Attachment B

SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT
ute. Certain other material, such as
copyrighted material, will be publicly
available only at the OPPT Docket.
(2) Physical location. Environmental
Protection Agency Docket Center
(EPA/DC), Environmental Protection
Agency, EPA West Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington,
DC 20460–0001. The telephone number
for the OPPT Docket is (202) 566–0280.
This is not a mailing address. For instructions on visiting the docket, go to
http://www.epa.gov/dockets/contacts.htm.
(3) United States Postal Service mailing
address. Document Control Office
(7407M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001.
(4) Hand/courier delivery address. Document Control Office, Office of Pollution Prevention and Toxics, Environmental Protection Agency, EPA East
Bldg., Rm. 6428, 1201 Constitution Ave.
NW., Washington, DC. Deliveries are
only accepted between 8:30 a.m. and 4
p.m., and special arrangements should
be made for deliveries of boxed information. The telephone number for the
Document Control Office is (202) 564–
8930.

PART 700—GENERAL
Subpart A—Addresses
Sec.
700.17 Addresses for the Office of Pollution
Prevention and Toxics.

Subpart B [Reserved]
Subpart C—Fees
700.40
700.41
700.43
700.45
700.49

Purpose and applicability.
Radon user fees.
Definitions.
Fee payments.
Failure to remit fees.

AUTHORITY: 15 U.S.C 2625 and 2665, 44 U.S.C.
3504.
SOURCE: 53 FR 31252, Aug. 17, 1988, unless
otherwise noted.

Subpart A—Addresses

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SOURCE: 77 FR 46292, Aug. 3, 2012, unless
otherwise noted.

§ 700.17 Addresses for the Office of
Pollution Prevention and Toxics.
The official addresses, unless otherwise noted, are as follows:
(a) Correspondence and non-docket materials—(1) United States Postal Service
mailing address. Office of Pollution Prevention and Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC
20460–0001.
(2) Hand/courier delivery address. Office of Pollution Prevention and
Toxics,
Environmental
Protection
Agency, EPA East Bldg., 1201 Constitution Ave. NW., Washington, DC 20004.
This is not a mailing address. You
must make arrangements with the person receiving your delivery.
(b) Office of Pollution Prevention and
Toxics Docket (OPPT Docket)—(1) Electronic docket address. Publicly available
docket materials are available in the
electronic
docket
at
http://
www.regulations.gov. Although listed in
the docket index at regulations.gov,
some information is not publicly available, e.g., Confidential Business Information (CBI) or other information
whose disclosure is restricted by stat-

Subpart B [Reserved]
Subpart C—Fees
§ 700.40

Purpose and applicability.

(a) Purpose. The purpose of this subpart is to collect fees from manufacturers, importers, and processors who submit notices and applications to EPA
under section 5 of the Toxic Substances
Control Act (15 U.S.C. 2604) to defray
part of EPA’s cost of administering the
Act.
(b) Applicability. This subpart applies
to all manufacturers, importers, and
processors who submit certain notices
and applications to EPA under section
5 of the Act.
§ 700.41

Radon user fees.

User fees relating to radon proficiency programs authorized under the

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§ 700.43

40 CFR Ch. I (7–1–18 Edition)

Toxic Substances Control Act appear
at 40 CFR part 195.

ated intermediate PMN and are submitted to EPA at the same time as,
and together with, the PMN for the
final product.
Joint submitters means two or more
persons who submit a section 5 notice
together.
Microbial commercial activity notice or
MCAN means any notice for microorganisms submitted to EPA pursuant to
section 5(a)(1) of the Act in accordance
with subpart D of part 725 of this chapter.
Person means a manufacturer, importer, or processor.
Premanufacture notice or PMN means
any notice submitted to EPA pursuant
to section 5(a)(1)(A) of the Act in accordance with part 720 of this chapter
or § 723.250 of this chapter.
Section 5 notice means any PMN, consolidated PMN, intermediate PMN, significant new use notice, exemption notice, exemption application, any MCAN
or consolidated MCAN submitted under
section 5 of the Act.
Significant new use notice means any
notice submitted to EPA pursuant to
section 5(a)(1)(B) of the Act in accordance with part 721 of this chapter.
Small business concern means any person whose total annual sales in the person’s fiscal year preceding the date of
the submission of the applicable section 5 notice, when combined with
those of the parent company (if any),
are less than $40 million.

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[59 FR 13177, Mar. 18, 1994]

§ 700.43 Definitions.
Definitions in section 3 of the Act (15
U.S.C. 2602), as well as definitions contained in §§ 704.3, 720.3, and 725.3 of this
chapter, apply to this subpart unless
otherwise specified in this section. In
addition, the following definitions
apply:
Consolidated microbial commercial activity notice or consolidated MCAN
means any MCAN submitted to EPA
that covers more than one microorganism (each being assigned a separate
MCAN number by EPA) as a result of a
prenotice agreement with EPA.
Consolidated premanufacture notice or
consolidated PMN means any PMN submitted to EPA that covers more than
one chemical substance (each being assigned a separate PMN number by
EPA) as a result of a prenotice agreement with EPA (See 48 FR 21734).
Exemption application means any application submitted to EPA under section 5(h)(2) of the Act.
Exemption notice means any notice
submitted to EPA under § 723.175 of this
chapter.
Final product means a new chemical
substance (as ‘‘new chemical substance’’ is defined in § 720.3 of this
chapter) that is manufactured by a person for distribution in commerce, or
for use by the person other than as an
intermediate.
Intermediate premanufacture notice or
intermediate PMN means any PMN submitted to EPA for a chemical substance which is an intermediate (as
‘‘intermediate’’ is defined in § 720.3 of
this chapter) in the production of a
final product, provided that the PMN
for the intermediate is submitted to
EPA at the same time as, and together
with, the PMN for the final product
and that the PMN for the intermediate
identifies the final product and describes the chemical reactions leading
from the intermediate to the final
product. If PMNs are submitted to EPA
at the same time for several intermediates used in the production of a final
product, each of those is an intermediate PMN if they all identify the
final product and every other associ-

[53 FR 31252, Aug. 17, 1988, as amended at 62
FR 17931, Apr. 11, 1997]

§ 700.45

Fee payments.

(a) Persons who must pay fees. Persons
submitting a section 5 notice to EPA
shall remit for each such notice the appropriate fee identified in paragraph
(b) of this section in accordance with
the procedures in paragraph (e) of this
section.
(b) Fees. Persons shall remit fee payments to EPA as follows:
(1) Small business concerns. Small
business concerns shall remit a fee of
$100 for each section 5 notice submitted.
(2) Others. Persons other than small
business concerns shall remit fees according to the type of section 5 notice
as follows:

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Environmental Protection Agency

§ 700.45

(i) Premanufacture notices and consolidated premanufacture notices. Persons
shall remit a fee of $2,500 for each PMN
or consolidated PMN submitted.
(ii) Intermediate premanufacture notices. Persons shall remit a fee of $1,000
for each intermediate PMN. However,
for the PMN for the final product the
person shall submit the fee in paragraph (b)(2)(i) of this section.
(iii) Significant new use notices. Persons shall remit a fee of $2,500 for each
significant new use notice submitted.
(iv) Exemption applications. Persons
shall remit a fee of $2,500 for each exemption application submitted under
section 5(h)(2) of the Act.
(v) Exemption notices. Persons shall
remit a fee of $2,500 for each exemption
notice submitted under § 723.175 of this
chapter.
(vi) MCAN and consolidated MCAN.
Persons shall remit a fee of $2,500 for
each MCAN or consolidated MCAN submitted.
(c) No fee required. Persons are exempt from remitting any fee for submissions under §§ 720.38, 723.50, and subparts E, F, and G of part 725 of this
chapter.
(d) Joint submitters. Joint submitters
of a section 5 notice are required to
remit the appropriate fee identified in
paragraph (b) of this section for each
section 5 notice regardless of the number of joint submitters for that notice.
To qualify for the fee identified in
paragraph (b)(1) of this section, each
joint submitter of a section 5 notice
must qualify as a small business concern under § 700.43.
(e) Remittance procedure. (1) Each remittance under this section shall be in
United States currency and shall be
paid by money order, bank draft, wire
transfer, Pay.gov service provided
through the Department of the Treasury, or check drawn to the order of the
Environmental Protection Agency.
(2) Each paper remittance shall be
sent to the Environmental Protection
Agency, Washington Finance Center,
Toxic Substances Control Act User
Fees, P.O. Box 979073, St. Louis, MO
63197–9000.
(3) Persons who submit a TSCA section 5 notice shall place an identifying
number and a payment identity number on the front page of each TSCA sec-

tion 5 notice submitted. The identifying number must include the letters
‘‘TS’’ followed by a combination of 6
numbers (letters may be substituted
for some numbers). The payment identity number may be a check number, a
wire transfer number, or a ‘‘Pay.gov’’
transaction number used to transmit
the user fee. The same TS number and
the submitter’s name must appear on
the corresponding fee remittance under
this section. If a remittance applies to
more than one TSCA section 5 notice,
the person shall include the name of
the submitter and a new TS number for
each TSCA section 5 notice to which
the remittance applies, and the amount
of the remittance that applies to each
notice. Any remittance not having the
identifying name and numbers described in this paragraph will be returned to the remitter.
(4)(i) Each person who remits the fee
identified in paragraph (b)(1) of this
section for a PMN, consolidated PMN,
intermediate PMN, or significant new
use notice shall insert a check mark
for the statement, ‘‘The company
named in part 1, section A is a small
business concern under 40 CFR 700.43
and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).’’ under
‘‘CERTIFICATION’’ on page 2 of the
Premanufacture Notice for New Chemical Substances (EPA Form 7710–25).
(ii) Each person who remits the fee
identified in paragraph (b)(1) of this
section for an exemption application
under TSCA section 5(h)(2) shall insert
a check mark for the statement, ‘‘The
company named in part 1, section A is
a small business concern under 40 CFR
700.43 and has remitted a fee of $100 in
accordance with 40 CFR 700.45(b).’’ in
the exemption application.
(iii) Each person who remits the fee
identified in paragraph (b)(1) of this
section for an exemption notice under
§ 723.175 of this chapter shall include
the words, ‘‘Each company identified in
this notice is a small business concern
under 40 CFR 700.43 and has remitted a
fee of $100 in accordance with 40 CFR
700.45(b).’’ in the certification required
in § 723.175(i)(1)(x) of this chapter.
(iv) Each person who remits the fee
identified in paragraph (b)(1) of this
section for a MCAN for a microorganism shall insert a check mark for the

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§ 700.49

40 CFR Ch. I (7–1–18 Edition)

statement, ‘‘The company named in
part 1, section A is a small business
concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with
40 CFR 700.45(b).’’ in the certification
required in § 725.25(b) of this chapter.
(5)(i) Each person who remits a fee
identified in paragraph (b)(2) of this
section for a PMN, consolidated PMN,
intermediate PMN, or significant new
use notice shall insert a check mark
for the statement, ‘‘The company
named in part 1, section A has remitted
the fee specified in 40 CFR 700.45(b).’’
under ‘‘CERTIFICATION’’ on page 2 of
the Premanufacture Notice for New
Chemical Substances (EPA Form 7710–
25).
(ii) Each person who remits a fee
identified in paragraph (b)(2) of this
section for an exemption application
under TSCA section 5(h)(2) shall insert
a check mark for the statement, ‘‘The
company named in part 1, section A
has remitted the fee specified in 40 CFR
700.45(b).’’ in the exemption application.
(iii) Each person who remits the fee
identified in paragraph (b)(2) of this
section for an exemption notice under
§ 723.175 of this chapter shall include
the words, ‘‘Each company identified in
this notice has remitted a fee of $2,500
in accordance with 40 CFR 700.45(b).’’ in
the
certification
required
in
§ 723.175(i)(1)(x) of this chapter.
(iv) Each person who remits the fee
identified in paragraph (b)(1) of this
section for a MCAN for a microorganism shall insert a check mark for the
statement, ‘‘The company named in
part 1, section A is a small business
concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with
40 CFR 700.45(b).’’ in the certification
required in § 725.25(b) of this chapter.
(f) Fee refunds. EPA will refund any
fee paid for a section 5 notice whenever
the Agency determines:
(1) That the chemical substance that
is the subject of a PMN, intermediate
PMN, exemption application, or exemption notice is not a new chemical
substance as of the date of submission
of the notice.
(2) In the case of a significant new
use notice, that the notice was not required.

(3) The notice is incomplete under either § 720.65(c) or 725.33, of this chapter.
(4) That as of the date of submission
of the notice: the microorganism that
is the subject of a MCAN is not a new
microorganism; nor is the use involving the microorganism a significant
new use.
[53 FR 31252, Aug. 17, 1988, as amended at 54
FR 21429, May 18, 1989; 58 FR 34204, June 23,
1993; 62 FR 17932, Apr. 11, 1997; 75 FR 784, Jan.
6, 2010]

§ 700.49

Failure to remit fees.

EPA will not consider a section 5 notice to be complete unless the appropriate certification under § 700.45(e) is
included and until the appropriate remittance under § 700.45(b) has been sent
to EPA as provided in § 700.45(e) and received by EPA. EPA will notify the
submitter that the section 5 notice is
incomplete
in
accordance
with
§§ 720.65(c) and 725.33 of this chapter.
[62 FR 17932, Apr. 11, 1997]

PART 702—GENERAL PRACTICES
AND PROCEDURES
Subpart A—Procedures for Prioritization of
Chemical Substances for Risk Evaluation
Sec.
702.1 General provisions.
702.3 Definitions.
702.4 [Reserved]
702.5 Candidate selection.
702.7 Initiation of prioritization process.
702.9 Screening review and proposed priority designation.
702.11 Final priority designation.
702.13 Revision of designation.
702.15 Effect of designation as a low-priority
substance.
702.17 Effect of designation as a high-priority substance.

Subpart B—Procedures for Chemical
Substance Risk Evaluations
702.31 General provisions.
702.33 Definitions.
702.35 Chemical substances designated for
risk evaluation.
702.37 Submission of manufacturer requests
for risk evaluations.
702.39 Interagency collaboration.
702.41 Evaluation requirements.
702.43 Risk Characterization.
702.45 Peer review.
702.47 Unreasonable risk determination.

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