Attachment A- FIFRA

Attachment A- FIFRA.pdf

Compliance Requirement for Child Resistant Packaging (Renewal)

Attachment A- FIFRA

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TITLE 7—AGRICULTURE

§ 136w

Pub. L. 95–396, § 22, Sept. 30, 1978, 92 Stat. 835;
Pub. L. 100–532, title VIII, § 801(m), Oct. 25, 1988,
102 Stat. 2682.)
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (c)(3), is act June 25, 1938, ch. 675, 52 Stat.
1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section
301 of Title 21 and Tables.
AMENDMENTS
1988—Pub. L. 100–532, § 801(m), inserted headings for
subsecs. (a) to (c) and realigned margins of pars. (1) to
(4) of subsec. (c).
1978—Subsec. (a). Pub. L. 95–396 inserted ‘‘federally
registered’’ before ‘‘pesticide or device’’.
Subsec. (b). Pub. L. 95–396 substituted ‘‘labeling or
packaging’’ and ‘‘required under’’ for ‘‘labeling and
packaging’’ and ‘‘required pursuant to’’, respectively.
Subsec. (c)(1). Pub. L. 95–396 incorporated existing
text in provisions designated par. (1) and substituted
‘‘registration for additional uses of federally registered
pesticides’’ for ‘‘registration for pesticides’’.
Subsec. (c)(2). Pub. L. 95–396 incorporated existing
text in provisions designated par. (2), conditioned disapproval of registration on communication of intention
to disapprove and reasons for disapproval and provision
for time to respond, and restricted authority of Administrator to prohibit or disapprove a State registration.
Subsec. (c)(3). Pub. L. 95–396 added par. (3).
Subsec. (c)(4). Pub. L. 95–396 incorporated existing
text in provisions designated par. (4) and authorized
suspension of registration authority of the State based
on findings of inability or failure to exercise adequate
controls following an indication of intention to suspend
and reasons for the suspension and provision for time
to respond.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–532 effective on expiration
of 60 days after Oct. 25, 1988, see section 901 of Pub. L.
100–532, set out as a note under section 136 of this title.
EFFECTIVE DATE
For effective date of section, see section 4 of Pub. L.
92–516, set out as a note under section 136 of this title.

§ 136w. Authority of Administrator
(a) In general
(1) Regulations
The Administrator is authorized, in accordance with the procedure described in paragraph (2), to prescribe regulations to carry out
the provisions of this subchapter. Such regulations shall take into account the difference in
concept and usage between various classes of
pesticides, including public health pesticides,
and differences in environmental risk and the
appropriate data for evaluating such risk between agricultural, nonagricultural, and public health pesticides.
(2) Procedure
(A) Proposed regulations
At least 60 days prior to signing any proposed regulation for publication in the Federal Register, the Administrator shall provide the Secretary of Agriculture with a
copy of such regulation. If the Secretary
comments in writing to the Administrator
regarding any such regulation within 30 days
after receiving it, the Administrator shall

Page 252

publish in the Federal Register (with the
proposed regulation) the comments of the
Secretary and the response of the Administrator with regard to the Secretary’s comments. If the Secretary does not comment in
writing to the Administrator regarding the
regulation within 30 days after receiving it,
the Administrator may sign such regulation
for publication in the Federal Register any
time after such 30-day period notwithstanding the foregoing 60-day time requirement.
(B) Final regulations
At least 30 days prior to signing any regulation in final form for publication in the
Federal Register, the Administrator shall
provide the Secretary of Agriculture with a
copy of such regulation. If the Secretary
comments in writing to the Administrator
regarding any such final regulation within 15
days after receiving it, the Administrator
shall publish in the Federal Register (with
the final regulation) the comments of the
Secretary, if requested by the Secretary, and
the response of the Administrator concerning the Secretary’s comments. If the Secretary does not comment in writing to the
Administrator regarding the regulation
within 15 days after receiving it, the Administrator may sign such regulation for publication in the Federal Register at any time
after such 15-day period notwithstanding the
foregoing 30-day time requirement. In taking any final action under this subsection,
the Administrator shall include among those
factors to be taken into account the effect of
the regulation on production and prices of
agricultural commodities, retail food prices,
and otherwise on the agricultural economy,
and the Administrator shall publish in the
Federal Register an analysis of such effect.
(C) Time requirements
The time requirements imposed by subparagraphs (A) and (B) may be waived or
modified to the extent agreed upon by the
Administrator and the Secretary.
(D) Publication in the Federal Register
The Administrator shall, simultaneously
with any notification to the Secretary of
Agriculture under this paragraph prior to
the issuance of any proposed or final regulation, publish such notification in the Federal Register.
(3) Congressional committees
At such time as the Administrator is required under paragraph (2) of this subsection
to provide the Secretary of Agriculture with a
copy of proposed regulations and a copy of the
final form of regulations, the Administrator
shall also furnish a copy of such regulations to
the Committee on Agriculture of the House of
Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate.
(4) Congressional review of regulations
Simultaneously with the promulgation of
any rule or regulation under this subchapter,
the Administrator shall transmit a copy
thereof to the Secretary of the Senate and the
Clerk of the House of Representatives. The

Page 253

TITLE 7—AGRICULTURE

rule or regulation shall not become effective
until the passage of 60 calendar days after the
rule or regulation is so transmitted.
(b) Exemption of pesticides
The Administrator may exempt from the requirements of this subchapter by regulation any
pesticide which the Administrator determines
either (1) to be adequately regulated by another
Federal agency, or (2) to be of a character which
is unnecessary to be subject to this subchapter
in order to carry out the purposes of this subchapter.
(c) Other authority
The Administrator, after notice and opportunity for hearing, is authorized—
(1) to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or
in living man or other living animals) which is
injurious to health or the environment;
(2) to determine any pesticide which contains any substance or substances in quantities highly toxic to man;
(3) to establish standards (which shall be
consistent with those established under the
authority of the Poison Prevention Packaging
Act (Public Law 91–601) [15 U.S.C. 1471 et seq.])
with respect to the package, container, or
wrapping in which a pesticide or device is enclosed for use or consumption, in order to protect children and adults from serious injury or
illness resulting from accidental ingestion or
contact with pesticides or devices regulated by
this subchapter as well as to accomplish the
other purposes of this subchapter;
(4) to specify those classes of devices which
shall be subject to any provision of section
136(q)(1) or section 136e of this title upon the
Administrator’s determination that application of such provision is necessary to effectuate the purposes of this subchapter;
(5) to prescribe regulations requiring any
pesticide to be colored or discolored if the Administrator determines that such requirement
is feasible and is necessary for the protection
of health and the environment; and
(6) to determine and establish suitable
names to be used in the ingredient statement.
(d) Scientific advisory panel
(1) In general
The Administrator shall submit to an advisory panel for comment as to the impact on
health and the environment of the action proposed in notices of intent issued under section
136d(b) of this title and of the proposed and
final form of regulations issued under subsection (a) of this section within the same
time periods as provided for the comments of
the Secretary of Agriculture under such section 136d(b) and subsection (a) of this section.
The time requirements for notices of intent
and proposed and final forms of regulation
may not be modified or waived unless in addition to meeting the requirements of section
136d(b) of this title or subsection (a) of this
section, as applicable, the advisory panel has
failed to comment on the proposed action
within the prescribed time period or has
agreed to the modification or waiver. The Ad-

§ 136w

ministrator shall also solicit from the advisory panel comments, evaluations, and recommendations for operating guidelines to improve the effectiveness and quality of scientific analyses made by personnel of the Environmental Protection Agency that lead to
decisions by the Administrator in carrying out
the provisions of this subchapter. The comments, evaluations, and recommendations of
the advisory panel submitted under this subsection and the response of the Administrator
shall be published in the Federal Register in
the same manner as provided for publication
of the comments of the Secretary of Agriculture under such sections. The chairman of
the advisory panel, after consultation with the
Administrator, may create temporary subpanels on specific projects to assist the full advisory panel in expediting and preparing its
evaluations, comments, and recommendations.
The subpanels may be composed of scientists
other than members of the advisory panel, as
deemed necessary for the purpose of evaluating scientific studies relied upon by the Administrator with respect to proposed action.
Such additional scientists shall be selected by
the advisory panel. The panel referred to in
this subsection shall consist of 7 members appointed by the Administrator from a list of 12
nominees, 6 nominated by the National Institutes of Health and 6 by the National Science
Foundation, utilizing a system of staggered
terms of appointment. Members of the panel
shall be selected on the basis of their professional qualifications to assess the effects of
the impact of pesticides on health and the environment. To the extent feasible to insure
multidisciplinary representation, the panel
membership shall include representation from
the disciplines of toxicology, pathology, environmental biology, and related sciences. If a
vacancy occurs on the panel due to expiration
of a term, resignation, or any other reason,
each replacement shall be selected by the Administrator from a group of 4 nominees, 2 submitted by each of the nominating entities
named in this subsection. The Administrator
may extend the term of a panel member until
the new member is appointed to fill the vacancy. If a vacancy occurs due to resignation,
or reason other than expiration of a term, the
Administrator shall appoint a member to
serve during the unexpired term utilizing the
nomination process set forth in this subsection. Should the list of nominees provided
under this subsection be unsatisfactory, the
Administrator may request an additional set
of nominees from the nominating entities. The
Administrator may require such information
from the nominees to the advisory panel as
the Administrator deems necessary, and the
Administrator shall publish in the Federal
Register the name, address, and professional
affiliations of each nominee. Each member of
the panel shall receive per diem compensation
at a rate not in excess of that fixed for GS–18
of the General Schedule as may be determined
by the Administrator, except that any such
member who holds another office or position
under the Federal Government the compensation for which exceeds such rate may elect to

§ 136w

TITLE 7—AGRICULTURE

receive compensation at the rate provided for
such other office or position in lieu of the
compensation provided by this subsection. In
order to assure the objectivity of the advisory
panel, the Administrator shall promulgate
regulations regarding conflicts of interest
with respect to the members of the panel. The
advisory panel established under this section
shall be permanent. In performing the functions assigned by this subchapter, the panel
shall consult and coordinate its activities with
the Science Advisory Board established under
the Environmental Research, Development,
and Demonstration Authorization Act of 1978
[42 U.S.C. 4365]. Whenever the Administrator
exercises authority under section 136d(c) of
this title to immediately suspend the registration of any pesticide to prevent an imminent
hazard, the Administrator shall promptly submit to the advisory panel for comment, as to
the impact on health and the environment, the
action taken to suspend the registration of
such pesticide.
(2) Science Review Board
There is established a Science Review Board
to consist of 60 scientists who shall be available to the Scientific Advisory Panel to assist
in reviews conducted by the Panel. Members of
the Board shall be selected in the same manner as members of temporary subpanels created under paragraph (1). Members of the
Board shall be compensated in the same manner as members of the Panel.
(e) Peer review
The Administrator shall, by written procedures, provide for peer review with respect to
the design, protocols, and conduct of major scientific studies conducted under this subchapter
by the Environmental Protection Agency or by
any other Federal agency, any State or political
subdivision thereof, or any institution or individual under grant, contract, or cooperative
agreement from or with the Environmental Protection Agency. In such procedures, the Administrator shall also provide for peer review, using
the advisory panel established under subsection
(d) of this section or appropriate experts appointed by the Administrator from a current list
of nominees maintained by such panel, with respect to the results of any such scientific studies relied upon by the Administrator with respect to actions the Administrator may take relating to the change in classification, suspension, or cancellation of a pesticide. Whenever
the Administrator determines that circumstances do not permit the peer review of the results of any such scientific study prior to the
Administrator’s exercising authority under section 136d(c) of this title to immediately suspend
the registration of any pesticide to prevent an
imminent hazard, the Administrator shall
promptly thereafter provide for the conduct of
peer review as provided in this sentence. The
evaluations and relevant documentation constituting the peer review that relate to the proposed scientific studies and the results of the
completed scientific studies shall be included in
the submission for comment forwarded by the
Administrator to the advisory panel as provided
in subsection (d) of this section. As used in this

Page 254

subsection, the term ‘‘peer review’’ shall mean
an independent evaluation by scientific experts,
either within or outside the Environmental Protection Agency, in the appropriate disciplines.
(June 25, 1947, ch. 125, § 25, as added Pub. L.
92–516, § 2, Oct. 21, 1972, 86 Stat. 997; amended
Pub. L. 94–140, §§ 2(a), 6, 7, Nov. 28, 1975, 89 Stat.
751, 753; Pub. L. 95–396, § 23, Sept. 30, 1978, 92 Stat.
836; Pub. L. 96–539, §§ 1, 2(a), 4, Dec. 17, 1980, 94
Stat. 3194, 3195; Pub. L. 98–201, § 1, Dec. 2, 1983, 97
Stat. 1379; Pub. L. 98–620, title IV, § 402(4)(D),
Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100–352, § 6(i),
June 27, 1988, 102 Stat. 664; Pub. L. 100–532, title
VI, §§ 602, 605, title VIII, § 801(n), Oct. 25, 1988, 102
Stat. 2678, 2679, 2683; Pub. L. 102–237, title X,
§ 1006(b)(1), (2), Dec. 13, 1991, 105 Stat. 1895; Pub.
L. 104–170, title I, § 104, title II, § 235, Aug. 3, 1996,
110 Stat. 1490, 1509.)
REFERENCES IN TEXT
The Poison Prevention Packaging Act, referred to in
subsec. (c)(3), is Pub. L. 91–601, Dec. 30, 1970, 84 Stat.
1670, as amended, which is classified principally to
chapter 39A (§ 1471 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 1471 of
Title 15, and Tables.
References in subsec. (c)(4) to ‘‘section 136(q)(1)’’ was,
in the original, a reference to ‘‘paragraph 2(q)(1)’’ and
has been editorially translated as ‘‘section 136(q)(1)’’ as
the probable intent of Congress.
The Environmental Research, Development, and
Demonstration Authorization Act of 1978, referred to in
subsec. (d), is Pub. L. 95–155, Nov. 8, 1977, 91 Stat. 1257,
as amended. Provisions of the Act establishing the
Science Advisory Board are classified to section 4365 of
Title 42, The Public Health and Welfare. For complete
classification of this Act to the Code, see Tables.
AMENDMENTS
1996—Subsec. (a)(1). Pub. L. 104–170, § 235, inserted
‘‘, including public health pesticides,’’ after ‘‘various
classes
of
pesticides’’
and
substituted
‘‘, nonagricultural, and public health pesticides’’ for
‘‘and nonagricultural pesticides’’.
Subsec. (d). Pub. L. 104–170, § 104, designated existing
text as par. (1), inserted heading, and added par. (2).
1991—Subsec. (a)(3). Pub. L. 102–237, § 1006(b)(1), substituted ‘‘the Administrator’’ for ‘‘he’’ before ‘‘shall’’.
Subsec. (b). Pub. L. 102–237, § 1006(b)(1), substituted
‘‘the Administrator’’ for ‘‘he’’ before ‘‘determines’’.
Subsec. (c)(4). Pub. L. 102–237, § 1006(b)(2), substituted
‘‘the Administrator’s’’ for ‘‘his’’.
Subsec. (c)(5). Pub. L. 102–237, § 1006(b)(1), substituted
‘‘the Administrator’’ for ‘‘he’’ before ‘‘determines’’.
Subsec. (d). Pub. L. 102–237, § 1006(b)(1), substituted
‘‘the Administrator’’ for ‘‘he’’ before ‘‘deems necessary’’ and before ‘‘shall publish’’.
1988—Subsec. (a). Pub. L. 100–532, § 801(n)(1), amended
heading and directed that pars. (1) to (3) be aligned at
left margin with subsec. (c)(1), and that subpars. (A) to
(D) of par. (2) be indented, and in par. (3) substituted
‘‘Committee on Agriculture, Nutrition, and Forestry’’
for ‘‘Committee on Agriculture and Forestry’’.
Subsec. (a)(4). Pub. L. 100–532, § 605, amended par. (4)
generally, substituting single unlettered par. (4) for
former subpars. (A) to (E).
Pub. L. 100–352, in subpar. (E), struck out ‘‘(i)’’ before
‘‘Any interested’’ and struck out cl. (ii) which provided
that notwithstanding any other provision of law, any
decision on a matter certified under cl. (i) of this subparagraph be reviewable by appeal directly to the Supreme Court of the United States, with such appeal to
be brought not later than 20 days after the decision of
the court of appeals.
Subsec. (d). Pub. L. 100–532, § 602, substituted ‘‘section
shall be permanent’’ for ‘‘subsection shall terminate
September 30, 1987’’.

Page 255

TITLE 7—AGRICULTURE

Subsec. (e). Pub. L. 100–532, § 801(n)(2), substituted
‘‘pesticide. Whenever’’ for ‘‘pesticide: Provided, That
whenever’’.
1984—Subsec. (a)(4)(E)(iii). Pub. L. 98–620 struck out
cl. (iii) requiring the court of appeals and the Supreme
Court to advance on the docket and expedite the disposition of any matter certified under cl. (i) of this subparagraph.
1983—Subsec. (d). Pub. L. 98–201 in fourth sentence,
inserted ‘‘under this subsection’’ after ‘‘submitted’’; in
eighth sentence, provided for utilization of a system of
staggered terms of appointment and substituted ‘‘7’’
and ‘‘6’’ for ‘‘seven’’ and ‘‘six’’, respectively, and inserted ninth through fourteenth sentences respecting
basis for selection of members, multidisciplinary representation, appointments to fill vacancies, extension
of term pending filling of vacancies, appointment for
unexpired term, and request for additional set of nominees from nominating entities; and in present eighteenth, formerly twelfth sentence, extended termination
date to Sept. 30, 1987, from Sept. 30, 1981.
1980—Subsec. (a)(4). Pub. L. 96–539, § 4, added par. (4).
Subsec. (d). Pub. L. 96–539, § 1, inserted provisions relating to composition of subpanels and submissions to
advisory panels respecting registration suspensions.
Subsec. (e). Pub. L. 96–539, § 2(a), added subsec. (e).
1978—Subsec. (a)(1). Pub. L. 95–396, § 23(1), required
regulations to take into account differences in environmental risk and appropriate data for evaluating such
risk between agricultural and nonagricultural pesticides.
Subsec. (a)(2)(B). Pub. L. 95–396, § 23(2), required the
Administrator, before taking any final action, to consider certain factors bearing on the agricultural economy and to publish an analysis of the effect in the Federal Register.
Subsec. (d). Pub. L. 95–396, § 23(3), (4), required the Administrator to solicit operating guidelines from the scientific advisory panel to improve scientific analyses
made by personnel of the Environmental Protection
Agency that lead to decisions by the Administrator in
carrying out this subchapter; extended requirement of
publication in the Federal Register to evaluations and
recommendations of the advisory panel; authorized creation of temporary subpanels on specific projects to assist in accelerating the work of the advisory panel; set
forth Sept. 30, 1981, as the termination date of the advisory panel; and required the panel to consult and coordinate its activities with the Science Advisory Board
established under section 4365 of title 42.
1975—Subsec. (a)(1). Pub. L. 94–140, § 2(a)(1), (2), redesignated existing provision as subsec. (a)(1) and inserted
‘‘, in accordance with the procedure described in paragraph (2),’’ after ‘‘is authorized’’.
Subsec. (a)(2). Pub. L. 94–140, § 2(a)(3), added par. (2).
Subsec. (a)(3). Pub. L. 94–140, § 6, added par. (3).
Subsec. (d). Pub. L. 94–140, § 7, added subsec. (d).
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100–532 effective on expiration
of 60 days after Oct. 25, 1988, see section 901 of Pub. L.
100–532, set out as a note under section 136 of this title.
Amendment by Pub. L. 100–352 effective ninety days
after June 27, 1988, except that such amendment not to
apply to cases pending in Supreme Court on such effective date or affect right to review or manner of reviewing judgment or decree of court which was entered before such effective date, see section 7 of Pub. L. 100–352,
set out as a note under section 1254 of Title 28, Judiciary and Judicial Procedure.
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 1980 AMENDMENT
Pub. L. 96–539, § 2(b), Dec. 17, 1980, 94 Stat. 3195, provided that: ‘‘The provisions of this section [amending

§ 136w–1

this section] shall become effective upon publication in
the Federal Register of final procedures for peer review
as provided in this section, but in no event shall such
provisions become effective later than one year after
the date of enactment of this Act [Dec. 17, 1980].’’
EFFECTIVE DATE
For effective date of section, see section 4 of Pub. L.
92–516, set out as a note under section 136 of this title.
REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY
RATES
References in laws to the rates of pay for GS–16, 17,
or 18, or to maximum rates of pay under the General
Schedule, to be considered references to rates payable
under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)]
of Pub. L. 101–509, set out in a note under section 5376
of Title 5.
USER FEES
Pub. L. 101–508, title I, § 1204(e), Nov. 5, 1990, 104 Stat.
1388–11, provided that: ‘‘Notwithstanding any provision
of the Omnibus Budget Reconciliation Act of 1990 [Pub.
L. 101–508, see Tables for classification], nothing in this
title or the other provisions of this Act shall be construed to require or authorize the Administrator of the
Environmental Protection Agency to assess or collect
any fees or charges for services and activities authorized under the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.).’’

§ 136w–1. State primary enforcement responsibility
(a) In general
For the purposes of this subchapter, a State
shall have primary enforcement responsibility
for pesticide use violations during any period for
which the Administrator determines that such
State—
(1) has adopted adequate pesticide use laws
and regulations, except that the Administrator may not require a State to have pesticide use laws that are more stringent than
this subchapter;
(2) has adopted and is implementing adequate procedures for the enforcement of such
State laws and regulations; and
(3) will keep such records and make such reports showing compliance with paragraphs (1)
and (2) of this subsection as the Administrator
may require by regulation.
(b) Special rules
Notwithstanding the provisions of subsection
(a) of this section, any State that enters into a
cooperative agreement with the Administrator
under section 136u of this title for the enforcement of pesticide use restrictions shall have the
primary enforcement responsibility for pesticide
use violations. Any State that has a plan approved by the Administrator in accordance with
the requirements of section 136i of this title that
the Administrator determines meets the criteria
set out in subsection (a) of this section shall
have the primary enforcement responsibility for
pesticide use violations. The Administrator
shall make such determinations with respect to
State plans under section 136i of this title in effect on September 30, 1978, not later than six
months after that date.
(c) Administrator
The Administrator shall have primary enforcement responsibility for those States that


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