Implementation of the FDA Food Safety
Modernization Act (FSMA, P.L. 111-353)
Renée Johnson
Specialist in Agricultural Policy
September 22, 2014
Congressional Research Service
7-5700
www.crs.gov
R43724
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Summary
Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety
February 25, 2016
(R43724)
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Summary
Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act, or FSMA, P.L. 111-353), representing the largest expansion and overhaul of
U.S. food safety authorities since the 1930s. FSMA greatly expanded food safety oversight
authority at the Food and Drug Administration (FDA) within the U.S. Department of Health and
Human Services (HHS). Among its many provisions, FSMA expanded FDA
’'s authority to
conduct a mandatory recall of contaminated food products; enhanced surveillance systems to
investigate foodborne illness outbreaks; established new preventive controls and food safety plans
at some food processing facilities and farms; enhanced FDA
’'s traceability capacity within the
nation’ nation's food distribution channels; increased inspection frequencies of high-risk food facilities
(both domestic and foreign facilities); and expanded FDA
’'s authority and oversight capabilities
with regard to foreign companies that supply food imports to the United States.
Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. However,
FDA actions on some major FSMA provisions—including rules specifying the requirements and
conditions for establishing preventive controls in food facilities, food safety standards for produce
growers, and requirements for food importers, among other provisions—have yet to be finalized,
and most rules have been delayed well beyond the implementation dates specified in the law.
Regulations were to have been proposed or, in some cases, finalized within one to two years of
enactment (roughly January 2012 and January 2013); other rules were to have been submitted
within 18 months of enactment (roughly mid-2012).
Several factors appear to have contributed to the delay in implementing FSMA. Substantial
delays in publication of several FSMA proposed rules were reportedly due to rules being held up,
often for months, by the Office of Management and Budget’s (OMB’s) review process. Delays in
the rulemaking process also resulted from FDA granting extensions in the public comment and
response period for many of the major FSMA proposed rules. These extensions were requested by
a wide range of stakeholders, given the complexity of the regulations as well as FDA’s delayed
release of other related FSMA rules that some groups argued needed to be considered together as
a full regulatory package. Further implementation delays are expected as a result of FDA’s reproposal of key provisions of some major FSMA regulations in September 2104, which many
Members of Congress and some key industry stakeholders have broadly supported. Finally,
according to FDA, limited resources and the lack of availability of discretionary appropriations
might also have affected FDA’s rollout and full implementation of FSMA.
Given delays in the rulemaking process, the Center for Food Safety filed suit in federal court
against FDA and OMB, citing the government’s failure to implement several food safety
regulations required by FSMA. FDA filed a motion to dismiss the complaint against the agency,
which was denied by the court in April 2013. FDA also filed a motion to reconsider, asking the
court to extend the implementation timeline for two FSMA-required rules, which was also
denied. Under a February 2014 agreement between FDA and the Center for Food Safety, the
agency has agreed to a new court-ordered schedule for issuing final FSMA regulations for many
of the major rules between late 2015 and mid-2016.
This report documents the scheduled timeline for action on selected FSMA provisions, as
specified in the enacted law, and FDA-reported actions taken to date, based on available FDA
press releases and publicly available progress reports.
Congressional Research Service
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Contents
Overview of Provisions ................................................................................................................... 1
Implementation Schedule ................................................................................................................ 3
Delays in Publication of Proposed Rules .................................................................................. 3
Extensions in Public Comment and Response Period ............................................................... 4
FDA’s Decision to Re-propose Certain Key Provisions ............................................................ 4
Budgetary and Staff Resources.................................................................................................. 5
Center for Food Safety Lawsuit ....................................................................................................... 6
Current Court-Order Deadlines for Final Rules............................................................................... 8
Tables
Table 1. Food Safety Modernization Act (P.L. 111-353), Selected Provisions,
Time/Schedule in Law, and Implementation Status...................................................................... 9
Contacts
Author Contact Information........................................................................................................... 19
Congressional Research Service
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
C
ongress passed comprehensive food safety legislation in December 2010 (FDA Food
Safety Modernization Act, or FSMA, P.L. 111-353), representing the largest expansion
and overhaul of U.S. food safety authorities since the 1930s. FSMA greatly expanded
food safety oversight authority at the Food and Drug Administration (FDA) within the U.S.
Department of Health and Human Services (HHS), but did not alter oversight authorities within
other federal agencies responsible for food safety, such as the U.S. Department of Agriculture.
Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. However,
to date, FDA has not yet issued final rules and guidance for many of the regulations required
under certain key sections of FSMA—including rules specifying the requirements and conditions
for establishing preventive controls in food facilities, food safety standards for produce growers,
and requirements for food importers, among other provisions. FDA action on most major FSMA
rules has been delayed well beyond the implementation dates specified in the law. Regulations
were to have been proposed or, in some cases, finalized within one to two years of enactment
(roughly January 2012 and January 2013); other rules were to be submitted within 18 months of
enactment (roughly mid-2012).
Given delays in the rulemaking process, the Center for Food Safety filed suit in federal court
against FDA and the Office of Management and Budget (OMB), citing the government’s failure
to implement several food safety regulations required by FSMA. Under a February 2014
agreement between FDA and the Center for Food Safety, the agency has agreed to a new courtordered schedule requiring that final FSMA regulations for many of the major rules be issued
between late 2015 and mid-2016. To date, FDA has not yet issued final rules and guidance for
many of the regulations required under certain key sections of FSMA.
Overview of Provisions
FSMA focused on FDA-regulated foods and amended FDA’s existing structure and authorities, in
particular the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). Among
its many provisions, FSMA expanded FDA’s authority to conduct a mandatory recall of
contaminated food products; enhanced surveillance systems to investigate foodborne illness
outbreaks; established new preventive controls and food safety plans at some food processing
facilities and farms; enhanced FDA’s traceability capacity within the nation’s food distribution
channels; increased inspection frequencies of high-risk food facilities (both domestic and foreign
facilities); and expanded FDA’s authority and oversight capabilities regarding foreign companies
that supply food imports to the United States. FSMA does not directly address meat and poultry
products under the jurisdiction of USDA.
FDA has identified five key elements of FSMA:1
•
Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. This included seven "foundational" rules required to fully implement FSMA covering:
Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards.
Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals.
Produce Safety: Establishes science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms.
Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers.
Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals.
Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food.
Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm.
These regulations were to have been proposed or, in some cases, finalized within one to two years of enactment (roughly January 2012 and January 2013); other rules were to have been submitted within 18 months of enactment (roughly mid-2012). However, many of these regulations did not become final until 2015, and regulations for two rules have yet to be finalized. Other FDA actions under FSMA also have been delayed. Several factors have contributed to delays in FSMA implementing, including the Office of Management and Budget's (OMB's) review process, extensions in the public comment and response period for many of FDA's proposed rules and the agency's re-proposal of key provisions of some major regulations, and also, according to FDA, limited agency resources and the lack of availability of discretionary appropriations. Delays in FDA's rulemaking process resulted in many FSMA regulations being released according to a court-ordered schedule under a federal lawsuit brought by the Center for Food Safety.
This report documents the scheduled timeline for action on selected FSMA provisions, as specified in the enacted law, and FDA-reported actions taken to date, based on available FDA press releases and publicly available progress reports.
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Congress passed comprehensive food safety legislation in December 2010 (FDA Food Safety Modernization Act, or FSMA, P.L. 111-353), which was signed into law on January 4, 2011. FSMA represented the largest expansion and overhaul of U.S. food safety authorities since the 1930s. FSMA greatly expanded food safety oversight authority at the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS), but did not alter oversight authorities within other federal agencies responsible for food safety, such as the U.S. Department of Agriculture.
Under FSMA, FDA is responsible for more than 50 regulations, guidelines, and studies. These included several "foundational" rules required to fully implement FSMA covering preventive controls for human food and for animal food, produce safety, sanitary transportation, intentional adulteration, and development of a Foreign Supplier Verification Program along with a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Most of these regulations become final in 2015 and 2016. This report documents the scheduled timeline for action on selected FSMA provisions, as specified in the enacted law, and FDA-reported actions taken to date.
Overview of FSMA Provisions
FSMA focused on FDA-regulated foods and amended FDA's existing structure and authorities, in particular the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.). Among its many provisions, FSMA expanded FDA's authority to conduct a mandatory recall of contaminated food products; enhanced surveillance systems to investigate foodborne illness outbreaks; established new preventive controls and food safety plans at some food processing facilities and farms; enhanced FDA's traceability capacity within the nation's food distribution channels; increased inspection frequencies of high-risk food facilities (both domestic and foreign facilities); and expanded FDA's authority and oversight capabilities regarding foreign companies that supply food imports to the United States. FSMA does not directly address meat and poultry products under the jurisdiction of USDA.
When the law was enacted, FDA has identified five key elements of FSMA:1
Preventive controls—FSMA provides FDA with a legislative mandate to require
comprehensive, prevention-based controls across the food supply. As examples,
the act requires mandatory preventive controls for food facilities and mandatory
produce safety standards, and also gives FDA the authority to prevent intentional
contamination.
1
See, for example, FDA, “Questions and Answers on the Food Safety Modernization Act,” “The New FDA Food
Safety Modernization Act (FSMA),” and “Background on the FDA Food Safety Modernization Act (FSMA).”
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1
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
•
contamination.
Inspection and Compliance—FSMA provides FDA with the ability to conduct
oversight and ensure compliance with new requirements and to respond when
problems emerge. Examples include establishing a mandated inspection
frequency (based on risk);
22 giving FDA access to industry records and food
safety plans; and requiring certain testing to be conducted by accredited labs.
•
Response
Response—FSMA provides FDA with the ability to respond to problems when
they emerge. Examples include giving FDA mandatory recall authority for all
food products; expanding FDA
’'s authority to administratively detain products
that are in violation of the law; giving FDA the authority to suspend a facility
’s
's registration, effectively prohibiting the company from selling any products within
the United States;
33 establishing pilot projects so FDA can enhance its product
tracing capabilities; and requiring additional recordkeeping by facilities that
“ "manufacture, process, pack or hold
”" foods designated as
“"high-risk.
”
•
"
Imported Food Safety—FSMA provides FDA with the ability to help ensure
that food imports meet U.S. food safety standards. Examples include requiring
importers to verify that their foreign suppliers have adequate preventive controls;
establishing a third-party verification system; requiring certification by a credible
third party for high-risk foods as a condition for entry into the United States;
establishing a voluntary qualified importer program for expedited review and
entry from participating importers; and giving FDA the right to refuse entry into
the United States of food from a foreign facility if FDA is denied access to the
facility or the country where the facility is located.
•
Enhanced Partnerships—FSMA provides FDA with the authority to improve
training of state, local, territorial, and tribal food safety officials. Examples
include requiring FDA to develop and implement strategies to enhance the food
safety capacities of state and local agencies through multi-year grants, as well as
strategies to enhance the capacities of foreign governments and their industries;
and giving FDA the authority to rely on inspections of other federal, state, and
local agencies in meeting its increased inspection mandate for domestic facilities.
FSMA authorized additional appropriations and staff for FDA
’'s future food safety activities. The
Congressional Budget Office (CBO) estimated that implementing the newly enacted law could
increase net federal spending subject to appropriations by $1.4 billion over a five-year period
(FY2011-FY2015).
4 FSMA authorizes an increase in FDA staff, to reach 5,000 in FY2014.
For more detailed information, see CRS Report R40443, The FDA Food Safety Modernization
Act (P.L. 111-353).
2
Specifically, all “high-risk” domestic facilities must be inspected within five years of enactment. High-risk facilities
will be identified based on “known safety risks of the facilities” according to “known safety risks of the food
manufactured, processed, packed, or held at the facility, ... compliance history of a facility, including ... food recalls,
outbreaks of foodborne illness, and violations of food safety standards” and “the rigor and effectiveness of the facility’s
hazard analysis and risk-based preventive controls” among other factors stated in the law (P.L. 111-353, §201).
3
If a facility’s food is found to have a “reasonable probability of causing serious adverse health consequences or
death.” FDA exercised this authority for the first time in November 2012 when it suspended the registration of Sunland
Inc., a peanut butter processor, because of concerns linking the plant to a Salmonella outbreak.
4
CBO, Cost Estimate, “S. 510, Food Safety Modernization Act, as reported by the Senate Committee on Health,
Education, Labor, and Pensions on December 18, 2009, incorporating a manager’s amendment released on August 12,
2010,” August 12, 2010.
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Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Implementation Schedule
FSMA was signed into law on January 4, 2011. Under FSMA, FDA is responsible for more than
50 regulations, guidelines, and studies. However, FDA actions on some major FSMA
provisions—including rules specifying the requirements and conditions for establishing
preventive controls in food facilities, food safety standards for produce growers, and requirements
for food importers, among other provisions—have yet to be finalized, and most rules have been
delayed well beyond the implementation dates specified in the law. Regulations were to have
been proposed or, in some cases, finalized within one to two years of enactment (roughly January
2012 and January 2013); other rules were to be submitted within 18 months of enactment
(roughly mid-2012).
Table 1 documents the scheduled timeline for action on selected FSMA provisions, as specified
in the law, and FDA-reported actions taken to date. For more information about each of these
provisions, see Appendix B in CRS Report R40443, The FDA Food Safety Modernization Act
(P.L. 111-353).
To date, FDA has not yet issued final rules and guidance for many of the regulations required
under certain key sections of FSMA, and it remains unclear when key provisions of the law will
be finalized. During 2013, FDA proposed a majority of the regulations that constitute the food
safety framework under FSMA, but there are continued delays in other rules, industry guidance,
and reports as required under the law. FDA’s decision to re-propose some aspects of several major
FSMA rules raises further questions about FDA’s ability to meet its deadlines under FSMA.
Several factors appear to have contributed to this delay in implementation, as discussed below.
Delays in Publication of Proposed Rules
Although FDA has issued a series of proposed rules, publication of these rules often took place
well after FSMA’s mandated rulemaking schedule. Most of the law’s key regulations were not
proposed until 2013, with some proposals being delayed until later that same year. For example,
proposed rules regarding Preventive Controls for Human Food (FSMA §103) and Produce Safety
Standards (FSMA §105) were both released in January 2013; however, two other related rules
regarding imported foods, Foreign Supplier Verification Program (FSMA §301) and Standards for
Third-Party Auditors (FSMA §307), were not released until July 2013. Preventive Controls for
Food for Animals (FSMA §103) was not released until October 2013. Press reports indicated that
several proposed rules were held up, often for many months, by the Office of Management and
Budget’s (OMB’s) review process.5 It was later reported that OMB had made changes to the
proposed rules while in review.6
5
See, for example, D. ElBoghdady, “Food-safety rules in limbo at Office of Management and Budget,” Washington
Post, May 2, 2012; and M. Patoka, “Three Food Safety Rules Grow Moldy at OIRA as Import-related Outbreaks
Continue,” Food Safety News, June 26, 2013.
6
See, for example, J. Murphy, “HHS documents reveal OMB edits of original FSMA preventive controls proposal,”
Food Chemical News, March 22, 2013; J. Murphy, “OMB removed mandatory onsite audits from FSVP proposal,
internal documents show,” Food Chemical News, October 25, 2013.
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Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Extensions in Public Comment and Response Period
Some of the proposed rules were granted multiple extensions for public comment and review. In
particular, the two proposed rules and related documents regarding Preventive Controls for
Human Food (FSMA §103) and Produce Safety Standards (FSMA §105) released in January
2013 were granted a series of extensions, eventually closing on November 15, 2013. These
extensions were requested by a wide range of stakeholders, given the complexity of the
regulations as well as FDA’s delayed release of other related FSMA rules that some groups
argued needed to be considered together as a full regulatory package.
FDA’s Decision to Re-propose Certain Key Provisions
Further delay is expected in FSMA’s implementation following FDA’s announcement that it plans
to re-propose some key provisions of regulations affecting farmers in two separate rulemakings.7
In the agency’s December 2013 announcement, it acknowledged that “significant changes will be
needed in key provisions of the two proposed rules affecting small and large farmers,” namely
regulations implementing Preventive Controls for Human Food (FSMA §103) and also Produce
4 FSMA authorizes an increase in FDA staff, to reach 5,000 in FY2014.
During the regulatory development phase of FSMA, seven "foundational" rules were identified as required to fully implement FSMA (see listing in text box below).5 These regulations were to have been proposed or, in some cases, finalized within one to two years of enactment (roughly January 2012 and January 2013); other rules were to have been submitted within 18 months of enactment (roughly mid-2012). However, many of these regulations did not become final until 2015, and regulations for two rules—Intentional Adulteration (FSMA §106) and Sanitary Transportation of Human and Animal Food proposal (FSMA §111)—are scheduled to be finalized in 2016. Some other FDA actions under FSMA have been delayed. Table 1 documents the scheduled timeline for action on selected FSMA provisions, as specified in the law, and FDA-reported actions taken to date, based on available FDA press releases and publicly available progress reports. For more information about each of these provisions, see Appendix B in CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353).
Seven "Foundational" Rules Required to Fully Implement FSMA
Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards (FSMA §103).
Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals (FSMA §103).
Produce Safety: Establishes science-based standards for growing, harvesting, packing, and holding produce on domestic and foreign farms (FSMA §105(a)).
Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers (FSMA §301(a)).
Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals (FSMA §307).
Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food (FSMA §111).
Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm (FSMA §106(b)).
Delays in FSMA's Implementation Schedule
FDA began to release proposed rules for some of the foundational regulations that constitute the food safety framework under FSMA in 2013. However, there were continued delays in the agency's release of other FSMA rules, industry guidance, and reports, well beyond the dates required under the law. These delays were exacerbated by FDA's decision to extend the public comment and response period for most FSMA proposed regulations as well as the agency's decision to re-propose key provisions of some regulations. Other factors also contributed to delays in FSMA implementation, including oftentimes a lengthy review process by the Office of Management and Budget's (OMB) and—according to FDA—limited agency resources and the lack of availability of discretionary appropriations. Delays in FDA's rulemaking process resulted in many FSMA regulations being released according to a court-ordered schedule under a federal lawsuit brought by the Center for Food Safety.
Delayed Publication of FDA's Proposed Rules
Publication of FDA proposed regulation often took place well after FSMA's mandated rulemaking schedule. Most of the law's key regulations were not proposed until 2013, with some proposals being delayed until later that same year. For example, proposed rules regarding Preventive Controls for Human Food (FSMA §103) and Produce Safety Standards (FSMA §105) were both released in January 2013. Two other related rules regarding imported foods—Foreign Supplier Verification Program (FSMA §301) and Standards for Third-Party Auditors (FSMA §307)—were not released until July 2013. Proposed requirements for Preventive Controls for Food for Animals (FSMA §103) were not released until October 2013, followed by proposed requirements for Intentional Adulteration (FSMA §106) in December 2013. FDA's Sanitary Transportation of Human and Animal Food proposal (FSMA §111) was released in February 2014.
For some proposed rules, press reports indicated that several proposals were held up, often for many months, by OMB's review process.6 It was also reported that OMB made changes to several proposed rules while in review.7
Extensions in Public Comment and Response Period
Some FSMA proposed rules were granted multiple extensions for public comment and review. For example, FDA's first two proposed foundational rules—Preventive Controls for Human Food (FSMA §103) and Produce Safety Standards (FSMA §105)—were released in January 2013 but later granted a series of extensions, eventually closing on November 15, 2013. These extensions were requested by a wide range of stakeholders, given the complexity of the regulations as well as FDA's delayed release of other related FSMA rules that some groups argued needed to be considered together as a full regulatory package.
FDA's Decision to Re-Propose Certain Key Provisions
Further delay in FDA's implementation of FSMA is attributable to FDA's announcement that would re-propose key provisions in some of its proposed regulations. In the agency's December 2013 announcement, it acknowledged that "significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers," namely regulations implementing Preventive Controls for Human Food (FSMA §103) and also Produce Safety Standards (FSMA §105).8Safety Standards (FSMA §105). Provisions that FDA plans to change
“"include water quality
standards and testing, standards for using raw manure and compost, certain provisions affecting
mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms.
”8
"9 Some stakeholders expect further changes to other provisions in these proposed rules.
910 In March
2014, FDA announced it would also re-propose regulations implementing a second preventive
controls regulation, namely the Preventive Controls for Food for Animals (FSMA §103).
10
11
FDA had suggested that they would likely publish the re-proposed sections of these rules at or
very near to the same time. The agency also indicated that it will accept
“"additional comments
only on those sections of the proposed rules that have been revised,
”" recognizing the
“"court order
regarding the timelines for finalizing these rules.
”11"12 In September 2014, FDA re-proposed certain
aspects of four major proposed rules, including preventative controls for both human food and
animal food (FSMA §103(a) and (c)), produce safety (FSMA §105(a)), and the Foreign Supplier
Verification Program (FSMA §301(a)).
Congress has continued to push
Congress pushed FDA to consider rewriting these proposed regulations. Several
Members of Congress have submitted a series of letters to FDA requesting that the agency release
a second set of proposed rules and solicit public comment before going final. Within Congress,
two letters were sent to FDA on November 22, 2013, including a House-Senate letter from
Senators Shaheen and Blunt and Representatives Courtney and Gibson, and a letter from
members of the House Organic Caucus, each expressing concerns about the proposed
requirements in FDA
’s produce rule, among other concerns. A third letter was sent to FDA on
7
FDA, “Statement from FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, on Key
Provisions of the Proposed FSMA Rules Affecting Farmers,” December 19, 2013.
8
Ibid.
9
See, for example, D. Flynn, “Letter From the Editor: Produce Growers Get Early Christmas Present,” Food Safety
News, December 22, 2013.
10
FDA, “Update on Proposed Rules under the FDA Food Safety Modernization Act,” March 19, 2014.
11
FDA, “Statement from FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, on Key
Provisions of the Proposed FSMA Rules Affecting Farmers,” December 19, 2013.
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Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
's produce rule, among other concerns. A third letter was sent to FDA on November 13, 2013, by Senators Tester and Hagan expressing concerns about the effects of the
proposed rules on small farms and facilities.
1213 Another letter was sent on November 15, 2013,
from Members from Vermont (Senators Leahy and Sanders, and Representative Welch), urging
FDA to re-propose these rules.
1314 A wide range of stakeholders have also expressed similar
concerns and are supporting FDA
’'s reexamination of some of its proposed regulations.
14
15
Other congressional actions taken regarding FSMA include the addition of a provision in the
enacted 2014 farm bill (P.L. 113-79, §12311) requiring FDA to provide Congress with a scientific
and economic analysis of FSMA, including an analysis of how the law affects farm businesses of
all sizes, prior to implementing final regulations under the law.
1516 Recent appropriations bills also
have addressed certain aspects of FDA
’'s implementation of regulations under FSMA. As part of
the enacted FY2014 appropriations, Congress directed FDA to implement a
“comprehensive
"comprehensive training program
”" for federal and state inspectors and commended FDA for its decision to revise
its proposed rules affecting farmers.
1617 As part of the
pending FY2015enacted FY2015 and FY2016 Agriculture appropriations, both the
House and Senate Appropriations Committees
makemade a number of recommendations in their
respective bills regarding FDA
’'s ongoing efforts to develop FSMA-related regulations and
guidance.
18 Both committees
address FSMA’have addressed FSMA's re-proposal of certain key regulations regarding food
safety preventive controls for both human and animal food, and
also standards for produce
.17
Budgetary and Staff Resources
, and have also expressed a range of concerns as FDA has developed regulations under FSMA, including concerns about extensive delays in FDA's rulemaking and implementation of FSMA.
Budgetary and Staff Resources
Limited resources and the availability of discretionary appropriations might also have affected
FDA’ FDA's rollout and full implementation of FSMA.
1819 Although the law authorized appropriations, it
did not provide the actual funding needed for FDA to perform these activities. When the law was
being debated in Congress, CBO had estimated that implementing the law could increase net
federal spending subject to appropriation by about $1.4 billion over a five-year period (
FY2011FY2015).19FY2011-FY2015).20 The Obama Administration has repeatedly requested that additional user fees be
implemented to cover some of these costs, which Congress has not approved. Increases in
appropriated funding for FDA
’'s Food Program have not matched the Administration
’'s additional
requested user fees. Staff levels at FDA also have remained below levels authorized in FSMA,
with an estimated 3,
800 FDA staff working on food-related activities in FY2014.20 Although
Congress has added to FDA’s budget for its Foods Program in the past few years—raising it from
12
Links to three of these congressional letters are provided at the National Sustainable Agriculture Coalition (NSAC)
website (http://sustainableagriculture.net/blog/congress-fsma-letters/).
13
“Vermont Lawmakers Urge Re-Write of FSMA Rules,” Food Chemical News, November 29, 2013.
14
Public comments are in FDA’s rulemaking docket. Also see comments posted by the National Association of State
Departments of Agriculture, http://www.nasda.org/Policy/; United Fresh Produce Association,
http://www.unitedfresh.org/; and the National Sustainable Agriculture Coalition, http://sustainableagriculture.net/.
15
For farm bill information, see CRS Report R43076, The 2014 Farm Bill (P.L. 113-79): Summary and Side-by-Side.
16
P.L. 113-76. Explanatory Statement regarding the House Amendment to the Senate Amendment on H.R. 3547.
17
For more information, see CRS Report R43669, Agriculture and Related Agencies: FY2015 Appropriations.
18
See annual FDA Budget Explanatory Notes for Committee on Appropriations, various years, http://www.fda.gov/
AboutFDA/ReportsManualsForms/Reports/BudgetReports/default.htm. Also see letter from Leslie Kux, FDA’s
Assistant Commissioner for Policy, to U.S. District Court judges regarding a food labeling policy, January 6, 2014.
19
CBO, Cost Estimate, “S. 510, Food Safety Modernization Act, as reported by the Senate Committee on Health,
Education, Labor, and Pensions on December 18, 2009,” August 12, 2010.
20
FSMA, P.L. 111-353, §401. By fiscal year, staff level increases were authorized at a total of not fewer than 4,000
staff members (FY2011); 4,200 staff (FY2012); 4,600 staff (FY2013); and 5,000 staff (FY2014).
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Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
$783.2 million in FY2010 to $882.8 million in FY2014—agency officials claim that FDA will
need an additional $400 million to $450 million more per year above its FY2012 base to fully
implement FSMA.21
As part of the agency’s implementation of FSMA, FDA has conducted stakeholder outreach and
hosted public meetings, and released web videos and other written materials and presentations.22
Center for Food Safety Lawsuit
In August 2012, the Center for Food Safety (CFS)23 filed suit in federal court against FDA and
OMB, citing the government’s failure to implement seven food safety regulations required by
FSMA (see box below).24 CFS argues that, by not meeting statutory deadlines for rulemaking,
FDA is breaking the law and needs to protect the public. FDA argues that careful development of
complex food safety rules needs to be balanced against meeting statutory deadlines.25
FDA filed a motion to dismiss the complaint against the agency in November 2012,26 which was
denied by the court in April 2013.27 As part of a June 2013 agreement, FDA was ordered to
complete the regulations as follows: by November 30, 2013, publish all remaining proposed
regulations; by March 31, 2014, close any comment period on these proposed regulations; and by
June 30, 2015, finalize all regulations.28
In July 2013, FDA filed a motion to reconsider, asking the court to extend the implementation
timeline for two FSMA-required rules: Sanitary Transport of Food and Feed (FSMA §111) and
Intentional Contamination (FSMA §106).29 This motion was also denied in August 2013.30
However, the Center for Food Safety accepted a 60-day extension of the deadline for publication
of the sanitary transport proposed rule (until January 31, 2014), provided that the comment period
end date not be extended beyond April 30, 2014, and that the final rule date remain June 30, 2015.
The rule timeline for the intentional contamination proposal was not extended, although in
November 2013 FDA was later granted a 20-day extension, until December 20, 2013, to publish
the proposed rule on intentional contamination due to setbacks that were likely caused by the
21
FDA, Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA), May 2013.
FY2012 appropriations totaled $866.1 million, not including revenue from user fees.
22
For information, see FDA’s FSMA website, http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359450.htm.
23
The Center for Food Safety is a national nonprofit public interest and environmental advocacy organization that has
been tracking FDA’s implementation of FSMA, as have other public health organizations, such as the Center for
Science in the Public Interest (CSPI) and others.
24
Center for Food Safety, et al. v. Margaret E. Hamburg, M.D., et al., Case No. 12 CV 4529 (N.D. Cal. 2012), August
29, 2012. The original complaint is at http://www.centerforfoodsafety.org/issues/308/food-safety/legal-actions. Other
information on the case is available at CFS’ website (http://www.centerforfoodsafety.org).
25
“FDA Seeks to Dismiss Lawsuit Over Delay of Food Safety Rules,” Food Safety News, December 4, 2012.
26
FDA’s motion to dismiss is at http://www.foodsafetynews.com/files/2012/12/FDA-motion-to-dismiss.pdf.
27
The April 2013 court decision on the case is at http://www.centerforfoodsafety.org/files/57-sj-decision_76498.pdf.
28
The June 2013 court order is available at http://www.centerforfoodsafety.org/files/fsma-remedy-order_52466.pdf.
29
FDA’s July 2013 motion to reconsider is at http://www.freeborn.com/assets/fda_motion_to_reconsider.pdf.
30
The August 2013 court order is available at http://www.centerforfoodsafety.org/files/69—order—granting-in-partdenying-in-part-mot-recons_34619.pdf.
Congressional Research Service
6
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
federal government shutdown in October 2013.31 FDA was able to meet the deadline for the
proposed intentional contamination rule and published the proposed sanitary transport rule in
early February 2014.
Center for Food Safety Lawsuit Against FDA and OMB
In August 2012, the Center for Food Safety (CFS) filed suit in federal court against FDA and OMB, citing the
government’s failure to implement seven food safety regulations required by FSMA:
•
final regulations due July 4, 2012, to “establish science-based minimum standards for conducting a hazard
analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the
preventive controls” (FSMA §103(a));
•
notice of proposed rulemaking due October 4, 2011 (with final rule due nine months after close of public
comment period), regarding activities that constitute on-farm manufacturing, processing, packing, or holding of
food (FSMA §103(c));
•
notice of proposed rulemaking due January 4, 2012 (with final rule due nine months after close of public
comment period), to establish science-based minimum standards for the safe production and harvesting of
produce (FSMA §105(a)-(b));
•
final regulations due July 4, 2012, regarding intentional adulteration of food (FSMA §106(b));
•
regulations due July 4, 2012, to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other
persons engaged in the transportation of food to use sanitary transportation practices (FSMA §111);
•
final regulations due January 4, 2012, regarding the supplier verification program for imported foods (FSMA
§301(a)); and
•
final regulations due July 4, 2012, regarding “model standards, including requirements for regulatory audit
reports, and for each recognized accreditation body to ensure that third-party auditors and audit agents of such
auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors”
(FSMA §307).
FDA filed a motion to dismiss the complaint against the agency in November 2012, which was denied by the court in
April 2013. FDA was ordered to new deadlines to complete the regulations, under a June 2013 agreement.
In July 2013, FDA filed a motion to reconsider, asking the court to extend the implementation timeline for two
FSMA-required rules. This motion was also denied in August 2013; however, CFS accepted extensions of the
deadline for publication of these rules.
As part of FDA’s July submission, the agency said it was prepared to meet court-imposed deadlines for several other
major FSMA rules. In February 2014, FDA and CFS reached an agreement regarding the deadlines for publishing final
rules implementing FSMA. Under the new agreement, FDA must issue regulations for many of the major rules
between late 2015 and mid-2016.
Source: Center for Food Safety, et al. v. Margaret E. Hamburg, M.D., et al., Case No. 12 CV 4529 (N.D. Cal. 2012),
700 FDA staff working on food-related activities in FY2014.21 As part of the agency's implementation of FSMA, FDA has conducted stakeholder outreach, hosted public meetings, and released web videos and other written materials and presentations.22
During the past six years (FY2011-FY2016), enacted budgetary changes for food safety and FSMA implementation (as reported by congressional appropriators) have totaled nearly $300 million.23 This amount includes the enacted FY2016 Agriculture appropriation for FDA food safety activities, which provided for a $104.5 million increase in budget authority to "assist the FDA in preparation for the implementation of FSMA prior to the effective dates of the seven foundational proposed rules."24 Previously, FDA reported that an additional $400 million to $450 million per year above the FY2012 base is needed to fully implement FSMA.25 Available FDA funding for FSMA implementation and other food safety activities has been lower than what FDA has said it needs to fully implement the law.
Lawsuit and Court-Order Deadlines for Final Rules
In August 2012, the Center for Food Safety (CFS)26 filed suit in federal court against FDA and OMB, citing the government's failure to implement seven food safety regulations required by FSMA (see box below).27 CFS argues that, by not meeting statutory deadlines for rulemaking, FDA is breaking the law and needs to protect the public.
FDA filed a motion to dismiss the complaint against the agency in November 2012,28 which was denied by the court in April 2013.29 As part of a June 2013 agreement, FDA was ordered to complete the regulations as follows: by November 30, 2013, publish all remaining proposed regulations; by March 31, 2014, close any comment period on these proposed regulations; and by June 30, 2015, finalize all regulations.30
Center for Food Safety Lawsuit Against FDA and OMB
In August 2012, the Center for Food Safety (CFS) filed suit in federal court against FDA and OMB, citing the government's failure to implement seven food safety regulations required by FSMA:
- final regulations due July 4, 2012, to "establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls" (FSMA §103(a));
- notice of proposed rulemaking due October 4, 2011 (with final rule due nine months after close of public comment period), regarding activities that constitute on-farm manufacturing, processing, packing, or holding of food (FSMA §103(c));
- notice of proposed rulemaking due January 4, 2012 (with final rule due nine months after close of public comment period), to establish science-based minimum standards for the safe production and harvesting of produce (FSMA §105(a)-(b));
- final regulations due July 4, 2012, regarding intentional adulteration of food (FSMA §106(b));
- regulations due July 4, 2012, to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices (FSMA §111);
- final regulations due January 4, 2012, regarding the supplier verification program for imported foods (FSMA §301(a)); and
- final regulations due July 4, 2012, regarding "model standards, including requirements for regulatory audit reports, and for each recognized accreditation body to ensure that third-party auditors and audit agents of such auditors meet such standards in order to qualify such third-party auditors as accredited third-party auditors" (FSMA §307).
FDA filed a motion to dismiss the complaint against the agency in November 2012, which was denied by the court in April 2013. FDA was ordered to new deadlines to complete the regulations, under a June 2013 agreement.
In July 2013, FDA filed a motion to reconsider, asking the court to extend the implementation timeline for two FSMA-required rules. This motion was also denied in August 2013; however, CFS accepted extensions of the deadline for publication of these rules.
As part of FDA's July submission, the agency said it was prepared to meet court-imposed deadlines for several other major FSMA rules. In February 2014, FDA and CFS reached an agreement regarding the deadlines for publishing final rules implementing FSMA. Under the new agreement, FDA must issue regulations for many of the major rules between late 2015 and mid-2016.
Source: Center for Food Safety, et al. v. Margaret E. Hamburg, M.D., et al., Case No. 12 CV 4529 (N.D. Cal. 2012), August 29, 2012. The original complaint and decision is at http://www.centerforfoodsafety.org/issues/
308/food-safety/308/foodsafety/legal-actions. Other information on the case is available at CFS
’'s website
( (http://www.centerforfoodsafety.org
).
In July 2013, FDA filed a motion to reconsider, asking the court to extend the implementation timeline for two FSMA-required rules: Sanitary Transport of Food and Feed (FSMA §111) and Intentional Contamination (FSMA §106).31 This motion was also denied in August 2013.32
The Center for Food Safety accepted a 60-day extension of the deadline for publication of the sanitary transport proposed rule (until January 31, 2014), provided that the comment period end date not be extended beyond April 30, 2014, and that the final rule date remain June 30, 2015. The rule timeline for the intentional contamination proposal was not extended, although in November 2013 FDA was later granted a 20-day extension, until December 20, 2013, to publish the proposed rule on intentional contamination due to setbacks that were likely caused by the federal government shutdown in October 2013.33 FDA was able to meet the deadline for the proposed intentional contamination rule and published the proposed sanitary transport rule in early February 2014.
Under a February 2014 agreement between FDA and the Center for Food Safety, the agency has agreed to a new court-ordered schedule requiring that final FSMA regulations for many of the major rules be issued between late 2015 and mid-2016 (Figure 1). This schedule further pushed back the implementation dates for final FSMA regulations beyond the dates originally mandated by Congress in the enacted law. As of late 2015, FDA has issued final rules for most of these foundational rules; however, some regulations and other additional FDA actions and guidance are still in the process of being developed.
Figure 1. FDA's Timetable to Develop Primary Regulations, Proposal and Final
Source: FDA presentation materials to embassies and international stakeholders, June 23, 2015, http://www.fda.gov/downloads/InternationalPrograms/NewsEvents/UCM452962.pdf.
Note: * denotes supplemental proposals published September 2014.
Further extension beyond these dates, however, would require FDA to request an extension through a written agreement to the parties and also to notify the court, according to the agreement. If the parties do not agree to the extension, FDA might still be able to seek an extension through other avenues.34
Reportedly, an FDA official indicated in September 2014 that full implementation of FSMA would likely take another 10 years, the amount of time needed to "reasonably expect all the rules to be working."35
Expected Compliance Post Rulemaking
FDA's Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA) was released in May 2014 and describes "the next phase of FSMA implementation by outlining broadly the drivers of change in FDA's approach to food safety and the operational strategy for implementing that change, as mandated and empowered by FSMA."36 Full implementation of the most FSMA regulations will be phased in, mostly to provide flexibility to farms and food businesses to comply with the new requirements, as provided for in the enacted law. Businesses that produce human and animal food are expected to comply with new preventive controls and become fully operational under the regulations by 2019 (Figure 2). Produce standards for produce farms become fully operational under the regulations by 2022 (Figure 3).
Figure 2. Proposed Preventive Controls Human and Animal Food Regulations, Implementation Timeline
|
Source: FDA presentation materials to embassies and international stakeholders, June 23, 2015, http://www.fda.gov/downloads/InternationalPrograms/NewsEvents/UCM452962.pdf.
|
Figure 3. Proposed Produce Safety Rule, Implementation Timeline
|
Source: FDA presentation materials to embassies and international stakeholders, June 23, 2015, http://www.fda.gov/downloads/InternationalPrograms/NewsEvents/UCM452962.pdf.
|
).
31
The November 2013 decision is at http://www.centerforfoodsafety.org/files/15—order-denying-motion-for-staypending-appeal3b-expediting-appellate-briefing-schedule-in-part_71389.pdf.
Congressional Research Service
7
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Current Court-Order Deadlines for Final Rules
Given delays in the current rulemaking schedule, in February 2014, FDA and the Center for Food
Safety reached a settlement agreement establishing a new deadline schedule for the agency to
fully implement FSMA.32 Under the new agreement, FDA must issue final regulations for some
key FSMA provisions under the following schedule:
•
preventative controls for both human food and animal food (FSMA §103(a) and
(c)): August 30, 2015;
•
imported food and foreign suppliers, including the Foreign Supplier Verification
Program (FSMA §301(a)) and Accreditation of Third Party Auditors (FSMA
§307): October 31, 2015;
•
produce safety (FSMA §105(a)): October 31, 2015;
•
sanitary transportation practices for food and feed (FSMA §111): March 31,
2016;
•
intentional adulteration of food (FSMA §106(b)): May 31, 2016.
This schedule further pushes back the implementation dates for final FSMA regulations beyond
the dates originally mandated by Congress in the enacted law (P.L. 111-353). Reportedly, an FDA
official indicated in September 2014 that full implementation of FSMA would likely take another
10 years, the amount of time needed to “reasonably expect all the rules to be working.”33
Although FDA has agreed to complete the final FSMA regulations under these new deadlines,
there may be an opportunity for the agency to seek an extension if it believes it has good cause
for doing so. Further extension beyond these dates, however, would require FDA to request an
extension through a written agreement to the parties and also to notify the court, according to the
agreement. If the parties do not agree to the extension, FDA might still be able to seek an
extension through other avenues.34
Table 1 documents the scheduled timeline for action on selected FSMA provisions, as specified
in the law, and FDA-reported actions taken to date, based on available FDA press releases and
publicly available progress reports.
FDA’s Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
was released in May 2014 and describes “the next phase of FSMA implementation by outlining
broadly the drivers of change in FDA’s approach to food safety and the operational strategy for
implementing that change, as mandated and empowered by FSMA.”35
32
The joint consent decree is available at http://www.centerforfoodsafety.org/files/2014-2-20-dkt-82-1—joint—
consent-decree_26503.pdf.
33
“Food Safety Law to Take a Decade to Implement, FDA Says,” CQ News, September 9, 2014.
34
“FDA, Center for Food Safety agree to new timeline for FSMA rules,” Food Chemical News, February 20, 2014.
35
FDA, Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA): Protecting Public
Health by Strategic Implementation of Prevention-Oriented Food Safety Standards, May 2, 2014.
Congressional Research Service
8
x
x
Report
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Guidance
Section(s)
Regulation
Table 1. Food Safety Modernization Act (P.L. 111-353), Selected Provisions,
Time/Schedule in Law, and Implementation Status
Available Information on Implementation Status
Title I—Improving Capacity to Prevent Food Safety Problems
Inspections of
Records
(§101)
Effective upon enactment of FSMA, the Department of
Health and Human Service (HHS) may inspect records
related to the “manufacture, processing, packing,
distribution, receipt, holding, or importation” of certain
foods of concern (as defined). Amends previous law
which contained one standard (trigger) for records
access, by creating two such standards.
In April 2014, FDA issued the following regarding FDA’s access to records:
•
Section(s)
|
Timeline/Schedule in Law (FSMA signed into law on January 4, 2011)
Regulation
|
Guidance
|
Report
|
Available Information on Implementation Status
|
|
Title I—Improving Capacity to Prevent Food Safety Problems
|
Inspections of Records (§101)
|
Effective upon enactment of FSMA, the Department of Health and Human Service (HHS) may inspect records related to the "manufacture, processing, packing, distribution, receipt, holding, or importation" of certain foods of concern (as defined). Amends previous law which contained one standard (trigger) for records access, by creating two such standards.
|
x
|
x
|
In April 2014, FDA issued the following regarding FDA's access to records:
Final Rule: Establishment, Maintenance, and Availability of Records: Amendment to Record
Availability Requirements
.
•
.
Guidance for Industry:
FDA Records Access Authority Under Sections 414 and 704 of the
Federal Food, Drug, & Cosmetic Act
.
•
.
Guidance for Industry:
What You Need to Know About Establishment and Maintenance
of Records; Small Entity Compliance Guide
.
.In February 2012, FDA issued the following regarding FDA
’'s access to records:
CRS-9
•
Interim Final Rule: Establishment, Maintenance, and Availability of Records: Amendment
to Record Availability Requirements (Docket Number: FDA-2002-N-0153).
•
Draft Guidance for Industry:
FDA Records Access Authority Under Sections 414 and
704 of the Federal Food, Drug, & Cosmetic Act (Docket Number: FDA-2011-D-0674).
•
Guidance for Industry:
Questions and Answers Regarding Establishment and Maintenance
of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold,
or Import Food
(5th (5th Edition) (Docket Number: FDA-2011-D-0598).
Registration of
Food Facilities
(§102)
Among other provisions, food facilities shall be subject to
biennial registration renewal (and HHS may suspend a
facility’ facility's registration in certain cases) either once HHS
issues interim final regulations or 180 days after
enactment of FSMA.
Report
Guidance
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
x
Available Information on Implementation Status
FDA’ enactment of FSMA.
HHS shall issue a small entity compliance policy guide to assist small entities in complying with registration requirements (no later than 180 days after it issues regulations).
x
|
x
|
Proposed Rule: Amendments to Registration of Food Facilities (Docket Number: FDA-2002-N-0323, in April 2015) [FSMA amended Section 415 of the FDCA by requiring that certain additional information be included in registrations.]
FDA's authority to suspend the registration of a food facility became effective on July 3,
2011. In November 2012, for the first time, FDA suspended the registration of a food facility,
Sundland Inc., due to illness from
SalmonellaSalmonella associated with its peanut products.
Guidance for Industry:
Necessity of the Use of Food Product Categories in Food Facility
Registrations and Updates to Food Product Categories (Docket Number: FDA-2012-D-0585,
October 2012).
HHS shall issue a small entity compliance policy guide to
assist small entities in complying with registration
requirements (no later than 180 days after it issues
regulations).
October 2012).
Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small
Entity Compliance Guide (Docket Number: FDA-2012-D-1003, December 2012).
Guidance for Industry:
Questions and Answers Regarding Food Facility Registration
(5th (5th
Edition) (Docket Number: FDA-2012-D-1002, December 2012).
In April 2013, FDA issued draft guidance, which, when finalized, will replace Compliance Policy
Guide Section 110.300 Registration of Food Facilities Under the Public Health Security and
Bioterrorism
PreparednessPreparedness and Response Act of 2002.
Hazard
Analysis and
Risk-Based
Preventive
Controls
(§103)
**Provisions
re. seafood,
see (§114)
Hazard Analysis and Risk-Based Preventive Controls (§103)
**Provisions re. seafood, see (§114)
|
Among other provisions, HHS (coordinating with DHS)
shall establish mandatory preventive controls for food
facilities, except for
“"small business
”" and
“"very small
business” business" as defined (§103(a)). Final regulations are due
no later than 18 months after enactment. HHS shall also
issue proposed regulations (within 9 months after
enactment) and final regulations (within 9 months after
the close of the public comment period on the proposed
rule) regarding certain on-farm activities (§103(c)). HHS
shall issue a small entity compliance guide, within 180 days
of the rules (§103(d)).
HHS, in consultation with USDA, shall issue a report on
the food processing sector (within 18 months after
enactment).
CRS-10
x
x
x
x
|
x
|
x
|
In May 2011, FDA opened a docket for information about preventive controls and other
practices. In March 2012, FDA issued information on how FDA identifies a high-risk facility.
Proposed Rules:
•
Final Rules:
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Docket Number: FDA-2011-N-0920, September 2015)
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Docket Number: FDA-2011-N-0922, September 2015)
Final Rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments (Docket Number: FDA-2011-N-0920, November 2015)
Proposed Rules:
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Human Food (Docket Number: FDA-2011-N-0920, January 2013)
•
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Food for Animals (Docket Number: FDA-2011-N-09226; October 2013).
In August 2012, FDA published a
“"Draft Qualitative Risk Assessment of Risk of Activity/Food
Combinations for Activities (Outside the Farm Definition) Conducted in a Facility
CoLocatedCo-Located on a Farm
”" to provide a science-based risk analysis of those activity/food
combinations that could be considered low risk.
In March 2013, FDA corrected technical errors to the proposed rule for Preventive
Controls for Human Food. FDA also extended the comment period on the proposed rule
numerous times until November 15, 2013. FDA has also conducted outreach and public
meetings, and released web videos and written materials.
Report
Guidance
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
Available Information on Implementation Status
Proposed Supplemental Rules:
•
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls
for Human Food (Docket Number: FDA-2011-N-0920, September 2014)
•
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls
for Food for Animals (Docket Number: FDA-2011-N-0922, September 2014)
Pending: HHS study on the food processing sector.
Performance
Standards
(§104)
Performance Standards (§104)
|
HHS, in coordination with USDA, shall review and
evaluate relevant health data and other relevant
information, to determine the most significant foodborne
contaminants, and shall issue contaminant-specific and
science-based guidance documents (not less frequently
than every two years).
Standards for
Produce
Safety (§105)
x
|
Status of guidance documents unknown.
|
Standards for Produce Safety (§105)
|
Among other provisions, HHS shall establish mandatory
science-based, minimum standards for the safe production
and harvesting of fruits and vegetables, except for
“small
business” and “"small business" and "very small business
”" as defined. Proposed
regulations shall be issued within one year after
enactment, with final regulations following one year after
the close of the public comment period on the proposed
rule (§105(a)-(b)).
x
x
Status of guidance documents unknown.
x
Proposed Rule:
x
|
x
|
Final Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Docket Number: FDA-2011-N-0921, November 2015)
Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for
Human Consumption (Docket Number: FDA-2011-N-0921, January 2013). In March 2013,
FDA corrected technical errors to the proposed rule. FDA also extended the comment
period on the proposed rule numerous times until November 15, 2013. FDA also has
conducted outreach and public meetings, and released web videos and written materials.
In August 2013, FDA announced it would prepare an Environmental Impact Statement (EIS)
to evaluate the potential environmental effects of the proposed rule for produce safety.
Proposed Supplemental Rule: Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption (Docket Number: FDA-2011-N-0921, September 2014)
Protection
Against
Intentional
Adulteration
(§106)
CRS-11
Protection Against Intentional Adulteration (§106)
|
HHS, in coordination with the Department of Homeland
Security (DHS) and in consultation with USDA, shall issue
regulations to protect against the intentional adulteration
of food (within 18 months of enactment). HHS, in
consultation with DHS and USDA, shall issue guidance
documents related to the intentional adulteration,
including mitigation strategies (no later than one year
after enactment).
x
x
x
|
x
|
Proposed Rule: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
(Docket Number: FDA-2013-N-14254, December 2013).
Status of guidance documents unknown.
Report
Fees (§107); Funding for Food Safety (§401)
|
Authorizes HHS to assess and collect fees for
reinspection, recall, and importation activities (§107).
HHS shall submit an annual report to include a
description of fees assessed and collected each year and a
description of the entities paying fees (no later than 120
days after each fiscal year).
Guidance
Fees (§107);
Funding for
Food Safety
(§401)
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
x
x
Food & Agric.
Coordinating
Councils
(§109)
CRS-12
Guidance for Industry: days after each fiscal year).
HHS shall increase its food safety field staff to the following levels: 4,000 staff (FY2011); 4,200 staff (FY2012); 4,600 staff (FY2013); and 5,000 staff (FY2014), with an increase of 150 field staff for food defense by FY2011 (§401).
x
|
x
|
Guidance for Industry:
Implementation of the Fee Provisions of Section 107 of the FDA Food
Safety Modernization Act (Docket Number: FDA-2011-D-072135, September 2011).
Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Docket Number: FDA-2012-D-1002; November 2014)
In August of 2011, 2012, 2013, and 2014 FDA announced, respectively, the FY2012, FY2013,
FY2014, and FY2015 fee schedule for certain domestic and foreign facility reinspection. FDA
began collecting user fees for some activities in FY2012.
Pending: HHS report on fees collected.
HHS shall increase its food safety field staff to the
following levels: 4,000 staff (FY2011); 4,200 staff (FY2012);
4,600 staff (FY2013); and 5,000 staff (FY2014), with an
increase of 150 field staff for food defense by FY2011
(§401).
National
Agric. and
Food Defense
Strategy
(§108)
Available Information on Implementation Status
HHS’
Pending: HHS report on fees collected.
HHS's Foods Program reports the following total full-time equivalents (FTEs) in recent years:
about 3,600 FTEs (FY2011); about 3,500 FTEs (FY2012); and about 3,700 FTEs (FY2013).
National Agric. and Food Defense Strategy (§108)
|
Requires that HHS and USDA develop a
“National
"National Agriculture and Food Defense Strategy,
”" in coordination
with DHS (no later than one year after the enactment of
FSMA), including an implementation plan and a
coordinated research agenda. It shall be updated at least
every four years.
x
DHS, coordinating with HHS and USDA, shall submit an
annual report on the activities of the Food and
Agriculture government and sector coordinating councils
(within 180 days of enactment).
x
every four years.
x
|
In April 2015, HHS released its report to Congress, National Agriculture and Food Defense Strategy, on national agriculture and food defense strategy, implementation plan, and research plan.
In April 2013, FDA published its Analysis of Results for FDA Food Defense Vulnerability
Assessments and Identification of Activity Types, documenting the results from 25 vulnerability
assessments, conducted by FDA over several years on more than 50 products or processes,
to determine if a potential
“threshold”"threshold" score for the implementation of mitigation strategies
could be identified.
Pending: HHS report on national agriculture and food defense strategy, implementation plan,
and research plan.
could be identified.
Food & Agric. Coordinating Councils (§109)
|
DHS, coordinating with HHS and USDA, shall submit an annual report on the activities of the Food and Agriculture government and sector coordinating councils (within 180 days of enactment).
|
x
|
Pending: DHS report on activities of the Food and Agriculture Government Coordinating
Council and the Food and Agriculture Sector Coordinating Council.
Building
Domestic
Capacity
(§110)
Building Domestic Capacity (§110)
|
HHS, in coordination with USDA and DHS, shall submit a
comprehensive report to Congress identifying programs
and practices intended to promote the safety and
supplychainsupply-chain security of food and to prevent outbreaks of
foodborne illness and other food-related hazards that can
be addressed through preventive activities (no later than
two years after the enactment). The report shall include a
report on traceback and surveillance, a food safety and
food defense research plan (biennial), and a study
regarding
“"unique identification numbers
”" (one year after
enactment).
Sanitary
Transport
(§111)
HHS shall issue regulations requiring shippers, carriers by
motor vehicle or rail vehicle, receivers, and other persons
engaged in the transportation of food to use sanitary
transportation practices prescribed by HHS (due no later
than 18 months after the enactment of FSMA). HHS shall
also conduct a study of the transportation of food for
consumption in the United States.
x
Report
Guidance
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
Available Information on Implementation Status
x
In May 2013, FDA issued its report, Building Domestic Capacity to Implement the FDA Food
Safety Modernization Act (FSMA), a comprehensive report to Congress that identifies
programs, practices, and resources needed to promote the safety of the U.S. food supply.
x
Proposed Rule: Sanitary Transportation of Human and Animal Food (Docket Number: FDA2013-N-0013, January 2014).
Pending: HHS study on food transportation.
Food Allergy
& Anaphylaxis
Management
(§112)
HHS, in consultation with the Department of Education,
shall develop guidelines (not later than one year after the
date of enactment) to be used on a voluntary basis to
develop plans for individuals to manage the risk of food
allergy and anaphylaxis in schools and children’s education
programs.
x
In December 2012, FDA opened a docket requesting data and information to determine
whether the agency can safely establish threshold levels for major food allergens.
New Dietary
Ingredients
(§113)
HHS shall publish guidance clarifying when a dietary
supplement ingredient is a new dietary ingredient, among
other things (no later than 180 days after enactment).
x
x
|
In May 2013, FDA issued its report, Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA), a comprehensive report to Congress that identifies programs, practices, and resources needed to promote the safety of the U.S. food supply.
|
Sanitary Transport (§111)
|
HHS shall issue regulations requiring shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by HHS (due no later than 18 months after the enactment of FSMA). HHS shall also conduct a study of the transportation of food for consumption in the United States.
|
x
|
x
|
Proposed Rule: Sanitary Transportation of Human and Animal Food (Docket Number: FDA-2013-N-0013, January 2014).
Pending: HHS study on food transportation.
|
Food Allergy & Anaphylaxis Management (§112)
|
HHS, in consultation with the Department of Education, shall develop guidelines (not later than one year after the date of enactment) to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and children's education programs.
|
x
|
In December 2012, FDA opened a docket requesting data and information to determine whether the agency can safely establish threshold levels for major food allergens.
|
New Dietary Ingredients (§113)
|
HHS shall publish guidance clarifying when a dietary supplement ingredient is a new dietary ingredient, among other things (no later than 180 days after enactment).
|
x
|
Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues
(Docket Number: FDA-2011-D-0376, July 2011).
CRS-13
Report
Guidance, Raw Oysters (§114); Other Seafood (§103)
|
HHS shall prepare and submit a report on post-harvest
processing of raw oysters regulation (within 90 days prior
to the issuance of any guidance or regulation by FDA, as
specified in FSMA §114). The Government Accountability
Office (GAO) shall review and evaluate the report. HHS
shall update the Fish and Fisheries Products Hazards and
Control Guidance (within 180 days of enactment) (§103).
Guidance
Guidance,
Raw Oysters
(§114); Other
Seafood
(§103)
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
x
x
Available Information on Implementation Status
x
|
x
|
Guidance for Industry: Fish and Fishery Products Hazards and Controls Guidance
(4th (4th Edition)
(Docket Number: FDA- 2011-D-0287, November 2011).
Pending: HHS report on post-harvest processing of raw oysters regulation.
Title II—Improving Capacity to Detect and Respond to Food Safety
Problems
Targeting of
Inspection
Resources
(§201)
Problems
Targeting of Inspection Resources (§201)
|
Among other provisions, HHS shall identify high-risk
facilities, increase the frequency of inspection of domestic
and foreign facilities (according to specified timeframe),
identify and conduct inspections at ports of entry (with
DHS), and improve coordination and cooperation with
USDA and DHS. HHS shall issue an annual report with
information about food facilities (as outlined in FSMA).
x
Recognition of
Laboratory
Accreditation
for Analyses
of Foods
(§202)
Among other provisions, HHS shall establish a program
for the testing of food by accredited laboratories (not
later than two years after enactment of FSMA). Food
testing shall be conducted by accredited labs within 30
months after enactment, unless otherwise exempted.
HHS shall submit a progress report on implementing a
national food emergency response laboratory network
(within 180 days after enactment and biennially
thereafter).
x
Integrated
Consortium
of Lab
Networks
(§203)
DHS (in coordination with HHS and EPA) shall maintain
an agreement to establish an integrated consortium of
laboratory networks. DHS shall submit a report on the
progress of the integrated consortium on a biennial basis.
CRS-14
x
HHS has sent Congress its first three annual reports, Report on Food Facilities, Food Imports,
and FDA Foreign Offices (November 2013; August 2012; and April 2011).
In March 2012, FDA issued information describing how the agency identifies a high-risk
facility.
x
In September 2011 and in November 2013, FDA issued its Biennial Report to Congress on the
Food Emergency Response Network (FERN).
x
The lntegrated Consortium of Laboratory Networks (ICLN) was established by a
x
|
x
|
HHS has sent Congress its first three annual reports, Report on Food Facilities, Food Imports, and FDA Foreign Offices (November 2013; August 2012; and April 2011).
In March 2012, FDA issued information describing how the agency identifies a high-risk facility.
|
Recognition of Laboratory Accreditation for Analyses of Foods (§202)
|
Among other provisions, HHS shall establish a program for the testing of food by accredited laboratories (not later than two years after enactment of FSMA). Food testing shall be conducted by accredited labs within 30 months after enactment, unless otherwise exempted. HHS shall submit a progress report on implementing a national food emergency response laboratory network (within 180 days after enactment and biennially thereafter).
|
x
|
x
|
In September 2011 and in November 2013, FDA issued its Biennial Report to Congress on the Food Emergency Response Network (FERN).
|
Integrated Consortium of Lab Networks (§203)
|
DHS (in coordination with HHS and EPA) shall maintain an agreement to establish an integrated consortium of laboratory networks. DHS shall submit a report on the progress of the integrated consortium on a biennial basis.
|
x
|
The lntegrated Consortium of Laboratory Networks (ICLN) was established by a Memorandum of Agreement (MOA) signed in June 2005 (https://www.icln.org/
).
).
Pending: Report on the progress of the ICLN.
Surveillance
(§205)
Mandatory
Recall
Authority
(§206)
CRS-15
Report
Tracking and Tracing Food, Records (§204)
|
HHS, coordinating with USDA and state officials, shall
establish pilot projects with industry to effectively and
rapidly track and trace foods in an outbreak (within 270
days of enactment) (§204(a)). HHS, with USDA, shall
establish a product tracing system. HHS shall publish a
notice of proposed rulemaking within two years of
enactment to establish additional recordkeeping for
highriskhigh-risk facilities (to be designated within one year of
enactment), along with a list of high-risk foods (published
at the time of the final rule) (§204(d)). Within a year of
the effective date of the recordkeeping rule, GAO shall
review and evaluate the pilot projects. HHS shall issue a
small entity compliance policy guide, within 180 days of
the rule. Small businesses will have one year and very
small businesses will have two years to comply.
Guidance
Tracking and
Tracing Food,
Records
(§204)
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
x
x
x
Available Information on Implementation Status
x
|
x
|
x
|
In September 2011, FDA announced that the Institute of Food Technologists (IFT) would
carry out two new pilot projects. In March 2012, FDA announced the types of foods for
product tracing pilots.
In March 2013, FDA called for public comment on an IFT final report, Pilot Projects for
Improving Product Tracing along the Food Supply System, which will be considered by FDA in the
development of recommendations in a report to Congress (pending).
In February 2014, FDA published its draft methodological approach to identify high-risk
foods under Section 204(d)(2), Requests
for Information: Designation of High-Risk Foods for
Tracing Tracing (Docket Number: FDA-2014-N-0053; February 2014).
Surveillance (§205)
|
HHS, acting through the CDC, shall enhance foodborne
illness surveillance systems, among other things
(authorized appropriations of $24 million annually,
FY2011-FY2015). HHS shall, within one year of
enactment, conduct an assessment of state and local food
safety and defense capacities. Reauthorizes food safety
capacity grants at $19.5 million (FY2010), and such sums
as necessary (FY2011-FY2015), subject to appropriations.
x
Gives HHS expanded mandatory recall authority of foods
under certain circumstances. Establishes reporting
requirements: GAO review (no later than 90 days after
enactment); USDA feasibility study (depending on GAO’s
findings); and annual Report to Congress by HHS (not
later than two years after enactment).
x
x
|
In September 2011, FDA awarded seven grants (totaling $7.3 million) to five land-grant
universities (Auburn University, Iowa State University, North Carolina State University,
University of California-Davis, and University of Tennessee-Knoxville) and two training
institutes.
In December 2011, FDA established the Food Safety Preventive Controls Alliance (FSPCA)
to provide training and curriculum.
In May 2012, FDA announced it had submitted to OMB for review a survey it intends to
conduct of state and local agencies to assess state and local food safety capacity.
In January 2014,
Mandatory Recall Authority (§206)
|
Gives HHS expanded mandatory recall authority of foods under certain circumstances. Establishes reporting requirements: GAO review (no later than 90 days after enactment); USDA feasibility study (depending on GAO's findings); and annual Report to Congress by HHS (not later than two years after enactment).
|
x
|
In May 2015, FDA issued Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls (Docket Number: FDA-2015-D-0138)
Annual Reports:
2014 FDA published its Annual Report to Congress on the Use of Mandatory Recall
Authority - 2013.
GAO issued FDA’s Authority (February 2015)
2013 FDA published its Annual Report to Congress on the Use of Mandatory Recall Authority(January 2014)
Pending: Report on use of recall authority
See also GAO's report, FDA's Food Advisory and Recall Process Needs Strengthening (GAO-12-589), July
2012.
Administrative Detention of Food (§207)
|
HHS shall issue an interim final rule (not later than 120
days after enactment of FSMA), effective 180 days after
enactment of FSMA, on the administrative detention of
foods that FDA believes are adulterated or misbranded.
x
x
Report
Guidance
Administrative
Detention of
Food (§207)
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
Available Information on Implementation Status
x
|
x
|
Final Rule: Criteria Used to Order Administrative Detention of Food for Human or Animal
Consumption Consumption (Docket Number: FDA-2011-N-0197, February 2013). FDA issued an interim
final rule in May 2011 on the criteria used to order administrative detention of food for
human or animal consumption.
Guidance for Industry:
What You Need to Know About Administrative Detention of Foods;
Small Entity Compliance Guide (Docket Number: FDA-2011-D-0643, March 2013).
Decontamination and
Disposal
Standards and
Plans (§208)
Decontami-nation and Disposal Standards and Plans (§208)
|
EPA shall provide support and technical assistance to
state, local, and tribal governments, and shall develop
standards and model plans (coordinating with HHS, DHS,
and USDA) regarding decontamination and disposal.
x
Status of EPA’
x
|
Status of EPA's model plans for decontamination and disposal is not known.
Training of
State, Local,
Territorial,
and Tribal
Officials,
Grants (§209)
Training of State, Local, Territorial, and Tribal Officials, Grants (§209)
|
HHS shall establish standards and administer training of
state, local, territorial, and tribal food safety officials, and
enter into agreements with USDA within 180 days after
enactment to establish a grant program (
“"National Food
Safety Training, Education, Extension, Outreach and
Technical Assistance Program
”"). Authorizes
appropriations of such sums as necessary (
FY2011FY2015).
x
FY2011-FY2015).
x
|
In July 2011, FDA and USDA entered into a MOU to collaborate on the establishment of a
competitive grant program for food safety training, and other projects.
Food Safety
Grants, and
Centers of
Excellence
(§210)
Food Safety Grants, and Centers of Excellence (§210)
|
HHS shall establish a grant program to
“"enhance food
safety,
”" authorizing appropriations of such sums as
necessary (FY2011-FY2015). HHS shall designate five
Centers of Excellence (within one year after enactment);
HHS shall submit a report on the effectiveness of the
Centers of Excellence (within two years of enactment).
x
Improving the
Reportable
Food Registry
(§211)
HHS shall obtain information for reportable foods (except
fruits and vegetables that are raw agricultural
commodities) no later than 18 months after enactment.
HHS shall prepare a one-page summary of each
reportable food, to be publicly available. Within one year
of enactment, HHS shall publish a list of “conspicuous
locations" for posting such notifications.
CRS-16
x
CDC has designated five Integrated Food Safety Centers of Excellence. After a competitive
process, five state health departments and their affiliated university partners were selected
and notified: Colorado, Florida, Minnesota, Oregon, and Tennessee.
Pending: Report on the effectiveness of the Centers of Excellence.
x
No reported activity by FDA. FDA has a Reportable Food Registry (RFR) website
(
x
|
x
|
CDC has designated five Integrated Food Safety Centers of Excellence. After a competitive process, five state health departments and their affiliated university partners were selected and notified: Colorado, Florida, Minnesota, Oregon, and Tennessee.
Pending: Report on the effectiveness of the Centers of Excellence.
|
Improving the Reportable Food Registry (§211)
|
HHS shall obtain information for reportable foods (except fruits and vegetables that are raw agricultural commodities) no later than 18 months after enactment. HHS shall prepare a one-page summary of each reportable food, to be publicly available. Within one year of enactment, HHS shall publish a list of "conspicuous locations" for posting such notifications.
|
x
|
No reported activity by FDA. FDA has a Reportable Food Registry (RFR) website (http://www.fda.gov/food/complianceenforcement/rfr/default.htm
).
|
Title III—Improving the Safety of Imported Food
|
Foreign Supplier Verification Program (§301)
|
).
Report
Guidance
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
Available Information on Implementation Status
Title III—Improving the Safety of Imported Food
Foreign
Supplier
Verification
Program
(§301)
HHS shall promulgate regulations to provide for the
content of the foreign supplier verification (FSVP), within
one year after enactment of FSMA, and shall issue
guidance to assist importers in developing FSVPs. The
program shall take effect two years after enactment.
x
x
|
Final Rule: Accredited Third-Party Certification (Docket Number: FDA-2011-N-0146, November 2015)
Proposed Rule: Food Supplier Verification Programs (FSVP) for Importers of Food for Humans
and Animals (Docket Number: FDA-2011-N-01438; July 2013). Under the proposed rule,
U.S. importers would need to verify that their suppliers are meeting U.S. food safety
requirements. FDA also has conducted outreach and public meetings, and released web
videos and written materials.
Proposed Supplemental Rule: Food Supplier Verification Programs (FSVP) for Importers of
Food for Humans and Animals
(Docket Number: FDA-2011-N-0143, September 2014)
Voluntary
Qualified
Importers
(§302)
.
Proposed Rule (Correction Notice): User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Docket Number: FDA-2011-N-0146, Correction Notice, July 2015).
Voluntary Qualified Importers (§302)
|
HHS, in consultation with DHS, shall establish a Voluntary
Qualified Importer Program (VQIP) to provide for the
expedited review and importation of food (beginning not
later than 18 months after enactment of FSMA).
Authority,
Import
Certifications
(§303)
x
|
In June 2015, FDA issued Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program (Docket Number: FDA-2011-N-0144)
|
Authority, Import Certifications (§303)
|
HHS may require, as a condition of granting admission to
an article of food imported or offered for import into the
United States, that an entity provide a certification
concerning imported foods.
Prior Notice,
Food Imports
(§304)
No reported activity by FDA.
|
Prior Notice, Food Imports (§304)
|
HHS shall issue an interim final rule regarding prior notice
of imported foods (within 120 days of enactment of
FSMA), which shall take effect 180 days after enactment
of FSMA.
x
No reported activity by FDA.
No reported activity by FDA.
x
x
Final Rule: of FSMA.
x
|
x
|
Final Rule: Information Required in Prior Notice of Imported Food (Docket Number: FDA-
2011N2011-N-0179, May 2013), establishing requirements for submitting prior notice of imported food,
including food for animals. The final rule adopts FDA
’'s interim final rule issued in May 2011.
Industry Guidance:
Industry Guidance: Enforcement Policy Concerning Certain Prior Notice Requirements
(June
2011). Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition
3), March 2014.
Capacity
Building,
Foreign
Govts. (§305)
Capacity Building, Foreign Govts. (§305)
|
HHS shall develop a comprehensive plan to expand the
technical, scientific, and regulatory food safety capacity of
foreign governments, and their food industries, which
export foods to the
U.S.United States (within two years of enactment).
x
x
x
|
x
|
In February 2013, FDA issued its
“"International Capacity-Building Plan,
”" outlining goals,
objectives, and key actions that will provide a strategic framework for the FDA in setting
priorities and managing international food safety capacity-building programs.
In May 2013, FDA released its report, Building Domestic Capacity to Implement the FDA Food
Safety and Modernization Act (FSMA), identifying programs and practices intended to promote
the safety of the U.S. food supply.
CRS-17
Inspection of Foreign Food Facilities (§306)
|
HHS may enter into arrangements and agreements with
foreign governments to facilitate inspections of registered
foreign facilities and direct resources to inspections of
foreign facilities, suppliers, and food types.
Accreditation
of Third-Party
Auditors
(§307)
HHS shall develop model standards (within 18 months of
enactment) and recognized accreditation bodies shall
ensure third-party auditors and audit agents meet such
standards to qualify third-party auditors as accredited
auditors.
Foreign
Offices of
FDA (§308)
HHS shall submit a congressional report regarding the
selection of the foreign countries for established offices
(no later than October 1, 2011).
Smuggled
Food (§309)
HHS, coordinating with DHS, shall develop and
implement a strategy to identify smuggled food and
prevent its entry into the U.S. (not later than 180 days
after enactment of FSMA)
Report
Inspection of
Foreign Food
Facilities
(§306)
Guidance
Timeline/Schedule in Law
(FSMA signed into law on January 4, 2011)
Regulation
Section(s)
Available Information on Implementation Status
foreign facilities, suppliers, and food types.
FDA has entered discussions with Australia, Belgium, Brazil, Canada, China, Costa Rica,
Denmark, European Union (EU), Finland, France, Germany, Iceland, Ireland, Italy, Japan,
Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Singapore, Spain, Sweden,
Switzerland, Taiwan, and the United Kingdom. (See FDA
’'s website,
“"Memoranda of
Understanding and Other Cooperative Arrangements,
”" available at http://www.fda.gov
.)
Accreditation of Third-Party Auditors (§307)
|
HHS shall develop model standards (within 18 months of enactment) and recognized accreditation bodies shall ensure third-party auditors and audit agents meet such standards to qualify third-party auditors as accredited auditors.
|
x
|
Final Rule: Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (Docket Number: FDA-2011-N-0143, November 2015)
.)
x
Proposed Rule: Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety
Audits and to Issue Certifications (Docket Number: FDA-2011-N-014610; July 2013) to
establish a program for accreditation of third-party auditors to conduct food safety audits
and issue certifications of foreign facilities and the foods they produce for both humans and
animals. FDA also has conducted outreach and public meetings, and released web videos and
written materials.
x
x
Amendment to Proposed Rule: User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Docket Number: FDA-2011-N-0146; July 2015).
In July 2015, FDA issued Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (Docket Number: FDA-2011-N-0146).
Foreign Offices of FDA (§308)
|
HHS shall submit a congressional report regarding the selection of the foreign countries for established offices (no later than October 1, 2011).
|
x
|
In February 2012, FDA issued its Report to Congress on the FDA Foreign Offices
.
.
Smuggled Food (§309)
|
HHS, coordinating with DHS, shall develop and implement a strategy to identify smuggled food and prevent its entry into the United States (not later than 180 days after enactment of FSMA)
|
x
|
In July 2011, HHS and DHS issued a joint anti-smuggling strategy to better identify and
prevent entry of smuggled food into the United States.
Source: CRS, from language in the FDA Food Safety Modernization Act (FSMA, P.L. 111-353) and FDA actions to date, from FDA progress reports (http://www.fda.gov/
Food/GuidanceRegulation/FSMA/ucm255893.htm) and FSMA rules and guidance (http://www.fda.gov/Food/GuidanceRegulation/FSMA/
ucm359436ucm253380.htm
).
).
Notes: For detailed information about each of these provisions, see Appendix B in CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353). Excludes
some FSMA provisions, including provisions in Title 4 (Miscellaneous Provisions) and also FSMA Section 115 (Port Shopping) and Section 116 (Alcohol-Related Facilities),
which mostly cover jurisdiction issues or address conforming language requirements.
CRS-18
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
Author Contact Information
Renée Johnson
Specialist in Agricultural Policy
rjohnson@crs.loc.gov, 7-9588
Congressional Research Service
19
Author Contact Information
[author name scrubbed], Specialist in Agricultural Policy
([email address scrubbed], [phone number scrubbed])
Footnotes
| 1.
|
See, for example, FDA, "Questions and Answers on the Food Safety Modernization Act," "The New FDA Food Safety Modernization Act (FSMA)," and "Background on the FDA Food Safety Modernization Act (FSMA)."
|
| 2.
|
FSMA specified that all "high-risk" domestic facilities must be inspected within five years of enactment. High-risk facilities will be identified based on "known safety risks of the facilities" according to "known safety risks of the food manufactured, processed, packed, or held at the facility, ... compliance history of a facility, including ... food recalls, outbreaks of foodborne illness, and violations of food safety standards" and "the rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls" among other factors stated in the law (P.L. 111-353, §201).
|
| 3.
|
If a facility's food is found to have a "reasonable probability of causing serious adverse health consequences or death." FDA exercised this authority for the first time in November 2012 when it suspended the registration of Sunland Inc., a peanut butter processor, because of concerns linking the plant to a Salmonella outbreak.
|
| 4.
|
CBO, cost estimate, "S. 510, Food Safety Modernization Act, as reported by the Senate Committee on Health, Education, Labor, and Pensions on December 18, 2009, Incorporating a Manager's Amendment Released on August 12, 2010," August 12, 2010.
|
| 5.
|
See, for example, FDA, "Frequently Asked Questions on FSMA."
|
| 6.
|
See, for example, D. ElBoghdady, "Food-Safety Rules in Limbo at Office of Management and Budget," Washington Post, May 2, 2012; and M. Patoka, "Three Food Safety Rules Grow Moldy at OIRA as Import-Related Outbreaks Continue," Food Safety News, June 26, 2013.
|
| 7.
|
See, for example, J. Murphy, "HHS Documents Reveal OMB Edits of Original FSMA Preventive Controls Proposal," Food Chemical News, March 22, 2013; J. Murphy, "OMB Removed Mandatory Onsite Audits from FSVP Proposal, Internal Documents Show," Food Chemical News, October 25, 2013.
|
| 8.
|
FDA, "Statement from FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, on Key Provisions of the Proposed FSMA Rules Affecting Farmers," December 19, 2013.
|
| 9.
|
Ibid.
|
| 10.
|
See, for example, D. Flynn, "Letter from the Editor: Produce Growers Get Early Christmas Present," Food Safety News, December 22, 2013.
|
| 11.
|
FDA, "Update on Proposed Rules Under the FDA Food Safety Modernization Act," March 19, 2014.
|
| 12.
|
FDA, "Statement from FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, on Key Provisions of the Proposed FSMA Rules Affecting Farmers," December 19, 2013.
|
13.
|
Links to three of these congressional letters are provided at the National Sustainable Agriculture Coalition (NSAC) website (http://sustainableagriculture.net/blog/congress-fsma-letters/).
| 14.
|
"Vermont Lawmakers Urge Re-Write of FSMA Rules," Food Chemical News, November 29, 2013.
|
| 15.
|
Public comments are in FDA's rulemaking docket. Also see comments posted by the National Association of State Departments of Agriculture; United Fresh Produce Association; and the National Sustainable Agriculture Coalition.
|
| 16.
|
For farm bill information, see CRS Report R43076, The 2014 Farm Bill (P.L. 113-79): Summary and Side-by-Side.
|
| 17.
|
P.L. 113-76. Explanatory Statement Regarding the House Amendment to the Senate Amendment on H.R. 3547.
|
| 18.
|
For more information, see CRS Report R44309, FY2016 Appropriations: Selected Federal Food Safety Agencies, and also CRS Report R43669, Agriculture and Related Agencies: FY2015 Appropriations.
|
| 19.
|
See annual FDA Budget Explanatory Notes for Committee on Appropriations, various years, http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/default.htm. Also see letter from Leslie Kux, FDA's Assistant Commissioner for Policy, to U.S. District Court judges regarding a food labeling policy, January 6, 2014.
|
| 20.
|
CBO, cost estimate, "S. 510, Food Safety Modernization Act, as Reported by the Senate Committee on Health, Education, Labor, and Pensions on December 18, 2009," August 12, 2010.
|
| 21.
|
FSMA, P.L. 111-353, §401. By fiscal year, staff level increases were authorized at a total of not fewer than 4,000 staff members (FY2011); 4,200 staff (FY2012); 4,600 staff (FY2013); and 5,000 staff (FY2014).
|
| 22.
|
For information, see FDA's FSMA website, http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359450.htm.
|
| 23.
|
For more information on FDA's budget for the agency's food safety activities and FSMA implementation, CRS Report R44309, FY2016 Appropriations: Selected Federal Food Safety Agencies.
|
| 24.
|
H.Rept. 114-205, S.Rept. 114-82.
|
| 25.
|
FDA, Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA), May 2013.
|
| 26.
|
The Center for Food Safety is a national nonprofit public interest and environmental advocacy organization that has been tracking FDA's implementation of FSMA, as have other public health organizations, such as the Center for Science in the Public Interest (CSPI).
|
| 27.
|
Center for Food Safety, et al. v. Margaret E. Hamburg, M.D., et al., Case No. 12 CV 4529 (N.D. Cal. 2012), August 29, 2012. The original complaint is at http://www.centerforfoodsafety.org/issues/308/food-safety/legal-actions. Other information on the case is available at CFS' website (http://www.centerforfoodsafety.org).
|
| 28.
|
FDA's motion to dismiss is at http://www.foodsafetynews.com/files/2012/12/FDA-motion-to-dismiss.pdf.
|
| 29.
|
The April 2013 court decision on the case is at http://www.centerforfoodsafety.org/files/57-sj-decision_76498.pdf.
|
| 30.
|
The June 2013 court order is available at http://www.centerforfoodsafety.org/files/fsma-remedy-order_52466.pdf.
|
| 31.
|
FDA's July 2013 motion to reconsider is at http://www.freeborn.com/assets/fda_motion_to_reconsider.pdf.
|
| 32.
|
The August 2013 court order is available at http://www.centerforfoodsafety.org/files/69—order—granting-in-part-denying-in-part-mot-recons_34619.pdf.
|
| 33.
|
The November 2013 decision is at http://www.centerforfoodsafety.org/files/15—order-denying-motion-for-stay-pending-appeal3b-expediting-appellate-briefing-schedule-in-part_71389.pdf.
|
| 34.
|
"FDA, Center for Food Safety Agree to New Timeline for FSMA Rules," Food Chemical News, February 20, 2014.
|
| 35.
|
"Food Safety Law to Take a Decade to Implement, FDA Says," CQ News, September 9, 2014.
|
| 36.
|
FDA, Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA): Protecting Public Health by Strategic Implementation of Prevention-Oriented Food Safety Standards, May 2, 2014.
|