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)

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.

[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]


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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.

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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