81 FR 58407 - Natamycin; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 165 (August 25, 2016)
Federal Register Volume 81, Issue 165 (August 25, 2016)
| Page Range | 58407-58410 | |
| FR Document | 2016-20409 |
[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)] [Rules and Regulations] [Pages 58407-58410] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20409] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0811; FRL-9949-03] Natamycin; Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the biochemical pesticide natamycin [6,11,28-Trioxatricyclo [22.3.1.05'7 ]octacosa-8,14,16,18,20-pentaene- 25-carboxylic acid, 22-[(3-amino-3,6-dideoxy-p-Dmannopyranosyl)oxy]- 1,3,26-trihydroxy-12-methyl-10-oxo-, (1R,3S,5R,7R,8E,12R,14E,16E,18E,20E, 22R,24S,25R,26S)-] in or on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates when used in accordance with label directions and good agricultural practices. DSM Food Specialties, B.V., P.O. Box 1, 2600 MA Delft, The Netherlands (c/o Keller and Heckman, LLP, 1001 G St. NW., Washington, DC 20001) 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 natamycin in or on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranate when used in accordance with label directions and good agricultural practices. DATES: This regulation is effective August 25, 2016. Objections and requests for hearings must be received on or before October 24, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0811, 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: Robert McNally, Biopesticides and Pollution Prevention Division (7511P), 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. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0811 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 October 24, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0811 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 April 25, 2016 (81 FR 24044) (FRL-9944- 86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5F8407) by Keller and Heckman, LLP, 1001 G St. NW., Washington, DC 2001 on behalf of [[Page 58408]] DSM Food Specialties, B.V., P.O. Box 1, 2600 MA Delft, The Netherlands. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of natamycin in or on citrus, pome, stone fruit crop groups, avocado, kiwi, mango, and pomegranates, when used in facilities as a post- harvest fungistat to control certain fungal diseases. That document referenced a summary of the petition prepared by the petitioner, DSM Food Specialties, which is available in the docket, http://www.regulations.gov. 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 in residential settings, but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing 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. . . . ''Additionally, FFDCA section 408(b)(2)(D) requires that 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 performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile 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. A. Overview of Natamycin Natamycin is a naturally occurring compound derived from the common soil microorganisms Streptomyces natalensis, Streptomyces lydicus, and Streptomyces chattanoogensis. Natamycin was originally discovered in Streptomyces natalensis in South Africa in the early 1950s, and was subsequently discovered to also occur naturally in North America in Streptomyces lydicus and Streptomyces chattanoogensis. It is commercially produced by a submerged oxygen-based fermentation of Streptomyces natalensis, Streptomyces lydicus, or Streptomyces chattanoogensis. Natamycin has been used as a food preservative worldwide for over 40 years and is approved as a food additive/ preservative by the European Union, the World Health Organization, and individual countries including New Zealand and Australia for use as a fungistat to suppress mold on cheese, meats and sausage. In the United States, natamycin is approved by the Food and Drug Administration (FDA) as a direct food additive/preservative for the inhibition of mold and yeast on the surface of cheeses (21 CFR 172.155) and as an additive to the feed and drinking water of broiler chickens to retard the growth of specific molds (21 CFR 573.685). Natamycin is also FDA approved for use as a treatment to suppress fungal eye infections such as blepharitis, conjunctivitis, and keratitis. As a biochemical pesticide active ingredient, natamycin is already approved for use as a fungistat to prevent and control the germination of mold and yeast spores in the growth media of mushrooms produced in enclosed mushroom production facilities (77 FR 29543), and to control fungal growth post-harvest on pineapples treated indoors (79 FR 75068). Natamycin has a non-toxic mode of action, has no effects on fungal mycelia, and development of antibiotic resistance to natamycin has not been reported during its entire history of use. See the document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Natamycin'' (June 16, 2016), available in the docket for this action. B. Biochemical Pesticide Toxicology Data Requirements All applicable mammalian toxicology data requirements supporting the petition to amend the existing tolerance exemption by adding use as a fungicide post-harvest, indoors, on citrus, pome, stone fruit crop groups, avocado, kiwi, mango, and pomegranates have been fulfilled. No toxic endpoints were established, and no significant toxicological effects were observed in any of the acute toxicity studies. In addition, studies submitted indicate that natamycin is not genotoxic, has no subchronic toxic effects, and is not a developmental toxicant. There are no known effects on endocrine systems via oral, dermal, or inhalation routes of exposure. For a summary of the data upon which EPA relied, and its human health risk assessment based on that data, please refer to the document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Natamycin'' (June 16, 2016). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. IV. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure The proposed use patterns may results in dietary exposure to natamycin, however, exposure is expected to be insignificant (see document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Natamycin'' (June 16, 2016), available in the docket for this action. No significant exposure via drinking water is expected; natamycin is applied indoors only. Some dietary exposure to natamycin might occur through other nonpesticidal sources as a result of its use as a food additive/preservative. Should exposure occur, however, minimal to no risk is expected for the general population, including infants and children, due to the low toxicity of natamycin as demonstrated in the data submitted and evaluated by the Agency, as fully explained in the document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) [[Page 58409]] Considerations for Natamycin'' (June 16, 2016), available in the docket for this action. B. Other Non-Occupational Exposure Other non-occupational exposure (other than dietary) from pesticidal use is not expected because natamycin is not approved for residential uses. The active ingredient is applied directly to commodities and degrades rapidly. There may be some exposure to natamycin as a result of its use as treatment of infections, but minimal to no risk is expected for the general population, including infants and children, due to the low toxicity of natamycin as demonstrated in the data submitted and evaluated by the Agency, as fully explained in the document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Natamycin'' (June 16, 2016), available in the docket for this action. 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 natamycin to share a common mechanism of toxicity with any other substances, and natamycin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that natamycin 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. Determination of Safety for U.S. Population, Infants, and Children FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibly of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) 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 database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor. In applying this provision, EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor. As part of its qualitative assessment, EPA evaluated the available toxicity and exposure data for natamycin and considered it validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA considers the toxicity database to be complete and has identified no residual uncertainty with regard to prenatal and postnatal toxicity or exposure. No hazard was identified based on the available studies, as fully explained in the document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Natamycin'' (June 16, 2016), available in the docket for this action. Based upon its evaluation, EPA concludes that there are no threshold effects of concern to infants, children, or adults when natamycin is applied to mushrooms, in enclosed mushroom production facilities, and on pineapples, citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates when used in accordance with label directions and good agricultural practices. As a result, EPA concludes that no additional margin of exposure (safety) is necessary. VII. Other Considerations 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. Further, residues are not expected on any other crops because natamycin will only be applied indoors to these particular crops. VIII. Conclusions Based on its assessment of natamycin, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to natamycin. Therefore, an amendment to the exemption of a tolerance is established for residues of natamycin in or on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates. The Agency is issuing the exemption for residues of natamycin in or on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates instead of limiting this exemption to post-harvest indoor applications to citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates because the restrictions are not relevant to the FFDCA safety finding for natamycin. Those limitations are related to the use of the pesticide and regulated under FIFRA. IX. 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 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 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 [[Page 58410]] 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). X. 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: July 19, 2016. Robert C. McNally, Director, Biopesticides and Pollution Prevention 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. Revise Sec. 180.1315 to read as follows: Sec. 180.1315 Natamycin; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for the residues of natamycin in or on mushrooms, pineapples, citrus, pome, stone fruit crop groups, avocado, kiwi, mango, and pomegranates when used in accordance with label directions and good agricultural practices. [FR Doc. 2016-20409 Filed 8-24-16; 8:45 am] BILLING CODE 6560-50-P
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Subpart CCC—Virgin Islands DATES: This regulation is effective idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
August 25, 2016. Objections and 40tab_02.tpl.
■ 2. Add an undesignated center requests for hearings must be received
heading and § 62.13357 to subpart CCC C. How can I file an objection or hearing
on or before October 24, 2016, and must
to read as follows: request?
be filed in accordance with the
instructions provided in 40 CFR part Under FFDCA section 408(g), 21
Air Emissions From Existing Sewage U.S.C. 346a, any person may file an
Sludge Incineration Units Constructed 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION). objection to any aspect of this regulation
on or Before October 14, 2010 and may also request a hearing on those
ADDRESSES: The docket for this action,
§ 62.13357 Identification of plan—negative identified by docket identification (ID) objections. You must file your objection
declaration. number EPA–HQ–OPP–2015–0811, is or request a hearing on this regulation
Letter from the Virgin Islands available at http://www.regulations.gov in accordance with the instructions
Department of Planning and Natural or at the Office of Pesticide Programs provided in 40 CFR part 178. To ensure
Resources, submitted December 1, 2015 Regulatory Public Docket (OPP Docket) proper receipt by EPA, you must
to EPA Regional Administrator Judith A. in the Environmental Protection Agency identify docket ID number EPA–HQ–
Enck, certifying that there are no Docket Center (EPA/DC), West William OPP–2015–0811 in the subject line on
existing Sewage Sludge Incinerator Jefferson Clinton Bldg., Rm. 3334, 1301 the first page of your submission. All
units in the Territory of the United Constitution Ave. NW., Washington, DC objections and requests for a hearing
States Virgin Islands subject to 40 CFR 20460–0001. The Public Reading Room must be in writing, and must be
part 60, subpart MMMM. is open from 8:30 a.m. to 4:30 p.m., received by the Hearing Clerk on or
Monday through Friday, excluding legal before October 24, 2016. Addresses for
[FR Doc. 2016–20307 Filed 8–24–16; 8:45 am]
holidays. The telephone number for the mail and hand delivery of objections
BILLING CODE 6560–50–P
Public Reading Room is (202) 566–1744, and hearing requests are provided in 40
and the telephone number for the OPP CFR 178.25(b).
In addition to filing an objection or
ENVIRONMENTAL PROTECTION Docket is (703) 305–5805. Please review
hearing request with the Hearing Clerk
AGENCY the visitor instructions and additional
as described in 40 CFR part 178, please
information about the docket available
40 CFR Part 180 submit a copy of the filing (excluding
at http://www.epa.gov/dockets.
any Confidential Business Information
FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket.
[EPA–HQ–OPP–2015–0811; FRL–9949–03]
Robert McNally, Biopesticides and Information not marked confidential
Natamycin; Exemption From the Pollution Prevention Division (7511P), pursuant to 40 CFR part 2 may be
Requirement of a Tolerance Office of Pesticide Programs, disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
AGENCY: Environmental Protection Pennsylvania Ave. NW., Washington, objection or hearing request, identified
Agency (EPA). DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
ACTION: Final rule. number: (703) 305–7090; email address: 2015–0811 by one of the following
BPPDFRNotices@epa.gov. methods:
SUMMARY: This regulation establishes an • Federal eRulemaking Portal: http://
SUPPLEMENTARY INFORMATION:
exemption from the requirement of a www.regulations.gov. Follow the online
tolerance for residues of the biochemical I. General Information instructions for submitting comments.
pesticide natamycin [6,11,28- Do not submit electronically any
A. Does this action apply to me?
Trioxatricyclo [22.3.1.05′7 ]octacosa- information you consider to be CBI or
8,14,16,18,20-pentaene-25-carboxylic You may be potentially affected by
other information whose disclosure is
acid, 22-[(3-amino-3,6-dideoxy-p- this action if you are an agricultural
restricted by statute.
Dmannopyranosyl)oxy]-1,3,26- producer, food manufacturer, or • Mail: OPP Docket, Environmental
trihydroxy-12-methyl-10-oxo-, pesticide manufacturer. The following Protection Agency Docket Center (EPA/
(1R,3S,5R,7R,8E,12R,14E,16E,18E,20E, list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
22R,24S,25R,26S)-] in or on citrus, Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
pome, stone fruit crop groups, avocado, not intended to be exhaustive, but rather • Hand Delivery: To make special
kiwi, mango and pomegranates when provides a guide to help readers arrangements for hand delivery or
used in accordance with label directions determine whether this document delivery of boxed information, please
and good agricultural practices. DSM applies to them. Potentially affected follow the instructions at http://
Food Specialties, B.V., P.O. Box 1, 2600 entities may include: www.epa.gov/dockets/contacts.html.
MA Delft, The Netherlands (c/o Keller • Crop production (NAICS code 111). Additional instructions on
and Heckman, LLP, 1001 G St. NW., • Animal production (NAICS code commenting or visiting the docket,
Washington, DC 20001) submitted a 112). along with more information about
petition to EPA under the Federal Food, • Food manufacturing (NAICS code dockets generally, is available at http://
Drug, and Cosmetic Act (FFDCA), 311). www.epa.gov/dockets.
requesting an exemption from the • Pesticide manufacturing (NAICS
requirement of a tolerance. This code 32532). II. Background and Statutory Findings
regulation eliminates the need to In the Federal Register of April 25,
establish a maximum permissible level B. How can I get electronic access to 2016 (81 FR 24044) (FRL–9944–86),
Lhorne on DSK30JT082PROD with RULES
for residues of natamycin in or on other related information? EPA issued a document pursuant to
citrus, pome, stone fruit crop groups, You may access a frequently updated FFDCA section 408(d)(3), 21 U.S.C.
avocado, kiwi, mango and pomegranate electronic version of 40 CFR part 180 346a(d)(3), announcing the filing of a
when used in accordance with label through the Government Printing pesticide tolerance petition (PP 5F8407)
directions and good agricultural Office’s e-CFR site at http:// by Keller and Heckman, LLP, 1001 G St.
practices. www.ecfr.gov/cgi-bin/text- NW., Washington, DC 2001 on behalf of
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government and the States or tribal accordance with label directions and Pursuant to WCPFC Conservation and
governments, or on the distribution of good agricultural practices. Management Measure 2015–01, NMFS
power and responsibilities among the [FR Doc. 2016–20409 Filed 8–24–16; 8:45 am] issued regulations that established a
various levels of government or between BILLING CODE 6560–50–P limit of 1,828 fishing days that may be
the Federal Government and Indian used by U.S. purse seine fishing vessels
tribes. Thus, the Agency has determined in the ELAPS in calendar year 2016 (see
that Executive Order 13132, entitled DEPARTMENT OF COMMERCE interim rule at 81 FR 33147, published
‘‘Federalism’’ (64 FR 43255, August 10, May 25, 2016, codified at 50 CFR
1999) and Executive Order 13175, National Oceanic and Atmospheric 300.223). The ELAPS consists of the
entitled ‘‘Consultation and Coordination Administration areas of the U.S. exclusive economic
with Indian Tribal Governments’’ (65 FR zone and the high seas that are in the
67249, November 9, 2000) do not apply 50 CFR Part 300 Convention Area between the latitudes
to this action. In addition, this action of 20° N. and 20° S. (see definition at
[Docket No. 160322276–6276–01]
does not impose any enforceable duty or 50 CFR 300.211). A fishing day means
contain any unfunded mandate as RIN 0648–XE741 any day in which a fishing vessel of the
described under Title II of the Unfunded United States equipped with purse seine
Mandates Reform Act (UMRA) (2 U.S.C. International Fisheries; Western and gear searches for fish, deploys a fish
1501 et seq.). Central Pacific Fisheries for Highly aggregating device (FAD), services a
This action does not involve any Migratory Species; Closure of Purse FAD, or sets a purse seine, with the
technical standards that would require Seine Fishery in the ELAPS in 2016 exception of setting a purse seine solely
Agency consideration of voluntary AGENCY: National Marine Fisheries for the purpose of testing or cleaning the
consensus standards pursuant to section Service (NMFS), National Oceanic and gear and resulting in no catch (see
12(d) of the National Technology Atmospheric Administration (NOAA), definition at 50 CFR 300.211).
Transfer and Advancement Act Commerce. Based on data submitted in logbooks
(NTTAA) (15 U.S.C. 272 note). ACTION: Temporary rule; fishery closure. and other available information, NMFS
X. Congressional Review Act expects that the limit of 1,828 fishing
SUMMARY: NMFS announces that the days in the ELAPS will be reached, and
Pursuant to the Congressional Review purse seine fishery in the Effort Limit in accordance with the procedures
Act (5 U.S.C. 801 et seq.), EPA will Area for Purse Seine, or ELAPS, will established at 50 CFR 300.223(a),
submit a report containing this rule and close as a result of reaching the 2016 announces that the purse seine fishery
other required information to the U.S. limit on purse seine fishing effort in the in the ELAPS will be closed starting at
Senate, the U.S. House of ELAPS. This action is necessary for the 00:00 on September 2, 2016 UTC, and
Representatives, and the Comptroller United States to implement provisions will remain closed until 24:00 on
General of the United States prior to of a conservation and management December 31, 2016 UTC. Accordingly, it
publication of the rule in the Federal measure adopted by the Commission for shall be prohibited for any fishing vessel
Register. This action is not a ‘‘major the Conservation and Management of of the United States equipped with
rule’’ as defined by 5 U.S.C. 804(2). Highly Migratory Fish Stocks in the purse seine gear to be used for fishing
List of Subjects in 40 CFR Part 180 Western and Central Pacific Ocean in the ELAPS from 00:00 on September
(WCPFC or Commission) and to satisfy 2, 2016 UTC until 24:00 December 31,
Environmental protection, the obligations of the United States 2016 UTC, except that such vessels will
Administrative practice and procedure, under the Convention on the not prohibited from bunkering in the
Agricultural commodities, Pesticides Conservation and Management of ELAPS during that period (50 CFR
and pests, Reporting and recordkeeping Highly Migratory Fish Stocks in the 300.223(a)).
requirements. Western and Central Pacific Ocean
Dated: July 19, 2016. (Convention), to which it is a Classification
Robert C. McNally, Contracting Party. There is good cause under 5 U.S.C.
Director, Biopesticides and Pollution DATES: Effective 00:00 on September 2, 553(b)(B) to waive prior notice and
Prevention Division, Office of Pesticide 2016 universal time coordinated (UTC), opportunity for public comment on this
Programs. until 24:00 on December 31, 2016 UTC. action. Compliance with the notice and
Therefore, 40 CFR chapter I is FOR FURTHER INFORMATION CONTACT: Tom comment requirement would be
amended as follows: Graham, NMFS Pacific Islands Regional impracticable and contrary to the public
Office, 808–725–5032. interest, since NMFS would be unable
PART 180—[AMENDED] SUPPLEMENTARY INFORMATION: U.S. purse to ensure that the 2016 limit on purse
seine fishing in the area of application seine fishing effort in the ELAPS is not
■ 1. The authority citation for part 180 of the Convention, or Convention Area, exceeded. This action is based on the
continues to read as follows: is managed, in part, under the Western best available information on U.S. purse
Authority: 21 U.S.C. 321(q), 346a and 371. and Central Pacific Fisheries seine fishing effort in the ELAPS. The
■ 2. Revise § 180.1315 to read as Convention Implementation Act (16 action is necessary for the United States
follows: U.S.C. 6901 et seq.). Regulations to comply with its obligations under the
implementing the Act are at 50 CFR part Convention and is important for the
§ 180.1315 Natamycin; exemption from the 300, subpart O. On behalf of the conservation and management of bigeye
requirement of a tolerance. Secretary of Commerce, NMFS tuna, yellowfin tuna, and skipjack tuna
Lhorne on DSK30JT082PROD with RULES
An exemption from the requirement promulgates regulations under the Act in the western and central Pacific
of a tolerance is established for the as may be necessary to carry out the Ocean. For the same reasons, there is
residues of natamycin in or on obligations of the United States under good cause under 5 U.S.C. 553(d)(3) to
mushrooms, pineapples, citrus, pome, the Convention, including establish an effective date less than 30
stone fruit crop groups, avocado, kiwi, implementation of the decisions of the days after the date of publication of this
mango, and pomegranates when used in Commission. notice.
VerDate Sep<11>2014 13:55 Aug 24, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\25AUR1.SGM 25AUR1](https://thefederalregister.org/doc/81_FR_58572/page/4.svg)
Document Created: 2016-08-25 00:35:08
Document Modified: 2016-08-25 00:35:08
| 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 August 25, 2016. Objections and requests for hearings must be received on or before October 24, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email | |
| FR Citation | 81 FR 58407 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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