McAfee v. U.S. Food and Drug Administration

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
MARK MCAFEE, et al., :
:
Plaintiffs, : Civil Action No.: 19-3161 (RC)
:
v. : Re Document Nos.: 15, 17
:
U.S. FOOD AND DRUG :
ADMINISTRATION, :
:
Defendant. :
MEMORANDUM OPINION
DENYING PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT AND
GRANTING DEFENDANT’S MOTION FOR SUMMARY JUDGMENT
I. INTRODUCTION
Federal regulations require those who sell dairy products across state lines to pasteurize
their products. But the plaintiffs in this case claim that those regulations should not apply to
butter. They say that the government lacked authority to mandate pasteurization of butter and
that such a requirement makes little sense anyway. They are wrong. Not only does the
pasteurization requirement fit well within the federal government’s broad power to combat the
spread of infectious diseases, but there is also a great deal of scientific research showing that
pasteurization is effective at doing so. The government is thus entitled to summary judgment.
II. BACKGROUND
Pioneered in the 1860s, pasteurization is the process of heating up milk for a period of
time to kill potentially harmful bacteria. J.A. 1073, 1116. The technique did not become
common in the United States until the late 1940s and early 1950s. J.A. 1089 n.15. Initially, the
federal government encouraged pasteurization but did not mandate it. See, e.g., U.S. Public
Health Service, Fed. Security Agency, Milk Ordinance and Code 96–97 (1939), http://
resource.nlm.nih.gov/101528318 (remarking that “[t]he public-health value of pasteurization is
unanimously agreed upon by health officials” but noting that some local opposition existed).
In 1972, the Food and Drug Administration (“FDA”) proposed a rule requiring
pasteurization for milk and related products traded in interstate commerce. Proposed Revision of
Existing Standards and Establishment of New Identity Standards, 37 Fed. Reg. 18,392 (Sept. 9,
1972). It finalized the rule the next year, concluding that a pasteurization requirement would
“assure[] the destruction of pathogenic bacteria that may be present” in milk products. 38 Fed.
Reg. 27,924, 27,924 (Oct. 10, 1973). In response to objections from industry, however, the
agency stayed the requirement as it applied to certified raw milk pending a public hearing.
Identity Standards for Milk and Cream; Order Staying Certain Provisions (“Stay Rule”), 39 Fed.
Reg. 42,351, 42,351 (Dec. 5, 1974).
For nearly a decade, the FDA “collected and evaluated scientific and medical information
to determine if the outbreak of certain diseases was associated with the consumption of certified
raw milk.” Pub. Citizen v. Heckler (Pub. Citizen II), 653 F. Supp. 1229, 1232 (D.D.C. 1986).
The agency eventually “conclude[d] that the consumption of certified raw milk and all forms of
raw milk and raw milk products was linked to the outbreak of serious disease,” so it “began
drafting a proposed regulation banning the interstate sale of all raw milk and raw milk products.”
Id. Debates within the FDA’s parent agency, the Department of Health and Human Services
(“HHS”), and a public hearing followed. Id. at 1232–34. After delays in acting on the proposal,
a court ultimately ordered HHS and the FDA to promulgate it. Id. at 1234–35, 1242.
The agencies complied. A final rule, published in 1987, banned the delivery into
interstate commerce of “any milk or milk product” that was not pasteurized. Requirements
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Affecting Raw Milk for Human Consumption in Interstate Commerce (“Pasteurization Rule”),
52 Fed. Reg. 29,509, 29,514 (Aug. 10, 1987) (to be codified at 21 C.F.R. § 1240.61(a)). A few
years later, the FDA issued a “technical amendment” to clarify that the pasteurization rule
“applie[d] to the dairy ingredients of certain dairy products, such as . . . butter” by including
butter in the definition of “milk products.” Control of Communicable Diseases; Definition of
Milk and Milk Products (“Definition Rule”), 57 Fed. Reg. 57,343, 57,343 (Dec. 4, 1992) (to be
codified at 21 C.F.R. § 1240.3(j)). The current version of the regulation bars from interstate
commerce “any milk or milk product . . . unless the product has been pasteurized or is made
from dairy ingredients (milk or milk products) that have all been pasteurized, except where
alternative procedures to pasteurization are provided for by regulation.” 21 C.F.R. § 1240.61(a).
Plaintiffs Mark McAfee and the Farm-to-Consumer Legal Defense Fund (“Plaintiffs”)
want to change that regulation. They filed a citizen petition with the FDA asking it to remove
butter from the definition of milk products and make an exception to the pasteurization
requirement for butter. J.A. 3. According to Plaintiffs, the FDA lacks statutory “authority to
require pasteurization of butter,” J.A. 7, and “there is no sound scientific basis” for doing so, J.A.
9. The agency denied their petition. J.A. 1072. Plaintiffs then filed a complaint claiming that
the denial violated the Administrative Procedure Act (“APA”). See Am. Compl., ECF No. 6.
Now, both sides move for summary judgment. See Mem. P & A Supp. Pls.’ Mot. Summ. J.
(“Pls.’ Mot.”), ECF No. 15-2; Combined Mem. Supp. Def.’s Cross-Mot. Summ. J. and Opp’n
Pls.’ Mot. Summ. J. (“Def.’s Mot.”), ECF No. 17-1. The Court grants the FDA’s motion and
denies Plaintiffs’ motion.
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III. LEGAL STANDARD
The usual standard for deciding summary judgment motions does not apply when
reviewing an agency action under the APA. See Rempfer v. Sharfstein, 583 F.3d 860, 865 (D.C.
Cir. 2009). Because the agency’s job is “to resolve factual issues” in reaching an administrative
decision, the court’s concomitantly limited role is merely to ensure that evidence in the record
supports that decision. Roberts v. United States, 883 F. Supp. 2d 56, 62 (D.D.C. 2012), aff’d,
741 F.3d 152 (D.C. Cir. 2014). The court thus “sits as an appellate tribunal” and treats “[t]he
‘entire case’ on review [as] a question of law.” Am. Bioscience, Inc. v. Thompson, 269 F.3d
1077, 1083 (D.C. Cir. 2001); see also Marshall Cty. Health Care Auth. v. Shalala, 988 F.2d
1221, 1226 (D.C. Cir. 1993) (“[The] complaint, properly read, actually presents no factual
allegations, but rather only arguments about the legal conclusion to be drawn about the agency
action.”). Plaintiffs bring two APA challenges that require assessment under different—but
related—standards. Both are unavailing.
IV. ANALYSIS
A. The FDA Had Statutory Authority to Issue the Pasteurization Rule
Plaintiffs first assert that the FDA lacked statutory authority to require pasteurization of
butter. Pls.’ Mot. at 9–13. In APA terms, they argue that the agency acted “in excess of
statutory jurisdiction, authority, or limitations, or short of statutory right.” 5 U.S.C. § 706(2)(C).
Courts review that kind of claim using the two-step Chevron framework. See Pharm. Rsch. &
Mfrs. of Am. v. FTC, 790 F.3d 198, 204 (D.C. Cir. 2015). The first step is to determine whether
Congress already answered the “precise question at issue.” Chevron, U.S.A., Inc. v. Nat. Res.
Def. Council, Inc., 467 U.S. 837, 842 (1984). If so, “that is the end of the matter.” Id. If not, the
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court proceeds to the second step, which asks whether the “agency’s answer” to the question “is
based on a permissible construction of the statute.” Id. at 843.
When the FDA promulgated the pasteurization rule, it purported to do so under the Public
Health Service Act (“PHSA”). See Pasteurization Rule, 52 Fed. Reg. at 29,510, 29,514; see also
Definition Rule, 57 Fed. Reg. at 57,343–44. That Act authorizes the FDA “to make and enforce
such regulations as in [its] 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. 1 The term
“communicable diseases” is liberally defined by regulation. It encompasses “[i]llnesses due to
infectious agents or their toxic products, which may be transmitted from a reservoir to a
susceptible host either directly as from an infected person or animal or indirectly through the
agency of an intermediate plant or animal host, vector, or the inanimate environment.” 21 C.F.R.
§ 1240.3(b). Aside from the pasteurization rule, the FDA has used its authority under the PHSA
to regulate the interstate transport of shellfish, id. § 1240.60, turtles, id. § 1240.62, psittacine
birds, id. § 1240.65, and human food waste used to feed to swine, id. § 1240.75.
Plaintiffs do not dispute that, on its own, the PHSA would seem to give the FDA
authority to mandate pasteurization. See Pls.’ Mot. at 10–13. Nor could they. The PHSA
“grant[s] broad, flexible powers to federal health authorities . . . to protect the public against the
spread of communicable disease.” Louisiana v. Mathews, 427 F. Supp. 174, 176 (E.D. La.
1977). And pasteurization eliminates “numerous . . . harmful microorganisms” that transmit
1
Although the PHSA grants regulatory power to the Surgeon General and the Secretary
of Health and Human Services, those officials have delegated their authority to the FDA. See
J.A. 1073 n.3; United States v. Regenerative Scis., LLC, 878 F. Supp. 2d 248, 257, 262 (D.D.C.
2012), aff’d, 741 F.3d 1314 (D.C. Cir. 2014); Indep. Turtle Farmers of La., Inc. v. United States,
703 F. Supp. 2d 604, 619 (W.D. La. 2010).
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infectious diseases. Pasteurization Rule, 52 Fed. Reg. at 29,512. The PHSA’s application thus
appears straightforward. See Pub. Citizen v. Heckler (Pub. Citizen I), 602 F. Supp. 611, 613
(D.D.C. 1985) (explaining that “both the Public Health Service Act’s authorization for
regulations to control communicable diseases and the Food, Drug and Cosmetic Act’s provisions
for the control of adulterated foods” provided the FDA “ample legal authority” to ban interstate
sales of raw milk (citations omitted)).
But Plaintiffs argue that another law comes into play where butter is concerned. They
say that a provision in the Food, Drug and Cosmetic Act (“FDCA”) prohibits any mandate that
butter be pasteurized. Some background on that Act helps to understand their argument. Among
other things, the FDCA permits the FDA to set “a reasonable definition and standard of identity”
for foods if doing so would “promote honesty and fair dealing in the interest of consumers.” 21
U.S.C. § 341. A standard of identity might list the ingredients a food can contain or provide
acceptable proportions of those ingredients. J.A. 1074–75. The purpose is to “eliminate a source
of confusion” to consumers who can have difficulty “determin[ing], solely on the basis of
informative labeling, the relative merits of a variety of products superficially resembling each
other.” Fed. Sec. Adm’r v. Quaker Oats Co., 318 U.S. 218, 230–31 (1943). Importantly,
however, the statute that grants the FDA authority to set standards of identity carves out an
exception for butter. See 21 U.S.C. § 341 (“No definition and standard of identity . . . shall be
established for . . . butter . . . .”). Another provision in the FDCA defines butter’s standard of
identity 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.” Id. § 321a.
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That statutory definition for butter is the foundation of Plaintiffs’ claim. Whatever the
PHSA might seem to permit, they say, it does not allow the FDA to issue a regulation that sets a
standard of identify for butter that differs from the FDCA’s statutory definition. See Pls.’ Mot. at
12–13. And by requiring the pasteurization of all butter in interstate commerce, Plaintiffs
continue, the FDA essentially makes pasteurization a part of butter’s definition. See id. Along
the same lines, Plaintiffs assert that the specific statutory definition of butter supplants the more
general delegation of power that the PHSA gives the FDA to protect against communicable
diseases—at least when it comes to butter. See id. at 10–11. They are mistaken.
Plaintiffs perceive a conflict between the PHSA and FDCA where there is none. Out of
respect for the separation of powers, a court faced with two statutes “allegedly touching on the
same topic” must “strive to give effect to both.” Epic Sys. Corp. v. Lewis, 138 S. Ct. 1612, 1624
(2018) (internal quotation marks and citation omitted). The party who asserts that one statute
displaces another thus “bears the heavy burden of showing a clearly expressed congressional
intention that such a result should follow.” Id. (internal quotation marks and citation omitted).
That “intention must be ‘clear and manifest.’” Id. (citation omitted). And only when statutes are
“irreconcilably conflicting” can a more specific one take precedence over the more general one.
See Adirondack Med. Ctr. v. Sebelius, 740 F.3d 692, 698 (D.C. Cir. 2014) (quoting Detweiler v.
Pena, 38 F.3d 591, 596 (D.C. Cir. 1994)).
There is no reason to suggest that the FDCA’s statutory definition of butter blocks the
PHSA’s operation as Plaintiffs say it does. The two statutes hardly “touch[] on the same topic,”
id., much less conflict in such a way that one would have to supersede the other. While the
PHSA is concerned with containing the spread of infectious diseases regardless of the means of
transmission, standards of identity are meant to ensure that customers know what foods they are
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buying. Rarely do statutes with such different purposes and scopes conflict. See Watt v. Alaska,
451 U.S. 259, 267 (1981) (“We must read the statutes to give effect to each if we can do so while
preserving their sense and purpose.”); see also Radzanower v. Touche Ross & Co., 426 U.S. 148,
157 (1976) (explaining that there was no conflict between a statute that “was enacted primarily
to halt securities fraud” and one that “regulate[d] banks”). If Congress wanted to exempt butter
from the PHSA’s reach, it could have said so. See Hall v. United States, 566 U.S. 506, 516
(2012) (“We assume that Congress is aware of existing law when it passes legislation . . . .”). In
fact, it did just that when it passed the FDCA and withheld from the FDA authority to create a
standard of identity for butter different from the preexisting statutory one. See 21 U.S.C. § 341. 2
Plaintiffs’ argument rests on the false premise that the pasteurization rule works a change
to butter’s standard of identity. They offer no statute, regulation, or case to back that position.
Their only support is a misreading of history. See Pls.’ Mot. at 12–13; Pls.’ Reply at 2–3. When
the FDA first required pasteurization in 1973, it did so by altering the standards of identity for
milk and related products (but not butter). See 38 Fed. Reg. at 27,924 (“In the matter of revising
existing standards and establishing new identity standards for milk and cream . . . .”). Then, the
agency gradually changed tack. In the rule staying the pasteurization requirement for certified
raw milk, the agency noted that it was now requiring pasteurization under the PHSA in addition
to the FDCA. See Stay Rule, 39 Fed. Reg. at 42,351. And after a court ordered the FDA to issue
a new rule, it grounded the rule—the one at issue here—solely in the PHSA; it did not purport to
modify the affected milk products’ standards of identity. See Pasteurization Rule, 52 Fed. Reg.
2Congress enacted the statutory definition for butter in 1923. See Act of Mar. 4, 1923,
Pub. L. No. 67-519, 42 Stat. 1500. It incorporated that definition into the FDCA when it passed
the Act in 1938. See Federal Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, § 902, 52 Stat.
1040, 1059 (1938) (“[T]he Act of March 4, 1923 . . . defining butter and providing a standard
therefor . . . shall remain in force and effect and be applicable to the provisions of this Act.”).
8
at 29,510 (“The provisions of the Public Health Service Act that relate to communicable
disease . . . form the legal basis for the final rule.” (citations omitted)); Definition Rule, 57 Fed.
Reg. at 57,343 (similar); see also Pub. Citizen II, 653 F. Supp. at 1232 (explaining that, before
the court-ordered promulgation of the current rule, the FDA proposed issuing a pasteurization
rule under the PHSA because it “would provide a more uniform and efficient regulatory
mechanism than a standard of identity proceeding, to assure public health protection”). The new
rule did “not apply to milk and milk products for which an alternative to pasteurization is
established in a standard of identity regulation.” Pasteurization Rule, 52 Fed. Reg. at 29,513.
It is difficult to follow Plaintiffs’ argument as to how that history shows the FDA cannot
require pasteurization under the PHSA without changing a product’s standard of identity. But
what discernable points they make are baseless. To begin, there was no problem with the FDA
using its standard-of-identity authority to issue one rule and then using its PHSA authority to
issue another. In the same way that an agency can choose between rulemaking or adjudication to
pursue its policy aims, it is free to choose which of its applicable statutory authorities should
form the basis of an administrative action. Cf. Friends of Animals v. Bernhardt, 961 F.3d 1197,
1208–09 (D.C. Cir. 2020) (“[A]n agency has broad discretion to choose whether to use
rulemaking or adjudication—assuming both options are authorized by the agency’s organic
statutes.”). Moreover, the latest rule’s exception for food products whose standards of identity
already include “an alternative to pasteurization” does not mean that a pasteurization mandate
necessarily affects standards of identity. The exception merely accounted for the fact that the
FDA had previously used another tool—the standard-of-identity authority—to approve safe
pasteurization substitutes for some foods. Finally, the FDA’s decision not to require
pasteurization for butter earlier does not suggest that the agency “lacked authority to do so.” See
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Pls.’ Mot. at 13. Even though the FDA recognized as early as 1974 that it could require
pasteurization through the PHSA, “[n]othing prohibits federal agencies from moving in an
incremental manner.” See FCC v. Fox Television Stations, Inc., 556 U.S. 502, 522 (2009).
Their historical argument unfounded, Plaintiffs cannot show that Congress clearly and
manifestly meant for the FDCA’s statutory definition of butter to limit the FDA’s authority under
the PHSA. Just because the FDA cannot alter the standard of identity for butter does not mean
the agency cannot regulate butter for other purposes under other statutes. See N.Y. Shipping
Ass’n, Inc. v. Fed. Mar. Comm’n, 854 F.2d 1338, 1367 (D.C. Cir. 1988) (“[T]here is no anomaly
if conduct privileged under one statute is nonetheless condemned by another; we expect persons
in a complex regulatory state to conform their behavior to the dictates of many laws, each
serving its own special purpose.”). The PHSA grants the FDA authority to combat infectious
diseases apart from the authority the FDCA gives the agency to set standards of identity. Those
separate authorities do not conflict here.
Absent a conflict with the FDCA, the PHSA comfortably authorizes the pasteurization
rule. The requirement that butter be pasteurized to eradicate disease-causing pathogens is a
textually reasonable interpretation of the broad power the PHSA gives the FDA “to make . . .
regulations . . . necessary to prevent the introduction, transmission, or spread of communicable
diseases.” See 42 U.S.C. § 264. Plaintiffs’ first claim fails.
B. The FDA Did Not Arbitrarily Deny Plaintiffs’ Citizen Petition
Plaintiffs next attack the pasteurization rule as scientifically unsupported. This second
claim asserts that the rule is “arbitrary, capricious, an abuse of discretion, or otherwise not in
accordance with law.” 5 U.S.C. § 706(2)(A). Judicial review under the arbitrary or capricious
standard is “highly deferential,” AT&T, Inc. v. FCC, 886 F.3d 1236, 1245 (D.C. Cir. 2018)
10
(citation omitted), especially when evaluating an agency’s “scientific judgment within its ‘area
of expertise,’” Rempfer, 583 F.3d at 867 (citation omitted). The basic requirement is that the
agency “examine the relevant data and articulate a satisfactory explanation for its action
including a rational connection between the facts found and the choice made.” Motor Vehicle
Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (internal
quotation marks and citation omitted).
The target of Plaintiffs’ arbitrariness challenge is the FDA’s denial of their citizen
petition. FDA regulations require the agency to promulgate a rule proposed in a citizen petition
if the petition (1) “contains facts demonstrating reasonable grounds for the proposal;” and
(2) “substantially shows that the proposal is in the public interest and will promote the objectives
of the [relevant organic statute] and the agency.” 21 C.F.R. § 10.40(a)(2); see also id.§ 10.30(b)(3) (providing that a petition should cite the “relevant statutory sections . . . of the . . .
[FDCA] or [PHSA] or any other statutory provision for which authority has been delegated to”
the FDA). Nevertheless, judicial review of an agency’s refusal to promulgate a rule in response
to a citizen petition is “extremely limited” and “highly deferential.” Massachusetts v. EPA, 549
U.S. 497, 527–28 (2007) (citation omitted); see also Defs. of Wildlife v. Gutierrez, 532 F.3d 913,
919 (D.C. Cir. 2008) (“[A]n agency’s refusal to institute rulemaking proceedings is at the high
end of the range of levels of deference we give to agency action under our arbitrary and
capricious review.” (internal quotation marks and citation omitted)). The agency is entitled to
such great deference because it has “broad discretion to choose how best to marshal its limited
resources and personnel to carry out its delegated responsibilities.” Massachusetts, 549 U.S. at
527. Furthermore, review “is limited to the ‘narrow issues as defined by the denial of the
petition for rulemaking.’” NLRB Union v. Fed. Lab. Rels. Auth., 834 F.2d 191, 196 (D.C. Cir.
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1987) (emphasis omitted) (quoting Pro. Drivers Council v. Bureau of Motor Carrier Safety, 706
F.2d 1216, 1217 n.2 (D.C. Cir. 1983)).
In denying Plaintiffs’ citizen petition, the FDA articulated the basic rationale behind its
pasteurization rule. The agency explained that “[t]he main ingredient in butter was cream” and
that “[r]aw cream may be contaminated with pathogens capable of causing disease.” J.A. 1077.
Creating butter from raw cream does not destroy those pathogens, the agency continued, but
pasteurization does. Id. Accordingly, pasteurization would help combat the spread of foodborne
illnesses. See, e.g., J.A. 1082 (“[W]e have determined that your Petition does not establish that
the chemical and biological characteristics of raw cream butter are sufficient to prevent the
presence of pathogenic organisms at levels that may cause human illness.”).
The FDA also rejected each of the substantive grievances that Plaintiffs raised in their
petition. See J.A. 1075–86; see also J.A. 9–23. Plaintiffs first asserted that “all butter, including
that made from raw milk,” must “pose[] a very low risk of foodborne illness” because there had
been no outbreaks of disease linked specifically to raw butter in the previous eighteen years.
J.A. 10. In response, the FDA pointed out that it had required pasteurization for butter shipped
in interstate commerce during that time period. J.A. 1076. It then provided a list detailing
outbreaks linked to butter “not known to be pasteurized” from 1908 to 2003. J.A. 1089. One
outbreak that stemmed from raw butter caused over 200 people to fall ill and occurred as recently
as 2001 and 2002. J.A. 1076.
Next, Plaintiffs claimed that butter is “rarely contaminated with pathogens at levels
necessary to cause human disease” because of its “chemical and biological characteristics.” J.A.
12. They said that pathogen counts in contaminated butter are “low” and, to illustrate the point,
offered a threshold for Listeria of less than 100 colony-forming units per gram. Id. (“[W]hen
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present, pathogen counts are low (<100 L. monocytogenes/g).”). The FDA countered that its list
of butter-related outbreaks undermined Plaintiffs’ claim. J.A. 1077. Moreover, despite
Plaintiffs’ focus on Listeria, the agency explained that raw butter was known to host Salmonella,
Staphylococcus, and E. coli too. J.A. 1077–80. The FDA then delved into a review of the
studies Plaintiffs cited, arguing that they did not support Plaintiffs’ position. J.A. 1077–82. It
said that one study drew on research that found Listeria in raw butter at levels above Plaintiffs’
“low” threshold of 100 colony-forming units per gram. J.A. 1078–79. It also stated that some
studies had traced disease outbreaks to bacteria levels below that threshold. J.A. 1078. One
study Plaintiffs cited even warned that “butter should not be manufactured from raw cream or, if
it is, it should be used only for cooking where it will receive adequate heat treatment,” i.e.,
pasteurization. J.A. 1081 (quoting J.A. 512). The agency concluded that the petition did “not
establish that the chemical and biological characteristics of raw cream butter are sufficient to
prevent the presence of pathogenic organisms at levels that may cause human illness.” J.A.
1082.
Plaintiffs further argued that, when butter is contaminated with pathogens, “its natural
properties limit or eliminate growth.” J.A. 18. Once again, the FDA took a different view of the
scientific studies that Plaintiffs relied on. It said that some were not directly applicable. For
instance, one study tested cultured butter instead of raw butter. J.A. 1082. The agency also
pointed out that Plaintiffs misconstrued other studies that had, in fact, detected bacterial growth.
Id. One study indicated that its results were consistent with another study that had concluded:
“[T]o produce Listeria-free butter, cream must be properly pasteurized and post-pasteurization
contamination must be avoided.” J.A. 1083.
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Seemingly reiterating their second argument, Plaintiffs next contended that the scientific
literature shows that “butter is a low-risk product.” J.A. 20. They cited more studies, but the
FDA again retorted that the studies did not provide the support that Plaintiffs said they did. J.A.
1083–86. In addition, the agency clarified that, while low levels of pathogens “may not cause
illness in all individuals,” research shows that even low levels “can cause illness in susceptible
individuals” such as pregnant women. J.A. 1084. Because the agency’s “regulations are
intended to protect, not just healthy individuals, but also people who may be more susceptible,”
the FDA determined that Plaintiffs had not “provide[d] a basis for modifying the existing
regulations.” Id. 3
Finally, Plaintiffs asserted that various regulatory agency’s treatments of butter “reflect”
its “relatively low risk.” J.A. 23. According to the FDA, however, the regulatory standards
Plaintiffs relied on were inapplicable because they were “measurement[s] of quality and not
safety.” J.A. 1086. And responding to Plaintiffs’ point that some states permit the sale of raw
dairy products including butter, J.A. 23, the FDA observed that many of those states nevertheless
“warn of the danger of consuming raw milk and raw milk products and emphasize that State
regulation does not ensure that raw milk is safe and free of pathogens.” J.A. 1087.
Before this Court, Plaintiffs renew their attack on just two grounds. Cf. Noble Energy,
Inc. v. Salazar, 691 F. Supp. 2d 14, 23 n.6 (D.D.C. 2010) (finding that a party forfeited an
argument it made in its complaint but not in summary judgment briefing). Neither is persuasive.
3
Plaintiffs fault the FDA for not specifically discussing two studies they cited. See Pls’
Reply at 11–12. But an agency does not need to “directly address every study” that a petition
mentions.” Nat’l Ass’n of Mfrs. v. EPA, 750 F.3d 921, 924–25 (D.C. Cir. 2014). It was enough
that the FDA responded—with evidence—to Plaintiffs’ general argument that the pathogens
found in butter are usually dangerous only at high levels.
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First, Plaintiffs argue that the FDA justified its pasteurization rule with the irrational
assumption that the pathogens found in butter are unsafe in any amount. See Pls.’ Mot. at 15–18.
Recall that, in support of their argument that butter usually carries low levels of pathogens,
Plaintiffs gave an illustrative threshold for Listeria of less than 100 colony-forming units per
gram. J.A. 12. The FDA remarked in response that its standard for detecting Listeria is
“negative by test” and cited its Bacteriological Analytical Manual, J.A. 1079 n.8, which provides
that the agency confirms the presence of Listeria when there is at least 1 colony-forming unit per
gram, J.A. 1392. Plaintiffs interpret that language as suggesting that the FDA believes that any
amount of a pathogen presents a health risk. Pls. Mot. at 15–16. They reiterate that low levels of
Listeria do not cause disease. Id. at 15–17. And they add that even pasteurized milk products
can be contaminated by pathogens and cause illness. Id. at 16–18. It is arbitrary, they conclude,
for the FDA to ban raw butter on the basis that the mere presence of pathogens is dangerous
when low levels do not cause illness and pasteurization cannot eliminate all pathogens anyway.
Id. at 17–18.
The argument completely misses the mark. When promulgating the pasteurization rule,
the FDA explained that its aim was to address “documented health risks” such as “the
transmission of disease” that “epidemiological evidence” had “repeatedly” linked to raw dairy
products. Pasteurization Rule, 52 Fed. Reg. at 29,511. Nowhere did the agency claim that it
required pasteurization because the presence of any amount of a pathogen would cause illness. It
certainly said no such thing in its passing remark (in a footnote) about its listeria testing
procedures. 4 Moreover, even though “[a]ll information available to the [FDA] documents that
4
Nevertheless, the agency acknowledges that the mere “presence of Listeria
monocytogenes in food causes that food to be ‘adulterated’ under the FDCA.” Def.’s Mot. at 26
15
pasteurization . . . effectively eliminates . . . numerous . . . harmful microorganisms,” id. at
29,512, the agency acknowledged in its response to Plaintiffs’ petition that contamination of
pasteurized butter can sometimes occur, J.A. 1078. That rare possibility does not mean
pasteurization is useless. Indeed, by Plaintiffs’ own account, contamination of pasteurized milk
products is “[u]sually” due to “germs introduced in the dairy after the pasteurization process.”
Pls.’ Mot. at 17 (emphasis added) (quoting Raw Milk Questions and Answers, Ctrs. for Disease
Control & Prevention, https://www.cdc.gov/foodsafety/rawmilk/raw-milk-questions-and-
answers.html). At bottom, there is little doubt that pasteurization minimizes the “documented
risks” posed by pathogens in dairy products like butter. See Pasteurization Rule, 52 Fed. Reg. at
29,513. The FDA thus reasonably concluded that requiring pasteurization would “result in some
benefit to the public health.” See id.
Second, Plaintiffs take issue with the FDA’s list of outbreaks connected to butter. They
point out that, for ten of the eleven outbreaks the agency identified, it was uncertain whether the
contaminated butter was pasteurized. Pls.’ Mot. at 18. As a result, Plaintiffs argue, the FDA
cannot say that raw butter is any more dangerous than pasteurized butter and thus ban only the
former product. Id. at 18–19.
This second argument is another nonstarter. As the FDA says, it compiled the list in
response to Plaintiffs’ assertion that “all butter, including that made from raw milk, poses a very
low risk of foodborne illness.” Defs.’ Mot. at 27 (quoting J.A. 10). Furthermore, “[t]he mere
fact that a ‘dataset was less than perfect . . . does not amount to arbitrary decision-making.’”
Hisp. Affs. Project v. Acosta, 901 F.3d 378, 392 (D.C. Cir. 2018) (quoting District Hosp.
n.12 (citing 21 U.S.C. § 342(a)(1); United States v. Blue Ribbon Smoked Fish, Inc., 179 F. Supp.
2d 30, 48 (E.D.N.Y. 2001), aff’d in relevant part, 56 F. App’x 542 (2d Cir. 2003)).
16
Partners, L.P. v. Burwell, 786 F.3d 46, 61 (D.C. Cir. 2015)). It is enough that an “agency
‘explain[s] the available evidence’ and rationally connect[s] the facts to the choice made.” See
id. (quoting New York v. EPA, 413 F.3d 3, 31 (D.C. Cir. 2005)). That is what the FDA did. It
explained that the early outbreaks listed in the table “were likely from raw cream butter because
pasteurization of milk and cream only gradually increased from 1915 to the late 1940’s in U.S.
cities.” J.A. 1076. That is a justifiable assumption given the history of pasteurization, so even if
someone could reasonably disagree, it does not mean the agency acted arbitrarily. See Bean
Dredging, LLC v. United States, 773 F. Supp. 2d 63, 85–86 (D.D.C. 2011) (explaining that, even
though “reasonable minds could differ” about the meaning of certain evidence, the agency’s
position was not arbitrary because it “was considered and informed and had a rational basis”
(citation omitted)). And in any case, the list was just one source of evidence the FDA drew on to
deny Plaintiffs’ petition. The agency also rested its denial on numerous studies that showed how
raw butter could host pathogens in high enough levels to be dangerous or that linked outbreaks to
other raw dairy products. See, e.g., J.A. 1078 (“Literature (Lyytikiiinen et al. 2000 and Maijala
et al. 2001) indicates that levels <100 cfu/g in butter have been implicated in outbreaks of human
illness.”); id. (“Verraes et al. . . . recognize that “for cream made from raw milk, the main
microbiological hazards are estimated to be [Listeria], [Staphylococcus], and [E. coli] because
[Listeria] and [Staphylococcus] have been detected in cream and [E. coli] was linked to a cream
outbreak.”). 5
5
Plaintiffs believe that the FDA acted arbitrarily because it never studied butter. See
Pls.’ Mot. at 15; Pls.’ Reply at 12–13. But they cite no authority establishing that the FDA must
conduct its own studies on every product it decides to regulate. In denying Plaintiffs’ petition,
the agency thoroughly examined data and third-party studies that shed light on the risks of raw
butter. See J.A. 1076–86. It “‘explained the available evidence’ and rationally connected the
facts to the choice made.” See Hisp. Affs. Project, 901 F.3d at 392 (quoting New York, 413 F.3d
at 31). And as the FDA points out, Plaintiffs did not offer evidence to challenge its assertion that
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Ultimately, the FDA’s decision to require the pasteurization of butter to prevent the
spread of communicable diseases is “a scientific judgment within its area of expertise” that is
entitled to “a high level of deference.” See Rempfer, 583 F.3d at 867 (internal quotation marks
and citation omitted); see also 42 U.S.C. § 264 (granting the FDA authority to “make and
enforce such regulations as in [its] judgment are necessary to prevent the introduction,
transmission, or spread of communicable diseases” (emphasis added)). Plaintiffs try to offer
counterpoints, but the agency effectively addressed those points and put forth a great deal of
scientific evidence in support of its judgment. Reweighing even a mixed bag of scientific
evidence is inappropriate when there is plenty to support the agency’s decision. See Nat’l Ass’n
of Mfrs. v. EPA, 750 F.3d 921, 924 (D.C. Cir. 2014) (“Under the arbitrary and capricious
standard, we exercise great deference when we evaluate claims about competing bodies of
scientific research.”). The Court declines Plaintiffs’ invitation to do so here. The FDA is
entitled to summary judgment on their second claim.
V. CONCLUSION
For the foregoing reasons, Plaintiffs’ motion for summary judgment (ECF No. 15) is
DENIED and Defendant’s motion for summary judgment (ECF No. 17) is GRANTED. An
order consistent with this Memorandum Opinion is separately and contemporaneously issued.
Dated: May 24, 2021 RUDOLPH CONTRERAS
United States District Judge
“‘[t]he main ingredient in butter is cream’ . . . and ‘the manufacturing process for butter does not
destroy pathogens that may be present in the cream.’” Def.’s Reply at 10 (quoting J.A. 1077).
18