Mandipropamid; Pesticide Tolerances for Emergency Exemptions, 55799-55804 [2011-22983]
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
States Postal Service, International Mail
Manual (IMM®) to describe the new
maximum limits for the outbound
mailing of lithium batteries to
international, or APO, FPO or DPO
locations. The parallel changes that
were to be made to other USPS
publications are also withdrawn.
POSTAL SERVICE
39 CFR Part 20
Outbound International Mailings of
Lithium Batteries
Postal ServiceTM.
Final rule; withdrawal.
AGENCY:
ACTION:
The Postal Service is
withdrawing a final rule that would
incorporate new maximum limits for the
outbound mailing of lithium batteries to
international, or APO, FPO or DPO
locations. The Postal Service also
withdraws the corresponding Code of
Federal Regulations revision to reflect
these new limits.
DATES: The final rule published on
August 25, 2011 (76 FR 53056–56057),
is withdrawn effective September 9,
2011.
FOR FURTHER INFORMATION CONTACT: Rick
Klutts at 813–877–0372.
SUPPLEMENTARY INFORMATION: In a final
rule with comment period published in
the Federal Register on August 25,
2011, the Postal Service provided new
maximum limits for mailpieces
containing equipment with lithium
metal or lithium-ion batteries that were
to be effective October 3, 2011. These
revisions were consistent with recent
amendments to the Universal Postal
Union (UPU) Convention and
regulations as announced in
International Bureau Circulars 114 and
115, dated June 14, 2011, that affected
UPU Convention Articles 15 and 16,
Article RL 131 of the letter post
regulations, and Article RC 120 of the
parcel post regulations.
The withdrawal of the revisions is
necessary because of a notice to the
UPU from the International Civil
Aviation Organization (ICAO) on
August 19, 2011, requesting that the
UPU delay implementation of the
aforementioned amendment until the
UPU revisions could be reviewed by the
ICAO Dangerous Goods Panel, and if
approved, incorporated into The
Technical Instructions for the Safe
Transport of Dangerous Goods by Air
manual. Therefore, the UPU has
informed its member countries that the
date of newly adopted UPU
amendments for lithium batteries will
be the subject of further notice based on
the decision of the panel and any
changes to the ICAO Technical
Instructions.
Accordingly, the Postal Service
withdraws its final rule published on
August 25, 2011. The Postal Service also
withdraws the revision to 39 CFR 20.1
whereby a new section 135.6 was added
to the Mailing Standards of the United
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SUMMARY:
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Stanley F. Mires,
Chief Counsel, Legislative.
[FR Doc. 2011–23054 Filed 9–8–11; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[FRL–9460–3]
Approval of Clean Air Act Prevention
of Significant Deterioration Permit
Issued to Avenal Power Center, LLC To
Construct the Avenal Energy Project
Environmental Protection
Agency (EPA).
ACTION: Final Action.
AGENCY:
This document announces
that EPA has issued a final permit
decision granting the Clean Air Act
Prevention of Significant Deterioration
(PSD) permit application submitted by
Avenal Power Center, LLC to authorize
construction of the Avenal Energy
Project.
SUMMARY:
The EPA’s PSD permit for the
Avenal Energy Project became effective
and final agency action on August 18,
2011, when administrative review
procedures were exhausted. Pursuant to
section 307(b)(1) of the Clean Air Act,
42 U.S.C. 7607(b)(1), judicial review of
this permit decision, to the extent it is
available, may be sought by filing a
petition for review in the United States
Court of Appeals for the Ninth Circuit
within 60 days of September 9, 2011.
ADDRESSES: The documents relevant to
the above-referenced action are
available for public inspection during
normal business hours at the following
address: U.S. Environmental Protection
Agency, Region 9, 75 Hawthorne St.,
San Francisco, CA 94105. To arrange for
viewing of these documents, call Shirley
Rivera at (415) 972–3966.
FOR FURTHER INFORMATION CONTACT:
Shirley Rivera, Air Division, U.S.
Environmental Protection Agency,
Region 9, 75 Hawthorne St., San
Francisco, CA 94105. The EPA
Environmental Appeals Board (EAB)
decision described below is available at
the following Web site: https://www.epa.
gov/eab/.
DATES:
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55799
The EPA
issued a PSD permit on May 27, 2011,
to Avenal Power Center, LLC for the
Avenal Energy Project, granting
approval to construct a new
600-megawatt natural gas-fired
combined-cycle power plant in Kings
County, California. The EPA issued an
administrative amendment to the permit
on June 21, 2011, to correct
typographical errors. The EPA’s
Environmental Appeals Board (EAB)
received four petitions for review of the
permit from the following entities
within 30 days of the EPA’s service of
notice of the issuance of the permit: (1)
El Pueblo Para El Aire y Agua Limpio;
(2) Greenaction for Health &
Environmental Justice; (3) Sierra Club
and Center for Biological Diversity; and
(4) Mr. Rob Simpson. The EAB denied
review of these petitions on August 18,
2011. All conditions of the Avenal
Power Center, LLC permit for the
Avenal Energy Project, as amended on
June 21, 2011, are final and effective.
Pursuant to 40 CFR 124.19(f)(1), final
agency action by EPA has occurred
because of the exhaustion of the agency
review procedures before the EAB. The
EPA Administrator has delegated
authority to the EAB to issue final
decisions in PSD permit appeals filed
under 40 CFR part 124. 40 CFR 124.2(a).
SUPPLEMENTARY INFORMATION:
Dated: August 31, 2011.
Gina McCarthy,
Assistant Administrator. Office of Air and
Radiation.
[FR Doc. 2011–22834 Filed 9–8–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0639; FRL–8886–8]
Mandipropamid; Pesticide Tolerances
for Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
mandipropamid in or on basil, fresh and
basil, dried. This action is in response
to EPA’s granting of an emergency
exemption under section 18 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing
use of the pesticide on basil. This
regulation establishes a maximum
permissible level for residues of
mandipropamid in or on these
commodities. The time-limited
tolerances expire on December 31, 2012.
SUMMARY:
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
This regulation is effective
September 9, 2011. Objections and
requests for hearings must be received
on or before November 8, 2011, 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: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2011–0639. All documents in the
docket are listed in the docket index
available in https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Marcel Howard, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6784; e-mail address:
howard.marcel@epa.gov.
DATES:
SUPPLEMENTARY INFORMATION:
I. General Information
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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. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
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(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
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://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
EPA, on its own initiative, in
accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e)
and 346a(1)(6), is establishing timelimited tolerances for residues of
mandipropamid, 4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-a-(2propynyloxy)-benzeneacetamide, in or
on basil, fresh at 20 parts per million
(ppm) and basil, dried at 240 ppm.
These time-limited tolerances expire on
December 31, 2012.
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 section 18 of FIFRA. Such
tolerances 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 to set binding
precedents for the application of section
408 of FFDCA 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(b)(2)(A)(i) of FFDCA
allows EPA to establish 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(b)(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. 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 * * *.’’
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–2011–0639 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before November 8, 2011. 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 that does not
contain any 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 a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2011–0639, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
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II. Background and Statutory Findings
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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
Mandipropamid on Basil and FFDCA
Tolerances
The Applicant stated that a new,
destructive fungal pathogen, known as
downy mildew (Peronospora belbahrii),
has been identified in Illinois and it
resulted in a 50% yield loss in basil
production using registered alternatives.
Illinois recently experienced some
atypical weather conditions (high
moisture and temperatures) that were
conducive to the development and
spread of the disease. The increase
presence of the disease and the zero
tolerance policy for downy mildew
adopted by the distributors led basil
grower to seek a spray program to
maintain season-long control of this
disease. The registered alternatives have
been deemed inadequate for season-long
control due to product application
restrictions or lack of product efficacy.
The Applicant stated that because of the
favorable weather conditions and the
inadequacy of the registered alternatives
to achieve season-long control of the
downy mildew, an emergency situation
exists and significant economic losses
will likely incur. Further, the Applicant
asserts that without a suitable additional
fungicide, such as mandipropamid, to
address the issue, the future viability of
basil industry in Illinois is threatened.
After having reviewed the submission,
EPA determined that an emergency
condition exists for this State, and that
the criteria for approval of an emergency
exemption are met. EPA has authorized
a specific exemption under FIFRA
section 18 for the use of mandipropamid
on basil for control of downy mildew in
Illinois.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of mandipropamid in or on
basil, fresh and basil, dried. In doing so,
EPA considered the safety standard in
section 408(b)(2) of FFDCA, and EPA
decided that the necessary tolerance
under section 408(l)(6) of FFDCA would
be consistent with the safety standard
and with FIFRA section 18. Consistent
with the need to move quickly on the
emergency 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
tolerance without notice and
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opportunity for public comment as
provided in section 408(l)(6) of FFDCA.
Although these time-limited tolerances
expire on December 31, 2012, under
section 408(l)(5) of FFDCA, residues of
the pesticide not in excess of the
amounts specified in the tolerance
remaining in or on basil, fresh and basil,
dried after that date will not be
unlawful, provided the pesticide was
applied in a manner that was lawful
under FIFRA, and the residues do not
exceed a level that was authorized by
these time-limited tolerances at the time
of that application. EPA will take action
to revoke these time-limited tolerances
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances
are being approved under emergency
conditions, EPA has not made any
decisions about whether
mandipropamid meets FIFRA’s
registration requirements for use on
basil or whether permanent tolerances
for this use would be appropriate.
Under these circumstances, EPA does
not believe that this time-limited
tolerance decision serves as a basis for
registration of mandipropamid by a
State for special local needs under
FIFRA section 24(c). Nor does this
tolerance by itself serve as the authority
for persons in any State other than
Illinois to use this pesticide on the
applicable crops under FIFRA section
18 absent the issuance of an emergency
exemption applicable within that State.
For additional information regarding the
emergency exemption for
mandipropamid, contact the Agency’s
Registration Division at the address
provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish 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(b)(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. 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
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55801
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 * * *.’’
Consistent with the factors specified
in FFDCA section 408(b)(2)(D), 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 expected as a result
of this emergency exemption request
and the time-limited tolerances for
residues of mandipropamid on basil,
fresh at 20 ppm and basil, dried at 240
ppm. EPA’s assessment of exposures
and risks associated with establishing
time-limited tolerances follows.
A. 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/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for mandipropamid used for
human risk assessment is discussed in
Unit III. of the final rule published in
the Federal Register of January 16, 2008
(73 FR 2812) (FRL–8346–6).
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to mandipropamid, EPA
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considered exposure under the timelimited tolerances established by this
action as well as all existing
mandipropamid tolerances in 40 CFR
180.637. EPA assessed dietary
exposures from mandipropamid in food
as follows:
i. Acute exposure. No such effects
were identified in the toxicological
studies for mandipropamid; therefore, a
quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
relied upon permanent tolerance level
residues established for mandipropamid
and 100 percent crop treated (PCT)
information for all agricultural
commodities. An unrefined chronic
exposure assessment that assumes 100
PCT was conducted for the proposed
Section 18 uses of mandipropamid. The
parent mandipropamid is the residue of
concern for tolerance monitoring, and
mandipropamid and its major aquatic
degradates (SYN 500003 and SYN
5044851) for the risk assessment.
iii. Cancer. EPA has determined that
mandipropamid is classified as ‘‘not
likely to be a human carcinogen’’ based
on the absence of treatment-related
increases in tumors in the rat and mouse
carcinogenicity studies. Therefore, an
exposure assessment to evaluate cancer
risk is unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for mandipropamid. Tolerance level
residues and 100 PCT were assumed for
all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for mandipropamid in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
mandipropamid. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
mandipropamid for acute exposures are
estimated to be 25.2 parts per billion
(ppb) for surface water and 0.05 ppb for
ground water. The estimated
environmental concentrations (EECs) for
the aquatic degradates SYN 500003 and
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SYN 504851 are estimated to be 2.32
and 8.99 ppb for surface water and 0.6
and 1.7 ppb for ground water,
respectively. The combined level of
mandipropamid and the degradates in
surface water is 36.5 ppb.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 36.5 ppb
was used to assess the contribution to
drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Mandipropamid is not registered for
any specific use patterns that would
result in residential exposure.
4. 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.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
mandipropamid and any other
substances, and mandipropamid does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
mandipropamid has 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 the policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
cumulating effects from substances
found to have a common mechanism on
EPA’s Web site at https://www.epa.gov/
pesticides/cumulative.
C. Safety Factor for Infants and Children
1. In general. 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
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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 SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence (quantitative or
qualitative) of increased susceptibility
and no residual uncertainties with
regard to prenatal toxicity following in
utero exposure to rats or rabbits
(developmental studies) and prenatal
and/or postnatal exposures to rats
(reproduction study).
3. Conclusion. EPA has determined
that reliable data show that the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
mandipropamid is complete except that
EPA has determined that an
immunotoxicity study is required as per
the revised 40 CFR part 158. However,
there is no need for an additional
uncertainty factor while the
immunotoxicity study is completed.
The overall weight of evidence in terms
of hematology, clinical chemistry, organ
weights, and/or histopathology
indicates that mandipropamid does not
directly target the immune system.
Therefore, EPA does not anticipate that
conducting a functional immunotoxicity
study will result in a lower point of
departure than currently selected for the
overall risk assessment. The
immunotoxicity study should be
conducted in conjunction with any
future petition for the section 3
registration of mandipropamid.
ii. There is no indication that
mandipropamid is a neurotoxic
chemical and there is no need for a
developmental neurotoxicity study or
additional uncertainty factors (UFs) to
account for neurotoxicity.
iii. There is no evidence that
mandipropamid results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
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mandipropamid in drinking water. EPA
used similarly conservative assumptions
to assess postapplication exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by mandipropamid.
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D. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, mandipropamid is
not expected to pose an acute risk.
2. Chronic risk. There are no
residential uses for mandipropamid,
and therefore aggregate risk is equal to
that from consumption of food and
water. EPA has concluded that chronic
exposure to mandipropamid from food
and water will utilize 44% of the cPAD
for (children 1 to 2 years of age) the
population group receiving the greatest
exposure, while the general U.S.
population utilizes 26% of the cPAD.
3. Short-term and intermediate risk.
Short-term aggregate exposure takes into
account short-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Mandipropamid is not
registered or proposed for use on any
sites that would result in residential
exposure. Therefore, the aggregate risk
is the sum of the risk from food and
water, which was previously addressed.
4. Aggregate cancer risk for U.S.
population. As explained in this unit,
mandipropamid is not likely to be
carcinogenic in humans.
5. Determination of safety. Based on
these risk assessments, 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
mandipropamid residues.
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V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(German Multi-residue Method DFG S–
19) is available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
There are no specific Codex, Canadian
or Mexican maximum residue limits
(MRL) for mandipropamid in or on
basil.
VI. Conclusion
Therefore, time-limited tolerances are
established for residues of
mandipropamid, 4-chloro-N-[2-[3methoxy-4-(2propynyloxy)phenyl]ethyl]-a-(2propynyloxy)- benzeneacetamide, in or
on basil, fresh at 20 ppm and basil,
dried at 240 ppm. These tolerances
expire on December 31, 2012.
VII. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under sections 408(e) and 408(l)(6) of
FFDCA. 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
PO 00000
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55803
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 in accordance with
sections 408(e) and 408(l)(6) of FFDCA,
such as the tolerances 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 section 408(n)(4) of FFDCA. 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) (Pub. L.
104–4).
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), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Rules and Regulations
the Congress and to the Comptroller
General of the United States. 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 this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 31, 2011.
Lois Rossi,
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. Section 180.637 is amended by
revising paragraph (b) to read as follows:
■
Mandipropamid; tolerances for
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of the mandipropamid, 4chloro-N-[2-[3-methoxy-4-(2propynyloxy)phenyl]ethyl]-a-(2propynyloxy)-benzeneacetamide in or
on the specified agricultural
commodities, resulting from use of the
pesticide pursuant to FFIFRA section 18
emergency exemptions. The tolerances
expire on the date specified in the table.
Parts per
million
Commodity
Basil, dried ........
Basil, fresh ........
*
*
*
240
20
*
Expiration
date
12/31/12
12/31/12
*
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[FR Doc. 2011–22983 Filed 9–8–11; 8:45 am]
BILLING CODE 6560–50–P
40 CFR Part 180
[EPA–HQ–OPP–2010–0496; FRL–8881–6]
Dicamba; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of dicamba in or
on teff, forage; teff, grain; teff, straw; and
teff, hay. Interregional Research Project
Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 9, 2011. Objections and
requests for hearings must be received
on or before November 8, 2011, 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: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0496. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm.
S–4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The
Docket Facility telephone number is
(703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address: nollen.
laura@epa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
List of Subjects in 40 CFR Part 180
§ 180.637
residues.
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
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producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
harmonized test guidelines referenced
in this document electronically, please
go https://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–2010–0496 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before November 8, 2011. 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 that does not
contain any CBI for inclusion in the
public docket. Information not marked
E:\FR\FM\09SER1.SGM
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Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55799-55804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22983]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0639; FRL-8886-8]
Mandipropamid; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of mandipropamid in or on basil, fresh and basil, dried. This
action is in response to EPA's granting of an emergency exemption under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) authorizing use of the pesticide on basil. This regulation
establishes a maximum permissible level for residues of mandipropamid
in or on these commodities. The time-limited tolerances expire on
December 31, 2012.
[[Page 55800]]
DATES: This regulation is effective September 9, 2011. Objections and
requests for hearings must be received on or before November 8, 2011,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0639. All documents in the
docket are listed in the docket index available in https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Marcel Howard, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6784; e-mail address: howard.marcel@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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
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://ecfr.gpoaccess.gov/cgi/t/text/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-
2011-0639 in the subject line on the first page of your submission. All
objections and requests for a hearing must be in writing, and must be
received by the Hearing Clerk on or before November 8, 2011. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0639, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing
time-limited tolerances for residues of mandipropamid, 4-chloro-N-[2-
[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-[alpha]-(2-propynyloxy)-
benzeneacetamide, in or on basil, fresh at 20 parts per million (ppm)
and basil, dried at 240 ppm. These time-limited tolerances expire on
December 31, 2012.
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 section 18
of FIFRA. Such tolerances 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 to set binding
precedents for the application of section 408 of FFDCA 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(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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.
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 55801]]
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 Mandipropamid on Basil and FFDCA
Tolerances
The Applicant stated that a new, destructive fungal pathogen, known
as downy mildew (Peronospora belbahrii), has been identified in
Illinois and it resulted in a 50% yield loss in basil production using
registered alternatives. Illinois recently experienced some atypical
weather conditions (high moisture and temperatures) that were conducive
to the development and spread of the disease. The increase presence of
the disease and the zero tolerance policy for downy mildew adopted by
the distributors led basil grower to seek a spray program to maintain
season-long control of this disease. The registered alternatives have
been deemed inadequate for season-long control due to product
application restrictions or lack of product efficacy. The Applicant
stated that because of the favorable weather conditions and the
inadequacy of the registered alternatives to achieve season-long
control of the downy mildew, an emergency situation exists and
significant economic losses will likely incur. Further, the Applicant
asserts that without a suitable additional fungicide, such as
mandipropamid, to address the issue, the future viability of basil
industry in Illinois is threatened. After having reviewed the
submission, EPA determined that an emergency condition exists for this
State, and that the criteria for approval of an emergency exemption are
met. EPA has authorized a specific exemption under FIFRA section 18 for
the use of mandipropamid on basil for control of downy mildew in
Illinois.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of mandipropamid
in or on basil, fresh and basil, dried. In doing so, EPA considered the
safety standard in section 408(b)(2) of FFDCA, and EPA decided that the
necessary tolerance under section 408(l)(6) of FFDCA would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency 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 tolerance
without notice and opportunity for public comment as provided in
section 408(l)(6) of FFDCA. Although these time-limited tolerances
expire on December 31, 2012, under section 408(l)(5) of FFDCA, residues
of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on basil, fresh and basil, dried after that
date will not be unlawful, provided the pesticide was applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these time-limited tolerances at the time
of that application. EPA will take action to revoke these time-limited
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
mandipropamid meets FIFRA's registration requirements for use on basil
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of mandipropamid
by a State for special local needs under FIFRA section 24(c). Nor does
this tolerance by itself serve as the authority for persons in any
State other than Illinois to use this pesticide on the applicable crops
under FIFRA section 18 absent the issuance of an emergency exemption
applicable within that State. For additional information regarding the
emergency exemption for mandipropamid, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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.
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 * *
*.''
Consistent with the factors specified in FFDCA section
408(b)(2)(D), 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 expected as a result of this emergency exemption request and
the time-limited tolerances for residues of mandipropamid on basil,
fresh at 20 ppm and basil, dried at 240 ppm. EPA's assessment of
exposures and risks associated with establishing time-limited
tolerances follows.
A. 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/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for mandipropamid used for
human risk assessment is discussed in Unit III. of the final rule
published in the Federal Register of January 16, 2008 (73 FR 2812)
(FRL-8346-6).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mandipropamid, EPA
[[Page 55802]]
considered exposure under the time-limited tolerances established by
this action as well as all existing mandipropamid tolerances in 40 CFR
180.637. EPA assessed dietary exposures from mandipropamid in food as
follows:
i. Acute exposure. No such effects were identified in the
toxicological studies for mandipropamid; therefore, a quantitative
acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA relied upon permanent
tolerance level residues established for mandipropamid and 100 percent
crop treated (PCT) information for all agricultural commodities. An
unrefined chronic exposure assessment that assumes 100 PCT was
conducted for the proposed Section 18 uses of mandipropamid. The parent
mandipropamid is the residue of concern for tolerance monitoring, and
mandipropamid and its major aquatic degradates (SYN 500003 and SYN
5044851) for the risk assessment.
iii. Cancer. EPA has determined that mandipropamid is classified as
``not likely to be a human carcinogen'' based on the absence of
treatment-related increases in tumors in the rat and mouse
carcinogenicity studies. Therefore, an exposure assessment to evaluate
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for mandipropamid. Tolerance level residues and 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for mandipropamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of mandipropamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of mandipropamid for
acute exposures are estimated to be 25.2 parts per billion (ppb) for
surface water and 0.05 ppb for ground water. The estimated
environmental concentrations (EECs) for the aquatic degradates SYN
500003 and SYN 504851 are estimated to be 2.32 and 8.99 ppb for surface
water and 0.6 and 1.7 ppb for ground water, respectively. The combined
level of mandipropamid and the degradates in surface water is 36.5 ppb.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 36.5 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Mandipropamid is not registered for any specific use patterns that
would result in residential exposure.
4. 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to mandipropamid and any
other substances, and mandipropamid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that mandipropamid has
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 the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's Web site at https://www.epa.gov/pesticides/cumulative.
C. Safety Factor for Infants and Children
1. In general. 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 SF when reliable data available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence
(quantitative or qualitative) of increased susceptibility and no
residual uncertainties with regard to prenatal toxicity following in
utero exposure to rats or rabbits (developmental studies) and prenatal
and/or postnatal exposures to rats (reproduction study).
3. Conclusion. EPA has determined that reliable data show that the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for mandipropamid is complete except that
EPA has determined that an immunotoxicity study is required as per the
revised 40 CFR part 158. However, there is no need for an additional
uncertainty factor while the immunotoxicity study is completed. The
overall weight of evidence in terms of hematology, clinical chemistry,
organ weights, and/or histopathology indicates that mandipropamid does
not directly target the immune system. Therefore, EPA does not
anticipate that conducting a functional immunotoxicity study will
result in a lower point of departure than currently selected for the
overall risk assessment. The immunotoxicity study should be conducted
in conjunction with any future petition for the section 3 registration
of mandipropamid.
ii. There is no indication that mandipropamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no evidence that mandipropamid results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to
[[Page 55803]]
mandipropamid in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by mandipropamid.
D. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
mandipropamid is not expected to pose an acute risk.
2. Chronic risk. There are no residential uses for mandipropamid,
and therefore aggregate risk is equal to that from consumption of food
and water. EPA has concluded that chronic exposure to mandipropamid
from food and water will utilize 44% of the cPAD for (children 1 to 2
years of age) the population group receiving the greatest exposure,
while the general U.S. population utilizes 26% of the cPAD.
3. Short-term and intermediate risk. Short-term aggregate exposure
takes into account short-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Mandipropamid is not registered or proposed for use on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which was
previously addressed.
4. Aggregate cancer risk for U.S. population. As explained in this
unit, mandipropamid is not likely to be carcinogenic in humans.
5. Determination of safety. Based on these risk assessments, 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 mandipropamid residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (German Multi-residue Method DFG
S-19) is available to enforce the tolerance expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no specific Codex, Canadian or Mexican maximum residue
limits (MRL) for mandipropamid in or on basil.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
[alpha]-(2-propynyloxy)- benzeneacetamide, in or on basil, fresh at 20
ppm and basil, dried at 240 ppm. These tolerances expire on December
31, 2012.
VII. Statutory and Executive Order Reviews
This final rule establishes tolerances under sections 408(e) and
408(l)(6) of FFDCA. 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 in accordance
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of
[[Page 55804]]
the Congress and to the Comptroller General of the United States. 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
this final rule in the Federal Register. This final rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 31, 2011.
Lois Rossi,
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. Section 180.637 is amended by revising paragraph (b) to read as
follows:
Sec. [emsp14]180.637 Mandipropamid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of the
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
[alpha]-(2-propynyloxy)-benzeneacetamide in or on the specified
agricultural commodities, resulting from use of the pesticide pursuant
to FFIFRA section 18 emergency exemptions. The tolerances expire on the
date specified in the table.
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Basil, dried.................................. 240 12/31/12
Basil, fresh.................................. 20 12/31/12
------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-22983 Filed 9-8-11; 8:45 am]
BILLING CODE 6560-50-P