Page 96 TITLE 21—FOOD AND DRUGS § 346

processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condi

tion that such food is not adulterated or mis

branded 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.)

A MENDMENTS 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.’’

E FFECTIVE D ATE OF 1990 A MENDMENT 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 regu

lations are not promulgated, the date proposed regula

tions 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.

C ONSTRUCTION OF A MENDMENTS BY P UB . 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 Fed

eral 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.

T RANSFER OF F UNCTIONS For transfer of functions of Federal Security Admin

istrator 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 re

quired in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the applica

tion of clause (2)(A) of section 342(a) of this title; but when such substance is so required or can

not be so avoided, the Secretary shall promul

gate 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 appli

cation of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect limit

ing 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 dif

ferent 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 af

fected by the same or other poisonous or delete

rious 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.)

A MENDMENTS 1960—Pub. L. 86–618 repealed subsec. (b) which re

quired 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.

E FFECTIVE D ATE OF 1960 A MENDMENT 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.
E FFECTIVE D ATE OF N EMATOCIDE , P LANT R EGULATOR , D EFOLIANT , AND D ESICCANT A MENDMENT 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.
E FFECTIVE D ATE OF 1958 A MENDMENT 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.

T RANSFER OF F UNCTIONS Functions vested in Secretary of Health, Education, and Welfare [now Health and Human Services] in estab

lishing 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 Environ

mental 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 Organiza

tion and Employees. For transfer of functions of Federal Security Admin

istrator 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 sec

tion 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 commod

ity 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 pes

ticide 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 chemi

cal 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 res

idue in or on the raw agricultural commod

ity has been removed to the extent possible in good manufacturing practice, and the concentration of the pesticide chemical resi

due 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 chemi

cal residue that is present in or on a proc

essed 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 sec

tion for residues of the precursor sub

stance in or on the food, and the combined level of residues of the degradation prod

uct and the precursor substance in or on the food is at or below the stoichi

ometrically 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 tol

erance 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 sub

stances 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 re

quirement 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 es

tablishing, 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 toler

ance is safe. The Administrator shall mod

ify or revoke a tolerance if the Adminis

trator 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 Adminis

trator has determined that there is a rea

sonable 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 subpara

graph (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 resi

due 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 appropriatelyPage 98 TITLE 21—FOOD AND DRUGS § 346a

assessed by quantitative risk assess

ment; and (III) with regard to any known or an

ticipated harm to human health for which the Administrator is able to iden

tify a level at which the residue will not cause such harm (referred to in this sec

tion as a ‘‘threshold effect’’), the Admin

istrator determines that the level of ag

gregate 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 de

scribed 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 condi

tions 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 di

etary risk from the residue. (II) Use of the pesticide chemical that produces the residue is necessary to avoid a significant disruption in domes

tic production of an adequate, whole

some, and economical food supply. (iv) Conditions regarding risk For purposes of clause (ii), the condi

tions 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 expo

sure to the residue does not exceed 10 times the yearly risk that would be al

lowed under subparagraph (A) for such effect. (II) The tolerance is limited so as to ensure that the risk over a lifetime asso

ciated 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 Ad

ministrator shall determine, after notice and opportunity for comment, whether it has been demonstrated to the Adminis

trator 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 com

ply 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 deter

mination, issue a regulation under sub

section (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 subpara

graph (C). (C) Exposure of infants and children In establishing, modifying, leaving in ef

fect, or revoking a tolerance or exemption for a pesticide chemical residue, the Admin

istrator— (i) shall assess the risk of the pesticide chemical residue based on— (I) available information about con

sumption patterns among infants and children that are likely to result in dis

proportionately high consumption of foods containing or bearing such residue among infants and children in compari

son to the general population; (II) available information concerning the special susceptibility of infants and children to the pesticide chemical resi

dues, including neurological differences between infants and children and adults, and effects of in utero exposure to pes

ticide chemicals; and (III) available information concerning the cumulative effects on infants and children of such residues and other sub

stances that have a common mechanism of toxicity; and (ii) shall— (I) ensure that there is a reasonable certainty that no harm will result to in

fants and children from aggregate expo

sure to the pesticide chemical residue; and (II) publish a specific determination re

garding the safety of the pesticide chem

ical residue for infants and children. The Secretary of Health and Human Serv

ices and the Secretary of Agriculture, in consultation with the Administrator, shall conduct surveys to document dietary expo

sure to pesticides among infants and chil

dren. In the case of threshold effects, for purposes of clause (ii)(I) an additional ten

fold margin of safety for the pesticide chem

ical residue and other sources of exposure shall be applied for infants and children totake into account potential pre- and postnatal toxicity and completeness of the data with respect to exposure and toxicity to in

fants and children. Notwithstanding such re

quirement for an additional margin of safe

ty, 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 chil

dren. (D) Factors In establishing, modifying, leaving in ef

fect, or revoking a tolerance or exemptionPage 99 TITLE 21—FOOD AND DRUGS § 346a

for a pesticide chemical residue, the Admin

istrator shall consider, among other rel

evant factors— (i) the validity, completeness, and reli

ability 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 consum

ers (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 con

sumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the tolerance and all other tolerances in effect for the pes

ticide 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 Adminis

trator may require on whether the pes

ticide chemical may have an effect in hu

mans 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 experi

mentation data. (E) Data and information regarding antici

pated and actual residue levels (i) Authority In establishing, modifying, leaving in ef

fect, or revoking a tolerance for a pes

ticide chemical residue, the Administrator may consider available data and informa

tion 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 antici

pated or actual residue levels in establish

ing, modifying, or leaving in effect a toler

ance, 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 sec

tion, as appropriate, to modify or revoke the tolerance. (F) Percent of food actually treated In establishing, modifying, leaving in ef

fect, or revoking a tolerance for a pesticide chemical residue, the Administrator may, when assessing chronic dietary risk, con

sider available data and information on the percent of food actually treated with the pesticide chemical (including aggregate pes

ticide 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 percent

age 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 signifi

cant 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 Adminis

trator; and (iv) provides for the periodic reevalua

tion of the estimate of anticipated dietary exposure. (3) Detection methods (A) General rule A tolerance for a pesticide chemical resi

due in or on a food shall not be established or modified by the Administrator unless the Administrator determines, after consulta

tion with the Secretary, that there is a prac

tical 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 resi

due 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 sub

paragraph (A). (4) International standards In establishing a tolerance for a pesticide chemical residue in or on a food, the Adminis

trator 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 pro

pose to adopt the Codex level, the Adminis

trator shall publish for public comment a no

tice explaining the reasons for departing from the Codex level.Page 100 TITLE 21—FOOD AND DRUGS § 346a

(c) Authority and standard for exemptions (1) Authority The Administrator may issue a regulation establishing, modifying, or revoking an ex

emption 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 re

quirement for a tolerance for a pesticide chemical residue in or on food only if the Administrator determines that the exemp

tion is safe. The Administrator shall mod

ify or revoke an exemption if the Adminis

trator determines it is not safe. (ii) Determination of safety The term ‘‘safe’’, with respect to an ex

emption for a pesticide chemical residue, means that the Administrator has deter

mined 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 consider

ations, the considerations set forth in sub

paragraphs (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 Adminis

trator determines, after consultation with the Secretary— (A) that there is a practical method for de

tecting and measuring the levels of such pes

ticide chemical residue in or on food; or (B) that there is no need for such a meth

od, and states the reasons for such deter

mination in issuing the regulation establish

ing 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 regula

tion— (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 toler

ance 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 reg

ulations issued by the Administrator, in

cluding— (i)(I) an informative summary of the pe

tition and of the data, information, and ar

guments submitted or cited in support of the petition; and (II) a statement that the petitioner agrees that such summary or any informa

tion 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 is

sued under this section; (ii) the name, chemical identity, and composition of the pesticide chemical resi

due and of the pesticide chemical that pro

duces the residue; (iii) data showing the recommended amount, frequency, method, and time of application of that pesticide chemical; (iv) full reports of tests and investiga

tions made with respect to the safety of the pesticide chemical, including full in

formation as to the methods and controls used in conducting those tests and inves

tigations; (v) full reports of tests and investiga

tions 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 meth

od is not needed; (vii) a proposed tolerance for the pes

ticide chemical residue, if a tolerance is proposed; (viii) if the petition relates to a toler

ance for a processed food, reports of inves

tigations conducted using the processing method(s) used to produce that food; (ix) such information as the Adminis

trator may require to make the deter

mination under subsection (b)(2)(C) of this section; (x) such information as the Adminis

trator may require on whether the pes

ticide chemical may have an effect in hu

mans 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 sub

paragraph 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 AdministratorPage 101 TITLE 21—FOOD AND DRUGS § 346a

may require a petition to be accompanied by samples of the pesticide chemical with re

spect to which the petition is filed. (B) Modification or revocation The Administrator may by regulation es

tablish 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 toler

ance. (3) Notice A notice of the filing of a petition that the Administrator determines has met the re

quirements 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 pes

ticide chemical residue with respect to which the petition is filed or shall set forth the peti

tioner’s statement of why such a method is not needed. The notice shall include the sum

mary 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 para

graph (1) and any other information avail

able to the Administrator— (i) issue a final regulation (which may vary from that sought by the petition) es

tablishing, modifying, or revoking a toler

ance for the pesticide chemical residue or an exemption of the pesticide chemical residue from the requirement of a toler

ance (which final regulation shall be is

sued without further notice and without further period for public comment); (ii) issue a proposed regulation under subsection (e) of this section, and there

after 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 modifica

tion of a tolerance or exemption for a pes

ticide chemical residue that appears to pose a significantly lower risk to human health from dietary exposure than pesticide chemi

cal 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 para

graph within 1 year. (ii) Required determinations If the Administrator issues a final regu

lation establishing a tolerance or exemp

tion 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 con

tinue 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 re

voking a tolerance for a pesticide chemical or a pesticide chemical residue; (B) establishing, modifying, suspending under subsection ( l )(3) of this section, or re

voking an exemption of a pesticide chemical residue from the requirement of a tolerance;
or (C) establishing general procedures and re

quirements to implement this section. (2) Notice Before issuing a final regulation under para

graph (1), the Administrator shall issue a no

tice of proposed rulemaking and provide a pe

riod of not less than 60 days for public com

ment 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 addi

tional data or information are reasonably re

quired to support the continuation of a toler

ance 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 associ

ated with such tolerance or exemption to submit the data or information under sec

tion 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 Ad

ministrator by one or more interested per

sons of a notice identifying the person or persons who will submit the required data and information;Page 102 TITLE 21—FOOD AND DRUGS § 346a

(ii) describing the type of data and infor

mation required to be submitted to the Ad

ministrator 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 Roden

ticide 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 Admin

istrator required to be prepared during and after the collection of the data and infor

mation; (iv) requiring the submission to the Ad

ministrator of the data, information, and reports referred to in clauses (ii) and (iii); and (v) establishing dates by which the sub

missions 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 para

graph require data or information pertaining to whether the pesticide chemical may have an effect in humans that is similar to an ef

fect produced by a naturally occurring estro

gen or other endocrine effects. (2) Noncompliance If a submission required by a notice issued in accordance with paragraph (1)(A), a rule is

sued 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 Ad

ministrator may by order published in the Federal Register modify or revoke the toler

ance 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 para

graph (1) was not made by the time specified. (g) Effective date, objections, hearings, and ad

ministrative review (1) Effective date A regulation or order issued under sub

section (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 pursu

ant 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 sec

tion, any person may file objections thereto with the Administrator, specifying with par

ticularity the provisions of the regulation or order deemed objectionable and stating rea

sonable 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 objec

tion. The Administrator shall, upon the ini

tiative of the Administrator or upon the re

quest of an interested person and after due notice, hold a public evidentiary hearing if and to the extent the Administrator deter

mines that such a public hearing is nec

essary to receive factual evidence relevant to material issues of fact raised by the ob

jections. The presiding officer in such a hearing may authorize a party to obtain dis

covery from other persons and may upon a showing of good cause made by a party issue a subpoena to compel testimony or produc

tion of documents from any person. The pre

siding officer shall be governed by the Fed

eral 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 ex

penses 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 war

ranted. If a hearing was held under subpara

graph (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 conclu

sions 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 va

lidity of any regulation issued under sub

section (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 sub

ject 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 prin

cipal 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 pur

pose, 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 titlePage 103 TITLE 21—FOOD AND DRUGS § 346a

1 See 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 follow

ing 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 rea

sonable grounds for the failure to adduce the evidence in the proceeding before the Adminis

trator, the court may order that the addi

tional evidence (and evidence in rebuttal thereof) shall be taken before the Adminis

trator in the manner and upon the terms and conditions the court deems proper. The Ad

ministrator may modify prior findings as to the facts by reason of the additional evidence so taken and may modify the order or regula

tion 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 set

ting 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 or

dered 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 ob

tainable under this subsection shall not be the subject of judicial review under any other pro

vision 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 ex

clusive use and data compensation to the same extent provided by sections 3 and 10 of the Federal Insecticide, Fungicide, and Roden

ticide 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 re

quirements as the Administrator may pro

vide by regulation, to— (i) employees of the United States au

thorized by the Administrator to examine such data and information in the carrying out of their official duties under this chap

ter or other Federal statutes intended to protect the public health; or (ii) contractors with the United States authorized by the Administrator to exam

ine such data and information in the car

rying out of contracts under this chapter or such statutes. (B) Congress This subsection does not authorize the withholding of data or information from ei

ther House of Congress or from, to the ex

tent of matter within its jurisdiction, any committee or subcommittee of such com

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

tee. (3) Summaries Notwithstanding any provision of this sub

section 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 inform

ative summary of the data relating to the reg

ulation or order. (j) Status of previously issued regulations (1) Regulations under section 346 Regulations affecting pesticide chemical res

idues 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 modifica

tion or revocation under subsections (d) and (e) of this section, and shall be subject to re

view under subsection (q) of this section. (2) Regulations under section 348 Regulations that established tolerances for substances that are pesticide chemical resi

dues in or on processed food, or that otherwise stated the conditions under which such pes

ticide 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 ef

fect unless modified or revoked under sub

section (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 in

cluded 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

-Page 104 TITLE 21—FOOD AND DRUGS § 346a

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 sub

stance 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 sub

stance that is a pesticide chemical was, with re

spect to a particular pesticidal use of the sub

stance and any resulting pesticide chemical resi

due 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 re

garded as exempt from the requirement for a tolerance, as of August 3, 1996. The Adminis

trator shall by regulation indicate which sub

stances are described by this subsection. Any ex

emption under this subsection may be modified or revoked as if it had been issued under sub

section (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 toler

ance or exemption for a pesticide chemical residue in or on food, the Administrator shall coordinate such action with any related nec

essary action under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.]. (2) Revocation of tolerance or exemption fol

lowing cancellation of associated registra

tions If the Administrator, acting under the Fed

eral 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 resi

dues 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 rev

ocation under this paragraph shall become ef

fective not later than 180 days after— (A) the date by which each such cancella

tion of a registration has become effective;
or (B) the date on which the use of the can

celed pesticide becomes unlawful under the terms of the cancellation, whichever is later. (3) Suspension of tolerance or exemption fol

lowing suspension of associated registra

tions (A) Suspension If the Administrator, acting under the Federal Insecticide, Fungicide, and Roden

ticide Act, suspends the use of each reg

istered 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 chemi

cal 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 be

come 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 exemp

tion under subparagraph (A) shall be effec

tive 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 toler

ance or exemption shall not be considered to be in effect. If the suspension of use of the pesticide under that Act is terminated, leav

ing the registration of the pesticide for such use in effect under that Act, the Adminis

trator shall rescind any associated suspen

sion of tolerance or exemption. (4) Tolerances for unavoidable residues In connection with action taken under para

graph (2) or (3), or with respect to pesticides whose registrations were suspended or can

celed 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 chemi

cal will unavoidably persist in the environ

ment and thereby be present in or on a food, the Administrator may establish a tolerance for the pesticide chemical residue. In estab

lishing 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 establish

ment 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 ap

plication of pesticide Notwithstanding any other provision of this chapter, if a tolerance or exemption for a pes

ticide chemical residue in or on a food has been revoked, suspended, or modified underPage 105 TITLE 21—FOOD AND DRUGS § 346a

this section, an article of that food shall not be deemed unsafe solely because of the pres

ence 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 Roden

ticide Act; and (B) the residue does not exceed a level that was authorized at the time of that applica

tion or use to be present on the food under a tolerance, exemption, food additive regula

tion, or other sanction then in effect under this chapter; unless, in the case of any tolerance or exemp

tion revoked, suspended, or modified under this subsection or subsection (d) or (e) of this section, the Administrator has issued a deter

mination that consumption of the legally treated food during the period of its likely availability in commerce will pose an unrea

sonable 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 pes

ticide chemical residue. Such a tolerance or exemption from a tolerance shall have an expi

ration date. The Administrator may establish such a tolerance or exemption without provid

ing notice or a period for comment on the tol

erance or exemption. The Administrator shall promulgate regulations within 365 days after August 3, 1996, governing the establishment of tolerances and exemptions under this para

graph. 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 re

quire the payment of such fees as will in the aggregate, in the judgment of the Adminis

trator, be sufficient over a reasonable term to provide, equip, and maintain an adequate serv

ice for the performance of the Administrator’s functions under this section. Under the regula

tions, 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 sec

tion; (B) establishing, modifying, leaving in ef

fect, or revoking a tolerance or establishing, modifying, leaving in effect, or revoking an exemption from the requirement for a toler

ance 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 Expe

dited 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, with

out 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 Ad

ministrator shall not collect any tolerance fees under paragraph (1). (n) National uniformity of tolerances (1) ‘‘Qualifying pesticide chemical residue’’ de

fined 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 ac

tive ingredient and that— (A) was first approved for such use in a registration of a pesticide issued under sec

tion 3(c)(5) of the Federal Insecticide, Fun

gicide, and Rodenticide Act [7 U.S.C. 136a(c)(5)] on or after April 25, 1985, on the basis of data determined by the Adminis

trator 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 rereg

istration 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 Au

gust 3, 1996, and determined by the Adminis

trator to meet the standard under sub

section (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 sec

tion is remaining in effect or is deemed to have been issued under this section, or is re

garded under subsection (k) of this section as exempt from the requirement for a toler

ance; 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 deter

mination described in paragraph (2)(B)(ii) onlyPage 106 TITLE 21—FOOD AND DRUGS § 346a

by issuing a rule in accordance with the proce

dure 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 ac

cordance 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 estab

lish or enforce any regulatory limit on a quali

fying pesticide chemical residue in or on any food if a qualifying Federal determination ap

plies to the presence of such pesticide chemi

cal 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 estab

lish or enforce a regulatory limit on a pes

ticide chemical residue in or on a food if it purports to prohibit or penalize the produc

tion, 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 de

termination 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 resi

due, and data on exposure of humans with

in 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 condi

tions; and (ii) would not cause any food to be a vio

lation of Federal law. (D) Treatment In lieu of any action authorized under sub

paragraph (C), the Administrator may treat a petition under this paragraph as a petition under subsection (d) of this section to mod

ify or revoke a tolerance or an exemption. If the Administrator determines to treat a pe

tition under this paragraph as a petition under subsection (d) of this section, the Ad

ministrator shall thereafter act on the peti

tion pursuant to subsection (d) of this sec

tion. (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 peti

tion. If an order by the Administrator to grant or deny the requested authorization in an ur

gent petition is not made within 30 days of re

ceipt of the petition, the petitioning State may establish and enforce a temporary regu

latory limit on a qualifying pesticide chemical residue in or on the food. The temporary regu

latory limit shall be validated or terminated by the Administrator’s final order on the peti

tion. (7) Residues from lawful application No State or political subdivision may en

force 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 applica

tion of the pesticide that resulted in such resi

due, the sale of such food with such residue level was lawful under this section and under the law of such State, unless the State dem

onstrates that consumption of the food con

taining 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 au

thority 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 Serv

ices, 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 mini

mum: (1) A discussion of the risks and benefits of pesticide chemical residues in or on food pur

chased by consumers. (2) A listing of actions taken under subpara

graph (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 subpara

graph (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

2 See References in Text note below. (3) Recommendations to consumers for re

ducing dietary exposure to pesticide chemical residues in a manner consistent with main

taining 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 appro

priate validated test systems and other sci

entifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect pro

duced by a naturally occurring estrogen, or such other endocrine effect as the Adminis

trator 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 estab

lished by section 4365 2 of title 42, the Adminis

trator shall implement the program. (3) Substances In carrying out the screening program de

scribed in paragraph (1), the Administrator— (A) shall provide for the testing of all pes

ticide 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 ex

posed to such substance. (4) Exemption Notwithstanding paragraph (3), the Adminis

trator may, by order, exempt from the re

quirements of this section a biologic substance or other substance if the Administrator deter

mines that the substance is anticipated not to produce any effect in humans similar to an ef

fect produced by a naturally occurring estro

gen. (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 per

son who manufactures or imports a sub

stance for which testing is required under this subsection, to conduct testing in ac

cordance with the screening program de

scribed in paragraph (1), and submit infor

mation obtained from the testing to the Ad

ministrator, within a reasonable time period that the Administrator determines is suffi

cient for the generation of the information. (B) Procedures To the extent practicable the Adminis

trator 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 informa

tion. (C) Failure of registrants to submit informa

tion (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 para

graph, the Administrator shall issue a no

tice of intent to suspend the sale or dis

tribution of the substance by the reg

istrant. 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 no

tice of intent to suspend, unless during that period a person adversely affected by the notice requests a hearing or the Ad

ministrator 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 hear

ing shall be whether the registrant has failed to comply with an order under sub

paragraph (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 sus

pension under this subparagraph issued with respect to a registrant if the Admin

istrator 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 subpara

graph (A) shall be liable for the same pen

alties 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 sec

tion 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 hu

mans, 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 protec

tion of public health.Page 108 TITLE 21—FOOD AND DRUGS § 346a

3 So 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 re

sulting from the screening program de

scribed 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 ac

tions (including any action described in paragraph (6)) that the Administrator deter

mines are appropriate based on the findings. (q) Schedule for review (1) In general The Administrator shall review tolerances and exemptions for pesticide chemical resi

dues in effect on the day before August 3, 1996, as expeditiously as practicable, assuring that— (A) 33 percent of such tolerances and ex

emptions are reviewed within 3 years of Au

gust 3, 1996; (B) 66 percent of such tolerances and ex

emptions are reviewed within 6 years of Au

gust 3, 1996; and (C) 100 percent of such tolerances and ex

emptions are reviewed within 10 years of Au

gust 3, 1996. In conducting a review of a tolerance or ex

emption, 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 toler

ances and exemptions under paragraph (1), the Administrator shall give priority to the re

view of the tolerances or exemptions that ap

pear 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 sched

ule for review of tolerances and exemptions es

tablished prior to August 3, 1996. The deter

mination of priorities for the review of toler

ances and exemptions pursuant to this sub

section 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 Fed

eral 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 Roden

ticide 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.)

R EFERENCES IN T EXT 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 sec

tion 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 Re

search, Development, and Demonstration Act of 1978’’, and was translated as meaning section 8 of the Envi

ronmental Research, Development, and Demonstration Authorization Act of 1978, to reflect the probable intent of Congress. The Toxic Substances Control Act, referred to in sub

sec. (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.

C ODIFICATION 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.

A MENDMENTS 2012—Subsec. (m)(3). Pub. L. 112–177 substituted ‘‘Sep

tember 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, sub

stituting, in subsec. (a), provisions relating to require

ment for tolerance or exemption for provisions relating to conditions for safety; in subsec. (b), provisions relat

ing to authority and standard for tolerance for provi

sions 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 pur

suant to petition, publication of notice, time for issu

ance, referral to advisory committees, effective date, and hearings; in subsec. (e), provisions relating to ac

tion 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 sub

mitted as confidential; in subsec. (g), provisions relat

ing to effective date, objections, hearings, and adminis

trative review for provisions relating to advisory com

mittees and their appointment, composition, com

pensation, and clerical assistance; in subsec. (h), provi

sions relating to judicial review for provisions relating to right of consultation; in subsec. (i), provisions relat

ing to confidentiality and use of data for provisions re

lating to judicial review; in subsec. (j), provisions relat

ing to status of previously issued regulations for provi

sions relating to temporary tolerances; in subsec. (k), provisions relating to transitions for provisions relat

ing to regulations based on public hearings before Jan

uary 1, 1953; in subsec. ( l ), provisions relating to harmo

nization with action under other laws for provisions re

lating to pesticides under Federal Insecticide, Fun

gicide, 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 ), pro

visions relating to consumer right to know for provi

sions 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 ‘‘Adminis

trator’’ 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 Agen

cy (hereinafter in this section referred to as the ‘Ad

ministrator’)’’ 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 Ad

ministrative 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 re

quested’’. 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 origi

nal 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 re

quire’’, 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 provi

sion 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 poi

son 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 provi

sions authorizing members of an advisory committee to receive compensation and travel expenses in accord

ance with section 376(b)(5)(D) of this title, for provi

sions authorizing such members to receive as com

pensation a reasonable per diem for time actually spent on committee work, and necessary traveling and sub

sistence expenses while serving away from their places of residence. 1958—Subsec. (i)(2). Pub. L. 85–791, §20(a), in first sen

tence, substituted ‘‘transmitted by the clerk of the court to the Secretary, or’’ for ‘‘served upon the Sec

retary, 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 fil

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

E FFECTIVE D ATE OF 2012 A MENDMENT 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.

E FFECTIVE D ATE OF 2007 A MENDMENT 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.

E FFECTIVE D ATE OF 1984 A MENDMENT 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.

E FFECTIVE D ATE OF 1972 A MENDMENT Amendment by Pub. L. 92–516 effective at close of Oct. 21, 1972, except if regulations are necessary for im

plementation of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of sub

chapter I of chapter 6 of Title 7, Agriculture, and regu

lations thereunder, relating to control of economic poi

sons, as in existence prior to Oct. 21, 1972, until super

seded 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.

T OLERANCE F EES 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 Agen

cy shall not collect any tolerance fees under that sec

tion.’’

D ATA C OLLECTION A CTIVITIES T O A SSURE H EALTH OF

I NFANTS AND C HILDREN Pub. L. 104–170, title III, §301, Aug. 3, 1996, 110 Stat. 1511, provided that: ‘‘(a) I N G ENERAL .—The Secretary of Agriculture, in consultation with the Administrator of the Environ

-Page 110 TITLE 21—FOOD AND DRUGS § 346b

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 in

fants and children are collected. ‘‘(b) P ROCEDURES .—To the extent practicable, the pro

cedures 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) R ESIDUE D ATA C OLLECTION .—The Secretary of Agriculture shall ensure that the residue data collec

tion activities conducted by the Department of Agri

culture in cooperation with the Environmental Protec

tion 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 ap

propriated, 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.)

C ODIFICATION 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 pack

aged, (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 ingre

dients 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 mar

garine 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 oleo

margarine or colored margarine at a public eat

ing 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 com

plies with the requirements of subsection (b) of this section. (e) Color content of oleomargarine For the purpose of this section colored oleo

margarine or colored margarine is oleo

margarine 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 equiv

alent. (June 25, 1938, ch. 675, §407, as added Mar. 16, 1950, ch. 61, §3(c), 64 Stat. 20.)

E FFECTIVE D ATE 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.’’

T RANSFER OF A PPROPRIATIONS Act Mar. 16, 1950, ch. 61, §5, 64 Stat. 22, provided that: ‘‘So much of the unexpended balances of appropria

tions, allocations, or other funds (including funds avail

able for the fiscal year ending June 30, 1950) for the use of the Bureau of Internal Revenue of the Treasury De

partment in the exercise of functions under the Oleo

margarine 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 Direc

tor of the Office of Management and Budget] may de

termine, shall be transferred to the Federal Security Agency (Food and Drug Administration) [now the De

partment of Health and Human Services] for use in the enforcement of this Act [see Effective Date note above].’’ § 347a. Congressional declaration of policy re

garding 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 other

wise adulterated or misbranded within the meaning of this chapter depresses the market in interstate commerce for butter and for oleo

margarine or margarine clearly identified and neither adulterated nor misbranded, and con

stitutes a burden on interstate commerce in such articles. Such burden exists, irrespective of whether such oleomargarine or margarine origi

nates from an interstate source or from the State in which it is sold.