1
 See References in Text note below.
of this title upon the basis of public hearings instituted before
2
 So in original. Probably should be “subsection”.
(b)(2) or (c)(2) and shall, by the deadline for the review of the tolerance or exemption, issue a regulation under subsection (d)(4) or (e)(1) to modify or revoke the tolerance or exemption if the tolerance or exemption does not meet such requirements.
Editorial Notes
References in Text

The Federal Rules of Civil Procedure, referred to in subsec. (g)(2)(B), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

Section 346 of this title, referred to in subsec. (j)(1), originally consisted of subsecs. (a) and (b). Subsec. (a) was redesignated as the entire section 346 and subsec. (b) was repealed by Pub. L. 86–618, title I, § 103(a)(1), 74 Stat. 398.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is classified generally to subchapter II (§ 136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables.

Section 4365 of title 42, referred to in subsec. (p)(2), was in the original “section 8 of the Environmental Research, Development, and Demonstration Act of 1978”, and was translated as meaning section 8 of the Environmental Research, Development, and Demonstration Authorization Act of 1978, to reflect the probable intent of Congress.

The Toxic Substances Control Act, referred to in subsec. (s), is Pub. L. 94–469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is classified generally to chapter 53 (§ 2601 et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title note set out under section 2601 of Title 15 and Tables.

Codification

August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A), and (p)(1), (2), (7), was in the original references to the date of enactment of this subsection and the date of enactment of this section, which was translated as meaning the date of enactment of Pub. L. 104–170, which amended this section generally, to reflect the probable intent of Congress.

Amendments

2022—Subsec. (m)(3). Pub. L. 117–328 substituted “December 29, 2022, and ending on September 30, 2027” for “October 1, 2007, and ending on September 30, 2023”.

2019—Subsec. (m)(3). Pub. L. 116–8 substituted “2023” for “2017”.

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

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

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

1996—Pub. L. 104–170 amended section generally, substituting, in subsec. (a), provisions relating to requirement for tolerance or exemption for provisions relating to conditions for safety; in subsec. (b), provisions relating to authority and standard for tolerance for provisions relating to establishment of tolerances; in subsec. (c), provisions relating to authority and standard for exemptions for provisions relating to exemptions; in subsec. (d), provisions relating to petition for tolerance or exemption for provisions relating to regulations pursuant to petition, publication of notice, time for issuance, referral to advisory committees, effective date, and hearings; in subsec. (e), provisions relating to action on Administrator’s own initiative for provisions relating to regulations pursuant to Administrator’s proposals; in subsec. (f), provisions relating to special data requirements for provisions relating to data submitted as confidential; in subsec. (g), provisions relating to effective date, objections, hearings, and administrative review for provisions relating to advisory committees and their appointment, composition, compensation, and clerical assistance; in subsec. (h), provisions relating to judicial review for provisions relating to right of consultation; in subsec. (i), provisions relating to confidentiality and use of data for provisions relating to judicial review; in subsec. (j), provisions relating to status of previously issued regulations for provisions relating to temporary tolerances; in subsec. (k), provisions relating to transitions for provisions relating to regulations based on public hearings before January 1, 1953; in subsec. (l), provisions relating to harmonization with action under other laws for provisions relating to pesticides under Federal Insecticide, Fungicide, and Rodenticide Act, functions of Administrator of Environmental Protection Agency, certifications, hearings, time limitations, opinions, and regulations; in subsec. (m), provisions relating to fees for provisions relating to amendment of regulations; in subsec. (n), provisions relating to national uniformity of tolerances for provisions relating to guaranties; in subsec. (o), provisions relating to consumer right to know for provisions relating to payment of fees, services or functions conditioned on payment, and waiver or refund of fees; and adding subsecs. (p) to (s).

1993—Pub. L. 103–80, § 3(k)(6), substituted “Administrator” for “Secretary” wherever appearing except when followed by “of Agriculture”.

Subsec. (a)(1). Pub. L. 103–80, § 3(k)(1), substituted “Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the ‘Administrator’)” for “Secretary of Health and Human Services”.

Subsec. (d)(5). Pub. L. 103–80, § 3(k)(2), substituted “section 556(c) of title 5” for “section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))”.

Subsec. (l). Pub. L. 103–80, § 3(k)(3), substituted “In the event” for “It the event” before “a hearing is requested”.

Subsec. (n). Pub. L. 103–80, § 3(k)(4), made technical amendment to reference to section 333(c) of this title to reflect amendment of corresponding provision of original act.

Subsec. (o). Pub. L. 103–80, § 3(k)(5), which directed the substitution of “Administrator” for “Secretary of Health and Human Services” wherever appearing in the original text, was executed by making the substitution in the first sentence before “shall by regulation require”, the only place “Secretary of Health and Human Services” appeared in the original text.

1992—Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102–300 substituted “Health and Human Services” for “Health, Education, and Welfare” wherever appearing in the original statutory text.

Subsec. (g). Pub. L. 102–571 substituted “379e” for “376”.

1984—Subsec. (i)(5). Pub. L. 98–620 struck out provision that required the court to advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.

1972—Subsecs. (d)(1), (e), (l). Pub. L. 92–516 substituted references to pesticide for references to economic poison wherever appearing therein.

1971—Subsec. (g). Pub. L. 92–157 struck out “, which the Secretary shall by rules and regulations prescribe,” after “as compensation for their services a reasonable per diem” prior to amendment in 1970, by Pub. L. 91–515, which overlooked such language when amending subsec. (g) as provided in 1970 Amendment note.

1970—Subsec. (g). Pub. L. 91–515 substituted provisions authorizing members of an advisory committee to receive compensation and travel expenses in accordance with section 376(b)(5)(D) of this title, for provisions authorizing such members to receive as compensation a reasonable per diem for time actually spent on committee work, and necessary traveling and subsistence expenses while serving away from their places of residence.

1958—Subsec. (i)(2). Pub. L. 85–791, § 20(a), in first sentence, substituted “transmitted by the clerk of the court to the Secretary, or” for “served upon the Secretary, or upon”, substituted “file in the court the record of the proceedings” for “certify and file in the court a transcript of the proceedings and the record”, and inserted “as provided in section 2112 of title 28”, and which, in second sentence, substituted “the filing of such petition” for “such filing”.

Subsec. (i)(3). Pub. L. 85–791, § 20(b), in first sentence, substituted “transmitted by the clerk of the court to the Secretary of Agriculture, or” for “served upon the Secretary of Agriculture, or upon”, substituted “file in the court the record of the proceedings” for “certify and file in the court a transcript of the proceedings and the record”, and inserted “as provided in section 2112 of title 28”, and, in second sentence, substituted “the filing of such petition” for “such filing”.

Statutory Notes and Related Subsidiaries
Effective Date of 2012 Amendment

Amendment by Pub. L. 112–177 effective Oct. 1, 2012, see section 2(c) of Pub. L. 112–177, set out as a note under section 136a–1 of Title 7, Agriculture.

Effective Date of 2007 Amendment

Amendment by Pub. L. 110–94 effective Oct. 1, 2007, see section 6 of Pub. L. 110–94, set out as a note under section 136a of Title 7, Agriculture.

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1972 Amendment

Amendment by Pub. L. 92–516 effective at close of Oct. 21, 1972, except if regulations are necessary for implementation of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, Agriculture, and regulations thereunder, relating to control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92–516 and regulations thereunder, see section 4 of Pub. L. 92–516, set out as an Effective Date note under section 136 of Title 7.

Extension of Prohibition of Tolerance Fees

Pub. L. 115–141, div. M, title IV, § 401(c), Mar. 23, 2018, 132 Stat. 1050, provided that: “Section 408(m)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(3)) shall be applied by substituting ‘September 30, 2018’ for ‘September 30, 2017’.”

Regulation of Sulfuryl Fluoride

Pub. L. 113–79, title X, § 10015, Feb. 7, 2014, 128 Stat. 952, provided that: “Notwithstanding any other provision of law, the Administrator of the Environmental Protection Agency shall exclude nonpesticideal sources of fluoride from any aggregate exposure assessment required under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) when assessing tolerances associated with residues from the pesticide.”

Tolerance Fees

Pub. L. 108–199, div. G, title V, § 501(d)(2), Jan. 23, 2004, 118 Stat. 422, provided that: “Notwithstanding section 408(m)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)), during the period beginning on October 1, 2003, and ending on September 30, 2008, the Administrator of the Environmental Protection Agency shall not collect any tolerance fees under that section.”

Data Collection Activities To Assure Health of Infants and Children

Pub. L. 104–170, title III, § 301, Aug. 3, 1996, 110 Stat. 1511, provided that:

“(a)
In General.—
The Secretary of Agriculture, in consultation with the Administrator of the 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.”