1

Attachment D

Federal Food, Drug, and Cosmetic Act (FFDCA) 

Section 408 - Tolerances and Exemptions for Pesticide Chemical Residues 

(21 U.S.C. 346a) 
2

Attachment D

Federal Food, Drug, and Cosmetic Act (FFDCA) 

Section 408 - Tolerances and Exemptions for Pesticide Chemical Residues 

(21 U.S.C. 346a) 

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

 January 3, 2005 and March 20, 2006]

[CITE: 21USC346a]

 TITLE 21--FOOD AND DRUGS

 CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT

 SUBCHAPTER IV--FOOD

Sec. 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 modification, 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 
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 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, 
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 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 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.
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 (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).
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 (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 post-natal 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 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 
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 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
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 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.

(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
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 (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
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 (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 may require a petition 

 to be accompanied by samples of the pesticide chemical with 

 respect to which the petition is filed.
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 (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) 
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 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 
13

 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;

 (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
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 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 
15

 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 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 
16

 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.

---------------------------------------------------------------------------

 \1\ See References in Text note below.

---------------------------------------------------------------------------

 (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 
17

 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 substance 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 
18

 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.
19

 (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 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 
20

 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).

(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 
21

 [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 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 
22

 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 
23

 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.

 (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 
24

 program.

---------------------------------------------------------------------------

 \2\ See References in Text note below.

---------------------------------------------------------------------------

 (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 
25

 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.

 (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--
26

 (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.

---------------------------------------------------------------------------

 \3\ So in original. Probably should be ``subsection''.

---------------------------------------------------------------------------

 (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, Sec. 408, as added July 22, 1954, ch. 559, 

Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28, 1958, 72 

Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct. 30, 1970, 84 

Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a), Nov. 18, 1971, 85 

Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. 
27

L. 98-620, title IV, Sec. 402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub. 

L. 102-300, Sec. 6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102-571, 

title I, Sec. 107(7), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, 

Sec. 3(k), Aug. 13, 1993, 107 Stat. 776; Pub. L. 104-170, title IV, 

Sec. 405, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct. 

30, 1998, 112 Stat. 3036.)

 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, Sec. 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 (Sec. 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 (Sec. 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

 1998--Subsec. (j)(4). Pub. L. 105-324 added par. (4).

 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 
28

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, Sec. 3(k)(6), substituted ``Administrator'' 

for ``Secretary'' wherever appearing except when followed by ``of 

Agriculture''.

 Subsec. (a)(1). Pub. L. 103-80, Sec. 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, Sec. 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, Sec. 3(k)(3), substituted ``In the 

event'' for ``It the event'' before ``a hearing is requested''.

 Subsec. (n). Pub. L. 103-80, Sec. 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, Sec. 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 
29

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, Sec. 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, Sec. 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 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.

 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, and functions of Department of Agriculture 

and Secretary of Agriculture under subsec. (l) of this section 

transferred to Administrator of Environmental Protection Agency by 

Reorg. Plan No. 3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 

15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government 
30

Organization and Employees.

 Tolerance Fees

 Pub. L. 108-199, div. G, title V, Sec. 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

 Section 301 of Pub. L. 104-170 provided that:

 ``(a) In General.--The Secretary of Agriculture, in consultation 

with the Administrator of the Environmental 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.''
31