ICR Attachment B - 40 CFR 700

Attachment B.doc

Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. (Renewal)

ICR Attachment B - 40 CFR 700

OMB: 2070-0012

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OMB Control Number 2070-0012; EPA ICR Number 0574.13


ICR ATTACHMENT B


40 CFR Part 700


40 CFR Protection of Environment

CHAPTER I

ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)


SUBCHAPTER R ‑‑ TOXIC SUBSTANCES CONTROL ACT


PART 700 ‑‑ GENERAL


Subparts A‑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 Toxic Substances Control

Act appear at 40 CFR part 195.


[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 associated 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.


[53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, April 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:


(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, or certified check drawn to the order of the Environmental Protection Agency.


(2) Each remittance shall be sent to the Environmental Protection Agency, HQ Accounting

Operations Branch (PM‑226), P.O. 360399M, Pittsburgh, PA 15251‑6399, ATTN: TSCA User

Fee.


(3) Persons who submit a section 5 notice shall place a unique identifying number, which must

include the letters "TS" followed by a combination of 6 numbers (letters may be substituted for some numbers), on the front page of each section 5 notice submitted. The same identifying number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one section 5 notice, the person shall include the name of the submitter, the identifying number for each section 5 notice to which the remittance applies, and the amount of the remittance which applies to each notice. Any remittance not having the identifying name and number described above 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 write or type the words, "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 (4‑26‑83)).


(ii) Each person who remits the fee identified in paragraph (b)(1) of this section for an exemption

application under section 5(h)(2) of the Act shall include the words, "Each company identified in this application 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 include the words, "The 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(d)," 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 write or type the words, "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 (4‑26‑83)).


(ii) Each person who remits the fee identified in paragraph (b)(2) of this section for an exemption

application under section (5)(h)(2) of the Act shall include the words, "Each company identified in this application has remitted a fee of $2,500 in accordance with 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 a fee identified in paragraph (b)(2) of this section for a MCAN for a

microorganism shall include the words, "The company identified in this notice has remitted the fee specified in 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, April 11, 1997]


' 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, April 11, 1997]




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