82 FR 14614 - Fatty Acids, Montan-Wax, Ethoxylated; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 54 (March 22, 2017)
Federal Register Volume 82, Issue 54 (March 22, 2017)
| Page Range | 14614-14617 | |
| FR Document | 2017-05721 |
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)] [Rules and Regulations] [Pages 14614-14617] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05721] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0337; FRL-9958-10] Fatty Acids, Montan-Wax, Ethoxylated; 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 fatty acids, montan-wax, ethoxylated (CAS No. 68476-04-0) when used as an inert ingredient in a pesticide chemical formulation. Clariant Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of fatty acids, montan-wax, ethoxylated on food or feed commodities. DATES: This regulation is effective March 22, 2017. Objections and requests for hearings must be received on or before May 22, 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-2016-0337, 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-2016-0337 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 22, 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-2016-0337, 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. [[Page 14615]] II. Background and Statutory Findings In the Federal Register of November 30, 2016 (81 FR 86312) (FRL- 9954-06), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN- 10949) filed by Clariant Corporation, 4000 Monroe Road, Charlotte, NC 28205. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of fatty acids, montan-wax, ethoxylated (CAS No. 68476-04-0). 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 FDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .'' and specifies factors EPA is to consider in establishing an exemption. III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 2- fatty acids, montan-wax, ethoxylated conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers. 1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. 7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6). Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 8. The polymer's number average MW of 1,800 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, Thus, fatty acids, montan-wax, ethoxylated 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 fatty acids, montan-wax, ethoxylated. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that fatty acids, montan-wax, ethoxylated 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 fatty acids, montan-wax, ethoxylated is 20,500 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since fatty acids, montan-wax, ethoxylated conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found fatty acids, montan-wax, ethoxylated to share a common mechanism of toxicity with any other substances, and fatty acids, montan-wax, ethoxylated does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fatty acids, montan- wax, ethoxylated 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. [[Page 14616]] 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 fatty acids, montan-wax, ethoxylated, 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 fatty acids, montan-wax, ethoxylated. VIII. Other Considerations A. Existing Exemptions From a Tolerance There are no existing exemptions from a tolerance for fatty acids, montan-wax, ethoxylated. 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 fatty acids, montan-wax, ethoxylated. IX. Conclusion Accordingly, EPA finds that exempting residues of fatty acids, montan-wax, ethoxylated 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: February 13, 2017. Daniel J. Rosenblatt, 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 to the table to read as follows: Sec. [emsp14]180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * [[Page 14617]] ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * fatty acids, montan-wax, ethoxylated, minimum number 68476-04-0 average molecular weight (in amu), 1800................ * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2017-05721 Filed 3-21-17; 8:45 a.m.] BILLING CODE 6560-50-P
![14614 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations
EPA-APPROVED GEORGIA NON-REGULATORY PROVISIONS
State submittal
Name of nonregulatory SIP Applicable geographic or non- date/effective EPA approval date Explanation
provision attainment area date
* * * * * * *
2008 8-hour ozone NAAQS Bartow, Cherokee, Clayton, 2/6/2015 3/22/2017, [insert Federal
Nonattainment New Source Cobb, Coweta, DeKalb, Register citation].
Review Requirements for Douglas, Fayette, Forsyth,
the Atlanta Area. Fulton, Gwinnett, Henry,
Newton, Paulding, and
Rockdale Counties.
[FR Doc. 2017–05459 Filed 3–21–17; 8:45 am] Monday through Friday, excluding legal objection to any aspect of this regulation
BILLING CODE 6560–50–P holidays. The telephone number for the and may also request a hearing on those
Public Reading Room is (202) 566–1744, objections. You must file your objection
and the telephone number for the OPP or request a hearing on this regulation
ENVIRONMENTAL PROTECTION Docket is (703) 305–5805. Please review in accordance with the instructions
AGENCY the visitor instructions and additional provided in 40 CFR part 178. To ensure
information about the docket available proper receipt by EPA, you must
40 CFR Part 180 at http://www.epa.gov/dockets. identify docket ID number EPA–HQ–
[EPA–HQ–OPP–2016–0337; FRL–9958–10] FOR FURTHER INFORMATION, CONTACT: OPP–2016–0337 in the subject line on
Michael Goodis, Registration Division the first page of your submission. All
Fatty Acids, Montan-Wax, Ethoxylated; (7505P), Office of Pesticide Programs, objections and requests for a hearing
Tolerance Exemption Environmental Protection Agency, 1200 must be in writing, and must be
Pennsylvania Ave. NW., Washington, received by the Hearing Clerk on or
AGENCY: Environmental Protection before May 22, 2017. Addresses for mail
Agency (EPA). DC 20460–0001; main telephone
number: (703) 305–7090; email address: and hand delivery of objections and
ACTION: Final rule. hearing requests are provided in 40 CFR
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION: 178.25(b).
SUMMARY: This regulation establishes an
exemption from the requirement of a In addition to filing an objection or
I. General Information hearing request with the Hearing Clerk
tolerance for residues of fatty acids,
montan-wax, ethoxylated (CAS No. A. Does this action apply to me? as described in 40 CFR part 178, please
68476–04–0) when used as an inert You may be potentially affected by submit a copy of the filing (excluding
ingredient in a pesticide chemical this action if you are an agricultural any Confidential Business Information
formulation. Clariant Corporation producer, food manufacturer, or (CBI)) for inclusion in the public docket.
submitted a petition to EPA under the pesticide manufacturer. The following Information not marked confidential
Federal Food, Drug, and Cosmetic Act list of North American Industrial pursuant to 40 CFR part 2 may be
(FFDCA), requesting an exemption from Classification System (NAICS) codes is disclosed publicly by EPA without prior
the requirement of a tolerance. This not intended to be exhaustive, but rather notice. Submit the non-CBI copy of your
regulation eliminates the need to provides a guide to help readers objection or hearing request, identified
establish a maximum permissible level determine whether this document by docket ID number EPA–HQ–OPP–
for residues of fatty acids, montan-wax, applies to them. Potentially affected 2016–0337, by one of the following
ethoxylated on food or feed entities may include: methods.
commodities. • Crop production (NAICS code 111). • Federal eRulemaking Portal: http://
DATES: This regulation is effective • Animal production (NAICS code www.regulations.gov. Follow the online
March 22, 2017. Objections and requests 112). instructions for submitting comments.
for hearings must be received on or • Food manufacturing (NAICS code Do not submit electronically any
before May 22, 2017, and must be filed 311). information you consider to be CBI or
in accordance with the instructions • Pesticide manufacturing (NAICS other information whose disclosure is
provided in 40 CFR part 178 (see also code 32532). restricted by statute.
Unit I.C. of the SUPPLEMENTARY B. How can I get electronic access to • Mail: OPP Docket, Environmental
INFORMATION). other related information? Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
ADDRESSES: The docket for this action, You may access a frequently updated NW., Washington, DC 20460–0001.
identified by docket identification (ID) electronic version of 40 CFR part 180
number EPA–HQ–OPP–2016–0337, is through the Government Printing • Hand Delivery: To make special
available at http://www.regulations.gov Office’s e-CFR site at http:// arrangements for hand delivery or
or at the Office of Pesticide Programs www.ecfr.gov/cgi-bin/text- delivery of boxed information, please
jstallworth on DSK7TPTVN1PROD with RULES
Regulatory Public Docket (OPP Docket) idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ follow the instructions at http://
in the Environmental Protection Agency 40tab_02.tpl. www.epa.gov/dockets/contacts.html.
Docket Center (EPA/DC), West William Additional instructions on
Jefferson Clinton Bldg., Rm. 3334, 1301 C. Can I file an objection or hearing commenting or visiting the docket,
Constitution Ave. NW., Washington, DC request? along with more information about
20460–0001. The Public Reading Room Under FFDCA section 408(g), 21 dockets generally, is available at http://
is open from 8:30 a.m. to 4:30 p.m., U.S.C. 346a, any person may file an www.epa.gov/dockets.
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![14616 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations
VI. Additional Safety Factor for the EPA explain the reasons for departing government and the States or tribal
Protection of Infants and Children from the Codex level. governments, or on the distribution of
Section 408(b)(2)(C) of FFDCA The Codex has not established a MRL power and responsibilities among the
provides that EPA shall apply an for fatty acids, montan-wax, various levels of government or between
additional tenfold margin of safety for ethoxylated. the Federal Government and Indian
infants and children in the case of tribes. Thus, the Agency has determined
IX. Conclusion
threshold effects to account for prenatal that Executive Order 13132, entitled
Accordingly, EPA finds that ‘‘Federalism’’ (64 FR 43255, August 10,
and postnatal toxicity and the
exempting residues of fatty acids, 1999) and Executive Order 13175,
completeness of the data base unless
montan-wax, ethoxylated from the entitled ‘‘Consultation and Coordination
EPA concludes that a different margin of
requirement of a tolerance will be safe. with Indian Tribal Governments’’ (65 FR
safety will be safe for infants and
children. Due to the expected low X. Statutory and Executive Order 67249, November 9, 2000) do not apply
toxicity of fatty acids, montan-wax, Reviews to this action. In addition, this action
ethoxylated, EPA has not used a safety does not impose any enforceable duty or
This action establishes a tolerance contain any unfunded mandate as
factor analysis to assess the risk. For the under FFDCA section 408(d) in
same reasons the additional tenfold described under Title II of the Unfunded
response to a petition submitted to the Mandates Reform Act (UMRA) (2 U.S.C.
safety factor is unnecessary. Agency. The Office of Management and 1501 et seq.).
VII. Determination of Safety Budget (OMB) has exempted these types
of actions from review under Executive This action does not involve any
Based on the conformance to the technical standards that would require
Order 12866, entitled ‘‘Regulatory
criteria used to identify a low-risk Agency consideration of voluntary
Planning and Review’’ (58 FR 51735,
polymer, EPA concludes that there is a consensus standards pursuant to section
October 4, 1993). Because this action
reasonable certainty of no harm to the has been exempted from review under 12(d) of the National Technology
U.S. population, including infants and Executive Order 12866, this action is Transfer and Advancement Act
children, from aggregate exposure to not subject to Executive Order 13211, (NTTAA) (15 U.S.C. 272 note).
residues of fatty acids, montan-wax, entitled ‘‘Actions Concerning
ethoxylated. XI. Congressional Review Act
Regulations That Significantly Affect
VIII. Other Considerations Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review
FR 28355, May 22, 2001) or Executive Act (5 U.S.C. 801 et seq.), EPA will
A. Existing Exemptions From a Order 13045, entitled ‘‘Protection of submit a report containing this rule and
Tolerance Children from Environmental Health other required information to the U.S.
There are no existing exemptions Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of
from a tolerance for fatty acids, montan- April 23, 1997). This action does not Representatives, and the Comptroller
wax, ethoxylated. contain any information collections General of the United States prior to
subject to OMB approval under the publication of the rule in the Federal
B. Analytical Enforcement Methodology
Paperwork Reduction Act (PRA) (44 Register. This action is not a ‘‘major
An analytical method is not required U.S.C. 3501 et seq.), nor does it require rule’’ as defined by 5 U.S.C. 804(2).
for enforcement purposes since the any special considerations under
Agency is establishing an exemption Executive Order 12898, entitled List of Subjects in 40 CFR Part 180
from the requirement of a tolerance ‘‘Federal Actions to Address Environmental protection,
without any numerical limitation. Environmental Justice in Minority Administrative practice and procedure,
Populations and Low-Income Agricultural commodities, Pesticides
C. International Residue Limits
Populations’’ (59 FR 7629, February 16, and pests, Reporting and recordkeeping
In making its tolerance decisions, EPA 1994). requirements.
seeks to harmonize U.S. tolerances with Since tolerances and exemptions that
international standards whenever are established on the basis of a petition Dated: February 13, 2017.
possible, consistent with U.S. food under FFDCA section 408(d), such as Daniel J. Rosenblatt,
safety standards and agricultural the tolerance in this final rule, do not Acting Director, Registration Division, Office
practices. EPA considers the require the issuance of a proposed rule, of Pesticide Programs.
international maximum residue limits the requirements of the Regulatory Therefore, 40 CFR chapter I is
(MRLs) established by the Codex Flexibility Act (RFA) (5 U.S.C. 601 et amended as follows:
Alimentarius Commission (Codex), as seq.), do not apply.
required by FFDCA section 408(b)(4). This action directly regulates growers, PART 180—[AMENDED]
The Codex Alimentarius is a joint food processors, food handlers, and food
United Nations Food and Agriculture retailers, not States or tribes, nor does ■ 1. The authority citation for part 180
Organization/World Health this action alter the relationships or continues to read as follows:
Organization food standards program, distribution of power and
Authority: 21 U.S.C. 321(q), 346a and 371.
and it is recognized as an international responsibilities established by Congress
food safety standards-setting in the preemption provisions of FFDCA ■ 2. In § 180.960, add alphabetically the
organization in trade agreements to section 408(n)(4). As such, the Agency polymer to the table to read as follows:
jstallworth on DSK7TPTVN1PROD with RULES
which the United States is a party. EPA has determined that this action will not
may establish a tolerance that is have a substantial direct effect on States § 180.960 Polymers; exemptions from the
different from a Codex MRL; however, or tribal governments, on the requirement of a tolerance.
FFDCA section 408(b)(4) requires that relationship between the national * * * * *
VerDate Sep<11>2014 16:28 Mar 21, 2017 Jkt 241001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM 22MRR1](https://thefederalregister.org/doc/82_FR_14668/page/3.svg)
![Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations 14617
Polymer CAS No.
* * * * * * *
fatty acids, montan-wax, ethoxylated, minimum number average molecular weight (in amu), 1800 ................................................. 68476–04–0
* * * * * * *
[FR Doc. 2017–05721 Filed 3–21–17; 8:45 a.m.] FOR FURTHER INFORMATION CONTACT: hearing requests are provided in 40 CFR
BILLING CODE 6560–50–P Michael Goodis, Registration Division 178.25(b).
(7505P), Office of Pesticide Programs, In addition to filing an objection or
Environmental Protection Agency, 1200 hearing request with the Hearing Clerk
ENVIRONMENTAL PROTECTION Pennsylvania Ave. NW., Washington, as described in 40 CFR part 178, please
AGENCY DC 20460–0001; main telephone submit a copy of the filing (excluding
number: (703) 305–7090; email address: any Confidential Business Information
40 CFR Part 180 RDFRNotices@epa.gov. (CBI)) for inclusion in the public docket.
[EPA–HQ–OPP–2016–0378; FRL–9956–02] SUPPLEMENTARY INFORMATION: Information not marked confidential
pursuant to 40 CFR part 2 may be
Isoamyl Acetate; Exemption From the I. General Information disclosed publicly by EPA without prior
Requirement of a Tolerance A. Does this action apply to me? notice. Submit the non-CBI copy of your
objection or hearing request, identified
AGENCY: Environmental Protection You may be potentially affected by by docket ID number EPA–HQ–OPP–
Agency (EPA). this action if you are an agricultural 2016–0378, by one of the following
ACTION: Final rule. producer, food manufacturer, or methods:
pesticide manufacturer. The following • Federal eRulemaking Portal: http://
SUMMARY: This regulation establishes an list of North American Industrial www.regulations.gov. Follow the online
exemption from the requirement of a Classification System (NAICS) codes is instructions for submitting comments.
tolerance for residues of isoamyl acetate not intended to be exhaustive, but rather Do not submit electronically any
(CAS Reg. No. 123–92–2) when used as provides a guide to help readers information you consider to be CBI or
an inert ingredient (buffering agent) in determine whether this document other information whose disclosure is
pesticide formulations applied to applies to them. Potentially affected restricted by statute.
growing crops and raw agricultural entities may include: • Mail: OPP Docket, Environmental
commodities after harvest. The • Crop production (NAICS code 111). Protection Agency Docket Center (EPA/
Technology Sciences Group on behalf of • Animal production (NAICS code DC), (28221T), 1200 Pennsylvania Ave.
the Jeneil Biosurfactant Company 112). NW., Washington, DC 20460–0001.
submitted a petition to EPA under the • Food manufacturing (NAICS code • Hand Delivery: To make special
Federal Food, Drug, and Cosmetic Act 311). arrangements for hand delivery or
(FFDCA), requesting establishment of an • Pesticide manufacturing (NAICS delivery of boxed information, please
exemption from the requirement of a code 32532). follow the instructions at http://
tolerance. B. How can I get electronic access to www.epa.gov/dockets/contacts.html.
DATES: This regulation is effective
Additional instructions on
other related information? commenting or visiting the docket,
March 22, 2017. Objections and requests
You may access a frequently updated along with more information about
for hearings must be received on or
electronic version of 40 CFR part 180 dockets generally, is available at http://
before May 22, 2017, and must be filed
through the Government Printing www.epa.gov/dockets.
in accordance with the instructions
Office’s e-CFR site at http://
provided in 40 CFR part 178 (see also II. Petition for Exemption
www.ecfr.gov/cgi-bin/text-
Unit I.C. of the SUPPLEMENTARY In the Federal Register of August 29,
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
INFORMATION). 2016 (81 FR 59165) (FRL–9950–22),
40tab_02.tpl
ADDRESSES: The docket for this action, EPA issued a document pursuant to
identified by docket identification (ID) C. How can I file an objection or hearing FFDCA section 408, 21 U.S.C. 346a,
number EPA–HQ–OPP–2016–0378, is request? announcing the filing of a pesticide
available at http://www.regulations.gov Under FFDCA section 408(g), 21 petition (PP IN–10851) by the
or at the Office of Pesticide Programs U.S.C. 346a, any person may file an Technology Sciences Group, 1150 18th
Regulatory Public Docket (OPP Docket) objection to any aspect of this regulation Street NW., Suite 1000, Washington, DC
in the Environmental Protection Agency and may also request a hearing on those 20036, on behalf of the Jeneil
Docket Center (EPA/DC), West William objections. You must file your objection Biosurfactant Company, 400 N. Dekora
Jefferson Clinton Bldg., Rm. 3334, 1301 or request a hearing on this regulation Woods Blvd., Saukville, WI 53080. The
Constitution Ave. NW., Washington, DC in accordance with the instructions petition requested that 40 CFR 180.910
20460–0001. The Public Reading Room provided in 40 CFR part 178. To ensure be amended by establishing an
is open from 8:30 a.m. to 4:30 p.m., proper receipt by EPA, you must exemption from the requirement of a
Monday through Friday, excluding legal identify docket ID number EPA–HQ– tolerance for residues of isoamyl acetate
jstallworth on DSK7TPTVN1PROD with RULES
holidays. The telephone number for the OPP–2016–0378 in the subject line on (CAS Reg. No.123–92–2) when used as
Public Reading Room is (202) 566–1744, the first page of your submission. All an inert ingredient (buffering agent) in
and the telephone number for the OPP objections and requests for a hearing pesticide formulations applied to
Docket is (703) 305–5805. Please review must be in writing, and must be growing crops and raw agricultural
the visitor instructions and additional received by the Hearing Clerk on or commodities after harvest. That
information about the docket available before May 22, 2017. Addresses for mail document referenced a summary of the
at http://www.epa.gov/dockets. and hand delivery of objections and petition prepared by the Technology
VerDate Sep<11>2014 16:28 Mar 21, 2017 Jkt 241001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM 22MRR1](https://thefederalregister.org/doc/82_FR_14668/page/4.svg)
Document Created: 2017-03-22 03:58:09
Document Modified: 2017-03-22 03:58:09
| 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 22, 2017. Objections and requests for hearings must be received on or before May 22, 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). | |
| FR Citation | 82 FR 14614 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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