*Of the Northern District of California, sitting by

designation.

United States Court of Appeals

For the First Circuit

________________

No. 04-1379

ARTHUR HARVEY,

Plaintiff, Appellant,

v.

ANN VENEMAN, SECRETARY OF AGRICULTURE,

Defendant, Appellee.

_____________________

APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF MAINE

[Hon. D. Brock Hornby, U.S. District Judge]

________________________ 

Before

Boudin, Chief Judge,

Selya, Circuit Judge,

and Schwarzer,* Senior District Judge.

 ____________________ 

Paula Dinerstein with whom Lobel, Novins & Lamont was on brief

for appellant.

Susan E. Stokes, Jill E. Krueger, Farmers’ Legal Action Group,

and Joseph Mendelson III, Center for Food Safety, on brief for

Rural Advancement Foundation International-USA, Center for Food

Safety, and Beyond Pesticides, Amici Curiae.

James Handley, Handley Environmental Law, on brief for Organic

Consumers Association, Sierra Club, Public Citizen, Inc., Northeast

Organic Farming Association/Massachusetts Chapter, Inc., John
Clark, Merrill Clark, Anne Mendenhall, Greenpeace USA, and

Waterkeeper Alliance, Amici Curiae.

Halsey B. Frank, Assistant United States Attorney, with whom

Paula D. Silsby, United States Attorney, was on the brief for

appellee. 

_______________

January 26, 2005

_______________
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SCHWARZER, Senior District Judge. Arthur Harvey appeals

the District Court’s grant of summary judgment to Secretary of

Agriculture Ann Veneman on Harvey’s claims alleging that multiple

provisions of the National Organic Program Final Rule (“Final Rule”

or “Rule”), 7 C.F.R. Pt. 205, are inconsistent with the Organic

Foods Production Act of 1990, 7 U.S.C. §§ 6501-6523 (“OFPA” or

“Act”).

Harvey appeals on seven of the nine counts he originally

brought. For the reasons set forth below, we affirm the judgment

on the first, second, fifth, sixth, and eighth counts and reverse

on the third and seventh counts, and we remand for entry of

judgment in accordance with this opinion. 

FACTUAL AND PROCEDURAL HISTORY

I. OVERVIEW OF OFPA AND IMPLEMENTING REGULATIONS

Congress enacted OFPA in 1990 to “establish national

standards governing the marketing” of organically produced

agricultural products, to “assure consumers that organically

produced products meet a consistent standard,” and to “facilitate

interstate commerce in” organically produced food. 7 U.S.C.

§ 6501. The Act furthers these purposes by establishing a national

certification program for producers and handlers of organic

products and by regulating the labeling of organic products. Id.

§§ 6503(a), 6504, 6505(a)(1)(A). In order to be labeled or sold as

organic, an agricultural product must be produced and handled
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without the use of synthetic substances, such as pesticides, and in

accordance with an organic plan agreed to by an accredited

certifying agent and the producer and handler of the product. Id.

§ 6504; see also id. § 6505 (listing OFPA requirements for

certification). Products meeting these standards may be labeled as

such and may bear the USDA seal. Id. § 6505(a)(2). 

Exceptions to the Act’s general prohibition on synthetic

substances appear on a National List of approved substances for

organic products. 7 U.S.C. § 6517. OFPA requires the Secretary to

establish a National Organic Standards Board to develop the

National List and to recommend exemptions for otherwise prohibited

substances. Id. §§ 6518(a), (k); 6517(c)(1). The Act contains

detailed guidelines for the inclusion of substances on the National

List. Id. § 6517(c).

The Act also requires the Secretary to promulgate

regulations “to carry out” OFPA. Id. § 6521. The Secretary

published the Final Rule at issue in this case in December 2000 and

it became effective on October 21, 2002. See generally 7 C.F.R.

Pt. 205. Among other things, the Rule sets forth a four-tier

labeling system for organic foods. Id. § 205.301. Under this

system, the type of labeling permitted on a product varies

according to the percentage of organic ingredients it contains.

Id. The Rule also includes loopholes concerning nonorganic

ingredients and synthetic substances, id. §§ 205.600(b),
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205.605(b), 205.606; exemptions for wholesalers and distributors,

id. § 205.101(b)(1), as well as livestock herds converting to

organic dairy production, id. § 205.236(a)(2)(i); and restrictions

on the activities of private certifiers, id. §§ 205.303(a)(5),

205.303(b), 205.304(a)(3), 205.304(b)(2), 205.305(b)(2),

205.501(a)(11), 205.501(b). These are the provisions at issue in

the present action and are outlined in more detail below.

II. HISTORY OF THE PRESENT ACTION

Plaintiff-appellant Harvey is a producer and handler of

organic blueberries and other crops, an organic inspector employed

by USDA-accredited certifiers, and a consumer of organic foods. In

October 2003 Harvey filed a complaint for declaratory and

injunctive relief under the Administrative Procedure Act, 5 U.S.C.

§§ 555(b), 702, 706(1), and under OFPA, alleging that nine

provisions of the Final Rule are inconsistent with the Act and

dilute its organic standards. 

On cross–motions for summary judgment, Magistrate Judge

Margaret J. Kravchuk issued a recommended decision finding that

Harvey lacked standing to bring his seventh claim, granting Harvey

summary judgment on his ninth claim, and granting the Secretary

summary judgment on the remaining claims. Harvey v. Veneman,

No. 02-216-P-H (D. Me. Oct. 10, 2003). The District Court adopted

the magistrate judge’s recommended decision with respect to

Harvey’s first eight claims, but granted summary judgment to the
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Secretary, rather than Harvey, on his ninth claim. Harvey v.

Veneman, 297 F. Supp. 2d 334, 335 (D. Me. 2004). Harvey timely

appealed the District Court’s judgment on the following seven of

his nine original claims:

Count 1: Harvey contends that the Rule provides for the

blanket exemption of nonorganic products “not

commercially available in organic form” from the review

and recommendation process OFPA requires for inclusion of

substances on the National List, in contravention of the

purposes of OFPA and the National List.

Count 2: Harvey contends that the Rule’s provisions

allowing use of a private certifier’s seal on products

containing less than 95% organic ingredients, even though

such products may not, according to OFPA, bear a USDA

organic seal, are contrary to the purposes of OFPA.

Count 3: Harvey contends that the Rule’s provisions

permitting the use of synthetic substances in processing

contravene OFPA, which prohibits the use of synthetic

substances generally and specifically forbids the

addition of synthetic ingredients in processing.

Count 5: Harvey contends that the Rule’s exclusion of

certain wholesalers and distributors from its coverage

contravenes OFPA, which includes such entities among the

“handlers” and “handling operations” to which it applies.

Count 6: Harvey contends that the Rule’s prohibition on

certifying agents’ provision of uncompensated advice

regarding certification standards contravenes OFPA, which

prohibits only advice for compensation, and also violates

the rights of such agents and their clients under the

First Amendment to the United States Constitution. 

Count 7: Harvey contends that the Rule’s provisions

allowing dairy animals being “converted” to organic

production to be fed 80% organic feed for the first nine

months of the year prior to sale of their products as

organic contravenes OFPA, which requires dairy animals to

be fed 100% organic feed for twelve full months prior to

the sale of their products as organic.

Count 8: Harvey contends that the Rule’s imposition of
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uniform standards on private certifiers contravenes the

purposes of OFPA.

DISCUSSION

I. STANDARD OF REVIEW

We review a district court’s grant of summary judgment de

novo. People to End Homelessness, Inc. v. Develco Singles Apts.

Assocs., 339 F.3d 1, 8 (1st Cir. 2003). In doing so, we draw all

reasonable inferences from the facts in favor of the appellant.

Id. 

We also review de novo challenges to agency action under

the APA (that is, we do not defer to a district court’s

conclusions). Associated Fisheries v. Daley, 127 F.3d 104, 109

(1st Cir. 1997). Legal issues presented in such challenges are

“‘for the courts to resolve, although even in considering such

issues the courts are to give some deference to the agency’s

informed judgment’ in applying statutory terms if the statute is

silent or ambiguous on the issue.” Penobscot Air Servs., Ltd. v.

FAA, 164 F.3d 713, 719 (1st Cir. 1999) (quoting FTC v. Indiana

Fed’n of Dentists, 476 U.S. 447, 454 (1986)). “That deference is

described in the familiar two-step test” of Chevron U.S.A., Inc. v.

Natural Resources Defense Council, Inc., 467 U.S. 837, 842-44

(1984), according to which we first use traditional tools of

statutory construction to determine congressional intent.

Penobscot Air Servs., 164 F.3d at 719. “[I]f the legislative

intent is clear, we do not defer to the agency” and simply require
-8-

that the regulations be consistent with the statute. Id. If, on

the other hand, “the statute is silent or ambiguous with respect to

the specific issue,” the question “is whether the agency’s answer

is based on a permissible construction of the statute.” Id.

(citation and internal quotation marks omitted). We accord

deference to the agency “as long as its interpretation is rational

and consistent with the statute.” Id. (citation omitted).

II. HARVEY’S STANDING 

A plaintiff bringing legal claims in federal court must

“establish standing to prosecute the action.” Elk Grove Unified

Sch. Dist. v. Newdow, __ U.S. __, 124 S. Ct. 2301, 2309 (2004).

This is partly a constitutional requirement; to meet the

requirements of Article III, a plaintiff must point to an “injury

in fact” that a favorable judgment will redress. See Lujan v.

Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). It is also a

prudential requirement. To establish prudential standing, Harvey

must show that his complaint “fall[s] within the zone of interests

protected by the law invoked.” Newdow, 124 S. Ct. at 2309

(citation and internal quotation marks omitted).

Harvey alleges that he has suffered an injury in fact

because the challenged regulations weaken the integrity of the

organic program and the standards it sets forth. This weakening

harms Harvey as a consumer of organic foods because it degrades the

quality of organically labeled foods. The magistrate judge
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properly held that this claimed harm represents concrete,

redressable injury sufficient to confer Article III standing with

respect to most of the counts in Harvey’s complaint. It is well

established that consumers injured by impermissible regulations

satisfy Article III’s standing requirements. See GMC v. Tracy, 519

U.S. 278, 286 (1997) (“Consumers who suffer [higher costs] from

regulation forbidden under the Commerce Clause satisfy the standing

requirements of Article III.”); Baur v. Veneman, 352 F.3d 625, 628,

641-42 (2d Cir. 2003) (finding cognizable injury in fact where

consumer alleged that USDA regulations permitting use of downed

livestock for human consumption caused him increased risk of

contracting food-borne illness); Ctr. for Auto Safety v. Nat’l

Highway Traffic Safety Admin., 793 F.2d 1322, 1324 (D.C. Cir. 1986)

(finding that consumers suffered sufficient injury in fact to

challenge regulations reducing fuel economy standards “because the

vehicles available for purchase will likely be less fuel efficient

than if the fuel economy standards were more demanding”). 

The magistrate judge concluded that Harvey lacked Article

III standing with respect to his seventh count because Harvey

failed to allege specifically that he was a consumer of organic

milk or inspector of organic dairy operations. Recommended

Decision on Cross-Motion for Summary Judgment, Civ. No. 02-216-P-H

(Oct. 10, 2003), at 33. But Harvey has continuously alleged, as

the magistrate judge acknowledged, that he purchases and consumes
-10-

organic products. Moreover, the record clearly contains Harvey’s

specific allegations that he has regular commercial dealings with

organic dairy farmers and has purchased products containing dairy

ingredients identified as organic. The magistrate judge erred in

requiring more. Harvey has established that this particular

regulation threatens sufficient injury to him as a consumer.

Harvey also clearly satisfies the requirements of

prudential standing. The zone of interests test excludes only

those whose interests are “so marginally related to or inconsistent

with the purposes implicit in the statute that it cannot reasonably

be assumed that Congress intended to permit the suit.” Clarke v.

Sec. Indus. Ass’n, 479 U.S. 388, 399 (1987). Congress enacted OFPA

to establish national standards governing the marketing of organic

products, to assure consumers that organic products meet these

standards, and to facilitate interstate commerce in organic

products. See 7 U.S.C. § 6501. Harvey alleges that the Final Rule

creates loopholes in the statutory standards, undermines consumer

confidence, and fails to protect producers of true organic

products. Harvey’s alleged injuries fall precisely within the zone

of interests that the statutes at issue were meant to protect. 

III. THE MERITS

A. First Count: Alleged Exemption for Nonorganic

Products Not Commercially Available

Harvey alleges that 7 C.F.R. § 205.606 permits the

introduction of a wide variety of nonorganic ingredients into
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organic or made-with-organic products in contravention of OFPA’s

general prohibition of such ingredients. The portion of the Rule

at issue provides:

The following nonorganically produced

agricultural products may be used as

ingredients in or on processed products

labeled as “organic” or “made with organic

(specified ingredients or food group(s))” only

in accordance with any restrictions specified

in this section.

Any nonorganically produced agricultural

product may be used in accordance with the

restrictions specified in this section and

when the product is not commercially available

in organic form.

(a) Cornstarch (native)

(b) Gums -- water extracted only (arabic,

guar, locust bean, carob bean)

(c) Kelp -- for use only as a thickener

and dietary supplement

(d) Lecithin -- unbleached

(e) Pectin (high-methoxy)

7 C.F.R. § 205.606 (emphasis added). Harvey maintains that the

emphasized portion of the Rule allows the introduction of any

nonorganic ingredient into processed products whenever an

individual certifier determines that the ingredient is not

commercially available in organic form. Harvey correctly points

out that §§ 6517 and 6518 of OFPA require all specific exemptions

to the Act’s ban on nonorganic substances to be placed on the

National List following notice and comment and subject to periodic

review. See 7 U.S.C. §§ 6517(a), (d), (e); 6518(k), (l), (m).

Harvey argues that the challenged provision allows ad hoc decisions

regarding the use of synthetic substances, in contravention of
-12-

these statutory procedural requirements. 

In the District Court and before this court, the

Secretary has taken the position that § 205.606 does not create a

blanket exemption, as Harvey contends, but rather permits use only

of the ingredients specifically listed in that section. In other

words, the Secretary maintains that the list of five products in

§ 205.606 is a part of the National List and that the provision

emphasized above and challenged by Harvey should be interpreted

simply as a further limitation on the addition of new nonorganic

ingredients to the National List.

We agree with the District Court that the interpretation

advanced by the Secretary is a plausible interpretation of the

language of § 205.606 that eliminates any conflict with OFPA’s

requirements. The District Court was correct to conclude that,

under the Secretary’s interpretation, § 205.606 is not in

contravention of OFPA. 

However, the District Court did not clarify that it is

necessary to interpret the Rule in this manner in order to find

this portion of the Rule valid. Under other interpretations,

§ 205.606 might exceed the Secretary’s authority under OFPA. In

particular, the interpretation suggested by Harvey, although it is

at odds with OFPA’s evident requirements, is not an implausible

construction of the language of § 205.606 considered alone.

Indeed, the Secretary herself appears to have espoused exactly this
-13-

interpretation in the past. See 65 Fed. Reg. 80,616 (“In the

regulation, a nonsynthetic and nonorganic agricultural

product . . . used as a processing aid does not have to appear on

the National List. Such products are included in the provision in

§ 205.606 that nonorganically produced agricultural products may be

used in accordance with any applicable restrictions when the

substance is not commercially available in organic form.”). 

In light of this possibility, it is insufficient for this

court simply to affirm the District Court’s judgment that § 205.606

is, as it stands, consistent with OFPA. Instead, to clarify that

this portion of the Rule may not be interpreted in a way that

contravenes the National List requirements of OFPA, we remand to

the District Court for entry of a declaratory judgment that

§ 205.606 does not establish a blanket exemption to the National

List requirements for nonorganic agricultural products that are not

commercially available. 

B. Second Count: Use of Private Certifiers’ Seals

on Products Containing Less Than 95% Organic

Ingredients 

Harvey also challenges a part of the Final Rule

permitting use of private certification notices and private

certifiers’ seals on products containing between 70 and 94% organic

ingredients. 7 C.F.R. §§ 205.304(a)(3), (b)(2). Harvey

acknowledges that the Act allows such products to be labeled as

containing “organic” ingredients but contends that OFPA implicitly
-14-

prohibits the certification of such ingredients or the use of nonUSDA seals on these products. In his view, such certification runs

afoul of § 6505(a)(1)(B) of the Act, which forbids labeling that

“implies, directly or indirectly, that [a] product is produced and

handled using organic methods” when it was not produced or handled

in such a way. Id. We conclude that the Act does not prohibit,

either implicitly or explicitly, the certification of organic

ingredients or the use of private certifiers’ seals and that the

challenged portion of the Rule was a permissible exercise of the

Secretary’s discretion in this area.

The provision to which Harvey objects is one aspect of a

comprehensive labeling and certification scheme set forth in the

Rule. See 7 C.F.R. §§ 205.301-205.305. This scheme provides for

four different types of product labels and for two different types

of certification, all depending on the percentage of organic

ingredients in the labeled product. The labeling scheme

distinguishes (1) products containing 100% organic ingredients,

which may be labeled “100 percent organic,” see id. § 205.301(a);

(2) products containing 94 to 100% organic ingredients, which may

be labeled “organic,” see id. § 205.301(b); (3) products containing

70 to 94% organic ingredients, which may be labeled “made with

organic (specified ingredients or food group(s)),” see id.

§ 205.301(c), and (4) products containing less than 70% percent

organic ingredients, which may identify each such ingredient on the
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label or ingredient statement with the word “organic,” see id.

§§ 205.301(d), 205.305(a)(1). Harvey does not contest these

portions of the Rule, which are plainly consistent with the Act’s

requirements. See 7 U.S.C. §§ 6505(a)-(c), 6510 (forbidding

labeling of products as organically produced unless produced in

accordance with the Act and providing that no more than 5%

nonorganic ingredients may be added to processed foods handled in

accordance with the Act, but also permitting labeling of

ingredients as organic in processed foods containing less than 94%

organic ingredients).

Harvey’s challenge is to a portion of the Rule’s parallel

certification scheme. This scheme allows (1) products in the first

two labeling categories, containing 95% or more organic

ingredients, to bear both a USDA seal and the seal of a private

certifying agent, see 7 C.F.R. §§ 205.303(b)(4)-(5), 205.311(a);

(2) products containing 70 to 94% organic ingredients to bear a

notice of private certification and the seal of a private

certifying agent, see id. 205.304(a)(3), (b)(2); and (3) products

containing less than 70% organic ingredients to bear neither a USDA

seal nor that of a private certifier, see id. § 205.305(b). Harvey

specifically objects to the second of these categories. He

maintains that “the Act’s limited exemption for identifying organic

ingredients does not authorize the certification of products which

do not meet the requirements of the Act” and that allowing
1See, e.g., 7 U.S.C. §§ 6502(3)-(5) (defining “certifying

agent,” “certified organic farm,” and “certified organic handling

operation”), 6503(d) (providing for certification of farms or

handling operations by agents), 6506(a)(4)-(6) (providing for

periodic review of organic programs by certifying agents), 6513(a)

(providing for submission of organic plans to certifying agents),

6514(a)-(c) (addressing accreditation of certifying agents),

6515(a)-(j) (setting forth “[r]equirements of certifying agents”),

6516(a)-(b) (addressing peer review of certifying agents),

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certification of such products misleads consumers, in contravention

of 7 U.S.C. § 6505(a)(1)(B).

We note again that Harvey does not challenge the third

tier of the Rule’s labeling scheme, which allows products

containing 70 to 94% organic ingredients to be labeled “made with

organic (specified ingredients or food group(s)).” 7 C.F.R.

§ 205.301(c). Rather, Harvey’s challenge is to the use of private

certification notices and seals on such products. His argument

that use of private certifiers’ seals to designate the presence of

organic ingredients in a product contravenes OFPA depends on two

related premises: (1) that the Act allows for only one kind or

level of certification, namely, USDA certification, which cannot be

uncoupled from private certification, and (2) that the Act does not

contemplate the certification of ingredients or the use of private,

non-USDA seals to indicate their certification. 

Neither premise is supported by the Act itself. First,

the Act does expressly restrict use of the USDA seal, see 7 U.S.C.

§ 6505(a)(2), and contemplates an extensive role for private

certifying agents in implementing the Act’s requirements.1
6518(b)(7) (setting aside seat on the National Organic Standards

Board for a certifying agent), 6519(d)-(e) (addressing violations

reported and committed by certifying agents).

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However, it is silent on the use of private certifiers’ seals and

on the standards for inclusion of private certification information

on product packaging. Since the Act does not address private

certification at all, it necessarily cannot address whether private

certification may be uncoupled from USDA certification.

Second, the Act does provide for the identification of

ingredients as organic when a product contains less than 95%

organic ingredients, id. § 6505(c)(1)-(2), but it is silent on

whether such identification may or may not include certification of

such ingredients as organic and/or a private certifier’s mark. In

other words, with respect to products containing less than 95%

organic ingredients, the Act speaks only to the labeling portion of

the tiered scheme described above. With respect to certification

of products in this category, the Act is silent.

Since the Act is silent on these issues, we must conclude

that Congress committed the questions to the Secretary’s discretion

and assess the challenged portions of the Rule for their

reasonableness in light of OFPA’s overall scheme. Penobscot Air

Servs., 164 F.3d at 719; see also United States v. Haggar Apparel

Co., 526 U.S. 380, 392 (1999) (“If . . . the agency’s statutory

interpretation fills a gap or defines a term in a way that is

reasonable in light of the legislature’s revealed design, we give
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that judgment controlling weight.” (citations and internal

quotation marks omitted)). 

The challenged regulations are reasonable in light of

OFPA’s overall scheme. The Act clearly authorizes the use of the

word “organic” on the packaging of products made with 70 to 94%

organic ingredients. 7 U.S.C. § 6505(c)(1). Under the Act,

certifying agents play a crucial role in determining whether an

ingredient derives from an organic operation. Id. § 6503(d).

Given these statutory directives, the Secretary’s requirement that

labels on third-tier products (containing 70 to 94% organic

ingredients) identify the agent responsible for certifying such

ingredients is not unreasonable. This information allows the

Secretary to identify and track certifiers on a product-by-product

basis, creates consumer confidence that the specified ingredients

are indeed organic, and provides the name of the certifier, which

may be useful to some consumers. Far from contravening the Act,

the certification requirement furthers its purpose of assuring

consistency. See id. § 6501 (stating purposes of OFPA). 

Nor is it unreasonable for the Secretary to permit

inclusion of private certifiers’ seals on such products. Such

seals will tend to increase consumer confidence and to facilitate

interstate commerce in organic products, furthering two of OFPA’s

three goals. See id. Harvey and the amici argue that the presence

of a non-USDA seal on some products will confuse consumers.
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Consumers might be confused by the presence of USDA seals on

products containing 70 to 94% organic ingredients. See id.

§§ 6505(a)(1)(B), 6505(a)(2), 6510(a)(4). But it is difficult to

see how a non-USDA seal applied in compliance with the challenged

provisions could create similar confusion, particularly since the

seal will be accompanied by labeling stating not that the product

is “100% organic” or “organic” but merely that it is “made with

organic (ingredients).” Under these circumstances, a private

certifier’s seal appearing alone on a label serves simply to

reiterate the identification of the agent certifying the

ingredient. Harvey points to no support, statutory or otherwise,

for his contention that the identification of an ingredient as

“organic” is somehow less confusing to consumers than

identification of a private certifier or use of such a certifier’s

seal, yet such a distinction is crucial to his argument. Because

we can see no basis for the distinction, we reject the inference.

We conclude that the District Court did not err in

upholding the challenged portions of the Final Rule as permissible

exercises of the Secretary’s authority. We therefore affirm the

District Court’s judgment on this count of Harvey’s complaint.

C. Third Count: Use of Synthetic Substances in

Processing

Harvey next challenges two parts of the Rule permitting

synthetic substances to be used in processed organic foods.

7 C.F.R. §§ 205.600(b), 205.605(b). Section 205.600(b) provides
-20-

that synthetic substances may be used “as a processing aid or

adjuvant” if they meet six criteria; § 205.605(b) lists thirtyeight synthetic substances specifically allowed in or on processed

products labeled as organic. These provisions, Harvey contends,

contravene the plain language of OFPA, which provides that

certified handling operations “shall not, with respect to any

agricultural product covered by this title . . . add any synthetic

ingredient during the processing or any postharvest handling of

this product.” 7 U.S.C. § 6510(a)(1). Harvey is correct; the

challenged regulations lie outside of the scope of authority

granted the Secretary by OFPA.

The Secretary conceded before the District Court that

§ 6510(a)(1) constitutes a “general prohibition” against adding

synthetic ingredients in handling operations. The Secretary

argues, however, that § 6517 of the Act, which directs the

establishment of the National List and governs the creation of

exemptions from the Act’s general prohibitions, allows the listing

of synthetics for use in the handling of products labeled organic.

We reject this argument. Section 6517 plainly forbids the use of

synthetic substances in handling operations. This section provides

that 

The National List may provide for the use of

substances in an organic farming or handling

operation that are otherwise prohibited under

this title only if . . . 

(B) the substance--

(i) is used in production and contains
2See 7 U.S.C. § 6502(8) (defining “handle” as “to sell,

process, or package agricultural products”), (18) (defining

“producer” as “a person who engages in the business of growing or

producing food or feed”). 

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an active synthetic ingredient in

the following categories . . .

(ii) is used in production and contains

synthetic inert ingredients that are

not classified by the Administrator

of the Environmental Protection

Agency as inerts of toxicological

concern; or 

(iii)is used in handling and i[s]

non-synthetic but is not organically

produced. . . . 

7 U.S.C. § 6517 (emphases added). This section contemplates use of

certain synthetic substances during the production, or growing, of

organic products, but not during the handling or processing

stages.2 The challenged regulations, which permit the use of

certain synthetic substances “as processing aids,” thus contravene

the plain language of this section of the Act as well.

The Secretary notes that some subsections of § 6517 refer

to “farming or handling” activities together, and the Secretary

claims that this language renders the Act ambiguous or

inconsistent, permitting the Secretary to draft a reasonable

reconciliation. We reject this characterization of the Act.

Section 6517(c) clearly establishes a three-prong test for

exemption of otherwise prohibited substances and their inclusion on

the National List. Prong (A), not quoted above, sets forth

requirements that any otherwise prohibited substance, whether used
3This subsection requires such substances to be “not . . .

harmful to human health or the environment”; necessary to

production or handling of an agricultural product “because of the

unavailability of wholly natural substitute products”; and

“consistent with organic farming and handling.” 7 U.S.C.

§ 6517(c)(1)(A)(i)-(iii). 

4We note that in his brief, Harvey admits that he has

withdrawn his challenge as to some of the thirty-eight substances

listed in 7 C.F.R. § 205.605(b) because use of the substances is

required by other statutes. Our reversal of the District Court’s

judgment is without prejudice to any such concessions made by

Harvey or to the general principle of 20 U.S.C. § 6519(f), which

provides that OFPA is not to be interpreted to alter the

Secretary’s authority under other statutes. 

-22-

in production or handling, must meet to be exempted.3 Prong (B),

quoted above, specifically requires that substances used in

handling be nonsynthetic. Prong (B) is not inconsistent with prong

(A); it merely sets forth more specific requirements with regard to

the types of substances that may be used in production and

handling, respectively. The Act is neither ambiguous nor

inconsistent; § 6510 bars addition of “any synthetic ingredient

during the processing or any postharvest handling of the product,”

and § 6517 furthers that prohibition. 

The challenged regulations are contrary to the plain

language of OFPA and therefore exceed the Secretary’s statutory

authority. See Chevron, 467 U.S. at 842-43 (“If the intent of

Congress is clear, that is the end of the matter. . . .”). We

therefore reverse the District Court’s grant of summary judgment to

the Secretary on this count.4
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D. Fifth Count: Exemption of Wholesalers and

Distributors from Certification Requirements

Harvey next challenges 7 C.F.R. § 205.101(b)(1), a

portion of the Final Rule that excludes from the Act’s coverage and

requirements “handling operations” selling products that are

“packaged or otherwise enclosed in a container prior to being

received or acquired by the operation” and that “[r]emain in the

same package or container and are not otherwise processed while in

the control of the handling operation.” Id. § 205.101(b)(1)(i)-

(ii). According to Harvey, this provision impermissibly excludes

wholesalers and distributors, a subset of those engaged in

“handling operations,” from certification and other OFPA

requirements. But, Harvey argues, OFPA expressly exempts from its

certification requirements only one subset of those engaged in

“handling operations,” namely, retailers who do not process the

foods they sell. 7 U.S.C. §§ 6502(9), (10). According to Harvey,

the Act cannot be read to permit the additional blanket exemption

of wholesalers and distributors. 

OFPA’s exclusion of final retailers from its coverage

shows that Congress knew how to exclude operations otherwise

subject to the Act and must be presumed to have acted deliberately

when it did not specifically exclude those that handle only

packaged products. See id. That, however, is not the end of the

story. Section 6510 of the Act specifies the requirements for

certification of handling operations. Id. § 6510. Each of the
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seven subsections of § 6510 prohibits either the addition of

contaminants or exposure to contaminating materials. Id.

§ 6510(a)(1)-(7). The evident purpose of this section is to ensure

that operations handling organic products will not contaminate or

expose to contamination those products. But operations handling

only packaged products (as defined in the regulation) do not

present the contamination hazards at which this section——and hence

the certification process——is aimed. Thus, certification is

irrelevant to those operations that handle only packaged products.

The statutory definition of handling operations in

§ 6502(10), on its face, appears to include operations handling

only sealed packaged products. But the requirements for

certification of handling operations in § 6510 appear to have no

application to operations handling only sealed packaged products,

which by their nature could not engage in any of the proscribed

activities. This portion of the statute therefore lacks coherence

and consistency, creating ambiguity concerning Congress’ intent.

See, e.g., Barnhart v. Signmon Coal Co., Inc., 534 U.S. 438, 450

(2002) (holding that inquiry as to statutory ambiguity ceases “if

the statutory language is unambiguous and the statutory scheme is

coherent and consistent”) (internal quotation marks and citation

omitted); Salinas v. United States, 522 U.S. 52, 60 (1997) (noting

that in order for a statute to be considered unambiguous, “[i]t

need only be plain to anyone reading the Act that the statute
-25-

encompasses the conduct at issue”) (internal quotation marks and

citations omitted); Brown v. Gardner, 513 U.S. 115, 118 (1994)

(“Ambiguity is a creature not of definitional possibilities but of

statutory context.”) (citation omitted). Because “the statute is

silent or ambiguous with respect to the specific issue,” the court

must defer to the Secretary’s reasonable interpretation of the

statute. Chevron, 467 U.S. at 843-44. We therefore affirm the

District Court’s grant of summary judgment to the Secretary on this

count.

E. Sixth Count: Prohibition on Uncompensated

Advice from Private Certifiers

Harvey also challenges 7 C.F.R. § 205.501(a)(11)(IV),

which prohibits certifying agents from “giving advice or providing

consultancy services, to certification applicants or certified

operations, for overcoming identified barriers to certification.”

Harvey contends, first, that this regulation clearly conflicts with

7 U.S.C. § 6515(h), which bars certifying agents only from mixing

advice with financial interest:

Any certifying agent shall not–- 

(1) carry out any inspections of any operation in

which such certifying agent . . . has, or has

had, a commercial interest, including the

provision of consultancy services;

(2) accept payment, gifts, or favors of any kind

from the business inspected other than

prescribed fees; or

(3) provide advice concerning organic practices or

techniques for a fee, other than fees

established under such program.

Id. Harvey argues further that even if the relevant portion of
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OFPA is ambiguous, deference to the Secretary’s interpretation as

embodied in the portion of the Rule at issue is not warranted,

because this regulation raises serious constitutional questions in

that it conditions receipt of a public benefit——USDA

accreditation——on the relinquishment of free speech rights. See

Legal Servs. Corp. v. Velazquez, 531 U.S. 533, 544 (2001).

In connection with the first of these arguments, Harvey

specifically contends that § 6515(h), titled “Conflicts of

interest,” constitutes the complete list of certifier activities

banned by Congress and may not be interpreted to bar activities not

involving financial benefit to the advice giver. But as the

Secretary points out, the statute is not quite so narrowly focused;

it also bars inspections when the certifier “has had” a commercial

interest in an operation and prohibits inspectors from accepting

“favors of any kind.” 7 U.S.C. § 6515(h)(1), (2). As its title

suggests, the subsection regulates conflicts of interest and

certifier integrity generally. It neither addresses nor excludes

the question of whether the provision of free advice may risk a

conflict of interest.

Since the statute is ambiguous on this point, we reach

step two of Chevron and must defer to the Secretary’s

interpretation if it is reasonable. Chevron, 467 U.S. at 843. We

conclude that this interpretation is reasonable. It is easy to

imagine situations in which providing free advice might create a
-27-

conflict of interest for a certifier; the Secretary outlines a

scenario in which a certifier provides well-meaning but erroneous

advice on compliance with the Act to a producer, then later is

faced with a choice between reporting the producer’s violation and

recanting the erroneous advice, a step that could injure the

certifier’s own reputation and credibility. Section 6515(h) is

concerned with ensuring certifiers’ integrity and avoiding

conflicts of interest. It does not preclude the Secretary from

imposing additional requirements tending to achieve these ends.

The challenged regulation is therefore neither inconsistent with

the Act nor an unreasonable interpretation of the Secretary’s

authority.

Harvey argues that if we find the statute ambiguous on

this point, any Chevron deference due the Secretary’s

interpretation is offset by the requirement that we construe

statutes, where possible, to avoid conflict with the Constitution.

See Rust v. Sullivan, 500 U.S. 173, 190-91 (1991); see also U.S.

West, Inc. v. FCC, 182 F.3d 1224, 1231 (10th Cir. 1999)

(“[D]eference to an agency interpretation is inappropriate not only

when it is conclusively unconstitutional, but also when it raises

serious constitutional questions.”). According to Harvey, the

challenged regulation raises a substantial constitutional question,

since it conditions receipt of a government benefit on speech

restrictions.
5The Secretary argues that the constitutionality of the

regulation should instead be analyzed under Pickering v. Board of

Education, 391 U.S. 563 (1968), because certifiers are government

employees. Pickering is not appropriate to analysis of this

regulation, since certifiers are not by definition government

employees or recipients of government funds. See 7 U.S.C. § 6514

(setting forth requirements for accreditation as applicable to both

State officials and “private person[s]”). 

-28-

In making this argument, Harvey relies primarily on Legal

Services Corp. v. Velazquez, 531 U.S. 533 (2001).5 In Legal

Services Corp., the Supreme Court invalidated restrictions on the

speech of attorneys representing welfare claimants in a governmentfunded legal services program. The Court noted that the challenged

program “was designed to facilitate private speech, not to promote

a governmental message,” and contrasted it in this regard with the

program in Rust v. Sullivan, 500 U.S. 173, in which the government

“used private speakers to transmit information pertaining to its

own program,” a program of federal funding for family planning

clinics. Legal Servs. Corp., 531 U.S. at 541-42 (citation and

quotation omitted). The Court in Legal Services Corp. emphasized

that “when the government disburses public funds to private

entities to convey a governmental message[, as in Rust], it may

take legitimate and appropriate steps to ensure that its message is

neither garbled nor distorted by the grantee.” Id. at 541 (quoting

Rosenberger v. Rector & Visitors of Univ. of Va., 515 U.S. 819, 833

(1995)). 

The present case is clearly more nearly analogous to
-29-

Rust, in which the Court found that speech restrictions did not

create a constitutional problem, than to Legal Services Corp., in

which the Court found that they did. In OFPA, the government has

not created a program to facilitate private speech, as in Legal

Services Corp. Instead it has created a scheme that uses private

certifiers to transmit information regarding the national

certification program, a clear example of a “governmental message.”

Legal Servs. Corp., 531 U.S. at 541; see also Rosenberger, 515 U.S.

at 833 (“we have permitted the government to regulate the content

of what is or is not expressed when it is the speaker or when it

enlists private entities to convey its own message”). 

The limitation at issue, as discussed above, is a

reasonable addition to OFPA’s provisions for minimizing certifier

conflicts of interest. We conclude that it is also an appropriate

restriction on speech within OFPA’s scheme and raises no serious

constitutional difficulties. We therefore affirm the District

Court’s grant of summary judgment to the Secretary on this count.

F. Seventh Count: Conversion of Dairy Herds to

Organic Production

Harvey also challenges a portion of the Rule creating an

exception to the Act’s requirements for dairy herds being converted

to organic production. 7 C.F.R. § 205.236(a)(2)(i). OFPA provides

that “[a] dairy animal from which milk or milk products will be

sold or labeled as organically produced shall be raised and handled

in accordance with this title for not less than the 12-month period
6This interpretation of “total feed ration” is consistent with

the legislative history of OFPA. See S. Rep. No. 101-357, 1990

U.S.C.C.A.N. 4656, 5222 (“Livestock must be fed 100 percent

organically grown feed. . . . [Dairy] livestock [must] be raised

according to all of the above standards for . . . not less than one

year.”). 

-30-

immediately prior to the sale of such milk and milk products.”

7 U.S.C. § 6509(e)(2). The challenged rule, in contrast, provides

that 

when an entire, distinct herd is converted to

organic production, the producer may: 

(i)For the first 9 months of the year,

provide a minimum of 80-percent feed that is

either organic or raised from land included in

the organic system plan and managed in

compliance with organic crop requirements; and

(ii)Provide feed in compliance with

§ 205.237 for the final 3 months.

7 C.F.R. § 205.236(a). Section 205.237, referred to in the quoted

portion of the Rule, provides that “[t]he producer of an organic

livestock operation must provide livestock with a total feed ration

composed of agricultural products, including pasture and forage,

that are organically produced and, if applicable, organically

handled.” Id. § 205.237 (emphasis added). The reference to a

“total feed ration” of organically produced feed products indicates

that livestock must ordinarily be fed 100% organic feed to qualify

as part of an “organic livestock operation.”6 Id. Under the

challenged regulation, a converting dairy herd must be fed this way

for only three months. In contrast, under § 6509(e)(2) of OFPA,

dairy animals must be “handled organically” for a full twelve
-31-

months before their products may be labeled organic. In other

words, OFPA clearly requires a single type of organic handling for

twelve months before sale of dairy products as organic, 7 U.S.C.

§ 6509(e)(2), whereas the Final Rule requires two different levels

of organic feed during that twelve-month period, 7 C.F.R.

§ 205.236(a). The statutory and regulatory directives directly

conflict on this point. 

The Secretary admits that OFPA requires dairy livestock

to be fed organically produced feed for the twelve months before

their milk is sold as organic. See 7 U.S.C. § 6509(e)(2). The

Secretary characterizes the challenged regulation, which provides

for a phased conversion process, as an “exception” to this

requirement. The Secretary justifies this exception through a

twofold argument for the validity of § 205.236(a): (1) OFPA is

silent on the question of dairy herd conversion, so the Secretary

has freedom to promulgate reasonable regulations on this subject;

and (2) even if § 6509(e)(2) of the Act is construed to govern the

conversion of dairy herds, the Act does not specify the meaning of

the term “handled organically,” so the Secretary may fill this gap

with a reasonable interpretation, such as that contained in

§ 205.236(a) of the Rule. We reject both arguments. 

First, the twelve-month requirement of § 6509(e)(2) has

little meaning if it does not govern situations in which a dairy

animal is being “converted” to organic production, and nothing in
-32-

the Act indicates that the standards for organic production are

different for entire herds than for single animals. Reasonably

construed, OFPA sets forth clear requirements for dairy herd

conversion in § 6509(e)(2), and the Secretary may not promulgate a

regulation directly at odds with those statutory requirements.

Second, while the Act itself does not define “handled

organically,” the Secretary appears to have filled that gap with

respect to the feed provided dairy animals in § 205.237(a), which,

fairly construed, requires 100% organic feed. This interpretation

is consistent with Congress’ intent as expressed in the legislative

history of OFPA. See S. Rep. No. 101-357, 1990 U.S.C.C.A.N. 4656,

5222. Even if the meaning of “handled organically” remained

unclear, it would be impossible to reconcile the phased conversion

process set forth in the challenged rule with the one-step process

that § 6509(e) of the Act sets forth. Nothing in the Act’s plain

language permits creation of an “exception” permitting a more

lenient phased conversion process for entire dairy herds.

The Secretary’s creation of such an exception in the

challenged provision of the Rule is contrary to the plain language

of the Act. See Chevron, 467 U.S. at 842-43. The District Court

was in error in concluding otherwise, and we therefore reverse its

judgment on this count of Harvey’s complaint. 

G. Eighth Count: Prohibition on Distinct Private

Certification Standards

Harvey’s final challenge is to a provision of the Final
-33-

Rule that prohibits a certifying agent from 

requir[ing] compliance with any . . .

practices other than those provided for in the

Act and the regulations . . . as a condition

of use of [the agent’s] identifying mark:

Provided, That, certifying agents certifying

production or handling operations within a

State with more restrictive requirements,

approved by the Secretary, shall require

compliance with such requirements as a

condition of use of their identifying

mark. . . .

7 C.F.R. § 205.501(b)(2). Harvey argues not that this regulation

contravenes any specific provision of the Act, but that its

limitation on more stringent private standards is counter to the

purposes of OFPA. Specifically, Harvey maintains that the

limitation will suppress competition among users of organic

production and handling methods, create consumer confusion, and

limit consumer choice. Harvey also argues for the first time on

appeal that the regulation impermissibly regulates commercial

speech and is therefore unconstitutional.

In fact, the challenged regulation does not frustrate the

purposes of the Act; it furthers them. Congress clearly set forth

OFPA’s purposes in the Act itself. The aim of the system

established by the Act is, in part, to help “establish national

standards governing the marketing” of organic products and to

“assure consumers that organically produced products meet a

consistent standard.” 7 U.S.C. § 6501. The Act accordingly calls

for the establishment of a national organic production program and
-34-

national standards for organic production, id. §§ 6503, 6504, and

provides that products may be labeled “organically produced only if

such product is produced and handled in accordance with this

title,” id. § 6505(a)(1)(A). OFPA further provides that State

certification programs may be more restrictive than the federal

program. Id. § 6507(b)(1). This provision, incidentally, allows

for the type of competition developing more stringent organic

standards sought by Harvey. 

The Act is silent, however, on the issue of more

stringent private standards or certification requirements, just as

it is silent on the use of private certifiers’ seals. Since this

is a matter on which Congress did not speak, Chevron requires us to

assess whether the challenged regulation is a reasonable

interpretation of the Act. Chevron, 467 U.S. at 843. We conclude

that it is. As noted above, the Act’s provision for more stringent

State standards allows for the kind of competitive advancement of

standards Harvey desires. Additionally, as the Secretary points

out, nothing in the challenged regulation prevents private

certifiers from making truthful claims about the products they

certify; it only bars such certifiers from applying more stringent

requirements as a condition of use of their USDA-accredited

certifying mark. This ban is a reasonable means of furthering the

Act’s concern with consistency.

We decline to consider Harvey’s constitutional argument.
-35-

Harvey concedes that he did not raise the issue before the District

Court but argues that our consideration of it is warranted under

National Ass’n of Social Workers v. Harwood, 69 F.3d 622, 627-29

(1st Cir. 1995). In Harwood, we noted that we countenance

consideration of arguments not raised below when six factors

“heavily preponderate in favor of” considering them. Id. at 628.

It may be appropriate to consider an omitted argument when it (1)

is “purely legal in nature and lends itself to satisfactory

resolution on the existing record without further development of

the facts,” (2) “raises an issue of constitutional magnitude,” (3)

“is highly persuasive” or threatens a “miscarriage of justice” if

not addressed, (4) does not threaten prejudice or inequity to the

adverse party if addressed, (5) was omitted inadvertently, and (6)

“implicates matters of great public moment.” Id. The issue here

is purely legal and constitutional, satisfying the first and second

Harwood factors, and it may have been omitted inadvertently,

satisfying the fourth, but Harvey does not argue convincingly that

failing to reach the claim will threaten a miscarriage of justice

or that the issue is one of great public moment. See id. (noting

that the “great public moment” factor is “perhaps most salient”).

On balance, the factors do not preponderate heavily in favor of

considering the question.

The provision at issue is a reasonable interpretation of

a matter on which the Act is silent, so it was a valid exercise of
-36-

the authority delegated to the Secretary by the Act. We therefore

affirm the District Court’s grant of summary judgment to the

Secretary on this count.

CONCLUSION

We REMAND the first count of Harvey’s complaint to the

District Court for entry of declaratory judgment clarifying the

permissible interpretation of the regulation at issue in accordance

with this opinion.

On the second, fifth, sixth, and eighth of Harvey’s

counts, we AFFIRM the District Court’s grant of summary judgment to

the Secretary.

On the third and seventh of Harvey’s counts, we REVERSE

the District Court’s grant of summary judgment to the Secretary and

REMAND the counts to the District Court for entry of summary

judgment in Harvey’s favor. 

The parties shall each bear their own costs.