ICR Attachment 2: 40 CFR 790

EPA ICR No. 1139.08; OMB Control No. 2070-0033
ATTACHMENT 2
Procedures Governing Testing Consent Agreements and Test Rules
40 CFR 790
SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT
(CONTINUED)
Subpart E—Exemptions From Test Rules

PART 790—PROCEDURES GOVERNING
TESTING
CONSENT
AGREEMENTS AND TEST RULES

790.80 Submission of exemption applications.
790.82 Content of exemption application.
790.85 Submission of equivalence data.
790.87 Approval of exemption applications.
790.88 Denial of exemption application.
790.90 Appeal of denial of exemption application.
790.93 Termination of conditional exemption.
790.97 Hearing procedures.
790.99 Statement of financial responsibility.
APPENDIX A TO SUBPART E—SCHEDULE FOR
DEVELOPING CONSENT AGREEMENTS AND
TEST RULES

Subpart A—General Provisions
Sec.
790.1
790.2
790.3
790.5
790.7

Scope, purpose, and authority.
Applicability.
Definitions.
Submission of information.
Confidentiality.

Subpart B—Procedures for Developing
Consent Agreements and Test Rules
790.20 Recommendation and designation of
testing candidates by the ITC.
790.22 Procedures for gathering information
and negotiating consent agreements on
chemicals which the ITC has recommended for testing with an intent to
designate.
790.24 Criteria for determining whether a
consensus exists concerning the provisions of a draft consent agreement.
790.26 Initiation and completion of rulemaking proceedings on ITC-designated
chemicals.
790.28 Procedures for developing consent
agreements and/or test rules for chemicals that have not been designated or
recommended with intent to designate
by the ITC.

AUTHORITY: 15 U.S.C. 2603.

Subpart A—General Provisions
§ 790.1

Scope, purpose, and authority.

(a) This part establishes procedures
for gathering information, conducting
negotiations, and developing and implementing test rules or consent agreements on chemical substances and mixtures under section 4 of TSCA.
(b) Section 4 of the Act authorizes
EPA to require manufacturers and
processors of chemical substances and
mixtures to test these chemicals to determine whether they have adverse
health or environmental effects. Section 4 (a) empowers the Agency to promulgate rules which require such testing. In addition, EPA has implied authority to enter into enforceable consent agreements requiring testing
where they provide procedural safeguards equivalent to those that apply
where testing is conducted by rule.
(c) EPA intends to use enforceable
consent agreements to accomplish
testing where a consensus exists among
EPA, affected manufacturers and/or
processors, and interested members of
the public concerning the need for and
scope of testing. If such a consensus
does not exist and the Agency believes
that it can make the findings specified
in section 4(a), EPA will initiate proceedings to promulgate test rules
which will be codified in part 799 of this
chapter.

Subpart C—Implementation, Enforcement,
and Modification of Test Rules
790.40 Promulgation of test rules.
790.42 Persons subject to a test rule.
790.45 Submission of letter of intent to conduct testing or exemption application.
790.48 Procedure if no one submits a letter
of intent to conduct testing.
790.50 Submission of study plans.
790.52 Phase II test rule.
790.55 Modification of test standards or
schedules during conduct of test.
790.59 Failure to comply with a test rule.

Subpart D—Implementation, Enforcement
and Modification of Consent Agreements
790.60 Contents of consent agreements.
790.62 Submission of study plans and conduct of testing.
790.65 Failure to comply with a consent
agreement.
790.68 Modification of consent agreements.

5

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00005

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.2

40 CFR Ch. I (7–1–03 Edition)
Exemption means an exemption from
a testing requirement of a test rule
promulgated under section 4 of the Act
and part 799 of this chapter.
Impurity means a chemical substance
which is uninitentionally present with
another chemical substance.
Joint sponsor means a person who
sponsors testing pursuant to section
4(b)(3)(A) of the Act.
Joint sponsorship means the sponsorship of testing by two or more persons
in accordance with section
4(b)(3)(A) of the Act.
Person means an individual, partnership, corporation, association, scientific or academic establishment, or
organizational unit thereof, and any
other legal entity.
Principal sponsor means an individual
sponsor or the joint sponsor who assumes primary responsibility for the
direction of a study and for oral and
written communication with EPA.
Protocol means the plan and procedures which are to be followed in conducting a test.
Reimbursement period refers to a period that begins when the data from
the last non-duplicative test to be completed under a test rule are submitted
to EPA and ends after an amount of
time equal to that which had been required to develop data or after five
years, whichever is later.
Sponsor means the person or persons
who design, direct and finance the testing of a substance or mixture.
Test substance means the form of
chemical substance or mixture that is
specified for use in testing.

(d) Appendix A to this part presents
timetables for various steps in the
evaluation of chemicals under consideration for testing, the initiation and
completion of negotiations to develop
consent agreements, and the proposal
and promulgation of test rules. All
deadlines which are imposed by the Act
are binding on EPA and will be observed by the Agency. The remaining
deadlines represent target dates that
EPA intends to meet.
[51 FR 23712, June 30, 1986]

§ 790.2 Applicability.
This part is applicable to manufacturers and processors of chemical substances or mixtures who are subject to
the testing requirements of a consent
agreement or a rule under section 4(a)
of the Act. The procedures for test
rules are applicable to each test rule in
part 799 or this chapter unless otherwise stated in specific test rules in part
799 of this chapter.
[51 FR 23712, June 30, 1986]

§ 790.3 Definitions.
Terms defined in the Act and not explicitly defined herein are used with
the meaning given in the Act. For the
purpose of this part:
Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
Additive means a chemical substance
that is intentionally added to another
chemical substance to improve its stability or impart some other desirable
quality.
Chemical means a chemical substance
or mixture.
Consortium means an association of
manufacturers and/or processors who
have made an agreement to jointly
sponsor testing.
EPA means the U.S. Environmental
Protection Agency.
Equivalence data means chemical
data or biological test data intended to
show that two substances or mixtures
are equivalent.
Equivalent means that a chemical
substance or mixture is able to represent or substitute for another in a
test or series of tests, and that the data
from one substance can be used to
make scientific and regulatory decisions concerning the other substance.

[49 FR 39782, Oct. 10, 1984, as amended at 51
FR 23712, June 30, 1986]

§ 790.5

Submission of information.

(a) All submissions to EPA under this
part must bear the Code of Federal
Regulations (CFR) section number of
the subject chemical test rule, or indicate the identity of the consent agreement. For all submissions under this
part, six copies must be provided to
EPA.
(b) Submissions containing both confidential business information or nonconfidential business information must
be addressed to the Document Control

6

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00006

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.20

Office (7407), Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Room G–
099, 1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: TSCA Section
4.

stances in the mixture? Describe how
this would occur.
(3) What harmful effects to your competitive position, if any, do you think
would result from disclosure of this information? How would a competitor
use such information? How substantial
would the harmful effects be? What is
the causal relationship between disclosure and the harmful effects?
(4) For what period of time should
confidential treatment be given? Until
a specific date, the occurrence of a specific event, or permanently? Why?
(5) What measures have you taken to
guard against disclosure of this information to others?
(6) To what extent has this information been disclosed to others? What
precautions have been taken in connection with such disclosures?
(7) Has this information been disclosed to the public in any forms? Describe the circumstances.
(8) Has the information been disclosed in a patent?
(9) Has EPA, another Federal agency,
or any Federal court made any pertinent confidentiality determination regarding this information? If so, copies
of such determinations must be included in the substantiation.
(d) If the substantiation provided
under paragraph (c) of this section contains information which the submitter
considers confidential, the submitter
must assert a separate claim of confidentiality for that information at the
time of submission in accordance with
paragraph (b) of this section.

[50 FR 20656, May 17, 1985, as amended at 51
FR 23712, June 30, 1986; 58 FR 34205, June 23,
1993; 60 FR 31922, June 19, 1995; 60 FR 34466,
July 3, 1995]

§ 790.7

Confidentiality.

(a) Any person subject to the requirements of a consent agreement or a test
rule under section 4 of the Act may assert a claim of confidentiality for certain information submitted to EPA in
response to the consent agreement or
the test rule. Any information claimed
as confidential will be treated in accordance with the procedures in part 2
of this title and section 14 of the Act.
Failure to assert a claim of confidentiality at the time the information is
submitted will result in the information being made available to the public
without further notice to the submitter.
(b) A claim of confidentiality must
be asserted by circling or otherwise
marking the specific information
claimed as confidential and designating it with the words ‘‘confidential
business information,’’ ‘‘trade secret,’’
or another appropriate phrase indicating its confidential character.
(c) If a person asserts a claim of confidentiality for study plan information
described in §§ 790.50(c)(1)(iii)(D), (iv),
(v), and (vi) and 790.62(b)(6), (7), (8), (9),
and (10), the person must provide a detailed written substantiation of the
claim by answering the questions in
this paragraph. Failure to provide written substantiation at the time the
study plan information is submitted
will be considered a waiver of the claim
of confidentiality, and the study plan
information will be disclosed to the
public without further notice.
(1) Would disclosure of the study plan
information disclose processes used in
the manufacture or processing of a
chemical substance or mixture? Describe how this would occur.
(2) Would disclosure of the study plan
information disclose the portion of a
mixture comprised by any of the sub-

[49 FR 39782, Oct. 10, 1984, as amended at 51
FR 23713, June 30, 1986]

Subpart B—Procedures for Developing Consent Agreements
and Test Rules
SOURCE: 51 FR 23713, June 30, 1986, unless
otherwise noted.

§ 790.20 Recommendation and designation of testing candidates by the
ITC.
(a) Recommendations with intent to designate. The ITC has advised EPA that it
will discharge its responsibilities under
section 4(e) of the Act in the following
manner:

7

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00007

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.22

40 CFR Ch. I (7–1–03 Edition)

(1) When the ITC identifies a chemical substance or mixture that it believes should receive expedited consideration by EPA for testing, the ITC
may add the substance or mixture to
its list of chemicals recommended for
testing and include a statement that
the ITC intends to designate the substance or mixture for action by EPA in
accordance with section 4(e)(1)(B) of
the Act.
(2) Chemical substances or mixtures
selected for expedited review under
paragraph (a)(1) of this section may, at
a later time, be designated for EPA action within 12 months of such designation. The ITC’s subsequent decision
would be based on the ITC’s review of
TSCA sections 8(a) and 8(d) data and
other relevant information.
(3) Where the ITC concludes that a
substance or mixture warrants testing
consideration but that expedited EPA
review of testing needs is not justified,
the ITC will add the substance or mixture to its list of testing recommendations without expressing an intent to
designate the substance or mixture for
EPA action in accordance with section
4(e)(1)(B) of the Act.
(4) The ITC reserves its right to designate any chemical that it determines
the Agency should, within 12 months of
the date first designated, initiate a
proceeding under section 4(a) of the
Act.
(b) EPA consideration of ITC recommendations. (1) Where a substance or
mixture is designated for EPA action
under section 4(e)(1)(B) of the Act, the
Agency will take either one of the following actions within 12 months after
receiving the ITC designation:
(i) Initiate rulemaking proceedings
under section 4(a) of the Act.
(ii) Publish a FEDERAL REGISTER notice explaining the Agency’s reasons
for not initiating such rulemaking proceedings. EPA may conclude that rulemaking proceedings under section 4(a)
of the Act are unnecessary if it determines that the findings specified in
section 4(a) of the Act cannot be made
or if the Agency has entered into a
consent agreement requiring testing in
accordance with the provisions of this
subpart.
(2) Where a substance or mixture has
been recommended for testing by the

ITC without an intent to designate,
EPA will use its best efforts to act on
the ITC’s recommendations as rapidly
as possible consistent with its other
priorities and responsiblities. EPA may
respond to the ITC’s recommendations
either by:
(i) Initiating rulemaking proceedings
under section 4(a) of the Act.
(ii) Publishing a FEDERAL REGISTER
notice explaining the Agency’s reasons
for concluding that testing is unnecessary.
(iii) Entering into a consent agreement in accordance with this subpart.
§ 790.22 Procedures for gathering information and negotiating consent
agreements on chemicals which the
ITC has recommended for testing
with an intent to designate.
(a) Preliminary EPA evaluation. Following receipt of an ITC report containing a recommendation with an intent to designate, EPA will use the following procedure for completing a preliminary evaluation of testing needs.
Appendix A 1 to this part presents the
schedule that EPA intends to follow for
this purpose.
(1) EPA will publish the ITC report in
the FEDERAL REGISTER and announce
that interested persons have 30 days to
submit comments on the ITC’s testing
recommendations.
(2) EPA will publish a FEDERAL REGISTER
notice adding all ITC-recommended chemicals to the automatic
reporting provisions of its rules under
sections 8(a) and 8(d) of the Act (40
CFR parts 712 and 716).
(3) EPA will hold a public ‘‘focus
meeting’’ to discuss the ITC’s testing
recommendations and obtain comments and information from interested
parties.
(4) EPA will evaluate submissions received under the sections 8(a) and 8(d)
reporting
requirements,
comments
filed on the ITC’s recommendations,
and other information and data compiled by the Agency.
(5) EPA will make a preliminary staff
determination of the need for testing
and, where testing appears warranted,
will tentatively select the studies to be
performed.
1 Editorial Note: Appendix A appears at the
end of subpart E.

8

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00008

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.22

(6) EPA will hold a public meeting to
announce its preliminary testing determinations.
(b) Negotiation procedures for consent
agreements. Where EPA believes that
testing is necessary, the Agency will
explore whether a consent agreement
can be negotiated that satisfies the
testing needs identified by the Agency.
EPA will use the following procedures
for negotiating, formulating and accepting consent agreements. Appendix
A 1 to this part presents the schedule
that EPA intends to follow for this
purpose.
(1) In the FEDERAL REGISTER notice
described in paragraph (a)(1) of this
section, EPA will explain its procedures and timetable for negotiating
consent agreements and invite persons
interested in participating in or monitoring negotiations to contact the
Agency in writing.
(2) Persons who respond to EPA’s notice by the announced date of the
Agency’s course-setting meeting will
be deemed ‘‘interested parties’’ for purposes of any negotiations that EPA
conducts.
(3) Following the course-setting
meeting announcing EPA’s preliminary
testing determinations, the Agency
will meet with manufacturers, processors and other interested parties for
the purpose of attempting to negotiate
a consent agreement. To facilitate attendance at these meetings, EPA will
contact all interested parties who have
expressed a desire to participate in or
monitor negotiations under paragraph
(b)(2) of this section and advise them of
meeting dates.
(4) All negotiating meetings will be
open to members of the public. The
minutes of each meeting will be prepared by EPA. Meeting minutes, testing proposals, background documents
and other materials exchanged at or
prepared for negotiating meetings will
be included in the public file established by EPA on each ITC-recommended chemical. Materials in this
file will be made available for inspection in the OPPTS Reading Room during EPA working hours.
(5) While negotiations are underway,
EPA will promptly circulate meeting
minutes, testing proposals, correspondence and other relevant materials to

interested parties who expressed a desire to participate in or monitor negotiations pursuant to paragraph (b)(2) of
this section.
(6) As negotiations progress, EPA
will make a tentative decision either
to proceed with formulation of a consent agreement or to initiate rulemaking. EPA will terminate negotiations after 10 weeks and proceed with
rulemaking unless negotiations are
likely to result in a draft consent
agreement within 4 additional weeks.
By the end of this 4-week period, EPA
either will have prepared a draft consent agreement reflecting the apparent
consensus of the parties or will terminate negotiations and proceed with
rulemaking. If EPA decides to proceed
with rulemaking, no further opportunity for negotiations will be provided. EPA will promptly send written
notice to all interested parties of the
termination of negotiations.
(7) Where EPA prepares a draft consent agreement, it will be circulated
for comment to all interested parties
who expressed a desire to participate in
or monitor negotiations under paragraph (b)(2) of this section. A period of
4 weeks will be provided for submitting
comments or written objections under
§ 790.24(a).
(8) If necessary, EPA will hold a public meeting to discuss comments on the
draft consent agreement and to determine whether revisions in the agreement are appropriate.
(9) Where a consensus exists concerning the contents of a draft consent
agreement, it will be circulated to EPA
management and interested parties for
final approval and signature.
(10) Upon final approval of a consent
agreement, EPA will publish a FEDERAL REGISTER notice that summarizes
the agreement, describes the ITC recommendations for the test substance,
outlines the chemical’s use and exposure characteristics, and explains the
background, objectives and rationale of
the testing to be conducted, and codifies in subpart C of part 799 the name of
the substance(s) to be tested and the
citation to the FEDERAL REGISTER notice of the agreement.

9

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00009

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.24

40 CFR Ch. I (7–1–03 Edition)
§ 790.26 Initiation and completion of
rulemaking proceedings on ITCdesignated chemicals.

§ 790.24 Criteria
for
determining
whether a consensus exists concerning the provisions of a draft
consent agreement.

(a) Where EPA concludes that a consensus does not exist concerning the
provisions of a draft consent agreement
and that the findings specified by section 4(a) can be made, the Agency will
proceed with rulemaking under section
4(a) of TSCA.
(b) When EPA decides to proceed
with rulemaking under paragraph (a) of
this section, the Agency intends to
publish a rulemaking proposal and a
final rule or a notice terminating the
rulemaking proceeding in accordance
with the schedule specified in Appendix
A 1 to this part.
(c) Where the testing recommendations of the ITC raise unusually complex and novel issues that require additional Agency review and opportunity
for public comment, the Agency may
publish an Advance Notice of Proposed
Rulemaking (ANPR). The schedule
that EPA intends to follow for rulemaking proceedings initiated by publication of an ANPR is presented in appendix A 1 to this part.

(a) EPA will enter into consent
agreements only where there is a consensus among the Agency, one or more
manufacturers and/or processors who
agree to conduct or sponsor the testing, and all other interested parties
who identify themselves in accordance
with § 790.22(b)(2). EPA will not enter
into a consent agreement in either of
the following circumstances:
(1) EPA and affected manufacturers
and/or processors cannot reach a consensus on the testing requirements or
other provisions to be included in the
consent agreement.
(2) A draft consent agreement is considered inadequate by other interested
parties who, pursuant to § 790.22(b)(2),
have asked to participate in or monitor
negotiations; and these parties have
submitted timely written objections to
the draft consent agreement which provide a specific explanation of the
grounds on which the draft agreement
is objectionable.
(b) EPA may reject objections described in paragraph (a)(2) of this section only where the Agency concludes
the objections are either:
(1) Not made in good faith.
(2) Untimely.
(3) Do not involve the adequacy of
the proposed testing program or other
features of the agreement that may affect EPA’s ability to fulfill the goals
and purposes of the Act.
(4) Not accompanied by a specific explanation of the grounds on which the
draft agreement is considered objectionable.
(c) The unwillingness of some manufacturers and/or processors of a prospective test chemical to sign the draft
consent agreement does not, in itself,
establish a lack of consensus if EPA
concludes that those manufacturers
and/or processors who are prepared to
sign the agreement are capable of accomplishing the testing to be required
and that the draft agreement will
achieve the purposes of the Act in all
other respects.

§ 790.28 Procedures for developing
consent agreements and/or test
rules for chemicals that have not
been designated or recommended
with intent to designate by the ITC.
(a) Where EPA believes that testing
is needed, it may also develop consent
agreements and/or test rules on chemical substances or mixtures that either:
(1) Have been recommended but not
‘‘recommended with intent to designate’’ by the ITC.
(2) Have been selected for testing
consideration by EPA on its own initiative.
(b) When EPA wishes to initiate negotiations concerning chemicals described in paragraph (a) of this section,
it will publish a FEDERAL REGISTER notice describing its tentative evaluation
of testing needs, announcing a date for
a public course-setting meeting, and
inviting persons interested in participating in or monitoring negotiations to
1 Editorial Note: Appendix A appears at the
end of subpart E.

10

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00010

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.42

contact the Agency in writing. Any negotiations that EPA conducts will conform to the procedures specified in
§ 790.22(b) and, to the extent feasible,
will follow the schedules presented in
appendix A 1 to this part.
(c) EPA will enter into consent
agreements on chemicals described in
paragraph (a) of this section only if
there is a consensus among EPA, affected manufacturers and/or processors, and any other persons who have
asked to participate in or monitor negotiations. In determining whether
such a consensus exists, EPA will employ the criteria specified in § 790.24. In
the absence of consensus, EPA will initiate rulemaking if it concludes that
the findings specified in section 4(a) of
the Act can be made. The schedule for
initiating and completing such rulemaking proceedings will, to the extent
feasible, follow the schedule specified
in appendix A 1 to this part.

(iii) Which test substance(s) must be
tested.
(iv) Standards for the development of
test data.
(v) The EPA Good Laboratory Practice requirements for the required testing.
(vi) Schedule for submission of interim reports and/or final reports to
EPA.
(vii) Who must submit either letters
of intent to conduct testing or exemption applications.
(viii) What types of data EPA will examine in determining equivalence if
more than one test substance is to be
tested.
(2) Under two-phase test rule development, EPA will promulgate a Phase I
test rule in part 799 of this chapter
through a notice and comment rulemaking which specifies the following:
(i) Identification of the chemical for
which testing is required under the
rule.
(ii) The health or environmental effect or effects or other characteristics
for which testing is being required.
(iii) Which test substance(s) must be
tested.
(iv) A reference to appropriate guidelines for the development of test data.
(v) The EPA Good Laboratory Practice requirements for the required testing.
(vi) Who must submit either letters
of intent to conduct testing and study
plans, or exemption applications.
(vii) What types of data EPA will examine in determining equivalence if
more than one test substance is to be
tested.
(3) Under two-phase test rule development, test standards and schedules will
be developed in a second phase of rulemaking as described in §§ 790.50 and
790.52.

Subpart C—Implementation, Enforcement, and Modification
of Test Rules
SOURCE: 50 FR 20657, May 17, 1985, unless
otherwise noted. Redesignated at 51 FR 23713,
June 30, 1986.

§ 790.40

Promulgation of test rules.

(a) If EPA determines that it is necessary to test a chemical substance or
mixture by rule under section 4 of the
Act, it will promulgate a test rule in
part 799 of this chapter.
(b) EPA will promulgate specific test
rules in part 799 of this chapter either
by a single-phase rulemaking procedure or by a two-phase rulemaking procedure.
(1) Under single-phase test rule development, EPA will promulgate a test
rule in part 799 of this chapter through
a notice and comment rulemaking
which specifies the following:
(i) Identification of the chemical for
which testing is required under the
rule.
(ii) The health or environmental effect or effects or other characteristics
for which testing is being required.

[50 FR 20657, May 17, 1985. Redesignated and
amended at 51 FR 23713, June 30, 1986; 54 FR
36313, Sept. 1, 1989]

§ 790.42

Persons subject to a test rule.

(a) Each test rule described in § 790.40
will specify whether manufacturers,
processors, or both are subject to the
requirement for testing of the subject
chemical under section 4(b)(3)(B) of the

1 Editorial Note: Appendix A appears at the
end of subpart E.

11

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00011

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.45

40 CFR Ch. I (7–1–03 Edition)

Act and will indicate who will be required to submit letters of intent to
conduct testing.
(1) If testing is being required to
allow evaluation of risks:
(i) Primarily associated with manufacture of the chemical, or
(ii) Associated with both manufacturer and processing of the chemical,
or
(iii) Associated with distribution in
commerce, use, and/or disposal activities concerning the chemical, each
manufacturer of the chemical will be
subject and must comply with the requirements of the test rule.
(2) While legally subject to the test
rule in circumstances described in
paragraphs (a)(1) (ii) and (iii) of this
section, processors of the chemical
must comply with the requirements of
the test rule only if processors are directed to do so in a subsequent notice
as set forth in § 790.48(b).
(3) If testing is being required to
allow evaluation of risks associated
solely with processing of the chemical,
processors will be subject and must
comply with the requirements of the
test rule.
(4) While legally subject to the test
rule in circumstances described in
paragraph (a)(1) of this section, persons
who manufacture less than 500 kg (1,100
lb) of the chemical annually during the
period from the effective date of the
test rule to the end of the reimbursement period, must comply with the requirements of the test rule only if such
manufacturers are directed to do so in
a subsequent notice as set forth in
§ 790.48, or if directed to do so in a particular test rule.
(5) While legally subject to the test
rule in circumstances described in
paragraph (a)(1) of this section, persons
who manufacture small quantities of
the chemical solely for research and
development (meaning quantities that
are not greater than those necessary
for purposes of scientific experimentation or analysis or chemical research
on, or analysis of, such chemical or another chemical, including such research or analysis for development of a
product) from the effective date of the
test rule to the end of the reimbursement period, must comply with the requirements of the test rule only if such

manufacturers are directed to do so in
subsequent notice set forth in § 790.48,
or if directed to do so in a particular
test rule.
(6) If testing is being required to
allow evaluation of risks associated
primarily with manufacture of a chemical for research and development (R &
D) purposes, manufacturers of the
chemical for R & D will be subject and
must comply with the requirements of
the test rule.
(b) [Reserved]
[50 FR 20657, May 17, 1985. Redesignated at 51
FR 23713, June 30, 1986, and amended at 55 FR
18884, May 7, 1990]

§ 790.45 Submission of letter of intent
to conduct testing or exemption application.
(a) No later than 30 days after the effective date of a test rule described in
§ 790.40, each person subject to that rule
and required to comply with the requirements of that rule as provided in
§ 790.42(a) must, for each test required,
either notify EPA by letter of his or
her intent to conduct testing or submit
to EPA an application for an exemption from testing requirements for the
test.
(b) EPA will consider letters of intent to test as commitments to sponsor
the tests for which they are submitted
unless EPA agrees to the substitution
of an exemption application in instances where more than one person indicates an intent to sponsor equivalent
tests.
(c) Each letter of intent to conduct
testing must include:
(1) Identification of test rule.
(2) Name, address, and telephone
number of the firm(s) which will be
sponsoring the tests.
(3) Name, address, and telephone
number of the appropriate individual
to contact for further information.
(4) For sponsors participating in a
testing consortium—a list of all members of the consortium, the signature
of an authorized representative of each
member, and a designation of who is to
serve as principal sponsor.
(5) A list of the testing requirements
for which the sponsor(s) intends to conduct tests.
(6) If EPA is requiring testing of
more
than
one
representative

12

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00012

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.48

substance—which test substance the
sponsor(s) intends to use in each of the
tests.
(d)(1) Any person not manufacturing
or processing the subject chemical as
of the effective date of the test rule describing in § 790.40 or by 30 days after
the effective date of the rule who, before the end of the reimbursement period, manufacturers or processes the
test chemical and who is subject to and
required to comply with the requirements of the test rule must submit the
letter of intent to test or an exemption
application required by paragraph (a)
of this section by the date manufacture
or processing begins, or
(2) When both manufacturers and
processors are subject to the rule, any
person not processing the subject
chemical as of the effective date of the
test rule described in § 790.40 or by 30
days after publication of the FEDERAL
REGISTER
notice
described
in
§ 790.48(b)(2) who, before the end of the
reimbursement period, processes the
test chemical and who is required to
comply with the requirements of the
rule must submit the letter of intent to
test or an exemption application required by § 790.48(b)(3) of the date processing begins.
(e) Manufacturers subject to a test
rule described in § 790.40 who do not
submit to EPA either a letter of their
intent to conduct tests or a request for
an exemption from testing for each
test for which testing is required in the
test rule will be considered in violation
of that rule beginning on the 31st day
after the effective date of the test rule
described in § 790.40 or on the date manufacture begins as described in paragraph (d) of this section.
(f) Processors subject to a test rule
described in § 790.40 and required to
comply with the requirements of test
rule pursuant to § 790.42(a)(2) or a FEDERAL REGISTER notice as described in
§ 790.48(b)(2) who do not submit to EPA
either a letter of their intent to conduct tests or a request for an exemption for each test for which testing is
required in the test rule will be considered in violation of that rule beginning
on the 31st day after the effective date
of the test rule described in § 790.40 or
31 days after publication of the FEDERAL REGISTER notice described in

§ 790.48(b)(2) or on the date processing
begins as described in paragraph (d) of
this section, as appropriate.
§ 790.48 Procedure if no one submits a
letter of intent to conduct testing.
(a) If only manufacturers are subject to
the rule. (1) This paragraph applies if
testing is being required solely to allow
evaluation of risks associated with
manufacturing and the test rule described in § 790.40 states that manufacturers only are responsible for testing.
(2) If no manufacturer subject to the
test rule has notified EPA of its intent
to conduct one or more of the required
tests within 30 days after the effective
date of the test rule described in
§ 790.40, EPA will notify all manufacturers, including those described in
§ 790.42(a)(4) and (a)(5), by certified mail
or by publishing a notice of this fact in
the FEDERAL REGISTER specifying the
tests for which no letter of intent has
been submitted and will give such manufacturers an opportunity to take corrective action.
(3) If no manufacturer submits a letter of intent to conduct one or more of
the required tests within 30 days after
receipt of the certified letter or publication of the FEDERAL REGISTER notice
described in paragraph (a)(2) of this
section, all manufacturers subject to
the rule will be in violation of the test
rule from the 31st day after receipt of
the certified letter or publication of
the FEDERAL REGISTER notice described
in this paragraph.
(b) If manufacturers and processors are
subject to the rule. (1) This paragraph
applies if testing is being required to
allow evaluation of risks associated
with manufacturing and processing or
with distribution in commerce, use, or
disposal of the chemical and the test
rule described in § 790.40 states that
manufacturers and processors are responsible for testing.
(2) If no manufacturer subject to the
rule has notified EPA of its intent to
conduct testing for one or more of the
required tests within 30 days after the
effective date of the test rule described
in § 790.40, EPA will publish a notice in
the FEDERAL REGISTER of this fact
specifying the tests for which no letter
of intent has been submitted.

13

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00013

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.50

40 CFR Ch. I (7–1–03 Edition)

(3) No later than 30 days after the
date of publication of the FEDERAL
REGISTER notice described in paragraph
(b)(2) of this section, each person described in § 790.40(a)(4) and (5) and each
person processing the subject chemical
as of the effective date of the test rule
described in § 790.40 or by 30 days after
the date of publication of the FEDERAL
REGISTER notice described in paragraph
(b)(2) of this section must, for each test
specified in the FEDERAL REGISTER notice, either notify EPA by letter of his
or her intent to conduct testing or submit to EPA an application for an exemption from testing requirements for
the test.
(4) If no manufacturer or processor of
the test chemical has submitted a letter of intent to conduct one or more of
the required tests within 30 days after
the date of publication of the FEDERAL
REGISTER notice described in paragraph
(b)(2) of this section, EPA will notify
all manufacturers and processors by
certified letter or publish a FEDERAL
REGISTER notice of this fact specifying
the tests for which no letter of intent
has been submitted. This letter or FEDERAL REGISTER notice will give the
manufacturers and processors an opportunity to take corrective action.
(5) If no manufacturer or processor
submits a letter of intent to conduct
one or more of the required tests within 30 days after receipt of the certified
letter or publication of the FEDERAL
REGISTER notice described in paragraph
(b)(4) of this section, all manufacturers
and processors subject to the rule will
be in violation of the test rule from the
31st day after receipt of the certified
letter or publication of the FEDERAL
REGISTER notice described in paragraph
(b)(4) of this section.
(c) Only processors are subject to the
rule. (1) This paragraph applies if testing is being required solely to allow
evaluation of risks associated with
processing and the test rule described
in § 790.40 states that only processors
are responsible for testing.
(2) If no processor subject to the rule
has notified EPA of its intent to conduct one or more of the required tests
within 30 days after the effective date
of the test rule described in § 790.40,
EPA will notify all the processors by
certified mail or publish a notice in the

FEDERAL REGISTER of this fact, specifying the tests for which no letter of
intent has been submitted and give the
processors an opportunity to take corrective action.
(3) If no processor submits a letter of
intent to conduct one or more of the
required tests within 30 days after receipt of the certified letter or publication of the FEDERAL REGISTER notice
described in paragraph (c)(2) of this
section, all processors subject to the
rule will be in violation of the test rule
from the 31st day after receipt of the
certified letter or publication of the
FEDERAL REGISTER notice described in
this paragraph.
[50 FR 20657, May 17, 1985. Redesignated at 51
FR 23713, June 30, 1986, and amended at 55 FR
18884, May 7, 1990]

§ 790.50

Submission of study plans.

(a) Who must submit study plans. (1)
Persons who notify EPA of their intent
to conduct tests in compliance with
the requirements of a single phase test
rule as described in § 790.40(b)(1) must
submit study plans for those tests prior
to the initiation of each of these tests,
unless directed by a particular test
rule or consent agreement to submit
study plans at a specific time.
(2) Persons who notify EPA of their
intent to conduct tests in compliance
with the requirements of a Phase I test
rule as described in § 790.40(b)(2) must
submit the proposed study plans for
those tests on or before 90 days after
the effective date of the Phase I rule;
or, for processors complying with the
notice described in § 790.48(b)(2), 90 days
after the publication date of that notice; or 60 days after the date manufacture or processing begins as described
in § 790.45(d), as appropriate, to the address in § 790.5(b).
(3) Study plans must be prepared according to the requirements of this
subpart B and part 792 of this chapter.
Only one set of study plans should be
prepared and submitted by persons who
are jointly sponsoring testing.
(4) Any person subject to a test rule
may submit a study plan for any test
required by the rule at any time, regardless of whether the person previously submitted an application for
exemption from testing for that test.

14

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00014

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.50

(5) Unless EPA has granted an extension of time for submission of proposed
study plans, manufacturers who notify
EPA that they intend to conduct testing in compliance with the requirements of a Phase I test rule as described in § 790.40(b)(2) and who do not
submit proposed study plans for those
tests on or before 90 days after the effective date of the Phase I test rule or
60 days after the date manufacture begins as described in § 790.45(d) will be
considered in violation of the test rule
as if no letter of intent to test had been
submitted.
(6) Unless EPA has granted an extension of time for submission of proposed
study plans, processors who notify EPA
that they intend to conduct testing in
compliance with the requirements of a
Phase I test rule as described in
§ 790.40(b)(2) and who do not submit proposed study plans for those tests on or
before 90 days after the effective date
of the Phase I test rule or 90 days after
the publication date of the notice described in § 790.48(b)(2), or 60 days after
the date processing begins as described
in § 790.45(d), as appropriate, will be
considered in violation of the test rule
as if no letter of intent to test had been
submitted.
(b) Extensions of time for submission of
study plans. (1) EPA may grant requests for additional time for the development of study plans on a case-bycase basis. Requests for additional time
for study plan development must be
made in writing to EPA at the address
in § 790.5(b). Each extension request
must state why EPA should grant the
extension.
(2) Under two-phase rulemaking, extension requests must be submitted to
EPA within 60 days after the effective
date of the Phase I test rule as described in § 790.40(b)(2); or for processors complying with the notice described in § 790.48(b)(2), 60 days after the
publication date of that notice; or 30
days after the date manufacture or
processing begins as described in
§ 790.45(d), as appropriate.
(3) EPA will notify the submitter by
certified mail of EPA’s decision to
grant or deny an extension request.
(4) Persons who have been granted an
extension of time for submission of
study plans as described in paragraph

(b)(1) of this section and who do not
submit proposed study plans in compliance with the requirements of a Phase
I test rule in accordance with the new
deadline granted by EPA will be considered in violation of the test rule as
if no letter of intent to test had been
submitted as described in § 790.45(e) and
(f).
(c) Content of study plans. (1) All
study plans are required to contain the
following information:
(i) Identity of the test rule.
(ii) The specific test requirements of
that rule to be covered by the study
plan.
(iii)(A) The names and addresses of
the test sponsors.
(B) The names, addresses, and telephone numbers of the responsible administrative officials and project manager(s) in the principal sponsor’s organization.
(C) The name, address, and telephone
number of the appropriate individual
to contact for oral and written communications with EPA.
(D)(1) The names and addresses of the
testing facilities and the names, addresses, and telephone numbers of the
testing facilities’ administrative officials and project manager(s) responsible for the testing.
(2) Brief summaries of the training
and experience of each professional involved in the study, including study director, veterinarian(s), toxicologist(s),
pathologist(s), chemist(s), microbiologist(s), and laboratory assistants.
(iv) Identity and data on the chemical substance(s) being tested, including physical constants, spectral data,
chemical analysis, and stability under
test and storage conditions, as appropriate.
(v) Study protocol, including the rationale for any combination of test
protocols; the rationale for species/
strain selection; dose selection (and
supporting data); route(s) or method(s)
of exposure; description of diet to be
used and its source; including nutrients
and contaminants and their concentrations; for in vitro test systems, a description of culture medium and its
source; and a summary of expected
spontaneous chronic diseases (including tumors), genealogy, and life span.

15

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00015

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.52

40 CFR Ch. I (7–1–03 Edition)

(vi) Schedule for initiation and completion of each short-term test and of
each major phase of long-term tests;
dates for submission of interim
progress and final reports to EPA that
are within the reporting deadlines
specified by EPA In the final test rule.
(2) Information required in paragraph
(c)(1)(iii)(D) of this section is not required in proposed study plans submitted in compliance with the requirements of a Phase I test rule if the information is not available at the time
of study plan submission; however, the
information must be submitted before
the initiation of testing.
(d) Incomplete study plans. (1) Upon receipt of a study plan, EPA will review
the study plan to determine whether it
complies with paragraph (c) of this section. If EPA determines that the study
plan does not comply with paragraph
(c) of this section, EPA will notify the
submitter that the submission is incomplete and will identify the deficiencies and the steps necessary to
complete the submission.
(2) The submitter will have 15 days
after the day it receives this notice to
submit appropriate information to
make the study plan complete.
(3) If the submitter fails to provide
appropriate information to complete a
proposed study plan submitted in compliance with the requirements of a
Phase I test rule on or before 15 days
after receipt of the notice, the submitter will be considered in violation
of the test rule as if no letter of intent
to conduct the test had been submitted
as described in § 790.45(e) and (f).
(e) Amendments to study plans. Test
sponsors shall submit all amendments
to study plans to the Director, Office of
Compliance Monitoring at the address
in § 790.5(d).

the proposed study plan to ensure that
data from the test will be reliable and
adequate.
(b) EPA will provide a 45-day comment period and will provide an opportunity for an oral presentation upon
the request of any person. EPA may extend the comment period if it appears
from the nature of the issues raised by
EPA’s review or from public comments
that further comment is warranted.
(c) After receiving and considering
public comments on the study plan,
EPA will adopt, as proposed or as
modified in response to EPA review
and public comments, the study protocol section of the study plan, as defined by § 790.50(c)(1)(v) of this chapter,
as the test standard for the required
testing, and the schedule section of the
study
plan,
as
defined
by
§ 790.50(c)(1)(vi) of this chapter, as the
schedule for the required testing in a
final Phase II test rule.
[50 FR 20657, May 17, 1985. Redesignated at 51
FR 23713, June 30, 1986, and amended at 52 FR
36569, Sept. 30, 1987]

§ 790.55 Modification of test standards
or schedules during conduct of test.
(a) Application. Any test sponsor who
wishes to modify the test schedule for
the mandatory testing conditions or
requirements (i.e., ‘‘shall statements’’)
in the test standard for any test required by a test rule must submit an
application in accordance with this
paragraph. Application for modification must be made in writing to EPA
at the address in § 790.5(b), or by phone
with written confirmation to follow
within 10 working days. Applications
must include an appropriate explanation and rationale for the modification. Where a test sponsor requests
EPA to provide guidance or to clarify a
non-mandatory testing requirement
(i.e., ‘‘should statements’’) in a test
standard, the test sponsor should submit these requests to EPA at the address in § 790.5(b).
(b) Adoption. (1) Where EPA concludes that the requested modification
of a test standard or schedule for a test
required under a test rule is appropriate, EPA will proceed in accordance
with this paragraph (b).

[50 FR 20657, May 17, 1985. Redesignated and
amended at 51 FR 23713, June 30, 1986; 52 FR
36569, Sept. 30, 1987; 54 FR 36313, Sept. 1, 1989;
55 FR 18884, May 7, 1990; 58 FR 34205, June 23,
1993; 60 FR 34466, July 3, 1995]

§ 790.52 Phase II test rule.
(a) If EPA determines that the proposed
study
plan
described
in
§ 790.50(a)(2) complies with § 790.50(c),
EPA will publish a proposed Phase II
test rule in the FEDERAL REGISTER requesting comments on the ability of

16

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00016

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.55

(2) Where, in EPA’s judgment, the requested modification of the test standard or schedule would not alter the
scope of the test or significantly
change the schedule for completing the
test, EPA will not ask for public comment before approving the modification. EPA will notify the test sponsor
by letter of EPA’s approval. EPA will
place copies of each application and
EPA approval letter in the rulemaking
record for the test rule in question.
EPA will publish a notice annually in
the FEDERAL REGISTER indicating the
test standards or schedules for tests required in test rules which have been
modified under this paragraph (b)(2)
and describing the nature of the modifications. Until the FEDERAL REGISTER
notice is published, any modification
approved by EPA under this paragraph
(b)(2) shall apply only to the test sponsor who applied for the modification
under this paragraph (a) of this section.
(3) Where, in EPA’s judgment, the requested modification of a test standard
or schedule would significantly alter
the scope of the test or significantly
change the schedule for completing the
test, EPA will publish a notice in the
FEDERAL REGISTER requesting comment on the proposed modification.
However, EPA will approve a requested
modification of a test standard under
paragraph (b)(3) of this section without
first seeking public comment if EPA
believes that an immediate modification to the test standard is necessary
to preserve the accuracy or validity of
an ongoing test. EPA may also modify
a testing requirement or test condition
in a test standard if EPA determines
that the completion or achievement of
this requirement or condition is not
technically feasible. EPA may approve
a test schedule extension under paragraph (b)(3) of this section without
first seeking public comment if EPA
determines, on a case-by-case basis,
that a delay of over 12 months is not
the fault of the test sponsor and is the
result of unforeseen circumstances
such as a lack of laboratory availability, lack of availability of suitable
test substance (e.g., 14–C labelled test
substance), lack of availability of
healthy test organisms, or the unexpected failure of a long-term test. EPA

will publish an annual notice in the
FEDERAL REGISTER announcing the approval of any test standard modifications and test schedule extensions
under paragraph (b)(3) of this section
and provide a brief rationale of why the
modification was granted.
(4) For purposes of this paragraph (b),
a requested modification of a test
standard or schedule for a test required
under a test rule would alter the scope
of the test or significantly change the
schedule for completing the test if the
modification would:
(i) Change the test species.
(ii) Change the route of administration of the test chemical.
(iii) Change the period of time during
which the test species is exposed to the
test chemical.
(iv) Except as provided in paragraph
(b)(3) of this section, extend the final
reporting deadline more than 12
months from the date specified in the
final rule.
(c) Disapproval. Where EPA concludes
that the requested modification of a
test standard or schedule for a test required under a test rule is not appropriate, EPA will so notify the test
sponsor in writing.
(d) Timing. (1) Test sponsors should
submit all applications for test schedule modifications at least 60 days before the reporting deadline for the test
in question.
(2) EPA will not normally approve
any test schedule extensions submitted
less than 30 days before the reporting
deadline for the test in question.
(3) Except as provided in paragraph
(b)(3) of this section, EPA may grant
extensions for up to 1 year but will normally limit extensions to a period of
time equal to the in-life portion of the
test plus 60 days.
(4) EPA will normally approve only
one deadline extension for each test.
(5) Test sponsors should submit requests for test standard modifications
as soon as they determine that the test
cannot be successfully completed according to the test standard specified
in the rule.
[50 FR 20657, May 17, 1985. Redesignated at 51
FR 23713, June 30, 1986, and amended at 52 FR
36571, Sept. 30, 1987; 54 FR 36314, Sept. 1, 1989;
60 FR 34466, July 3, 1995]

17

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00017

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.59

40 CFR Ch. I (7–1–03 Edition)
(10) A statement that the results of
testing conducted pursuant to the consent agreement will be announced to
the public in accordance with the procedures specified in section 4(d) of the
Act and that the disclosure of data
generated by such testing will be governed by section 14(b) of the Act.
(11) A requirement that the manufacturers and/or processors signing the
consent agreement will comply with
the notification requirements of section 12(b)(1) of the Act and part 707 of
this chapter if they export or intend to
export the substance or mixture for
which the submission of data is required under the agreement and a
statement that any other person who
exports or intends to export such substance or mixture is subject to the
above cited export notification requirements.
(12) A requirement that, in the event
EPA promulgates a significant new use
rule applicable to the test chemical
under section 5(a)(2), the consent
agreement will have the status of a
test rule for purposes of section
5(b)(1)(A) and manufacturers and/or
processors signing the agreement will
comply with the data submission requirements imposed by that provision.
(13) A statement that each manufacturer and/or processor signing the
agreement agrees that violation of its
requirements will constitute a ‘‘prohibited act’’ under section 15(1) of the
Act and will trigger all provisions of
TSCA applicable to a violation of section 15.
(14) A statement that, in the event
one or more provisions of the agreement are determined to be unenforceable by a court, the remainder of the
agreement would not be presumed to be
valid and EPA will then either initiate
a rulemaking proceeding or publish in
the FEDERAL REGISTER the Administrator’s reason for not initiating such a
proceeding.
(15) A statement that the Agency
may conduct laboratory inspections
and/or study audits of the testing being
conducted pursuant to the consent
agreement in accordance with the authority and procedures contained in
section 11 of the Act.

§ 790.59 Failure to comply with a test
rule.
(a) Persons who notified EPA of their
intent to conduct a test required in a
test rule in part 799 of this chapter and
who fail to conduct the test in accordance with the test standards and schedules adopted in the test rule, or as
modified in accordance with § 790.55,
will be in violation of the rule.
(b) Any person who fails or refuses to
comply with any aspect of this part or
a test rule under part 799 of this chapter is in violation of section 15 of the
Act. EPA will treat violations of the
Good Laboratory Practice standards as
indicated in § 792.17 of this chapter.

Subpart D—Implementation, Enforcement and Modification
of Consent Agreements
SOURCE: 51 FR 23715, June 30, 1986, unless
otherwise noted.

§ 790.60 Contents
ments.

of

consent

agree-

(a) Standard provisions. All consent
agreements will contain the following
provisions:
(1) Identification of the chemical(s)
to be tested.
(2) The health effects, environmental
effects and/or other characteristics for
which testing will be required.
(3) The names and addresses of each
manufacturer and/or processor who will
sign the agreement.
(4) The name and address of the manufacturer, processor or other entity
who has agreed to act as the principal
test sponsor.
(5) The technical or commercial
grade, level of purity or other characteristics of the test substances(s) or
mixture(s).
(6) Standards for the development of
test data.
(7) A requirement that testing will be
conducted in accordance with the EPA
Good Laboratory Practice (GLP) regulations (40 CFR part 792).
(8) Schedules with reasonable deadlines for submitting interim progress
and/or final reports to EPA.
(9) A requirement that the principal
sponsor will submit a study plan to
EPA in accordance with § 790.62.

18

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00018

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.62

(16) A statement that EPA acceptance of a consent agreement constitutes ‘‘final agency action’’ for purposes of 5 U.S.C. 704.
(17) Any other requirements that the
parties agree are necessary to achieve
the purposes of the Act.
(b) Contents of standards for the development of data. The standards for the
development of the data included in
consent agreements will be based on
the TSCA test guidelines in 40 CFR
parts 796, 797, and 798, the Organization
for Economic Cooperation and Development (OECD) test guidelines, the EPA
pesticide assessment guidelines published by The National Technical Information Service (NTIS), or other suitable test methodologies. During the negotiation of consent agreements, EPA
will initially propose suitable test
guidelines as the required test standards; manufacturers and processors or
other interested parties may then suggest alternative methodologies or
modifications to the Agency’s proposed
guidelines. These alternative methodologies or modifications will be
adopted only where, in the judgment of
EPA, they will develop at least equally
reliable and adequate data on the
chemical substance or mixture subject
to the agreement.
(c) Statement of rationale for consent
agreement. EPA will prepare a written
explanation of the basis for each consent agreement. This document will
summarize the agreement, describe any
ITC testing recommendations for the
chemical involved, outline the chemical’s use and exposure characteristics,
and explain the objectives of the testing to be conducted and the rationale
for the specific studies selected. This
document will be published in the FEDERAL REGISTER and, for ITC-designated
chemicals, will constitute the statement of EPA’s reasons for not initiating rulemaking required by section
4(e)(1)(B) of the Act.

study plan no later than 45 days prior
to the initiation of testing.
(b) Content of study plans. All study
plans are required to contain the following information:
(1) Identity of the consent agreement
under which testing will be performed.
(2) The specific test requirements to
be covered by the study plan.
(3) The name and address of the principal test sponsor.
(4) The names, addresses, and telephone numbers of the responsible administrative official[s] and project
manager[s] in the principal sponsor’s
organization.
(5) The names, addresses, and telephone numbers of the technical contacts at each manufacturer and/or
processor subject to the agreement.
(6) The names and addresses of the
testing facilities responsible for the
testing and the names, addresses, and
telephone numbers of the administrative officials[s] and project manager[s]
assigned to oversee the testing program at these facilities.
(7) Brief summaries of the training
and experience of each professional involved in the study, including study director, veterinarian[s], toxicologist[s],
pathologist[s],
chemist[s],
microbiologist[s],
and
laboratory
assistants.
(8) Identity and supporting data on
the chemical substance[s] being tested,
including physical constants, spectral
data, chemical analysis, and stability
under test and storage conditions, as
appropriate.
(9) Study protocol, including the rationale for any combination of test
protocols; the rationale for species/
strain selection; dose selection (and
supporting data); route(s) or method(s)
of exposure; description of diet to be
used and its source, including nutrients
and contaminants and their concentrations; for in vitro test systems, a description of culture medium and its
source; and a summary of expected
spontaneous chronic diseases (including tumors), genealogy, and life span.
(10) A schedule, with reasonable
timeables and deadlines, for initiation
and completion of each short-term test
and of each major phases of long-term
tests, and submission of interim
progress and/or final reports to EPA.

[51 FR 23715, June 30, 1986, as amended at 54
FR 36314, Sept. 1, 1989]

§ 790.62 Submission of study plans and
conduct of testing.
(a) Timing of submission. The principal
sponsor of testing conducted pursuant
to a consent agreement shall submit a

19

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00019

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.65

40 CFR Ch. I (7–1–03 Edition)

(c) Review and modification. (1) Upon
receipt of a study plan, EPA will review it to determine whether it complies with paragraph (b) of this section.
If EPA determines that the study plan
does not comply with paragraph (b) of
this section, EPA will notify the submitter that the plan is incomplete and
will identify the deficiencies and the
steps necessary to complete the plan.
It is the responsibility of the test sponsor to review the study protocols to determine if they comply with all the
mandatory testing conditions and requirements in the test standards (i.e.,
‘‘shall statements’’).
(2) The submitter will have 15 days
after the day it receives a notice under
paragraph (c)(1) of this section to submit appropriate information to make
the study plan complete.
(3) If the submitter fails to provide
appropriate information to complete a
study plan within 15 days after having
received a notice under paragraph (c)(1)
of this section, the submitter will be
considered to be in violation of the
consent agreement and subject to enforcement proceedings pursuant to
§ 790.65 (c) and (d).
(4) The test sponsor shall submit any
amendments to study plans to EPA at
the address specified in § 790.5(b).
(d) Functions of the principal test sponsor. When testing is being conducted
pursuant to a consent agreement, the
principal test sponsor will be responsible for submitting interim progress
and final reports to EPA, informing the
Agency of any proposed changes in
standards for the development of data,
study plans or testing schedules, and
communicating with the Agency about
laboratory inspections and other matters affecting the progress of testing.

adopted pursuant to § 790.68, will be in
violation of the consent agreement.
(b) The Agency considers failure to
comply with any aspect of a consent
agreement to be a ‘‘prohibited act’’
under section 15 of TSCA, subject to all
of the provisions of the Act applicable
to violations of section 15. Section 15(1)
of TSCA makes it unlawful for any person to fail or refuse to comply with any
rule or order issued under section 4.
Consent agreements adopted pursuant
to this part are ‘‘orders issued under
section 4’’ for purposes of section 15(1)
of TSCA.
(c) Manufacturers and/or processors
who violate consent agreements are
subject to criminal and/or civil liability. Under the penalty provisions of
section 16 of TSCA, such firms could be
subject to a civil penalty of up to
$25,000 per violation with each day in
violation constituting a separate violation of section 15. Intentional violations could lead to the imposition of
criminal penalties of up to $25,000 for
each day of violation and imprisonment for up to one year. In addition,
EPA could invoke the remedies available under section 17 of TSCA, including seeking an injunction to compel
adherence to the requirements of the
consent agreement.
(d) Noncompliance with a consent
agreement will constitute conduct ‘‘in
violation of this Act’’ under section
20(a)(1) of TSCA. Thus, failure to comply with the requirements of a consent
agreement could result in a citizens’
civil action under section 20(a)(1) of
TSCA.
§ 790.68 Modification of consent agreements.
(a) Changes in the scope of testing. (1)
Manufacturers or processors subject to
a consent agreement, other persons or
EPA may seek modifications in the
scope of testing performed under the
consent agreement. If, upon receiving a
request for modification, EPA determines that new issues have been raised
that warrant reconsideration of the
scope of testing, or if EPA determines
on its own that such reconsideration is
appropriate, EPA will publish a FEDERAL REGISTER notice describing the
proposed modification and soliciting

[51 FR 23715, June 30, 1986, as amended at 54
FR 36314, Sept. 1, 1989; 60 FR 34466, July 3,
1995]

§ 790.65 Failure to comply with a consent agreement.
(a) Manufacturers and/or processors
who have signed a consent agreement
and who fail to comply with the test
requirements, test standards, GLP regulations, schedules, or other provisions
contained in the consent agreement, or
in modifications to the agreement

20

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00020

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.68

public comment. If, based on the comments received, EPA concludes that
differences of opinion may exist about
the proposed modification, EPA will
establish a schedule for conducting negotiations and invite parties who wish
to participate in or monitor these negotiations to contact the Agency in
writing. Any negotiations that EPA
conducts will conform to the procedures specified in § 790.22(b).
(2) The scope of testing required by a
consent agreement will be modified
only where there is a consensus concerning the modified testing requirements among EPA, affected manufacturers and/or processors, and other persons who have asked to participate in
or monitor negotiations under paragraph (a)(1) of this section. In determining whether a consensus exists,
EPA will employ the criteria specified
in § 790.24. In the absence of consensus,
EPA may initiate rulemaking under
section 4(a) of the Act if it concludes
that any testing beyond that required
by the consent agreement is necessary
and that the other statutory findings
required by section 4(a) can be made.
While such rulemaking proceedings are
underway, the consent agreement will
remain in effect unless EPA finds that
the testing required by the agreement
is or may be unnecessary in view of the
testing requirements included in EPA’s
proposed rule.
(b) Changes in test standards or schedules. (1) Any test sponsor who wishes to
modify the test schedule for any test
required under a consent order must
submit an application in accordance
with this paragraph. Application for
modification must be made in writing
to EPA at the address in § 790.5(b), or
by phone with written confirmation to
follow within 10 working days. Applications must include an appropriate explanation and rationale for the modification. EPA will consider only those
applications that request modifications
to mandatory testing conditions or requirements (‘‘shall statements’’ in the
consent order). Where a test sponsor
requests EPA to provide guidance or to
clarify a non-mandatory testing requirement (i.e., ‘‘should statements’’),
the test sponsor should submit these
requests to EPA at the address in section 790.5(b).

(2)(i) Where EPA concludes that the
requested modification of a test standard or schedule for a test required
under a consent agreement is appropriate, EPA will proceed in accordance
with this paragraph (b)(2).
(ii) Where, in EPA’s judgment, the
requested modification of a test standard or schedule would not alter the
scope of the test or significantly
change the schedule for completing the
test, EPA will not ask for public comment before approving the modification. EPA will notify the test sponsor,
and any other persons who have signed
the consent agreement, by letter of
EPA’s approval. EPA will place copies
of each application and EPA approval
letter in the administrative record
maintained for the consent agreement
in question. EPA will publish a notice
annually in the FEDERAL REGISTER indicating the test standards or schedules for test required in consent agreements which have been modified under
this paragraph (b)(2)(ii) and describing
the nature of the modifications.
(iii) Where, in EPA’s judgment, the
requested modification of a test standard or schedule would significantly
alter the scope of the test or significantly change the schedule for completing the test, EPA will publish a notice in the FEDERAL REGISTER requesting comment on the proposed modification. However, EPA will approve a requested modification of a test standard
under paragraph (b)(2)(iii) of this section without first seeking public comment if EPA believes that an immediate modification to the test standard
is necessary to preserve the accuracy
or validity of an ongoing test. EPA
also may modify a testing requirement
or test condition in a test standard if
EPA determines that the completion or
achievement of this requirement or
condition is not technically feasible.
EPA may approve a requested modification of a test schedule under paragraph (b)(2)(iii) of this section without
first seeking public comment if EPA
determines, on a case-by-case basis,
that a delay of over 12 months is not
the fault of the test sponsor and is due
to unforeseen circumstances such as a
lack of laboratory availability, lack of
availability of suitable test substance
(e.g., 14–C labelled test substance), lack

21

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00021

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.80

40 CFR Ch. I (7–1–03 Edition)
cording to the test standard specified
in the consent order.

of availability of healthy test organisms, or the unexpected failure of a
long-term test. EPA will publish an annual notice in the FEDERAL REGISTER
announcing the approval of any test
standard modifications and test scheduled
extensions
under
paragraph
(b)(2)(iii) of this section, and provide a
brief rationale of why the modification
was granted.
(iv) For purposes of this paragraph
(b)(2), a requested modification of a
test standard of schedule for a test required under a consent agreement
would alter the scope of the test or significantly change the schedule for completing the test if the modification
would:
(A) Change the test species.
(B) Change the route of administration of the test chemical.
(C) Change the period of time during
which the test species is exposed to the
test chemical.
(D) Except as provided in paragraph
(b)(2)(iii) of this section, extend the
final reporting deadline more than 12
months from the date specified in the
consent order.
(3) Where EPA concludes that the requested modification of a test standard
or schedule for a test requirement
under a consent agreement is not appropriate, EPA will so notify the test
sponsor in writing.
(c) Timing. (1) Test sponsors should
submit all applications for test schedule modifications at least 60 days before the reporting deadline for the test
in question.
(2) EPA will not normally approve
any test schedule extensions submitted
less than 30 days before the reporting
deadline for the test in question.
(3) Except as provided in paragraph
(b)(2)(iii) of this section, EPA may
grant extensions as shown necessary
for up to 1 year but will normally limit
extensions to a period of time equal to
the in-life portion of the test plus 60
days.
(4) EPA will normally approve only
one deadline extension for each test.
(5) Test sponsors should submit requests for test standard modifications
as soon as they determine that the test
cannot be successfully completed ac-

[51 FR 23715, June 30, 1986, as amended at 52
FR 36571, Sept. 30, 1987; 54 FR 36314, Sept. 1,
1989; 60 FR 34466, July 3, 1995]

Subpart E—Exemptions From Test
Rules
SOURCE: 50 FR 20660, May 17, 1985, unless
otherwise noted.

§ 790.80 Submission of exemption applications.
(a) Who should file applications. (1)
Any manufacturer or processor subject
to a test rule in part 799 of this chapter
may submit an application to EPA for
an exemption from performing any or
all of the tests required under the test
rule.
(2) Processors will not be required to
apply for an exemption or conduct testing unless EPA so specifies in a test
rule or in a special FEDERAL REGISTER
notice as described in § 790.48(b)(2)
under the following circumstances:
(i) If testing is being required to
allow evaluation of risks associated
with manufacturing and processing or
with distribution in commerce, use, or
disposal of the chemical and manufacturers do not submit notice(s) of intent
to conduct the required testing; or
(ii) If testing is being required solely
to allow evaluation of risks associated
with processing of the chemical.
(b) When applications must be filed. (1)
Exemption applications must be filed
within 30 days after the effective date
of the test rule described in § 790.40 or,
if being submitted in compliance with
the FEDERAL REGISTER notice described
in § 790.48(b)(2), within 30 days after the
publication of that notice.
(2) Exemption applications must be
filed by the date manufacture or processing begins by any person not manufacturing or processing the subject
chemical as of the effective date of the
test rule described in § 790.40 or by 30
days after the effective date of the test
rule described in § 790.40, who, before
the end of the reimbursement period,
manufactures or processes the test substance and who is subject to the requirement to submit either a letter of
intent to test or an exemption application.

22

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00022

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

§ 790.87

(3) When both manufacturers and
processors are subject to the rule, exemption applications must be filed by
the date processing begins by any person not processing as of the effective
date of the test rule described in § 790.40
or by 30 days after publication of the
FEDERAL REGISTER notice described in
§ 790.48(b)(2) who, before the end of the
reimbursement period, processes the
test substance and who is subject to
the requirement to submit either a letter of intent to test or an exemption
application.
(c) Scope of application. A person may
apply for an exemption from all, or one
or more, specific testing requirements
in a test rule in part 799 of this chapter.

§ 790.85 Submission of equivalence
data.
If EPA requires in a test rule promulgated under section 4 of the Act the
testing of two or more test substances
which are forms of the same chemical,
each exemption applicant must submit
the following data:
(a) The chemical identity of each
technical-grade chemical substance or
mixture manufactured and/or processed
by the applicant for which the exemption is sought. The exact type of identifying data required will be specified
in the test rule, but may include all
characteristics and properties of the
applicant’s substance or mixture, such
as boiling point, melting point, chemical analysis (including identification
and amount of impurities), additives,
spectral data, and other physical or
chemical information that may be relevant in determining whether the applicant’s substance or mixture is equivalent to the specific test substance.
(b) The basis for the applicant’s belief that the substance or mixture is
equivalent to the test substance or
mixture.
(c) Any other data which exemption
applicants are directed to submit in
the test rule which may bear on a determination of equivalence. This may
include a description of the process by
which each technical-grade chemical
substance or mixture for which an exemption is sought is manufactured or
processed prior to use or distribution
in commerce by the applicant.

[50 FR 20660, May 17, 1985, as amended at 58
FR 34205, June 23, 1993]

§ 790.82 Content of exemption application.
The exemption application must contain:
(a) The identity of the test rule, the
chemical identity, and the CAS No. of
the test substance on which the application is based.
(b) The specific testing requirement(s) from which an exemption is
sought and the basis for the exemption
request.
(c) Name, address, and telephone
number of applicant.
(d) Name, address, and telephone
number of appropriate individual to
contact for further information.
(e)(1) If required in the test rule to
establish equivalence:
(i) The chemical identity of the test
substance on which the application is
based.
(ii) Equivalence data specified in
§ 790.85.
(2) If a test rule requires testing of a
single representative substance, EPA
will consider all forms of the chemical
subject to that rule to be equivalent
and will not require the submission of
equivalence data as described in
§ 790.85.

§ 790.87 Approval of exemption applications.
(a) EPA will conditionally approve
exemption applications if:
(1)(i) For single-phase test rules, EPA
has received a letter of intent to conduct the testing from which exemption
is sought;
(ii) For two-phase test rules, EPA has
received a complete proposed study
plan for the testing from which exemption is sought and has adopted the
study plan, as proposed or modified, as
test standards and schedules in a final
Phase II test rule; and
(2) The chemical substance or mixture with respect to which the application was submitted is equivalent to a
test substance or mixture for which the

[50 FR 20660, May 17, 1985, as amended at 54
FR 36315, Sept. 1, 1989]

23

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00023

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

§ 790.88

40 CFR Ch. I (7–1–03 Edition)

required data have been or are being
submitted in accordance with a test
rule; and
(3) Submission of the required test
data concerning that chemical substance or mixture would be duplicative
of data which have been or are being
submitted to EPA in accordance with a
test rule.
(b)(1) If a single representative substance is to be tested under a test rule,
EPA will consider all forms of the
chemical subject to that rule to be
equivalent and will contact the exemption applicant only if information is
missing or unclear.
(2) If two or more representative substances are to be tested under a test
rule, EPA will evaluate equivalence
claims made in each exemption application according to the criteria discussed in the test rule.
(i) If EPA finds an equivalence claim
to be in error or inadequately supported, the applicant will be notified
by certified mail. The applicant will be
given 15 days to provide clarifying information.
(ii) Exemption applicants will be notified that equivalence has been accepted or rejected.
(c) The final Phase II test rule which
adopts the study plans in two-phase
rulemaking, a separate FEDERAL REGISTER notice in single-phase rulemaking, or a letter by certified mail
will give exemption applicants final
notice that they have received a conditional exemption. All conditional exemptions thus granted are contingent
upon the test sponsors’ successful completion of testing according to the
specifications in the test rule.

(4)(i) For single-phase test rules, EPA
has not received a letter of intent to
conduct the test for which exemption
is sought; or
(ii) For two-phase test rules, EPA has
not received an adequate study plan for
the test for which exemption is sought;
or
(5) The study sponsor(s) fails to initiate the required testing by the deadlines adopted in the test rule; or
(6) The study sponsor(s) fails to submit data as required in the test standard and deadlines for submission of test
data as adopted in the test rule or as
modified in accordance with § 790.55.
(b) EPA will notify the exemption applicant by certified mail or FEDERAL
REGISTER notice of EPA’s determination that the exemption application is
denied.
§ 790.90 Appeal of denial of exemption
application.
(a) Within 30 days after receipt of notification that EPA has denied an application for exemption, the applicant
may file an appeal with EPA.
(b) The appeal shall indicate the
basis for the applicant’s request for reconsideration.
(c)(1) The applicant may also include
a request for a hearing. Hearings will
be held according to the procedures described in § 790.97.
(2) Hearing requests must be in writing and must be received by EPA within 30 days of receipt of the letter or
publication of the FEDERAL REGISTER
notice described in § 790.88(b). Hearing
requests must provide reasons why a
hearing is necessary.
(d) If EPA determines that there are
material issues of fact, then the request for a hearing will be granted. If
EPA denies a hearing request, EPA will
base its decision on the written submission.
(e) EPA will notify the applicant of
its decision within 60 days after EPA
receives the appeal described in paragraph (a) of this section or within 60
days after completion of a hearing described in paragraph (c) of this section.
(f) The filing of an appeal from the
denial of an exemption shall not act to
stay the applicant’s legal obligations
under a test rule promulgated under
section 4 of the Act.

§ 790.88 Denial of exemption application.
(a) EPA may deny any exemption application if:
(1) EPA determines that the applicant has failed to demonstrate that the
applicant’s chemical is equivalent to
the test substance; or
(2) The exemption applicant fails to
submit any of the information specified in § 790.82; or
(3) The exemption applicant fails to
submit any of the information specified in § 790.85 if required in the test
rule; or

24

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00024

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T

Environmental Protection Agency

Pt. 790, Subpt. E, App. A
former exemption holder must take to
avoid being found in violation of the
test rule.

§ 790.93 Termination of conditional exemption.
(a) EPA shall terminate a conditional
exemption if it determines that:
(1) The test which provided the basis
for approval of the exemption application has not been started by the deadlines for initiation of testing adopted
in the test rule or modified in accordance with § 790.55; or
(2) Data required by the test rule
have not been generated in accordance
with the test standards or submitted in
accordance with the deadlines for submission of test data that were adopted
in the test rule or modified in accordance with § 790.55; or
(3) The testing has not been conducted or the data have not been generated in accordance with the Good
Laboratory Practice requirements in
part 792 of this chapter.
(b) If EPA determines that one or
more of the criteria listed in paragraph
(a) of this section has been met, EPA
will notify each holder of an affected
conditional exemption by certified
mail or FEDERAL REGISTER notice of
EPA’s intent to terminate that conditional exemption.
(c) Within 30 days after receipt of a
letter of notification or publication of
a notice in the FEDERAL REGISTER that
EPA intends to terminate a conditional exemption, the exemption holder may submit information to rebut
EPA’s preliminary decision or notify
EPA by letter of its intent to conduct
the required test pursuant to the test
standard established in the final test
rule. Such a letter of intent shall contain all of the information required by
§ 790.45(c).
(d)(1) The exemption holder may also
include a request for a hearing. Hearings will be held in accordance with the
procedures set forth in § 790.97.
(2) Hearing requests must be in writing and must be received by EPA within 30 days after receipt of the letter or
publication in the FEDERAL REGISTER
notice described in paragraph (b) of
this section.
(e) EPA will notify the exemption
holder by certified letter or by FEDERAL REGISTER notice of EPA’s final
decision concerning termination of
conditional exemptions and will give
instructions as to what actions the

§ 790.97

Hearing procedures.

(a) Hearing requests must be in writing to EPA and must include the applicant’s basis for appealing EPA’s decision.
(b) If more than one applicant has requested a hearing on similar grounds,
all of those appeals will be considered
at the same hearing unless confidentiality claims preclude a joint hearing.
(c) EPA will notify each applicant of
EPA’s decision within 60 days after the
hearing.
§ 790.99 Statement of financial responsibility.
Each applicant for an exemption
shall submit the following sworn statement with his or her application:
I understand that if this application is
granted before the reimbursement period described in section 4(c)(3)(B) of TSCA expires,
I must pay fair and equitable reimbursement
to the person or persons who incurred or
shared in the costs of complying with the requirement to submit data and upon whose
data the granting of my application was
based.

APPENDIX A TO SUBPART E OF PART
790—SCHEDULE
FOR
DEVELOPING
CONSENT AGREEMENTS AND TEST
RULES
EPA intends to follow the schedule set
forth in this Appendix to evaluate testing
candidates, conduct negotiations, develop
consent agreements where appropriate, and
propose and promulate test rules in those instances where testing can be required under
section 4(a) of TSCA but agreement cannot
be reached in timely manner on a consent
agreement. Where deadlines are imposed by
the statute, they are binding on EPA and
will be observed by the Agency. The remaining dates represent targets that EPA intends
to meet.
This schedule is based on what EPA currently believes are reasonable target dates.
As EPA gains experience with the process
and determines the feasibility of these
schedules, it may adjust the schedule accordingly. EPA will solicit public comment before implementing any changes in the schedule.
Week 1
0 ............

Event
Receive ITC report, recommendation.

25

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00025

Fmt 8010

Sfmt 8002

Y:\SGML\200167T.XXX

200167T

Pt. 791

40 CFR Ch. I (7–1–03 Edition)

Week 1

Event

Week 1

Event

2 ............

Publish ITC report, 8(a) and 8(d) notices, and invitation for public participation in negotiations.
Comment period on ITC report.
Public focus meeting.
8(a) and 8(d) reporting period.
Public meeting on course-setting decision and
deadline for requests to participate in negotiations.

22–30 ....
32 ..........

Negotiations.
EPA decision point: consent agreement or test
rule.

3–6 ........
6 ............
7–14 ......
22 ..........

Week

Consent Agreement

36–40 ....
42 ..........

Comment period on consent agreement
Comment resolution meeting if necessary.
Sign-off consent agreement and FEDERAL
REGISTER notice.
Publish FEDERAL REGISTER notice ...........

48 ..........
50 ..........

1 The dates contained in the left-hand column are calculated
from the date EPA receives the ITC report recommending a
chemical for testing.

Week

Test Rule

32–60
62

Rule preparation, agency review and sign-off.
Publish proposed rule in FEDERAL REGISTER.1

70–106

Agency reviews comments; preparation of final rule or no-test
decision, agency review and sign-off.1
Publish final rule or no-test decision in FEDERAL REGISTER.1

108

1 As

stated in § 790.26, EPA may publish an Advance Notice of Proposed Rulemaking (ANPR) where the testing recommendations of the ITC raise unusually novel and complex issues that require additional Agency review and opportunity for public comment. EPA intends to publish such ANPRs by Week 62 following receipt of the initial ITC report; to publish a proposed rule or
decision-not-to-test by Week 108; and to publish a final rule or notice terminating the rulemaking process by Week 154.

[51 FR 23717, June 30, 1986]

SOURCE: 48 FR 31791, July 11, 1983, unless
otherwise noted.

PART 791—DATA REIMBURSEMENT
Subpart A—General Provisions
Sec.
791.1
791.2
791.3

Subpart A—General Provisions
§ 791.1 Scope and authority.
(a) This part establishes procedures
and criteria to be used in determining
fair amounts of reimbursement for
testing costs incurred under section
4(a) of the Toxic Substances Control
Act (TSCA) (15 U.S.C. 2603(a)).
(b) Section 4(c) of TSCA requires
EPA to develop rules for the determination of fair and equitable reimbursement (15 U.S.C. 2603 (c)).

Scope and authority.
Applicability.
Definitions.

Subpart B—Hearing Procedures
791.20 Initiation of reimbursement
ceeding.
791.22 Consolidation of hearings.
791.27 Pre-hearing preparation.
791.29 Appointment of hearing officer.
791.30 Hearing procedures.
791.31 Expedited procedures.
791.34 Serving of notice.
791.37 The award.
791.39 Fees and expenses.

pro-

§ 791.2 Applicability.
(a) This rule is potentially applicable
to all manufacturers, importers and
processors who may be required by a
specific test rule promulgated under
section 4(a) of TSCA to conduct tests
and submit data, and who seek the assistance of the Administrator in determining the amount or method of reimbursement. Persons subject to a test
rule have an obligation from the date
the test rule becomes effective until
the end of the reimbursement period,
either to test or to obtain an exemption and pay reimbursement.
(b) The provisions of this rule will
take effect only when private efforts to
resolve a dispute have failed and a
manufacturer or processor requests
EPA’s assistance.

Subpart C—Basis for Proposed Order
791.40
791.45
791.48
791.50
791.52

Basis for the proposed order.
Processors.
Production volume.
Costs.
Multiple tests.

Subpart D—Review
791.60

Review.

791.85

Availability of final Agency order.

Subpart E—Final Order

Subpart F—Prohibited Acts
791.105

Prohibited acts.

AUTHORITY: 15 U.S.C. 2603 and 2607.

26

VerDate Jan<31>2003

14:25 Jul 21, 2003

Jkt 200167

PO 00000

Frm 00026

Fmt 8010

Sfmt 8010

Y:\SGML\200167T.XXX

200167T