[alpha]-Alkyl-[omega]-hydroxypoly(oxypropylene) and/or poly (oxyethylene) Polymers Where the Alkyl Chain Contains a Minimum of 6 Carbons; Exemptions From the Requirement of a Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes exemptions from the requirement of a tolerance for α-alkyl-ω-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons when used as inert ingredients in certain pesticide formulations. Spring Regulatory Sciences, on behalf of Sasol Chemicals (USA) LLC, 12120 Wickchester Ln., Houston, Texas 77224, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting amendments to existing exemptions from the requirement of a tolerance when used in accordance with these exemptions.

DATES:

This regulation is effective August 27, 2021. Objections and requests for hearings must be received on or before October 26, 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-2021-0161, is available at http://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: RDFRNotices@epa.gov.

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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl .

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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 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-2021-0161 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 October 26, 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-2021-0161, by one of the following methods:

• Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

In the Federal Register of August 5, 2009 (74 FR 38935) (FRL-8430-1), EPA issued a final rule, announcing the establishment of a tolerance exemption pursuant to a pesticide petition (PP 9E7534) by The Joint Inerts Task Force, Cluster Support Team 1 (CST 1), c/o CropLife America, 1156 15th Street NW, Suite 400, Washington, DC 20005. The petition requested that 40 CFR 180.910, 180.930, 180.940(a), and 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of a group of substances known as α-alkyl-ω-hydroxypoly(oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of 6 carbons, herein referred to in this document as AAA.

The current petition seeks to expand the exemptions for AAA by adding additional CAS Reg. Nos. In the Federal Register of March 22, 2021 (86 FR 15162) (FRL-10021-44), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11422) by Spring Regulatory Sciences, on behalf of Sasol Chemicals (USA) LLC, 12120 Wickchester Ln., Houston, Texas 77224. The petition requested that 40 CFR 180.910, 180.930, 180.940(a), and 180.960 be amended by establishing exemptions from the requirement of a tolerance for alcohols, C20-30, ethoxylated (CAS Reg. No. 68439-48-5); alcohols, C16-18, distn. residues, ethoxylated, propoxylated (CAS Reg. No. 2409830-33-5); alcohol, C22, ethoxylated (CAS Reg. No. 26636-40-8); poly(oxy-1,2-ethanediyl), α-(2-butyloctyl)-ω-hydroxy- (CAS Reg. No. 60636-37-5); 2-octyldodecan-1-ol, ethoxylated (CAS Reg. No. 32128-65-7); and alcohols, C16-20, branched, ethoxylated (CAS Reg. No. 161133-70-6). That document referenced a summary of the petition prepared by Spring Regulatory Sciences on behalf of Sasol Chemicals (USA) LLC, the petitioner, which is available in the docket, http://www.regulations.gov.

There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA determined that CAS Reg. No. 68439-48-5 currently has exemptions from the requirement of a tolerance under the current AAA descriptor in 40 CFR 180.910, 180.930, 180.940(a), and 180.960. EPA has confirmed that the other petitioned CAS Reg. Nos. are acceptable for consideration under the current AAA descriptor. This determination is based on the Agency's risk assessments, which can be found at http://www.regulations.gov in documents “Alkyl Alcohol Alkoxylates (AAA-JITF CST 1 Inert Ingredient), Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance when used as an Inert Ingredient in Pesticide Formulations” and “Alkyl Alcohol Alkoxylates (AAA-JITF CST 1 Inert Ingredient), Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance Under 40 CFR 180.960 When Used as an Inert Ingredient in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2009-0145.

III. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

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 tolerance 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 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 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 . . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm 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 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(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure to alcohols, C16-18, distn. residues, ethoxylated, propoxylated; alcohol, C22, ethoxylated; poly(oxy-1,2-ethanediyl), α- (2-butyloctyl)-ω-hydroxy-; 2-octyldodecan-1-ol, ethoxylated; and alcohols, C16-20, branched, ethoxylated, including exposure resulting from the exemptions established by this action. EPA's assessment of exposures and risks associated with the group of substances known as AAA follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published tolerance rulemakings for AAA, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to AAA and established exemptions from the requirement of a tolerance for residues of those chemicals. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological Profile. EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies 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. Specific information on the studies received and the nature of the adverse effects caused by AAA as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in Unit IV.A. of the previous AAA tolerance rulemaking published in the Federal Register of August 5, 2009 (74 FR 38935) (FRL-8430-1).

Toxicological Points of Departure/Levels of Concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment, see Unit IV.B. of the August 5, 2009 rulemaking.

Exposure Assessment. The exposure assessment associated with the 2009 rulemaking for the AAA descriptor included the potential use of all chemicals in this category and therefore no additional exposure is expected from the exemptions established by this action. For a description of the Agency's approach to and assumptions for the exposure assessments, see Unit IV.C. of the August 5, 2009 rulemaking.

Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor for infants and children from 10X to 1X. See Unit IV.D. of the August 5, 2009 rulemaking for a discussion of the Agency's rationale for that determination.

Aggregate Risks and Determination of Safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

An acute dietary exposure assessment was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD with a value of 37% of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. EPA concluded that the short- and intermediate-term aggregated food, water, and residential exposures both resulted in an aggregate MOEs of 110 for children. As the level of concern is for MOEs that are lower than 100, these MOEs are not of concern. The AAAs are not expected to be carcinogenic as described in Unit IV.C. of the August 5, 2009 rulemaking. Therefore, a cancer dietary exposure assessment is not necessary to assess cancer risk.

Based on the risk assessment and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to AAA residues, including residues of alcohols, C16-18, distn. residues, ethoxylated, propoxylated (CAS Reg. No. 2409830-33-5); alcohol, C22, ethoxylated (CAS Reg. No. 26636-40-8); poly(oxy-1,2-ethanediyl), α-(2-butyloctyl)-ω-hydroxy- (CAS Reg. No. 60636-37-5); 2-octyldodecan-1-ol, ethoxylated (CAS Reg. No. 32128-65-7); and alcohols, C16-20, branched, ethoxylated (CAS Reg. No. 161133-70-6). More detailed information about the Agency's analysis can be found at http://www.regulations.gov in the documents titled “Alkyl Alcohol Alkoxylates (AAA—JITF CST 1 Inert Ingredient), Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations” and “Alkyl Alcohol Alkoxylates (AAA-JITF CST 1 Inert Ingredient), Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance Under 40 CFR 180.960 When Used as an Inert Ingredient in Pesticide Formulations” in docket ID number EPA-HQ-OPP-2009-0145.

V. Analytical Enforcement Methodology

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

VI. Conclusions

Therefore, exemptions from the requirement of a tolerance are established for residues of the following α-alkyl-ω-hydroxypoly(oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of 6 carbons: alcohols, C16-18, distn. residues, ethoxylated, propoxylated (CAS Reg. No. 2409830-33-5); alcohol, C22, ethoxylated (CAS Reg. No. 26636-40-8); poly(oxy-1,2-ethanediyl), α-(2-butyloctyl)-ω-hydroxy- (CAS Reg. No. 60636-37-5); 2-octyldodecan-1-ol, ethoxylated (CAS Reg. No. 32128-65-7); and alcohols, C16-20, branched, ethoxylated (CAS Reg. No. 161133-70-6) when used as inert ingredients in pesticide formulations pre- and post-harvest under 40 CFR 180.910, applied to animals under 40 CFR 180.930, and in antimicrobial formulations applied to food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils under 40 CFR 180.940(a). Additionally, exemptions from the requirement of a tolerance are established under 40 CFR 180.960 for residues of these substances with a minimum number average molecular weight (in amu) of 1,100 when used as an inert ingredient in pesticide formulations, including antimicrobial formulations.

VII. Statutory and Executive Order Reviews

This action establishes exemptions from the requirement of 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 exemptions 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).

VIII. 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 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

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

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

2. In § 180.910, revise inert ingredient “α-Alkyl-ω-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons” in table 1 to read as follows:

3. In § 180.930, revise inert ingredient “α-Alkyl-ω-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons” in table 1 to read as follows:

4. In § 180.940, revise inert ingredient “α-Alkyl-ω-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons” in the table in paragraph (a) to read as follows:

5. In § 180.960, revise entry “α-Alkyl-ω-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and a minimum number average molecular weight (in amu) 1,100” in the table to read as follows: