2014-11204. Amine Salts of Alkyl (C8

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation amends two exemptions from the requirement of a tolerance for residues of diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid (not to exceed 7% of pesticidal formulations) and two exemptions from the requirement of a tolerance for residues of dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid (without limitation), herein referred to collectively as amine salts of alkyl (C₈-C₂₄) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono-, di-, and triethanolamine), or ASABSA, when used as inert ingredients applied to growing crops and to animals. The Joint Inerts Task Force Cluster Support Team 8 (JITF CST 8) c/o Huntsman Corp., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting amendment of two existing exemptions from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ASABSA.

DATES:

This regulation is effective May 16, 2014. Objections and requests for hearings must be received on or before July 15, 2014, 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-2012-0863, 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), EPA West 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 [phone], and the telephone number for the OPP Docket is [phone]. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

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 Printing 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, 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-2012-0863 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 July 15, 2014. 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-2012-0863, 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 38924) (FRL-8430-2), EPA issued a final rule announcing the establishment of a tolerance exemption pursuant to a pesticide petition (PP 8E7472) by the Joint Inerts Task Force Cluster Support Team 8 (JITF CST 8) c/o CropLife America, 1156 15th St. NW., Suite 400, Washington, DC 20005. The petition requested that 40 CFR 180.920 and 180.930 be amended by establishing exemptions from the requirement of a tolerance for residues of diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid and dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid when used as inert ingredients (surfactants) in pesticide formulations applied to growing crops and animals. The current petition seeks to expand the exemptions for ASABSA by adding additional chemicals identified by Chemical Abstract Service Registry Numbers (CAS Reg. Nos.).

In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 2E8087) by the Joint Inerts Task Force, Cluster Support Team 8, (JITF CST 8), c/o Huntsman Corp., 8600 Gosling Rd., The Woodlands, TX 77381. The petition requested that 40 CFR 180.920 and 180.930 be amended by modifying two exemptions from the requirement of a tolerance for residues of diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid (not to exceed 7% of pesticide formulation) to include CAS Reg. Nos. 67815-95-6, 67889-94-5, 67889-95-6, 68259-34-7, 68478-47-7, 68567-68-0, 68815-34-9, 68815-37-2, 68891-02-1, 84989-15-1, 85338-09-6, 90194-39-1, 90194-40-4, and 90218-08-9 and two exemptions from the requirement of a tolerance for residues of dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid (without limitation) to include CAS Reg. Nos. 3088-30-0, 12068-12-1, 26836-07-7, 58089-99-9, 61886-59-7, 61931-76-8, 67924-05-4, 68110-32-7, 68259-35-8, 68442-72-8, 68567-69-1, 68815-30-5, 68815-35-0, 68953-98-0, 70528-84-6, 72391-21-0, 84961-74-0, 85480-55-3, 85480-56-4, 85995-82-0, 90194-54-0, 90194-55-1, 90218-09-0, 90218-11-4, 96687-54-6, 99924-49-9, 121617-08-1, and 193562-36-6. That document referenced a summary of the petition prepared by JITF CST 8, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

In this petition, the JITF CST 8 claims that the requested chemical CAS Reg. Nos. listed in Unit II. should be covered by the published tolerance exemptions for ASABSA and that no further data or review is required to amend the existing tolerance exemption to include the additional CAS Reg. Nos.

Based upon review of the data supporting the petition, EPA has confirmed that the requested CAS Reg. Nos. are appropriately added to the currently approved respective descriptors for ASABSA.

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 exemption is “safe.” Section 408(b)(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 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(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 for ASABSA including exposure resulting from the exemption amended by this action. EPA's assessment of exposures and risks associated with ASABSA follows.

The Agency agrees with the petitioner that CAS Reg. Nos. 67815-95-6, 67889-94-5, 67889-95-6, 68259-34-7, 68478-47-7, 68567-68-0, 68815-34-9, 68815-37-2, 68891-02-1, 84989-15-1, 85338-09-6, 90194-39-1, 90194-40-4, and 90218-08-9 are diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid similar to those present in the existing exemption.

The Agency agrees with the petitioner that CAS Reg. Nos. 3088-30-0, 12068-12-1, 26836-07-7, 58089-99-9, 61886-59-7, 61931-76-8, 67924-05-4, 68110-32-7, 68259-35-8, 68442-72-8, 68567-69-1, 68815-30-5, 68815-35-0, 68953-98-0, 70528-84-6, 72391-21-0, 84961-74-0, 85480-55-3, 85480-56-4, 85995-82-0, 90194-54-0, 90194-55-1, 90218-09-0, 90218-11-4, 96687-54-6, 99924-49-9, 121617-08-1, and 193562-36-6 are dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid similar to those present in the existing exemption.

In 2009, in establishing the exemptions for ASABSA, EPA assessed the safety generally using worst case exposure assumptions (74 FR 38924) (FRL-8430-2). Based upon the review of the data supporting this petition, EPA has confirmed that the requested CAS Reg. Nos. are appropriately added to the currently approved descriptors. The requested CAS Reg. Nos. consist of compounds that are amine salts of alkyl (C₈-C₂₄) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono-, di-, and triethanolamine). As such, the requested CAS Reg. Nos. fall within the existing tolerance exemption descriptors for diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid and dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid given in 40 CFR 180.920 and 180.930.

The Agency has determined that the proposed addition of the requested CAS Reg. Nos. is adequately supported by the existing data and assessment and that no additional data or review is required. Inclusion of the additional chemicals described in Unit IV. in the risk assessments for the ASABSA would in no way alter the prior risk assessments given the generic findings on toxicity and the worst case exposure assumptions used in those risk assessments. Accordingly, based on the findings in that earlier rule, EPA has determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to ASABSA by including the additional chemicals described in Unit IV., under reasonably foreseeable circumstances. Therefore, the amendment to an existing requirement of a tolerance under 40 CFR 180.920, and 180.930 for residues of ASABSA to include the chemicals described in Unit IV. is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical level of residues of diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid that cannot be exceeded in or on any food commodities. EPA is establishing a limitation on the amount of the diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid that may be used in pesticide formulations. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution that contains greater than 7% of the diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid by weight in the pesticide formulation.

VI. Conclusions

Therefore, the exemptions from the requirement of a tolerance under 40 CFR 180.920 and 180.930 for diethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid (not to exceed 7% of pesticide formulations) and dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C₈-C₂₄) benzenesulfonic acid are amended to include the requested CAS Reg. Nos. when used as inert ingredients (surfactants) in pesticide formulations applied to growing crops and to animals.

VII. Statutory and Executive Order Reviews

This final rule establishes an exemption from the requirement for a tolerance in response to a petition submitted to the Agency under FFDCA section 408(d). 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 final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 exemption 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 final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (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

Dated: May 7, 2014.

G. Jeffrey Herndon,

Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

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

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

2. In § 180.920, revise the following inert ingredients in the table to read as follows:

§ 180.920

Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.

* * * * *

Inert ingredients	Limits	Uses
*         *         *         *         *         *         *
Diethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26545-53-9, 67815-95-6, 67889-94-5, 67889-95-6, 68259-34-7, 68478-47-7, 68567-68-0, 68815-34-9, 68815-37-2, 68891-02-1, 68953-97-9, 84989-15-1, 85338-09-6, 90194-39-1, 90194-40-4, 90218-08-9)	Not to exceed 7% of pesticide formulation	Surfactants, related adjuvants of surfactants.
*         *         *         *         *         *         *
Dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 3088-30-0, 12068-12-1, 26264-05-1, 26836-07-7, 27323-41-7, 55470-69-4, 58089-99-9, 61886-59-7, 61931-76-8, 67924-05-4, 68110-32-7, 68259-35-8, 68411-31-4, 68442-72-8, 68567-69-1, 68584-24-7, 68584-25-8, 68648-81-7, 68648-96-4, 68649-00-3, 68815-30-5, 68815-35-0, 68910-32-7, 68953-93-5, 68953-98-0, 70528-84-6, 72391-21-0, 84961-74-0, 85480-55-3, 85480-56-4, 85995-82-0, 90194-42-6, 90194-53-9, 90194-54-0, 90194-55-1, 90218-09-0, 90218-11-4, 90218-35-2, 96687-54-6, 99924-49-9, 121617-08-1, 157966-96-6, 193562-36-6, 319926-68-6, 877677-48-0, 1093628-27-3)		Surfactants, related adjuvants of surfactants.
*         *         *         *         *         *         *

3. In § 180.930, revise the following inert ingredients in the table to read as follows:

§ 180.930

Inert ingredients applied to animals; exemptions from the requirement of a tolerance.

* * * * *

Inert ingredients	Limits	Uses
*         *         *         *         *         *         *
Diethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 26545-53-9, 67815-95-6, 67889-94-5, 67889-95-6, 68259-34-7, 68478-47-7, 68567-68-0, 68815-34-9, 68815-37-2, 68891-02-1, 68953-97-9, 84989-15-1, 85338-09-6, 90194-39-1, 90194-40-4, 90218-08-9)	Not to exceed 7% of pesticide formulation	Surfactants, related adjuvants of surfactants.
*         *         *         *         *         *         *
Dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C8-C24) benzenesulfonic acid (CAS Reg. Nos. 3088-30-0, 12068-12-1, 26264-05-1, 26836-07-7, 27323-41-7, 55470-69-4, 58089-99-9, 61886-59-7, 61931-76-8, 67924-05-4, 68110-32-7, 68259-35-8, 68411-31-4, 68442-72-8, 68567-69-1, 68584-24-7, 68584-25-8, 68648-81-7, 68648-96-4, 68649-00-3, 68815-30-5, 68815-35-0, 68910-32-7 68953-93-5, 68953-98-0, 70528-84-6, 72391-21-0, 84961-74-0, 85480-55-3, 85480-56-4, 85995-82-0, 90194-42-6, 90194-53-9, 90194-54-0, 90194-55-1, 90218-09-0, 90218-11-4, 90218-35-2, 96687-54-6, 99924-49-9, 121617-08-1, 157966-96-6, 193562-36-6, 319926-68-6, 877677-48-0, 1093628-27-3).		Surfactants, related adjuvants of surfactants.
*         *         *         *         *         *         *