Fosetyl-Al; Pesticide Tolerances, 2315-2320 [2015-00491]
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Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations
submission requirement. Because
Oregon submitted this SIP to address
the applicable requirements of CAA
section 110(a)(2)(D)(i)(I) with respect to
the 2006 24-hour PM2.5 NAAQS, it need
only demonstrate that the SIP is
adequate to prohibit emissions that
significantly contribute to
nonattainment or interfere with
maintenance of the 2006 24-hour PM2.5
NAAQS in other states. Any emissions
that have such impacts with respect to
other NAAQS must be addressed as
appropriate in the CAA section
110(a)(2)(D)(i)(I) SIP submissions for
those other NAAQS. In its May 14,
2014, action, the EPA proposed to
conclude that Oregon’s 2010 Interstate
Transport SIP submission addressed the
requirements of CAA section
110(a)(2)(D)(i)(I) with respect to the
2006 24-hour PM2.5 NAAQS (79 FR
27528). The commenter has offered no
data or evidence to suggest that the
submission does not do so.
III. Final Action
The EPA is approving the portion of
the June 28, 2010, SIP submission from
Oregon that addresses the interstate
transport requirements of CAA section
110(a)(2)(D)(i)(I) for the 2006 24-hour
PM2.5 NAAQS. The EPA is determining
that Oregon’s existing SIP contains
adequate provisions to ensure that air
emissions from Oregon will not
significantly contribute to
nonattainment or interfere with
maintenance of the 2006 24-hour PM2.5
NAAQS in any other state. This action
is being taken under section 110 of the
CAA.
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IV. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
CAA and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely approves state law as meeting
Federal requirements and does not
impose additional requirements beyond
those imposed by state law. For that
reason, this action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
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• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
this action does not involve technical
standards; and does not provide the
EPA with the discretionary authority to
address, as appropriate,
disproportionate human health or
environmental effects, using practicable
and legally permissible methods, under
Executive Order 12898 (59 FR 7629,
February 16, 1994).
The SIP is not approved to apply on
any Indian reservation land or in any
other area where EPA or an Indian tribe
has demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications as specified by Executive
Order 13175 (65 FR 67249, November 9,
2000), nor will it impose substantial
direct costs on tribal governments or
preempt tribal law.
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. The EPA will
submit a report containing this action
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. A major rule cannot take effect
until 60 days after it is published in the
Federal Register. This action is not a
‘‘major rule’’ as defined by 5 U.S.C.
804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
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2315
Court of Appeals for the appropriate
circuit by March 17, 2015. Filing a
petition for reconsideration by the
Administrator of this final rule does not
affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. (See section
307(b)(2)).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and
recordkeeping requirements, Sulfur
oxides, and Volatile organic
compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: December 31, 2014.
Michelle Pirzadeh,
Acting Regional Administrator, Region 10.
40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for Part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart MM—Oregon
2. In § 52.1990 is amended by adding
paragraph (b) to read as follows:
■
§ 52.1990 Interstate Transport for the 2006
24-hour PM2.5 NAAQS.
*
*
*
*
*
(b) The EPA approves the portion of
Oregon’s SIP submitted on June 28,
2010 (cover letter dated June 23, 2010)
addressing the requirements of CAA
section 110(a)(2)(D)(i)(I) for the 2006 24hour PM2.5 NAAQS.
[FR Doc. 2015–00645 Filed 1–15–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0540; FRL–9920–54]
Fosetyl-Al; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of Aluminum tris
(O-ethylphosphonate) (fosetyl-Al) in or
SUMMARY:
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on pepper/eggplant, subgroup 8–10B.
Bayer CropScience requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 16, 2015. Objections and
requests for hearings must be received
on or before March 17, 2015, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0540, 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 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).
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
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the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl. To access the OCSPP test
guidelines referenced in this document
electronically, please go to 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–2014–0540 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 17, 2015. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0540, 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. Summary of Petitioned-For
Tolerance
In the Federal Register of November
7, 2014 (79 FR 66347) (FRL–9918–69),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 3E8182) by Bayer
CropScience, 2 T.W. Alexander Dr., P.O.
Box 12014, Research Triangle Park, NC
27709. The petition requested that 40
CFR 180.415 be amended by
establishing tolerances for residues of
the fungicide fosetyl-Al, aluminum tris
(O-ethylphosphonate), in or on pepper/
eggplant, subgroup 8–10B at 0.01 parts
per million (ppm) and non-bell (chili)
pepper, dried fruit at 0.01 ppm. That
document referenced a summary of the
petition prepared by Bayer CropScience,
the registrant, which is available in the
docket, https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed in Unit IV.C.
Based upon review of the data
supporting the petition, EPA is not
establishing a separate tolerance for
residues of fosetyl-Al on pepper, nonbell (chili), dry fruit. The reason for this
is explained in Unit IV.D.
III. 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 FFDCA section
408(b)(2)(D), and 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 for fosetyl-Al
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including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fosetyl-Al follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
The major target organs following
repeated oral exposure to fosetyl-Al are
the reproductive system in the dog
(testicular degeneration: Spermatocytic
and/or spermatidic giant cells in the
lumen of the seminiferous tubules) and
the urinary system in the rat
(histopathological changes in the
kidney, impairment of calcium/
phosphorus metabolism, calculi and
hyperplasia in the urinary tract, bladder
tumors). There is no concern for
increased quantitative or qualitative
susceptibility of the young following in
utero (rats and rabbits) and pre-and
postnatal exposure (rats) to fosetyl-Al.
Also, there is no evidence of
developmental toxicity, reproductive
toxicity in the rat, neurotoxicity, or
immunotoxicity at dose levels that do
not exceed the limit dose. The
microscopic finding in the dog testes
may be considered an isolated finding
in light of the lack of any functional
deficits in the rat 2-generation
reproductive toxicity study and the lack
of effects on the rat reproductive organs
following chronic exposure.
Additionally, a clear no-observedadverse-effect level (NOAEL) was
established for the effect observed in the
dog and was selected as a suitable point
of departure (POD) for the chronic
dietary (all populations) exposure
scenario. Fosetyl-Al is negative for
carcinogenicity except at extremely high
doses (>limit dose) in rats and mice, and
it did not show any genotoxic potential
(classified as not likely to be
carcinogenic to humans). Fosetyl-Al is
not acutely toxic via the oral, dermal,
and inhalation routes. It produces
severe eye irritation, is not a dermal
irritant, and is negative for dermal
sensitization.
Specific information on the studies
received and the nature of the adverse
effects caused by fosetyl-Al as well as
the NOAEL and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Fosetyl-Aluminum [Fosetyl-Al]:
Human Health Risk Assessment for the
Establishment of Tolerances with No
U.S. Registration in/on Pepper/eggplant,
Subgroup 8–10B and Pepper, Non-bell
(Chili), Dry Fruit’’ in docket ID number
EPA–HQ–OPP–2014–0540.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
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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 fosetyl-Al used for human
risk assessment is shown in Table 1 of
this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOSETYL-AL FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (General population including infants and
children).
No hazard or appropriate acute endpoint was identified in the database.
Chronic dietary (All populations)
NOAEL = 250 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL = 300 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Inhalation (or oral)
study NOAEL =
300 mg/kg/day (inhalation absorption
rate = 100%).
UFA = 10x
UFH = 10x
FQPA SF = 1x
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Incidental oral short-term (1 to
30 days) and intermediateterm (1 to 6 months).
Inhalation short-term (1 to 30
days) and intermediate-term
(1 to 6 months).
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Chronic RfD = 2.5
mg/kg/day.
cPAD = 2.5 mg/kg/
day
Chronic oral toxicity (dog).
LOAEL = 500 mg/kg/day based on increased incidence of testicular degeneration (spermatocytic and/or spermatidic giant
cells in the lumen of the seminiferous tubules).
Residential LOC for
MOE <100.
3-generation reproduction (rat).
LOAEL = 600 mg/kg/day based on decreased body weight
gains in the F2b generation and urinary tract changes in
adults.
Residential LOC for
MOE <100.
3-generation reproduction (rat).
LOAEL = 600 mg/kg/day based on decreased body weight
gains in the F2b generation and urinary tract changes in
adults.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOSETYL-AL FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Cancer (Oral, dermal, inhalation).
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Classification: Not likely to be carcinogenic to humans.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (c = chronic).
RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity
among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fosetyl-Al, EPA considered
exposure under the petitioned-for
tolerances as well as all existing fosetylAl tolerances in 40 CFR 180.415. EPA
assessed dietary exposures from fosetylAl in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. No such effects were
identified in the toxicological studies
for fosetyl-Al; 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 U.S. Department of
Agriculture’s (USDA’s) 2003–2008
National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). As to
residue levels in food, EPA’s unrefined
chronic analysis is based on tolerancelevel residues and 100% crop treated
(PCT) assumptions. Default processing
factors were used for all crops except for
citrus where processing studies showed
no residue concentration; thus, the
processing factor was set to one for
processed citrus commodities.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that fosetyl-Al is not
carcinogenic to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing 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 fosetyl-Al. Tolerance level residues
and/or 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
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exposure analysis and risk assessment
for fosetyl-Al in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of fosetyl-Al.
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.
Environmental fate properties suggest
that fosetyl-Al is not likely to reach
ground or surface water under most
conditions, and if it does reach surface
water, it is expected to degrade rapidly.
Using the Screening Concentration in
Ground Water (SCI–GROW) model, the
estimated drinking water concentration
(EDWC) of fosetyl-Al for chronic
exposures for non-cancer assessments is
estimated to be 0.006 parts per billion
(ppb) for ground water. Thus, the
ground water EDWC of 0.006 ppb was
directly incorporating into the chronic
dietary risk assessment.
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). FosetylAl is currently registered for the
following use that could result in
residential exposure: Turf. EPA assessed
residential exposure using the following
assumptions: Residential handler and
residential post-application exposures.
The residential handler assessment
quantitatively evaluated inhalation
exposure from hose end sprayer for turf
applications but not dermal exposure as
no dermal point of departure was
identified. There is the potential for
short-term post-application exposure for
individuals exposed as a result of being
in an environment that has been
previously treated with fosetyl-Al
(based on contact with treated turf at the
maximum turf application rate of 17.6
pounds (lbs) active ingredient/Acre (ai/
A)). Incidental oral post-application
exposure is quantitatively assessed for
children 1 to <2 years old for exposure
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to treated turf. Dermal post-application
exposure was not assessed because no
dermal hazard was identified. Further
information regarding EPA standard
assumptions and generic inputs for
residential exposures may be found at
https://www.epa.gov/pesticides/science/
residential-exposure-sop.html.
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.’’
Although fosetyl-Al shares a similar
chemical structure with many
organophosphates (OPs), there is no
evidence of neurotoxicity or evidence of
cholinesterase inhibition following
exposure to fosetyl-Al at dose levels at
and greater than the limit dose. EPA has
concluded that fosetyl-Al is a not
member of the OP cumulative group.
EPA has not found fosetyl-Al to share a
common mechanism of toxicity with
any other substances either, and fosetylAl does not appear to produce a toxic
metabolite produced by any other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that fosetyl-Al does not have a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at
https://www.epa.gov/pesticides/
cumulative.
D. 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 Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
There is no evidence of increased
susceptibility following in utero
exposure to fosetyl-Al in either the rat
(at dose levels that do not exceed the
limit dose) or rabbit developmental
toxicity study, and there is no evidence
of increased susceptibility following in
utero and/or pre-/postnatal exposure in
the 3-generation reproduction study in
rats.
3. Conclusion. EPA has determined
that reliable data show 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 fosetyl-Al
is complete.
ii. There is no indication that fosetylAl 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 fosetylAl results in increased susceptibility in
in utero rats or rabbits in the prenatal
developmental studies or in young rats
in the 3-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 water modeling used to assess
exposure to fosetyl-Al in drinking water.
EPA used similarly conservative
assumptions to assess post-application
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by fosetyl-Al.
E. 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
VerDate Sep<11>2014
16:51 Jan 15, 2015
Jkt 235001
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, fosetyl-Al is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to fosetyl-Al from
food and water will utilize 12% of the
cPAD for children 1–2 years old, the
population group receiving the greatest
exposure. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of fosetyl-Al is not expected.
3. Short-term risk. Fosetyl-Al is
currently registered for uses that could
result in short-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to fosetyl-Al.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 3,200 for adult residential
handlers applying liquid concentrates to
turf via hose-end sprayer and for
children, 540 for children’s incidental
oral post-application exposure from
contacting treated lawns. Because EPA’s
level of concern for fosetyl-Al is an
MOE of 100 or below, these MOEs are
not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Because no intermediate-term nonoccupational exposures are expected,
fosetyl-Al is not expected to pose an
intermediate-term risk.
5. Aggregate cancer risk for U.S.
population. Based on the discussion in
Unit III.A, fosetyl-Al is not expected to
pose a cancer risk to humans.
6. 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 fosetyl-Al
residues.
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
2319
IV. Other Considerations
A. Analytical Enforcement Methodology
Rhone-Poulenc Method No. AR 154–
97 underwent successfully independent
laboratory validation for use as an
enforcement analytical method.
Although the tolerance expression
includes only parent fosetyl-Al, Method
AR 154–97 was validated for both
fosetyl-Al and its metabolite,
phosphorous acid.
In support of the pepper trials, the
registrant made use of a data collection
method, Method No. 00861/M001,
which achieved a lower Limit of
Quantitation (LOQ) than Method AR
154–97. Method No. 00861/M001 is an
HPLC–MS/MS (high performance liquid
chromatography–tandem mass
spectrometry) method that uses the
same extraction solvent as Method AR
154–97. Sufficient method validation
data were submitted with the field trial
data to support a LOQ of 0.01 ppm for
fosetyl-Al residues in pepper (bell and
non-bell). As EPA encourages the
development of improved analytical
methods and because both methods use
the same extraction solvent, EPA
considers Method No. 00861/M001 to
also be a suitable enforcement method
for peppers. Thus, both methods may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; email 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
United Nations 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.
The Codex has not established a MRL
for fosetyl-Al.
E:\FR\FM\16JAR1.SGM
16JAR1
2320
Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations
C. Response to Comments
The Agency received a comment
expressing concerns about allowing
residues of pesticides on eggplant and
peppers. The Agency understands the
commenter’s concerns and recognizes
that some individuals believe that no
residue of pesticides should be allowed
because of potential effects. However,
under the existing legal framework
provided by FFDCA section 408, EPA is
authorized to establish pesticide
tolerances where persons seeking such
tolerances have demonstrated that the
pesticide meets the safety standard
imposed by the statute. Based on its
assessment of the available data, the
Agency has concluded there is a
reasonable certainty that no harm will
result from aggregate exposure to
residues of fosetyl-Al.
D. Revisions to Petitioned-For
Tolerances
EPA is not establishing a separate
tolerance for residues of fosetyl-Al in or
on pepper, non-bell (chili), dry fruit.
The residues found on the dried
commodity will be covered by the
tolerance for residues of fosetyl-Al in or
on pepper/eggplant, subgroup 8–10B;
therefore, no separate tolerance is
needed.
asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
V. Conclusion
Therefore, tolerances are established
for residues of fosetyl-Al, aluminum tris
(O-ethylphosphonate), in or on pepper/
eggplant, subgroup 8–10B at 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
VerDate Sep<11>2014
16:51 Jan 15, 2015
Jkt 235001
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance 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 final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. 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.
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
Dated: December 23, 2014.
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 § 180.415, add alphabetically
‘‘Pepper/eggplant, subgroup 8–10’’ to
the table in paragraph (a) to read as
follows:
■
§ 180.415 Aluminum tris (Oethylphosphonate); tolerances for residues.
(a) * * *
Parts per
million
Commodity
*
*
*
Pepper/eggplant, subgroup
8–10B 1 ..............................
*
*
*
*
*
0.01
*
*
1 There
are no U.S. registrations as of December 23, 2014.
*
*
*
*
*
[FR Doc. 2015–00491 Filed 1–15–15; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 571
[Docket No. NHTSA–2011–0107]
RIN 2127–AL56
Federal Motor Vehicle Safety
Standards; Electric-Powered Vehicles;
Electrolyte Spillage and Electrical
Shock Protection
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
ACTION: Final rule; response to petitions
for reconsideration and technical
corrections.
AGENCY:
This document denies a
petition for reconsideration of Federal
Motor Vehicle Safety Standard (FMVSS)
No. 305, ‘‘Electric-powered vehicles;
electrolyte spillage, and electrical shock
protection’’ from Nissan Motor
Company (Nissan) requesting the use of
a megohmmeter as an alternative
measurement method for the electrical
isolation test procedure. Further, this
SUMMARY:
E:\FR\FM\16JAR1.SGM
16JAR1
]]>Agencies
[Federal Register Volume 80, Number 11 (Friday, January 16, 2015)]
[Rules and Regulations]
[Pages 2315-2320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00491]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0540; FRL-9920-54]
Fosetyl-Al; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
Aluminum tris (O-ethylphosphonate) (fosetyl-Al) in or
[[Page 2316]]
on pepper/eggplant, subgroup 8-10B. Bayer CropScience requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 16, 2015. Objections and
requests for hearings must be received on or before March 17, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0540, 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 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 EPA's
tolerance regulations at 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. To access the OCSPP
test guidelines referenced in this document electronically, please go
to 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-2014-0540 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 17, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0540, 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. Summary of Petitioned-For Tolerance
In the Federal Register of November 7, 2014 (79 FR 66347) (FRL-
9918-69), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E8182) by Bayer CropScience, 2 T.W. Alexander Dr., P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.415 be amended by establishing tolerances for residues of the
fungicide fosetyl-Al, aluminum tris (O-ethylphosphonate), in or on
pepper/eggplant, subgroup 8-10B at 0.01 parts per million (ppm) and
non-bell (chili) pepper, dried fruit at 0.01 ppm. That document
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, which is available in the docket, https://www.regulations.gov. Comments were received on the notice of filing.
EPA's response to these comments is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA is not
establishing a separate tolerance for residues of fosetyl-Al on pepper,
non-bell (chili), dry fruit. The reason for this is explained in Unit
IV.D.
III. 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 FFDCA section 408(b)(2)(D), and 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 for fosetyl-Al
[[Page 2317]]
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
fosetyl-Al follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The major target organs following repeated oral exposure to
fosetyl-Al are the reproductive system in the dog (testicular
degeneration: Spermatocytic and/or spermatidic giant cells in the lumen
of the seminiferous tubules) and the urinary system in the rat
(histopathological changes in the kidney, impairment of calcium/
phosphorus metabolism, calculi and hyperplasia in the urinary tract,
bladder tumors). There is no concern for increased quantitative or
qualitative susceptibility of the young following in utero (rats and
rabbits) and pre-and postnatal exposure (rats) to fosetyl-Al. Also,
there is no evidence of developmental toxicity, reproductive toxicity
in the rat, neurotoxicity, or immunotoxicity at dose levels that do not
exceed the limit dose. The microscopic finding in the dog testes may be
considered an isolated finding in light of the lack of any functional
deficits in the rat 2-generation reproductive toxicity study and the
lack of effects on the rat reproductive organs following chronic
exposure. Additionally, a clear no-observed-adverse-effect level
(NOAEL) was established for the effect observed in the dog and was
selected as a suitable point of departure (POD) for the chronic dietary
(all populations) exposure scenario. Fosetyl-Al is negative for
carcinogenicity except at extremely high doses (>limit dose) in rats
and mice, and it did not show any genotoxic potential (classified as
not likely to be carcinogenic to humans). Fosetyl-Al is not acutely
toxic via the oral, dermal, and inhalation routes. It produces severe
eye irritation, is not a dermal irritant, and is negative for dermal
sensitization.
Specific information on the studies received and the nature of the
adverse effects caused by fosetyl-Al as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at https://www.regulations.gov in document ``Fosetyl-
Aluminum [Fosetyl-Al]: Human Health Risk Assessment for the
Establishment of Tolerances with No U.S. Registration in/on Pepper/
eggplant, Subgroup 8-10B and Pepper, Non-bell (Chili), Dry Fruit'' in
docket ID number EPA-HQ-OPP-2014-0540.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fosetyl-Al used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fosetyl-Al for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population No hazard or appropriate acute endpoint was identified in the database.
including infants and children).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 250 mg/kg/ Chronic RfD = 2.5 Chronic oral toxicity (dog).
day. mg/kg/day. LOAEL = 500 mg/kg/day based on
UFA = 10x........... cPAD = 2.5 mg/kg/ increased incidence of testicular
UFH = 10x........... day. degeneration (spermatocytic and/
FQPA SF = 1x........ or spermatidic giant cells in the
lumen of the seminiferous
tubules).
Incidental oral short-term (1 to NOAEL = 300 mg/kg/ Residential LOC for 3-generation reproduction (rat).
30 days) and intermediate-term day. MOE <100. LOAEL = 600 mg/kg/day based on
(1 to 6 months). UFA = 10x........... decreased body weight gains in
UFH = 10x........... the F2b generation and urinary
FQPA SF = 1x........ tract changes in adults.
Inhalation short-term (1 to 30 Inhalation (or oral) Residential LOC for 3-generation reproduction (rat).
days) and intermediate-term (1 study NOAEL = 300 MOE <100. LOAEL = 600 mg/kg/day based on
to 6 months). mg/kg/day decreased body weight gains in
(inhalation the F2b generation and urinary
absorption rate = tract changes in adults.
100%).
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
[[Page 2318]]
Cancer (Oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (c = chronic). RfD = reference dose. UF = uncertainty factor. UFA =
extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of
the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fosetyl-Al, EPA considered exposure under the petitioned-
for tolerances as well as all existing fosetyl-Al tolerances in 40 CFR
180.415. EPA assessed dietary exposures from fosetyl-Al in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for fosetyl-Al; 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 U.S. Department
of Agriculture's (USDA's) 2003-2008 National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA's unrefined chronic analysis is based on
tolerance-level residues and 100% crop treated (PCT) assumptions.
Default processing factors were used for all crops except for citrus
where processing studies showed no residue concentration; thus, the
processing factor was set to one for processed citrus commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fosetyl-Al is not carcinogenic to humans. Therefore, a
dietary exposure assessment for the purpose of assessing 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 fosetyl-Al. Tolerance level residues and/or 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 fosetyl-Al in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fosetyl-Al. 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.
Environmental fate properties suggest that fosetyl-Al is not likely
to reach ground or surface water under most conditions, and if it does
reach surface water, it is expected to degrade rapidly. Using the
Screening Concentration in Ground Water (SCI-GROW) model, the estimated
drinking water concentration (EDWC) of fosetyl-Al for chronic exposures
for non-cancer assessments is estimated to be 0.006 parts per billion
(ppb) for ground water. Thus, the ground water EDWC of 0.006 ppb was
directly incorporating into the chronic dietary risk assessment.
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). Fosetyl-Al is
currently registered for the following use that could result in
residential exposure: Turf. EPA assessed residential exposure using the
following assumptions: Residential handler and residential post-
application exposures. The residential handler assessment
quantitatively evaluated inhalation exposure from hose end sprayer for
turf applications but not dermal exposure as no dermal point of
departure was identified. There is the potential for short-term post-
application exposure for individuals exposed as a result of being in an
environment that has been previously treated with fosetyl-Al (based on
contact with treated turf at the maximum turf application rate of 17.6
pounds (lbs) active ingredient/Acre (ai/A)). Incidental oral post-
application exposure is quantitatively assessed for children 1 to <2
years old for exposure to treated turf. Dermal post-application
exposure was not assessed because no dermal hazard was identified.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/science/residential-exposure-sop.html.
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.''
Although fosetyl-Al shares a similar chemical structure with many
organophosphates (OPs), there is no evidence of neurotoxicity or
evidence of cholinesterase inhibition following exposure to fosetyl-Al
at dose levels at and greater than the limit dose. EPA has concluded
that fosetyl-Al is a not member of the OP cumulative group. EPA has not
found fosetyl-Al to share a common mechanism of toxicity with any other
substances either, and fosetyl-Al does not appear to produce a toxic
metabolite produced by any other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fosetyl-Al does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at https://www.epa.gov/pesticides/cumulative.
D. 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
[[Page 2319]]
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 Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility following in utero exposure to fosetyl-Al in
either the rat (at dose levels that do not exceed the limit dose) or
rabbit developmental toxicity study, and there is no evidence of
increased susceptibility following in utero and/or pre-/postnatal
exposure in the 3-generation reproduction study in rats.
3. Conclusion. EPA has determined that reliable data show 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 fosetyl-Al is complete.
ii. There is no indication that fosetyl-Al 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 fosetyl-Al results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 3-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 water modeling used to assess exposure
to fosetyl-Al in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by fosetyl-Al.
E. 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,
fosetyl-Al is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fosetyl-Al from food and water will utilize 12% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fosetyl-Al is not expected.
3. Short-term risk. Fosetyl-Al is currently registered for uses
that could result in short-term residential exposure, and the Agency
has determined that it is appropriate to aggregate chronic exposure
through food and water with short-term residential exposures to
fosetyl-Al.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 3,200 for adult
residential handlers applying liquid concentrates to turf via hose-end
sprayer and for children, 540 for children's incidental oral post-
application exposure from contacting treated lawns. Because EPA's level
of concern for fosetyl-Al is an MOE of 100 or below, these MOEs are not
of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Because no intermediate-term non-occupational exposures are
expected, fosetyl-Al is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A, fosetyl-Al is not expected to pose a cancer
risk to humans.
6. 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 fosetyl-Al residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Rhone-Poulenc Method No. AR 154-97 underwent successfully
independent laboratory validation for use as an enforcement analytical
method. Although the tolerance expression includes only parent fosetyl-
Al, Method AR 154-97 was validated for both fosetyl-Al and its
metabolite, phosphorous acid.
In support of the pepper trials, the registrant made use of a data
collection method, Method No. 00861/M001, which achieved a lower Limit
of Quantitation (LOQ) than Method AR 154-97. Method No. 00861/M001 is
an HPLC-MS/MS (high performance liquid chromatography-tandem mass
spectrometry) method that uses the same extraction solvent as Method AR
154-97. Sufficient method validation data were submitted with the field
trial data to support a LOQ of 0.01 ppm for fosetyl-Al residues in
pepper (bell and non-bell). As EPA encourages the development of
improved analytical methods and because both methods use the same
extraction solvent, EPA considers Method No. 00861/M001 to also be a
suitable enforcement method for peppers. Thus, both methods may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email 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 United Nations
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.
The Codex has not established a MRL for fosetyl-Al.
[[Page 2320]]
C. Response to Comments
The Agency received a comment expressing concerns about allowing
residues of pesticides on eggplant and peppers. The Agency understands
the commenter's concerns and recognizes that some individuals believe
that no residue of pesticides should be allowed because of potential
effects. However, under the existing legal framework provided by FFDCA
section 408, EPA is authorized to establish pesticide tolerances where
persons seeking such tolerances have demonstrated that the pesticide
meets the safety standard imposed by the statute. Based on its
assessment of the available data, the Agency has concluded there is a
reasonable certainty that no harm will result from aggregate exposure
to residues of fosetyl-Al.
D. Revisions to Petitioned-For Tolerances
EPA is not establishing a separate tolerance for residues of
fosetyl-Al in or on pepper, non-bell (chili), dry fruit. The residues
found on the dried commodity will be covered by the tolerance for
residues of fosetyl-Al in or on pepper/eggplant, subgroup 8-10B;
therefore, no separate tolerance is needed.
V. Conclusion
Therefore, tolerances are established for residues of fosetyl-Al,
aluminum tris (O-ethylphosphonate), in or on pepper/eggplant, subgroup
8-10B at 0.01 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. 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 23, 2014.
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. 180.415, add alphabetically ``Pepper/eggplant, subgroup 8-
10'' to the table in paragraph (a) to read as follows:
Sec. 180.415 Aluminum tris (O-ethylphosphonate); tolerances for
residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Pepper/eggplant, subgroup 8-10B \1\.................... 0.01
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of December 23, 2014.
* * * * *
[FR Doc. 2015-00491 Filed 1-15-15; 8:45 am]
BILLING CODE 6560-50-P
