83 FR 62486 - 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 233 (December 4, 2018)
Federal Register Volume 83, Issue 233 (December 4, 2018)
| Page Range | 62486-62489 | |
| FR Document | 2018-26347 |
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)] [Rules and Regulations] [Pages 62486-62489] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26347] [[Page 62486]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2018-0290; FRL-9985-99] 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-Propanesulfonic acid, 2-methyl-2-[(1- oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer; 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 1-propanesulfonic acid, 2-methyl-2-[(1- oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt (CAS Reg. No. 55141-01-0), and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- y1)amino]-, sodium salt (1:1), homopolymer (CAS Reg. No. 35641-59-9); when used as inert ingredients in a pesticide chemical formulation. BASF Corporation 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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt) and 1-propanesulfonic acid, 2-methyl-2[(1oxo-2propen-1-y1)amino]- , sodium salt (1:1), homopolymer on food or feed commodities. DATES: This regulation is effective December 4, 2018. Objections and requests for hearings must be received on or before February 4, 2019, 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-2018-0290, 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: [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-2018-0290 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 February 4, 2019. 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-2018-0290, 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 June 14, 2018 (83 FR 27743) (FRL-9978- 41), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11148) filed by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 277709-3528. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo- 2-propen-1-y1)amino]-, homopolymer, sodium salt (CAS Reg. No. 55141-01- 0), and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- y1)amino]-, sodium salt (1:1), homopolymer (CAS Reg. Reg. No. 35641-59- 9). 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 filling. 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 [[Page 62487]] result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . '' and specifies factors EPA is to consider in establishing an exemption. III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 1-Propanesulfonic acid, 2-methyl-2-[(1- oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1- propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer both conform to the definition of a polymer given in 40 CFR 723.250(b) and meet 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 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. 7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF 3- 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). 8. The polymer's number average MW of 14,000 is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. Thus, 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2- methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer meet the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on their conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2- methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 1-propanesulfonic acid, 2-methyl-2-[(1- oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1- propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer 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 1- propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1- oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer are greater than 14,000 daltons. Generally, polymers of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2- methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer 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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2- propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer to share a common mechanism of toxicity with any other substances, and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2- methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2- methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer do not have a common mechanism of toxicity with [[Page 62488]] 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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer, 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 1-propanesulfonic acid, 2-methyl-2- [(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1- propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer. 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 1-propanesulfonic acid, 2- methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt or 1- propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1-y1)amino]-, sodium salt (1:1), homopolymer. IX. Conclusion Accordingly, EPA finds that exempting residues of 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2propen-1- y1)amino]-, sodium salt (1:1), homopolymer 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: November 14, 2018. Donna Davis, Acting 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 polymers in the table to read as follows: [[Page 62489]] Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- 55141-01-0 y1)amino]-, homopolymer, sodium salt, minimum number average molecular weight (in amu) 14,000............... * * * * * * * 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1- 35641-59-9 y1)amino]-, sodium salt (1:1), homopolymer, minimum number average molecular weight (in amu) 14,000........ * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2018-26347 Filed 12-3-18; 8:45 am] BILLING CODE 6560-50-P
![62486 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Rules and Regulations
ENVIRONMENTAL PROTECTION Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
AGENCY the visitor instructions and additional submit a copy of the filing (excluding
information about the docket available any Confidential Business Information
40 CFR Part 180 at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
FOR FURTHER INFORMATION CONTACT: Information not marked confidential
[EPA–HQ–OPP–2018–0290; FRL–9985–99]
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be
1-Propanesulfonic acid, 2-methyl-2-[(1- (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
oxo-2-propen-1-y1)amino]-, Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
homopolymer, sodium salt and 1- Pennsylvania Ave., NW, Washington, objection or hearing request, identified
Propanesulfonic acid, 2-methyl-2-[(1- DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
oxo-2-propen-1-y1)amino]-, sodium number: (703) 305–7090; email address: 2018–0290, by one of the following
salt (1:1), homopolymer; Tolerance RDFRNotices@epa.gov. methods.
• Federal eRulemaking Portal: http://
Exemption SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
AGENCY: Environmental Protection I. General Information instructions for submitting comments.
Agency (EPA). Do not submit electronically any
A. Does this action apply to me?
ACTION: Final rule. information you consider to be CBI or
You may be potentially affected by other information whose disclosure is
SUMMARY: This regulation establishes an this action if you are an agricultural restricted by statute.
exemption from the requirement of a producer, food manufacturer, or • Mail: OPP Docket, Environmental
tolerance for residues of 1- pesticide manufacturer. The following Protection Agency Docket Center (EPA/
propanesulfonic acid, 2-methyl-2-[(1- list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
oxo-2-propen-1-y1)amino]-, Classification System (NAICS) codes is NW, Washington, DC 20460–0001.
homopolymer, sodium salt (CAS Reg. not intended to be exhaustive, but rather • Hand Delivery: To make special
No. 55141–01–0), and 1- provides a guide to help readers arrangements for hand delivery or
propanesulfonic acid, 2-methyl-2-[(1- determine whether this document delivery of boxed information, please
oxo-2-propen-1-y1)amino]-, sodium salt applies to them. Potentially affected follow the instructions at http://
(1:1), homopolymer (CAS Reg. No. entities may include: www.epa.gov/dockets/contacts.html.
35641–59–9); when used as inert • Crop production (NAICS code 111). Additional instructions on
ingredients in a pesticide chemical • Animal production (NAICS code commenting or visiting the docket,
formulation. BASF Corporation 112). along with more information about
submitted a petition to EPA under the • Food manufacturing (NAICS code dockets generally, is available at http://
Federal Food, Drug, and Cosmetic Act 311). www.epa.gov/dockets.
(FFDCA), requesting an exemption from • Pesticide manufacturing (NAICS
II. Background and Statutory Findings
the requirement of a tolerance. This code 32532).
regulation eliminates the need to In the Federal Register of June 14,
B. How can I get electronic access to 2018 (83 FR 27743) (FRL–9978–41),
establish a maximum permissible level other related information?
for residues of 1-propanesulfonic acid, EPA issued a document pursuant to
2-methyl-2-[(1-oxo-2-propen-1- You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
y1)amino]-, homopolymer, sodium salt) electronic version of 40 CFR part 180 announcing the receipt of a pesticide
and 1-propanesulfonic acid, 2-methyl- through the Government Printing petition (PP IN–11148) filed by BASF
2[(1oxo-2propen-1-y1)amino]-, sodium Office’s e-CFR site at http:// Corporation, 26 Davis Drive, P.O. Box
salt (1:1), homopolymer on food or feed www.ecfr.gov/cgi-bin/text- 13528, Research Triangle Park, NC
commodities. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 277709–3528. The petition requested
40tab_02.tpl. that 40 CFR 180.960 be amended by
DATES: This regulation is effective establishing an exemption from the
December 4, 2018. Objections and C. Can I file an objection or hearing
requirement of a tolerance for residues
requests for hearings must be received request?
of 1-propanesulfonic acid, 2-methyl-2-
on or before February 4, 2019, and must Under FFDCA section 408(g), 21 [(1-oxo-2-propen-1-y1)amino]-,
be filed in accordance with the U.S.C. 346a, any person may file an homopolymer, sodium salt (CAS Reg.
instructions provided in 40 CFR part objection to any aspect of this regulation No. 55141–01–0), and 1-
178 (see also Unit I.C. of the and may also request a hearing on those propanesulfonic acid, 2-methyl-2-[(1-
SUPPLEMENTARY INFORMATION). objections. You must file your objection oxo-2-propen-1-y1)amino]-, sodium salt
ADDRESSES: The docket for this action, or request a hearing on this regulation (1:1), homopolymer (CAS Reg. Reg. No.
identified by docket identification (ID) in accordance with the instructions 35641–59–9). That document included a
number EPA–HQ–OPP–2018–0290, is provided in 40 CFR part 178. To ensure summary of the petition prepared by the
available at http://www.regulations.gov proper receipt by EPA, you must petitioner and solicited comments on
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– the petitioner’s request.
Regulatory Public Docket (OPP Docket) OPP–2018–0290 in the subject line on There were no comments received in
in the Environmental Protection Agency the first page of your submission. All response to the notice of filling.
Docket Center (EPA/DC), West William objections and requests for a hearing Section 408(c)(2)(A)(i) of FFDCA
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be allows EPA to establish an exemption
Constitution Ave., NW, Washington, DC received by the Hearing Clerk on or from the requirement for a tolerance (the
20460–0001. The Public Reading Room before February 4, 2019. Addresses for legal limit for a pesticide chemical
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections residue in or on a food) only if EPA
Monday through Friday, excluding legal and hearing requests are provided in 40 determines that the exemption is ‘‘safe.’’
holidays. The telephone number for the CFR 178.25(b). Section 408(c)(2)(A)(ii) of FFDCA
Public Reading Room is (202) 566–1744, In addition to filing an objection or defines ‘‘safe’’ to mean that ‘‘there is a
and the telephone number for the OPP hearing request with the Hearing Clerk reasonable certainty that no harm will
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![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Rules and Regulations 62487
result from aggregate exposure to the homopolymer, sodium salt and 1- propanesulfonic acid, 2-methyl-2-[(1-
pesticide chemical residue, including propanesulfonic acid, 2-methyl-2-[(1- oxo-2-propen-1-y1)amino]-,
all anticipated dietary exposures and all oxo-2-propen-1-y1)amino]-, sodium salt homopolymer, sodium salt and 1-
other exposures for which there is (1:1), homopolymer both conform to the propanesulfonic acid, 2-methyl-2-[(1-
reliable information.’’ This includes definition of a polymer given in 40 CFR oxo-2-propen-1-y1)amino]-, sodium salt
exposure through drinking water and 723.250(b) and meet the following (1:1), homopolymer could be present in
use in residential settings, but does not criteria that are used to identify low-risk all raw and processed agricultural
include occupational exposure. Section polymers. commodities and drinking water, and
408(b)(2)(C) of FFDCA requires EPA to 1. The polymer is not a cationic that non-occupational non-dietary
give special consideration to exposure polymer nor is it reasonably anticipated exposure was possible. The number
of infants and children to the pesticide to become a cationic polymer in a average MW of 1-propanesulfonic acid,
chemical residue in establishing an natural aquatic environment. 2-methyl-2-[(1-oxo-2-propen-1-
exemption from the requirement of a 2. The polymer does contain as an y1)amino]-, homopolymer, sodium salt
tolerance and to ‘‘ensure that there is a integral part of its composition the and 1-propanesulfonic acid, 2-methyl-2-
reasonable certainty that no harm will atomic elements carbon, hydrogen, and [(1-oxo-2propen-1-y1)amino]-, sodium
result to infants and children from oxygen. salt (1:1), homopolymer are greater than
aggregate exposure to the pesticide 3. The polymer does not contain as an 14,000 daltons. Generally, polymers of
chemical residue . . . ’’ and specifies integral part of its composition, except this size would be poorly absorbed
factors EPA is to consider in as impurities, any element other than through the intact gastrointestinal tract
establishing an exemption. those listed in 40 CFR 723.250(d)(2)(ii). or through intact human skin. Since
4. The polymer is neither designed propanesulfonic acid, 2-methyl-2-[(1-
III. Risk Assessment and Statutory nor can it be reasonably anticipated to oxo-2-propen-1-y1)amino]-,
Findings substantially degrade, decompose, or homopolymer, sodium salt and 1-
EPA establishes exemptions from the depolymerize. propanesulfonic acid, 2-methyl-2-[(1-
requirement of a tolerance only in those 5. The polymer is manufactured or oxo-2-propen-1-y1)amino]-, sodium salt
cases where it can be shown that the imported from monomers and/or (1:1), homopolymer conform to the
risks from aggregate exposure to reactants that are already included on criteria that identify a low-risk polymer,
pesticide chemical residues under the TSCA Chemical Substance there are no concerns for risks
reasonably foreseeable circumstances Inventory or manufactured under an associated with any potential exposure
will pose no appreciable risks to human applicable TSCA section 5 exemption. scenarios that are reasonably
health. In order to determine the risks 6. The polymer is not a water foreseeable. The Agency has determined
from aggregate exposure to pesticide absorbing polymer with a number that a tolerance is not necessary to
inert ingredients, the Agency considers average molecular weight (MW) greater protect the public health.
the toxicity of the inert in conjunction than or equal to 10,000 daltons.
with possible exposure to residues of 7. The polymer does not contain V. Cumulative Effects From Substances
the inert ingredient through food, certain perfluoroalkyl moieties With a Common Mechanism of Toxicity
drinking water, and through other consisting of a CF3- or longer chain Section 408(b)(2)(D)(v) of FFDCA
exposures that occur as a result of length as listed in 40 CFR 723.250(d)(6). requires that, when considering whether
pesticide use in residential settings. If Additionally, the polymer also meets to establish, modify, or revoke a
EPA is able to determine that a finite as required the following exemption tolerance, the Agency consider
tolerance is not necessary to ensure that criteria specified in 40 CFR 723.250(e). ‘‘available information’’ concerning the
there is a reasonable certainty that no 8. The polymer’s number average MW cumulative effects of a particular
harm will result from aggregate of 14,000 is greater than or equal to pesticide’s residues and ‘‘other
exposure to the inert ingredient, an 10,000 daltons. The polymer contains substances that have a common
exemption from the requirement of a less than 2% oligomeric material below mechanism of toxicity.’’
tolerance may be established. MW 500 and less than 5% oligomeric EPA has not found 1-propanesulfonic
Consistent with FFDCA section material below MW 1,000. acid, 2-methyl-2-[(1-oxo-2-propen-1-
408(b)(2)(D), EPA has reviewed the Thus, 1-propanesulfonic acid, 2- y1)amino]-, homopolymer, sodium salt
available scientific data and other methyl-2-[(1-oxo-2-propen-1-y1)amino]-, and 1-propanesulfonic acid, 2-methyl-2-
relevant information in support of this homopolymer, sodium salt and 1- [(1-oxo-2-propen-1-y1)amino]-, sodium
action and considered its validity, propanesulfonic acid, 2-methyl-2-[(1- salt (1:1), homopolymer to share a
completeness and reliability and the oxo-2-propen-1-y1)amino]-, sodium salt common mechanism of toxicity with
relationship of this information to (1:1), homopolymer meet the criteria for any other substances, and 1-
human risk. EPA has also considered a polymer to be considered low risk propanesulfonic acid, 2-methyl-2-[(1-
available information concerning the under 40 CFR 723.250. Based on their oxo-2-propen-1-y1)amino]-,
variability of the sensitivities of major conformance to the criteria in this unit, homopolymer, sodium salt and 1-
identifiable subgroups of consumers, no mammalian toxicity is anticipated propanesulfonic acid, 2-methyl-2-[(1-
including infants and children. In the from dietary, inhalation, or dermal oxo-2-propen-1-y1)amino]-, sodium salt
case of certain chemical substances that exposure to 1-propanesulfonic acid, 2- (1:1), homopolymer do not appear to
are defined as polymers, the Agency has methyl-2-[(1-oxo-2-propen-1-y1)amino]-, produce a toxic metabolite produced by
established a set of criteria to identify homopolymer, sodium salt and 1- other substances. For the purposes of
categories of polymers expected to propanesulfonic acid, 2-methyl-2-[(1- this tolerance action, therefore, EPA has
present minimal or no risk. The oxo-2-propen-1-y1)amino]-, sodium salt assumed that 1-propanesulfonic acid, 2-
definition of a polymer is given in 40 (1:1), homopolymer. methyl-2-[(1-oxo-2-propen-1-y1)amino]-,
CFR 723.250(b) and the exclusion homopolymer, sodium salt and 1-
criteria for identifying these low-risk IV. Aggregate Exposures propanesulfonic acid, 2-methyl-2-[(1-
polymers are described in 40 CFR For the purposes of assessing oxo-2-propen-1-y1)amino]-, sodium salt
723.250(d). 1-Propanesulfonic acid, 2- potential exposure under this (1:1), homopolymer do not have a
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, exemption, EPA considered that 1- common mechanism of toxicity with
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![62488 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Rules and Regulations
other substances. For information organization in trade agreements to retailers, not States or tribes, nor does
regarding EPA’s efforts to determine which the United States is a party. EPA this action alter the relationships or
which chemicals have a common may establish a tolerance that is distribution of power and
mechanism of toxicity and to evaluate different from a Codex MRL; however, responsibilities established by Congress
the cumulative effects of such FFDCA section 408(b)(4) requires that in the preemption provisions of FFDCA
chemicals, see EPA’s website at http:// EPA explain the reasons for departing section 408(n)(4). As such, the Agency
www.epa.gov/pesticides/cumulative. from the Codex level. has determined that this action will not
The Codex has not established a MRL have a substantial direct effect on States
VI. Additional Safety Factor for the for 1-propanesulfonic acid, 2-methyl-2-
Protection of Infants and Children or tribal governments, on the
[(1-oxo-2-propen-1-y1)amino]-, relationship between the national
Section 408(b)(2)(C) of FFDCA homopolymer, sodium salt or 1- government and the States or tribal
provides that EPA shall apply an propanesulfonic acid, 2-methyl-2-[(1- governments, or on the distribution of
additional tenfold margin of safety for oxo-2propen-1-y1)amino]-, sodium salt power and responsibilities among the
infants and children in the case of (1:1), homopolymer. various levels of government or between
threshold effects to account for prenatal the Federal Government and Indian
and postnatal toxicity and the IX. Conclusion
tribes. Thus, the Agency has determined
completeness of the data base unless Accordingly, EPA finds that that Executive Order 13132, entitled
EPA concludes that a different margin of exempting residues of 1- ‘‘Federalism’’ (64 FR 43255, August 10,
safety will be safe for infants and propanesulfonic acid, 2-methyl-2-[(1- 1999) and Executive Order 13175,
children. Due to the expected low oxo-2-propen-1-y1)amino]-, entitled ‘‘Consultation and Coordination
toxicity of 1-propanesulfonic acid, 2- homopolymer, sodium salt and 1- with Indian Tribal Governments’’ (65 FR
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, propanesulfonic acid, 2-methyl-2-[(1- 67249, November 9, 2000) do not apply
homopolymer, sodium salt and 1- oxo-2propen-1-y1)amino]-, sodium salt to this action. In addition, this action
propanesulfonic acid, 2-methyl-2-[(1- (1:1), homopolymer from the does not impose any enforceable duty or
oxo-2-propen-1-y1)amino]-, sodium salt requirement of a tolerance will be safe. contain any unfunded mandate as
(1:1), homopolymer, EPA has not used described under Title II of the Unfunded
X. Statutory and Executive Order
a safety factor analysis to assess the risk. Mandates Reform Act (UMRA) (2 U.S.C.
Reviews
For the same reasons the additional 1501 et seq.).
tenfold safety factor is unnecessary. This action establishes a tolerance
under FFDCA section 408(d) in This action does not involve any
VII. Determination of Safety response to a petition submitted to the technical standards that would require
Based on the conformance to the Agency. The Office of Management and Agency consideration of voluntary
criteria used to identify a low-risk Budget (OMB) has exempted these types consensus standards pursuant to section
polymer, EPA concludes that there is a of actions from review under Executive 12(d) of the National Technology
reasonable certainty of no harm to the Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
U.S. population, including infants and Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
children, from aggregate exposure to October 4, 1993). Because this action XI. Congressional Review Act
residues of 1-propanesulfonic acid, 2- has been exempted from review under Pursuant to the Congressional Review
methyl-2-[(1-oxo-2-propen-1-y1)amino]-, Executive Order 12866, this action is
Act (5 U.S.C. 801 et seq.), EPA will
homopolymer, sodium salt and 1- not subject to Executive Order 13211, submit a report containing this rule and
propanesulfonic acid, 2-methyl-2-[(1- entitled ‘‘Actions Concerning other required information to the U.S.
oxo-2propen-1-y1)amino]-, sodium salt Regulations That Significantly Affect Senate, the U.S. House of
(1:1), homopolymer. Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
VIII. Other Considerations FR 28355, May 22, 2001) or Executive General of the United States prior to
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
A. Analytical Enforcement Methodology Children from Environmental Health
Register. This action is not a ‘‘major
An analytical method is not required Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2).
for enforcement purposes since the April 23, 1997). This action does not
Agency is establishing an exemption contain any information collections List of Subjects in 40 CFR Part 180
from the requirement of a tolerance subject to OMB approval under the Environmental protection,
without any numerical limitation. Paperwork Reduction Act (PRA) (44 Administrative practice and procedure,
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
B. International Residue Limits any special considerations under and pests, Reporting and recordkeeping
In making its tolerance decisions, EPA Executive Order 12898, entitled requirements.
seeks to harmonize U.S. tolerances with ‘‘Federal Actions to Address
international standards whenever Dated: November 14, 2018.
Environmental Justice in Minority
possible, consistent with U.S. food Populations and Low-Income Donna Davis,
safety standards and agricultural Populations’’ (59 FR 7629, February 16, Acting Director, Registration Division, Office
practices. EPA considers the 1994). of Pesticide Programs.
international maximum residue limits Since tolerances and exemptions that Therefore, 40 CFR chapter I is
(MRLs) established by the Codex are established on the basis of a petition amended as follows:
Alimentarius Commission (Codex), as under FFDCA section 408(d), such as
required by FFDCA section 408(b)(4). PART 180—[AMENDED]
the tolerance in this final rule, do not
The Codex Alimentarius is a joint require the issuance of a proposed rule, ■ 1. The authority citation for part 180
United Nations Food and Agriculture the requirements of the Regulatory continues to read as follows:
Organization/World Health Flexibility Act (RFA) (5 U.S.C. 601 et
Organization food standards program, Authority: 21 U.S.C. 321(q), 346a and 371.
seq.), do not apply.
and it is recognized as an international This action directly regulates growers, ■ 2. In § 180.960, alphabetically add the
food safety standards-setting food processors, food handlers, and food polymers in the table to read as follows:
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![Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Rules and Regulations 62489
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
* * * * *
Polymer CAS No.
* * * * * * *
Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, homopolymer, sodium salt, minimum number average molec-
ular weight (in amu) 14,000 ............................................................................................................................................................. 55141–01–0
* * * * * * *
1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propen-1-y1)amino]-, sodium salt (1:1), homopolymer, minimum number average
molecular weight (in amu) 14,000 ................................................................................................................................................... 35641–59–9
* * * * * * *
[FR Doc. 2018–26347 Filed 12–3–18; 8:45 am] FOR FURTHER INFORMATION CONTACT: proper receipt by EPA, you must
BILLING CODE 6560–50–P Michael Goodis, Registration Division identify docket ID number EPA–HQ–
(7505P), Office of Pesticide Programs, OPP–2015–0820 in the subject line on
Environmental Protection Agency, 1200 the first page of your submission. All
ENVIRONMENTAL PROTECTION Pennsylvania Ave. NW, Washington, DC objections and requests for a hearing
AGENCY 20460–0001; main telephone number: must be in writing and must be received
(703) 305–7090; email address: by the Hearing Clerk on or before
40 CFR Part 180 RDFRNotices@epa.gov. February 4, 2019. Addresses for mail
SUPPLEMENTARY INFORMATION: and hand delivery of objections and
[EPA–HQ–OPP–2015–0820; FRL–9986–87]
hearing requests are provided in 40 CFR
I. General Information 178.25(b).
Oxytetracycline; Pesticide Tolerances
A. Does this action apply to me? In addition to filing an objection or
AGENCY: Environmental Protection hearing request with the Hearing Clerk
Agency (EPA). You may be potentially affected by as described in 40 CFR part 178, please
this action if you are an agricultural submit a copy of the filing (excluding
ACTION: Final rule.
producer, food manufacturer, or any Confidential Business Information
SUMMARY: This regulation establishes pesticide manufacturer. The following (CBI)) for inclusion in the public docket.
tolerances for residues of list of North American Industrial Information not marked confidential
oxytetracycline in or on fruit, citrus, Classification System (NAICS) codes is pursuant to 40 CFR part 2 may be
crop group 10–10. Geo Logic not intended to be exhaustive, but rather disclosed publicly by EPA without prior
Corporation requested these tolerances provides a guide to help readers notice. Submit the non-CBI copy of your
under the Federal Food, Drug, and determine whether this document objection or hearing request, identified
Cosmetic Act (FFDCA). applies to them. Potentially affected by docket ID number EPA–HQ–OPP–
DATES: This regulation is effective
entities may include: 2015–0820, by one of the following
• Crop production (NAICS code 111). methods:
December 4, 2018. Objections and
• Animal production (NAICS code • Federal eRulemaking Portal: http://
requests for hearings must be received
112). www.regulations.gov. Follow the online
on or before February 4, 2019 and must
• Food manufacturing (NAICS code instructions for submitting comments.
be filed in accordance with the
311). Do not submit electronically any
instructions provided in 40 CFR part • Pesticide manufacturing (NAICS
178 (see also Unit I.C. of the information you consider to be CBI or
code 32532). other information whose disclosure is
SUPPLEMENTARY INFORMATION).
B. How can I get electronic access to restricted by statute.
ADDRESSES: The docket for this action, • Mail: OPP Docket, Environmental
identified by docket identification (ID) other related information?
Protection Agency Docket Center (EPA/
number EPA–HQ–OPP–2015–0820, is You may access a frequently updated DC), (28221T), 1200 Pennsylvania Ave.,
available at http://www.regulations.gov electronic version of EPA’s tolerance NW, Washington, DC 20460–0001.
or at the Office of Pesticide Programs regulations at 40 CFR part 180 through • Hand Delivery: To make special
Regulatory Public Docket (OPP Docket) the Government Printing Office’s e-CFR arrangements for hand delivery or
in the Environmental Protection Agency site at http://www.ecfr.gov/cgi-bin/text- delivery of boxed information, please
Docket Center (EPA/DC), West William idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ follow the instructions at http://
Jefferson Clinton Bldg., Rm. 3334, 1301 40tab_02.tpl. www.epa.gov/dockets/contacts.html.
Constitution Ave. NW, Washington, DC Additional instructions on
20460–0001. The Public Reading Room C. How can I file an objection or hearing
request? commenting or visiting the docket,
is open from 8:30 a.m. to 4:30 p.m., along with more information about
Monday through Friday, excluding legal Under FFDCA section 408(g), 21 dockets generally, is available at http://
holidays. The telephone number for the U.S.C. 346a, any person may file an www.epa.gov/dockets.
Public Reading Room is (202) 566–1744, objection to any aspect of this regulation
and the telephone number for the OPP and may also request a hearing on those II. Summary of Petitioned-For
Docket is (703) 305–5805. Please review objections. You must file your objection Tolerance
the visitor instructions and additional or request a hearing on this regulation In the Federal Register of March 16,
information about the docket available in accordance with the instructions 2016 (81 FR 14030) (FRL–9942–86),
at http://www.epa.gov/dockets. provided in 40 CFR part 178. To ensure EPA issued a document pursuant to
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Document Created: 2018-12-04 00:42:47
Document Modified: 2018-12-04 00:42:47
| 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 December 4, 2018. Objections and requests for hearings must be received on or before February 4, 2019, 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 62486 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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