Following is the final brief from USDA to the Court prior to its decision. It is especially
interesting because it shows which arguments USDA thinks are still persuasive after
previous exchanges of briefs have shot down other arguments. It was followed two
weeks later by my final brief which replied to this one. Lists of citations have been
omitted.
* * * * * * * * * * * * * * * * * * * * * * * * * * * *
No. 04-1379
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
ARTHUR HARVEY,
Plaintiff/Appellant,
v.
ANN VENEMAN, SECRETARY OF
THE UNITED STATES DEPARTMENT OF AGRICULTURE
Defendant/Appellee.
ON APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MAINE
BRIEF OF APPELLEE ANN VENEMAN, SECRETARY OF
THE UNITED STATES DEPARTMENT OF AGRICULTURE
Paula D. Silsby
United States Attorney
Halsey B. Frank
Assistant U.S. Attorney
District of Maine
100 Middle Street Plaza
East Tower
Portland, Maine 04104
Tel. (207) 780-3257
TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES.........................................iii
JURISDICTIONAL STATEMENT.....................................vii
STATEMENT OF ISSUES PRESENTED................................viii
STATEMENT OF THE CASE........................................x
I. Complaint.........................................xi
II. Schedule, discovery and preliminary matters.......xi
III. Motions for summary judgment and associated
matters...........................................iv
IV. Recommended decision, objections thereto and final
judgment..........................................vi
V. Motions to Intervene..............................xvii
STATEMENT OF FACTS...........................................1
SUMMARY OF THE ARGUMENT......................................5
ARGUMENT.....................................................6
I.THIS COURT SHOULD SUSTAIN THE RULE THAT THE SECRETARY PROMULGATED
TO IMPLEMENT THE ORGANIC FOODS PRODUCTION ACT OF 1990 BECAUSE
APPELLANT HAS FAILED TO DEMONSTRATE THAT IT IS CONTRARY TO LAW OR
PROCEDURE IN ANY RESPECT AND BECAUSE THE RULE IS A PERMISSIBLE
CONSTRUCTION OF THE ACT
A. Standard of Review.................................. 6
B. Standing............................................ 8
C. Count 1: 7 C.F.R. § 205.606......................... 9
D. Count 2: 7 C.F.R. §§ 205.303, 205.304...............17
E. Count 3: 7 C.F.R. § 205.606(b)......................20
F. Count 5: 7 C.F.R. § 205.101(b)(1)...................24
G. Count 6: 7 C.F.R. § 205.501(a)(11)(iv)..............28
1. 7 CFR § 205.501(a)(11) is a permissible
construction of 7 U.S.C. §6515(h).............29 2. 7 C.F.R. § 205.501(a)(11)
is constitutional...31
H. Count 7: 7 C.F.R. § 205.236(a)(i)...................36
I. Count 8: 7 C.F.R. § 205.501(b)(2)...................40
CONCLUSION...................................................45
TABLE OF AUTHORITIES
FEDERAL CASES
JURISDICTIONAL STATEMENT
Original jurisdiction. Pursuant to 28 U.S.C. § 1331, "[t]he district courts shall have
original jurisdiction of all civil actions arising under the Constitution, laws, or treaties
of the United States." Pursuant to 5 U.S.C. § 702, "[a] person suffering legal wrong
because of agency action, or adversely affected or aggrieved by agency action within
the meaning of a relevant statute, is entitled to judicial review thereof. . . ."
Appellate jurisdiction. Pursuant to 28 U.S.C. § 1291, the courts of appeal "shall have
jurisdiction of appeals from all final decisions of the district courts of the United
States . . . ." An appeal from a final judgment of the district court of Maine is taken to
the United States Court of Appeals for the First Circuit. See 28 U.S.C. § 1294. The
final judgment of the district court in this matter was entered on January 8, 2004. D.
58. According to F.R.A.P. 4(a), a notice of appeal must be filed in the district court
within 60 days after entry of the judgment. In this matter, the notice of appeal was
timely filed on March 8, 2004. D. 66.
STATEMENT OF THE ISSUES PRESENTED
C.Whether Mr. Harvey has demonstrated that 7 C.F.R. § 205.606, which currently
lists 6 nonorganic products that may be used in processed products labeled organic
when their organic equivalent is commercially unavailable, is contrary to 7 U.S.C. §
6517, which authorizes the National List of otherwise generally prohibited substances
exempted for use in products produced, handled, labeled and sold as organic when
natural alternative substances are unavailable.
D.Whether Mr. Harvey has demonstrated that 7 C.F.R. §§ 205.303, 205.304 and
205.305, which implement a three-tier labeling hierarchy for organic products
("100% organic" or "organic," "made with organic," and products composed of less
than 70% organic ingredients which may only identify those ingredients that are
organic), are contrary to the Act in general, and to 7 U.S.C. § 6505(c) in particular,
which exempts processed foods containing less than 50% organic ingredients to the
extent that those products may use the word organic to describe organic ingredients
on their ingredient listing panel.
E.Whether Mr. Harvey has demonstrated that 7 C.F.R. 205.606(b), which lists 36
synthetic substances allowed as ingredients in or on processed organic products, is
contrary to 7 U.S.C. § 6517, which authorizes the National List of otherwise generally
prohibited substances exempted for use in products produced, handled, labeled and
sold as organic.
F.Whether Mr. Harvey has demonstrated that 7 C.F.R. § 205.101(b)(1), which
creates a temporary administrative exclusion from the Act’s certification and
inspection requirements, for wholesalers and distributors who do not process but
just resell prepackaged organic products, is contrary to the Act which primarily
governs producers and handlers who do process.
G.Whether Mr. Harvey has demonstrated that 7 C.F.R. 205.501(a)(11)(iv), which
prohibits certifying agents from giving advice to regulated parties on how to
overcome identified barriers to certification, is contrary to 7 U.S.C. § 6515(h), which
prohibits certifying agents from engaging in activities involving conflicts of interest.
H.Whether Mr. Harvey has demonstrated that 7 C.F.R. § 205.236(a)(i), which
creates a one-time exception to the rule that organic dairy herds be fed an organic
diet for 12 months, in order to facilitate conversion of conventional dairy herds to
organic production, is contrary to the Act which does not precisely address the issues
of what exactly organic dairy livestock should be fed or how conventional dairy herds
should be converted to organic production.
I.Whether Mr. Harvey has demonstrated that 7 C.F.R. § 205.501(b)(2), which
prohibits private certifying agents from certifying as organic products whose
production and handling practices differ from those provided by the Act, is contrary
to the Act, which calls for a consistent national standard of organic.
STATEMENT OF THE CASE
This is an appeal from the judgment entered in a civil case in the United States
District Court for the District of Maine (Hon. D. Brock Hornby, United States District
Judge) in favor of Defendant/Appellee Ann Veneman, Secretary of the United States
Department of Agriculture (Secretary, Department, Agriculture, Agency, or USDA) and
against Plaintiff/Appellant Arthur Harvey. D. 58.1 Mr. Harvey is an organic blueberry
farmer, a processor and consumer of organic foods, and an inspector who works for
an accredited certifying agent within the USDA’s National Organic Program (NOP). D.
1 at p. 2; D. 29 at ¶¶ 5, 6. As an inspector, Mr. Harvey inspects organic food
production and handling operations to determine whether they comply with program
requirements. See 7 C.F.R. § 205.403.
I. Complaint
On October 23, 2003, only slightly more than a year after the final rule became fully
effective, proceeding pro se, Mr. Harvey filed his Complaint under the Administrative
Procedure Act, 5 U.S.C. §§ 551 et seq. and 701 et seq. (APA). D. 1. Although he
participated in the rulemaking process by making comments, see e.g., D. 35 at
Appendix 5, Mr. Harvey did not make any administrative claim prior to filing his
Complaint, and there is no administrative record of any proceedings below besides
the record of the rulemaking.
In the 9 counts of his Complaint, Harvey challenged the validity of the Rule that the
Department of Agriculture’s Agricultural Marketing Service (AMS) wrote to implement
the Organic Foods Production Act of 1990, 7 U.S.C. § 6501 et seq. (OFPA or Act). See
D. 1 passim. The rule appears at 7 C.F.R. Part 205 (Rule, Regulation, or OFPA Rule or
Regulation). Harvey argued that various provisions of the Rule were arbitrary,
capricious, and contrary to law and procedure. D. 1 passim. Harvey perfected service
on Appellee on January 3, 2003, and after an extension of time, Appellee answered
the Complaint on March 10, 2003. D. 9.
II. Schedule, discovery and preliminary matters
On March 21, 2003, the district court issued its standard scheduling order which
contemplated standard track discovery lasting approximately 4 months, with limits of
30 interrogatories, 30 requests for admission, 2 sets of requests for production of
documents, and 5 depositions per side. D. 10. Pursuant to that order, the parties met
and conferred on April 2, 2003, with representatives of the Department of Agriculture
participating by phone. See id. and D. 11.
The meeting lasted several hours, during which the parties discussed each of the
counts in Harvey’s Complaint and the issues implicated thereby, including whether
Harvey had exhausted his administrative remedies with respect to some of his claims
and whether he had standing to raise each of his claims. See D. 11 passim. Mr. Harvey
explained his claims. See id. at p. 2. He mentioned the possibility of adding the Maine
Organic Farmers and Growers Association (MOFGA) as a party. The parties discussed
the nature of Administrative Procedure Act litigation and how such cases were usually
decided on the basis of motions and an administrative record. See id. at p. 2. They
discussed what of the enormous administrative record underlying the Rule would be
needed to litigate each of Mr. Harvey’s claims. See id. at p. 1. They discussed the
principle that there was no discovery in such cases absent a strong showing of bad
faith or other impropriety. See id. at p. 2
The parties agreed that Harvey’s Complaint was a challenge to the Rule as written
and not a challenge to the Rule as applied. See id. at p. 2. They agreed that only very
limited portions of the administrative record would be needed in order to resolve Mr.
Harvey’s claims. See id. at p. 2, D.12. Mr. Harvey wanted to reserve the option of
citing non-record material and expert witnesses in support of his claims, and Appellee
explained its belief that was not appropriate. See D. 11 at p. 2-4, and at the
handwritten note attached thereto. The parties agreed to a motions schedule and
agreed to file a joint objection to the district court’s scheduling order. See D. 11 at p.
2, D. 12. However, Mr. Harvey seemed to waver from that understanding, see D. 11 at
p. 3 and at attached handwritten note, and the Secretary filed a unilateral objection
to the scheduling order instead, D. 11.
Contrary to the parties’ suggestion, the court issued an amended scheduling order
that called for the parties to file cross-motions simultaneously. D. 13. Appellee
objected on the grounds that it made more sense to have Mr. Harvey go first in order
to clarify, narrow and focus his claims. D. 16. Meanwhile, Mr. Harvey filed a motion to
compel production of certain post hoc audit reports, D. 14, which he alleged would
"bring an entirely new dimension to count 8" of his Complaint, id. at p. 2, and "reflect
[ed] the implementation" of the Rule, D. 15. He filed a further objection to the
scheduling order. Id. Harvey suggested that the audit reports he sought might alter
the focus of his claims from "what results could be expected from the regulation" to
"the actual results" of the regulation. D. 14 at p. 2. Appellee expressed concern that
Mr. Harvey’s claims were beginning to shift. See D. 16 at p. 1.
On May 1, 2003, the court held a conference of counsel, at which the court and
parties discussed the court’s amended motions schedule and Mr. Harvey’s request for
discovery. See D. 18. Harvey pressed his request to obtain the Agency’s reports of
audits of organic certifiers in order to raise new claims about the way that the Rule
was being applied. See id. and D. 22 passim. The Secretary reemphasized that there
was no discovery in APA review cases absent a strong showing of bad faith or other
impropriety, neither of which Mr. Harvey had demonstrated. See D. 18, 20. She
pressed for a staggered briefing schedule with Harvey going first in order to better
define the claims that the Secretary would have to respond to. See D. 18. The court
denied Harvey’s request for discovery and authorized the Secretary to file a cross-
motion at the same time it filed its opposition to Harvey’s motion for summary
judgment. See id. and D. 19.
On June 20, 2003, Mr. Harvey filed a motion repeating his request for discovery of
Agency reports of post hoc audits of organic certifiers, which he argued
demonstrated that the USDA was improperly using its power to accredit organic
certifiers. D. 23 at p. 1. The Secretary opposed such discovery on the grounds that
Harvey still had not made the showing required to obtain discovery in an APA review
case, and because the reports were not relevant to the claims that Mr. Harvey pleaded
in his Complaint, which were claims that the Agency had misconstrued the Act when it
wrote the Rule, and not claims that the Agency was misapplying the Rule. D. 24 at pp.
1-2.
The Secretary explained that this was not a minor misunderstanding because it
begged the question of whether Harvey had exhausted his administrative remedies
with respect to his new claims, and because the addition of new claims affected the
type and amount of administrative record that would be required to resolve those
claims. Id. at p. 3. In fact, there was no administrative record of any challenge to the
way that the Agency was administering the Rule because Mr. Harvey never made such
a challenge administratively. Id. The court denied Harvey’s request for discovery. D.
25.
III.Motions for summary judgment and associated matters
On July 1, 2003, Mr. Harvey filed his motion for summary judgment, including a
motion to supplement the administrative record with two affidavits and a printout
from the USDA website. D. 27, 28, 29. Harvey argued that he had standing to raise his
claims, and that he had exhausted his administrative remedies. D. 27 passim. With
respect to each count of his Complaint, Mr. Harvey made several arguments why the
Rule was contrary to the substance of the Act or to procedures that the Act
contemplated. Id. He sought declaratory judgment that the Rule was contrary to the
Act in the respects that he identified, deletion of the regulatory language he found
offensive to the Act, and he sought injunctions enjoining the Agency from enforcing
those respects of the Rule pending its rewriting. Id.
On July 22, 2003, the Secretary filed excerpts of the administrative record relevant
to Mr. Harvey’s claims and its defenses,2 a motion to strike the extra-record material
that Harvey had filed, D. 30, and a consolidated opposition to Harvey’s motion for
summary judgment and cross-motion for summary judgment, D. 31. In its motion to
strike, the Secretary again argued that Harvey failed to show bad faith or impropriety
warranting supplementation of the record. D. 30. It argued that Harvey was trying to
use extra-record material to support claims outside of his Complaint. Id. In its
opposition and cross-motion, the Secretary argued that Harvey lacked standing and
failed to exhaust his administrative remedies. D. 31. She refuted Harvey’s arguments
that the Rule was a misconstruction of the Act, and demonstrated how the Rule was
faithful to, and a permissible construction of, the Act. Id.
On August 12, 2003, Harvey filed a response to the Secretary’s motion to strike, D.
34, and a consolidated opposition to its cross-motion and reply in support of his own
motion for summary judgment, D. 35, which included 60 pages of attachments. See
motion for leave to exceed page limit, D. 33. Of these attachments, only two appeared
to be part of the administrative record: Appendix 1, an excerpt from a transcript of a
National Organic Standards Board (NOSB) meeting held on May 8, 2002, and
Appendix 5, a written comment authored by Arthur Harvey and dated March 20,
2001. D. 35 at Appendices 1 and 5. The rest were extra-record materials, including a
second Appendix numbered 5 which consisted of 11 pages of copies of labels of food
products. D. 33 at Appendix 5. In its reply filed on August 22, 2003, the Secretary
moved to strike these materials and the new claim that Harvey was making based
upon them. D. 38 at p. 2 n. 1.
IV. Recommended decision, objections thereto and final judgement
On October 10, 2003, United States Magistrate Judge Margaret Kravchuk issued a
Recommended Decision recommending that Harvey’s motion for summary judgment
be denied with respect to counts 1 through 8 of his Complaint and be granted with
respect to count 9. D. 43. Judge Kravchuk recommended that the Secretary’s cross
motion be granted with respect to counts 1 through 8 and denied with respect to
count 9. Id. The parties filed objections to the Recommended Decision, D. 50, 51, and
responses to each others’ objections, D. 52, 53. Harvey filed a motion to narrow
counts 3 and 5, D. 54, to which the Secretary filed a non-opposition, D. 55. On
January 8, 2004, over Harvey’s objection, and in accordance with the Secretary’s
objection, United States District Judge Hornby affirmed the Recommended Decision
with respect to counts 1 through 8, rejected the Recommended Decision with respect
to count 9, and granted judgment in the Secretary’s favor with respect to all 9
counts. D. 57. Judgment issued the same day. D. 58. This appeal followed.
VI. Motions to intervene
On February 25, 2004, two attorneys filed appearances on behalf of Mr. Harvey,
who had thus far been proceeding pro se. D. 59, 60. That same day, which was 14
months after Harvey filed his Complaint, over four and one-half months after the
Recommended Decision issued, 48 days after judgment had entered, and less than
two weeks before the 60 day period for filing an appeal was due to expire, those
same attorneys filed a motion to intervene on behalf of Beyond Pesticides (BP), John
and Merrill Clark, and the Organic Consumers Organization (OCA). D. 61. Days later,
the same attorneys filed two more motions to intervene on behalf of Northeast
Organic Farming Association and Anne Mendenhall. D. 63, 64.
The Secretary opposed those motions on the grounds, among others, that they
were late and the presence of prospective interveners was going to be disruptive and
not helpful. D. 65. The district court denied the motions. D. 70. Together with several
others, all of those applicants filed a motion to intervene in this Court which the Court
denied on May 25, 2004, giving leave for those parties to seek amicus status.
STATEMENT OF FACTS
Prior to the enactment of the OFPA in 1990, there were as many as 33 private and
11 state agencies that certified agricultural products as organic, each with their own
standards and identification marks. 62 Fed. Reg. 65850 (Dec. 16, 1997). There was
no industry-wide agreement with respect to what substances should be permitted or
prohibited from use in organic products. Id. The number and variety of these
regulatory schemes caused members of the organic community problems producing,
marketing, purchasing, and consuming organically produced and handled products.
Id.
In the late 1980s, the organic community tried to address these problems on its
own. Id. It attempted to establish a national, voluntary organic certification program.
Id. When that effort failed, the organic industry trade association petitioned Congress
to legislate a mandatory, national organic program. Id. The result was the Organic
Foods Production Act of 1990. P.L. 101-624; Food, Agriculture, Conservation and
Trade Act of 1990. See S. Rep. No. 101-357, 101st Cong., 2d Sess at 290-1 (July 6,
1990), reprinted in 1990 U.S.C.C.A.N. at p. 4945.
The purpose of the Act is 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 agricultural products. 7 U.S.C. § 6501. The Act
does so by establishing a national certification program for producers and handlers of
organic products, 7 U.S.C. § 6503(a), and by regulating the use of labeling terms
such as "organic," "100% organic," and "made with organic," see 7 U.S.C. §§ 6504,
6505(a)(1).
In order to be sold or labeled as organic, and subject to exceptions made in the Act,
an agricultural product must be produced and handled without the use of synthetic
chemicals (such as herbicides and pesticides), must be produced and handled in
accordance with the Act generally, 7 U.S.C. § 6505(a)(1), and must be in accordance
with an organic plan agreed to by the certifying agent and the producer and handler
of the product, 7 U.S.C. § 6504.
The major exception to the Act’s general rule that organic agricultural products be
natural and not contain synthetics is the National List of approved and prohibited
substances authorized by 7 U.S.C. § 6517. The List itemizes each synthetic substance
permitted, and each natural substance prohibited, in agricultural products produced,
handled, labeled and sold as organic. 7 U.S.C. § 6517(b). Subsection 6517(c)(1)
creates an exemption for prohibited substances. It permits the use of substances that
the Act otherwise prohibits in organic farming and handling if those substances are
"not . . . harmful to human health or the environment," are "necessary to the
production or handling of the agricultural product because of the unavailability of
wholly natural substitute products," and are "consistent with organic farming and
handling." 7 U.S.C. § 6517(c)(1)(A).
7 U.S.C. § 6521 authorizes and requires the Secretary of the Department of
Agriculture to promulgate regulations "to carry out" the OFPA. After extensive
rulemaking, on December 16, 1997, the Secretary published the first proposed rule to
implement the Act. 65 Fed. Reg. 13512 (Mar. 13, 2000). It generated significant
public response. Id. In total, the Secretary received 275,603 comments with respect
to the first proposed rule. Id. In response to those comments, the Secretary rewrote
the rule. On March 13, 2000, the Secretary published a second proposed rule which
received an additional 40,774 comments. 65 Fed. Reg. 80549.
On December 21, 2000, the Secretary published the Final Rule, which is codified at 7
C.F.R. Part 205. The Rule was subject to a 90-day review by Congress, and to an 18-
month phase-in period to allow the industry time to adjust before the Rule became
fully effective, which it did on October 21, 2002. 7 U.S.C. § 6521. See D. 31 at pp. 2-9.
Together, the Act and Rule create a robust enforcement program. 7 U.S.C. § 6519
establishes penalties for various violations of the Act. For example, "[a]ny person
who knowingly sells or labels a product as organic, except in accordance with [the
Act]," is subject to a civil monetary penalty. 7 U.S.C. § 6519(a). Any person who
affixes to a product a label indicating that product is organically produced knowing
that product has not been produced or handled in accordance with the Act is subject
to being disqualified from receiving certification for five years, as is any person who
"violates the purposes of the applicable organic certification program." 7 U.S.C. §
6519(c)(1)(B) and (C).
Certifying agents may investigate complaints of noncompliance, 7 C.F.R. § 205.661
(a), may test agricultural input or products sold as organic, 7 C.F.R. § 204.670(b),
and are responsible for reporting violations, 7 U.S.C. § 6519(d). Violators are entitled
to notice, hearing and appeal from adverse action. See 7 U.S.C. §§ 6519(c), 6520; 7
C.F.R. §§ 205.680-.681.
SUMMARY OF THE ARGUMENT
Mr. Harvey has not borne his burden of proving that any of the seven sections of the
Final Rule that the Secretary of Agriculture wrote to implement the Organic Foods
Production Act of 1990 is arbitrary, capricious or contrary to law. In fact, those
sections of the Rule are faithful to, and a permissible construction of, the Act and
should be upheld.
ARGUMENT
I.THIS COURT SHOULD SUSTAIN THE RULE THAT THE SECRETARY PROMULGATED
TO IMPLEMENT THE ORGANIC FOODS PRODUCTION ACT OF 1990 BECAUSE
APPELLANT HAS FAILED TO DEMONSTRATE THAT IT IS CONTRARY TO LAW OR
PROCEDURE IN ANY RESPECT AND BECAUSE THE RULE IS A PERMISSIBLE
CONSTRUCTION OF THE ACT.
A. Standard of Review
Judicial review of agency action is an unusual process in which the federal courts at
every level conduct quasi-appellate review on a de novo basis. See Florida Power &
Light v. Lorion, 470 U.S. 729, 744 (1985); Bradley v. Weinberger, 483 F.2d 410, 414
(1st Cir. 1973).3 The courts do not conduct any fact finding but rather rely upon an
administrative record created by the agency. See Am. Bioscience, Inc. v. Thompson,
269 F.3d 1077, 1083 (D.C. Cir. 2001)(citing cases) (issue is a legal one); Commercial
Drapery Contractors v. U.S., 133 F.3d 1, 7 (D.C. Cir. 1998)(review is based on
administrative record).
They defer to agency expertise and presume agency action valid unless the party
challenging the action demonstrates that action is arbitrary, capricious, contrary to
law or procedure. See Ass’d Fisheries of Maine v. Daley, 127 F.3d 104, 109 (1st Cir.
1997)(citing Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415-6 (1971)
(presume valid); Sierra Club v. Marsh, 976 F.2d 763, 769 (1st Cir. 1992)(presume
valid)). The party challenging the action bears the burden of showing that it was
arbitrary, capricious or contrary to law. See Southshore Hosp. v. Thompson, 308 F.3d
91, 101 (1st Cir. 2002).
When the type of agency action under review is rulemaking, the rules that an agency
has promulgated using its expertise are presumed valid unless and until the
challenger demonstrates that they are contrary to the authorizing legislation or were
promulgated contrary to established procedure. 5 U.S.C. §§ 706(2)(A), (B), (C), (D).
See Ass’d Fisheries, 127 F.3d at 109; Adams v. EPA, 38 F.3d 43, 49 (1st Cir. 1994).
Whether a particular rule is a permissible construction of a statute is a function of two
related considerations: how clearly and precisely Congress has spoken to a particular
issue and how much authority to regulate Congress has delegated to the agency. See
Maine Ass’n of Neighborhoods v. MDHS, 946 F.2d 4, 6 (1st Cir. 1991). The first is
largely a matter of statutory construction, beginning with the plain language of the
statute and employing the traditional tools of statutory interpretation if necessary.
See id. at pp. 6-7. A certain amount of authority to regulate is inherent in the
respective natures of the Congress as legislature which enacts relatively general
legislation and Executive Branch agencies whose task is to implement that legislation.
See Chevron v. NRDC, 467 U.S. 837, 843-44 (1984)(quoting Morton v. Ruiz, 415 U.S.
199, 231 (1974)).
Beyond this, authority to regulate can be explicitly delegated by the plain language
of authorizing legislation or it can be implicitly delegated by the gap between the
guidance that Congress has provided in the legislation and what is required to
implement that guidance on the ground, in the field, in production and handling
operations, and in the marketplace. See United States v. Mead Corp., 533 U.S. 218,
226 (2001)(when Congress leaves a gap in legislation it delegates rulemaking
authority); Becker v. FEC, 230 F.3d 381, 390-7 (1st Cir. 2000), cert. denied, 523 U.S.
1007 (2001)(affirming Chevron deference given FEC’s regulations permitting
corporate funding of debate staging organizations in the face of ambiguous Federal
Election Campaign Act); Strickland v. Com’r, Maine DHS, 96 F.3d 542, 546 (1st Cir.
1996)(affirming Chevron deference given USDA’s interpretation of ambiguous word
"cost" in food stamp program legislation); Dunn v. USDA, 921 F.2d 365, 366-7 (1st
Cir. 1990)(where Congress has been ambiguous or silent, an agency has authority to
promulgate regulations that are a permissible construction of the statute). See
generally, D. 31 at pp. 10-13.4 Here, the OFPA explicitly delegates general rulemaking
authority to the Secretary in 7 U.S.C. § 6521(a).
B. Standing
In addition to prudential considerations peculiar to administrative review cases,
plaintiffs in such cases must satisfy the traditional, constitutional requirements for
standing. The case or controversy clause of the constitution requires that a plaintiff
have suffered a concrete injury that can be traced to the action taken by the
defendant about which the plaintiff complains, and that can be remedied by the court.
See U.S. Con. Art. III, Sec. 2; Lujan v. Defenders of Wildlife, 504 U.S. 555, 560
(1992); Mangual v. Rotger-Sabat, 317 F.3d 45, 56 (1st Cir. 2003). It exists in order
to ensure that courts do not waste their energies, and risk their authority, on abstract
disputes between bystanders, and in order to sharpen and focus the issues so that
they are easier to resolve. Valley Forge Christian College v. Americans United for
Separation of Church and State, 454 U.S. 464, 471-73 (1982); Cotter v. City of
Boston, 323 F.3d 160, 165 (1st Cir.), cert. denied, 124 S.Ct. 179 (2003); Becker, 230
F.3d at 384; D. 31 at pp. 16-18. The issues in this litigation have been difficult to
define, respond to and decide, because Mr. Harvey lacks the type of concrete,
particularized injury that standing requires in order to sharpen and focus them.
C. Count 1: 7 C.F.R. § 205.606's list of 6 nonorganic products that may be used in
processed products labeled organic when their organic alternatives are not
commercially available is a permissible construction of the National List of otherwise
generally prohibited substances exempted for use in products produced, handled,
labeled and sold as organic, which List is authorized by 7 U.S.C. § 6517.
Sections 205.600 through 205.607 of Title 7 of the Code of Federal Regulations
implement the National List of synthetic substances allowed, and natural substances
prohibited, in foods labeled and sold as organic. In section 205.600, the Rule
elaborates upon the criteria that the Act requires to be considered when evaluating
substances for inclusion in the National List. Section 205.607 explains how a person
may petition to amend the list to include or delete a substance. In sections 205.601
through 205.606, the Rule lists substances in categories such as "synthetic
substances allowed for use in organic crop production," (section 205.601) and
"nonsynthetic substances prohibited for use in organic crop production" (Section
205.602).
Section 205.606 of Title 7 of the Code of Federal Regulations governs nonorganic
ingredients allowed in processed organic products. It provides that:
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 (the Secretary has added a sixth substance, see infra). The district
court held that 7 C.F.R. § 205.606 "is consistent with the OFPA." D. 43 at p. 9; D. 57,
58.
Mr. Harvey apparently concedes that the 5 products listed in 7 C.F.R. § 205.606(a)-
(e) are properly included in the National List. See Brief of Plaintiff-Appellant Arthur
Harvey (Br.) at pp. 20, 21 ("[o]nly the five products specifically listed in the
regulation went through the required National List procedures").5 He argues that 7 C.
F.R. § 205.606 violates the Act by creating a "blanket" exemption pursuant to which
any nonorganic agricultural ingredient may be used in processed organic food when
that ingredient is not commercially available in organic form. It does not. The section
is a list of products that may be used as ingredients when their organic form is not
commercially available. Items may be added and subtracted from the list according to
the procedures that govern the National List. For example, acting pursuant to those
procedures, the Secretary has added carrageenan to this list. See Fed. Reg. Vol. 68
No. 211 at pp. 61988 (October 31, 2003).
Mr. Harvey is only able to make this argument on the basis of the most
unsympathetic reading of the Rule and guidance. Harvey reads the phrase "[a]ny
nonorganically produced agricultural product may be used . . .," as that phrase
appears in 7 C.F.R. § 205.606, in isolation. See Appellant’s Brief at p. 24. He reads
permissive, prospective and conditional language in agency guidance as mandatory,
actual and unconditional. See id. When the guidance is that nonorganic ingredients
"could be used in handling" (emphasis added) organic products if they were listed
pursuant to National List procedures the way that the five specific ingredients in 7 C.F.
R. § 205.606 have been listed, Harvey reads that guidance as any nonorganic
ingredient may be used in any event. See Br. at p. 24. When the guidance is that
organic products may contain up to 5% nonorganic ingredients if those ingredients
are otherwise on the National List, he reads the guidance without the qualification.
See id.6
Harvey makes sweeping, unsubstantiated assertions such as that nonorganic
agricultural products other than the 5 listed in 7 C.F.R. § 205.606 have been
authorized for use in processed organic products without following National List
procedures. See id. at p. 21 ("Of course, none of these procedures were followed
with respect to "any . . . agricultural product."). He asserts that the sunset provision
cannot operate when products are not listed. Br. at pp. 21-2. However, he never
identifies any particular nonorganic ingredient that the USDA knew was used in
processed organic products without appearing on the National List and that should
have been dropped from the National List under the sunset provision.
Harvey argues that the National List procedures, such as National Organic Standards
Board and Technical Advisory Panel review, cannot be applied to products that are
not specifically listed, Br. at pp. 20-1, but there is no record of this having happened.
Harvey concedes that the five products listed in section 205.606 "went through the
required National List procedures." Br. at p. 21. They can be unlisted or treated under
the sunset provision on the same basis as they were listed.
Harvey argues that delegating to certifying agents the determination of whether any
particular product listed in 7 C.F.R. § 205.606 is "commercially available," violates the
spirit if not the letter of the Act by converting what he believes Congress intended to
be a very public process into a private one, and by converting the product of that
process from one short, public, consistent National List into a multitude of private and
inconsistent lists. Br. at pp. 22-3, 25.
To the contrary, in 7 U.S.C. § 6517(c)(1)(A), the Act explicitly contemplates the
commercial availability determination. One of the statutory guidelines for exempting
prohibited substances is that the "substance be necessary to the production or
handling of the agricultural product because of the unavailability of wholly natural
substitute products." 7 U.S.C. § 6517(c)(1)(A).
In 7 C.F.R. § 205.2, the Secretary defined "commercially available" as "[t]he ability
to obtain a production input in an appropriate form, quality, or quantity to fulfill an
essential function in a system of organic production or handling, as determined by the
certifying agent in the course of reviewing the organic plan." Thus, the determination
of whether one of the six substances currently listed in 7 C.F.R. § 205.606 is
commercially unavailable such that it may be used in organic production falls to
certifying agents acting pursuant to this definition. The decentralization of this
determination is a necessary feature of a national standards program that regulates
agricultural products processors in a large and diverse country with supply, demand
and market conditions that vary from locality to locality. See 65 Fed. Reg. 80562-4.7
The Secretary is in the process of providing certifying agents with further guidance
on how to make the commercial availability determination. She has asked the National
Organic Standards Board to submit a proposal for her consideration, which the Board
has done, as Mr. Harvey notes in his Brief at footnote 17.
In the middle of his lawsuit in district court, Mr. Harvey submitted the copies of
labels referred to in his Brief at footnote 14. See D. 33 at Appendix 5. Harvey argues
that these labels demonstrate "that some organically-certified products had the same
ingredients in nonorganic form as other products had in organic form, demonstrating
that the individual certifier lists are inconsistent and that some supposedly
‘unavailable’ ingredients in fact are available in organic form." Br. at n. 14. Apparently
referring to this "evidence," in their brief at pp. 27-28, Amici RAFI et al. state that
"Harvey submitted evidence tending to show that handlers and accredited certifying
agents believe that ‘any’ nonorganically produced nonsynthetic substance may be
used under this regulation, whether or not it has been screened by the NOSB and
placed on the National List." (Emphasis added.)
This argument is riddled with missing facts, unsubstantiated speculations and
unstated assumptions. One assumption is that the labels at issue accurately reflect the
contents of their packages. Another is that products with supposedly inconsistent
labels were produced at the same time and place where the commercial availability of
the particular organic ingredient was the same, while the labels may imply otherwise.
A third assumption is that inconsistencies in certifier determinations of commercial
availability necessarily mean that the Rule violates the Act.
As a whole, the argument is one about the way that the Act and Rule are being
administered. Harvey makes it in the context of a facial challenge to the Rule. He has
not exhausted his administrative remedies with respect to this claim and it is not in a
posture for this or any court to decide. 5 U.S.C. § 704 limits "judicial review" to "final
agency action." See Adams v. EPA, 38 F.3d 43, 50 (1st Cir. 1994); Weinberger, 483 F.
2d at 414-15. Contrast Becker, 230 F.2d at 384 (there may be no need to exhaust
administrative remedies before bringing a facial challenge to a regulation in district
court).
As an inspector for a certifying agent, Mr. Harvey could have investigated any
suspicion that his own clients’ processed products were out of compliance pursuant
to 7 C.F.R. § 205.606. He could have conducted tests of products and their
ingredients or inputs to determine whether those products contained any nonorganic
ingredients not on the National List. 7 C.F.R. § 205.670. If he found an ingredient
that was on the National List, he could have investigated where it came from and who
certified that its organic form was not commercially available and on what basis. He
could complain to the National Organic Program. 7 C.F.R. §§ 205.660(a) and (b)(1).
In any event, pursuant to 7 C.F.R. § 205.662, Harvey’s certifying agent could have
brought a noncompliance action against any producer or handler who Harvey had
inspected and who was not in compliance with the Act or regulation. That action
would entail Harvey describing each instance of noncompliance and the facts upon
which the allegation of noncompliance was based. 7 C.F.R. §§ 205.662(a)(1) and (a)
(2). The producer or handler would have an opportunity to rebut the allegation or
correct the noncompliance. 7 C.F.R. § 205.662(a)(3). If the producer or handler did
not resolve the noncompliance, its certification would be suspended or revoked. 7 C.F.
R. §§ 205.662(b), (c), (e). They would have access to the administrative appeal
procedures specified in 7 C.F.R. §§ 205.680-681.
This process of investigation, noncompliance action, resolution and appeal would
accomplish several things. It would develop facts and expose the truth about whether
any regulatory violation occurred and, if so, who committed it and how they
committed it. It might resolve the matter once and for all. If not, the process would
produce an administrative record which could then form the basis for further review.
That record does not exist in this case because Mr. Harvey and his certifying agent did
not engage in this part of the process. Any claim challenging the way that 7 C.F.R. §
205.606 is administered should be dismissed for failure to exhaust administrative
remedies.
D. Count 2: The three-tiered labeling hierarchy implemented in 7 C.F.R. §§ 205.303
and 205.304 is a permissible construction of the OFPA in general and, in particular, of
7 U.S.C. § 6505(c), which exempts processed foods containing less than 50% organic
ingredients to the extent that those products use the word organic to describe
ingredients on their ingredient listing panel.
Subject to qualifications, Harvey essentially argues that 7 C.F.R. § 205.304 violates
the Act by permitting the certification of products that contain less than 95% organic
content when the Act only permits the certification of 95% organic products. Br. at
pp. 27-31. His argument is based upon a misreading of both the Act and the
Regulation. The district court ruled that "Congress has expressly delegated rule
making authority to the Secretary and conferred discretion to make rules about
allowance of the use of the word ‘organic’ in labeling products that do not meet the
ninety-five-percent mark of 7 U.S.C. § 6510(a)(4). Given the express statutory
authority granted the Secretary under § 6505(c) to permit other uses of the term
organic, the development of rules on this score is not contrary to the OFPA." D. 43 at
p. 16; D. 57, 58.
The OFPA gives the Secretary discretion to enact a three-tiered labeling hierarchy.
See 7 U.S.C. § 6505; S. Rep. No. 357, reprinted in 1990 U.S.C.C.A.N. at 4955-56.
Agricultural products that contain at least 95% organic ingredients and limit the
remaining 5% of ingredients to National List substances qualify as first-tier organic
foods. See 7 U.S.C. § 6510(a)(4); S. Rep. No. 357, reprinted in 1990 U.S.C.C.A.N. at
4955-56. These products may be labeled "100% organic" or "organic" as
appropriate. See 7 C.F.R. § 205.303. Only first tier organic foods may use the USDA
seal of organic approval. See 7 C.F.R. § 205.303(a)(4). The remaining two tiers focus
on processed foods that contain less than 95% organic ingredients. See 7 U.S.C. §
6505(c). Congress allowed the USDA this flexibility to establish lower tiers so that
food processors would not be discouraged from purchasing organic ingredients
simply because their final products would not qualify for the official 95% seal. See S.
Rep. No. 357, reprinted in 1990 U.S.C.C.A.N. at 4956.
7 U.S.C. § 6505(c) exempts processed food from the general rule stated in 7 U.S.C.
§ 6505(a) that agricultural products may only be sold or labeled as organic if they are
produced and handled in accordance with the OFPA. It provides that the general rule
does not apply to agricultural products that contain at least 50% organically
produced ingredients to the extent that the word "organic" is used to describe the
organically produced ingredients on the product’s principal display panel; nor does it
apply to agricultural products that contain less than 50 percent organically produced
ingredients to the extent that the word "organic" is used to describe the organically
produced ingredients on the product’s ingredient listing panel. 7 U.S.C. § 6505(c).8
Sections 205.304 and 205.305 of the Rule implement this part of the Act and the
second and third tiers in the labeling hierarchy. 7 C.F.R. § 205.304 governs the
labeling of "[a]gricultural products in packages described in § 205.301(c)." 7 C.F.R.
§§ 205.301(a) and (b). Those products are "[m]ulti-ingredient agricultural product
[s] . . . [that] contain (by weight or fluid volume, excluding water and salt) at least
70 percent organically produced ingredients which are produced and handled
pursuant to requirements in subpart C of this part. No ingredients may be produced
using prohibited practices . . . " 7 C.F.R. § 205.301(c).
Section 205.304 provides that such products may be labeled as "made with organic"
ingredients or food groups provided that those ingredients or food groups are
organically produced. Such labels may also display the percentage of the organic
ingredients in the product, and the identifying mark of the certifying agent that
certified the handler of the finished product, among other information. See AR,
Document Number 8, "Memo from Kathleen Merrigan to Margaret Malanoski,
September 1, 2000, Re: Response to Comments - Subpart D - Labels, Labeling, and
Market Information," at pp. 6-7.
7 C.F.R. § 205.305 governs the third tier: "agricultural product[s] with less than 70
percent organically produced ingredients." They "may only identify [their] organic
content . . . by [i]dentifying each organically produced ingredient in the ingredient
statement with the word ‘organic’ . . . to indicate that the ingredient is organically
produced, and . . . [by] displaying the product’s percentage of organic contents on
the information panel." 7 C.F.R. § 205.305(a). This three-tiered labeling hierarchy is a
perfectly permissible construction of the Act.
E. Count 3: 7 C.F.R. § 205.606(b), which lists 36 synthetic substances allowed as
ingredients in or on processed organic products, is a permissible construction of the
National List of otherwise generally prohibited substances exempted for use in
products produced, handled, labeled and sold as organic.
7 U.S.C. § 6517 authorizes the National List. In subsection 6517(a), it provides that
"[t]he Secretary shall establish a National List of approved and prohibited substances
that shall be included in the standards for organic production and handling
established under this chapter in order for such products to be sold or labeled as
organically produced under this chapter." 7 U.S.C. § 6517(c)(1) provides that the
"National list may provide for the use of [prohibited] substances in an organic
farming or handling operation . . ." if they are ". . . necessary to production or
handling," and "consistent with organic farming and handling." 7 U.S.C. § 6517(c)(2)
provides guidance pursuant to which "the National List may prohibit the use of
specific natural substances in an organic farming or handling operation that are
otherwise allowed under this chapter . . ."
7 U.S.C. §§ 6517(c) describes the "guidelines" for exempting generally prohibited
substances and for prohibiting generally permissible substances. Harvey argues that 7
U.S.C. § 6517(c)(1)(B), which describes one of three guidelines for exempting
generally prohibited substances, contemplates only that synthetics be exempted for
use in production and nonsynthetics be exempted for use in handling. According to
Harvey, the subsection does so by stating criteria for exempting synthetics for use in
production and stating criteria for exempting nonsynthetics for use in handling or
processing but not stating any such criteria for exempting synthetics for use in
handling or processing.9 See Br. at 31 ("the National List provision of the statute
does not allow the listing of synthetics for use in processing") - 32 ("synthetic
materials may be included on the National List ‘only if’ used in production").
The flaw with this argument is that in subsections 7 U.S.C. § 6517(a), (c)(1) and (c)
(1)(A)(iii), the Act clearly contemplate making exceptions to permit the use of
prohibited substances (including synthetics) in handling as well as production. 7 U.S.
C. § 6517(a) provides that "[t]he Secretary shall establish a National List of approved
and prohibited substances that shall be included in the standards for organic
production and handling . . ." (Emphasis added). 7 U.S.C. § 6517(c)(1) provides that
the "National list may provide for the use of [prohibited] substances in an organic
farming or handling operation . . ." if they are ". . . necessary to production or
handling," and "consistent with organic farming and handling." (Emphasis added).
To the extent that there is uncertainty or inconsistency in the Act, the Secretary has
discretion to craft a reconciliation that reasonably interprets the Act’s broader
mandates, which she has done in 7 C.F.R. §§ 205.600- .607. The district court agreed
that the Act anticipated some exceptions to the general prohibition on synthetics and
gave the Secretary discretion to fashion them. See D. 43 at pp. 12-13; D. 57, 58. 7 C.
F.R. § 205.605(b) lists 36 synthetic substances which may be used as ingredients in
processed products labeled "organic" or "made with organic."10 It makes little sense
to categorically prohibit the use of these synthetics in handling and processing if, as
Mr. Harvey does not dispute, they may be excepted for use upstream in production.11
F. Count 5: 7 C.F.R. § 205.101(b)(1), which temporarily, administratively excludes
from the OFPA’s certification and inspection requirements, wholesalers and
distributors who do not process but just resell prepackaged organic products, is a
permissible construction of the Act which primarily governs producers and handlers
who process.12
Harvey argues that the OFPA applies to handlers, that Congress made a precise
determination of which handlers could be exempted from the OFPA’s provisions (final
retailers who do not process), and that the Secretary has exceeded her authority by
promulgating 7 C.F.R. § 205.101(b)(1) excluding wholesalers and distributors
without limitation. Br. at 36-40. The district court held that Congress did not directly
address the question of whether wholesalers and distributors should be regulated,
and that this omission implicitly delegated rulemaking authority to the Secretary who
made a reasonable policy decision to defer regulation pending the development of
greater consensus. See D. 43 at pp. 22-24; D. 57, 58.
7 C.F.R. § 205.101(b)(1) is an entirely reasonable construction of the Act. The Act
regulates producers, processors and handlers who are defined as persons who either
grow, produce or process organic food. It explicitly exempts retailers who do not
process, and it is at least ambiguous, if not silent, with respect to the issue of
wholesalers and distributors. Its interstices certainly permit the agency’s
interpretation to exclude wholesalers and distributors who only resell previously
packaged organic products.
The Act primarily regulates producers and handlers of organic agricultural products.
7 U.S.C. §§ 6501 et seq. passim. For example, 7 U.S.C. § 6503(a) provides that "[t]he
Secretary shall establish an organic certification program for producers and handlers
of agricultural products that have been produced using organic methods . . ." 7 U.S.C.
§ 6504 provides that "[t]o be sold or labeled as an organically produced agricultural
product . . ., an agricultural product shall . . . (3) be produced and handled in
compliance with an organic plan agreed to by the producer and handler of such
product and the certifying agent." 7 U.S.C. § 6506(a) provides that "to be sold or
labeled as organically produced," an agricultural product must "be produced only on
certified organic farms and handled only through certified organic handling
operations . . ."
The Act does not for the most part regulate retailers and retail food establishments.
7 U.S.C. § 6502(17) broadly defines "person" as "an individual, group of individuals,
corporation, association, organization, cooperative, or other entity." 7 U.S.C. § 6502
(18) defines producer as "a person who engages in the business of growing or
producing food or feed." 7 U.S.C. §§ 6502(9) and (10) define handlers and handling
operations to exclude "final retailers of agricultural products that do not process
agricultural products."
The Act defines "processing" as "cooking, baking, heating, drying, mixing, grinding,
churning, separating, extracting, cutting, fermenting, eviscerating, preserving,
dehydrating, freezing, or otherwise manufacturing, and includes the packaging,
canning, jarring, or otherwise enclosing food in a container." 7 U.S.C. § 6502(17). It
also creates an exemption allowing processed food to be labeled so as to describe its
organically produced ingredients. 7 U.S.C. § 6505(c).
This scheme is carried through in the Rule. 7 C.F.R. § 205.101(b) creates two
exclusions for:
(1) A handling operation or portion of a handling operation is excluded from the
requirements of this part, except for the requirements for the prevention of
commingling and contact with prohibited substances as set forth in §205.272 with
respect to any organically produced products, if such operation or portion of the
operation only sells organic agricultural products labeled as "100 percent organic,"
"organic," or "made with organic (specified ingredients or food group(s))" that:
(i) Are packaged or otherwise enclosed in a container prior to being received or
acquired by the operation; and
(ii) Remain in the same package or container and are not otherwise processed while
in the control of the handling operation.
(2) A handling operation that is a retail food establishment or portion of a retail food
establishment that processes, on the premises of the retail food establishment, raw
and ready-to-eat food from agricultural products that were previously labeled as
"100 percent organic," "organic," or "made with organic (specified ingredients or
food group(s)) is excluded from the requirements of this part, except:
(i) the requirement for the prevention of contact with prohibited substances as set
forth in §205.272; and
(ii) the labeling provisions of §205.310.
The Rule excludes only wholesale and retail operations that sell previously packaged
organic products and retail food establishments that sell processed food containing
organic ingredients. These entities are not wholly excluded. They are prohibited from
contaminating and commingling organic products, and they are not excluded from the
Act’s certification and inspection requirements. See 7 C.F.R. §§ 205.272, 205.310.
Even so, no person, including no wholesaler, distributor or retailer, can misrepresent
the organic content of products. Notwithstanding the exemptions of 7 U.S.C. § 6505
(c), which allow people to describe qualifying ingredients in processed food as
organic, "no person may affix a label to, or provide other market information
concerning, an agricultural product if such label of information implies, directly or
indirectly, that such product is produced and handled using organic methods, except
in accordance with [the Act]." 7 U.S.C. § 6505(a)(1)(B). "Any person who knowingly
sells or labels a product as organic, except in accordance with [the Act] shall be
subject to a civil penalty of not more than $10,000." 7 U.S.C. § 6519(a).
The Secretary received many comments with respect to wholesale and retail
operations that sell previously packaged organic products and retail food
establishments that sell processed food containing organic ingredients. See 65 Fed.
Reg. 80555. Some commenters suggested that the Secretary require certification of
all such establishments. Id. Others suggested that they be entirely exempted. Id.
There was no consensus as to whether retail establishments should be regulated or
what the standard for their certification should be. Id. There was concern about the
capacity of certifying agents to certify the enormous number of such establishments.
Id. As a result, the Secretary reasonably deferred regulation of this sector of the
organic community until she can discern greater agreement about how it should be
regulated. Id.13 In the meantime, states are free to develop programs to regulate
organic food retail establishments as components of their State Organic Programs so
long as the Secretary reviews and approves them. Id.
G. Count 6: 7 C.F.R. 205.501(a)(11)(iv), which prohibits certifying agents from
giving advice to regulated parties on how to overcome identified barriers to
certification, is a constitutional regulation of speech and a permissible construction of
7 U.S.C.§ 6515(h) which prohibits certifying agents from engaging in activities
involving conflicts of interest.
1.7 C.F.R. § 205.501(a)(11) is a permissible construction of 7 U.S.C. § 6515(h)
Harvey argues that the Act explicitly enumerates the activities that it prohibits
because they constitute conflicts of interest, that all of those activities involve the
receipt of some sort of compensation, and that 7 C.F.R. § 205.501 exceeds the Act’s
authority by prohibiting certifying agents from providing producers with free advice
on how to overcome barriers to certification. Br. at pp. 40-44. The district court ruled
that the OFPA has a conflict of interest provision, and while that provision does not
mandate a restriction on free advice, such a restriction is in harmony with the Act. See
D. 43 at p. 26; D. 57, 58.
7 C.F.R. § 205.501 is an elaboration of the provisions of 7 U.S.C. § 6515 which
states the requirements of certifying agents. Subsection 6515(h) governs conflicts of
interest. It provides that:
Any certifying agent shall not –
(1) carry out any inspections of any operation in which such certifying agent, or
employees of 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;
(3) provide advice concerning organic practices or techniques for a fee, other than
fees established under such program.
7 U.S.C. § 6515(h). Harvey argues that the focus of the section is the receipt of
"compensation" or "financial benefit" such that [t]he statute may not be interpreted
to prohibit activities which do not involve financial benefit." Br. at p. 44. However,
subsection 6515(h)(1) expresses a concern for operations in which the certifying
agent "has had" a commercial interest in the past, and subsection 6515(h)(2)
includes a concern about certifying agents accepting "favors of any kind." They
indicate a concern for certifying agents’ integrity that extends beyond conflicts of
interest involving a financial benefit to the agent. Read as a whole, the plain language
of section 6515(h) expresses a concern for the integrity of organic agents generally,
and a concern that they avoid conflicts of interest and bribery in particular.
7 C.F.R. § 205.501 enumerates 21 general requirements for accreditation as a
certifying agent. Subsection 205.501(11) specifies the measures that such accredited
certifying agents must take in order to avoid conflicts of interest. One of those
measures is that certifiers "not [give] advice or [provide] consultancy services, to
certification applicants or certified operations, for overcoming barriers to
certification." 7 C.F.R. § 205.501(a)(11)(iv). It is a permissible construction of 7 U.S.
C. § 6515(h). As the Secretary noted, "[i]t would be a conflict of interest for a
certifying agent to tell an operation how to comply inasmuch as the certifying agent’s
impartiality and objectivity will be lost should the advice or consultancy prove
ineffective in resolving the noncompliance." 65 Fed. Reg. 80601.
For example, in the Appendix at page 72, Mr. Harvey explains that he would like to
be able to recommend appropriate buffers to the blueberry growers whom he
inspects and whom his employer certifies. He has special interest and expertise which
he would like to share "free of any additional charge beyond [his] usual inspection
fee," thus saving growers "hundreds of dollars for expert consultation." Id. However,
doing so puts Mr. Harvey in an awkward position, to say the least, if his freely-offered
opinion proves to be erroneous. When called upon to subsequently inspect the same
grower, he could experience a conflict between the free advice that he gave and his
obligation to report on the growing operation’s compliance with the NOP.
The Act expresses concern for certifying agents’ integrity and conflicts of interest. It
provides some guidance with respect to that concern. It explicitly gives the USDA
rulemaking authority. The USDA has exercised that authority by conducting notice
and comment rulemaking. It has extrapolated from Congress’ lead an additional,
entirely reasonable, constraint on certifying agents’ behavior. That constraint should
be upheld.
2. 7 C.F.R. § 205.501(a)(11) is constitutional
However analyzed, whether as a condition to the receipt of the government benefit
of certification or as a restriction that the government has imposed on one of its
employees, 7 C.F.R. § 205.501(a)(11) is constitutional. The district court had doubts
about which analytical framework applied. It found that Mr. Harvey’s argument was
"skeletal," and held that given the state of the record, the regulation did not appear
to be unreasonable or unconstitutional. See D. 43 at p. 28; D. 57, 58.
Certifying agents are private individuals and organizations who are accredited by,
and work for, the USDA . See 7 C.F.R. § 205.2. Among other things, they certify that
production and handling operations comply with the Act and regulations. See id. They
are paid by the operations that they certify. 7 C.F.R. § 205.642. The potential for
conflict of interest is inherent in this arrangement.
7 C.F.R. § 205.501(a)(11) prohibits a certifying agent who has sought the
government benefit of accreditation from coaching a regulated operation on how to
overcome barriers to certification. The Secretary did so in order to maintain certifiers’
integrity and objectivity by prohibiting them from laboring under conflicts of interest.
See 65 Fed. Reg. 80601, 80606-7. If Appellant wants the benefit of being an
inspector for an accredited certifying agent, then he must abide by this condition. His
freedom of _expression may be limited to some extent while he acts as an inspector;
but that limitation is a consequence of his decision to participate in the organic
program as an inspector. See Rust v. Sullivan, 500 U.S. 173, 196-200 (1991)
(government may insist that public funds be spent as authorized).
The situation here is different from that in Legal Services Corporation v. Velazquez,
et al., 531 U.S. 533 (2001) (cited in Br. at 47). The National Organic Program was not
designed to facilitate private speech, and certifying agents who inspect and certify
organic operations are not engaging in private speech. The program is a regulation of
commercial speech in the interest of facilitating commerce in organic products with a
consistent standard of what "organic" means. Certifiers and inspectors are agents
whom the government is using to administer a government program, in part by
explicitly and implicitly conveying information about the program. Their speech is
government speech and the government has the latitude to ensure that its program is
being furthered and its message is being delivered. In doing so, one branch of
government is not distorting some well-established system of a co-equal branch like
the legal system.14 Rather, with this regulation, the Secretary of Agriculture is trying
to ensure the integrity and proper functioning of a new federal program whose
essence is the regulation of commercial speech.15
Assuming that certifying agents and their employees are government employees, the
balancing test announced in Pickering v. Board of Ed., 391 U.S. 563, 568 (1968),
applies to the Secretary’s regulation of their speech. See Brasslett v. Cota, 609 F.
Supp. 948, 962 n. 14 (D. Me. 1984) (Pickering test is adaptable to varying
circumstances). A court should consider the interests of the speaker, audience and
government employer; the content, form and context of the speech, its nexus to the
speaker-
employee’s official duties, and whether it is a matter of public or private interest; and
the burden on _expression that the regulation places. See United States v. National
Treasury Employees Union, 513 U.S. 454, 465-77, 115 S.Ct. 1003 (1995); Connick v.
Meyers 461 U.S. 138, 146-7 (1983). It should sustain the regulation if the
government’s interest outweighs that of the employee. See Martin v. Inhabitants of
Brewer, 2003 WL 1712510, *8 (suggesting that ultimate question in balancing test is
whether free speech interest is outweighed by government interest), adopted by 261
F. Supp. 2d 34 (D. Me. 2003); Parks v. City of Brewer, 56 F. Supp. 2d 89, 95 (D. Me.
1999)(explaining operation of the Pickering standard within the context of an
employment discrimination claim).
Here, Mr. Harvey is an inspector within the organic program, a program that is
essentially a regulation of organic producers and handlers’ commercial speech. He has
the power to confer favors upon those he inspects. He wants to be able to coach the
people he is charged with inspecting. See Connick, 461 U.S. at 147-50 (nature of
speech is a threshold inquiry that must be determined by its content, form and
context).
Such speech is directly related to the operation of the organic program and to
Harvey’s function as an inspector for a certifying agent that works for the USDA. It is
speech that the government as Harvey’s ultimate employer has a strong interest in.
Inspectors are the primary points of contact between the program and organic
handlers and producers. It is not speech about the performance of the agency or
about a matter of general concern to the community. See Levinsky’s, Inc. v. Wal-Mart
Stores, Inc., 999 F. Supp. 137, 139 (D. Me. 1998).
The Secretary regulates this type of speech in order to maintain the integrity of the
inspection program which would be undercut by inspectors coaching the people they
inspect. Even so, the regulations permit accredited certifying agents other
opportunities to speak with the regulated community and to achieve greater program
compliance through educational workshops and training sessions, conferences,
meetings, field days, and other group events which do not raise the specter of unfair
dealing. See 65 Fed. Reg. 80601. Harvey’s certifying agent could employ him to give
such speeches. The regulation does not restrict "free and unhindered debate on
matters of public importance," see Pickering 391 U.S. at 573, or the "interchange of
ideas for the bringing about of political and social changes desired by the people," see
Connick, 461 U.S. at 145. Unlike the situation in Pickering, Harvey is in no way
restricted from, much less has he been fired for, commenting upon or criticizing the
Act, Rule or organic program, as his activism and prolific commentary demonstrate.
7 C.F.R. § 205.501(a)(11) should withstand Harvey’s constitutional claim. Both
parties are interested in the same ultimate goal: the effective operation of the organic
program. Harvey wants to coach those that he is responsible for inspecting and
certifying. The Secretary employs the certifying agent that employs Harvey to inspect
organic operations. She is concerned that such speech threatens the integrity of the
program. The Act expresses concern for this type of conflict of interest, and the
Secretary has promulgated a particularized regulation to address it. In doing so, the
regulation leaves Harvey with other opportunities to advise in good faith organic
producers and handlers in other settings, as well as with the opportunity to criticize
the program generally.
H. Count 7: 7 C.F.R. § 205.236(a)(i), which creates a one-time exception to the rule
that organic dairy herds be fed an organic diet for 12 months, in order to facilitate
conversion of whole conventional dairy herds to organic production, is a permissible
construction of the OFPA, which does not specifically address the issues of what
organic dairy livestock should be fed or how conventional herds should be converted
to organic production.
7 U.S.C. § 6509 governs animal production practices and materials. Subsection 6509
(c) governs the production of livestock. It provides that "[f]or a farm to be certified
under this chapter as an organic farm with respect to the livestock produced by such
farm, producers on such farm – (1) shall feed such livestock organically-produced
feed that meets the requirements of this chapter . . ." 7 U.S.C. § 6509(c). 7 U.S.C. §
6509(e)(2) applies to dairy livestock. It 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 chapter for not less than the 12-month period
immediately prior to the sale of such milk and milk products."16
Congress recognized that this area of the law would require additional
administrative attention. In addition to the general grant of rulemaking authority
contained in 7 U.S.C. § 6521, 7 U.S.C. § 6509 provides the Secretary with additional
rulemaking authority. It provides that "[t]he Secretary shall hold public hearings and
shall develop detailed regulations, with notice and public comment, to guide the
implementation of the standards for livestock products provided under this section."
The Secretary exercised that authority.
7 C.F.R. §205.236(a) provides that:
(a) Livestock products that are to be sold, labeled, or represented as organic must be
from livestock under continuous organic management from the last third of gestation
or hatching: Except, That:
***
(2) Dairy animals. Milk or milk products must be from animals that have been under
continuous organic management beginning no later than 1 year prior to the
production of the milk or milk products that are to be sold, labeled, or represented as
organic: Except, That, when an entire, distinct herd is converted to organic
production, the producer may:
(i) for the first nine 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.
(iii) Once an entire, distinct herd has been converted to organic production, all dairy
animals shall be under organic management from the last third of gestation.
This subsection makes a one-time exception for conversion of a whole dairy herd
from conventional to organic production.
The Act requires that dairy livestock be handled organically (fed organically
produced feed, etc.) for the 12 months prior to their milk being sold as organic.
However, it does not precisely address the question of what constitutes organic feed,
nor does it precisely address the question of dairy herd conversion, which is a
relatively rare occurrence. While "organically produced" is defined in 7 U.S.C. § 6502
(14) as "produced and handled in accordance with [the Act]," it is not further
defined. Read together, these provisions are at least ambiguous, if not silent, with
respect to what exactly it is that organic dairy animals should be fed in general and
what non-organic dairy animals should be fed during the 12 months before their
products are sold as organic in particular. In order to address this ambiguity, the
Secretary engaged in notice and comment rulemaking. See AR, Document Number 6,
September 15, 2000 Memo from Kathleen Merrigan to Margaret Malanowski, at p. 2
(where the Administrator of the USDA’s Agricultural Marketing Service was
transmitting to the Office of Budget and Management, commentary on 7 C.F.R. §
205.237(a), the section of the proposed rule addressing feed for organic livestock,
indicating that the general issue of what to feed organic livestock was considered at
the highest levels of the rulemaking process).
In 7 C.F.R. § 205.237(a), the USDA reasonably interpreted these sections of the Act
to mean that organic livestock be fed "a total feed ration composed of agricultural
products . . . that are organically produced and if applicable, organically handled . . ."
It went on to create an exception to this rule for whole herd conversion in 7 C.F.R. §
205.235(a)(2), which creates a one-time exception to the general rule that
organically raised dairy animals be fed a total ration of organically produced feed.
During conversion, the dairy livestock may be fed 80% organic feed for the first 9 of
the 12 months before their milk is sold as organic, and fully-compliant organic feed
for the last 3 months. The milk cannot be labeled organic during the conversion
period; only after the herd has been converted may its milk be sold as organic. See
AR, Document Number 16, "Comment from NOSB to NOP," at p. 6; Document Number
6, "Memo from Kathleen Merrigan to Margaret Malanoski, September 15, 2000, Re:
Response to Comments - Subpart C - Livestock Production Requirements," at pp. 1-2
Reasonable people may disagree about what exactly organic dairy cows should be
fed. The Secretary could have required some other standard organic and conversion
diet. She could have provided for some other conversion period. However, by
omitting to directly address these matters itself, Congress implicitly delegated to the
Secretary the discretion to make these policy choices using the Department’s
expertise. The provisions that the Secretary promulgated are not contrary to the Act
and Harvey has not demonstrated that they are arbitrary or capricious. Therefore,
they must stand.17
I. Count 8: 7 C.F.R. § 205.501(b)(2), which prohibits private certifying agents from
certifying as organic products should production and handling practices differ from
those provided for by the Act, is a permissible construction of the Act which calls for a
consistent national standard of organic.
7 C.F.R. § 205.501 governs the general requirements for accreditation of certifying
agents. Subsection 205.501(b) provides that:
A private or governmental entity accredited as a certifying agent under this subpart
may establish a seal, logo, or other identifying mark to be used by production and
handling operations certified by the certifying agent to indicate affiliation with the
certifying agent: Provided, That, the certifying agent:
* * *
(2) Does not require compliance with any production or handling practices other than
those provided for in the Act and the regulations in this part as a condition of use of
its 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 by such operations.
7 C.F.R. § 205.501(b).
Harvey argues that the section effectively defines organic as a "uniform" standard or
one that imposes a ceiling on the purity of products that may be certified, labeled and
sold as organic. He argues that such a standard is arbitrary and contrary to Congress’
intent that the Act create a minimum standard of organic, leaving producers,
handlers, and certifying agents free to produce label, certify and market super-
organic products. Br. at p. 57. The district court ruled that 7 C.F.R. § 205.501(b) is
"consonant with [the Secretary’s] powers and reasoned, given the concern for
consistent standards that motivate the OFPA’s enactment." D. 43 at p. 37; D. 57, 58.
In fact, the Act speaks of creating a "consistent standard" of what it means to be
organic. Webster’s Ninth New Collegiate Dictionary (Merriam-Webster 1990) defines
"consistent" as, among other things, " . . . marked by harmony, regularity, or steady
continuity; compatible; showing steady conformity to character; free from variation
or contradiction . . ." Congress intended a consistent standard in order to remedy the
problem of the multitude of inconsistent standards that were causing confusion and
obstructing commerce. Congress’ intent was not limited to protecting consumers from
substandard organic products as Harvey argues in his Brief at p. 54.
Even so, the current scheme contemplates a continuing role for private and state
certifiers. It allows producers to produce and certify food to more restrictive
standards. They can distinguish their products. They just cannot label or market them
as superior to the organic products that are certified under the National Organic
Program. 7 U.S.C. § 6507((b)(1) provides that "[a] State organic certification
program . . . may contain more restrictive requirements governing organic
certification . . . than are contained in the program established by the Secretary." See
S. Rep. No. 357, reprinted in 1990 U.S.C.C.A.N. at pp. 4946-47. The Rule allows
certifiers to certify to additional standards; it just prohibits them from making
additional standards a requirement of certification (unless a State program approved
by the Secretary has set those standards), or a requirement for the use of the USDA
organic seal or mark of approval. See 7 C.F.R. § 205.501(b)(2).
The Secretary explained as much. See 65 Fed. Reg. at pp. 80607-8. She
acknowledged that numerous commenters wanted the USDA to permit private
certifying agents to impose higher standards so as to refine the industry standards
over time. Id. The Secretary believed that position was inconsistent with the Act’s
purpose of assuring consumers a consistent national standard. Id. She stated that "it
is vital that an accredited certifying agent accept the certification decisions made by
another certifying agent accredited or accepted by USDA . . . " Id. at p. 80607. She
went on to explain that "[a]ccredited certifying agents may establish other standards
outside of the NOP. They may not, however, refer to them as organic standards nor
require . . . [compliance] with such standards as a requirement for certification under
the NOP." Id. at p. 80608.
So, for example, Mr. Harvey may further distinguish his blueberries as produced
without the use of herbicides, or without the use of hexazinone or Velpar. He may
make other claims about the manner in which his products are produced so long as
he does not claim that his products are more "organic" than the classes of organic
products that the regulatory regime recognizes. His certifying agent may certify those
claims with its seal. He is free to distinguish his products and to compete in the
marketplace according to the rules, including the OFPA and its regulations.18
CONCLUSION
This Court should deny Mr. Harvey’s claims, uphold the Rule, and affirm the
judgment entered by the district court.
Dated at Portland, Maine, July 6, 2004.
Paula D. Silsby
United States Attorney
Halsey B. Frank
Assistant United States Attorney
United States Court of Appeals
FOR THE FIRST CIRCUIT
CERTIFICATE OF COMPLIANCE WITH
TYPEFACE AND LENGTH LIMITATIONS
No. 04-1379
ARTHUR HARVEY
v.
ANN VENEMAN, Secretary of the United States Department of Agriculture
TO BE INCLUDED IMMEDIATELY BEFORE THE
CERTIFICATE OF SERVICE FOR ALL BRIEFS FILED IN THIS COURT
1. This brief has been prepared using (SELECT AND COMPLETE ONLY ONE):
14 point, proportionally spaced, serif typeface (such as CG Times or Times New
Roman). Specify software name and version, typeface name, and point size below
(for example, Wordperfect 8, CG Times, 14 point):
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New). Specify software name and version, typeface name, and characters per inch
below (for example, Wordperfect 8, Courier, 10 1/2 CPI):
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2. EXCLUSIVE of the corporate disclosure statement; table of contents; table of
citations; addendum; and the certificate of service, the brief contains (SELECT AND
COMPLETE ONLY ONE):
❑ ___________ Pages (give specific number of pages; may not exceed 30 pages for
opening or answering brief or 15 pages for reply brief); OR
☒ 13,998 Words (give specific number of words; may not exceed 14,000 words for
opening or answering brief or 7,000 for reply brief); OR
❑ ____________ Lines of Mono spaced Type (give specific number of lines; may not
exceed 1,300 lines for opening or answering brief or 650 for reply brief; may be used
ONLY for briefs prepared in monospaced type such as Courier or Courier New).
❑
I understand that a material misrepresentation can result in the Court striking the
brief or imposing sanctions. If the Court so directs, I will provide a copy of the word
or line print-out.
________________________________
Signature of Fi1ing Party
CERTIFICATE OF SERVICE
I hereby certify that on July 7, 2004, I served two copies of the Brief of Appellee
Ann Veneman, Secretary of the United States Department of Agriculture, on the
following parties of record by first class mail, postage prepaid:
Arthur Harvey
RFD
Canton, ME 04221
Martica S. Douglas, Esq.
DOUGLAS, DENHAM, BUCCINA & ERNST
103 Exchange Street
Portland, ME 04112-7108
James Handley, Esq.
Handley Environmental Law
1707 Bay Street, S.E.
Washington, DC 20003
Melody A. Richardson
Paralegal Specialist
1The designation "D." and a number refers to the pleading entered on the District
Court’s Docket at that number.
2These excerpts appear in the district court’s docket between entries numbers 31
and 32. They do not have their own docket number and will be referred to using the
designation "AR."
3Even so, an appellant cannot raise new issues for the first time on appeal, see In re
604 Columbus Ave Realty Trust, 968 F.2d 1332, 1343 (1st Cir. 1992); G.D. v.
Westmoreland School Dist., 930 F.3d 942, 950 (1st Cir. 1991), which, as prospective
intervener, Amici pledged not to do, D. 61 at p. 1; D. 63 at p. 1; D. 64 at p. 1.
4In their brief at p. 22, Amici Rural Advancement Foundation International (RAFI)
et al. were fairly candid about the necessity for rulemaking with respect to the OFPA:
"The OFPA left many gaps and policy decisions to be filled by the Secretary, following
consideration of the recommendations of the NOSB and comments from the public via
rule-making."
5In their Brief at pp. 24-28, Amici RAFI et al. ask this Court to issue a declaratory
judgment in accordance with the Secretary’s reading of 7 C.F.R. § 205.606 because
they do not trust the Secretary. If the Court agrees with the Secretary, it should
grant judgment in her favor.
6However, the Secretary concedes that the guidance that Harvey quotes on page 24
of his Brief, which appeared at 65 Fed. Reg. 80616, is misleading. Non-organic
soybean oil cannot be used as a defoaming agent-processing aid pursuant to 7 C.F.R
§. 205.606, even if it were commercially unavailable, unless it had been specifically
listed in section 205.606 which it has not.
7In their brief at p. 16, Amici OCA et al. make the new and unsubstantiated
argument that 7 C.F.R. § 205.606 "stunts" markets for organic ingredients. It does
not. It offers producers a way to maintain production when confronted with the
commercial unavailability of organic ingredients.
87 U.S.C. § 6510 does not, as Harvey argues in his Brief at p. 29, require that
processed products be 95% organic in order to be labeled organic. It governs the
certification of handling operations. The Act defines "handling operations" as
operations that receive or acquire agricultural products and processes, package or
store such products. 7 U.S.C. § 6502(10). In order to be certified as an organic
handling operation, handling operations must, among other things, not
add any ingredients that are not organically produced in accordance with this chapter
and the applicable organic certification program, unless such ingredients are included
on the National List and represent not more than 5 percent of the weight of the total
finished product (excluding salt and water) . . .
7 U.S.C. § 6510(a)(4). 7 U.S.C. § 6510(a)(4) has no bearing on whether and how
multi-ingredient agricultural products can be labeled as "organic" or "made with
organic," which is governed by 7 U.S.C. § 6505(C) and 7 C.F.R. § 205.304.
9 The Act defines "handle" to mean "sell, process or package agricultural products."
7 U.S.C. § 6502(9). It defines "processing" to include "manufacturing, . . . including
packaging, canning, jarring, or otherwise enclosing food in a container." 7 U.S.C. §
6502(17).
10In their brief at p. 8-12, Amici RAFI et al. apparently diverge from Mr. Harvey in
this respect. They argue that Congress reserved to itself the decision about which
categories of substances may be exempted from the general prohibition on
synthetics, and that the OFPA provides for no exception in handling beyond what is
necessary to comply with food safety laws in order to "force" handlers to search for
new natural substances or processes. They present no evidence that this was one of
Congress’ purposes in passing the OFPA.
11In his Brief at page 34, Harvey reiterates an argument he first made in his
Response to the Secretary’s Cross Motion for Summary Judgment below, D. 35 at 7-
9. That argument is that through the Food and Drug Administration (FDA), the USDA
is allowing 315 synthetic substances to be used in processed organic products
without being on the National List. While Mr. Harvey is not concerned about those
substances "used as components of food processing machinery or as surface
cleaners," he is concerned that "some [of the 315 substances] are in fact synthetic
ingredients added to processed foods in contravention of" the Act’s prohibitions on
the use of synthetics in organic products. Br. at p. 34.
This argument should be rejected out of hand because Mr. Harvey did not plead it in
his Complaint, did not make it in his motion for summary judgment, but only first
made it in his opposition to the Secretary’s cross motion for summary judgment. It
should be rejected because it is a claim about the way that the Act and Rule operate
that Mr. Harvey is trying to make in the context of a challenge to the way that the
Rule was written. These 315 substances were not before the Secretary during the
rulemaking and they do not appear in the Final Rule. They appear in a May 2003,
"Inventory of Effective Premarket Notifications for Food Contact Substances"
published by the FDA. See Appendix at p. 83. The inventory postdates the Final Rule’s
effectiveness. Mr. Harvey attached a printout of the Inventory as Appendix 4 to his
Response to the Secretary’s Cross Motion, D. 35.
The argument should be rejected because its subject is not a reviewable, final
agency action. The Inventory is referred to in a document that was posted on the
National Organic Program’s website for discussion. See id. It is part of an ongoing
deliberation about how the Act and Rule operate.
Finally, the argument should be rejected on its merits. 7 U.S.C. § 6519(f) makes
abundantly clear that the OFPA does not "alter" or preempt the authority of the
"Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic
Act (21 U.S.C. 301 et seq.)." That authority is wide-ranging and encompasses more
than food safety. As is evident from Mr. Harvey’s argument, it includes the regulation
of food additives. The OFPA explicitly disclaims any ability to alter that FDA authority.
12Mr. Harvey did not appeal the district court’s decision with respect to counts 4
and 9 of his Complaint which explains the gap in counts addressed in this brief.
13The Secretary has not ignored retailers. She has provided them with voluntary
guidance while she considers whether to take more formal action. See "How Retail
Establishments Can Comply with National Organic Program Regulations," at http:
//www.ams.usda.gov/nop/ProdHandlers/RetailFoodEstablishments.html., copy
attached at Exhibit 1 to D. 52. There, the Secretary provides guidance to both
retailers that do not process and those that do. For those that do not process and are
therefore exempted from regulation, the Secretary nevertheless has described how
they can comply with National Organic Program Regulations by preventing
commingling with nonorganic products, preventing contact with prohibited
substances, labeling properly, and keeping records. Id. at pp. 1-4. For those that do
process, the Secretary has provided a description of best practices for receiving,
storage, pest control, preparation and display of processed organic foods. Id. at pp.
4-9. Harvey withdrew his challenge to subsection 205.101(b)(2). Br. at p. 37.
14Harvey’s situation is not comparable to Stanford University’s in Stanford
University v. Sullivan, 773 F. Supp. 472 (D.D.C. 1991) cited in Br. at p. 47. The
regulation of the commercial use of the term "organic" is not the conduct of
significant scientific and medical research. A certifying agent within the National
Organic Program is not a scientist at a premier academic institution. Science and
universities are "traditional sphere[s] of free _expression . . . fundamental to the
functioning of our society . . . .’" Sullivan, 773 F.Supp. at 477 (quoting Rust, 111 S.
Ct. at 1776). 7 C.F.R. § 205.501 (a)(11) is not a broad and vague restraint that
threatens a chilling effect on speech. Mr. Harvey’s ability to coach the program
participants in overcoming barriers to certification is not like a scientist’s ability to
speak about his research.
15Harvey’s situation is even less like Sindermann’s in Perry v. Sindermann, 408 U.S.
593 (1972), cited in Br. at p. 47. Even if the government benefit of his status as an
inspector for a certifying agent were a property right tantamount to the de facto
tenure system that was entitled to procedural due process in Perry, Harvey has not
been retaliated against for expressing criticism of the organic program. To the
contrary, the Department of Agriculture has patiently entertained Mr. Harvey’s
extensive criticisms.
16Contrary to this clear statutory language, in their brief at pp.16-17, 18-19, Amici
RAFI et al. argue that the OFPA requires that organic dairy livestock be managed
organically from before birth (from the last third of gestation), including that they be
fed fully compliant feed from that point on. They argue that 7 U.S.C. 6509(e)(2) is
the Congressionally legislated exception for herd conversion, and that it just reduces
the timeframe during which organic management is required but not the content of
that management regime. Id. In their brief at pp. 26-28, Amici OCA et al. argue
something similar: that Congress has spoken clearly to the issue of herd conversion
and the Secretary has gone further than Congress intended. The plain language of
the OFPA does not support either argument. 7 U.S.C. § 6509(e)(2) does not provide
for herd conversion. It provides additional guidance with respect to dairy livestock
that is a modification of the general guidance section 6509 provides with respect to
animal production practices.
17The district court ruled that Mr. Harvey lacked standing to raise this claim because
he failed to demonstrate that he suffered any concrete, personal injury caused by the
regulatory violation about which he complained. There was no allegation that he was
a milk drinker or that he inspected dairy operations. D. 43 at p. 33; D. 57, 58.
18In his Brief at pp. 57-58, Harvey argues that the section is unconstitutional
because it restricts commercial speech without the justification of a substantial
governmental interest. He complains that the Secretary offered no justification for the
restriction below. Br. at p. 57. That is because Mr. Harvey did not make this argument
below. The argument should be rejected for this reason alone. However, the section’s
restriction on commercial speech, like the Act as a whole, is justified by the
substantial governmental interest in having a consistent national standard of organic
to eliminate confusion in the marketplace and facilitate commerce. See Central Hudson
Gas & Elec. Corp. v. Public Serv. Comm’n, 447 U.S. 557, 564, 561-6 (1980) (setting
forth test for commercial speech), cited in, Consolidated Cigar Corp. v. Reilly, 218 F.
3d 30, 43 (1st Cir. 2000) ,aff’d in relevant part, 69 USLW 4582.
USDA brief
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