Styrene-2-Ethylhexyl Acrylate Copolymer; Tolerance Exemption, 6213-6216 [2013-02011]

Download as PDF Federal Register / Vol. 78, No. 20 / Wednesday, January 30, 2013 / Rules and Regulations may enforce the rules in this section. In the navigable waters of the United States to which this section applies, when immediate action is required and representatives of the Coast Guard are not present or are not present in sufficient force to provide effective enforcement of this section, any Federal Law Enforcement Officer, Oregon Law Enforcement Officer, or Washington Law Enforcement Officer may enforce the rules contained in this section pursuant to 46 U.S.C. 70118. In addition, the Captain of the Port may be assisted by other federal, state, or local agencies in enforcing this section. (h) Waiver. The Captain of the Port Columbia River may waive any of the requirements of this section for any vessel or class of vessels upon finding that operational conditions or other circumstances are such that application of this section is unnecessary or impractical for the purpose of port safety or environmental safety. filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). Dated: January 17, 2013. B.C. Jones, Captain, U.S. Coast Guard, Captain of the Port, Sector Columbia River. FOR FURTHER INFORMATION CONTACT: Mark Dow, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW. Washington, DC 20460–0001; telephone number: (703) 305–5533; email address: dow.mark@epa.gov. [FR Doc. 2013–01941 Filed 1–29–13; 8:45 am] BILLING CODE 9110–04–P ENVIRONMENTAL PROTECTION AGENCY SUPPLEMENTARY INFORMATION: I. General Information 40 CFR Part 180 A. Does this action apply to me? [EPA–HQ–OPP–2012–0456; FRL–9367–2] Styrene-2-Ethylhexyl Acrylate Copolymer; Tolerance Exemption Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-ethylhexyl ester, polymer with ethenylbenzene; also known as styrene2-ethylhexyl acrylate copolymer when used as an inert ingredient in a pesticide chemical formulation. H. B. Fuller Company 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 2propenoic acid, 2-Ethylhexyl Ester, Polymer with Ethenylbenzene on food or feed commodities. DATES: This regulation is effective January 30, 2013. Objections and requests for hearings must be received on or before April 1, 2013, and must be sroberts on DSK5SPTVN1PROD with SUMMARY: VerDate Mar<15>2010 15:43 Jan 29, 2013 The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0456, 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), EPA West 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. ADDRESSES: Jkt 229001 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:// ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 6213 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–2012–0456 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 April 1, 2013. 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– 2012–0456, 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.htm. 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 August 22, 2012 (77 FR 50661) (FRL–9358–9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 2E8033) filed by H.B. Fuller Company (1200 Willow Lake Boulevard, St. Paul, MN 55110–5101). The petition requested that 40 CFR 180.960 be amended by establishing an exemption E:\FR\FM\30JAR1.SGM 30JAR1 6214 Federal Register / Vol. 78, No. 20 / Wednesday, January 30, 2013 / Rules and Regulations sroberts on DSK5SPTVN1PROD with from the requirement of a tolerance for residues of 2-propenoic acid, 2ethylhexyl ester, polymer with ethenylbenzene; CAS No. 25153–46–2. 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, VerDate Mar<15>2010 15:43 Jan 29, 2013 Jkt 229001 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). Styrene-2-ethylhexyl acrylate copolymer 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 number average MW of 14,000 daltons 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, styrene-2-ethylhexyl acrylate copolymer 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 styrene-2-ethylhexyl acrylate copolymer. PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that styrene-2-ethylhexyl acrylate copolymer could be present in all raw and processed agricultural commodities and drinking water, and that nonoccupational non-dietary exposure was possible. The number average MW of styrene-2-ethylhexyl acrylate copolymer is 14,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since styrene-2-ethylhexyl acrylate copolymer conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found styrene-2ethylhexyl acrylate copolymer to share a common mechanism of toxicity with any other substances, and styrene-2ethylhexyl acrylate copolymer does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that styrene-2-ethylhexyl acrylate copolymer 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 styrene-2-ethylhexyl acrylate E:\FR\FM\30JAR1.SGM 30JAR1 Federal Register / Vol. 78, No. 20 / Wednesday, January 30, 2013 / Rules and Regulations copolymer, 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 styrene-2-ethylhexyl acrylate copolymer. VIII. Other Considerations A. Existing Exemptions From a Tolerance There are no existing exemptions from the requirements of a tolerance. 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 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 styrene-2-ethylhexyl acrylate copolymer. sroberts on DSK5SPTVN1PROD with IX. Conclusion Accordingly, EPA finds that exempting residues of styrene-2ethylhexyl acrylate copolymer from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and VerDate Mar<15>2010 15:43 Jan 29, 2013 Jkt 229001 Budget (OMB) has exempted these rules from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 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 of 1995 (NTTAA) (15 U.S.C. 272 note). 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 final rule 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, or otherwise have any unique impacts on local governments. 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 6215 Although this action does not 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), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or lowincome populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population. 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: January 23, 2013. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.960, the table is amended by adding alphabetically the following polymer to read as follows: ■ § 180.960 Polymers; exemptions from the requirement of a tolerance. * E:\FR\FM\30JAR1.SGM * * 30JAR1 * * 6216 Federal Register / Vol. 78, No. 20 / Wednesday, January 30, 2013 / Rules and Regulations Polymer CAS No. * * * * * 2-Propenoic acid, 2-ethylhexyl ester, polymer with ethenylbenzene 14,000 daltons ....................................... 25153–46–2 * * * * * [FR Doc. 2013–02011 Filed 1–29–13; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF THE INTERIOR Office of the Secretary David J. Hayes, Deputy Secretary of the Interior. 43 CFR Part 2 [FR Doc. 2013–02064 Filed 1–29–13; 8:45 am] BILLING CODE 4310–10–P RIN 1093–AA15 Freedom of Information Act Regulations Office of the Secretary, Interior. ACTION: Final rule; correction. AGENCY: This document contains corrections to the final rule published on December 31, 2012 (77 FR 76898). The regulation revises the Department’s Freedom of Information Act regulations. DATES: Effective January 30, 2013 FOR FURTHER INFORMATION CONTACT: Cindy Cafaro, Office of Executive Secretariat and Regulatory Affairs, 202– 208–5342. SUPPLEMENTARY INFORMATION: We published a document in the Federal Register on December 31, 2012, revising the Department of the Interior Freedom of Information Act (FOIA) regulations. This document inadvertently omitted amendatory language needed to replace a phrase, to amend a sentence, and to renumber the sections in several redesignated subparts. This publication corrects that omission. SUMMARY: sroberts on DSK5SPTVN1PROD with Correction of Publication Accordingly, the publication on December 31, 2012, of the final rule that was the subject of FR Doc. 2012–31117, is corrected as follows: ■ 1. On page 76902, in the third column, revise numbered instruction 3 to read as follows: ‘‘3. Subpart F (consisting of § 2.41), subpart G (consisting of §§ 2.45 through 2.79), and subpart H (consisting of §§ 2.80 through 2.90) are redesignated as subpart J (consisting of § 2.200), subpart K (consisting of §§ 2.220 through 2.254), and subpart L (consisting of §§ 2.280 through 2.290).’’ VerDate Mar<15>2010 19:37 Jan 29, 2013 2. On page 76903, in the third column, in § 2.5(d), remove the words ‘‘does not hear from you’’ and add in their place the words ‘‘does not receive a written response.’’ ■ 3. On page 76911, in the first column, in paragraph (b)(1), remove the words ‘‘hears from you’’ and add in their place the words ‘‘receives a written response.’’ ■ 4. On page 76905, in the first column, add the following sentence at the end of paragraph (h): If you believe this response was in error, you may file an appeal in accordance with the procedures in § 2.59. ■ Jkt 229001 FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 4 [PS Docket No. 11–82; DA 12–1962] Extension of the Commission’s Rules Regarding Outage Reporting to Interconnected Voice Over Internet Protocol Service Providers and Broadband Internet Service Providers Federal Communications Commission. ACTION: Final rule; correction. AGENCY: This document contains a correction to text in the Report and Order, FCC 12–22, adopted on February 15, 2012 and released on February 21, 2012, in PS Docket No. 11–82. The Report and Order was published in the Federal Register on Friday, April 27, 2012. This document also contains a related correction to text in the Federal Register but makes no changes to the final rules. DATES: This correction is effective January 30, 2013. The rules in the Report and Order contain information collection requirements. The Federal Communications Commission published a document in the Federal Register announcing that OMB approved the information collection and that the rules in the Report and Order became effective December 16, 2012 (77 FR 63757). FOR FURTHER INFORMATION CONTACT: Gregory Intoccia, Special Counsel, Cybersecurity and Communications Reliability Division, Public Safety and Homeland Security Bureau, (202) 418– SUMMARY: PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 1470 or gregory.intoccia@fcc.gov (email). On February 21, 2012, the Federal Communications Commission released a Report and Order, FCC 12–22, in PS Docket No. 11–82, which was published at 27 FCC Rcd 2650 (2012). Under delegated authority, the Public Safety and Homeland Security Bureau of the Federal Communications Commission adopted and released Order DA 12–1962 on December 6, 2012. Order DA 12– 1962, an Erratum, made a correction to the second sentence of paragraph 89 of the Report and Order. Specifically, in paragraph 89, in the second sentence, the phrase ‘‘(1) that potentially affects at least 900,000 users;’’ was corrected to read as ‘‘(1) that potentially affects at least 900,000 user minutes of interconnected VoIP service and results in complete loss of service;’’. The change was made to correct some inconsistency with the related rule and with text in several other places in the Report in Order reflecting language identical to the rule. In FR Doc. 2012– 9749, which appears on pages 25088 through 25097 in the Federal Register of Friday, April 27, 2012 (77 FR 25088), the following correction is made: SUPPLEMENTARY INFORMATION: On page 25094, the first column in the Discussion section, paragraph 52. second sentence, ‘‘We apply to interconnected VoIP service providers the obligation to report when they have experienced, on any facilities that they own, operate, lease, or otherwise utilize, an outage of at least 30 minutes duration: (1) That potentially affects at least 900,000 users; * * *’’ is corrected to read ‘‘We apply to interconnected VoIP service providers the obligation to report when they have experienced, on any facilities that they own, operate, lease, or otherwise utilize, an outage of at least 30 minutes duration: (1) That potentially affects at least 900,000 user minutes of interconnected VoIP service and results in complete loss of service; * * *.’’ The Bureau has not changed the text of the final rules that amended 47 CFR part 4. Federal Communications Commission. David S. Turetsky, Chief, Public Safety and Homeland Security Bureau. [FR Doc. 2013–01996 Filed 1–29–13; 8:45 am] BILLING CODE 6712–01–P E:\FR\FM\30JAR1.SGM 30JAR1

Agencies

[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Rules and Regulations]
[Pages 6213-6216]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02011]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0456; FRL-9367-2]


Styrene-2-Ethylhexyl Acrylate 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 2-propenoic acid, 2-ethylhexyl ester, 
polymer with ethenylbenzene; also known as styrene-2-ethylhexyl 
acrylate copolymer when used as an inert ingredient in a pesticide 
chemical formulation. H. B. Fuller Company 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, 2-Ethylhexyl Ester, Polymer with 
Ethenylbenzene on food or feed commodities.

DATES: This regulation is effective January 30, 2013. Objections and 
requests for hearings must be received on or before April 1, 2013, 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-2012-0456, 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), EPA West 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: Mark Dow, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW. Washington, DC 20460-0001; telephone number: 
(703) 305-5533; email address: dow.mark@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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-2012-0456 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 
April 1, 2013. 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-2012-0456, 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.htm.
    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 August 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (PP 2E8033) filed 
by H.B. Fuller Company (1200 Willow Lake Boulevard, St. Paul, MN 55110-
5101). The petition requested that 40 CFR 180.960 be amended by 
establishing an exemption

[[Page 6214]]

from the requirement of a tolerance for residues of 2-propenoic acid, 
2-ethylhexyl ester, polymer with ethenylbenzene; CAS No. 25153-46-2. 
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). Styrene-2-ethylhexyl acrylate copolymer 
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 number average MW of 14,000 daltons 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, styrene-2-ethylhexyl acrylate copolymer 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 styrene-2-
ethylhexyl acrylate copolymer.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that styrene-2-ethylhexyl acrylate copolymer 
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 styrene-2-ethylhexyl acrylate 
copolymer is 14,000 daltons. Generally, a polymer of this size would be 
poorly absorbed through the intact gastrointestinal tract or through 
intact human skin. Since styrene-2-ethylhexyl acrylate copolymer 
conforms to the criteria that identify a low-risk polymer, there are no 
concerns for risks associated with any potential exposure scenarios 
that are reasonably foreseeable. The Agency has determined that a 
tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA has not found styrene-2-ethylhexyl acrylate copolymer to share 
a common mechanism of toxicity with any other substances, and styrene-
2-ethylhexyl acrylate copolymer does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that styrene-2-ethylhexyl 
acrylate copolymer 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 styrene-2-ethylhexyl 
acrylate

[[Page 6215]]

copolymer, 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 styrene-2-ethylhexyl acrylate 
copolymer.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    There are no existing exemptions from the requirements of a 
tolerance.

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 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 styrene-2-ethylhexyl 
acrylate copolymer.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of styrene-2-
ethylhexyl acrylate copolymer from the requirement of a tolerance will 
be safe.

X. Statutory and Executive Order Reviews

    This final rule 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 rules from review under 
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 
FR 51735, October 4, 1993). Because this final rule has been exempted 
from review under Executive Order 12866, this final rule 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 final rule 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 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 of 1995 (NTTAA) (15 U.S.C. 272 
note).
    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 final rule 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, or otherwise have any unique 
impacts on local governments. 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 final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (2 U.S.C. 1501 et seq.).
    Although this action does not 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), EPA seeks to achieve 
environmental justice, the fair treatment and meaningful involvement of 
any group, including minority and/or low-income populations, in the 
development, implementation, and enforcement of environmental laws, 
regulations, and policies. As such, to the extent that information is 
publicly available or was submitted in comments to EPA, the Agency 
considered whether groups or segments of the population, as a result of 
their location, cultural practices, or other factors, may have atypical 
or disproportionately high and adverse human health impacts or 
environmental effects from exposure to the pesticide discussed in this 
document, compared to the general population.

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: January 23, 2013.
Lois Rossi,
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, the table is amended by adding alphabetically the 
following polymer to read as follows:


Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

[[Page 6216]]



------------------------------------------------------------------------
                          Polymer                              CAS No.
------------------------------------------------------------------------
 
                                * * * * *
2-Propenoic acid, 2-ethylhexyl ester, polymer with            25153-46-2
 ethenylbenzene 14,000 daltons.............................
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2013-02011 Filed 1-29-13; 8:45 am]
BILLING CODE 6560-50-P