81 FR 47309 - Isaria fumosorosea Strain FE 9901; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 140 (July 21, 2016)
Federal Register Volume 81, Issue 140 (July 21, 2016)
| Page Range | 47309-47311 | |
| FR Document | 2016-17275 |
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)] [Rules and Regulations] [Pages 47309-47311] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17275] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0329; FRL-9945-41] Isaria fumosorosea Strain FE 9901; 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 Isaria fumosorosea strain FE 9901 in or on all food commodities when used in accordance with label directions and good agricultural practices. Novozymes BioAg, Inc. 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 Isaria fumosorosea strain FE 9901 under FFDCA. DATES: This regulation is effective July 21, 2016. Objections and requests for hearings must be received on or before September 19, 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-2014-0329, 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(g), 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-2014-0329 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 September 19, 2016. Addresses for mail and hand delivery of objections [[Page 47310]] 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-2014-0329, 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 In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911- 67), 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 3F8193) by Technology Sciences Group, Inc., 1150 18th St., NW., Suite 1000, Washington, DC 20036 (on behalf of Novozymes BioAg, Inc., 13100 W. Lisbon Rd., Suite 600, Brookfield, WI 53005). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Isaria fumosoroseus strain FE 9901 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner Novozymes BioAg, Inc., which is available in the docket via http://www.regulations.gov. There were no comments received in response to this notice of filing. Based upon a tolerance exemption that EPA established for a different strain of this microbe in 2011 and a review of public literature, EPA revised the active ingredient name from ``Isaria fumosoroseus strain FE 9901'' to ``Isaria fumosorosea strain FE 9901.'' The reason for this change is explained in Unit III.C. III. Final Rule A. EPA's Safety Determination 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 or tolerance exemption, 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 EPA consider ``available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.'' EPA evaluated the available toxicity and exposure data on Isaria fumosorosea strain FE 9901 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the April 11, 2016, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Isaria fumosorosea strain FE 9901.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that Isaria fumosorosea strain FE 9901 is not toxic, is not pathogenic, and is not infective. Although there may be some exposure to residues when used as an insecticide on food, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor (SF) was not necessary as part of the qualitative assessment conducted for Isaria fumosorosea strain FE 9901. Based on its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Isaria fumosorosea strain FE 9901. Therefore, an exemption from the requirement of a tolerance is established for residues of Isaria fumosorosea strain FE 9901 in or on all food commodities when used in accordance with label directions and good agricultural practices. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes for the reasons contained in the April 11, 2016, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Isaria fumosorosea strain FE 9901'' and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. Revision to the Requested Tolerance Exemption One modification has been made to the requested tolerance exemption. When Novozymes BioAg, Inc. first submitted this petition in 2013, it described the active ingredient as ``Paecilomyces fumosoroseus strain FE 9901.'' After conducting an initial review of this petition, EPA asked Novozymes BioAg, Inc. to revise the genus name of the active ingredient from ``Paecilomyces'' to ``Isaria'' based upon what it believed to be current, acceptable taxonomy. Novozymes BioAg, Inc. responded to EPA's request by representing the active ingredient as ``Isaria fumosoroseus strain FE 9901'' instead of ``Paecilomyces fumosoroseus strain FE 9901'' in its petition. After recently reviewing a tolerance exemption established in 2011 for a different strain of this microbe (40 CFR 180.1306 for Isaria fumosorosea Apopka strain 97) and public literature, EPA realizes that it should have also asked Novozymes BioAg, Inc. to change the species name of the active ingredient from ``fumosoroseus'' to ``fumosorosea'' to align completely with current, acceptable taxonomy (Refs. 1, 2, and 3). Use of Isaria fumosorosea strain FE 9901 throughout this document is supported by public literature, is consistent with a previous tolerance exemption that EPA established for a different strain of this microbe, and [[Page 47311]] should assist in preventing confusion with regard to the proper nomenclature for this particular active ingredient in the future. EPA does not believe the change from ``fumosoroseus'' to ``fumosorosea'' will cause confusion among the public as there is a clear history linking the first term to the second and because the names refer to the same microbe. IV. References 1. U.S. EPA. 2011. Isaria fumosorosea Apopka Strain 97; Exemption From the Requirement of a Tolerance--Final Rule (Dated September 18, 2011). Available from https://www.thefederalregister.org/fdsys/pkg/FR-2011-09-28/pdf/2011-24990.pdf. 2. USDA. 2011. Agricultural Research Service (ARS) Collection of Entomopathogenic Fungal Cultures--Isaria Plus Paecilomyces, Purpureocillium and Evlachovaea (Dated July 28, 2011). Available from http://www.ars.usda.gov/sp2userfiles/place/80620510/arsefpdfs/isaria.july2011.pdf. 3. Zimmermann G. 2008. The entomopathogenic fungi Isaria farinosa (formerly Paecilomyces farinosus) and the Isaria fumosorosea species complex (formerly Paecilomyces fumosoroseus): biology, ecology and use in biological control. Biocontrol Science and Technology 18:865-901. Available from http://www.tandfonline.com/doi/abs/10.1080/09583150802471812. V. Statutory and Executive Order Reviews This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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 exemption in this action, 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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 EPA's 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). VI. 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 6, 2016. Richard P. Keigwin, Jr., Director, 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. Add Sec. 180.1335 to subpart D to read as follows: Sec. 180.1335 Isaria fumosorosea strain FE 9901; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Isaria fumosorosea strain FE 9901 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2016-17275 Filed 7-20-16; 8:45 am] BILLING CODE 6560-50-P
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relationship between the national Parts per holidays. The telephone number for the
Commodity
government and the States or tribal million Public Reading Room is (202) 566–1744,
governments, or on the distribution of and the telephone number for the OPP
power and responsibilities among the Docket is (703) 305–5805. Please review
various levels of government or between * * * * * the visitor instructions and additional
Potato, wet peel .......................... 0.03
the Federal Government and Indian information about the docket available
tribes. Thus, the Agency has determined * * * * * at http://www.epa.gov/dockets.
that Executive Order 13132, entitled Vegetable, tuberous and corm, FOR FURTHER INFORMATION CONTACT:
‘‘Federalism’’ (64 FR 43255, August 10, subgroup 1C ........................... 0.01 Robert McNally, Biopesticides and
1999) and Executive Order 13175, Pollution Prevention Division (7511P),
entitled ‘‘Consultation and Coordination * * * * * Office of Pesticide Programs,
with Indian Tribal Governments’’ (65 FR Environmental Protection Agency, 1200
67249, November 9, 2000) do not apply * * * * * Pennsylvania Ave. NW., Washington,
to this action. In addition, this action [FR Doc. 2016–17268 Filed 7–20–16; 8:45 am]
DC 20460–0001; main telephone
does not impose any enforceable duty or BILLING CODE 6560–50–P number: (703) 305–7090; email address:
contain any unfunded mandate as BPPDFRNotices@epa.gov.
described under Title II of the Unfunded SUPPLEMENTARY INFORMATION:
Mandates Reform Act (UMRA) (2 U.S.C. ENVIRONMENTAL PROTECTION
1501 et seq.). AGENCY I. General Information
This action does not involve any 40 CFR Part 180 A. Does this action apply to me?
technical standards that would require You may be potentially affected by
Agency consideration of voluntary [EPA–HQ–OPP–2014–0329; FRL–9945–41]
this action if you are an agricultural
consensus standards pursuant to section producer, food manufacturer, or
12(d) of the National Technology Isaria fumosorosea Strain FE 9901;
Exemption From the Requirement of a pesticide manufacturer. The following
Transfer and Advancement Act list of North American Industrial
(NTTAA) (15 U.S.C. 272 note). Tolerance
Classification System (NAICS) codes is
VII. Congressional Review Act AGENCY: Environmental Protection not intended to be exhaustive, but rather
Agency (EPA). provides a guide to help readers
Pursuant to the Congressional Review ACTION: Final rule. determine whether this document
Act (5 U.S.C. 801 et seq.), EPA will applies to them. Potentially affected
submit a report containing this rule and SUMMARY: This regulation establishes an entities may include:
other required information to the U.S. exemption from the requirement of a • Crop production (NAICS code 111).
Senate, the U.S. House of tolerance for residues of Isaria • Animal production (NAICS code
Representatives, and the Comptroller fumosorosea strain FE 9901 in or on all 112).
General of the United States prior to food commodities when used in • Food manufacturing (NAICS code
publication of the rule in the Federal accordance with label directions and 311).
Register. This action is not a ‘‘major good agricultural practices. Novozymes • Pesticide manufacturing (NAICS
rule’’ as defined by 5 U.S.C. 804(2). BioAg, Inc. submitted a petition to EPA code 32532).
under the Federal Food, Drug, and
List of Subjects in 40 CFR Part 180 B. How can I get electronic access to
Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a other related information?
Environmental protection,
Administrative practice and procedure, tolerance. This regulation eliminates the You may access a frequently updated
Agricultural commodities, Pesticides need to establish a maximum electronic version of 40 CFR part 180
and pests, Reporting and recordkeeping permissible level for residues of Isaria through the Government Printing
requirements. fumosorosea strain FE 9901 under Office’s e-CFR site at http://
Dated: July 11, 2016.
FFDCA. www.ecfr.gov/cgi-bin/text-
DATES: This regulation is effective July idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Daniel Kenny,
21, 2016. Objections and requests for 40tab_02.tpl.
Acting Director, Registration Division, Office
of Pesticide Programs. hearings must be received on or before C. How can I file an objection or hearing
September 19, 2016, and must be filed request?
Therefore, 40 CFR chapter I is in accordance with the instructions
amended as follows: Under FFDCA section 408(g), 21
provided in 40 CFR part 178 (see also U.S.C. 346a(g), any person may file an
Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation
PART 180—[AMENDED] INFORMATION).
and may also request a hearing on those
■ 1. The authority citation for part 180 ADDRESSES: The docket for this action, objections. You must file your objection
continues to read as follows: identified by docket identification (ID) or request a hearing on this regulation
number EPA–HQ–OPP–2014–0329, is in accordance with the instructions
Authority: 21 U.S.C. 321(q), 346a and 371.
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
■ 2. In § 180.532, add alphabetically the or at the Office of Pesticide Programs proper receipt by EPA, you must
commodities ‘‘Potato, wet peel’’ and Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
‘‘Vegetable, tuberous and corm, in the Environmental Protection Agency OPP–2014–0329 in the subject line on
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subgroup 1C’’ to the table in paragraph Docket Center (EPA/DC), West William the first page of your submission. All
(a) to read as follows: Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
Constitution Ave. NW., Washington, DC must be in writing, and must be
§ 180.532 Cyprodinil; tolerances for 20460–0001. The Public Reading Room received by the Hearing Clerk on or
residues. is open from 8:30 a.m. to 4:30 p.m., before September 19, 2016. Addresses
(a) General. (1) * * * Monday through Friday, excluding legal for mail and hand delivery of objections
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and hearing requests are provided in 40 fumosorosea strain FE 9901.’’ The effects. EPA also determined that
CFR 178.25(b). reason for this change is explained in retention of the Food Quality Protection
In addition to filing an objection or Unit III.C. Act (FQPA) safety factor (SF) was not
hearing request with the Hearing Clerk necessary as part of the qualitative
as described in 40 CFR part 178, please III. Final Rule
assessment conducted for Isaria
submit a copy of the filing (excluding A. EPA’s Safety Determination fumosorosea strain FE 9901.
any Confidential Business Information Section 408(c)(2)(A)(i) of FFDCA Based on its evaluation, EPA
(CBI)) for inclusion in the public docket. allows EPA to establish an exemption concludes that there is a reasonable
Information not marked confidential from the requirement for a tolerance (the certainty that no harm will result to the
pursuant to 40 CFR part 2 may be legal limit for a pesticide chemical U.S. population, including infants and
disclosed publicly by EPA without prior residue in or on a food) only if EPA children, from aggregate exposure to
notice. Submit the non-CBI copy of your residues of Isaria fumosorosea strain FE
determines that the exemption is ‘‘safe.’’
objection or hearing request, identified 9901. Therefore, an exemption from the
Section 408(c)(2)(A)(ii) of FFDCA
by docket ID number EPA–HQ–OPP– requirement of a tolerance is established
defines ‘‘safe’’ to mean that ‘‘there is a
2014–0329, by one of the following for residues of Isaria fumosorosea strain
reasonable certainty that no harm will
methods: FE 9901 in or on all food commodities
• Federal eRulemaking Portal: http:// result from aggregate exposure to the
when used in accordance with label
www.regulations.gov. Follow the online pesticide chemical residue, including
directions and good agricultural
instructions for submitting comments. all anticipated dietary exposures and all
practices.
Do not submit electronically any other exposures for which there is
information you consider to be CBI or reliable information.’’ This includes B. Analytical Enforcement Methodology
other information whose disclosure is exposure through drinking water and in An analytical method is not required
restricted by statute. residential settings but does not include for enforcement purposes for the
• Mail: OPP Docket, Environmental occupational exposure. Pursuant to reasons contained in the April 11, 2016,
Protection Agency Docket Center (EPA/ FFDCA section 408(c)(2)(B), in document entitled ‘‘Federal Food, Drug,
DC), (28221T), 1200 Pennsylvania Ave. establishing or maintaining in effect an and Cosmetic Act (FFDCA)
NW., Washington, DC 20460–0001. exemption from the requirement of a Considerations for Isaria fumosorosea
• Hand Delivery: To make special tolerance, EPA must take into account strain FE 9901’’ and because EPA is
arrangements for hand delivery or the factors set forth in FFDCA section establishing an exemption from the
delivery of boxed information, please 408(b)(2)(C), which require EPA to give requirement of a tolerance without any
follow the instructions at http:// special consideration to exposure of numerical limitation.
www.epa.gov/dockets/contacts.html. infants and children to the pesticide
chemical residue in establishing a C. Revision to the Requested Tolerance
Additional instructions on commenting Exemption
or visiting the docket, along with more tolerance or tolerance exemption, and to
information about dockets generally, is ‘‘ensure that there is a reasonable One modification has been made to
available at http://www.epa.gov/ certainty that no harm will result to the requested tolerance exemption.
dockets. infants and children from aggregate When Novozymes BioAg, Inc. first
exposure to the pesticide chemical submitted this petition in 2013, it
II. Background residue . . . .’’ Additionally, FFDCA described the active ingredient as
In the Federal Register of August 1, section 408(b)(2)(D) requires that EPA ‘‘Paecilomyces fumosoroseus strain FE
2014 (79 FR 44729) (FRL–9911–67), consider ‘‘available information 9901.’’ After conducting an initial
EPA issued a document pursuant to concerning the cumulative effects of [a review of this petition, EPA asked
FFDCA section 408(d)(3), 21 U.S.C. particular pesticide’s] . . . residues Novozymes BioAg, Inc. to revise the
346a(d)(3), announcing the filing of a and other substances that have a genus name of the active ingredient
pesticide tolerance petition (PP 3F8193) common mechanism of toxicity.’’ from ‘‘Paecilomyces’’ to ‘‘Isaria’’ based
by Technology Sciences Group, Inc., EPA evaluated the available toxicity upon what it believed to be current,
1150 18th St., NW., Suite 1000, and exposure data on Isaria acceptable taxonomy. Novozymes
Washington, DC 20036 (on behalf of fumosorosea strain FE 9901 and BioAg, Inc. responded to EPA’s request
Novozymes BioAg, Inc., 13100 W. considered its validity, completeness, by representing the active ingredient as
Lisbon Rd., Suite 600, Brookfield, WI and reliability, as well as the ‘‘Isaria fumosoroseus strain FE 9901’’
53005). The petition requested that 40 relationship of this information to instead of ‘‘Paecilomyces fumosoroseus
CFR part 180 be amended by human risk. A full explanation of the strain FE 9901’’ in its petition. After
establishing an exemption from the data upon which EPA relied and its risk recently reviewing a tolerance
requirement of a tolerance for residues assessment based on that data can be exemption established in 2011 for a
of Isaria fumosoroseus strain FE 9901 in found within the April 11, 2016, different strain of this microbe (40 CFR
or on all food commodities. That document entitled ‘‘Federal Food, Drug, 180.1306 for Isaria fumosorosea Apopka
document referenced a summary of the and Cosmetic Act (FFDCA) strain 97) and public literature, EPA
petition prepared by the petitioner Considerations for Isaria fumosorosea realizes that it should have also asked
Novozymes BioAg, Inc., which is strain FE 9901.’’ This document, as well Novozymes BioAg, Inc. to change the
available in the docket via http:// as other relevant information, is species name of the active ingredient
www.regulations.gov. There were no available in the docket for this action as from ‘‘fumosoroseus’’ to ‘‘fumosorosea’’
comments received in response to this described under ADDRESSES. Based upon to align completely with current,
notice of filing. its evaluation, EPA concludes that Isaria acceptable taxonomy (Refs. 1, 2, and 3).
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Based upon a tolerance exemption fumosorosea strain FE 9901 is not toxic, Use of Isaria fumosorosea strain FE
that EPA established for a different is not pathogenic, and is not infective. 9901 throughout this document is
strain of this microbe in 2011 and a Although there may be some exposure supported by public literature, is
review of public literature, EPA revised to residues when used as an insecticide consistent with a previous tolerance
the active ingredient name from ‘‘Isaria on food, there is a lack of concern due exemption that EPA established for a
fumosoroseus strain FE 9901’’ to ‘‘Isaria to the lack of potential for adverse different strain of this microbe, and
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should assist in preventing confusion ‘‘Federal Actions to Address Dated: July 6, 2016.
with regard to the proper nomenclature Environmental Justice in Minority Richard P. Keigwin, Jr.,
for this particular active ingredient in Populations and Low-Income Director, Office of Pesticide Programs.
the future. EPA does not believe the Populations’’ (59 FR 7629, February 16,
Therefore, 40 CFR chapter I is
change from ‘‘fumosoroseus’’ to 1994).
Since tolerances and exemptions that amended as follows:
‘‘fumosorosea’’ will cause confusion
among the public as there is a clear are established on the basis of a petition PART 180—[AMENDED]
history linking the first term to the under FFDCA section 408(d), such as
second and because the names refer to the tolerance exemption in this action, ■ 1. The authority citation for part 180
the same microbe. do not require the issuance of a continues to read as follows:
proposed rule, the requirements of the
IV. References Regulatory Flexibility Act (RFA) (5 Authority: 21 U.S.C. 321(q), 346a and 371.
1. U.S. EPA. 2011. Isaria fumosorosea U.S.C. 601 et seq.) do not apply. ■ 2. Add § 180.1335 to subpart D to read
Apopka Strain 97; Exemption From This action directly regulates growers, as follows:
the Requirement of a Tolerance— food processors, food handlers, and food
Final Rule (Dated September 18, retailers, not States or tribes. As a result, § 180.1335 Isaria fumosorosea strain FE
2011). Available from https:// this action does not alter the 9901; exemption from the requirement of a
tolerance.
www.gpo.gov/fdsys/pkg/FR-2011- relationships or distribution of power
09-28/pdf/2011-24990.pdf. and responsibilities established by An exemption from the requirement
2. USDA. 2011. Agricultural Research Congress in the preemption provisions of a tolerance is established for residues
Service (ARS) Collection of of FFDCA section 408(n)(4). As such, of Isaria fumosorosea strain FE 9901 in
Entomopathogenic Fungal EPA has determined that this action will or on all food commodities when used
Cultures—Isaria Plus Paecilomyces, not have a substantial direct effect on in accordance with label directions and
Purpureocillium and Evlachovaea States or tribal governments, on the good agricultural practices.
(Dated July 28, 2011). Available relationship between the national [FR Doc. 2016–17275 Filed 7–20–16; 8:45 am]
from http://www.ars.usda.gov/ government and the States or tribal BILLING CODE 6560–50–P
sp2userfiles/place/80620510/ governments, or on the distribution of
arsefpdfs/isaria.july2011.pdf. power and responsibilities among the
3. Zimmermann G. 2008. The various levels of government or between ENVIRONMENTAL PROTECTION
entomopathogenic fungi Isaria the Federal Government and Indian AGENCY
farinosa (formerly Paecilomyces tribes. Thus, EPA has determined that
farinosus) and the Isaria Executive Order 13132, entitled 40 CFR Part 370
fumosorosea species complex ‘‘Federalism’’ (64 FR 43255, August 10, [EPA–HQ–SFUND–2010–0763; FRL 9949–
(formerly Paecilomyces 1999), and Executive Order 13175, 05–OLEM]
fumosoroseus): biology, ecology and entitled ‘‘Consultation and Coordination
use in biological control. Biocontrol RIN 2050–AG85
with Indian Tribal Governments’’ (65 FR
Science and Technology 18:865– 67249, November 9, 2000), do not apply
901. Available from http:// Hazardous Chemical Reporting:
to this action. In addition, this action Community Right-to-Know; Revisions
www.tandfonline.com/doi/abs/ does not impose any enforceable duty or
10.1080/09583150802471812. to Hazard Categories and Minor
contain any unfunded mandate as Corrections; Correction
V. Statutory and Executive Order described under Title II of the Unfunded
Reviews Mandates Reform Act (UMRA) (2 U.S.C. AGENCY: Environmental Protection
1501 et seq.). Agency (EPA).
This action establishes a tolerance This action does not involve any
exemption under FFDCA section 408(d) ACTION: Final rule; technical
technical standards that would require amendment, correction.
in response to a petition submitted to EPA’s consideration of voluntary
EPA. The Office of Management and consensus standards pursuant to section SUMMARY: The Environmental Protection
Budget (OMB) has exempted these types 12(d) of the National Technology Agency (EPA or the Agency) issued a
of actions from review under Executive Transfer and Advancement Act final rule in the Federal Register on
Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note). June 13, 2016 (81 FR 38104) amending
Planning and Review’’ (58 FR 51735, its hazardous chemical reporting
October 4, 1993). Because this action VI. Congressional Review Act
regulations. That document
has been exempted from review under Pursuant to the Congressional Review inadvertently omitted the hazard
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will ‘‘serious eye damage or eye irritation’’ in
not subject to Executive Order 13211, submit a report containing this rule and § 370.66 under the definition of ‘‘health
entitled ‘‘Actions Concerning other required information to the U.S. hazard’’. This action corrects that
Regulations That Significantly Affect Senate, the U.S. House of definition.
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
FR 28355, May 22, 2001), or Executive General of the United States prior to DATES: Effective Date: This final rule is
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal effective July 21, 2016.
Children from Environmental Health Register. This action is not a ‘‘major Compliance Date: The compliance
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). date is January 1, 2018.
April 23, 1997). This action does not ADDRESSES: The EPA has established a
Lhorne on DSK30JT082PROD with RULES
contain any information collections List of Subjects in 40 CFR Part 180 docket for this action under Docket ID
subject to OMB approval under the Environmental protection, No. EPA–HQ–SFUND–2010–0763. All
Paperwork Reduction Act (PRA), 44 Administrative practice and procedure, documents in the docket are listed on
U.S.C. 3501 et seq., nor does it require Agricultural commodities, Pesticides the http://www.regulations.gov Web
any special considerations under and pests, Reporting and recordkeeping site. Although listed in the index, some
Executive Order 12898, entitled requirements. information is not publicly available,
VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\21JYR1.SGM 21JYR1](https://thefederalregister.org/doc/81_FR_47449/page/3.svg)
Document Created: 2018-02-08 07:59:19
Document Modified: 2018-02-08 07:59:19
| 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 July 21, 2016. Objections and requests for hearings must be received on or before September 19, 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 47309 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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