Order Code RS22318
Updated November 18, 2005
CRS Report for Congress
Received through the CRS Web
Harvey v. Veneman and the National Organic
Program: A Legal Analysis
Stephen R. Viña
Legislative Attorney
American Law Division
Summary
The First Circuit’s ruling in Harvey v. Veneman brought much attention and
uncertainty to the U.S. Department of Agriculture’s National Organic Program. In the
case, Harvey alleged that multiple provisions of the National Organic Program Final
Rule (Final Rule) were inconsistent with the Organic Foods Production Act of 1990
(OFPA). The First Circuit sided with Harvey on three counts, putting into question the
use of synthetics and commercially unavailable organic agricultural products, as well as
certain feeding practices for dairy herds converting to organic production. On remand,
the district court ordered a two-year time frame for the implementation and enforcement
of new rules consistent with the ruling; however, in the FY2006 agriculture
appropriations act (P.L. 109-97), Congress amended the OFPA to address the holdings
of the case. This report describes the OFPA, discusses those holdings where the court
determined that a provision of the Final Rule was inconsistent with the OFPA and
analyzes the most recent legislative action. This report will be updated as warranted.
The Organic Foods Production Act of 1990
The Organic Foods Production Act of 1990 (OFPA)1 regulates the marketing of
organic products by setting national standards for production and processing (handling).
To be labeled or sold as “organic,” an agricultural product must be produced and handled
without the use of synthetic substances, such as chemical pesticides, and in accordance
with an organic plan agreed to by an accredited certifying agent and the producer and
handler of the product. Products meeting these standards may be labeled as “organic” and
may bear a U.S. Department of Agriculture (USDA) seal. Exceptions to the OFPA’s
general prohibition on the use of synthetic substances in organic products appear on a
National List of Allowed and Prohibited Substances. The OFPA requires the Secretary
to establish a National Organic Standards Board (NOSB) to develop the National List and
1 7 U.S.C. §§ 6501-6523. For more information on the National Organic Program and organics,
in general, see CRS Report RL31595, Organic Agriculture in the U.S.: Program and Policy
Issues, by Jean M. Rawson.
Congressional Research Service ˜ The Library of Congress

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to recommend exemptions for otherwise prohibited substances. The OFPA contains
guidelines for the inclusion of substances on the National List.
The OFPA also requires the Secretary to promulgate regulations “to carry out” the
Act. The Secretary published the National Organic Program Final Rule (Final Rule) in
December 2000 and it became effective on October 21, 2002 (codified at 7 C.F.R. pt.
205). Among other things, the Final Rule sets forth a four-tier labeling system for organic
foods. Under this system, the type of labeling permitted on a product varies according to
the percentage of organic ingredients it contains. The labeling scheme distinguishes:
products containing 100% organic ingredients, which may be labeled “100 percent
organic”; (2) products containing 94 to 100% organic ingredients, which may be labeled
“organic”; (3) products containing 70 to 94% organic ingredients, which may be labeled
“made with organic (specified ingredients or food group(s))”; and (4) products containing
less than 70% percent organic ingredients, which may identify each organic ingredient on
the label or in the ingredient statement with the word “organic.”2
Harvey v. Veneman
In October 2002, Mr. Arthur Harvey filed a pro se suit against the USDA in the U.S.
District Court for the District of Maine, alleging that multiple provisions of the Final Rule
were inconsistent with the OFPA and the Administrative Procedures Act.3 The district
court ruled in favor of the USDA (i.e., granted summary judgment) on all nine counts
brought by Harvey.4 Harvey subsequently appealed the case to the First Circuit and was
supported by a number of public interest groups that filed “friends of the court” or Amici
Curiae briefs. The First Circuit sided with Harvey on three counts and remanded the
holdings to the district court for further action.5 In brief, the court found that:
! nonorganic ingredients not commercially available in organic form but
used in the production of items labeled “organic” must have individual
reviews in order to be placed on the National List of Allowed and
Prohibited Substances;
! synthetic substances are barred in the processing or handling of products
labeled “organic”; and
! dairy herds converting to organic production are not allowed to be fed
feed that is only 80% organic for the first nine months of a one-year
conversion.
2 7 C.F.R. §205.301(a)-(d).
3 5 U.S.C. §§ 555(b), 702, and 706(l).
4 The case was initially heard by a magistrate for the District of Maine. The magistrate
recommended summary judgment be granted in favor of the USDA on eight of the nine counts
brought. The district court, however, rejected the magistrate’s decision as to the one count that
favored Harvey. See Harvey v. Veneman, No. 02-216-P-H, 2003 U.S. Dist. LEXIS 18162 (D.
Me., Oct. 10, 2003) accepted and rejected in part by 297 F. Supp. 2d 334 (D. Me., Jan. 7, 2004).
5 Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005).

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The three holdings did not invalidate OFPA provisions, but rather, qualified or
invalidated agency regulations, thereby affecting the implementation of the National
Organic Program. On June 9, 2005, for example, the district court issued an order
pursuant to the circuit court’s instructions that established a two-year time frame in which
the Secretary of Agriculture is to create and enforce new rules for the implementation of
the National Organic Program in compliance with the circuit court’s ruling. Under the
order, the Secretary is to issue new regulations within a year (June 9, 2006) but has an
additional year to start enforcing them (June 9, 2007). The phase-in implementation was
selected by the Court in an effort to prevent consumer confusion, commercial disruption,
and unnecessary litigation.
The rulings in Harvey and subsequent requirements for new regulations, however,
appear to have been superceded in part, as a result of amendments made to the OFPA by
the FY2006 agriculture appropriations act (P.L. 109-97, §797).6 In general, the
amendments address many of the legal concerns (e.g., lack of authority for agency action)
observed by the First Circuit. Section 724 of the FY2006 act also requires the USDA to
submit a report to Congress that evaluates the impacts of Harvey within 90 days of
enactment.7 The following paragraphs examine each holding where the court determined
that a provision of the Final Rule was inconsistent with the OFPA and then discuss the
effect of the applicable provisions from the FY2006 agriculture appropriations act.
Count One: Alleged Exemption for Nonorganic Products Not
Commercially Available
Court Action. Plaintiff challenged the portion 7 C.F.R. §205.606 which permits
the introduction of nonorganically produced agricultural products as ingredients in, or as
substances on, processed products labeled as “organic” when the specified product is not
commercially available in organic form. The regulation lists five specific products —
Cornstarch, Gums, Kelp, Lecithin, and Pectin — and also allows for any other
nonorganically produced agricultural product when the product is not commercially
available in organic form. The OFPA, however, requires all specific exemptions to the
Act’s prohibition on nonorganic substances to be placed on the National List following
notice and comment and periodic review.8 Harvey claimed that §205.606 provided a
blanket exemption to the OFPA’s review requirements and allowed ad hoc decisions to
be made regarding the use of synthetic substances. The USDA, on the other hand,
maintained that the regulation does not establish a blanket exemption, but rather, only
6 Sec. 797 was added during Conference for the FY 2006 agriculture appropriations bills (H.R.
2744). See H.Rept. 109-255. H.R. 2744 was signed into law on Nov. 10, 2005.
7 Specifically, the report is to: (1) determine whether restoring the National Organic Program to
its pre-Harvey operation would adversely affect organic farmers and food processors and
consumers; (2) analyze issues regarding the use of synthetic ingredients in processing and
handling; (3) analyze the utility of expedited petitions for commercially unavailable agricultural
commodities; and (4) consider the use of crops from land included in the organic system plan of
dairy farms that are in the third year of organic management. This provision was originally
included in the Senate-passed version of H.R. 2744.
8 See 7 U.S.C. §6517(a) (establishment of National List), (d) (notice and comment), (e) (sunset
review within five years) and §6518(k) (technical advisory reviews), (l) (required consultations
and reviews), (m) (required evaluations).

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permits the use of the five products specifically listed in the section. The court found the
USDA’s interpretation plausible; however, because the district court did not clarify the
regulation’s meaning, the circuit court also found Harvey’s interpretation potentially
credible. Accordingly, the court remanded the count to the district court for entry of a
declaratory judgment that would interpret the regulation in a manner consistent with the
National List requirements of the OFPA.
A declaratory judgement stating that §205.606 does not establish a blanket
exemption to the National List requirements in statute for nonorganic agricultural
products that are not commercially available was issued on June 9, 2005. The USDA, in
compliance with the order, issued a Notice in the Federal Register clarifying the meaning
of the regulation on July 1, 2005.9 However, because of the potential for confusion, the
order states that the clarified meaning of §205.606 will not become effective and
enforceable until two years from the date of the judgment (June 9, 2007). Whether the
products that are currently listed in §205.606 must undergo some type of further review
is not clear; however, it was noted in the district court opinion that the NOSB did make
recommendations with respect to the five products listed in conformity with its §6517
mandates.10

Congressional Action. In the FY2006 agriculture appropriations act, Congress
amended 7 U.S.C. §6517(d) — titled “Procedure for Establishing a National List” — to
authorize the Secretary of the USDA to develop emergency procedures for designating
agricultural products that are commercially unavailable in organic form for placement on
the National List for a period of no longer than 12 months. The amendment does not
define what an “emergency procedure” would entail; thus, the Secretary would appear to
have the authority to describe the term’s parameters and to select the substances subject
to it. While this amendment creates an expedited petition process for commercially
unavailable organic agricultural products, it does not appear to alter the ruling described
above. Accordingly, the clarified interpretation that §205.606 does not create a blanket
exemption would still appear to be valid, though the regulation might need to be modified
to reflect that there is a new expedited process in place.
Count Three: Use of Synthetic Substances in Processing
Court Action. Plaintiff challenged 7 C.F.R. §205.600(b) and the portion of
§205.605(b) that permits synthetic substances as ingredients in, or as substances on,
processed products labeled as “organic.”11 Section 205.600(b) provides that synthetic
substances may be used “as a processing aid or adjuvant” if they meet six criteria;
§205.605(b) lists 38 synthetic substances specifically allowed in or on processed products
9 70 Fed. Reg. 38090.
10 Harvey, 2003 U.S. Dist. LEXIS 18162 at *16.
11 Upon initial publication of the ruling, there was some confusion as to whether count three
applied to products labeled both as “organic” and “made with organic (specified ingredients or
food groups(s)).” Harvey’s intent, however, in bringing the action was only to prohibit the use
of synthetic substances in products labeled as “organic.” Thus, Harvey filed a Motion for
Clarification and the court amended its decision (by adding a footnote) to make clear that
synthetic substances are not banned from products labeled as “made with organic.” See Harvey,
396 F.3d at 39, n. 2.

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labeled as “organic.” The court found that 7 U.S.C. §6510(a)(1) and §6517(c)(B)(iii)
forbid the use of synthetic substances during the processing12 or handling13 of a product,
unless otherwise required by law.14 The court noted that the OFPA contemplates the use
of certain synthetic substances during the production or growing of organic products, but
not during the handling or processing stages. By allowing the use of certain synthetic
substances “as processing aids,” the court concluded that the regulations contravened the
plain language of the OFPA. The circuit court reversed the district court’s grant of
summary judgment and remanded the count to the district court for entry of summary
judgment in Harvey’s favor.15 On remand, the district court ordered the Secretary of the
USDA to publish new rules implementing the circuit court’s judgment within one year
of the date of the judgment (June 9, 2006), but allowed the Secretary to exempt
nonconforming products placed in commerce as “organic” for up to two years after the
date of the judgment (June 9, 2007).
Congressional Action. The FY2006 agriculture appropriations act amended
§6510(a)(1) and strikes §6517(c)(B)(iii) — provisions that the First Circuit relied upon
to emphasize that synthetics were not allowed during the processing or handling of a
product. Before the amendment, §6510(a)(1) barred a person on a handling operation
from adding any synthetic ingredient during the processing or postharvest handling of a
covered product. The amendment added the phrase “not appearing on the National List”
after “ingredient,” thereby apparently allowing the use of synthetics on the National List
during processing or postharvest handling of a covered product. Section 6517(c)
establishes guidelines for placing substances on the National List and in subsection (B)
sets forth specific requirements with regard to the types of substances that may be
exempted for use in production and handling. Specifically subpart (iii) of §6517(c)(B)
states that the substance “is used in handling and is non-synthetic but is not organically
produced” (emphasis added). This provision, which the court noted “specifically requires
the exempted substances be nonsynthetic [sic],” was deleted by the amendment.16 As
there no longer appears to be any general prohibition (though there are other requirements
that must be met) against the placement of synthetics on the National List for use during
the processing or handling of a covered product, the First Circuit’s ruling in count three
12 Processing is defined as “cooking, baking, curing, heating, drying, mixing, grinding, churning,
separating, extracting, slaughtering, cutting, fermenting, distilling, eviscerating, preserving,
dehydrating, freezing, chilling, or otherwise manufacturing and includes the packaging, canning,
jarring, or otherwise enclosing food in a container.” 7 C.F.R. §205.2.
13 A handling operation is defined as “any operation or portion of an operation (except final
retailers of agricultural product that do not process agricultural products) that receives or
otherwise acquires agricultural products and processes, packages, or stores such products.” 7
C.F.R. §205.2.
14 See 7 U.S.C. §6519(f) for a listing of laws.
15 Many speculated that these holdings could have had far reaching effects on the organic
industry, since it is generally accepted that the use of synthetic substances on the National List
is widespread in organic processing. For more information on the impacts of Harvey on the
organic industry, see CRS Report RL31595, Organic Agriculture in the U.S.: Program and
Policy Issues, by Jean M. Rawson.
16 Harvey, 396 F.3d at 39.

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is likely moot. The Secretary may promulgate new regulations to reflect the changes
made in law by Congress.
Count Seven: Conversion of Dairy Herds to Organic Production
Court Action. Plaintiff challenged the Final Rule’s exception to the OFPA’s
requirements for dairy herds being converted to organic production. Pursuant to 7 U.S.C.
§6509(e)(2), a dairy animal whose milk or milk products will be sold or labeled as
organically produced must be raised and handled in accordance with the OFPA for not
less than the 12-month period immediately prior to the sale of such milk or milk products.
Section §205.236(a)(2) of the Final Rule, however, allows whole dairy herds transitioning
to organic production to use 80% organic feed for the first nine months and 100% organic
feed for the final three months. The court found the OFPA’s requirement for a single type
of organic handling for twelve months and the Final Rule’s bifurcated approach in direct
conflict. The court determined that nothing in the OFPA’s plain language permits the
creation of an “‘exception’ permitting a more lenient phased conversion process for entire
dairy herds,” and consequently, found the regulation invalid.17 The circuit court reversed
the district court’s grant of summary judgment and remanded the count to the district
court for entry of summary judgment in Harvey’s favor. On remand, the district court
ordered the USDA to promulgate regulations implementing the circuit court’s decision
within one year of the date of the judgment (June 9, 2006) and to start enforcement by
June 9, 2007.
Congressional Action. In the FY2006 agriculture appropriations act, Congress
amended 7 U.S.C. §6509(e)(2) by adding an exception to the general feeding requirement
listed in the provision (i.e., raised and handled in accordance with the OFPA for not less
than the 12-month period immediately prior to sale).18 The new provision — titled
“Transition Guideline” — allows crops and forage from land included in the organic
system plan of a dairy farm that is in the third year of organic management to be
consumed by the dairy animals of the farm during the 12-month period immediately prior
to the sale of the organic milk or milk products. Generally, crops or forage intended to
be sold or labeled as “organic” can not have prohibited substances under the OFPA
applied to them for the three years immediately preceding harvest of the crop.
Accordingly, this amendment seems to allow feed for dairy animals to come from land
that is still transitioning to “organic” status. This change would appear to provide the
“exception” for a more lenient conversion process that the First Circuit concluded was
absent from the statute. As such, the court’s ruling in count seven is likely moot. The
Secretary, moreover, may draft new regulations to reflect the changes made in law by
Congress.
17 Many believed that this holding would prove most costly for small and medium size operations
seeking to convert. For example, the USDA, in articulating some of the reasoning for the phased
conversion regulation, stated that the one-year organic feed requirement posed an
“insurmountable economic barrier for small and medium size operations seeking to convert.”
Harvey, 2003 U.S. Dist. LEXIS 18162 at *51-54 (USDA concurring with commenters).
18 7 C.F.R. §205.236 also requires the producer of an organic livestock operation to provide
livestock with at total feed ration composed of agricultural products, including pasture and
forage, that are organically produced and, if applicable, organically handled.

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