Amicus Curiae Brief — Young v. Community Nutrition Institute

Supreme Court brief1986

Ask Donna

What actually matters in this document.

Text

Supreme Court, U.S.

FILED

NOV 18 1986

No. 85-664

lOSEPH F. SPANIOL, J

IN THE

Supreme Cut of the United States

OCTOBER TERM, 1985

FRANK YOUNG, COMMISSIONER OF FOOD AND DRUGS,

Petitioner,

Vv.

COMMUNITY NUTRITION INSTITUTE, et al.,

Respondents.

On Petition for a Writ of Certiorari to the

United States Court of Appeals

for the District of Columbia Circuit

BRIEF OF NATIONAL PEANUT COUNCIL, INC.

AS AMICUS CURIAE IN SUPPORT OF

PETITION FOR WRIT OF CERTIORARI

JAMES M. GOLDBERG *

CHRISTOPHER R. COSTA

ABRAMS, WESTERMEIER

& GOLDBERG, P.C.

1828 L Street, N.W., Suite 660

Washington, D.C. 20036

(202) 785-2050

Attorneys for National Peanut

Council, Inc. as Amicus Curiae

©...

ee |

> |

Laden

—

—_—

Fe)

bedhed

* Counsel of Record

Dated: November 19, 1985

———————

W'LSON - EPES PRINTING Co., INC. - 789-0096 - WASHINGTON, D.C. 20001

QUESTION PRESENTED

Whether the Food and Drug Administration is required

to regulate unavoidable “added” poisonous or deleterious

substances in food by adopting tolerances through formal

rulemaking, rather than by adopting informal action

levels which are applied on a case-by-case basis.

(i)

TABLE OF CONTENTS

Page

INTEREST OF AMICUS CURIAE 0000000000000000000......... 2

STATEMENT OF THE CASE .......00....0.0000.020- eee 3

SUMMARY OF ARGUMENT W000. 4

darned tanalcnaerentinieinitnenetinnimnaneniiedindeslinipie 5

I. THE COURT OF APPEALS’ INTERPRETA-

TION OF THE FDCA RENDERS ALMOST

ALL FOODS ADULTERATED AND IMMEDI-

ATELY VULNERABLE TO ENFORCEMENT

IEEE sok hip scccsclenisdasaledvetnnsiibcciasiitibinivebaneisieliiebieiesinaiindam 5

Il. THE COURT OF APPEALS’ INTERPRETA-

TION OF THE FDCA SUBJECTS ALL FOOD

PRODUCERS, PROCESSORS, AND DISTRIB-

UTORS TO POTENTIAL CIVIL AND CRIMI-

NAL LIABILITY FOR THE INTERSTATE

COMMERCE OF AGRICULTURAL COM-

IIE sihistsvevesscetoxensenenicneteasanns ivesesensecnnncenvaniine 10

ee Ft srsteuveiei enmassiebeiianvaniabannaiiansinn 12

(iii)

TABLE OF AUTHORITIES

CASES: Page

Triangle Candy Co. v. United States, 144 F.2d 195

I I 11

United States v. Acri Wholesale Grocery Co., 409

F. Supp. 529 (S.D. Iowa 1976)....................0000000..... 11

United States v. Anderson Seafoods, Inc., 447 F.

Supp. 1151 (N.D. Fla. 1978), aff’d, 622 F.2d 157

(5th Cir. 1980) _........... eee ee 8

United States v. Barnett, 587 F.2d 252 (5th Cir.),

cert. denied, 441 U.S. 923 (1979) _... Fy eee Bore 11

United States v. Boston Farm Center, Inc., 590

Fe le CI Is I ivcteccesecetecveccnecesaciscencosncoosins x

United States v. Cassaro, Inc., 443 F.2d 153 (1st

on ere rere eS thee See ea 11

United States v. Colosse Cheese & Butter Co., 133

F. Supp. 953 (S.D.N.Y. 1955)................ ee 11

United States v. Dotterweich, 320 U.S. 277 (1943) .. 11

United States v. Park, 421 U.S. 628 (1975).............. 11

United States v. 449 Cases, Containing Tomato

Paste, 212 F.2d 567 (2d Cir. 1954)... 10

STATUTES AND REGULATIONS:

Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

a PNG Pan a A 2

21 U.S.C. §$ 331......... a a a 11

21 U.S.C. § 386.......... EES TRE IEE Tee TTL TS Te x

hd ll ene Fe

21 U.S.C. § 342(a) (2) (A) ..................... ECAR IRS. x

21 U.S.C. § 346........... A ESE ae Poe. 3, 4,5, 8, 12

Ie nr sc 6,8

MISCELLANEOUS:

es ee, ee CD nn 9

Ge Ps BE, I GOOD cncecncen-ncnccecceee-eccccsecsscses:. re)

4B Wee. Maw. GRGLE CIOTT) ............ccccccccececcccceccenesese. 8,9

Aflatoxin and Other Mycotorins: An Agricultural

Perspective, Council for Agricultural Science

and Technology, Report No. 80, December, 1979. 7

TABLE OF AUTHORITIES—Continuec

Aflatorins Continue To Be a Problem, Countryside,

PRR OR eE A PHI P LOR VOM RP aI

Diener, U.L., Deterioration of Peanut Quality

Cause by Fungi, in PEANUTS—CULTURE AND

UsES, at 523, American Peanut Res. Educ. Assn.,

Food and Drug Administration, Compliance Pro-

gram Manual, Programs on “Mycotoxins in

Rodricks, J.V., Hazards From Nature-Aflatorins,

reprinted from FDA CONSUMER, H.E.W. Pub.

No. (FDA) 78-2102, May 1979 .............................

Shotwell, O.L., Aflatoxin In Corn, J. Am. Oil Chem.

Soc. 54:215A, 1977 ..

Soybeans Aflatoxin Control Secret, News, Chester-

town, Maryland, May 2, 1979.................................

Stoloff, L., Aflatorins—An Overview, in MycoTox-

INS IN HUMAN AND ANIMAL HEALTH (1977)......

Stoloff, L., Occurrence of Mycotoxins in Foods and

Feeds, in MYCOTOXINS AND OTHER FUNGAL RE-

LATED Food PROBLEMS 149 (J.V. Rodricks ed.

Page

6,7

IN THE

Suprenw Court of the United States

OCTOBER TERM, 1985

No. 85-664

FRANK YOUNG, COMMISSIONER OF FOOD AND DRUGS,

Petitioner,

Vv.

COMMUNITY NUTRITION INSTITUTE, et al.,

Respondents.

On Petition for a Writ of Certiorari to the

United States Court of Appeals

for the District of Columbia Circuit

BRIEF OF NATIONAL PEANUT COUNCIL, INC.

AS AMICUS CURIAE IN SUPPORT OF

PETITION FOR WRIT OF CERTIORARI

The National Peanut Council, Inc. (“NPC”), by its at-

torneys, files this brief as amicus curiae in support of the

Petitioner, Frank Young, Commissioner of Food and

Drugs (“FDA”), and respectfully urges this Court to issue

a Writ of Certiorari to the United States Court of Appeals

for the District of Columbia Circuit to review the judg-

ment entered in the above-captioned case. This brief is

submitted with the written consent of all parties on

file with the Clerk of this Court.

INTEREST OF AMICUS CURIAE

The National Peanut Council, Ine. (“NPC”) is a non-

profit Georgia corporation, chartered in 1940, which rep-

resents and serves individuals, companies, corporations,

and associations engaged in, or providing goods or serv-

ices to, the production, processing, marketing, or manu-

facturing of peanuts and peanut products. NPC members

include peanut growers and affiliated associations, shellers,

custom processors, brokers, manufacturers, and interna-

tional and allied entities.

The subject matter of the instant case—-whether the

Focd and Drug Administration (“FDA”) is required to

regulate unavoidable “added” poisonous or deleterious

substances in food by means of tolerances promulgated

through formal rulemaking, rather than by informal ac-

tion levels resulting in case-by-case adjudication—is of

great concern to NPC, since the specific substances at

issue here, “aflatoxins,” are chemical byproducts of molds

that grow on corn and numerous other agricultural com-

modities. Furthermore, NPC and its members would be

adversely affected by an interpretation of the Federal

Food, Drug and Cosmetic Act (“FDCA’”), as amended,

21 U.S.C. §§ 301 et seg., that renders adulterated all

foods which contain detectable amounts of any unavoid-

able poisonous or deleterious substance, unless and until

a tolerance for each substance and food has been estab-

lished and promulgated by the FDA.

The interest of NPC is predicated upon the substantial

and far-reaching consequences of the result of the instant

case. The concern of the amicus curiae is that the Court,

in formulating the principles to govern the particular dis-

pute involved in the present case, should have the benefit

of NPC’s views, which may not otherwise be presented

in the arguments of the parties, in order to be aware of

the broader ramifications of its decision herein.

STATEMENT OF THE CASE

This case presents a challenge to the FDA’s method of

regulating the interstate commerce of foods which evi-

dence any “added” poisonous or deleterious substance that

is required in the production of food or that cannot be

avoided by good manufacturing practices. Since the en-

actment of the FDCA in 1938, FDA has regulated the

amounts of substances like aflatoxi: principally by issu-

ing “action levels,” which e”nounce the level of the

particular substance that FDA regards as resulting in

adulteration under 21 U.S.C. § 342(a) (1).

Respondents brought this suit to challenge FDA’s

method of regulation of aflatoxins in corn products. Re-

spondents contended that: (1) FDA should be compelled

to adopt a formal aflatoxin tolerance pursuant to 21

U.S.C. § 346, as opposed to an informally implemented

action level; (2) the action level, in the alternative,

should be made subject to notice-and-comment rulemaking;

and (3) certain exemptions to the action level were con-

trary to law. The United States District Court for the

District of Columbia granted summary judgment in favor

of FDA on all three issues. Recognizing that an agency’s

interpretation of its statute is entitled to substantial

deference, the court found that FDA’s construction of 21

U.S.C. § 346 was reasonable and that 21 U.S.C. § 346 “‘con-

fers discretionary, not mandatory, authority on the agency

to establish tolerances.” Pet. App. 3la-32a (footnote

omitted). It also concluded that action levels were gen-

oral statements of policy not requiring notice-and-comment

rulemaking and that the exemptions granted were within

the agency’s discretion. /d. at 32a-34a.

The United States Court of Appeals for the District of

Columbia Circuit reversed, holding that “the FDA may

not proceed by means of action levels rather than toler-

ances,” Pet. App. 2a, which require time-consuming and

burdensome formal rulemaking procedures and induce in-

flexible standards. The court reiterated its holding by

stating that, “since the existence of a regulation [under

21 U.S.C. § 346] operates to render the food legally un-

adulterated, the statute, in our view, plainly requires the

establishment by regulation of tolerances before aflatoxin-

tainted corn may lawfully be shipped in interstate com-

merce.” Pet. App. 7a.

NPC, as amicus curiae, fully supports Petitioner’s state-

ment of the general principles applicable to the instant

case and the interpretation of the underlying statutory

and regulatory scheme.

SUMMARY OF ARGUMENT

In support of Petitioner’s position, NPC respectfuily

suggests that the Writ of Certiorari be granted as the

question raised by Petitioner is substantial and of vital

national importance for the following reasons:

(1) The District of Columbia Circuit’s interpretation

of the FDCA renders almost all foods adulterated and

immediately vulnerable to enforcement action, and

(2) The District of Columbia Circuit’s interpretation

of the FDCA subjects all food producers, processors, and

distributors to potential civil and criminal liability for

the interstate commerce of agricultural commodities.

ARGUMENT

I. THE COURT OF APPEALS’ INTERPRETATION

OF THE FDCA RENDERS ALMOST ALL FOODS

ADULTERATED AND IMMEDIATELY VULNER-

ABLE TO ENFORCEMENT ACTION.

The court of appeals’ interpretation of the FDCA, that

“the FDA may not proceed by means of action levels

rather than tolerances,” ' was buttressed by an argument

which renders almost all foods adulterated under the pro-

visions of the FDCA. The court stated that: “Since the

existence of a regulation operates to render the food

legally unadulterated, the statute, in our view, plainly

requires the establishment by regulation of tolerances be-

fore aflatoxin-tainted corn may lawfully be shipped in

interstate commerce.” Pet. App. 7a. The court inter-

preted 21 U.S.C. § 346 to mean that any food which con-

tains an “added” unavoidable poisonous or deleterious

substance is adulterated unless “a regulation establishing

a tolerance is in effect.” Pet. App. 7a. The court pro-

vided no support for its reasoning, found “little guidance

in the legislative history,” Pet. App. 9a, and failed to cite

any supporting judicial authority for this sweeping and

novel interpretation of the FDCA which threatens the

nation’s food supply.

A necessary implication of the court of appeals’ deci-

sion is that, before a tolerance is adopted, the presence of

any “added’’ poisonous or deleterious substance, even if

necessary or unavoidable, renders food adulterated and,

therefore, barred from shipment in interstate commerce.

Because tolerances can only be adopted through the ex-

traordinarily cumbersome and time consuming procedures

1 Pet. App. 2a. The cour! reiterated its holding by stating that

“‘we have concluded that the FDA is required to issue regulations

establishing tolerances in order for food containing unavoidable

added poisonous or deleterious substances to be considered unadul-

terated for the purposes of 21 U.S.C. §342(a)(1). .. .” Pet.

App. 15a.

set forth in 21 U.S.C. § 371(e), many years could well

pass during which a substantial portion of the nation’s

food supply was technically “adulterated.” It is clear

that the court of appeals failed to fully comprehend the

nature of aflatoxin, the practical realities of FDA’s regu-

latory scheme, and the economics of the nation’s food sup-

ply. Its decision, if not reversed, could completely elimi-

nate the interstate commerce of many agricultural com-

modities, and apply severe economic forces to intrastate

commerce in foods, which will cause prices of certain

commodities and their nutrition-substitutes to skyrocket.

In order to clearly appreciate the national interests at

stake and the magnitude of the consequences of this de-

cision, NPC, as amicus curiae, pruters a brief discussion

of the nature of aflatoxins and FDA’s regulatory scheme.

1. The Nature of Aflatoxins.

The specific “added” poisonous or deleterious substances

at issue here, “aflatoxins,” are naturally occurring chem-

ical substances produced by the molds Aspergillus flavus

and Aspergillus paresiticus. Aflatoxins occur worldwide

in many agricultural commodities; their production is

favored by warm temperatures and high moisture levels

typical of tropical and subtropical areas, including south-

ern United States. In addition, A. flavus invasion of

crops and resulting aflatoxin production has also been

associated with drought-induced stress, over-maturity,

and physical and biological damage.’ Aflatoxins are fre-

quently found in corn, cottonseed, tree nuts, figs, peanuts,

grains, animal products (such as milk and milk prod-

ucts), and meat products of animals which have ingested

aflatoxin-contaminated feeds.* Although considerable

* Diener, U.L., Deterioration of Peanut Quality Caused By Fungi,

in PEANUTS—CULTURE AND USES, at 523, American Peanut Res.

Educ. Assn. 1973; Shotwell, O.L., Aflatoxin In Corn, J. Am. Oil

Chem. Soc. 54: 216A, 1977.

% Stoloff, L., .sflatoxins—An Overview, in MYCOTOXINS IN HUMAN

AND ANIMAL HEALTH (1977) ; Stoloff, L., Occurrence of Mycotoxins

progress has been made in controlling the aflatoxin con-

tamination of foods and feeds, detoxifying contaminated

products,‘ and identifying their significant relationships

with the presence of zinc and absence of phytic acid,’ the

complete prevention of mold growth and aflatoxin pro-

duction in foods appears unattainable at the present

time.® Since its discovery in the early 1960’s, aflatoxin

contamination has continued to concern FDA. Soon after

the discovery of aflatoxins in foods FDA began a pro-

gram for their control,’ and in 1965 FDA established an

informal] action level of 30 parts per billion (“ppb”) total

aflatoxins for edible agricultural commodities. In 1969,

FDA reduced the action level to its current level of 20

ppb total aflatoxins for human foods and animal feed.°-

Action levels have permitted FDA the necessary flexi-

bility to set realistic limits on the presence of aflatoxins

and other contaminants in foods, free sufficient staff for

in Foods and Feeds, in MYCOTOXINS AND OTHER FUNGAL RE-

LATED FOOD PROBLEMS 149 (J.V. Rodricks ed. 1976) ; Rodricks, J.V.,

Hazards From Nature— Aflatoxins, reprinted from, FDA CONSUMER,

H.E.W. Pub. No. (FDA) 78-2102, May 1979.

4 Aflatoxin and Other Mycotoxins: An Agricultural Perspective,

Council for Agricultural Science and Technology, Report No. 80,

December, 1979, at 1.

5 Soybeans Aflatoxin Controi Secret, News, Chestertown, Mary-

land, May 2, 1979, Aflatoxins Continue To Be A Problem, Country-

side. August 1979, at 51.

® Stoloff, L., Afatoxins—An Overview, in MYCOTOXINS IN HUMAN

AND ANIMAL HEALTH (1977). Major causes of peanut invasion by

A. flavus and A. parasiticus are plant stress, insect damage,

mechanical damage, delayed drying, and inadequate ventilation.

7 Food and Drug Administration, Compliance Program Guidance

Manual, Programs on “Mycotoxins in Foods,’ 1973. This docu-

ment, or one similar to it, is released each year to provide guidance

to FDA District Offices. Summaries of all aflatoxin control activi-

ties are contained in these programs.

8 Pet. App. 22a.

important enforcement duties,° and, where necessary,

grant exemptions’ from regulatory action pursuant to

those regulations."

2. FDA’s Regulatory Scheme.

The procedures employed in issuing action levels, under

21 U.S.C. § 342(a) (1), differ from those required for

tolerances, under 21 U.S.C. § 342(a) (2) (A). Pet. 4-5,

Pet. App. 22a. The most significant difference in the

method of issuance is that tolerances are subject to

notice-and-comment rulemaking procedures before issu-

ance, under 21 U.S.C. §§ 346, 371(e), while comment op-

portunities concerning action levels are provided after

issuance by FDA. FDA’s method of issuing action levels

affords the public substantial participation, even though

action levels are not subject to the notice-and-comment

rulemaking procedures of 21 U.S.C. § 371(e). To estab-

lish an action level, FDA publishes a notice in the Fed-

eral Register announcing the new level and the avaiiabil-

ity of all relevant data and invites public comment. 42

Fed. Reg. 52814 (Sept. 30, 1977). FDA would require

several years, and incur a substantial administrative bur-

den, to establish formal tolerances under 21 U.S.C.

§ 371(e).

Action levels are public statements of the exercise of

FDA’s substantial enforcement discretion under 21 U.S.C.

$ 336 of the FDCA and in furtherance of the agency’s

responsibilities under 21 U.S.C. § 342(a)(1). The level

fixed advises the public of the point at which FDA will

® United States v. Boston Farm Center, Inc., 590 F.2d 149 (5th

Cir. 1979) (action to enjoin shipment of corn containing an amount

of aflatoxin exceeding FDA’s action level), see also, United States

v. Anderson Seafoods, Inc., 447 F. Supp. 1151 (N.D. Fla. 1978),

aff'd, 622 F.2d 157 (5th Cir. 1980).

10 Pet. App. 24a. P

11 Pet. App. 25a-26a. The FDA has granted two exemptions in

eight years. The FDA’s 1980 limited exemption was the underlying

cause of Respondents’ suit.

undertake regulatory action. It is akin to the local police

department which, for reasons of resources and priorities,

will not stop speeding cars unless they are traveling at

speeds in excess of 55 miles per hour, even though the

posted limit may be something less.

3. Consequences of a Tolerance Requirement.

In light of the pervasive presence of many unavoid-

able environmental contaminants in the air, soil, and

water, most agricultural commodities will be in violation

of the FDCA under the court of appeals’ interpretation.

Furthermore, for over ten years, FDA has publicly

advancea this fact: “The Commissioner advises that

it is not possible to produce food or food ingredients

that are entirely free from contamination by foreign

substances or impurities,” 42 Fed. Reg. 52814 (Sept. 30,

1977),’* and has identified the consequences of a non-

detectable-residue requirement which are strikingly sim-

ilar to the consequences of a tolerance requirement:

If a nondetectable-residue requirement were auto-

matically applied to environmental contaminants al-

ready present in the food supply, enforcement activ-

ities could significantly disrupt the food supply. Re-

moving food containing any detectable residue from

the marketplace could lead to enforcement action

against food commodities not deemed to present any

significant risk to public health.

42 Fed. Reg. 17490 (April 1, 1977).

The consequences of the court of appeals’ interpreta-

tion are: (1) severe FDA administrative burden caused

by the promulgation requirements of formal tolerances,

(2) findings that, in the absence of tolerances, many

foods are adulterated and therefore barred from inter-

12 With respect to wildlife, FDA has asserted: “{MJercury con-

tamination of the aquatic habitat and thereby of fish and shellfish

is ubiquitous and unavoidable... .” 39 Fed. Reg. 42739 (Dec. 6,

1974).

state commerce, (3) uncertainty and possible civil and

criminal liability caused by the expected delay in issuing

tolerances and (4) the resulting economic forces on the

price of food caused by limiting the nation’s food supply.

This case construes FDA’s regulatory methods for all

unavoidable “added” poisonous or deleterious substances,

of which aflatoxin presence in corn is only a specific

instance. Hence, the consequences of the court of appeals’

interpretation must be multiplied by the enormous num-

ber of agricultural and animal commodities which may

contain contaminants classified as necessary or unavoid-

able “added” poisonous or deleterious substances and

which contaminate our air, water or soil. Therefore, if

allowed to stand, the court of appeals’ interpretation of

the FDCA renders almost all food adulterated and imme-

diately subject to enforcement action under the FDCA.

Furthermore, due to the great number of tolerances

which must be promulgated, FDA may not be able to

remedy this situation for an extended period of time.

II. THE COURT OF APPEALS’ INTERPRETATION OF

THE FDCA SUBJECTS ALL FOOD PRODUCERS,

PROCESSORS, AND DISTRIBUTORS TO POTEN-

TIAL CIVIL AND CRIMINAL LIABILITY FOR THE

INTERSTATE COMMERCE OF AGRICULTURAL

COMMODITIES.

The court of appeals’ interpretation of the FDCA,

that absent tolerances any amount of a necessary or un-

avoidable environmental contaminant renders food adul-

terated, would severely aggravate the problems noted

by Judge Frank’s dissent in United . tates v. 449 Cases,

Containing Tomato Paste, 212 F.2d 567 (2d Cir. 1954),

until such time as FDA promulgates tolerances for all

foods. The specific problems noted by Judge Frank, and

compounded by the opinion beiow, include the possibility

of dangerous administrative arbitrariness of enforce-

ment of the FDCA without recognizable standards which

activate enforcement and lack of publication of those

standards. /d. at 577-79. Clearly, the possible imposi-

tion of civil liability without notice of tolerances, due

to the protracted promulgation requirements of formal

tolerances, should be avoided as a disservice to the public

and the food industry.

In addition to the imposition of civil liability without

notice of enforcement tolerances, the FDCA provides,

at 21 U.S.C. § 331, that the interstate commerce of any

food that is adulterated is prohibited by the FDCA,”

and provides for strict criminal liability.'"* Corporate

officials, officers, and managers have been held criminally

liable for placing adulterated foods into interstate com-

merce,'* and this Court has held that they have a “a

duty to implement measures that will insure that viola-

tions will not occur.” United States v. Park, 421 USS.

628 (1975).

Under the interpretation espoused by the court of

appeals, the only way that corporate officials could insure

that ‘violations will not occur” would be to halt ship-

ment of most foods, thereby seriously disrupting the

nation’s food supply and causing product shortages and

economic instability. Clearly, the ramifications of the

court of appeals decision have not been properly con-

sidered and weighed.

13 See United States v. Barnett, 587 F.2d 252 (5th Cir.), cert.

den., 441 U.S. 923 (1979); United States v. Cassaro, Inc., 443 F.2d

153 (1st Cir. 1971).

i4 Triangle Candy Co. v. United States, 144 F.2d 195 (9th Cir.

1944) (persons introducing adulterated food in interstate com-

merce are criminally liable, regardless of their intent or lack of

knowledge as to adulteration); United States v. Dotterweich, 320

U.S. 277 (1943).

15 United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529

(S.D. Iowa 1976); United States v. Colosse Cheese & Butter Co.,

133 F. Supp. 953 (S.D.N.Y. 1955).

The currently enforced action levels have given the

public notice of levels which FDA has determined would

give rise to a violation of 21 U.S.C. § 342(a)(1) and

thus ameliorates the problems identified by Judge Frank.

However, the court of appeals’ decision will create an

opportunity for arbitrary enforcement, at least until

such time as formal tolerances under 21 U.S.C. § 346

can be adopted for the broad range of environmental

contaminants.

NPC is seriously concerned that the far-reaching con-

sequences of this case be appreciated. If allowed to

stand, the court of appeals’ decision threatens either “a

cessation of the production and shipment of all foods

containing any amount of any ‘added’ poisonous or dele-

terious substance, or all segments of the food industry

must act in apparent violation of the FDCA until the

lengthy process of issuing formal tolerances is completed.”

Pet. 18.

CONCLUSION

For the reasons set forth herein, the National Peanut

Council, Inc., as amicus curiae in support of Petitioner’s

position, respectfully urges this Court to issue a Writ of

Certiorari to review the judgment and opinion of the

District of Columbia Circuit.

Respectfully submitted,