February 2007 Harvey Brief
No. 06-2738
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
ARTHUR HARVEY,
Plaintiff - Appellant
v.
MIKE JOHANNS,
SECRETARY OF AGRICULTURE,
Defendant - Appellee
Appeal from the U.S. District Court
for the District of Maine
BRIEF OF PLAINTIFF-APPELLANT, ARTHUR HARVEY
Paula Dinerstein
First Circuit Bar No. 97079
Public Employees for Environmental Responsibility
2000 P St., N.W., Suite 240
Washington, DC 20036
(202) 265-7337
Attorney for Plaintiff-Appellant, Arthur Harvey
February 20, 2007
TABLE OF CONTENTS
TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . i
TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . iii
STATEMENT IN SUPPORT OF ORAL ARGUMENT . . . . . . . . . . . . . . . . . . viii
JURISDICTIONAL STATEMENT
1
STATEMENT OF THE ISSUES
2
STATEMENT OF THE CASE
3
STATEMENT OF FACTS
4
SUMMARY OF ARGUMENT
14
ARGUMENT
17
STANDARD OF REVIEW
17
DISCUSSION OF THE ISSUES
19
I. THIS COURT’S DECISION AND MANDATE AND THE CONSENT JUDGMENT MUST BE
ENFORCED WITH
REGARD TO SYNTHETIC PROCESSING AIDS
19
A. The Amendment to § 6510 At Most Permits the Use of Synthetic Ingredients on the
National List in the Handling of Organic Products
24
B. The Amendment to Section 6517 Does Not Provide an Authorization for the Use of
Synthetic Processing Aids in Handling
32
II. USDA’S FOOD CONTACT SUBSTANCES POLICY IS IN DIRECT CONFLICT WITH THIS
COURT’S
MANDATE, THE CONSENT JUDGMENT AND OFPA, AS AMENDED.
40
CONCLUSION
48
CERTIFICATE OF COMPLIANCE
CERTIFICATE OF SERVICE
ADDENDUM
1. Memorandum Decision on Motion to Enforce Judgment and
Cross Motion for Relief from Judgment, November 2, 2006
2. Amendment to Judgment, November 21, 2006
3. Consent Final Judgment and Order, June 9, 2005
4. Proposed Rules, 71 Fed. Reg. 24820 (April 27, 2006)
5. Final Rules, 71 Fed. Reg. 32803 (June 7, 2006)
6. Public Law 109-97, 119 Stat. 2153, 2165
7. Synthetic Substances Subject to Review and Recommendation by the
National Organic Standards Board When Such Substances Are Used as
Ingredients in Processed Food Products
TABLE OF AUTHORITIES
CASES
Atlantic Cleaners & Dyers, Inc. v. United States, 286 U.S. 427 (1932) . . . . . . . 27
Arnold v. United Parcel Service, Inc., 136 F.3d 854 (1st Cir. 1998) . . . . . . . . . .
18
Brown v. Gardner, 513 U.S. 115 (1994) . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . 27
Cable & Telecommunications Ass’n v. Brand X Internet Services,
545 U.S. 967, 981 (2005) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 32
Chevron, U.S.A. v. Natural Res. Defense Council, 467 U.S. 837 (1984) . . . . 17-19
Christensen v. Harris County, 529 U.S. 576 (2000) . . . . . . . . . . . . . . . . . . .
.
. . . 19
Duckworth v. Pratt & Whitney, Inc., 152 F.3d 1 (1st Cir. 1998) . . . . . . . . . . . .
.
17
Good Samaritan Hospital v. Shalala, 508 U.S. 402 (1993) . . . . . . . . . . . . . . . .
.
31
Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005) . . . . . . . . . . . . . . . . . . . .
.
. passim
Harvey v. Veneman, 297 F. Supp. 2d 334 (D. Me. 2004) . . . . . . . . . . . . . . . . .
.
. 3
Harvey v. Veneman, No. 02-cv-216-P-H, 2003 U.S. Dist. LEXIS 18162
(D. Me. Oct. 10, 2003) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . 3
In re Young, 66 F.3d 376 (1st Cir. 1995) . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . 17
Lorillard v. Pons, 434 US 575 (1978) . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . 29
Ortega v. Star-Kist Foods, Inc., 370 F.3d 124, 135 (1st Cir. 2004);
rev’d on other grounds sub nom, Exxon Mobil Corp. v.
Allapattah Services, Inc., 545 U.S. 546 (2005) . . . . . . . . . . . . . . . . . . . .
.
. . . . . . 19
Penobscot Air Services, Ltd. v. F.A.A., 164 F.3d 713 (1st Cir. 1999) . . . . . . . . .
.
18
Riley v. Kurtz, 361 F.3d 906 (6th Cir. 2004) . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . 19
Summit Investment and Development Corp. v. Leroux, 69 F.3d 608
(1st Cir. 1995) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . 17
Ticoalu v. Gonzales, 472 F.3d 8 (1st Cir. 2006) . . . . . . . . . . . . . . . . . . . .
.
. . . . . . 18
United States v. Mead Corp., 533 U.S. 218 (2001) . . . . . . . . . . . . . . . . . . .
.
19, 31
United States v. Ramirez-Ferrer, 82 F.3d 1131 (1st Cir. 1996) . . . . . . . . . . . . .
.
29
United States v. Roberson, 459 F.3d 39 (1st Cir. 2006) . . . . . . . . . . . . . . . .
.
. . . . 19
Visiting Nurse Ass’n v. Thompson, 447 F.3d 68 ( 1st Cir. 2006) . . . . . . . . . . . .
.
. 19
STATUTORY PROVISIONS
Federal Food, Drug and Cosmetic Act ("FFDCA"), 7 U.S.C. § 301, et. seq. . . . 29
Organic Foods Production Act of 1990, 7 U.S.C. §§6501-6523 . . . . . . . . . . . . . .
3
7 U.S.C. § 6501 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . 5
7 U.S.C. § 6501(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . 25
7 U.S.C. § 6502(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . 5
7 U.S.C. § 6502 (16) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . 27
7 U.S.C. § 6502(18) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 5
7 U.S.C. § 6502(21) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . 27
7 U.S.C. § 6504 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . 5, 8, 25, 29
7 U.S.C. § 6504(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . passim
7 U.S.C. § 6504(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 28
7 U.S.C. § 6505(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 7
7 U.S.C. § 6505(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 7
7 U.S.C. § 6505 ( c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 7
7 U.S.C. §6508 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . 28
7 U.S.C. § 6510 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . passim
7 U.S.C. § 6510(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . 8, 10, 26
7 U.S.C. § 6510(a)(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . passim
7 U.S.C. § 6510(a)(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . 45
7 U.S.C. § 6510(a)(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . 26, 27
7 U.S.C. §§ 6510(a)(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . 7, 9, 45
7 U.S.C. § 6510 (a)(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . 7, 9
7 U.S.C. § 6510(a)(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . 9, 45
7 U.S.C. § 6517 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . passim
7 U.S.C. § 6517(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . 30, 35, 36
7 U.S.C. § 6517( c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . 21, 30, 33
7 U.S.C. § 6517(c)(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . passim
7 U.S.C. § 6517(c)(1)(A) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . 33
7 U.S.C. § 6517(c)(1)(B) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . 33, 34, 36
7 U.S.C. § 6517(c)(1)(B)(iii) . . . . . . . . . . . . . . . . . . . . . . . . . .
11, 27, 34, 36
7 U.S.C. § 6517(c)(1)( C) . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . 34
7 U.S.C. § 6517(d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . 21, 34
7 U.S.C. § 6517(d)(1) and (2) . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . 40
7 U.S.C. § 6518(k) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 28
7 U.S.C. § 6518(l)(2) and (3), (m) and (n) . . . . . . . . . . . . . . . . . . .
.
. . . . . 28
7 U.S.C. § 6519(f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . 9, 28
7 U.S.C. § 6520 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 1
28 U.S.C. § 1291 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . . . 2
28 U.S.C. § 1331 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . . . 1
28 U.S.C. §2201. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . . . 1
42 U.S.C. § 300f et seq. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . 9, 45
FY 2006 Agriculture Appropriations Act, HR-2744, H. Rept. 109-255,
P. L. 109-97, Title VII, Sec. 724 (Nov. 10, 2005), 119 Stat. 2153 . . . . . . . . . . .
10
FY 2006 Agriculture Appropriations Act, HR-2744, H. Rept. 109-255,
P. L. 109-97, Title VII, Sec. 797 (Nov. 10, 2005), 119 Stat. 2165 . . . . . . . . . . .
.
10
REGULATIONS
7 C.F.R. Part 205 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . . . 3
7 CFR 205.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . 28
7 C.F.R. §§ 205.600(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . passim
7 C.F. R. 205.605(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . passim
21 C.F.R. 101.100(3)(ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 29
21 C.F.R. 101.4(a)(1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . 29
OTHER AUTHORITIES
71 Fed. Reg. 24820 (April 27, 2006) . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . 4
71 Fed. Reg. 32803 (June 7, 2006) . . . . . . . . . . . . . . . . . . . . . . . . . 4,
12, 30, 39, 46
Comments of NOP proposed rules to implement Harvey decision, available at
http://ww.ams.usda.gov/nop/PublicComments/HarveyRule/PublicComments
HarveyRule.html . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . 12
House Conference Report, H. Rept. 109-255 (Nov. 10, 2005) . . . . . . . . . . . . . . .
20
S.Rep. No. 101-357, 101st Cong., 2d Sess. at 298 (July 6, 1990)
(Agriculture, Nutrition and Forestry Committee), reprinted in, 1990 U.S. Code
Cong..&.Admin. News, pp. 4656, 4943-960, 5220-228 . . . . . . . . . . . . . . . . . . .
.
21
S. Zellmer, "Sacrificing Legislative Integrity at the Altar of
Appropriations Riders: A Constitutional Crisis," 21 Harv. Envtl
L Rev. 457, 510 (1997) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . 20
"Synthetic Substances Subject to Review and Recommendation by the
National Organic Standards Board When Such Substances are Used as
Ingredients in Processed Food Products," Dec. 12, 2002, available at
http://www.ams.usda.gov/nop/NOP/PolicyStatements/SyntheticSubstances.html.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.
. . . . . . . . . . . . . . . . . . . 12
STATEMENT IN SUPPORT OF ORAL ARGUMENT
Appellant requests oral argument because this case raises complex issues
concerning
the interrelationship between this court’s judgment in a prior appeal and subsequent
amendments to the underlying statute, the Organic Foods Production Act of 1990.
Appellant
believes the court would be aided in its understanding of the issues presented in this
brief by the presentation of oral argument.
UNITED STATES COURT OF APPEALS
FOR THE FIRST CIRCUIT
ARTHUR HARVEY,
Plaintiff - Appellant
v. No. 06-2738
MIKE JOHANNS,
SECRETARY OF AGRICULTURE,
Defendant - Appellee
BRIEF OF PLAINTIFF-APPELLANT, ARTHUR HARVEY
JURISDICTIONAL STATEMENT
This case was previously before this court as Harvey v. Veneman, No. 04-1379,
decision reported at 396 F.3d 28 (1st Cir. 2005).1 The current appeal is from a
post-judgment decision and Amendment to Judgment in the same District Court docket
which
was the subject of the previous appeal. Thus, the jurisdictional foundations of this
appeal are the same as those of the prior appeal. The District Court’s jurisdiction was
founded on 28 U.S.C. § 1331, 28 U.S.C. §2201, and 7 U.S.C. § 6520. On November 2,
2006,
the District Court issued a Memorandum Decision denying Harvey’s Motion to Enforce the
Judgment and granting USDA’s Motion for Relief from Judgment. Addendum, #1. On
November
21, 2006, the District Court issued an Amendment to Judgment, relieving USDA from
those
terms of the Final Judgment that pertained to Count Three of Harvey’s Complaint.
Addendum
#2. This appeal was timely filed on December 8, 2006. This court has jurisdiction
pursuant to 28 U.S.C. § 1291.
STATEMENT OF THE ISSUES
1. Did the District Court err in denying Harvey’s Motion to Enforce the Judgment
which implemented this court’s mandate in Harvey v. Veneman, No. 04-1379, and in
granting
the Secretary of Agriculture’s Motion for Relief from Judgment with regard to Count
Three
of the prior appeal?
2. Do the 2005 amendments to the Organic Foods Production Act of 1990 supersede
this court’s decision and mandate in Harvey v. Veneman and the District Court’s Consent
Judgment implementing that mandate, with respect to the use of synthetic processing
aids
in organic food handling?
3. Does the National Organic Program’s Food Contact Substances Policy Statement,
which permits the use of synthetic ingredients and processing aids in organic handling
without their inclusion on the "National List," violate this court’s prior decision and
mandate and the District Court’s Consent Judgment?
STATEMENT OF THE CASE
Plaintiff-Appellant Harvey, an organic farmer, handler, inspector and consumer,
brought this action in the U.S. District Court for the District of Maine to challenge
several provisions of the National Organic Program ("NOP") Final Rule2 as inconsistent
with the Organic Foods Production Act of 1990 ("OFPA").3 The District Court granted
summary judgment in favor of the Secretary of Agriculture ("Secretary" or "USDA") on
all
counts. Harvey v. Veneman, 297 F. Supp. 2d 334 (D. Me. 2004).4 Harvey appealed seven
of
his nine original counts. This court ruled in his favor on Counts One, Three and Seven,
and ruled in favor of USDA on counts Two, Five, Six and Eight. Harvey, 396 F.3d at 46.
Pursuant to the mandate of this Court, the District Court entered a Consent Final
Judgment and Order ("Consent Judgment") on June 9, 2005. Addendum #3. The
Consent
Judgment entered a declaratory judgment with regard to Count One, and ordered USDA
to
conduct notice and comment rulemaking to implement the Judgment with regard to
Counts
Three and Seven within 360 days. Id. at 3-4. USDA published proposed regulations
purportedly implementing the Consent Judgment on April 27, 2006, 71 Fed. Reg. 24820,
Addendum #4, and published a final rule on June 7, 2006. 71 Fed. Reg. 32803.
Addendum
#5.
On June 30, 2006, Harvey filed a Motion to Enforce the Judgment, District Court
Docket No. 89, claiming that USDA’s rulemaking had failed to implement the Consent
Judgment and this court’s mandate with respect to Count Three of his Complaint. USDA
filed an Opposition and Cross Motion for Relief from Judgment with regard to Count
Three.
District Court Docket Nos. 94 and 102. On November 2, 2006, the District Court issued a
Memorandum Decision denying Harvey’s Motion to Enforce and granting USDA’s Motion
for
Relief from Judgment. Addendum #1. On November 21, 2006, the District Court issued an
Amendment to Judgment, relieving USDA from those terms of the Consent Judgment that
pertained to Count Three. Addendum # 2. This appeal followed.
STATEMENT OF FACTS
As this court explained in the prior appeal, OFPA was enacted to "‘establish
national standards governing the marketing’ of organically produced agricultural
products, to ‘assure consumers that organically produced products meet a consistent
standard’ and to ‘facilitate interstate commerce in’ organically produced food."
Harvey,
396 F.3d at 31-32, quoting, OFPA, 7 U.S.C. § 6501.
The subject of Count Three was the use of synthetic substances in the handling of
organic products. This court found that OFPA requires organic products to "be produced
and handled without the use of synthetic substances," citing to 7 U.S.C. § 6504.5 The
court noted that "[e]xceptions to the Act’s general prohibition on synthetic substances
appear on a National List of approved substances for organic products. 7 U.S.C. §
6517."
396 F.3d at 32. Further, the "Act contains detailed guidelines for the inclusion of
substances on the National List." Id., citing, 7 U.S.C. § 6517(c)(1).
The court described Count Three as follows:
Harvey contends that the Rule’s provisions permitting the use of synthetic substances
in
processing contravene OFPA, which prohibits the use of synthetic substances generally
and
specifically forbids the addition of synthetic ingredients in processing.
396 F.3d at 33. This court rejected USDA’s arguments that language in 7 U.S.C. 6517,
the
National List provision, authorized any exemptions to OFPA’s general prohibition of the
use of synthetic substances in handling. 396 F.3d at 39-40.
This court ruled that the challenged regulations at 7 C.F.R. §§ 205.600(b) and
205.605(b) "are contrary to the plain language of OFPA and therefore exceed the
Secretary’s statutory authority." 396 F.3d at 40. "Section 205.600(b) provides that
synthetic substances may be used ‘as a processing aid or adjuvant’ if they meet six
criteria; § 205.605(b) lists thirty-eight synthetic substances specifically allowed in
or
on processed products labeled as organic." 396 F.3d at 38-39. Both regulations were
invalidated.
Subsequent to this court’s decision, Harvey filed a Motion for Clarification of
Decision. First Circuit No. 04-1379, Docket Entry 3/14/05. Harvey expressed a concern
that the court’s decision could be misinterpreted, and requested clarification
concerning
two issues. The first concern was that the court’s determination that synthetic
substances could not be used in organic handling operations might be interpreted to
apply
to the non-organic ingredients in "made with organic" products.6 In response, the Court
added a footnote which clarified that:
The ban on the addition of synthetic substances in handling applies only to those
products labeled "organic" or "100% organic." The statute does not prohibit the
addition
of synthetic substances to foods labeled "made with organic [ingredients]," provided
the
other requirements of the Act are met. See 7 U.S.C. § 6505( c).
Errrata, First Circuit No. 04-1379, Docket Entry 3/30/05 at 1-2; 396 F.3d at 39, n.2.
Harvey’s second concern was that the decision could be misinterpreted to mean
that
no synthetic substances could be used in handling in any capacity, including functions
such as packaging and storage. Motion for Clarification at 2. Harvey pointed out that 7
U.S.C. §§ 6510(a)(5) and (a)(6) contain separate guidelines for packaging and storage
in
organic handling. Id., at 11. He asked the court to clarify that its decision was
"limited to synthetic ingredients and processing aids ‘added to’ organic products in
processing or post-harvest handling . . . ". Id. at 12. The limitation to processing
aids
and ingredients was based on the fact that the invalidated regulations applied to these
categories, and that 7 U.S.C. § 6510(a) specifically prohibited the addition of
synthetic
ingredients in organic handling. Id. at 10-11.
In response, the court made several wording changes to its opinion. Errata at 2.
In
the context of the rest of the decision, these changes clarified that the National List
provision does not affirmatively bar the use of synthetics in handling generally. The
prohibitions on synthetics in handling are contained in other parts of the statute
(sections 6504 and 6510), while the National List provision serves to authorize
exemptions of "otherwise prohibited" substances.7 The National List provision was not
the
source of the prohibition on synthetics in handling found by the court, but also did
not
supply an exception to those prohibitions.
The court’s clarification implicitly recognized OFPA’s limited, explicit
exceptions
to its general prohibition of the use of synthetics in handling apart from the National
List provision.8 These exceptions were reflected in the Consent
Judgment which implemented this court’s mandate. Addendum #3. The Consent
Judgment
states:
With respect to Count 3: 7 C.F.R. §§ 205.600(b) and 605(b) are contrary to OFPA and
exceed the Secretary’s rulemaking authority to the extent that they permit the addition
of synthetic ingredients and processing aids in handling and processing of products
which
contain a minimum of 95% organic content and which are eligible to bear the USDA seal.
This declaration does not apply to synthetic ingredients and processing aids authorized
by 7 U.S.C. § 6519(f) or
§ 6510(a)(7).9
The Consent Judgment is not explicitly made inapplicable to packaging and storage, but
the limitation of its coverage to synthetic ingredients and processing aids implicitly
excludes those functions, which are left to the operation of 7 U.S.C. §§ 6510(a) (5)
and
(6).
Prior to USDA’s issuance of the revised regulations mandated by the
Consent Judgment, Congress amended OFPA (hereinafter "2005 OFPA Amendments" or
"amendments"). These amendments were added in the Conference Committee as a rider
to
the
FY 2006 Agriculture Appropriations Act.10 They made changes to two provisions of OFPA
which are relevant here.
First, Congress amended 7 U.S.C. § 6510(a), which prohibited the addition of any
synthetic ingredient in the handling of organic foods, by adding the words "not
appearing
on the National List" after the word "ingredient." The provision now reads (with added
language in italics):
(a) In general
For a handling operation to be certified under this chapter, each person on such
handling
operation shall not, with respect to any agricultural product covered by this chapter –
(1) add any synthetic ingredient not appearing on the National List during the
processing
or any postharvest handling of the product.
Second, the amendments made two changes to the National List provision, 7 U.S.C.
§
6517. First, the language "in organic production and handling operations" was added to
the title at § 6517(c)(1). It now reads (with added language in italics):
( c) Guidelines for prohibitions or exemptions
(1) Exemption for prohibited substances in organic production and handling
operations
The National List may provide for the use of substances in an organic farming or
handling operation that are otherwise prohibited under this chapter only if –
. . .
Section § 6517(c)(1) goes on to specify the required criteria for including substances
on
the National List.
Second, the amendment eliminated § 6517(c)(1)(B)(iii), which provided the
required
criterion for substances used in handling, which was that the substance "is
non-synthetic
but is not organically-produced." OFPA now contains no criteria permitting the listing
of
synthetics for use in handling.
On April 27, 2006, USDA published proposed regulations implementing the Consent
Judgment in this case. 71 Fed. Reg. 24820, Addendum #4. USDA proposed no changes
to 7
C.F.R. §§ 205.600(b) or 605(b), which had been invalidated by this court. USDA claimed
that the amendments restored the regulations and thus no revisions were necessary. Id.
at
24821. Mr. Harvey and others submitted comments asserting that the amendments to
OFPA
at
most authorized the allowance of synthetic ingredients on the National List, and that
the
Final Judgment still needed to be implemented concerning synthetic processing aids.11
These comments also sought repeal or revision of NOP’s Food Contact Substances Policy
Statement (hereinafter "FCS Policy").12 This Policy permits the use of dozens of
synthetic ingredients and processing aids in organic handling without being on the
National List.
The Final Rule contained no change from the proposed rule with respect to
synthetics, and no discussion or even acknowledgment of the comments of Harvey and
others
described above. 71 Fed. Reg. 32803 (June 7, 2006), Addendum #5.
In his June 30, 2006 Motion to Enforce, Harvey claimed that USDA was in violation
of the Consent Judgment because it had failed to make any changes to the regulations at
7
C.F.R. 600(b) and 605(b). As he had argued in his comments on the proposed
regulations,
Harvey claimed that the amendment to §6510(a)(1) changed only its prohibition on the
use
of synthetic ingredients in handling, to permit synthetic ingredients appearing on the
National List.13 Further, the changes to 7 U.S.C. § 6517 did not add any authority to
permit synthetic substances other than ingredients on the National List. Motion to
Enforce at 9, n. 12; Reply re Motion to Enforce, Dist. Ct. Docket No. 106 at 7-9.
Therefore, Harvey asserted, the 2005 OFPA Amendments had no effect on the portion
of this court’s mandate which invalidated 7 C.F.R. 205.600(b), as implemented in the
Consent Judgment. That regulation provided criteria for inclusion on the National List
of
synthetic processing aids and adjuvants, and had nothing to do with ingredients. USDA
was
required by the mandate and the Consent Judgment to rescind that regulation, but had
failed to do so. USDA also failed to implement the Consent Judgment with regard to 7
C.F.R. 605(b), the National List of allowed synthetics in processing, insofar as it had
failed to remove synthetic processing aids from the List embodied in that regulation.
Finally, Harvey contended that USDA was also in violation of the this court’s
mandate and the Consent Judgment because its FCS Policy continued to allow the use in
organic foods of hundreds of synthetic chemicals, including dozens of ingredients and
processing aids, without being on the National List. USDA could not permit by Policy
Statement what this court had ruled could not be permitted by regulation. Because the
2005 OFPA Amendments only legalized synthetic "ingredients" "appearing on the National
List," the authorization in the FCS Policy of synthetic processing aids and ingredients
without being on the National List remained in violation of the mandate, the Final
Judgment, and OFPA as amended.
The District Court denied Harvey’s Motion to Enforce and granted USDA’s Motion
for
Relief from Judgment. Addendum #1. The District Court held that the 2005 OFPA
Amendments
completely superseded this court’s decision and the Consent Judgment with respect to
Count Three. It also ruled that Harvey’s claim concerning the FCS Policy failed for the
same reason, and in addition because it was beyond the scope of a motion to enforce the
judgment.14
SUMMARY OF ARGUMENT
This court’s decision in the prior appeal held that it was beyond USDA’s
authority
to permit the use of synthetic substances in organic handling, and invalidated
regulations which authorized the use of both synthetic ingredients and processing aids.
The Consent Judgment implementing this court’s mandate was explicitly applicable to
synthetic ingredients and processing aids. The subsequent amendments to OFPA at most
authorize the use of synthetic ingredients on the National List, and do not supersede
this court’s decision and the Consent Judgment with regard to synthetic processing
aids.
Congress amended a provision of OFPA specifically applicable to "ingredients,"
apparently to remove the prohibition on synthetic ingredients in handling when those
ingredients "appear on the National List." Congress did not employ OFPA’s more
inclusive
terms "substances" or "chemicals," which are used to encompass ingredients, processing
aids and other substances. USDA recognizes the distinct meanings of "ingredients" and
"processing aids" in its implementing regulations. There is no rational basis for
ignoring those distinctions in the interpretation of the OFPA amendments.
The National List provision of OFPA allows the use of "otherwise prohibited"
substances if they meet certain criteria set out in that provision and are added to the
List in accordance with mandated procedures. As amended, that provision still does not
contain any authority for the listing of synthetic processing aids.
Therefore, USDA remains obligated to amend its regulations to eliminate any
authorization for the use of synthetic processing aids in organic handling, and the
District Court erred in denying Harvey’s motion to enforce its Judgment. Likewise, that
Court erred in granting USDA’s motion for relief from judgment, and in amending its
Judgment to relieve USDA of its terms relevant to Count Three of Harvey’s complaint.
USDA’s Food Contact Substances Policy Statement permits the use of synthetic
ingredients and processing aids in organic handling without their inclusion on the
"National List." As such, it violates this court’s prior decision and mandate and the
District Court’s Consent Judgment. The prior decision forbade the use of synthetic
substances in handling, and USDA may not permit by Policy Statement what this court
held
it could not permit by regulation.
The OFPA amendments superseded this court’s decision at most to the extent of
permitting the use of synthetic ingredients appearing on the National List. The
allowance
of both synthetic ingredients and processing aids via the Food Contact Substances
Policy,
all without being on the National List, continues to violate this court’s prior
decision
and the Consent Judgment. Even if USDA is correct that the OFPA amendments authorize
the
use of all synthetic substances, including processing aids, there is no dispute that
the
amendments apply to substances which appear on the National List. The Food Contact
Substances Policy remains in violation of the prior decision and OFPA as amended.
ARGUMENT
STANDARD OF REVIEW
The question addressed in Part I of the Argument, whether this court’s decision
and
mandate, as reflected in the Consent Judgment, must be enforced with regard to the use
of
synthetic processing aids, turns on the meaning of the 2005 OFPA Amendments, and to
what
extent they supersede this court’s earlier decision with respect to Count Three.
Such questions of statutory interpretation "are subject to plenary review,"
Summit
Investment and Development Corp. v. Leroux, 69 F.3d 608, 610 (1st Cir. 1995), "without
paying special deference to the courts below." In re Young, 66 F.3d 376, 378 (1st Cir.
1995). De novo review extends to the question of whether a statute is ambiguous.
Duckworth v. Pratt & Whitney, Inc., 152 F.3d 1, 6 (1st Cir. 1998).
Deference to the statutory interpretation of the administering agency (here USDA)
is accorded only if "the statute is silent or ambiguous with respect to the specific
issue." Chevron, U.S.A. v. Natural Res. Defense Council, 467 U.S. 837, 843 (1984).
"[I]f
the legislative intent is clear, we do not defer to the agency and we end the Chevron
analysis at step one." Penobscot Air Services, Ltd. v. F.A.A., 164 F.3d 713, 719 (1st
Cir. 1999). If the statute is ambiguous, the court
defers to the interpretation by an agency charged with enforcement of the statute, so
long as that interpretation flows rationally from a permissible construction of the
statute.
Arnold v. United Parcel Service, Inc., 136 F.3d 854, 858 (1st Cir. 1998). (internal
quotation marks and citation omitted).
Here, the 2005OFPA Amendments are clear with regard to the fact that their
authorization for the use of synthetics in organic handling is applicable, at most, to
synthetic ingredients and not to synthetic processing aids. Thus, there is no need to
give deference to USDA’s interpretation. Even assuming that there is ambiguity in the
statute, as amended, USDA’s interpretation lacks a rational basis and is not a
permissible construction of the statute.
Interpretation of this court’s prior decision is also, of course, a legal
question
subject to de novo review. E.g., Ticoalu v. Gonzales, 472 F.3d 8 (1st Cir. 2006).
The question addressed in Part II of the Argument, whether USDA’s FCS Policy
violates this court’s decision and mandate and the Consent Judgment, is also a legal
question subject to de novo review, "subject to established principles of agency
deference." Ticoalu, 472 F.3d 8. A policy statement, unlike agency regulations, is not
entitled to Chevron deference. United States v. Mead Corp., 533 U.S. 218, 234 (2001),
citing, Christensen v. Harris County, 529 U.S. 576, 587 (2000); Visiting Nurse Ass’n v.
Thompson, 447 F.3d 68, 73 ( 1st Cir. 2006).
DISCUSSION OF THE ISSUES
I. THIS COURT’S DECISION AND MANDATE AND THE CONSENT JUDGMENT MUST BE
ENFORCED WITH
REGARD TO SYNTHETIC PROCESSING AIDS.
As the District Court stated, whether the Consent Judgment with respect to Count
Three should be enforced or vacated "depends upon the meaning and effect of the 2005
OFPA
amendments." Addendum #1 at 4.
As in any case of statutory construction, our analysis begins with the language of the
statute. . . . We accord the statutory text its ordinary meaning by reference to the
specific context in which that language is used, and the broader context of the statute
as a whole.
United States v. Roberson, 459 F.3d 39, 51 (1st Cir. 2006)(internal quotation marks and
citations omitted). The court must also consider the legal background in which Congress
legislated. E.g., Ortega v. Star-Kist Foods, Inc., 370 F.3d 124, 135 (1st Cir. 2004);
rev’d on other grounds sub nom, Exxon Mobil Corp. v. Allapattah Services, Inc., 545
U.S.
546 (2005); Riley v. Kurtz, 361 F.3d 906, 915 (6th Cir. 2004) ("It is a settled
principle
that when Congress drafts a statute, courts presume that it does so with full knowledge
of the existing law") (internal quotation marks and citation omitted).
There is no legislative history of the 2005 OFPA Amendments which could provide
any
insight as to their meaning.15 They were added as a rider to an appropriations bill in
the conference committee, without hearings, discussion or debate. They were never
subject
to a committee mark-up or explained in any committee report.16 Thus, the task of
statutory interpretation is limited to the language of the amendments in the context of
the amended provisions and the statute as a whole, and the legal background of the
amendments.
The analysis of the statute as a whole must begin with the cornerstone of OFPA,
recognized in this court’s prior opinion, forbidding synthetic chemicals in organic
production and handling, except as expressly permitted in the Act. 7 U.S.C. § 6504(1).
"[N]o synthetic substances . . . used in organic production . . . is the basic tenet of
this legislation" with "a few limited exceptions." 17 Section 6510(a)(1), as it existed
at the time of the prior decision, reinforced and elaborated this basic prohibition by
providing that certified organic handlers could not "add any synthetic ingredient
during
the processing or postharvest handling of the product."
As this court also recognized, exceptions to the general prohibitions on
synthetic
substances are primarily contained in the National List authorized by 7 U.S.C. § 6517.
The National List may permit the use of specific "otherwise prohibited" substances
which
meet the criteria set out in that section, and which are proposed and reviewed by the
National Organic Standards Board ("NOSB") and subject to public notice and comment. 7
U.S.C. § 6517( c) and (d).18
Part of the legal background of the 2005 OFPA Amendments is this court’s prior
decision, which was referenced in the amendments. Amendment § 724, Addendum #6 at
1.
The
primary dispute with regard to Count Three in the previous appeal was whether the
National List provision provided an exception to OFPA’s general prohibition on
synthetic
substances in handling, by authorizing their inclusion on the National List.19 This
court
held that § 6517 provided no such authority, and that therefore the challenged
regulations exceeded the Secretary’s statutory authority. 396 F.3d at 39-40.
This court relied in part on § 6510, which is applicable to ingredients, to
strike
down these regulations. However, the invalidated regulations themselves apply to
substances, see, 396 F.3d at 38-39, and the court’s holding applied to synthetic
substances and not just ingredients.20 In describing OFPA, the court recognized that
§ 6504 required that organic products "must be produced and handled without the use
of
synthetic substances," and that "[e]xceptions to the Act’s general prohibition on
synthetic substances appear on a National List of approved substances for organic
products." 396 F.3d at 32 (emphasis supplied).
In describing Count Three, the Court recognized the OFPA’s general prohibition on
the use of synthetics substances in handling, as well as the specific prohibition on
the
addition of synthetic ingredients:
Harvey contends that the Rule’s provisions permitting the use of synthetic substances
in
processing contravene OFPA, which prohibits the use of synthetic substances generally
and
specifically forbids the addition of synthetic ingredients in processing.
396 F.3d at 33. In the footnote it added in response to the motion to clarify, the
court
states that its "ban on the addition of synthetic substances in handling applies only
to
those products labeled ‘organic’ or ‘100% organic.’" 396 F.3d at 39, n.2 (emphasis
supplied). And, of course, one of the invalidated regulations applies by its terms not
to
ingredients, but to "processing aids or adjuvants." 396 F.3d at 38.
Thus, the question with regard to the 2005 OFPA Amendments is what, if any, new
exemptions they supplied to what this court found were OFPA’s basic prohibitions on
synthetic substances in organic handling. Harvey contends that these amendments, at
most,
authorized the presence of synthetic ingredients on the National List for use in
handling. The amendment to § 6510 applies only to ingredients on the National List, and
the amendment to § 6517 adds no new authority for the use of synthetics in handling
which
are not ingredients.
The District Court agreed with Harvey with respect to the amendment to
§ 6510. However, it found new authority for "the use of synthetic substances, whether
ingredients or processing aids, for use in handling operations, so long as they appear
on
the National List." Addendum #1 at 9 (emphasis supplied; footnote omitted).
The amendment to § 6510 simply clarifies that the old prohibition on the use of
synthetic
ingredients in handling no longer applies to the use of synthetic ingredients appearing
on the National List. To use Harvey’s words, "Section 6510 is by its terms applicable
only to the addition of ingredients," Motion to Clarify at 10-11, and says nothing one
way or another about processing aids. Congress authorized the use of synthetic
processing
aids in handling with its amendments to section 6517.
Id. (emphasis in original).
The District Court was correct with respect to its analysis of the amendment to §
6510, but erred with respect to the amendment to § 6517.
A. The Amendment to § 6510 At Most Permits the Use of Synthetic Ingredients on
the National List in the Handling of Organic Products
As the District Court observed, Congress amended a provision of OFPA,
§ 6510, that is applicable by its terms only to ingredients. The question becomes why
it
did so in the context of a statute which generally uses the terms "substances,"
"chemicals" or "materials" when it means to be all encompassing, and in the context of
a
court decision and invalidated regulations explicitly applicable to substances. The
answer, based on the plain language of the amendment, is that Congress intended to
supersede this court’s decision only to a limited degree, i.e., with respect to
ingredients.
While there is no evidence as to congressional intent regarding these amendments,
it is likely that the reason Congress limited the allowance of synthetics in handling
to
ingredients is that ingredients, but not processing aids, must be disclosed on a
product’s label. See, n.25, infra. One of OFPA’s purposes is to "assure consumers that
organically produced products meet a consistent standard." 7 U.S.C. § 6501(2). This
cannot be done if "organic" products are processed with undisclosed synthetic
substances.
In the OFPA scheme, synthetics are presumptively antithetical to the organic ideal. If
synthetic processing aids are permitted, "organic" products which appear to be
identical
based on their labels could have numerous synthetics added during processing, or none
at
all. There would be no way for consumers to tell the difference.
Although we cannot know Congress’ motivation, we do know that Congress did not
change the wording of § 6510 to use the more general terms "substances" or
"chemicals"
found in § 6517 and § 6504. OFPA uses these general terms in a distinctly contrasting
fashion from the use of the focused term "ingredients" in
§ 6510.
At first blush it may appear that the former § 6510(a)(1) merely duplicated what
is
in § 6504(1), and that the use of the term "synthetic ingredient," instead of
"synthetic
chemical" in that section has no significance. However, an examination of
§ 6510(a)(1) in context reveals otherwise. The term "ingredients" is used in § 6510 to
mean something more narrow than "substances" or "chemicals." The fact that Congress
amended this section without changing the term "ingredients" is crucial to
understanding
the meaning and coverage of the amendment.
Section 6510 sets forth the requirements applicable to organic "handling." It is
in
handling that multi-ingredient products are created. Section 6510(a)(4) provides that
such products may not contain "any ingredients that are not organically produced,"
i.e.,
nonorganic ingredients are "otherwise prohibited." However, there is an exception to
that
prohibition, permitting up to five percent nonorganic ingredients by weight which are
"included on the National List."
The use of the term "ingredient" in § 6510(a)(4) is consistent with the
pre-existing FDA regulatory scheme and the way in which the term is defined in the NOP
regulations. See, notes 24 and 25, infra. "Ingredient" is defined in the NOP
regulations
as a substance that is still present in the finished product. In contrast, "processing
aids" are defined in both the FDA and NOP regulations as substances which may remain in
finished food products only at insignificant levels. "Ingredients" but not "processing
aids" would affect the weight of a product, and thus are the subject of § 6510(a)(4).
The term "ingredient" in § 6510(a)(1) is connected to, and has the same meaning
as
that term in § 6510(a)(4). "[T]here is a presumption that a given term is used to mean
the same thing throughout a statute . . . ." Brown v. Gardner, 513 U.S. 115, 118 (1994)
(citing, Atlantic Cleaners & Dyers, Inc. v. United States, 286 U.S. 427, 433 (1932)).
Sec. 6510(a)(4) permits five percent nonorganic ingredients on the National List in
processed organic products, but does not specify whether or not those ingredients may
be
synthetic. Former section 6510(a)(1) made clear that such nonorganic ingredients could
not be synthetics. This is consistent with the former
§ 6517(c)(1)(B)(iii), which limited National List substances used in handling to
"nonsynthetic" substances. Thus, § 6510(a)(1) is addressed to the ingredients permitted
in § 6510(a)(4).
OFPA does not define the term "substance," but it is repeatedly used as an
all-inclusive term, e.g., to define "pesticide"21 and "synthetic."22 It is used to
describe what is prohibited for use on land on which organic food is produced. 7 U.S.C.
§
6504(2). "Substances" is also used to describe what the NOSB evaluates for inclusion on
the National List. 7 U.S.C. § 6518(l)(2) and (3), (m) and (n).23
The term "ingredient" also is not specifically defined in the statute. However,
USDA’s implementing regulations define both "ingredient" and "processing aid." The
regulatory definitions demonstrate not only that ingredients and processing aids are
distinct and contrasting categories, but also that they are both sub-categories of
"substances."24 Thus, USDA recognized the distinct meanings of these terms when it
interpreted OFPA in its implementing regulations.25
It must be assumed that Congress’ determination to amend a provision applicable
only to "ingredients" and not to use the term "substances" or "chemicals" was
intentional
and that Congress was aware of the definitions and use of these terms in the statute
and
regulations. E.g., United States v. Ramirez-Ferrer, 82 F.3d 1131, 1137 (1st Cir. 1996)
("Courts must presume that Congress knows of prior judicial or executive branch
interpretations of a statute when it re-enacts or amends a statute," citing, Lorillard
v.
Pons, 434 US 575, 580 (1978)).
Most significantly, Congress did not amend the section of OFPA, 7 U.S.C.
§ 6504(1), which contains the broader prohibition on the use of "synthetic chemicals,
except as otherwise provided in this chapter." The language of the amendment to
§ 6510 can be read as at most a limited exception to § 6504's global prohibition of
synthetics, "otherwise providing" for the use in handling of synthetic ingredients
which
appear on the National List.26
In order to justify the use of synthetic processing aids, however, the 2005 OFPA
amendments must be read as applicable to "substances" and not only "ingredients." As
noted above, the District Court admitted that § 6510, as amended, is still applicable
only to ingredients. It found the authority for the use of synthetic substances in the
amendment to § 6517.
It is unclear how USDA justifies its claim that the amendments are applicable to
"substances," but it appears to rely on amended § 6510. In its rulemaking, USDA stated
that
Congress amended the OFPA by permitting the addition of synthetic substances
appearing
on
the National List for use in products labeled ‘organic.’ The amendment restores the NOP
regulation for organic processed products containing at least 95 percent organic
ingredients . . . .
71 Fed. Reg. at 32803-804, Addendum #5 (emphasis supplied). This language appears to
track generally the language of amended § 6510, (handlers are forbidden to "add any
synthetic ingredient not appearing on the National List"), but transforms the statutory
term "ingredient" to "substances." USDA appears to claim that the amendment to § 6510
is
what overrides this court’s decision on Count Three and permits the use of synthetic
substances (not only ingredients) in handling.
If USDA is in fact interpreting the amendment to § 6510 in a manner which erases
the distinctions between "ingredients," "processing aids" and "substances" contained in
its own regulations, its statutory interpretation is inconsistent with the prior
interpretation contained in its regulations. As such, its interpretation of the
amendments is entitled to little, if any, deference. United States v. Mead Corp., 533
U.S. at 228 (measure of deference to agency interpretation of statute varies according
to
consistency of agency position, citing, Good Samaritan Hospital v. Shalala, 508 U.S.
402,
417 (1993).
The Supreme Court in Good Samaritan noted that an agency may change what it
believes to be a mistaken legal interpretation, but an agency interpretation in
conflict
with an earlier interpretation is entitled to "considerably less deference" than a
consistently held agency view. 508 U.S. at 417. Here, USDA has not claimed that its
earlier interpretation was mistaken. In fact, it continues to adhere to the regulatory
treatment of "ingredients" and "processing aids" as subcategories of "substances." It
simply ignores those distinctions in conflating "ingredients" with "substances" in its
interpretation of the amended § 6510. As such, its change in position has no rational
basis and should be accorded no deference.27
If, on the other hand, USDA, like the District Court, is relying on the
amendments
to § 6517 to authorize the use of all synthetic substances in handling, its statutory
interpretation is also contrary to the plain language of the amendment and lacks a
reasonable basis.
B. The Amendment to Section 6517 Does Not Provide an Authorization for the Use
of
Synthetic Processing Aids in Handling
The 2005 Amendment made two changes to § 6517. First, the amendment added "in
organic production and handling operations" to the title "Exemption for prohibited
substances" found at 7 U.S.C. § 6517(c)(1). That section now reads (with added
language
in italics):
( c) Guidelines for prohibitions or exemptions
(1) Exemption for prohibited substances in organic production and handling
operations
The National List may provide for the use of substances in an organic farming or
handling operation that are otherwise prohibited under this chapter only if –
. . .
The addition of the language "in organic production and handling operations" to
the
introductory language to subsection (c)(1) adds nothing new to this subsection, since
the
following line already stated "in an organic farming or handling operation."
Moreover, in the prior appeal, this court rejected the argument that the
application of § 6517 generally to both farming and handling lends any support to the
contention that it authorizes the use of synthetic substances in handling. 396 F.3d at
39-40. The court explained that "[s]ection 6517( c)) clearly establishes a three-prong
test for exemption of otherwise prohibited substances and their inclusion on the
National
List." 396 F.3d at 39. Prong A (7 U.S.C. § 6517(c)(1)(A)) "sets forth requirements that
any otherwise prohibited substance, whether used in production or handling, must meet
to
be exempted." Id.28 Prong B (7 U.S.C. § 6517(c)(1)(B)) -- which then limited National
List substances used in handling to "nonsynthetic" substances -- "sets forth more
specific requirements with regard to the types of substances that may be exempted for
use
in production and handling, respectively." Id. The court found that the general
applicability of subsection (c)(1) to both production and handling did not in any way
contradict Prong B’s limitation of National List substances used in handling to
nonsynthetic substances.29 The title of the section appears to indicate that the
National
List may contain some substances for use in handling, but one must look to Prong B to
determine which ones.
This brings us to the second amendment to § 6517, which modified Prong B by
eliminating
subsection (iii) from § 6517(c)(1)(B). As explained above, this court’s prior decision,
as clarified, did not rely on this subsection to hold that synthetics in handling were
prohibited. Thus, the removal of this provision from OFPA does not necessarily
undermine
that holding. The court found the prohibition on synthetics in handling in OFPA §§ 6504
and 6510. With regard to former § 6517(c)(1)(B)(iii), the court found only that it
"simply does not say what the Secretary needs it to say." 396 F.3d at 39. In other
words,
that subsection did not provide authorization to place the "otherwise prohibited"
synthetics in handling on the National List. It still does not do so.
Prior to amendment, Prong B provided that the National List could provide for the
use of an otherwise prohibited substance only if:
(B) the substance –
(I) is used in production and contains an active synthetic ingredient in the following
categories . . .
(ii) is used in production and contains synthetic inert ingredients that are not
classified by the Administrator of the Environmental Protection Agency as inerts of
toxicological concern; or
(iii) is used in handling and is non-synthetic but is not organically produced.
In order to understand what the removal of subsection (iii) means, one must start
with an understanding of its context in the National List provision. First of all,
§ 6517(b) provides that no otherwise prohibited substance may be added to the list
unless
it meets the criteria set out in §6517(c)(1):
(b) Content of list
The list established under subsection (a) of this section shall contain an
itemization, by specific use or application, of each synthetic substance permitted
under
subsection (c)(1) of this section . . .
(emphasis supplied). As this court recognized, all three prongs of 7 U.S.C.
§ 6517(c)(1) must be met in order for a substance to qualify to be on the National
List.
396 F.3d at 39. Substances may be placed on the List "only if" they meet each of these
requirements.
The National List may provide for the use of substances in an organic farming or
handling
operation that are otherwise prohibited under this chapter only if –
followed by Prongs A, B and C. 7 U.S.C. § 6517(c)(1) (emphasis supplied).
After the 2005 amendments, Prong B provides that otherwise prohibited substances
may be placed on the National List only if they are used in production and fall into
certain categories. There is no allowance for the exemption of otherwise prohibited
substances for use in handling. Prior to the amendments, only non-synthetic substances
were "permitted under subsection (c)(1)" to be placed on the National List for use in
handling. 7 U.S.C. § 6517(b); former § (c)(1)(B)(iii). After the amendment, subsection
(c)(1)(B) permits the use of otherwise prohibited substances only if they are used in
production. It still "does not say what the Secretary needs it to say." 396 F.3d at 39.
As such, the amendment to § 6517(c)(1)(B) actually removes the authority to put
any
otherwise prohibited substances for use in handling on the National List. The amendment
to § 6510, which, when viewed in isolation, appears to permit organic handlers to add
synthetic ingredients "appearing on the National List," is ineffective to do so. No
such
ingredients could "appear on the National List," since the amendment to the National
List
provision removed the authority to include substances used in handling. Presumably,
Congress did mean to accomplish something by means of its amendment to § 6510, but
the
package of amendments was inartfully drawn.
There is no legislative history to guide the court’s interpretation of these
apparently inept amendments to OFPA. Because of the lack of review and scrutiny of such
legislative riders, they are prone to containing language that does not correctly
reflect
even the intent of their few proponents, inside or outside of Congress, much less the
will of Congress as a whole. However, this possibility should not lead this court to
ignore the plain language of the congressional enactment, or to relax the usual
standards
for discerning congressional intent in favor of the wishful thinking of USDA.
Thus, while some degree of interpretation may be necessary to draw any consistent
meaning from these amendments, the court should depart from the plain language as
little
as possible. The court certainly should not read in anything that clearly is not there,
such as the allowance of all synthetic substances for use in handling, as opposed to
ingredients appearing on the National List.
Harvey’s Motion to Enforce assumed, though this court need not do so, that the
amendments did succeed in permitting organic handlers to add synthetic ingredients
"appearing on the National List."30 To reach this conclusion, it is necessary to
abandon
a literal reading of the amendment to § 6517, which states that the National List may
provide for the use of otherwise prohibited substances "only if" they are used in
production.
Instead, one would need to assume that while Congress removed the required
criteria
for synthetics in handling from the National List provision, the 2005 OFPA Amendments
provided those criteria in § 6510. Under this interpretation, both synthetic and
non-synthetic "ingredients appearing on the National List" may be used in organic
handling, subject to the five percent by weight limitation.
What cannot be assumed is that these amendments broadly authorized the listing of
all types of synthetic substances in handling, without any limiting criteria at all.
This
simply is not consistent with the language of the amendments or with the basic
structure
of OFPA. A foundational premise of the entire statutory scheme is that no synthetics
are
to be used in either organic production or handling, with only limited and specifically
authorized exceptions. Certainly, a broad new exception to that cornerstone of the Act
should not be inferred from dubious statutory language.31
In sum, the District Court failed to enforce the Consent Judgment implementing
this
court’s mandate to the effect that 7 C.F.R. 205.600(b) and 205.605(b) are contrary to
the
OFPA and exceed the Secretary’s rulemaking authority. While the amendments to OFPA
may
have authorized the use of synthetic ingredients appearing on the National List in
handling, they did not authorize the use of the broader universe of non-ingredient
substances in handling, including the processing aids that are specifically addressed
in
the Consent Judgment.
The District Court must enforce its Judgment with regard to Count Three to the
extent of ordering USDA to amend or repeal the regulation at 205.600(b), which
provides
criteria for inclusion on the National List for "any synthetic substance used as a
processing aid or adjuvant," so that it does not authorize or provide criteria for the
use of synthetic processing aids. The District Court must also require USDA to amend §
205.605(b) to delete from the National List any synthetics for use as processing aids,
and to require that no synthetics used as processing aids be added to the List in the
future.
II. USDA’S FOOD CONTACT SUBSTANCES POLICY IS IN DIRECT CONFLICT WITH THIS
COURT’S
MANDATE, THE CONSENT JUDGMENT AND OFPA, AS AMENDED
This court’s decision and the Consent Judgment determined that allowing synthetic
substances, including processing aids, in organic handling is contrary to OFPA and in
excess of the Secretary’s authority. The 2005 OFPA amendments leave this determination
intact, at the least with regard to processing aids and to ingredients not appearing on
the National List. The authorization for the use of these substances in the FCS Policy
violates the mandate and Consent Judgment as much as if they were permitted by
regulation.
The FCS Policy permits the use of hundreds of synthetic substances in organic
handling, dozens of which are processing aids and ingredients, without review by the
NOSB
or inclusion on the National List. It does so based upon their placement on a
(continually expanding) Food and Drug Administration (FDA) list of substances which are
approved for use in conventional food production. (hereinafter "FCS List").32 The FCS
list is intended for use in conventional foods, and does not take into consideration
the
requirements of OFPA and its implementing regulations.33
If it is in excess of the Secretary’s authority to permit synthetic substances in
handling by regulation, it is certainly beyond his authority to do so by means of a
Policy Statement on the agency website, and equally in violation of this court’s
mandate.
In fact, the FCS Policy permits the use of some of the very same chemical substances
that
are listed in the regulation that was struck down by this court. See, Motion to Enforce
at 3-4. It amounts to an evasion of the mandate and Consent Judgment.
USDA’s position is inconsistent. First, it claims that § 6510, as amended, serves
to permit synthetic substances, including processing aids, if they appear on the
National
List. This appears to be the basis on which USDA claims that the regulations
invalidated
by this court were restored. 71 Fed. Reg. at 32804, Addendum #5. In contradiction,
USDA
claims that it may permit processing aids via the FCS List without being on the
National
List.
For the same reasons that it violates this court’s mandate, the FCS Policy violates
OFPA, as amended. The only possible authorization for the use of synthetics in handling
now in OFPA is both limited to ingredients and explicitly forbids synthetic ingredients
"not appearing on the National List." Thus, synthetic processing aids and ingredients
which are not on the National List are still forbidden, and may not be permitted by the
FCS Policy.
On the other hand, assuming, as USDA claims, that amended § 6510 applies to all
substances, including ingredients and processing aids, then none of these substances
may
be used without being on the National List.34 Either way, the authorization of the use
of
synthetic ingredients and processing aids by the FCS violates OFPA, this court’s
decision
and mandate, and the Consent Judgment.
The District Court ruled that the FCS policy was outside of the bounds of this
litigation, because the Consent Judgment did not mention it and the First Circuit
decision did not consider it. Addendum #1 at 10-11. However, the issue is not whether
the
FCS Policy Statement was addressed in the litigation, but whether its existence
violates
this court’s mandate and the Consent Judgment. USDA cannot evade these commands by
allowing by means of a Policy Statement what this court has ordered it cannot permit by
regulation.
Moreover, it is not true that the FCS policy was not raised in this litigation.
Harvey did raise it, and it was briefed.35 However, USDA represented to that Court that
the Policy Statement was not a reviewable final agency action, but instead "a document
that was posted on the National Organic Program’s website for discussion. . . . It is
part of an ongoing deliberation about how the Act and the Rule operate." Appendix at
34-35, n. 11. It is likely that this court did not address the issue because it
believed
that the FCS Policy was only posted for discussion and was not actually being
implemented.
However, this is not the case. The Policy Statement has been on the USDA website
continuously since December, 2002. Although nothing with regard to it has changed since
USDA made its representation to this court in the prior appeal, USDA’s more recent
brief
to the District Court clearly admits that it is operational. USDA states that the
Policy:
authoriz[ed] the use of Food and Drug Administration (FDA) classified food contact
substances. . . . In doing so, the Secretary established a threshold below which
substances did not have to go through National List procedures in order to be used in
organic processing and handling.
Defts. Opp. and Cross-Motion, Appendix at 63.
The FCS Policy is a fully operational act of the Secretary which stands in
contravention of this court’s ruling on synthetics.
The District Court should be ordered to enforce its judgment by ordering USDA to
revoke its FCS Policy Statement, or revise it so that synthetic ingredients may not be
used in the handling of organic foods without being on the National List, and to
eliminate the authorization for the use of synthetic processing aids in organic
handling.
CONCLUSION
This court’s mandate and the Consent Judgment must still be enforced with respect
to synthetic processing aids. This Court should remand to the District Court with
instructions to enforce its judgment by ordering USDA to amend its regulations to
remove
any authorization for the use of synthetic processing aids in organic handling. This
court should also order USDA to revoke or amend its Food Contact Substances Policy so
that it does not authorize the use in organic handling of any synthetic ingredients
which
do not appear on the National List, or any synthetic processing aids.
Respectfully submitted,
_________________________
Paula Dinerstein
First Circuit Bar No. 97079
Public Employees for Environmental Responsibility
2000 P St., N.W., Suite 240
Washington, DC 20036
(202) 265-7337
Attorney for Plaintiff-Appellant, Arthur Harvey
CERTIFICATE OF COMPLIANCE WITH RULE 32(a)
1. This brief complies with the type-volume limitations of Fed.R.App.P. 32(a)(7)(B)
because:
this brief contains 12,592 words, excluding the parts of the brief exempted by
Fed.R.App.P. 32(a)(7)(B)(iii).
2. This brief complies with the typeface requirements of Fed.R.App.P. 32(a)(5) and the
type style requirements of Fed.R.App.P 32(a)(6) because:
this brief was prepared in proportionally spaced typeface 14-point Times New
Roman,
using WordPerfect 12.
______________________
Paula Dinerstein
Attorney for Appellant Arthur Harvey