81 FR 10776 - Alpha-[2,4,6-Tris[1-(phenyl)ethyl]phenyl]-Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 41 (March 2, 2016)
Federal Register Volume 81, Issue 41 (March 2, 2016)
| Page Range | 10776-10779 | |
| FR Document | 2016-04599 |
[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)] [Rules and Regulations] [Pages 10776-10779] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-04599] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0485; FRL-9942-48] Alpha-[2,4,6-Tris[1-(phenyl)ethyl]phenyl]-Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer; 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 Alpha-[2,4,6-Tris[1- (phenyl)ethyl]phenyl]-Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer, the poly(oxypropylene) content averages 2-8 moles, the poly(oxyethylene) content averages 16-30 moles, when used as an inert ingredient in a pesticide formulation. Stepan Co. 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 Alpha-[2,4,6-Tris[1- (phenyl)ethyl]phenyl]-Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer, the poly(oxypropylene) content averages 2-8 moles, the poly(oxyethylene) content averages 16-30 moles, on food or feed commodities. DATES: This regulation is effective March 2, 2016. Objections and requests for hearings must be received on or before May 2, 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-2015-0485, 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: 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 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-2015-0485 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 May 2, 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. [[Page 10777]] 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-2015-0485, 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 Wednesday, August 26, 2015 (80 FR 51763) (FRL-9931-74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN- 10837) filed by Stepan Company, 22 West Frontage Road, Northfield, IL 60093. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of Alpha-[2,4,6-Tris[1-(phenyl)ethyl]phenyl]-Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer, the poly(oxypropylene) content averages 2-8 moles, the poly(oxyethylene) content averages 16- 30 moles; CAS No. 70880-56-7. 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. 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). The polymer 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. Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer's minimum number average MW (in amu) of 1,500 is greater than 1,000 and less than 10,000 Daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, the polymer 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 the polymer. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that the polymer 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 the polymer is 1,500 Daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since the polymer 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. [[Page 10778]] 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 the polymer to share a common mechanism of toxicity with any other substances, and the polymer does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that the polymer 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 the polymer, 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 the polymer. 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 Alpha-[2,4,6-Tris[1- (phenyl)ethyl]phenyl]-Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer, the poly(oxypropylene) content averages 2-8 moles, the poly(oxyethylene) content averages 16-30 moles. IX. Conclusion Accordingly, EPA finds that exempting residues of the polymer 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. [[Page 10779]] Dated: February 24, 2016. 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 entry in the table to read as follows: Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * Alpha-[2,4,6-Tris[1-(phenyl)ethyl]phenyl]-Omega- 70880-56-7 hydroxy poly(oxyethylene) poly(oxypropylene) copolymer, the poly(oxypropylene) content averages 2- 8 moles, the poly(oxyethylene) content averages 16- 30 moles. Minimum number-average molecular weight (in amu) of 1,500................................... * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2016-04599 Filed 3-1-16; 8:45 am] BILLING CODE 6560-50-P
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List of Subjects in 40 CFR Part 180 ENVIRONMENTAL PROTECTION FOR FURTHER INFORMATION CONTACT:
AGENCY Susan Lewis, Registration Division
Environmental protection, (7505P), Office of Pesticide Programs,
Administrative practice and procedure, 40 CFR Part 180 Environmental Protection Agency, 1200
Agricultural commodities, Pesticides Pennsylvania Ave. NW., Washington,
and pests, Reporting and recordkeeping [EPA–HQ–OPP–2015–0485; FRL–9942–48] DC 20460–0001; main telephone
requirements. number: (703) 305–7090; email address:
Dated: February 23, 2016. Alpha-[2,4,6-Tris[1- RDFRNotices@epa.gov.
(phenyl)ethyl]phenyl]-Omega-hydroxy SUPPLEMENTARY INFORMATION:
Susan Lewis,
poly(oxyethylene) poly(oxypropylene)
Director, Registration Division, Office of copolymer; Tolerance Exemption I. General Information
Pesticide Programs.
AGENCY: Environmental Protection A. Does this action apply to me?
Therefore, 40 CFR chapter I is Agency (EPA). You may be potentially affected by
amended as follows: this action if you are an agricultural
ACTION: Final rule.
producer, food manufacturer, or
PART 180—[AMENDED] pesticide manufacturer. The following
This regulation establishes an
SUMMARY:
exemption from the requirement of a list of North American Industrial
■ 1. The authority citation for part 180 tolerance for residues of Alpha-[2,4,6- Classification System (NAICS) codes is
continues to read as follows: Tris[1-(phenyl)ethyl]phenyl]-Omega- not intended to be exhaustive, but rather
Authority: 21 U.S.C. 321(q), 346a and 371. hydroxy poly(oxyethylene) provides a guide to help readers
poly(oxypropylene) copolymer, the determine whether this document
■ 2. In § 180.605, paragraph (a) is poly(oxypropylene) content averages 2– applies to them. Potentially affected
revised to read as follows: 8 moles, the poly(oxyethylene) content entities may include:
averages 16–30 moles, when used as an • Crop production (NAICS code 111).
§ 180.605 Penoxsulam; tolerances for
inert ingredient in a pesticide • Animal production (NAICS code
residues.
formulation. Stepan Co. submitted a 112).
(a) General. Tolerances are petition to EPA under the Federal Food, • Food manufacturing (NAICS code
established for residues of penoxsulam, Drug, and Cosmetic Act (FFDCA), 311).
including its metabolites and requesting an exemption from the • Pesticide manufacturing (NAICS
degradates, in or on the commodities requirement of a tolerance. This code 32532).
listed in the table below. Compliance regulation eliminates the need to B. How can I get electronic access to
with the tolerance levels specified establish a maximum permissible level other related information?
below is to be determined by measuring for residues of Alpha-[2,4,6-Tris[1-
You may access a frequently updated
only penoxsulam 2-(2,2-difluoroethoxy)- (phenyl)ethyl]phenyl]-Omega-hydroxy
poly(oxyethylene) poly(oxypropylene) electronic version of 40 CFR part 180
N-(5,8-dimethoxy[1,2,4]triazolo[1,5-c]
copolymer, the poly(oxypropylene) through the Government Printing
pyrimidin-2-yl)-6-(trifluoromethyl) Office’s e-CFR site at http://
benzenesulfonamide, in or on the content averages 2–8 moles, the
poly(oxyethylene) content averages 16– www.ecfr.gov/cgi-bin/text-
commodity. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
30 moles, on food or feed commodities.
DATES: This regulation is effective
40tab_02.tpl.
Parts per
Commodity million March 2, 2016. Objections and requests C. Can I file an objection or hearing
for hearings must be received on or request?
Almond, hulls .............................. 0.01 before May 2, 2016, and must be filed
Fish ............................................. 0.01 in accordance with the instructions Under FFDCA section 408(g), 21
Fish, shellfish, crustacean .......... 0.01 provided in 40 CFR part 178 (see also U.S.C. 346a, any person may file an
Fish, shellfish, mollusc ............... 0.02 Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation
Fruit, pome, group 11–10 ........... 0.01 INFORMATION). and may also request a hearing on those
Fruit, small, vine climbing, sub- objections. You must file your objection
group 13–07F, except fuzzy ADDRESSES: The docket for this action, or request a hearing on this regulation
kiwifruit .................................... 0.01 identified by docket identification (ID) in accordance with the instructions
Fruit, stone, group 12–12 ........... 0.01 number EPA–HQ–OPP–2015–0485, is provided in 40 CFR part 178. To ensure
Nut, tree, group 14–12 ............... 0.01 available at http://www.regulations.gov proper receipt by EPA, you must
Olive ............................................ 0.01 or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Pomegranate .............................. 0.01 Regulatory Public Docket (OPP Docket) OPP–2015–0485 in the subject line on
Rice, grain .................................. 0.02 in the Environmental Protection Agency the first page of your submission. All
Rice, straw .................................. 0.50 Docket Center (EPA/DC), West William objections and requests for a hearing
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
* * * * * Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
[FR Doc. 2016–04598 Filed 3–1–16; 8:45 am] 20460–0001. The Public Reading Room before May 2, 2016. Addresses for mail
BILLING CODE 6560–50–P is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and
asabaliauskas on DSK3SPTVN1PROD with RULES
Monday through Friday, excluding legal hearing requests are provided in 40 CFR
holidays. The telephone number for the 178.25(b).
Public Reading Room is (202) 566–1744, In addition to filing an objection or
and the telephone number for the OPP hearing request with the Hearing Clerk
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
the visitor instructions and additional submit a copy of the filing (excluding
information about the docket available any Confidential Business Information
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
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Information not marked confidential use in residential settings, but does not to become a cationic polymer in a
pursuant to 40 CFR part 2 may be include occupational exposure. Section natural aquatic environment.
disclosed publicly by EPA without prior 408(b)(2)(C) of FFDCA requires EPA to 2. The polymer does contain as an
notice. Submit the non-CBI copy of your give special consideration to exposure integral part of its composition the
objection or hearing request, identified of infants and children to the pesticide atomic elements carbon, hydrogen, and
by docket ID number EPA–HQ–OPP– chemical residue in establishing an oxygen.
2015–0485, by one of the following exemption from the requirement of a
methods. tolerance and to ‘‘ensure that there is a 3. The polymer does not contain as an
• Federal eRulemaking Portal: http:// reasonable certainty that no harm will integral part of its composition, except
www.regulations.gov. Follow the online result to infants and children from as impurities, any element other than
instructions for submitting comments. aggregate exposure to the pesticide those listed in 40 CFR 723.250(d)(2)(ii).
Do not submit electronically any chemical residue . . .’’ and specifies 4. The polymer is neither designed
information you consider to be CBI or factors EPA is to consider in nor can it be reasonably anticipated to
other information whose disclosure is establishing an exemption. substantially degrade, decompose, or
restricted by statute. depolymerize.
• Mail: OPP Docket, Environmental III. Risk Assessment and Statutory
Protection Agency Docket Center (EPA/ Findings 5. The polymer is manufactured or
DC), (28221T), 1200 Pennsylvania Ave. imported from monomers and/or
EPA establishes exemptions from the reactants that are already included on
NW., Washington, DC 20460–0001. requirement of a tolerance only in those
• Hand Delivery: To make special cases where it can be shown that the
the TSCA Chemical Substance
arrangements for hand delivery or Inventory or manufactured under an
risks from aggregate exposure to applicable TSCA section 5 exemption.
delivery of boxed information, please pesticide chemical residues under
follow the instructions at http:// reasonably foreseeable circumstances 6. The polymer is not a water
www.epa.gov/dockets/contacts.html. will pose no appreciable risks to human absorbing polymer with a number
Additional instructions on average molecular weight (MW) greater
health. In order to determine the risks
commenting or visiting the docket, than or equal to 10,000 Daltons.
from aggregate exposure to pesticide
along with more information about
inert ingredients, the Agency considers Additionally, the polymer also meets
dockets generally, is available at http://
the toxicity of the inert in conjunction as required the following exemption
www.epa.gov/dockets.
with possible exposure to residues of criteria specified in 40 CFR 723.250(e).
II. Background and Statutory Findings the inert ingredient through food, 7. The polymer’s minimum number
In the Federal Register of Wednesday, drinking water, and through other average MW (in amu) of 1,500 is greater
August 26, 2015 (80 FR 51763) (FRL– exposures that occur as a result of
than 1,000 and less than 10,000 Daltons.
9931–74), EPA issued a document pesticide use in residential settings. If
The polymer contains less than 10%
pursuant to FFDCA section 408, 21 EPA is able to determine that a finite
oligomeric material below MW 500 and
U.S.C. 346a, announcing the receipt of tolerance is not necessary to ensure that
less than 25% oligomeric material
a pesticide petition (PP IN–10837) filed there is a reasonable certainty that no
below MW 1,000, and the polymer does
by Stepan Company, 22 West Frontage harm will result from aggregate
not contain any reactive functional
Road, Northfield, IL 60093. The petition exposure to the inert ingredient, an
groups.
requested that 40 CFR 180.960 be exemption from the requirement of a
tolerance may be established. Thus, the polymer meets the criteria
amended by establishing an exemption
from the requirement of a tolerance for Consistent with FFDCA section for a polymer to be considered low risk
residues of Alpha-[2,4,6-Tris[1- 408(b)(2)(D), EPA has reviewed the under 40 CFR 723.250. Based on its
(phenyl)ethyl]phenyl]-Omega-hydroxy available scientific data and other conformance to the criteria in this unit,
poly(oxyethylene) poly(oxypropylene) relevant information in support of this no mammalian toxicity is anticipated
copolymer, the poly(oxypropylene) action and considered its validity, from dietary, inhalation, or dermal
content averages 2–8 moles, the completeness and reliability and the exposure to the polymer.
poly(oxyethylene) content averages 16– relationship of this information to IV. Aggregate Exposures
30 moles; CAS No. 70880–56–7. That human risk. EPA has also considered
document included a summary of the available information concerning the For the purposes of assessing
petition prepared by the petitioner and variability of the sensitivities of major potential exposure under this
solicited comments on the petitioner’s identifiable subgroups of consumers, exemption, EPA considered that the
request. The Agency did not receive any including infants and children. In the polymer could be present in all raw and
comments. case of certain chemical substances that processed agricultural commodities and
Section 408(c)(2)(A)(i) of FFDCA are defined as polymers, the Agency has drinking water, and that non-
allows EPA to establish an exemption established a set of criteria to identify occupational non-dietary exposure was
from the requirement for a tolerance (the categories of polymers expected to possible. The number average MW of
legal limit for a pesticide chemical present minimal or no risk. The the polymer is 1,500 Daltons. Generally,
residue in or on a food) only if EPA definition of a polymer is given in 40 a polymer of this size would be poorly
determines that the exemption is ‘‘safe.’’ CFR 723.250(b) and the exclusion absorbed through the intact
Section 408(c)(2)(A)(ii) of FFDCA criteria for identifying these low-risk gastrointestinal tract or through intact
asabaliauskas on DSK3SPTVN1PROD with RULES
defines ‘‘safe’’ to mean that ‘‘there is a polymers are described in 40 CFR human skin. Since the polymer conform
reasonable certainty that no harm will 723.250(d). The polymer conforms to to the criteria that identify a low-risk
result from aggregate exposure to the the definition of a polymer given in 40 polymer, there are no concerns for risks
pesticide chemical residue, including CFR 723.250(b) and meets the following associated with any potential exposure
all anticipated dietary exposures and all criteria that are used to identify low-risk scenarios that are reasonably
other exposures for which there is polymers: foreseeable. The Agency has determined
reliable information.’’ This includes 1. The polymer is not a cationic that a tolerance is not necessary to
exposure through drinking water and polymer nor is it reasonably anticipated protect the public health.
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V. Cumulative Effects From Substances possible, consistent with U.S. food Since tolerances and exemptions that
With a Common Mechanism of Toxicity safety standards and agricultural are established on the basis of a petition
Section 408(b)(2)(D)(v) of FFDCA practices. EPA considers the under FFDCA section 408(d), such as
requires that, when considering whether international maximum residue limits the tolerance in this final rule, do not
to establish, modify, or revoke a (MRLs) established by the Codex require the issuance of a proposed rule,
tolerance, the Agency consider Alimentarius Commission (Codex), as the requirements of the Regulatory
‘‘available information’’ concerning the required by FFDCA section 408(b)(4). Flexibility Act (RFA) (5 U.S.C. 601 et
cumulative effects of a particular The Codex Alimentarius is a joint seq.), do not apply.
pesticide’s residues and ‘‘other United Nations Food and Agriculture
Organization/World Health This action directly regulates growers,
substances that have a common food processors, food handlers, and food
mechanism of toxicity.’’ Organization food standards program,
and it is recognized as an international retailers, not States or tribes, nor does
EPA has not found the polymer to this action alter the relationships or
share a common mechanism of toxicity food safety standards-setting
organization in trade agreements to distribution of power and
with any other substances, and the
which the United States is a party. EPA responsibilities established by Congress
polymer does not appear to produce a
may establish a tolerance that is in the preemption provisions of FFDCA
toxic metabolite produced by other
substances. For the purposes of this different from a Codex MRL; however, section 408(n)(4). As such, the Agency
tolerance action, therefore, EPA has FFDCA section 408(b)(4) requires that has determined that this action will not
assumed that the polymer does not have EPA explain the reasons for departing have a substantial direct effect on States
a common mechanism of toxicity with from the Codex level. or tribal governments, on the
other substances. For information The Codex has not established a MRL relationship between the national
regarding EPA’s efforts to determine for Alpha-[2,4,6–Tris[1– government and the States or tribal
which chemicals have a common (phenyl)ethyl]phenyl]–Omega–hydroxy governments, or on the distribution of
mechanism of toxicity and to evaluate poly(oxyethylene) poly(oxypropylene) power and responsibilities among the
the cumulative effects of such copolymer, the poly(oxypropylene) various levels of government or between
chemicals, see EPA’s Web site at content averages 2–8 moles, the the Federal Government and Indian
http://www.epa.gov/pesticides/ poly(oxyethylene) content averages 16– tribes. Thus, the Agency has determined
cumulative. 30 moles. that Executive Order 13132, entitled
VI. Additional Safety Factor for the IX. Conclusion ‘‘Federalism’’ (64 FR 43255, August 10,
Protection of Infants and Children 1999) and Executive Order 13175,
Accordingly, EPA finds that entitled ‘‘Consultation and Coordination
Section 408(b)(2)(C) of FFDCA exempting residues of the polymer from with Indian Tribal Governments’’ (65 FR
provides that EPA shall apply an the requirement of a tolerance will be 67249, November 9, 2000) do not apply
additional tenfold margin of safety for safe. to this action. In addition, this action
infants and children in the case of
X. Statutory and Executive Order does not impose any enforceable duty or
threshold effects to account for prenatal
Reviews contain any unfunded mandate as
and postnatal toxicity and the
described under Title II of the Unfunded
completeness of the data base unless This action establishes a tolerance
EPA concludes that a different margin of Mandates Reform Act (UMRA) (2 U.S.C.
under FFDCA section 408(d) in
safety will be safe for infants and response to a petition submitted to the 1501 et seq.).
children. Due to the expected low Agency. The Office of Management and This action does not involve any
toxicity of the polymer, EPA has not Budget (OMB) has exempted these types technical standards that would require
used a safety factor analysis to assess of actions from review under Executive Agency consideration of voluntary
the risk. For the same reasons the Order 12866, entitled ‘‘Regulatory consensus standards pursuant to section
additional tenfold safety factor is Planning and Review’’ (58 FR 51735, 12(d) of the National Technology
unnecessary. October 4, 1993). Because this action Transfer and Advancement Act
has been exempted from review under (NTTAA) (15 U.S.C. 272 note).
VII. Determination of Safety
Executive Order 12866, this action is
Based on the conformance to the not subject to Executive Order 13211, XI. Congressional Review Act
criteria used to identify a low-risk entitled ‘‘Actions Concerning
polymer, EPA concludes that there is a Pursuant to the Congressional Review
Regulations That Significantly Affect
reasonable certainty of no harm to the Act (5 U.S.C. 801 et seq.), EPA will
Energy Supply, Distribution, or Use’’ (66
U.S. population, including infants and submit a report containing this rule and
FR 28355, May 22, 2001) or Executive
children, from aggregate exposure to Order 13045, entitled ‘‘Protection of other required information to the U.S.
residues of the polymer. Children from Environmental Health Senate, the U.S. House of
Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller
VIII. Other Considerations General of the United States prior to
April 23, 1997). This action does not
A. Analytical Enforcement Methodology contain any information collections publication of the rule in the Federal
An analytical method is not required subject to OMB approval under the Register. This action is not a ‘‘major
for enforcement purposes since the Paperwork Reduction Act (PRA) (44 rule’’ as defined by 5 U.S.C. 804(2).
asabaliauskas on DSK3SPTVN1PROD with RULES
Agency is establishing an exemption U.S.C. 3501 et seq.), nor does it require List of Subjects in 40 CFR Part 180
from the requirement of a tolerance any special considerations under
without any numerical limitation. Executive Order 12898, entitled Environmental protection,
‘‘Federal Actions to Address Administrative practice and procedure,
B. International Residue Limits Environmental Justice in Minority Agricultural commodities, Pesticides
In making its tolerance decisions, EPA Populations and Low-Income and pests, Reporting and recordkeeping
seeks to harmonize U.S. tolerances with Populations’’ (59 FR 7629, February 16, requirements.
international standards whenever 1994).
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![Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Rules and Regulations 10779
Dated: February 24, 2016. PART 180—[AMENDED] ■ 2. In § 180.960, add alphabetically the
Susan Lewis, following entry in the table to read as
Director Registration Division, Office of ■ 1. The authority citation for part 180 follows:
Pesticide Programs. continues to read as follows: § 180.960 Polymers; exemptions from the
Therefore, 40 CFR chapter I is Authority: 21 U.S.C. 321(q), 346a and 371. requirement of a tolerance.
amended as follows: * * * * *
Polymer CAS No.
* * * * * * *
Alpha–[2,4,6–Tris[1–(phenyl)ethyl]phenyl]–Omega-hydroxy poly(oxyethylene) poly(oxypropylene) copolymer, the
poly(oxypropylene) content averages 2–8 moles, the poly(oxyethylene) content averages 16–30 moles. Minimum number-
average molecular weight (in amu) of 1,500 ............................................................................................................................. 70880–56–7
* * * * * * *
[FR Doc. 2016–04599 Filed 3–1–16; 8:45 am]
BILLING CODE 6560–50–P
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Document Created: 2018-02-02 15:04:01
Document Modified: 2018-02-02 15:04:01
| 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 March 2, 2016. Objections and requests for hearings must be received on or before May 2, 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 | 81 FR 10776 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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