Amicus Brief — United States v. Park

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IN THE MICHAEL ROUAK, JR., CLER

Supreme Court of the United States ~~

OcToBEerR TERM, 1974

No. 74-215

Unirep States or America, Petitioner

Vv.

JoHn R. Park

On Writ of Certiorari to the United States Court of Appeals

for the Fourth Circuit

BRIEF AMICUS CURIAE OF THE NATIONAL

ASSOCIATION OF FOOD CHAINS

JAMES F.. RILn

Rosert A. CoLLrer

Pure C. OLSSON

JoHN Harpin Youna

1666 K Street, N.W.

Washington, D.C. 20006

Attorneys for National Association

of Food Chains, Ine.

Press or Byron S. ADAMS PRINTING, INC., WASHINGTON, D. C.

- INDEX

| Page

STATEMENT OF INTEREST .........000+sceeccccccccces 1

SuMMARY OF CASE ..........ccseeseeeccces apeescens 4

SUMMABY OF ARGUMENT ........ceeceeeescseccceens 6

BROOME cccccccccccccccccccccccessesesescosecse 8

The Decision of the Court of Appeals Is Consistent

with This Court’s Decision in United States v.

DED. bc < ccddeduacebsco beberensdebeneeess 8

Criminal Liability of a Supervisory Employee

for Violations of the Act Must Be Based on Gross

Negligence, Inattention in Discharging Corporate

Duties or Other Acts of Commission or Omission

Which Cause the Contamination of Food ........ 13

The Decision of the Fourth Cireuit Will Result

in More Effective Compliance with the Act by En-

couraging Greater Numbers of People To Become

Involved in Sanitation Activities .............. 18

re -. . cp sanekatdésunden dutabindetasdatee 24

CasEs :

California v. Robinson, 370 U.S. 660 rehearing denied,

Se We St ED, ptendeadduccecnecedcabauteeed 16

Morisette v. United States, 342 U.S. 246 (1952) ...... 17

United States v. Dotterweich, 320 U.S. 277 (1943) .. .5, 6,7,

9, 10, 11, 12, 13, 15

United States v. Park, 499 F.2d 839 (4th Cir. 1974)

5, 6, 7, 8, 9, 11, 12, 13,

15, 16, 17, 18, 21, 23, 25

United States v. Wiesenfield Warehouse Co., 376 U.S.

ee GED baccuoces ceenedencneseoeandeussoeeucs 17

ii Index Continued

Page

STATUTES:

Federal Food, Drug, and Cosmetic Act of 1938,

31 UB.C. SOL of 006. ....cccccess 2, 3, 4, 6, 8, 10, 12,

15, 19, 20, 24, 25

Section 301(k), 21 U.S.C. § 331(k) ............ 2

TY OE nk a ee de ea eee ad 10, 12

MISCELLANEOUS:

Comptroller General of the United States, Dimensions

of Insanitary Conditions in the Food Manufactur-

PE eauccnenededecededecdetenedeuaccks 23

J. Hagan, A ManaGeMEntT Rove ror Quauity Conrrot,

Se GED Saud Nadeicccudepanssendebencecdceces 19

Joint Appendix, United States v. Park, (No. 74-215,

cert. granted Nov. 11, 1974) — U.S. — (1975) .... 5

Note, Criminal Responsibility for Pollution of the En-

vironment, 37 AuBany L. Rev. 62 (1972) : 13

P. Drucker, Manacement, 400 (1974) .............. 20

Sayre, Criminal Responsibility for Acts of Another, 43

Harv. L. Rev. 689 (1930) .................. 14, 15, 16

Voluntary Industry Sanitation Guidelines for Food

Distribution Centers and Warehouses, prepared

by NAFC, et al (1974) .............. 3, 19, 20, App. A

IN THE

Supreme Court of the United States

OctToBeR TERM, 1974

No. 74-215

JoHN R. Park

Untrep States or America, Petitioner

On Writ of Certiorari to the United States Court of Appeals

for the Fourth Circuit

BRIEF AMICUS CURIAE OF THE NATIONAL

ASSOCIATION OF FOOD CHAINS

STATEMENT OF INTEREST

The National Association of Food Chains, Inc.

[hereinafter ‘“‘NAFC’’], submits this brief as amicus

curiae because of the concern of its members with the

matter before the Court. Both parties have given their

consent to NAFO’s participation, pursuant to Rule

42.2.

NAFC is a non-profit trade association whose ap-

proximately 200 members are engaged in the retail dis-

tribution of food and grocery products. The Associa-

tion is composed of all the larger, most of the medium-

sized and a cross-section of smaller food chains in the

United States.

The members of the Association engage in numerous

activities subject to the Federal Food, Drug and Cos-

metic Act, 21 U.S.C. § 301 et seq., including warehous-

ing and distributing food products to individual stores.

NAFC members are also extensively engaged in food

processing activities such as the operation of dairies,

bakeries, coffee plants, and canneries.

Members of NAFC have a substantial and continu-

ing interest in the effective enforcement of the Federal

Food, Drug and Cosmetic Act. It is to the obvious

benefit of ali food chains that the food which they pur-

chase from suppliers and sell to customers is free from

adulteration, handled under sanitary conditions and

accurately labeled. -

The case before the Court concerns the responsibility

of top-level management for warehouse sanitation. In

order to provide guidance to its members in this im-

portant area, NAFC has recently taken responsibility

for coordinating the efforts of seven trade associations

and the Food and Drug Administration of the Depart-

ment of Health, Education and Welfare in the prep-

aration and publication of Voluntary Industry Sani-

tation Guidelines for Food Distribution Centers and

Warehouses. These guidelines are attached as Appen-

dix A. The Guidelines indicate the continuing efforts

which NAFC and its members have undertaken to

achieve compliance with § 301(k) of the Federal Food,

Drug and Cosmetic Act, 21 U.S.C. § 331(k).

The implications of this case, however, extend be-

yond the issue of warehouse sanitation and the appli-

eation of § 301(k), 21 U.S.C. § 331(k). The decision in

this case will have a direct impact on the extent of

criminal prosecution for all offenses under the Federal

Food, Drug and Cosmetic Act [hereinafter ‘‘Act’’].

As presented to the Court, the issue is whether or not

an individual can be held criminally liable for a cor-

porate violation of the Act where there is no evidence

of his participation in the alleged violation.

NAFC does not question whether an individual em-

ployee should be subject to criminal sanctions under

the Federal Food, Drug and Cosmetic Act, where

through some act or omission on his part a food prod-

uct is unlawfully adulterated or misbranded. Where,

however, a corporate officer or other employee has dili-

gently undertaken to establish and implement a com-

prehensive compliance program neither the statute

nor prior cases require that he be convicted of

a criminal offense. To the contrary, the under-

lying purpose of the Act, purity and accurate la-

beling of food, should encourage such comprehen-

sive compliance. This purpose would be ill-served

by a construction of the Act which would sub-

ject a company employee to criminal punishment for

inadvertent, often unavoidable, violations without re-

gard to the comprehensiveness of the compliance pro-

gram which he has established or the diligence of his

supervisory efforts.

NAFC’s interest in this case, thus, derives from a

basie conclusion that effective compliance with the

Act will best be obtained by requiring a high standard

of effort as evidenced, in part, by its warehouse sani-

tation guidelines. See, Appendix A. The Government’s

advocacy of an absolute criminal liability rule based

solely on an individual’s corporate position adds noth-

ing to effective compliance and, in fact, may detract

from it.

The decision of the United States Court of Appeals

for the Fourth Cireuit established a correct, practical,

and equitable standard which will result in better com-

pliance with the Federal Food, Drug and Cosmetic

Act.

The decision of the Court of Appeals provides that

an individual’s criminal liability under § 303 of the

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

§ 333, must be based on his own acts or omissions which

eontribute to a violation. NAFC’s members strongly

urge that this standard be affirmed, both because it

correctly interprets applicable law, and because it es-

tablishes a workable rule for compliance with the Act.

SUMMARY OF THE CASE

This action was initiated in the United States Dis-

trict Court for the District of Marvland by criminal

informations against Acme Markets, Ine. [herein-

after ‘*Acme’’] and Aecme’s President, Respondent

John R. Park. The informations were based on the

presence of rodents in a portion of Acme’s Baltimore

warehouse. Acme, a large retail food chain employing

approximately 36,000 persons in 874 retail outlets, has

twelve main warehouses and four special warehouses.

The informations against Aeme and Park contained

five counts, four of them based on deficiencies noted

during a Food and Drug Administration inspection in

November-December 1971, and one based on a defi-

ciency noted in a subsequent inspection in March of

1972. The corporate defendant, Acme, Ine., entered a

plea of guilty to each of the five counts.

Prior to trial, Park filed a Motion for Bill of Par-

ticulars seeking the details of his alleged liability

for the violations. (Jt. App. at 10) The government

responded to the motion by disclosing that the evidence

would not show that defendant Park personally per-

formed any of the acts described in the information,

but that ‘“‘the government’s evidence will simply show

that the defendant was a corporate officer who, under

law, bore a relationship to the receipt and storage of

food which would subject him to criminal liability

under United States v. Dotterweich, 320 U.S. 277

(1943).’’ (Jt. App. at 14-15)

At Park’s trial, the charge to the jury was given in

substantially the form requested by the government

and incorporated the same theory of liability set forth

in the government’s response to the motion for bill of

particulars. After defining the elements of interstate

shipment and unsanitary conditions, the trial court

charged the jury to consider a third element:

“Thirdly, that John R. Park held a position of

authority in the operation of business of Acme

Markets, Incorporated.

‘*However, you need not concern yourself with the

first two elements of the case. The main issue for

vour determination is only with the third element,

whether the Defendant held a position of author-

ity and responsibility in the business of Acme

Markets.’’ (Jt. App. at 61)

This portion of the charge to the jury, combined

with other portions reflecting the view that criminal

liability might exist without evidence of any wrongful

action on the part of the Respondent, resulted in the

Court of Appeals reversing. United States v. Park,

499 F.2d 839 (4th Cir. 1974).

In reversing Park’s conviction, the Court of Ap-

peals concluded:

[A] finding of guilt must be predicated upon some

wrongful action by Park. That action may be

gross negligence and inattention in discharging

his corporate duties and obligations or any of a

host of other acts of commission of omission which

would ‘‘eause’’ the contamination of the food.

United States v. Park, supra, 499 F.2d at 842.

The Court of Appeals also concluded:

It is the defendant’s relation to the criminal acts,

not merely his relation to the corporation, which

the jury must consider; 21 U.S.C. § 331 is con-

eerned with criminal conduct and not proprietary

relationships. United States v. Park, Supra, 499

F.2d at 841.

The government petitioned for a writ of certiorari

claiming that individual guilt may be based on ‘‘con-

structive participation,’’ a test to be applied solely on

the basis of the individual’s formal duties and official

responsibilities (Petitioner’s Brief for Certiorari at

12).

SUMMARY OF ARGUMENT

The decision of the Court of Appeals correctly in-

terprets the applicability of criminal sanctions under

the Federal Food, Drug and Cosmetie Act, 21 U.S.C.

§ 301, et seq., and is consistent with the decision of the

Court in United States v. Dotterweich, supra. Justice

Frankfurter’s decision in Dotterweich concludes that

the Federal Food, Drug and Cosmetic Act is part of a

class of legislation which ‘‘. . . dispenses with the con-

ventional requirement for criminal conduet—aware-

ness of some wrongdoing,’’ United States v. Dotter-

weich, supra, 320 U.S. at 281. A person who violates

this type of statute is subject to ‘‘strict’’ liability for

his violative act, whether or not he was aware that his

action violated a regulatory standard. The Fourth

Circuit correctly followed Dotterweich in concluding

that while awareness of wrongdoing is not an element

of the offense, Park could not be found guilty in the

absence of ‘‘wrongful action’? on his part. United

States v. Park, supra, 499 F.2d at 841. See text 8-13,

infra.

IL.

—

Criminal liability for the acts of others must be

based on the accused’s participation in a criminal act,

or his aiding and abetting in its commission. See, text

13-16, infra.

The government’s position erroneously states the

law by confusing the element of ‘‘awareness of wrong-

doing’’ which need not be proved, with the element of

‘‘wrongful action’? which must be found to hold Park

as President of the company criminally liable. Until

the government demonstrates that Park ‘‘partici-

pated’’ in causing a violation of the Act, he is not

within the class of persons who may be subject to the

Act’s strict liability. The net effect of the govern-

ment’s position is to advocate that Park be held crim-

inally liable by virtue of his office alone, which is a

fundamental misconstruction of the Court’s reasoning

in Dotterweich. The government and the district court

have erred in applying strict liability to Park without

requiring proof of the casual connection, if any, be-

tween Park and the alleged violations. They have,

thus, erroneously ignored controlling and traditional

requirements of aiding and abetting which must be

proved to establish vicarious participation in the

wrongful action. See text 16-24, infra.

ITT.

The decision of the Court of Appeals would lead to

more effective compliance with the Federal Food,

Drug and Cosmetie Act than can be achieved through

the standard urged by the government. The Court of

Appeals has provided an incentive for managers to be-

come responsibly involved in complying with the Fed-

eral Food, Drug and Cosmetic Act, and to build af-

firmative records demonstrating their eare and dili-

gence in exercising such responsibility. The govern-

ment’s standard would deter the involvement of cor-

porate officials in compliance programs.

The decision of the Court of Appeals would make

diligence a defense, while the standard of constructive

participation urged by the government would make

mere corporate position a crime. Successful compli-

ance with the Federal Food, Drug and Cosmetie Act

requires broad-seale and positive involvement of com-

pany managers and employees which would be eneour-

aged by the Court of Appeals’ standard. See text 17-

24, infra.

ARGUMENT

I. THE DECISION OF THE COURT OF APPEALS IS CON-

SISTENT WITH THIS COURT’S DECISION IN UNITED

STATES v. DOTTERWEICH.

The Court of Appeals properly recognized that:

... For an accused individual to be convicted, it

must be proved that he was in some way per-

sonally responsible for the act constituting the

crime. The Supreme Court recognized this in Dot-

terweich: **The offenses committed . .. by all who

do have such a responsible share in the further-

ance of the transaction which the statute outlaws

... United States v. Park, supra, 499 F.2d at

841 (4th Cir. 1974).

The Court of Appeals cited further language from

Dotterweich in support of its decision:

... To use the language of Dotterweich, ‘under

Section 301 [21 U.S.C. § 331], a corporation may

commit an offense and all persons who aid and

abet its commission are equally guilty.’’ Id. (Em-

phasis supplied by Court of Appeals.)

The government has relied on Dotterweich through-

out its prosecution of Park. Dotterweich has been

cited as authority by the government in its response

to Park’s motion for bill of particulars, its request

for a charge to the jury and its petition for a writ

of certiorari and its brief on the merits. The position

enunciated by the government and incorporated by

the district court in its jury charge is a misinterpre-

tation of Dotterweich.

The government erroneously ignores the distinction

set forth in Dotterweich between the ‘‘strict’’ liability

for violations of the Federal Food, Drug and Cosmetic

Act and “‘viearious’’ liability of individuals for these

violations. Strict liability is applied where aware-

ness by the aeeused that his action was wrongful

is not an element of the crime. Justice Frankfurter

characterized the Federal Food, Drug and Cosmetic

Act as a statute embodying this type of liability:

. . . Such legislation dispenses with the conven-

tional requirement for criminal econduect—aware-

ness of wrongdoing. In the interest of the larger

good it puts the burden of acting at hazard upon

a person otherwise innocent but standing in a

responsible relation to a publie danger. United

States v. Dotterweich, supra, 320 U.S. at 281.

Although the Federal Food, Drug and Cosmetic Act

establishes a standard of strict liability for deter-

mining whether individuals are criminally liable, this

standard was carefully limited by Justice Frankfur-

ter to individuals ‘‘. . . standing in a responsible re-

lation to a public danger.”’ United States v. Dotter-

weich, supra, 320 U.S. at 281.

While Mr. Justice Frankfurter held that an indi-

vidual who has no ‘‘awareness of wrongdoing” could

he convieted of violating the Federal Food, Drug and

Cosmetic Act, he carefully defined those who might

be subject to this strict liability as persons having the

same causal relationship to the violation as described

in section 322 of the penal code, 18 U.S.C. § 550 (1943)

later codified in 18 U.S.C. § 2. United States v. Dotter-

weich, supra, 320 U.S. at 281 (1974).

Standards of liability for aiders and abetters in

federal crimes are defined in 18 U.S.C, § 2:

‘*(a) Whoever commits an offense against the

United States or aids, abets, counsels, commands,

induces or procures its commission is punishable

as a principal.

(b) Whoever willfully causes an act to be done

which if directly performed by him or another

would he an offense against the United States, is

punishable as a principal.’’

In United States v. Dotterweich, supra, the defend-

ant had a close causal relationship to the violations

charged since the defendant had direct supervisory

responsibility over the physical acts which resulted in

the violation. Joseph Dotterweich admitted personal

involvement with and oversight of all the activities of

Buffalo Pharmacal Company, Inc., the eornerate de-

a ee ‘

{

;

fendant.’ The language of the Dotterweich decision

which concluded that ‘‘awareness of wrongdoing’’ is

not a necessary condition precedent for criminal con-

viction under the Federal Food, Drug and Cosmetic

Act is addressed to the defendant’s strict liability for

acts in which he participated, not to his vicarious

liability for acts in which he did not participate.

Dotterweich cannot be interpreted, as it has been

by the government, to extend criminal liability to in-

dividual employees, absent any evidence of their per-

sonal participation in a violation of the Federal Food,

Drug and Cosmetie Act. The Federal Food, Drug and

Cosmetic Act imposes strict liability only on those who

participate in violating the Act; it does not impose a

unique standard of vicarious liability, absent aiding

and abetting as defined in 18 U.S.C. § 2.

‘The Record which was before this Court in Dotterweich shows

that not only was Mr. Dotterweich responsible for every aspect of

the corporate defendant's busienss, but also that he testified in a

manner which emphasized his personal responsibility. See, Appel-

lant’s Brief at 12, United States v. Park, 499 F.2d 839 (4th Cir.

1974) which states in pertinent part:

The violations charged in Dotterweich arose from two shipments

of digitalis alleged to be less potent than required by law and a

shipment of pills alleged to be misbranded. The evidence showed

that the corporate defendant had been ‘‘ereated’’ by Dotterweich,

in the words of defense counsel (R. 63), was owned by him, had

approximately 26 employees, working on one floor of an office

building, with Dotterweich as President, ‘‘General Manager,’’ and

the only supervisor. During the testimony by Dotterweich, his

counsel almost invariably used the word ‘‘you’’ to refer to actions

taken by other employees who worked under Dotterweich’s super-

vision (R. 128, 141, 142). On eross examination, Dotterweich ad-

mitted that, ‘‘ When I am in the place, I am in charge,’’ and that

he was ‘‘the boss,’’ and that he must have been in charge on a day

when one of the challenged shipments went out sinee he had signed

a letter that day in his capacity as ‘‘General Manager’ (R. 143-

144).

The decision of the Court of Appeals in the

present case is carefully consistent with Dotterweich.

It explains that ‘“‘strict’’ liability for violations of

the Act is not at issue, United States v. Park, 499

F.2d supra, 840, n.2, and addresses the separate ques-

tion of whether the charge to the jury in the District

Court properly stated the law as to Park’s liability

as president and chief executive officer of Acme. The

Court of Appeals found the charge incorrect since it

would have allowed the jury to find Park guilty solely

on the basis of his *. . . position of authority and

responsibility in the business of Acme Markets . . .

even though he had not ‘personally participated in the

situation’.”’ United States v. Park, supra, 499 F.2d

at 840.

The Court of Appeals properly perceived that “*. . .

the Government has confused the element of ‘aware-

ness of wrongdoing’ with the element of ‘wrongful

action’; Dotterweich dispenses with the need to prove

the first of those elements but not the second.’ United

States v. Park, supra 499 F.2d at 841. The Court of

Appeals further reasoned that, ‘*. . . It is the defend-

ant’s relation to the criminal acts, not merely his rela-

tion to the corporation, which the jury must consider;

21 U.S.C. § 331 is concerned with criminal conduct

and not proprietary relationships.”’ Id.

The Court of Appeals correctly reversed Park’s con-

Viction since the jury could have based its verdict on

Park’s corporate position without considering his

participation in the violative acts. The Court of Ap-

peals’ reversal is in harmony with the Court’s decision

in Dotterweich, which eliminated the need to prove

awareness of wrongdoing, but which did not eliminate

the need to prove the accused’s causal participation

in the wrongdoing.

II. CRIMINAL LIABILITY OF A SUPERVISORY EM-

PLOYEE FOR VIOLATIONS OF THE ACT MUST BE

BASED ON GROSS NEGLIGENCE, INATTENTION IN

DISCHARGING CORPORATE DUTIES OR OTHER ACTS

OF COMMISSION OR OMISSION WHICH CAUSE THE

CONTAMINATION OF FOOD.

The basic issue presented by this case is the legal

standard governing criminal liability of supervisory

employees for violations of the law committed by

subordinates. The government contends that a supervi-

sory employee may be convicted for a violation oceur-

ring anywhere within the company on the basis of

his position of authority. The Fourth Circuit holds

that a supervisor may be found guilty only where he

has participated in wrongful action.

The position of the government fails to provide a

standard which juries can use in their deliberations.’

On the other hand, the position of the Fourth Circuit

provides a workable and legally sound standard for

instructing juries on the possible criminal liability of

company Officers.

The present case involves the criminal liability of

a general supervisor for the acts of subordinates. It

is the type of liability which requires a causal connec-

tion between the supervisor’s act and the alleged

violation.’ If supervisors are to be prosecuted under

?The government's position is based on a fundamental miscon-

ception regarding the criminal responsibility of one individual for

the acts of another. Such liability is ‘‘vieavious’’ and yet the gov-

ernment asserts that, ‘‘ While the liability created by the 1938 Act

is strict, it is not viearious.’’ (Brief for the Government at 14.)

> The desirability of holding supervisory officials vicariously liable

for cerporate violations of environmental standards is examined at

length in Note, Criminal Responsibility for Pollution of the En-

section 301 of the Act, those prosecutions must be

subject to the general standards for the imposition of

criminal liability. These standards as embodied in the

vironment, 37 ALBany L. Rev. 61 (1972). That article discusses

Dotterweich’s imposition of individual criminal liability for viola-

tions of the Federal Food, Drug and Cosmetie Act and advocates a

similar standard for environmental legislation. The article goes on

to describe the existing standard for vicarious liability as follows:

The general rule is that an official will net be criminally liable

for the acts of others within the corporation unless he partiei-

pates in the act or aids and abets the eriminal activity—3

Fletcher Cye. Corp. § 1348 (1965); State v. Flahe, 83 S.D.

655, 165 N.W. 2d 55 (1969); Clifton vy. State, 51 Del, 339,

145 A 2d 392 (1958) ; State v. Pincus, 41 N.J. Super. 454, 125

A 2d 420 (1956) : Hartson v. People, 125 Colo. 1, 240 P 2d 907

(1952). 37 ALeany L. Rev. 61, 70.

The general rule recommended in this Note is compatible with the

standard proposed by the Fourth Cireuit. United States v. Park,

499 F.2d 839. (4th Cir. 1974) See also Sayre, Criminal Responsi-

bility for Aets of Another, 43 Hany. L. Rev. 689, 702-704 (1930).

Sayre noted the importance of finding ‘‘causation’’ in those areas

where criminal liability was based on the acts of another:

‘*Viearious liability is a conception repugnant to every instinct

of the criminal jurist. It is not surprising, therefore, that courts

today as a general rule . . . make criminal liability exclusively

dependent upon causation. Causation may he proved either

(1) by authorization, procurement, incitation or moral encour-

agement, or (2) by knowledge plus acquiescence. Apart from

exceptional groups of cases... the law may be summarized as

follows :

(1) If the defendant can be shown himself to have coun-

seled, procured, commanded, incited, authorized, or en-

couraged the commission of the particular act which forms

the subject of the prosecution, al] courts agree in holding

him eriminally liable, even though the agent committed

the aet through a different instrumentality, or at a differ.

ent time, or in a different place from that ordered or

authorized.

(2) Where the defendant has neither authorized nor

consented to the partieular criminal aet, even though he

has authorized the general business in the course of which

ee ae Oe ore

Cite Rate ts 8 SB Ae ec ttn. Creesad eb bos

Court’s decision in Dotterweich and further developed

by Court of Appeals require a ‘responsible relation-

ship’? or causal connection between the wrongful act

and the individual charged under the Act.

The decision of the Court of Appeals correctly states

the law governing the vicarious liability of an indi-

vidual employee for violations of the Federal Food,

Drug and Cosmetic Act:

... For an accused individual to be convicted it

must be proved that he was in some way person-

ally responsible for the act constituting the crime.

United States v. Park, supra, 499 F.2d at 841.

The Fourth Circuit further concludes:

Upon a subsequent trial the jury should be in-

structed that a finding of guilt must be predicated

upon some wrongful action by Park. That action

may be gross negligence and inattention in dis-

charging his corporate duties and obligations or

any of a host of other acts of commission or

omission which would ‘‘cause’’ the contamination

of the food. United States v. Park, supra, 499 F.2d

at 842.

The Court of Appeals correctiy declared that, ‘‘. .. The

question of causation is to be distinguished from that

of intent.’’ United States v. Park, supra, 499 F.2d at

842, n.7.

the act was committed, the defendant may be civilly, but

is not, except as under (3), eriminally, liable.

(3) On the other hand, even if the particular criminal

act has not been authorized or consented to, if it grows

out of and is the proximate consequence of one that has

been authorized or procured, the defendant is criminally

liable, whether or not the agent is acting in the course of

the defendant's business.’’ Sayre, Criminal Responsibility

for Acts of Another, 43 Harv. L. Rev. 689, 702-704 (1930).

In holding that a supervisor’s wrongful action must

be causally related to a violation of the Federal Food,

Drug and Cosmetic Act, before an individual may be

held criminally responsible, the Fourth Circuit has

enunciated a legally sound standard to be applied to

cases involving ‘‘vicarious’’ liability. In the present

ease there is no allegation that Mr. Park counseled,

procured, commanded, incited, authorized or encour-

aged the commission of the particular acts which

forms the subject of the prosecution.’ If Park is to be

held vicariously liable, then it must be because his

conduct falls within the category of vicarious criminal

liability where:

‘*.. [E]ven if the particular criminal act has not

been authorized or consented to, if it grows out of

and is the proximate consequence of one that has

been authorized or procured, the defendant is

criminally liable ...’’°

The Fourth Cireuit concludes that ‘‘ gross negligence

and inattention”? are the kind of wrongful action upon

which vicarious liahility may be predicated ; thus, find-

ing supervisory employees responsible only for the

‘*proximate consequences”’ of their actions. United

States v. Park, supra, 499 F.2d at 842.

The standard of liability urged by the government

is based solely upon the supervisory position of the

defendant.” Tlowever, while the government sug-

gests that this is not the standard it is advocating,’

* See Sayre, Note 3, supra, at 702.

® See Sayre, Note 3, supra, at 703-704.

° This standard based on corporate office-holding comes very close

to the type of ‘‘status’’ offense held unconstitutional in California

v. Robinson, 370 U.S. 660, rehearing denied 371 U.S, 905 (1962).

***The majority of the Court of Appeals believed the government

to be arguing ‘that the conviction may be predicated solely upon a

RR te nnd ct nM alpen A oe

ls 4

the only additional element which the government ap-

parently views as a prerequisite for a conviction is

the existence of a violation on the part of the corporate

employer. The government apparently concedes that

an accused may demonstrate his lack of power and

responsibility as defense to alleged liability.*

The proper standard for determining the liability

of a supervisor must turn on his causal connection

to a wrongful act as enunciated by the Fourth Circuit.

The per se standard of guilt by position urged by the

government is contrary to law. The standard of crimi-

nal liability adopted by the Fourth Circuit, is correct

and should be affirmed.

III. THE DECISION OF THE FOURTH CIRCUIT WILL RE-

SULT IN MORE EFFECTIVE COMPLIANCE WITH THE

ACT BY ENCOURAGING GREATER NUMBERS OF IN-

DIVIDUALS TO BECOME INVOLVED IN SANITATION

ACTIVITIES.

The standard for imposition of criminal liability

established by the Court of Appeals will result in more

effective compliance with the Federal Food, Drug and

showing that the defendant, Park, was the President of the offend-

ing corporation’.’’ (Brief for Government at 11.)

* Brief for Government at 14. See, United States v. Wiesenfield

Warehouse Co., 376 U.S. 86, 91 (1964). See also, Morisette v. United

States, 342 U.S. 246 (1952), wherein Mr. Justice Jackson noted

the limited applicability of strict liability to publie welfare offenses.

Mr. Justice Jackson raises the implication that strict liability is

only appropriate where the accused has failed in a duty which he

could reasonably be expected to perform.

... The accused, if he does not will the violation, usually is in

a position to prevent it with no more care than society might

reasonably expect and no more exertion than it might reason-

ably exact from one who assumed his responsibilities. 342

U.S. at 256.

‘osmetie Act than will the standard urged by the gov-

ernment. Successful compliance with the Federal

Food, Drug and Cosmetic Act requires the extensive

and positive involvement of many individual em-

ployees. The standard announced by the Court of

Appeals is more likely to encourage such involvement

than the standard urged by the government, since it

provides an incentive for individual employees to

establish an affirmative record showing due care and

diligence in complying with the requirements of the

Act. The decision of the Court of Appeals will make

diligence a defense, while the standard of liability by

office urged by the government will make the mere

holding of corporate office a crime.

The net effect of the Court of Appeals decision is

to encourage individual employees and supervisors to

become involved with programs of compliance under

the Federal Food, Drug and Cosmetie Act. This exten-

sive involvement is particularly important in ecomply-

ing with the Act’s sanitation requirements since opti-

mal compliance entails complex activities which, in

most companies, cannot be handled by a single em-

ployee or even by a small group of employees. The

complexity of a good sanitation program is indieated

by the Voluntary Industry Sanitation Guidelines for

Food Distribution Centers and Warehouses.’ The

appendix to the Guidelines describes the commitment

of personnel necessary for an effective sanitation

program:

To ensure product wholesomeness and proper

sanitation, the food warehouse sanitation program

must have the commitment of top management,

must be implemented by operating supervision,

® Reprinted infra as Appendix A,

ia etic i ere Ee

and must be supported by the entire food ware-

house staff. Preventive sanitation—the perform-

ance of inspection, sanitation, building mainte-

nance, and pest control functions designed to pre-

vent insanitation in preference to correcting 1t—

should be an important goal of food warehouse

management and of food warehouse operations.

A program to ensure continued success in safe-

guarding the wholesomeness of food and in pro-

viding good sanitation will ordinarily include:

(1) An organizational chart showing chain of

authority and responsibility.

(2) A flow diagram of receiving, storage, and

shipping operations.

(3) Regular maintenance schedules.

(4) Regular sanitation programs.

(5) Regular pest control programs.

(6) An effective program of follow-up and con-

trol including reports to responsible executive

officer(s).’’ Appendix A, infra, at 15a-16a.

An effective sanitation program must utilize the

most modern techniques of management through qual-

ity control to systematically achieve product standards

and eliminate defects. Management through quality

control utilizes methodical inspection at various points

in the manufacturing or distribution process to pre-

vent defects and achieve higher quality standards

than are obtainable by direct visual product inspec-

tion.’®

©The genesis of quality control is described in J. HAGan, A

MANAGEMENT ROLE FoR QUALITY CoN'TROL, 62 (1968)

‘‘Quality control originated in inspection. So many defects

were originally found in delivered products that inspection

was established to sereen good products from bad at the end

Preventive techniques, utilizing up-to-date methods

of systematic quality control, are the best way to

assure compliance with federal sanitation stand-

ards. The Voluntary Industry Sanitation Guidelines

stress that ‘“‘preventive sanitation’ is preferable to

the correction of insanitation and recommend regular

maintenance schedules, sanitation programs and pest

control programs, together with effective follow-up

and reports to responsible executives. The manage-

ment of this type of recommended sanitation program

involves the coordination of a number of people. No

one individual can personally sweep every floor or bait

every rodent trap. The Court of Appeals by holding

each individual liable for his own performance en-

courages individuals to beeome involved in eompli-

ance programs knowing that their individual responsi-

a for preventive activities must be diligently pur-

sued.

The tasks of a manager have been defined by Peter

Drucker, a leading authority on management tech-

niques, to include: (1) setting objectives; (2) organiz-

ing to achieve those objectives; (3) motivating and

communicating with employees; and (4) measuring

the degree to which objectives are achieved and com-

municating those measurements to both subordinates

and superiors."' All of these tasks are involved in the

of the production line, thus enabling the company to maintain

an acceptable performance image and so continue to grow

productively, Before long, when it became obvions that the

rejected products represented an ever-inercasing cost, inspee-

tion was extended to include points within the manufacturing

process. This move was intended to prevent the manufacture

of defective articles and was the start of quality control.’’

* P. DrucKER, MANAGEMENT, 400 (1974).

en eae Cece ee ee ee eee

Sep tiecbadd tre sive

bt GI RE MRO OS ee

a a hs Se a4

management of a sanitation program. The objectives

of meeting or exceeding federal sanitation standards

are obvious. The organization necessary to achieve

the objectives may take many forms. In every case,

the success of that organization will depend upon the

following integral factors: first, management’s com-

munication of program objectives to employees;

second, employees’ communication of barriers pre-

venting the achievement of program objectives to

management; third, on-going measurement of com-

plianee progress.

Improved sanitation can only result from orderly

and systematic management utilizing the latest quality-

control techniques. The government, in describing

courses of action open to Mr. Park, advocates pro-

cedures which are disorganized and unsystematic.”

12«“There were a number of constructive actions [Mr. Park]

should have taken. With the list of observations before him, he

could have applied his own common sense to the situation and per-

sonally ordered corrective action. He could have, for instance,

demanded that the warehouse be completely emptied and cleaned,

that each lot of food be moved and checked thoroughly for rodents,

and that the structure be thoroughly checked to make sure that all

possible points of rodent entry be closed. Such measures are ele-

mentary methods of house cleaning.

‘“At the very best, respondent should have personally diseussed

with MeCahan the list of observations item by item and ascertained

precisely what MeCahan would do about cach. He could have de-

manded to know why the Baltimore facility had been allowed to

deteriorate to the point that it had. He could have attempted to

ascertain the amount of effort and money that would be necessary

to insure that the premises would be cleaned up properly and offered

McCahan whatever assistance was necessary. Any one or all of these

things would have impressed upon MeCahan the importance which

he attached to the situation. He could also have instructed the

appropriate corporate officials to utilize the resources necessary to

remedy the situation. Certainly respondent could have followed up

by ealling McCahan and other corporate officials who handled

sanitation problems to get personal briefings on the specifie correc-

Even if a company employee took all of the un-

coordinated measures suggested by the government,

he would still be subject to criminal prosecution solely

on the basis of his corporate position if any violative

condition remained,

The decision of the Court of Appeals will have a

salutary effect. Under that decision, an individual’s

failure to organize, communicate, or measure the suc-

cess of sanitation efforts may constitute evidence suffi-

cient to sustain a criminal conviction, while active

effor{s to improve sanitation will only create indi-

vidua! liability where such efforts causally contribute

to vioiations of the Act.

(nder the standard of liability by office urged by

ithe government, an individual employee who takes

part in communication and measurement of compli-

ance is subjeet to criminal prosecution if any part

of the eoeplianee system fails, even where the failure

occurs through no fault of the accused. This approach

would deter individual employees from involving

themselves in the communication and measurement

process, Which is necessary to achieve optimal sani-

jation standards. Orderly management requires the

tions being made. Indeed, given the fact that these same employees

had already failed twice in the recent past, respondent could have

retained a reputable outside consultant familiar with FDA require-

ments. Nor would it have been unreasonable for respondent to have

personally visited the Baltimore warehouse to see for himself what

progress, if any, was being made in correcting the situation. Final-

ly, he could have elosed the warehouse down unless and until he

was personally satisfied that it had, beyond any doubt, been cleaned

up. Given respondent's apathetic behavior, it is not surprising that

the necessary steps were not taken and that many of the conditions

went uneorrected until a criminal prosecution was instituted.”’

(Brief for Government at 54, n.19)

oft

ee ah

active involvement of large numbers of employees.

Active involvements is the government’s own professed

goal for the management of sanitation programs. Yet

the standard of liability urged by the government

would discourage involvement.

The Court of Appeals has correctly decided that the

government’s standard is not in accordance with

settled doctrines of law. The government’s standard

is inherently unjust because it fails to distinguish be-

tween the criminal liability of an employee who exer-

cises due care and diligence in carrying out his respon-

sibilities and one who does not. The sole determinant

of per se liability under the government’s standard

is whether any evidence of violation is discovered with-

in an accused’s formal scope of authority. No con-

sideration is given to whether the accused had a role

in causing that violation. Such an approach would

provide an incentive to place responsibility for com-

plying with the Federal Food, Drug and Cosmetic Act

on the fewest possible employees rather than making

such compliance an extensive, cooperative effort by

many employees.

Although the government’s policy of liability by

office for Food and Drug Act violations can only be

justified as a deterrent, there is no demonstration

that this standard has been successful in the past.”

The Court of Appeals’ decision, by requiring that

the government prove that an individual act, or gross

negligence, or inattention is causally related to the

*® See e.g., Comptroller General of the United States, Dimensions

of Insanitary Conditions in the Food Manufacturing Industry, Re-

port to Congress, No. B-164031(2) (Apr. 18, 1972).

violation, will encourage the greater involvement re-

quired for effective sanitation management. This po-

tential for improved compliance is in furtherance of

the Act’s objectives and compels affirmation of the

Court of Appeals’ decision.

CONCLUSION

Therefore, the decision of the United States of Ap-

peal for the Fourth Circuit should be affirmed.

Respectfully submitted:

JAMES F. RIL

Roperr A, CoLLier

Pump C. OLSSON

JoHN Harpin Younc

1666 K Street, N.W.

Washington, D.C. 20006

Attorneys for National Association

of Food Chains, Ine.

APPENDIX

APPENDIX A

VOLUNTARY

INDUSTRY SANITATION

GUIDELINES FOR

FOOD DISTRIBUTION

CENTERS AND

WAREHOUSES

1974

I. Foreworp

These guidelines were prepared for receiving, handling,

storage, and shipping of food and food products con-

tained in retail and/or shipping containers at food dis-

tribution centers and food warehouse establishments,

referred to as ‘‘food warehouses’’ throughout these guide-

lines. The term ‘‘food(s)’’ in these guidelines means foods

and food products which are contained in retail and/or

shipping containers, but includes items such as fresh

produce received unpackaged or in partially open packages,

which are subject to various specific additional portions

of the guidelines.

The purpose of these guidelines is to promote receiving,

handling, storage, and shipping of food and related items

at such establishments in a manner that will assure the

continued delivery of safe, sanitary, and wholesome foods

to consumers.

It is further intended that conscientious adherence to

the letter and spirit of these guidelines will not only

minimize the chance of noncompliance with applicable

governmental requirements for food sanitation, but will

improve and maintain the overall effectiveness and quality

of the practices by which foods are brought io the

American consumer.

In this context, it is essential that management, including

those directly responsible for any food warehousing

activity, make provision for persons empluyed in a food

handling capacity to receive the degree of training,

emphasis, and support commensurate with their job re-

sponsibilities and with ensuring the effective implementa-

tion of the provisions of this document.

These guidelines, of necessity, are neither exclusive nor

all inclusive; they are, however, intended to assist manage-

ment and food warehouse operators in developing and

maintaining facilities, methods, practices, and controls for

the receiving, handling, storage, and shipping of foods at

the food warehouse establishment in a manner that pro-

tects the public health.

They are designed to deal with exposed or otherwise

uncovered foods only to the extent that such foods are

exposed or uncovered during receiving, handling, storage,

and shipping in the food warehouse establishment.

They are not designed to cover food manufacturing,

processing, or packaging areas and related equipment,

practices, and procedures which are subject to regulations

and/or guidelines specifically developed for those types

of operations.

If food warehousing and food manufacturing, processing,

or packaging operations are maintained in the same

establishment, neither type of operation should interfere

with the compliance with any good sanitation practices,

guidelines, or regulations applicable to the other type or

types of operations.

Il. Bumprxnes anp Grounps

A. Maintain Grounds Around Warehouses in a

Sanitary Manner :

e Maintain the grounds around food warehouse buildings

under the control of the operator in a well-drained condi-

tion, and free from conditions likely to lead to contami-

nation of foods in the food warehouse, leaving the food

warehouse, or being delivered to the food warehouse.

¢ Keep grounds clean and free of discarded equipment,

lumber, litter, waste, refuse, and uncut weeds or grasses

within the immediate vicinity of the food warehouse which

may provide breeding places or harborages for rodents,

insects and other pests.

e Locate outside waste disposal containers on properly

drained areas, clean them as needed, and keep them covered

between use.

e Maintain and surface driveways, truck aprons, and

rail sidings at receiving and shipping areas and parking

areas to facilitate good drainage and to minimize dust and

dirt being blown or tracked into the food warehouse.

Maintain them in a clean, well-drained condition.

e If the food warehouse buildings are closely bordered

by grounds not under the operator’s control, exercise

special care in the food warehouse, by inspection, extermi-

nation, or other means, to exclude and control pests, dirt,

and other potential contaminants originating from such

non-controlled grounds,

B. Maintain and Operate Food Warehouse Buildings

and Structures ina Sanitary Manner:

e Provide floors and interior walls which are adequately

cleanable and keep them clean and in good repair.

e Suspend fixtures, ducts, and pipes which are over

working areas so as to prevent drip or condensate from

contaminating food or food packages.

e Maintain adequate separation by location or other

effective means for those operations which may cause con-

tamination of foods with undesirable chemicals, filth, or

other extraneous material.

e Provide adequate lighting to areas where food is

received, stored, held or assembled for delivery, in order

to facilitate handling, processing, and examination of mer-

chandise and to permit adequate inspection, clean-up, and

repair of the buildings and their structures.

¢ Provide adequate lighting in hand washing areas,

dressing and locker rooms (if present), and toilet rooms.

¢ Employ appropriate special efforts to maintain sani-

tation whenever necessitated by unique features of

structure or design.

e Ina food warehouse utilizing light bulbs, light fixtures,

skylights or other glass over exposed food, such as produce

items in mesh bags, ete., use safety type bulbs or shielded

fixtures to prevent food contamination in ease of breakage.

Ill. Fixtures anp EqQuirpMENT

e Provide food warchouse equipment which is suitable

as used and maintained, and is of design, material, and

workmanship which permits it to be adequately cleaned

and properly maintained by the methods used at the

establishment.

e Use and maintain the equipment so as to prevent the

adulteration of foods with lubricants, fuel, metal fragments,

contaminated water, or any other contaminants.

e Install and maintain equipment in a manner which

will facilitate its cleaning and the cleaning of adjacent

spaces.

TV. Sanitary Factuitres

Provide the food warehouse with adequate sanitary

facilities and accommodations:

A. Water Supply:

e From an adequate source, provide a water supply

which is sufficient for the food warehouse operations.

B. Sewage:

e Dispose of sewage into an adequate sewerage system

or through other appropriate means.

C. Plumbing:

e Install and maintain plumbing of adequate capacity

and design and in accordance with applicable governmental

sanitation requirements, if any, so as to provide sufficient

quantities of water to required locations throughout the

food warehouse, and to properly convey sewage and

liquid disposable waste from the food warehouse.

D. Toilet Facilities:

e Provide toilet facilities which are adequate, kept in

good repair, conveniently located, well-ventilated, and in

compliance with applicable governmental sanitation re-

quirements, if any.

¢ Provide them with self-closing doors and with walls,

ceilings, and floors which are tight fitting and of a material

which ean be easily cleaned and kept in good repair; and

maintain them in a clean condition.

s Furnish toilet rooms with toilet tissue, and post signs

instructing employees to wash their hands with soap or

detergent before returning to work.

e If toilet rooms are located near areas in the food ware-

house where exposed foods, such as produce items in mesh

bags, might be subjected to airborne contamination, pro-

vide them with self-closing doors which do not open directly

into such areas.

E. Hand Washing Facilities:

° Provide adequate hand washing facilities in the toilet

rooms or in places convenient to the toilet rooms for hand

washing after use of the toilets.

¢ Furnish such facilities with hot and cold running

water, hand-cleansing soaps or detergents, sanitary towels,

or other suitable drying devices.

e Provide adequate receptacles, with covers, for disposal

of hand-drying articles or waste material.

e Maintain the washing facilities and the surrounding

areas in a clean condition.

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F. Dressing and Locker Areas:

e If dressing and locker areas are present, provide them

with adequate ventilation and lighting, and maintain them

in a clean and orderly condition.

e If lockers are present, provide them with sufficient

ventilation to keep them dry fer the retardation of mold

and odors and maintain them in a clean condition, free from

trash, food seraps, or litter which serve as insect or rodent

attractants. Keep the tops of such lockers clean, and do

not use them as surfaces for the storage of materials.

G. Eating Areas:

e If there are eating areas in the food warehouse, en-

close them adequately or locate them in areas away from

operations. Provide adequate space, light, and ventilation

in such areas. Clean eating areas regularly, and provide

them with a sufficient number of covered receptacles for

disposal of meal trash. Clean such trash receptacles regu-

larly and do not permit them to become insect or rodent

attractants.

e Clean and inspect vending machines and surrounding

areas at regular and frequent intervals to detect and cor-

rect conditions of insanitation which may exist in or around

such machines.

e If drinking fountains are provided, locate them con

veniently and clean them regularly.

V. Sanrrary OPERATIONS

A. Keep Buildings and Equipment Sanitary:

e Maintain buildings, fixtures, equipment, and other

physical facilities of the food warehouse in good repair

and in a sanitary condition.

e Conduct cleaning operations in such a manner as to

minimize the danger of contamination. For cleaning and

sanitizing procedures, utilize detergents, sanitizers and

other supplies which are safe and effective for their in-

tended uses.

e Exclusive of packaged products held for distribution,

store and use in the food warehouse only such toxic mater-

ials as are required for necessary activities, such as for

maintaining sanitary and pest free conditions, for use in

laboratory testing procedures, or for food warehouse and

equipment maintenance and operation. Identify and use

such products only in such manner and under such condi-

tions as will be safe for the intended use.

e Use pesticides only under such precautions and re-

strictions as will prevent the contamination of food and

food packaging materials.

B. Rubbish:

e Convey, store, and dispose of rubbish in a manner

which will minimize the development of odor, prevent

waste from becoming an attractant and harborage or

breeding place for vermin, and prevent contamination of

warehoused food, food containers, ground surfaces, and

water supplies.

C. Pest Control Programs:

e Establish and maintain positive control programs de-

signed to exclude and eliminate pests from the food ware-

house and to deny them harborage, in order to protect

against the contamination of foods in or on the premises

by animals, birds, and vermin (including, but not limited

to, rodents and insects).

e Keep trained security dogs out of actual storage areas

to avoid excreta contamination of foods stored at floor

level. Keep cats out of the food warehouse.

e Implement these programs as an integral part of the

construction, maintenance, operational, and personnel

programs described elsewhere in the guidelines.

VI. Procepures anp ConTROLs

Conduct operations in the receiving, inspecting, trans-

porting, handling, segregating, recouping, and storing of

foods in accordance with appropriate sanitation principles.

Implement overall sanitation under the supervision of an

individual assigned responsibility for this function.

Take reasonable precautions, including the following, to

assure that food warehouse procedures do not contribute

to contamination of foods by harmful chemicals, objection-

able odors, or other objectionable materials.

A. Incoming Product Shipments:

The integrity of the food warehouse sanitation pro-

gram requires that the materials, including foods and their

packaging, which are received into the warehouse do not

expose the food warehouse to contamination by reason of

infestation by insects, birds, rodents, or other vermin, or

by introduction of filth or other contaminants. It is often

useful, when practicable, to work with suppliers and ship-

pers in advance to establish guidelines for acceptance, re-

jection, and where appropriate, reconditioning of particular

product, taking into consideration factors such as the na-

ture, method of shipment, and ownership of the product,

in order to facilitate the effective implementation of these

programs.

1. Within a reasonable time after the arrival of a car

or truck, and before product is unloaded, the product

should be inspected to the extent permitted by the loading

of the vehicle for evidence of damage or of insect or rodent

infestation, objectionable odor, or other form of contamin-

ation.

Where an adequate inspection has not been possible

prior to unloading, further inspect such product during and

immediately after unloading.

10a

2. If damaged product has been accepted, keep it sepa

rate from other product, and recondition or otherwise

handle it as necesary in a manner which will not expose

foods or the food warehouse to contamination or infesta-

tion.

3. If the inspection reveals evidence of infestation or

contamination:

e Determine whether the condition is only ‘‘suspect,’’

or is superficial (such as surface infestation of flying in-

sects which may be on, but have not penetrated, soiled, or

compromised the integrity of the packaging) and might be

fully correctable by fumigation or other means,

e In each such case, remove the product from the food

warehouse area, utilizing the vehicle in which it arrived, if

feasible, after closing and sealing it.

* In case of contamination, if rejection is appropriate

(based on the origin and ownership of the product),

promptly notify the carrier and shipper of the time, place,

and circumstances of the rejection.

e After removal from the food warehouse because of

suspect and/or superficial conditions, concentrated efforts

can be made to further evaluate the actual condition of

the product, and to recondition it, when possible.

4. Give special attention to product which has prev-

iously been rejected, or has otherwise been removed from

the focd warehouse because of suspect and/or superficial

conditions, when it is subsequently received again, to assure

that the product and packaging are fully acceptable on

reinspection.

5. In the event of serious question, or of failure to

agree with the shipper or carrier, as appropriate, as to

condition or reconditioning, consider requesting eval ation

of the suspect or rejected product by appropriate federal,

state, or local authorities.

lla

B. Store Product Properly:

e Place foods received into the food warehouse for

handling or storage in a manner which will facilitate clean-

ing and the implementation of insect, rodent, and other

sanitary controls and will maintain product wholesomeness.

C. Proper Stock Rotation:

¢ Adopt and implement effective procedures to provide

stock rotation appropriate to the particular food.

D. Contaminated or Damaged Foods:

e Unless promptly and adequately repaired or cor-

rected at or near the point of detection, promptly sevarate

foods which are identified as being damaged or are other-

wise suspect from other foods for further inspection,

sorting, and disposition.

e Promptly destroy or remove from the food warehouse

product determined to present a hazard of contamination to

foods in the food warehouse.

E. Hazardous Non-Food Products:

e Handle and store non-food products which present

hazards of contamination to foods stored in the same food

warehouse by reason of undesirable odors, toxicity of con-

tents, or otherwise, in a manner which will keep them from

contaminating the foods.

¢ Take special measures to safeguard from damage and

infestation those foods which are particularly susceptible

to such risks.

F. Avoid Damage to Packaging:

e Exercise care in moving, handing and storing product

to avoid damage to packaging which would affect the

contents of food packages, would cause spillage, or would

l2a

otherwise contribute to the creation of insanitary

conditions.

G. Shipping:

e Prior to loading with foods, inspect rail car and truck

and trailer interiors for general cleanliness and for freedom

from moisture; from foreign materials which would cause

product contamination (such as broken glass, oil, toxic

chemicals, ete.) or damage to packaging and contents

(such as boards, nails, harmful protrusions, ete.) ; and from

wall, floor, or ceiling defects that could contribute to

insanitary conditions,

e Clean, repair, or reject them as necessary to protect

foods before loading.

e Exercise care in loading foods to avoid spillage or

damage to packaging and contents,

e Maintain docks, rail sidings, truck bays, and driveways

free from accumulations of debris and spillage.

H. Warehouse Temperatures:

e Maintain warehouse temperatures (particularly for

refrigerated and frozen food storage areas) which are in

compliance with applicable governmental temperature

requirements, if any, for maintaining the wholesomeness

of the particular foods received and held in such areas.

I. Housekeeping, Sanitation and Inspection:

e Establish a regularly scheduled program of general

housekeeping, sanitation, and inspection to maintain

floors, walls, fixtures, equipment, and other physical

facilities in a state of sanitation sufficient to protect foods

from contamination or adulteration, and to prevent waste

from becoming an attractant and harborage or breeding

place for vermin.

e In addition, develop and implemen an effective pro-

gram and procedure for timely cleanup of any debris and

spillage resulting from accidents or other unscheduled

occurrences.

ere S TS Se ~~

si i eer VN

13a

J. Pest Control Measures:

e Implement pest control measures designed to prevent

the entrance of pests, to deny them harborage, and to

detect and eliminate them, with such schedules, instruc-

tions, and procedures, and by such trained and qualified

personnel or professional representatives as may be nee-

essary, based on the nature of the foods and other products

handled, the structure and condition of the building and

equipment, and the surroundings and environment of the

warehouse.

e Monitor traps and bait stations, whether inside or

outside of buildings, on a regular basis. Use covered

interior bait stations designed, located, or protected to

prevent spillage. Where appropriate, use bait stations

constructed of moistureproof material.

K. Pesticides:

e Use only pesticides with labels showing USDA or

EPA registration numbers, and only for the uses specified

in the labeling.

e Have them applied only by responsible personnel in

accordance with the manufacturer’s labeling instructions

and in a manner which prevents contamination of foods.

While not in use, clearly mark and store pesticides in a

secure place apart from foods.

L. Audit Food Warchouse Sanitation Programs:

e Establish programs internally and/or through outside

consultants for effectively auditing the food warehouse

sanitation program.

VII. Personne.

A. Employee Practices:

¢ Prohibit employees affected by disease in a communi-

cable form, while carriers of such disease, or while afflicted

with boils, sores, infected wounds, or other abnormal

l4a

sources of bacteria! infection, from working in the tood

warehouse in capacities in which there is a likelihood of

food becoming contaminated, or of disease being transmitted

to other persons,

e Prohibit clothing or other personal belongings from

being stored and food and beverages from being consumed

and tobacco from being used in areas where foods are

handled or stored.

e Instruct employees who are working in direct contact

with exposed or partially exposed foods, such as produce

items in mesh bags, ete., to maintain personal cleanliness

and to conform to hygienic practices to avoid contamination

of such foods with microorganisms or foreign substances

such as human hair, perspiration, cosmetics, tobacco,

chemicals, and medicants and, if gloves are used in

handling such foods, to use only gloves which are of an

impermeable material in handling such foods, and to

maintain them in a clean and sanitary condition.

B. Management Responsibilities:

e Assign responsibility for the overall food warehouse

sanitation program and authority commensurate with this

responsibility to persons who, by education, training, and/

or experience are able to identify sanitation risks and

failures and food contamination hazards.

e Instruct employees in the sanitation and hygienic

practices appropriate to their duties and the locations of

their work assignments within the food warehouse. In-

struct employees to report observations of infestations

(such as evidence of rodents, insects or harborages) or

construction defects permitting entry or harborage of

pests, or other developments of insanitary conditions.

e Exercise programs of follow-up and control to ensure

that your employees, consultants, and outside services are

doing their jobs effectively.

Pe ee es

et 0 SURE ere

l5a

APPENDIX

This appendix to the Voluntary Industry Sanitation

Guidelines for Food Distribution Centers and Warehouses

has been prepared to assist the food warehouse operator in

implementation of Sections (I) through (VII) of the

Guidelines. Information in this appendix will require

adaptation for specific application to your operations.

Since no single document can provide all the information

necessary for every situation or specify the only methods

for compliance, develop your own appendix or company

guidelines to reflect your individual applications in the

general areas dealt with in the Guidelines and this ap-

pendix.

I. Foreworp

To ensure product wholesomeness and proper sanitation,

the food warehouse sanitation program must have the

commitment of top management, must be implemented by

operating supervision, and must be supported by the en-

tire food warehouse staff. Preventive sanitation—the per-

formance of inspection, sanitation, building maintenance,

and pest control functions designed to prevent insanita-

tion in preference to correcting it—should be an important

goal of food warehouse management and of food ware-

house operations.

II. Orcanization aNp Procrams

A program to ensure continued success in safeguarding

the wholesomeness of food and in providing good sanita-

tion will ordinarily include:

1. An organizational chart showing chain of authority

and responsibility.

2. A flow diagram of receiving, storage, and shipping

operations,

l6a

3. Regular maintenance schedules.

4. Regular sanitation programs.

5. Regular pest control programs.

6. An effective program of follow-up and control in-

cluding reports to responsible executive officer(s).

IIL. Cuecx Porsts anp AppiTrionaL GUIDES

1. Grounds:

e Keep nearby grounds free of liquid or solid emissions

that could be sources of contamination.

e Prevent grounds from providing conditions for insect

or rodent harborage.

e Check paving, drainage, weed, and litter control regu-

larly.

e Stack materials which are stored in the open neatly and

away from buildings, and on racks above ground level

where feasible.

e ‘‘No-vegetation strips’? around exterior building

walls and at property lines adjacent to properties con

taining potential harborages are helpful for discovering

and discouraging travel by rodents.

2. Buildings:

e Provide separate and sufficient space for placement of

equipment and storage of materials necessary for proper

operations,

e Separate activities that might cause contamination of

stored foods with chemicals, filth, or other harmful ma-

terial.

e Check structural conditions, pest barriers, repair of

windows, screens, and doors continuously.

—- _ re

rn et |

oe ee ee eee

seit Cie ia HN i i i im) a 2 a A atk cle Re

17a

e Seal and clean floor wall junctions and fill holes and

cracks; a painted inspection strip is also recommended.

e Keep offices—including overhead offices—in the food

warehouse clean, and do not permit them to become attract-

ants or harborages for insects or vermin. Include them in

the pest control program.

e Check false ceilings for harborage of insects and

possibly rodents.

e Give basements, attics, elevators, and rail sidings, ete.,

special attention.

3. Sanitary Operations:

e Keep walls, ceilings and rafters free of soil, insect

webbing, mold, and similar materials.

e Do not leave unscreened doors and windows open un-

necessarily.

e Do not permit dust to accumulate.

e Keep floors free of product spillage, oil drippage, and

buildup in all areas.

e Provide proper trash and refuse storage and removal.

e Store tools and equipment properly.

e Clean and flush drains regularly.

¢ Maintain railroad and truck courts free of debris, and

properly patrol them for pest control.

e Keep eating and break areas, locker rooms, ete. clean

and orderly. Vending machines are often overlooked:

keep them and the areas adjacent to them clean and

sanitary. Maintain equipment in a properly functioning

condition and do not permit it to serve as a source of

sanitation or harborage problems.

18a

4. Receiving and Inspection:

e Inspect the materials which are being received for

evidence of damage; insect, bird, rodent, or other vermin

infestation; and moisture, odor, or chemical contamination.

e Exclude contaminated materials, including product,

pallets, and slip sheets, from the building.

e If damaged merchandise is accepted, segregate it for

special handling.

e Make sure that incoming and outgoing vehicles are

free of conditions that could contaminate product—no

birds, rodents, insects, spillage, or objectionable odor

should be evident.

e Code or mark foods received at the receiving point to

ensure proper stock rotation.

e To facilitate handling of rejected and suspect pro-

duct, it is often a good idea to develop procedures with in-

dividual shippers, carriers, and/or manufacturers for re-

inspections, returns, ete.

5. Storage:

e Store products in an orderly manner and so that date

codes are visible for proper rotation.

e Generally, it is desirable to stack foods on pallets or

racks (or on slip sheets, where a clamp truck operation is

utilized), and away from walls so as to allow for inspec-

tion aisles between stacks and walls. Painting inspection

aisles in a light color is often helpful in maintaining their

effectiveness. Where full inspection aisles are not pro-

vided, take special care (such as more frequent inspection,

rotation, and removal of product for cleaning) to ensure

sanitary, pest free conditions.

e Separate bagged and baled foods to provide visibility

between stacks.

’

19a

e Dispose of contaminated or infested merchandise, or

otherwise remove it from the food warehouse promptly.

e Promptly remove damaged merchandise and broken

containers from general food storage areas, Handle and

process salvageable merchandise separately in an area

isolated from general food storage; this area probably will

require extra sanitation and pest control attention.

e If salvage operations include the repackaging or other

manipulation of exposed foods (other than items such as

fresh produce received unpackaged or in partially open

packages), conduct such operations in compliance with the

food sanitation practices, guidelines, or regulations, such

as 21 CFR 128, which are applicable to handling exposed

foods,

e Do not intermingle chemicals, including pesticides, with

food or food products. Such products are best separated

by an aisleway.

6. Pest Control:

e Maintain written schedules, log activity, and monitor

traps and bait stations regularly.

e Use covered bait stations which are of such types and

so located as to reduce the danger of spoilage; and where

appropriate, use moisture-proof bait stations.

e Keep the pesticides which are used in the food ware-

house securely, and separate from foods. Permit their

use only by properly trained personnel. Use only types

registered and approved by an appropriate government

agency for the intended use.

e Check especially for:

e rodent burrows in nearby grounds,

e activity at floor wall junctions and doorways, and

20a

e insect crawl marks in dust accumulation, especially

on overhead pipes, beams, window sills, around

flour, sugar, and pet food storage.

e Where feasible, seal load levelers at docks to prevent

trash accumulations and rodent harborage and entry; and

clean them frequently.

e Look for insect activity in folds of bagged foods.

e Use black light, supplemented with means for dis-

tinguishing other chemicals that fluoresce, to check for

rodent urine stains; and use flashlights to check for other

evidence of contamination.

7. Shipping:

e Make sure that transportation equipment into which

food warehouse food is loaded is maintained in a sanitary

condition comparable to that of the food warehouse.

e Make sure that rail cars, trailers and trucks ... are

free of birds, rodents and insects or contamination from

them,

. are free of odors, nails, splinters, oil, and grease,

. are free of accumulations of dirt or dunnage, and

. are in good repair and have no holes, cracks, or

crevices that could provide entrances or harborages for

pests.

8. Follow-Up:

8 Exercise programs of follow-up and control to ensure

that your employees, consultants, and outside services are

doing their jobs effectively.

Li ltl lace

2la

Reprint oF Parr 128, Tire 21 or Feperat ReGuLations

Part 128—IIuman Foops; Current Gioop MANUFACTURING

Practice (SaNitaTIoN) IN MANUFACTURE, PROCESSING,

Or Howprne

See.

128.1 Definitions.

128.2 Current good manufacturing practice (sanitation).

128.3 Plant and grounds,

128.4 Equipment and utensils.

128.5 Sanitary facilities and controls.

128.6 Sanitary operations.

128.7, Processes and controls.

128.8 Personnel.

128.9 Exclusions.

128.10 Natural or unavoidable defects in food for

human use that present no health hazard.

Avtnority: The provisions of this Part 128 issued under

sees. 402(a)(4), 701(a), 52 Stat. 1046, 1055; 21 U.S.C.

342(a)(4), 371(a) unless otherwise noted.

Source: The provisions of this Part 128 appear at 34

FR 6977, Apr. 26, 1969, unless otherwise noted.

§ 128.1 Definitions.

The definitions and interpretations contained in section

201 of the Federal Food, Drug, and Cosmetic Act are

applicable to such terms when used in this part. The fol-

lowing definitions shall also apply:

(a ‘‘ Adequate’’ means that which is needed to accomplish

the intended purpose in keeping with good public health

practice.

(b) ‘*Plant’’? means the building or buildings or parts

thereof, used for or in connection with the manufacturing,

processing, packaging, labeling, or holding of human food.

22a

by a process that is effective in destroying vegetative cells

of pathogenic bacteria and in substantially reducing other

micro-organisms. Such treatment shall not adversely

affect the product and shall be safe for the consumer.

§ 128.2 Current good manufacturing practice (sanitation).

The criteria in §$128.3 through 128.8 shall apply in

determining whether the facilities, methods, practices, and

controls used in the manufacture, processing, packing, or

holding food are in conformance with or are operated or

administered in conformity with good manufacturing

practices to assure that food for human consumption is

safe and has been prepared, packed, and held under sani-

tary conditions.

§ 128.3 Plant and grounds.

(a) Grounds. The grounds about a food plant under the

control of the operator shall be free from conditions which

may result in the contamination of food including, but not

limited to, the following:

(1) Improperly stored equipment, litter, waste, refuse,

and uncut weeds or grass within the immediate vicinity of

the plant buildings or structures that may constitute an

attractant, breeding place, or harborage for rodents, in-

sects, and other pests.

(2) Exeessively dusty roads, yards, or parking lots

that may constitute a source of contamination in areas

where food is exposed.

(3) Inadequately drained areas that may contribute

contamination to food products through seepage or foot-

borne filth and by providing a breeding place for insects

or micro-organisms.

If the plant grounds are bordered by grounds not under

the operator’s control of the kind described in subpara-

23a

graphs (1) through (3) of this paragraph, care must be

exercised in the plant by inspection, extermination, or other

means to effect exclusion of pests, dirt, and other filth that

may be a source of food contamination.

(b) Plant construction and design. Plant buildings

and structures shall be suitable in size, construction, and

design to facilitate maintenance and sanitary operations

for food-processing purposes. The plant and facilities

shall:

(1) Provide sufficient space for such placement of

equipment and storage of materials as is necessary for

sanitary operations and production of safe food. Floors,

walls, and ceilings in the plant shall be of such construction

as to be adequately cleanable and shall be kept clean and

in good repair. Fixtures, ducts, and pipes shall not be

so suspended over working areas that drip or condensate

may contaminate foods, raw materials, or food-contact sur-

faces. Aisles or working spaces between equipment and

between equipment and walls shall be unobstructed and of

sufficient width to permit employees to perform their duties

without contaminaton of food or food-contact surfaces with

clothing or personal contact.

(2) Provide separation by partition, location, or other

effective means for those operations which may cause

contamination of food products with undesirable micro-

organisms, chemicals, filth, or other extraneous material.

(3) Provide adequate lighting to hand-washing areas,

dressing and locker rooms, and toilet rooms and to all

areas where food or food ingredients are examined, proc-

essed, or stored and where equipment and utensils are

cleaned. Light bulbs, fixtures, skylights, or other glass

suspended over exposed food in any step of preparation

shall be of the safety type or otherwise protected to

prevent food contamination in case of breakage.

24a

(4) Provide adequate ventilation or control equipment

to minimize odors and noxious fumes or vapors (including

steam) in areas where they may contaminate food. Such

ventilation or control equipment shall not create conditions

that may contribute to food contamination by airborne

contaminants.

(5) Provide, where necessary, effective screening or

other protection against birds, animals, and vermin

(including, but not limited to, insects and rodents)

§ 128.4 Equipment and utensils.

(a) General. All plant equipment and utensils should

be (1) suitable for their intended use, (2) so designed and

of such material and workmanship as to be adequately

eleanable, and (3) properly maintained. The design,

construction, and use of such equipment and utensils shall

preclude the adulteration of food with lubricants, fuel,

metal fragments, contaminated water, or any other con-

taminants. All equipment should be so installed and

maintained as to facilitate the cleaning of the equipment

and of all adjacent spaces.

(b) Use of polychlorinated biphenyls in food plants.

Polychlorinated biphenyls (PCB’s) represent a class of

toxie industrial chemicals manufactured and sold under a

variety of trade names, including: Aroclor (United States) ;

Phenoclor (France); Colphen (Germany); and Kanaclor

(Japan). PCB’s are highly stable, heat resistant, and

non-flammable chemicals. Industrial uses of PCB’s in-

elude, or did include in the past, their use as electrical

transformer and capacitor fluids, heat transfer fluids,

hydraulic fluids, and plasticizers, and in formulations of

lubricants, coatings, and inks. Their unique physical and

chemical properties and widespread, uncontrolled industrial

applications have caused PCB’s to be a persistent and

ubiquitous contaminant in the environment and causing

the contamination of certain foods. In addition, incidents

25a

have occurred in which PCB’s have directly contaminated

animal feeds as a result of industrial accidents (leakage

or spillage of PCB fluids from plant equipment). These

accidents in turn cause the contamination of food intended

for human consumption (meat, milk, and eggs). Since

PCB’s are toxic chemicals, the PCB contamination of food

as a result of these accidents represents a hazard to human

health. It is therefore necessary to place certain re-

strictions on the industrial uses of PCB’s in the production,

handling, and storage of food. The following special pro-

visions are necessary to preclude accidental PCB contami-

nation of food:

(1) New equipment, utensils, and machinery for hand-

ling or processing food in or around a food plant shall not

contain PCB’s,

(2) On or before September 4, 1973, the management

of food plants shall:

(i) Have the heat exchange fluid used in existing

equipment or machinery for handling or processing food

sampled and tested to determine whether it contains PCB’s,

or verify the absence of PCB’s in such formulations by

other appropriate means. On or before Sept. 4, 1973, any

such fluid formulated with PCB’s must be replaced with a

heat exchange fluid that does not include PCB’s.

(ii) Eliminate from the food plant any PCB-containing

food-contact surfaces of equipment or utensils and any

PCB-containing lubricants for equipment or machinery

that is used for handling or processing food.

(iii) Eliminate from the food plant any other PCB-

containing materials wherever there is a reasonable ex-

pectation that such materials could cause food to become

contaminated with PCB’s either as a result of normal use

or as a result of accident, breakage, or other mishap.

(iv) The toxicity and other characteristics of fluids

selected as PCB replacements must be adequately de-

26a

termined so that the least potentially hazardous replace-

ment is used. In making this determination with respect

to a given fluid, consideration should be given to (a) its

toxicity; (6) the maximum quantity that could be spilled

onto a given quantity of food before it would be noticed,

taking into account its color and odor; (¢) possible signal-

ing devices in the equipment to indicate a loss of fluid,

ete.; and (7) its environmental stability and tendency to

survive and be concentrated through the food chain. The

judgment as to whether a replacement fluid is sufficiently

non-hazardous is to be made on an individual installation

and operation basis.

(3) For the purposes of this section, the provisions do

not apply to electrical transformers and condensers con-

taining PCB’s in sealed containers.

(38 rr 18012, July 6, 1973]

§ 128.5 Sanitary facilities and controls.

Fach plant shall be equipped with adequate sanitary fa-

cilities and accommodations including, but not limited to,

the following:

(a) Water supply. The water supply shall be sufficient

for the operations intended and shall be derived from an

adequate source, Any water that contacts foods or food-

contact surfaces shall be safe and of adequate sanitary

quality. Running water at a suitable temperature and un-

der pressure as needed shall be provided in all areas where

the processing of food, the cleaning of equipment utensils,

or containers, or employee sanitary facilities require.

(b) Sewage disposal. Sewage disposal shall be made

into an adequate sewerage system or disposed of through

other adequate means.

design and adequately installed and maintained to:

27a

(1) Carry sufficient quantities of water to required

locations throughout the plant.

(2) Properly convey sewage and liquid disposable

waste from the plant.

(3) Not constitute a source of contamination to foods,

food products or ingredients, water supplies, equipment or

utensils or create an insanitary condition.

(4) Provide adequate floor drainage in all areas where

floors are subject to flood-type cleaning or where normal

operations release or discharge water or other liquid waste

on the floor.

(d) Toilet facilities. Each plant shall provide its em-

ployees with adequate toilet and associated hand-washing

facilities within the plant. Toilet rooms shall be furnished

with toilet tissue. The facilities shall be maintained in a

sanitary condition and kept in good repair at all times.

Doors to toilet rooms shall be self-closing and shall not open

directly into areas where food is exposed to airborne con-

tamination, except where alternate means have been taken

to prevent such contamination (such as double doors, posi-

tive air-flow systems, ete.). Signs shall be posted directing

employees to wash their hands with cleaning soap or de-

tergents after using toilet.

(e) Hand-washing facilities. Adequate and convenient

facilities for hand washing and, where appropriate, hand

sanitizing shall be provided at each location in the plant

where good sanitary practices require employees to wash or

sanitize and dry their hands. Such facilities shall be

furnished with running water at a suitable temperature for

hand washing, effective hand-cleaning and sanitizing pre-

parations, sanitary towel service or suitable drying devices,

and, where appropriate, easily cleanable waste receptacles.

(f) Rubbish and offal disposal. Rubbish and any offal

shall be so conveyed, stored, and disposed of as to minimize

the development of odor, prevent waste from becoming an

28a

attractant and harborage or breeding place for vermin,

and prevent contamination of food, food-contact surfaces,

ground surfaces, and water supplies.

§ 128.6 Sanitary operations.

(a) General maintenance. Buildings, fixtures, and other

physical facilities of the plant shall be kept in good repair

and shall be maintained in a sanitary condition. Cleaning

operations shall be conducted in such a manner as to min-

imize the danger of contamination of food and food-contact

surfaces. Detergents, sanitizers, and other supplies em-

ployed in cleaning and sanitizing procedures shall be free

of significant microbiological contamination and shall be

safe and effective for their intended uses. Only such toxie

materials as are required to maintain sanitary conditions,

for use in laboratory testing procedures, for plant and

equipment maintenance and operation, or in manuracturing

or processing operations shall be used or stored in the

plant. These materials shall be identified and used only in

such manner and under conditions as will be safe for their

intended uses.

(b) Animal and vermin control. No animals or birds,

other than those essential as raw material, shall be al-

lowed in any area of a food plant. Effective measures shall

be taken to exclude pests from the processing areas and to

protect against the contamination of foods in or on the

premises by animals, birds, and vermin (including, but not

limited to, rodents and insects). The use of insecticides or

rodenticides is permitted only under such precautions and

restrictions as will prevent the contamination of food or

packaging materials with illegal residues.

and product-contact surfaces of equipment shall be cleaned

as frequently as necessary to prevent contamination of food

and food products. Nonproduect contact surfaces of equip-

ment used in the operation of food plants should be cleaned

as frequently as necessary to minimize accumulation of

29a

dust, dirt, food particles, and other debris. Single-service

articles (such as utensils intended for one-time use, paper

cups, paper towels, ete.) should be stored in appropriate

containers and handled, dispensed, used, and disposed of

in a manner that prevents contamination of food or food-

contact surfaces. Where necessary to prevent the introduc-

tion of undesirable microbiological organisms into food

products, all utensils and product-contact surfaces of equip-

ment used in the plant shall be cleaned and sanitized prior

to such use and following any interruption during which

such utensils and contact surfaces may have become con-

taminated. Where such equipment and utensils are used

in a continuous production operation, the contact surfaces

of such equipment and utensils shall be cleaned and sani-

tized on a predetermined schedule using adequate methods

for cleaning and sanitizing. Sanitizing agents shall be ef-

fective and safe under conditions of use. Any facility, pro-

cedure, machine, or device may be acceptable for cleaning

and sanitizing equipment and utensils if it is established

that such facility, procedure, machine, or device will rou-

tinely render equipment and utensils clean and provide

adequate sanitizing treatment.

(d) Storage and handling of cleaned portable equip-

ment and utensils. Cleaned and sanitized portable equip-

ment and utensils with product-contact surfaces should

be stored in such a location and manner that product-con-

tact surfaces are protected from splash, dust, and other

contamination.

§ 128.7 Processes and controls.

All operations in the receiving, inspecting, transporting,

packaging, segregating, preparing, processing, and storing

of food shall be conducted in accord with adequate sani-

tation principles. Overall sanitation of the plant shall be

under the supervision of ‘an individual assigned responsi-

bility for this function. All reasonable precautions, in-

cluding the following, shall be taken to assure that produc-

30a

tion procedures do not contribute contamination such as

filth, harmful chemicals, undesirable micro-organisms, or

any other objectionable material to the processed product:

(a) Raw material and ingredients shall be inspected

and segregated as necessary to assure that they are clean,

wholesome, and fit for processing into human food and shall

be stored under conditions that will protect against con-

tamination and minimize deterioration. Raw materials

shall be washed or cleaned as required to remove soil or

other contamination. Water used for washing, rinsing,

or conveying of food products shall be of adequate quality,

and water shall not be reused for washing, rinsing, or

conveying products in a manner that may result in con-

tamination of food products.

(b) Containers and carriers of raw ingredients should

he inspected on receipt to assure that their condition has

not contributed to the contamination or deterioration of

the products.

it shall be made from potable water and shall be used only

if it has been manufactured in accordance with adequate

standards and stored, transported, and handled in a sani-

tary manner.

(d) Food-processing areas and equipment used for

processing human food should not be used to process non-

human food-grade animal feed or inedible products unless

there is no reasonable possibility for the contamination of

the human food.

(e) Processing equipment shall be maintained in a

sanitary condition through frequent cleaning including

sanitization where indicated. Insofar as necessary, equip-

ment shall be taken apart for thorough cleaning.

(f) All food processing, including packaging and

storage, should be conducted under such conditions and con-

trols as are necessary to minimize the potential for unde-

3la

sirable bacterial or other microbiological growth, toxin

formation, or deterioration or contamination of the proc-

essed product or ingredients. This may require careful

monitoring of such physical factors as time, temperature,

humidity, pressure, flow-rate and such processing opera-

tions as freezing, dehydration, heat processing, and re-

frigeration to assure that mechanical breakdowns, time

delays, temperature fluctuations, and other factors do not

contribute to the decomposition or contamination of the

processed products.

(g) Chemical, microbiological, or extraneous-material

testing procedures shall be utilized where necessary to iden-

tify sanitation failures or food contamination, and all foods

and ingredients that have become contaminated shall be

rejected or treated or processed to eliminate the contami-

nation where this may be properly accomplished.

(h) Packaging processes and materials shall not trans-

mit contaminants or objectionable substances to the prod-

ucts, shall conform to any applicable foed additive regula-

tion (Part 121 of this chapter), and should provide ade-

quate protection from contamination.

(i) Meaningful coding of products sold or otherwise

distributed from a manufacturing, processing, packing, or

repacking activity should be utilized to enable positive lot

identification to facilitate, where necessary, the segregation

of specific food lots that may have become contaminated or

otherwise unfit for their intended use. Records should be

retained for a period of time that exceeds the shelf life

of the product, except that they need not be retained more

than 2 years.

(j) Storage and transportation of finished products

should be under such conditions as will prevent contamina-

tion, including development of pathogenic or toxigenic

micro-organisms, and will protect against undesirable de-

terioration of the product and the container.

32a

§ 128.8 Personnel.

The plant management shall take all reasonable measures

and precautions to assure the following:

(a) Disease control. No person affected by disease in

a communicable form, or while a carrier of such disease,

or while affected with boils, sores, infected wounds, or

other abnormal sources of microbiological contamination,

shall work in a food plant in any capacity in which there is

a reasonable possibility of food or food ingredients be-

coming contaminated by such person, or of disease being

transmitted by such person to other individuals.

(b) Cleanliness. All persons, while working in direct

contact with food preparation, food ingredients, or surfaces

coming into contact therewith shall:

(1) Wear clean outer garments, maintain a high de-

gree of personal cleanliness, and conform to hygienic prac-

tices while on duty, to the extent necessary to prevent con-

tamination of food products.

(2) Wash their hands thoroughly (and sanitize if

necessary to prevent contamination by undesirable micro-

organism) in an adequate hand-washing facility before

starting work, after each absence from the work station,

and at any other time when the hands may have become

soiled or contaminated.

(3) Remove all insecure jewelry and, during periods

where food is manipulated by hand, remove from hands

any jewelry that cannot be adequately sanitized.

(4) If gloves are used in food handling, maintain them

in an intact, clean, and sanitary condition. Such gloves

should be of an impermeable material except where their

usage would be inappropriate or incompatible with the

work involved.

(5) Wear hair nets, headbands, caps, or other ef-

fective hair restraints.

(6) Not store clothing or other personal belongings,

eat food or drink beverages, or use tobacco in any form in

33a

areas where food or food ingredients are expose or in areas

used for washing equipment or utensils.

(7) Take any other necessary precautions to prevent

contamination of foods with micro-organisms or foreign

substances including, but not limited to perspiration, hair,

cosmetics, tobacco, chemicals, and medicants.

identifying sanitation failures or food contamination should

have a background of education, or experience, or a com-

bination thereof, to provide a level of competency neces-

sary for production of clean and safe food. Food handlers

and supervisors should receive appropriate training in

proper food-handling techniques and food-protection prin-

ciples and should be cognizant of the danger of poor per-

sonal hygiene and insanitary practices.

(d) Supervision, Responsibility for assuring compli-

ance by all personnel with all requirements of this Part

128 shall be clearly assigned to competent supervisory

personnel.

§ 128.9 Exclusions.

The following operations are excluded from coverage

under these general regulations, however, the Commis-

sioner will issue special regulations when he believes it nec-

essary to cover these excluded operations: Establishments

engaged solely in the harvesting, storage, or distribution

of one or more raw agricultural commodities, as defined in

section 201(r) of the act, which are ordinarily cleaned,

prepared, treated or otherwise processed before being

marketed to the consuming public.

§ 128.10 Natural or unavoidable defects in food for

human use that present no health hazard.

(a) Some foods, even when produced under current

good manufacturing and/or processing practices, contain

natural or unavoidable defects at lower levels that are not

34a

hazardous to health. The Food and Drug Administration

establishes maximum levels for such defects in foods pro-

duced under good manufacturing and/or processing

practices and uses these levels for recommending regula-

tory actions.

(b) Defect action levels are established for products

whenever it is necessary and feasible. Such levels are

subject to change upon the development of new technology

or the availability of new information.

cuse failure to observe either the requirement in section 402

(a) (4) of the Federal Food, Drug, and Cosmetie Act that

food may not be prepared, packed, or held under insanitary

conditions or the other requirements in this part that food

manufacturers must observe current good manufacturing

practices. Evidence obtained through factory inspection

indicating such a violation renders the food unlawful, even

though the amounts of natural or unavoidable defects are

lower than the currently established action levels. The

manufacturer of food must at all times utilize quality

control procedures which will reduce natural or unavoid-

able defects to the lowest level currently feasible.

(d) The mixing of a food containing defects above the

current defect action level with another lot of food is not

permitted and renders the final food unlawful regardless

of the defect level of the final food.

(e) Current action levels for natural and unavoidable

defects in food for human use that present no health hazard

are as follows. (Levels that have been adopted on a tem-

porary basis prior to publication as a regulation may be

obtained upon request at the Office of the Assistant Com-

missioner for Publie Affairs, Food and Drug Administra-

tion, Room 15B-42, 5600 Fishers Lane, Rockville, Md.

20852. )

[38 F.R. 855, Jan. 5, 1973]

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.