[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Rules and Regulations]
[Pages 63707-63710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22357]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0742; FRL-9951-44]


Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; 
Temporary Exemptions From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes temporary exemptions from the 
requirement of a tolerance for residues of Aspergillus flavus strains 
TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities 
of corn, field; corn, pop; and corn, sweet when

[[Page 63708]]

used in accordance with the terms of Experimental Use Permit (EUP) No. 
91163-EUP-1. Interregional Research Project Number 4 (IR-4) submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting these temporary tolerance exemptions. This regulation 
eliminates the need under FFDCA to establish a maximum permissible 
level for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, 
and TC46G when used under the terms of EUP No. 91163-EUP-1. The 
temporary tolerance exemptions expire on June 30, 2020.

DATES: This regulation is effective September 16, 2016. Objections and 
requests for hearings must be received on or before November 15, 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-2015-0742, 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-2015-0742 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 
November 15, 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-2015-0742, 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 February 9, 2016 (81 FR 6826) (FRL-9941-
42), 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 5E8397) by IR-4, Rutgers University, 500 College Rd. East, 
Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 
part 180 be amended by establishing a temporary exemption from the 
requirement of a tolerance for residues of Aspergillus flavus strains 
TC16F, TC35C, TC38B, and TC46G in or on corn. That document referenced 
a summary of the petition prepared by the petitioner IR-4, which is 
available in the docket via http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    EPA changed the commodity name reflected in the tolerance exemption 
expression from ``corn'' to ``food and feed commodities of corn, field; 
corn, pop; and corn, sweet'' and changed ``tolerance exemption'' to 
``tolerance exemptions''. The reasons for these changes are explained 
in Unit III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(r) of FFDCA authorizes EPA to establish a temporary 
exemption from the requirement of a tolerance for residues covered by 
an experimental use permit issued under the Federal Insecticide, 
Fungicide, and Rodenticide Act. That section states that the provisions 
of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA 
section 408(r). 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

[[Page 63709]]

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 
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G 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 August 18, 2016, document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G.'' 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 Aspergillus flavus 
strains TC16F, TC35C, TC38B, and TC46G are not toxic, not pathogenic, 
and not infective. Although there may be some exposure to residues when 
used on corn in accordance with the terms of EUP No. 91163-EUP-1, 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 was not necessary as part of the qualitative 
assessment conducted for Aspergillus flavus strains TC16F, TC35C, 
TC38B, and TC46G.
    Based upon 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 
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G. Therefore, 
temporary exemptions from the requirement of a tolerance are 
established for residues of Aspergillus flavus strains TC16F, TC35C, 
TC38B, and TC46G in or on the food and feed commodities of corn, field; 
corn, pop; and corn, sweet when used in accordance with the terms of 
EUP No. 91163-EUP-1.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons contained in the August 18, 2016, document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 
Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G'' and because 
EPA is establishing temporary exemptions from the requirement of a 
tolerance without any numerical limitation.

C. Revisions to the Requested Tolerance Exemption

    Two modifications have been made to the requested tolerance 
exemption. EPA changed ``corn'' to ``food and feed commodities of corn, 
field; corn, pop; and corn, sweet'' to align with the Agency's food and 
feed commodity vocabulary. EPA also changed ``tolerance exemption'' to 
``tolerance exemptions'' as four different active ingredients are 
covered with this action.

IV. Statutory and Executive Order Reviews

    This action establishes exemptions from the requirement of a 
tolerance 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 
exemptions 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).

V. 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: August 30, 2016.
Jack Housenger,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346a and 371.


[[Page 63710]]



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2. Add Sec.  180.1338 to subpart D to read as follows:


Sec.  180.1338  Aspergillus flavus strains TC16F, TC35C, TC38B, and 
TC46G; temporary exemptions from the requirement of a tolerance.

    Temporary exemptions from the requirement of a tolerance are 
established for residues of Aspergillus flavus strains TC16F, TC35C, 
TC38B, and TC46G in or on the food and feed commodities of corn, field; 
corn, pop; and corn, sweet when used in accordance with the terms of 
Experimental Use Permit No. 91163-EUP-1. These temporary exemptions 
from the requirement of a tolerance expire on June 30, 2020.

[FR Doc. 2016-22357 Filed 9-15-16; 8:45 am]
 BILLING CODE 6560-50-P