[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30874]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Isopyrazam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
isopyrazam in or on apple and peanut for which there are no
accompanying United States registrations. Syngenta Crop Protection,
Inc., requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective December 27, 2013. Objections and
requests for hearings must be received on or before February 25, 2014,
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-2012-0509, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave., NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: [email protected].
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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0509 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 25, 2014. 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-2012-0509, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), 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
2E8039) by Syngenta Crop Protection, Inc., 410 Swing Rd., P.O. Box
18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR
180.654 be amended by establishing tolerances for residues of the
fungicide isopyrazam, in or on apple at 0.6 parts per million (ppm) and
peanut at 0.01 ppm. That document referenced a summary of the petition
prepared by Syngenta Crop Protection, Inc., the registrant, which is
available in the docket, http://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 has
proposed a higher tolerance level for apple. The reason for this change
is explained in Unit IV.D.
There are no registered food uses for isopyrazam in the United
States. These tolerances were requested in connection with use of
isopyrazam on apples and peanuts grown outside the United States. These
tolerances will allow apples and peanuts containing isopyrazam residues
to be imported into the United States.
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 isopyrazam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with isopyrazam 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
Subchronic and chronic oral toxicity studies in the rat, mouse, and
dog demonstrate that the primary target organ for isopyrazam is the
liver (increased organ weight and centrilobular hepatocyte
hypertrophy). Liver toxicity is usually accompanied by reductions in
bodyweight and food consumption.
Isopyrazam did not cause reproductive toxicity. Effects seen in the
offspring (bodyweight gain during lactation and increase liver weight
at weaning) in the rat reproduction study
occurred at the same doses that cause general toxicity in the parents.
Developmental effects described as small eyes and/or microphthalmia
were observed in both the Himalayan and New Zealand rabbit strains.
However, in the Himalayan strain, the intraocular abnormalities occur
in the absence of maternal toxicity while in the New Zealand the ocular
abnormalities occurred at doses that were maternally toxic.
Developmental effects observed in the rat (increased post-implantation
loss, reduced fetal weight and a slight retardation of ossification)
occurred at doses that also produced maternal toxicity (mortality,
decreased body weights, body weight gains, and food consumption).
No evidence of specific neurotoxicity was seen in acute and
subchronic oral neurotoxicity studies in rats. Clinical signs seen in
two subchronic dog studies (side-to-side head wobble, ataxia, reduced
stability) are consistent with neurotoxic effects. However detailed and
specific neuropathological analyses were not conducted for the dog
studies (i.e., functional observational battery, motor activity,
detailed histopathology with special stains). Consequently, there is
uncertainty regarding whether the effects seen in the dog studies are
in fact signs of neurotoxicity. However, clear no observed adverse
effect levels (NOAELs)/lowest adverse effect levels (LOAELs) were
established for both subchronic dog studies. The point of departure
selected for the acute dietary assessment is based on clinical signs
seen on day 2 in one of four males in the subchronic dog study. This
study provides the lowest NOAEL in the database (most sensitive
endpoint) for a single dose effect. The dose used for the chronic
dietary risk assessment is eight times lower than the dose at which
clinical effects were seen at four weeks in the second subchronic dog
There is no evidence of immunotoxicity based on a 28-day dietary
immunotoxicity study in rats. The LOAEL for immunotoxicity was not
identified and the NOAEL for immunotoxicity was 1,356 milligrams/
Isopyrazam is classified as ``Likely to be Carcinogenic to Humans''
based on increased incidence of uterine endometrial adenocarcinomas and
liver hepatocellular adenomas in female rats and increased incidence of
thyroid follicular cell adenomas and/or carcinomas in male rats.
Isopyrazam is not carcinogenic in the mouse. There is no evidence of
genotoxicity, mutagenicity, or clastogenicity in the in vivo and in
vitro studies. There are no structural relationships with other known
carcinogens. A linear low-dose approach (Q1*) was used to
extrapolate experimental animal tumor data for the quantification of
human cancer risk.
Isopyrazam is of low acute toxicity by the oral, dermal, and
inhalation routes and is not a skin or eye irritant.
Specific information on the studies received and the nature of the
adverse effects caused by isopyrazam as well as the NOAEL and the LOAEL
from the toxicity studies can be found at http://www.regulations.gov in
the document ``Human Health Risk Assessment for the Establishment of
Tolerances with No U.S. Registrations for Isopyrazam in/on Imported
Apple and Peanut'' at pp. 14-18 in docket ID number EPA-HQ-OPP-2012-
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for used for human risk assessment is shown in Table 1 of
Table 1--Summary of Toxicological Doses and Endpoints for Isopyrazam for Use in Human Health Risk Assessment
RfD, PAD, level
Point of Uncertainty/ of concern for Study and toxicological
Exposure/scenario departure (mg/ FQPA safety risk assessment effects
kg/day) factors (mg/kg/day)
Acute Dietary................ NOAEL= 30...... UFA = 10x...... Acute RfD = Subchronic Toxicity--Dog.
(All populations)............ UFH = 10x...... 0.30. LOAEL = 100 mg/kg/day based
FQPA SF = 1x... aPAD = 0.30.... on clinical signs (side-to-
side head wobble) in male
Chronic Dietary (All NOAEL = 5.5.... UFA = 10x...... Chronic RfD = Chronic Toxicity/
populations). UFH = 10x...... 0.055. Carcinogenicity--Rats. LOAEL
FQPA SF = 1x... cPAD = 0.055... = 27.6 mg/kg/day based on
decreased body weight and
body weight gain in females;
increased incidences of
pigment in centrilobular
foci of altered hepatocytes,
vacuolation of centrilobular
hepatocytes, bile duct
hyperplasia, and bile duct
fibrosis in both sexes; and
brown pigment in the kidney
Cancer (All routes).......... Classification: CARC classified isopyrazam as ``Likely to be Carcinogenic to
Humans'' based on increased liver and uterine endometrial epithelial tumors in
female rats and increased thyroid follicular cell tumors in male rats. A cancer
slope factor (Q1*) of 0.00629 (mg/kg/day)-1 was calculated based on an increase
in increase in liver tumors in female rats.
CARC = Cancer Assessment Review Committee. Food Quality Protection Act Safety Factor = FQPA SF. LOAEL = lowest
observed adverse effect level. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level.
PAD = population adjusted dose (a = acute, c = chronic). Point of Departure = A data point or an estimated
point that is derived from observed dose-response data and used to mark the beginning of extrapolation to
determine risk associated with lower environmentally relevant human exposures. Q1* = Linear low-dose approach.
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 isopyrazam, EPA considered exposure under the petitioned-
for tolerances as well as all existing isopyrazam tolerances in 40 CFR
180.654. EPA assessed dietary exposures from isopyrazam in food as
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. In estimating acute dietary
exposure, EPA used food consumption information from the U.S.
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As
to residue levels in food, maximum residues of isopyrazam (as the sum
of its syn-isomer and anti-isomer) plus its tertiary alcohol metabolite
(CSCD460260; as the sum of its syn-isomer (CSCD459488; free and
conjugated) and anti-isomer (CSCD459489; free and conjugated)) from
field trials reflecting maximum use rates and 100 percent crop treated
(PCT) assumptions were used. Dietary Exposure Evaluation Model (DEEM)
default processing factors were used for all processed commodities
including dried apple (8.0), apple juice/cider (1.3), dried banana/
plantain (3.9), and peanut butter (1.89). In the absence of peanut
processing data, the maximum theoretical concentration factor was used
for peanut oil (2.8).
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA used the same residue
levels, processing factors and PCT assumptions as in the acute dietary
iii. Cancer. Isopyrazam is classified as ``Likely to be
Carcinogenic to Humans'' based on increased liver and uterine
endometrial epithelial tumors in female rats and increased thyroid
follicular cell tumors in male rats. In the absence of mode of action
data, a linear low dose extrapolation for cancer risk assessment was
used. A cancer slope factor (Q1*) of 0.00629 (mg/kg/
day)-1 was used for the quantification of human cancer risk.
In evaluating cancer risk, EPA used the same residue levels, processing
factors, and PCT assumptions as the acute and chronic dietary exposure
iv. Anticipated residue and PCT information. While EPA did not use
PCT information in the dietary assessment for isopyrazam, anticipated
residues were used. Maximum residues from field trials conducted at the
maximum use rates were used to estimate residues of isopyrazam (as the
sum of its syn-isomer and anti-isomer) plus its tertiary alcohol
metabolite (CSCD460260; as the sum of its syn-isomer (CSCD459488; free
and conjugated) and anti-isomer (CSCD459489; free and conjugated)).
Analyses assumed 100 PCT and used DEEM default processing factors. In
the absence of peanut processing data, the maximum theoretical
concentration factor was used as a processing factor for peanut oil
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. An assessment of residues
in drinking water is not needed for isopyrazam because there is no
drinking water exposure associated with the existing (banana) and
proposed uses (apple and peanut) which are all non-domestic.
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). Isopyrazam is not
registered for any specific use patterns that would result in
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.''
EPA has not found isopyrazam to share a common mechanism of
toxicity with any other substances, and isopyrazam does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
isopyrazam does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate
the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
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
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
SF when reliable data available to EPA support the choice of a
2. Prenatal and postnatal sensitivity. There are no residual
uncertainties for pre- and/or post natal susceptibility even though
qualitative susceptibility was observed in the range-finding
developmental studies in rabbits. Developmental effects (eye
abnormalities) were observed in the absence of maternal toxicity in two
range finding developmental toxicity studies in the Himalayan rabbit.
However, the eye effects were only observed at relatively high doses
(200-400 mg/kg/day) with clear NOAELs/LOAELs established for the
developmental effects. Developmental effects observed in the rat
(reduced fetal weight and a slight retardation of ossification)
occurred only at doses that also produced maternal toxicity (mortality,
decreased body weights, body weight gains, and food consumption). There
was no evidence of increased susceptibility in a 2-generation
reproduction study following pre- or postnatal exposure to isopyrazam.
There was also no evidence of neuropathology or abnormalities in the
development of the fetal nervous system from the available toxicity
studies conducted with isopyrazam. Clear NOAELs/LOAELs were established
for the developmental effects observed in rats and rabbits as well as
for the offspring effects (increased liver weights) seen in the 2-
generation reproduction study and a dose-response relationship for the
effects of concern is well characterized. The dose used for the acute
dietary risk assessment (30 mg/kg/day), based on effects seen in the
subchronic dog study, is protective of the developmental effects seen
in rats (44.5 mg/kg/day) and rabbits (200 mg/kg/day). Based on these
considerations, there are no residual uncertainties for pre- and/or
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
i. The toxicity database for isopyrazam is complete.
ii. As discussed in Unit III.D.2, there are no residual
uncertainties for pre-and/or postnatal susceptibility and thus, it is
unnecessary to retain the 10X FQPA SF to adequately protect infants and
iii. The dietary risk assessment is based on parent plus metabolite
residues and will not underestimate dietary exposure to isopyrazam. For
the acute, chronic and cancer dietary analyses, maximum residues of
parent plus metabolite and 100 PCT assumptions were used for all
treated commodities. There are no residual uncertainties identified in
the exposure databases.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
isopyrazam will occupy 4.2% of the aPAD for children 1-2 years old, the
population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
isopyrazam from food will utilize 6.1% of the cPAD for children 1-2
years old, the population group receiving the greatest exposure.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Isopyrazam is not
registered in the United States. Short- and intermediate-term risk is
assessed based on short- and intermediate-term residential exposure
plus chronic dietary exposure. Because there is no short- or
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD, no
further assessment of short- or intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
short- and intermediate-term risk for isopyrazam.
4. Aggregate cancer risk for U.S. population. Using the exposure
assumptions discussed in this unit for cancer exposure, the cancer
dietary risk estimate for the U.S. population is 2 x 10-6.
EPA generally considers cancer risks (expressed as the probability
of an increased cancer case) in the range of 1 in 1 million (or 1 x
10-6) or less to be negligible. The precision that can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the logarithmic scale; for
example, risks falling between 3 x 10-7 and 3 x
10-6 are expressed as risks in the range of 10-6.
Considering the precision with which cancer hazard can be estimated,
the conservativeness of low-dose linear extrapolation, and the rounding
procedure described above, cancer risk should generally not be assumed
to exceed the benchmark level of concern of the range of
10-6 until the calculated risk exceeds approximately 3 x
10-6. This is particularly the case where some conservatism
is maintained in the exposure assessment. For isopyrazam, EPA's
exposure assessment assumes maximum residues of concern from field
trials reflecting the maximum use rates, default processing factors,
the maximum theoretical concentration for residues in peanut oil and
100 PCT, which is highly conservative. Accordingly, EPA has concluded
the cancer risk from exposure to isopyrazam falls within the range of 1
x 10-6 and is thus negligible.
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 isopyrazam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology.
Adequate enforcement methodology (Method GRM006.01B) 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; email address:
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). 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.
No Codex or MRLs have been established for residues of isopyrazam
in or on apple or peanut commodities.
C. Response to Comments
EPA received a comment to the notice of filing which said that no
residues of isopyrazam should be permitted on food. The Agency
understands the commenter's concerns and recognizes that some
individuals believe that pesticides should be banned on agricultural
crops. However, the existing legal framework provided by FFDCA section
408 states that tolerances may be set when persons seeking such
tolerances or exemptions have demonstrated that the pesticide meets the
safety standard imposed by that statute. This citizen's comment appears
to be directed at the underlying statute and not EPA's implementation
of it; the citizen has made no contention that EPA has acted in
violation of the statutory framework.
D. Revisions to Petitioned-For Tolerances
For the purposes of harmonization with a pending European Union MRL
for residues of isopyrazam in or on pome fruit (0.7 mg/kg), EPA is
establishing a tolerance of 0.70 ppm in or on apple in lieu of the 0.6
ppm as requested by the petitioner. This increase to the proposed
tolerance is supported by the data reviewed for the petition. No
changes were made to the proposed tolerance for peanut.
Therefore, tolerances are established for residues of isopyrazam in
or on apple at 0.70 ppm and peanut at 0.01 ppm. The Agency is also
revising the tolerance expression to clarify that determining
compliance with the tolerance requires measuring both the syn-isomer
and the anti-isomers of isopyrazam. This change is supported by the
available enforcement method which sums the two isomers for the
tolerance detection. The tolerance expression revision will not impact
the current banana tolerance.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the 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 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
Dated: December 19, 2013.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.654:
a. Revise the introductory text in paragraph (a).
b. Add alphabetically the commodities ``Apple'' and ``Peanut'' to the
table in paragraph (a).
c. Revise footnote one to the table in paragraph (a).
The additions and revisions read as follows:
Sec. 180.654 Isopyrazam; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide isopyrazam, including its metabolites and degradates, in or
on the commodities listed in the following table. Compliance with the
tolerance levels specified in the following table is to be determined
by measuring only isopyrazam (3-(difluoromethyl)-1-methyl-N-[1,2,3,4-
4-carboxamide), as the sum of its syn-isomer (3-(difluoromethyl)-1-
methyl-N-[(1RS, 4SR, 9RS)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-
methanonaphthalen-5-yl]-1H-pyrazole-4-carboxamide) and anti-isomer (3-
(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4-tetrahydro-9-(1-
or on the commodity.
Apple \1\................................................... 0.70
* * * * *
Peanut \1\.................................................. 0.01
\1\ There are no U.S. registrations for use of isopyrazam on apple,
banana, or peanut.
* * * * *
[FR Doc. 2013-30874 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P