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40 CFR Part 700 — General

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PART 700—GENERAL 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 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 United States Postal Service mailing address. (2) Hand/courier delivery address. (b) Office of Pollution Prevention and Toxics Docket (OPPT Docket) Electronic docket address. http://www.regulations.gov. (2) Physical location. http://www.epa.gov/dockets/contacts.htm. (3) United States Postal Service mailing address. (4) Hand/courier delivery address. Subpart B [Reserved] Subpart C—Fees § 700.40 Purpose and applicability. (a) Purpose. (b) Applicability. (c) Effective date. [83 FR 52713, Oct. 17, 2018] § 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 applicable to this subpart. Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in §§ 704.3, 720.3, 723.175(b), 725.3, and 790.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply: Consolidated microbial commercial activity notice consolidated MCAN Consolidated premanufacture notice consolidated PMN See Consortium Enforceable consent agreement EPA-initiated risk evaluation Exemption notice Final product Joint submitters Manufacturer-requested risk evaluation Microbial commercial activity notice MCAN Person Premanufacture notice PMN Principal sponsor Production volume Risk evaluation Section 5 notice Significant new use notice SNUN Small business concern Potentially affected NAICS NAICS description Small business concern size standards 324110 Petroleum Refineries 1,500 or fewer. 325110 Petrochemical Manufacturing 1,000 or fewer. 325120 Industrial Gas Manufacturing 1,000 or fewer. 325130 Synthetic Dye and Pigment Manufacturing 1,000 or fewer. 325180 Other Basic Inorganic Chemical Manufacturing 1,000 or fewer. 325193 Ethyl Alcohol Manufacturing 1,000 or fewer. 325194 Cyclic Crude, Intermediate, and Gum and Wood Chemical Manufacturing 1,250 or fewer. 325199 All Other Basic Organic Chemical Manufacturing 1,250 or fewer. 325211 Plastics Material and Resin Manufacturing 1,250 or fewer. 325212 Synthetic Rubber Manufacturing 1,000 or fewer. 325220 Artificial and Synthetic Fibers and Filaments Manufacturing 1,000 or fewer. 325311 Nitrogenous Fertilizer Manufacturing 1,000 or fewer. 325312 Phosphatic Fertilizer Manufacturing 750 or fewer. 325314 Fertilizer (Mixing Only) Manufacturing 500 or fewer. 325320 Pesticide and Other Agricultural Chemical Manufacturing 1,000 or fewer. 325411 Medicinal and Botanical Manufacturing 1,000 or fewer. 325412 Pharmaceutical Preparation Manufacturing 1,250 or fewer. 325413 InVitro Diagnostic Substance Manufacturing 1,250 or fewer. 325414 Biological Product (except Diagnostic) Manufacturing 1,250 or fewer. 325510 Paint and Coating Manufacturing 1,000 or fewer. 325520 Adhesive Manufacturing 500 or fewer. 325611 Soap and Other Detergent Manufacturing 1,000 or fewer. 325612 Polish and Other Sanitation Good Manufacturing 750 or fewer. 325613 Surface Active Agent Manufacturing 750 or fewer. 325620 Toilet Preparation Manufacturing 1,250 or fewer. 325910 Printing Ink Manufacturing 500 or fewer. 325920 Explosives Manufacturing 750 or fewer. 325991 Custom Compounding of Purchased Resins 500 or fewer. 325992 Photographic Film, Paper, Plate and Chemical Manufacturing 1,500 or fewer. 325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing 500 or fewer. 424690 Other Chemical and Allied Products Merchant Wholesalers 150 or fewer. 424710 Petroleum Bulk Stations and Terminals 200 or fewer. 424720 Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals) 200 or fewer. Small quantities solely for research and development Test order Test rule [53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, Apr. 11, 1997; 83 FR 52713, Oct. 17, 2018; 89 FR 12974, Feb. 21, 2024] § 700.45 Fee payments. (a) Persons who must pay fees. (2) Manufacturers and processors of chemical substances and mixtures required to submit information for these chemical substances and mixtures under a TSCA section 4(a) test order or enforceable consent agreement, or manufacturers of chemical substances and mixtures required to submit information for these chemical substance and mixtures under a TSCA section 4(a) test rule, shall remit for each such test rule, order, or enforceable consent agreement the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section. Manufacturers of a chemical substance subject to a test rule under TSCA section 4(a) are exempted from fee payment requirements in this section, if they meet one or more of the exemptions under this paragraphs (a)(2)(i) through (v) of this section on or after the certification cutoff date identified in paragraph (b)(6) of this section and do not conduct manufacturing outside of those exemptions after the certification cutoff dates or if they meet the exemptions under paragraph (a)(2)(vi) of this section for the five-year period preceding publication of the preliminary list and do not conduct manufacturing outside of that exemption during the five-year period preceding publication of the preliminary list; and the exemptions are only available if the manufacturer will meet one or more of the exemptions in this paragraph (a)(2)(i) through (vi) in the successive five years; and will not conduct manufacturing outside of the exemptions in paragraphs (a)(2)(i) through (v) of this section in the successive five years or will meet the exemption in paragraph (a)(2)(vi) of this section in the successive five years: (i) Import articles containing that chemical substance; (ii) Produce that chemical substance as a byproduct that is not later used for commercial purposes or distributed for commercial use; (iii) Manufacture that chemical substance as an impurity as defined in 40 CFR 704.3; (iv) Manufacture that chemical substance as a non-isolated intermediate as defined in 40 CFR 704.3; (v) Manufacture small quantities of that chemical substance solely for research and development, as defined in 40 CFR 700.43; or (vi) Manufacture that chemical substance in quantities below a 1,100 lbs annual production volume as described in § 700.43, unless all manufacturers of that chemical substance manufacture that chemical in quantities below a 1,100 lbs annual production volume as defined in § 700.43, in which case this exemption is not applicable. (3) Manufacturers of a chemical substance that is subject to a risk evaluation under section 6(b) of the Act, shall remit for each such chemical risk evaluation the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section. Manufacturers of a chemical substance subject to risk evaluation under section 6(b) of the Act are exempted from fee payment requirements in this section, if they meet one or more of the exemptions under paragraphs (a)(3)(i) through (v) of this section on or after the certification cutoff date identified in paragraph (b)(6)(i) of this section and do not conduct manufacturing outside of those exemptions after the certification cutoff dates or if they meet the exemptions under paragraph (a)(3)(vi) of this section for the five-year period preceding publication of the preliminary list and do not conduct manufacturing outside of that exemption during the five-year period preceding publication of the preliminary list; and the exemptions are only available if the manufacturer will meet one or more of the exemptions in paragraphs (a)(3)(i) through (vi) of this section in the successive five years and will not conduct manufacturing outside of the exemptions in paragraphs (a)(3)(i) through (v) of this section in the successive five years or will meet the exemption in paragraph (a)(3)(vi) of this section in the successive five years: (i) Import articles containing that chemical substance; (ii) Produce that chemical substance as a byproduct that is not later used for commercial purposes or distributed for commercial use; (iii) Manufacture that chemical substance as an impurity as defined in 40 CFR 704.3; (iv) Manufacture that chemical substance as a non-isolated intermediate as defined in 40 CFR 704.3; (v) Manufacture small quantities of that chemical substance solely for research and development, as defined in § 700.43; or (vi) manufacture that chemical substance in quantities below a 2,500 lbs annual production volume as described in § 700.43, unless all manufacturers of that chemical substance manufacture that chemical in quantities below a 2,500 lbs annual production volume as defined in § 700.43, in which case this exemption is not applicable. (4) Processors submitting a SNUN or TME under TSCA section 5 to EPA shall remit for each such notice the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section. (5) Processors of chemical substances and mixtures subject to a TSCA section 4(a) test rule, test order, or enforceable consent agreement in association with a SNUN submission referenced in paragraph (a)(4) of this section shall remit for each such test rule, order, or enforceable consent agreement the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section. (b) Identifying manufacturers subject to fees In general. (2) Data sources. (3) Publication of preliminary list. (ii) For test rules under section 4, the preliminary list will be published with the proposed test rule. (4) Public comment period. (5) Self-identification. (i) Contact information. (ii) Certification of cessation. (iii) Certification of no manufacture. (iv) Certification of meeting exemption. (v) Production volume. (6) Certification cutoff date. (ii) For a section 4 test rule, the cutoff date for purposes of paragraph (b)(5)(ii) of this section is the day prior to publication of the proposed test rule for the applicable chemical substance. (7) Publication of final list. (8) Effect of final list. (9) Identifying manufacturers for other fee categories. e.g., (i) For section 4 test orders and enforceable consent agreements, the informational submission in this paragraph (b)(9) must be provided within 30 days following notification from EPA. (ii) For section 6 manufacturer-requested risk evaluations, the informational submission in this paragraph (b)(9) is required as part of the procedural process for making such requests, and must be completed at the time of making the request. (10) Recordkeeping. (i) All manufacturers other than those listed in paragraph (a)(2)(i) through (v) or (a)(3)(i) through (v) of this section must maintain production volume records related to compliance with paragraph (b)(5)(v) of this section. These records must be maintained for a period of five years from the date notice is submitted pursuant to paragraph (b)(5) of this section. (ii) Those manufacturers that are exempt from fee payment requirements pursuant to paragraph (a)(2)(iv) or (a)(3)(iv) of this section must maintain manufacturing and other business records related to compliance with the exemption criteria described in paragraph (a)(2)(iv) or (a)(3)(iv) of this section, respectively. These records must be maintained for a period of five years from the date the notice is submitted pursuant to paragraph (b)(5) of this section. (iii) Those manufacturers that are exempt from fee payment requirements pursuant to paragraph (a)(2)(v) or (a)(3)(v) of this section must maintain manufacturing and other business records related to compliance with the exemption criteria described in paragraph (a)(2)(v) or (a)(3)(v) of this section, respectively, such as production volume, plans of study, information from research and development notebooks, study reports, or notice solely for research and development use. These records must be maintained for a period of five years from the date the notice is submitted pursuant to paragraph (b)(5) of this section. (iv) Those manufacturers that are exempt from fee payment requirements pursuant to paragraph (a)(2)(vi) or (a)(3)(vi) of this section must maintain production volume records related to compliance with the exemption criteria described in paragraph (a)(2)(vi) or (a)(3)(vi) of this section, respectively. These records must be maintained for a period of five years from the date the notice is submitted pursuant to paragraph (b)(5) of this section. (c) Fees for the 2024, 2025, and 2026 fiscal years. Persons shall remit fee payments to EPA as follows: (1) Small business concerns. (i) Premanufacture notice and consolidated premanufacture notice. (ii) Significant new use notice. (iii) Exemption application. (A) Low releases and low exposures exemption LoREX (B) Low volume exemption LVE (C) Test marketing exemption TME (D) TSCA experimental release application TERA (E) Tier II exemption (iv) Instant photographic film article exemption notice. (v) Microbial commercial activity notice consolidated microbial commercial activity notice. (vi) Persons shall remit a total of twenty percent of the applicable fee under paragraph (c)(2)(vi), (vii) or (viii) of this section for a test rule, test order, or enforceable consent agreement. (vii) Persons shall remit a total fee of twenty percent of the applicable fee under paragraphs (c)(2)(ix) of this section for an EPA-initiated risk evaluation. (viii) Persons shall remit the total fee under paragraph (c)(2)(x) or (xi) of this section, as applicable, for a manufacturer-requested risk evaluation. (2) Others. (i) PMN consolidated PMN. (ii) SNUN. (iii) Exemption applications. (A) Low releases and low exposures exemption LoREX (B) Low volume exemption LVE (C) Test marketing exemption TME (D) TSCA experimental release application TERA (E) Tier II exemption (iv) Instant photographic film article exemption notice. (v) MCAN and consolidated MCAN. (vi) Test rule. (vii) Test order. (viii) Enforceable consent agreement. (ix) EPA-initiated chemical risk evaluation. (x) Manufacturer-requested risk evaluation of a Work Plan Chemical. (xi) Manufacturer-requested risk evaluation of a non-work plan chemical. (d) Fees for 2026 fiscal year and beyond. FA = F × I Where: FA = the inflation-adjusted future year fee amount. F = the fee specified in paragraph (c) of this section. I = Producer Price Index for Chemicals and Allied Products inflation value with 2024 as a base year. (2) Updated fee amounts for PMNs, SNUNs, MCANs, exemption notices, exemption applications, and manufacturer-requested risk evaluation requests apply to submissions received by the Agency on or after October 1 of every three-year fee adjustment cycle beginning in fiscal year 2024 (October 1, 2023). Updated fee amounts also apply to test rules, test orders, enforceable consent agreements and EPA-initiated risk evaluations that are “noticed” on or after October 1 of every three-year fee adjustment cycle, beginning in fiscal year 2026. (3) The Agency will initiate public consultation through notice-and-comment rulemaking prior to making fee adjustments beyond inflation. If it is determined that no additional adjustment is necessary beyond for inflation, EPA will provide public notice of the inflation-adjusted fee amounts through posting to the Agency's web page by the beginning of each three-year fee adjustment cycle (October 1, 2026, October 1, 2029, etc.). If the Agency determines that adjustments beyond inflation are necessary, EPA will provide public notice of that determination and the process to be followed to make those adjustments. (e) No fee required. (f) Multiple parties, including joint submitters and consortia. (2) Any consortium formed to split the cost of the applicable fee under section 4 of the Act is required to remit the appropriate fee identified in paragraph (c) of this section for each test rule, test order, or enforceable consent agreement regardless of the number of manufacturers and/or processors in that consortium. For the consortium to qualify for the fee identified in paragraph (c)(1) of this section, each person in the consortium must qualify as a small business concern under § 700.43 of this chapter. Failure to submit fee payment pursuant to this paragraph, or to provide notice of failure to reach agreement pursuant to paragraph (f)(2)(v) of this section constitutes a violation by each consortium member. (i) The consortium must identify a principal sponsor and provide notification to EPA that a consortium has formed. The notification must be accomplished within 90 days of the publication date of a test rule under section 4 of the Act, or within 90 days of the effective date of a test order under section 4 of the Act, or within 90 days of the signing of an enforceable consent agreement under section 4 of the Act. EPA may permit additional entities to join an existing consortium after the expiration of the notification period if the principal sponsor provides updated notification. (ii) Notification must be submitted electronically via the Agency's electronic reporting software—Central Data Exchange (CDX)—and include the following information: (A) Full name, address, telephone number and signature of principal sponsor; (B) Name(s) and contact information for each manufacturer and/or processor associating with the consortium. (iii) It is up to the consortium to determine how fees will be split among the persons in the consortium. (iv) Consortia are strongly encouraged to set lower fees for small business concerns participating in the consortium. (v) If a consortium is unable to come to terms on how fees will be split among the persons in the consortium, the principal sponsor must notify EPA in writing before the end of the notification period in paragraph (f)(2)(i) of this section. (vi) If a consortium provides notice to EPA under paragraph (f)(2)(v) of this section that they failed to reach agreement on payment, EPA will assess fees to all persons as individuals described under paragraph (f)(4) of this section. (3) Any consortium formed to split the cost of the applicable fee supporting a risk evaluation under section 6(b) of the Act is required to remit the appropriate fee identified in paragraph (c) of this section for each risk evaluation, regardless of the number of manufacturers in that consortium. For the consortium to qualify for the fee identified in paragraph (c)(1)(vii) of this section, each person in the consortium must qualify as a small business concern under § 700.43 of this chapter. Failure to provide notice or submit fee payment pursuant to this paragraph (f)(3) constitutes a violation by each consortium member. (i) Notification must be provided to EPA that a consortium has formed. The notification must be accomplished within 90 days of the publication of the final scope of a chemical risk evaluation under section 6(b)(4)(D) of the Act or within 90 days of EPA providing notification to a manufacturer that a manufacturer-requested risk evaluation has been granted. EPA may permit additional entities to join an existing consortium after the expiration of the notification period if the principal sponsor provides updated notification. (ii) Notification must be submitted electronically via the Agency's electronic reporting software—Central Data Exchange (CDX)—and include the following information: (A) Full name, address, telephone number and signature of principal sponsor; (B) Name(s) and contact information for each manufacturer and/or processor associating with the consortium. (iii) It is up to the consortium to determine how fees will be split among the persons in the consortium. (iv) Consortia are strongly encouraged to set lower fees for small business concerns participating in the consortium. (v) If a consortium is unable to come to terms on how fees will be split among the persons in the consortium, the principal sponsor must notify EPA in writing before the end of the notification period in paragraph (f)(3)(i) of this section. (vi) If a consortium provides notice to EPA under paragraph (f)(3)(v) of this section that they failed to reach agreement on payment, EPA will assess fees to all persons as individuals as described under paragraph (f)(4) of this section. (4) If multiple persons are subject to fees triggered by section 4 or 6(b) of the Act and no consortium is formed, EPA will determine the portion of the total applicable fee to be remitted by each person subject to the requirement. (i) Each person's share of the applicable fees triggered by section 4 of the Act specified in paragraph (c) of this section shall be in proportion to the total number of manufacturers and/or processors of the chemical substance, with lower fees for small businesses: Where: P s P o F = the total fee required under paragraph (c) of this section. M t M s (ii) Each person's share of the applicable fees triggered by section 6(b) of the Act specified in paragraph (c) of this section shall be in proportion to the total number of manufacturers and their reported production volume as described in § 700.45(b)(v) of the chemical substance, with lower fees for small businesses: (iii) Remaining manufacturers ( i.e., Table 1 to Paragraph (f)(4)(iii) Manufacturer(s) Assigned Manufacturer with lowest production volume 1 Manufacturer with 2nd lowest production volume 2 Manufacturer with 3rd lowest production volume 3 . . . etc. Where: P s P ≥20th P <20th F = the total fee required under paragraph (c) of this section. M t M s N 20th M ≥20th 20th M <20th 20th F o (iv) In the event there are three or less manufacturers identified for a chemical substance, EPA will distribute the fee evenly among those three or less fee payers, regardless of production volume. (v) In the event the number assigned to the top 20th percentile is not an integer, EPA will round to the nearest integer to determine the manufacturer(s) with the reported production volume as described in § 700.45(b)(v) greater than or equal to the top 20th percentile. (vi) In the event multiple manufacturers report the same production volume as described in § 700.45(b)(v) and are greater than or equal to the top 20th percentile, EPA will include all manufacturers with that same production volume in the fee calculation for the top 20th percentile group. (5) If multiple persons are subject to fees triggered by section 4 of the Act and some inform EPA of their intent to form a consortium while others choose not to associate with the consortium, EPA will take the following steps to allocate fee amounts: (i) Count the total number of manufacturers, including the number of manufacturers within any consortia; divide the total fee amount by the total number of manufacturers; and allocate equally on a per capita basis to generate a base fee; (ii) Provide all small businesses who are either not associated with a consortium, or associated with an all- small business consortium, with an 80% discount from the base fee referenced previously; (iii) Calculate the total remaining fee and total number of remaining manufacturers by subtracting out the discounted fees and the number of small businesses identified; (iv) Reallocate the remaining fee across those remaining individuals and groups in equal amounts, counting each manufacturer in a consortium as one person; and (v) Inform consortia and individuals of their requisite fee amount. Small businesses in a successfully-formed consortium, other than a consortium of all small businesses, will not be afforded the 80% discount by EPA, but consortia managers are strongly encouraged to provide a discount for small business concerns. (6) If multiple persons are subject to fees triggered by section 6(b) of the Act and some inform EPA of their intent to form a consortium while others choose not to associate with the consortium, EPA will take the following steps to allocate fee amounts: (i) Count the total number of manufacturers, including the number of manufacturers within any consortia; divide the total fee amount by the total number of manufacturers; and allocate equally on a per capita basis to generate a base fee; (ii) Provide all small businesses who are either not associated with a consortium, or associated with an all-small business consortium, with an 80% discount from the base fee referenced previously; (iii) Calculate the total remaining fee and total number of remaining manufacturers by subtracting out the discounted fees and the number of small businesses identified; (iv) Place remaining manufacturers in ascending order (from lowest to highest) based on reported production volume as described in § 700.45(b)(v). Assign each remaining manufacturer a number with 1 for lowest production volume, 2 for second lowest production volume, etc.; (v) Determine the manufacturer(s) in the top 20th percentile by multiplying the total number of remaining manufacturers by 0.8. then comparing that number to the manufacturer(s) with that assigned number as described in paragraph (f)(6)(iv) of this section; (vi) Reallocate 80% of the total remaining fee evenly across that manufacturer(s) with a production volume amount equal to or larger than that manufacturer(s) (the top 20th percentile), counting each manufacturer in a consortium as one person; (vii) Reallocate the remaining fee evenly across the remaining manufacturers, counting each manufacturer in a consortium as one person; and (viii) Inform consortia and individuals of their requisite fee amount. Small businesses in a successfully formed consortium, other than a consortium of all small businesses, will not be afforded the 80% discount by EPA, but consortia managers are strongly encouraged to provide a discount for small business concerns. (g) Remittance procedure Electronic payment. Pay.gov (2) Fees incurred prior to (3) Fees incurred after (i) Test orders and test rules. (ii) Enforceable onsent agreements. (iii) Section 5 notice. (iv) Risk evaluations. (B) For manufacturer-requested risk evaluations under section 6(b)(4)(C)(ii) of the Act, the applicable fees specified in paragraph (c) of this section shall be paid as follows: ( 1 ( 2 ( 3 (4) Payment identity. Pay.gov (ii) Persons who are required to submit a letter of intent to conduct testing per § 790.45 of this chapter shall place a payment identity number on the front page of each letter 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 “ Pay.gov (iii) Persons who sign an enforceable consent agreement per § 790.60 of this chapter shall place a payment identity number within the contents of the signed agreement. 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 “ Pay.gov (5) Small business certification. (ii) Each person who remits the fee identified in paragraph (c)(1) of this section for a LVE, LoREX, TERA, TME, or Tier II exemption request under TSCA section 5 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 $2,180 in accordance with 40 CFR 700.45(c).” in the exemption application. (iii) Each person who remits the fee identified in paragraph (c)(1) of this section for an exemption notice under § 723.175 of this chapter shall include the words, “The company or companies identified in this notice is/are a small business concern under 40 CFR 700.43 and has/have remitted a fee of $2,180 in accordance with 40 CFR 700.45(c).” in the certification required in § 723.175(i)(1)(x) of this chapter. (iv) Each person who remits the fee identified in paragraph (c)(1) of this section for a MCAN or consolidated 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 $6,480 in accordance with 40 CFR 700.45(c).” in the certification required in § 725.25(b) of this chapter. (6) Payment certification statement. (ii) Each person who remits a fee identified in paragraph (c)(2) of this section for a LVE, LoREX, TERA, TME, or Tier II exemption request under TSCA section 5 shall insert a check mark for the statement, “The company named in part 1, section A has remitted the fee of $10,870 specified in 40 CFR 700.45(c).” in the exemption application. (iii) Each person who remits the fee identified in paragraph (c)(2) of this section for an exemption notice under § 723.175 of this chapter shall include the words, “The company or companies identified in this notice has/have remitted a fee of $10,870 in accordance with 40 CFR 700.45(c).” in the certification required in § 723.175(i)(1)(x) of this chapter. (iv) Each person who remits the fee identified in paragraph (c)(2) 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 has remitted the fee of $37,000 in accordance with 40 CFR 700.45(c).” in the certification required in § 725.25(b) of this chapter. (h) Full fee refunds. (1) That the chemical substance that is the subject of a PMN, consolidated PMN, exemption request, or exemption notice, is not a new chemical substance as of the date of submission of the notice, (2) In the case of a SNUN, that the notice was not required, (3) That as of the date of submission of the notice: The microorganism that is the subject of a MCAN or consolidated MCAN is not a new microorganism; nor is the use involving the microorganism a significant new use; or (4) When the Agency fails to make a determination on a notice by the end of the applicable notice review period under § 720.75 or § 725.50 of this chapter, unless the Agency determines that the submitter unduly delayed the process, or (5) When the Agency fails to approve, or deny an exemption request within the applicable period under § 720.38(d), § 723.50(g), or § 725.50(b) of this chapter, unless the Agency determines that the submitter unduly delayed the process. (i) Partial fee refunds. (2) Once withdrawn, any future submission related to the TSCA section 5 notice must be submitted as a new notice. (3) If EPA determines that the initial payment for a manufacturer-requested risk evaluation exceed the applicable fee in paragraph (c) of this section, EPA will refund the difference. [83 FR 52714, Oct. 17, 2018, as amended at 89 FR 12974, Feb. 21, 2024] § 700.49 Failure to remit fees. (a) EPA will not consider a TSCA section 5 notice to be complete unless the appropriate certification under § 700.45(g) is included and until the appropriate remittance under § 700.45(c) has been submitted as provided in § 700.45(g). EPA will notify the submitter of a section 5 notice that it is incomplete in accordance with §§ 720.65(c) and 725.33(b)(1) of this chapter. (b) Failure to submit the appropriate remittance specified under § 700.45(c) for a test order, test rule, enforceable consent agreement, or EPA-initiated risk evaluation as provided in § 700.45(g) is a violation of TSCA and enforceable under section 15 of the Act. (c) EPA will not initiate a manufacturer-requested risk evaluation the request for which the Agency has otherwise determined to be complete unless EPA has determined to grant the request and the appropriate initial remittance under § 700.45(c) has been submitted as provided in § 700.45(g). (d) Failure to submit the appropriate final remittance specified under § 700.45(c) for a manufacturer-requested risk evaluation as provided in § 700.45(g) is a violation of TSCA and enforceable under section 15 of the Act. [83 FR 52719, Oct. 17, 2018]

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