Center for Food Safety v. Fda

• Court: Court of Appeals for the Ninth Circuit
• Decided: May 3, 2021
• Docket: 20-70747
• Status: Unpublished

Opinion

FILED NOT FOR PUBLICATION MAY 3 2021 UNITED STATES COURT OF APPEALS MOLLY C. DWYER, CLERK U.S. COURT OF APPEALS

FOR THE NINTH CIRCUIT

CENTER FOR FOOD SAFETY, No. 20-70747

Petitioner, FDA No. FDA- 2018-C-4464

v. MEMORANDUM* U.S. FOOD & DRUG ADMINISTRATION; JANET WOODCOCK, in her official capacity as Acting Commissioner,**

Respondents, ______________________________

IMPOSSIBLE FOODS INC.,

Intervenor.

On Petition for Review of an Order of the Food & Drug Administration

Argued and Submitted April 14, 2021 Seattle, Washington

* This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3.

** Pursuant to Federal Rule of Appellate Procedure 43(c)(2), Janet Woodcock is automatically substituted as the Acting Commissioner of the U.S. Food and Drug Administration. Before: O’SCANNLAIN, GRABER, and CALLAHAN, Circuit Judges. Dissent by Judge O’SCANNLAIN

Petitioner Center for Food Safety ("CFS") seeks review of Respondent

United States Food and Drug Administration’s ("FDA") denial of its objections to

the agency’s approval of soy leghemoglobin as a color additive for use in

Intervenor Impossible Foods Inc.’s ("Impossible") products. We have jurisdiction

under 21 U.S.C. § 371(f)(1).1 Reviewing the FDA’s decision for substantial

evidence, Id. § 371(f)(3), we deny CFS’s petition.

1. The FDA applied the correct standard for evaluating the safety of soy

leghemoglobin as a color additive; it did not violate the Federal Food, Drug, and

Cosmetic Act. The agency stated that federal color additive regulations "define

‘safe’ to mean that there is convincing evidence that establishes with reasonable

certainty that no harm will result" from soy leghemoglobin’s use. Listing of Color

Additives Exempt from Certification; Soy Leghemoglobin, 84 Fed. Reg. 37573,

37574 (Aug. 1, 2019) (citing 21 C.F.R. § 70.3(i)). It is clear from reading the

1 At a minimum, Janet Maker’s declaration establishes a sufficient injury in fact to satisfy Article III. Maker consumed Impossible’s product, stopped consuming it because of a health condition that the product could affect adversely, and would consume the product again were she adequately assured of its safety. By discounting Maker’s reliance on evidence of adverse effect, the dissent conflates the standing inquiry with the merits. See Citizens for Better Forestry v. U.S. Dep't of Agric., 341 F.3d 961, 971–72 (9th Cir. 2003); Ecological Rights Found. v. Pac. Lumber Co., 230 F.3d 1141, 1151 (9th Cir. 2000).

2 FDA’s decision as a whole that the FDA performed the appropriate analysis.

Isolated instances in which the FDA phrased the safety standard differently do not

establish that the agency used the wrong standard.

2. Substantial evidence supports the FDA’s decision to approve soy

leghemoglobin as a color additive. See Nat. Res. Def. Council v. U.S. EPA, 735

F.3d 873, 877 (9th Cir. 2013) (stating standard). CFS’s contention that one study

Impossible commissioned did not conform to the FDA’s "Redbook" is unavailing;

the agency’s recommendations regarding the design of toxicology studies are non-

binding. See Nat’l Family Farm Coal. v. U.S. EPA, 966 F.3d 893, 920 (9th Cir.

2020) (explaining that the agency’s reliance on studies that did not precisely track

non-binding guidelines did not undermine its decision). The FDA provided

adequate justification for why it viewed that study as reliable despite its durational

and size deviations from the Redbook guidelines.

Additionally, the FDA did not err by relying on the study, which Impossible

had submitted with its prior notification that soy leghemoglobin is generally

recognized as safe for use as a food additive. The agency performed internal

scientific assessments and reviewed other evidence of safety, beyond its evaluation

of the study at issue. The agency’s expertise and experience in reviewing studies

3 are entitled to deference. N. Plains Res. Council, Inc. v. Surface Transp. Bd., 668

F.3d 1067, 1075 (9th Cir. 2011).

PETITION DENIED.

4 FILED Center for Food Safety v. U.S. Food & Drug Administration, No. 20-70747 MAY 3 2021 O’SCANNLAIN, J., dissenting: MOLLY C. DWYER, CLERK U.S. COURT OF APPEALS

I respectfully dissent because I believe that we lack jurisdiction to entertain

this petition challenging the FDA’s approval of soy leghemoglobin for use as a

color additive in beef analogue products. I would dismiss the petition for review

on the basis that the Center for Food Safety (“CFS”) lacks constitutional standing.

I

Whether a party has standing to sue is a “‘threshold issue’ concerning an

‘essential and unchanging part of the case-or-controversy requirement of Article

III.’” Gonzalez v. U.S. Immigr. & Customs Enf’t, 975 F.3d 788, 802 (9th Cir.

2020) (quoting Horne v. Flores, 557 U.S. 433, 445 (2009)). Simply put, a federal

court lacks subject matter jurisdiction over a dispute in which the petitioner lacks

Article III standing. See Cetacean Cmty. v. Bush, 386 F.3d 1169, 1174 (9th Cir.

2004) (citing Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83, 101 (1998)).

“‘Without jurisdiction, the court cannot proceed at all in any cause; it may not

assume jurisdiction for the purpose of deciding the merits of the case.’” Carijano

v. Occidental Petroleum Corp., 686 F.3d 1027, 1029 (9th Cir. 2012) (Kozinski, J.,

dissenting from denial of reh’g en banc) (quoting Sinochem Int’l Co. v. Malaysia

Int’l Shipping Corp., 549 U.S. 422, 431 (2007)).

1 For this reason, I believe that we are constitutionally obligated to examine

CFS’s Article III standing before considering the merits of its petition for review.

See L.A. Cnty. Bar Ass’n v. Eu, 979 F.2d 697, 700 (9th Cir. 1992) (“[S]tanding is a

threshold question which we must resolve before proceeding to the merits.”). We

must not cut to the chase, so to speak, even when it may promote judicial

convenience or efficiency to gloss over jurisdictional prerequisites. To do so

would carry the court “beyond the bounds of authorized judicial action and thus

offend[] fundamental principles of separation of powers.” Carijano, 686 F.3d at

1030 (Kozinski, J., dissenting from denial of reh’g en banc) (quoting Steel, 523

U.S. at 94.). I would therefore begin by addressing CFS’s standing to sue.

II

Here, CFS maintains that it has associational standing. To establish such

standing, CFS must demonstrate that: (1) its members would otherwise have

standing to sue in their own right; (2) the interests that it seeks to protect are

germane to the organization’s purpose; and (3) neither the claim asserted nor the

relief requested requires the participation of individual members in the lawsuit.

Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S. 333, 343 (1977).

In turn, to satisfy the first prong of Hunt’s standard for associational

standing, CFS must demonstrate that at least one of its members: (1) has suffered

an injury in fact that is (a) concrete and particularized and (b) actual or imminent,

2 rather than conjectural or hypothetical; (2) the injury is fairly traceable to the

FDA’s challenged action; and (3) it is likely, as opposed to merely speculative, that

the injury will be redressed by a favorable decision. See Nat. Res. Def. Council v.

U.S. E.P.A., 735 F.3d 873, 878 (9th Cir. 2013) (“NRDC”).

To establish the requisite injury in fact, CFS has attached declarations from

four of its members. Three of them—Natasha Kaluza, M’Lisa Kelley, and Micah

Thomas—state that they previously purchased and consumed Impossible Foods’

beef analogue products containing soy leghemoglobin, but that they ceased to do

so after learning of alleged deficiencies in the FDA’s review of the potential health

effects of soy leghemoglobin. The fourth CFS member, Janet Maker, also states

that she purchased and consumed Impossible Foods’ beef analogue products, and

that she is similarly concerned as to whether they are safe to eat, particularly

considering that she is in remission from breast cancer. Nevertheless, Maker states

that she will likely consume Impossible Foods’ beef analogue products again in the

future.

CFS maintains that its members have suffered two kinds of injury. First, a

health injury, in the form of an increased risk of adverse health effects, such as

inflammatory disease and cancer, resulting from exposure to beef analogue

products containing soy leghemoglobin. Second, an economic injury, in the form

3 of costs incurred in avoiding beef analogue products out of concern for such

adverse health effects. I consider the sufficiency of each asserted injury in turn.

A

To sustain CFS’s claim for prospective relief as it relates to the asserted

health injury, such injury must be one that is likely to develop because of either:

(1) past—and therefore irreversible—exposure to beef analogue products

containing soy leghemoglobin; or (2) inevitable future exposure to such products.

CFS has failed to make an adequate showing with respect to either mode of health

injury.

An increased risk of health injury from past exposure to an allegedly

dangerous food product is a “probabilistic harm,” and therefore constitutes an

injury in fact only where there exists a “credible threat that the probabilistic harm

will materialize.” NRDC, 735 F.3d at 878. Previously, we have relied upon

government confirmation of petitioner allegations in determining whether a

credible threat of harm exists. See, e.g., Cent. Delta Water Agency v. United

States, 306 F.3d 938, 950 (9th Cir. 2002) (finding credible threat of harm from

water management plan where agency’s own modeling showed environmental

violation); accord Baur v. Veneman, 352 F.3d 625, 637 (2d Cir. 2003) (finding

credible threat of harm from downed cattle where government studies and

4 statements confirmed such cattle were especially susceptible to disease).

Government confirmation provides a firm factual basis for a petitioner’s health

concerns, which suggests that the claimed injury is not merely speculative.

But here, there is no such confirmation of CFS’s members’ “concern”

regarding potential adverse health effects of soy leghemoglobin. The only

evidence—of any kind—substantiating a health concern is a blog post on a third-

party website, referenced in Maker’s declaration, which criticizes the FDA’s

reliance upon a rat-feeding study insofar as that study allegedly revealed adverse

effects in rats exposed to soy leghemoglobin.

The FDA determined, however, that any observed effects from the study

were not toxicologically relevant, because they were “within historical ranges of

control values, did not show a dose-response relationship, and did not occur in both

sexes.” Moreover, there is nothing elsewhere in the record to suggest that the

FDA—or anyone else, for that matter—has credited any of the health concerns

articulated by Maker or CFS’s other members. Indeed, Maker’s stated intent to

continue eating beef analogue products, regardless of whether the FDA orders

additional studies, would seem further to undermine the claim that adverse effects

are likely to materialize as a result of exposure to such products. Accordingly,

CFS has not demonstrated a “credible threat” that its members’ past exposure to

soy leghemoglobin will result in a health injury. Cf. NRDC, 735 F.3d at 878.

5 2

With respect to future exposure to the alleged risk of health injury, if a

petitioner can avoid such exposure altogether, there can be no credible threat of

harm. See Coal. for Mercury-Free Drugs v. Sebelius, 671 F.3d 1275, 1280 (D.C.

Cir. 2012) (Kavanaugh, J.) (holding that association lacked standing to challenge

FDA’s approval of thimerosal for use in vaccines because association’s members

could access all vaccines in thimerosal-free versions).

To be sure, where exposure to a verified risk of health injury cannot

reasonably be avoided, we have at times recognized an adequate injury in fact. In

NRDC, for example, we concluded that an association had standing to challenge

the EPA’s decision to register a pesticide for use with manufactured textiles. See

735 F.3d at 878. The association’s members demonstrated that textiles were

ubiquitous, and that there was little or no public information as to which chemicals

had been used to treat them, making it impossible for the members to reduce their,

or their children’s, exposure to the allegedly dangerous pesticide. Id. Together

with evidence substantiating the petitioner’s concern regarding the pesticide’s

effects, we determined that a credible threat of harm existed. Id.

Here, by contrast, beef analogue products containing soy leghemoglobin are

clearly identifiable and far from ubiquitous, such that CFS’s members can readily

avoid exposure to them. They need only consult the product label and then decline

6 to purchase items that contain the additive. Accordingly, there is no credible threat

that CFS’s members will suffer a health injury from further exposure to beef

analogues. Any such exposure would be self-inflicted, and thus inadequate to

support Article III standing. See Clapper v. Amnesty Int’l USA, 568 U.S. 398, 416

(2013).

B

Finally, CFS also maintains that, even if the health injuries allegedly

resulting from soy leghemoglobin are avoidable, the cost of avoiding such

exposure constitutes an independent economic injury. However, there is no

evidence in the declarations, or anywhere else in the record, suggesting that

avoiding beef analogues requires CFS’s members to incur any quantifiable

avoidance costs. Any avoidance costs here are properly characterized as trivial or

de minimis, and are therefore not cognizable as an injury in fact. Cf. Monsanto Co.

v. Geertson Seed Farms, 561 U.S. 139, 155 (2010) (recognizing adequate injury in

fact where farmers specified substantial increased administrative costs incurred in

avoiding contamination from genetically engineered seeds).

III

Based on the reasoning articulated above, I would conclude that CFS has

failed to demonstrate an injury in fact sufficient to establish Article III standing.

7 Accordingly, I would dismiss the petition for review for lack of jurisdiction, and

without consideration of any of CFS’s arguments on the merits.