82 FR 2897 - Butanedioic Acid, 2-Methylene-, Telomer With Sodium Phosphinate (1:1), Acidified, Potassium Salts; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 6 (January 10, 2017)
Federal Register Volume 82, Issue 6 (January 10, 2017)
| Page Range | 2897-2900 | |
| FR Document | 2016-31830 |
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)] [Rules and Regulations] [Pages 2897-2900] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31830] [[Page 2897]] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0487; FRL-9954-53] Butanedioic Acid, 2-Methylene-, Telomer With Sodium Phosphinate (1:1), Acidified, Potassium Salts; 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 butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts when used as an inert ingredient in a pesticide chemical formulation. Itaconix 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 butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts on food or feed commodities. DATES: This regulation is effective January 10, 2017. Objections and requests for hearings must be received on or before March 13, 2017, 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-2016-0487, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. Can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0487 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 March 13, 2017. 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-2016-0487, 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 18, 2016 (Vol. 81, 71668) (FRL- 9952-19), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 10922) filed by Itaconix, 2 Marin Way, Stratham, NH 03885. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts; CAS Reg. No. 1663489-14-2. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. There were no comments received in response to the notice of 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 [[Page 2898]] 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). Butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts 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 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, butanedioic acid, 2- methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts 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 butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salt is 3800 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salt 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 butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts to share a common mechanism of toxicity with any other substances, and butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts 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 butanedioic acid, 2- methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts, 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 butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts. [[Page 2899]] 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 butanedioic acid, 2- methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts. IX. Conclusion Accordingly, EPA finds that exempting residues of butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salts from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). XI. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 18, 2016. Michael Goodis, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.960, add alphabetically the polymer in the table to read as follows: Sec. [emsp14]180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * Butanedioic acid, 2-methylene-, telomer with sodium 1663489-14-2 phosphinate (1:1), acidified, potassium salt minimum number average molecular weight (in amu), 3800......... * * * * * * * ------------------------------------------------------------------------ [[Page 2900]] [FR Doc. 2016-31830 Filed 1-9-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Rules and Regulations 2897
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
AGENCY www.regulations.gov. Follow the online
I. General Information
instructions for submitting comments.
40 CFR Part 180 A. Does this action apply to me? Do not submit electronically any
[EPA–HQ–OPP–2016–0487; FRL–9954–53] You may be potentially affected by information you consider to be CBI or
other information whose disclosure is
this action if you are an agricultural
Butanedioic Acid, 2-Methylene-, restricted by statute.
producer, food manufacturer, or
Telomer With Sodium Phosphinate • Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
(1:1), Acidified, Potassium Salts; list of North American Industrial
Tolerance Exemption DC), (28221T), 1200 Pennsylvania Ave.
Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
AGENCY: Environmental Protection not intended to be exhaustive, but rather • Hand Delivery: To make special
Agency (EPA). provides a guide to help readers arrangements for hand delivery or
ACTION: Final rule. determine whether this document delivery of boxed information, please
applies to them. Potentially affected follow the instructions at http://
SUMMARY: This regulation establishes an entities may include: www.epa.gov/dockets/contacts.html.
exemption from the requirement of a • Crop production (NAICS code 111). Additional instructions on commenting
tolerance for residues of butanedioic • Animal production (NAICS code or visiting the docket, along with more
acid, 2-methylene-, telomer with 112). information about dockets generally, is
sodium phosphinate (1:1), acidified, • Food manufacturing (NAICS code available at http://www.epa.gov/
potassium salts when used as an inert 311). dockets.
ingredient in a pesticide chemical • Pesticide manufacturing (NAICS
formulation. Itaconix submitted a code 32532). II. Background and Statutory Findings
petition to EPA under the Federal Food, In the Federal Register of October 18,
Drug, and Cosmetic Act (FFDCA), B. How can I get electronic access to
other related information? 2016 (Vol. 81, 71668) (FRL–9952–19),
requesting an exemption from the EPA issued a document pursuant to
requirement of a tolerance. This You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
regulation eliminates the need to electronic version of 40 CFR part 180 announcing the receipt of a pesticide
establish a maximum permissible level through the Government Printing petition (PP 10922) filed by Itaconix, 2
for residues of butanedioic acid, 2- Office’s e-CFR site at http:// Marin Way, Stratham, NH 03885. The
methylene-, telomer with sodium www.ecfr.gov/cgi-bin/text- petition requested that 40 CFR 180.960
phosphinate (1:1), acidified, potassium idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ be amended by establishing an
salts on food or feed commodities. 40tab_02.tpl. exemption from the requirement of a
DATES: This regulation is effective tolerance for residues of butanedioic
C. Can I file an objection or hearing
January 10, 2017. Objections and acid, 2-methylene-, telomer with
request?
requests for hearings must be received sodium phosphinate (1:1), acidified,
on or before March 13, 2017, and must Under FFDCA section 408(g), 21 potassium salts; CAS Reg. No. 1663489–
be filed in accordance with the U.S.C. 346a, any person may file an 14–2. That document included a
instructions provided in 40 CFR part objection to any aspect of this regulation summary of the petition prepared by the
178 (see also Unit I.C. of the and may also request a hearing on those petitioner and solicited comments on
SUPPLEMENTARY INFORMATION). objections. You must file your objection the petitioner’s request. There were no
ADDRESSES: The docket for this action, or request a hearing on this regulation comments received in response to the
identified by docket identification (ID) in accordance with the instructions notice of filing. Section 408(c)(2)(A)(i) of
number EPA–HQ–OPP–2016–0487, is provided in 40 CFR part 178. To ensure FFDCA allows EPA to establish an
available at http://www.regulations.gov proper receipt by EPA, you must exemption from the requirement for a
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– tolerance (the legal limit for a pesticide
Regulatory Public Docket (OPP Docket) OPP–2016–0487 in the subject line on chemical residue in or on a food) only
in the Environmental Protection Agency the first page of your submission. All if EPA determines that the exemption is
Docket Center (EPA/DC), West William objections and requests for a hearing ‘‘safe.’’ Section 408(c)(2)(A)(ii) of
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be FFDCA defines ‘‘safe’’ to mean that
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or ‘‘there is a reasonable certainty that no
20460–0001. The Public Reading Room before March 13, 2017. Addresses for harm will result from aggregate
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections exposure to the pesticide chemical
Monday through Friday, excluding legal and hearing requests are provided in 40 residue, including all anticipated
holidays. The telephone number for the CFR 178.25(b). dietary exposures and all other
Public Reading Room is (202) 566–1744, In addition to filing an objection or exposures for which there is reliable
and the telephone number for the OPP hearing request with the Hearing Clerk information.’’ This includes exposure
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please through drinking water and use in
the visitor instructions and additional submit a copy of the filing (excluding residential settings, but does not include
information about the docket available any Confidential Business Information occupational exposure. Section
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. 408(b)(2)(C) of FFDCA requires EPA to
FOR FURTHER INFORMATION CONTACT: Information not marked confidential give special consideration to exposure
pmangrum on DSK3GDR082PROD with RULES
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be of infants and children to the pesticide
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior chemical residue in establishing an
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your exemption from the requirement of a
Pennsylvania Ave. NW., Washington, objection or hearing request, identified tolerance and to ‘‘ensure that there is a
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP– reasonable certainty that no harm will
number: (703) 305–7090; email address: 2016–0487, by one of the following result to infants and children from
RDFRNotices@epa.gov. methods. aggregate exposure to the pesticide
VerDate Sep<11>2014 14:51 Jan 09, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\10JAR1.SGM 10JAR1](https://thefederalregister.org/doc/82_FR_2903/page/1.svg)
![Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Rules and Regulations 2899
VIII. Other Considerations Planning and Review’’ (58 FR 51735, with Indian Tribal Governments’’ (65 FR
October 4, 1993). Because this action 67249, November 9, 2000) do not apply
A. Analytical Enforcement Methodology
has been exempted from review under to this action. In addition, this action
An analytical method is not required Executive Order 12866, this action is does not impose any enforceable duty or
for enforcement purposes since the not subject to Executive Order 13211, contain any unfunded mandate as
Agency is establishing an exemption entitled ‘‘Actions Concerning described under Title II of the Unfunded
from the requirement of a tolerance Regulations That Significantly Affect Mandates Reform Act (UMRA) (2 U.S.C.
without any numerical limitation. Energy Supply, Distribution, or Use’’ (66 1501 et seq.).
B. International Residue Limits FR 28355, May 22, 2001) or Executive This action does not involve any
Order 13045, entitled ‘‘Protection of technical standards that would require
In making its tolerance decisions, EPA Children from Environmental Health
seeks to harmonize U.S. tolerances with Agency consideration of voluntary
Risks and Safety Risks’’ (62 FR 19885, consensus standards pursuant to section
international standards whenever April 23, 1997). This action does not
possible, consistent with U.S. food 12(d) of the National Technology
contain any information collections Transfer and Advancement Act
safety standards and agricultural subject to OMB approval under the
practices. EPA considers the (NTTAA) (15 U.S.C. 272 note).
Paperwork Reduction Act (PRA) (44
international maximum residue limits XI. Congressional Review Act
U.S.C. 3501 et seq.), nor does it require
(MRLs) established by the Codex
any special considerations under Pursuant to the Congressional Review
Alimentarius Commission (Codex), as
Executive Order 12898, entitled Act (5 U.S.C. 801 et seq.), EPA will
required by FFDCA section 408(b)(4).
‘‘Federal Actions to Address submit a report containing this rule and
The Codex Alimentarius is a joint
Environmental Justice in Minority other required information to the U.S.
United Nations Food and Agriculture
Populations and Low-Income Senate, the U.S. House of
Organization/World Health
Populations’’ (59 FR 7629, February 16, Representatives, and the Comptroller
Organization food standards program,
1994). General of the United States prior to
and it is recognized as an international
Since tolerances and exemptions that publication of the rule in the Federal
food safety standards-setting
are established on the basis of a petition Register. This action is not a ‘‘major
organization in trade agreements to
under FFDCA section 408(d), such as rule’’ as defined by 5 U.S.C. 804(2).
which the United States is a party. EPA
the tolerance in this final rule, do not
may establish a tolerance that is List of Subjects in 40 CFR Part 180
require the issuance of a proposed rule,
different from a Codex MRL; however,
the requirements of the Regulatory
FFDCA section 408(b)(4) requires that Environmental protection,
Flexibility Act (RFA) (5 U.S.C. 601 et
EPA explain the reasons for departing Administrative practice and procedure,
seq.), do not apply.
from the Codex level. Agricultural commodities, Pesticides
This action directly regulates growers,
The Codex has not established a MRL and pests, Reporting and recordkeeping
food processors, food handlers, and food
for butanedioic acid, 2-methylene-, requirements.
telomer with sodium phosphinate (1:1), retailers, not States or tribes, nor does
this action alter the relationships or Dated: November 18, 2016.
acidified, potassium salts.
distribution of power and Michael Goodis,
IX. Conclusion responsibilities established by Congress Acting Director, Registration Division, Office
Accordingly, EPA finds that in the preemption provisions of FFDCA of Pesticide Programs.
exempting residues of butanedioic acid, section 408(n)(4). As such, the Agency Therefore, 40 CFR chapter I is
2-methylene-, telomer with sodium has determined that this action will not amended as follows:
phosphinate (1:1), acidified, potassium have a substantial direct effect on States
salts from the requirement of a tolerance or tribal governments, on the PART 180—[AMENDED]
will be safe. relationship between the national
government and the States or tribal ■ 1. The authority citation for part 180
X. Statutory and Executive Order governments, or on the distribution of continues to read as follows:
Reviews power and responsibilities among the
Authority: 21 U.S.C. 321(q), 346a and 371.
This action establishes a tolerance various levels of government or between
under FFDCA section 408(d) in the Federal Government and Indian ■ 2. In § 180.960, add alphabetically the
response to a petition submitted to the tribes. Thus, the Agency has determined polymer in the table to read as follows:
Agency. The Office of Management and that Executive Order 13132, entitled
Budget (OMB) has exempted these types ‘‘Federalism’’ (64 FR 43255, August 10, § 180.960 Polymers; exemptions from the
of actions from review under Executive 1999) and Executive Order 13175, requirement of a tolerance.
Order 12866, entitled ‘‘Regulatory entitled ‘‘Consultation and Coordination * * * * *
Polymer CAS No.
* * * * * * *
Butanedioic acid, 2-methylene-, telomer with sodium phosphinate (1:1), acidified, potassium salt minimum number average mo-
lecular weight (in amu), 3800 .......................................................................................................................................................... 1663489–14–2
pmangrum on DSK3GDR082PROD with RULES
* * * * * * *
VerDate Sep<11>2014 14:51 Jan 09, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\FR\FM\10JAR1.SGM 10JAR1](https://thefederalregister.org/doc/82_FR_2903/page/3.svg)
![2900 Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Rules and Regulations
[FR Doc. 2016–31830 Filed 1–9–17; 8:45 am] I. General Information instructions for submitting comments.
BILLING CODE 6560–50–P Do not submit electronically any
A. Does this action apply to me?
information you consider to be CBI or
You may be potentially affected by other information whose disclosure is
ENVIRONMENTAL PROTECTION this action if you are an agricultural restricted by statute.
AGENCY producer, food manufacturer, or • Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
40 CFR Part 180 list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.,
Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
[EPA–HQ–OPP–2015–0695; FRL–9955–74] not intended to be exhaustive, but rather • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
Tetraconazole; Pesticide Tolerances determine whether this document delivery of boxed information, please
applies to them. Potentially affected follow the instructions at http://
AGENCY: Environmental Protection entities may include: www.epa.gov/dockets/contacts.html.
Agency (EPA). • Crop production (NAICS code 111). Additional instructions on
ACTION: Final rule. • Animal production (NAICS code commenting or visiting the docket,
112). along with more information about
• Food manufacturing (NAICS code dockets generally, is available at http://
SUMMARY: This regulation establishes
311). www.epa.gov/dockets.
tolerances for residues of tetraconazole
• Pesticide manufacturing (NAICS
in or on vegetable, fruiting (Crop Group II. Summary of Petitioned-For
code 32532).
8–10) at 0.30 parts per million (ppm) Tolerance
and vegetable, cucurbit (Crop Group 9) B. How can I get electronic access to In the Federal Register of March 16,
at 0.15 ppm and revises the tolerance for other related information? 2016 (81 FR 14030) (FRL–9942–86),
residues on beet, sugar, root; beet, sugar, You may access a frequently updated EPA issued a document pursuant to
dried pulp; and beet, sugar molasses. electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
Isagro S.P.A. (d/b/a Isagro USA, Inc.) regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
requested these tolerances under the the Government Printing Office’s e-CFR pesticide petition (PP 5F8400) by Isagro
Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text- S.P.A. (d/b/a Isagro USA, Inc.), 430
(FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Davis Drive, Suite 240, Morrisville, NC
DATES: This regulation is effective 40tab_02.tpl. 27560. That document provided notice
January 10, 2017. Objections and that the petition requested that 40 CFR
C. How can I file an objection or hearing 180.557 be amended by establishing
requests for hearings must be received request?
on or before March 13, 2017, and must tolerances for residues of the fungicide
Under FFDCA section 408(g), 21 tetraconazole, in or on Vegetable,
be filed in accordance with the
U.S.C. 346a, any person may file an Fruiting (Crop Group 8–10) at 0.30 parts
instructions provided in 40 CFR part
objection to any aspect of this regulation per million (ppm) and Vegetable,
178 (see also Unit I.C. of the
and may also request a hearing on those Cucurbit (Crop Group 9) at 0.15 ppm. In
SUPPLEMENTARY INFORMATION).
objections. You must file your objection the Federal Register of August 29, 2016
ADDRESSES: The docket for this action, or request a hearing on this regulation (81 FR 59165) (FRL–9950–22), EPA
identified by docket identification (ID) in accordance with the instructions issued another document pursuant to
number EPA–HQ–OPP–2015–0695, is provided in 40 CFR part 178. To ensure FFDCA section 408(d)(3), 21 U.S.C.
available at http://www.regulations.gov proper receipt by EPA, you must 346a(d)(3), announcing the remainder of
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– that petition requesting revision of the
Regulatory Public Docket (OPP Docket) OPP–2015–0695 in the subject line on existing tolerances for tetraconazole
in the Environmental Protection Agency the first page of your submission. All residues on beet, sugar, root to 0.15
Docket Center (EPA/DC), West William objections and requests for a hearing ppm; beet, sugar, dried pulp to 0.20
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be ppm; and beet, sugar molasses to 0.25
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or ppm. Those documents referenced a
20460–0001. The Public Reading Room before March 13, 2017. Addresses for summary of the petition prepared by
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections Isagro S.P.A. (d/b/a Isagro USA, Inc.),
Monday through Friday, excluding legal and hearing requests are provided in 40 the registrant, which is available in the
holidays. The telephone number for the CFR 178.25(b). docket, http://www.regulations.gov.
Public Reading Room is (202) 566–1744, In addition to filing an objection or There were no comments received in
and the telephone number for the OPP hearing request with the Hearing Clerk response to these notices of filing.
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 III. Aggregate Risk Assessment and
information about the docket available any Confidential Business Information Determination of Safety
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(i) of FFDCA
Information not marked confidential allows EPA to establish a tolerance (the
FOR FURTHER INFORMATION CONTACT:
pursuant to 40 CFR part 2 may be legal limit for a pesticide chemical
Michael Goodis, Registration Division
disclosed publicly by EPA without prior residue in or on a food) only if EPA
pmangrum on DSK3GDR082PROD with RULES
(7505P), Office of Pesticide Programs,
notice. Submit the non-CBI copy of your determines that the tolerance is ‘‘safe.’’
Environmental Protection Agency, 1200
objection or hearing request, identified Section 408(b)(2)(A)(ii) of FFDCA
Pennsylvania Ave. NW., Washington,
by docket ID number EPA–HQ–OPP– defines ‘‘safe’’ to mean that ‘‘there is a
DC 20460–0001; main telephone
2015–0695, by one of the following reasonable certainty that no harm will
number: (703) 305–7090; email address:
methods: result from aggregate exposure to the
RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http:// pesticide chemical residue, including
SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online all anticipated dietary exposures and all
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Document Created: 2018-02-01 14:54:08
Document Modified: 2018-02-01 14:54:08
| 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 January 10, 2017. Objections and requests for hearings must be received on or before March 13, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 2897 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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