§ 346 TITLE 21—FOOD AND DRUGS Page 96

processed, labeled, or repacked in substantial

quantities at establishments other than those

where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this chapter

upon removal from such processing, labeling, or

repacking establishment. This section does not

apply to the labeling requirements of sections

343(q) and 343(r) of this title.

(June 25, 1938, ch. 675, §405, 52 Stat. 1049; Pub. L.

101–535, §5(a), Nov. 8, 1990, 104 Stat. 2362.)

AMENDMENTS

1990—Pub. L. 101–535 inserted at end ‘‘This section

does not apply to the labeling requirements of sections

343(q) and 343(r) of this title.’’

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101–535 effective six months

after the date of the promulgation of final regulations

to implement section 343(r) of this title, or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations

(Nov. 8, 1992), with exception for persons marketing

food the brand name of which contains a term defined

by the Secretary under section 343(r)(2)(A)(i) of this

title, see section 10(a) of Pub. L. 101–535, set out as a

note under section 343 of this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to

alter authority of Secretary of Health and Human

Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et

seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et

seq.), the Poultry Products Inspection Act (21 U.S.C. 451

et seq.), and the Egg Products Inspection Act (21 U.S.C.

1031 et seq.), see section 9 of Pub. L. 101–535, set out as

a note under section 343 of this title.

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare

[now Health and Human Services], and of Food and

Drug Administration in the Department of Agriculture

to Federal Security Agency, see notes set out under

section 321 of this title.

§ 346. Tolerances for poisonous or deleterious

substances in food; regulations

Any poisonous or deleterious substance added

to any food, except where such substance is required in the production thereof or cannot be

avoided by good manufacturing practice shall be

deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title;

but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein

or thereon to such extent as he finds necessary

for the protection of public health, and any

quantity exceeding the limits so fixed shall also

be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this

title. While such a regulation is in effect limiting the quantity of any such substance in the

case of any food, such food shall not, by reason

of bearing or containing any added amount of

such substance, be considered to be adulterated

within the meaning of clause (1) of section 342(a)

of this title. In determining the quantity of such

added substance to be tolerated in or on different articles of food the Secretary shall take

into account the extent to which the use of such

substance is required or cannot be avoided in

the production of each such article, and the

other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

(June 25, 1938, ch. 675, §406, 52 Stat. 1049; Pub. L.

85–929, §3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L.

86–618, title I, §103(a)(1), July 12, 1960, 74 Stat.

398.)

AMENDMENTS

1960—Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate regulations for listing

of coal-tar colors.

1958—Subsec. (a). Pub. L. 85–929 substituted ‘‘clause

(2)(A)’’ for ‘‘clause (2)’’ in first sentence.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86–618 effective July 12, 1960,

subject to the provisions of section 203 of Pub. L. 86–618,

see section 202 of Pub. L. 86–618, set out as a note under

section 379e of this title.

EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR,

DEFOLIANT, AND DESICCANT AMENDMENT OF 1959

Effective date of subsec. (a) as in force prior to July

22, 1954, with respect to particular commercial use of a

nematocide, plant regulator, defoliant, or desiccant in

or on a raw agricultural commodity made before Jan.

1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73

Stat. 288.

EFFECTIVE DATE OF 1958 AMENDMENT

For effective date of amendment by Pub. L. 85–929,

see section 6(b), (c) of Pub. L. 85–929, set out as a note

under section 342 of this title.

TRANSFER OF FUNCTIONS

Functions vested in Secretary of Health, Education,

and Welfare [now Health and Human Services] in establishing tolerances for pesticide chemicals under this

section together with authority to monitor compliance

with tolerances and effectiveness of surveillance and

enforcement and to provide technical assistance to

States and conduct research under this chapter and

section 201 et seq. of Title 42, The Public Health and

Welfare, transferred to Administrator of Environmental Protection Agency by Reorg. Plan No. 3 of 1970,

§2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086, set

out in the Appendix to Title 5, Government Organization and Employees.

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare

[now Health and Human Services], and of Food and

Drug Administration to Federal Security Agency, see

notes set out under section 321 of this title.

§ 346a. Tolerances and exemptions for pesticide

chemical residues

(a) Requirement for tolerance or exemption

(1) General rule

Except as provided in paragraph (2) or (3),

any pesticide chemical residue in or on a food

shall be deemed unsafe for the purpose of section 342(a)(2)(B) of this title unless—

(A) a tolerance for such pesticide chemical

residue in or on such food is in effect under

this section and the quantity of the residue

is within the limits of the tolerance; or

(B) an exemption from the requirement of

a tolerance is in effect under this section for

the pesticide chemical residue.

For the purposes of this section, the term

‘‘food’’, when used as a noun without modifica-
Page 97 TITLE 21—FOOD AND DRUGS § 346a

tion, shall mean a raw agricultural commodity or processed food.

(2) Processed food

Notwithstanding paragraph (1)—

(A) if a tolerance is in effect under this

section for a pesticide chemical residue in or

on a raw agricultural commodity, a pesticide chemical residue that is present in or

on a processed food because the food is made

from that raw agricultural commodity shall

not be considered unsafe within the meaning

of section 342(a)(2)(B) of this title despite the

lack of a tolerance for the pesticide chemical residue in or on the processed food if the

pesticide chemical has been used in or on the

raw agricultural commodity in conformity

with a tolerance under this section, such residue in or on the raw agricultural commodity has been removed to the extent possible

in good manufacturing practice, and the

concentration of the pesticide chemical residue in the processed food is not greater than

the tolerance prescribed for the pesticide

chemical residue in the raw agricultural

commodity; or

(B) if an exemption for the requirement for

a tolerance is in effect under this section for

a pesticide chemical residue in or on a raw

agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the food is made from

that raw agricultural commodity shall not

be considered unsafe within the meaning of

section 342(a)(2)(B) of this title.

(3) Residues of degradation products

If a pesticide chemical residue is present in

or on a food because it is a metabolite or other

degradation product of a precursor substance

that itself is a pesticide chemical or pesticide

chemical residue, such a residue shall not be

considered to be unsafe within the meaning of

section 342(a)(2)(B) of this title despite the

lack of a tolerance or exemption from the need

for a tolerance for such residue in or on such

food if—

(A) the Administrator has not determined

that the degradation product is likely to

pose any potential health risk from dietary

exposure that is of a different type than, or

of a greater significance than, any risk

posed by dietary exposure to the precursor

substance;

(B) either—

(i) a tolerance is in effect under this section for residues of the precursor substance in or on the food, and the combined

level of residues of the degradation product and the precursor substance in or on

the food is at or below the stoichiometrically equivalent level that would be

permitted by the tolerance if the residue

consisted only of the precursor substance

rather than the degradation product; or

(ii) an exemption from the need for a tolerance is in effect under this section for

residues of the precursor substance in or

on the food; and

(C) the tolerance or exemption for residues

of the precursor substance does not state

that it applies only to particular named substances and does not state that it does not

apply to residues of the degradation product.

(4) Effect of tolerance or exemption

While a tolerance or exemption from the requirement for a tolerance is in effect under

this section for a pesticide chemical residue

with respect to any food, the food shall not by

reason of bearing or containing any amount of

such a residue be considered to be adulterated

within the meaning of section 342(a)(1) of this

title.

(b) Authority and standard for tolerance

(1) Authority

The Administrator may issue regulations establishing, modifying, or revoking a tolerance

for a pesticide chemical residue in or on a

food—

(A) in response to a petition filed under

subsection (d) of this section; or

(B) on the Administrator’s own initiative

under subsection (e) of this section.

As used in this section, the term ‘‘modify’’

shall not mean expanding the tolerance to

cover additional foods.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or

leave in effect a tolerance for a pesticide

chemical residue in or on a food only if the

Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if the Administrator determines it is not safe.

(ii) Determination of safety

As used in this section, the term ‘‘safe’’,

with respect to a tolerance for a pesticide

chemical residue, means that the Administrator has determined that there is a reasonable certainty that no harm will result

from aggregate exposure to the pesticide

chemical residue, including all anticipated

dietary exposures and all other exposures

for which there is reliable information.

(iii) Rule of construction

With respect to a tolerance, a pesticide

chemical residue meeting the standard

under clause (i) is not an eligible pesticide

chemical residue for purposes of subparagraph (B).

(B) Tolerances for eligible pesticide chemical

residues

(i) Definition

As used in this subparagraph, the term

‘‘eligible pesticide chemical residue’’

means a pesticide chemical residue as to

which—

(I) the Administrator is not able to

identify a level of exposure to the residue at which the residue will not cause

or contribute to a known or anticipated

harm to human health (referred to in

this section as a ‘‘nonthreshold effect’’);

(II) the lifetime risk of experiencing

the nonthreshold effect is appropriately
§ 346a TITLE 21—FOOD AND DRUGS Page 98

assessed by quantitative risk assessment; and

(III) with regard to any known or anticipated harm to human health for

which the Administrator is able to identify a level at which the residue will not

cause such harm (referred to in this section as a ‘‘threshold effect’’), the Administrator determines that the level of aggregate exposure is safe.

(ii) Determination of tolerance

Notwithstanding subparagraph (A)(i), a

tolerance for an eligible pesticide chemical

residue may be left in effect or modified

under this subparagraph if—

(I) at least one of the conditions described in clause (iii) is met; and

(II) both of the conditions described in

clause (iv) are met.

(iii) Conditions regarding use

For purposes of clause (ii), the conditions described in this clause with respect

to a tolerance for an eligible pesticide

chemical residue are the following:

(I) Use of the pesticide chemical that

produces the residue protects consumers

from adverse effects on health that

would pose a greater risk than the dietary risk from the residue.

(II) Use of the pesticide chemical that

produces the residue is necessary to

avoid a significant disruption in domestic production of an adequate, wholesome, and economical food supply.

(iv) Conditions regarding risk

For purposes of clause (ii), the conditions described in this clause with respect

to a tolerance for an eligible pesticide

chemical residue are the following:

(I) The yearly risk associated with the

nonthreshold effect from aggregate exposure to the residue does not exceed 10

times the yearly risk that would be allowed under subparagraph (A) for such

effect.

(II) The tolerance is limited so as to

ensure that the risk over a lifetime associated with the nonthreshold effect from

aggregate exposure to the residue is not

greater than twice the lifetime risk that

would be allowed under subparagraph (A)

for such effect.

(v) Review

Five years after the date on which the

Administrator makes a determination to

leave in effect or modify a tolerance under

this subparagraph, and thereafter as the

Administrator deems appropriate, the Administrator shall determine, after notice

and opportunity for comment, whether it

has been demonstrated to the Administrator that a condition described in clause

(iii)(I) or clause (iii)(II) continues to exist

with respect to the tolerance and that the

yearly and lifetime risks from aggregate

exposure to such residue continue to comply with the limits specified in clause (iv).

If the Administrator determines by such

date that such demonstration has not been

made, the Administrator shall, not later

than 180 days after the date of such determination, issue a regulation under subsection (e)(1) of this section to modify or

revoke the tolerance.

(vi) Infants and children

Any tolerance under this subparagraph

shall meet the requirements of subparagraph (C).

(C) Exposure of infants and children

In establishing, modifying, leaving in effect, or revoking a tolerance or exemption

for a pesticide chemical residue, the Administrator—

(i) shall assess the risk of the pesticide

chemical residue based on—

(I) available information about consumption patterns among infants and

children that are likely to result in disproportionately high consumption of

foods containing or bearing such residue

among infants and children in comparison to the general population;

(II) available information concerning

the special susceptibility of infants and

children to the pesticide chemical residues, including neurological differences

between infants and children and adults,

and effects of in utero exposure to pesticide chemicals; and

(III) available information concerning

the cumulative effects on infants and

children of such residues and other substances that have a common mechanism

of toxicity; and

(ii) shall—

(I) ensure that there is a reasonable

certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue;

and

(II) publish a specific determination regarding the safety of the pesticide chemical residue for infants and children.

The Secretary of Health and Human Services and the Secretary of Agriculture, in

consultation with the Administrator, shall

conduct surveys to document dietary exposure to pesticides among infants and children. In the case of threshold effects, for

purposes of clause (ii)(I) an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure

shall be applied for infants and children to

take into account potential pre- and postnatal toxicity and completeness of the data

with respect to exposure and toxicity to infants and children. Notwithstanding such requirement for an additional margin of safety, the Administrator may use a different

margin of safety for the pesticide chemical

residue only if, on the basis of reliable data,

such margin will be safe for infants and children.

(D) Factors

In establishing, modifying, leaving in effect, or revoking a tolerance or exemption
Page 99 TITLE 21—FOOD AND DRUGS § 346a

for a pesticide chemical residue, the Administrator shall consider, among other relevant factors—

(i) the validity, completeness, and reliability of the available data from studies

of the pesticide chemical and pesticide

chemical residue;

(ii) the nature of any toxic effect shown

to be caused by the pesticide chemical or

pesticide chemical residue in such studies;

(iii) available information concerning

the relationship of the results of such

studies to human risk;

(iv) available information concerning the

dietary consumption patterns of consumers (and major identifiable subgroups of

consumers);

(v) available information concerning the

cumulative effects of such residues and

other substances that have a common

mechanism of toxicity;

(vi) available information concerning the

aggregate exposure levels of consumers

(and major identifiable subgroups of consumers) to the pesticide chemical residue

and to other related substances, including

dietary exposure under the tolerance and

all other tolerances in effect for the pesticide chemical residue, and exposure from

other non-occupational sources;

(vii) available information concerning

the variability of the sensitivities of major

identifiable subgroups of consumers;

(viii) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced

by a naturally occurring estrogen or other

endocrine effects; and

(ix) safety factors which in the opinion

of experts qualified by scientific training

and experience to evaluate the safety of

food additives are generally recognized as

appropriate for the use of animal experimentation data.

(E) Data and information regarding anticipated and actual residue levels

(i) Authority

In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administrator

may consider available data and information on the anticipated residue levels of

the pesticide chemical in or on food and

the actual residue levels of the pesticide

chemical that have been measured in food,

including residue data collected by the

Food and Drug Administration.

(ii) Requirement

If the Administrator relies on anticipated or actual residue levels in establishing, modifying, or leaving in effect a tolerance, the Administrator shall pursuant to

subsection (f)(1) of this section require

that data be provided five years after the

date on which the tolerance is established,

modified, or left in effect, and thereafter

as the Administrator deems appropriate,

demonstrating that such residue levels are

not above the levels so relied on. If such

data are not so provided, or if the data do

not demonstrate that the residue levels

are not above the levels so relied on, the

Administrator shall, not later than 180

days after the date on which the data were

required to be provided, issue a regulation

under subsection (e)(1) of this section, or

an order under subsection (f)(2) of this section, as appropriate, to modify or revoke

the tolerance.

(F) Percent of food actually treated

In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide

chemical residue, the Administrator may,

when assessing chronic dietary risk, consider available data and information on the

percent of food actually treated with the

pesticide chemical (including aggregate pesticide use data collected by the Department

of Agriculture) only if the Administrator—

(i) finds that the data are reliable and

provide a valid basis to show what percentage of the food derived from such crop is

likely to contain such pesticide chemical

residue;

(ii) finds that the exposure estimate does

not understate exposure for any significant subpopulation group;

(iii) finds that, if data are available on

pesticide use and consumption of food in a

particular area, the population in such

area is not dietarily exposed to residues

above those estimated by the Administrator; and

(iv) provides for the periodic reevaluation of the estimate of anticipated dietary

exposure.

(3) Detection methods

(A) General rule

A tolerance for a pesticide chemical residue in or on a food shall not be established

or modified by the Administrator unless the

Administrator determines, after consultation with the Secretary, that there is a practical method for detecting and measuring

the levels of the pesticide chemical residue

in or on the food.

(B) Detection limit

A tolerance for a pesticide chemical residue in or on a food shall not be established

at or modified to a level lower than the limit

of detection of the method for detecting and

measuring the pesticide chemical residue

specified by the Administrator under subparagraph (A).

(4) International standards

In establishing a tolerance for a pesticide

chemical residue in or on a food, the Administrator shall determine whether a maximum

residue level for the pesticide chemical has

been established by the Codex Alimentarius

Commission. If a Codex maximum residue

level has been established for the pesticide

chemical and the Administrator does not propose to adopt the Codex level, the Administrator shall publish for public comment a notice explaining the reasons for departing from

the Codex level.
§ 346a TITLE 21—FOOD AND DRUGS Page 100

(c) Authority and standard for exemptions

(1) Authority

The Administrator may issue a regulation

establishing, modifying, or revoking an exemption from the requirement for a tolerance

for a pesticide chemical residue in or on food—

(A) in response to a petition filed under

subsection (d) of this section; or

(B) on the Administrator’s initiative under

subsection (e) of this section.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or

leave in effect an exemption from the requirement for a tolerance for a pesticide

chemical residue in or on food only if the

Administrator determines that the exemption is safe. The Administrator shall modify or revoke an exemption if the Administrator determines it is not safe.

(ii) Determination of safety

The term ‘‘safe’’, with respect to an exemption for a pesticide chemical residue,

means that the Administrator has determined that there is a reasonable certainty

that no harm will result from aggregate

exposure to the pesticide chemical residue,

including all anticipated dietary exposures

and all other exposures for which there is

reliable information.

(B) Factors

In making a determination under this

paragraph, the Administrator shall take into

account, among other relevant considerations, the considerations set forth in subparagraphs (C) and (D) of subsection (b)(2) of

this section.

(3) Limitation

An exemption from the requirement for a

tolerance for a pesticide chemical residue in

or on food shall not be established or modified

by the Administrator unless the Administrator determines, after consultation with the

Secretary—

(A) that there is a practical method for detecting and measuring the levels of such pesticide chemical residue in or on food; or

(B) that there is no need for such a method, and states the reasons for such determination in issuing the regulation establishing or modifying the exemption.

(d) Petition for tolerance or exemption

(1) Petitions and petitioners

Any person may file with the Administrator

a petition proposing the issuance of a regulation—

(A) establishing, modifying, or revoking a

tolerance for a pesticide chemical residue in

or on a food; or

(B) establishing, modifying, or revoking an

exemption from the requirement of a tolerance for such a residue.

(2) Petition contents

(A) Establishment

A petition under paragraph (1) to establish

a tolerance or exemption for a pesticide

chemical residue shall be supported by such

data and information as are specified in regulations issued by the Administrator, including—

(i)(I) an informative summary of the petition and of the data, information, and arguments submitted or cited in support of

the petition; and

(II) a statement that the petitioner

agrees that such summary or any information it contains may be published as a part

of the notice of filing of the petition to be

published under this subsection and as

part of a proposed or final regulation issued under this section;

(ii) the name, chemical identity, and

composition of the pesticide chemical residue and of the pesticide chemical that produces the residue;

(iii) data showing the recommended

amount, frequency, method, and time of

application of that pesticide chemical;

(iv) full reports of tests and investigations made with respect to the safety of

the pesticide chemical, including full information as to the methods and controls

used in conducting those tests and investigations;

(v) full reports of tests and investigations made with respect to the nature and

amount of the pesticide chemical residue

that is likely to remain in or on the food,

including a description of the analytical

methods used;

(vi) a practical method for detecting and

measuring the levels of the pesticide

chemical residue in or on the food, or for

exemptions, a statement why such a method is not needed;

(vii) a proposed tolerance for the pesticide chemical residue, if a tolerance is

proposed;

(viii) if the petition relates to a tolerance for a processed food, reports of investigations conducted using the processing

method(s) used to produce that food;

(ix) such information as the Administrator may require to make the determination under subsection (b)(2)(C) of this

section;

(x) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced

by a naturally occurring estrogen or other

endocrine effects;

(xi) information regarding exposure to

the pesticide chemical residue due to any

tolerance or exemption already granted for

such residue;

(xii) practical methods for removing any

amount of the residue that would exceed

any proposed tolerance; and

(xiii) such other data and information as

the Administrator requires by regulation

to support the petition.

If information or data required by this subparagraph is available to the Administrator,

the person submitting the petition may cite

the availability of the information or data

in lieu of submitting it. The Administrator
Page 101 TITLE 21—FOOD AND DRUGS § 346a

may require a petition to be accompanied by

samples of the pesticide chemical with respect to which the petition is filed.

(B) Modification or revocation

The Administrator may by regulation establish the requirements for information

and data to support a petition to modify or

revoke a tolerance or to modify or revoke an

exemption from the requirement for a tolerance.

(3) Notice

A notice of the filing of a petition that the

Administrator determines has met the requirements of paragraph (2) shall be published

by the Administrator within 30 days after such

determination. The notice shall announce the

availability of a description of the analytical

methods available to the Administrator for

the detection and measurement of the pesticide chemical residue with respect to which

the petition is filed or shall set forth the petitioner’s statement of why such a method is

not needed. The notice shall include the summary required by paragraph (2)(A)(i)(I).

(4) Actions by the Administrator

(A) In general

The Administrator shall, after giving due

consideration to a petition filed under paragraph (1) and any other information available to the Administrator—

(i) issue a final regulation (which may

vary from that sought by the petition) establishing, modifying, or revoking a tolerance for the pesticide chemical residue or

an exemption of the pesticide chemical

residue from the requirement of a tolerance (which final regulation shall be issued without further notice and without

further period for public comment);

(ii) issue a proposed regulation under

subsection (e) of this section, and thereafter issue a final regulation under such

subsection; or

(iii) issue an order denying the petition.

(B) Priorities

The Administrator shall give priority to

petitions for the establishment or modification of a tolerance or exemption for a pesticide chemical residue that appears to pose

a significantly lower risk to human health

from dietary exposure than pesticide chemical residues that have tolerances in effect

for the same or similar uses.

(C) Expedited review of certain petitions

(i) Date certain for review

If a person files a complete petition with

the Administrator proposing the issuance

of a regulation establishing a tolerance or

exemption for a pesticide chemical residue

that presents a lower risk to human health

than a pesticide chemical residue for

which a tolerance has been left in effect or

modified under subsection (b)(2)(B) of this

section, the Administrator shall complete

action on such petition under this paragraph within 1 year.

(ii) Required determinations

If the Administrator issues a final regulation establishing a tolerance or exemption for a safer pesticide chemical residue

under clause (i), the Administrator shall,

not later than 180 days after the date on

which the regulation is issued, determine

whether a condition described in subclause

(I) or (II) of subsection (b)(2)(B)(iii) of this

section continues to exist with respect to

a tolerance that has been left in effect or

modified under subsection (b)(2)(B) of this

section. If such condition does not continue to exist, the Administrator shall, not

later than 180 days after the date on which

the determination under the preceding

sentence is made, issue a regulation under

subsection (e)(1) of this section to modify

or revoke the tolerance.

(e) Action on Administrator’s own initiative

(1) General rule

The Administrator may issue a regulation—

(A) establishing, modifying, suspending

under subsection (l)(3) of this section, or revoking a tolerance for a pesticide chemical

or a pesticide chemical residue;

(B) establishing, modifying, suspending

under subsection (l)(3) of this section, or revoking an exemption of a pesticide chemical

residue from the requirement of a tolerance;

or

(C) establishing general procedures and requirements to implement this section.

(2) Notice

Before issuing a final regulation under paragraph (1), the Administrator shall issue a notice of proposed rulemaking and provide a period of not less than 60 days for public comment on the proposed regulation, except that

a shorter period for comment may be provided

if the Administrator for good cause finds that

it would be in the public interest to do so and

states the reasons for the finding in the notice

of proposed rulemaking.

(f) Special data requirements

(1) Requiring submission of additional data

If the Administrator determines that additional data or information are reasonably required to support the continuation of a tolerance or exemption that is in effect under this

section for a pesticide chemical residue on a

food, the Administrator shall—

(A) issue a notice requiring the person

holding the pesticide registrations associated with such tolerance or exemption to

submit the data or information under section 3(c)(2)(B) of the Federal Insecticide,

Fungicide, and Rodenticide Act [7 U.S.C.

136a(c)(2)(B)];

(B) issue a rule requiring that testing be

conducted on a substance or mixture under

section 4 of the Toxic Substances Control

Act [15 U.S.C. 2603]; or

(C) publish in the Federal Register, after

first providing notice and an opportunity for

comment of not less than 60 days’ duration,

an order—

(i) requiring the submission to the Administrator by one or more interested persons of a notice identifying the person or

persons who will submit the required data

and information;
§ 346a TITLE 21—FOOD AND DRUGS Page 102

(ii) describing the type of data and information required to be submitted to the Administrator and stating why the data and

information could not be obtained under

the authority of section 3(c)(2)(B) of the

Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or section

4 of the Toxic Substances Control Act [15

U.S.C. 2603];

(iii) describing the reports of the Administrator required to be prepared during and

after the collection of the data and information;

(iv) requiring the submission to the Administrator of the data, information, and

reports referred to in clauses (ii) and (iii);

and

(v) establishing dates by which the submissions described in clauses (i) and (iv)

must be made.

The Administrator may under subparagraph

(C) revise any such order to correct an error.

The Administrator may under this paragraph require data or information pertaining

to whether the pesticide chemical may have

an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.

(2) Noncompliance

If a submission required by a notice issued

in accordance with paragraph (1)(A), a rule issued under paragraph (1)(B), or an order issued

under paragraph (1)(C) is not made by the time

specified in such notice, rule, or order, the Administrator may by order published in the

Federal Register modify or revoke the tolerance or exemption in question. In any review

of such an order under subsection (g)(2) of this

section, the only material issue shall be

whether a submission required under paragraph (1) was not made by the time specified.

(g) Effective date, objections, hearings, and administrative review

(1) Effective date

A regulation or order issued under subsection (d)(4), (e)(1), or (f)(2) of this section

shall take effect upon publication unless the

regulation or order specifies otherwise. The

Administrator may stay the effectiveness of

the regulation or order if, after issuance of

such regulation or order, objections are filed

with respect to such regulation or order pursuant to paragraph (2).

(2) Further proceedings

(A) Objections

Within 60 days after a regulation or order

is issued under subsection (d)(4), (e)(1)(A),

(e)(1)(B), (f)(2), (n)(3), or (n)(5)(C) of this section, any person may file objections thereto

with the Administrator, specifying with particularity the provisions of the regulation or

order deemed objectionable and stating reasonable grounds therefor. If the regulation

or order was issued in response to a petition

under subsection (d)(1) of this section, a

copy of each objection filed by a person

other than the petitioner shall be served by

the Administrator on the petitioner.

(B) Hearing

An objection may include a request for a

public evidentiary hearing upon the objection. The Administrator shall, upon the initiative of the Administrator or upon the request of an interested person and after due

notice, hold a public evidentiary hearing if

and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant

to material issues of fact raised by the objections. The presiding officer in such a

hearing may authorize a party to obtain discovery from other persons and may upon a

showing of good cause made by a party issue

a subpoena to compel testimony or production of documents from any person. The presiding officer shall be governed by the Federal Rules of Civil Procedure in making any

order for the protection of the witness or the

content of documents produced and shall

order the payment of reasonable fees and expenses as a condition to requiring testimony

of the witness. On contest, such a subpoena

may be enforced by a Federal district court.

(C) Final decision

As soon as practicable after receiving the

arguments of the parties, the Administrator

shall issue an order stating the action taken

upon each such objection and setting forth

any revision to the regulation or prior order

that the Administrator has found to be warranted. If a hearing was held under subparagraph (B), such order and any revision to the

regulation or prior order shall, with respect

to questions of fact at issue in the hearing,

be based only on substantial evidence of

record at such hearing, and shall set forth in

detail the findings of facts and the conclusions of law or policy upon which the order

or regulation is based.

(h) Judicial review

(1) Petition

In a case of actual controversy as to the validity of any regulation issued under subsection (e)(1)(C) of this section, or any order

issued under subsection (f)(1)(C) or (g)(2)(C) of

this section, or any regulation that is the subject of such an order, any person who will be

adversely affected by such order or regulation

may obtain judicial review by filing in the

United States Court of Appeals for the circuit

wherein that person resides or has its principal place of business, or in the United States

Court of Appeals for the District of Columbia

Circuit, within 60 days after publication of

such order or regulation, a petition praying

that the order or regulation be set aside in

whole or in part.

(2) Record and jurisdiction

A copy of the petition under paragraph (1)

shall be forthwith transmitted by the clerk of

the court to the Administrator, or any officer

designated by the Administrator for that purpose, and thereupon the Administrator shall

file in the court the record of the proceedings

on which the Administrator based the order or

regulation, as provided in section 2112 of title
Page 103 TITLE 21—FOOD AND DRUGS § 346a

1See References in Text note below.

28. Upon the filing of such a petition, the court

shall have exclusive jurisdiction to affirm or

set aside the order or regulation complained of

in whole or in part. As to orders issued following a public evidentiary hearing, the findings

of the Administrator with respect to questions

of fact shall be sustained only if supported by

substantial evidence when considered on the

record as a whole.

(3) Additional evidence

If a party applies to the court for leave to

adduce additional evidence and shows to the

satisfaction of the court that the additional

evidence is material and that there were reasonable grounds for the failure to adduce the

evidence in the proceeding before the Administrator, the court may order that the additional evidence (and evidence in rebuttal

thereof) shall be taken before the Administrator in the manner and upon the terms and

conditions the court deems proper. The Administrator may modify prior findings as to

the facts by reason of the additional evidence

so taken and may modify the order or regulation accordingly. The Administrator shall file

with the court any such modified finding,

order, or regulation.

(4) Final judgment; Supreme Court review

The judgment of the court affirming or setting aside, in whole or in part, any regulation

or any order and any regulation which is the

subject of such an order shall be final, subject

to review by the Supreme Court of the United

States as provided in section 1254 of title 28.

The commencement of proceedings under this

subsection shall not, unless specifically ordered by the court to the contrary, operate as

a stay of a regulation or order.

(5) Application

Any issue as to which review is or was obtainable under this subsection shall not be the

subject of judicial review under any other provision of law.

(i) Confidentiality and use of data

(1) General rule

Data and information that are or have been

submitted to the Administrator under this

section or section 348 of this title in support of

a tolerance or an exemption from a tolerance

shall be entitled to confidential treatment for

reasons of business confidentiality and to exclusive use and data compensation to the same

extent provided by sections 3 and 10 of the

Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a, 136h].

(2) Exceptions

(A) In general

Data and information that are entitled to

confidential treatment under paragraph (1)

may be disclosed, under such security requirements as the Administrator may provide by regulation, to—

(i) employees of the United States authorized by the Administrator to examine

such data and information in the carrying

out of their official duties under this chapter or other Federal statutes intended to

protect the public health; or

(ii) contractors with the United States

authorized by the Administrator to examine such data and information in the carrying out of contracts under this chapter

or such statutes.

(B) Congress

This subsection does not authorize the

withholding of data or information from either House of Congress or from, to the extent of matter within its jurisdiction, any

committee or subcommittee of such committee or any joint committee of Congress

or any subcommittee of such joint committee.

(3) Summaries

Notwithstanding any provision of this subsection or other law, the Administrator may

publish the informative summary required by

subsection (d)(2)(A)(i) of this section and may,

in issuing a proposed or final regulation or

order under this section, publish an informative summary of the data relating to the regulation or order.

(j) Status of previously issued regulations

(1) Regulations under section 346

Regulations affecting pesticide chemical residues in or on raw agricultural commodities

promulgated, in accordance with section 371(e)

of this title, under the authority of section

346(a) 1 of this title upon the basis of public

hearings instituted before January 1, 1953,

shall be deemed to be regulations issued under

this section and shall be subject to modification or revocation under subsections (d) and

(e) of this section, and shall be subject to review under subsection (q) of this section.

(2) Regulations under section 348

Regulations that established tolerances for

substances that are pesticide chemical residues in or on processed food, or that otherwise

stated the conditions under which such pesticide chemicals could be safely used, and that

were issued under section 348 of this title on or

before August 3, 1996, shall be deemed to be

regulations issued under this section and shall

be subject to modification or revocation under

subsection (d) or (e) of this section, and shall

be subject to review under subsection (q) of

this section.

(3) Regulations under section 346a

Regulations that established tolerances or

exemptions under this section that were issued

on or before August 3, 1996, shall remain in effect unless modified or revoked under subsection (d) or (e) of this section, and shall be

subject to review under subsection (q) of this

section.

(4) Certain substances

With respect to a substance that is not included in the definition of the term ‘‘pesticide

chemical’’ under section 321(q)(1) of this title

but was so included on the day before October

30, 1998, the following applies as of October 30,

1998:

(A) Notwithstanding paragraph (2), any

regulation applying to the use of the sub-
§ 346a TITLE 21—FOOD AND DRUGS Page 104

stance that was in effect on the day before

October 30, 1998, and was on such day deemed

in such paragraph to have been issued under

this section, shall be considered to have been

issued under section 348 of this title.

(B) Notwithstanding paragraph (3), any

regulation applying to the use of the substance that was in effect on such day and

was issued under this section (including any

such regulation issued before August 3, 1996)

is deemed to have been issued under section

348 of this title.

(k) Transitional provision

If, on the day before August 3, 1996, a substance that is a pesticide chemical was, with respect to a particular pesticidal use of the substance and any resulting pesticide chemical residue in or on a particular food—

(1) regarded by the Administrator or the

Secretary as generally recognized as safe for

use within the meaning of the provisions of

subsection (a) of this section or section 321(s)

of this title as then in effect; or

(2) regarded by the Secretary as a substance

described by section 321(s)(4) of this title;

such a pesticide chemical residue shall be regarded as exempt from the requirement for a

tolerance, as of August 3, 1996. The Administrator shall by regulation indicate which substances are described by this subsection. Any exemption under this subsection may be modified

or revoked as if it had been issued under subsection (c) of this section.

(l) Harmonization with action under other laws

(1) Coordination with FIFRA

To the extent practicable and consistent

with the review deadlines in subsection (q) of

this section, in issuing a final rule under this

subsection that suspends or revokes a tolerance or exemption for a pesticide chemical

residue in or on food, the Administrator shall

coordinate such action with any related necessary action under the Federal Insecticide,

Fungicide, and Rodenticide Act [7 U.S.C. 136 et

seq.].

(2) Revocation of tolerance or exemption following cancellation of associated registrations

If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide

Act, cancels the registration of each pesticide

that contains a particular pesticide chemical

and that is labeled for use on a particular food,

or requires that the registration of each such

pesticide be modified to prohibit its use in

connection with the production, storage, or

transportation of such food, due in whole or in

part to dietary risks to humans posed by residues of that pesticide chemical on that food,

the Administrator shall revoke any tolerance

or exemption that allows the presence of the

pesticide chemical, or any pesticide chemical

residue that results from its use, in or on that

food. Subsection (e) of this section shall apply

to actions taken under this paragraph. A revocation under this paragraph shall become effective not later than 180 days after—

(A) the date by which each such cancellation of a registration has become effective;

or

(B) the date on which the use of the canceled pesticide becomes unlawful under the

terms of the cancellation, whichever is later.

(3) Suspension of tolerance or exemption following suspension of associated registrations

(A) Suspension

If the Administrator, acting under the

Federal Insecticide, Fungicide, and Rodenticide Act, suspends the use of each registered pesticide that contains a particular

pesticide chemical and that is labeled for use

on a particular food, due in whole or in part

to dietary risks to humans posed by residues

of that pesticide chemical on that food, the

Administrator shall suspend any tolerance

or exemption that allows the presence of the

pesticide chemical, or any pesticide chemical residue that results from its use, in or on

that food. Subsection (e) of this section shall

apply to actions taken under this paragraph.

A suspension under this paragraph shall become effective not later than 60 days after

the date by which each such suspension of

use has become effective.

(B) Effect of suspension

The suspension of a tolerance or exemption under subparagraph (A) shall be effective as long as the use of each associated

registration of a pesticide is suspended

under the Federal Insecticide, Fungicide,

and Rodenticide Act. While a suspension of a

tolerance or exemption is effective the tolerance or exemption shall not be considered to

be in effect. If the suspension of use of the

pesticide under that Act is terminated, leaving the registration of the pesticide for such

use in effect under that Act, the Administrator shall rescind any associated suspension of tolerance or exemption.

(4) Tolerances for unavoidable residues

In connection with action taken under paragraph (2) or (3), or with respect to pesticides

whose registrations were suspended or canceled prior to August 3, 1996, under the Federal

Insecticide, Fungicide, and Rodenticide Act, if

the Administrator determines that a residue

of the canceled or suspended pesticide chemical will unavoidably persist in the environment and thereby be present in or on a food,

the Administrator may establish a tolerance

for the pesticide chemical residue. In establishing such a tolerance, the Administrator

shall take into account both the factors set

forth in subsection (b)(2) of this section and

the unavoidability of the residue. Subsection

(e) of this section shall apply to the establishment of such tolerance. The Administrator

shall review any such tolerance periodically

and modify it as necessary so that it allows no

greater level of the pesticide chemical residue

than is unavoidable.

(5) Pesticide residues resulting from lawful application of pesticide

Notwithstanding any other provision of this

chapter, if a tolerance or exemption for a pesticide chemical residue in or on a food has

been revoked, suspended, or modified under
Page 105 TITLE 21—FOOD AND DRUGS § 346a

this section, an article of that food shall not

be deemed unsafe solely because of the presence of such pesticide chemical residue in or

on such food if it is shown to the satisfaction

of the Secretary that—

(A) the residue is present as the result of

an application or use of a pesticide at a time

and in a manner that was lawful under the

Federal Insecticide, Fungicide, and Rodenticide Act; and

(B) the residue does not exceed a level that

was authorized at the time of that application or use to be present on the food under

a tolerance, exemption, food additive regulation, or other sanction then in effect under

this chapter;

unless, in the case of any tolerance or exemption revoked, suspended, or modified under

this subsection or subsection (d) or (e) of this

section, the Administrator has issued a determination that consumption of the legally

treated food during the period of its likely

availability in commerce will pose an unreasonable dietary risk.

(6) Tolerance for use of pesticides under an

emergency exemption

If the Administrator grants an exemption

under section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act (7 U.S.C. 136p)

for a pesticide chemical, the Administrator

shall establish a tolerance or exemption from

the requirement for a tolerance for the pesticide chemical residue. Such a tolerance or

exemption from a tolerance shall have an expiration date. The Administrator may establish

such a tolerance or exemption without providing notice or a period for comment on the tolerance or exemption. The Administrator shall

promulgate regulations within 365 days after

August 3, 1996, governing the establishment of

tolerances and exemptions under this paragraph. Such regulations shall be consistent

with the safety standard under subsections

(b)(2) and (c)(2) of this section and with section

18 of the Federal Insecticide, Fungicide, and

Rodenticide Act.

(m) Fees

(1) Amount

The Administrator shall by regulation require the payment of such fees as will in the

aggregate, in the judgment of the Administrator, be sufficient over a reasonable term to

provide, equip, and maintain an adequate service for the performance of the Administrator’s

functions under this section. Under the regulations, the performance of the Administrator’s

services or other functions under this section,

including—

(A) the acceptance for filing of a petition

submitted under subsection (d) of this section;

(B) establishing, modifying, leaving in effect, or revoking a tolerance or establishing,

modifying, leaving in effect, or revoking an

exemption from the requirement for a tolerance under this section;

(C) the acceptance for filing of objections

under subsection (g) of this section; or

(D) the certification and filing in court of

a transcript of the proceedings and the

record under subsection (h) of this section;

may be conditioned upon the payment of such

fees. The regulations may further provide for

waiver or refund of fees in whole or in part

when in the judgment of the Administrator

such a waiver or refund is equitable and not

contrary to the purposes of this subsection.

(2) Deposit

All fees collected under paragraph (1) shall

be deposited in the Reregistration and Expedited Processing Fund created by section 4(k)

of the Federal Insecticide, Fungicide, and

Rodenticide Act [7 U.S.C. 136a–1(k)]. Such fees

shall be available to the Administrator, without fiscal year limitation, for the performance

of the Administrator’s services or functions as

specified in paragraph (1).

(3) Prohibition

During the period beginning on October 1,

2007, and ending on September 30, 2017, the Administrator shall not collect any tolerance

fees under paragraph (1).

(n) National uniformity of tolerances

(1) ‘‘Qualifying pesticide chemical residue’’ defined

For purposes of this subsection, the term

‘‘qualifying pesticide chemical residue’’ means

a pesticide chemical residue resulting from

the use, in production, processing, or storage

of a food, of a pesticide chemical that is an active ingredient and that—

(A) was first approved for such use in a

registration of a pesticide issued under section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.

136a(c)(5)] on or after April 25, 1985, on the

basis of data determined by the Administrator to meet all applicable requirements

for data prescribed by regulations in effect

under that Act [7 U.S.C. 136 et seq.] on April

25, 1985; or

(B) was approved for such use in a reregistration eligibility determination issued

under section 4(g) of that Act [7 U.S.C.

136a–1(g)] on or after August 3, 1996.

(2) ‘‘Qualifying Federal determination’’ defined

For purposes of this subsection, the term

‘‘qualifying Federal determination’’ means a

tolerance or exemption from the requirement

for a tolerance for a qualifying pesticide

chemical residue that—

(A) is issued under this section after August 3, 1996, and determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance)

or (c)(2) (in the case of an exemption) of this

section; or

(B)(i) pursuant to subsection (j) of this section is remaining in effect or is deemed to

have been issued under this section, or is regarded under subsection (k) of this section

as exempt from the requirement for a tolerance; and

(ii) is determined by the Administrator to

meet the standard under subsection (b)(2)(A)

(in the case of a tolerance) or (c)(2) (in the

case of an exemption) of this section.

(3) Limitation

The Administrator may make the determination described in paragraph (2)(B)(ii) only
§ 346a TITLE 21—FOOD AND DRUGS Page 106

by issuing a rule in accordance with the procedure set forth in subsection (d) or (e) of this

section and only if the Administrator issues a

proposed rule and allows a period of not less

than 30 days for comment on the proposed

rule. Any such rule shall be reviewable in accordance with subsections (g) and (h) of this

section.

(4) State authority

Except as provided in paragraphs (5), (6), and

(8) no State or political subdivision may establish or enforce any regulatory limit on a qualifying pesticide chemical residue in or on any

food if a qualifying Federal determination applies to the presence of such pesticide chemical residue in or on such food, unless such

State regulatory limit is identical to such

qualifying Federal determination. A State or

political subdivision shall be deemed to establish or enforce a regulatory limit on a pesticide chemical residue in or on a food if it

purports to prohibit or penalize the production, processing, shipping, or other handling of

a food because it contains a pesticide residue

(in excess of a prescribed limit).

(5) Petition procedure

(A) In general

Any State may petition the Administrator

for authorization to establish in such State

a regulatory limit on a qualifying pesticide

chemical residue in or on any food that is

not identical to the qualifying Federal determination applicable to such qualifying

pesticide chemical residue.

(B) Petition requirements

Any petition under subparagraph (A)

shall—

(i) satisfy any requirements prescribed,

by rule, by the Administrator; and

(ii) be supported by scientific data about

the pesticide chemical residue that is the

subject of the petition or about chemically

related pesticide chemical residues, data

on the consumption within such State of

food bearing the pesticide chemical residue, and data on exposure of humans within such State to the pesticide chemical

residue.

(C) Authorization

The Administrator may, by order, grant

the authorization described in subparagraph

(A) if the Administrator determines that the

proposed State regulatory limit—

(i) is justified by compelling local conditions; and

(ii) would not cause any food to be a violation of Federal law.

(D) Treatment

In lieu of any action authorized under subparagraph (C), the Administrator may treat

a petition under this paragraph as a petition

under subsection (d) of this section to modify or revoke a tolerance or an exemption. If

the Administrator determines to treat a petition under this paragraph as a petition

under subsection (d) of this section, the Administrator shall thereafter act on the petition pursuant to subsection (d) of this section.

(E) Review

Any order of the Administrator granting

or denying the authorization described in

subparagraph (A) shall be subject to review

in the manner described in subsections (g)

and (h) of this section.

(6) Urgent petition procedure

Any State petition to the Administrator

pursuant to paragraph (5) that demonstrates

that consumption of a food containing such

pesticide residue level during the period of the

food’s likely availability in the State will pose

a significant public health threat from acute

exposure shall be considered an urgent petition. If an order by the Administrator to grant

or deny the requested authorization in an urgent petition is not made within 30 days of receipt of the petition, the petitioning State

may establish and enforce a temporary regulatory limit on a qualifying pesticide chemical

residue in or on the food. The temporary regulatory limit shall be validated or terminated

by the Administrator’s final order on the petition.

(7) Residues from lawful application

No State or political subdivision may enforce any regulatory limit on the level of a

pesticide chemical residue that may appear in

or on any food if, at the time of the application of the pesticide that resulted in such residue, the sale of such food with such residue

level was lawful under this section and under

the law of such State, unless the State demonstrates that consumption of the food containing such pesticide residue level during the

period of the food’s likely availability in the

State will pose an unreasonable dietary risk

to the health of persons within such State.

(8) Savings

Nothing in this chapter preempts the authority of any State or political subdivision to

require that a food containing a pesticide

chemical residue bear or be the subject of a

warning or other statement relating to the

presence of the pesticide chemical residue in

or on such food.

(o) Consumer right to know

Not later than 2 years after August 3, 1996, and

annually thereafter, the Administrator shall, in

consultation with the Secretary of Agriculture

and the Secretary of Health and Human Services, publish in a format understandable to a lay

person, and distribute to large retail grocers for

public display (in a manner determined by the

grocer), the following information, at a minimum:

(1) A discussion of the risks and benefits of

pesticide chemical residues in or on food purchased by consumers.

(2) A listing of actions taken under subparagraph (B) of subsection (b)(2) of this section

that may result in pesticide chemical residues

in or on food that present a yearly or lifetime

risk above the risk allowed under subparagraph (A) of such subsection, and the food on

which the pesticide chemicals producing the

residues are used.
Page 107 TITLE 21—FOOD AND DRUGS § 346a

2See References in Text note below.

(3) Recommendations to consumers for reducing dietary exposure to pesticide chemical

residues in a manner consistent with maintaining a healthy diet, including a list of food

that may reasonably substitute for food listed

under paragraph (2).

Nothing in this subsection shall prevent retail

grocers from providing additional information.

(p) Estrogenic substances screening program

(1) Development

Not later than 2 years after August 3, 1996,

the Administrator shall in consultation with

the Secretary of Health and Human Services

develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine

whether certain substances may have an effect

in humans that is similar to an effect produced by a naturally occurring estrogen, or

such other endocrine effect as the Administrator may designate.

(2) Implementation

Not later than 3 years after August 3, 1996,

after obtaining public comment and review of

the screening program described in paragraph

(1) by the scientific advisory panel established

under section 25(d) of the Federal Insecticide,

Fungicide, and Rodenticide Act [7 U.S.C.

136w(d)] or the science advisory board established by section 4365 2 of title 42, the Administrator shall implement the program.

(3) Substances

In carrying out the screening program described in paragraph (1), the Administrator—

(A) shall provide for the testing of all pesticide chemicals; and

(B) may provide for the testing of any

other substance that may have an effect

that is cumulative to an effect of a pesticide

chemical if the Administrator determines

that a substantial population may be exposed to such substance.

(4) Exemption

Notwithstanding paragraph (3), the Administrator may, by order, exempt from the requirements of this section a biologic substance

or other substance if the Administrator determines that the substance is anticipated not to

produce any effect in humans similar to an effect produced by a naturally occurring estrogen.

(5) Collection of information

(A) In general

The Administrator shall issue an order to

a registrant of a substance for which testing

is required under this subsection, or to a person who manufactures or imports a substance for which testing is required under

this subsection, to conduct testing in accordance with the screening program described in paragraph (1), and submit information obtained from the testing to the Administrator, within a reasonable time period

that the Administrator determines is sufficient for the generation of the information.

(B) Procedures

To the extent practicable the Administrator shall minimize duplicative testing of

the same substance for the same endocrine

effect, develop, as appropriate, procedures

for fair and equitable sharing of test costs,

and develop, as necessary, procedures for

handling of confidential business information.

(C) Failure of registrants to submit information

(i) Suspension

If a registrant of a substance referred to

in paragraph (3)(A) fails to comply with an

order under subparagraph (A) of this paragraph, the Administrator shall issue a notice of intent to suspend the sale or distribution of the substance by the registrant. Any suspension proposed under

this paragraph shall become final at the

end of the 30-day period beginning on the

date that the registrant receives the notice of intent to suspend, unless during

that period a person adversely affected by

the notice requests a hearing or the Administrator determines that the registrant

has complied fully with this paragraph.

(ii) Hearing

If a person requests a hearing under

clause (i), the hearing shall be conducted

in accordance with section 554 of title 5.

The only matter for resolution at the hearing shall be whether the registrant has

failed to comply with an order under subparagraph (A) of this paragraph. A decision

by the Administrator after completion of a

hearing shall be considered to be a final

agency action.

(iii) Termination of suspensions

The Administrator shall terminate a suspension under this subparagraph issued

with respect to a registrant if the Administrator determines that the registrant has

complied fully with this paragraph.

(D) Noncompliance by other persons

Any person (other than a registrant) who

fails to comply with an order under subparagraph (A) shall be liable for the same penalties and sanctions as are provided under

section 16 of the Toxic Substances Control

Act [15 U.S.C. 2615] in the case of a violation

referred to in that section. Such penalties

and sanctions shall be assessed and imposed

in the same manner as provided in such section 16.

(6) Agency action

In the case of any substance that is found, as

a result of testing and evaluation under this

section, to have an endocrine effect on humans, the Administrator shall, as appropriate,

take action under such statutory authority as

is available to the Administrator, including

consideration under other sections of this

chapter, as is necessary to ensure the protection of public health.
§ 346a TITLE 21—FOOD AND DRUGS Page 108

3So in original. Probably should be ‘‘subsection’’.

(7) Report to Congress

Not later than 4 years after August 3, 1996,

the Administrator shall prepare and submit to

Congress a report containing—

(A) the findings of the Administrator resulting from the screening program described in paragraph (1);

(B) recommendations for further testing

needed to evaluate the impact on human

health of the substances tested under the

screening program; and

(C) recommendations for any further actions (including any action described in

paragraph (6)) that the Administrator determines are appropriate based on the findings.

(q) Schedule for review

(1) In general

The Administrator shall review tolerances

and exemptions for pesticide chemical residues in effect on the day before August 3, 1996,

as expeditiously as practicable, assuring

that—

(A) 33 percent of such tolerances and exemptions are reviewed within 3 years of August 3, 1996;

(B) 66 percent of such tolerances and exemptions are reviewed within 6 years of August 3, 1996; and

(C) 100 percent of such tolerances and exemptions are reviewed within 10 years of August 3, 1996.

In conducting a review of a tolerance or exemption, the Administrator shall determine

whether the tolerance or exemption meets the

requirements of subsections 3 (b)(2) or (c)(2) of

this section and shall, by the deadline for the

review of the tolerance or exemption, issue a

regulation under subsection (d)(4) or (e)(1) of

this section to modify or revoke the tolerance

or exemption if the tolerance or exemption

does not meet such requirements.

(2) Priorities

In determining priorities for reviewing tolerances and exemptions under paragraph (1), the

Administrator shall give priority to the review of the tolerances or exemptions that appear to pose the greatest risk to public health.

(3) Publication of schedule

Not later than 12 months after August 3,

1996, the Administrator shall publish a schedule for review of tolerances and exemptions established prior to August 3, 1996. The determination of priorities for the review of tolerances and exemptions pursuant to this subsection is not a rulemaking and shall not be

subject to judicial review, except that failure

to take final action pursuant to the schedule

established by this paragraph shall be subject

to judicial review.

(r) Temporary tolerance or exemption

The Administrator may, upon the request of

any person who has obtained an experimental

permit for a pesticide chemical under the Federal Insecticide, Fungicide, and Rodenticide Act

[7 U.S.C. 136 et seq.] or upon the Administrator’s

own initiative, establish a temporary tolerance

or exemption for the pesticide chemical residue

for the uses covered by the permit. Subsections

(b)(2), (c)(2), (d), and (e) of this section shall

apply to actions taken under this subsection.

(s) Savings clause

Nothing in this section shall be construed to

amend or modify the provisions of the Toxic

Substances Control Act [15 U.S.C. 2601 et seq.] or

the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.].

(June 25, 1938, ch. 675, §408, as added July 22,

1954, ch. 559, §3, 68 Stat. 511; amended Pub. L.

85–791, §20, Aug. 28, 1958, 72 Stat. 947; Pub. L.

91–515, title VI, §601(d)(1), Oct. 30, 1970, 84 Stat.

1311; Pub. L. 92–157, title III, §303(a), Nov. 18,

1971, 85 Stat. 464; Pub. L. 92–516, §3(3), Oct. 21,

1972, 86 Stat. 998; Pub. L. 98–620, title IV,

§402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub. L.

102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub.

L. 102–571, title I, §107(7), Oct. 29, 1992, 106 Stat.

4499; Pub. L. 103–80, §3(k), Aug. 13, 1993, 107 Stat.

776; Pub. L. 104–170, title IV, §405, Aug. 3, 1996,

110 Stat. 1514; Pub. L. 105–324, §2(b), Oct. 30, 1998,

112 Stat. 3036; Pub. L. 110–94, §4(d)(2), Oct. 9, 2007,

121 Stat. 1002; Pub. L. 112–177, §2(a)(3), Sept. 28,

2012, 126 Stat. 1329.)

REFERENCES IN TEXT

The Federal Rules of Civil Procedure, referred to in

subsec. (g)(2)(B), are set out in the Appendix to Title 28,

Judiciary and Judicial Procedure.

Section 346 of this title, referred to in subsec. (j)(1),

originally consisted of subsecs. (a) and (b). Subsec. (a)

was redesignated as the entire section 346 and subsec.

(b) was repealed by Pub. L. 86–618, title I, §103(a)(1), 74

Stat. 398.

The Federal Insecticide, Fungicide, and Rodenticide

Act, referred to in subsecs. (l), (n)(1)(A), (r), and (s), is

act June 25, 1947, ch. 125, as amended generally by Pub.

L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified

generally to subchapter II (§136 et seq.) of chapter 6 of

Title 7, Agriculture. For complete classification of this

Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.

Section 4365 of title 42, referred to in subsec. (p)(2),

was in the original ‘‘section 8 of the Environmental Research, Development, and Demonstration Act of 1978’’,

and was translated as meaning section 8 of the Environmental Research, Development, and Demonstration

Authorization Act of 1978, to reflect the probable intent

of Congress.

The Toxic Substances Control Act, referred to in subsec. (s), is Pub. L. 94–469, Oct. 11, 1976, 90 Stat. 2003, as

amended, which is classified generally to chapter 53

(§2601 et seq.) of Title 15, Commerce and Trade. For

complete classification of this Act to the Code, see

Short Title note set out under section 2601 of Title 15

and Tables.

CODIFICATION

August 3, 1996, referred to in subsecs. (k), (n)(1)(B),

(2)(A), and (p)(1), (2), (7), was in the original references

to the date of enactment of this subsection and the

date of enactment of this section, which was translated

as meaning the date of enactment of Pub. L. 104–170,

which amended this section generally, to reflect the

probable intent of Congress.

AMENDMENTS

2012—Subsec. (m)(3). Pub. L. 112–177 substituted ‘‘September 30, 2017’’ for ‘‘September 30, 2012’’.

2007—Subsec. (m)(3). Pub. L. 110–94 added par. (3).

1998—Subsec. (j)(4). Pub. L. 105–324 added par. (4).
Page 109 TITLE 21—FOOD AND DRUGS § 346a

1996—Pub. L. 104–170 amended section generally, substituting, in subsec. (a), provisions relating to requirement for tolerance or exemption for provisions relating

to conditions for safety; in subsec. (b), provisions relating to authority and standard for tolerance for provisions relating to establishment of tolerances; in subsec.

(c), provisions relating to authority and standard for

exemptions for provisions relating to exemptions; in

subsec. (d), provisions relating to petition for tolerance

or exemption for provisions relating to regulations pursuant to petition, publication of notice, time for issuance, referral to advisory committees, effective date,

and hearings; in subsec. (e), provisions relating to action on Administrator’s own initiative for provisions

relating to regulations pursuant to Administrator’s

proposals; in subsec. (f), provisions relating to special

data requirements for provisions relating to data submitted as confidential; in subsec. (g), provisions relating to effective date, objections, hearings, and administrative review for provisions relating to advisory committees and their appointment, composition, compensation, and clerical assistance; in subsec. (h), provisions relating to judicial review for provisions relating

to right of consultation; in subsec. (i), provisions relating to confidentiality and use of data for provisions relating to judicial review; in subsec. (j), provisions relating to status of previously issued regulations for provisions relating to temporary tolerances; in subsec. (k),

provisions relating to transitions for provisions relating to regulations based on public hearings before January 1, 1953; in subsec. (l), provisions relating to harmonization with action under other laws for provisions relating to pesticides under Federal Insecticide, Fungicide, and Rodenticide Act, functions of Administrator

of Environmental Protection Agency, certifications,

hearings, time limitations, opinions, and regulations;

in subsec. (m), provisions relating to fees for provisions

relating to amendment of regulations; in subsec. (n),

provisions relating to national uniformity of tolerances

for provisions relating to guaranties; in subsec. (o), provisions relating to consumer right to know for provisions relating to payment of fees, services or functions

conditioned on payment, and waiver or refund of fees;

and adding subsecs. (p) to (s).

1993—Pub. L. 103–80, §3(k)(6), substituted ‘‘Administrator’’ for ‘‘Secretary’’ wherever appearing except

when followed by ‘‘of Agriculture’’.

Subsec. (a)(1). Pub. L. 103–80, §3(k)(1), substituted

‘‘Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the ‘Administrator’)’’ for ‘‘Secretary of Health and Human

Services’’.

Subsec. (d)(5). Pub. L. 103–80, §3(k)(2), substituted

‘‘section 556(c) of title 5’’ for ‘‘section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))’’.

Subsec. (l). Pub. L. 103–80, §3(k)(3), substituted ‘‘In

the event’’ for ‘‘It the event’’ before ‘‘a hearing is requested’’.

Subsec. (n). Pub. L. 103–80, §3(k)(4), made technical

amendment to reference to section 333(c) of this title to

reflect amendment of corresponding provision of original act.

Subsec. (o). Pub. L. 103–80, §3(k)(5), which directed the

substitution of ‘‘Administrator’’ for ‘‘Secretary of

Health and Human Services’’ wherever appearing in the

original text, was executed by making the substitution

in the first sentence before ‘‘shall by regulation require’’, the only place ‘‘Secretary of Health and Human

Services’’ appeared in the original text.

1992—Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L.

102–300 substituted ‘‘Health and Human Services’’ for

‘‘Health, Education, and Welfare’’ wherever appearing

in the original statutory text.

Subsec. (g). Pub. L. 102–571 substituted ‘‘379e’’ for

‘‘376’’.

1984—Subsec. (i)(5). Pub. L. 98–620 struck out provision that required the court to advance on the docket

and expedite the disposition of all causes filed therein

pursuant to this section.

1972—Subsecs. (d)(1), (e), (l). Pub. L. 92–516 substituted

references to pesticide for references to economic poison wherever appearing therein.

1971—Subsec. (g). Pub. L. 92–157 struck out ‘‘, which

the Secretary shall by rules and regulations prescribe,’’

after ‘‘as compensation for their services a reasonable

per diem’’ prior to amendment in 1970, by Pub. L.

91–515, which overlooked such language when amending

subsec. (g) as provided in 1970 Amendment note.

1970—Subsec. (g). Pub. L. 91–515 substituted provisions authorizing members of an advisory committee to

receive compensation and travel expenses in accordance with section 376(b)(5)(D) of this title, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent

on committee work, and necessary traveling and subsistence expenses while serving away from their places

of residence.

1958—Subsec. (i)(2). Pub. L. 85–791, §20(a), in first sentence, substituted ‘‘transmitted by the clerk of the

court to the Secretary, or’’ for ‘‘served upon the Secretary, or upon’’, substituted ‘‘file in the court the

record of the proceedings’’ for ‘‘certify and file in the

court a transcript of the proceedings and the record’’,

and inserted ‘‘as provided in section 2112 of title 28’’,

and which, in second sentence, substituted ‘‘the filing

of such petition’’ for ‘‘such filing’’.

Subsec. (i)(3). Pub. L. 85–791, §20(b), in first sentence,

substituted ‘‘transmitted by the clerk of the court to

the Secretary of Agriculture, or’’ for ‘‘served upon the

Secretary of Agriculture, or upon’’, substituted ‘‘file in

the court the record of the proceedings’’ for ‘‘certify

and file in the court a transcript of the proceedings and

the record’’, and inserted ‘‘as provided in section 2112 of

title 28’’, and, in second sentence, substituted ‘‘the filing of such petition’’ for ‘‘such filing’’.

EFFECTIVE DATE OF 2012 AMENDMENT

Amendment by Pub. L. 112–177 effective Oct. 1, 2012,

see section 2(c) of Pub. L. 112–177, set out as a note

under section 136a–1 of Title 7, Agriculture.

EFFECTIVE DATE OF 2007 AMENDMENT

Amendment by Pub. L. 110–94 effective Oct. 1, 2007,

see section 6 of Pub. L. 110–94, set out as a note under

section 136a of Title 7, Agriculture.

EFFECTIVE DATE OF 1984 AMENDMENT

Amendment by Pub. L. 98–620 not applicable to cases

pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620,

set out as an Effective Date note under section 1657 of

Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by Pub. L. 92–516 effective at close of

Oct. 21, 1972, except if regulations are necessary for implementation of any provision that becomes effective

on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, Agriculture, and regulations thereunder, relating to control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92–516 and regulations

thereunder, see section 4 of Pub. L. 92–516, set out as an

Effective Date note under section 136 of Title 7.

TOLERANCE FEES

Pub. L. 108–199, div. G, title V, §501(d)(2), Jan. 23, 2004,

118 Stat. 422, provided that: ‘‘Notwithstanding section

408(m)(1) of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 346a(m)(1)), during the period beginning on

October 1, 2003, and ending on September 30, 2008, the

Administrator of the Environmental Protection Agency shall not collect any tolerance fees under that section.’’

DATA COLLECTION ACTIVITIES TO ASSURE HEALTH OF

INFANTS AND CHILDREN

Pub. L. 104–170, title III, §301, Aug. 3, 1996, 110 Stat.

1511, provided that:

‘‘(a) IN GENERAL.—The Secretary of Agriculture, in

consultation with the Administrator of the Environ-
§ 346b TITLE 21—FOOD AND DRUGS Page 110

mental Protection Agency and the Secretary of Health

and Human Services, shall coordinate the development

and implementation of survey procedures to ensure

that adequate data on food consumption patterns of infants and children are collected.

‘‘(b) PROCEDURES.—To the extent practicable, the procedures referred to in subsection (a) shall include the

collection of data on food consumption patterns of a

statistically valid sample of infants and children.

‘‘(c) RESIDUE DATA COLLECTION.—The Secretary of

Agriculture shall ensure that the residue data collection activities conducted by the Department of Agriculture in cooperation with the Environmental Protection Agency and the Department of Health and Human

Services, provide for the improved data collection of

pesticide residues, including guidelines for the use of

comparable analytical and standardized reporting

methods, and the increased sampling of foods most

likely consumed by infants and children.’’

§ 346b. Authorization of appropriations

There are authorized to be appropriated, out of

any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for

the purpose and administration of sections

321(q), (r), 342(a)(2), and 346a of this title.

(July 22, 1954, ch. 559, §4, 68 Stat. 517.)

CODIFICATION

Section was not enacted as part of the Federal Food,

Drug, and Cosmetic Act which comprises this chapter.

§ 347. Intrastate sales of colored oleomargarine

(a) Law governing

Colored oleomargarine or colored margarine

which is sold in the same State or Territory in

which it is produced shall be subject in the same

manner and to the same extent to the provisions

of this chapter as if it had been introduced in

interstate commerce.

(b) Labeling and packaging requirements

No person shall sell, or offer for sale, colored

oleomargarine or colored margarine unless—

(1) such oleomargarine or margarine is packaged,

(2) the net weight of the contents of any

package sold in a retail establishment is one

pound or less,

(3) there appears on the label of the package

(A) the word ‘‘oleomargarine’’ or ‘‘margarine’’

in type or lettering at least as large as any

other type or lettering on such label, and (B)

a full and accurate statement of all the ingredients contained in such oleomargarine or

margarine, and

(4) each part of the contents of the package

is contained in a wrapper which bears the word

‘‘oleomargarine’’ or ‘‘margarine’’ in type or

lettering not smaller than 20-point type.

The requirements of this subsection shall be in

addition to and not in lieu of any of the other

requirements of this chapter.

(c) Sales in public eating places

No person shall possess in a form ready for

serving colored oleomargarine or colored margarine at a public eating place unless a notice

that oleomargarine or margarine is served is

displayed prominently and conspicuously in

such place and in such manner as to render it

likely to be read and understood by the ordinary

individual being served in such eating place or is

printed or is otherwise set forth on the menu in

type or lettering not smaller than that normally

used to designate the serving of other food

items. No person shall serve colored oleomargarine or colored margarine at a public eating place, whether or not any charge is made

therefor, unless (1) each separate serving bears

or is accompanied by labeling identifying it as

oleomargarine or margarine, or (2) each separate

serving thereof is triangular in shape.

(d) Exemption from labeling requirements

Colored oleomargarine or colored margarine

when served with meals at a public eating place

shall at the time of such service be exempt from

the labeling requirements of section 343 of this

title (except paragraphs (a) and (f)) if it complies with the requirements of subsection (b) of

this section.

(e) Color content of oleomargarine

For the purpose of this section colored oleomargarine or colored margarine is oleomargarine or margarine having a tint or shade

containing more than one and six-tenths degrees

of yellow, or of yellow and red collectively, but

with an excess of yellow over red, measured in

terms of Lovibond tintometer scale or its equivalent.

(June 25, 1938, ch. 675, §407, as added Mar. 16,

1950, ch. 61, §3(c), 64 Stat. 20.)

EFFECTIVE DATE

Act Mar. 16, 1950, ch. 61, §7, 64 Stat. 22, provided that:

‘‘This Act [enacting this section and sections 347a and

347b of this title and amending sections 331 and 342 of

this title and sections 45 and 55 of Title 15, Commerce

and Trade] shall become effective on July 1, 1950.’’

TRANSFER OF APPROPRIATIONS

Act Mar. 16, 1950, ch. 61, §5, 64 Stat. 22, provided that:

‘‘So much of the unexpended balances of appropriations, allocations, or other funds (including funds available for the fiscal year ending June 30, 1950) for the use

of the Bureau of Internal Revenue of the Treasury Department in the exercise of functions under the Oleomargarine Tax Act (26 U.S.C., §2300, subchapter A) [now

section 4591 et seq. of Title 26, Internal Revenue Code],

as the Director of the Bureau of the Budget [now Director of the Office of Management and Budget] may determine, shall be transferred to the Federal Security

Agency (Food and Drug Administration) [now the Department of Health and Human Services] for use in the

enforcement of this Act [see Effective Date note

above].’’

§ 347a. Congressional declaration of policy regarding oleomargarine sales

The Congress finds and declares that the sale,

or the serving in public eating places, of colored

oleomargarine or colored margarine without

clear identification as such or which is otherwise adulterated or misbranded within the

meaning of this chapter depresses the market in

interstate commerce for butter and for oleomargarine or margarine clearly identified and

neither adulterated nor misbranded, and constitutes a burden on interstate commerce in

such articles. Such burden exists, irrespective of

whether such oleomargarine or margarine originates from an interstate source or from the

State in which it is sold.