# Petition — National Pork Producers Council v. Block > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385007_0749%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition - **Published:** January 1, 1981 - **Citation:** 450 U.S. 912 ## Text 1, i supreme Lourt, U. 9. FILED 80-74 NOV 10 1980 Mo. 742 —— ye insscsscompicos JR., CLERK Iu the Supreme Court of the United States Octoser TERM, 1980 NATIONAL PORK PRODUCERS COUNCIL, CHARLES GRASSLEY, THOMAS HAGEDORN, and STEVEN SYMMS, Petitioners, vs. BOB BERGLAND, Secretary of Agriculture, CAROL TUCKER FOREMAN, and DONALD H. HOUSTON, Respondents. PETITION FOR WRIT OF CERTIORARI TO THE COURT OF APPEALS FOR THE EIGHTH CIRCUIT DONALD P. COLLETON Counsel of Record JAMES L. FOX ABRAMSON & FOX One East Wacker Drive Chicago, Illinois 60601 (312) 644-8500 Attorneys for Petitioners UNITED STATES LAW PRINTING CO., CHICAGO, ILLINOIS 60618 (312) 525-6581 QUESTIONS PRESENTED FOR REVIEW Whether the court of appeals in its review of United States Department of Agriculture rulemaking has itself, in disregard of Overton Park*, arbitrarily exposed the American consumer to the deadly hazards of botulism. Whether USDA exceeded its authority in promoting sales of unpreserved foods through a rule which needless- ly jeopardizes public health. Whether the decision below permitting USDA to omit assessment under the National Environmental Policy Act of a department rule’s public health impact conflicts with the construction placed on NEPA by other circuits and if so whether this Court should resolve the conflict. PARTIES Petitioners NationaL Pork Propucers CounciL CuHarLes Grasstey M.C. Tuomas Haceporn M.C. Steven Syms M.C. Respondents Bos Brerciand, Secretary of Agriculture Caro, Tuckrr Foreman, Assistant Secretary of Agricul- ture Donatp H. Houston, Acting Administrator of the Food Safety & Quality Service within the Department of Agriculture * Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971). iil TABLE OF CONTENTS PAGE a cia cpnninaysancoctconcectnncnesvere v Constitutional Provisions and Statutes -......00020020....... vii ness sncesesdacousonsnsonicosiesenebtvsceanse 2 EE NDE SOL OO 2 Statutory Provisions Involved ~.......22...2....:.:c:ccceeceeeeeees 2 Statement of the Case —..0.0.0.000.0.000...0.. STL A ee ee 2 The Proceedings and Jurisdiction of the Court a cicaecipecedteionccemuevchdoarsenaeomenecensvees 2 RESTS SO a ote CE 3 | ee 3 Se nos sceussbhsseneneseactee 3 C. The Rulemaker’s Explanation ...................... 7 D. Final Impact Statement ..............................0 8 EK. The District Court’s Review ....................... 9 F. The Circuit Court’s Review .......................--- 10 Reasons for Granting the Writ 2.002000... cece 11 I. The Department’s Disregard of Relevant Factors Violates the Requirements of Over- ton Park and Seriously Jeopardizes Con- sumer Health and Safety -.....0020200200..... 11 a) Labeling efficacy overlooked ...................... 12 b) Botulism risk overlooked ..........0................. 18 PREVIOUS PAGE WAS BLANK | iv PAGE II. The Department Exceeded its Authority by Promulgating the Rule for an Unlawful RR EEE ENC oe ea OE 2 is 22 III. This Court Should Resolve the Conflict Be- tween the Circuits Regarding the Require- ments of ihe National Environmental Policy BE siieenientprerhcaiigtadectighi bia a iat eke idathbandibals 24 PLR ae AL SCI SLD NR RT 26 Appendix Opinion of Court of Appeals (8th Cir. September SINUS Lalinscsdinnntdal schaticsadraalesteglbhahacsnsigakss clade App. 1 Final Ruling and Order (S.D. Ia. February 12 OD pains aconidnhcaccindarndadabedebicated dtspacsnsdh App. 21 NIE. ities dibdencdeetiniacoedcied. icledbbecitaen App. 48 pe ADSI re Ponte) RR Li App. 48 ee eR OP Chia ee Scie ae FPA WRU App. 50 OP Shae SOROe ksi App. 51 Notice of Proposed Ruiemaking, 43 Fed. Reg. 18193-18195 (April 28, 1978) 2.0.o.u........ccccscececoeee App. 52 Selected Comment RENT RN OR Ah EP SN eR App. 60 RII: III. seciehseensoenihidimibiin, slbidlicsephaidias tec anlar el tree App. 65 fe TS IETS TER, AER! App. 70 Final Impact Statement, June 14, 1979 .................... App. 72 Final Rule and Preamble, 44 Fed. Reg. 48959- 48961 (August 21, 1979), 9 C.F.R. §§317.17(b) ec. ec cc Oe I Oe Ma App. 83 Transcript Excerpts (November 9, 1979) ............ App. 94 Vv TABLE OF CASES PAGE Angel v. Butz, 487 F2d 260 (10th Cir. 1973), cert. de- I Er is PE CED iasektcch dicing -ncgeeecdteeestiicnlenes 15 Asarco, Ine. v. E.P.A., 616 F2d 1153 (9th Cir. 1980)... 11 Burlington Truck Lines v. U. S., 371 U.S. 156 (1956)..15, 16 Camp v. Pitts, 411 U.S. 138 (1973) .................cccescecscswese 13 Citizens to Preserve Overton Park v. Volpe, 401 U.S. ag 5 rae nape ne eee 11, 12, 13, 16, 18, 25, 26 Environmental Defense Fund v. E.P.A, 465 F2d 528 See ONIN UPI igiictroac% scscetdatireneniaeaennntepoas ipitamelaninnenlinbis 17 Environmental Defense Fund, Inc. v. Ruckelhaus, 439 ee SNe TE) 5 cekincnsdeataceniincnnidaieseobalaevies 15 Federal Security Administrator v. Quaker Oats Co., ST, SIR scenic 18 Federation of Homemakers v. Butz, 466 F2d 462 (D. Se TE UE UE sukahiecs sie ecenctamhalantstdlaminiliptasntiineedinbamaiaabinnniianipnen 18 First National Bank of Fayetteville v. Smith, 508 F2d 1371 (8th Cir. 1974), cert. denied, 421 U.S. 930 (1975) 11 Pw, Deen BAF UE. BO CORT OD, secctecectessecenncicrsenscsccns 25 Greene County Planning Board v. FPC, 455 F2d 412 (2nd Cir.), cert. denied, 409 U.S. 849 (1972) ............ 25 Hiatt Grain and Feed, Inc. v. Bergland, 602 F2d 929 (10th Cir. 1979), cert. denied, ...... US. ..... (1980) ... @ Houston v. St. Louis Independent Packing Co., 249 Ek, HAE. GNI, “scccsdinchdsveahctdeebeuiiasnaveneirs tasipiiohecsiadninbenstginnnns 18 Karlen v. Harris, 590 F2d 39 (2nd Cir. 1978) .............. 25 National Nutritional Foods Ass’n. v. Weinberger, 512 F2d 688 (2nd Cir.), cert. denied, 423 U.S. 827 STR scene iiaicttedesninheiiipigiionaiecioinniteiatiieigientniesectnsentiiaiata 15, 16 vi PAGE National Organization for Reform of Marijuana Laws v. U. S., 452 F. Supp. 1226 (D.D.C. 1978)... 25 Nucleus of Chgo. Homeowner Assn. v. Lynn, 524 F2d 225 (7th Cir. 1975), cert. deneid, 426 U.S. 939 ( 1976) 24 Phelps Dodge Corp. v. NLRB, 313 U.S. 177 (1941) ... 21 Poleover v. Sec’y of Treasury, 477 F2d 1223 (D.C. Cir.) cert. denied, 414 U.S. 1001 (1973) 00. 11 Rodway v. USDA, 514 F2d 809 (D.C. Cir. 1975) ........ 22 Sabin v. Butz, 515 F2d 1061 (10th Cir. ae 13 Scientists Institute for Public Information v. Atomic Energy Commission, 481 F2d 1079 (D.C. Cir. 1973) 24 SEC v. Chenery, 318 U.S. 80 (1943) ——a_ ~ { SEC v. Chenery, 332 U.S. 194 (1947) 000. 15, 22 Sec’y of Agriculture v. U. S., 347 U. S. 645 (1954) ... 15 Steubing v. Brinegar, 511 F2d 489 (2nd Cir. 1975) ... 25 S. W. Neighborhood Assembly v. Kekard, 445 F. Supp. ee NRE TN Soe REE LS 25 Tabor v. Joint Board, 566 F2d 705 (D.C. Cir. 1977 )..22, 25 Trinity Episcopal School Corp. v. Romney, 523 F2d CS (Ue Gi CIGD anit ee 24 U. S. v. Chgo. Milwaukee, St. Paul & Pac. Ry., 294 SS: | ern Wee Ft eS 15, 22, 25 U. S. v. Neva Scotia Food Products Corp., 568 F2d 240 (2nd Cir. 1977) .............. linsentilpinkcesiaiegiiitbinahieeliditaai’ 13, 14 Vermont Yankee Nuclear Power Corp. v. NRDC, 435 Ci SOD GD di hei ee 11, 13, 26 Wagner Electric Corp. v. Volpe, 466 F2d 1013 (3rd Ce: SE ‘ncaa seciensiditiiitetadericleitihatiniagi 22 Wellford v. Ruckelhaus, 439 F2d 598 (D.C. Cir. 1971) 20 Vil Constitutional Provisions and Statutes PAGE Be III. “ohisteceth sho hianntedins cinbeonqaniaphisinadtiiuecnsonadveen illtinaisiniessions 22 Oh I III wikis sccpens deitcrsaprisiionsvvbecinnaspenecahnsnedthivenseigies 3 Ts ENE TET © scestienenonstblegoentinillighensdikceceisinhonéguinnen cote 26 Bt GI wired cen tocercinstnstios hicinieeibinbatbenabiconnteaienaas 3 EEE MIE BD “oases ccediscnqusdvthcningiaitlinntsdncunecanainesotoeininaniie 2 SE AIEEE | cdbcsscisshiietscsdvaescicnens conse Leeenennateinbvtiotoastesephiboekis 3 28 U.S.C. §§1331, 1332, 1837 and 2201-2202 ................... 3 Br NII ic ras bsosavadiniedianeaeaobarbectusisaienaectannnisedeiionnied 24 9 C.F.R. §§317.17(b) and (c) and 319.2 ......................... 2 40 C.F.R. 1501.4(¢c) and (e) and 1508.19 ....................... 24 Oe EIN aria icecachiencesipeseexatinssonannetenioinaionts 25 39 Fed. Reg. 18680 (May 29, 1974) .W.2... eee 20 43 Fed. Reg. 21987 (May 22, 1978) .20.0..........sccc-seececeneee 20 Iu the Supreme Court of the United States OctrosEerR TERM, 1980 No. NATIONAL PORK PRODUCERS COUNCIL, CHARLES GRASSLEY, THOMAS HAGEDORN, and STEVEN SYMMS, Petitioners, vs. BOB BERGLAND, Secretary of Agriculture, CAROL TUCKER FOREMAN, and DONALD H. HOUSTON, Respondents. PETITION FOR WRIT OF CERTIORARI TO THE COURT OF APPEALS FOR THE EIGHTH CIRCUIT TO: The Honorable Chief Justice of the United States and the Associates Justices of the Supreme Court of the United States: Petitioners respectfully pray that a Writ of Certiorari issue to review the opinion of the United States Court of Appeals entered September 23, 1980, reversing the perma- nent injunction of the district court in Des Moines. 2 OPINIONS BELOW The district court’s opinion is published at 484 F. Supp. 040 (S.D. Ia. 1980). The opinion of the court of appeals has not been officially published. Both opinions appear in the Appendix. JURISDICTION The decision of the court of appeals was entered on September 23, 1980 within ninety days of which this peti- tion has been filed. Jurisdiction in this Court is invoked under 28 U.S.C. §1254(1). STATUTORY PROVISIONS INVOLVED This petition involves: 9 C.F.R. §§317.17(». and (c) and 319.2 5 U.S.C. $553 5 U.S.C. §706(2) (A) 42 U.S.C. $4332 40 C.F.R. 1501.4(c) and (e) and 1508.13 These provisions appear in the Appendix. (Emphasis added throughout unless otherwise indicated ) STATEMENT OF THE CASE Proceedings and Jurisdiction of the Court Below On September 20, 1979 the Natrona, Pork Propucers Councu. and three United States Congressmen brought suit in the Southern District of Iowa to enjoin, as arbitrary and capricious, a United States Department of Agriculture (Department) labeling regulation, 44 Fed. Reg. 48959-61 (August 21, 1979), 9 C.F.R. §317.17(b) and (c) and 3 $319.2 (the Rule), App. 91-93, which permits nitrite-free foods to be sold under the guise and name of traditional nitrite preserved foods. Jurisdiction was invoked under 21 U.S.C. $674, 5 U.S.C. $§$701-706 and 28 U.S.C. §1331, 1332, 1337 and 2201-2202. On February 12, 1980 the dis- trict court permanently enjoined enforcement or applica- tion of the rule. App. 21-47. The government appealed basing jurisdiction for appzal on 28 U.S.C. §1291. On September 23, 1980, a panel of the Eighth Circuit re- versed, App. 1-20, but upon petitioners’ motion has stayed issuance of its mandate pending consideration of the case by this Court. THE FACTS A. Botulism and Nitrite Clostridium botulinum, a bacterium considered present in all raw foods, produces a deadly toxin known as botulin in a short period of time at elevated temperatures in the absence of molecular oxygen. When added to food as a preservative, nitrite salts have proven highly effective in inhibiting the production of botulin in meat products. As a result popular nitrite-cured products such as frank- furters, cold cuts and bacon can be and are sometimes, perhaps often, handled safely in unrefrigerated ways which without nitrite could promote the formation of botulin. B. The Rulemaking On April 28, 1978 the Department’s Food Safety & Quality Service proposed the challenged Rule, App. 52-59, in response, according to the Court below, App. 13-16, to suggestious by some that ‘‘nitrite-free products were dif- ficult to locate or not available.’’ App. 15. Under the proposal, nitriteless meat products could have the same 4 flavor, consistency and name of meats preserved with nitrites provided labeling disclosed the absence of nitrite and called for refrigeration below 40° F. The proposal drew 365 comments. Among others, these concerns were expressed: (1) The proposed cautionary labels will not be read at all by many. A variety of reasons for this was suggested. Some habitually do not read labels. Others, because of illiteracy, old or young age or language barriers, cannot read them. The presence of familiar color, form, and texture, coupled with the common name, will implicitly persuade still others that the product is the familiar one and hence there is no rea- son to search the label for new, special handling in- structions. (2) Some who read the label wil] not understand the disclosures. (3) Some who read and understand the label dis- closures, will, not unreasonably, be skeptical because everything else about the apparently familiar product will seem to contradict the warning. (4) Consumers will be greatly confused. (5) Because many consumers have long learned prac- tices of handling cured products in ways that would be hazardous without nitrite, the proposed label dis- closure will not suffice to protect against botulism. As a result, the Rule will injure consumers and the entire meat industry. See, e.g., Comments 97, 130, 169, 174, 175, 182, 186, 190, 197, 199, 206, 252, 253, 257, 258 (App. 60), 260 (App. 65), 273, 280 (App. 70), 290, 291, 298, 324, 329 and 352. The same concerns were later reiterated at a meeting of the Department’s Meat and Poultry Advisory Committee, attended by respondents Houston and Foreman. v To illustrate, a public interest group wrote: ‘‘The consumer who is accustomed to leaving cold cuts or frankfurthers exposed and is uncautious with left- overs is unlikely to change his or her habits when pre- sented with what appears to be the same product, with the addition of a warning label. The required duplication of the original product in color, form and texture, coupled with the use of the same product name, will promote acceptance; the con- sumer’s familiarity with the product, however, will reduce the likelihood that the label will be read for new requirements of product use. ‘¢ Assuming the label is read, there is the added prob- lem of consumer skepticism or indifference. Products which have been widely used and accepted have sud- denly been proclaimed ‘unsafe’ and a rash of new warning labels have appeared. The result is that the labeling device is losing credibility, as is apparent with cigarette and saccharin warnings. Where there is no apparent product change, the consumer may ig- nore any warnings or directions on new use or new dangers of products, assuming that they are merely new warnings attached to an old product which they know how to use. ‘‘The proposed rule would allow both the product cured with nitrite and the product preserved without or with low levels of this substance to be available to cousumers, and to be marketed under the self-same name. The potential for misuse and confusion seems obvious where consumers are confronted with two products which are virtually indistinguishable but de. mand different use habits. ‘‘The marketing of both meat products under the commonly-used name may increase the risk of botu- lism and other diseases. A higher incidence of botu- lism exists in countries which do not cure meats with nitrites .. . The confusion resulting from two prod- 6 ucts with different use requirements but the same product name might even compound the botulism problem, with consumers being less cautious than where only a nitrite-free product is available. In ad- dition, the packaging will become separated from the food product. As a result, leftovers and/or products stored out of their original packaging will give no warning of the procedures required to avoid risk. The effect of the proposed rule may therefore ultimately be a reduction in confidence and consumer use of both the nitrite-free produce and the nitrite-cured prod- uct.’’ Comment 260; App. 65-69 Notably, while commentators familiar with nitrites or desirous of avoiding foods containing them, suggested that they would read the proposed labeling instructions, few contended directly that these instructions would in fact be read by all or most consumers. The rulemaking reeord contains no professional or expert studies, testimony, com- ment or analysis of any kind establishing the fact, likeli- hood or even possibility that the warning labels would be generally read, understood or believed by ordinary con- sumers, apart from those interested in the current nitrite controversy. Notwithstanding the concerns expressed, the Rule for labeling unpreserved meats, as proposed, was adopted on August 21, 1979 with the added requirements that nitrite- free meats be similar to preserved meats in size and qgen- eral appearance and, as originally proposed, in flavor and consistency and that the term ‘‘uncured”’ precede the tra- ditional name. App. 91-93. That term. according to the rulemaker, is ‘‘commonly understood’’ to mean that the product does not contain nitrite. App. 85. Neither the preamble to the Rule nor the Rule itself addressed the concerns, listed above, of commentors and the Committee other than to note that questions had been 5 ‘ raised about the adequacy of the proposed warning labels and to observe, without explanation, that the Administra- tor C. ‘ig aware that the products requiring such special handling such as pork sausage, bratwurst and bock- wurst have presented no apparent health hazards even though prepared without nitrates or nitrites and mar- keted unfrozen. He concludes that consumers have demonstrated a knowledge of the handling practices necessary for any of such products prepared without nitrates or nitrites and that the prescribed labeling for such products, i.e., ‘‘Not Preserved—Keep Re- frigerated Below 40°F At All Times’’, will adequately inform the consumer of how to maintain such products in a wholesome condition until consumed.’’ App. 86-87. The Rulemaker’s Explanation In the course of the district court’s review, the govern- ment explained the challenged rulemaking through Irwin Fried, the Department employee who supervised the ad- ministrative proceeding. His explanation ran as follows: 1. It is true ‘‘that nitrites have been found to prevent the growth of clostridium botulinum, a natural conta- minant of improperly preserved meat products, and which produces an extremely potent poison usually fatal to man; that there are no substances that could be utilized under sufficiently broad scale to prevent botulism in commercially processed meats’’ end that ‘‘without nitrites’’ ‘‘|c|ommon usage of such products as hot dogs and ham would not be possible without severe health hazards.’’ Tr. 146, App. 95-96. 2. He would agree that ‘‘not too many people read ... handling mstructions’’ but instead rely on ‘‘previ- ous experience.’’ Tr. 195; App. 97-98. 3. His basis for believing consumers will read the label prescribed by the Rule [the sole means proposed by the Rule to distinguish an apparently nitrite-pre- D. 8 served from a nitrite-free product] is ‘‘everything that we have received ... from people who want to have nitrite-free products.’’ Tr. 197, App. 98. 4. No consideration is given in the Rule as to how consumers are to be protected from the hazards of nitrite-free products which look like traditional ni- trite-preserved products when a) the prescribed label is removed. b) the nitrite-free products are sold in bulk as in delicatessen sales when bologna is hand-sliced and wrapped. c) the nitrite-free products are ‘‘displayed in the old-fashioned cases with the butcher behind. and there are no labels on the product.”’ d) the consumers are non-English speaking. e) the consumers are functional illiterates, Tr. 142- 3, App. 94-95. 0. Not ‘‘everybody’’ will understand what the term ‘“‘uncured’’ (as required by the Rule to alert consumers to the nitrite-free character of what appears to be a traditional nitrite-preserved product) mrans. Tr. 192, App. 96. 6. He does not know whether the meaning of ‘‘un- cured’’ would be understood by functional illiterates, non-English speaking consumers or children, Tr. 192- 3; App. 96-98. Final Impact Statement A Final Impact Statement (FIS) for the Rule, App. 72- 82 disclosed in a note to the final Rule, App. 93 showed: (1) some 34 establishments market nitrate and/or nitrite-free processed meat products under 168 different product labels. (2) the Rule was expected to advantage nitrite-free product manufacturers by facilitating develop- ment of their markets. 9 (3) the Rule was not expected to result in any increase in the incidence of types A and B botulism because ‘*these types do not generally grow at tempera- tures below 40°F.’’ The FIS also noted concerns expressed in the Comments about consumer confusion between nitrite-free and nitrite- preserved products and about ‘‘the possibility that abuses could occur because of . careless food handlers ... and food taken on picnics, to work, and to school.’’ The FIS did not undertake to answer these concerns. E. The District Court’s Review Confining its review to the administrative record and the explanatory testimony offered by the government, the district court set aside the Rule on four grounds: (1) a lack of rational basis in the record for the con- clusion that ordinary consumers, faced with a long- established product and a new product which differ only in the information on its label, will distinguish between the two and a failure by the Department ade- quately to consider relevant factors regarding con- sumer conduct in reading labels and caring for nitrite products and the resulting danger of botulism from similar handling of nitriteless products. App. 29-32. (2) lack of Department authority to enact a rule solely to facilitate markets of uncured producers at the expense of producers of cured products. App. 36. (3) lack of Department authority to impose the simi- larity requirements and subjective flavor standard contained in the Rule. App. 36-41. (4) failure to comply with the requirements of the National Environmental Policy Act in that the De- partment neither filed nor considered the need to file an Environmental Impact Statement. App. 44-47. 10 F. The Circuit Court’s Review The court of appeals reversed, concluding that: (1) the Department adequately considered the risk of botulism and the efficacy of the required labeling (2) the Department’s purpose in adopting the Rule was to expand the availability of nitriteless products, and that this purpose, when accomplished ‘‘in a form and manner consistent with the public health and wel- fare’’, was lawful, and that the Rule bears a rational relationship to this purpose (3) the similarity and subjective flavor requirements are lawful (4) the agency considered the Rule’s potential for significantly affecting the quality of the human en- vironment and properly found no such effects. 11 REASONS FOR GRANTING THE WRIT Courts should generally leave regulations to the regula- tors. Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519 (1978). When, however, regulators substantially omit the key issue inquiry and analysis required for ra- tional rulemaking, Congress has authorized judicial inter- vention, not to rewrite bad rules but to shield the public from their arbitrary effects. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971). When the impact of deficient rulemaking is life-threatening, this Court is the public’s last but most necessary protection. The presently challenged Rule, by arbitrarily exposing consumers to botulism food poisoning, is such a rule and, therefore, war- rants this Court’s scrutiny.’ I. The Department’s Disregard of Relevant Factors Violates the Requirements of Overton Park and Seriously Jeopardizes Consumer Health and Safety The most compelling reason for granting the writ is the Rule’s jeopardy to human health resulting from manifest 1 Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971) establishes the standards for judicial review of agency action under the arbitrary and capricious standard of the Administrative Pro- cedure Act, 5 U.S.C. §706(2)(A). In making that review, this Court accords no special deference to the decisions of the court of appeals or district court, Cf. Asarco, Inc. v. E.P.A., 616 F.2d 1153, 1161 (9th Cir. 1980) ; Polcover v. Sec’y of Treasury, 477 F.2d 1223, 1226-27 (D.C. Cir.), cert. denied, 414 U.S. 1001 (1973); First National Bank of Fayetteville v. Smith, 508 F.2d 1371, 1374 (8th Cir. 1974), cert. denied, 421 U.S. 930 (1975), but itself makes a fresh determination of whether the statutory requirements have been met. 12 agency disregard of factors bearing directly on consumer safety. The Rule permits unpreserved meats to be sold in the marketplace under the names of and in forms visually (size and color) identical to preserved meats such as hot dogs, bologna and bacon. Because without nitrites meats support the production of botulin if subjected to the un- refrigerated handling (picnics, overnight camping, school lunching, etc.) associated with the traditional products, the crucial questions in the rulemaking were (1) whether the cautionary labeling prescribed by the Rule for unpreserved meats would be read, understood and believed by ordinary consumers so as to forestall the unrefrigerated use pres- ently associated with preserved counterparts and (2) if not, what increased risk of botulism would result under the Rule. Petitioners contend that contrary to the require- ments of Citizens to Preserve Overton Park vy. Volpe, supra, the Department not only gave insufficient considera- tion to these questions but knew at the time it promulgated the Rule that labeling would not suffice to alter handling practices or remove the danger of botulism. Hence peti- tioners say the Rule is arbitrary and capricious. a) Labeling efficacy overlooked It was no doubt the potential for illness from confusion of look and name alike products that led the rulemaker to consider a requirement for distinctive precautionary label- ing in the final Rule. See, e.g., App. 84-85. The rulemaker and the court of appeals, however, did net go on to assess whether that requirement—the sole means of protection afforded by the Rule—would be efficacious under the cir- cumstances mentioned in the Comments. Therein lies the deficiency and health danger of which the present peti- tioners complain. 13 More specifically, under the labeling requirement the plight of illiterates, non-English speaking consumers and those with infirm vision-—interests clearly present in the consumer body and noted in the comments—arbitrarily was not considered either by the rulemaker or by the court of appeals in its review. Indeed, there is not mere silence on this point, which without more would be a proper basis for setting the Rule aside, Sabin v. Butz, 515 F2d 1061, 1069 (10th Cir. 1975); U. S. v. Nova Scotia Food Products Corp., 568 F2d 240, 251 (2nd Cir. 1977); rather, in ‘‘ex- plaining’’ its position, Overton, supra, 401 U.S. at 420; Camp v. Pitts, 411 U.S. 138, 143 (1973). the Department affirmatively conceded that the final Rule omits considera- tion not only of illiterates and the non-English speaking but of consumers in general when the precautionary label is removed or the product is sold without labels as through delicatessens. App. 94-95. This failure alone requires re- versal.” The Department’s analysis of the efficacy of the required labeling in protecting literate, English speaking people when the label remains attached is equally inadequate. The administrative record® shows, and the court of appeals and district court found App. 11 and 32, that some com- mentators said 2 Petitioner's do not ask this Court to substitute its judgment for that of the Department. Vermont Yankee Nuclear Power Corp. v. NRDC, supra, says that where the rulemaker fails to indicate judgment either way or the basis for its judgment on a relevant factor such as protection of large subgroups in the population, the rulemaking cannot be sustained. * The administrative record consists of the April 28, 1978 Notice of Proposed Rulemaking, App. 52-59, 365 Comments, a transcript of the July 18, 1979 meeting of the Department’s Meat and Poultry Advisory Committee at which the proposed rule was discussed, the August 21, 1979 final rule and explanation. App. 83-93, and the FIS. App. 72-82. 14 they acquire knowledge of food products from label reading and they are willing to follow handling instructions. These comments came largely if not exclusively from either nitrite-free manufacturers or from individual con- sumers or professional consumer groups with an active preference for additive-free foods or a professed hostility toward nitrite. See, e.g., Comments 54, 106, 132, 196 and 246 cited by the government in the court below. Indispu- tably they would search out label information about ni- trites and safe handling. The relevant question, however, concerned not what those people would do with the cau- tionary label prescribed by the Rule but what ordinary consumers, who consume millions of pounds of hot dogs, lunch meats and bacon daily and who have little or no acquaintance with or interest in the nitrite controversy,’ would do.® The final Rule fails, and petitioners submit, * If the Department believed the anti-nitrite comments were fairly representative of the ordinary consumer who consumes and wishes to continue consuming traditional, preserved meats, Overton Park required a clear statement to that effect and the reasons justifying it in the preamble to the Rule so as to facilitate proper judicial review. The absence here of both precludes this Court from in- cdulging in or sustaining such a belief and thereby the Rule. (". S. v. Nova Scotia Food Products Corp., 568 F.2d 240, 251 (3rd Cir. 1977). "The Department official responsible for the rulemaking says his basis for believing consumers will read the label prescribed by the Rule is “everything that we have received . . . from people who want to have nitrite-free products.” App. 98. No doubt that is true. But the observation only points up more sharply the Depart- ment’s irrational conclusion that all other people, patently the over- whelming majority of consumers, who are not cognizant of or in- volved in the nitrite controversy will search out special handling instructions on the labels of what appear to be the same hot dogs and lunch meats they have been purchasing and subjecting to un- refrigerated use all their lives. 15 fatally, to disclose that the Department made any analysis whatsoever of this factor. National Nutritional Foods Ass’n v. Weinberger, 512 F2d 688, 701 (2nd Cir.), cert. denied, 423 U.S. 827 (1975) ; Environmental Defense Fund, Inc. v. Ruckelhaus, 439 F2d 584 (D. C. Cir. 1971); Angel v. Butz, 487 F2d 260, 263 (10th Cir. 1973), cert. denied, 417 U.S. 967 (1974). Even if, contrary to proper procedure, SEC v. Chenery, 332 U.S. 194, 196 (1947); Sec’y of Agriculture v. U.S., 347 U.S. 645, 653-4 (1954); U. S. v. Chgo Milwaukee, St. Paul & Pac Ry., 294 U.S. 499, 510-511 (1985); Angel v. Butz, supra, this Court were to attempt its own analysis of label efficacy, it would find the administrative record barren of any expert comments, studies, surveys or treatises tending to establish that ordinary consumers would read the cau- tionary information contained in the challenged labels.° In ‘Tf the Department wishes to rely on agency “expertise or ex- perience” to establish that consumers will universally read, under- stand aad believe its cautionary labels, that reliance must ‘be clearly disclesed and adequately sustained”, SEC v. Chenery Corp., 318 U.S. 80, 94 (1943) “in the [challenged] order . . . itself”, Burlington Truck Lines vy. U. S., 371 U.S. 156, 169 (1962), that is “in the ‘Statement of the Bases and Considerations’ filed with the adopted vegulations.” Angel v. Butz, 487 F.2d 260, 263 (10th Cir. 1973), cert. denied, 417 U.S. 967 (1974). No such disclosure appears in the present rulemaking. Indeed, there is complete silence with regard to the critical aspects about label reading, e.g., prior experi- ence, specialized interest in product avoidance, consumer literacy, product appearance, ete., which, according to the testimony of Dr. Jacob Jacoby, world expert on consumer attention to safety in- structions, are essential to any expert assessment of the likeli- hood that food product labels will or will not be read. Dr. Jacoby testified in support of the motion for preliminary injunction that the majority of conumers will not read, understand or believe the labels prescribed by the Rule. While his substantive conclusion is not to be considered by this Court, his testimony does show the inadequacy of the administrative record regarding expert analysis of label read- ing propensities of the broad spectrum of the consuming public. 16 fact, the rulemaker’s thinking on this point was just the opposite: ‘‘not too many people read .. . handling in- structions’? but instead rely on ‘previous experience,’’ App. 97-98. Yet previous consumer experience with hot dogs, lunch meats and bacon is that unrefrigerated use is safe. Their nitrite-free, counterpart look alikes authorized by the Rule are potentially lethal with the same handling. It follows that even if the Rule were not vulnerable for ‘inadequacy of explanation’, National Nutritional Foods Assn v. Weinberger, supru, regarding the efficacy of label- ing, it should fall either for lack of rational support for any implied conclusion that labeling would suffice to pro- tect the ordinary consumer under the look alike cireum- stances permitted by the Rule, Burlington Truck Lines vy. U.S., 371 U.S. 156 (1956), or for arbitrariness in exposing consumers to the risk of botulism in the face of the known inefficacy of cautionary labels. The fact that the Rule requires the term ‘‘uncured’’ on the label of nitriteless meats supplies neither the missing analysis of labeling efficacy nor the rational support for the Rule demanded by Overton. Recognition of the need for distinguishing preserved from unpreserved products, App. 84-85, does not in itself rationally demonstrate that prefixing the term ‘‘uncured’’ to the traditional name will differentiate look alike products in the eyes of the ordinary consumer, Certainly the term will not warn those just men- tioned who cannot or, relying on ‘‘previous experience’’, likely will not read the label. Nor will the administrative record suppor: a finding that those who do read the term will ‘‘commonly’’ App. 85, understand it to mean no- nitrite. While it may be true, as indicated by the comments, that a few with special interest in the nitrite controversy will understand this term, it is, as the district court ob- served, irrational to conclude from this ‘‘that the 200 mil- 17 lion consumers in this country generally share the same definition.’’ App. 32.7 Certainly, the two comments re- lied on by counsel in the court below, Comments 55 and 238, do not provide the required record support for the critical conclusion that consumers universally understand the term ‘‘uncured’’ to mean ‘‘without nitrite.’ * Likewise, recognition by the Department that consumers have safely handled uncured products such as bockwurst and bratwurst in the past does not supply the missing ra- tional focus on the efficacy of labeling. Contra App. 12-13. These products do not take on the appearance of familiar preserved meats for, as the Department explained, their ‘*basic color difference’’, Tr, 254-7, 260, distinguishes them. The challenged Rule, however, requires similarity in ap- pearance and size as well as flavor and consistency, thus removing not only the color differential but also any size characteristics that might otherwise serve to distinguish cured from uncured.’ ? Petitioners daresay a poll by the court of its own members and staff regarding the meaning of the term “uncured” will not yield results significantly different from those of an informal survey re- ported by petitioners’ expert at the hearing on the motion for pre- liminary injunction in which not one among some 250 college and graduate students and PhDs knew the meaning of this technical term. Tr. 122-3. ®’ The Department's complete silence as to the basis for its con- clusion that “uncured” is “commonly” understood to mean nitrite- free does not come close to meeting the requisite “high standard of articulation.” Environmental Defense Fund v. EPA, 465 F.2d 528, 541 (D.C. Cir. 1972). ® The court of appeals erroneously separated its analysis of peti- tioners’ contentions regarding arbitrariness from the similarity re- quirements. See App. 10-13 and 16-19, The arbitrariness of the Rule arises precisely from the rulemaker’s failure to consider the likely impact of the similarity requirements on the effectiveness of the pre- scribed labeling in preventing confusion and thereby botulism. 18 In sum, while the rulemaker facially considered” the question of labeling, his analysis, in clear violation of the standards set out in Overton, failed to consider, or to draw articulated, rationally drawn conclusions supported by record findings regarding the needs of the illiterate, the non-English speaking, those with impaired sight, those who have no interest in the nitrite-free meat controversy, and those exposed to the unpreserved product when the label is not attached or, in other words, the needs of most of us. That failing renders the rulemaking arbitrary. b) Botulism risk The inadequacy of the Department’s inquiry regarding the increase of botulism poisoning in the absence of re- frigerated handling is equally patent. '* The supposed albeit undemonstrated efficacy of warning labels and lack of increased botulism risk would appear completely to be helied by a post-rulemaking official Department publication contain- ing instruction for safe packing of a child’s lunch of the unpreserved look alikes permitted under the Rule: “To pack a safe ‘brown bag’ lunch, use one of these methods: Prepare and freeze the meat sandwich the evening before. . . it will thaw in time for lunch. Pack sandwich in a small in- sulated container such as the commercially available foam plastic. Double wrap the sandwich and pack it with a cold piece of fruit or cold can of juice. Put a cold device into the lunchbag. The device might be a commercial freezer gel, a plastic bag filled with ice cubes, or a cleaned-out margarine tub that you have filled with water and frozen.” Exh. 17; Tr. 151, It deception, injury or confusion would be likely but for an un- supported general assumption that consumers will read explanatory information on a label, it is now common ground that the label can- not stand. Houston v. St. Louis Independent Packing Co., 249 U.S. 479, 487 (1918) ; Federation of Homemakers v. Buts, 466 F.2d 462. 405-6 (D.C. Cir. 1972); Cf. Federal Security Administrator v. Quaker Oats Co., 318 U.S. 218, 230 (1943). 19 The court of appeals held that the rulemaker adequately considered the dangers of botulism by noting in the pro- posal for rulemaking that reducing or eliminating nitrites ‘‘may better support’’ the production of botulism, App. 10, and by adopting the label requirements included in the final Rule. App. 11. The Department’s assessment of increased risk, however, was premised entirely on the assumption that labeling would be completely effective in altering existing handling practices and assuring proper refrigeration: ‘“‘This regulation is not expected to result in any in- crease in incidence of food poisoning from Clostridium botulinum toxin types of A & B, those primarily asso- ciated with red meats. Research has shown that spores of these types do not generally grow at temperatures below 40° F.’’ App. 80 The relevant factor, however, was whether an increased incidence rate was likely should uncured products be han- dled as their cured counterparts now are at 70°, 80° and 90°F for prolonged periods on picnics, kitchen tables and camping trips and in lunch pails and school lockers. The Rule’s statement of bases and purpose simply does not address this point and nothing found in the court of ap- peals analysis fills the void. The Department’s disregard of this relevant factor is highly material for botulin is a killer toxin, Tr. 21, 101, and a finding, had it been made, of increased risk would, absent unfailing safeguards against unrefrigerated han- dling, if indeed such exist, render the Rule arbitrary on its face.!' For the same reason, a finding of no increased 11 Even if some extraordinary reason were advanced (and none was) to justify tolerating a slight increase in risk, the rulemaker's quantification of the risk and basis therefor would still be highly relevant to judicial appraisal of the justification. 20 risk would require a demonstrably ‘‘reasoned decision”. Wellford v. Ruckelhaus, 439 F2d 598, 601 (D.C. Cir. 1971) for ‘‘personal interests in life and heaith’”’ are at stake and ‘‘close judicial scrutiny is particularly appropriate. ’’ Id, Yet no such reasoned analysis appears."? Given this ’* Admissions, made contemporaneously with the rulemaking by respondents and their agents (if this is what the Government meant below by “other” relevant material on which the rulemaker was entitled to rely), would cast doubt on the soundness of any down- play of the botulism risk if uncured product were exposed to han- dling now given some cured meats: “Consumers and food retailers handle cured meat products in ways that would foster the formation of the botulism toxin— for example, stores sometimes hold or display these products without refrigeration and consumers sometimes take them on camping trips or extended picnics. Without nitrite. such prac- tices, particularly in combination, could produce botulism in most people eating it.” FDA’s and USDA’s Action Regarding Nitrite, Aug. 1978, Pl. Ex. 22, p. 28-29; Tr. 77 “[Without nitrites common usage of such products as hot dogs and ham would not be possible without severe health hazards.” “With current food processing and handling technology and practices, the protection provided by nitrite is essential to the public health. Its immediate elimination would subject the public to a grave risk of botulism.” FDA/USDA Fact Sheet. March 28, 1979, Pl. Exh. 19, p. 1; Tr. 82. | Petitioners note that the Rule would effect an “immediate elimina- tion” of nitrite in the affected products] “Under current procedures for the manufacture or processing of food, and the conditions of its distribution and handling . . . [nitrites and nitrates] are essential to prevent the develop- ment in some meat food products . . . of a toxin that causes a deadly form of food poisoning known as botulism.” Def Bergland, et al., March 30, 1979, Pl. Exh. 20, p. 1; Tr. 890. (footnote continued ) 21 absence of requisite ‘‘clarity’’, Phelps Dodge Corp v. NLIJB, 313 U.S. 177, 197 (1941) regarding botulism risk in the agency’s stated basis of the Rule, this Court cannot elucidate ‘‘what the agency has left vague and indecisive’’, (footnote continued ) So would statements contained in the administrative record from the Department’s Meat & Poultry Advisory Con mittee: “|T]here is no question . . . that the immediate elimination of nitrites from the food supply could create a serious, acute public health hazard in the form of botulism poisoning in some food products” (Grumbly, Adv. Tr. 21). “Without nitrites, you do have some special cautions in preser- vation (Nelson, Adv. Tr. 54). “Of course, a biggy was a concern for botulism and there were 30 comments that specified botulism directly, I mean, stated ‘Botulism’, in the comment, ‘is a hazard if you proceed.’” (Nelson, Adv. Tr. 63). “[W Jithout nitrite, they [meat products] all can develop botu- lism without refrigeration’’ (Nelson, Adv. Tr. 63). “[T]here have been surveys made to determine the incidence of botulinal spores on meat products. I don’t know of any way to determine that incidence except to have them grow. Now, it might be, you know, that they were able to grow them under very good conditions but, once they begin growing, it doesn’t take long for them to do what they have got to do” (Nelson, Adv. C. Tr. 66-67). “(T]oxin can be produced at certain levels of temperature even though it would be under refrigeration for botulism” (Dr. May, Adv. Tr. 81-82). “|Wle are talking about something that literally can kill a person. It is not a slow process ... It can actually kill you. It can do it very rapidly” (Dr. May, Adv. Tr. 101). “(|T]here is plenty of information to show that, even at the lower levels [of spore load], you still get botulinal toxin pro- duced, under the right conditions” (Def. Houston, Adv. Tr. 69). 9) SEC v. Chenery, 332 U. 8. 194, 197 (1947) but must instead set the Rule aside. U. 8. v. Chicago Milwaukee, St. Paul & Pac. Ry., 294 U. 8. 499, 510-511 (1935); SEC v. Chenery, 318 U.S. 80, 94-5 (1943). II, The Department Exceeded Its Authority By Promulgating the Rule For an Unlawful Purpose The district court held that the Rule’s purpose was the active promotion of markets for uncured products at the expense of producers of cured products, App. 36. The court of appeals held that the Department adopted the Rule to expand the availability of nitrite-free products. App. 15." In either case the Department has exceeded its authority. First, for reasons given, supra 18-22, the Rule’s poten- tial effect of increasing the incidence of botulism is not consistent with the public health and welfare, a consistency which the court of appeals held was required for the Rule’s purpose to be valid. App. 14. ‘The court of appeals correctly held that the Rule was “not based on the asserted cancer dangers” of nitrite, App. 15, inas- much as “not a word”, Rodway v. USDA, 514 F2d 809, 814-815 (D.C. Cir. 1975), about cancer, potential carcinogencity of nitrite or related compounds, Department cancer policy, consumer con- cerns about the dangers of nitrites or relevant research appears in either the final Rule or its preamble. To hold otherwise would have placed the court in the position impermissibly of “substituting”, SEC v. Chenery, supra, 332 U. S. at 196; Cf. Tabor v. Joint Board, supra, its own purpose for that of the agency and of sustaining a purpose as to which proper notice and opportunity to comment were not afforded. 5 U.S.C. § 553; Rodway v. USDA, supra, Wayner Electric Corp. v. Volpe, 466 F2d 1013 (3rd Cir. 1972). 23 Second, while a favorable competitive impact on one market segment may be justifiable as incidental and un- avoidable in the accomplishment of some other congres- sionally authorized purpose, Cf. Hiatt Grain and Feed, Inc. \. Bergland, 602 F2d 929, 933 (10th Cir. 1979), cert. dened, ies U.S. ........ (1980), the direct promotion, as here, of the interests of nitrite-free product manufacturers at the expense of competitors as an end in itself is outside the Department’s statutory. Finally, the means chosen by the Department to expand markets and/or consumer availability of nitrite-free prod- ucts—namely the imposition of similarity requirements— are irrational. Contra App. 16-19. The court of appeals argues that these requirements are justified under the Department’s general authority to establish standards of identity to prevent confusion and economic adulteration. App. 17. The obvious effect of the requirements, how- ever, will, as the district court noted, be just the opposite: ‘*OContrary to the purposes of the standards, the simi- larity requirements will confuse, if not deceive, con- sumers as to the identity of the products they are re- ceiving and the handling requirements of those prod- ucts.’’ App. 39. That confusion will not only be detrimental to expansion of the nitrite-free product market but will be disastrous to the market for nitrite-preserved products, especially in the event of a botulism fatality resulting from the confusion. It is no answer to say without further analysis as did the court of appeals App. 17, that the authority for the present rulemaking falls within the Department’s general ingredient or label approving power. No doubt that gen- eral authority exists. But it does not include the power to exercise such authority arbitrarily or irrationally. 24 ITT. This Court Should Resolve the Conflict Between the Circuits Regarding the Requirements of the National Environmental Policy Act The Second, Seventh and District of Columbia Circuits, among others, hold that the National nvironmental] Policy Act of 1969, 42 U.S.C. §4321 et seq (NEPA) and The Coun- cil on Environmental Quality, 40 C.F.R. 1500 et seq, re- quire a rulemaker who determines not to file a draft and final environmental impact statement (EIS) to assess all relevant factors considered in that determination, state its reasons for not preparing an EIS, and affirmatively develop a reviewable administrative record in support of the decision not to file an KIS. Trinity Episcopal School Corp v. Romney, 523 F2d 88, 93 (2nd Cir, 1975) ; Scientists Institute for Public Information v. Atomic Energy Com- mission, 481 F2d 1079, 1094-5 (D.C. Cir. 1973) ; Nucleus of Chgo. Homeowner Assn v. Lynn, 524 F2d 225, 231 (7th Cir. 1975), cert denied, 426 U.S. 939 (1976); see 40 C.F.R. 1501.4(c) and (e) and 1508.13. The present rulemaking, conceded by the Department to be of ‘‘major’’ character, App. 93, includes neither an KIS, consideration of factors (such as label reading prac- tices of ordinary consumers) relevant to a decision not to file an EIS, reasons for not preparing an EIS, nor a de- veloped record to justify not filing. The Eighth Circuit excused this complete disregard of NEPA and in doing so is in direct conflict with other cir- cuits, mentioned above, which construe NEPA to require setting aside rulemaking under such circumstances. The court of appeals does not deny that the Department dis- regarded NEPA but says instead that the court is able to sift out from the rulemaking record evidence of De- 25 partment attention to health dangers. App. 19-20. That, however, is in the manner of a forbidden post-hoe ration- alization. Citizens to Preserve Overton Park v. Volpe, supra, 401 U. S. at 419-420; FPC v. Texas, 417 U. S. 380, 397 (1974); Tabor v. Joint Board, 566 F2d 705, 709-710 (D.C. Cir. 1977) and is not the court’s function, U/. S. v. Chgo. Milwaukee, St. Paul & Pac. Ry., supra. With NEPA, as with any other aspect of agency rulemaking, it is for the agency to state its grounds and the court merely to review them. ‘‘If those grounds are not ‘‘clearly dis- closed’’, SEC v. Chenery Corp., supra, 318 U.S. at 94, the Rule cannot be sustained. This Court should resolve the conflict in favor of the other circuits. In so resolving the conflict, this Court will assure the full analysis, ‘‘reasoned decision’’ and ‘‘balanc- ing’’ of risks, Karlen v. Harris, 59) F2d 39, 44 (2nd Cir. 1978) commanded by Congress but absent here and there- by forestall substantial health hazards such as those cre- ated by the present rulemaking.” The Final Impact Statement prepared by the Department, App. 72-82, is not equivalent to an EIS. App. 46; See 43 Fed. Reg. 21987 (May 22, 1978); Cf. 39 Fed. Reg. 18680 (May 29, 1974), CEQ Regulations 40 C.F.R. 1502.10 (1978) ; Cf. Greene County Planning Board vy. FPC, 455 F2d 412 (2nd Cir.) cert. denied, 409 U.S. 849 (1972); Steubing v. Brinegar, 511 F2d 489 (2nd Cir. 1975); S. W. Neighborhood Assembly v. Eckard, 445 F. Supp. 1195 (D.D.C. 1978). Moreover, the FIS was markedly less sensitive to environmental effects significantly impacting the public health, National Organization for Reform of Marijuana Laws v. U. S., 452 F. Supp. 1226 (D.D.C. 1978) and less exacting in its analysis than the duty under NEPA to file an EIS or to leave a visible explanation for not filing. Scientists’ Institute for Public Information, Inc. v. AEC, supra. 26 CONCLUSION Petitioners do not ask that this Court usurp the agency function or second guess well supported conclusions reached by the agency. Petitioners do not ask that this Court determine for itself whether the labeling system adopted by the agency will or will not be efficacious to pre- vent confusion under the look and name alike cireum- stances authorized by the Rule or whether the risk of botulism will be greatly or minimally increased in the event of such confusion. Overton Park and Vermont Yankee forbid such judicial intrusion. Petitioners do, however, earnestly urge that this Court affirm the district court’s strong conclusion that the rule- maker failed by a long measure adequately to examine the relevant factors of label efficacy and botulism risk, reach reasoned conclusions regarding them, and make and articu- late findings based on the administrative record which lend credible support to those conclusions. It may well be true that the administrative record will support a conclusion that members of an elite subgroup who read labels in exercising their personal preferences for additive-free food are not jeopardized by the Rule. But what is to happen to the rest of us? Petitioners be- lieve Section 706(2)(A) was enacted by Congress to as- sure protection of the latter as well as the former and that this Court will not hesitate to provide Congressionally mandated review when as here agency rulemaking is arbi- trary and capricious on its face. 27 Wuererore, Petitioners respectfully request that the writ issue. Respectfully submitted, DonaLp P. CoLLEetTon James L. Fox Attorneys for Petitioners, CuHarLes GrassLEy, THomas HaGEpornN, NatTionaL Pork Propucers CouncliL, and Srever Syms Of Counsel: ApramMson & Fox One East Wacker Drive Chicago, Illinois 60601 (312) 644-8500 APPENDIX APPENDIX UNITED STATES COURT OF APPEALS For The Highth Circuit No. 80-1229 National Pork Producers Council, an Iowa corporation; Charles Grassley; Tom Hagedorn; and Steven Symms; and National Independent Meat Packers Association, Appellees. v. Bob Bergland, Secretary of Agriculture; Carol Tucker Foreman, Assistant Secretary of Agriculture for Food and Consumer Services; and Donald Houston, Acting Admin- istrator, Food Safety and Quality Service, United States Department of Agriculture, Appellants. Appeal from the United States District Court for the Southern District of Iowa. Submitted: June 13, 1980 Filed: September 23, 1980 Before HEANEY and BRIGHT, Circuit Judges, and HUNGATE, District Judge.* HEANEY, Circuit Judge. This appeal presents the question of whether the United , States Department of Agriculture (USDA) properly exer- cised its authority when it issued regulations permitting * The Honorable WILLIAM L. HUNGATE, United States Dis- trict Judge, Eastern District of Missouri, sitting by designation. App. 2 nitrate and nitrite-free meat products to be sold under product names traditionally reserved for foods containing these compounds. The district court held that it did not. We reverse. I The history of nitrate and nitrite use in curing meat and poultry products is a long one. As early as Homer’s time (900 B.C.), curing meat with salt was an established prac- tice. Although it surely was not known at the time, the desert salts used in the curing process contained nitrate impurities, which caused cured meat to develop a charac. teristic spicy flavor and pink color. In addition, the curing process helped preserve the meat from bacteria! spoilage. The cure was particularly effective, it is now known, in inhibiting the growth of Clostridium botulinum, the bac- teria that produce the deadly toxin responsible for the food poisoning known as botulism. Although curing is a centuries-old practice, it was not until the first part of the twentieth century that scientists identified the active agent responsible for the cure. The color, flavor and preservative effects were caused by the meat’s reaction with nitric oxide, which was formed from nitrite, which was, in turn, formed from the nitrate used in the curing process. Because these reactions are difficult to control when meat products are cured with nitrate, the USDA formerly authorized the direct addition of nitrite in 1925. In some products, such as bacon, some form of nitrite is required by USDA regulations. See 9 C.F.R. § 318.7(b) (1980). Because nitrite was recognized as po- tentially toxic, however, a maximum residual amount of 200 parts per million was established. Nitrate was not di- rectly regulated. In the late 1960’s, concern developed over nitrite use as studies suggested that nitrites combined with other compounds in the food or in the body to form nitrosamines, App. 3 which were known to be potent carcinogens in animals. As one report presented to a Senate Committee indicates, the possibility that nitrites could cause cancer touched off a flurry of activity: In October 1969, meat industry scientists met with the Assistant Secretary of Agriculture to discuss the pos- sibility of a nitrosamine problem existing in U.S. cured meat products. In December of 1969, a group of USDA, FDA, and industry scientists met to dis- cuss the problem, resulting in the scheduling of a co- operative research program to be funded by industry and actively participated in by industry, DA, and the Department. The Food and Drug Administration (FDA) and the U.S. Department of Agriculture or- ganized a scientific study group to review appropriate information and data. In 1971, the House Intergovern- mental Relations Subcommittee conducted hearings on the issue of nitrosamine formation and the possible in- volvement of nitrite in cured foods. The matter was widely discussed by the public and the media, and fur- ther studies were carried out by the scientific com- munity. Numerous conferences were held during 1972, to discuss available information on the role of nitrite in curing and preserving, and to determine what new information was needed. Because of the widespread interest in the subject, the Secretary appointed an Expert Panel in 1973 to assess the data concerning the presence of nitrosam- ines in foods, to evaluate the public health significance and specific problems identified with the use of nitrites in foods, and to determine if alternate methods of pro- cessing were available. Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 1979: Hearings before a Subcomm. of the Senate Comm. on Appropriations, 95th Cong., 2d Sess. 2936, 2937 (1978) (Final Report on Nitrites App. 4 and Nitrosamines to the Secretary of Agriculture by the Expert Panel on Nitrites and Nitrosamines). One conclusion of the new round of studies was that nitrosamines are formed in nitrite-cured bacon when it is fried at high temperatures, particularly if it is cooked until crisp. As a result, in 1978, the USDA promulgated revised regulations that reduced the permissible levels of nitrite in bacon, required that other additives be used to lessen the likelihood that nitrosamines would form, and established procedures for testing bacon to ensure that it contains no confirmable levels of nitrosamines after cook- ing. 9 C.F.R. § 318.7(b) (1980); see American Meat Inst. v. Bergland, 459 F.Supp. 1308 (D. D.C. 1978). Another, more tentative, conclusion of the scientific studies on nitrate and nitrite use was stated in 1978 by Paul Newberne of the Massachusetts Institute of Tech- nology. The Newborne Report determined that nitrites themselves caused cancer in laboratory animals, even if nitrosamines had not formed prior to ingestion. This re- port prompted a wave of criticism from the meat industry on the one hand, and resulted in increased pressure on the USDA to completely ban the use of nitrites on the other. The Department resisted these pressures, however, find- ing that greater scientific study was required.’ See Schuck v. Butz, 500 F.2d 810 (D.C. Cir. 1974). 1 Following the release of the 1978 Newberne Report, the FDA and the USDA established an Interagency Working Group on Nitrite Research to evaluate the MIT study. The interagency group, composed of scientists from the FDA, the USDA, the Na- tional Cancer Institute and the National Institute of Environmental Health Sciences, evaluated the design and conduct of the study and ordered an intensive pathology review of Dr. Newberne’s diagnoses. Tn a report dated August 15, 1980, the group announced their find- ings, concluding that “insufficient evidence exists to support the (footnote continued) App. 5 As the USDA and FDA studies continued, public aware- ness of the problem resulted in increased consumer de- mand for nitrate and nitrite-free products. USDA regula- tions, however, prohibited the production, saie or distribu- tion of nitrate and nitrite-free products under their tradi- tional names such as frankfurters, bacon, ete. As a result, consumers complained of some difficulty in identifying or finding the products they desired. The Food Safety and Quality Service of the USDA re- sponded to these complaints on April 28, 1978, by publish- ing a notice of proposed rulemaking in the Federal Regis- ter. 43 Fed.Reg. 18,193 (1978). In this notice, the USDA proposed to amend the federal meat inspection regulations to permit the sale of nitrate and nitrite-free products under their traditional names, provided that certain labeling and quality requirements were met. In the sixty-day comment period following notice of the proposed rule, the USDA received 365 comments from in- dividual consumers, consumer organizations, and industry and trade associations. In addition, the USDA consulted the National Advisory Committee on Meat and Poultry (footnote continued ) conclusion that sodium nitrite per se fed to rats causes cancer, based on the MIT study.” The FDA and USDA announced in a news release accompanying the report that they have decided to contract with the National Academy of Sciences to review all relevant data on nitrite before additional action is taken. The agencies stated that the National Academy of Sciences “will conduct an independent assessment of all available scientific information about nitrite and will analyze scientific data and develop a research agenda on potential alternatives to nitrite as a preservative in meats and poultry.” The release concluded: “Because of its widespread usage, we believe that our agencies must continue to be concerned about the effects, if any, that nitrite consumption might have on the public’s health.” App. 6 Inspection about the proposal and the comments. On June 14, 1979, the USDA issued a Final Impact Statement on the proposed rule, detailing the need for the rule, the Oop- tions considered, and the expected impact of its implemen- tation. On August 21, 1979, the USDA promulgated the final regulation, to be effective September 20, 1979. See 9 C.F.R. §§ 317.17(b) & (c), 318.7, 319.2.2 The final rule pro- vides that meat and meat products that are not cured with nitrates, nitrites or other preservatives may be sold under their traditional names, so long as the word ‘‘Uncured”’ appears on the label as part of the product name and the label states: ‘‘No Nitrate or Nitrite Added’’ and ‘‘Not Preserved—Keep Refrigerated Below 40° F. At All Times.’’ In addition, the regulation requires that the un- cured products be similar in size, flavor, consistency and general appearance to the products commonly prepared with nitrate or nitrite.’ 29 C.F.R. § 318.7, which prohibits the use of nitrates or nitrites in baby, juaior or toddler foods, is not being challenged in this action. * The final regulations in question read as follows: § 317.17. Interpretation and statement of labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. ** * * (b) Any products, such as bacon and pepperoni, which is required to be labeled by a common or usual name or descrip- tive name in accordance with § 317.2(c)(1) and to which nitrate or nitrite is permitted or required to be added may be pre- pared without nitrate or nitrite and labeled with such common or usual name or descriptive name when immediately preceded with the term “Uncured” as part of the product name in the same size and style of lettering as the product name, provided that the product is found by the Administrator to be similar in size, flavor, consistency, and general appearance to such (footnote continued ) App. 7 II On September 20, 1979, the National Pork Producers Council, a trade organization representing approximately 92,500 United States pork producers, tugether with three members of the United States House of Representatives, (footnote continued ) product as commonly prepared with nitrate or nitrite, or both. (c)(1) Products described in paragraph (b) of this sec- tion or § 319.2 of this subchapter, which contain no nitrate or nitrite shall bear the statement ‘No Nitrate or Nitrite Added.” This statement shall be adjacent to the product name in letter- ing of easily readable style and at least one-half the size of the product name. (2) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall bear, adjacent to the product name in lettering of easily readable style and at least one-half the size of the product name, the statement “Not Preserved——-Keep Refrigerated Below 40° F. At All Times” unless they have been thermally processed to F° 3 or more; they have been fermented or pickled to pH or 4.6 or less; or they have been dried to a water activity of 0.92 or less. (3) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall not be subject to the labeling requirements of paragraphs (b) and (c) of this section if they contain an amount of salt sufficient to achieve a brine concentration of 10 percent or more. * * %* § 319.2 Products and nitrates and nitrites. Any product such as frankfurters and corned beef, for which there is a standard in this part and to which nitrate or nitrite is permitted or required to be added, may be prepared without nitrate or nitrite and labeled with such standard name when immediately preceded with the term “Uncured” in the same size and style of lettering as the rest of such standard name: Provided, That the product is found by the Administrator to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate and nitrite: And provided further, That labeling for such product complies with the provisions of § 317.17(c) of this subchapter. 9 C.F.R. §§ 317.17, 319.2 (1980). App. 8 filed this lawsuit challenging the regulations. The National Independent Meat Packers Association, a trade associa- tion representing approximately 300 meat packers. was subsequently granted leave to intervene as a party plain- tiff. The plaintiffs sought declaratory and injunctive relief. On February 12, 1980, the district court entered a final order permanently enjoining the government from enfore- ing or applying the challenged regulations.‘ The court rested its decision on four grounds: (1) The Secretary of Agriculture acted arbitrarily and capriciously because he failed to consider whether con- sumers would be subjected to botulism poisoning if they were to handle uncured products in the fashion in which they now handle cured products, and because there was no rational basis in the record for assuming that the re- quired labels would effectively prevent confusion between the two types of products. (2) The Secretary exceeded his authority under the Federal Meat Inspection Act, 21 U.S.C. § 601 et seq., be- cause the regulation was promulgated for the unlawful purpose of promoting or encouraging a market for nitrate and nitrite-free products. (3) The Secretary exceeded his authority because the similarity requirement bore no rational relationship to the purposes of the Federal Meat Inspection Act and be- cause it constituted a subjective standard of identity rather than an objective recipe or formula. ‘The district court had earlier denied a motion for a temporary restraining order, but had granted a motion for a preliminary in- junction. App. 9 (4) The Secretary failed to comply with the require- ments of the National Environmental Policy Act, 42 U.S.C. $ 4321 et seq., because he neither filed nor considered the need for an Environmental Impact Statement (KIS).* Il Before discussing in detail the reasoning of the district court, we briefly consider the appropriate standard for reviewing regulations, such as these, promulgated pursu- ant to the ‘‘notice and comment’’ provision of the Admin- istrative Procedure Act, 5 U.S.C. § 553(¢). The standard ‘is that specified by 5 U.S.C. § 706(2)(A), which authorizes a reviewing court to set aside agency action found to be ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’ ’’ Independent Meat Packers Ass’n v. Butz, 526 F.2d 228, 238 (8th Cir. 1975), cert. denied, 424 U.S. 966 (1976). Furthermore, ‘‘ynless an inadequate evidentiary development before the agency can be shown and supplemental information sub- mitted by the ageney does not provide an adequate basis for judicial review, the court * * * should limit its inquiry to the administrative record already in existence supple- mented, if necessary, by affidavits, depositions, or other proof of an explanatory nature.’’ 7d. at 239. The district court explicitly recognized this standard in its opinion, but it nevertheless held a hearing that included the presen- tation of some evidence beyond ‘‘proof of an explanatory nature.’’ We turn now to an independent examination of the record to determine whether the USDA acted arbi- trarily, capriciously, or otherwise not in accordance with law. 5Jn addition, the court rejected the plaintiffs’ contention that the nitrate and nitrite-free products must be labeled “imitation” in ac- cordance with 21 U.S.C. § 601(n)(3) finding that the uncured nroducts were not imitations of their cured counterparts. App. 10 IV A. Arbitrary and capricious action. The district court’s reasons for holding that the Secre- tary’s action was arbitrary and capricious were that the USDA failed to consider whether consumers would be sub- jected to botulism poisoning if they were to handle uncured products in the same manner they now handle cured prod- ucts and whether the labeling requirements would elimi- nate the risk. We find these rationales unconvincing. First, it is clear from the record that the USDA was very concerned with the possible problem of botulism poisoning. The dangers of botulism and the handling prac- tices necessary to ensure safety were carefully considered by the Secretary. As noted earlier, the USDA and other governmental agencies have been studying the health ef- fects of nitrates and nitrites at least since the 1960's. These agencies have been looking for alternative preserva- tives and have sought ways to make nitrates and nitrites less dangerous without destroying their ability to control the growth of Clostridium botulinum. When the agency promulgated regulations to reduce the levels of nitrites in bacon, it reduced them only to the lowest level thought necessary to control these bacteria. More importantly, the agency expressly recognized the potential botulism danger in the official documents in this administrative proceeding. The notice of proposed rulemaking stated: The Administrator recognizes that meat products prepared without nitrate and/or nitrite or with re- duced levels of nitrate and/or nitrite may better sup- port the growth and toxin production of Clostridium botulinum that [sic] meat products prepared with the traditional levels of nitrate and/or nitrite currently permitted by regulation * * *. Clostridium botulinum intoxication (botulism) is a type of food poisoning which often causes death. App. 11 43 Fed.Reg. 18,193 (1978). Similarly, the explanation accompanying the final rule re- flected the agency’s awareness of the dangers of botulism and the value of nitrites in reducing that danger. See 44 Fed.Reg. 48,959 (1979). Indeed, it was this awareness that prompted the strict labeling requirements in the regula- tions. The agency was not only fully aware of the botulism risk, it considered evidence of the effect of the proposed regulation, particularly the labeling requirements, on that risk. It noted that some of the 365 comments submitted to it ‘‘expressed concern whether such labeling provisions would be adequate to protect against botulism with respect to * * * unpreserved products. In this connection, some commentators questioned whether products would always be handled in accordance with the warnings on the labeling and be kept below 40° F’.’’ 44 Fed.Reg. 48,959 (1979). Nevertheless, the agency found persuasive evidence that the benefits of the regulation would outweigh any potential safety problem. Many of the comments demonstrated con- sumer awareness of the potential dangerous consequences of marketing and consuming meat products that do not contain nitrates or nitrites. Many commentators referred to the positive safe experiences they had had with pur- chasing uncured products in the past. Others stated that their knowledge of food products came from a careful reading of product labels. Still others indicated an under- standing of the term ‘‘uncured’’ and expressed a willing- ness to adhere to the instructions on the label in exchange for an opportunity to buy meat products without nitrates or nitrites. Indeed, even the comment of the plaintiff- * The public record also supports the proposition that consumers have become increasingly aware of the role of nitrates and nitrites in preserving meat products. App. 12 congresspersons in this action recognized the efficacy of warning labels; the congiesspersons suggested, inter alia, that a revised regulation require strict warning labels. Moreover, not only was the agency aware of the botulism danger at the outset, and not only did it consider further evidence of the danger, once it reviewed the evidence, it took positive steps to eliminate the chance of any danger resulting from the regulations. The final rule differed from the proposed rule in two significant respects. First, the labels on nitrate or nitrite-free products were required to contain the word ‘‘Uncured’’ as part of the product uname, The agency described its reasons for the change as follows: (T jhe Administrator has determined, based on the comments, that the use of nitrates and nitrites is of such importance in products preserved by these sub- stances, that products prepared without such sub- stances should have different names from those pre- pared with nitrates or nitrites in order to more clear- ly distinguish such products. Under these circum- stances, it has been determined that such products prepared without nitrates or nitrites may bear the traditional name, but that the traditional name must be preceded by the term ‘‘Uncured.’’ 44 Fed.Reg. 48,959 (1979). Second, the proposed rule had permitted the sale, under traditional names, of products with low nitrate levels if they were labeled ‘‘Not Fully Preserved, Must Be Re- frigerated Below 40° F. At All Times.’’ This provision was deleted, partly in response to concern about whether ‘‘consumers might misuse such products not otherwise preserved, based on a false assurance that the listing of nitrates or nitrites in the ingredients statement would be understood to represent that products could be handled under the same circumstances acceptable for products fully preserved by nitrates or nitrites.’’ Id. at 48,960. App. 13 These changes in the regulation are further proof that the agency carefully considered the evidence of botulism risk and made a reasoned determination in response to that evidence.’ After considering the submitted comments, consulting the Advisory Commission, and reviewing the relevant evidence before it, the agency made the following state- ment: The Administrator * * * is aware that products requiring such special handling such as pork sausage, bratwurst and bockwurst have presented no apparent health hazards even though prepared without nitrates or nitrites and marketed unfrozen. He concludes that consumers have demonstrated a knowledge of the han- dling practices necessary for any of such products prepared without nitrates or nitrites and that the pre- scribed labeling for such products. i.e., ‘‘Not Pre- served—Keep Refrigerated Below 40° F. At All Times,’’ will adequately inform the consumer of how to maintain such products in a wholesome condition until consumed. Id. Although the record contains some evidence that would suggest a different conclusion, we cannot say that the Secretary’s determination is without basis in the record. Accordingly, the district court erred in holding that the Secretary acted arbitrarily and capriciously in promul- gating these regulations. B. Unlawful purpose. The district court determined that the Secretary was without authority to promulgate the regulations in ques- tion because they were issued for the unlawful purpose ‘To further guard against any botulism risk, the USDA printed, primarily for distribution to consumers in supermarkets, educational pamphlets warning of the handling requirements of uncured products. App. 14 of promoting a market for uncured products. In support of this position, the district court quotes the Final Impact Statement released by the USDA on June 14, 1979, which states that one of the purposes of the regulations is ‘to allow the use of familiar names for the traditional, but nitrite-free processed meat products. Allowing these prod- ucts to be marketed by traditional names will increase consumer awareness of their availability as well as con- sumption by those wishing to forego consumption of nitrite cured products.’’ In addition, the court noted that the agency considered continuing the prohibition on the use of traditional product names on meat products without nitrates or nitrites, but rejected this option because ‘‘it does not facilitate the development of markets for nitrate and/or nitrite-free products.’’ This, the court concluded, proves that the agency acted with an improper purpose. We disagree. Congress expressly charged the USDA with ‘‘assuring that meat and meat food products dis- tributed to [consumers] are wholesome, not adulterated, and properly marked, labeled, and packaged.’’ 21 U.S.C. § 602. In our view, this directive authorizes the Depart- ment to ensure that the products desired by consumers be made available to them in a form and manner consistent with the public health and welfare. Every time the Seecre- tary approves a product’s ingredients or label, he, in one sense, is promoting that product. To be sure, the agency should not be promoting a particular company or a par- ticular product of a particular company, but merely ful- filling consumer desires, while ensuring consumer health and safety, does not constitute such unlawful promotion. The district court overlooked the agency’s statement, both in the rulemaking notice and the explanation accom- panying the final rule, that the regulations were proposed in response to requests by individual consumers, consumer interest groups and manufacturers. The comments sup- App. 15 port the agency’s determination that nitrate and nitrite- free products were difficult to locate or not available to consumers. The regulation bears a rational relationship to this claimed purpose of availability. Moreover, contrary to what the appellees would have us think, the preducers of nitrate and nitrite-free preserved products have no right to be free from competition. See Hiatt Grain & Feed, Inc. v. Bergland, 602 F.2d 929, 933 (10th Cir. 1979), cert. denied, 62 L.Ed.2d 755 (1980). See also Westport Taai Serv., Inc. v. Adams, 571 F.2d 697, 700 n.3 (2d Cir.), cert. denied, 439 U.S. 829 (1978). The chal- lenged regulation is actually an exception to USDA regu- lations that formerly prohibited selling nitrate and nitrite- free products under their traditional names. The pro- ducers of nitrited products enjoyed a benefit from the old rule, but they have no vested right in the continuation of it. Upon the Secretary’s finding that it was in the public interest to permit marketing under traditional names, the competitive effect on the producers of nitrate and nitrite- preserved products is of no consequence. Finally, we emphasize the modest nature of the USDA proposal. Despite sustained pressure to ban the use of all nitrites,® the agency determined that regulations permit- * The district court stated that the public health threat from nitrite-induced cancer could not be considered as a valid purpose tor the rule, because the USDA did not indicate in the final rules that the regulations’ purpose was cancer prevention. We note that the failure to mention the alleged carcinogenic effects of nitrites was probably no accident. While the agency was studying the proposed rule, the United States Attorney General, in response to a USDA request, issued an opinion stating that if nitrites were found to be carcinogenic in animals, current law would require the USDA to ban their use in food products. See 43 Op. Att’y Gen. 1 (1979). Because scientific studies were not complete, the Secretary wisely decided to promulgate regulations not based on the asserted cancer dangers. mo — App. 16 ting the sale of nitrate and nitrite-free products under traditional names would be sufficient to serve the public interest at this time. Under the new rules, no meat packer is required to manufacture nitrate and nitrite-free prod- ucts, no wholesaler is required to supply them, and no retailer is required to stock them. Furthermore, the pro- duction and sale of nitrate and nitrite-preserved products are unaffected. In short, we conclude that the regulations are a rational response to the legitimate requests of con- cerned consumers and were not promulgated for an un- lawful purpose. C. Similarity requirement. The district court’s third rationale for invalidating the USDA regulations was that the requirement that uncured products be similar in size, flavor, consistency and general appearance to their cured counterparts was contrary to law. The court gave three reasons for this holding. First, the court determined that ‘‘the similarity require- ment is a standard of identity that bears no rational rela- tionship to the purpose of such standards.’’ In support of this assertion, the district court cited several cases pur- porting to define the purpose of the identity standards provisions of the Meat Inspection Act, 21 U.S.C. § 607(e). The court read these cases as holding that the purpose of such standards is to prevent the ‘‘economie adulteration”? or to promote the ‘‘integrity’’ of meat food products. The similarity requirement in the challenged regulation does not serve this purpose, the court concluded, because it ‘will confuse, if not deceive, consumers as to the identity of the products they are receiving and the handling re. quirements of those products.”’ We cannot agree that the similarity requirement bears no rational relationship to the purposes of identity stan- App. 17 dards as intended by Congress. Initially, we note that none of the cases cited by the court involved successful challenges to USDA standards of identity. Most impor- tantly, we think it clear that Congress intended the USDA to have the authority to issue the type of regulation here in question. Section 21 of the Act, 21 U.S.C. § 621, gives the agency broad authority to implement the statute: ‘“‘[The] Secretary shall * * * make such rules and regula- tions as are necessary for the efficient execution of the provisions of this Act.’’ Section 7(c) of the Act, 21 U.S.C. $ 607(c), specifically provides that the Secretary may pre- scribe labeling requirements ‘‘to avoid false or misleading labeling’’ as well as definitions an' standards of identity or composition ‘‘whenever he determines such action is necessary for the protection of the public.’’ In our view, the similarity requirement is well within these powers granted the Secretary by Congress. It is designed to pre- vent the sale of products under traditional names when those products bear no resemblance to items commonly sold under those names. When a consumer buys a product labeled ‘‘Uncured Hot Dog,’’ he will receive a product similar to any other ‘‘Hot Dog.’’ Thus, the requirement furthers the goals of the Act by promoting truthful label- ing. The second reason given by the district court for hold- ing the similarity requirement unlawful is that it ‘fis a subjective standard of identity that is beyond the [USDA’s] authority to promulgate or enforce.’’ The court offers no authority for this proposition, however, other than to say that a standard of identity ‘‘normally sets forth a ‘recipe’ for a food.’’ (quoting American Frozen Food Inst. v. Mathews, 413 F.Supp. 548, 554 (D. D.C. 1976), aff’d on other grounds, 555 F.2d 1059 (D.C. Cir. 1977)). App. 18 We find this reasoning unpersuasive. As noted earlier, the statutory grant of authority to the Secretary is broad, and no restrictions on the permissible types of standards are contained in the statute. The Secretary’s implementa- tion of the Act shows that subjective standards were con- templated; a number of current USDA regulations specify standards of identity that are not based on objective eri- teria. See, e.g., 9 C.F.R. § 319.15(c) (‘Beef Patties’’— ‘‘Binders [and other ingredients may be added| only in amounts such that the product characteristics are essen- tially that of a meat pattie.’’); §§ 319.15(e) & 319.29 (‘‘Partially defatted beef fatty tissue’? & ‘‘Partially de- fatted pork fatty tissue’’—‘Such product shall have a pinkish color and a fresh odor and appearance’’); § 319.80 (‘Barbecued Meats’’—must have ‘‘the usual character- isties of a barbecued article’); § 319.181 (‘‘Cheesefurters and similar products’’—‘‘resemble frankfurters except that they contain sufficient cheese to give definite charac- teristics to the finished article.’’); § 319.700(a)(3) (iv) (‘‘Oleomargarine or margarine’’—may contain ‘‘[a]ny safe and suitable artificial flavoring substance that imparts to the food a flavor in semblance of butter.’’). The dis- trict court disregarded these regulations, noting that the Administrator of the USDA’s Food Safety and Quality Service told the Advisory Committee that the Department did not regulate flavor and taste. This reliance on the comment of the Administrator is misplaced; the regula- tions speak for themselves. The court apparently was per- suaded by the difficulty in enforcing subjective standards, and it may well be that the Administrator would wish to avoid such standards for that reason. Nevertheless, if the Secretary decides he is willing to assume the burden of enforcing this subjective standard of identity, it is not for us to say it would be too difficult. App. 19 The district court’s final reason for invalidating the similarity requirement is that it ‘‘is so unorthodox and contrary to previous USDA policy and practice that it was incumbent upon defendants to give a reasoned expla- nation for their decision to impose the requirement.’’ The soundness of this reasoning, obviously, is dependent upon the validity of the district court’s finding that the USDA had not previously established subjective standards of identity for food products. For the reasons stated above, we are satisfied that the Secretary has set such standards in the past. Accordingly, the district court’s third ration- ale for holding the similarity requirement invalid must fall. D. EIS requirement. Section 102(2)(C) of the National Environmental Policy Act, 42 U.S.C. § 4332(2)(C), provides in part that a fed- eral agency must prepare a ‘‘detailed statement,’’ com- monly known as an EIS, whenever it proposes ‘‘major Federal actions significantly affecting the quality of the human environment.’’ ‘he district court held that the USDA did not fulfill the requirements of the Act when it promulgated the regulations involved in this case because it failed ‘‘to make a determination as to whether an EIS should have been prepared and [it failed] to develop a reviewable administrative record supporting a negative decision * * *,”’ We are not willing to find the regulations infirm on this basis. The EIS requirement of 42 U.S.C. § 4332(2)(C) is triggered when an agency proposes major federal action ‘‘significantly affecting the quality of the human environ- ment.’’ In this case, the record does not support a finding that such environmental effects may result from imple- App. 20 mentation of the regulations; moreover, it is clear that the agency considered the potential for such effects. The only ‘‘environmental’’ effects mentioned by the district court were the ‘‘significant public health concerns * * * implicated by the regulation.’’ As detailed earlier in this opinion, however, the record shows that the USDA gave full consideration to the question of the regulations’ health effects and determined that no significant health dangers were presented. Consequently, the sole ground for finding the existence of a major federal action ‘‘significantly af- fecting the quality of the human environment”’ is unsup- ported, and no KIS need be filed. The decision of the district court is reversed. A true copy. Attest: CLERK, U. 8S. COURT OF APPEALS, EIGHTH CIRCUIT. App. 21 UNITED STATES DISTRICT COURT For The SOUTHERN DISTRICT OF [OWA— CENTRAL DIVISION NATIONAL PORK PRODUCERS COUNCIL, et al, and NATIONAL INDEPENDENT MEAT PACKERS ASSOCIATION, vs. BOB 8S. BERGLAND, et al Civil Action File No. 79-431-C JUDGMENT This action came on for hearing before the Court, Honor- able W. C. Stuart, United States District Judge, presiding, and the issues having been duly (heard) and a decision hav- ing been duly rendered, It is Ordered and Adjudged that 9 C.F.R. $317.17 (b) and (c) and $319.2, 44 Fed. Reg. 48961 (August 21, 1979) hereby are declared to be arbitrary, capricious, an abuse of discretion and otherwise not in accordance with law; It IS FURTHER ORDERED AND ADJUDGED that defendants and their officers, agents, servants, employees, or successors and attorneys and those in active concert or participation with them are hereby permanently enjoined and restrained from enforcing or applying 9 C.F.R. : 317.17 (b) and (c) and § 319.2, 44 Fed. Reg. 48961 (Au- gust 21, 1979). Dated at Des Moines, lowa, this 12th day of February, 1980. /s/ James R. Rosenbaum Clerk of Court App. 22 IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF IOWA CENTRAL DIVISION NATIONAL PORK PRODUCERS COUNCIL, et al., Plaintiffs, and NATIONAL INDEPENDENT MEAT PACKERS ASSOCIATION, Plaintiff-Intervenor. vs. BOB §. BERGLAND, et al., Defendants. Civil No. 79-431-C RULING AND ORDER This is an action for judicial review of agency action pursuant to the Administrative Procedure Act (APA), 5 U.S.C. §§ 551, et seq. Plaintiffs are three members of the United States House of Representatives and two trade associations representing pork producers and meat pack- ers. Defendants are the Secretary of Agriculture, the As- sistant Secretary of Agriculture for Food and Consumer Services, and the Acting Administrator of the Food Safety and Quality Service (FSQS) of the United States Depart- ment of Agriculture (USDA). Plaintiffs seek a declara- tory judgment that a USDA regulation permitting meat products prepared without nitrates or nitrites to be mar. keted under traditional names, such as bacon, ham, corned beef, and frankfurters, is arbitrary, capricious, an abuse of discretion and not otherwise in accordance with law. App. 23 They also request permanent injunctive relief preventing defendants from approving meat product labels under the challenged provision. On April 28, 1978, the Administrator of FSQS proposed to amend the federal meat inspection regulations (See Federal Meat Inspection Act of 1907, 21 U.S.C. §§ 601 et seq.) to permit the preparation and sale of meat food prod- ucts under those traditional names, even though such prod- ucts, which have traditionally been cured with nitrates or nitrites, would be prepared without such preservatives. 43 Fed. Reg. 18193 (April 28, 1978). He further proposed that: (1) 3 or more; they have been fermented or pickeld to pH of 4.6 or less; or they have been dried to a water activity of 0.92 or less. (3) Products described in paragraph (b) of this section and § 319.2 of this subchapter shall not be subject to the labeling requirements of paragraphs (b) and (c) of this section if they contain an amount of salt sufficient to achieve a brine concentration of 10 percent or more, § 318.7 (Amended) (2) The first reference to the term ‘‘Cured products’’ in the ‘‘ Products’’ column with respect to ‘‘Curing agents’’ in the chart in § 318.7(c)(4) is amended to read ‘‘Cured products other than bacon. Nitrates may not be used in baby, junior, and toddler foods.’’ The second reference to the term ‘‘Cured products’’ in the column is amended to read ‘‘Cured products. Nitrates may not be used in baby, junior, or toddler foods.’’ App. 93 3. The table of contents for Subpart A of Part 319 of the regulations is amended by adding ‘‘§ 319.2 Products and nitrates and nitrites,’’ and a new § 319.2 is added to read: § 319.2 Products and nitrates and nitrites. Any product, such as frankfurters and corned beef, for which there is a standard in this part and to which nitrate or nitrite is permitted or required to be added, may be prepared without nitrate or nitrite and labeled with such standard name when immediately preceded with the term ‘‘Uncured’’ in the same size and style of lettering as the rest of such standard name: Provided, That the product is found by the Administrator to be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate and nitrite: And provided further, That labeling for such product complies with the provisions of § 317.17(c) of this subchapter. (Sec. 21, 34 Stat. 1264, as amended, 21 U.S.C. 621; 42 FR 35625, 35626, 35631) Note.—-This final rule has been reviewed under the USDA criteria established to implement Executive Order 12044, ‘‘Improving Government Regulations,’’ and has been designated ‘‘significant.’’ An approved Final Im- pact Statement is available from Mr. Irwin Fried, Acting Director, Meat and Poultry Standards and Labeling Divi- sion. Compliance, Food Safety and Quality Service, U.S. Department of Agriculture. Washington, D.C. 20250. Done at Washington, D.C., on August 15, 1979. Donald L. Houston, Acting Administrator, Food Safety and Quality Service. [FR Doe. 79-25824 Filed 8-20-79, 8:45 a.m.] Billing Code 3410-DM-M App. 94 EXCERPTS FROM TRANSCRIPT of November 9, 1979 PROCEEDING Page 141— Mr. Fox: We would identify as Plaintiffs’ Exhibit No. 28 a copy of an excerpt from the Federal Register dated August 21, 1979, which | will now show the witness. Mr. Colleton: Pages 48959, 48960 and 48961. Q. (By Mr. Fox) I ask you to examine the exhibit, Mr. Fried, and then answer my question. Where in that final rule is there consideration by the Department or the [Page 142] administrator of how consumers are to be protected if the label on these uncured products is removed, either in transit or in the home? A. There is no statement, to the best of my knowledge, in this document that deals specifically with your question. Q. Where in that final rule is there any consideration given as to how consumers are to be protected if the prod- nets, the uncured products, are sold, let’s say, in bulk, as a consumer going into a delicatessen and buying a half- pound or pound of sliced bologna which the butcher or the delicatessen owner slices off in the machine, puts it to- gether, wraps it up and gives it to the consumer? A. There is nothing stated in this document that deals with that question. Q. The same question as to selling such things as frank- furters or other uncured products in a meat market, not a self-service type, where the meats generally, and frank- furters and other items are displayed in the old fashioned eases with the butcher behind, and there are no labels on the product. Where in the rule is there consideration given as to how the consumers are to be protected in that particular case? App. 95 A. There is nothing in this document that deals with your question. [Page 143] Q. Where in the final rule is there consideration given as to how non-English-speaking consumers are to be pro- tected in their use—purchase, use and consumption of the non-nitrate products? A. There is nothing in this document that deals with your question. Q. Where in the final rule is there consideration of how functional illiterates among the consumer body are to be protected in the case of these non-nitrated products? A. Again there is nothing in this document that deals with that question. Mr. Hirt: Your Honor—Nothing, Your Honor. I’m sorry. Q. (By Mr. Fox) Do you have any idea, as you sit here today, Mr. Fried, as to how many functional illiterates there may be in the United States? A. No, I couldn’t give that number. Q. Would you think it would be a reasonable propor- tion, let’s say in the neighborhood of what Dr. Jacoby referred to in his testimony? A. I have absolutely no frame of reference to judeg that. @. You never made any investigation into that par- ticular parameter? A. No. [Page 145] Q. I show you what has been admitted in evidence as Plaintiffs’ Exhibit 18, reading from Page 5 thereof—this App. 96 [Page 146] happens to be a letter from Mrs. Foreman to Honorable Griffen Bell, the Attorney General of August 1978. ‘‘It should further be noticed, however, that we have also been advised by such officials, namely, USDA and FDA administrative officials, hat nitrites have been found to prevent the growth of clostridium botulinum, a natural contaminant of improperly preserved meat products, and which produces an extremely potent poison usually fatal to man; that there are no substances that could be ultilized under sufficiently broad scale to prevent botulism in com- mercially processed meats produced and without nitrites. Common usage of such products as hotdogs and ham would not be possible without severe health hazards.’’ Have you been familiar with that statement of the De- partment prior to the time that you came here today and sat on this witness stand? A. Yes. I’ve got no objection to that statement. (). You were familiar with it? A. Well, I’m roughly familiar with it, yes. Q. And that statement is true; is that correct? A. Yes. I have no problem with that statement at all. [Page 192] CROSS EXAMINATION By Mr. Fox: Q. 1 just have one question, Mr. Fried. Do you think consumers will understand what the word ‘‘uncured’’ means? A. I think they will. Q. Now, when I say ‘‘consumers’’, I mean everybody out there. Do you think they are going to understand what the word ‘‘uncured’’ means? A. If you say everybody, and mean everybody, I would have to agree not everybody will. App. 97 Q. Do you think that the functional illiterates in the United States will understand what the word ‘‘uncured”’ means? Mr. Hirt: Your Honor, | object. Mr. Fox: Wait a minute. On what ground? Mr. Hirt: I think this is an irrelevant issue in terms of functional illiterates because any label which FDA or USDA puts out is in standard English. The Court: He may answer subject to the objection. Q. (By Mr. Fox) Do you think the functional illiter- ates will understand what the word ‘‘uncured’’ means? A. If they can’t read it, 1 don’t know whether they can understand it or not. Q. Same thing— A. If that’s what you mean by ‘‘illiterate’’. Q. The same thing would apply for non-English-speak- ing people. [Page 193] A. Yes, if they only see the English. Q. The same thing might apply for a child who might pop a package of those franks into a grocery cart, going along shopping with his mother? A. If the mother would allow him to do that, sure. Q. Or a child sent to the store to buy a package of franks? [Page 195] Q. And what is the decision that the Department has made with regard to selling these particular products in bulk, or should the labels become obliterated or removed just as | removed the labels here before you this afternoon? A. I believe I have answered a previous question as stating that it is my absolute belief that a person buying a product, it is in fact— I would agree with Dr. Jacoby. He said—I don’t know about the figures, but he said not— as I recall, not too many peope read the handling instruc- tions, and I believe that in many instances people buying— App. 98 and I believe this is because of previous experience, you buy a product in the refrigerated case, and you take it home and put it in the refrigerator. You don’t put it on the kitchen table and leave it for three days and then eat it. [Page 197] Q. My question is, on what do you base your opinion that consumers would read those labels? A. From everything that we have received in the De- partment, from people who want to have nitrite-free prod- ucts. Mr. Colleton: Thank you very much, Mr. Fried. --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385007_0749%3A1. Public record. Not legal advice.