83 FR 29014 - Oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 121 (June 22, 2018)
Federal Register Volume 83, Issue 121 (June 22, 2018)
| Page Range | 29014-29017 | |
| FR Document | 2018-13457 |
[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)] [Rules and Regulations] [Pages 29014-29017] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13457] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2018-0071; FRL-9978-08] Oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] ether; 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 oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether, number average molecular weight 1900 daltons; when used as an inert ingredient in a pesticide chemical formulation. SciReg, Inc. on behalf of Solvay USA 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 oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] ether on food or feed commodities. DATES: This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 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-2018-0071, 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 [[Page 29015]] 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: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government 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-2018-0071 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 August 21, 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-2018-0071, 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 April 11, 2018 (83 FR 15528) (FRL-9975- 57), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11112) filed by SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of Solvay USA Inc., 504 Carnegie Center Princeton, NJ 08540. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] ether (CAS Reg. No. 2112825-11-1). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. No relevant comments were received on 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 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 [[Page 29016]] 723.250(d). oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] 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 not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition 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 Toxic Substances Control Act (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 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 polymer's number average MW 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 contains only reactive functional groups listed in 40 CFR 723.250(e)(1)(ii)(A). Thus, oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] 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 oxirane, 2- methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] ether. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether 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 oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] ether is 1900 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] ether 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 oxirane, 2-methyl-, polymer with oxirane, mono[2- [2-(2-methoxymethylethoxy)methylethoxy]methylether] ether to share a common mechanism of toxicity with any other substances, and oxirane, 2- methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] 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 oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] 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 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 oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] 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 residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether. VIII. Other Considerations A. Existing Exemptions From a Tolerance There are no existing exemptions from a tolerance for oxirane, 2- methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] ether polymers. B. 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 oxirane, 2- methyl-, polymer with oxirane, mono[2-[2-(2- methoxymethylethoxy)methylethoxy]methylether] 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 [[Page 29017]] 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: June 8, 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, alphabetically add the following polymer to the table to read as follows: Sec. [emsp14]180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * Oxirane, 2-methyl-, polymer with oxirane, CAS Reg. No. 2112825-11-1. mono[2-[2-(2-methoxymethylethoxy) methylethoxy]methylether] ether, minimum number average molecular weight (in amu), 1400 daltons. * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2018-13457 Filed 6-21-18; 8:45 am] BILLING CODE 6560-50-P
![29014 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations
preparation, planting, cultivating, and perform hand-labor tasks on pesticide- Dated: June 13, 2018.
crop protecting services; and treated crops, such as harvesting, Charlotte Bertrand,
establishments or persons primarily thinning or pruning) and handlers Acting Principal Deputy Assistant
engaged in performing services on (those who mix, load and apply Administrator, Office of Chemical Safety and
crops, subsequent to their harvest, with pesticides). The 2015 revised WPS Pollution Prevention.
the intent of preparing them for market requirements retained many of the 1992 [FR Doc. 2018–13353 Filed 6–21–18; 8:45 am]
or further processing. WPS requirements, while increasing the BILLING CODE 6560–50–P
• Pesticide Handling on Farms stringency of some standards and
(NAICS code 115112), e.g., adding new requirements.
establishments or persons primarily ENVIRONMENTAL PROTECTION
engaged in performing a soil preparation III. Availability of Training Materials AGENCY
activity or crop production service, such and Deadline for Compliance With New
as seed bed preparation, planting, Training Requirements 40 CFR Part 180
cultivating, and crop protecting Sections 170.401 and 170.501 of the [EPA–HQ–OPP–2018–0071; FRL–9978–08]
services. 2015 revised WPS allowed employers to
• Farm Labor Contractors and Crew Oxirane, 2-methyl-, polymer with
omit certain topics from training
Leaders (NAICS code 115115), e.g., oxirane, mono[2-[2-(2-methoxy
materials until 180 days after EPA
establishments or persons primarily methylethoxy)methylethoxy]
publishes in the Federal Register a
engaged in supplying labor for methylether] ether; Tolerance
notification of availability of new WPS
agricultural production or harvesting. Exemption
• Pesticide Handling in Forestry training materials. EPA is announcing
(NAICS code 115310), e.g., the availability of new training materials AGENCY: Environmental Protection
establishments or persons primarily covering the expanded training content Agency (EPA).
providing support activities for forestry, for both workers and handlers. These
ACTION: Final rule.
such as forest pest control. materials, developed through a
• Pesticide Manufacturers (NAICS cooperative agreement with the SUMMARY: This regulation establishes an
code 325320), e.g., establishments Pesticide Education Resources exemption from the requirement of a
primarily engaged in the formulation Collaborative (PERC), are available at tolerance for residues of oxirane, 2-
and preparation of agricultural and http://pesticideresources.org/. These methyl-, polymer with oxirane, mono[2-
household pest control chemicals materials have been approved by EPA [2-(2-
(except fertilizers). and contain the content required by the methoxymethylethoxy)methylethoxy]
• Farm Worker Support 2015 revised WPS. There are also new methylether] ether, number average
Organizations (NAICS codes 813311, training materials developed by other molecular weight 1900 daltons; when
813312, and 813319), e.g., organizations that have been approved used as an inert ingredient in a pesticide
establishments or persons primarily by EPA and contain the content chemical formulation. SciReg, Inc. on
engaged in promoting causes associated required by the 2015 revised WPS; some behalf of Solvay USA Inc., submitted a
with human rights either for a broad or of these materials are available on the petition to EPA under the Federal Food,
specific constituency; establishments or PERC website and others are Drug, and Cosmetic Act (FFDCA),
persons primarily engaged in promoting proprietary. requesting an exemption from the
the preservation and protection of the EPA is currently reconsidering three requirement of a tolerance. This
environment and wildlife; and requirements of the 2015 revised WPS regulation eliminates the need to
establishments primarily engaged in and plans to solicit comments on establish a maximum permissible level
social advocacy. potential changes to the designated for residues of oxirane, 2-methyl-,
• Farm Worker Labor Organizations representative provision, the minimum polymer with oxirane, mono[2-[2-(2-
(NAICS code 813930), e.g., age for handlers and early-entry methoxymethylethoxy)
establishments or persons primarily workers, and the application exclusion methylethoxy]methylether] ether on
engaged in promoting the interests of zone. If those requirements are changed food or feed commodities.
organized labor and union employees. through a final rulemaking, training DATES: This regulation is effective June
• Crop Advisors (NAICS codes materials may need to be amended to 22, 2018. Objections and requests for
115112, 541690, 541712) e.g., reflect such changes. hearings must be received on or before
establishments or persons who August 21, 2018, and must be filed in
The publication of this notification of
primarily provide advice and assistance accordance with the instructions
availability of the training materials
to businesses and other organizations on provided in 40 CFR part 178 (see also
specified in 40 CFR 170.401(c)(3) and
scientific and technical issues related to Unit I.C. of the SUPPLEMENTARY
170.501(c)(3) commences the 180-day
pesticide use and pest pressure. INFORMATION).
period provided in those provisions. Per
II. Background §§ 170.401(c)(3) and 170.501(c)(3), WPS ADDRESSES: The docket for this action,
On November 2, 2015, EPA published training programs must include all of identified by docket identification (ID)
a final rule making changes to the WPS, the topics specified in number EPA–HQ–OPP–2018–0071, is
40 CFR part 170, referred to as the §§ 170.401(c)(3)(i)–(xxiii) and available at http://www.regulations.gov
‘‘2015 revised WPS’’ (80 FR 67496) 170.501(c)(3)(i)–(xiv) no later than or at the Office of Pesticide Programs
(FRL–9931–81). The WPS is a regulation December 19, 2018. Regulatory Public Docket (OPP Docket)
primarily intended to reduce the risks of in the Environmental Protection Agency
daltland on DSKBBV9HB2PROD with RULES
List of Subjects in 40 CFR Part 170
injury or illness resulting from Docket Center (EPA/DC), West William
agricultural workers’ and handlers’ use Environmental protection, Jefferson Clinton Bldg., Rm. 3334, 1301
of and contact with agricultural Agricultural worker, Employer, Farms, Constitution Ave. NW, Washington, DC
pesticides on farms, forests, nurseries Forests, Greenhouses, Nurseries, 20460–0001. The Public Reading Room
and greenhouses. The rule primarily Pesticide handler, Pesticides, Worker is open from 8:30 a.m. to 4:30 p.m.,
seeks to protect workers (those who protection standard. Monday through Friday, excluding legal
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![Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 29015
holidays. The telephone number for the and hearing requests are provided in 40 defines ‘‘safe’’ to mean that ‘‘there is a
Public Reading Room is (202) 566–1744, CFR 178.25(b). reasonable certainty that no harm will
and the telephone number for the OPP In addition to filing an objection or result from aggregate exposure to the
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk pesticide chemical residue, including
the visitor instructions and additional as described in 40 CFR part 178, please all anticipated dietary exposures and all
information about the docket available submit a copy of the filing (excluding other exposures for which there is
at http://www.epa.gov/dockets. any Confidential Business Information reliable information.’’ This includes
FOR FURTHER INFORMATION CONTACT:
(CBI)) for inclusion in the public docket. exposure through drinking water and
Michael Goodis, Registration Division Information not marked confidential use in residential settings, but does not
(7505P), Office of Pesticide Programs, pursuant to 40 CFR part 2 may be include occupational exposure. Section
Environmental Protection Agency, 1200 disclosed publicly by EPA without prior 408(b)(2)(C) of FFDCA requires EPA to
notice. Submit the non-CBI copy of your give special consideration to exposure
Pennsylvania Ave. NW, Washington, DC
objection or hearing request, identified of infants and children to the pesticide
20460–0001; main telephone number:
by docket ID number EPA–HQ–OPP– chemical residue in establishing an
(703) 305–7090; email address:
2018–0071, by one of the following exemption from the requirement of a
RDFRNotices@epa.gov.
methods. tolerance and to ‘‘ensure that there is a
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// reasonable certainty that no harm will
I. General Information www.regulations.gov. Follow the online result to infants and children from
instructions for submitting comments. aggregate exposure to the pesticide
A. Does this action apply to me? Do not submit electronically any chemical residue . . .’’ and specifies
You may be potentially affected by information you consider to be CBI or factors EPA is to consider in
this action if you are an agricultural other information whose disclosure is establishing an exemption.
producer, food manufacturer, or restricted by statute.
• Mail: OPP Docket, Environmental III. Risk Assessment and Statutory
pesticide manufacturer. The following Findings
list of North American Industrial Protection Agency Docket Center (EPA/
Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave. EPA establishes exemptions from the
not intended to be exhaustive, but rather NW, Washington, DC 20460–0001. requirement of a tolerance only in those
• Hand Delivery: To make special cases where it can be shown that the
provides a guide to help readers
arrangements for hand delivery or risks from aggregate exposure to
determine whether this document
delivery of boxed information, please pesticide chemical residues under
applies to them. Potentially affected
follow the instructions at http:// reasonably foreseeable circumstances
entities may include:
www.epa.gov/dockets/contacts.html. will pose no appreciable risks to human
• Crop production (NAICS code 111). Additional instructions on health. In order to determine the risks
• Animal production (NAICS code commenting or visiting the docket, from aggregate exposure to pesticide
112). along with more information about inert ingredients, the Agency considers
• Food manufacturing (NAICS code dockets generally, is available at http:// the toxicity of the inert in conjunction
311). www.epa.gov/dockets. with possible exposure to residues of
• Pesticide manufacturing (NAICS the inert ingredient through food,
code 32532). II. Background and Statutory Findings
drinking water, and through other
In the Federal Register of April 11, exposures that occur as a result of
B. How can I get electronic access to
2018 (83 FR 15528) (FRL–9975–57), pesticide use in residential settings. If
other related information?
EPA issued a document pursuant to EPA is able to determine that a finite
You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a, tolerance is not necessary to ensure that
electronic version of 40 CFR part 180 announcing the receipt of a pesticide there is a reasonable certainty that no
through the Government Printing petition (PP IN–11112) filed by SciReg, harm will result from aggregate
Office’s e-CFR site at http:// Inc., 12733 Director’s Loop, exposure to the inert ingredient, an
www.ecfr.gov/cgi-bin/text-idx?&c= Woodbridge, VA 22192 on behalf of exemption from the requirement of a
ecfr&tpl=/ecfrbrowse/Title40/40tab_ Solvay USA Inc., 504 Carnegie Center tolerance may be established.
02.tpl. Princeton, NJ 08540. The petition Consistent with FFDCA section
requested that 40 CFR 180.960 be 408(b)(2)(D), EPA has reviewed the
C. Can I file an objection or hearing
amended by establishing an exemption available scientific data and other
request?
from the requirement of a tolerance for relevant information in support of this
Under FFDCA section 408(g), 21 residues of oxirane, 2-methyl-, polymer action and considered its validity,
U.S.C. 346a, any person may file an with oxirane, mono[2-[2-(2- completeness and reliability and the
objection to any aspect of this regulation methoxymethylethoxy)methylethoxy] relationship of this information to
and may also request a hearing on those methylether] ether (CAS Reg. No. human risk. EPA has also considered
objections. You must file your objection 2112825–11–1). That document available information concerning the
or request a hearing on this regulation included a summary of the petition variability of the sensitivities of major
in accordance with the instructions prepared by the petitioner and solicited identifiable subgroups of consumers,
provided in 40 CFR part 178. To ensure comments on the petitioner’s request. including infants and children. In the
proper receipt by EPA, you must No relevant comments were received on case of certain chemical substances that
identify docket ID number EPA–HQ– the notice of filing. are defined as polymers, the Agency has
OPP–2018–0071 in the subject line on Section 408(c)(2)(A)(i) of FFDCA established a set of criteria to identify
daltland on DSKBBV9HB2PROD with RULES
the first page of your submission. All allows EPA to establish an exemption categories of polymers expected to
objections and requests for a hearing from the requirement for a tolerance (the present minimal or no risk. The
must be in writing, and must be legal limit for a pesticide chemical definition of a polymer is given in 40
received by the Hearing Clerk on or residue in or on a food) only if EPA CFR 723.250(b) and the exclusion
before August 21, 2018. Addresses for determines that the exemption is ‘‘safe.’’ criteria for identifying these low-risk
mail and hand delivery of objections Section 408(c)(2)(A)(ii) of FFDCA polymers are described in 40 CFR
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![29016 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations
723.250(d). oxirane, 2-methyl-, polymer IV. Aggregate Exposures chemicals, see EPA’s website at http://
with oxirane, mono[2-[2-(2- www.epa.gov/pesticides/cumulative.
methoxymethylethoxy)methylethoxy] For the purposes of assessing
potential exposure under this VI. Additional Safety Factor for the
methylether] ether conforms to the Protection of Infants and Children
definition of a polymer given in 40 CFR exemption, EPA considered that
723.250(b) and meets the following oxirane, 2-methyl-, polymer with Section 408(b)(2)(C) of FFDCA
criteria that are used to identify low-risk oxirane, mono[2-[2-(2- provides that EPA shall apply an
polymers. methoxymethylethoxy) additional tenfold margin of safety for
1. The polymer is not a cationic methylethoxy]methylether] ether could infants and children in the case of
polymer nor is it reasonably anticipated be present in all raw and processed threshold effects to account for prenatal
to become a cationic polymer in a agricultural commodities and drinking and postnatal toxicity and the
natural aquatic environment. water, and that non-occupational non- completeness of the data base unless
2. The polymer does contain as an dietary exposure was possible. The EPA concludes that a different margin of
integral part of its composition at least number average MW of oxirane, 2- safety will be safe for infants and
two of the atomic elements carbon, methyl-, polymer with oxirane, mono[2- children. Due to the expected low
hydrogen, nitrogen, oxygen, silicon, and [2-(2-methoxymethylethoxy) toxicity of oxirane, 2-methyl-, polymer
sulfur. methylethoxy]methylether] ether is with oxirane, mono[2-[2-(2-
3. The polymer does not contain as an 1900 daltons. Generally, a polymer of methoxymethylethoxy)
integral part of its composition, except this size would be poorly absorbed methylethoxy]methylether] ether, EPA
as impurities, any element other than through the intact gastrointestinal tract has not used a safety factor analysis to
those listed in 40 CFR 723.250(d)(2)(ii). or through intact human skin. Since assess the risk. For the same reasons the
4. The polymer is neither designed oxirane, 2-methyl-, polymer with additional tenfold safety factor is
nor can it be reasonably anticipated to oxirane, mono[2-[2-(2- unnecessary.
substantially degrade, decompose, or methoxymethylethoxy)
VII. Determination of Safety
depolymerize. methylethoxy]methylether] ether
conform to the criteria that identify a Based on the conformance to the
5. The polymer is manufactured or criteria used to identify a low-risk
imported from monomers and/or low-risk polymer, there are no concerns
for risks associated with any potential polymer, EPA concludes that there is a
reactants that are already included on reasonable certainty of no harm to the
the Toxic Substances Control Act exposure scenarios that are reasonably
foreseeable. The Agency has determined U.S. population, including infants and
(TSCA) Chemical Substance Inventory children, from aggregate exposure to
or manufactured under an applicable that a tolerance is not necessary to
protect the public health. residues of oxirane, 2-methyl-, polymer
TSCA section 5 exemption. with oxirane, mono[2-[2-(2-
6. The polymer is not a water V. Cumulative Effects From Substances methoxymethylethoxy)
absorbing polymer with a number With a Common Mechanism of Toxicity methylethoxy]methylether] ether.
average molecular weight (MW) greater
than or equal to 10,000 daltons. Section 408(b)(2)(D)(v) of FFDCA VIII. Other Considerations
Additionally, the polymer also meets requires that, when considering whether
to establish, modify, or revoke a A. Existing Exemptions From a
as required the following exemption Tolerance
criteria specified in 40 CFR 723.250(e). tolerance, the Agency consider
7. The polymer does not contain ‘‘available information’’ concerning the There are no existing exemptions
certain perfluoroalkyl moieties cumulative effects of a particular from a tolerance for oxirane,
consisting of a CF3- or longer chain pesticide’s residues and ‘‘other 2-methyl-, polymer with oxirane,
length as listed in 40 CFR 723.250(d)(6) substances that have a common mono[2-[2-(2-methoxymethylethoxy)
Additionally, the polymer also meets mechanism of toxicity.’’ methylethoxy]methylether] ether
as required the following exemption EPA has not found oxirane, polymers.
criteria: Specified in 40 CFR 723.250(e): 2-methyl-, polymer with oxirane, B. Analytical Enforcement Methodology
The polymer’s number average MW of mono[2-[2-(2- An analytical method is not required
polymer’s number average MW is methoxymethylethoxy)methylethoxy] for enforcement purposes since the
greater than 1,000 and less than 10,000 methylether] ether to share a common Agency is establishing an exemption
daltons. The polymer contains less than mechanism of toxicity with any other from the requirement of a tolerance
10% oligomeric material below MW 500 substances, and oxirane, 2-methyl-, without any numerical limitation.
and less than 25% oligomeric material polymer with oxirane, mono[2-[2-(2-
below MW 1,000, and the polymer methoxymethylethoxy) IX. Conclusion
contains only reactive functional groups methylethoxy]methylether] ether does Accordingly, EPA finds that
listed in 40 CFR 723.250(e)(1)(ii)(A). not appear to produce a toxic metabolite exempting residues of oxirane, 2-
Thus, oxirane, 2-methyl-, polymer produced by other substances. For the methyl-, polymer with oxirane, mono[2-
with oxirane, mono[2-[2-(2- purposes of this tolerance action, [2-(2-methoxymethylethoxy)
methoxymethylethoxy)methylethoxy] therefore, EPA has assumed that methylethoxy]methylether] ether from
methylether] ether meets the criteria for oxirane, 2-methyl-, polymer with the requirement of a tolerance will be
a polymer to be considered low risk oxirane, mono[2-[2-(2- safe.
under 40 CFR 723.250. Based on its methoxymethylethoxy)methylethoxy]
conformance to the criteria in this unit, methylether] ether does not have a X. Statutory and Executive Order
daltland on DSKBBV9HB2PROD with RULES
no mammalian toxicity is anticipated common mechanism of toxicity with Reviews
from dietary, inhalation, or dermal other substances. For information This action establishes a tolerance
exposure to oxirane, 2-methyl-, polymer regarding EPA’s efforts to determine under FFDCA section 408(d) in
with oxirane, mono[2-[2-(2- which chemicals have a common response to a petition submitted to the
methoxymethylethoxy) mechanism of toxicity and to evaluate Agency. The Office of Management and
methylethoxy]methylether] ether. the cumulative effects of such Budget (OMB) has exempted these types
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![Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 29017
of actions from review under Executive this action alter the relationships or submit a report containing this rule and
Order 12866, entitled ‘‘Regulatory distribution of power and other required information to the U.S.
Planning and Review’’ (58 FR 51735, responsibilities established by Congress Senate, the U.S. House of
October 4, 1993). Because this action in the preemption provisions of FFDCA Representatives, and the Comptroller
has been exempted from review under section 408(n)(4). As such, the Agency General of the United States prior to
Executive Order 12866, this action is has determined that this action will not publication of the rule in the Federal
not subject to Executive Order 13211, have a substantial direct effect on States Register. This action is not a ‘‘major
entitled ‘‘Actions Concerning or tribal governments, on the rule’’ as defined by 5 U.S.C. 804(2).
Regulations That Significantly Affect relationship between the national
Energy Supply, Distribution, or Use’’ (66 government and the States or tribal List of Subjects in 40 CFR Part 180
FR 28355, May 22, 2001) or Executive governments, or on the distribution of
Order 13045, entitled ‘‘Protection of power and responsibilities among the Environmental protection,
Children from Environmental Health various levels of government or between Administrative practice and procedure,
Risks and Safety Risks’’ (62 FR 19885, the Federal Government and Indian Agricultural commodities, Pesticides
April 23, 1997). This action does not tribes. Thus, the Agency has determined and pests, Reporting and recordkeeping
contain any information collections that Executive Order 13132, entitled requirements.
subject to OMB approval under the ‘‘Federalism’’ (64 FR 43255, August 10, Dated: June 8, 2018.
Paperwork Reduction Act (PRA) (44 1999) and Executive Order 13175,
Michael Goodis,
U.S.C. 3501 et seq.), nor does it require entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR Director, Registration Division, Office of
any special considerations under Pesticide Programs.
Executive Order 12898, entitled 67249, November 9, 2000) do not apply
‘‘Federal Actions to Address to this action. In addition, this action Therefore, 40 CFR chapter I is
Environmental Justice in Minority does not impose any enforceable duty or amended as follows:
Populations and Low-Income contain any unfunded mandate as
Populations’’ (59 FR 7629, February 16, described under Title II of the Unfunded PART 180—[AMENDED]
1994). Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.). 1. The authority citation for part 180
Since tolerances and exemptions that ■
This action does not involve any
are established on the basis of a petition technical standards that would require continues to read as follows:
under FFDCA section 408(d), such as Agency consideration of voluntary Authority: 21 U.S.C. 321(q), 346a and 371.
the tolerance in this final rule, do not consensus standards pursuant to section
require the issuance of a proposed rule, ■ 2. In § 180.960, alphabetically add the
12(d) of the National Technology
the requirements of the Regulatory Transfer and Advancement Act following polymer to the table to read as
Flexibility Act (RFA) (5 U.S.C. 601 et (NTTAA) (15 U.S.C. 272 note). follows:
seq.), do not apply.
XI. Congressional Review Act § 180.960 Polymers; exemptions from the
This action directly regulates growers, requirement of a tolerance.
food processors, food handlers, and food Pursuant to the Congressional Review
retailers, not States or tribes, nor does Act (5 U.S.C. 801 et seq.), EPA will * * * * *
Polymer CAS No.
* * * * * * *
Oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy) methylethoxy]methylether] CAS Reg. No. 2112825–11–1.
ether, minimum number average molecular weight (in amu), 1400 daltons.
* * * * * * *
[FR Doc. 2018–13457 Filed 6–21–18; 8:45 am] requested these tolerances under the Jefferson Clinton Bldg., Rm. 3334, 1301
BILLING CODE 6560–50–P Federal Food, Drug, and Cosmetic Act Constitution Ave. NW, Washington, DC
(FFDCA). 20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
ENVIRONMENTAL PROTECTION DATES: This regulation is effective June Monday through Friday, excluding legal
AGENCY 22, 2018. Objections and requests for holidays. The telephone number for the
hearings must be received on or before Public Reading Room is (202) 566–1744,
40 CFR Part 180 August 21, 2018, and must be filed in and the telephone number for the OPP
accordance with the instructions Docket is (703) 305–5805. Please review
[EPA–HQ–OPP–2017–0156; FRL–9976–21]
provided in 40 CFR part 178 (see also the visitor instructions and additional
Tolfenpyrad; Pesticide Tolerances Unit I.C. of the SUPPLEMENTARY information about the docket available
INFORMATION). at http://www.epa.gov/dockets.
AGENCY: Environmental Protection
Agency (EPA). ADDRESSES: The docket for this action, FOR FURTHER INFORMATION CONTACT:
identified by docket identification (ID) Michael Goodis, Registration Division
daltland on DSKBBV9HB2PROD with RULES
ACTION: Final rule.
number EPA–HQ–OPP–2017–0156, is (7505P), Office of Pesticide Programs,
SUMMARY: This regulation establishes available at http://www.regulations.gov Environmental Protection Agency, 1200
tolerances for residues of tolfenpyrad in or at the Office of Pesticide Programs Pennsylvania Ave. NW, Washington, DC
or on multiple commodities which are Regulatory Public Docket (OPP Docket) 20460–0001; main telephone number:
identified and discussed later in this in the Environmental Protection Agency (703) 305–7090; email address:
document. Nichino America, Inc. Docket Center (EPA/DC), West William RDFRNotices@epa.gov.
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Document Created: 2018-11-06 09:51:07
Document Modified: 2018-11-06 09:51:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 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). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone | |
| FR Citation | 83 FR 29014 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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