Lignosulfonic Acid, Calcium, Comp. With 1,6 Hexanediamine Polymer With Guanidine Hydrochloride (1:1); Tolerance Exemption, 42780-42783 [2018-18407]

Download as PDF 42780 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations security zone lasting eleven hours that will prohibit entry within a half mile radius of the Olmsted Lock and Dam, located at mile marker 964.5 on the Ohio River. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023–01–001–01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. G. Protest Activities The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: BILLING CODE 9110–04–P ENVIRONMENTAL PROTECTION AGENCY 1. The authority citation for part 165 continues to read as follows: ■ Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1. 2. Add § 165.T08–0700 to read as follows: ■ sradovich on DSK3GMQ082PROD with RULES Security Zone; Ohio River, (a) Location. The following area is a security zone: all navigable waters within a half mile of Olmsted Lock and Dam, located at MM 964.5 on the Ohio River, Olmstead, IL. (b) Effective period. This section is effective from 6 a.m. through 5 p.m. on August 30, 2018. (c) Regulations. (1) Under the general security zone regulations in subpart D of this part, you may not enter the security zone described in paragraph (a) of this section unless authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Ohio Valley. A designated representative may be a Patrol VerDate Sep<11>2014 00:53 Aug 24, 2018 Jkt 244001 Dated: August 17, 2018. M.B. Zamperini, Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley. [FR Doc. 2018–18389 Filed 8–23–18; 8:45 am] PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS. § 165.T08–0700 Olmsted, IL. Commander (PATCOM). The PATCOM may be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Patrol Commander may be contacted on Channel 16 VHF–FM (156.8 MHz) by the call sign ‘‘PATCOM’’. (2) To seek permission to enter, contact the COTP or the COTP’s designated representative via VHF–FM Channel 16 or 502–779–5422. (3) Those in the security zone must comply with all lawful orders or directions given to them by the COTP or the COTP’s designated representative. (d) Informational broadcasts. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners (BNMs) of the enforcement period for the temporary security zone as well as any changes in the dates and times of enforcement. 40 CFR Part 180 [EPA–HQ–OPP–2017–0520; FRL–9979–94] Lignosulfonic Acid, Calcium, Comp. With 1,6 Hexanediamine Polymer With Guanidine Hydrochloride (1:1); Tolerance Exemption Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) number average molecular weight 4,500 to 7,000 when used as an inert ingredient in a pesticide chemical formulation. Acadia Regulatory Consulting on behalf of Lidan, 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 lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) on food or feed commodities. DATES: This regulation is effective August 24, 2018. Objections and SUMMARY: PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 requests for hearings must be received on or before October 23, 2018, 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: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2017–0520. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; 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. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to E:\FR\FM\24AUR1.SGM 24AUR1 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. sradovich on DSK3GMQ082PROD with RULES 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:// ecfr.gpoaccess.gov/cgi/t/text/textidx?&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 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–2017–0520 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 23, 2018. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2017–0520, by one of the following methods. • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The VerDate Sep<11>2014 00:53 Aug 24, 2018 Jkt 244001 Docket Facility telephone number is (703) 305–5805. II. Background and Statutory Findings In the Federal Register of March 21, 2018 (83 FR 12311) (FRL–9974–76), EPA issued a notification pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN–11005) filed by Acadia Regulatory Consulting, LLC (331 W King Road, Ithaca, NY 14850) on behalf of Lidan, Inc. (30 Wall Street, 8th Floor, New York, NY 10005). The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1); CAS Reg. No. 1905409–74–6 as a stabilizer and safener in pesticide formulations. That notification 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 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 42781 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). Lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) 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 a cationic polymer or it is reasonably anticipated to become a cationic polymer in natural aquatic environments; however, the polymer is a solid material that is not soluble or dispersible in water and will be used only in the solid phase and is not excluded from exemption by other factors. 2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur. 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. E:\FR\FM\24AUR1.SGM 24AUR1 42782 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES 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 does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6). Additionally, the polymer also meets as required the following exemption criteria: Specified in 40 CFR 723.250(e): The polymer’s number average MW of 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 and does not contain any reactive functional groups. Thus, lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) 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 lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1). IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational nondietary exposure was possible. The number average MW of lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) is 4,500 to 7,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) 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 VerDate Sep<11>2014 00:53 Aug 24, 2018 Jkt 244001 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 lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) to share a common mechanism of toxicity with any other substances, and lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) 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 http:// www.epa.gov/pesticides/cumulative. VI. Additional Safety Factor for the Protection of Infants and Children Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1), EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VII. 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 lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1). VIII. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 from the requirement of a tolerance without any numerical limitation. IX. Conclusion Accordingly, EPA finds that exempting residues of lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1) from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This final rule establishes a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these rules 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 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), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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 section 408(n)(4) of FFDCA. 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 E:\FR\FM\24AUR1.SGM 24AUR1 42783 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Rules and Regulations the Federal Government and Indian tribes, or otherwise have any unique impacts on local governments. 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) (Pub. L. 104–4). Although this action does not 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), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population. XI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this rule in the Federal Register. This rule 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: August 16, 2018. Michael Goodis, 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 § 180.960, the table is amended by adding alphabetically the following polymers to read as follows: ■ § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Polymer CAS No. * * * * * * Lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1), minimum number average molecular weight (in amu); 4,500 daltons ................................................................................................................................ * * * * 40 CFR Part 180 and Cosmetic Act (FFDCA), requesting establishment of an amended new use for an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of zinc oxide when used in accordance with the limitations of the exemption. [EPA–HQ–OPP–2017–0574; FRL–9978–36] DATES: [FR Doc. 2018–18407 Filed 8–23–18; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY Zinc Oxide; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation amends an exemption from the requirement of a tolerance for residues of zinc oxide (CAS Reg. No. 1314–13–2) when used as an inert ingredient in pesticide formulations applied to growing crops or raw agricultural commodities after harvest, to include use as a stabilizer, at a concentration not to exceed 15% by weight of the pesticide formulation. Nutrenare-AG, Inc. submitted a petition to EPA under the Federal Food, Drug, SUMMARY: sradovich on DSK3GMQ082PROD with RULES * VerDate Sep<11>2014 00:53 Aug 24, 2018 Jkt 244001 This regulation is effective August 24, 2018. Objections and requests for hearings must be received on or before October 23, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0574, 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., ADDRESSES: PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 * * 1905409–74–6 * 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. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, 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 E:\FR\FM\24AUR1.SGM 24AUR1

Agencies

[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Rules and Regulations]
[Pages 42780-42783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18407]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0520; FRL-9979-94]


Lignosulfonic Acid, Calcium, Comp. With 1,6 Hexanediamine Polymer 
With Guanidine Hydrochloride (1:1); Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of lignosulfonic acid, calcium, comp. with 
1,6 hexanediamine polymer with guanidine hydrochloride (1:1) number 
average molecular weight 4,500 to 7,000 when used as an inert 
ingredient in a pesticide chemical formulation. Acadia Regulatory 
Consulting on behalf of Lidan, 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 lignosulfonic acid, calcium, comp. with 1,6 hexanediamine 
polymer with guanidine hydrochloride (1:1) on food or feed commodities.

DATES: This regulation is effective August 24, 2018. Objections and 
requests for hearings must be received on or before October 23, 2018, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2017-0520. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; 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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to

[[Page 42781]]

certain entities. If you have any questions regarding the applicability 
of this action to a particular entity, consult the person listed under 
FOR FURTHER INFORMATION CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/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 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-2017-0520 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 23, 2018. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2017-0520, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S Crystal Dr., Arlington, VA. Deliveries are only accepted 
during the Docket Facility's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 21, 2018 (83 FR 12311) (FRL-9974-
76), EPA issued a notification pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11005) filed by Acadia Regulatory Consulting, LLC (331 W King Road, 
Ithaca, NY 14850) on behalf of Lidan, Inc. (30 Wall Street, 8th Floor, 
New York, NY 10005). The petition requested that 40 CFR 180.960 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of lignosulfonic acid, calcium, comp. with 1,6 
hexanediamine polymer with guanidine hydrochloride (1:1); CAS Reg. No. 
1905409-74-6 as a stabilizer and safener in pesticide formulations. 
That notification 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). Lignosulfonic acid, calcium, comp. with 
1,6 hexanediamine polymer with guanidine hydrochloride (1:1) 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 a cationic polymer or it is reasonably 
anticipated to become a cationic polymer in natural aquatic 
environments; however, the polymer is a solid material that is not 
soluble or dispersible in water and will be used only in the solid 
phase and is not excluded from exemption by other factors.
    2. The polymer does contain as an integral part of its composition 
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, 
silicon, and sulfur.
    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.

[[Page 42782]]

    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 does not contain certain perfluoroalkyl moieties 
consisting of a CF3- or longer chain length as listed in 40 CFR 
723.250(d)(6).
    Additionally, the polymer also meets as required the following 
exemption criteria: Specified in 40 CFR 723.250(e):
    The polymer's number average MW of 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 and does not contain any reactive functional 
groups.
    Thus, lignosulfonic acid, calcium, comp. with 1,6 hexanediamine 
polymer with guanidine hydrochloride (1:1) 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 
lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with 
guanidine hydrochloride (1:1).

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that lignosulfonic acid, calcium, comp. with 
1,6 hexanediamine polymer with guanidine hydrochloride (1:1) 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 lignosulfonic acid, calcium, comp. with 1,6 
hexanediamine polymer with guanidine hydrochloride (1:1) is 4,500 to 
7,000 daltons. Generally, a polymer of this size would be poorly 
absorbed through the intact gastrointestinal tract or through intact 
human skin. Since lignosulfonic acid, calcium, comp. with 1,6 
hexanediamine polymer with guanidine hydrochloride (1:1) 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 lignosulfonic acid, calcium, comp. with 1,6 
hexanediamine polymer with guanidine hydrochloride (1:1) to share a 
common mechanism of toxicity with any other substances, and 
lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with 
guanidine hydrochloride (1:1) does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that lignosulfonic acid, 
calcium, comp. with 1,6 hexanediamine polymer with guanidine 
hydrochloride (1:1) 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 http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base unless EPA concludes 
that a different margin of safety will be safe for infants and 
children. Due to the expected low toxicity of lignosulfonic acid, 
calcium, comp. with 1,6 hexanediamine polymer with guanidine 
hydrochloride (1:1), EPA has not used a safety factor analysis to 
assess the risk. For the same reasons the additional tenfold safety 
factor is unnecessary.

VII. 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 lignosulfonic acid, calcium, comp. 
with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1).

VIII. 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.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of lignosulfonic 
acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine 
hydrochloride (1:1) from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA in response to a petition submitted to the Agency. The 
Office of Management and Budget (OMB) has exempted these rules 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 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), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 
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 section 408(n)(4) of FFDCA. 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

[[Page 42783]]

the Federal Government and Indian tribes, or otherwise have any unique 
impacts on local governments. 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) (Pub. L. 
104-4).
    Although this action does not 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), EPA seeks to achieve 
environmental justice, the fair treatment and meaningful involvement of 
any group, including minority and/or low-income populations, in the 
development, implementation, and enforcement of environmental laws, 
regulations, and policies. As such, to the extent that information is 
publicly available or was submitted in comments to EPA, the Agency 
considered whether groups or segments of the population, as a result of 
their location, cultural practices, or other factors, may have atypical 
or disproportionately high and adverse human health impacts or 
environmental effects from exposure to the pesticide discussed in this 
document, compared to the general population.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this rule in the Federal 
Register. This rule 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: August 16, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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, the table is amended by adding alphabetically the 
following polymers to read as follows:


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

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
Lignosulfonic acid, calcium, comp. with 1,6                 1905409-74-6
 hexanediamine polymer with guanidine hydrochloride
 (1:1), minimum number average molecular weight (in
 amu); 4,500 daltons....................................
 
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. 2018-18407 Filed 8-23-18; 8:45 am]
 BILLING CODE 6560-50-P