Case: 20-70747, 01/28/2021, ID: 11985349, DktEntry: 45, Page 1 of 52
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`
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`No. 20-70747
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`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
`CENTER FOR FOOD SAFETY,
`
`Petitioner,
`v.
`
`UNITED STATES FOOD AND DRUG ADMINISTRATION, et al.,
`
`Respondents,
`and
`IMPOSSIBLE FOODS INC.,
`
`Intervenor-Respondent.
`
`
`
`
`
`ON PETITION FOR REVIEW FROM THE UNITED STATES
`ENVIRONMENTAL PROTECTION AGENCY
`
`PETITIONER’S COMBINED REPLY BRIEF
`______________________
`
`
`
`
`CENTER FOR FOOD SAFETY
`Ryan D. Talbott
`Sylvia Shih-Yau Wu
`2009 NE Alberta St., Suite 207
`Portland, OR 97211
`T: (971) 271-7372
`rdtalbott@centerforfoodsafety.org
`swu@centerforfoodsafety.org
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 20-70747
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`
`
`CENTER FOR FOOD SAFETY,
`
`Petitioner,
`v.
`
`UNITED STATES FOOD AND DRUG ADMINISTRATION, et al.,
`
`Respondents,
`and
`IMPOSSIBLE FOODS INC.,
`
`Intervenor-Respondent.
`
`
`
`
`
`ON PETITION FOR REVIEW FROM THE UNITED STATES
`ENVIRONMENTAL PROTECTION AGENCY
`
`PETITIONER’S COMBINED REPLY BRIEF
`______________________
`
`
`
`
`CENTER FOR FOOD SAFETY
`Ryan D. Talbott
`Sylvia Shih-Yau Wu
`2009 NE Alberta St., Suite 207
`Portland, OR 97211
`T: (971) 271-7372
`rdtalbott@centerforfoodsafety.org
`swu@centerforfoodsafety.org
`
`
`
`
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`
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`
`
`
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`
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`Case: 20-70747, 01/28/2021, ID: 11985349, DktEntry: 45, Page 2 of 52
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`TABLE OF CONTENTS
`TABLE OF CONTENTS ............................................................................. i
`TABLE OF AUTHORITIES ....................................................................... ii
`INTRODUCTION ....................................................................................... 1
`SUMMARY OF ARGUMENT .................................................................... 2
`ARGUMENT ............................................................................................... 8
`I.
`CFS HAS STANDING ............................................................. 8
`II. FDA FAILED TO APPLY THE CONVINCING
`EVIDENCE STANDARD TO IMPOSSIBLE FOODS’
`COLOR ADDITIVE PETITION. ........................................... 15
`III. FDA FAILED TO SUPPORT ITS DECISION WITH
`SUBSTANTIAL EVIDENCE. ................................................ 22
`A. The estimated exposure and novelty of soy
`leghemoglobin should have prompted rigorous
`testing. ........................................................................... 23
`Impossible Foods’ 28-day rat-feeding study with
`only ten animals per sex per dosage group did not
`meet FDA’s minimum requirements for
`subchronic toxicity studies. .......................................... 28
`C. History of consumption of soy and soy
`leghemoglobin does not constitute substantial
`evidence. ........................................................................ 34
`D. FDA and Impossible Foods present no substantial
`evidence for claim that soy leghemoglobin is
`“rapidly digested” in the stomach. ............................... 35
`IV. THE COURT SHOULD VACATE FDA’S DECISION. ........ 38
`CONCLUSION ......................................................................................... 44
`i
`
`B.
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`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Federal Cases
`All. for the Wild Rockies v. U.S. Forest Serv.,
`907 F.3d 1105 (9th Cir. 2018) .................................................. 39, 42, 43
`Altamirano v. Gonzales,
`427 F.3d 586 (9th Cir. 2005) ................................................................ 33
`Amoco Prod. Co. v. Village of Gambell,
`480 U.S. 531 (1987) .............................................................................. 42
`Bowen v. Georgetown Univ. Hosp.,
`488 U.S. 204 (1988) .............................................................................. 32
`Citizens for Better Forestry v. U.S. Dep’t of Agric.,
`341 F.3d 961 (9th Cir. 2003) .............................................................. 8, 9
`Clapper v. Amnesty Int’l USA,
`568 U.S. 398 (2013) ........................................................................ 13, 14
`Food & Water Watch v. Vilsack,
`808 F.3d 905 (D.C. Cir. 2015) ........................................................ 13, 14
`Friends of the Earth v. Laidlaw Envtl. Servs.,
`528 U.S. 167 (2000) .............................................................................. 10
`Humane Soc’y of U.S. v. Locke,
`626 F.3d 1040 (9th Cir. 2010) .............................................................. 38
`Idaho Farm Bureau Fed’n v. Babbitt,
`58 F.3d 1392 (9th Cir. 1995) ................................................................ 39
`Lujan v. Defs. of Wildlife,
`504 U.S. 555 (1992) .............................................................................. 12
`
` ii
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`
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`Page(s)
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`Federal Cases (Cont’d)
`McIlwain v. Hayes,
`690 F.2d 1041 (D.C. Cir. 1982) ...................................................... 19, 20
`Monsanto Co. v. Geertson Seed Farms,
`561 U.S. 139 (2010) .............................................................................. 13
`Nat. Res. Def. Council v. U.S. E.P.A.,
`735 F.3d 873 (9th Cir. 2013) .............................................. 10, 14, 29, 30
`Nat’l Family Farm Coal. v. EPA,
`960 F.3d 1120 (9th Cir. 2020) ........................................................ 39, 43
`Nw. Coal. for Alts. to Pesticides v. U.S. E.P.A.,
`544 F.3d 1043 (9th Cir. 2008) ........................................................ 17, 18
`Nw. Envtl. Def. Ctr. v. Bonneville Power Admin.,
`117 F.3d 1520 (9th Cir. 1997) .............................................................. 11
`Nw. Requirements Utils. v. FERC,
`798 F.3d 796 (9th Cir. 2015) ................................................................ 15
`Ocean Advocs. v. U.S. Army Corps of Eng’rs,
`402 F.3d 846 (9th Cir. 2005) ................................................................ 10
`Pollinator Stewardship Council v. EPA,
`806 F.3d 520 (9th Cir. 2015) ........................................................ passim
`Public Citizen v. Young,
`831 F.2d 1108 (D.C. Cir. 1987) ............................................................ 21
`San Luis & Delta-Mendota Water Auth. v. Jewell,
`747 F.3d 581 (9th Cir. 2014) .......................................................... 36, 37
`WildEarth Guardians v. U.S. Dep’t of Agric.,
`795 F.3d 1148 (9th Cir. 2015) .......................................................... 9, 10
`In re Zappos.com, Inc.,
`888 F.3d 1020 (9th Cir. 2018) ........................................................ 13, 14
`
` iii
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`Federal Statutes
`21 U.S.C. § 379e ................................................................................ passim
`21 U.S.C. § 321(s) ..................................................................................... 21
`21 U.S.C. § 321(t) ...................................................................................... 21
`21 U.S.C. § 379e(a) ............................................................................... 3, 15
`21 U.S.C. § 379e(b)(4) ................................................................................. 3
`Regulations
`21 C.F.R. § 70.3(i) ..................................................................... 4, 16, 18, 22
`21 C.F.R. § 70.55 ....................................................................................... 41
`21 C.F.R. § 71.1 ......................................................................................... 41
`21 C.F.R. § 170.3(i) ......................................................................... 4, 16, 22
`Other Authorities
`FDA, Good Laboratory Practice Regulations Management
`Briefings, Post Conference Report, subpt. A General
`Provisions, #23 (Aug. 1979), available at
`https://www.fda.gov/regulatory-information/search-fda-
`guidance-documents/good-laboratory-practice-regulations-
`management-briefings-post-conference-report-aug-1979 .................. 31
`FDA, Guidance for Industry: Summary Table of
`Recommended Toxicological Testing for Additives Used in
`Food, available at https://www.fda.gov/regulatory-
`information/search-fda-guidance-documents/guidance-
`industry-summary-table-recommended-toxicological-
`testing-additives-used-food ...................................................... 24, 27, 28
`
` iv
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`Page(s)
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`Other Authorities (Cont’d)
`H.R. 7624 and S. 2197 Before the H. Comm. on Interstate
`and Foreign Commerce, 86th Cong., 2d Sess. 108 (1960)
`(statement of Rep. James Delaney of New York) ............................... 21
`Pub. Interest, “Barebones” FDA Review of Impossible
`Burger’s Soy Leghemoglobin Inadequate, Says CSPI (Sept.
`3, 2019) available at https://cspinet.org/news/barebones-
`fda-review-impossible-burger-soy-leghemoglobin-
`inadequate-20190903 ........................................................................... 11
`
`
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` v
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`INTRODUCTION
`Color additives add no nutritional value to food; they are, just like
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`they sound, only for appearance. For that reason, Congress intended
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`they be subject to greater scrutiny by the U.S. Food and Drug
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`Administration (FDA) than other food additives before they can be put
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`in food. In furtherance of that congressional intent, FDA’s color additive
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`regulations require “convincing evidence” of safety, words that are
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`notably absent from the agency’s food additive regulations.
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`Despite the plain language distinction, it is not remotely clear
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`what safety standard FDA applied in its review of soy leghemoglobin,
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`Impossible Foods’ novel color additive for which there is “no history or
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`knowledge of human dietary exposure.” 1-ER-081. For that reason
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`alone, the Court should vacate FDA’s decision. FDA’s and Impossible
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`Foods’ attempts to conflate the two standards cannot escape the simple
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`fact that one standard (color additive) requires “convincing evidence”
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`while the other (food additive) does not.
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`FDA’s decision also lacks substantial evidence in the record. The
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`novelty of soy leghemoglobin and the large amount consumers are
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`exposed to, place it in FDA’s “highest probable risk to human health”
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`1
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`category, FER-004, which according to FDA’s own authoritative
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`guidelines should have triggered extensive toxicity testing, including
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`subchronic, chronic, carcinogenicity, and reproductive testing. That did
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`not occur. Instead, Impossible Foods submitted a study purporting to be
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`a “subchronic toxicity” study, but which did not meet the minimum
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`standards for such studies to warrant meaningful analysis. And even
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`this deficient study produced suggestive evidence of health harms in
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`test animals that also should have triggered additional, long-term
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`testing, which again, did not happen.
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`For any or all of these reasons the Court should apply the default
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`remedy and vacate FDA’s unlawful color additive approval decision.
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`SUMMARY OF ARGUMENT
`
`First and as an initial matter, Center for Food Safety (CFS) has
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`standing, which Impossible Foods alone challenges. In its opening brief,
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`CFS explained how FDA’s approval of soy leghemoglobin as a color
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`additive increases the risk of harm, thereby posing a credible food
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`safety threat to CFS and its members. FDA increased that risk by using
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`an improperly low legal threshold for its action, as well as relying on
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`inadequate evidence. Op. Br. 32-56, ECF No. 19. Under the Ninth
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` 2
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`Circuit’s longstanding jurisprudence in probabilistic injury cases, such
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`an increase in risk from the agency’s unlawful approval action plainly
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`satisfies the injury-in-fact requirement for Article III standing, which is
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`the only prong that Impossible Foods challenges. This is also a
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`procedural case, where FDA failed to properly respond to CFS’s
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`objections to the additive approval, a context where the standing
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`showing is relaxed. Finally, CFS also has statutory standing, because
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`its interests in food safety are far more than marginally related to and
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`entirely consistent with the purposes of Section 721 of the Federal Food,
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`Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 379e, which is all that is
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`required.
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`Second, FDA applied an incorrect, lower safety standard than
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`required by its own color additive regulations when it approved soy
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`leghemoglobin as a color additive. This violated the FFDCA. Under the
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`FFDCA, FDA must presume that a color additive is unsafe unless the
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`petitioner (here, Impossible Foods), supplies data establishing that its
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`use will be safe. 21 U.S.C. § 379e(a), (b)(4). The burden of proof on
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`petitioners seeking approval of new color additives is high: unlike its
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`regulations for food additives, FDA’s color additive regulations plainly
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` 3
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`require “convincing evidence that establishes with reasonable certainty
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`that no harm will result from the intended use of the color additive.” 21
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`C.F.R. § 70.3(i) (emphasis added). FDA instead approved Impossible
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`Foods’ soy leghemoglobin under the lower standard for food additives.
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`See 21 C.F.R. § 170.3(i).
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`FDA wrongly claims that any difference between the food additive
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`and color additive regulations are “chiefly rhetorical.” FDA Br. 21, ECF
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`No. 30. Somewhat confusingly, Impossible Foods seems to agree with
`
`FDA that the standards of safety are similar, but at the same time
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`admits that the standard of proof for color additives (“convincing
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`evidence”) is different. Int. Br. 29, 31, ECF No. 35. That not even FDA
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`and Impossible Foods can agree on this vital point underscores CFS’s
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`argument that FDA’s objection response was at best “vague, making it
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`impossible . . . to determine” what standard of safety FDA actually used
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`in reviewing Impossible Foods’ petition. Op. Br. 41.
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`Regardless, neither FDA nor Impossible Foods can explain away
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`the simple fact that in denying CFS’s objections, FDA entirely omitted
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`the “convincing evidence” test from the standard it applied, equating
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`the safety standard of color additives with that of food additives and
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`GRAS substances. 1-ER-004. This was no “simple clerical error,” Int.
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`Br. 30, but rather indicative of FDA’s systemic failure to apply the
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`“convincing evidence” standard in its color additive regulations. 2-ER-
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`152. By so doing, FDA based its approval of soy leghemoglobin on an
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`incorrect, lower safety standard. And post hoc non-record rationale by
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`either Respondent cannot explain that error away.
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`Third, FDA’s approval of soy leghemoglobin lacks substantial
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`evidence in the record, also violating the FFDCA. Under FDA’s own
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`authoritative guidelines, the high exposure level and extreme novelty of
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`synthetic biology-created soy leghemoglobin mandate a full battery of
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`toxicity tests, which it critically did not do. Estimated exposure to soy
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`leghemoglobin vastly exceeds FDA’s level that triggers the need for
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`multiple long-term animal studies, including subchronic, chronic,
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`carcinogenicity, and reproductive testing. FDA’s guidelines also
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`specifically states that novel color additives, like soy leghemoglobin,
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`undergo a full battery of toxicity testing, regardless of exposure level.
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`FDA’s failure to mandate these studies for a novel color additive
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`consumed in large quantities renders its decision without substantial
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`evidence.
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`Fourth, lacking this full battery of toxicity testing, Respondents
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`claim that the company’s limited studies, including a 28-day rat-feeding
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`study, were adequate.1 FDA Br. 24; Int. Br. 33-42. But the 28-day rat-
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`feeding study simply did not meet the minimum standards for either (1)
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`study duration or (2) the number of test animals. And there is no
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`evidence that Impossible Foods justified instead using a shorter
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`timeframe or fewer animals.
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`Fifth, beyond its attempts to rehabilitate the improper toxicity
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`study, Respondents seek to rely on the penumbra of the other
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`information Impossible Foods submitted to FDA in order to meet its
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`substantial evidence burden, such as the alleged safe history of both soy
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`and soy leghemoglobin. FDA Br. 23; Int. Br. 42-43. Contrary to
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`Impossible Foods’ core claim, there is simply no “long history of safe
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`consumption of . . . soy leghemoglobin protein.” Int. Br. 1. And, as even
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`FDA admits, as it must, the consumption history of traditional soy
`
`
`1 Impossible Foods submitted three studies to FDA. The first
`(Study 43167) was a 14-day study “to establish the dose range” for the
`second 28-day study (Study 43166). SER-32-33. The third study (Study
`44856) was conducted to address “estrous cycle distributions observed
`in [the second study],” i.e., “disruptions in the reproductive cycle.” SER-
`34, 1-ER-092. It is the second study (Study 43166) that FDA largely
`relied on and which is the subject of the briefing.
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`cannot be assumed to support the purported safety of the novel color
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`additive soy leghemoglobin. 1-ER-081.
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`Sixth, Respondents now claim that a longer study with more
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`animals compliant with FDA’s own guidelines was unnecessary because
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`soy leghemoglobin allegedly is “rapidly digested.” Int. Br. 37; FDA Br.
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`25. But this was based on artificial tests involving highly acidic
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`“simulated gastric fluid,” which do not reflect the milder, less acidic
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`conditions characterizing the stomachs of adults after meals, infants,
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`the elderly, and those who take antacids. Translation: in real world
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`conditions of many human stomachs, soy leghemoglobin will not be
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`rapidly digested.
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`Seventh and finally, for these reasons, the Court should vacate the
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`color additive approval, not simply remand it. In a case like this, where
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`FDA applied the wrong legal standard, it is much more than a
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`“technical” violation. Int. Br. 44. Rather, it goes to the agency’s core
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`legal duty to ensure that novel color additives are safe before they are
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`sold. 21 U.S.C. § 379e. Leaving FDA’s legally deficient decision in place
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`risks more potential harm to public health than vacating it.
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`ARGUMENT
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`I. CFS HAS STANDING
`As an initial matter, only Impossible Foods challenges standing;
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`FDA does not. Moreover, even that dispute is narrow: Impossible Foods
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`only challenges the injury-in-fact prong; it does not challenge causation
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`or redressability grounds.
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`
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`First, it is undisputed that the injury-in-fact prong is a low bar,
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`for when agency procedural violations are at issue—such as an agency’s
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`failure to apply the correct legal standard in issuing a denial of CFS’s
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`color additive approval objections—for cognizable injury-in-fact, a
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`petitioner only needs to show that (1) the agency violated certain
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`procedural rules, (2) those rules protect petitioner’s concrete interests,
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`and (3) it is reasonably probable that the challenged action will
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`threaten those concrete interests. Citizens for Better Forestry v. U.S.
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`Dep’t of Agric., 341 F.3d 961, 969-70 (9th Cir. 2003); Int. Br. 23. Here,
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`FDA violated its color additive procedures, which protect CFS’s
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`interests in health and food safety, and it is reasonably probable that
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`FDA’s improper decision will threaten those concrete interests.
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`
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`Importantly, and contrary to Impossible Foods’ framing, CFS need
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`not assert that any specific injury will occur, but rather the injury is
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`that consumer safety consequences might be overlooked by the agency,
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`as a result of the deficiencies in the government’s analysis under food
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`safety statutes. Citizens for Better Forestry, 341 F.3d at 971-72. The
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`color additive provisions of the FFDCA and FDA’s implementing
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`regulations and processes are most certainly there to protect
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`Petitioner’s (and their members’) interests in safe food. Yet, here for
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`example because FDA did not apply the proper legal standard for color
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`additive approvals, and instead improperly employed a lower one, it is
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`reasonably probable that FDA may have overlooked health risks it
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`otherwise would have flagged. Or, because FDA settled for a 28-day
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`study instead of requiring a longer one pursuant to its own guidelines,
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`it is reasonably probable that FDA may have overlooked health risks it
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`otherwise would have found—and as discussed more below, it has. See
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`infra 11-12, 37. Nothing more is required.
`
`
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`Further, once a petitioner seeking to enforce a procedural
`
`requirement establishes a concrete injury, “the causation and
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`redressability requirements are relaxed.” WildEarth Guardians v. U.S.
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`Dep’t of Agric., 795 F.3d 1148, 1154 (9th Cir. 2015). “Plaintiffs alleging
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`procedural injury must show only that they have a procedural right
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` 9
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`that, if exercised, could protect their concrete interests.” Id. (emphasis
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`in original). Here, if FDA applied the proper legal standard to its
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`review, it might reach a different result and deny the color additive
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`approval.
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`
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`Second and more generally, CFS has (1) suffered injury (2) fairly
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`traceable to FDA’s challenged conduct that is (3) redressable. Friends of
`
`the Earth v. Laidlaw Envtl. Servs., 528 U.S. 167, 180-81 (2000). In a
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`probabilistic injury case such as this, CFS does not need to show actual
`
`harm will occur but rather simply an “increased risk of harm” resulting
`
`from FDA’s actions. Ocean Advocs. v. U.S. Army Corps of Eng’rs, 402
`
`F.3d 846, 860 (9th Cir. 2005). The Ninth Circuit has “consistently held
`
`that an injury is ‘actual or imminent’ where there is a ‘credible threat’
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`that a probabilistic harm will materialize.” Nat. Res. Def. Council
`
`(NRDC) v. U.S. E.P.A., 735 F.3d 873, 878 (9th Cir. 2013).
`
`
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`Despite its shortcomings, a rat-feeding study commissioned by
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`Impossible Foods nonetheless reveals such a credible threat to CFS’s
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`members (and through them, CFS organizationally), in numerous
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`forms. These include a large number of statistically significant adverse
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`effects, such as:
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`(1) decreased reticulocyte (immature red blood cell) count,
`which can indicate anemia and/or bone marrow damage);
`(2) decreased blood clotting ability;
`(3) decreased blood levels of alkaline phosphate, which can
`indicate celiac disease and/or malnutrition;
`(4) increased blood albumin, which can indicate acute
`infections or tissue damage;
`(5) increased potassium levels, which can indicate kidney
`disease,
`(6) decreased blood glucose, which can indicate low blood
`sugar;
`(7) decreased chloride, which can indicate kidney problems;
`(8) and increased blood globulin values, which is common in
`inflammatory disease and cancer.
`
`
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`1-ER-091-92.2 Despite the evident intent of Respondents to downplay
`
`these adverse effects as “incidental,” both concede, for example, that
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`“blood clotting ability,” also referred to as “coagulation,” was reduced in
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`two treated groups of male rats, clearly a negative impact. FDA Br. 26;
`
`
`2 See also Ctr. for Science in the Pub. Interest, “Barebones” FDA
`Review of Impossible Burger’s Soy Leghemoglobin Inadequate, Says
`CSPI (Sept. 3, 2019) (explaining how the World Health Organization
`says there is “‘strong evidence’ that heme contributes to the
`carcinogenic mechanisms associated with red and processed meats” and
`that “both soy leghemoglobin and animal-based myoglobin release
`identical heme B molecules into the digestive system”), available at
`https://cspinet.org/news/barebones-fda-review-impossible-burger-soy-
`leghemoglobin-inadequate-20190903. The court may accept this for
`standing purposes. See Nw. Envtl. Def. Ctr. v. Bonneville Power Admin.,
`117 F.3d 1520, 1528 (9th Cir. 1997) (court may consider extra-record
`evidence for purposes of standing).
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`2-ER-273, 2-ER-312.3 In simple English, these health risks are shown
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`in Respondent’s own study about this novel color additive with no
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`history of human consumption: risks of inflammatory disease, cancer,
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`kidney disease, anemia, blood clotting, and celiac disease among them.
`
`
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`Further, CFS members are at an increased risk of harm from
`
`consuming soy leghemoglobin because Impossible Foods’ “products are
`
`widely available in restaurants and supermarkets across the country.”
`
`Int. Br. 44. Even if some of CFS’s members are less likely to eat these
`
`products, some may choose to do so because they do not eat meat. And
`
`contrary to Impossible Foods’ claim, Int. Br. 26-27, unilateral control
`
`over exposure to harm “does not necessarily render the harm
`
`nonspeculative.” Lujan v. Defs. of Wildlife, 504 U.S. 555, 593 (1992).
`
`Moreover, the number of Impossible Foods’ products are
`
`increasing, Op. Br. 51-52, increasing the exposure risks, and many CFS
`
`members might not know that these products also contain soy
`
`leghemoglobin unless they read the ingredient list on the product label.
`
`
`3 Molecular geneticist Michael Antoniou, PhD, confirms that the
`statistically significant difference conceded by Impossible Foods and
`FDA was in fact a decrease in blood clotting ability in treated rats. 1-
`ER-092.
`
` 12
`
`
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`Case: 20-70747, 01/28/2021, ID: 11985349, DktEntry: 45, Page 19 of 52
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`As stated above, all of CFS’s declarants that have previously eaten
`
`Impossible Foods’ meatless burger said they did so without knowing
`
`that it contained soy leghemoglobin. See Kaluza Decl. ¶ 6; Kelley Decl.
`
`¶¶ 7-8; Maker Decl. ¶ 5; Thomas Decl. ¶ 10. It stands to reason that
`
`many other CFS members have done the same and will continue,
`
`especially with an expanding product line.
`
`That expanding product line will also require these and other CFS
`
`members to take proactive steps to research product labels in stores or
`
`online to make sure they are not purchasing products that have
`
`undergone limited safety testing that could increase risks of kidney
`
`disease, inflammatory disease, and cancer. 1-ER-092. This also is a
`
`cognizable injury-in-fact. See Monsanto Co. v. Geertson Seed Farms, 561
`
`U.S. 139, 153-56 (2010) (standing found where members took “certain
`
`measures to minimize the likelihood” of potential harm).
`
`
`
`Third, Impossible Foods also gets the legal standard for injury-in-
`
`fact wrong, citing this Court’s decision in In re Zappos.com, Inc., 888
`
`F.3d 1020 (9th Cir. 2018) and the D.C. Circuit’s decision in Food &
`
`Water Watch v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015). See Int. Br. 26.
`
`Both of these cases relied on the Supreme Court’s decision in Clapper v.
`
` 13
`
`
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`Case: 20-70747, 01/28/2021, ID: 11985349, DktEntry: 45, Page 20 of 52
`
`Amnesty Int’l USA, 568 U.S. 398 (2013). As this Court has explained,
`
`the standing showing in Clapper was “especially rigorous” because it
`
`arose in a sensitive national security context. In re Zappos.com, 888
`
`F.3d at 1026. This Court has subsequently used the “credible threat”
`
`standard in other contexts not involving national security, including
`
`cases like this involving public health. See, e.g., NRDC, 735 F.3d at 878.
`
`
`
`Moreover, the extra-circuit Food & Water Watch is inapposite to
`
`this Court’s “credible threat” standard, see NRDC, 735 F.3d at 878, a
`
`standard instead consistent with the approaches of other circuits in
`
`similar cases. In Baur v. Veneman, for example, the Second Circuit
`
`explained that “[l]ike threatened environmental harm, the potential
`
`harm from exposure to dangerous food products or drugs ‘is by nature
`
`probabilistic,’ yet an unreasonable exposure to risk may itself cause
`
`cognizable injury.” 352 F.3d 625, 634 (2d Cir. 2003). Indeed, the “very
`
`purpose of the . . . FFDCA . . . is to ensure the safety of the nation’s food
`
`supply and to minimize the risk to public health from potentially
`
`dangerous food and drug products.” Id.
`
`
`
`Finally, contrary to Impossible Foods’ claim, Int. Br. 28-29, CFS
`
`also has statutory standing. Statutory standing turns on simply
`
` 14
`
`
`
`Case: 20-70747, 01/28/2021, ID: 11985349, DktEntry: 45, Page 21 of 52
`
`whether CFS’s interests “are arguably protected by” Section 721 of the
`
`FFDCA. See Nw. Requirements Utils. v. FERC, 798 F.3d 796, 807-08
`
`(9th Cir. 2015). As long as CFS’s interests are not “so marginally
`
`related to or inconsistent with the purposes implicit in the statute,”
`
`CFS has statutory standing. Id. at 808.
`
`Under Section 721, Congress declared that color additives are
`
`unsafe unless FDA issues a regulation prescribing the conditions under
`
`which the additive may be safely used. 21 U.S.C. § 379e(a). CFS’s
`
`organizational interests in food safety, the consumer’s right to know
`
`what’s in the food they eat, and the public health are easily more than
`
`marginally related to and consistent with the safe regulation of color
`
`additives. See Hanson Decl. ¶¶ 3-20. Therefore, in addition to having
`
`Article III standing, CFS also has statutory standing.
`
`II. FDA FAILED TO APPLY THE CONVINCING EVIDENCE
`STANDARD TO IMPOSSIBLE FOODS’ COLOR ADDITIVE
`PETITION.
`As CFS explained in its opening brief, Congress intended FDA to
`
`
`
`subject color additives to greater scrutiny than food additives. Op. Br.
`
`16-19, 32-43. This is evident from the fact that Congress did not include
`
`a GRAS exemption like it did for food additives. Id. at 17-18. It is also
`
` 15
`
`
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`
`evident from the plain language of FDA’s regulations implementing the
`
`Color Additives Amendment, in which the agency required “convincing
`
`evidence that establishes with reasonable certainty that no harm will
`
`result from the intended use of the color additive.” 21 C.F.R. § 70.3(i)
`
`(emphasis added). FDA failed to apply the convincing evidence standard
`
`in its review and approval of Impossible Foods’ petition.
`
`
`
`The plain text of the regulations, the statutory scheme and
`
`legislative history, multiple canons of construction, all support CFS’s
`
`interpretation: that the color additive standard is different, and higher,
`
`than the food additive standard. Op. Br. 32-39. Yet FDA claims that the
`
`differences in wording between the two standards are “chiefly
`
`rhetorical.” FDA Br. 21. Impossible Foods seemingly agrees, but
`
`elsewhere acknowledges that the “burden of proof” is different for color
`
`additives. Int. Br. 5. But this is a distinction without a difference: the
`
`burden of proof required is part and parcel of what the legal standard
`
`is. These semantics cannot obfuscate the fact that, by their plain
`
`language, the standards of safety are different, with color additives
`
`requiring more to establish safety (“convincing evidence”) than food
`
`additives. See Op. Br. 19, 34-39; 21 C.F.R. §§ 70.3(i), 170.3(i). More
`
` 16
`
`
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`Case: 20-70747, 01/28/2021, ID: 11985349, DktEntry: 45, Page 23 of 52
`
`fundamentally, Respondents’ inconsistency on this key point supports
`
`CFS’s argument that FDA’s objection response was at best “vague,
`
`making it impossible . . . to determine” what standard of safety FDA
`
`used in its review of Impossible Foods’ petition. Op. Br. 41 (quoting Nw.
`
`Coal. for Alts. to Pesticides (NCAP) v. U.S. E.P.A., 544 F.3d 1043, 1051
`
`(9th Cir. 2008) (EPA failed to explain its departure from established
`
`safety factor)).
`
`
`
`Contrary to Impossible Foods’ claim, FDA’s failure to apply the
`
`convincing evidence standard was no “simple clerical error.” Int. Br. 30.
`
`Rather, it is a systemic problem at FDA in which the agency blurs the
`
`lines for these distinct regulatory programs. See 1-ER-004 (FDA
`
`explaining that it considers the standards of safety for color additives,
`
`food additives, and GRAS substances to be “the same”); 2-ER-152
`
`(guidance document omitting “convincing evidence” from standard of
`
`safety for color additives). In FDA’s review of Impossible Foods’ first
`
`GRAS notice, the agency stated that the notification “should adequately
`
`address” the safety of soy leghemoglobin. 1-ER-081. “Should adequately
`
`address” is not “the same” as “convincing evidence that establishes with
`
`reasonable certainty that no harm will result from the intended use of
`
` 17
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`
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`Case: 20-70747, 01/28/2021, ID: 11985349, DktEntry: 45, Page 24 of 52
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`the color additive.” 21 C.F.R. § 70.3(i). But according to FDA, the
`
`standards of safety for color additives, food additives, and GRAS
`
`substances are indistinguishable.
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