No. 06-2738 IN THE UNITED STATES COURT OF APPEALS FOR THE FIRST CIRCUIT ____________________ ARTHUR HARVEY, Plaintiff-Appellant, v. MICHAEL JOHANNS, Secretary of the United States Department of Agriculture, Defendant-Appellee. ____________________ On Appeal from a Final Judgment of the United States District Court for the District of Maine, Case No. 02-00216 ____________________ AMICUS CURIAE BRIEF FOR THE ORGANIC TRADE ASSOCIATION, THE INTERNATIONAL DAIRY FOODS ASSOCIATION AND THE UNITED FRESH PRODUCE ASSOCIATION IN SUPPORT OF APPELLEE AND FOR AFFIRMANCE ____________________ April 4, 2007 WILLIAM J. FRIEDMAN, No. 117050 RICHARD D. DIETZ, No. 118048 Covington & Burling LLP 1201 Pennsylvania Avenue, NW Washington, DC 20004-2401 (202) 662-6000 CORPORATE DISCLOSURE STATEMENT Amici curiae, the Organic Trade Association, the International Dairy Foods Association, and the United Fresh Produce Association, are industry trade associations. Amici have no parent corporations, and no publicly-held corporation owns 10% or more of the stock of these associations. TABLE OF CONTENTS TABLE OF AUTHORITIES.....................................................................iii INTEREST OF AMICI...............................................................................1 STATEMENT OF THE CASE...................................................................2 SUMMARY OF ARGUMENT....................................................................4 ARGUMENT...............................................................................................8 I. CONGRESS ACTED IN RESPONSE TO THIS LITIGATION AND PROMPTLY AMENDED THE OFPA TO REMOVE THE CONFLICT IDENTIFIED BY THIS COURT’S OPINION...........................................................................................8 A. Congress Completed the Authorization to USDA to Allow the Use of Synthetic Substances in the “Organic” Products Labeling Tier and Did Not Intend to Distinguish Between Ingredients and Processing Aids in the 2005 Amendments.......................................................10 B. This Court Did Not Draw A Distinction Between “Ingredients” and “Processing Aids” But Treated Both as “Substances” When It Analyzed the OFPA And This Result is Binding on the District Court and The Parties.....................................................................................16 C. The District Court’s Order on Remand Did Not Create a Distinction Between “Ingredients” and “Processing Aids Under This Court’s Ruling, and the OFPA and Congress Did Not Create One in the 2005 Amendments.....17 D. Failing to Treat “Ingredients” and “Processing Aids” As Substances Under the OFPA Leads to Unreasonable Results and Undermines The Careful Line Drawing Between the Product Tiers Commanded by Congress and Implemented by USDA...................................................19 - i - II. HARVEY’S CLAIM REGARDING THE FOOD CONTACT SUBSTANCE POLICY WAS NOT PART OF THE CONSENT JUDGMENT AND IS NOT PROPERLY BEFORE THE COURT...................................................................22 CONCLUSION.........................................................................................25 - ii - TABLE OF AUTHORITIES FEDERAL CASES Agostini v. Felton, 521 U.S. 203 (1997)......................................................9 Dankese v. Defense Logistics Agency, 693 F.2d 13 (1st Cir. 1982).........22 Diaz-Fonseca v. Puerto Rico, 451 F.3d 13 (1st Cir. 2006).......................23 Firefighters Local Union No. 1984 v. Stotts, 467 U.S. 561 (1984)................................................................................9 Frew ex rel. Frew v. Hawkins, 540 U.S. 431, 441 (2004)..........................9 Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005).................5, 9, 10, 16, 17 Massachusetts ex rel. Div. of Marine Fisheries v. Daley, 170 F.3d 23 (1st Cir. 1999)..................................................................22 Monsanto Co. v. Kennedy, 613 F.2d 947 (D.C. Cir. 1979)......................24 Rodriguez v. Doral Mortg. Corp., 57 F.3d 1168 (1st Cir. 1995)..............23 Sullivan v. CIA, 992 F.2d 1249 (1st Cir. 1993).................................20, 25 Thomas Jefferson Univ. v. Shalala, 512 U.S. 504 (1994).......................12 United States v. Rivera-Martinez, 931 F.2d 148 (1st Cir. 1991)............19 Visiting Nurse Ass’n Gregoria Auffant, Inc. v. Thompson, 447 F.3d 72 (1st Cir. 2006)..................................................................12 FEDERAL STATUTES AND RULES 7 U.S.C. § 6504.........................................................................................16 - iii - 7 U.S.C. § 6510.........................................................................5, 10, 11, 19 7 U.S.C. § 6517................................................................5, 7, 10, 11, 12 19 21 U.S.C. § 348..........................................................................................24 Pub. L. No. 109-97, Title VII, 119 Stat. 2165 (Nov. 10, 2005).....................................................................9, 11, 13, 15 FEDERAL REGULATIONS 7 C.F.R. § 205.2 (2006).............................................................................20 7 C.F.R. § 205.100 (2006).........................................................................20 7 C.F.R. § 205.301 (2006)...................................................................17, 20 7 C.F.R. § 205.600 (2006)...................................................................16, 17 7 C.F.R. § 205.605 (2006).............................................................12, 16, 17 21 C.F.R. § 170.39 (2006).........................................................................24 67 Fed. Reg. 35724 (May 21, 2002)..........................................................24 71 Fed. Reg. 24820 (April 27, 2006).........................................................14 71 Fed. Reg. 32803 (June 7, 2006)...........................................................15 OTHER AUTHORITIES A Report to Congress: The National Organic Program Impact of Harvey v. Johanns and Restoring the NOP to Pre-Lawsuit Status, at 2-3 (March 2006) available at http:// www.ams.usda.gov/nop/NOPCongress Study1_06_06.pdf. ..........13-14 - iv - Vina, S., Harvey v. Veneman, and the National Organic Program: A Legal Analysis, CRS No. RS22318 (November 18, 2005)...............14 Rawson, J., Organic Agriculture in the US: Program and Policy Issues, CRS Report RL31595 (November 3, 2005).............................14 - v - INTEREST OF AMICI Amici are the Organic Trade Association (“OTA”), the International Dairy Foods Association (“IDFA”) and the United Fresh Produce Association (“United Fresh”). OTA is a national business association whose members are involved in the organic foods industry. OTA’s mission is to promote and protect organic trade. In its role as a representative for the organic industry, OTA advocates for and protects existing organic standards and assists in developing and refining organic standards for emerging product areas. OTA also takes positions on legislation that affects organic agriculture and products, and represents the industry to regulators, elected-officials, and international bodies. OTA is the largest organic-related organization in North America, and has more than 1000 members. IDFA is a national business association representing the nation’s dairy manufacturing and marketing industries and their suppliers. IDFA has more than 500 members. IDFA’ s members are affected by regulations governing organic products and the IDFA takes an active role in advocating dairy industry positions relating to organic products before regulators and legislators. United Fresh is a national industry association that represents the interests of thousands of members of the fresh produce supply chain. United Fresh promotes the growth and success of the fresh produce industry and advocates for the interests of the industry, including organic-related issues, before various legislative, regulatory and legal bodies. Amici submit this brief in support of Appellee Michael Johanns, Secretary of the United States Department of Agriculture, and respectfully offer the Court the following additional relevant arguments in support of the judgment of the district court. This amicus curiae brief is filed with the consent of all parties. STATEMENT OF THE CASE Amici adopt the government's statement of the facts and case with the following short addition. This case is back before this court on a very narrow appeal of the denial of Plaintiff Arthur Harvey's request to reopen the case. Following the remand from this Court to the district court in March 2005, the parties agreed in June 2005 to a remand to the agency to implement this Court's decision no later than June 2006. (Harvey Br. Add. 1.) In November 2005, before USDA began - 2 - rulemaking, Congress recognized this Court's analysis in its deliberations and amended the underlying statute to remove the conflict identified in this Court's opinion and thus fully authorized the existing federal organic program. (Harvey Br. Add. 6.) The amendments were surgically targeted to alter nothing but the language that was deemed by this court to create the conflict between the pre-lawsuit rules and the statute. The USDA went forward with the rulemaking required by the June 2005 Final Order and completed it on time in June 2006. (Harvey Br. Add. 5.) The agency concluded that it was no longer required to amend the existing rules in so far as they applied to the use of synthetic substances because of the OFPA amendments. Harvey requested reopening of the case for what he called the limited purpose of enforcing certain language in the district court's Final Order, and the Secretary cross- moved for dismissal because the OFPA amendments mooted the language in the district court’s order. Harvey simply disagreed with the agency's conclusion that the statutory amendments removed the conflict identified by this Court. Harvey conceded that Congress's amendments eliminated the conflict - 3 - this Court identified for all ingredients used in organic products but seized on materially insignificant language in the district court's Final Order to claim that Congress must have responded to that language rather than this Court’s opinion that was the law of the case. Harvey’s argument, in its starkest form, is nothing less than a contention that Congress intended to create a new conflict between the statute and the rules. Referring to the argument as "far fetched," (Harvey Br. Add. 1 at 7), the district court determined the agency had timely complied with its Final Order in light of the November 2005 amendments, and denied Harvey's motion and granted the Secretary's cross-motion, (Harvey Br. Add. 1 at 10). With regard to Harvey's attempt to secure a new ruling on the USDA Food Contact Substances policy not at issue in the lawsuit, the district court determined that the issue was not properly before it. (Harvey Br. Add. 1 at 10-11.) SUMMARY OF ARGUMENT The district court correctly rejected Harvey’s motion to reopen this case and enforce the provisions of the district court’s Final Order that - 4 - had been superseded by statutory changes and timely-completed agency rulemaking. In Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005), this Court declared the 2002 National Organic Program (“NOP”) rules that permitted certain synthetic substances (ingredients and processing aids) to be used by food manufacturers when making “organic” products to be in conflict with the authorizing statute. The opinion relied on two sections of the Organic Foods Production Act (“OFPA”), 7 U.S.C. §§ 6510 and 6517, to conclude the NOP rules allowing synthetic substances to be used in products containing 95% organic content and labeled “organic” were insufficiently authorized by the OFPA. Following the remand of this Court’s decision and the entry of a Final Order that required conforming rulemaking by USDA within one year, Congress instructed the USDA to issue a report on the impact of this Court’s decision and the effect of restoring the NOP to its pre-lawsuit terms. Congress then amended the OFPA, changing and repealing the specific statutory language that this Court found was in conflict with the NOP rules. The sole purpose of the 2005 OPFA amendments was to address this Court’ s concerns by changing the - 5 - language relied on by this Court in order to permit USDA to retain its rules and to meet the June 2006 deadline imposed by the district court’s Final Order. Abiding by the language of the amended OFPA and Congress’s plain intent, the USDA issued a final rule that announced that the treatment of synthetic substances was unchanged from its pre-lawsuit status. Harvey asks this Court to unwind this remarkable example of coordination between the three branches of the federal government that resolved a significant threat to a vital new industry and restored 12 years of citizen advisory board work and notice and comment rulemakings. Moreover, he asks this court to engage in a freewheeling review of the 2005 amendments to the OFPA unconstrained by the deference typically due a federal agency undertaking rulemaking authorized by Congress and the deference due a district court construing its own orders. Harvey likewise disregards the context of the OFPA amendments and the impact of misreading them on the industry that must live with the final agency rules. Congress agreed with this Court’s January 2005 analysis of the OFPA and enacted the 2005 OFPA amendments to remove the - 6 - language that this Court found inconsistent with the agency’s rules. Congress thus intended that the USDA leave intact the NOP’s basic scheme that had been adopted in 2002, after ten years of public meetings and rulemakings. The existing labeling scheme authorized the limited use of synthetic substances in organic food processing, including the use of substances used as either ingredients or processing aids. Indeed, what makes Harvey’s argument so odd is that Congress has never sharply distinguished between substances used as either ingredients or processing aids in the OFPA – as Harvey believes – and instead has ordered that any gap in detail regarding usage of substances be filled by the agency and the National Organic Standards Board (“NOSB”). See 7 U.S.C. § 6517(b) (requiring Secretary to decide “the use or application, of each synthetic substance”). Finally, Harvey’s argument that in 2005 Congress amended the OFPA to explicitly allow the use of synthetic substances as “ingredients” but to prohibit them as “processing aids” was rejected by the district court because it flatly misapplied this Court’s construction of the OFPA and ignored Congress’s plain focus on remediating the impact of this Court’s ruling on this federal program. (Harvey Br. App. - 7 - 1 at 8-9 n.6.) In Harvey’s view, the 2005 amendments left intact the NOSB and agency authority over substances used as ingredients and processing aids generally, but stripped it only with regard to processing aids in one of the four labeling tiers. Such a strained reading of the amendments would create a new, arbitrary asymmetry in the organic labeling rules and would place the amendments at odds with the purposes and structure of the OFPA, where Congress placed great confidence in the public-private partnership that underpins the National List decisions. Accordingly, this Court should affirm the district court’s conclusion that its Final Order was fully complied with, and hold that Harvey’s motion to enforce was properly denied. ARGUMENT1 I. CONGRESS ACTED IN RESPONSE TO THIS LITIGATION AND PROMPTLY AMENDED THE OFPA TO REMOVE THE CONFLICT IDENTIFIED BY THIS COURT’S OPINION. With the November 2005 amendments to the OFPA, Congress eliminated the inconsistency between the agency’s final organic rules 1 Amici herein identify and focus on the grounds upon which the District Court’s decision should be affirmed. For a more detailed review of the First Circuit authority as applied to the arguments advanced by Harvey, see Consolidated Reply Pleading of Amici (Sept. 11, 2006) (Dkt. 113). - 8 - and its authorizing statute, the OFPA, that this Court identified in the first Harvey decision. See 2006 Agriculture Appropriations Act, Pub. L. No. 109-97, Title VII, §§ 724, 797(a), 119 Stat. 2165 (Nov. 10, 2005); Harvey, 396 F.3d at 40. The legislative history and court-related context in which the 2005 amendments were enacted, the tailoring of the amendments to the sections relied upon in this Court’s opinion, and the district court’s own determination that its Final Order was fully complied with, inescapably demonstrate that the district court properly rejected Harvey’s motion to reopen the case to force a different outcome. (Harvey Br. App. 1 at n.6 (summarizing reasons).) See generally Agostini v. Felton, 521 U.S. 203, 215 (1997) (noting that modification of a consent decree may be warranted when the statutory or decisional law has changed to make legal what the decree was designed to prevent); Firefighters Local Union No. 1984 v. Stotts, 467 U.S. 561, 576 n. 9 (1984) (noting that authority to “adopt a consent decree comes only from the statute which the decree is intended to enforce, not from the parties' consent to the decree”) (citation and internal quotation marks omitted); Frew ex rel. Frew v. Hawkins, 540 U.S. 431, 441 (2004) (noting - 9 - that federal rules authorize dismissal when “it is no longer equitable that the judgment should have prospective application”). A. Congress Completed the Authorization to USDA to Allow the Use of Synthetic Substances in the “Organic” Products Labeling Tier and Did Not Intend to Distinguish Between Ingredients and Processing Aids in the 2005 Amendments In Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005), this Court generally approved the NOP’s four labeling tiers or classes for organic products, where the authorized labeling claims are based on the percentage of organic content. Harvey, 396 F.3d at 36-37; see also Consolidated Reply Pleading of Amici (Sept. 11, 2006) (Dkt. 113). The opinion also affirmed the reliance on the National List of Allowed and Prohibited Substances, noting the OFPA “does not prohibit the addition of synthetic substances to foods.” Harvey, 396 F.3d at 36-37. However, the Court also held that the use of synthetic substances in products in the third labeling tier or class — the “organic” or 95% organic content class — was in conflict with the OFPA. Although the substances had been properly recommended by the NOSB, and were properly adopted under the criteria for inclusion on the National List, this court concluded that two specific provisions of the OFPA – 7 U.S.C. §§ 6510 - 10 - and 6517 – forbid their addition to products in the top two organic labeling tiers. Id. at 39. Following this Court’s identification of the limited conflict between the rules and the statute – and before the USDA had acted to change its existing rules – Congress amended the language of § 6510 relied on by the Court and repealed the language of § 6517 relied on by the Court. See Pub. L. No. 109-97, Title VII, §797(a), 119 Stat. 2165 (Nov. 10, 2005). The amendments were requested by the organic community and did not depend in any way on the agency’s distinction between substances used as “processing aids” or “ingredients.” See id. § 797(a), 119 Stat. 2165. Indeed, Congress did not use either term in the 2005 amendments. This is not surprising. As the district court correctly noted, the distinction between ingredients and processing aids that Harvey claims Congress intended in the amendments is one that Congress has never before drawn, and did not draw in November 2005. (Harvey Br. Add. 1 at 6-7.) In fact, Congress ratified the approach taken under the OFPA since 1990 by leaving unchanged the requirement that the NOSB and the Secretary determine the use to which an approved synthetic - 11 - substance may be put. See 7 U.S.C. § 6517 (b) (noting the Secretary must create a National List that identifies the substance and its “specific use or application”); 7 C.F.R. § 205.605 (“substances may be used . . . only in accordance with any restrictions specified in this section”). Thus, Congress has always delegated to the USDA and NOSB the role of defining usages of synthetic substances and has declined to define the terms “ingredient” and “processing aid,” or give those terms any special emphasis or meaning in the OFPA. Rather, the terms ingredient and processing aid were created by the USDA when implementing the OFPA to harmonize with the FDA’s definitions. The agency’s definitions and interpretation of those definitions within the legislative scheme is entitled to considerable deference. See Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512 (1994) (courts owe “substantial deference to an agency's interpretation of its own regulations.”); Visiting Nurse Ass’n Gregoria Auffant, Inc. v. Thompson, 447 F.3d 68, 72 (1st Cir. 2006) (same). In addition, in the same legislation that enacted the 2005 Amendments, Congress issued instructions to the USDA that confirm the 2005 amendments were meant to remove the conflict identified by - 12 - this Court in Harvey and restore the NOP to its pre-lawsuit status: SEC. 724. The Secretary of Agriculture shall-- (1) as soon as practicable after the date of enactment of this Act, conduct an evaluation of any impacts of the court decision in Harvey v. Veneman, 396 F.3d 28 (1st. Cir. Me. 2005); and (2) not later than 90 days after the date of enactment of this At, submit to Congress a report that-- (A) describes the results of the evaluation conducted under paragraph (1); (B) includes a determination by the Secretary on whether restoring the National Organic Program, as in effect on the day before the date of the court decision described in paragraph (1), would adversely affect organic farmers, organic food processors, and consumers . . . Pub. L. No. 109-97, Title VII, § 724, 119 Stat. 2165 (Nov. 10, 2005). The Secretary submitted the above-mentioned report, which is titled in part “Restoring the NOP to Pre-Lawsuit Status,” to Congress in March 2006. The report concluded that the November 2005 amendments that restored the NOP served the public interest, restored transactional stability to the marketplace and improved the “climate for continued growth and investment in a unique market opportunity for U.S. agriculture in today’s business climate.” See A Report to Congress: - 13 - The National Organic Program Impact of Harvey v. Johanns and Restoring the NOP to Pre-Lawsuit Status, at 2-3 (March 2006) available at http://www.ams.usda. gov/nop/NOPCongress Study1_06_06.pdf. No member of Congress objected to or questioned the report’s conclusions. In addition, the conclusion that was submitted by USDA to Congress was echoed by the Congressional Research Service. The Service has twice recognized that the effect of the 2005 amendments was to restore the NOP to its pre-lawsuit status. See Vina, S., Harvey v. Veneman, and the National Organic Program: A Legal Analysis, CRS No. RS22318 (November 18, 2005) at 5-6; Rawson, J., Organic Agriculture in the US: Program and Policy Issues, CRS Report RL31595 (November 3, 2005) (noting that “the overall effect of [the 2005 amendments] is to change the statutory language to make moot the latter two of the three court holdings”). Finally, after submitting the report to Congress, the Secretary proceeded with notice and comment rulemaking to fulfill the terms of the district court’s June 2005 Final Order. See 71 Fed. Reg. 24820, 24821 (April 27, 2006). (Harvey Br. Add 3.) After receiving and reviewing all comments, the Secretary issued a Final Rule in June - 14 - 2006. The Final Rule provided: 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 on the National List and their ability to carry the USDA seal. Therefore, USDA is not revising the NOP regulations to prohibit the use of synthetic ingredients in processed products labeled as organic nor [to] restrict these products’ eligibility to carry the USDA Seal. 71 Fed. Reg. 32803 (June 7, 2006). In the context of this Court’s earlier decision, which is specifically mentioned by Congress, the purpose of the 2005 amendments is hardly questionable: Congress addressed this Court’s concerns and intended to replace the deficient parts of the OFPA by enacting corrective legislation to permit the federal organic program to continue as before. (Harvey Br. Add. 1 at n.6.) Any other reading of the two sections in Public Law No. 109-97, §§ 724 and 797, would fail to capture the link Congress drew between its amendment of the OFPA and its command that the consequences of not adopting the restorative amendment be evaluated. This is one of those rare instances where Congress specifically and expressly relied on the relevant court opinion to frame the changes it sought through its amendments. - 15 - B. This Court Did Not Draw A Distinction Between “Ingredients” and “Processing Aids” But Treated Both as “Substances” When It Analyzed the OFPA And This Result is Binding on the District Court and The Parties. This Court’s earlier Harvey opinion noted that the gravamen of Harvey’s attack on 7 C. F.R. §205.600(b) and §205.605(b) was that the cited rules allowed “synthetic substances to be used in processed foods,” Harvey v. Veneman, 396 F.3d at 38, and that at bottom he had stated a single claim that § 6510’s prohibition on the addition of “any synthetic ingredient” barred the addition of synthetic substances by food processors regardless of the reason for which the substance was added.2. Harvey v. Veneman, 396 F.3d at 39. 2 Harvey repeatedly cites 7 U.S.C. § 6504’s general prohibition on the use of synthetic substances. But he overlooks that this Court never mentioned § 6504 in its analysis of the statutory exceptions that authorize the use of synthetic substances. Instead, the Court relied on § 6510 and described it as constituting a “general prohibition.” Harvey v. Veneman, 396 F.3d at 39. This Court correctly reached that conclusion because § 6504 authorized the addition or use of synthetic substances in accordance with the other, more specific, statutory sections ultimately construed in the Court’s opinion. Further eroding the limited grounds upon which Harvey’s attack rests, the opinion concluded that under the existing rules synthetic substances may be used in processing and noted that the rules list “thirty eight synthetic substances” that may be used in the “made with organic ingredients” tier products. Harvey v. Veneman, 396 F.3d at 38-39. - 16 - Moreover, in its amended opinion, this Court clarified that it had not drawn any distinction between “processing aids” and “ingredients.” Harvey, 396 F.3d at 38-39. Instead, the Court relied on the term “substances” as is more generally used throughout the OFPA. Id. Most importantly, this Court never ruled that the use of synthetic substances or the criteria by which they are allowed (appearing in the agency’ s rules at §205.600(b) and §205.605(b)) were entirely invalidated. Instead, the Court generally affirmed the rules, holding the sole issue was the limited use of otherwise acceptable synthetic substances in products belonging to the “organic” labeling tier, and that issue did not require analysis of the terms “ingredient” and “processing aid.” Harvey, 396 F.3d at 36-38; see also 7 C.F.R. §205.301(b) (Product Composition). (Harvey Br. Add. 1 at 7.) C. The District Court’s Order on Remand Did Not Create a Distinction Between “Ingredients” and “Processing Aids Under This Court’s Ruling, and the OFPA and Congress Did Not Create One in the 2005 Amendments Harvey’s arguments turn on the district court’s use of the terms “ingredients” and “processing aids” in the district court’s June 2005 final order. (Harvey Br. 8-9.). In essence, Harvey argues against interpreting the 2005 amendment in the context of this Court’s earlier - 17 - analysis and Congress’s instructions to the agency, and against the agency’s report to Congress and the legal conclusions of the Congressional Research Service. Instead, Harvey argues the 2005 amendments should be interpreted based on immaterial references to ingredients and processing aids made in the district court’s Final Order following remand. The best evidence that Harvey’s construction of the district court’s Final Order is wrong is the district court’s rejection of it. (Harvey Br. Add. 1 at 7.) The district court noted that there was nothing to suggest Congress intended to adopt the district court’s passing reference to ingredients and processing aids as reflecting some kind of effort to pass the OFPA in a manner inconsistent with this Court’s earlier Harvey opinion. (Harvey Br. Add. 1 at 7-8.) If the Court that entered the Order discounts the reference to ingredients and processing aids in its own Order, it would be odd indeed to be reversed for failing to enforce a distinction that this Court, the district court and Congress have never considered material. Furthermore, nothing in the district court’s remand order may conflict with this Court’s mandate and thus any attempt by Harvey to use the district court’s order to rebut this Court’s plain acceptance of - 18 - USDA’s treatment of “processing aids” and “ingredients” under the allowance for synthetic substances is unavailing. See United States v. Rivera-Martinez, 931 F.2d 148, 150 (1st Cir. 1991) (noting that “when a case is decided by an appellate court and remanded any questions that were before the appellate court and disposed of by its decree become the law of the case and bind the district court on remand.”) (citations omitted). This Court relied on §§ 6510 and 6517 and both were amended by Congress to restore the pre-existing rules that underpin the boom in organic product sales. The district court’s happenstance use of the terms “ingredients” and “processing aids” in its remand order cannot override this Court’s opinion or the intent of Congress. D. Failing to Treat “Ingredients” and “Processing Aids” As Substances Under the OFPA Leads to Unreasonable Results and Undermines The Careful Line Drawing Between the Product Tiers Commanded by Congress and Implemented by USDA. Harvey’s persistently wooden construction of the amended OFPA also ascribes to Congress a patently bizarre intent – that organic food processors may add up to 5% synthetic substances as “ingredients” in organic food products under § 6510 but may not use any synthetic substances as “processing aids” that do not even appear in the final - 19 - food product. Such a construction cannot stand. See Sullivan v. CIA, 992 F.2d 1249, 1252 (1st Cir. 1993); compare 7 C.F.R. § 205.100(2) (ingredient: “still present” in consumed product; processing aid: “removed . . . from the food before it is packaged”). Harvey nowhere identifies a rational policy purpose that would be served by letting organic consumers consume a synthetic substance as an “ingredient” but not allow the use of such substances as “processing aids” that no consumer ever eats or touches. Instead, Harvey illogically claims that permitting the use of synthetic “processing aids” in the “organic” product class would mean consumers would have no way to know when synthetic substances have been included in their organic food products because, unlike ingredients, processing aids are not listed in the product’s ingredient label. (Harvey Br 25.) This argument fails for two reasons. First, “processing aids” by NOP definition are removed from the product or converted to constituent elements in the food and thus are not present when the final product is purchased by consumers. See 7 C.F.R. § 205.2 (definition of “processing aid”). Thus, no disclosure benefit arises even if Harvey’s argument is accepted. Second, Congress and the USDA - 20 - have already adopted an organic product labeling tier by which consumers may select products that are completely free of any synthetic substances, whether considered ingredients or processing aids: the “100% organic” label. See 7 CFR § 205.301(a). It would strain credulity to find that Congress intended to erase the prohibition on the use of synthetic substances for the third labeling tier identified by this Court while imposing a new prohibition on only those substances used as “processing aids.” It is even stranger to assume Congress intended an outcome that would erase a key distinction for products in the highest labeling tier that have always been required to be formulated with no synthetic substances. See 7 C.F.R. § 205.301 (Product Composition). In sum, Harvey fails to identify a rational governmental or commercial reason for disrupting the symmetry that exists in all labeling tiers – that allows synthetic substances appearing on the National List to be used as either ingredients or processing aids – and replace it with a “processing aids” prohibition that is not only damaging to businesses relying on the current rules, but provides no consumer benefit and is illogical. - 21 - II. HARVEY’S CLAIM REGARDING THE FOOD CONTACT SUBSTANCE POLICY WAS NOT PART OF THE CONSENT JUDGMENT AND IS NOT PROPERLY BEFORE THE COURT It is axiomatic that the district court does not have the power to issue rulings, on a motion to enforce a final judgment and order, on issues that were not presented to the court and made part of that final judgment and order. See Dankese v. Defense Logistics Agency, 693 F.2d 13, 16 (1st Cir. 1982) (noting authority to enforce court decrees is limited to terms incorporated into order). Harvey argues that, regardless of whether the issue was litigated, or whether the district court ruled on the issue, the language of the district court’s Final Order is broad enough to permit Harvey to raise the issue now. (Harvey Br. 40.) This argument is meritless. As the district court noted, review of the Food Contact Substances policy requires analysis of facts that were not before the court for review. (Harvey Br. Add. 1 at 11.) An agency record on this issue does not exist before this Court. See Massachusetts ex rel. Div. of Marine Fisheries v. Daley, 170 F.3d 23, 28 n. 4 (1st Cir. 1999). Nor did the district court make findings on this issue in its rulings. (Harvey Br. Add. 1 at 10-11). - 22 - Any review of the Food Contact Substances policy would require a factual record that is not before this Court and it is simply too late in the course of these proceedings to begin developing a new factual record to address matters not part of the district court’ s Final Order. If Harvey intended to pursue a challenge to the Food Contact Substance policy, he should have presented that issue in his complaint and, at a minimum, sought a ruling on the issue after remand and before the district court’s June 2005 Final Order. See generally Rodriguez v. Doral Mortg. Corp., 57 F.3d 1168, 1174 (1st Cir. 1995) (theories not presented at trial may not be litigated later.); Diaz-Fonseca v. Puerto Rico, 451 F.3d 13, 42 (1st Cir. 2006) (“The judgment in a suit for declaratory judgment must be responsive to the pleadings and issues presented[,] and . . . a judgment which goes beyond the issues presented constitutes an advisory opinion upon a hypothetical basis, which the court cannot give.”). At this point, the proper avenue to challenge the policy is to bring a new action, not to raise the matter on a motion to enforce a final order addressing entirely separate issues. Finally, as a policy matter, this Court should decline to consider this issue because food contact substances are addressed in food law - 23 - generally and the OFPA contains no language to suggest Congress intended the volunteer NOSB to review substances that play no role in the organic content calculations that underpin the four-tiered organic labeling scheme, and that Congress considers too insignificant to review for food safety purposes. See 21 U.S.C. § 348 (h) (6) (defining “food contact substance” as “materials used in manufacturing, packing, packaging, transporting, or holding food” provided they provide no “technical effect in such food.”); accord, 21 C.F.R. § 170.39; see also Food Additives: Food Contact Substance Notification System, 67 Fed. Reg. 35724, 35724 (May 21, 2002). The FDA has determined that such substances are “a component of food at levels that are below the threshold of regulation,” 21 C.F.R. § 170.39, and there is no reason to impose on organic products a different standard than those that apply to other food products in this regard. Moreover, regardless of whether the language of the OFPA can be stretched to prohibit the inclusion of food contact substances, the USDA is authorized to recognize de minimis exceptions to federal statutes to avoid absurd results. The lead case on this point is Monsanto Co. v. Kennedy, 613 F.2d 947, 954, (D.C. Cir. 1979). In that case the D.C. - 24 - Circuit exhaustively reviewed an FDA decision under a statutory provision that contained an absolute prohibition and concluded that the agency had discretion to determine de minimis departures from a rigid statutory proscription to avoid paralyzing results with regard to remote possibilities of migration of tiny amounts of substances. The First Circuit has endorsed a similar approach. Sullivan, 992 F.2d at 1252 (“the plain meaning rule…may yield if giving effect to literal meaning would produce a bizarre result.”) In this case, Congress plainly authorized the presence of 5% synthetic substances as ingredients (permanently added to the product) and processing aids (used to make the product and then removed). A holding that prohibited food contact substances – substances that may not even actually touch an organic product – would produce precisely the sort of absurd result that authorizes the USDA to make a de minimis exception to the rule. Sullivan, 992 F.2d at 1252. CONCLUSION The judgment of the district court should be affirmed. - 25 - Respectfully submitted, _______________________ William J. Friedman, No. 117050 Richard D. Dietz, No. 118048 Covington & Burling LLP 1201 Pennsylvania Avenue, NW Washington, D.C. 20004-2401 (202) 662-6000 Dated: April 4, 2007 Attorneys for Amici Curiae - 26 - CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION, TYPEFACE REQUIREMENTS, AND TYPE STYLE REQUIREMENTS 1. This brief complies with the type-volume limitation of Fed. R. App. P. 32(a)(7)(B) and Fed. R. App. P. 29(d) because this brief contains 4,842 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 has been prepared in a proportionally spaced typeface using Microsoft® Office Word 2003 in 14 point, Century Schoolbook font. _________________________ William J. Friedman Attorney for Amici Curiae - 27 - CERTIFICATE OF SERVICE The undersigned attorney certifies that on the 4th day of April, 2007, I caused two copies of the foregoing Amicus Curiae Brief to be served by e-mail attachment and first- class mail to: Paula Dinerstein First Circuit Bar No. 97079 Public Employees for Environmental Responsibility 2000 P St., N.W., Suite 240 Washington, DC 20036 Halsey Frank, AUSA U.S. Attorney’s Office 100 Middle St. Plaza, 6th Floor East Tower Portland, ME 04101-5018 _________________________ William J. Friedman Attorney for Amici Curiae - 28 -