Mark M C Afee and Farm - To-Consumer Legal Defense Fund v. United States Food and Drug Administration

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued April 8, 2022 Decided June 10, 2022
No. 21-5170
M ARK M C A FEE AND FARM - TO-CONSUMER LEGAL DEFENSE
FUND,
APPELLANTS
v.
UNITED STATES FOOD AND DRUG A DMINISTRATION ,
APPELLEE
Appeal from the United States District Court
for the District of Columbia
(No. 1:19-cv-03161)
Mahesha P. Subbaraman argued the cause for appellants.
With him on the briefs was Samantha J. Ellingson.
Aditya Dynar was on the brief for amicus curiae Pacific
Legal Foundation in support of appellants.
Marisa C. Maleck was on the brief for amici curiae The
Weston A. Price Foundation, et al. in support of appellants.
Cynthia A. Barmore, Attorney, U.S. Department of
Justice, argued the cause for appellee. With her on the brief

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were Brian M. Boynton, Acting Assistant Attorney General,
and Daniel Tenny, Attorney.
Before: SRINIVASAN , Chief Judge, TATEL* and PILLARD,
Circuit Judges.
Opinion for the Court filed by Circuit Judge PILLARD.
PILLARD, Circuit Judge: Dairy farmer Mark McAfee sells
raw, unpasteurized butter within his home state of California.
Looking to expand his market, McAfee petitioned the FDA to
revoke the agency’s decades-old rule under the Public Health
Service Act (PHSA) that bars the interstate sale of raw butter
and replace it with a rule that allows such sale. McAfee told
the FDA that his proposed rule was legally required because
the Food, Drug, and Cosmetic Act (FDCA) exhaustively
defines “butter” without describing it as pasteurized. In
McAfee’s view that makes the FDA’s rule banning raw butter
sales an unlawful change to butter’s statutory definition. The
FDA denied McAfee’s petition. It concluded that the PHSA
authorizes the agency to require pasteurization, that substantial
evidence justified doing so, and that regulating butter for safety
does not contravene its FDCA definition. McAfee challenged
the FDA’s action in court, and on cross motions for summary
judgment the district court ruled in the agency’s favor.
On appeal, McAfee raises only one preserved claim: that a
rulemaking is necessary because the FDA’s regulation banning
interstate sale of raw butter violates the FDCA’s definition of
butter. Because we agree with the district court that challenge
is meritless, and because McAfee has forfeited his other claims
by failing to raise them below, we affirm.
* Judge Tatel assumed senior status after this case was argued and
before the date of this opinion.

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I.
An agency decision to deny a petition for rulemaking is
subject to only “extremely limited and highly deferential”
review, Massachusetts v. EPA, 549 U.S. 497, 527-28 (2007)
(internal quotation marks omitted), under which we may
reverse the agency’s choice “only for compelling cause, such
as plain error of law or a fundamental change in the factual
premises previously considered by the agency,” Nat’l Customs
Brokers & Forwarders Ass’n of Am., Inc. v. United States, 883
F.2d 93, 97 (D.C. Cir. 1989). See generally WildEarth
Guardians v. EPA, 751 F.3d 649, 653 (D.C. Cir. 2014); Harry
T. Edwards & Linda A. Elliott, Federal Standards of Review:
Review of District Court Decisions and Agency Actions 195-
96 (3d ed. 2018).
McAfee’s rulemaking petition turns on the interaction of
two statutes. The first is the Public Health Service Act, which
provides the statutory basis for the FDA’s pasteurization
requirement. That Act authorizes the Surgeon General “to
make and enforce such regulations as in his judgment are
necessary to prevent the introduction, transmission, or spread
of communicable diseases from foreign countries into the
States or possessions, or from one State or possession into any
other State or possession.” 42 U.S.C. § 264(a). It includes a
non-exhaustive list of appropriate ways to do so, including
through “inspection, fumigation, disinfection, sanitation, pest
extermination, destruction of animals or articles found to be so
infected or contaminated as to be sources of dangerous
infection to human beings, and other measures, as in [the
Surgeon General’s] judgment may be necessary.” Id.
The FDA today exercises that authority as it relates to food
and other products. See, e.g., 21 C.F.R. § 1240.62 (banning
certain turtles known to carry salmonella); id. § 1240.60

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(regulating shellfish). The FDA determined that raw cream
may contain dangerous bacteria and that pasteurization
disinfects and sanitizes it by killing those bacteria.
Accordingly, the agency exercised its PHSA authority to
require that milk products, including butter, be pasteurized. Id.
§ 1240.61.
The second relevant statutory provision is a food-naming
power in the FDCA, 21 U.S.C. § 341, designed to prevent
confusion and ensure that consumers know what they are
buying. See Fed. Sec. Adm’r v. Quaker Oats Co., 318 U.S. 218,
230-32 (1943). That provision authorizes the FDA to set “a
reasonable definition and standard of identity” for “any food,
under its common or usual name,” to “promote honesty and fair
dealing in the interest of consumers.” 21 U.S.C. § 341. The
agency thus delineates the basic characteristics of foods
associated with their common or usual names. For example,
products labeled “fruit jam” must contain a certain amount of
fruit, 21 C.F.R. § 150.160; those labeled “maple syrup” (or
“maple sirup”) must contain a certain amount of maple sap, id.
§ 168.140; and so on.
Importantly, however, Congress exempted butter and most
fruits and vegetables from the FDA’s naming power and
instead set those definitions itself in the statute. In 1938,
Congress set the standard of identity of butter as “the food
product usually known as butter, and which is made
exclusively from milk or cream, or both, with or without
common salt, and with or without additional coloring matter,
and containing not less than 80 per centum by weight of milk
fat, all tolerances having been allowed for.” 21 U.S.C. § 321a.
At the same time, Congress specified that “[n]o [other] . . .
standard of identity . . . shall be established for . . . butter . . . .”
Id. § 341.

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The FDA in 1987 banned the interstate distribution of “any
milk or milk product” that has not been pasteurized. 21 C.F.R.
§ 1240.61. It did so following a district court ruling that the
FDA had unreasonably delayed responding to a national
consumer group’s petition for such a ban, which emphasized
that the “overwhelming evidence of the risks associated with”
consuming raw milk products supported a pasteurization
requirement. Pub. Citizen v. Heckler, 653 F. Supp. 1229, 1238
(D.D.C. 1986); see id. at 1242 (ordering FDA to promulgate “a
rule banning the interstate sale of all raw milk and all raw milk
products”). The FDA confirmed in 1992 that “milk product”
includes “butter,” and that the Public Health Service Act is the
statutory authority for the pasteurization rule. Control of
Communicable Diseases; Definition of Milk and Milk
Products, 57 Fed. Reg. 57,343, 57,343 (Dec. 4, 1992).
McAfee’s 2016 petition for a rulemaking to exclude butter
from the rule requiring pasteurization of milk products—and
thereby allow interstate sale of “raw” butter—argued that the
FDA lacked sound legal or scientific grounds for its ban.
Petition for Rulemaking at 1-24, J.A. 94-117. After some
delay, the FDA denied the petition. FDA Denial of
McAfee/FTCLDF Citizen Petition, dated Feb. 27, 2020 (FDA
1072-1093) [hereinafter Denial Letter] at 1-17, J.A. 459-75. It
reasoned that the pasteurization rule does not conflict with or
change the statutory definition of butter, which does not
mention pasteurization; “manufacturing controls intended to
ensure safety,” it wrote, “may exist independent of any
standards of identity.” Denial Letter at 4, J.A. 462. The FDA
addressed McAfee’s arguments and the relevant scientific
literature and concluded they did not alter the agency’s
conclusion that the ban on raw butter helps prevent the spread
of communicable diseases. Denial Letter at 4-17, J.A. 462-75.

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The district court sustained the FDA’s denial of McAfee’s
Rulemaking petition on the ground that the agency’s raw butter
ban was a “straightforward” exercise of its PHSA authority,
McAfee v. U.S. Food & Drug Admin, 541 F. Supp. 3d 21, 27
(D.D.C. 2021), and that such food safety regulation posed no
conflict with the standard of identity of butter in the FDCA, id.
at 29. “Just because the FDA cannot alter the standard of
identity for butter,” the court reasoned, “does not mean the
agency cannot regulate butter for other purposes under other
statutes.” Id. The district court also rejected McAfee’s
arbitrary-and-capricious challenges: Given the “great deal of
scientific evidence” the FDA presented in support of its
judgment, id. at 34, the district court held these challenges
“completely miss[ed] the mark” and were a “nonstarter,” id. at
32-33.
McAfee timely appealed. We have jurisdiction over this
appeal from the district court’s final order under 28 U.S.C.
§ 1291, and McAfee has standing as a raw butter manufacturer.
He does not directly challenge the FDA’s 1987 or 1992
pasteurization rules, but instead challenges the agency’s denial
of his petition for a rulemaking to repeal the raw butter ban and
allow interstate sale of unpasteurized butter.
II.
McAfee’s only preserved challenge is that a rulemaking is
necessary because the FDA’s regulation under the Public
Health Service Act barring interstate sale of raw butter violates
the FDCA’s definition of butter. When Congress set the
standard of identity for butter, it explicitly prevented the FDA
from altering that definition. See 21 U.S.C. § 341. But,
McAfee argues, the agency’s pasteurization requirement under
the FDCA does just that. That is incorrect: The pasteurization
rule did not amend the statutory standard of identity for butter,

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either formally or functionally. Raw-cream butter, though
unpasteurized, is still “butter” notwithstanding the FDA’s
determination that its interstate sale would threaten public
health. As the district court succinctly observed, McAfee’s
argument “rests on the false premise that the pasteurization rule
works a change to butter’s standard of identity.” McAfee, 541
F. Supp. 3d at 28. Particularly given our very limited review,
we have no basis to overturn the FDA’s denial of McAfee’s
request for rulemaking resting on that false premise.
The absence of the conflict McAfee perceives follows
from the distinct roles of the food-naming and public-health
provisions. Congress and the FDA’s standards of identity
under the FDCA ensure consumers know what they are buying.
Recall, for instance, that a product labeled “fruit jam” must
contain a certain amount of fruit. 21 C.F.R. § 150.160.
Products containing a lower fruit content are not unsafe; they
just must be marketed under a different name, such as “fruit
topping.” See Food Standards; General Principles and Food
Standards Modernization, 70 Fed. Reg. 29,214, at 29,216 (May
20, 2005). Here, the statutory definition setting butter’s
standard of identity determines only what may be marketed as
“butter.” Products not meeting that definition may well be safe
but must be called something else.
Altogether separate is the FDA’s authority under the
Public Health Service Act, which authorizes the agency to
require processes including “inspection, fumigation,
disinfection, [and] sanitation” to ensure that the food supply is
safe and does not spread communicable diseases. 42 U.S.C.
§ 264(a). Those public health requirements do not alter a
food’s definition or standard of identity. Indeed, the FDA
acknowledges that both pasteurized and unpasteurized butter
are “butter,” Appellee Br. at 25, since each “is made
exclusively from milk or cream, or both, with or without

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common salt, and with or without additional coloring matter,
and containing not less than 80 per centum by weight of milk
fat, all tolerances having been allowed for.” 21 U.S.C. § 321a.
For safety reasons, however, the agency disallowed interstate
sale of some (specifically, unpasteurized) butter. Even though
raw cream butter may accurately be labeled “butter” at a local
farmers’ market, the FDA has deemed it too dangerous to be
sold interstate. Accordingly, the FDA permissibly concluded
that the raw butter ban did “not purport to be a standard of
identity rulemaking” and “did not serve to operate as one in
practice either.” Denial Letter at 4, J.A. 462.
McAfee offers no persuasive response. He insists that the
FDA has at least functionally amended the definition of butter
by adding a safety requirement—pasteurization—not found in
21 U.S.C. § 321a. But as already discussed, the FDA did not
alter the statutory definition because the FDA’s public health
regulatory authorities are distinct from, serve different
purposes than, and do not conflict with its standard-of-identity
rules. To be sure, we need not rule out the possibility that in
an unusual case a food-safety control might be so integral to a
food’s identity that altering it would functionally amend how
that food is defined under the FDCA. The FDA recognized that
“sometimes standards of identity may also designate the
manner in which products are produced when the
manufacturing process has a bearing on the identity of the
finished food,” although ordinarily “manufacturing controls
intended to ensure safety may exist independent of any
standards of identity.” Denial Letter at 5, J.A. 463. But the
statutory definition at issue here contains no mention of
pasteurization nor any other suggestion that undergoing that
process prevents a product from qualifying as butter. McAfee
may be correct that unpasteurized butter has a distinct taste,
texture, and other qualities, but Congress did not speak to those
qualities as part of butter’s statutory standard of identity. That

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statutory provision neither references pasteurization nor
requires qualities that pasteurized butter lacks. At least in this
case, then, the standard-of-identity statute does not extinguish
the agency’s authority under the PHSA to ensure food safety.
McAfee argues that the FDA’s reading would give the
agency sweeping authority to alter standards of identity
through public health requirements. But the FDA may act
under the Public Health Service Act only where “necessary” to
prevent the spread of disease. 42 U.S.C. § 264(a). As the
Supreme Court has recently emphasized, actions under that
statute must “directly relate to preventing the interstate spread
of disease.” Ala. Ass’n of Realtors v. Dep’t of Health & Hum.
Servs., 141 S. Ct. 2485, 2488 (2021). Even then, they must also
withstand arbitrary-and-capricious review.
Indeed, it is McAfee’s interpretation that would produce
odd consequences: It would substantially exempt from public
health controls those products whose standards of identity
Congress itself set by statute, including most fruits and
vegetables, see 21 U.S.C. § 341, because on his approach any
safety control not in the statutory standard of identity would
seem to unlawfully supplement it. The majority of foods,
however, would remain subject to FDA safety regulation
because the statute authorizes the agency to set their standards
of identity, leaving the FDA free to build safety requirements
under the PHSA into those definitions. Nothing suggests
Congress intended that anomalous bifurcated result.
McAfee raises several other issues for the first time on
appeal, including (1) whether the FDA has authority under the
PHSA, standing alone, to require that butter marketed interstate
be made from pasteurized cream, Appellant Br. at 44; (2)
whether the adulteration provisions of the FDCA at 21 U.S.C.
§ 342 otherwise limit the FDA’s Public Health Service Act

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authority, Appellant Reply Br. at 6-7, 8-10; and (3) whether the
FDA’s exercise of rulemaking authority following department
reorganization exceeds its authority under the Act, Appellant
Br. at 42-43. McAfee forfeited those arguments because he did
not raise them before either the FDA or the district court. See,
e.g., McAfee, 541 F. Supp. 3d at 27 (noting McAfee “do[es] not
dispute” that the PHSA “would seem to give the FDA authority
to mandate pasteurization”); Petition for Rulemaking at 5-9,
J.A. 98-102; Plaintiffs’ Br. in Supp. Of. Mot. For Summ. J. at
9-14, No. 19-3161 (D.D.C. Oct. 21, 2020), ECF 15-2, S.A. 15-
20; see also Koretoff v. Vilsack, 707 F.3d 394, 398 (D.C. Cir.
2013) (per curiam) (holding challenge to statutory authority
forfeited). McAfee’s counsel also clarified at oral argument
that he does not raise a freestanding arbitrary and capricious
challenge. Recording of Oral Arg. 10:39-11:33. Amici raise
additional challenges, which rest on theories not raised by the
parties and thus are not properly before us. See Metlife, Inc. v.
Fin. Stability Oversight Council, 865 F.3d 661, 666 n.4 (D.C.
Cir. 2017).
* * *
For the foregoing reasons, the judgment of the district
court is affirmed.
So ordered.

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