80 FR 45443 - Benalaxyl-M; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 146 (July 30, 2015)

Page Range		45443-45448
FR Document		2015-18741

This regulation establishes tolerances for residues of benalaxyl-M in or on grape and tomato. Since there are currently no U.S. registrations of benalaxyl-M for use on grape and tomato, this tolerance will allow the import of grape and tomato containing residues of benalaxyl-M. Technology Sciences Group, on behalf of Isagro S.p.A, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 146 (Thursday, July 30, 2015)

[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Rules and Regulations]
[Pages 45443-45448]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-18741]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0714; FRL-9927-63]

Benalaxyl-M; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
benalaxyl-M in or on grape and tomato. Since there are currently no
U.S. registrations of benalaxyl-M for use on grape and tomato, this
tolerance will allow the import of grape and tomato containing residues
of benalaxyl-M. Technology Sciences Group, on behalf of Isagro S.p.A,
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective July 30, 2015. Objections and
requests for hearings must be received on or before September 28, 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).

[[Page 45444]]

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0714, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (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: 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 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-2013-0714 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
September 28, 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-2013-0714, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

In the Federal Register of February 21, 2014 (79 FR 9870) (FRL-
9904-98), 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
3E8162) by Technology Sciences Group on behalf of Isagro S.p.A., 1150
18th Street NW., Suite 1000, Washington, DC 20036. The petition
requested that 40 CFR part 180 be amended by establishing import
tolerances for residues of the fungicide benalaxyl-M in or on grape at
1.1 parts per million (ppm); grape juice at 1.1 ppm; grape wine at 1.1
ppm; grape raisin at 2.2 ppm; tomato at 0.25 ppm; and tomato processed
at 0.25 ppm. That document referenced a summary of the petition
prepared by Technology Sciences Group on behalf of Isagro S.p.A., the
registrant, which is available in the docket, http://www.regulations.gov. No tolerance-related comments were submitted.
Based upon review of the data supporting the petition, EPA is
establishing tolerances as follows: 3.0 ppm for grapes and 0.20 ppm for
tomato. The reasons for these changes are explained in Unit IV.C.

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 benalaxyl-M including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with benalaxyl-M 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

[[Page 45445]]

concerning the variability of the sensitivities of major identifiable
subgroups of consumers, including infants and children.
Benalaxyl-M has no significant acute toxicity via oral, dermal or
inhalation route of exposure. It is not a skin irritant and does not
cause skin sensitization.
The liver and thyroid are the primary target organs for benalaxyl-
M. In rats, increased liver weights, clinical chemistry changes
indicative of liver toxicity, hepatocellular hypertrophy, and thyroid
follicular cell hypertrophy were seen following subchronic and chronic
exposure. In mice, increased liver weight and microscopic lesions in
the liver (hepatocellular hypertrophy, necrosis, eosinophilic foci)
were observed following subchronic and chronic exposure. Additionally,
chronic exposure in rats and mice led to increases in the incidence of
liver (rat, mouse) and thyroid (rat) tumors. In dogs, increased liver
weight, changes in clinical chemistry indicative of liver toxicity, and
hepatocellular hypertrophy were observed following subchronic exposure
via the diet, whereas clinical chemistry changes indicative of liver
toxicity, fat vacuolation in the liver, and thyroid follicular cell
hypertrophy were observed following chronic exposure via capsules.
No evidence of increased quantitative or qualitative susceptibility
was seen in the benalaxyl-M hazard database following in utero exposure
with rats or rabbits in the prenatal developmental studies or in young
rats in the 2-generation reproduction study. No evidence of maternal
toxicity or developmental effects was observed in the developmental
toxicity studies in rabbits or rats. There is no reproductive concern.
No neurotoxic effects were observed in the acute and subchronic
neurotoxicity studies in rats, and no immunotoxic effects were observed
in the immunotoxicity study in rats.
Benalaxyl-M was classified as ``Likely to be Carcinogenic to
Humans''. This determination was based on the treatment-related liver
tumors observed in male mice, liver tumors observed in male and female
rats; and thyroid follicular cell tumors observed in female rats. No
treatment-related tumors were observed in female mice. A linear low-
dose extrapolation model (Q*1) was used to estimate cancer
risk, based on the male mouse liver tumor rates. There is no
mutagenicity concern from the in vivo or in vitro genetic toxicity
assays.
Specific information on the studies received and the nature of the
adverse effects caused by benalaxyl-M as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Benalaxyl-M. Human-Health Risk
Assessment for Tolerances in/on Imported Grape and Tomato'' on pages 10
through 20 in docket ID number EPA-HQ-OPP-2013-0714.

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 benalaxyl-M used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Benalaxyl-M for
Use in Human Health Risk Assessment

Table 4.5.4.--Summary of Toxicological Doses and Endpoints for Benalaxyl-M for Use in Dietary Human Health Risk
Assessments
----------------------------------------------------------------------------------------------------------------
Uncertainty/ RfD, PAD, Level
Exposure/Scenario Point of FQPA safety of concern for Study and toxicological
departure factors risk assessment effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General No appropriate
Population, including acute endpoint
Infants, Children, and was identified.
females 13+).
Chronic Dietary.............. NOAEL= 20 mg/kg/ UFA= 10x....... Chronic RfD =.. Chronic Toxicity/
(All Popyulations)........... day. UFH= 10x....... cPAD = 0.02 mg/ Carcinogenicity Study--rat
FQPA UFDB = 10x kg/day. (49040634)
LOAEL = 135 mg/kg/day based on
based on an increase in
[gamma]-glutamyl transferase
(GGT) in males, slight
increases liver weight in
both sexes, increased
incidence of hepatocellular
hypertrophy in both sexes,
increased incidence of
thyroid follicular cell
hypertrophy in both sexes,
increased incidence of
thyroid cell hyperplasia in
females, increased incidence
of thyroid follicular ectasia
in females, and an increased
incidence of ovarian stromal
cell hyperplasia in females.

[[Page 45446]]

Cancer (oral)................ Classification:
``Likely to be
Carcinogenic
to Humans''.
Based on male
mouse liver
tumors, Q1*=
5.90 x 10\-3\
(mg/kg/day)\-
1\.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = 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. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). UFDB = to account for the
absence of a comparative thyroid study. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c =
chronic). RfD = reference dose.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to benalaxyl-M, EPA assessed dietary exposures from benalaxyl-
M in food as follows:
i. Acute exposure. No such effects were identified in the
toxicological studies for benalaxyl-M; therefore, a quantitative acute
dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
CSFII. As to residue levels in food, EPA used tolerance-level residues
and 100% crop treated.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or nonlinear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that benalaxyl-M should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk. Cancer risk was quantified using the same
estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for benalaxyl-M. Tolerance level residues and/or
100% CT were assumed for all food commodities.
2. Dietary exposure from drinking water. An assessment of residues
in drinking water is not required for this assessment because there is
no drinking water exposure in the U.S. associated with the
establishment of an import tolerance.
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). Benalaxyl-M is not
registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found benalaxyl-M to share a common mechanism of
toxicity with any other substances, and benalaxyl-M does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
benalaxyl-M 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 FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. No evidence of increased
quantitative or qualitative susceptibility was seen following in utero
exposure to benalaxyl-M with rats or rabbits in the prenatal
developmental toxicity studies or in young rats in the 2-generation
reproduction study. The 2-generation reproduction study resulted in no
effects on reproductive function or fertility. The offspring effects
occurred at the same dose that caused parental effects. No evidence of
developmental delay or developmental toxicity was observed in
developmental toxicity studies in rabbits or in rats.
The rabbit was tested at the limit dose (1000 mg/kg/day), and no
maternal or developmental toxicity was observed. No significant
developmental or maternal toxicity occurred at the highest dose level
tested in the rat study, but the

[[Page 45447]]

limit dose was not tested. It is not necessary to require the
submission of an additional rat study since a study at higher dose
levels would not result in a lower NOAEL and the point of departure is
already 10-fold lower than the NOAEL in the rat study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were retained at 10x. That decision is based on the following
findings:
i. The toxicity database for benalaxyl-M is complete for purposes
of assessing the exposures from the use of benalaxyl-M on imported
grapes and tomatoes. However, there remains some uncertainty regarding
the potential for benalaxyl-M effects on thyroid. Thyroid toxicity was
seen following subchronic and chronic exposures to adult rats. There
are, however, no data regarding the potential effects of benalaxyl-M on
thyroid homeostasis in the young animals. This lack of characterization
creates uncertainty with regards to potential life stage sensitivities
due to exposure to benalaxyl-M. For future uses with higher exposure
potential, the Agency will require a comparative thyroid assay in rats
to assess the potential impact of benalaxyl-M exposure on thyroid
function in the young given the pivotal role of thyroid hormones in
brain development.
ii. There is no indication that benalaxyl-M is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that benalaxyl-M results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases.

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,
benalaxyl-M 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
benalaxyl-M from food will utilize 1.4% of the cPAD for the general
U.S. population and all population sub-groups. The most highly exposed
population subgroup was children 1-2 years old with an estimated risk
of 7.1% cPAD.
3. Aggregate cancer risk for U.S. population. The cancer dietary
assessment made use of the same input assumptions as the chronic
analysis. Benalaxyl-M has been classified as ``Likely to be
Carcinogenic to Humans''. A linear low-dose extrapolation model
(Q1*) was used to estimate cancer risk, with a
Q1* = 5.90 x 10^-3 (mg/kg/day) ^-1. The
cancer risk estimate to the U.S. population is 1.7 x 10^-6.
EPA generally considers cancer risks in the range of 10^-6 or
less to be negligible. The precision which can be assumed for cancer
risk estimates is best described by rounding to the nearest integral
order of magnitude on the log 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 in this unit,
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.
4. Determination of safety. There are no existing or proposed US
registrations of benalaxyl-M and the only route of exposure is via
dietary ingestion from imported grape and tomato commodities.
Therefore, aggregate exposure and risk estimates are equivalent to the
dietary exposures and risk estimates. 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 benalaxyl-M residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (RA.09.01, a high-performance
liquid chromatography method with tandem mass spectrometry detection
(HPLC/MS/MS) 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:
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 established MRLs for benalaxyl-M at 0.3 and 0.2 ppm
in or on grape and tomato, respectively. As a result, the EPA
recommendations will result in harmonization of the U.S. tolerance with
the Codex MRL for tomato, but not for grape since benalaxyl-M residues
from the grape trials in Argentina were significantly higher than the
Codex MRL.

C. Revisions to Petitioned-for Tolerances

The requested tolerance levels differ from those being established
by EPA. The petitioner used the NAFTA calculator to propose tolerance
levels while EPA used OECD MRL calculation procedures. Additionally,
for determination of the grape and tomato tolerance levels, the
petitioner included the results from all trials. In contrast, EPA
included only those data that matched the critical Good Agricultural
Practice (cGAP). The tolerance for grape, raisin was not recommended
because it is covered by the grape tolerance. No separate tolerances
are needed for grape juice, grape wine, or processed tomato products as
processing studies showed that residues of benalaxyl-M do not
concentrate in these processed commodities.

[[Page 45448]]

V. Conclusion

Therefore, tolerances are established for residues of benalaxyl-M,
in or on grape and tomato at 3.0 and 0.20 ppm, respectively.

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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

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: July 24, 2015.
Marty Monell,
Acting Director, 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. Add Sec. 180.684 to subpart C to read as follows:

Sec. 180.684 Benalaxyl-M; tolerances for residues.

(a) General. Tolerances are established for residues of the
fungicide benalaxyl-M, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only benalaxyl
[methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate] in or on
the commodity.

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Grape \1\............................................... 3.0
Tomato \1\.............................................. 0.20
------------------------------------------------------------------------
\1\ There is no U.S. registration for use on this commodity as of July
30, 2015.

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2015-18741 Filed 7-29-15; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 45443

proposed by the petitioner including section 408(n)(4). As such, the Agency and degradates, in or on the
canola, refined oil at 0.03 ppm; flax, has determined that this action will not commodities in the table below.
seed, oil at 0.03 ppm; grape, raisin at 5.0 have a substantial direct effect on States Compliance with the tolerance levels
ppm; mustard, seed, oil at 0.03 ppm and or tribal governments, on the specified below is to be determined by
sesame, oil at 0.03 ppm. relationship between the national measuring only isofetamid, N-[1,1-
V. Conclusion government and the States or tribal dimethyl-2-[2-methyl-4-(1-
governments, or on the distribution of methylethoxy)phenyl]-2-oxoethyl]-3-
Therefore, tolerances are established power and responsibilities among the methyl-2-thiophenecarboxamide, in or
for residues of isofetamid, in or on various levels of government or between on the following commodities:
almond at 0.01 ppm; almond, hulls at the Federal Government and Indian
0.01 ppm; canola, refined oil at 0.03 tribes. Thus, the Agency has determined Parts per
Commodity
ppm; flax, seed, oil at 0.03 ppm; grape, that Executive Order 13132, entitled million
raisin at 5.0 ppm; lettuce, head at 5.0 ‘‘Federalism’’ (64 FR 43255, August 10,
ppm; lettuce, leaf at 7.0 ppm; berry, low Almond .................................. 0.01
1999) and Executive Order 13175, Almond, hulls ........................ 0.01
growing, subgroup 13–07G at 4.0 ppm; entitled ‘‘Consultation and Coordination Berry, low growing, subgroup
mustard, seed, oil at 0.03 ppm; rapeseed with Indian Tribal Governments’’ (65 FR 13–07G ............................. 4.0
subgroup 20A at 0.015 ppm; sesame, oil 67249, November 9, 2000) do not apply Canola, refined oil ................ 0.03
at 0.03 ppm; and fruit, small vine to this action. In addition, this action Flax, seed, oil ....................... 0.03
climbing, except fuzzy kiwifruit, does not impose any enforceable duty or Fruit, small vine climbing, ex-
subgroup 13–07F at 3.0 ppm. contain any unfunded mandate as cept fuzzy kiwifruit, sub-
described under Title II of the Unfunded group 13–07F .................... 3.0
VI. Statutory and Executive Order Grape, raisin ......................... 5.0
Reviews Mandates Reform Act (UMRA) (2 U.S.C. Lettuce, head ........................ 5.0
This action establishes tolerances 1501 et seq.). Lettuce, leaf .......................... 7.0
This action does not involve any Mustard, seed, oil ................. 0.03
under FFDCA section 408(d) in
technical standards that would require Rapeseed subgroup 20A ...... 0.015
response to a petition submitted to the
Agency consideration of voluntary Sesame, oil ........................... 0.03
Agency. The Office of Management and
consensus standards pursuant to section
Budget (OMB) has exempted these types
12(d) of the National Technology (b) Section 18 emergency exemptions.
of actions from review under Executive
Transfer and Advancement Act [Reserved]
Order 12866, entitled ‘‘Regulatory
(NTTAA) (15 U.S.C. 272 note). (c) Tolerances with regional
Planning and Review’’ (58 FR 51735,
registrations. [Reserved]
October 4, 1993). Because this action VII. Congressional Review Act (d) Indirect or inadvertent residues.
has been exempted from review under Pursuant to the Congressional Review [Reserved]
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will [FR Doc. 2015–18738 Filed 7–29–15; 8:45 am]
not subject to Executive Order 13211, submit a report containing this rule and BILLING CODE 6560–50–P
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect Senate, the U.S. House of
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller ENVIRONMENTAL PROTECTION
FR 28355, May 22, 2001) or Executive General of the United States prior to AGENCY
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
Children from Environmental Health Register. This action is not a ‘‘major 40 CFR Part 180
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). [EPA–HQ–OPP–2013–0714; FRL–9927–63]
April 23, 1997). This action does not
contain any information collections List of Subjects in 40 CFR Part 180 Benalaxyl-M; Pesticide Tolerances
subject to OMB approval under the Environmental protection,
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, AGENCY: Environmental Protection
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides Agency (EPA).
any special considerations under and pests, Reporting and recordkeeping ACTION: Final rule.
Executive Order 12898, entitled requirements.
‘‘Federal Actions to Address SUMMARY: This regulation establishes
Dated: July 21, 2015. tolerances for residues of benalaxyl-M
Environmental Justice in Minority
Populations and Low-Income Jack Housenger, in or on grape and tomato. Since there
Populations’’ (59 FR 7629, February 16, Director, Office of Pesticide Programs. are currently no U.S. registrations of
1994). Therefore, 40 CFR chapter I is benalaxyl-M for use on grape and
Since tolerances and exemptions that amended as follows: tomato, this tolerance will allow the
are established on the basis of a petition import of grape and tomato containing
under FFDCA section 408(d), such as PART 180—[AMENDED] residues of benalaxyl-M. Technology
the tolerance in this final rule, do not Sciences Group, on behalf of Isagro
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 S.p.A, requested these tolerances under
the requirements of the Regulatory continues to read as follows: the Federal Food, Drug, and Cosmetic
Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371. Act (FFDCA).
seq.), do not apply. DATES: This regulation is effective July
■ 2. Add § 180.681 to subpart C to read
This action directly regulates growers, 30, 2015. Objections and requests for
Lhorne on DSK7TPTVN1PROD with RULES

as follows:
food processors, food handlers, and food hearings must be received on or before
retailers, not States or tribes, nor does § 180.681 Isofetamid; tolerances for September 28, 2015, and must be filed
this action alter the relationships or residues. in accordance with the instructions
distribution of power and (a) General. Tolerances are provided in 40 CFR part 178 (see also
responsibilities established by Congress established for residues of the fungicide Unit I.C. of the SUPPLEMENTARY
in the preemption provisions of FFDCA isofetamid, including its metabolites INFORMATION).

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Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations 45447

limit dose was not tested. It is not exposure estimates from dietary chromatography method with tandem
necessary to require the submission of consumption of food and drinking mass spectrometry detection (HPLC/
an additional rat study since a study at water. No adverse effect resulting from MS/MS) is available to enforce the
higher dose levels would not result in a single oral exposure was identified tolerance expression.
a lower NOAEL and the point of and no acute dietary endpoint was The method may be requested from:
departure is already 10-fold lower than selected. Therefore, benalaxyl-M is not Chief, Analytical Chemistry Branch,
the NOAEL in the rat study. expected to pose an acute risk. Environmental Science Center, 701
3. Conclusion. EPA has determined 2. Chronic risk. Using the exposure Mapes Rd., Ft. Meade, MD 20755–5350;
that reliable data show the safety of assumptions described in this unit for telephone number: (410) 305–2905;
infants and children would be chronic exposure, EPA has concluded email address: residuemethods@
adequately protected if the FQPA SF that chronic exposure to benalaxyl-M epa.gov.
were retained at 10×. That decision is from food will utilize 1.4% of the cPAD
based on the following findings: for the general U.S. population and all B. International Residue Limits
i. The toxicity database for benalaxyl- population sub-groups. The most highly In making its tolerance decisions, EPA
M is complete for purposes of assessing exposed population subgroup was seeks to harmonize U.S. tolerances with
the exposures from the use of benalaxyl- children 1–2 years old with an international standards whenever
M on imported grapes and tomatoes. estimated risk of 7.1% cPAD. possible, consistent with U.S. food
However, there remains some 3. Aggregate cancer risk for U.S. safety standards and agricultural
uncertainty regarding the potential for population. The cancer dietary practices. EPA considers the
benalaxyl-M effects on thyroid. Thyroid assessment made use of the same input international maximum residue limits
toxicity was seen following subchronic assumptions as the chronic analysis. (MRLs) established by the Codex
and chronic exposures to adult rats. Benalaxyl-M has been classified as Alimentarius Commission (Codex), as
There are, however, no data regarding ‘‘Likely to be Carcinogenic to Humans’’. required by FFDCA section 408(b)(4).
the potential effects of benalaxyl-M on A linear low-dose extrapolation model The Codex Alimentarius is a joint
thyroid homeostasis in the young (Q1*) was used to estimate cancer risk, United Nations Food and Agriculture
animals. This lack of characterization with a Q1* = 5.90 × 10¥3 (mg/kg/ Organization/World Health
creates uncertainty with regards to day) ¥1. The cancer risk estimate to the Organization food standards program,
potential life stage sensitivities due to U.S. population is 1.7 × 10¥6. EPA and it is recognized as an international
exposure to benalaxyl-M. For future generally considers cancer risks in the food safety standards-setting
uses with higher exposure potential, the range of 10¥6 or less to be negligible. organization in trade agreements to
Agency will require a comparative The precision which can be assumed for which the United States is a party. EPA
thyroid assay in rats to assess the cancer risk estimates is best described may establish a tolerance that is
potential impact of benalaxyl-M by rounding to the nearest integral order different from a Codex MRL; however,
exposure on thyroid function in the of magnitude on the log scale; for FFDCA section 408(b)(4) requires that
young given the pivotal role of thyroid example, risks falling between 3 × 10¥7 EPA explain the reasons for departing
hormones in brain development. and 3 × 10¥6 are expressed as risks in from the Codex level.
ii. There is no indication that the range of 10¥6. Considering the
benalaxyl-M is a neurotoxic chemical The Codex has established MRLs for
precision with which cancer hazard can benalaxyl-M at 0.3 and 0.2 ppm in or on
and there is no need for a be estimated, the conservativeness of
developmental neurotoxicity study or grape and tomato, respectively. As a
low-dose linear extrapolation, and the result, the EPA recommendations will
additional UFs to account for rounding procedure described above in
neurotoxicity. result in harmonization of the U.S.
this unit, cancer risk should generally tolerance with the Codex MRL for
iii. There is no evidence that not be assumed to exceed the
benalaxyl-M results in increased tomato, but not for grape since
benchmark level of concern of the range benalaxyl-M residues from the grape
susceptibility in in utero rats or rabbits of 10¥6 until the calculated risk exceeds
in the prenatal developmental studies or trials in Argentina were significantly
approximately 3 × 10¥6. This is higher than the Codex MRL.
in young rats in the 2-generation particularly the case where some
reproduction study. conservatism is maintained in the C. Revisions to Petitioned-for Tolerances
iv. There are no residual uncertainties exposure assessment.
identified in the exposure databases. The requested tolerance levels differ
4. Determination of safety. There are from those being established by EPA.
E. Aggregate Risks and Determination of no existing or proposed US registrations The petitioner used the NAFTA
Safety of benalaxyl-M and the only route of calculator to propose tolerance levels
EPA determines whether acute and exposure is via dietary ingestion from while EPA used OECD MRL calculation
chronic dietary pesticide exposures are imported grape and tomato procedures. Additionally, for
safe by comparing aggregate exposure commodities. Therefore, aggregate determination of the grape and tomato
estimates to the acute PAD (aPAD) and exposure and risk estimates are tolerance levels, the petitioner included
chronic PAD (cPAD). For linear cancer equivalent to the dietary exposures and the results from all trials. In contrast,
risks, EPA calculates the lifetime risk estimates. Based on these risk EPA included only those data that
probability of acquiring cancer given the assessments, EPA concludes that there matched the critical Good Agricultural
estimated aggregate exposure. Short-, is a reasonable certainty that no harm Practice (cGAP). The tolerance for grape,
intermediate-, and chronic-term risks will result to the general population, or raisin was not recommended because it
are evaluated by comparing the to infants and children from aggregate is covered by the grape tolerance. No
Lhorne on DSK7TPTVN1PROD with RULES

estimated aggregate food, water, and exposure to benalaxyl-M residues. separate tolerances are needed for grape
residential exposure to the appropriate IV. Other Considerations juice, grape wine, or processed tomato
PODs to ensure that an adequate MOE products as processing studies showed
exists. A. Analytical Enforcement Methodology that residues of benalaxyl-M do not
1. Acute risk. An acute aggregate risk Adequate enforcement methodology concentrate in these processed
assessment takes into account acute (RA.09.01, a high-performance liquid commodities.

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45448 Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / Rules and Regulations

V. Conclusion retailers, not States or tribes, nor does List of Subjects in 40 CFR Part 180
Therefore, tolerances are established this action alter the relationships or Environmental protection,
for residues of benalaxyl-M, in or on distribution of power and Administrative practice and procedure,
grape and tomato at 3.0 and 0.20 ppm, responsibilities established by Congress Agricultural commodities, Pesticides
respectively. in the preemption provisions of FFDCA and pests, Reporting and recordkeeping
section 408(n)(4). As such, the Agency requirements.
VI. Statutory and Executive Order has determined that this action will not
Reviews have a substantial direct effect on States
Dated: July 24, 2015.
This action establishes tolerances Marty Monell,
or tribal governments, on the
under FFDCA section 408(d) in relationship between the national Acting Director, Office of Pesticide Programs.
response to a petition submitted to the government and the States or tribal Therefore, 40 CFR chapter I is
Agency. The Office of Management and governments, or on the distribution of amended as follows:
Budget (OMB) has exempted these types power and responsibilities among the
of actions from review under Executive various levels of government or between PART 180—[AMENDED]
Order 12866, entitled ‘‘Regulatory the Federal Government and Indian
Planning and Review’’ (58 FR 51735, ■ 1. The authority citation for part 180
tribes. Thus, the Agency has determined
October 4, 1993). Because this action continues to read as follows:
that Executive Order 13132, entitled
has been exempted from review under Authority: 21 U.S.C. 321(q), 346a and 371.
‘‘Federalism’’ (64 FR 43255, August 10,
Executive Order 12866, this action is
1999) and Executive Order 13175, ■ 2. Add § 180.684 to subpart C to read
not subject to Executive Order 13211,
entitled ‘‘Consultation and Coordination as follows:
entitled ‘‘Actions Concerning
with Indian Tribal Governments’’ (65 FR
Regulations That Significantly Affect § 180.684 Benalaxyl-M; tolerances for
Energy Supply, Distribution, or Use’’ (66 67249, November 9, 2000) do not apply
residues.
FR 28355, May 22, 2001) or Executive to this action. In addition, this action
does not impose any enforceable duty or (a) General. Tolerances are
Order 13045, entitled ‘‘Protection of established for residues of the fungicide
Children from Environmental Health contain any unfunded mandate as
described under Title II of the Unfunded benalaxyl-M, including its metabolites
Risks and Safety Risks’’ (62 FR 19885, and degradates, in or on the
April 23, 1997). This action does not Mandates Reform Act (UMRA) (2 U.S.C.
commodities in the table below.
contain any information collections 1501 et seq.).
Compliance with the tolerance levels
subject to OMB approval under the This action does not involve any specified below is to be determined by
Paperwork Reduction Act (PRA) (44 technical standards that would require measuring only benalaxyl [methyl N-
U.S.C. 3501 et seq.), nor does it require Agency consideration of voluntary (2,6-dimethylphenyl)-N-(phenylacetyl)-
any special considerations under consensus standards pursuant to section DL-alaninate] in or on the commodity.
Executive Order 12898, entitled 12(d) of the National Technology
‘‘Federal Actions to Address Transfer and Advancement Act Commodity Parts per million
Environmental Justice in Minority (NTTAA) (15 U.S.C. 272 note).
Populations and Low-Income Grape 1 ................................ 3.0
Populations’’ (59 FR 7629, February 16, VII. Congressional Review Act Tomato 1 ............................. 0.20
1994). 1 There is no U.S. registration for use on
Since tolerances and exemptions that Pursuant to the Congressional Review
this commodity as of July 30, 2015.
are established on the basis of a petition Act (5 U.S.C. 801 et seq.), EPA will
under FFDCA section 408(d), such as submit a report containing this rule and (b) Section 18 emergency exemptions.
the tolerance in this final rule, do not other required information to the U.S. [Reserved]
require the issuance of a proposed rule, Senate, the U.S. House of (c) Tolerances with regional
the requirements of the Regulatory Representatives, and the Comptroller registrations. [Reserved]
Flexibility Act (RFA) (5 U.S.C. 601 et General of the United States prior to (d) Indirect or inadvertent residues.
seq.), do not apply. publication of the rule in the Federal [Reserved]
This action directly regulates growers, Register. This action is not a ‘‘major [FR Doc. 2015–18741 Filed 7–29–15; 8:45 am]
food processors, food handlers, and food rule’’ as defined by 5 U.S.C. 804(2). BILLING CODE 6560–50–P
Lhorne on DSK7TPTVN1PROD with RULES

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Document Created: 2018-02-23 09:30:03
Document Modified: 2018-02-23 09:30:03

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective July 30, 2015. Objections and requests for hearings must be received on or before September 28, 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).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 45443
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements