Formaldehyde, Polymer With 1,3-Benzenediol, Ethers With Polyethylene Glycol Mono-Me Ether; Exemption From the Requirement of a Tolerance, 51355-51358 [2017-24111]

Download as PDF Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2017–0363; FRL–9970–00] Formaldehyde, Polymer With 1,3Benzenediol, Ethers With Polyethylene Glycol Mono-Me Ether; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether (CAS Reg. No. 1998118–32–3) when used as an inert ingredient in a pesticide chemical formulation. Eco Verde Technologies, 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 formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether on food or feed commodities. DATES: This regulation is effective November 6, 2017. Objections and requests for hearings must be received on or before January 5, 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: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0363, 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. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone Pmangrum on DSK3GDR082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:35 Nov 03, 2017 Jkt 244001 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). 51355 2017–0363, 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. B. How can I get electronic access to other related information? II. Background and Statutory Findings 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl In the Federal Register of September 15, 2017 (82 FR 43352; FRL–9965–43), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP) IN–11042 filed by Eco Verde Technologies, Inc., 400 NW. 172nd Avenue, Pembroke Pines, FL. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether (CAS Reg. No. 1998118–32–3). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner’s request. There were no comments received in response to the notice of filing. 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 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–2017–0363 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 January 5, 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 (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– PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\06NOR1.SGM 06NOR1 51356 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations 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. Pmangrum on DSK3GDR082PROD with RULES 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). Formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether 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 or potentially cationic polymer with low cationic density (the percent of cationic or potentially cationic species with VerDate Sep<11>2014 14:44 Nov 03, 2017 Jkt 244001 respect to the overall weight of polymer). 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer’s minimum number average MW of 1,000,000 daltons is greater than 1,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether 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 formaldehyde, polymer with 1,3benzenediol, ethers with polyethylene glycol mono-Me ether. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that formaldehyde, polymer with 1,3benzenediol, ethers with polyethylene glycol mono-Me ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether is 1,000,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 ether conforms 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 formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether to share a common mechanism of toxicity with any other substances, and formaldehyde, polymer with 1,3benzenediol, ethers with polyethylene glycol mono-Me ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether 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 Web site 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 formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether, 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 E:\FR\FM\06NOR1.SGM 06NOR1 51357 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether. 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. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for formaldehyde, polymer with 1,3benzenediol, ethers with polyethylene glycol mono-Me ether. IX. Conclusion Accordingly, EPA finds that exempting residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). XI. 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: October 20, 2017. 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, alphabetically add the polymer to the table to read as follows: ■ § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Pmangrum on DSK3GDR082PROD with RULES Polymer CAS No. * * * * * * Formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether, minimum number average molecular weight (in amu) 1,000,000 ........................................................................................................................................................ * VerDate Sep<11>2014 * 14:44 Nov 03, 2017 * Jkt 244001 PO 00000 * Frm 00025 Fmt 4700 * Sfmt 4700 E:\FR\FM\06NOR1.SGM * 06NOR1 * 1998118–32–3 * 51358 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Rules and Regulations [FR Doc. 2017–24111 Filed 11–3–17; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF LABOR Office of the Secretary 48 CFR Parts 22 and 52 ZRIN 1290–ZA02 Guidance for Executive Order 13673, ‘‘Fair Pay and Safe Workplaces’’ Department of Labor. ACTION: Final guidance; rescission. AGENCY: Under the Congressional Review Act, Congress has passed, and the President has signed, Public Law 115–11, a resolution of disapproval of the rule promulgated by the Department of Defense, General Services Administration, and National Aeronautics and Space Administration to implement Executive Order 13673, Fair Pay and Safe Workplaces, as amended (the ‘‘Order’’). Additionally, the President has issued an Executive Order revoking the Order, and directing all executive departments and agencies, as appropriate and to the extent consistent with law, to consider promptly rescinding any orders, rules, regulations, guidance, guidelines, or policies implementing or enforcing the Order. Accordingly, the Department of Labor is rescinding its guidance on the Order, published on August 25, 2016. DATES: Effective November 6, 2017. FOR FURTHER INFORMATION CONTACT: Stephanie Swirsky, Deputy Assistant Secretary for Policy, U.S. Department of Labor, Room S–2312, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693–5959 (this is not a toll-free number). Copies of this notice may be obtained in alternative formats (large print, Braille, audio tape or disc), upon request, by calling (202) 693–5959 (this is not a toll-free number). TTY/ TDD callers may dial toll-free [1–877– 889–5627] to obtain information or request materials in alternative formats. SUPPLEMENTARY INFORMATION: On July 31, 2014, President Barack Obama issued Executive Order 13673, Fair Pay and Safe Workplaces. 79 FR 45309. Executive Order 13673 was amended twice, first by section 3 of Executive Order 13683 on December 11, 2014, 79 FR 75041, and again by Executive Order 13738 on August 23, 2016, 81 FR 58807. The Order directed the Federal Acquisition Regulatory Council (‘‘FAR Council’’) to amend its regulations consistent with the Order’s requirements, and directed the Secretary Pmangrum on DSK3GDR082PROD with RULES SUMMARY: VerDate Sep<11>2014 14:44 Nov 03, 2017 Jkt 244001 of Labor (‘‘Secretary’’) to develop guidance to assist agencies in implementing the Order. After notice and comment, the final rule and guidance were published on August 25, 2016. 81 FR 58562 (FAR Council’s rule); 81 FR 58654 (Secretary’s guidance). On October 24, 2016, the United States District Court for the Eastern District of Texas issued a preliminary injunction partially enjoining the FAR Council’s rule and the Secretary’s guidance. See Associated Builders & Contractors of Se. Texas v. Rung, No. 1:16–CV–425, 2016 WL 8188655 (E.D. Tex. Oct. 24, 2016). On October 25, 2016, the FAR Council issued a memorandum directing that all steps necessary be taken to ensure that the enjoined provisions of the rule would not be implemented while the injunction was in force. On December 16, 2016, the Department of Defense, General Services Administration, and National Aeronautics and Space Administration, on behalf of the FAR Council, amended the FAR Council’s rule to conform to the district court’s injunction. 81 FR 91636. On March 27, 2017, President Donald Trump signed Public Law 115–11, a resolution of disapproval of the FAR Council’s rule under the Congressional Review Act, 5 U.S.C. 801 et seq. The resolution had previously passed the House of Representatives on February 2, 2017 and the Senate on March 6, 2017. See 163 Cong. Rec. S1601 (daily ed. Mar. 6, 2017); 163 Cong. Rec. H907 (daily ed. Feb. 2, 2017). Under the Congressional Review Act, a rule shall not take effect or continue if a joint resolution of disapproval of the rule is enacted. 5 U.S.C. 801(b)(1). Additionally, on March 27, 2017, President Trump issued Executive Order 13782, revoking Executive Order 13673, section 3 of Executive Order 13683, and Executive Order 13738, and directing all executive departments and agencies, ‘‘as appropriate and to the extent consistent with law, [to] consider promptly rescinding any orders, rules, regulations, guidance, guidelines, or policies implementing or enforcing the revoked Executive Orders and revoked provision[.]’’ 82 FR 15607. Accordingly, the Secretary is hereby rescinding the guidance on Fair Pay and Safe Workplaces, published on August 25, 2016. In a separate entry published in today’s Federal Register, the Department of Defense, General Services Administration, and National Aeronautics and Space Administration, on behalf of the FAR Council, are rescinding the FAR Council’s rule. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 Signed this 13th day of October, 2017. R. Alexander Acosta, Secretary, U.S. Department of Labor. [FR Doc. 2017–23588 Filed 11–3–17; 8:45 am] BILLING CODE 4510–HL–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 20 [Docket No. FWS–HQ–MB–2015–0073; FF09M21200–178–FXMB1231099BPP0] RIN 1018–BB06 Migratory Bird Hunting; Approval of Corrosion-Inhibited Copper Shot as Nontoxic for Waterfowl Hunting Fish and Wildlife Service, Interior. ACTION: Final rule. AGENCY: Having completed our review of the application materials for corrosion-inhibited copper shot, the U.S. Fish and Wildlife Service (hereinafter Service or we) approves the shot for hunting waterfowl and coots. We have concluded that this type of shot left in terrestrial or aquatic environments is unlikely to adversely affect fish, wildlife, or their habitats. Approving this shot formulation would increase the nontoxic shot options for hunters. SUMMARY: This rule is effective on November 6, 2017. ADDRESSES: You can view the final environmental assessment by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Search for Docket No. FWS–HQ–MB–2015–0073. • Request a copy by contacting the person listed under FOR FURTHER INFORMATION CONTACT. FOR FURTHER INFORMATION CONTACT: Ron Kokel, Division of Migratory Bird Management, at 703–358–1967; ronald_ kokel@fws.gov. SUPPLEMENTARY INFORMATION: DATES: Background The Migratory Bird Treaty Act of 1918 (Act) (16 U.S.C. 703–712 and 16 U.S.C. 742 a–j) implements migratory bird treaties between the United States and Great Britain for Canada (1916 and 1996, as amended), Mexico (1936 and 1972, as amended), Japan (1972 and 1974, as amended), and Russia (then the Soviet Union, 1978). These treaties protect most migratory bird species from take, except as permitted under the Act, which authorizes the Secretary of the E:\FR\FM\06NOR1.SGM 06NOR1

Agencies

[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Rules and Regulations]
[Pages 51355-51358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24111]



[[Page 51355]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0363; FRL-9970-00]


Formaldehyde, Polymer With 1,3-Benzenediol, Ethers With 
Polyethylene Glycol Mono-Me Ether; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of formaldehyde, polymer with 1,3-
benzenediol, ethers with polyethylene glycol mono-Me ether (CAS Reg. 
No. 1998118-32-3) when used as an inert ingredient in a pesticide 
chemical formulation. Eco Verde Technologies, 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 formaldehyde, polymer with 1,3-benzenediol, ethers with 
polyethylene glycol mono-Me ether on food or feed commodities.

DATES: This regulation is effective November 6, 2017. Objections and 
requests for hearings must be received on or before January 5, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0363, 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. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael 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 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. 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-2017-0363 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 
January 5, 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 (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-2017-0363, 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. Background and Statutory Findings

    In the Federal Register of September 15, 2017 (82 FR 43352; FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the receipt of a pesticide petition (PP) IN-
11042 filed by Eco Verde Technologies, Inc., 400 NW. 172nd Avenue, 
Pembroke Pines, FL. The petition requested that 40 CFR 180.960 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of formaldehyde, polymer with 1,3-benzenediol, 
ethers with polyethylene glycol mono-Me ether (CAS Reg. No. 1998118-32-
3). That document included a summary of the petition prepared by the 
petitioner and solicited comments on the petitioner's request. There 
were no comments received in response to the notice of filing.
    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

[[Page 51356]]

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). Formaldehyde, polymer with 1,3-
benzenediol, ethers with polyethylene glycol mono-Me ether 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 or potentially cationic polymer with 
low cationic density (the percent of cationic or potentially cationic 
species with respect to the overall weight of polymer).
    2. The polymer does contain as an integral part of its composition 
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or 
reactants that are already included on the TSCA Chemical Substance 
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's minimum number average MW of 1,000,000 daltons is 
greater than 1,000 daltons. The polymer contains less than 2% 
oligomeric material below MW 500 and less than 5% oligomeric material 
below MW 1,000, and the polymer does not contain any reactive 
functional groups.
    Thus, formaldehyde, polymer with 1,3-benzenediol, ethers with 
polyethylene glycol mono-Me ether 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 formaldehyde, polymer with 
1,3-benzenediol, ethers with polyethylene glycol mono-Me ether.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that formaldehyde, polymer with 1,3-
benzenediol, ethers with polyethylene glycol mono-Me ether could be 
present in all raw and processed agricultural commodities and drinking 
water, and that non-occupational non-dietary exposure was possible. The 
minimum number average MW of formaldehyde, polymer with 1,3-
benzenediol, ethers with polyethylene glycol mono-Me ether is 1,000,000 
daltons. Generally, a polymer of this size would be poorly absorbed 
through the intact gastrointestinal tract or through intact human skin. 
Since formaldehyde, polymer with 1,3-benzenediol, ethers with 
polyethylene glycol mono-Me ether conforms 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 formaldehyde, polymer with 1,3-benzenediol, 
ethers with polyethylene glycol mono-Me ether to share a common 
mechanism of toxicity with any other substances, and formaldehyde, 
polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me 
ether does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that formaldehyde, polymer with 1,3-benzenediol, ethers 
with polyethylene glycol mono-Me ether 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 Web site 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 formaldehyde, polymer 
with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether, 
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

[[Page 51357]]

residues of formaldehyde, polymer with 1,3-benzenediol, ethers with 
polyethylene glycol mono-Me ether.

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.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for formaldehyde, polymer with 
1,3-benzenediol, ethers with polyethylene glycol mono-Me ether.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of formaldehyde, 
polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me 
ether from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

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

XI. 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: October 20, 2017.
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, alphabetically add the polymer to the table to 
read as follows:


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

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
Formaldehyde, polymer with 1,3-benzenediol, ethers with     1998118-32-3
 polyethylene glycol mono-Me ether, minimum number
 average molecular weight (in amu) 1,000,000............
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 51358]]

[FR Doc. 2017-24111 Filed 11-3-17; 8:45 am]
 BILLING CODE 6560-50-P