Aspergillus flavus AF36; Time Limited Exemption From the Requirement of a Tolerance, 1890-1894 [2016-00665]
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1890
Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Rules and Regulations
§ 52.1320
Subpart AA—Missouri
2. Section 52.1320(e) is amended by
adding new entry (68) at the end of the
table to read as follows:
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Identification of plan.
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(e) * * *
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EPA-APPROVED MISSOURI NONREGULATORY SIP PROVISIONS
Name of nonregulatory SIP
provision
Applicable geographic or nonattainment area
State submittal
date
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(68) Missouri Early Progress
St. Louis .................................
Plan.
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8/26/13
[FR Doc. 2016–00428 Filed 1–13–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 52 and 70
[EPA–R07–OAR–2013–0765; FRL–9940–97–
Region 7]
Approval and Promulgation of
Implementation Plans; State of
Kansas; Annual Emissions Fee and
Annual Emissions Inventory
Environmental Protection
Agency (EPA).
ACTION: Direct final rule; technical
amendment.
AGENCY:
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paragraph (f) ‘‘The Kansas Department
of Health and Environment submitted
revisions to Kansas Administrative
Record (KAR) 28–19–202 and 28–19–
517 on April 15, 2011; approval of
section (c) effective March 28, 2014.’’
This technical amendment removes
the erroneous part 52 approval of KAR
28–19–202 ‘‘Annual Emissions Fees’’
and recodifies the table. This action also
revises paragraph (f) to read as follows:
(f) ‘‘The Kansas Department of Health
and Environment submitted revisions to
Kansas Administrative Record (KAR)
28–19–202 and 28–19–517 on April 15,
2011; effective March 28, 2014.’’
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Lead,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Administrative practice and
procedure, Air pollution control,
Intergovernmental relations, Operating
permits, Reporting and recordkeeping
requirements.
Dated: December 23, 2015.
Becky Weber,
Acting Regional Administrator, Region 7.
Chapter I, title 40 of the Code of
Federal Regulations is amended as
follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
2. In § 52.870, paragraph(c) is
amended by removing the table entry
‘‘K.A.R. 28–19–202.’’
■
PART 70—STATE OPERATING PERMIT
PROGRAMS
3. The authority citation for part 70
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
4. Appendix A is amended by revising
paragraph (f) under Kansas to read as
follows:
■
Appendix A to Part 70—Approval
Status of State and Local Operating
Permits Programs
*
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Kansas
*
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(f) The Kansas Department of Health and
Environment submitted revisions to Kansas
Administrative Record (KAR) 28–19–202 and
28–19–517 on April 15, 2011; effective March
28, 2014.
*
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[FR Doc. 2016–00573 Filed 1–13–16; 8:45 am]
1. The authority citation for part 52
continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0538; FRL–9939–53]
Aspergillus flavus AF36; Time Limited
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
time-limited exemption from the
Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(a) requirement of a
tolerance for residues of the pesticide
Aspergillus flavus AF36 in or on dried
figs resulting from use in accordance
SUMMARY:
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[Amended]
BILLING CODE 6560–50–P
40 CFR Part 70
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§ 52.870
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40 CFR Part 52
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Explanation
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1/14/16 [Insert Federal Reg- [EPA–R07–OAR–2015–0587;
ister citation].
FRL–9941–01–Region 7].
List of Subjects
The Environmental Protection
Agency (EPA) inadvertently approved
and codified this action under both part
52 (Approval and Promulgation of
Implementation Plans) and part 70
(State Operating Permit Programs). This
technical amendment removes the part
52 approval and codification and makes
a clarification to part 70.
DATES: This action is effective January
14, 2016.
FOR FURTHER INFORMATION CONTACT:
Lachala Kemp at (913) 551–7214, or by
email at kemp.lachala@epa.gov.
SUPPLEMENTARY INFORMATION: On
January 27, 2014 (79 FR 4274), EPA
published a direct final rule approving
a SIP revision for Kansas that included
revisions to K.A.R. 28–19–202 ‘‘Annual
Emission Fees.’’ The rule revision
amended KAR 28–19–202 ‘‘Annual
Emissions Fees’’ to align the state’s
reporting requirements with EPA’s
reporting requirements, and was
incorrectly approved and codified under
part 52 and part 70.
This rule also included revisions to
the operating permits program, K.A.R
28–19–517 ‘‘Class I Operating Permits;
Annual Emissions Inventory.’’ This part
70 appendix A revision added new
SUMMARY:
EPA approval date
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with the terms of an emergency
exemption issued under section 18 of
the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). This action is
in response to the issuance of a crisis
emergency exemption under FIFRA
section 18 authorizing use of the
pesticide on dried figs. The time-limited
exemption from the requirement of a
tolerance expires on December 31, 2017.
DATES: This regulation is effective
January 14, 2016. Objections and
requests for hearings must be received
on or before March 14, 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–2015–0538, 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 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan T. Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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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).
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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 https://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 section 408(g) of the Federal
Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2015–0538 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 March 14, 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–
2015–0538, 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/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
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II. Background and Statutory Findings
EPA, on its own initiative, in
accordance with FFDCA sections 408(e)
and 408(l)(6), 21 U.S.C. 346a(e) and
346a(1)(6), is establishing a time-limited
exemption from the requirement of a
tolerance for residues of Aspergillus
flavus AF36, in or on dried figs. This
time-limited exemption from the
requirement of a tolerance expires on
December 31, 2017.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under FIFRA section 18. Such
tolerances or exemptions from the
requirement of a tolerance must be
consistent with the safety standard in
408(b)(2) and (c)(2), respectively, and
can be established without providing
notice or period for public comment.
EPA does not intend for its actions on
FIFRA section 18 related time-limited
tolerances or exemptions from the
requirement of a tolerance to set binding
precedents for the application of FFDCA
section 408 and the safety standard to
other tolerances and exemptions.
Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption
from the requirement of a tolerance on
its own initiative, i.e., without having
received any petition from an outside
party.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement of 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. In evaluating the
safety of an exemption, section
408(c)(2)(B) requires EPA to take into
account the considerations set forth in
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. . . .’’
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Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Aspergillus flavus AF36 on Dried Figs
and FFDCA Tolerances
The California Department of
Pesticide Regulation asserted that an
emergency condition, brought on by an
ongoing drought in California, existed in
accordance with the criteria for
approval of an emergency exemption,
and utilized a crisis exemption under
FIFRA section 18 to allow the use of
Aspergillus flavus AF36 to reduce
aflatoxin-producing fungi on dried figs
in California. The California Department
of Pesticide Regulation invoked the
crisis exemption provision on June 15,
2015. After having reviewed the crisis
exemption, EPA concurred on the
emergency action in order to meet the
emergency needs of fig growers in
California. The crisis exemption
program expired on July 31, 2015.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of Aspergillus flavus AF36 in
or on dried figs. In doing so, EPA
considered the safety standard in
FFDCA section 408(c)(2), and EPA
decided that the necessary exemption
from the requirement of a tolerance
under FFDCA section 408(l)(6) would be
consistent with the safety standard and
with FIFRA section 18. Consistent with
the need to move quickly on the crisis
exemption in order to address an urgent,
non-routine situation and to ensure that
the resulting food is safe and lawful,
EPA is issuing this exemption from the
requirement of a tolerance without
notice and opportunity for public
comment as provided in FFDCA section
408(l)(6). This time-limited exemption
from the requirement of a tolerance
expires on December 31, 2017. EPA will
take action to revoke the time-limited
exemption from the requirement of a
tolerance earlier if any experience with
scientific data, or other relevant
information on this pesticide indicates
that the residues are not safe.
Because this time-limited exemption
from the requirement of a tolerance is
being approved under emergency
conditions, EPA has not made any
decisions about whether Aspergillus
flavus AF36 meets FIFRA’s registration
requirements for use on dried figs or
whether permanent tolerances or
exemption from the requirement of a
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tolerance for this use would be
appropriate. Under these circumstances,
EPA does not believe that this timelimited exemption from the requirement
of a tolerance serves as a basis for
registration of Aspergillus flavus AF36
by a State for special local needs under
FIFRA section 24(c). Nor does this
exemption from the requirement of a
tolerance by itself serve as the authority
for persons in any State other than
California to use this pesticide on the
applicable crop under FIFRA section 18
absent the issuance of an emergency
exemption applicable within that State.
For additional information regarding the
crisis exemption for Aspergillus flavus
AF36, contact the Agency’s Registration
Division at the address provided under
FOR FURTHER INFORMATION CONTACT.
IV. Toxicological Profile
Consistent with the FFDCA section
408(b)(2)(D), the EPA reviewed the
available scientific data and other
relevant information for Aspergillus
flavus AF36, and considered its validity,
completeness, and reliability, as well as
the relationship of this information to
human risk. The EPA also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
Aspergillus flavus refers to a diverse
group of saprophytic soil fungi strains,
which are ubiquitously distributed
throughout the United States. This
fungal group includes strains that
produce aflatoxin (i.e., toxigenic strains)
and strains that do not produce
aflatoxins (i.e., atoxigenic strains). The
toxigenic strains can cause aflatoxin
contamination in seed, nut, and grain
crops pre- and postharvest. In addition,
toxigenic strains of several Aspergillus
spp. can cause aspergillosis disease in
humans (Ref. 1, 2).
Aspergillus flavus AF36 is an
atoxigenic strain registered as a
microbial pesticide for use on cotton,
corn, and pistachios. The AF36 strain is
a soil colonizing fungus and displaces
toxigenic strains through competition,
thereby reducing aflatoxin levels on
crops contaminated with toxigenic
strains of Aspergillus spp. (Ref. 3).
The toxicological profile of
Aspergillus flavus were previously
described in the Federal Register July
14, 2003 (68 FR 41535) (FRL–7311–6)
and the data were used to establish the
tolerance exemption for Aspergillus
flavus AF36 in or on cotton (see the
Federal Register of July 14, 2003), corn
(see the Federal Register of March 23,
2011 (76 FR 16297) (FRL–8868–7)), and
pistachio (see the Federal Register of
March 9, 2012 (77 FR 14287) (FRL–
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9341–5). The studies used to establish
the tolerance exemptions in or on
cotton, corn, and pistachio tested the
toxicity/pathogenicity of Aspergillus
flavus AF36 to rats through acute oral
and pulmonary exposures and did not
find any evidence of toxicity or
infection (Ref. 1). Further, when
exposed through intratracheal dosing,
rats cleared Aspergillus flavus AF36
from their systems within 8 days.
Moreover, rats exposed to Aspergillus
flavus AF36 cleared the fungus from
their body without compromising their
immune system. After more than a
decade of agricultural use in cotton and
several years of use in corn and
pistachio, there have not been any
reports of hypersensitivity or other
problems from workers exposed to
Aspergillus flavus AF36. Therefore,
based on the atoxigenic profile of
Aspergillus flavus AF36, and previous
toxicological evaluations to establish
tolerance exemptions in or on cotton
(see the Federal Register of July 14,
2003), corn (see the Federal Register of
March 23, 2011), and pistachio (see the
Federal Register of March 9, 2012), EPA
concludes that there are no toxicological
endpoints of concern for Aspergillus
flavus AF36 and that there are no
hazards associated with this particular
isolate; therefore, any expected residues
on food would be safe to consume.
V. Aggregate Exposure
In examining aggregate exposure,
FFDCA section 408 directs the EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational 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).
Food exposure: Aspergillus flavus
AF36 will be applied as a single
broadcast application to soil in
California fig orchards from mid-June to
mid-July 2015. The proposed method of
application is by grain seed (wheatinfested Aspergillus flavus AF36
inoculum) applied to the orchard floor
by ground. Grain seed inoculum is
directed under the fig tree canopy where
soil is wetted before and after the
application. After application,
Aspergillus flavus AF36 germinates
using a grain carrier as a nutrient source
and displaces aflatoxin-producing
strains of Aspergillus flavus. Thus, the
use of Aspergillus flavus AF36 in fig
orchards should not increase the total
Aspergillus flavus population in the
environment (Ref. 1). Although, total
Aspergillus flavus populations may
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increase immediately after applying
Aspergillus flavus AF36, populations of
Aspergillus flavus AF36 decline by
spring of the year after application and
there is no evidence of long term
increases in populations of Aspergillus
flavus resulting from application of
Aspergillus flavus AF36. In addition,
levels of natural Aspergillus flavus
populations can fluctuate greatly over
the course of a year (Ref. 1). Therefore,
a temporary increase in Aspergillus
flavus populations resulting from an
application of Aspergillus flavus AF36
are not expected to produce effects that
do not already occur from exposure to
natural Aspergillus flavus populations.
Drinking water exposure: Similar to
previous drinking water exposures for
cotton and corn uses (see Federal
Register of July 14, 2003 and March 23,
2011) exposure to residues of
Aspergillus flavus AF36 ensuing from
application in fig orchards is possible as
a result of consuming drinking water,
but it is not likely to be greater than
existing exposures to naturally
occurring strains of Aspergillus flavus
AF36. This time-limited exemption
from the requirement of a tolerance will
only allow for applications in California
in an area where the climate is arid,
which minimizes the potential for
contamination of surface or ground
water that may serve as a source of
drinking water. Further, because
Aspergillus flavus AF36 will only be
applied as a granular formulation to
terrestrial sites, offsite movement into
water is not anticipated. If Aspergillus
flavus AF36 residues should be present
in drinking water, the results of a study
assessing acute oral toxicity and
pathogenicity found that no toxicity,
pathogenicity, and/or infectivity is
likely to occur from exposure to any
level of Aspergillus flavus AF36
resulting from an application of
Aspergillus flavus AF36 made in
accordance with good agricultural
practice.
Other non-occupational exposure:
Non-occupational dermal and
inhalation exposure is expected to be
minimal to non-existent for the use of
Aspergillus flavus AF36 on figs. As
previously described in the Federal
Register of July 14, 2003, March 23,
2011, and March 9, 2012; Aspergillus
flavus AF36 will be applied to
agricultural sites and not in the
proximity of schools, residential areas,
nursing homes, or daycare facilities.
Moreover, Aspergillus flavus AF36 will
be applied in a granular form which will
minimize drift and exposure.
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VI. 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 EPA consider ‘‘available
information concerning the cumulative
effects of a particular pesticide’s . . .
residues and other substances that have
a common mechanism of toxicity.’’
The EPA has not found Aspergillus
flavus AF36 to share a common
mechanism of toxicity with any other
substances, and Aspergillus flavus AF36
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
exemption from the requirement of a
tolerance action, therefore, the EPA has
assumed that Aspergillus flavus AF36
does not have a common mechanism of
toxicity with other substances since
there is no indication of mammalian
toxicity or pathogenicity resulting from
exposure to Aspergillus flavus AF36.
For information regarding the EPA’s
efforts to determine chemicals that have
a common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see the EPA’s Web site at
https://www.epa.gov/pesticides/
cumulative.
VII. Determination of Safety for the U.S.
Population, Infants and Children
In considering the establishment of a
time-limited exemption from the
requirement of a tolerance for a
pesticide chemical residue, FFDCA
section 408(b)(2)(C) requires that EPA
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
exposure (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 exposure (safety) will be safe
for infants and children. This additional
margin of exposure (safety) is commonly
referred to as the Food Quality
Protection Act Safety Factor. 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.
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In this instance, based on all the
available information, EPA concludes
that there are no effects of concern to
infants, children, or adults when
Aspergillus flavus AF36 is used in
accordance with the crisis exemption.
As a result, EPA concludes that no
additional margin of exposure (safety) is
necessary to protect infants and
children.
Moreover, based on the data and EPA
analysis presented in this document, the
Agency is able to conclude that there is
a reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to the residues of Aspergillus
flavus AF36 when it is used as an
antifungal agent in accordance with the
crisis exemption. Such exposure
includes all anticipated dietary
exposures and all other exposures for
which there is reliable information. As
discussed previously, there is
reasonable certainty of no harm via
dietary exposure from this fungus when
used as an antifungal agent because the
microorganism is non-toxic and nonpathogenic to animals and humans. EPA
arrived at this conclusion based on the
very low levels of mammalian toxicity
for acute oral and pulmonary effects
with no toxicity or infectivity at the
doses tested (see Unit IV. of this
document).
VIII. Other Considerations
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.
IX. Conclusion
The 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 AF36. Therefore, a time-limited
exemption from the requirement of a
tolerance is established for residues of
Aspergillus flavus AF36 in or on dried
figs when used in accordance with the
crisis exemption. This time-limited
exemption from the requirement of a
tolerance for residues of Aspergillus
flavus AF36 in or on dried figs will
expire and is revoked on December 31,
2017.
X. References
1. U.S. EPA. 2015. Human Health and
Environmental Assessment for the
California Section 18 (Emergency
Exemption) request for the use of AF36,
an end use formulation containing the
active ingredient, Aspergillus flavus
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mstockstill on DSK4VPTVN1PROD with RULES
Strain AF36. Memorandum from G.
Tomimatsu, Ph.D. and M. Djurickovic,
M.S. to S. Borges.
2. Jensen, A.B., K. Aronstein, J.M. Flores, S.
Vojvodic, M.A. Palacio and M. Spivak.
2013. Standard methods for fungal brood
disease research. J. Apic. Res. 52 (1).
3. Ehrlich, K.C. 2014. Non-aflatoxigenic
Aspergillus flavus to prevent aflatoxin
contamination in crops: Advantages and
limitations. Front. Micro. https://dx.doi.
org/10.3389/fmicb.2014.00050.
XI. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
under FFDCA sections 408(e) and
408(l)(6). 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 in accordance with
FFDCA sections 408(e) and 408(l)(6),
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
VerDate Sep<11>2014
16:27 Jan 13, 2016
Jkt 238001
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).
XII. 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 18, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.1206, add a new paragraph
(d) to read as follows:
■
§ 180.1206 Aspergillus flavus AF36;
exemption from the requirement of a
tolerance.
*
*
*
*
*
(d) Section 18 emergency exemptions.
A time-limited exemption from the
requirement of a tolerance is established
for residues of Aspergillus flavus AF36,
in or on dried figs, resulting from use of
the pesticide pursuant to a FIFRA
section 18 emergency exemption. This
time-limited exemption from the
requirement of a tolerance for residues
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
of Aspergillus flavus AF36 in or on
dried figs will expire and is revoked on
December 31, 2017.
[FR Doc. 2016–00665 Filed 1–13–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2015–0001; Internal
Agency Docket No. FEMA–8417]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/fema/csb.shtm.
DATES: The effective date of each
community’s scheduled suspension is
the third date (‘‘Susp.’’) listed in the
third column of the following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact Patricia Suber,
Federal Insurance and Mitigation
Administration, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–4149.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
SUMMARY:
E:\FR\FM\14JAR1.SGM
14JAR1
Agencies
[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Rules and Regulations]
[Pages 1890-1894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00665]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0538; FRL-9939-53]
Aspergillus flavus AF36; Time Limited Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited exemption from the
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(a) requirement
of a tolerance for residues of the pesticide Aspergillus flavus AF36 in
or on dried figs resulting from use in accordance
[[Page 1891]]
with the terms of an emergency exemption issued under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This
action is in response to the issuance of a crisis emergency exemption
under FIFRA section 18 authorizing use of the pesticide on dried figs.
The time-limited exemption from the requirement of a tolerance expires
on December 31, 2017.
DATES: This regulation is effective January 14, 2016. Objections and
requests for hearings must be received on or before March 14, 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-2015-0538, 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 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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan T. Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
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 https://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 section 408(g) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect
of this regulation and may also request a hearing on those objections.
You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2015-0538 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 March 14, 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-2015-0538, 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/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with FFDCA sections
408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
a time-limited exemption from the requirement of a tolerance for
residues of Aspergillus flavus AF36, in or on dried figs. This time-
limited exemption from the requirement of a tolerance expires on
December 31, 2017.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under FIFRA
section 18. Such tolerances or exemptions from the requirement of a
tolerance must be consistent with the safety standard in 408(b)(2) and
(c)(2), respectively, and can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances or exemptions from the
requirement of a tolerance to set binding precedents for the
application of FFDCA section 408 and the safety standard to other
tolerances and exemptions. Section 408(e) of FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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. In evaluating the safety of an exemption,
section 408(c)(2)(B) requires EPA to take into account the
considerations set forth in 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. . . .''
[[Page 1892]]
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Aspergillus flavus AF36 on Dried Figs and
FFDCA Tolerances
The California Department of Pesticide Regulation asserted that an
emergency condition, brought on by an ongoing drought in California,
existed in accordance with the criteria for approval of an emergency
exemption, and utilized a crisis exemption under FIFRA section 18 to
allow the use of Aspergillus flavus AF36 to reduce aflatoxin-producing
fungi on dried figs in California. The California Department of
Pesticide Regulation invoked the crisis exemption provision on June 15,
2015. After having reviewed the crisis exemption, EPA concurred on the
emergency action in order to meet the emergency needs of fig growers in
California. The crisis exemption program expired on July 31, 2015.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of Aspergillus
flavus AF36 in or on dried figs. In doing so, EPA considered the safety
standard in FFDCA section 408(c)(2), and EPA decided that the necessary
exemption from the requirement of a tolerance under FFDCA section
408(l)(6) would be consistent with the safety standard and with FIFRA
section 18. Consistent with the need to move quickly on the crisis
exemption in order to address an urgent, non-routine situation and to
ensure that the resulting food is safe and lawful, EPA is issuing this
exemption from the requirement of a tolerance without notice and
opportunity for public comment as provided in FFDCA section 408(l)(6).
This time-limited exemption from the requirement of a tolerance expires
on December 31, 2017. EPA will take action to revoke the time-limited
exemption from the requirement of a tolerance earlier if any experience
with scientific data, or other relevant information on this pesticide
indicates that the residues are not safe.
Because this time-limited exemption from the requirement of a
tolerance is being approved under emergency conditions, EPA has not
made any decisions about whether Aspergillus flavus AF36 meets FIFRA's
registration requirements for use on dried figs or whether permanent
tolerances or exemption from the requirement of a tolerance for this
use would be appropriate. Under these circumstances, EPA does not
believe that this time-limited exemption from the requirement of a
tolerance serves as a basis for registration of Aspergillus flavus AF36
by a State for special local needs under FIFRA section 24(c). Nor does
this exemption from the requirement of a tolerance by itself serve as
the authority for persons in any State other than California to use
this pesticide on the applicable crop under FIFRA section 18 absent the
issuance of an emergency exemption applicable within that State. For
additional information regarding the crisis exemption for Aspergillus
flavus AF36, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. Toxicological Profile
Consistent with the FFDCA section 408(b)(2)(D), the EPA reviewed
the available scientific data and other relevant information for
Aspergillus flavus AF36, and considered its validity, completeness, and
reliability, as well as the relationship of this information to human
risk. The EPA also considered available information concerning the
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children.
Aspergillus flavus refers to a diverse group of saprophytic soil
fungi strains, which are ubiquitously distributed throughout the United
States. This fungal group includes strains that produce aflatoxin
(i.e., toxigenic strains) and strains that do not produce aflatoxins
(i.e., atoxigenic strains). The toxigenic strains can cause aflatoxin
contamination in seed, nut, and grain crops pre- and postharvest. In
addition, toxigenic strains of several Aspergillus spp. can cause
aspergillosis disease in humans (Ref. 1, 2).
Aspergillus flavus AF36 is an atoxigenic strain registered as a
microbial pesticide for use on cotton, corn, and pistachios. The AF36
strain is a soil colonizing fungus and displaces toxigenic strains
through competition, thereby reducing aflatoxin levels on crops
contaminated with toxigenic strains of Aspergillus spp. (Ref. 3).
The toxicological profile of Aspergillus flavus were previously
described in the Federal Register July 14, 2003 (68 FR 41535) (FRL-
7311-6) and the data were used to establish the tolerance exemption for
Aspergillus flavus AF36 in or on cotton (see the Federal Register of
July 14, 2003), corn (see the Federal Register of March 23, 2011 (76 FR
16297) (FRL-8868-7)), and pistachio (see the Federal Register of March
9, 2012 (77 FR 14287) (FRL-9341-5). The studies used to establish the
tolerance exemptions in or on cotton, corn, and pistachio tested the
toxicity/pathogenicity of Aspergillus flavus AF36 to rats through acute
oral and pulmonary exposures and did not find any evidence of toxicity
or infection (Ref. 1). Further, when exposed through intratracheal
dosing, rats cleared Aspergillus flavus AF36 from their systems within
8 days. Moreover, rats exposed to Aspergillus flavus AF36 cleared the
fungus from their body without compromising their immune system. After
more than a decade of agricultural use in cotton and several years of
use in corn and pistachio, there have not been any reports of
hypersensitivity or other problems from workers exposed to Aspergillus
flavus AF36. Therefore, based on the atoxigenic profile of Aspergillus
flavus AF36, and previous toxicological evaluations to establish
tolerance exemptions in or on cotton (see the Federal Register of July
14, 2003), corn (see the Federal Register of March 23, 2011), and
pistachio (see the Federal Register of March 9, 2012), EPA concludes
that there are no toxicological endpoints of concern for Aspergillus
flavus AF36 and that there are no hazards associated with this
particular isolate; therefore, any expected residues on food would be
safe to consume.
V. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 directs the 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).
Food exposure: Aspergillus flavus AF36 will be applied as a single
broadcast application to soil in California fig orchards from mid-June
to mid-July 2015. The proposed method of application is by grain seed
(wheat-infested Aspergillus flavus AF36 inoculum) applied to the
orchard floor by ground. Grain seed inoculum is directed under the fig
tree canopy where soil is wetted before and after the application.
After application, Aspergillus flavus AF36 germinates using a grain
carrier as a nutrient source and displaces aflatoxin-producing strains
of Aspergillus flavus. Thus, the use of Aspergillus flavus AF36 in fig
orchards should not increase the total Aspergillus flavus population in
the environment (Ref. 1). Although, total Aspergillus flavus
populations may
[[Page 1893]]
increase immediately after applying Aspergillus flavus AF36,
populations of Aspergillus flavus AF36 decline by spring of the year
after application and there is no evidence of long term increases in
populations of Aspergillus flavus resulting from application of
Aspergillus flavus AF36. In addition, levels of natural Aspergillus
flavus populations can fluctuate greatly over the course of a year
(Ref. 1). Therefore, a temporary increase in Aspergillus flavus
populations resulting from an application of Aspergillus flavus AF36
are not expected to produce effects that do not already occur from
exposure to natural Aspergillus flavus populations.
Drinking water exposure: Similar to previous drinking water
exposures for cotton and corn uses (see Federal Register of July 14,
2003 and March 23, 2011) exposure to residues of Aspergillus flavus
AF36 ensuing from application in fig orchards is possible as a result
of consuming drinking water, but it is not likely to be greater than
existing exposures to naturally occurring strains of Aspergillus flavus
AF36. This time-limited exemption from the requirement of a tolerance
will only allow for applications in California in an area where the
climate is arid, which minimizes the potential for contamination of
surface or ground water that may serve as a source of drinking water.
Further, because Aspergillus flavus AF36 will only be applied as a
granular formulation to terrestrial sites, offsite movement into water
is not anticipated. If Aspergillus flavus AF36 residues should be
present in drinking water, the results of a study assessing acute oral
toxicity and pathogenicity found that no toxicity, pathogenicity, and/
or infectivity is likely to occur from exposure to any level of
Aspergillus flavus AF36 resulting from an application of Aspergillus
flavus AF36 made in accordance with good agricultural practice.
Other non-occupational exposure: Non-occupational dermal and
inhalation exposure is expected to be minimal to non-existent for the
use of Aspergillus flavus AF36 on figs. As previously described in the
Federal Register of July 14, 2003, March 23, 2011, and March 9, 2012;
Aspergillus flavus AF36 will be applied to agricultural sites and not
in the proximity of schools, residential areas, nursing homes, or
daycare facilities. Moreover, Aspergillus flavus AF36 will be applied
in a granular form which will minimize drift and exposure.
VI. 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 EPA consider
``available information concerning the cumulative effects of a
particular pesticide's . . . residues and other substances that have a
common mechanism of toxicity.''
The EPA has not found Aspergillus flavus AF36 to share a common
mechanism of toxicity with any other substances, and Aspergillus flavus
AF36 does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this exemption from the requirement of
a tolerance action, therefore, the EPA has assumed that Aspergillus
flavus AF36 does not have a common mechanism of toxicity with other
substances since there is no indication of mammalian toxicity or
pathogenicity resulting from exposure to Aspergillus flavus AF36. For
information regarding the EPA's efforts to determine chemicals that
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see the EPA's Web site at https://www.epa.gov/pesticides/cumulative.
VII. Determination of Safety for the U.S. Population, Infants and
Children
In considering the establishment of a time-limited exemption from
the requirement of a tolerance for a pesticide chemical residue, FFDCA
section 408(b)(2)(C) requires that EPA 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 exposure (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 exposure (safety) will
be safe for infants and children. This additional margin of exposure
(safety) is commonly referred to as the Food Quality Protection Act
Safety Factor. 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.
In this instance, based on all the available information, EPA
concludes that there are no effects of concern to infants, children, or
adults when Aspergillus flavus AF36 is used in accordance with the
crisis exemption. As a result, EPA concludes that no additional margin
of exposure (safety) is necessary to protect infants and children.
Moreover, based on the data and EPA analysis presented in this
document, the Agency is able to conclude that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to the residues of
Aspergillus flavus AF36 when it is used as an antifungal agent in
accordance with the crisis exemption. Such exposure includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. As discussed previously, there is reasonable
certainty of no harm via dietary exposure from this fungus when used as
an antifungal agent because the microorganism is non-toxic and non-
pathogenic to animals and humans. EPA arrived at this conclusion based
on the very low levels of mammalian toxicity for acute oral and
pulmonary effects with no toxicity or infectivity at the doses tested
(see Unit IV. of this document).
VIII. Other Considerations
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.
IX. Conclusion
The 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 AF36.
Therefore, a time-limited exemption from the requirement of a tolerance
is established for residues of Aspergillus flavus AF36 in or on dried
figs when used in accordance with the crisis exemption. This time-
limited exemption from the requirement of a tolerance for residues of
Aspergillus flavus AF36 in or on dried figs will expire and is revoked
on December 31, 2017.
X. References
1. U.S. EPA. 2015. Human Health and Environmental Assessment for the
California Section 18 (Emergency Exemption) request for the use of
AF36, an end use formulation containing the active ingredient,
Aspergillus flavus
[[Page 1894]]
Strain AF36. Memorandum from G. Tomimatsu, Ph.D. and M. Djurickovic,
M.S. to S. Borges.
2. Jensen, A.B., K. Aronstein, J.M. Flores, S. Vojvodic, M.A.
Palacio and M. Spivak. 2013. Standard methods for fungal brood
disease research. J. Apic. Res. 52 (1).
3. Ehrlich, K.C. 2014. Non-aflatoxigenic Aspergillus flavus to
prevent aflatoxin contamination in crops: Advantages and
limitations. Front. Micro. https://dx.doi.org/10.3389/fmicb.2014.00050.
XI. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA sections 408(e) and 408(l)(6). 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 in accordance
with FFDCA sections 408(e) and 408(l)(6), 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).
XII. 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 18, 2015.
Susan Lewis,
Director, Registration 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. In Sec. 180.1206, add a new paragraph (d) to read as follows:
Sec. 180.1206 Aspergillus flavus AF36; exemption from the requirement
of a tolerance.
* * * * *
(d) Section 18 emergency exemptions. A time-limited exemption from
the requirement of a tolerance is established for residues of
Aspergillus flavus AF36, in or on dried figs, resulting from use of the
pesticide pursuant to a FIFRA section 18 emergency exemption. This
time-limited exemption from the requirement of a tolerance for residues
of Aspergillus flavus AF36 in or on dried figs will expire and is
revoked on December 31, 2017.
[FR Doc. 2016-00665 Filed 1-13-16; 8:45 am]
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