[Federal Register: February 4, 2010 (Volume 75, Number 23)]
[Proposed Rules]
[Page 5707-5708]
[DOCID:fr04fe10-16]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2009-0745; FRL-9110-1]

Approval and Promulgation of Implementation Plans; Albuquerque-
Bernalillo County, NM; Excess Emissions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The EPA is proposing to approve revisions to the New Mexico
State Implementation Plan (SIP) submitted by the Governor of New Mexico
on behalf of the Albuquerque Environmental Health Department (AEHD) in
a letter dated September 23, 2009 (the September 23, 2009 SIP
submittal). The September 23, 2009 SIP submittal concerns revisions to
New

Mexico Administrative Code Title 20, Chapter 11, Part 49, Excess
Emissions (20.11.49 NMAC--Excess Emissions) occurring during startup,
shutdown, and malfunction related activities. We are proposing to
approve the September 23, 2009 SIP submittal in accordance with the
requirements of section 110 of the Clean Air Act.

DATES: Written comments must be received on or before March 8, 2010.

ADDRESSES: Comments may be mailed to Mr. Guy Donaldson, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the Addresses section of the direct final
rule located in the Rules Section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Mr. Alan Shar, Air Planning Section
(6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>, fax
(214) 665-7263, e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
action, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. The EPA will not institute a second comment period.
Any parties interested in commenting on this action should do so at
this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule, which is
located in the Rules Section of this Federal Register.

    Dated: January 25, 2010.
Al Armendariz,
Regional Administrator, Region 6.
[FR Doc. 2010-2394 Filed 2-3-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 2, 2009 (Volume 74, Number 126)]
[Rules and Regulations]
[Page 31620-31622]
[DOCID:fr02jy09-6]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 748

[Docket No.<PHONE_NUMBER>-91048-01]
RIN 0694-AE65

Authorization Validated End-User (VEU): List of Approved End-
Users and Respective Eligible Items for India

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: In this final rule, the Bureau of Industry and Security (BIS)
amends the Export Administration Regulations (EAR) to include the
initial list of end-users for India approved to receive exports,
reexports and transfers of certain items under Authorization Validated
End-User (VEU). Specifically, this rule amends the EAR to authorize one
VEU in India and identify the respective eligible items for export and
reexport to that VEU's facilities.

DATES: This rule is effective July 2, 2009. Although there is no formal
comment period, public comments on this regulation are welcome on a
continuing basis.

ADDRESSES: You may submit comments, identified by RIN 0694-AE65, by any
of the following methods:
    E-mail<EMAIL_ADDRESS>Include ``RIN 0694-AE65'' in the
subject line of the message.
    Fax:<PHONE_NUMBER>. Please alert the Regulatory Policy Division,
by calling<PHONE_NUMBER>, if you are faxing comments.
    Mail or Hand Delivery/Courier: Sheila Quarterman, U.S. Department
of Commerce, Bureau of Industry and Security, Regulatory Policy
Division, 14th Street & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230, Attn: RIN 0694-AE65.
    Send comments regarding the collection of information associated
with this rule, including suggestions for reducing the burden to
Jasmeet Seehra, Office of Management and Budget (OMB), by e-mail to
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>. Comments
on this collection of information should be submitted separately from
comments on the final rule (i.e., RIN 0694-AE65)--all comments on the
latter should be submitted by one of the three methods outlined above.

FOR FURTHER INFORMATION CONTACT: Karen Nies-Vogel, Chairman, End-User
Review Committee, Bureau of Industry and Security, U.S. Department of
Commerce, 14th Street & Pennsylvania Avenue, NW., Washington, DC 20230;
by telephone<PHONE_NUMBER>, or by e-mail to<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

Authorization Validated End-User (VEU): Initial List of Approved End-
Users, Eligible Items and Destinations for India

    Consistent with U.S. Government policy to facilitate trade for
civilian end-users, BIS amended the EAR in a final rule on June 19,
2007 (72 FR 33646) by creating a new authorization for ``validated end-
users'' (VEUs) located in eligible destinations to which eligible items
(commodities, software and technology, except those controlled for
missile technology or crime control reasons) may be exported,
reexported or transferred under a general authorization instead of a
license in conformance with Section 748.15 of the EAR. In a final rule
published in the Federal Register on October 1, 2007 (72 FR 56010,
October 1, 2007), BIS identified India as an eligible destination under
Authorization VEU.

    Authorization VEU would facilitate increased high-technology
exports to companies in India that have a record of using such items
responsibly. VEUs may obtain eligible items that are on the Commerce
Control List without having to wait for their suppliers to obtain
export licenses from BIS. A wide range of items are eligible for
shipment under Authorization VEU. In addition to U.S. exporters,
Authorization VEU may be used by foreign reexporters. Finally, while a
VEU authorization may be revised, suspended or revoked pursuant to
Section 748.15(a)(3), it does not have an expiration date, unlike the
two-year validity period of an export license.

Approved VEU India and Its Respective ``Eligible Items (By ECCN)'' and
``Eligible Destinations''

    This final rule amends Supplement No. 7 to Part 748 of the EAR to
identify a company, with eligible facilities, in India as a VEU and to
identify the items that may be exported, reexported or transferred to
it and its approved facilities under Authorization VEU. This new entry
is for GE India. Below are the specific Export Control Classification
Numbers (ECCNs) defining the materials, material and aerospace
technologies, and explosive detection equipment, software and
technology matched to the respective GE India facility names and
addresses. Supplement 7 to Part 748 identifies the ECCNs and facilities
under the headings ``Eligible Items (By ECCN)'' and ``Eligible
Destinations'', respectively:

GE India, AIFACS Bldg., 1 Rafi Marg, New Delhi 110 001 India.
GE India Technology Centre Private Ltd. (GEITC), 122, EPIP, Phase II,
Hoodi Village, Whitefield Road, Bangalore, Karnataka 560066 India,
1C002.a.1, 1C002.a.2, 1C002b.1.a and 1C002.b.1.b, 1E001, 2E983,
9E003.a.1, 9E003.a.4, 9E003.a.5, 9E003.a.6, 9E003.a.8, and 9E003.c.
Bangalore Engineering Centre (BEC), c/o GE India Technology Centre
Private Ltd. (GEITC), 122, EPIP, Phase II, Hoodi Village, Whitefield
Road, Bangalore, Karnataka 560066 India, 1C002.a.1, 1C002.a.2,
1C002.b.1.a, 1C002.b.1.b, 1E001, 9E003.a.1, 9E003.a.2, 9E003.a.4,
9E003.a.5, 9E003.a.6, 9E003.a.8, and 9E003.c.
GE Fanuc Systems PVT Ltd., 90/B Electronics City, Hosur Road, Bangalore
561229 India, 2A983, 2D983.

    The VEUs listed in Supplement No. 7 to Part 748 were reviewed and
approved by the U.S. Government in accordance with the provisions of
Section 748.15 and Supplement Nos. 8 and 9 to Part 748 of the EAR.
    Approving this new end-user as a VEU is expected to further
facilitate exports to civil end-users in India. Approval of this
company also represents a significant savings of time for suppliers and
end-users. Authorization VEU will eliminate the burden on exporters and
reexporters of preparing license applications and on BIS for processing
such applications, as exports and reexports will be made under general
authorization instead of under a license. These savings will enable
exporters and reexporters to supply VEUs much more quickly, thus
enhancing the competitiveness of U.S. exporters, as well as
reexporters, and end-users in India.
    To ensure appropriate facilitation of exports and reexports, on-
site reviews of the VEUs may be warranted pursuant to paragraph
748.15(a)(2) and Section 7(iv) of Supplement No. 8 to Part 748 of the
EAR. If such reviews are warranted, BIS will inform the Government of
India, as appropriate.
    Since August 21, 2001, the Export Administration Act has been in
lapse and the President, through Executive Order 13222 of August 17,
2001 (3 CFR, 2001 Comp., p. 783 (2002)), as extended most recently by
the Notice of July 23, 2008 (73 FR 43603, July 25, 2008), has continued
the EAR in effect under the International Emergency Economic Powers
Act. BIS continues to carry out the provisions of the Act, as
appropriate and to the extent permitted by law, pursuant to Executive
Order 13222.

Rulemaking Requirements

    1. This final rule has been determined to be not significant for
the purposes of Executive Order 12866.
    2. Notwithstanding any other provisions of law, no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, subject to the requirements of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This rule involves
collections previously approved by the OMB under control number 0694-
0088, ``Multi-Purpose Application,'' which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748; and for
recordkeeping, reporting and review requirements in connection with
Authorization Validated End-User, which carries an estimated burden of
30 minutes per submission. This rule is expected to result in a
decrease in license applications submitted to BIS. Total burden hours
associated with the Paperwork Reduction Act and Office of Management
and Budget control number 0694-0088 are not expected to increase
significantly as a result of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined under Executive Order 13132.
    4. The provisions of the Administrative Procedure Act requiring
notice of proposed rulemaking, the opportunity for public
participation, and a delay in effective date, are inapplicable because
this regulation involves a military and foreign affairs function of the
United States (5 U.S.C. 553(a)(1)). Further, no other law requires that
a notice of proposed rulemaking and an opportunity for public comment
be given for this final rule. Because a notice of proposed rulemaking
and an opportunity for public comment are not required to be given for
this rule under the Administrative Procedure Act or by any other law,
the analytical requirements of the Regulatory Flexibility Act (5 U.S.C.
601 et seq.) are not applicable. Therefore, this regulation is issued
in final form. Although there is no formal comment period, public
comments on this regulation are welcome on a continuing basis. Comments
should be submitted to Sheila Quarterman, Regulatory Policy Division,
Bureau of Industry and Security, U.S. Department of Commerce, 14th
Street & Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230

List of Subjects in 15 CFR Part 748

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

0
Accordingly, part 748 of the Export Administrative Regulations (15 CFR
parts 730-774) is amended as follows:

PART 748--[AMENDED]

0
1. The authority citation for 15 CFR Part 748 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13026, 61 FR 58767, 3 CFR 1996 Comp., p. 228; E.O. 13222, 66 FR
44025, 3 CFR 2001 Comp., p. 783; Notice of July 23, 2008, 73 FR
43603 (July 25, 2008).

0
2. Supplement No. 7 to Part 748 is amended by:
0
a. Adding a new column ``Country'' before the column ``Validated end-
user'';
0
b. Adding ``China (People's Republic of)'' in the ``Country'' column;
and
0
c. Adding an entry for ``India''.
    The additions read as follows:

  Supplement No. 7 to Part 748--Authorization Validated End-User (VEU); List of Validated End-Users, Respective
                   Items Eligible for Export, Reexport and Transfer and Eligible Destinations
----------------------------------------------------------------------------------------------------------------
                                                                  Eligible items (by
              Country                   Validated end-user              ECCN)             Eligible destination
----------------------------------------------------------------------------------------------------------------
China (People's Republic of)......  * * * * *.................  * * * * *............  * * * * *
India.............................  GE India..................  .....................  AIFACS Bldg., 1 Rafi
                                                                                Marg, New Delhi 110 001
                                                                                India.
                                                                For GEITC:
                                                                   1C002.a.1,          GE India Technology
                                                                    1C002.a.2,.         Centre Private Ltd.
                                                                1C002b.1.a and          (GEITC) 122, EPIP, Phase
                                                                 1C002.b.1.b.           II, Hoodi Village,
                                                                1E001, 2E983,........   Whitefield Road,
                                                                9E003.a.1, 9E003.a.4,   Bangalore, Karnataka
                                                                9E003.a.5, 9E003.a.6,   560066 India.
                                                                9E003.a.8, and
                                                                 9E003.c.
                                                                For BEC:
                                                                   1C002.a.1,          Bangalore Engineering
                                                                    1C002.a.2,.         Centre (BEC), c/o GE
                                                                1C002.b.1.a,            India Technology Centre
                                                                 1C002.b.1.b.           Private Ltd. (GEITC),
                                                                1E001................   122, EPIP, Phase II,
                                                                9E003.a.1, 9E003.a.2,   Hoodi Village,
                                                                9E003.a.4, 9E003.a.5,   Whitefield Road,
                                                                9E003.a.6, 9E003.a.8,   Bangalore, Karnataka
                                                                 and.                   560066 India.
                                                                9E003.c..............
                                                                For GE Fanuc Systems
                                                                 PVT Ltd.:
                                                                   2A983.............  GE Fanuc Systems PVT
                                                                2D983................   Ltd., 90/B Electronics
                                                                                City, Hosur Road,
                                                                                Bangalore 561229 India.
----------------------------------------------------------------------------------------------------------------

    Dated: June 26, 2009.
Matthew S. Borman,
Acting Assistant Secretary for Export Administration.
[FR Doc. E9-15649 Filed 7-1-09; 8:45 am]

BILLING CODE 3510-33-P


[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Rules and Regulations]
[Pages 78558-78561]
[FR Doc No: 2022-27869]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0189; FRL-10458-01-OCSPP]

Iron Oxide (Fe3O4) in Pesticide Formulations Applied to Animals;
Tolerance Exemption

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 iron oxide (Fe3O4)
(CAS Reg. No. 1317-61-9) when used as an inert ingredient (colorant) in
pesticide formulations applied to animals. The United States Department
of Agriculture (USDA) Animal and Plant Health Inspection Service
submitted a petition (IN-11661) to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting establishment of an exemption from
the requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of iron oxide
(Fe3O4), when used in accordance with the terms
of that exemption.

DATES: This regulation is effective December 22, 2022. Objections and
requests for hearings must be received on or before February 21, 2023
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-2022-0189, is available at
https://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 and the OPP docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; 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 Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

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-2022-0189 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 February 21, 2023. 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-2022-0189, by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov//where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/.

II. Petition for Exemption

    In the Federal Register of March 22, 2022 (87 FR 16133) (FRL-9410-
11-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11661) by the USDA Animal and Plant Health Inspection Service, 4700
River Road, Unit 149, Riverdale, MD 20737. The petition requested that
40 CFR 180.930 be amended by establishing an exemption from the
requirement of a tolerance for residues of iron oxide
(Fe3O4) (CAS Reg. No. 1317-61-9) when used as an
inert ingredient (colorant) in pesticide formulations at no more than
2,000 parts per million (ppm) (0.2% by weight) in the final formulation
applied to animals. That document referenced a summary of the petition
prepared by the USDA Animal and Plant Health Inspection Service, the
petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    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 tolerance 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. When making a safety determination for an
exemption for the requirement of a tolerance, FFDCA section
408(c)(2)(B) directs EPA to consider the considerations in section
408(b)(2)(C) and (D). Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing 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. . . .'' Section 408(b)(2)(D) lists other factors for EPA
consideration making safety determinations, e.g., the validity,
completeness, and reliability of available data, nature of toxic
effects, available information concerning the cumulative effects of the
pesticide chemical and other substances with a common mechanism of
toxicity, and available information concerning aggregate exposure
levels to the pesticide chemical and other related substances, among
others.
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for iron oxide
(Fe3O4) including exposure resulting from the
exemption established by this action. EPA's assessment of exposures and
risks associated with iron oxide (Fe3O4) follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the adverse effects caused by iron oxide
(Fe3O4) as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are discussed in this unit.
    The toxicological database of iron oxide
(Fe3O4) is supported by data regarding iron oxide
red and iron oxide yellow. EPA has determined that it is appropriate to
bridge iron oxide red and iron oxide yellow data to assess iron oxide
(Fe3O4) due to similarities in structure, and
similarities among the

available human health toxicity data of these substances.
    Iron oxide (Fe3O4) exhibits low levels of
acute toxicity via the oral and inhalation routes of exposure and is
anticipated to have low acute dermal toxicity. It is not a skin or eye
irritant nor a skin sensitizer. No adverse effects were reported in the
90-day study in rats. No evidence of neurotoxicity was observed in the
neurotoxicity screening performed in the 90-day oral rat study, and no
evidence of immunotoxicity was seen in the available studies. No
adverse reproduction or developmental effects were reported in the
available reproduction and developmental toxicity study summaries in
rats. Furthermore, concern for carcinogenicity is low, based on
negative results in a mutagenicity study, and the lack of structural
alerts for mutagenicity or carcinogenicity.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    The hazard profile of iron oxide (Fe3O4) is
adequately defined. Overall, iron oxide (Fe3O4)
is of low acute, subchronic, and developmental toxicity. No systemic
toxicity is observed up to 1,000 mg/kg/day. Since signs of toxicity
were not observed, no toxicological endpoints of concern or PODs were
identified. Therefore, a qualitative risk assessment for iron oxide
(Fe3O4) can be performed.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses and drinking water. In
evaluating dietary exposure to iron oxide
(Fe3O4), EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from iron oxide (Fe3O4) in food
as follows:
    Dietary exposure to iron oxide (Fe3O4) may
occur from consuming game treated with pesticide formulations (baits)
containing this inert ingredient and from non-pesticidal uses (food
additive uses and inactive ingredient uses in FDA-approved drugs).
Exposure to iron oxide (Fe3O4) via drinking water
is expected to be negligible, based on the limited use pattern (baits).
However, no toxicological endpoints of concern were selected, and
therefore, a quantitative dietary exposure assessment for iron oxide
(Fe3O4) was not conducted.
    2. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    No residential exposure is anticipated from the proposed uses for
iron oxide (Fe3O4) in pesticide formulation
applied to animals. Iron oxide (Fe3O4) may be
present in current pesticide and non-pesticide products that may be
used in and around the home. However, a quantitative residential
exposure assessment was not conducted since a toxicological endpoint
for risk assessment was not identified.
    3. 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.''
    Based on the lack of toxicity in the available database, EPA has
not found iron oxide (Fe3O4) to share a common
mechanism of toxicity with any other substances, and iron oxide
(Fe3O4) does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance exemption, therefore, EPA has assumed that iron oxide
(Fe3O4) 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 website at
https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (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 based on reliable data 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 (SF). In applying this provision, EPA either
retains the default value of 10X, or uses a different additional safety
factor when reliable data available to EPA support the choice of a
different factor.
    Based on an assessment of available data for iron oxide
(Fe3O4), EPA has concluded that there are no
toxicological endpoints of concern for the U.S. population, including
infants and children. Because there are no threshold effects associated
with iron oxide (Fe3O4), EPA conducted a
qualitative assessment. As part of that assessment, the Agency did not
use safety factors for assessing risk, and no additional safety factor
is needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, 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 iron oxide (Fe3O4) residues.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
iron oxide (Fe3O4) in or on any food commodities.
EPA is establishing a limitation on the amount of iron oxide
(Fe3O4) that may be used in pesticide
formulations applied to animals. This limitation will be enforced
through the pesticide registration process under the Federal

Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136
et seq. EPA will not register any pesticide formulation for food use
that exceeds 0.2% iron oxide (Fe3O4) in the final
pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established in 40 CFR 180.930 for residues of iron oxide
(Fe3O4) (CAS Reg. No. 1317-61-9) when used as an
inert ingredient (colorant) in pesticide formulations at no more than
0.2% by weight of the final formulation applied to animals.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 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 exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. 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: December 13, 2022.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.930, amend table 1 by adding in alphabetical order an
entry for ``Iron oxide (Fe3O4) (CAS Reg. No. 1317-61-9)'' to read as
follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.

* * * * *

                           Table 1 to 180.930
------------------------------------------------------------------------
       Inert ingredients              Limits                Uses
------------------------------------------------------------------------

                              * * * * * * *
Iron oxide (Fe3O4) (CAS Reg.    Not to exceed      Colorant.
 No. 1317-61-9).                 0.2% of
                                 pesticide
                                 formulations.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2022-27869 Filed 12-21-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Rules and Regulations]
[Pages 75065-75068]
[FR Doc No: 2014-29306]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0352; FRL-9919-35]

Natamycin; Amendment to an 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 in
or on pineapples. DSM Food Specialties B.V. submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
amendment to the 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 pineapple.

DATES: This regulation is effective December 17, 2014. Objections and
requests for hearings must be received on or before February 17, 2015,
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-2014-0352, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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. To access the OCSPP test guidelines referenced in this
document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.''

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-2014-0352 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
February 17, 2015. 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-2014-0352, 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 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 4F8233) by DSM Food Specialties B.V. (the Petitioner),
Alexander Fleminglaan 1, 2613 AX 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 for post-
harvest indoor use on pineapples. That document referenced a summary of
the petition prepared by the Petitioner, 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 (21CFR
172.155) and as an additive to the feed and drinking water of broiler
chickens to retard the growth of specific molds (21CFR 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). Additional
potential uses of natamycin include controlling fungal growth post-
harvest on pineapples treated indoors. 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'' (November 7,
2014), 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 pineapples 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'' (November 7, 2014). 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'' (November 7, 2014), 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) Considerations for Natamycin'' (November 7, 2014),
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'' (November 7, 2014),
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 susceptibility
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 Safety Factor (FQPA SF). 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 on natamycin and considered its 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'' (November 7, 2014), 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 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. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation. Further, residues are not
expected on any other crops because natamycin will only be applied
indoors to these particular crops.

VIII. Conclusion

    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 pineapple.
    The Agency is issuing the exemption for residues on pineapple
instead of limiting this exemption to post-harvest indoor applications
to pineapple 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 an exemption from the requirement of 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 final rule has been exempted from review
under Executive Order 12866, this final rule 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 final rule 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 exemption 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 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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: December 1, 2014.
Robert 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
residues of natamycin in or on mushrooms when applied as a fungistat to
prevent the germination of fungal spores on mushrooms produced in
enclosed mushroom production facilities, and in or on pineapples when
applied as a fungistat in accordance with label directions and good
agricultural practices.

[FR Doc. 2014-29306 Filed 12-16-14; 8:45 am]
BILLING CODE 6560-50-P