Attachment B-2 40 CFR Part 162

Environmental Protection Agency

§ 162.151

(d) The master schedule sheet, copies
of protocols, and records of quality assurance inspections, as required by
§ 160.35(c) shall be maintained by the
quality assurance unit as an easily accessible system of records for the period of time specified in paragraph (b)
of this section.
(e) Summaries of training and experience and job descriptions required to be
maintained by § 160.29(b) may be retained along with all other testing facility employment records for the
length of time specified in paragraph
(b) of this section.
(f) Records and reports of the maintenance and calibration and inspection of
equipment, as required by § 160.63 (b)
and (c), shall be retained for the length
of time specified in paragraph (b) of
this section.
(g) If a facility conducting testing or
an archive contracting facility goes
out of business, all raw data, documentation, and other material specified in this section shall be transferred
to the archives of the sponsor of the
study. The EPA shall be notified in
writing of such a transfer.
(h) Specimens, samples, or other nondocumentary materials need not be retained after EPA has notified in writing the sponsor or testing facility holding the materials that retention is no
longer required by EPA. Such notification normally will be furnished upon
request after EPA or FDA has completed an audit of the particular study
to which the materials relate and EPA
has concluded that the study was conducted in accordance with this part.
(i) Records required by this part may
be retained either as original records
or as true copies such as photocopies,
microfilm, microfiche, or other accurate reproductions of the original
records.

PART 162—STATE REGISTRATION OF
PESTICIDE PRODUCTS
Subparts A—C [Reserved]
Subpart D—Regulations Pertaining to State
Registration of Pesticides To Meet Special Local Needs
Sec.
162.150
162.151

General.
Definitions.

162.152 State registration authority.
162.153 State registration procedures.
162.154 Disapproval of State registrations.
162.155 Suspension of State registration authority.
162.156 General requirements.

Subpart E—[Reserved]

Subparts A—C [Reserved]
Subpart D—Regulations Pertaining
to State Registration of Pesticides To Meet Special Local
Needs
AUTHORITY: 7 U.S.C. 136v, 136w.
SOURCE: 46 FR 2014, Jan. 7, 1981, unless otherwise noted.

§ 162.150 General.
(a) Scope. This subpart sets forth regulations governing the registration by
any State of pesticide products, or uses
thereof, formulated for distribution
and use within the State to meet special local needs under sec. 24(c) of the
Act. It also sets forth regulations governing the exercise by the Administrator of the power to disapprove specific State registrations and to suspend
a State’s registration authority under
sec. 24(c). Unless otherwise indicated,
any reference herein to registrations
issued by a State includes amendments
of registrations issued by States.
(b) Applicability. This subpart applies
only to State registration authority
granted by sec. 24(c) of FIFRA. It does
not apply to any authority granted, or
procedures established, by State law
with respect to registration, licensing,
or approval required for use within the
State of federally registered pesticide
products.
[46 FR 2014, Jan. 7, 1981, as amended at 53 FR
15999, May 4, 1988; 60 FR 32097, June 19, 1995]

§ 162.151 Definitions.
Unless otherwise indicated, terms
used in this subpart have the meanings
set forth in FIFRA and in subpart A of
this part. In addition, as used in this
subpart, the following terms have the
meanings set forth below:
(a) Federally registered means currently registered under sec. 3 of the
Act, after having been initially registered under the Federal Insecticide,

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Fungicide, and Rodenticide Act of 1947
(Pub. L. 86–139; 73 Stat. 286; June 25,
1947) by the Secretary of Agriculture or
under FIFRA by the Administrator.
(b) Manufacturing-use product means
any pesticide product other than a
product to be labeled with directions
for end use. This term includes any
product intended for use as a pesticide
after re-formulation or repackaging.
(c) New product means a pesticide
product which is not a federally registered product.
(d) Pest problem means (1) a pest infestation and its consequences, or (2) any
condition for which the use of plant
regulators, defoliants, or desiccants
would be appropriate.
(e) Product or pesticide product means
a pesticide offered for distribution and
use, and includes any labeled container
and any supplemental labeling.
(f) Similar composition refers to a pesticide product which contains only the
same active ingredient(s), or combination of active ingredients, and which is
in the same category of toxicity, as a
federally registered pesticide product.
(g) Similar product means a pesticide
product which, when compared to a
federally registered product, has a
similar composition and a similar use
pattern.
(h) Similar use pattern refers to a use
of a pesticide product which, when
compared to a federally registered use
of a product with a similar composition, does not require a change in precautionary labeling under § 156.10(h) of
this chapter, and which is substantially the same as the federally registered use. Registrations involving
changed use patterns are not included
in this term.
(i) Special local need means an existing or imminent pest problem within a
State for which the State lead agency,
based upon satisfactory supporting information, has determined that an appropriate federally registered pesticide
product is not sufficiently available.
(j) State or State lead agency as used
in this subpart means the State agency
designated by the State to be responsible for registering pesticides to meet
special local needs under sec. 24(c) of
the Act.
[46 FR 2014, Jan. 7, 1981, as amended at 53 FR
15999, May 4, 1988]

§ 162.152

State registration authority.

(a) Statutory limitations. In accordance with sec. 24(c) of the Act, each
State is authorized to register a new
end use product for any use, or an additional use of a federally registered pesticide product, if the following conditions exist:
(1) There is a special local need for
the use within the State;
(2) The use is covered by necessary
tolerances, exemptions or other clearances under the Federal Food, Drug
and Cosmetic Act (21 U.S.C. 346 et seq.),
if the use is a food or feed use;
(3) Registration for the same use has
not previously been denied, disapproved, suspended or cancelled by
the Administrator, or voluntarily cancelled by the registrant subsequent to
issuance by the Administrator of a notice of intent to cancel that registration, because of health or environmental concerns about an ingredient
contained in the pesticide product, unless such denial, disapproval, suspension or cancellation has been superseded by subsequent action of the Administrator; and
(4) The registration is in accord with
the purposes of FIFRA.
(b) Types of registrations—(1) Amendments to federal registrations.
(i) Subject to the provisions of paragraphs (a) and (b)(1)(ii)(iv) of this section, States may register any new use
of a federally registered pesticide product.
(ii) A State may register any use of a
federally registered product for which
registration of other uses of the product was denied, disapproved, suspended,
or cancelled by the Administrator, provided that the State may register a use
not considered by the Administrator in
reaching such a determination only
after the State consults with appropriate EPA personnel.
(iii) Except as provided in paragraph
(a)(3) of this section, a State may register any use of a federally registered
product for which registration of some
or all uses has been voluntarily cancelled by the registrant, provided that
a State may register such a use only
after the State has consulted with appropriate EPA personnel.

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§ 162.153

(iv) A State may not register an
amendment to a federally registered
manufacturing-use product.
(2) New products. (i) Subject to the
provisions of paragraph (a) and subparagraphs (b)(2) (ii) and (iii) of this
section, a State may issue registrations to meet special local needs for
the following types of new end-use
products:
(A) A product which is identical in
composition to a federally registered
product, but which has differences in
packaging, or in the identity of the formulator.
(B) A product which contains the
same active and inert ingredients as a
federally registered product, but in different percentages.
(C) Subject to the requirements of
paragraph (b)(2)(ii) of this section, a
product containing a new combination
of active, or active and inert, ingredients.
(ii) A State may register a new product only if each of the active ingredients in the new product is present because of the use of one or more federally registered products and if each of
the inert ingredients in the new product is contained in a federally registered product.
(iii) A State may not register a new
manufacturing-use product.
(iv) A State may register any use of
a new product containing an ingredient
described in paragraph (a)(3) of this
section, if the new product registration
is for a formulation or a use not included in the denial, disapproval, suspension, or cancellation, or if the federally registered use was voluntarily
cancelled without a prior notice of intent to cancel by the Administrator.
However, a formulation or use of such
a new product which was not considered by the Administrator during such
proceedings, or which was not the subject of a notice of intent to cancel, may
be registered by a State only after the
State consults with appropriate EPA
personnel regarding the registration
application.
(c) Effect of State registration. (1) A
State registration issued under FIFRA
sec. 24(c) which meets the conditions
described in paragraphs (a) and (b) of
this section, and which is not disapproved by the Administrator under

§ 162.154, shall be considered a federal
registration, but shall authorize distribution and use only within that
State. Accordingly, such registrations
are subject to all provisions of FIFRA
which apply to currently registered
products, including provisions for cancellation and suspension of registrations, and reregistration of products.
(2) A State may require, as a condition of distribution or use of a pesticide product within the State, that
the pesticide product be registered
under State law as well as under
FIFRA. Neither FIFRA sec. 24(c) nor
§§ 162.150–162.156 affects a State’s right
under its own law to revoke, suspend,
cancel, or otherwise affect such a registration issued under State law. However, the federal registration, whether
issued under FIFRA sec. 3 or 24(c), is
not affected by such a State action.
§ 162.153 State
registration
procedures.
(a) Application for registration. States
shall require all applicants for registration to submit the following information:
(1) Name and address of the applicant
and any other person whose name will
appear on the labeling or in the directions for use.
(2) The name of the pesticide product,
and, if the application is for an amendment to a federally registered product,
the EPA registration number of that
product.
(3) A copy of proposed labeling, including all claims made for the product
as well as directions for its use to meet
the special local need, consisting of:
(i) For a new product, a copy of the
complete proposed labeling; or,
(ii) For an additional use of a federally registered product, a copy of proposed supplemental labeling and a copy
of the labeling for the federally registered product.
(4) The complete formula of the product, if the application is for a new
product registration.
(5) Any other information which is
required to be reviewed prior to registration under this section.
(b) Special local need determination. In
reviewing any application for registration, the State shall determine whether there is a special local need for the

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registration. Situations which a State
may consider as not involving a special
local need may include, but are not
limited to, applications for registrations to control a pest problem present
on a nationwide basis, or for use of a
pesticide product registered by other
States on an interregional or nationwide basis.
(c) Unreasonable adverse effects determination. (1) Prior to issuing a registration in the following cases, the State
shall determine that use of the product
for which registration is sought will
not cause unreasonable adverse effects
on man or the environment, when used
in accordance with labeling directions
or widespread and commonly recognized practices:
(i) For use of a product which has a
composition not similar to any federally registered product.
(ii) For use of a project involving a
use pattern not similar to any federally registered use of the same product
or of a product with a similar composition.
(iii) For use of a product for which
other uses of the same product, or of a
product with a similar composition,
have had registration denied, disapproved, suspended, or cancelled by
the Administrator.
(2) Determinations required by paragraph (c)(1) of this section shall be
based on data and criteria consistent
with those sections of part 152 of this
chapter, applicable to the type of product or use under consideration. Such
determinations may also involve consideration of the effect of the anticipated classification of the product or
use under § 162.153(h).
(d) Efficacy determination. Prior to
registration of any use of a product for
public health purposes—that is, a use
which could result in substantial harm
to the public health if the product does
not perform its intended function, the
State shall determine that the product
warrants the claims made for it in the
registration application. Such determinations shall be based on criteria
specified in applicable sections of part
152 of this chapter and on any additional criteria established by the
State.
(e) Labeling requirements. (1) Prior to
issuing any registration, the State

shall review the proposed labeling submitted with the application to determine compliance with this paragraph.
In addition, the State shall review a
copy of the final printed labeling as
soon as practical after a registration is
issued in order to verify compliance
with this paragraph.
(2) For a new product, the State
must, as a condition of the registration, require that the product be accompanied from the time it enters the
stream of commerce by labeling meeting all applicable criteria of § 156.10 of
this chapter. New product labeling
must all contain:
(i) A statement identifying the State
where registration is to be valid.
(ii) The special local need registration number assigned by the State.
(3) Except as provided in paragraph
(e)(4) of this section, as a condition for
a registration of an additional use of a
federally registered product, the State
must require that at the time of sale to
users, labeling from the federally registered product be accompanied by supplemental labeling which contains:
(i) A statement identifying the State
where registration is valid.
(ii) Directions for use to meet the
special local need which satisfy the criteria of § 156.10(i) of this chapter.
(iii) The trade name of the product.
(iv) The name and address of the section 24(c) registrant.
(v) The EPA registration number of
the federally registered product.
(vi) The special local need registration number assigned by the State.
(vii) A statement prohibiting use of
the product in a manner inconsistent
with all applicable directions, restrictions, and precautions found in the labeling of the federally registered product and accompanying supplemental
labeling.
(4) When a federally registered product is already in the stream of commerce at the time the State issues a
registration for an additional use of
that product, the State must ensure
that supplemental labeling for the additional use, meeting the criteria of
paragraph (e)(3) of this section, is made
available to purchasers and users of the
product within 45 days of the date on
which the State approves the final
printed supplemental labeling.

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(5) If a State classifies for restricted
use a product or use registered by the
State, which is not required to be so
classified by paragraph (g) of this section, then the State may require supplemental labeling for the product or
use containing additional appropriate
precautions, and a statement that the
product or use is for restricted use
within that State.
(f) Packaging and coloration standards.
All products registered by a State must
meet all appropriate packaging standards prescribed by the Administrator
under sec. 25(c)(3) of FIFRA. State registered products must also meet all appropriate standards for coloration, or
discoloration, established by regulation under sec. 25(c) of FIFRA, including the standards contained in subpart
H of part 153 of this chapter. Prior to
issuing any registration, the State
shall determine that the product will
conform to these requirements.
(g) Classification. (1) As part of the
registration of any product or use, a
State shall classify the product or use
as a restricted use pesticide if:
(i) The product is identical or similar
in composition to a federally registered
product:
(A) For which all federally registered
uses have been classified as restricted
by the Administrator; or
(B) For which a use similar to the
State registered use has been classified
as restricted by the Administrator; or
(ii) The State registered product or
use meets the criteria for classification
as a restricted use pesticide under the
applicable provisions of § 152.170 of this
chapter.
(2) [Reserved]
(h) Notification and Submission of
Data. (1) Within ten working days from
the date a State issues, amends, or revokes a registration, the State shall
notify EPA, in writing, of the action.
Notification of State registrations, or
amendments thereto, shall include the
effective date of the registration or
amendment, a confidential statement
of the formula of any new product, and
a copy of the draft labeling reviewed
and approved by the State, provided
that labeling previously approved by
the Administrator as part of a federal
registration need not be submitted.

(2) Notification of State registrations
or amendments shall be supplemented
by the State sending to EPA a copy of
the final printed labeling approved by
the State within 60 days after the effective date of the registration or amendment.
(3) Notification of revocation of a
registration by a State shall indicate
the effective date of revocation, and
shall state the reasons for revocation.
(4) The Administrator or his designee
may request, when appropriate, that a
State submit to EPA any data used by
the State to determine that unreasonable adverse effects will not be caused
when the State registers any use described in paragraph (c)(1) of this section. Within 15 working days of receipt
of such a request from EPA, the State
shall submit two copies of the requested data.
(i) Federal Register Publication. The
Administrator shall publish in the FEDERAL REGISTER, on a regular basis, a
summary of all State registrations
made under sec. 24(c) during a previous
reporting period established by the Administrator. For each product or use
registered, the notice shall indicate:
(1) The name of the product.
(2) The name of the registrant.
(3) The registered use(s) of the product.
(4) The effective date of the State
registration.
(5) If the registration is for an additional use of a federally registered
product, whether the State registration involves a changed use pattern.
[46 FR 2014, Jan. 7, 1981, as amended at 53 FR
15999, May 4, 1988; 60 FR 32097, June 19, 1995]

§ 162.154 Disapproval of State registrations.
(a) General disapprovals. (1) Except as
provided in paragraph (b) of this section, the Administrator may disapprove, on any reasonable grounds,
any state registration which, when
compared to a federally registered
product, does not have both a similar
composition and a similar use pattern;
provided that the Administrator may
not disapprove such a registration solely because of a lack of essentiality.

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Grounds for disapproval of State registrations not involving similar products may include, but are not limited
to:
(i) Probable creation of unreasonable
adverse effects on man or the environment by the registered use.
(ii) Refusal of the registering State
to submit information supporting the
registration as required by § 162.153(h).
(iii) Failure of information submitted
by the State to support the State’s decision to issue the registration under
standards established by § 162.153.
(2) Prior to disapproval of any State
registration under this paragraph, the
Administrator shall notify the registering State, in writing, of the Administrator’s intent to disapprove, and
of the reasons for disapproval. The notice of intent will provide a reasonable
time, not less than ten days from the
date the notice is received by the
State, for the State to respond, and
will invite the State to consult with
the Administrator or his designee. If
the grounds for disapproval are based
on actions or omissions by the State,
the notice will, if possible, also provide
the State with a reasonable amount of
time in which to take corrective action, not to exceed the time allowed for
disapproval under paragraph (c) of this
section.
(3) The registering State may, within
ten days of receipt of a notice of intent
to disapprove, request that the Administrator, or his designee, consult with
appropriate State officials prior to the
Administrator’s final decision on disapproval. The Administrator will consider any relevant information presented at such a consultation, or in any
other timely and appropriate fashion,
in deciding whether to withdraw the
notice of intent to disapprove.
(b) Special disapprovals. (1) The Administrator may disapprove any State
registration, including a registration
for a similar product, at any time, if
the Administrator determines that use
of the product under the State registration:
(i) Would constitute an imminent
hazard.
(ii) May result in a residue on food or
feed exceeding, or not covered by, a
tolerance, exemption, or other clear-

ance under the Federal Food, Drug and
Cosmetic Act (21 U.S.C. 346a et seq.).
(2) If the Administrator disapproves a
registration under this paragraph, the
Administrator shall provide the registering State with written notification of disapproval, in accordance with
paragraph (c) of this section, as soon
thereafter as practicable. Such notification will specify the grounds for disapproval and invite the State to comment on the decision.
(3) If requested by the State within
ten days of its receipt of a notice of
disapproval, the Administrator, or his
designee, will consult with appropriate
State officials. The Administrator may
consider any information presented at
such a consultation, or in any other appropriate fashion, in determining
whether the disapproval should be rescinded.
(c) Decision and notification of disapproval. Except as provided in paragraph (b)(1) of this section, the Administrator will make a final decision on
disapproval of a State registration, and
provide written notification thereof to
the State, within 90 days of the effective date of the registration; provided
that, if the State does not notify the
Agency of a registration within ten
days of its effective date, then the Administrator will make a final decision
on disapproval within 90 days of the
date on which EPA receives notification of the State registration. The notice of disapproval will specify an appropriate date on which the disapproval will become effective. Disapproval may become effective immediately, or at anytime within the period allowed for the Administrator to
make a final decision on disapproval.
The notice of disapproval will also,
when appropriate, give instructions for
use or disposal of the pesticide. Each
notice of disapproval will be published
in the FEDERAL REGISTER.
(d) Effect of disapproval. If a registration issued by a State is disapproved by
the Administrator, that registration
will not be valid for any purpose under
FIFRA, as of the date the disapproval
becomes effective. Thereafter, distribution or sale of the pesticide, in either
interstate or intrastate commerce, for
uses subject to the disapproval will be
a violation of sec. 12(a)(1) of FIFRA.

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(e) Rescission of disapproval. If the Administrator determines, after consultation with the State lead agency, that a
registration, previously issued by the
State and disapproved by the Administrator, should not have been disapproved under FIFRA, then the Administrator shall rescind the disapproval. The Administrator shall send
written notification of the rescission to
the State. In addition, the Administrator shall publish notice of any rescission of disapproval in the FEDERAL
REGISTER.
(f) Notification of registrants. Any
State that issues a registration which
has been disapproved, or which is subject to a notice of intent to disapprove,
shall be responsible for notifying the
affected registrant of any such notice
of intent or disapproval, and of any recession of disapproval by the Administrator.
§ 162.155 Suspension of State registration authority.
(a) General. (1) If the Administrator
finds that a State is not capable of exercising, or has failed to exercise, adequate control over its registration program, so that the State cannot ensure
that registrations issued by it will be
in accord with the purposes of FIFRA,
then the Administrator may suspend
the State’s authority to register pesticides under sec. 24(c) of the Act. Registrations issued by the State after suspension of its authority will not be
considered valid under FIFRA. Registrations issued by the State prior to
suspension will not be affected by the
suspension.
(2) The Administrator may suspend
all or any part of a State’s registration
authority, as appropriate.
(b) Grounds for Suspension. (1) The Administrator may suspend a State’s registration authority due to lack of, or
failure to exercise, adequate control by
the State over its sec. 24(c) registration
program. Adequate control includes,
but is not limited to, all of the following:
(i) Access to appropriate scientific
and technical personnel to review data
and make determinations as required
by § 162.153.
(ii) Registration procedures satisfying § 162.153.

(iii) Complete and accurate records of
State registrations.
(iv) Adequate legal authority. (A) To
deny, suspend, revoke, or amend a
State registration when the registration is not in compliance with FIFRA,
this subpart, or State law, or when necessary to prevent unreasonable adverse
effects on the environment.
(B) To enter, at reasonable times, by
consent, warrant, or other legal means,
any establishment where pesticides are
produced or held for distribution or
sale, to inspect, sample, and observe
whether pesticides are being produced
or distributed in compliance with
FIFRA, this subpart, State law, and
the terms of any State registration.
(2) The Administrator may suspend a
State’s registration authority if the
State fails to exercise the controls
specified in paragraph (b)(1) of this section, or if the State refuses to correct
within a reasonable time any other significant deficiencies in its regulatory
program, as specified by the Administrator in a notice of intent to suspend.
(c) Procedures for Suspension. (1) Prior
to suspending the registration authority of any State, the Administrator
will notify the State lead agency, in
writing, of the Administrator’s intent
to suspend, and of the specific grounds
for suspension. The notice of intent
will specify whether the suspension
will be complete or partial, and will
provide the State an opportunity to respond and a reasonable amount of
time, not less than 30 days from the
date the notice is received, in which to
correct the deficiencies specified in the
notice. If the State does not correct
the specified deficiencies within the
reasonable time allowed by the notice,
or if the Administrator has not withdrawn the notice of intent before that
time, the notice of intent will be published in the FEDERAL REGISTER, and
the public given an opportunity to
comment thereon.
(2) If requested by the affected State
lead agency within 30 days of receipt of
the notice of intent to suspend, an informal consultation between appropriate State and EPA officials will be
held to discuss the proposed suspension. In such a case, the Administrator
shall not make a final decision on the
proposed suspension until after the

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consultation. The Administrator shall
consider all relevant information presented at the consultation, or in any
other appropriate manner, in determining whether to suspend the State’s authority. If the Administrator determines, on the basis of such information, that the deficiencies listed in the
notice of intent no longer exist, or will
be corrected in a reasonable time, then
the Administrator will withdraw, in
writing, the notice of intent to suspend.
(3) Within ten days of the date a notice of intent to suspend is published in
the FEDERAL REGISTER, a State may request a public hearing to consider the
proposed suspension. If a hearing is requested, the Administrator will:
(i) Schedule a public hearing to be
held in that State.
(ii) Publish in the FEDERAL REGISTER
a notice announcing the date, time,
and location of the hearing.
(iii) Appoint a presiding officer who
shall preside over the hearing.
(iv) Prescribe additional, appropriate
procedures for the conduct of the hearing, including procedures for the presentation of relevant material evidence
from the State, EPA, or members of
the public who would be affected by the
outcome of the hearing. Evidence may
be presented in either oral or written
form, at the discretion of the Administrator.
(4) Following the close of any hearing
held under paragraph (c)(3) of this section, the presiding officer shall make a
recommended decision that the State’s
authority to register pesticides under
sec. 24(c) of FIFRA be suspended, in
whole or in part, or that the State’s authority not be suspended and that the
notice of intent to suspend be withdrawn.
(5) Any recommended decision made
by a presiding officer under paragraph
(c)(4) of this section may be appealed
to the Administrator within 30 days
after its issuance by the State or by
EPA. Any recommended decision which
is not appealed, or which the Administrator does not review on his own initiative, will become a final Agency action 30 days after its issuance.
(6) If no hearing is requested under
paragraph (c)(3) of this section, or if a
recommended decision is appealed to

the Administrator under paragraph
(c)(5) of this section, the Administrator
shall issue a final order either suspending the State’s authority to register
pesticides under section 24(c) of
FIFRA, in whole or in part, or withdrawing the notice of intent to suspend.
(7) Any final order suspending State
registration authority, issued under
paragraph (c) (5) or (6) of this section,
will specify the grounds therefor and
an effective date for the suspension. If
the suspension is merely partial, the
notice of suspension will specify the
types of registrations which will not be
recognized as valid under sec. 24(c). All
final orders issued under paragraph (c)
(5) or (6) will be published in the FEDERAL REGISTER.
(d) Termination of suspension. Suspension of a State’s authority will be effective for the period specified in the
notice of suspension, or if no period
was specified, until such time as the
Administrator is satisfied that the
State can and will exercise adequate
control over its program. In the latter
case, the Administrator will notify the
State that the suspension is terminated, or that it will be terminated on
a specific date. In either case, the Administrator will publish a notice of the
termination of suspension in the FEDERAL REGISTER.
(e) Judicial review. Any State whose
authority to register pesticides has
been finally suspended by the Administrator may seek judicial review of the
Administrator’s decision under sec. 16
of FIFRA, at any time prior to termination of the suspension. Such suspension shall remain in effect during the
period of judicial review unless otherwise ordered by the Administrator.
§ 162.156 General requirements.
(a) Requirements for distribution and
use. (1) Any product whose State registration has been issued in accordance
with §§ 162.152 and 162.153 may be distributed and used in that State, subject
to the following provisions of the Act
and the regulations promulgated thereunder:
(i) Sec. 12(a)(1) (A) through (E), in accordance with:
(A) Sec. 2(q)(1) (A) through (G).
(B) Sec. 2(q)(2) (A) through (D).

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§ 163.2

(ii) Sec. 12(a)(2) (A) through (G) and
(I) through (P).
(2) A product or use classified by a
State
for
restricted
use
under
§ 162.153(g) may be used only by, or
under the direct supervision of, an applicator certified under a plan approved by EPA in accordance with sec.
4 of FIFRA.
(3) State registrations which are not
issued in accordance with § 162.152 (a)
and (b)(2) (i), (ii) and (iii) are not authorized by section 24(c) and are not
considered valid for any purposes under
FIFRA. When the Administrator determines that a registration is invalid,
the Administrator shall notify the registering State that the registration is
invalid, and may specify the reason for
the invalidity.
(b) Establishment registration requirements. No person may produce any pesticide, including any pesticide registered by a State under section 24(c),
unless the establishment in which it is
produced is registered by the Administrator in accordance with sec. 7 of
FIFRA and 40 CFR part 167.
(c) Books and records requirements. All
producers of pesticides, including those
producers of pesticides registered by
States under sec. 24(c), must maintain
records in accordance with the requirements imposed under sec. 8 of FIFRA
and 40 CFR part 169.

Subpart E—[Reserved]
PART 163—CERTIFICATION OF USEFULNESS OF PESTICIDE CHEMICALS
Sec.
163.1 Words in the singular form.
163.2 Definitions.
163.3 Administration.
163.4 Filing of requests for certification.
163.5 Material in support of the request for
certification.
163.6 Certification limited to economic poison uses.
163.7 Factors considered in determining usefulness.
163.8 Basis for determination of usefulness.
163.9 Proposed certification; notice; request
for hearing.
163.10 Withdrawal of request for certification pending clarification or completion.

163.11 Registration under the Federal Insecticide, Fungicide, and Rodenticide Act.
163.12 Opinion as to residue.
AUTHORITY: 21 U.S.C. 346a.
SOURCE: 36 FR 22533, Nov. 25, 1971, unless
otherwise noted.

§ 163.1

Words in the singular form.

Words in this part in the singular
form shall be deemed to import the
plural, and vice versa, as the case may
demand.
§ 163.2

Definitions.

Unless the context otherwise requires, the following terms shall be
construed, respectively, to mean:
(a) Act means the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301
et seq.), as amended by Pub. L. 518, 83d
Congress, 2d Session, ‘‘An Act to
amend the Federal Food, Drug, and
Cosmetic Act with respect to residues
of pesticide chemicals in or on raw agricultural commodities’’ (68 Stat. 511).
(b) Director means the Director of the
Pesticides Regulation Division, Environmental Protection Agency, Washington, D.C.
(c) Agency means the Environmental
Protection Agency.
(d) Pesticide chemical and raw agricultural commodity shall have the same
meanings as they have in paragraphs
(q) and (r), respectively, of section 201
of the Act.
(e) Economic poison shall have the
same meaning as it has under the Federal
Insecticide,
Fungicide,
and
Rodenticide Act (7 U.S.C. 135–135k) and
the regulations issued thereunder.
(f) Person means individuals, partnerships, corporations, and associations.
(g) Certification means a certification
by the Director that a pesticide chemical is useful for the purpose for which
a tolerance or exemption is sought
under the act.
(h) Petition means a petition filed
with the Administrator, Environmental Protection Agency pursuant to
section 408(d)(1) of the Act.
[36 FR 22533, Nov. 25, 1971, as amended at 53
FR 15999, May 4, 1988]

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