80 FR 79708 - 2-Propenoic Acid, Homopolymer, Ester With α-[2,4,6-Tris(1-Phenylethyl)Phenyl]-ω-Hydroxypoly(Oxy-1,2-Ethanediyl), Compd. With 2,2′,2″-Nitrilotris[Ethanol]; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 246 (December 23, 2015)
Federal Register Volume 80, Issue 246 (December 23, 2015)
| Page Range | 79708-79711 | |
| FR Document | 2015-32176 |
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)] [Rules and Regulations] [Pages 79708-79711] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32176] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0630; FRL-9939-71] 2-Propenoic Acid, Homopolymer, Ester With [alpha]-[2,4,6-Tris(1- Phenylethyl)Phenyl]-[omega]-Hydroxypoly(Oxy-1,2-Ethanediyl), Compd. With 2,2',2''-Nitrilotris[Ethanol]; 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 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy- 1,2-ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] (CAS Reg. No. 1477613-46-9) when used as an inert ingredient in a pesticide chemical formulation. Spring Trading Company on behalf of Lamberti USA, Incorporated 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 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]- [omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''- nitrilotris[ethanol] on food or feed commodities. DATES: This regulation is effective December 23, 2015. Objections and requests for hearings must be received on or before February 22, 2016, 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-2015-0630, 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 [[Page 79709]] information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, 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 Publishing 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-2015-0630 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 22, 2016. 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-2015-0630, 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 October 21, 2015 (80 FR 63731) (FRL- 9934-29), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN- 10836) filed by Spring Trading Company, 203 Dogwood Trail, Magnolia, Texas 77354-5201 on behalf of Lamberti USA, Inc., 14622 Exxon Road, Conroe, Texas 77302. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2- ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] (CAS Reg. No. 1477613-46-9). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure 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). 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy- 1,2-ethanediyl), [[Page 79710]] compd. with 2,2',2''-nitrilotris[ethanol] 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 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 CF3- or longer chain length as specified 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 minimum number average MW 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, 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6- tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] 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 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1- phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol]. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy- 1,2-ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] 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 2-propenoic acid, homopolymer, ester with [alpha]- [2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2- ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] is 10,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1- phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] 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 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2- ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] to share a common mechanism of toxicity with any other substances, and 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1- phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol] does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]- [omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''- nitrilotris[ethanol] does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. VI. Additional Safety Factor for the Protection of Infants and Children Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]- [omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''- nitrilotris[ethanol], 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 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy- 1,2-ethanediyl), compd. with 2,2',2''-nitrilotris[ethanol]. VIII. Other Considerations A. Existing Exemptions From a Tolerance There are no existing tolerance exemptions 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]- [omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''- nitrilotris[ethanol]). 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. C. 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 [[Page 79711]] 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 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]- [omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''- nitrilotris[ethanol]. IX. Conclusion Accordingly, EPA finds that exempting residues of 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6-tris(1-phenylethyl)phenyl]- [omega]-hydroxypoly(oxy-1,2-ethanediyl), compd. with 2,2',2''- nitrilotris[ethanol] 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: December 11, 2015. Susan Lewis, 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, add alphabetically 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. ------------------------------------------------------------------------ * * * * * 2-propenoic acid, homopolymer, ester with [alpha]-[2,4,6- 1477613-46-9 tris(1-phenylethyl)phenyl]-[omega]-hydroxypoly(oxy-1,2- ethanediyl), compd. with 2,2',2''- nitrilotris[ethanol]), minimum number average molecular weight (in amu), 10,000................................ * * * * * ------------------------------------------------------------------------ [FR Doc. 2015-32176 Filed 12-22-15; 8:45 am] BILLING CODE 6560-50-P
![79708 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations
Significantly Affect Energy Supply, have a substantial direct effect on States Senate, the U.S. House of
Distribution, or Use’’ (66 FR 28355, May or tribal governments, on the Representatives, and the Comptroller
22, 2001) or Executive Order 13045, relationship between the national General of the United States prior to
entitled ‘‘Protection of Children from government and the States or tribal publication of the rule in the Federal
Environmental Health Risks and Safety governments, or on the distribution of Register. This action is not a ‘‘major
Risks’’ (62 FR 19885, April 23, 1997). power and responsibilities among the rule’’ as defined by 5 U.S.C. 804(2).
This action does not contain any various levels of government or between
List of Subjects in 40 CFR Part 180
information collections subject to OMB the Federal Government and Indian
approval under the Paperwork tribes. Thus, the Agency has determined Environmental protection,
Reduction Act (PRA) (44 U.S.C. 3501 et that Executive Order 13132, entitled Administrative practice and procedure,
seq.), nor does it require any special ‘‘Federalism’’ (64 FR 43255, August 10, Agricultural commodities, Pesticides
considerations under Executive Order 1999) and Executive Order 13175, and pests, Reporting and recordkeeping
12898, entitled ‘‘Federal Actions to entitled ‘‘Consultation and Coordination requirements.
Address Environmental Justice in with Indian Tribal Governments’’ (65 FR Dated: December 11, 2015.
Minority Populations and Low-Income 67249, November 9, 2000) do not apply Susan Lewis,
Populations’’ (59 FR 7629, February 16, to this action. In addition, this action
Director, Registration Division, Office of
1994). does not impose any enforceable duty or Pesticide Programs.
Since tolerances and exemptions that contain any unfunded mandate as
are established on the basis of a petition described under Title II of the Unfunded Therefore, 40 CFR chapter I is
under FFDCA section 408(d), such as Mandates Reform Act (UMRA) (2 U.S.C. amended as follows:
the tolerance exemption in this final 1501 et seq.).
rule, do not require the issuance of a This action does not involve any PART 180—[AMENDED]
proposed rule, the requirements of the technical standards that would require
■ 1. The authority citation for part 180
Regulatory Flexibility Act (RFA) (5 Agency consideration of voluntary
continues to read as follows:
U.S.C. 601 et seq.), do not apply. consensus standards pursuant to section
This action directly regulates growers, 12(d) of the National Technology Authority: 21 U.S.C. 321(q), 346a and 371.
food processors, food handlers, and food Transfer and Advancement Act ■ 2. In § 180.920, add alphabetically the
retailers, not States or tribes, nor does (NTTAA) (15 U.S.C. 272 note). following inert ingredient to the table to
this action alter the relationships or read as follows:
distribution of power and VIII. Congressional Review Act
responsibilities established by Congress Pursuant to the Congressional Review § 180.920 Inert ingredients used pre-
in the preemption provisions of FFDCA Act (5 U.S.C. 801 et seq.), EPA will harvest; exemptions from the requirement
section 408(n)(4). As such, the Agency submit a report containing this rule and of a tolerance.
has determined that this action will not other required information to the U.S. * * * * *
Inert ingredients Limits Uses
* * * * * * *
Ammonium acetate (CAS No. 631–61–8) .................................................................... 15% Buffering Agent.
* * * * * * *
[FR Doc. 2015–32170 Filed 12–22–15; 8:45 am] acid, homopolymer, ester with a-[2,4,6- on or before February 22, 2016, and
BILLING CODE 6560–50–P tris(1-phenylethyl)phenyl]-w- must be filed in accordance with the
hydroxypoly(oxy-1,2-ethanediyl), instructions provided in 40 CFR part
compd. with 2,2′,2″-nitrilotris[ethanol] 178 (see also Unit I.C. of the
ENVIRONMENTAL PROTECTION (CAS Reg. No. 1477613–46–9) when SUPPLEMENTARY INFORMATION).
AGENCY used as an inert ingredient in a pesticide
chemical formulation. Spring Trading ADDRESSES: The docket for this action,
40 CFR Part 180 Company on behalf of Lamberti USA, identified by docket identification (ID)
Incorporated submitted a petition to number EPA–HQ–OPP–2015–0630, is
[EPA–HQ–OPP–2015–0630; FRL–9939–71] available at http://www.regulations.gov
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an or at the Office of Pesticide Programs
2-Propenoic Acid, Homopolymer, Ester
With α-[2,4,6-Tris(1- exemption from the requirement of a Regulatory Public Docket (OPP Docket)
Phenylethyl)Phenyl]-w- tolerance. This regulation eliminates the in the Environmental Protection Agency
Hydroxypoly(Oxy-1,2-Ethanediyl), need to establish a maximum Docket Center (EPA/DC), West William
Compd. With 2,2′,2″- permissible level for residues of 2- Jefferson Clinton Bldg., Rm. 3334, 1301
Nitrilotris[Ethanol]; Tolerance propenoic acid, homopolymer, ester Constitution Ave. NW., Washington, DC
Exemption with a-[2,4,6-tris(1- 20460–0001. The Public Reading Room
asabaliauskas on DSK5VPTVN1PROD with RULES
phenylethyl)phenyl]-w- is open from 8:30 a.m. to 4:30 p.m.,
AGENCY: Environmental Protection hydroxypoly(oxy-1,2-ethanediyl), Monday through Friday, excluding legal
Agency (EPA). compd. with 2,2′,2″-nitrilotris[ethanol] holidays. The telephone number for the
ACTION: Final rule. on food or feed commodities. Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
SUMMARY: This regulation establishes an DATES: This regulation is effective
Docket is (703) 305–5805. Please review
exemption from the requirement of a December 23, 2015. Objections and
the visitor instructions and additional
tolerance for residues of 2-propenoic requests for hearings must be received
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![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations 79709
information about the docket available any Confidential Business Information all anticipated dietary exposures and all
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. other exposures for which there is
FOR FURTHER INFORMATION CONTACT: Information not marked confidential reliable information.’’ This includes
Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be exposure through drinking water and
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior use in residential settings, but does not
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your include occupational exposure. Section
Pennsylvania Ave. NW., Washington, objection or hearing request, identified 408(b)(2)(C) of FFDCA requires EPA to
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP– give special consideration to exposure
number: (703) 305–7090; email address: 2015–0630, by one of the following of infants and children to the pesticide
RDFRNotices@epa.gov. methods. chemical residue in establishing an
• Federal eRulemaking Portal: http:// exemption from the requirement of a
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online tolerance and to ‘‘ensure that there is a
I. General Information instructions for submitting comments. reasonable certainty that no harm will
Do not submit electronically any result to infants and children from
A. Does this action apply to me?
information you consider to be CBI or aggregate exposure to the pesticide
You may be potentially affected by other information whose disclosure is chemical residue . . .’’ and specifies
this action if you are an agricultural restricted by statute. factors EPA is to consider in
producer, food manufacturer, or • Mail: OPP Docket, Environmental establishing an exemption.
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. III. Risk Assessment and Statutory
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. Findings
not intended to be exhaustive, but rather • Hand Delivery: To make special EPA establishes exemptions from the
provides a guide to help readers arrangements for hand delivery or requirement of a tolerance only in those
determine whether this document delivery of boxed information, please cases where it can be shown that the
applies to them. Potentially affected follow the instructions at http:// risks from aggregate exposure to
entities may include: www.epa.gov/dockets/contacts.html. pesticide chemical residues under
• Crop production (NAICS code 111). Additional instructions on commenting reasonably foreseeable circumstances
• Animal production (NAICS code or visiting the docket, along with more will pose no appreciable risks to human
112). information about dockets generally, is health. In order to determine the risks
• Food manufacturing (NAICS code available at http://www.epa.gov/ from aggregate exposure to pesticide
311). dockets. inert ingredients, the Agency considers
• Pesticide manufacturing (NAICS the toxicity of the inert in conjunction
code 32532). II. Background and Statutory Findings with possible exposure to residues of
In the Federal Register of October 21, the inert ingredient through food,
B. How can I get electronic access to 2015 (80 FR 63731) (FRL–9934–29), drinking water, and through other
other related information? EPA issued a document pursuant to exposures that occur as a result of
You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a, pesticide use in residential settings. If
electronic version of 40 CFR part 180 announcing the receipt of a pesticide EPA is able to determine that a finite
through the Government Publishing petition (PP IN–10836) filed by Spring tolerance is not necessary to ensure that
Office’s e-CFR site at http:// Trading Company, 203 Dogwood Trail, there is a reasonable certainty that no
www.ecfr.gov/cgi-bin/text- Magnolia, Texas 77354–5201 on behalf harm will result from aggregate
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ of Lamberti USA, Inc., 14622 Exxon exposure to the inert ingredient, an
40tab_02.tpl. Road, Conroe, Texas 77302. The petition exemption from the requirement of a
requested that 40 CFR 180.960 be tolerance may be established.
C. Can I file an objection or hearing amended by establishing an exemption Consistent with FFDCA section
request? from the requirement of a tolerance for 408(b)(2)(D), EPA has reviewed the
Under FFDCA section 408(g), 21 residues of 2-propenoic acid, available scientific data and other
U.S.C. 346a, any person may file an homopolymer, ester with a-[2,4,6-tris(1- relevant information in support of this
objection to any aspect of this regulation phenylethyl)phenyl]-w- action and considered its validity,
and may also request a hearing on those hydroxypoly(oxy-1,2-ethanediyl), completeness and reliability and the
objections. You must file your objection compd. with 2,2′,2″-nitrilotris[ethanol] relationship of this information to
or request a hearing on this regulation (CAS Reg. No. 1477613–46–9). That human risk. EPA has also considered
in accordance with the instructions document included a summary of the available information concerning the
provided in 40 CFR part 178. To ensure petition prepared by the petitioner and variability of the sensitivities of major
proper receipt by EPA, you must solicited comments on the petitioner’s identifiable subgroups of consumers,
identify docket ID number EPA–HQ– request. The Agency did not receive any including infants and children. In the
OPP–2015–0630 in the subject line on comments in response to the notice of case of certain chemical substances that
the first page of your submission. All filing. are defined as polymers, the Agency has
objections and requests for a hearing Section 408(c)(2)(A)(i) of FFDCA established a set of criteria to identify
must be in writing, and must be allows EPA to establish an exemption categories of polymers expected to
received by the Hearing Clerk on or from the requirement for a tolerance (the present minimal or no risk. The
asabaliauskas on DSK5VPTVN1PROD with RULES
before February 22, 2016. Addresses for legal limit for a pesticide chemical definition of a polymer is given in 40
mail and hand delivery of objections residue in or on a food) only if EPA CFR 723.250(b) and the exclusion
and hearing requests are provided in 40 determines that the exemption is ‘‘safe.’’ criteria for identifying these low-risk
CFR 178.25(b). Section 408(c)(2)(A)(ii) of FFDCA polymers are described in 40 CFR
In addition to filing an objection or defines ‘‘safe’’ to mean that ‘‘there is a 723.250(d). 2-propenoic acid,
hearing request with the Hearing Clerk reasonable certainty that no harm will homopolymer, ester with a-[2,4,6-tris(1-
as described in 40 CFR part 178, please result from aggregate exposure to the phenylethyl)phenyl]-w-
submit a copy of the filing (excluding pesticide chemical residue, including hydroxypoly(oxy-1,2-ethanediyl),
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![79710 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations
compd. with 2,2′,2″-nitrilotris[ethanol] hydroxypoly(oxy-1,2-ethanediyl), VI. Additional Safety Factor for the
conforms to the definition of a polymer compd. with 2,2′,2″-nitrilotris[ethanol] Protection of Infants and Children
given in 40 CFR 723.250(b) and meets could be present in all raw and Section 408(b)(2)(C) of FFDCA
the following criteria that are used to processed agricultural commodities and provides that EPA shall apply an
identify low-risk polymers. drinking water, and that non- additional tenfold margin of safety for
1. The polymer is not a cationic occupational non-dietary exposure was infants and children in the case of
polymer nor is it reasonably anticipated possible. The number average MW of 2- threshold effects to account for prenatal
to become a cationic polymer in a propenoic acid, homopolymer, ester and postnatal toxicity and the
natural aquatic environment. with a-[2,4,6-tris(1- completeness of the data base unless
2. The polymer does contain as an phenylethyl)phenyl]-w- EPA concludes that a different margin of
integral part of its composition the hydroxypoly(oxy-1,2-ethanediyl), safety will be safe for infants and
atomic elements carbon, hydrogen, and compd. with 2,2′,2″-nitrilotris[ethanol] children. Due to the expected low
oxygen. is 10,000 daltons. Generally, a polymer
toxicity of 2-propenoic acid,
3. The polymer does not contain as an of this size would be poorly absorbed
homopolymer, ester with a-[2,4,6-tris(1-
integral part of its composition, except through the intact gastrointestinal tract
phenylethyl)phenyl]-w-
as impurities, any element other than or through intact human skin. Since 2-
hydroxypoly(oxy-1,2-ethanediyl),
those listed in 40 CFR 723.250(d)(2)(ii). propenoic acid, homopolymer, ester
4. The polymer is neither designed compd. with 2,2′,2″-nitrilotris[ethanol],
with a-[2,4,6-tris(1-
nor can it be reasonably anticipated to EPA has not used a safety factor analysis
phenylethyl)phenyl]-w-
substantially degrade, decompose, or to assess the risk. For the same reasons
hydroxypoly(oxy-1,2-ethanediyl),
depolymerize. the additional tenfold safety factor is
compd. with 2,2′,2″-nitrilotris[ethanol]
5. The polymer is manufactured or unnecessary.
conform to the criteria that identify a
imported from monomers and/or low-risk polymer, there are no concerns VII. Determination of Safety
reactants that are already included on for risks associated with any potential Based on the conformance to the
the TSCA Chemical Substance exposure scenarios that are reasonably criteria used to identify a low-risk
Inventory or manufactured under an foreseeable. The Agency has determined polymer, EPA concludes that there is a
applicable TSCA section 5 exemption. that a tolerance is not necessary to
6. The polymer is not a water reasonable certainty of no harm to the
protect the public health. U.S. population, including infants and
absorbing polymer with a number
average molecular weight (MW) greater V. Cumulative Effects From Substances children, from aggregate exposure to
than or equal to 10,000 daltons. With a Common Mechanism of Toxicity residues of 2-propenoic acid,
7. The polymer does not contain Section 408(b)(2)(D)(v) of FFDCA homopolymer, ester with a-[2,4,6-tris(1-
certain perfluoroalkyl moieties requires that, when considering whether phenylethyl)phenyl]-w-
consisting of a CF3- or longer chain to establish, modify, or revoke a hydroxypoly(oxy-1,2-ethanediyl),
length as specified in 40 CFR tolerance, the Agency consider compd. with 2,2′,2″-nitrilotris[ethanol].
723.250(d)(6). ‘‘available information’’ concerning the VIII. Other Considerations
Additionally, the polymer also meets cumulative effects of a particular
as required the following exemption pesticide’s residues and ‘‘other A. Existing Exemptions From a
criteria specified in 40 CFR 723.250(e). substances that have a common Tolerance
8. The polymer’s minimum number mechanism of toxicity.’’ There are no existing tolerance
average MW is greater than or equal to EPA has not found 2-propenoic acid, exemptions 2-propenoic acid,
10,000 daltons. The polymer contains homopolymer, ester with a-[2,4,6-tris(1- homopolymer, ester with a-[2,4,6-tris(1-
less than 2% oligomeric material below phenylethyl)phenyl]-w- phenylethyl)phenyl]-w-
MW 500 and less than 5% oligomeric hydroxypoly(oxy-1,2-ethanediyl), hydroxypoly(oxy-1,2-ethanediyl),
material below MW 1,000. compd. with 2,2′,2″-nitrilotris[ethanol] compd. with 2,2′,2″-nitrilotris[ethanol]).
Thus, 2-propenoic acid, to share a common mechanism of
homopolymer, ester with a-[2,4,6-tris(1- toxicity with any other substances, and B. Analytical Enforcement Methodology
phenylethyl)phenyl]-w- 2-propenoic acid, homopolymer, ester An analytical method is not required
hydroxypoly(oxy-1,2-ethanediyl), with a-[2,4,6-tris(1- for enforcement purposes since the
compd. with 2,2′,2″-nitrilotris[ethanol] phenylethyl)phenyl]-w- Agency is establishing an exemption
meets the criteria for a polymer to be hydroxypoly(oxy-1,2-ethanediyl), from the requirement of a tolerance
considered low risk under 40 CFR compd. with 2,2′,2″-nitrilotris[ethanol] without any numerical limitation.
723.250. Based on its conformance to does not appear to produce a toxic
metabolite produced by other C. International Residue Limits
the criteria in this unit, no mammalian
toxicity is anticipated from dietary, substances. For the purposes of this In making its tolerance decisions, EPA
inhalation, or dermal exposure to 2- tolerance action, therefore, EPA has seeks to harmonize U.S. tolerances with
propenoic acid, homopolymer, ester assumed that 2-propenoic acid, international standards whenever
with a-[2,4,6-tris(1- homopolymer, ester with a-[2,4,6-tris(1- possible, consistent with U.S. food
phenylethyl)phenyl]-w- phenylethyl)phenyl]-w- safety standards and agricultural
hydroxypoly(oxy-1,2-ethanediyl), hydroxypoly(oxy-1,2-ethanediyl), practices. EPA considers the
compd. with 2,2′,2″-nitrilotris[ethanol]. compd. with 2,2′,2″-nitrilotris[ethanol] international maximum residue limits
asabaliauskas on DSK5VPTVN1PROD with RULES
does not have a common mechanism of (MRLs) established by the Codex
IV. Aggregate Exposures toxicity with other substances. For Alimentarius Commission (Codex), as
For the purposes of assessing information regarding EPA’s efforts to required by FFDCA section 408(b)(4).
potential exposure under this determine which chemicals have a The Codex Alimentarius is a joint
exemption, EPA considered that 2- common mechanism of toxicity and to United Nations Food and Agriculture
propenoic acid, homopolymer, ester evaluate the cumulative effects of such Organization/World Health
with a-[2,4,6-tris(1- chemicals, see EPA’s Web site at http:// Organization food standards program,
phenylethyl)phenyl]-w- www.epa.gov/pesticides/cumulative. and it is recognized as an international
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![Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Rules and Regulations 79711
food safety standards-setting this action alter the relationships or § 180.960 Polymers; exemptions from the
organization in trade agreements to distribution of power and requirement of a tolerance.
which the United States is a party. EPA responsibilities established by Congress * * * * *
may establish a tolerance that is in the preemption provisions of FFDCA
different from a Codex MRL; however, section 408(n)(4). As such, the Agency Polymer CAS No.
FFDCA section 408(b)(4) requires that has determined that this action will not
EPA explain the reasons for departing have a substantial direct effect on States * * * * *
from the Codex level. or tribal governments, on the 2-propenoic acid,
The Codex has not established a MRL relationship between the national homopolymer, ester with
for 2-propenoic acid, homopolymer, government and the States or tribal a-[2,4,6-tris(1-
ester with a-[2,4,6-tris(1- governments, or on the distribution of phenylethyl)phenyl]-w-
phenylethyl)phenyl]-w- power and responsibilities among the hydroxypoly(oxy-1,2-
hydroxypoly(oxy-1,2-ethanediyl), various levels of government or between ethanediyl), compd. with
compd. with 2,2′,2″-nitrilotris[ethanol]. the Federal Government and Indian 2,2′,2″-nitrilotris[ethanol]),
tribes. Thus, the Agency has determined minimum number average
IX. Conclusion molecular weight (in amu),
that Executive Order 13132, entitled 10,000 ............................... 1477613–46–9
Accordingly, EPA finds that ‘‘Federalism’’ (64 FR 43255, August 10,
exempting residues of 2-propenoic acid, 1999) and Executive Order 13175, * * * * *
homopolymer, ester with a-[2,4,6-tris(1- entitled ‘‘Consultation and Coordination
phenylethyl)phenyl]-w- with Indian Tribal Governments’’ (65 FR [FR Doc. 2015–32176 Filed 12–22–15; 8:45 am]
hydroxypoly(oxy-1,2-ethanediyl), 67249, November 9, 2000) do not apply BILLING CODE 6560–50–P
compd. with 2,2′,2″-nitrilotris[ethanol] to this action. In addition, this action
from the requirement of a tolerance will does not impose any enforceable duty or
be safe. contain any unfunded mandate as ENVIRONMENTAL PROTECTION
X. Statutory and Executive Order described under Title II of the Unfunded AGENCY
Reviews Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.). 40 CFR Part 180
This action establishes a tolerance
under FFDCA section 408(d) in This action does not involve any [EPA–HQ–OPP–2014–0788; FRL–9939–83]
response to a petition submitted to the technical standards that would require
Agency consideration of voluntary Propiconazole; Pesticide Tolerances
Agency. The Office of Management and
Budget (OMB) has exempted these types consensus standards pursuant to section AGENCY: Environmental Protection
of actions from review under Executive 12(d) of the National Technology Agency (EPA).
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
ACTION: Final rule.
Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
October 4, 1993). Because this action XI. Congressional Review Act SUMMARY: This regulation establishes
has been exempted from review under tolerances for residues of propiconazole
Pursuant to the Congressional Review in or on multiple commodities which
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, are identified and discussed later in this
submit a report containing this rule and document. Interregional Research
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect Project Number 4 (IR–4) requested these
Senate, the U.S. House of tolerances under the Federal Food,
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
FR 28355, May 22, 2001) or Executive Drug, and Cosmetic Act (FFDCA).
General of the United States prior to DATES: This regulation is effective
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
Children from Environmental Health December 23, 2015. Objections and
Register. This action is not a ‘‘major requests for hearings must be received
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2).
April 23, 1997). This action does not on or before February 22, 2016, and
contain any information collections List of Subjects in 40 CFR Part 180 must be filed in accordance with the
subject to OMB approval under the instructions provided in 40 CFR part
Environmental protection,
Paperwork Reduction Act (PRA) (44 178 (see also Unit I.C. of the
Administrative practice and procedure,
U.S.C. 3501 et seq.), nor does it require SUPPLEMENTARY INFORMATION).
Agricultural commodities, Pesticides
any special considerations under ADDRESSES: The docket for this action,
and pests, Reporting and recordkeeping
Executive Order 12898, entitled requirements. identified by docket identification (ID)
‘‘Federal Actions to Address number EPA–HQ–OPP–2014–0788, is
Dated: December 11, 2015. available at http://www.regulations.gov
Environmental Justice in Minority
Populations and Low-Income Susan Lewis, or at the Office of Pesticide Programs
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of Regulatory Public Docket (OPP Docket)
1994). Pesticide Programs. in the Environmental Protection Agency
Since tolerances and exemptions that Therefore, 40 CFR chapter I is Docket Center (EPA/DC), West William
are established on the basis of a petition amended as follows: Jefferson Clinton Bldg., Rm. 3334, 1301
under FFDCA section 408(d), such as Constitution Ave. NW., Washington, DC
asabaliauskas on DSK5VPTVN1PROD with RULES
PART 180—[AMENDED] 20460–0001. The Public Reading Room
the tolerance in this final rule, do not
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 is open from 8:30 a.m. to 4:30 p.m.,
the requirements of the Regulatory continues to read as follows: Monday through Friday, excluding legal
Flexibility Act (RFA) (5 U.S.C. 601 et holidays. The telephone number for the
Authority: 21 U.S.C. 321(q), 346a and 371. Public Reading Room is (202) 566–1744,
seq.), do not apply.
This action directly regulates growers, ■ 2. In § 180.960, add alphabetically the and the telephone number for the OPP
food processors, food handlers, and food following polymer to the table to read as Docket is (703) 305–5805. Please review
retailers, not States or tribes, nor does follows: the visitor instructions and additional
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Document Created: 2018-03-02 09:20:26
Document Modified: 2018-03-02 09:20:26
| 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 23, 2015. Objections and requests for hearings must be received on or before February 22, 2016, 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 | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 80 FR 79708 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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