Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid (AASUAA); Exemption From the Requirement of a Tolerance, 37055-37058 [2021-14818]

Download as PDF Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations § 52.370 Identification of plan. Agencies Section 22a–174–22e, entitled ‘‘Control of nitrogen oxide emissions from fuel-burning equipment at major stationary sources of nitrogen oxides,’’ as amended October 8, 2019, as follows: (1) 22a–174–22e (a), Definitions; (12) ‘‘emergency’’ and (13) ‘‘emergency engine.’’ (2) 22a–174–22e (g), Compliance options; (4) and (6). * * * * * (c) * * * (125) Revisions to the State Implementation Plan submitted by the Connecticut Department of Environmental Protection on December 20, 2019. (i) Incorporation by reference. (A) Regulations of Connecticut State 37055 3. In § 52.385, Table 52.385 is amended by adding two entries in state citations for ‘‘22a–174–22e’’ between existing entries for ‘‘22a–174–22e: Control of nitrogen oxides . . .’’ and ‘‘22a–174–22f’’ to read as follows: § 52.385 - EPA-approved Connecticut regulations. * * * * * TABLE 52.385—EPA-APPROVED REGULATIONS Dates Connecticut State citation Title/subject 22a–174–22e ... * Definitions .... * 10/8/19 Compliance options. 10/8/19 22a–174–22e ... * Date adopted by State Date approved by EPA * * 7/14/2021 [Insert Federal Register citation]. 7/14/2021 [Insert Federal Register citation]. * * BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2021–0197; FRL–8581–01– OCSPP] Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid (AASUAA); Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid; (also known as AASUAA) when used as an inert ingredient in a pesticide chemical formulation. Croda Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid on food or feed commodities. lotter on DSK11XQN23PROD with RULES1 SUMMARY: This regulation is effective July 14, 2021. Objections and requests for hearings must be received on or before 16:14 Jul 13, 2021 Jkt 253001 Comments/description * * [Insert next available paragraph number in sequence]. [Insert next available paragraph number in sequence]. * Definitions revised for ‘‘emergency’’ and ‘‘emergency engine.’’ Approve subsection (g)(4) and (g)(6): Two compliance options relating to ISO-New England OP–4 removed. * * The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2021–0197, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Due to the public health concerns related to COVID–19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. ADDRESSES: 40 CFR Part 180 VerDate Sep<11>2014 Section 52.370 September 13, 2021, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). [FR Doc. 2021–14828 Filed 7–13–21; 8:45 am] DATES: Federal Register citation FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 * * SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/text-idx?&c= ecfr&tpl=/ecfrbrowse/Title40/40tab_ 02.tpl. C. Can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation E:\FR\FM\14JYR1.SGM 14JYR1 37056 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations lotter on DSK11XQN23PROD with RULES1 in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2021–0197 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before September 13, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2021–0197 by one of the following methods. • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Background and Statutory Findings In the Federal Register of March 22, 2021, (Vol. 86, No. 53 FR 15164) (FRL10021–44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN–11424) filed by Croda, Inc., 300–A Columbus Circle, Edison, NJ 08837. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid; with a minimum number average molecular weight (in amu) of 1,300 when used as a pesticide inert ingredient (surfactant or adjuvant); CAS Reg. Nos. 397247–05–1; 227755–70–6; 397247–06–2; 1065234–83–4, and VerDate Sep<11>2014 16:14 Jul 13, 2021 Jkt 253001 497157–72–9. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner’s request. The Agency did not receive any comments. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and use in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .’’ and specifies factors EPA is to consider in establishing an exemption. III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers. 1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer’s number average MW of 1,300 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid. IV. Aggregate Exposures For the purposes of assessing potential exposure under this E:\FR\FM\14JYR1.SGM 14JYR1 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations exemption, EPA considered that Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid could be present in all raw and processed agricultural commodities and drinking water, and that nonoccupational non-dietary exposure was possible. The number average MW of Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid is 1,300 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid (AASUAA) conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid (AASUAA) to share a common mechanism of toxicity with any other substances, and Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid that does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticides/cumulative. lotter on DSK11XQN23PROD with RULES1 VI. Determination of Safety Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid (AASUAA). VerDate Sep<11>2014 16:14 Jul 13, 2021 Jkt 253001 VII. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid, short chemical name (AASUAA). VIII. Conclusion Accordingly, EPA finds that exempting residues of Alkoxylated C8C18 Saturated and Unsaturated Alcohol and Adipic Acid, Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid short chemical name (AASUAA) from the requirement of a tolerance will be safe. IX. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 37057 April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). X. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal E:\FR\FM\14JYR1.SGM 14JYR1 37058 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations Dated: July 7, 2021. Marietta Echeverria, Acting Director, Registration Division, Office of Pesticide Programs. Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD 2. In § 180.960, amend the table by adding in alphabetical order the polymer ‘‘Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid, (AASUAA), minimum number average molecular weight (in amu), 1,300’’ to read as follows: ■ § 180.960 Polymers; exemptions from the requirement of a tolerance. 1. The authority citation for part 180 continues to read as follows: ■ * * * * * Polymer CAS No. * * * * Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid, (AASUAA), minimum number average molecular weight (in amu), 1,300. * * * 397247–05–1, 227755–70–6, 397247–06–2, 1065234– 83–4, and 497157–72–9. * * * [FR Doc. 2021–14818 Filed 7–13–21; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [GN Docket No. 20–32; FCC 20–150; FRS 37029] Establishing a 5G Fund for Rural America Federal Communications Commission. ACTION: Final rule; announcement of effective date. AGENCY: In this document, the Commission announces that the Office of Management and Budget has approved new information collection requirements associated with a new or amended rule adopted in the Federal Communications Commission’s 5G Fund Report and Order, FCC 20–150. This document is consistent with the 5G Fund Report and Order, which states that the Commission will publish a document in the Federal Register announcing the effective date for the new or amended rule section. DATES: The addition of 47 CFR 54.322(c)(4), published at 85 FR 75770 on November 25, 2020, is effective July 14, 2021. FOR FURTHER INFORMATION CONTACT: Valerie Barrish, Auctions Division, Office of Economics and Analytics, at (202) 418–0354 or Valerie.Barrish@ fcc.gov. SUMMARY: lotter on DSK11XQN23PROD with RULES1 Authority: 21 U.S.C. 321(q), 346a and 371. This document announces that the Office of SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:14 Jul 13, 2021 Jkt 253001 * * Management and Budget (OMB) approved the information collection requirements in 47 CFR 54.322(c)(4), on June 16, 2021. This rule was adopted in the 5G Fund Report and Order, FCC 20– 150. The Commission publishes this document as an announcement of the effective date for this new rule. OMB approval for all other new or amended rules adopted in the 5G Fund Report and Order for which OMB approval is required will be requested, and the effective date for those rules will be announced following OMB’s approval. See 85 FR 75770 (Nov. 25, 2020). If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 3.317, 45 L Street NE, Washington, DC 20554, regarding OMB Control Number 3060–1289. Please include the OMB Control Number in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). Synopsis As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received final OMB approval on June 16, 2021, for the information collection requirements contained in 47 CFR 54.322(c)(4). Under 5 CFR part PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 * * 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number for the information collection requirements in 47 CFR 54.322(c)(4) is 3060–1289. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104–13, October 1, 1995, and 44 U.S.C. 3507. The total annual reporting burdens and costs for the respondents are as follows: OMB Control Number: 3060–1289. OMB Approval Date: June 16, 2021. OMB Expiration Date: June 30, 2024. Title: Legacy Support Usage Flexibility Certification. Form Number: N/A. Respondents: Business or other forprofit entities, not-for-profit institutions, and state, local or tribal governments. Number of Respondents and Responses: Up to 110 respondents and 110 responses. Estimated Time per Response: 1.75 hours. Frequency of Response: One-time reporting requirement. Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154, 254 and 303(r). Total Annual Burden: 193 hours. Total Annual Cost: $16,500. Privacy Act Impact Assessment: No impact(s). E:\FR\FM\14JYR1.SGM 14JYR1

Agencies

[Federal Register Volume 86, Number 132 (Wednesday, July 14, 2021)]
[Rules and Regulations]
[Pages 37055-37058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14818]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0197; FRL-8581-01-OCSPP]


Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic 
Acid (AASUAA); Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Alkoxylated C8-C18 Saturated and 
Unsaturated Alcohol and Adipic Acid; (also known as AASUAA) when used 
as an inert ingredient in a pesticide chemical formulation. Croda Inc. 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of Alkoxylated C8-C18 Saturated and 
Unsaturated Alcohol and Adipic Acid on food or feed commodities.

DATES: This regulation is effective July 14, 2021. Objections and 
requests for hearings must be received on or before September 13, 2021, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0197, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation

[[Page 37056]]

in accordance with the instructions provided in 40 CFR part 178. To 
ensure proper receipt by EPA, you must identify docket ID number EPA-
HQ-OPP-2021-0197 in the subject line on the first page of your 
submission. All objections and requests for a hearing must be in 
writing and must be received by the Hearing Clerk on or before 
September 13, 2021. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2021-0197 by one of 
the following methods.
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of March 22, 2021, (Vol. 86, No. 53 FR 
15164) (FRL- 10021-44), EPA issued a document pursuant to FFDCA section 
408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 
IN-11424) filed by Croda, Inc., 300-A Columbus Circle, Edison, NJ 
08837. The petition requested that 40 CFR 180.960 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and 
Adipic Acid; with a minimum number average molecular weight (in amu) of 
1,300 when used as a pesticide inert ingredient (surfactant or 
adjuvant); CAS Reg. Nos. 397247-05-1; 227755-70-6; 397247-06-2; 
1065234-83-4, and 497157-72-9. That document included a summary of the 
petition prepared by the petitioner and solicited comments on the 
petitioner's request. The Agency did not receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and use in residential settings but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing an exemption from the 
requirement of a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue . . .'' and 
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be shown that the risks from aggregate 
exposure to pesticide chemical residues under reasonably foreseeable 
circumstances will pose no appreciable risks to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. In the case of certain chemical substances that 
are defined as polymers, the Agency has established a set of criteria 
to identify categories of polymers expected to present minimal or no 
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the 
exclusion criteria for identifying these low-risk polymers are 
described in 40 CFR 723.250(d). Alkoxylated C8-C18 Saturated and 
Unsaturated Alcohol and Adipic Acid conforms to the definition of a 
polymer given in 40 CFR 723.250(b) and meets the following criteria 
that are used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. The polymer does contain as an integral part of its composition 
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or 
reactants that are already included on the TSCA Chemical Substance 
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW of 1,300 is greater than 1,000 
and less than 10,000 daltons. The polymer contains less than 10% 
oligomeric material below MW 500 and less than 25% oligomeric material 
below MW 1,000, and the polymer does not contain any reactive 
functional groups.
    Thus, Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and 
Adipic Acid meets the criteria for a polymer to be considered low risk 
under 40 CFR 723.250. Based on its conformance to the criteria in this 
unit, no mammalian toxicity is anticipated from dietary, inhalation, or 
dermal exposure to Alkoxylated C8-C18 Saturated and Unsaturated Alcohol 
and Adipic Acid.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this

[[Page 37057]]

exemption, EPA considered that Alkoxylated C8-C18 Saturated and 
Unsaturated Alcohol and Adipic Acid could be present in all raw and 
processed agricultural commodities and drinking water, and that non-
occupational non-dietary exposure was possible. The number average MW 
of Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid 
is 1,300 daltons. Generally, a polymer of this size would be poorly 
absorbed through the intact gastrointestinal tract or through intact 
human skin. Since Alkoxylated C8-C18 Saturated and Unsaturated Alcohol 
and Adipic Acid (AASUAA) conform to the criteria that identify a low-
risk polymer, there are no concerns for risks associated with any 
potential exposure scenarios that are reasonably foreseeable. The 
Agency has determined that a tolerance is not necessary to protect the 
public health.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' EPA has not found Alkoxylated C8-C18 
Saturated and Unsaturated Alcohol and Adipic Acid (AASUAA) to share a 
common mechanism of toxicity with any other substances, and Alkoxylated 
C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed 
Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and Adipic Acid 
that does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no 
harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of Alkoxylated C8-C18 Saturated and 
Unsaturated Alcohol and Adipic Acid (AASUAA).

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Alkoxylated C8-C18 
Saturated and Unsaturated Alcohol and Adipic Acid, short chemical name 
(AASUAA).

VIII. Conclusion

    Accordingly, EPA finds that exempting residues of Alkoxylated C8-
C18 Saturated and Unsaturated Alcohol and Adipic Acid, Alkoxylated C8-
C18 Saturated and Unsaturated Alcohol and Adipic Acid short chemical 
name (AASUAA) from the requirement of a tolerance will be safe.

IX. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or Tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal

[[Page 37058]]

Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 7, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.960, amend the table by adding in alphabetical order 
the polymer ``Alkoxylated C8-C18 Saturated and Unsaturated Alcohol and 
Adipic Acid, (AASUAA), minimum number average molecular weight (in 
amu), 1,300'' to read as follows:


Sec.  180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
                 Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
Alkoxylated C8-C18 Saturated and          397247-05-1, 227755-70-6,
 Unsaturated Alcohol and Adipic Acid,      397247-06-2, 1065234-83-4,
 (AASUAA), minimum number average          and 497157-72-9.
 molecular weight (in amu), 1,300.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2021-14818 Filed 7-13-21; 8:45 am]
BILLING CODE 6560-50-P
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