented in
two tables at the end of this report, including, where specified, who pays the fee, the fee amount,
restrictions on the fee amount, the result of nonpayment, how funds may be used, required reports
and meetings, authorizations, appropriations-related restrictions on fee collection, and expiration
dates. For fees paid annually, see Table 5, at the end of this report. For periodic fees, see Table 6,
also at the end of this report.
Table 4. Types of Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment
to S. 510
H.R. 2749, House-passed
S. 510, Manager’s Amendment
Facility Registration Fee
§ 101
None
Importer Registration Fee
§ 204
None
Reinspection Fee
§ 108
§ 107
Recall Fee
§ 108 (for all recalls)
§ 107 (for noncompliance with recall)
Export Certification Fee
§ 203
§ 401
VICP Fee
None
§ 107
Source: Prepared by the CRS based on the text of the House-passed H.R. 2749 and Senate manager’s
amendment to S. 510.
Organization of Food Safety Responsibilities
Would Restructuring Improve Oversight?
The current divisions of federal responsibility for food safety are rooted in the early history of
U.S. food regulation. Congress created separate statutory frameworks when it enacted, on the
same day in 1906, both the Pure Food and Drugs Act and the Meat Inspection Act. The former
was passed to address the widespread marketing of intentionally adulterated foods, and its
implementation was assigned to USDA’s Bureau of Chemistry. The latter law was passed to deal
with unsafe and unsanitary conditions in meat packing plants, and implementation was assigned
to a different USDA agency, the Bureau of Animal Industry. This bifurcated system has been
perpetuated and split further into additional food safety activities under additional agencies (for
example, the Environmental Protection Agency, the National Marine Fisheries Service, and
others) by a succession of statutes and executive directives. The separation of the two major food
safety agencies was further reinforced when, in 1940, the President moved responsibilities for
safe foods and drugs, other than meat and poultry, from USDA to the progenitor of HHS, the
Federal Security Agency. Meat inspection remained in USDA.73
Critics have argued for decades that this dispersal of food safety responsibilities has been
problematic. In its annual (January 2007) report, where it designated food safety oversight as a
“high risk” federal program area, the Government Accountability Office called the current federal
safety system “fragmented,” resulting in:
73 For an extensive discussion of the history of federal food safety organization and of efforts to change it, see Merrill,
Richard A. and Jeffrey K. Francer, “Organizing Federal Food Safety Regulation,” Seton Hall Law Review, Vol. 31:61,
2000.
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Food Safety in the 111th Congress
inconsistent oversight, ineffective coordination, and inefficient use of resources. GAO has
recommended that Congress consider a fundamental reexamination of the system and other
improvements to help ensure the rapid detection of and response to any accidental or deliberate
contamination of food before public health and safety is compromised.74
The GAO echoed the observations and recommendations of a number of other reports and
studies. For example, a committee of the National Academy of Sciences-National Research
Council concluded in a 1998 report that a strong federal role “requires central management of
now-dispersed efforts,” noting that the various agencies report to different congressional
committees, sometimes compete for resources and public attention, and all lack direct access to
the White House.75
Opponents of major structural changes, including some in the food and agricultural industries,
assert that the system already is scientifically based, that the statutes are adequate, and that food
companies already produce and distribute safe food, making the U.S. system a model for food
safety around the world. A number of those pressing for food safety reform have cautioned that a
reorganization, while it might have merit, could divert time and attention from other fundamental
problems in the system.
Past debates have examined proposals to combine all federal food safety agencies and authorities
under a single, possibly Cabinet-level, agency. Recent discussions have focused on more limited
options such as transferring FDA’s food safety activities to a new food safety agency within HHS.
This option is encompassed by the DeLauro bill (H.R. 875), creating a Food Safety
Administration with an Administrator appointed to a five-year term by the President and
confirmed by the Senate. Among other provisions, the measure would transfer all functions,
personnel, and assets of the following offices: FDA’s Center for Food Safety and Applied
Nutrition, Center for Veterinary Medicine, and National Center for Toxicological Research; all
portions of both the FDA Office of Regulatory Affairs and the FDA Commissioner’s Office
devoted to food safety; and the seafood inspection program operated by the National Marine
Fisheries Service in the Department of Commerce.
Legislative Proposals
Neither the House-passed nor Senate measure encompasses a major reorganization of food safety
agencies. Both the House bill and the Senate amendment have provisions (Sections 4 and 403,
respectively) that ensure that the jurisdiction between FDA and USDA would not be altered.
74 GAO, High Risk Series: An Update (GAO-07-310), January 31, 2007.
75 Ensuring Safe Food From Production to Consumption, Committee to Ensure Safe Food from Production to
Consumption, Institute of Medicine, National Research Council, National Academy Press, 1998.
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Table 5. Comparison of Annual Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment to S. 510
H.R. 2749, House-passed
S. 510, Manager’s Amendment
Category
Facility Registration Fee
Importer Registration Fee
VICP Fee
Who Pays
Facilities required to register under
Importers required to register under new Importers participating in the voluntary importer certification
amended FFDCA § 415.
FFDCA § 801(s).
program, under new FDCA § 806.
Fee Amount
$500/facility (inflation adjusted annually),
$500/importer (inflation adjusted
Amounts estimated as specified to cover 100% of the VICP
annual y).
costs for that year.
Fee Amount Cap
$175,000/person with multiple facilities
None.
None.
(not inflation-adjusted).
(Note: The Secretary must waive either the facility or importer fee for persons
otherwise required to pay both.)
Result of
Fees over 30 days past due treated as a
Nothing fee-specific, but registration
Fees over 30 days past due treated as a claim of the U.S.
Nonpayment
claim of the U.S. Government under 31
under new FFDCA § 801(s) my be
Government under 31 U.S.C., chapter 37, subchapter II
U.S.C., chapter 37, subchapter II (Claims
suspended or cancelled for FFDCA
(Claims of the United States Government).
of the United States Government).
violations; foods are deemed misbranded
if imported by an importer not duly
registered under § 801(s).
How Funds may be
For food safety activities, as defined.
For registering importers under new
For administering the VICP program.
Used
FFDCA § 801(s) and ensuring compliance
with food good importer practices.
Required Reports,
Secretary is required to: (1) submit to
None.
Secretary is required to: (1) publish within 180 days of
Meetings
Congress an annual report on the
enactment a proposed set of guidelines related to the burden
implementation of the authority and use of
of fee amounts on smal businesses; (2) submit to Congress,
the fee; (2) hold an annual public meeting
not later than 120 days after each fiscal year in which fees are
on how the fees would be used and
assessed, a specified report describing fees assessed and
collected.
col ected, entities paying such fees their types of business.
Authorization
Such sums as may be necessary for each of Such sums as may be necessary for each
For FY2010 and each FY thereafter, an amount equal to the
FY2010 through FY2014.
of FY2010 through FY2014.
revenue amount determined as specified.
Appropriations-
Fees must be refunded if appropriations
None.
Fees must be refunded if appropriations for FDA’s food
Related Restrictions
for FDA’s salaries and expenses (total, not
safety activities, excluding fees, are less than the preceding
on Fee Collection
just for food) are less than the preceding
year’s appropriations adjusted for inflation as specified.
year’s appropriations adjusted for inflation
as specified.
Expiration Date
Fee sunsets after FY2014.
None.
None,
Source: Prepared by the CRS based on the text of the House-passed H.R. 2749 and Senate Manager’s Amendment to S. 510.
CRS-34
Table 6. Comparison of Periodic Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment to S. 510
H.R. 2749, House-passed
S. 510, Manager’s Amendment
Category
Reinspection and Recall
Export Certification
Fee
Fee
Reinspection Fee
Recall Fee
Export Certification
Fee
Who Pays
Facilities that must
Exporters who voluntarily
If subject to reinspection
If noncompliant with a
Exporters who voluntarily
undergo an additional
request and receive within
in a fiscal year: the
recall order under FFDCA
request and receive within
inspection for violating the
20 days Secretary’s export
responsible party for a
§ 423 or § 412(f): the
20 days Secretary’s export
FFDCA; or are subject to
certification under
domestic facility (defined in responsible party for
certification under
a food recall.
amended FFDCA
new FFDCA § 415(b)), the
domestic facilities (defined
amended FFDCA
§ 801(e)(4).
U.S. registered agent for a
in new FFDCA § 415(b)),
§ 801(e)(4).
foreign facility, or the
or the importer.
importer.
Fee Amount
Secretary sets fees at a
Secretary sets inflation-
Secretary annual y
Secretary annual y
Fees may cover the cost of
level to fully cover cost of
adjusted fee annually.
establishes fees for
establishes fees to cover
certification.
reinspections and/or
facilities and for importers
100% of estimated cost of
recalls.
so each fee covers 100% of food recal activities
the respective estimated
associated with such order
reinspection-related costs.
performed by the
Secretary.
Fee Amount Cap /
Secretary waives / refunds
Fee may not exceed
The amount of fees
The amount of fees
Fee may not exceed $175
Waiver
fees resulting from
amount reasonably related
collected may not exceed
collected may not exceed
per certification.
inappropriately ordered
to the cost of issuing
$25,000,000 in a given FY,
$20,000,000 in a given FY,
recalls.
certificates.
except that if a domestic
except that if a domestic
facility or importer
facility or importer
becomes subject to a fee
becomes subject to a fee
in a given year, the
in a given year, the
Secretary may collect it.
Secretary may collect it.
Result of Nonpayment
No provision in § 108 of
No provision in § 203 of
Fees over 30 days past due treated as a claim of the U.S.
No provision in § 107 of
bill.
bill.
Government under 31 U.S.C., chapter 37, subchapter II
amendment.
(Claims of the United States Government).
How Funds may be Used For recal and
For issuing certifications.
For reinspection-related
For food-recall-related
For issuing certifications.
reinspection.
activities.
costs associated with the
recal order, that are
performed by the
Secretary.
CRS-35
H.R. 2749, House-passed
S. 510, Manager’s Amendment
Category
Reinspection and Recall
Export Certification
Fee
Fee
Reinspection Fee
Recall Fee
Export Certification
Fee
Required Reports,
None.
None.
Secretary is required to: (1) publish within 180 days of
None.
Meetings
enactment a proposed set of guidelines related to the
burden of fee amounts on smal businesses; (2) submit to
Congress, not later than 120 days after each fiscal year in
which fees are assessed, a specified report describing fees
assessed and collected, entities paying such fees their
types of business.
Authorization
Such sums as may be
Fees shall be collected in
For FY2010 and each FY thereafter, an amount equal to
No provision in § 107 of
necessary for each of
each FY in an amount
the revenue amount determined as specified.
amendment.
FY2010 through FY2014.
equal to the amount
specified in appropriations
Acts.
Appropriations-Related
None.
None.
Fees must be refunded if appropriations for FDA’s food
None.
Restrictions on Fee
safety activities, excluding fees, are less than the
Collection
preceding year’s appropriations adjusted for inflation as
specified.
Expiration
Date
None. None. None. None. None.
Source: Prepared by the CRS based on the text of the House-passed H.R. 2749 and Senate Manager’s Amendment to S. 510.
CRS-36
Appendix. Comparison of Provisions in H.R. 2749 (House-Passed)
and S. 510 (Senate Manager’s Amendment) with Current Law
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Food Facility Registration Requirements
Changes in Registration of Food Facilities (§ 101)
Registration of Food Facilities (§ 102)
Some assert that registration requirements should be
Amends FFDCA § 415 both to require facilities to register
Amends FFDCA § 415 to require biennial facility registration,
strengthened so that FDA is notified when a firm moves,
annual y, by each December 31, and to pay an annual
with an abbreviated process for registrants whose information
undertakes a new food business, or changes product lines.
registration fee of $500. (This fee is described in more detail
has not changed. Registrants are required to provide
Otherwise, the FDA's records on what facilities are
later in this memorandum.) The Secretary is authorized to
additional contact information, including an e-mail address and,
manufacturing and marketing food are continual y out of date,
suspend the registration of any facility for an FFDCA violation
for foreign facilities, the United States agent for the facility.
it is argued. Others have argued that additional registration
that could result in serious adverse health consequences or
Registrants must also provide an assurance that the Secretary
requirements would be needlessly intrusive and costly for the
death to humans or animals. Where the Secretary exercises
will be permitted to inspect the facility. The Secretary is
industry.
this discretionary suspension authority, the Secretary must
authorized or required to suspend and/or reinstate
first provide the facility a notice of intent and opportunity for
registrations, based on the Secretary’s determination that
Both domestic and foreign food facilities are required to
an informal hearing, after which a suspension order may be
“food manufactured, processed, packed, or held by a facility
register with FDA pursuant to FFDCA § 415. Farms,
written for finding a violation, with timelines for doing so
registered under this section has a reasonable probability of
restaurants, other retail food establishments, and most
specified. A suspended registration could be reinstated based
causing serious adverse health consequences or death to
nonprofit food establishments and fishing vessels are excluded
on criteria published by the Secretary. Places limitations on the humans or animals” for a facility that “created, caused, or was
from the requirement. Renewal is not required on any
Secretary’s authority to delegate suspension decisions.
otherwise responsible” or “that knew of, or had reason to
periodic basis, but registrants must notify the Secretary in a
know of, such reasonable probability.” The bill delineates an
timely manner of any relevant changes in their status. FFDCA
Makes failure to register an act of “misbranding” under
appeal process, including a requirement for an informal hearing
§ 301(dd) designates failure to register as a prohibited act.
FFDCA § 403.
general y within two business days, and procedures for
FFDCA § 801(l) provides that imported food may not be
submission of a corrective action plan and for lifting a
delivered to the importer, owner, or consignee of the article
Also amends the information requirements of registrants to
suspension. The Secretary shal review corrective action plans
until the foreign facility is registered. FDA does not have
include: the name, address, and emergency contact of each
“not later than 14 days after the submission” of such plans.
explicit authority to require a registration fee.
facility being registered; its primary purpose and business
activity, including dates of operation if seasonal; the category
The Secretary also shall promulgate regulations regarding
Obama Administration: The Hamburg and Taylor
of food manufactured, processed, packed or held there; al
suspension and reinstatement procedures. If its registration is
testimonies express support for § 101 of the House bill.
business trade names; and the name, address and 24-hour
suspended, a facility may not import food, or introduce food
emergency contact information of the U.S. distribution agent.
into interstate or intrastate commerce, in the United States.
Further requires registrants to notify the Secretary of any
The Secretary’s authority to suspend registration shal not be
changes in products, function or legal status within 30 days of
delegated to anyone other than the FDA Commissioner. The
a change, unless otherwise specified by the Secretary, who
Secretary may require that registration be submitted
may cancel a registration that is improperly updated or
electronical y, but not earlier than 5 years after enactment.
contains false, misleading, or inaccurate information, or if the
Contains provisions for consideration of smal businesses.
required fee is not paid within 30 days.
Requires the Secretary to issue a ”small entity compliance
Contains extensive language defining what is and is not a
policy guide” setting forth the requirements of such
facility. A facility is “any factory, warehouse, or establishment
regulations to assist small entities in complying with the
(including a factory, warehouse or establishment of an
registration requirements and other activities (no later than
180 days after the issuance of the regulations under this
CRS-37
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
importer) that manufactures, processes, packs or holds food.”
section).
Stipulates that a facility is not a farm, a private residence, a
restaurant or other retail food establishment, a nonprofit
establishment that prepares or serves food directly, or a
fishing vessel, and further clarifies what is meant by these
exceptions. Also specifies what a farm may or may not do to
be exempted from facility registration requirements.
Records Access and Records Inspection
Access to Records (§ 106)
Inspections of Records (§ 101)
Many advocates of reform argue that recordkeeping
Broader than S. 510; amends FFDCA § 414(a) regarding
Amends FFDCA § 414, which contains one standard (trigger)
requirements must be strengthened to improve the ability of
Records Inspection. Although much of the amended language
for records access, by creating two such standards. The first is
regulators to determine whether firms are complying with the
appears similar to existing language, several qualifying phrases
somewhat similar to current law by authorizing access “If the
law and to facilitate efforts to find the source of problems
are now absent. For example, the bill broadens the ability to
Secretary has a reasonable belief that an article of food and
(including during product recal s) when they do occur. One of
access records by deleting the following conditional phrase in
any other article of food that the Secretary reasonably believes
their concerns has been that records are not required to be
the current law: “If the Secretary has a reasonable belief that
is likely to be affected in a similar manner is adulterated and
maintained in electronic format, which if required, these
an article of food is adulterated and presents a threat of
presents a threat of serious adverse health consequences or
advocates assert, would greatly speed outbreak response.
serious adverse health consequences or death to humans or
death to humans or animals...” The second standard authorizes
Related issues include the types of records to be kept, how
animals...” (Drafters of the bill view this as new authority to
access “If the Secretary believes that there is a reasonable
detailed they should be, how long they should be kept, and
access records during routine inspections.) The bill also no
probability that the use of or exposure to an article of food,
access and use of these records by authorities. For example,
longer requires that “written notice” be provided in advance
and any other article of food that the Secretary reasonably
are the current legal premises for accessing records (see
of accessing records. However, records not required to be
believes is likely to be affected in a similar manner, will cause
below), adequate? Proposals for increased recordkeeping
immediately available at the start of a records inspection must
serious adverse health consequences or death to humans or
requirements often raise questions about the intrusiveness of
be immediately available if requested in advance by letter.
animals...” It appears that by invoking the second standard, the
government, privacy concerns, and the protection of sensitive
Also, relevant records (i.e., for access and copying) are to be
Secretary would no longer be required to have a reasonable
commercial information (trade secrets), for example.
all those “relating to such article bearing on whether the food
belief that a food is adulterated in order to have access to
is adulterated, misbranded, or otherwise in violation of this
records.
FFDCA § 414 currently authorizes the Secretary, by
Act...” rather than the higher current threshold—which is
regulation, to require that food establishments (except farms
those records “needed to assist the Secretary in determining
Also apparently new under both standards would be the ability
and restaurants) maintain certain records regarding foods,
whether a food is adulterated and presents a threat of serious
to access records if “any other article of food” could be
including immediate previous sources, and immediate
adverse health consequences.”
similarly affected, such as food produced on the same
subsequent recipients. “If the Secretary has a reasonable belief
manufacturing line as an implicated food, or food produced
that an article of food is adulterated and presents a threat of
New provisions spell out the conditions under which the
using implicated ingredients. Under either trigger, a designee
serious adverse health consequences or death to humans or
Secretary could require remote access to records (i.e., not
of the Secretary is to be granted access to records upon
animals,” such records must be made available for inspection
appear at a facility to review them), notably where “...the
presentation of appropriate credentials and a written notice to
and copying upon written notice. (Emphasis added.) The
Secretary has reasonable belief that an article of food presents
such person, at reasonable times and within reasonable limits
Secretary is required to take appropriate measures to ensure
a threat of serious adverse health consequences or death to
and in a reasonable manner. Requirements apply to all records
that unauthorized disclosure of any trade secret or
humans or animals.”
relating to the manufacture, processing, packing, distribution,
confidential information is prevented.
receipt, holding, or importation of a food, in any format
Restaurants would be subject to some records access
(including paper and electronic formats), and at any location.
Obama Administration: The FSWG stated that the
requirements. However, the only distribution of records
No specific format is required. Farms and restaurants would
Administration would work with Congress on “critical
which may be required of restaurants under this subjection are continue to be excluded under FFDCA § 414.
legislation that will provide key tools .... to keep food safe.”
those showing the restaurant’s suppliers and subsequent
CRS-38
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
One tool it cited was “the ability to access basic food safety
distribution other than to consumers.
records at facilities.” The Hamburg and Taylor testimonies
express support for § 106 of the House bill.
Also, states that access to records provisions do not apply to
farms—except that a farm owner, operator, or agent must
permit an officer or employee of the Secretary to have access
to and copy al records relating to an article of food that is
produced, manufactured, processed, packed, or held on the
farm. This exception applies only if the article of food either: is
a fruit, vegetable, nut or fungus that is subject to a standard
under new § 419A (see Safety Standards for Produce and
Certain Other Raw Agricultural Commodities, §104); or is the
subject of an active investigation by the Secretary of a
foodborne illness outbreak and is further not a grain or
similarly handled commodity (generally, the list in the bill
encompasses the row crops covered by USDA price
supports).
Additional y for farms, that Secretary must as soon as
practicable (in coordination with the Secretary of Agriculture)
identify and issue guidance on one or more fruits, vegetables,
nuts, or fungi where access to records will be used. This
section also requires such identification to be based on illness
outbreaks, requires its expiration when the new § 419A rules
take effect, and requires the Secretary to consult with the
Secretary of Agriculture in issuing regulations “with respect to
farms under this subsection and shal take into account the
nature of and impact on farms,” among other things. (See also
the records provisions in Traceability of Food, § 107.)
Registration for Customs Brokers (§ 205)
A provision in this section requires every person importing or
brokering for import a food to permit an officer or employee
of the Secretary to “inspect the facilities of such person and
have access to, and to copy and verify, any related records.”
Preventive Control Plans
Hazard Analysis, Risk-Based Preventive Controls,
Hazard Analysis and Risk-Based Preventive Controls
Food Safety Plan, Finished Product Test Results from
(§ 103)
A broad consensus of policymakers agrees that FDA's system
Category 1 Facilities (§ 102)
of safeguards, which is based on a law first written early the
Establishes a new FFDCA § 418, requiring the owner,
last century, is primarily reactive. By and large, the agency's
Also establishes a new FFDCA § 418, with provisions broadly
operator, or agent in charge of a facility to develop a written
statute and regulations spell out the reasons a food article is
similar to those in S. 510, but differing somewhat in detail and
plan and carry out certain preventive activities in the plan,
to be considered adulterated or misbranded and therefore
organization. Like S. 510, requires the owner, operator, or
including:
unfit for consumption. In effect, industry players are expected
agent of a facility to analyze hazards and implement controls to
CRS-39
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
to abide by the rules; generally it is only when a problem is
prevent or reduce them, but unlike S. 510, requires a food
•
conducting an analysis to identify and evaluate known or
detected—often after an illness outbreak is reported or
safety plan to be developed and implemented before a facility
reasonably foreseeable hazards that may be associated with
testing finds a contaminant in a product—that officials step in
introduces or delivers for introduction into interstate
the facility, hazards that may be intentionally introduced,
to correct it, or order the industry to do. So virtually all
commerce any shipment of food.
including by acts of terrorism; and preparing a written analysis;
stakeholders, including regulators, the regulated industries,
consumer advocates, and food safety scientists now agree that
Requires (under § 418A) that this plan include a hazard analysis • identifying and implementing preventive controls,
the foundations of any new program should be an
to identify whether there are hazards, including those due to
including at critical control points, if any, to provide assurances
understanding of what, and how, hazards can enter the food
the source of ingredients, that are reasonably likely to occur in that identified hazards will be prevented or minimized, and
supply, fol owed by implementation of measures to prevent
the absence of preventive controls. The plan also must include
that food is not adulterated or misbranded;
these hazards.
descriptions of:
•
developing a means to verify the effectiveness of these
FDA currently requires that managers of certain food
•
preventive controls being implemented including those to
preventive controls;
facilities—those producing or processing seafood, some juices,
address hazards identified by the Secretary;
•
implementing corrective actions if controls are found,
and low-acid canned foods—prepare Hazard Analysis and
•
procedures for monitoring preventive controls;
through monitoring, not to have been effective (specifies that
Critical Control Point (HACCP) plans for their operations.
corrective actions ensure “(1) appropriate action is taken to
HACCP is a preventive approach that incorporates hazard
•
procedures for taking corrective actions;
reduce the likelihood of recurrence of the implementation
analysis, appropriate process controls, verification, and other
•
verification activities including validation that such
failure; (2) all affected food is evaluated for safety; and (3) all
steps throughout the production process. A cornerstone of
controls are effective (to include use of environmental and
affected food is prevented from entering into commerce if the
HACCP is the identification of hazards by industry that are
product testing programs);
owner, operator or agent in charge of such facility cannot
“reasonably likely to occur.” The emphasis on hazards that are
ensure that the affected food is not adulterated,” as defined by
reasonably likely to occur assures that such hazards—such as
•
monitoring of such preventive controls to verify
law)
microbial contamination in fresh juices, or botulism in low-acid effectiveness;
canned foods—are systematically and consistently addressed.
•
record keeping procedures (records must be kept for at
•
verifying that preventive controls are effective, that
monitoring is ongoing, that corrective actions are taken when
There is no explicit statutory authority or requirement
least two years);
needed, and that the plan is periodically reviewed for
regarding HACCP systems for FDA-regulated foods. FDA
•
both established recall procedures and traceback
continued relevance;
regulations requiring HACCP plans and systems for seafood,
procedures;
fruit and vegetable juices, and low-acid canned foods cite the
•
keeping and maintaining, for at least two years, records
applicable statutory authority as FFDCA § 402(a), which
•
procedures to ensure the safety of the supply chain for
documenting the monitoring of preventive controls, relevant
defines adulteration, and the Secretary’s general authority to
ingredients;
instances of nonconformance, instances when corrective
promulgate regulations to assure the safety of foods, at
actions were implemented, and the efficacy of preventive
FFDCA § 701(a).
•
procedures to implement performance standards issued
controls and corrective actions.
by the Secretary (under a new FFDCA § 419).
At the U.S. Department of Agriculture, the Food Safety and
Applicable definitions are provided in this section for “critical
Inspection Service (FSIS) in 1996 began implementing rules to
The owner, operator, or agent must conduct a reanalysis of
control point,” “facility,” and “preventive controls.” The
establish a mandatory HACCP for meat and poultry, using its
hazards (and revise preventive controls if necessary): (1) at
required plan and associated documentation of performance
authority to regulate major meat and poultry species under
least every two years (S. 510 is every three years); (2) if there
must be made promptly available to an authorized
the Federal Meat Inspection Act (FMIA) and Poultry Products
is a change in the process or product that could affect the
representative of the Secretary upon oral or written request.
Inspection Act (PPIA). Record keeping and verification are
hazard analysis; and (3) if the Secretary determines it is
The hazards must be reanalyzed at least every three years, or
used to ensure that the system is working. Following a phase-
appropriate to protect public health. Limits the Secretary’s
sooner if there is a change in processes or practices that could
in period to accommodate smaller sized establishments, and
ability to delegate the authority to order revisions. Contains
create or worsen a hazard. The Secretary may require a
since January 2000, al slaughter and processing operations
applicable definitions (including one not in S. 510 defining
revision of the plan based on a new hazard or new scientific
have been required to have HACCP plans in place. HACCP is
“hazard that is reasonably likely to occur”), the same deemed
information, including, as appropriate, “results from the
CRS-40
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
intended to operate as an adjunct to the traditional methods
compliance for seafood, juice, and low-acid canning facilities,
Department of Homeland Security biological, chemical,
of facility inspection, which still are mandatory under the
and the same effective dates based on business size as in S.
radiological, or other terrorism risk assessment.” Failure to
original statutes.
510.
comply with the requirements of this section is prohibited
under FFDCA § 301.
Obama Administration: The FSWG stated that the
Also as is similar in S. 510, the Secretary is required to issue
Administration would work with Congress on “critical
guidance or regulations on standards for conducting a hazard
Seafood, juice, and low-acid canned-food facilities that are
legislation that will provide key tools .... to keep food safe.”
analysis and establishing preventive controls. However, the
already in compliance with applicable FDA regulations are
One tool it cited was the ability to require sanitation and
Secretary must allow the facility to implement an alternative
deemed to be in compliance with this section. Facilities subject
preventive controls at food facilities, based on a scientific
preventive control if it is able to demonstrate that it effectively to requirements in FFDCA § 419, as established by this act
hazard analysis. The Hamburg and Taylor testimonies express
addresses the hazard. Food from facilities not in compliance
(regarding safety standards for produce), are not subject to
support for § 102 of the House bill.
with these provisions are to be considered adulterated under
this section. The Secretary may, by regulation, exempt or
the FFDCA.
modify the requirements of this section for facilities that are
solely engaged in the production of food for animals other
In issuing guidance or regulations, the Secretary must, to seek
than man, the storage of raw agricultural commodities (other
consistency, review relevant international standards for hazard
than fruits and vegetables) intended for further distribution or
analysis and preventive controls. The Secretary also must
processing, or the storage of packaged foods that are not
consider their impact on small businesses and must issue
exposed to the environment. This section does not limit the
guidance to assist small businesses in complying.
Secretary’s authority to revise, issue or enforce regulations for
The Secretary is authorized to exempt from or modify, by
specific types of foods, such as the HACCP regulations
regulation, the requirements with respect to facilities engaged
currently in effect for certain foods. This section does not
solely in the production of food for nonhumans (and may take
apply to dietary supplements.
into account differences between human and animal foods),
Considering existing regulatory hazard analysis and preventive
facilities that store packaged foods not exposed to the
control programs to determine applicable internationally
environment, or facilities that store raw agricultural
recognized standards, the Secretary shall promulgate
commodities for further distribution or processing.
regulations not later than 18 months after enactment
Further, under a new FFDCA § 418B, the Secretary must
regarding the implementation of requirements under this
require submission of finished product test results by the
section, and shall issue an applicable guidance document.
owner, operator, or agent of each category 1 facility (see
Regulations shall be sufficiently flexible to be applicable in all
“Risk-Based Inspection Schedule,” below, for definition of such situations, including the operations of small businesses. This
facility) “...documenting the presence of contaminants in food
section does not provide the Secretary with the authority to
in the possession or control of such facility posing a risk of
apply specific technologies, practices, or critical controls to an
severe adverse health consequences or death.” Such
individual facility.
submissions are those determined by the Secretary to be
Contains clarifying language regarding the promulgation of
feasible and appropriate and taking into consideration available
FDA regulations, including consideration for various types of
information on potential risks; and this section is not to:
businesses and activities (on-farm and at processing facilities).
construe a requirement for mandated “testing or submission
Contains provisions for consideration of smal businesses.
of test results that the Secretary determines would not
Requires the Secretary to issue a ”small entity compliance
provide useful information in assessing the potential risk
policy guide” setting forth the requirements of such
presented by a facility or product category”; or to limit the
regulations to assist small entities in complying with the
Secretary’s authority under other provisions to access
registration requirements and other activities (no later than
information or test results including in the course of an
180 days after the issuance of the regulations under this
CRS-41
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
investigation of an illness or contamination incident.
section), along with other flexibility and extended
implementation deadlines for smal and very smal businesses.
This requirement is to take effect on the sooner of either 2
Requirements become effective in stages according to the size
years from date of enactment or the completion of a feasibility of the business: businesses must be compliant 18 months after
study and at least two pilot projects that are required. Food
the date of enactment, except smal businesses (as defined by
from a facility not in compliance with the requirements of new
the Secretary) are to have 2 years after enactment, and very
§ 418B is adulterated.
smal businesses (as defined by the Secretary) 3 years after
enactment.
Seafood
No comparable provisions.
Requirements for Guidance Relating to Post Harvest
Processing of Raw Oysters (§ 114)
The National Shel fish Sanitation Program (NSSP) is the
federal/state cooperative program recognized by FDA and the
Creates for the Secretary and GAO certain requirements (see
Interstate Shel fish Sanitation Conference (ISSC; see next
below) triggered when the FDA issues—related to the post
paragraph) for the sanitary control of shel fish produced and
harvest processing of raw oysters—(1) guidance, regulation,
sold for human consumption. The purpose of the NSSP is to
or suggested amendment to the NSSP’s Model Ordinance; or
promote and improve the sanitation of shel fish (oysters,
(2) guidance or regulation relating to the Seafood HACCP
clams, mussels and scal ops) moving in interstate commerce
Program (21 CFR parts 123 and 1240).
through federal/state cooperation and uniformity of state
shellfish programs. Participants in the NSSP include agencies
Not later than 90 days prior to issuance, requires the
from shel fish producing and non-producing States, FDA, EPA,
Secretary to submit to Congress a report on the projected
NOAA, and the shellfish industry.
public health benefits, cost of compliance, feasibility of
implementation, and certain other topics. This requirement
The ISSC is a voluntary national organization of state shellfish
does not apply to the guidance described in 103(h) (Updating
regulatory officials that provide guidance and counsel on
Guidance Relating to Fish and Fisheries Products Hazards and
matters for the sanitary control of shel fish. The ISSC has
Controls, discussed below). This requirement is waived if the
adopted formal procedures for state representatives to review
Secretary issues a guidance that is adopted as a consensus
shellfish sanitation issues and develop regulatory guidelines.
agreement between federal and state regulators and the
Following FDA concurrence, these guidelines are published in
oyster industry, acting through the ISSC.
revisions of the NSSP Model Ordinance.
Not later than 30 days after the Secretary issues a proposed
FDA’s Seafood HACCP Program regulations are articulated in
regulation or guidance described above, requires the GAO to
21 CFR parts 123 (fish and fishery products) and 1240 (control
(1) review and evaluate the Secretary’s report and report its
of communicable diseases).
findings to Congress, (2) compare such proposed regulation or
guidance to similar regulations or guidance for other regulated
FDA’s Fish and Fisheries Products Hazards and Controls
foods, including a comparison of risk, and (3) evaluate the
Guidance was published by the agency to assist processors of
impact of post harvest processing on the competitiveness of
fish and fishery products in the development of HACCP plans,
the U.S. oyster industry domestically and in international
which are required under regulations at 21 CFR 12. Despite
markets.
FDA’s stated intention to update the guidance every 2 to 3
years, the most recent edition is dated June 2001.
Requires any report prepared under the section to be made
public.
Updating Guidance Relating to Fish and Fisheries Products
CRS-42
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Hazards and Controls (part of §103) Requires the Secretary to
update the Fish and Fisheries Products Hazards and Control
Guidance to take into account advances in technology since its
previous publication.
Performance Standards
Performance Standards (§ 103)
Performance Standards (§ 104)
Performance standards are typically specific, quantitative
Similar in intent but not identical to S. 510. Under a new
In coordination with USDA, the Secretary shall, at least every
measurements of a property of, or a substance in, food. They
FFDCA § 419, the Secretary must at least every two years
two years, review and evaluate relevant health data and other
may apply strictly to the property being measured, or serve as
review and evaluate epidemiological data and other
relevant information, including epidemiological and
benchmarks for whether the food is safe in a broader sense.
appropriate information, including research under § 123 (the
toxicological data and other appropriate information to
For example, a performance standard for a single microbe
research section) of the bill, to identify the most significant
determine the most significant foodborne contaminants.
might be used to determine whether a product is
food-borne contaminants and resulting hazards. Following each
contaminated with microbes in general. (This approach is
review, the Secretary must publish in the Federal Register a
Based on such review and evaluation and when appropriate to
sometimes cal ed process verification.) Such a finding could
list of contaminants that have the greatest adverse impact on
reduce the risk of serious illness or death to humans or
indicate a problem with the product’s processing, and prompt
public health (and must consider the number and severity of
animals, or to prevent the adulteration of the food under
a review of processing activities. The FFDCA (in various
illnesses and deaths associated with the contaminant in a
FFDCA § 402 or the spread of communicable disease under
provisions in Chapter IV, regarding food) authorizes FDA to
food).
PHS Act § 361, the Secretary shall issue contaminant-specific
promulgate standards for certain hazards, such as maximum
and science-based guidance documents, actions levels, or
permissible levels (called tolerances) for residues of pesticides
The Secretary must issue, “as soon as practicable” through
regulations. Such standards shall apply to products and
or drugs in foods. The FFDCA does not grant FDA the explicit guidance or by regulation, science-based performance
product classes, may differentiate between food for humans
authority to develop standards solely as a means to verify that
standards (which may include action levels) to significantly
and food for animals, and shall not be written to be facility-
processing is carried out in a manner that assures the safety of
minimize, prevent, or eliminate such hazards. The standards
specific. HHS shall coordinate with USDA to avoid duplication
the food.
shal apply to foods and food classes. Foods not meeting
of effort regarding guidance documents for the same
required standards are to be considered adulterated. The
contaminant. The Secretary will issue and periodically
Obama Administration: The FSWG stated that the
Secretary is authorized to make recommendations to industry
review/revise all guidance documents and regulation.
Administration would work with Congress on “critical
on product sampling. Finally, the Secretary must report to
legislation that will provide key tools .... to keep food safe.”
Congress on the review including how the Secretary will
One tool it cited was the ability to establish performance
address significant hazards and any resource or data limitations
standards to measure the implementation of proper food
that preclude further action.
safety standards. The Hamburg and Taylor testimonies express
support for § 103 of the House bill.
Produce and On-Farm Food Safety
Safety Standards for Produce and Certain Other Raw
Standards for Produce Safety (§ 105)
Agricultural Commodities (§ 104)
As noted earlier, the FFDCA authorizes FDA to promulgate
Subsection (a) of this section establishes a new FFDCA § 419,
standards for certain hazards, some of which, such as
Under a new FFDCA § 419A, within 18 months of enactment,
regarding safety standards for produce. Within one year of
maximum permissible levels (called tolerances) for residues of
the Secretary (in coordination with the Secretary of
enactment, the Secretary (in consultation with USDA and
pesticides, may apply to produce. The FFDCA does not grant
Agriculture) must publish a notice of proposed rulemaking,
state agriculture departments, including with regard to the
FDA explicit authority to develop standards solely as a means
and within three years after such date, final rules establishing
national organic foods program, and in consultation with
to verify that processing is carried out in a manner that
scientific and risk-based standards for the safe growing,
DHS), is required to publish a notice of proposed rulemaking
assures the safety of the food. FDA has several voluntary
harvesting, processing, packing, sorting, transporting, and
for science-based minimum standards for the safe production
efforts in place to address safety in the produce industry. For
holding of those types of raw agricultural commodities that are and harvesting of those fruits and vegetables that are raw
CRS-43
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
example, in February 2008, the agency issued the final version
from a fruit, vegetable, nut, or fungus, and for which the
agricultural commodities (including mixes and specific
of the Guide to Minimize Microbial Food Safety Hazards of
Secretary has determined such standards are reasonably
categories of fruits and vegetables), for which the Secretary
Fresh-cut Fruits and Vegetables, which contains non-binding
necessary to minimize the risk of serious adverse health
has determined that such standards minimize the risk of
recommendations regarding: primary production and
consequences or death to humans or animals
serious adverse health consequences or death. The Secretary
harvesting of fresh fruits and vegetables; personnel; buildings
may exclude from such rulemaking commodities determined
and equipment; sanitation operations; production and process
These regulations may set forth procedures and practices that
to be low risk when produced or harvested by small or very
controls; documentation and records; traceback; and recall.
the Secretary determines reasonable to prevent known or
small businesses. The Secretary shall hold at least 3 public
On September 2, 2008, FDA published a notice in the Federal
reasonably foreseeable biological, chemical, and physical
meetings on such rulemaking in diverse geographic areas.
Register seeking comments and data to assist the agency in its
hazards, including natural ones, that may be intentionally or
revision, now underway, of its 1998 Guide to Minimize
unintentionally introduced. The regulations may include
Proposed rulemaking shall “provide sufficient flexibility to be
Microbial Food Safety Hazards for Fresh Fruits and Vegetables. minimum safety standards, and address manure use, water
applicable to various types of entities…including small
Also, FDA asserts that it has been engaged in efforts to
quality, employee hygiene, sanitation and animal control, and
businesses and entities that sel directly to consumers, and be
identify hazards commonly associated with fresh produce, and
temperature controls, as the Secretary determines to be
appropriate to the scale and diversity” of production and
to develop tracking and tracing methods.
reasonably necessary. They may provide for coordination of
harvesting. The proposed rule also shal address minimum
education and enforcement activities and must provide a
standards for other specified elements, including soil
Under the Agricultural Marketing Agreement Act of 1937 (7
reasonable time for compliance, taking into account the needs
amendments, hygiene, packaging, temperature controls, animal
U.S.C. § 601 et seq.), producers and handlers can organize
of small businesses for additional time, among other permitted
encroachment and water, as well as hazards that occur
themselves under legally binding marketing orders that can
activities. The Secretary is required to take into consideration
natural y or that may have been introduced, intentional y or
include quality (and possibly, safety) standards. The act is
(consistent with public health) “the impact on small-scale and
unintentionally. The proposal shall take into consideration,
overseen by USDA’s Agricultural Marketing Service (AMS). In
diversified farms, and on wildlife habitat, conservation
consistent with public health protection, “conservation and
an advance notice of proposed rulemaking, AMS in October
practices, watershed-protection efforts, and organic
environmental practice standards and policies established by
2007 invited comments on whether to create such a federal
production methods.” The Secretary shal coordinate with the
Federal natural resource conservation, wildlife conservation,
marketing program that specifical y would require handlers
Secretary of Agriculture and may contract and coordinate with and environmental agencies,” and also “in the case of
(packers, processors, shippers) of leafy greens, including
a Governor-designated state agency for education and
production that is certified organic, not include any
lettuce and spinach, to meet prescribed safety standards. A
compliance activities (emphasis added to distinguish from S.
requirements that conflict with or duplicate the requirements
similar state order was adopted by California growers in 2006. 510, which mandates use of state agencies).
of” the national organic foods program, while providing the
Further action on a federal order had not occurred as of early
same level of protection as required under this act. Priority is
August 2009.
Under this new provision, a food is adulterated if it is grown,
to be given to those raw fruits and vegetables that have been
harvested, packed, sorted, transported or held under
associated with food-borne illness outbreaks.
Obama Administration: The FSWG announced, and FDA
conditions that do not meet these new requirements. The bill
issued on July 31, 2009, new draft guidances on three specific
appears to lack the variance procedures, and the express
Subsection (b) states that within a year of the closing of the
types of produce: Guide to Minimize Microbial Food Safety
exemption for those required to meet hazard analysis and
comment period, the Secretary shall adopt a final rule to
Hazards of Tomatoes, Guide to Minimize Microbial Food
prevention standards that are in S. 510.
provide for minimum standards for certain types of fruits and
Safety Hazards of Melons, and Guide to Minimize Microbial
vegetables, as needed to minimize the risk of serious adverse
Food Safety Hazards of Leafy Greens, which, when finalized
Requires the Secretary to update the 1998 guidance for
health consequences. Among other requirements, the final
(and as is the case for all FDA guidance documents), will be
minimizing hazards in fresh fruits and vegetables.
rule shall provide for coordination of education and
nonbinding and will represent FDA’s current thinking on these
enforcement activities with state and local officials, minimize
topics. Comments on the documents are to be accepted until
recordkeeping burdens, and describe the variance process and
October 2, 2009 (see 74 FR 38437-40).
the types of permissible variances that the Secretary may grant
to states and foreign countries to address local growing
Also, the Hamburg and Taylor testimonies express support for
conditions. Effective dates for compliance are phased in for
§ 104 of the House bill.
small and very small business (see below). The Secretary may
CRS-44
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
coordinate with USDA and shall contract as appropriate with
states to conduct compliance activities (emphasis added). Not
later than one year after enactment, the Secretary shal publish
updated good agricultural practices and guidance for the safe
production and harvesting of specific types of produce, after
consultation with stakeholders (as specified). This section shall
not apply to facilities subject to FFDCA § 418 (Hazard Analysis
and Risk-based Preventive Controls), as established by this act.
Failure to comply with requirements under this section is
prohibited. Amendments made by this section do not limit the
authority of the Secretary under the FFDCA or the Public
Health Service (PHS) Act [42 U.S.C. § 201 et seq.] to revise,
issue, or enforce product and category-specific regulations,
such as those for HACCP programs already in place.
This section contains provisions for consideration of small
businesses. As noted above, smal and very smal businesses
may be exempted from regulation if the Secretary has
determined these “are low risk and do not present a risk of
serious adverse health consequences or death.” Extended
implementation deadlines for smal and very smal businesses
apply: smal businesses (as defined by the Secretary) are to
have 1 year after final regulation are promulgated, and very
smal businesses (as defined by the Secretary) 2 years after
final regulations. Requires the Secretary to issue a ”smal entity
compliance policy guide” setting forth the requirements of
such regulations to assist smal entities in complying with the
registration requirements and other activities (no later than
180 days after the issuance of the regulations under this
section), along with other flexibility for small businesses.
Requires the Secretary to ensure any updated guidance
comply with the Paperwork Reduction Act (PRA) and
minimize regulatory burden and unnecessary paperwork and
the number of separate standards on the facility, among other
clarification regarding acknowledgment of risk differences and
compliance burden.
Targeting of Inspection Resources
Risk-Based Inspection Schedule (§ 105)
Targeting of Inspection Resources for Domestic
Facilities, Foreign Facilities, and Ports of Entry;
Reform advocates argue that many of the recent problems
Amends § 704 (Inspection, in the General Authority chapter of Annual Report (§ 201)
that have led to illness outbreaks and recalls might have been
the FFDCA) to require each § 415-registered facility to be
avoided if inspectors were more frequently present in plants
inspected randomly by officers duly designated by the
Subsection (a) of this section establishes a new FFDCA § 421
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S. 510 (Manager’s Amendment)
to monitor sanitary conditions and processes. Due to the
Secretary at a frequency based on the risk of the facility. The
(in the food chapter of the FFDCA), requiring the Secretary,
differing laws and circumstances that apply to FSIS, for
Secretary may use federal, state, or local officials for domestic
with respect to facilities that must register under FFDCA §
example, that agency's inspectors are in meat and poultry
inspections and foreign country representatives for foreign
415, to al ocate inspection resources according to the “known
slaughter and processing plants every day, where they must
ones. The inspection schedule must be implemented within 18
safety risks” of the food and countries involved, as well as the
organoleptically (by the senses) examine every live animal and
months of enactment and follow these prescribed categories
facility’s compliance history, the rigor of its hazard analysis and
every carcass for defects, and must pass every item before it
and frequencies:
risk-based preventive controls, among other stated criteria.
can enter commerce.
Establishes separate inspection frequencies and increasing
•
Category 1, a high-risk food facility that manufactures or
frequency rates for domestic and foreign facilities for both
Current law, which derives from FFDCA § 704 (in the General processes food, must be inspected at least every 6-12 months;
high-risk and non-high-risk entities. Establishes requirements
Authority chapter of the FFDCA), authorizes but does not
for identification and inspection at ports for imported foods,
require FDA to inspect food facilities. Therefore, no periodic
•
Category 2, a low-risk facility that manufactures or
including consideration of whether the shipment has been
inspection frequency is currently required.
processes food or a facility that packs or labels food, must be
inspected at least every 18 months to 3 years;
certified under a voluntary qualified importer program or
Obama Administration: The FSWG stated that the
other criteria.
Administration would work with Congress on “critical
•
Category 3, a food facility that holds food, must be
The Secretary shall improve coordination and cooperation
legislation that will provide key tools .... to keep food safe.”
inspected at least every 5 years.
with the Secretaries of Agriculture and Homeland Security to
One tool it cited was “the ability to use resources flexibly to
Authorizes the Secretary to modify the types of food facilities
target food inspection resources. It also authorizes interagency
target food at the highest risk and achieve the maximum gain
within each category, to alter inspection frequencies if needed
agreements regarding seafood (involving HHS, DHS,
for public health.” However, Dr. Hamburg’s testimony noted
to respond to illness outbreaks and recalls, and to inspect a
Commerce Department, and the Federal Trade Commission,
several issues regarding § 105 of the House bill (as introduced
facility more frequently than specified. In doing so, the
among other agencies); such agreements may include
prior to subcommittee markup), including both the large
Secretary is to consider the type of food at the facility, its
examining and testing seafood imports, coordinating
amount of resources needed to meet the inspection goals in
compliance history, whether an importing facility is certified
inspections of foreign facilities, standardizing data, among
the bill and the difficulty of hiring and training the additional
(under the new certification requirements the bill would set;
others. Provides for advisory committee consultation within
staff that would be needed. She recommended modification
see below), and other factors determined relevant by the
HHS with respect to allocating inspection resources.
“to take into account the operational challenges involved, such Secretary. The Secretary is authorized to publish in the
as by changing these inspection frequencies .... flexibility to
Federal Register adjustments to inspection frequencies in
Subsection (b) of this section requires the Secretary to report
modify the inspection requirements based on the best available category 2 and 3 facilities, and is required to publish in the
to Congress, by February 1 of each year, providing specified
data on risk,” among other things. In his subsequent testimony
Federal Register any proposed modifications of the
information regarding: domestic and foreign food facility
on the House committee-approved bill, Mr. Taylor expressed
categorization of any facility or facility type. The Secretary
inspections (including those scheduled but not completed);
support for its flexibility to adjust inspection frequencies.
must submit an annual report on the inspections to Congress,
food imports; and FDA foreign offices. Such reports shall be
made publicly available.
which is to include numbers inspected and cost estimates, and
also to submit a 3-year report on any needed adjustments to
the risk-based inspection schedule. These recommendations
must consider a number of factors listed in this section such as
the nature of the food product and how it is handled; its
association with food-borne illnesses, and others.
Laboratory Accreditation
Testing by Accredited Laboratories (§ 110)
Recognition of Laboratory Accreditation for Analyses
of Foods (§ 202)
Neither the FFDCA nor applicable regulations address the
Establishes a new FFDCA § 714, which requires the Secretary
accreditation of food laboratories or the establishment of
to establish a standards-based program for the recognition of
Subsection (a) establishes a new FFDCA § 422, requiring the
laboratory networks.
laboratory accreditation bodies that accredit laboratories to
Secretary, within two years of enactment, to establish a
perform analytical testing for the purposes of this section. In
program for food testing by accredited laboratories that meet
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S. 510 (Manager’s Amendment)
FDA continues to support an existing Food Emergency
evaluating whether such bodies meet the Secretary’s
certain requirements established by the Secretary; to establish
Response Network (FERN), a nationwide network made up of standards, the Secretary is authorized to observe these bodies’ a publicly available (subject to national security concerns)
more than 130 federal, state and local public health
on-site audits of laboratories, and to conduct an on-site audits
registry of accrediting bodies recognized by the Secretary and
laboratories that support emergency response activities
under specified conditions. The Secretary is required to
accredited laboratories (such accredited entities would be
related to food defense and food safety. The FDA Office of
publish on the FDA website a list of accreditation bodies.
required to report any changes to the Secretary). Foreign labs
Regulatory Affairs publishes a Laboratory Manual with a
would need to meet the same accreditation standards as
Any analytical testing must be done by a laboratory that is
section on “Private Laboratory Guidance.” The Guidance
domestic labs. The Secretary shall develop model accreditation
accredited by an above-accredited body and that samples such
seeks to “establish a uniform, systematic, and effective
standards that address sampling and analytic procedures,
articles with adequate controls to ensure the integrity of the
approach to ensuring that private labs performing analyses on
quality controls, personnel training and qualifications, and
samples, except that testing pursuant to FFDCA §801(a)
FDA-regulated imported commodities submit scientifically
other matters. The Secretary shall review accreditation bodies
(relating to testimony on refused imports) must be by an
sound data.” The Guidance, although unenforceable, provides
at least once every five years and promptly revoke recognition
independent laboratory. This section contains notification
recommendations on sampling techniques, requirements of lab
for an accrediting body that is not in compliance with this
requirements for accreditation bodies and for others (such as
analysts, reviewing the analyzed packages, and auditing
section. Food testing shall be conducted by accredited labs no
the results of al analyses conducted), among other provisions.
analyzed samples.
later than 30 months after enactment, unless otherwise
Any violation of this section’s requirements is considered a
exempted.
In January 2009, FDA issued guidance regarding voluntary
prohibited act under the FFDCA.
third-party certification programs for foods and feeds. The
Food testing in the following situations shall be conducted by a
guidance does not focus on laboratory accreditation, but
federal laboratory or a laboratory accredited according to the
rather the ways in which third-party certifiers should use
requirements of this section whenever such testing is: (1) by
laboratory results in their assessments. The guidance, which
or for an owner or consignee in response to a specific testing
also is not enforceable, says that laboratories should conform
requirement under the FFDCA or its regulations when applied
to existing international standards and guidelines.
to address an identified or suspected food safety problem and
as required by the Secretary as the Secretary deems
appropriate; and (2) on behalf of an owner or consignee in
support of an imported food submission under Section 801(a)
and under an FDA Import Alert that requires successful
consecutive tests.
Any such testing results must be sent directly to the FDA,
unless the Secretary by regulation exempts the submission of
those results upon a determination that the results “do not
contribute to the protection of public health.” Certain
exceptions may apply.
If testing performed by an accredited state or local
government laboratory results in a state recalling a food, the
Secretary shall review the sampling and testing results for the
purpose of determining the need for a national recall, or other
compliance and enforcement activities. This authority does not
limit the ability of the Secretary to review and act upon
information from food testing, including determining the
sufficiency of such information and testing.
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S. 510 (Manager’s Amendment)
Subsection (b) requires the Secretary, within 180 days of
enactment and biennial y thereafter, and in consultation with
federal agencies and state, local, and tribal governments, to
make a publical y available report to Congress regarding
progress in implementing a national food emergency response
laboratory network. Such a network: (1) provides ongoing
surveillance, rapid detection, and surge capacity for large-scale
food-related emergencies, including intentional adulteration of
the food supply; (2) coordinates the capacities of state, local,
and tribal food laboratories, including data sharing to develop
national situational awareness; (3) provides accessible, timely,
accurate, and consistent food laboratory services nationwide;
(4) develops and implements a methods repository for use by
federal, state, and local officials; (5) responds to food-related
emergencies; and (6) is integrated with relevant laboratory
networks administered by other federal agencies.
Other Laboratory Provisions
Plan and Review of Continued Operation of Field
Integrated Consortium of Laboratory Networks (§
Laboratories (§ 209)
203)
Several national networks of laboratories are currently in
operation. None is explicitly authorized in law. Existing
The House bill contains no provision comparable to the
The Secretary of Homeland Security, in consultation with the
networks include: the Laboratory Response Network (LRN),
integrated consortium provision in S. 510. § 209 does require
Secretaries of HHS and USDA and the EPA Administrator,
run by CDC and federal and state partner groups to conduct
the Secretary to submit, to Congress and the Comptrol er
shall maintain an agreement whereby relevant laboratory
public health testing during emergencies; the Food Emergency
General, a reorganization plan at least 90 days prior to
network members: (1) agree on common laboratory methods
Response Network (FERN), coordinated by FDA; and the
terminating or consolidating any of the 13 field laboratories
to facilitate information sharing regarding animal health,
National Animal Health Laboratory Network, coordinated by
responsible for analyzing food that are operated by FDA’s
agriculture, and human health; (2) identify the means by which
USDA.
Office of Regulatory Affairs, or terminating or consolidating
each laboratory network member could work cooperatively
any of the 20 district offices with responsibility for food safety.
to optimize national laboratory preparedness and provide
Obama Administration: Its FY2010 budget requested an
This section also subjects such a reorganization plan to the
surge capacity during emergencies; and (3) engage in ongoing
increase in the number of chemical laboratories under FERN
requirements of the Congressional Review Act (5 U.S.C. §§
dialogue and build relationships to support a more effective
through cooperative agreements, and to invest in FDA high-
801-808), which establishes a special set of expedited or "fast
and integrated response during emergencies. The Secretary of
volume laboratories for better sample analyses and faster
track" legislative procedures, primarily in the Senate, through
Homeland Security shal publish and report biennial y to
testing. The administration proposed retaining the FY2010
which Congress may enact joint resolutions disapproving
Congress on the progress of this integrated consortium.
level for FY2011.
agencies' final rules.
Third-Party Accreditation
Certification and Accreditation (§ 109, part)
Accreditation of Third-Party Auditors (§ 307)
The use of so-called third parties is increasingly being
Appears to be less detailed with regard to how the Secretary
Amends FFDCA Chapter VIII (regarding imports and exports),
promoted as a method for helping regulators such as the FDA
is to establish a third-party certification program. As noted,
adding a new § 808, for a system of third-party auditors and
to carry out their oversight responsibilities, particularly when
qualified certifying entities are to be accredited and given the
audit agents that are accredited to certify that entities involved
they are being asked to stretch and careful y target finite
responsibility to provide such certifications when the
with imports are meeting applicable FDA requirements.
inspection dollars and personnel. However, the idea is
Secretary determines such certifications are needed, and the
Generally, the Secretary would first recognize accreditation
controversial, particularly among food safety advocates, who
specifics of that certification, including its format, would be left bodies. Such bodies in turn could accredit the third-party
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H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
have expressed concern about potential conflicts of interest
to the Secretary’s regulatory discretion. § 109 defines
auditors or audit agents, who in turn could be tasked to certify
between auditors and the companies they audit and about
“qualified certifying entity” as “an agency or a representative of eligible entities. Defines the following terms: audit agent,
potential y less rigorous oversight. They cite a number of
the government from which the article originated, as
accreditation body, third-party auditor, accredited third-party
recent food safety crises including the Salmonella
designated by such government or the Secretary; or an
auditor, consultative audit, eligible entity, and regulatory audit.
contamination of peanut products in late 2008 and early 2009,
individual or entity determined by the Secretary or an
even though the peanut product supplier had passed several
accredited body recognized by the Secretary to be qualified to
The Secretary must establish the new system within two years
private third-party and state inspections.
provide a certification...”
of enactment and is required to: promptly revoke recognition
of accreditation bodies found not in compliance with this
Among many questions is the definition of a “third party.”
Requires the Secretary to issue regulations to ensure that
section’s requirements and develop model accreditation
Broadly, it may be any entity or person that is formal y
certifying entities and their auditors are free from conflicts of
standards (within 18 months after enactment), taking into
assigned one or more responsibilities that otherwise would be
interest (in doing so, the Secretary may rely on or incorporate account existing standards so as to avoid duplication of efforts
performed by another entity. In practice and in proposed
international certification standards), Contains extensive
and costs. Accreditation bodies must submit to the Secretary a
legislation, third parties might variously and specifically be
language on what these regulations are to stipulate, such as
list of all accredited third-party auditors and audit agents they
defined as a state or local agency, another federal agency, a
that entities have written policies; that they obtain and
have accredited.
foreign government, a professional or scientific body, or even
maintain annual declarations of al personnel involved in audits
a private company, often one that specializes in the task to be
regarding their financial interests in any producer,
Accreditation bodies must, prior to accrediting a foreign
performed. Private companies frequently rely on third party
manufacturer, and other specified types of food companies;
government or foreign government agency, perform reviews
auditors, certifying agents and the like, often including
that they not be owned, operated, controlled, or have any
and audits of that government or agency’s food safety
provisions in their contracts with suppliers, for example, that a other financial ties to those or the products they are
programs, systems, and standards, as the Secretary deems
third party verify that certain specifications—whether safety,
certifying. (However, the certifying entity could provide
necessary, to determine that the foreign government is
quality, quantity, or other desired attributes—are being
consultative services to a facility it is certifying so long as the
capable of ensuring that entities or foods it certifies will meet
achieved. Within the federal government, examples include a
Secretary has approved its procedures ensuring the separation
the requirements of the FFDCA. Prior to accrediting foreign
variety of voluntary third-party auditing programs. For
of these two functions.)
cooperatives and other third parties, accreditation bodies
example, “Process Verification and Audit Based Programs,”
must perform reviews and audits as the Secretary deems
operated by USDA's Agricultural Marketing Service (AMS) and
The Secretary must require that, to the extent applicable, any
necessary to determine that the entities to be certified have
are funded through user fees. These programs are intended
certification provided by a certifying entity be renewed
systems in place to ensure the entities or foods will meet the
primarily to certify food quality and marketing attributes, as
whenever the Secretary deems it appropriate; and he/she must requirements of the FFDCA.
opposed to safety requirements per se.
refuse to accept any certification determined to be no longer
valid or reliable. The Secretary must provide for the electronic Accreditation bodies may not accredit a third party auditor
FDA appears to have argued in the past that its authority is
submission of certifications, in coordination with Customs and
unless it agrees to issue a written food or facility certification
broad enough, under the FFDCA and the PHS Act, at least to
Border Protection.
to accompany each food shipment into the United States from
propose regulations on how independent sampling services
an eligible entity. The Secretary must consider certifications of
and private laboratories can be used to satisfy food import
Authorizes the Secretary, in evaluating an accreditation body,
foods offered for import and participation in the voluntary
requirements. However, FDA does not currently regulate
to observe that body’s on-site audits of qualified certifying
qualified importer program when targeting inspection
private laboratories that analyze imported, FDA regulated
entities, and to conduct on-site audits of certified facilities
resources and must use certification to determine whether
goods. (Under FFDCA § 704, FDA has been required to have
“upon request. .... and upon presentation of appropriate
food meets the requirements for import and to determine
published criteria for accrediting independent persons to
credentials, at reasonable times and within reasonable limits
whether facilities are eligible for the voluntary qualified
conduct inspections related to Class II and III devices.)
and in a reasonable manner ....” to include access to records.
importer program established in § 302 of this act. Accredited
third-party auditors can only issue food and facility
In January 2009, following a request for information and
certifications after conducting certain audits and activities.
publication of a draft document, FDA issued guidance setting
Only the Secretary and accredited third-party auditors can
criteria for others’ use of voluntary third-party certification
provide facility certifications. Only the Secretary, a Secretary-
programs for foods and animal feeds, noting that the federal
designated agency or representative of the country from
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S. 510 (Manager’s Amendment)
government “supports voluntary certification programs as one
which the food for import originated, or accredited third-
way to help ensure products meet U.S. safety and security
party auditors can provide food certifications.
standards and to allow federal agencies to target their
resources more effectively.” FDA has also published a notice
Accredited third-party auditors or audit agents must prepare
of a pilot program of voluntary third-party certification for
audit reports, which are to include a number of specified
imported shrimp.
elements; provide, at the Secretary’s request, an onsite audit
report or other reports or documents required for the audit
Obama Administration: Dr. Hamburg’s testimony
process for any eligible entity it has certified (with certain
expresses support for relying not only on foreign governments
exceptions); and immediately notify the Secretary of the
for international inspections but also having the flexibility to
discovery during an audit of “a condition that could cause or
explore use of an accreditation system and audit the
contribute to a serious risk to the public health” and the
performance of accredited third parties.
identification of the eligible entity subject to the audit. Third-
party auditors and audit agents must adhere to a series of
explicit prohibitions in this section designed to avoid conflicts
of interest. The Secretary is required to promulgate
regulations within 18 months of enactment to protect against
conflicts of interest between accredited third-party auditors
and eligible entities to be certified by such auditors or audit
agents.
The Secretary must withdraw accreditation from a third-party
auditor in certain circumstances, such as if a food certified by
the auditor is linked to an outbreak of foodborne illness, and
the Secretary must also establish procedures to reinstate
accreditations that have been withdrawn. The Secretary must
also establish, by regulation, a program similar to that used by
USDA, by which third-party auditors and audit agents
reimburse FDA for the cost of establishing and administering
the accreditation system. The reimbursement program must
be revenue neutral and not generate surplus revenue.
Eligible entities must apply for annual recertification if they
intend to participate in the voluntary qualified importer
program or if they are required to provide certification to the
Secretary for food offered for import into the U.S. False
statements made to or by accredited third-party auditors are
subject to criminal penalties. The Secretary must, at least once
every 4 years, reevaluate accreditation bodies and evaluate the
performance of accredited third-party auditors and audit
agents (in part through the compliance history of the entities
they certified). The Secretary may conduct onsite audits of
certified entities with or without the accredited third-party
auditor present. The Secretary must make publicly available a
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H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
registry of accreditation bodies and third-party auditors.
Audits performed are not considered inspections under
FFDCA § 704, and this section does not affect the Secretary’s
authority to inspect any eligible entity.
Food Traceability
Traceability of Food (§ 107); Unique identification
Enhancing Tracking and Tracing of Food and
number for food facilities, importers, and custom
Recordkeeping (§ 204)
Traceability means the ability to follow the movement of a
brokers (§ 206)
product through its stages of production and distribution. As a
The Secretary, in coordination with USDA and state officials,
food safety tool, traceability helps government authorities and
Amends FFDCA § 414 to require the Secretary to establish by
shal improve the capacity of FDA to effectively and rapidly
industry officials to locate the source of contamination
regulation a tracing system for food in, or to be imported into, track and trace foods in the event of an outbreak. Within 270
(traceback) and to locate those who may have received the
the United States. These regulations are to enable the
days of enactment, the Secretary is required to establish pilot
contaminated food (trace forward). Records sufficient to
Secretary “to identify each person who grows, produces,
projects in coordination with the food industry to explore and
identify products and to trace them quickly are considered to
manufactures, processes, packs, transports, holds, or sel s such evaluate methods to rapidly and effectively identify recipients
be important prerequisites for a successful recall. (see below.)
food in as short a timeframe as practicable but no longer than
of food to prevent or mitigate a foodborne illness outbreak
Among other issues are the potential administrative and cost
2 business days.” The Secretary is authorized to include in
and to address credible threats of serious adverse health
burdens that a more extensive regulatory program might
such regulations the use of lot numbers, a standardized format
consequences or death to humans or animals as a result of
impose on those in the food system, as well as privacy
for pedigree information, and the use of a common food
such food being adulterated or misbranded.
concerns about records.
nomenclature.
Participants are to include one or more projects with the
§ 306 of the Public Health Security and Bioterrorism Response However, before promulgating regulations the Secretary is
processed food sector and one or more projects coordinating
Act of 2002 amended the FFDCA to require any person who
required to first identify tracing technologies and
processors or distributors of fruits and vegetables that are
manufactures, processes, packs, transports, receives, holds or
methodologies that can enable each of the food industry
“raw agricultural commodities,” reflecting the diversity of the
imports foods into the United States to keep records that
sectors to: maintain the full pedigree of the food from source
food supply and include at least three different types of foods
enable the identification of the immediate previous supplier
through subsequent distribution; make traceback
that have been the subject of significant outbreaks during the
and the immediate subsequent recipient of the food (FFDCA §
interoperable with other systems; and use a unique identifier
5-year period preceding enactment, among other criteria for
414; see also “Records Access and Records Inspection,”
for each facility. Prior to proposing regulations, the Secretary
project selection intended to inform future rule promulgation.
above).
also first must, to the extent practicable, assess costs, benefits
The Secretary shall report to Congress its findings for
and feasibility of adopting such technologies; conduct at least
improving the tracking and tracing of food within 18 months of
Obama Administration: The FSWG announced in July
two public meetings; and conduct one or more pilots.
enactment.
2009 the following actions intended to improve traceability:
The traceback regulations will apply to agricultural producers
The Secretary, in coordination with USDA and state
•
within 3 months, FDA is to issue draft guidance on what
(and retailers), but the provision specifically exempts food that departments of health and agriculture, shall collect additional
industry could do to establish product tracing systems;
is produced on a farm or fishery (wild or farmed) and sold by
data to assess product tracing technologies, among other
•
within 3 months, federal agencies are to implement a new that farm or fishery directly to a consumer, restaurant, or
information. The Secretary, in consultation with USDA, shall
“incident command system to address outbreaks of foodborne grocery store. However, such farms and fisheries must keep
also establish within FDA a product tracing system to receive
illness;
records for at least 6 months documenting the restaurants or
information needed to track and trace food.
grocery stores to which it sold; and the restaurants and
•
within 6-12 months, FSIS is to increase the capacity of its
grocery stores are required to keep records documenting the
The Secretary shal publish a notice of proposed rulemaking to
public health epidemiology liaison program to State public
farm source. The Secretary may also exempt a food or a type
establish additional recordkeeping requirements for high-risk
health departments through new hires and expanded
of facility, farm, or restaurant from the regulations, or modify
foods, subject to certain specified conditions (no later than
outreach;
the requirements for these entities, if the Secretary
two years after enactment). The Secretary shall designate such
high-risk foods within one year after enactment based on
•
By July 2009, federal agencies were to ask State and local
“determines that a tracing system for such food ... is not
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S. 510 (Manager’s Amendment)
agencies to update their emergency operations procedures to
necessary to protect the public health.” For this latter
criteria specified in the provision, and shall publish the list of
be consistent with new food disease outbreak guidelines being
category of exemptions, each person who produces,
foods designated as high-risk, which may be subject to updates
issued by the Council to Improve Foodborne Outbreak
manufactures, processes, packs, transports, or holds such food and revision. The provision addresses information protection;
Response;
still must maintain records that identify the immediate
requirements for public input; rules on retention of records;
previous sources of the food and its ingredients and the
and less restrictive requirements (as specified) for: farm-to-
•
A promise that CDC is to work with collaborating States
immediate subsequent recipients.
school or farm-to-institution programs of USDA and other
to evaluate and optimize best practices for more effective
related programs; “identity-preserved labels” with respect to
outbreak investigations, and within 12 months launch a new
Contains language limiting applicability to farms, including
farm sales of food that is produced and packaged on a farm;
system to facilitate information-sharing and adoption of best
requirements that the Secretary coordinate with the Secretary food that is produced through the use of a fishing vessel;
practices.
of Agriculture when conducting pilot projects with respect to
producers of commingled raw agricultural commodities;
farms and when issuing regulations that will impact farms.
Also, the Hamburg and Taylor testimonies express support for
grocery stores; direct farm sales to consumers or grocery
Furthermore, any new tracing system with respect to grain or
§ 107 of the House bill.
store; and others. The Secretary may modify requirements, or
any “similarly handled commodities” (generally, those row
exempt a food or facility from them, if product tracing
crops that have been covered by USDA price supports) must
requirements are not needed to protect public health.
be “limited to enabling the Secretary to identify those who
received, processed, packed, transported, distributed, held, or
The Secretary shall submit a report to Congress “taking into
sold” such a commodity “from the initial warehouse operator
consideration the costs of compliance and other regulatory
that held” it “for any period of time to the ultimate
burdens on smal businesses, and federal, state, and local food
consumer.”
safety practices and requirements, that evaluates the public
health benefits and risks” of limiting the product tracing
requirements to certain identified foods and also limiting the
participation of restaurants in the recordkeeping
requirements.
The provision also specifies the information the Secretary may
request from U.S. farms, subject to certain limitations, but
specifies that the Secretary is not authorized to impose any
limitations on comingled foods. With the exception of farms,
failure to comply with recordkeeping provisions under this
section is prohibited.
This section contains provisions for consideration of small
businesses. Requires the Secretary to issue a ”smal entity
compliance policy guide” setting forth the requirements of
such regulations to assist smal entities in complying with the
registration requirements and other activities (no later than
180 days after the issuance of the regulations under this
section), along with phased-in compliance deadlines for small
and very smal businesses. Smal businesses (as defined by the
Secretary) will have 1 year after final regulations are
promulgated, and very smal businesses (as defined by the
Secretary) 2 years after final regulations.
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Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Foodborne Illness Surveillance and Education
Surveillance (§ 121)
Surveillance (§ 205)
Surveillance for foodborne illness is carried out by the states,
This section generally mirrors the language in § 205 of the
For the purposes of this section, “foodborne illness outbreak”
with assistance from the CDC. States also conduct
Senate bill, but lacks two of the provisions: the requirement
is defined as two or more cases of a similar illness resulting
investigations of foodborne illness outbreaks, in coordination
for a working group on foodborne illness surveillance; and the
from the ingestion of a certain food. This section requires the
with CDC, either FDA or FSIS (depending on implicated or
reauthorization of the food safety capacity grants (see column
Secretary, acting through the Director of the CDC, to
suspected foods), and, if appropriate, other federal agencies.
at left).
enhance foodborne illness surveillance systems by, among
FDA is authorized to carry out such investigations, or to
other things, enhancing system capacity; improving
coordinate with states in doing so: (1) under broad,
coordination and information sharing; incorporating research
permanent authorities in FFDCA § 702 regarding examinations Public Education and Advisory System (§ 122)
findings; making surveillance data available to the public in
and investigations, and § 909 regarding authority to assist
appropriate formats; and integrating systems and data with
states with examinations and investigations; and (2) under
This section of the bill requires the Secretary, in cooperation
other biosurveillance and related federal, state and local
several broad, permanent disease control authorities of the
with private, state and other public organizations, to design
surveillance systems. Appropriations are authorized for these
Secretary of HHS in Title III of the PHS Act, which underpin
and implement a national public education program on food
activities at $24 million annually (FY2011-FY2015). The
CDC’s activities as well. These include PHS Act § 301
safety. The section describes the elements to be included in
Secretary must also establish a working group, comprised of
regarding research and investigations, §§ 311 and 317
the program, and further requires the Secretary to work with
public- and private-sector experts and stakeholders, to meet
regarding federal-state cooperation, and § 361 regarding
states and others to develop and incorporate into the public
and report at least annual y, and make recommendations for
control of communicable diseases. PHS Act § 317R provides
education program regional and national advisories concerning
the improvement of foodborne illness surveillance systems.
an explicit but expired authority of the Secretary of HHS to
food safety.
award grants to state and tribal governments to enhance food
The Secretary shall, within one year of enactment, conduct an
safety surveillance and laboratory capacities. Although this
assessment of state and local food safety and defense
authority has expired, the Secretary of HHS may carry out this
capacities, and shall subsequently develop and implement
activity under the broad, permanent authorities mentioned
strategies to enhance these capacities, in order to achieve a
earlier.
number of stated goals. This section also reauthorizes the
food safety capacity grants in PHS Act § 317R at $19.5 million
A foodborne illness “outbreak” is not defined in law or
for FY2010, and such sums as may be necessary for FY2011
regulations that apply to either CDC or FDA. In common
through FY2015.
public health practice, and as used by CDC, a “foodborne
disease outbreak” is defined as “the occurrence of two or
more cases of a similar illness resulting from the ingestion of a
common food.” As a practical matter, particularly for less
serious hazards, foodborne disease outbreak investigations are
not always launched when only two people are affected.
Botulism is an exception. Because the disease is so often
deadly, and usual y results from improperly canned products
that consumers could keep for years before eating, authorities
typically launch an investigation to identify and remove all
potential y hazardous products that may be linked to a single
case of botulism.
CRS-53
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Mandatory Recall Authority; Reportable Food Registry Notification, Nondistribution, and Recall of
Mandatory Recall Authority (§ 206)
Adulterated or Misbranded Food (§ 111)
The Secretary does not have mandatory recal authority for
Subsection (a) of this section establishes a new FFDCA § 423
foods, except for infant formula under FFDCA § 412(f). A
This section establishes a new FFDCA § 420, effective not
regarding recall of food. If the Secretary determines, based on
voluntary recal by a manufacturer or distributor may be
later than one year after enactment, which requires certain
information gathered through the reportable food registry
undertaken at any time for other foods and al other FDA-
persons who place food in commerce to notify the Secretary
under FFDCA § 417 or through any other means, that there is
regulated products. In urgent situations, FDA may request a
of potential food safety problems; provides the Secretary with
a reasonable probability that an article of food (other than
voluntary recall of an FDA-regulated product [21 CFR
authority to request a voluntary recal of food and to order
infant formula) is adulterated under FFDCA § 402, or
7.40(b)]. The Secretary has authority under FFDCA § 304 to
that distribution of a food be ceased; and establishes authority
misbranded under FFDCA § 403(w) (specifical y regarding
seize foods, drugs, and cosmetics that are adulterated or
of the Secretary to mandate a recall, with procedures
allergen labeling), and the use of or exposure to such article
misbranded when introduced into or while in interstate
reflecting two different levels of threat that may be posed by
will cause serious adverse health consequences or death to
commerce, or while held for sale after shipment in interstate
an affected food.
humans or animals, the Secretary shall provide the responsible
commerce.
party (as defined in FFDCA § 417) with an opportunity to
FFDCA § 420, subsection (a), requires a responsible party [as
cease distribution and recal such article.
Also, the FDA Amendments Act of 2007 (FDAAA, P.L. 110-
defined in FFDCA § 417(a)(1)] or a person required to
85) created FFDCA § 417, which required FDA to establish a
register to import food under § 801(r) (as established by this
If a person fails to comply voluntarily with a request by the
reportable food registry to facilitate product identification and
act), to notify the Secretary if there is reason to believe that
Secretary to cease distribution or sale of, or to recall, an
tracing. Under FFDCA § 417, a “reportable food” is “an article an article of food when introduced into or while in interstate
article of food, the Secretary may order the person to cease
of food (other than infant formula) for which there is a
commerce, or while held for sale (regardless of whether the
distribution and sale, and to immediately notify all persons
reasonable probability that the use of, or exposure to, such
first sale) after shipment in interstate commerce, is adulterated “manufacturing, processing, packing, transporting, distributing,
article of food will cause serious adverse health consequences
or misbranded in a manner that presents a reasonable
receiving, holding, or importing and selling such article;...and to
or death to humans or animals,” and registered food facilities
probability that the use or consumption of, or exposure to,
which such article has been distributed, transported or sold,
must notify the FDA electronically about such a reportable
the article (or an ingredient or component used in any such
to immediately cease distribution of such article,” including
food. Although FDA did not meet the deadline to implement
article) will cause a threat of serious adverse health
products distributed to a warehouse-based third party logistics
the registry within 1 year of enactment of FDAAA, the agency
consequences or death to humans or animals. (This language
providers. The Secretary shall offer the responsible party an
published compliance guidance for industry in September,
is similar to the reporting threshold currently established
opportunity for an informal hearing within two days of
2009, and the reporting requirement became effective at that
under FFDCA § 417.) Failure to notify the Secretary when
issuance of such an order. If the Secretary subsequently
time.
required is prohibited under FFDCA § 301.
determines that the affected foods should not remain in
commerce, the Secretary shall: amend the order to require a
Obama Administration: One of the actions announced by
FFDCA § 420, subsection (b), authorizes the Secretary to
recall; specify a timetable for the recall; require periodic
the FSWG was to begin enhancing communication to the
request a voluntary recal by any person who distributes an
reports from the responsible party; and provide notice to
public, including through an improved individual alert system
article of food that the Secretary has reason to believe is
consumers to whom the food was or may have been
allowing consumers to receive food safety information such as
adulterated, misbranded, or otherwise in violation of the
distributed. If, after the informal hearing, the Secretary
notification of recalls. The FSWG, and the Statement of
FFDCA.
determines that adequate grounds do not exist for the order’s
Administration Policy on H.R. 2749, noted support for
required actions, the Secretary shal vacate or modify the
mandatory recal authority. The Hamburg and Taylor
FFDCA § 420, subsections (c) and (d), authorize the Secretary
order.
testimonies express support for § 112 of the House bill.
to issue an order to cease distribution of any article of food
that the Secretary has reason to believe that the use or
Alcohol beverage are exempt from a mandatory recall or any
consumption of, or exposure to, an article of food may cause
action pending initial action by the Alcohol and Tobacco Tax
serious adverse health consequences or death to humans or
and Trade Bureau.
animals, with an appeal process and other administrative
matters specified (including limits on the Secretary’s authority
The Secretary shall work with state and local public health
to delegate decisions regarding orders). Subsection (e)
officials in carrying out this section, as appropriate. In
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Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
requires the Secretary to issue a mandatory recall order if the
conducting a recal under this section, the Secretary shal issue
Secretary determines that problems have not been addressed
a press release, and other notices as appropriate, to provide
through procedures under subsections (c) and (d). Certain
consumers and retailers with information about the affected
requirements of such order are stipulated.
articles of food and the risks posed; and shall consult USDA
policies regarding providing to the public a list of retail
FFDCA § 420, subsection (f), authorizes the Secretary to
consignees receiving products involved in a Class I recall, and
proceed directly to a mandatory recal order if the Secretary
consider providing such a list to the public, if appropriate. If
has credible evidence or information that an article of food
available, an image of the recalled article must be published on
subject to an order to cease distribution presents an imminent the FDA website. The Secretary’s authority to issue or vacate
threat of serious adverse health consequences or death to
recall orders shall not be delegated to anyone other than the
humans or animals. In such case, the person must immediately
FDA Commissioner and this section shall not affect the
recal the food while stipulated appeal procedures are carried
authority of the Secretary to request or participate in a
out. ("Serious," which distinguishes the thresholds for the
voluntary recall. The Secretary shall establish an “incident
routine (subsection (e)) and emergency (subsection (f))
command operation” within HHS no later than 24 hours after
mandatory recall authorities, is not defined.)
the initiation of a mandatory recall that will adhere to
The Secretary is required, as the Secretary deems necessary,
requirements for coordinated and timely communication. Not
to notify consumers, and state and local health officials, of any
later than 90 days after enactment the Secretary shal include
recall order issued under this section. Failure of a person to
on the FDA website a consumer-friendly search engine for
comply with any order issued by the Secretary under this
locating information about recalled food.
section is prohibited under FFDCA section 301. Any articles
Under subsection (c) of this section, pursuant to FFDCA §
of food intended for import and subject to a cease-distribution 303(f)(2)(A), a person who does not comply with a recal
or recal order under this section shall be refused entry, under order under this section shal be subject to civil money
FFDCA section 801. Nothing in this section shal limit the
penalties. Under subsection (d) of this section, failure to
Secretary's authority to assure food safety through any other
comply with such an order is prohibited under FFDCA § 301.
provisions of the FFDCA, or the Public Health Service Act.
Reporting requirements:
Reportable Food Registry: Exchange of Information (§
112)
•
Requires GAO to submit a report to Congress (no later
than 90 days after enactment) that identifies and evaluates
The food registry reporting requirements under apply to
federal, state and local agencies with mandatory recall
facilities that are required to register under FFDCA § 415.
authority of food, considers models for famer restitution in
This section of the House bill expands coverage to farms
the case of erroneous recal s, and recommends how to
where food is produced for sale or distribution in interstate
minimize economic costs.
commerce, to restaurants and other retail food
establishments, and to those required by this bill to register as
•
Depending on the findings in GAO’s review, USDA shall
importers. The bill newly requires the reporting also of
conduct a feasibility study of implementing a farmer
documented results of any sampling and testing of a reportable indemnification program to provide restitution to producers
food article and of a component of a food article, including:
for incurred losses as a result of an erroneous mandatory
tests conducted pursuant to new § 418 (Hazard Analysis and
recall. This report will be submitted to the House and Senate
Risk-Based Preventive Controls), new § 418A (Food Safety
Agriculture Committees.
Plan), new § 419 (Performance Standards), or new § 714
(Testing by Accredited Laboratories); analytical results of
•
The Secretary shal submit an annual report to the Senate
CRS-55
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
facility environmental testing; or any other information
HELP and House Energy and Commerce Committees on the
deemed relevant by the Secretary.
use of recal authority under § 423. This report shal identify
foods subject to a public health advisory; the number of
This section does not amend the definition of “reportable
responsible parties given an opportunity to cease distribution
food,” which establishes the reporting threshold. The
of or recal a food; the number of recal orders; and a
Secretary must offer an alternative to electronic reporting for
description of instances in which there was no testing for
farms, restaurants, and retail food establishments. Finally, § 112 adulteration.
of the bill contains extensive language on the conditions under
which food registry information may or may not be shared
Improving the Reportable Food Registry (§ 211)
with or disclosed to others including other agencies and to the
public.
Amends FFDCA § 417 to require the Secretary to obtain
from a responsible party consumer-oriented information
Note: The bill here references 21 CFR 1.227(b)(3) to define a
regarding reportable foods (except for fruits and vegetables
farm as “... a facility in one general physical location devoted to that are raw agricultural commodities), no later than 18
the growing and harvesting of crops, the raising of animals
months after enactment: description of the food, affected
(including seafood), or both. Washing, trimming of outer
product identification codes, contact information for
leaves of, and cooling produce are considered part of
responsible parties, and other information deemed relevant by
harvesting. The term ``farm'' includes: (i) Facilities that pack
the Secretary. The Secretary shall also prepare a one-page
or hold food, provided that all food used in such activities is
summary of the reportable food, to be available by internet
grown, raised, or consumed on that farm or another farm
and for grocery stores, as part of its notification process. If a
under the same ownership; and (ii) Facilities that
grocery store sold a reportable food subject to posting, the
manufacture/process food, provided that all food used in such
store shal prominently display such summary information for
activities is consumed on that farm or another farm under the
14 days no later than 24 hours after the one-page notification
same ownership.” The bill here also makes the same reference is published. Within one year of enactment, the Secretary shall
to define a retail food establishment.)
publish a list of “conspicuous locations” for posting such
notifications. Failure to post a required notification is
prohibited.
Administrative Detention of Food
Administrative Detention (§ 132)
Administrative Detention of Food (§ 207)
The Secretary has authority for the administrative detention of Like the S. 510 manager’s amendment, this section amends
This section amends FFDCA § 304(h) in two ways. First, the
foods pursuant to FFDCA §§ 304(h) and 801. Under FFDCA §
FFDCA § 304(h) to requirement for “credible evidence or
requirement for “credible evidence or information” is lowered
304(h), an FDA officer or qualified employee may order the
information” to “reason to believe” and amends the standard
to “reason to believe.” Second, the standard “a threat of
detention of an article of food for up to 30 days if the FDA
of “a threat of serious adverse health consequences or death
serious adverse health consequences or death to humans or
official “has credible evidence or information indicating that
to humans or animals” to “adulterated or misbranded,” but
animals” is changed to “adulterated or misbranded.” Thus,
such article presents a threat of serious adverse health
the House-passed version of H.R. 2749 also adds “or
FFDCA § 304(h)(1)(A) would read: “An officer or qualified
consequences or death to humans or animals.” The detention
otherwise in violation of this Act.” Unlike S. 510, the House
employee of the Food and Drug Administration may order the
request must be approved by the Secretary or the Secretary’s
bill extends the maximum period to detain an article of food
detention . . . of any article of food that is found during an
designated official. Detention orders may be appealed to the
under § 304(h) from 30 days to 60 days; strikes a sentence
inspection, examination, or investigation under this Act
Secretary.
regarding how a subsection may be construed regarding
conducted by such officer or qualified employee, if the officer
delivery of an article of food pursuant to the execution of a
or qualified employee has reason to believe that such article is
Under FFDCA § 801, FDA officers and qualified employees
bond while the food is subject to a detention order; and
adulterated or misbranded.” Within 120 days of enactment,
must request the Secretary of Homeland Security to hold food extends the time al owed for the Secretary to act after an
the Secretary shall issue an interim final rule to implement the
CRS-56
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
at the port of entry for up to 24 hours if they possess
appeal of a detention order has been filed from 5 days to 15
amended authority, and the amendments to FFDCA § 304(h)
“credible evidence or information indicating that an article of
days. The Secretary is required to issue regulations or
shal be in effect 180 days after enactment.
food presents a threat of serious adverse health consequences
guidance to implement the amendments, and the amendments
or death to humans or animals,” and that officer or qualified
shall take effect 180 days after enactment.
employee “is unable to inspect, examine, or investigate such
article upon the article being offered for import.” The request
to hold the food must be approved by the HHS Secretary or
his or her appropriately designated official. The FDA’s ability
to hold such food for up to 24 hours is intended to enable
“the Secretary to inspect, examine, or investigate the article as
appropriate.”
Obama Administration: The Hamburg and Taylor
testimonies express support for § 132 of the House bill.
Intentional Adulteration and Domestic Food Defense
Hazard Analysis, Risk-Based Preventive Controls,
Protection Against Intentional Adulteration (§ 106)
Food Safety Plan, Finished Product Test Results from
Intentional adulteration of foods can occur due to terrorism
Category 1 Facilities (§ 102)
Subsection (a) of this section establishes a new FFDCA § 420,
or out of economic motivation. Examples of the latter include
requiring the Secretary, within 18 months of enactment, in
findings in early 2007 of melamine in pet food ingredients from Subsection (c) of this section establishes a new FFDCA §
coordination with the DHS and in consultation with USDA, to
China. Melamine—apparently added to boost the ingredients'
418C, Food Defense, requiring the owner, operator, or agent
promulgate regulations to protect against the intentional
protein readings—sickened or killed many dogs and cats in
of a facility to develop and implement a written food defense
adulteration of food subject to this act. Regulations shal apply
North America. The ingredients subsequently were found in
plan before introducing any shipment of food into interstate
only to food: (1) for which the Secretary has identified clear
some hog, chicken, and fish feed. Although a risk assessment
commerce. Lists required elements of the plan, including an
vulnerabilities; and (2) that is in bulk form rather than final
by FDA and USDA indicated the problem posed virtual y no
assessment to identify conditions and practices that may
packaging. To make such determinations, the Secretary shall
risk to humans, melamine turned up again in 2008 in milk
permit a hazard to be intentionally introduced, a description of conduct vulnerability assessment of the food system (including
products, milk-derived ingredients, and finished food products
preventive measures to minimize such risks and of corrective
consideration by DHS), considering uncertainties, risks, costs,
containing milk from China.
actions to be taken if necessary, and other elements.
benefits, available mitigation strategies, and other factors. This
section shal not apply to food produced on farms, except for
FFDCA § 801(h) and (i), regarding imports and exports,
Defines “hazard” for the purposes of this section. Authorizes
milk. Failure to comply with the requirements of this
require the Secretary to increase the number of import
the Secretary to require by regulation or guidance the
subsection is prohibited.
inspections, giving greatest priority to the detection of
adoption of preventive measures for specific product types;
intentional adulteration of food, and to improve information
al ows for alternative measures to be approved by the
Subsection (b) of this section requires the Secretary, within
management systems and develop rapid detection methods to
Secretary; contains a number of reassessment, plan revision,
one year of enactment, to issue appropriate guidance
serve this purpose. FDA’s current food regulations do not
recordkeeping, and records access requirements similar to
regarding the requirements of this section, and authorizes the
specifically address intentional contamination of foods. FDA
those that facilities must follow under this section of the bill
Secretary, in coordination with the Secretaries of DHS and
has published some guidance documents regarding protection
when developing and implementing hazard prevention plans
USDA, to issue guidance documents related to protection
of the food supply from intentional contamination. The agency for unintentional contamination.
against intentional food adulteration. These guidance
also has an internal work group on intentional economic
documents and the vulnerability assessment of the food
adulteration and conducted, on May 1, 2008, a public meeting
system may require limited distribution due to national
on the issue.
security concerns. The Secretary will periodically review
required regulations and guidance required by this section, and
There is currently no statutory requirement for the
update them if needed.
CRS-57
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
development of a comprehensive agriculture and food defense
National Agriculture and Food Defense Strategy (§
strategy. There are, however, other examples of required,
108)
comprehensive, quadrennial reviews of this type. The
Quadrennial Defense Review is perhaps the best-known
Within one year of enactment, the Secretary and the
example. The Implementing Recommendations of the 9/11
Secretary of Agriculture, and in consultation with the
Commission Act of 2007 (P.L. 110-53) requires the Secretary
Secretary of Homeland Security, shal prepare a National
of the Department of Homeland Security (DHS) to routinely
Agriculture and Food Defense Strategy, to be submitted to
conduct a Quadrennial Homeland Security Review, beginning
relevant congressional committees and made public on USDA
in FY2009. The Pandemic and Al -Hazards Preparedness Act
and HHS websites (in a manner consistent with national
(P.L. 109-417, December, 2006) requires the Secretary of HHS
security interests). The strategy shall include an
to routinely prepare a quadrennial National Health Security
implementation plan and a research agenda, and be consistent
Strategy and implementation plan, beginning in 2009.
with the National Incident Management System; the National
Response Framework; the National Infrastructure Protection
“In November 2002, Congress passed legislation creating
Plan; the National Preparedness Goals; and other relevant
[DHS]. Among its responsibilities is overall coordination of
national strategies. The strategy must be revised at least every
critical infrastructure protection activities....In June 2006, the
four years. The strategy shall describe the process by which
Bush Administration released a National Infrastructure
HHS, DHS, and USDA will achieve a set of goals laid out in
Protection Plan. This Plan presents the process by which the
this act, and evaluate the progress made by federal, state, local,
Department of Homeland Security intends to identify those
and tribal governments towards achieving those goals. The act
specific assets most critical to the United States, across all
lists 17 specific goals, covering preparedness, detection,
sectors, based on the risk associated with their loss to attack
emergency response, and recovery.
or natural disaster, and then to prioritize activities aimed at
maximizing the reduction of those risks for a given
Food and Agriculture Coordinating Councils (§ 109)
investment.” (Source: CRS Report RL 30153, Critical
Requires the Secretary of Homeland Security, in coordination
Infrastructures: Background, Policy, and Implementation, by
with the Secretaries of HHS and Agriculture, within 180 days
John D. Moteff.) At present, DHS has identified several critical
of enactment and annually thereafter, to report on the
infrastructure and key resources sectors, including
activities of the Food and Agriculture Government
“Agriculture and Food.” For each sector, a Government
Coordinating Council and the Food and Agriculture Sector
Coordinating Council and a (private) Sector Coordinating
Coordinating Council, regarding their progress in facilitating
Council have been established to share data and best
public-private partnerships; facilitating information exchange;
practices, and to support risk-based planning.
developing best practices for coordinated preparedness and
With regard to building domestic capacity, in general,
response; and means to protect the U.S. economy and public
requirements in this section are not explicit in current law, but
health in the event of a food or agricultural incident.
the Secretary would not be prohibited from undertaking these
Building Domestic Capacity (§ 110)
assessments and reporting the findings.
Establishes a number of assessment and reporting
FDA has initiated a number of activities focusing on economic
requirements regarding domestic capacity to prevent or
adulteration of foods and other products it regulates, including
address food safety threats, as follows:
the establishment of an internal working group.
Within two years of enactment, the Secretary (in coordination
with USDA and DHS) must report to Congress regarding
measures to promote food safety and supply chain security,
CRS-58
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
and prevent foodborne illness outbreaks, covering certain
identified areas. In preparing the initial report, the Secretary
shall describe ways to improve laboratory capability and
capacity, information systems, risk assessment systems for
food, and include an analysis of FDA’s handling of foodborne
outbreaks during the five years prior to enactment that
involved fruits and vegetables that are raw agricultural
commodities, as defined in FFDCA § 201(r).
HHS and USDA shall, biennially, submit to Congress a joint
food safety and food defense research plan, which may include
studying the long-term health effects of foodborne illness. The
plan shal include a list and description of projects conducted
during the previous two-year period, and the plan for projects
to be conducted in the following two years.
HHS shall, annually, submit to Congress an evaluation of the
effectiveness of each HHS-administered program. The
evaluation will assess each program’s effectiveness in achieving
“legislated intent, purposes, and objectives,” and will include
recommendations for consolidation and elimination to reduce
duplication and inefficiencies. The report will be made publicly
available. (Note: The language of this provision is not limited
to food safety programs.)
Not later than one year after enactment, the Secretary shal
conduct a study of issues associated with developing and
implementing a program that requires “unique identification
numbers” for each food facility registered with FDA and for
each broker that imports to the United States. A report to
Congress on “unique identification numbers” is due within 15
months after enactment.
State and Local Food Safety Roles and Training
Support for Training Institutes (§ 214)
Improving the Training of State, Local, Territorial,
and Tribal Food Safety Officials (§ 209)
Although federal agencies such as the FDA and FSIS have
Requires the Secretary to provide financial and other
national responsibility for food safety under their respective
assistance to appropriate entities to establish and maintain at
Creates a new FFDCA § 1011 which requires the Secretary to
authorizing statutes, state and local food safety agencies
least one university-affiliated institute to train federal, state
set standards and administer training and education programs
(usually located within health, agriculture, or environment
and local officials in food protection activities.
for employees of state, local, territorial, and tribal food safety
departments) have long played major, and in some cases lead,
authorities relating to their responsibilities under the FFDCA,
roles, with responsibility for illness surveillance, response to
and authorizes the Secretary to enter into examination,
local outbreaks, and inspection and oversight of food safety
testing, and investigations partnerships with such officials and
and local public health laws in restaurants and grocery stores.
their employees.
CRS-59
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Often these activities may be conducted in col aboration, or
The Secretary shall coordinate with USDA’s extension
under contract, with federal authorities. Notable examples
activities of the National Institute of Food and Agriculture
include the Grade A Pasteurized Milk Ordinance and the
(NIFA) in advising producers and smal processors of new
National Conference of Interstate Milk Shipments (where
requirements under this act. Also, the Secretary, within 180
federal authorities collaborate with state authorities and the
days of enactment, shal enter into agreements with the
milk industry to ensure the safety of milk shipped in interstate
Secretary of Agriculture to provide competitive training and
commerce), the National Shel fish Sanitation Program (a
technical assistance grants, through NIFA, for farmers, smal
federal-state program to ensure the safety of shellfish), and
food processors, and smal fruit and vegetable merchant
FDA-state contract inspection agreements (where states
wholesalers, in accordance with § 405 of the Agricultural
conduct facility inspections for FDA).
Research, Extension, and Education Reform Act of 1998
Currently no specific legislative language authorizes support
(AREERA), as established by this act (see below). There are
for a training institute. FDA does provide funding to state and
authorized to be appropriated for new FFDCA §1011 such
local agencies through various grants and cooperative
sums as necessary for FY2011-FY2015.
agreements to help them conduct such activities as food
Creates a new AREERA § 405, “National Food Safety Training,
defense, laboratory improvements, and food safety training;
Education, Extension, Outreach and Technical Assistance
this funding totaled approximately $11.4 million in FY2008 and
Program.” The Secretary of Agriculture shall, through NIFA,
was in addition to an estimated $8 million states received for
award competitive grants to carry out the program authorized
FDA contracts to conduct food inspection that year
above, as specified. Priority shall be given to projects for small
Source: Stronger Partnerships for Safer Food: An Agenda for
and medium-sized farms, beginning farmers, social y
Strengthening State and Local Roles in the Nation’s Food
disadvantaged farmers, smal processors, or smal fresh fruit
Safety System, accessed February 3, 2010 at
and vegetable merchant wholesalers. Grants are limited to
http://www.rwjf.org/files/research/
terms of not more than three years. Eligible entities are: (1) a
20090417foodsafetyfinalreport.pdf.
state cooperative extension service; (2) a federal, state, local,
or tribal agency, a nonprofit community-based or non-
governmental organization, or an organization representing
owners and operators of farms, smal food processors, or
small fruit and vegetable merchant wholesalers that meet
specified requirements; (3) an institution of higher education
(as defined) or a foundation maintained by such institution; (4)
a collaboration of 2 of more eligible entities; or (5) other
entities as determined by the Secretary. Grants may be made
to projects involving more than one state. The Secretary may
issue best practices or other guidelines based on findings from
this grant program. There are authorized to be appropriated
for new AREERA § 405 such sums as necessary for FY2011-
2015.
Enhancing Food Safety (§ 210)
Subsection (a) of this section replaces FFDCA § 1009,
regarding grants to states for inspections. New language would
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authorize grants to states, localities, territories, Indian tribes,
and certain non profit entities, to be used for: undertaking
food safety examinations, inspections and investigations;
training to the Secretary’s standards for conducting such
activities; and building laboratory capacity, among other things.
Sets out eligibility and application requirements and
procedures; authorizes appropriation of such sums as
necessary for grants from FY2011-FY2015. Requirements for
eligible entities are specified, including maintenance of effort
with respect to grantee funding contributions. Also, the
Secretary shall measure the status and success of each grant
program, based on information provided by recipients of how
grant funds were spent and the status of their efforts.
Subsection (b) of this section requires the Secretary and the
CDC Director (in consultation with other groups) to
designate five “Integrated Food Safety Centers of Excellence”
at selected state health departments to serve as resources for
federal, state, and local public health professionals. Authorizes
the appropriation of such sums as necessary to carry out this
provision.
Whistleblower Protection
Whistleblower Protections (§ 212)
Employee Protections (§ 402)
A variety of federal and state measures have been adopted to
Creates a new FFDCA § 911, “Protections for Employees
Creates a new FFDCA § 1012 prohibiting food businesses
protect so-called whistleblowers, or those employees who
Who Refuse to Violate, or Who Disclose Violations of, This
from discharging or otherwise discriminating against an
disclose information about illegal or improper activity,
Act or Section 351 of the Public Health Service Act.”
employee who provides or causes to be provided information
general y at their place of employment. Many federal
Extensive language here makes it illegal to “discharge, demote,
relating to violations of the FFDCA; who testifies, assists, or
employees, for example, are covered by the Whistleblower
suspend, threaten, harass, on in any other manner discriminate participates in a proceeding on such a violation; or who
Protection Act (P.L. 101-12). The FFDCA itself contains no
against an employee in the terms and conditions of
refuses to participate in an activity reasonably believed to
such language regarding a private employee who must, or
employment” if such an employee provides information on a
violate the act. Contains extensive (but different from House)
willingly provides, information related to an FDA-related
food, relating to a possible violation of the FFDCA or the
language on the procedures for treating and protecting
product.
Public Health Service Act .
whistleblowers.
Seizure of FDA-Regulated Products
Procedures for Seizure (§ 131)
No comparable provision.
FFDCA § 304 spells out the grounds, jurisdiction, and
Appears to expedite the process for seizing adulterated or
procedures to be used to seize FDA-regulated products
misbranded articles of food by altering the current statutory
through a court order. (This extensive FFDCA provision and
procedures for doing so.
the implementing steps involved are detailed in FDA’s
Regulatory Procedures Manual at http://www.fda.gov/ICECI/
ComplianceManuals/RegulatoryProceduresManual/default.htm.)
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S. 510 (Manager’s Amendment)
Quarantine Authority
Authority to Prohibit or Restrict the Movement of
No comparable provision.
Food (§ 133)
The seizure provisions of FFDCA § 304 do not appear to
specifically authorize geographical quarantines of an article of
Amends FFDCA § 304 (seizure section) by adding that where
food in the United States.
the Secretary, after consulting with the Governor or other
appropriate state elected official, “determines that there is
On occasion, FDA does subject certain imports or groups of
credible evidence or information that an article of food
imports from an entire country or region to “detention
presents an imminent threat of serious adverse health
without physical examination” until the importer can
consequences or death to humans or animals,” the Secretary
demonstrate that the product satisfies FDA requirements.
is authorized to prohibit or restrict the movement of the
Examples of this in 2007 were imports of all Chinese plant
article of food within the state or a portion of it. The
protein products (including wheat gluten and rice gluten) after
Secretary must determine that “there is no less drastic action
some were found to contain melamine, an unapproved
that is feasible and that would be adequate to prevent the
substance; and of al farm-raised shrimp, catfish, basa, dace,
imminent threat of serious adverse health consequences or
and eel from China until the shippers of these products could
death to humans or animals.”
demonstrate that they were free of unapproved drug residues. Violation of a prohibition or restriction is a prohibited act
under FFDCA § 301. The remainder of § 133 describes the
notification procedures the Secretary must fol ow (including
public announcement and publication in the Federal Register)
for such a prohibition or restriction, requires renewal every
14 days, and includes limitations on the ability to delegate
quarantine authority to others.
Criminal Penalties
Criminal Penalties (§ 134)
No comparable provision.
Under FFDCA § 301(a) (as adjusted by 18 U.S.C. §§ 3559 and
Any person who knowingly violates specified prohibited acts
3571) the maximum criminal penalty for individuals convicted
under FFDCA § 301 would be subject to increased penalties,
of a misdemeanor under the act is $100,000 if it does not
of up to 10 years in prison and/or fines in accordance with the
result in death; $250,000 if it results in death; and/or
U.S. Criminal Code (Title 18 of the U.S.C.). This section also
imprisonment of one year. The maximum criminal
requires the revision of penalties for violations of the FFDCA.
misdemeanor penalty for organizations (as adjusted by 18
U.S.C. §§ 3559 and 3571) is $200,000 if the offense does not
result in death and $500,000 if the offense results in death.
For felony convictions the maximum criminal penalty for
individuals (as adjusted by 18 U.S.C. §§ 3559 and 3571) is
imprisonment for not more than three years or a fine of not
more than $250,000, or both. The maximum criminal penalty
for organizations (as adjusted by 18 U.S.C. §§ 3559 and 3571)
is a fine of not more than $500,000.
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Obama Administration: The Hamburg and Taylor
testimonies express support for § 134 of the House bill.
Civil Penalties
Civil Penalties for Violations Relating to Foods (§ 135)
No comparable provision.
FFDCA § 303(f)(2) FFDCA subjects any person who
Amends FFDCA § 303(f)(2) ) to delete restrictions on civil
“introduces into interstate commerce or delivers for
penalty provisions regarding pesticide chemical residues that
introduction into interstate commerce an article of food that
result in a food being deemed adulterated under FFDCA §
is adulterated within the meaning of [FFDCA] section
402(a)(2)(B). It also amends § 303(f)(2) by authorizing the
402(a)(2)(B)” to a civil monetary penalty of up to $50,000 if an
Secretary to assess a civil penalty of up to $20,000 (not to
individual and up to $250,000 on any other person, to a
exceed $50,000 in a single proceeding) on an individual and of
maximum of $500,000 for al such violations adjudicated in a
up to $250,000 on any other person (not to exceed $1 million
single hearing. However, 402(a)(2)(B) applies only to the
in a single proceeding) for committing a violation of FFDCA §
presence of illegal pesticide residues. The section further
301 (prohibited acts). For knowing violations, maximum civil
exempts from this penalty any person who grew the article of
penalties for individuals are $50,000 (not to exceed $100,000
food, and it prohibits use of FDA’s seizure, injunction, or
in a single proceeding), and for any other person $500,000
criminal authorities if such a civil monetary penalty is assessed.
(not to exceed $7.5 million in a single proceeding). Each
prohibited act and each day is to be considered a separate
Currently, there are no maximum civil penalties tied to
offense. The rewording of this section appears to effectively
FFDCA § 303(a), which addresses criminal penalties for
broaden the reasons for which civil penalties could be applied;
prohibited acts under the FFDCA.
subjects those growing an article of food that is adulterated
Obama Administration: The Hamburg and Taylor
under § 402(a)(2)(B) to them; and appears to no longer
testimonies express support for § 135 of the House bill.
preclude use of seizure, injunction, or criminal authorities with
regard to violations of § 402(a)(2)(B). It does not strike §
303(f)(2)(C) regarding hearings on the assessment of civil
penalties.
False or Misleading Reporting
False or Misleading Reporting to FDA (§ 210)
No comparable provision.
FFDCA § 301delineates prohibited acts under the law, one of
Expands the FDA-regulated products covered by this
which is “With respect to any device, the submission of any
prohibited act to include a “food, drug, or biological product.”
report that is required by or under this Act that is false or
misleading in any material respect.” [§ 301(q)(2)].
FDA Subpoena Authority
Subpoena Authority (§ 211)
No comparable provision.
The FFDCA provides authority for issuing subpoenas under
Expands subpoena authority by permitting the FDA
certain specified conditions. For example, in the course of an
Commissioner to issue subpoenas for witnesses and “the
investigation or hearing leading to either civil penalties or
production of records and other things” for the purpose of
withdrawal of approval for violations of the law related to drug any hearing, investigation, or other proceeding on a violation
applications under §§ 335(b) and 335(c), the Secretary is
of the FFDCA. This section contains extensive language on the
authorized, among other things, to issue subpoenas requiring
timing of compliance and service of a subpoena, among other
attendance of witnesses and production of evidence. Similar
things.
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S. 510 (Manager’s Amendment)
authorities are provided regarding violations related to devices
under § 333(f), and regarding debarment proceedings for
certain drug applications and for food imports (i.e., preventing
entry of a food import), under § 335(a).
Food Decontamination and Disposal
No comparable provision.
Decontamination and Disposal Standards and Plans (§
208)
Depending on the type(s) of contaminant and the type(s) of
food involved, several federal agencies and a variety of laws
Requires the Administrator of the Environmental Protection
may be involved in various steps in the process of
Agency (EPA), in coordination with the Secretaries of HHS,
decontamination, disposal, and/or remediation following an
DHS, and USDA, to provide support and technical assistance
agriculture or food emergency. In addition to agencies that
to state, local, and tribal governments in preparing for,
provide scientific and technical assistance—particularly EPA,
assessing, decontaminating, and recovering from an agriculture
and various agencies in DHS, HHS, and USDA—the Federal
or food emergency. Activities shall include: (1) the
Emergency Management Agency (FEMA) may be involved if the
development and dissemination of standards and protocols; (2)
incident is sufficiently large in scope, and the Federal Bureau of
jointly developed model plans for the decontamination of
Investigation may be involved if it resulted from a deliberate
individuals, equipment, and facilities following an intentional
act. In addition, state authorities may play a leading role, and
incident, and the disposal of large quantities of infected or
may seek technical and other assistance from appropriate
contaminated animals, plants, or food products; and (3) the
federal agencies. Several Emergency Support Function annexes
conduct of annual exercises, consistent with the mandated
in FEMA’s National Response Framework provide insights into
DHS national exercise program. Based on findings from
the possible roles and coordination of various federal agencies
exercises, model plans shal be updated at least biennial y. The
in response to an agriculture or food emergency.
development of standards and plans shal be prioritized,
considering: the highest-risk biological, chemical, and
radiological threat agents; agents that could cause the greatest
economic devastation to the agriculture and food system; and
agents that are most difficult to clean or remediate.
Import Certification
Certification and Accreditation (§ 109, part)
Authority to Require Import Certifications for Food (§
303)
The steady increase in food imports, a result of globalization
Amends FFDCA § 801 by authorizing the Secretary to require,
and consumer desire for a wider variety of foods year-round,
as a condition of granting admission for an imported food
Amends FFDCA § 801 by authorizing the Secretary to require
has generated growing concerns about whether current
article, that a “qualified certifying entity provide a certification
certification or other assurance of the safety of an article of
federal programs sufficiently ensure the safety of these
that the article complies with specified requirements” of the
food imported or offered for import, and to deny entry to any
imports. Most of the recent debate has included extensive
FFDCA. This requirement is to take effect on or after three
food offered for import that does not meet such a
discussion about how to improve current import safeguards,
years from date of enactment. However, the Secretary must
requirement. The Secretary may base such a requirement on
within resource constraints, and without unduly restraining
public health considerations, including risks associated with the
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S. 510 (Manager’s Amendment)
free trade.
only require such certification in the following situations:
food or its place of origin. Such certification shall be used for
designated food imported from countries with which the FDA
Current law does not explicitly authorize, or require, any
•
For food imported from a particular country, territory,
has an agreement to establish a certification program.
certification of imports, and whether FDA has what is often
or region, where the Secretary finds based on scientific risk-
Certifying entities—those who may provide certification or
cal ed "equivalence authority" has been a matter of debate
based evidence that the government controls there are
assurances—include an agency or a representative of the
(also see below). Regardless, it does not have a program like
inadequate and that such certification would assist in
government of the country from which the article of food at
that of FSIS, which many consider to be a form of certification.
determining the admissibility of the food;
issue originated, as designated by such government or the
Under the FMIA and PPIA, no foreign establishment can ship
Secretary; or such other persons or entities accredited to
its products to the United States until FSIS has determined
•
For a food type for which there is scientific evidence that
conduct audits, pursuant to § 808, as established by this act, to
that the establishment's country has a meat and/or poultry
there is a particular risk that presents a threat of serious
provide such certification or assurance. The Secretary may
safety program that provides a level of protection that is at
adverse health consequences or death and that such
require periodic renewal, or determine that a current
least equivalent to the U.S. system. FSIS visits the exporting
certification would assist in determining whether the article
certification is not valid. The Secretary shall provide for
country to review its rules and regulations, meets with foreign
poses such risk; or
electronic submission of required certifications. Certifying
officials, and accompanies them on visits to establishments. In
•
For an article imported from a particular country or
agents who make false statements shall be subject to criminal
addition, FSIS operates a reinspection program at 150 import
territory, if the Secretary has an agreement with that
fines or imprisonment pursuant to 18 U.S.C. § 1001. If the
houses located near approximately 35 border entry points.
government providing for such certification.
Secretary determines that the food safety systems of a foreign
Some have suggested that the FDA program should operate
country or region do not meet the requirements of this
more like that of FSIS, although they acknowledge the
The Secretary, in coordination with the Commissioner for
section, the Secretary shall, to the extent practicable, identify
difficulties and resource demands of attempting to regulate
Customs and Border Protection, shall provide for the
such inadequacies and a means for the country or region to
many more different types of foods from many more countries electronic submission of certifications. A certification may take notify the Secretary of subsequent improvements.
of origin.
the form of a statement that the article, or the facility or farm
“that manufactured, processed, packed, held, grew, harvested,
Amendments made by this section shall not limit the
Obama Administration: Dr. Hamburg’s testimony
sorted, or transported” it, complies with FFDCA
Secretary’s authority to conduct inspections of imported food
expresses support for relying not only on foreign governments requirements as specified by the Secretary, or take any other
or to take such other steps as the Secretary deems
for international inspections but also having the flexibility to
form specified by the Secretary including a listing of certified
appropriate to determine the admissibility of imported food.
explore use of an accreditation system and audit the
facilities or other entities.
performance of accredited third parties.
Before requiring certification, the Secretary must establish a
process for a country or territory to demonstrate that its
controls are adequate to ensure that a food destined for the
United States is safe. The Secretary cannot require a
certification for a food from a country or territory that has
made such a demonstration. The application of these
certification requirements must be consistent with U.S.
international obligations.
A qualified certifying entity must notify the Secretary
whenever it cancels or suspends the certification of a facility
or other listed entity. Imports required to have but lacking
certification are to be denied entry. Finally, this section is not
to limit the Secretary’s authority to conduct random import
inspections, issue import alerts for detaining products, or take
other steps necessary to determine imports’ admissibility.
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S. 510 (Manager’s Amendment)
Other § 109 provisions regarding qualified certifying entities
are discussed in a later section, “Third-Party Accreditation.”
Inspection of Foreign Facilities
Prohibition Against Delaying, Limiting, or Refusing
Inspection of Foreign Food Facilities (§ 306)
Inspection (§ 207); Risk-Based Inspection Schedule (§
FFDCA § 704 authorizes officers and employees designated by
105)
Amends FFDCA Chapter VIII (regarding imports and exports),
the Secretary of HHS to, among other things, enter and
adding a new § 807, authorizing the Secretary to enter into
inspect “any factory, warehouse, or establishment in which
Amends FFDCA § 402 by newly considering a food
arrangements and agreements with foreign governments to
food, drugs, devices, or cosmetics are manufactured,
adulterated if it is from any farm, factory, warehouse, or
facilitate the inspection of foreign facilities registered under
processed, packed, or held, for introduction into interstate
establishment and the owner, operator, or agent,” or any
FFDCA § 415; and requiring the Secretary to direct resources
commerce or after such introduction.” Inspections must be
agent of a governmental authority in the foreign country,
to inspections of foreign facilities, suppliers, and food types,
conducted “at reasonable times and within reasonable limits
“delays or limits an inspection or refuses to permit entry or
especially such facilities, suppliers, and food types that present
and in a reasonable manner.” The refusal to permit such
inspection” under FFDCA § 414 (records inspection) or § 704
a high risk (as identified by the Secretary), to help ensure the
inspections is prohibited under FFDCA § 301. “Interstate
(factory inspection). (The remainder of the bill’s § 203
safety and security of the food supply of the United States.
commerce” is defined under FFDCA § 201 to mean “(1)
consists of similar proscriptions for drugs, devices, and
commerce between any State or Territory and any place
cosmetics.)
Imported foods shall be refused admission if “from a foreign
outside thereof, and (2) commerce within the District of
factory, warehouse, or other establishment of which the
Columbia or within any other Territory not organized with a
The general risk-based inspection provisions in § 105 (above)
owner, operator, or agent in charge, or the government of the
legislative body.” A “factory, warehouse, or establishment” is
apply to both imported and domestic inspections. As noted
foreign country, refuses to permit entry of United States
not defined in the FFDCA; nor does there appear to be any
above, §105 requires foreign facilities to be inspected by an
inspectors or other individuals duly designated by the
statutory distinction here between foreign and domestic.
agency or representative of a foreign country that is
Secretary, upon request, to inspect such factory, warehouse,
Although the FFDCA appears neither to expressly include nor
recognized by the Secretary as meeting U.S. standards. (See
or other establishment,” if an inspection is refused “during the
to expressly exclude foreign facilities with regard to the right
also § 208 of the House bill, below.)
24-hour period after such request is submitted, or after such
of inspection by the HHS Secretary or designee, the Bush
other time period, as agreed upon by the Secretary and the
Risk-Based Inspection Schedule (§ 105, part);
Administration had argued that FDA lacks the authority to
foreign factory, warehouse, or other establishment.’’
Certification and Accreditation (§ 109, part)
refuse food imports when the agency has been denied access
The Secretary of Commerce, in coordination with HHS, may
to a foreign facility.
The Secretary has authority under § 105 (Risk-Based
send one or more inspectors to a country or facility of an
Inspection Schedule) to “recognize Federal, State, and local
Note: Whether FDA now has what is often called
exporter of seafood imported to the United States. The
officials and agencies and representatives of foreign countries
“equivalency authority” is a matter of debate. “In a May 9,
inspection will assess the practices used in connection with the
as meeting standards established by the Secretary for
2007 hearing before the House Agriculture Committee, FDA’s
farming, cultivation, harvesting, preparation for market,
conducting inspections” under the FFDCA (recognition for
chief food officer, David Acheson, responded to a question
transportation of the seafood; technical assistance may be
such inspections could be limited to specific commodities or
that the agency theoretical y has the authority to require
provided for such activities. The Secretary, coordinating with
food types); and under § 109 (accreditation of third-party
equivalency for imports but that FDA’s situation is significantly
the Secretary of Commerce, shall prepare an inspection
certifying agents), whereby a foreign government may be
more complex than USDA’s.... [The Government
report, which will also be provided to the exporter who will
eligible to be a qualified certifying agent.
Accountability Office] had suggested in 1998 that border
be given 30 days to provide a rebuttal or comments to HHS.
inspections alone were ineffective, but that FDA lacks the
Before requiring certification under § 109, (see above), the
authority to mandate equivalency.” However, FDA has visited
Secretary must establish a process for a country or territory
certain importing countries at their invitation to conduct such
to demonstrate that its controls are adequate to ensure that a
reviews, suggesting that current authority does not bar the
food destined for the United States is safe. The Secretary
Secretary from conducting such assessments.
cannot require a certification for a food from a country or
territory that has made such a demonstration. The application
FSIS has import equivalency authority, in that most meat,
of these certification requirements must be consistent with
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poultry, and processed egg products may only be imported
U.S. international obligations.
from countries that have demonstrated to FSIS that they
maintain regulatory protections for specified products that are
equivalent to the U.S. system (34 in March 2008). The United
States accepts FDA-regulated products from any country. The
FDA may detain or refuse admission to imported products
based on physical inspections, the appearance of a violation of
the FFDCA, or an import alert. In 2007, FDA issued an import
alert with respect to illegal drug residues in specific seafood
products from China, requiring that importers demonstrate
through testing that illegal residues are absent.
Obama Administration: Mr. Taylor’s testimony stated
that, “FDA plans to increase inspection of foreign facilities, but
we are concerned that the House bill’s foreign inspection
mandate may not result in the best use of FDA’s resources, in
light of the approximately 200,000 registered foreign facilities
and the high cost of overseas inspections. We think we can
achieve cost-effective oversight of imports by working with
foreign governments, using the bill’s new tools for import
oversight, supporting strong third-party inspections, and
increasing targeted, risk-based foreign inspections.”
Foreign Supplier Verification
Registration for Commercial Importers of Food; Fee
Foreign Supplier Verification Program (§ 301)
(§ 204); Registration for Customs Brokers (§ 205);
The FFDCA does not explicitly authorize, and does not
Unique Identification Number for Food Facilities,
Amends FFDCA Chapter VIII (regarding imports and exports)
require, the establishment of a foreign supplier verification
Importers and Customs Brokers (§ 206)
by adding a new § 805, effective two years after the date of
program. The FFDCA also does not require those who are
enactment, requiring each importer to establish risk-based
importers or import brokers to register with FDA under the
These sections require an importer of foods to register
foreign supplier verification activities. Importing, or offering for
food facility registration provisions of § 415. At a House
annual y with the Secretary and to submit an appropriate
importation, a food by an importer who does not have such a
Energy and Commerce Committee hearing on June 3, 2009,
unique facility identification as a condition of such registration.
program in place is prohibited under FFDCA § 301, and the
U.S. officials acknowledged that they had no firm data on the
Further conditions for importers (but not customs brokers)
Secretary shall refuse admission to any such product that
number of entities that import food.
include compliance with “good importer practices.” Among
appears to be in violation of this requirement. Defines an
other provisions in this section is a requirement that
importer as the U.S. owner or consignee of the article of food
Obama Administration: The Hamburg and Taylor
importers permit an officer or employee of the Secretary to
at the time of entry of such article into the United States; or
testimonies express support for § 204 of the House bill.
“inspect the facilities of such person and have access to, and to the United States agent or representative of a foreign owner
copy and verify, any related records.”
or consignee of the article of food at the time of entry of such
article into the United States.
The Secretary (in consultation with Customs and Border
Protection) must promulgate regulations on the measures an
The importer is required to develop a program that: (1)
importer must take to ensure that the importer has adequate
assures that imported food is not adulterated or misbranded;
information about a food, its hazards, and applicable
and (2) complies with the program of hazard analysis and
requirements; the ability to verify that both the food and each
preventive controls in FFDCA § 418, or the produce safety
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S. 510 (Manager’s Amendment)
person who produced, manufactured, processed, packed,
requirements in FFDCA § 419, each as established by this act.
transported, or held the food including its components are in
Within one year of enactment, the Secretary shall issue
compliance; and procedures to take corrective actions
guidance and promulgate regulations regarding the
regarding noncompliant foods. This provision also authorizes
development of foreign supplier verification programs,
the Secretary, in promulgating good import practices
including appropriate verification steps that importers may
regulations, to incorporate certification of compliance under
apply to the products of their foreign suppliers, to assure that
FFDCA § 801(q) and participation in the safe and secure food
safety requirements are met. The importer shall maintain
importation program under FFDCA § 805, and to take into
appropriate documentation for not less than two years, and
account differences among importers and types of imports.
make such records available for inspection. Importers of
seafood, juice, or low-acid canned food whose products are
Provisions in this part of the bill provide for conditions for
currently in compliance with FDA’s relevant standards and
suspending registrations, and for exemptions from the
regulations are deemed to be compliant with this section. The
requirements by the Secretary, among other things. Failure to
Secretary shall publish and maintain a current list of
register is prohibited under FFDCA § 301; any food offered
participating importers.
for import that is not from a duly registered person is
misbranded under FFDCA § 403. Fees must be charged to
importers (but apparently not customs brokers, even though
“Fee” was in the title of § 205 marked up in committee). Fees
are discussed later in this comparison.
Improper Import Entry Filings (§ 136)
This different but somewhat related section amends FFDCA §
801 (imports and exports) by authorizing the Secretary to
require by regulation or guidance the submission of
documentation (in certain circumstances, in consultation with
Customs and Border Protection) or other information for
articles of food that are imported or offered for import into
the United States. Failure to submit required information,
submission of inaccurate or incomplete information, is
prohibited under FFDCA § 301.
Expediting Imports
Safe and Secure Food Importation Program (§ 113)
Voluntary Qualified Importer Program (§ 302)
The FFDCA does not explicitly provide authority for
Amends FFDCA Chapter VIII (regarding imports and exports), Amends FFDCA Chapter VIII (regarding imports and exports),
expediting imports. Among the questions raised during the
adding a new § 805, which appears to leave more aspects of
adding a new § 806. It requires the Secretary, within 18
policy debate: Should importers, or those foreign facilities
implementation to the Secretary’s discretion than does the
months of enactment: (1) to establish, in consultation with the
which supply them, that have good histories of compliance
expedited import program proposed in S. 510. This section
Secretary of Homeland Security, a voluntary program to
with U.S. food safety laws, and/or that import relatively low-
authorizes the Secretary ( in coordination with Customs and
expedite review and importation of foods from qualified
risk foods, be permitted to fol ow abbreviated procedural
Border Protection) to establish a program to facilitate the
importers; and (2) to issue applicable program guidance. An
requirements? If so, what if any additional standards should
movement of food through the import process, if the importer importer is defined in this section as “the person that brings
they have to meet?
verifies that each facility involved in its production,
food, or causes food to be brought, from a foreign country
manufacture, processing, packaging, and holding is in
into the customs territory of the United States.” An importer
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S. 510 (Manager’s Amendment)
compliance with safety and security guidelines that the
that intends to participate in the program under this section in
Secretary would develop (taking into account a number of
a fiscal year shall submit a notice to the Secretary of such
prescribed factors). The importer also is to ensure that
intent at time and in a manner established by the Secretary.
appropriate safety and security controls are in place
Eligibility is limited to an importer who offers for importation
throughout the supply chain and to provide supporting
a food from a facility that has a certification under § 809(b), as
information to the Secretary.
established by this act. The Secretary shall consider, in making
such determinations, the risk posed with respect to: (1) the
nature of the food; (2) the compliance history of the foreign
supplier; (3) the regulatory system of the country of export;
(4) the compliance of the importer with the requirements of
the foreign supplier verification program under § 805, as
established by this act; (5) recordkeeping, testing, inspections
and audits of facilities, traceability of articles of food,
temperature controls, and sourcing practices of the importer;
(6) the potential risk for intentional adulteration of the food;
and (7) other factors that the Secretary determines
appropriate. The Secretary shall review each importer’s
qualifications at least every three years, and shal promptly
revoke an importer’s qualified status if the importer is found
not to be in compliance. Making of false statements under this
authority may subject an importer to criminal fines and/or
imprisonment, pursuant to 18 U.S.C. § 1001.
FDA Foreign Offices
Dedicated Foreign Inspectorate (§ 208)
Foreign Offices of the Food and Drug Administration
(§ 308)
The FFDCA neither prohibits nor requires the establishment
Amends FFDCA § 704 (in the General Authority chapter) to
of FDA field offices in other countries. FDA reports that it is
require the Secretary to establish and maintain a corps of
The Secretary is required, in consultation with the Secretaries
establishing offices in China, Latin America, India, Europe, and
inspectors dedicated to inspecting foreign food facilities. This
of State and Homeland Security and the United States Trade
the Middle East, and was implementing a Memorandum of
corps is to be staffed and funded at a level to assist the
Representative, to establish FDA offices in foreign countries
Agreement with China, in order to coordinate food safety
Secretary to achieve the frequency of inspections for food
selected by the Secretary, to assist the appropriate
activities.
facilities described in this Act.
governmental entities of those countries regarding measures
to provide for the safety of food and other FDA-regulated
products exported by those countries to the United States.
FDA activities may include the conduct of risk-based
inspections of such products, and supporting such inspections
by the governmental entity. The Secretary shal report to
Congress by October 1, 2011, with respect to the selection of
specific countries, the progress of the established offices in
assisting those foreign governments, and plans to establish
additional foreign offices. Clarifies that nothing in this
provision shall affect the Secretary’s authority to issue public
notifications under other circumstances.
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S. 510 (Manager’s Amendment)
Country of Origin Labeling
Country of Origin Labeling (§ 202)
No comparable provision.
Since the 1930s, § 304 of the Tariff Act of 1930, as amended,
Amends the misbranding provision of FFDCA § 403 to
has required most imports to carry labels so that the "ultimate consider a processed food misbranded if its label fails to
purchaser," usual y the retail consumer, can determine their
identify the country in which final processing occurred. A non-
country of origin. Certain products, including a number of
processed food is misbranded if its label fails to identify the
agricultural commodities in their "natural" state such as meats,
country of origin. Processed foods and non-processed foods
fruits and vegetables, were excluded. Effective in 2009, many
are deemed to meet the requirements of this section if they
retail food stores are now required to inform consumers
are subject to and meet the requirements of, respectively, the
about the country of origin of fresh fruits and vegetables,
U.S. Customs and Border Protection or USDA. The Secretary
seafood, peanuts, pecans, macadamia nuts, ginseng, and ground is required to promulgate final regulations on this provision
and muscle cuts of beef, pork, lamb, chicken, and goat, under
within 180 days of enactment, and the new requirements take
provisions of the 2002 farm bill (P.L. 107-171) as amended by
effect two years after enactment.
the 2008 farm bill (P.L. 110-246).
The FFDCA does not expressly require country-of-origin
labeling (COOL) for foods. FFDCA § 403(e) does consider a
packaged food misbranded if it lacks a label containing the
name and place of business of the manufacturer, packer, or
distributor. However, this is not an indicator of the origin of
the product itself.
Prior Notice of Imports
No comparable provision.
Prior Notice of Imported Food Shipments (§ 304)
FFDCA § 801(m) requires the Secretary to establish, by
Amends the list of elements that must be provided in the
regulation, procedures and requirements by which an
notice required under FFDCA § 801(m) by adding the identity
importer shall give FDA prior notice of shipments of food
of “any country to which the article has been refused entry.”
intended for importation, in order that FDA can make
Within 120 days of enactment, the Secretary shal publish an
determinations regarding the admissibility of the food. The
interim final rule implementing this amendment, which shall
FFDCA stipulates certain required data elements that must be
take effect 180 days after the date of enactment.
included in the notice, including the country from which the
food originated, and the country from which the food is
shipped. In November 2008, FDA published a final regulation
to implement the current authority. The final rule does not
require that information be provided regarding refusal of an
article of food by another country.
Foreign Capacity Building
No comparable provision.
Building Capacity of Foreign Governments with
Respect to Food (§ 305)
Current law would not prohibit the development of the plan
proposed by this section of S. 510 (right). Implementation of
Requires the Secretary, within two years of enactment, to
certain elements of such a plan may be authorized under: (1)
develop a comprehensive plan to expand the technical,
FFDCA § 803, which authorizes an HHS Office of International
scientific, and regulatory capacity of foreign governments, and
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Relations to, among other things, reach agreements with other
their respective food industries, from which foods are
governments regarding practices and standards; and (2) PHS
exported to the United States. In developing the plan, the
Act § 307, authorizing collaborations with foreign governments
Secretary shal consult with the Secretaries of Agriculture,
for the purposes of research and education regarding health-
State, Treasury, Homeland Security, and Commerce, the U.S.
related matters.
Trade Representative, representatives of the food industry,
appropriate foreign government officials, and non-
governmental organizations that represent the interests of
consumers, and other stakeholders. The plan shal include, as
appropriate: (1) recommendations for bilateral and multilateral
arrangements and agreements, including provisions for
responsibility of exporting countries to ensure the food safety;
(2) provisions for electronic data sharing; (3) provisions for
mutual recognition of inspection reports; (4) training of
foreign governments and food producers on U.S. food safety
requirements; (5) recommendations to harmonize
requirements under Codex Alimentarius; and (6) provisions
for multilateral acceptance of laboratory methods and
detection techniques. This section does not apply to dietary
supplements.
Smuggled Food
No comparable provision.
Smuggled Food (§ 309)
The FFDCA does not appear to address or to define the term
Requires the Secretary, within 180 days of enactment, in
“smuggled food,” although Chapter VIII of the act covers
consultation with designated officials in the Department of
imports and exports.
Homeland Security, to develop and implement a strategy “to
better identify smuggled food and prevent its entry into the
United States.” Contains notification requirements regarding
smuggled food, defined here as “any food that a person
introduces into the United States through fraudulent means or
with the intent to defraud or mislead.”
Port Shopping
No comparable provision.
Port Shopping (§ 115)
FFDCA section 801(n) provides FDA with the authority to
Until the Secretary promulgates a final rule that implements
help prevent “port shopping,” whereby importers of refused
the amendments made by section 308 of the Bioterrorism Act
goods try to import through another port when refused entry
of 2002, requires the Secretary to notify the Secretary of
at one port. The provision authorizes FDA to require refused
Homeland Security of instances of import refusals under
food to be marked with the statement “UNITED STATES:
FFDCA section 801(a) (Imports; list of registered foreign
REFUSED ENTRY.” This authority was enacted in section 308
establishments; samples from unregistered foreign
of the Bioterrorism Act of 2002 (P.L. 107-188)
establishments; examination and refusal of admission) to alert
U.S. Customs and Border Protection and prevent imports
refused at one port from being admitted by another port.
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S. 510 (Manager’s Amendment)
Jurisdiction
Rules of Construction (§ 4)
Jurisdiction; Authorities (§ 403)
The preemption doctrine is derived from the Supremacy
This so-called preemption provision states that “Nothing in
Not a preemption provision; provides that this Act, and any
Clause of the U.S. Constitution, which establishes that the
this Act or the Amendments made by this Act shal be
amendment made by it, would not: (1) alter jurisdiction
laws of the United States "shall be the supreme law of the
construed to prohibit or limit—(1) any cause of action under
between HHS and USDA under applicable statutes,
land; and the judges in every state shal be bound thereby, any
State law; or (2) the introduction or evidence of compliance
regulations, or agreements regarding products eligible for
thing in the Constitution or laws of any State to the contrary
or noncompliance with” the FFDCA.
voluntary inspection under the Agricultural Marketing Act (7
notwithstanding." In general terms, federal preemption occurs
U.S.C. 1621 et seq.); (2) alter the jurisdiction between the
when a validly enacted federal law supersedes any inconsistent
Also clarifies that nothing in this Act is to limit or otherwise
Administration of the Alcohol and Tobacco Tax and Trade
state law. Courts’ application of this may involve such factors
alter the current jurisdiction or authorities between the
Bureau and the HHS Secretary; (3) limit the authority of the
as whether or not a federal statute has explicitly stated
Secretaries of HHS and of Agriculture, including those under
HHS or Agriculture Secretary under specified existing statutes
Congress’ intent on the matter, This issue is discussed
the FFDCA, Public Health Service Act, the FMIA, PPIA, or
(including the FFDCA); or (4) impede, minimize, or affect the
regarding medical devices in CRS Report R40534, Riegel v.
EPIA.
authority of the Secretary of Homeland Security under the
Medtronic, Inc.: Federal Preemption of State Tort Law Regarding
USDA Exemptions (§ 5)
Homeland Security Act (6 U.S.C. 101 et seq.).
Medical Devices with FDA Premarket Approval.
Explicitly exempts from this Act foods and establishments to
Alcohol-Related Facilities (§ 116)
Separately, FFDCA § 902(b) general y exempts meat and meat
the extent that they are regulated under the FMIA, PPIA, or
food products from the provisions of the FFDCA; § 24 of the
General y exempts from this Act (the Manager’s Amdt.)
EPIA. Exempts a farm “to the extent such farm raises animals
Poultry Products Inspection Act (PPIA) general y exempts
beverages and facilities that are primarily regulated under the
from which” such foods are derived. Clarifies that livestock
poultry and poultry products from FFDCA provisions.
Alcohol Administration Act. Certain of the act’s provisions are
and poultry intended for slaughter under the FMIA, PPIA, as
excepted from this exemption, including those related to
Alcohol
well as milk-producing cows, sheep, or goats are exempt.
registration, mandatory recall, and administrative detention,
among others; these provisions would apply to alcohol-related
The Federal Alcohol Administration Act (27 U.S.C. 201 et
Alcohol-Related Facilities (§ 6)
beverages and facilities.
seq.) provides for regulation of those engaged in the alcohol
Similar provision, except that it contains a shorter list of
beverage industry, and for the protection of consumers.
provisions excepted from the exemption. Notably, mandatory
Compliance With International Agreements (§ 404)
recal and administrative detention provisions are not
Nothing in this Act shall be construed in a manner inconsistent
excepted from the exemption. Therefore, they would not
with the agreement establishing the World Trade
apply to alcohol-related beverages and facilities.
Organization or any other agreement or treaty to which the
Extraterritorial Jurisdiction (§ 213)
United States is a party.
Makes the following a prohibited act under the FFDCA: “The
production, manufacture, processing, preparation, packaging,
holding, or distribution of an adulterated or misbranded food
with the knowledge or intent that such article will be imported
into the United States.”
Adds a new § 312 to the FFDCA stating that “There is
extraterritorial Federal jurisdiction over any violation of this
Act relating to any food if such article was intended for import
into the United States or if any act in furtherance of the
violation was committed in the United States.”
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S. 510 (Manager’s Amendment)
Funding and Fees
Various Sections (§ 101, § 108, § 203, § 204)
Authority to Collect Fees (§ 107)
Many critics argue that—irrespective of the need, if any, to
Authority to assess new types of food-related fees appear in
Authorizes FDA to col ect two types of fees related to food:
reform food safety statutes and organization—a fundamental
four sections of the House bill.
export certification fees and user fees. The export certification
problem has been the lack of sufficient funding and staff to
provisions in current law are amended to allow food
carry out congressional y mandated (and existing)
Under § 101 (Changes in Registration of Food Facilities), the
exporters to request that the Secretary certify that exported
responsibilities to ensure a safe food supply.
Secretary is required to assess and collect a facility registration foods comply with provisions in the FFDCA, and would thus
fee each year from facilities required to register under FFDCA
enable the associated fee to be charged to the exporter. The
Proposed increases in program spending raise a variety of
§ 415. This fee is to be set at $500 per facility in FY2010; for
food user fees are established by inserting a new FFDCA § 743
policy issues. Requests for higher appropriations always
FY2011 and each subsequent fiscal year, the fee is to be
: “Part 6–Fees Related to Food.” The new part authorizes,
compete with other priorities throughout the federal
adjusted to reflect the cost of inflation, under a specified
indefinitely, the assessment and collection of four user fees:
discretionary budget (the programs do not operate, like farm
formula. § 101 also sets a maximum annual fee payment of
support programs, for example, as mandatory authorizations).
$175,000 for those who have multiple facilities. Other
•
fees paid by domestic facilities subject to a reinspection
Such requests currently are being made during a period of
provisions in this section: require the Secretary to hold a
(to cover reinspection-related costs);
huge budget deficits. Efforts to fill perceived shortfalls through
public meeting each fiscal year to explain the fees’ use and to
new fees on the food industry always meet with resistance,
solicit stakeholder views; are intended to ensure that these
•
fees paid by domestic facilities and importers subject to
both from the companies that would have to absorb such
fees do not supplant FDA appropriations or reduce HHS
food recal s (to cover food recal activities performed by the
costs, and from consumer advocates, who have long argued
Department staffing; address their collection, crediting and
Secretary);
that industry funds might compromise public health programs.
availability vis a vis appropriations; sunset the fees after
•
fees paid by importers participating in the voluntary
FY2014; and require annual reports to Congress. “Food safety
Congressional appropriators have increased funding for FDA
qualified importer program (to cover administrative costs of
activities” and “costs of food safety activities” are extensively
food safety activities for FY2008 and FY2009. The Obama
the program); and
defined in this section. The provisions in this section are
Administration request for FY2010 cal s for a more than $1
modeled in part on existing user fee authorities for drugs and
•
fees paid by importers subject to reinspection (to cover
billion FDA food safety budget, which would be a $259 million
devices.
reinspection-related costs).
increase over the FY2009 level of $785 million. Of this
increase, $165 million is proposed to come from new budget
Under § 108 (Reinspection and Food Recall Fees Applicable to
Overdue fees are treated as claims of the United States
authority (appropriations) and $94 million through new fees
Facilities), the Secretary is required to assess and collect a fee
Government under 21 U.S.C. § 37. The Secretary is required
on industry. These fees would include $75 million raised
from each facility that either: violates any food-related
to report annual y to Congress describing the entities paying
through an apparently annual food inspection and facility
requirement of the FFDCA and therefore must undergo
fees, and the fees assessed and collected for each year.
registration fee, $15 million raised through a re-inspection fee,
additional FDA inspection; or is subject to a food recall. The
The Secretary is required to establish and publish the fee
and $4 million raised through export certification fees (see
Secretary must set the fee amount at a level to ful y cover the
amounts annual y, setting fees so that each one covers 100% of
below for more on the latter two fees). The FY2010
reinspection and/or recall costs and use the collection solely
the cost of the associated activity, with certain caveats. For the
appropriations bills for USDA (H.R. 2997/S. 1406) that have
for that purpose. If the Secretary determines that a recal “was first five years that user fees are assessed, the Secretary is to
passed both chambers but not yet been enacted both ful y
inappropriately required,” the fee must be waived or refunded. include a surcharge in order to recoup the costs associated
fund the President’s request, although both appear to provide
Other language here addresses their col ection, crediting and
with establishing the user fee programs. Fees col ected for a
the money through new budget authority rather than new
availability vis a vis appropriations, with a sunset for the fees
given fiscal year for food recal activities may not exceed $20
user fees.
after FY2014.
million. Fees collected for a given fiscal year for reinspection of
In general, FDA’s fee-funded programs for drugs and devices
Under § 203 (Exportation Certificate Program), the Secretary
both domestic facilities and importers may not exceed $25
have finite appropriations authorities that sunset, prohibiting
is authorized to impose a fee for food export certifications
million combined. Despite these limitations, the Secretary may
the agency from collecting fees beyond the authorized time
that meet the specifications of a foreign purchaser and that do
collect fees from facilities or importers who become subject
frame. These authorities do not apply to food safety programs
not conflict with the destination country’s laws. (Such fees
to the fees after the limitations are reached. The Secretary
at this time. In addition, some discretionary-funded grant
already may be charged for certifications of some other FDA-
must credit to the following year any fees collected in excess
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S. 510 (Manager’s Amendment)
programs have finite appropriations authorities, and may or
regulated products.) The fee shal be “reasonably related” to
of actual costs, and adjust fee amounts for that following year
may not continue to be funded if authority expires. But, in
the cost of issuing such certificates; this fee authority is
to account for the excess fees and other factors the Secretary
general, FDA’s enforcement activities, such as those for food
permanent.
determines are appropriate.
safety, are based in broad, permanent authorities in the
FFDCA. These authorities do not expire, and they are not
Section 204 establishes a new FFDCA § 744, requiring the
The Secretary is authorized to collect fees only to the extent
accompanied by authorized levels of appropriations. Decisions
Secretary to assess and col ect a $500 annual fee for the
that amounts have been specified in advance in appropriations
to apportion annual appropriations among FDA’s various
registration of an importer of food, with administrative
acts. Additional “triggers” apply. Fees collected in a given year
programs and activities are made through the annual
provisions somewhat comparable to those set under § 101
must be refunded unless appropriations to FDA for food
appropriations process without explicit directives in
(above). (This fee is to be tied to the new requirement that
safety activities are maintained at the FY2009 level, with
authorizing legislation.
such importers begin to register with FDA within one year of
specified adjustments. Fees can be used solely to fund the
enactment.) Importers that already must pay the facility fee
specified food safety activity.
FDA is currently authorized to collect several types of fees.
under § 101 are exempt from this importer registration fee.
Among them are user fees and export certification fees,
This fee authority sunsets after FY2014.
Note: The proposed food user fee is different from existing
neither of which may currently be collected for food-related
user fees in several ways. First, the proposed fee would be
activities. FDA’s authority to collect user fees extends to
authorized indefinitely, while each of the existing user fees
human prescription drugs, medical devices, and animal drugs,
have been authorized in five-year increments. Second, the fees
under FFDCA Chapter VII, Subchapter C, §§ 735-740.
would be used to fund inspection and enforcement activities
Generally, these fees can only be used to fund the “process for
for foods on the market. For other products, the existing user
the review of applications.” (FDA reviews applications to
fees only fund application-review related activities, as defined
determine whether to permit drugs, medical devices, and
in the law—though, as noted above, FDA does not inspect
animal drugs to be legally marketed. Prior approval is not
foods before they can be marketed as it does some of the
required for most foods, which can be legal y marketed
other products that it regulates. Third, the act does not
without the agency’s prior permission.) The user fee
authorize specific fee levels in advance, but rather allows the
programs have been authorized in five-year increments. Each
Secretary to set fee levels based upon estimated costs. For
authorization specifies the fee amounts FDA may collect
currently authorized fees, the amounts are articulated in law,
annual y, and makes the authority to col ect these fees
either individually, or in aggregate, for a given type of fee.
contingent upon “triggers,” which require that appropriated
Funding for Food Safety (§ 401)
and internally allocated funding amounts for certain activities
meet specified threshold levels.
This section authorizes, for activities of FDA’s Center for
Food Safety and Applied Nutrition, Center for Veterinary
FDA’s authority to collect export certification fees extends to
Medicine, and related field activities in the Office of Regulatory
drugs, medical devices and biological products, according to
Affairs, such sums as may be necessary for FY2011-FY2014. In
FFDCA § 801(e)(4). A person who exports a human drug,
addition, the Secretary is required to increase the field staff of
animal drug, or device may request that the Secretary certify
these three entities with a goal of not fewer than: (1) 4,000
in writing that the product meets FFDCA requirements. If the
staff members in FY2011; (2) 4,200 staff members in FY2012;
Secretary issues a written export certification, a fee may be
(3) 4,600 staff members in FY2013; and (4) 5,000 staff
charged.
members in FY2014. Within the total, field staff for food
Obama Administration: In addition to requesting increased
defense activities and for smuggled food detection and removal
funds for FY2010 (see above), the Administration has
shal be increased by 150 employees by FY2011.
endorsed the registration, reinspection, and export
certification fees in §§ 101, 108, and 203 of the House bill.
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S. 510 (Manager’s Amendment)
Food Safety Research
Research (§ 123)
Food Safety Integrated Centers of Excellence (§ 210)
FDA, along with other federal agencies, is already involved in a
Requires the Secretary to conduct research to assist in
Section 210(b) of this section, regarding Food Safety
variety of research activities, in such areas as how and where
implementation of the Act, including studies to improve
Integrated Centers of Excel ence, which would, among other
food contamination occurs, biotechnology and al ergenicity
sanitation and food safety practices in food production,
things, conduct food safety research. Requires the Secretary
issues, seafood safety, color additives, consumer studies, the
harvesting, processing, develop improved monitoring and food
and the CDC Director (in consultation with other groups) to
detection, characterization, and behavior of foodborne
inspection techniques, develop efficient and rapid methods for
designate five “Integrated Food Safety Centers of Excellence”
pathogens, for example. Collaborative research efforts have
detecting the presence of food contaminants, among other
at selected state health departments to serve as resources for
been underway for some time with USDA’s Agricultural
specific areas of emphasis.
federal, state, and local public health professionals. Authorizes
Research Service and Cooperative State Research, Education,
the appropriation of such sums as necessary to carry out this
and Extension Service, and with academia, state health and
provision.
agricultural officials, industry and others. The Administration’s
FY2010 budget proposal anticipates research in high priority
areas such as reducing risk of E. coli in produce, speeding
response to outbreaks through improved testing and other
new technologies, limiting the adverse health effects of both
intentional and unintentional food contamination, and
upgraded information technology systems.
Bisphenol A (BPA)
Bisphenol A in Food and Beverage Containers (§ 215)
No comparable provision.
Bisphenol A (BPA) is used to produce certain types of plastic,
Requires the Secretary to notify Congress by December 31,
including food containers. In the United States and elsewhere,
2009 on whether available scientific data support “a
scientific disagreement about the possibility of human health
determination that there is a reasonable certainty of no harm,
effects that may result from BPA exposure through food and
for infants, young children, pregnant women, and adults, for
water has led to conflicting regulatory decisions regarding the
approved uses” of plastics made with BPA in food and
safety of food containers, especial y those intended for use by
beverage containers. If such a determination cannot be made
infants and children.
for any use, the Secretary must inform Congress on what
actions will be taken to protect public health.
BPA-containing PC polymers and epoxy resins used in food
containers—such as baby bottles and infant formula cans,
respectively—are regulated by FDA as food contact
substances. Applicable FDA regulations are at 21 CFR §§
177.1580, 175.300(b)(3)(viii), 177.1440, and 177.2280. A
conclusion of safety by FDA conflicted with earlier findings by
one panel of scientific advisors, and was later challenged by a
second panel. These events have prompted some to question
FDA's process for the assessment of health risks. (See also
CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible
Human Health Effects.)
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S. 510 (Manager’s Amendment)
Requirements for Infant Formula
Infant Formula (§ 114)
No comparable provision.
FFDCA § 412 sets forth detailed requirements whereby
Alters several requirements which apply to a manufacturer of
manufacturers of infant formula are required to provide FDA
a new infant formula; e.g., FDA would have additional time to
with assurances of the nutritional quality of their formulations
review certain safety information regarding new ingredients.
before marketing the formula. FDA has requirements for
certain labeling, nutrient content, quality control procedures,
and company recordkeeping and reporting. The FDA website
states that the agency is also working to finalize a proposed
rule for good manufacturing practices, quality control
procedures, quality factors, notification requirements, and
reports and records, for the production of infant formulas.
Additive and Labeling Requirements
Food Substances Generally Recognized As Safe (§ 201) No comparable provision.
This issue revolves around FDA’s exercise of so-called
Requires the Secretary to publish within 60 days on the FDA
“generally recognized as safe” (GRAS) determinations. Under
public website, notice of receipt of a request for a substance
current law, substances which FDA agrees are GRAS are
to be determined by the Secretary to be Generally Recognized
exempt from the much more rigorous premarket approval
As Safe (GRAS), and supporting scientific justifications, among
process required for other food additives. Under a 1997
other provisions. This section does not appear to address the
proposed rule, FDA proposed creating a notification
GRAS notification procedure, as it discusses requests for
procedure for GRAS substances through which manufacturers
substances to be determined by the Secretary to be GRAS. In
can notify the FDA of their “determination that a particular
the notification procedure, the manufacturer or other
use of a substance is GRAS,” thereby bypassing the regular
individual makes the conclusion that the substance is GRAS
federal rulemaking procedures. In fact, FDA has been using this and the FDA states that it has “no questions” about this
GRAS notification procedure since the publication of the
conclusion, that the notice does not provide a basis for a
proposed rule on an “interim policy” basis.
GRAS status determination, or that the individual has stopped
the GRAS notification process.
Lead in Ceramics
Lead Content Labeling Requirement for Ceramic
No comparable provision.
Tableware and Cookware (§ 216)
Pursuant to its FFDCA authority, FDA regulates food contact
surfaces as well as food. The FDA has standards regarding the
Would deem ceramic tableware and cookware misbranded
leaching of lead from ceramics that are to be used for food.
under the FFDCA if it includes a glaze or decorations
These are at “Compliance Policy Guide (CPG) Sec. 545.450
containing lead for an intended functional purpose, unless
Pottery (Ceramics); Import and Domestic—Lead
either: it and its package bears statement: “This product is
Contamination” (CPG 7117.07).
made with lead-based glaze consistent with FDA guidelines for
such lead”; or [sic] the product is in compliance with FDA
requirements applicable to ornamental and decorative ceramic
ware. Further requires the Secretary to educate consumers on
the safety of ceramic ware for food use.
CRS-76
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Sanitary Transportation of Food
No comparable provision.
Sanitary Transportation of Food (§ 111)
FFDCA § 416, regarding sanitary transportation practices for
Requires the Secretary, within one year of enactment, to
food, was established in § 7202 of the Safe, Accountable,
promulgate regulations described in FFDCA § 416(b), which
Flexible, Efficient Transportation Equity Act: A Legacy for
say, “The Secretary shall by regulation require shippers,
Users (SAFETEA-LU), P.L. 109-59, August, 2005. The law
carriers by motor vehicle or rail vehicle, receivers, and other
requires the Secretary to promulgate applicable regulations,
persons engaged in the transportation of food to use sanitary
but does not state a deadline for doing so.
transportation practices prescribed by the Secretary to ensure
that food is not transported under conditions that may render
the food adulterated.” Requires FDA conduct a study of the
transportation of food for U.S. consumption, addressing
certain issues including an examination of the “unique needs of
rural and frontier areas with regard to delivery of safe food.”
Food Allergies
No comparable provision.
Food Allergy and Anaphylaxis Management (§ 112)
FFDCA § 403(w) requires food products that contain any of
Requires the Secretary, within one year of enactment and in
the eight most common food allergens (defined in FFDCA §
consultation with the Secretary of Education, to develop, and
201(qq)) to declare their presence on the food label.
make available to local educational agencies (LEAs), guidelines
Noncompliant food is deemed misbranded. This requirement
to develop plans for individuals to manage the risk of food
was established by the Food Allergen Labeling and Consumer
allergy and anaphylaxis in schools and early childhood
Protection Act of 2004 (P.L. 108-282). The act focused
education programs. The voluntary guidelines shall address
specifically on food labeling and did not address food allergy
specified elements, as follows: (1) parental obligation to
and anaphylaxis (a severe, whole-body allergic reaction)
provide the school with information regarding a student’s food
management in schools or elsewhere. FDA has announced it is
allergy and risk of anaphylaxis; (2) an individual plan created
developing a long-term strategy to assist manufacturers to
with the parent and tailored to each student with a
better inform food allergic consumers about the allergens in
documented risk for anaphylaxis; (3) communication strategies
their products.
between schools and emergency medical services; (4)
strategies to reduce the risk of exposure to anaphylactic
causative agents in classrooms and common areas for affected
students; (5) training and education for school and program
personnel, parents, and children; (6) authority and training of
program personnel to administer epinephrine when the nurse
is not immediately available, and the availability of epinephrine
for this purpose; (7) as part of an individual plan, a plan that
addresses the response to an anaphylactic incident in a child
engaged in extracurricular programs; (8) maintenance of
information for each administration of epinephrine to a child,
and prompt notification of parents; and (9) other elements the
Secretary determines to be necessary. An individual
management plan developed pursuant to this section shal be
considered an education record for the purpose of the Family
Educational Rights and Privacy Act of 1974 (FERPA) [20 U.S.C.
CRS-77
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
§ 1232g]. Nothing in this section or the guidelines developed
by the Secretary shall be construed to preempt state law,
including any state law regarding whether students at risk for
anaphylaxis may self-administer medication.
Authorizes the Secretary to award non-renewable food al ergy
management incentive grants for up to two years to assist
LEAs with adoption and implementation of the voluntary food
allergy management guidelines. LEAs must provide matching
funds of at least 25% of the amount of the grant and report to
the Secretary with information on how the grant money was
spent and the status of implementation of the guidelines. In
awarding grants under this subsection, the Secretary shall give
priority to LEAs with the highest percentages of economically
disadvantaged children, as defined by § 1124(c) of the
Elementary and Secondary Education Act of 1965 [20 U.S.C. §
6333(c)]. The grant program is authorized for $30 million for
FY2011, and such sums as may be necessary for each of four
succeeding fiscal years. Though the guidelines developed by
the Secretary are voluntary, the Secretary is authorized to
enforce an agreement by an LEA to implement such guidelines
as a condition of receipt of a grant authorized by this section.
Note: This provision authorizes grant-making by the Secretary
of HHS to assist LEAs in implementing food allergy and
anaphylaxis management guidelines. Because any individual
management plans developed pursuant to this funding would
be considered as education records, such records may not be
available for disclosure to the Secretary.of HHS.
Vitamins and Minerals, Anabolic Steroids
No comparable provision.
New Dietary Ingredients (§ 113)
FFDCA section 413 [21 U.S.C. 350b] requires that
Amends 21 U.S.C. 350b. Requires the Secretary to notify the
manufacturers and distributors of dietary supplements who
U.S. Drug Enforcement Agency, as specified, if s/he determines
wish to market dietary supplements that contain "new dietary
that the information in a new dietary ingredient notification
ingredients" (those not marketed in the United States in a
submitted under this section for an article purported to be a
dietary supplement before October 15, 1994) notify FDA
new dietary ingredient is inadequate to establish that a dietary
about these ingredients.
supplement containing such article will reasonably be expected
to be safe because the article may be, or may contain, an
anabolic steroid or an analogue of an anabolic steroid.
Requires the Secretary to publish guidance that clarifies when
a dietary supplement ingredient is a new dietary ingredient,
among other things.
Source: Prepared by CRS.
CRS-78
Food Safety in the 111th Congress
Author Contact Information
Renée Johnson
Specialist in Agricultural Policy
rjohnson@crs.loc.gov, 7-9588
Acknowledgments
This report was originally written by Geoffrey S. Becker, Specialist in Agricultural Policy.
Congressional Research Service
79