McAfee v. U.S. Food and Drug Administration

M
                            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




                                                2
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.




                                                  3
                                    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




                                                  4
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).


                                                   5
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.




                                                  6
       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




                                                  7
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.


       2
          Congress 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




                                                   9
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.




                                                   11
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




                                                 12
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.




                                                 13
        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.


                                                 14
       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


                                                 17
       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

Add comment

By

Recent Posts

Recent Comments