Dimethomorph; Pesticide Tolerance, 14014-14019 [2015-06106]
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Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations
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).
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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.
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Revise § 180.589(a)(1) as follows:
a. Add in alphabetical order entries
for ‘‘Dill, seed’’ and ‘‘Herb subgroup
19A’’.
■ b. Remove the entries for ‘‘Fruit,
stone, group 12’’ and ‘‘Nut, tree, group
14’’ and add in their place entries for
‘‘Fruit, stone, group 12–12’’ and ‘‘Nut,
tree, group 14–12’’, respectively.
■ c. Remove the entry for ‘‘Pistachio.’’
■ d. Remove the entry for ‘‘Papya’’ and
add in its place an entry for ‘‘Papaya.’’
The addition and revisions read as
follows:
§ 180.589 Boscalid; tolerances for
residues.
(a) * * *
(1) * * *
Parts per
million
Commodity
*
Dill, seed ...............................
*
*
100
*
*
Fruit, stone, group 12–12 .....
*
*
*
*
*
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3.5
*
*
Herb subgroup 19A ..............
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*
*
*
*
*
0.70
*
*
Papaya ..................................
*
*
*
*
*
*
*
*
1.5
*
*
*
*
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of dimethomorph
in or on papaya at 1.5 parts per million
(ppm). BASF Corporation requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA) to cover
residues of dimethomorph in papaya
imported into the United States; there
are currently no U.S. registrations for
pesticides containing dimethomorph
that are used on papaya.
DATES: This regulation is effective
March 18, 2015. Objections and requests
for hearings must be received on or
before May 18, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0483, 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
ADDRESSES:
*
*
*
Nut, tree, group 14–12 .........
Dimethomorph; Pesticide Tolerance
■
■
*
*
[EPA–HQ–OPP–2014–0483; FRL–9923–59]
1. The authority citation for part 180
continues to read as follows:
*
*
*
40 CFR Part 180
■
*
*
*
ENVIRONMENTAL PROTECTION
AGENCY
PART 180—[AMENDED]
*
*
BILLING CODE 6560–50–P
Therefore, 40 CFR chapter I is
amended as follows:
*
*
[FR Doc. 2015–06141 Filed 3–17–15; 8:45 am]
Dated: March 3, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
*
Parts per
million
Commodity
150
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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 Publishing Office’s eCFR site at https://www.ecfr.gov/cgi-bin/
text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
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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–2014–0483 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 May 18, 2015. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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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–
2014–0483, 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 December
17, 2014 (79 FR 75107) (FRL–9918–90),
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 3E8218) by BASF
Corporation, P.O. Box, 13528, Research
Triangle Park, North Carolina 27709.
The petition requested that 40 CFR part
180 be amended by establishing a
tolerance for residues of the fungicide
dimethomorph, in or on papaya at 1.5
ppm. That document referenced a
summary of the petition prepared by
BASF Corporation, the registrant, which
is available in the docket, https://
www.regulations.gov. No comments
were received on the notice of filing.
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
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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 dimethomorph
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with dimethomorph 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.
Dimethomorph has low acute toxicity
by the oral, dermal, or inhalation route
of exposure. It is not an eye or skin
irritant, and is not a skin sensitizer.
There is no evidence that
dimethomorph is a developmental,
reproductive, carcinogenic, mutagenic
or immunotoxic chemical.
Dimethomorph is classified as ‘‘not
likely to be carcinogenic to humans’’
based upon lack of evidence of
carcinogenicity in rats and mice.
No biologically significant effect was
observed in the rat subchronic oral
toxicity study while decreased body
weight and increased incidence of
arteritis in male rats and decreased body
weights and increased incidence of
‘‘ground-glass’’ foci in livers of female
rats were observed in the rat chronic
toxicity study. In the dog subchronic
oral toxicity study, decreased absolute
and relative prostate weights, and slight
liver effects were observed. No toxicity
was observed at the limit dose in the rat
28-day dermal toxicity study. The
developmental toxicity studies showed
no increased sensitivity to offspring of
either rats or rabbits as demonstrated by
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no-observed-adverse-effect-level’s
(NOAEL) equal to or higher than those
producing toxicity in the maternal
animals. Likewise, in the 2-generation
reproduction study, there was no
toxicity to the offspring at doses lower
than that causing parental toxicity.
In an acute neurotoxicity study,
functional observational battery (FOB)
findings and reduced motor activity
were observed. However, these findings
were considered an impairment of the
overall condition of the animals
following treatment, rather than direct
neurotoxic effects of the dimethomorph
exposure. No neurotoxic effects were
observed in the subchronic
neurotoxicity study in rats and there is
no evidence of neurotoxicity throughout
the dimethomorph toxicity database.
There was no evidence of
immunotoxicity in the immunotoxicity
study.
Specific information on the studies
received and the nature of the adverse
effects caused by dimethomorph 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
Dimethomorph: Human Health Risk
Assessment to Support Establishment of
a Tolerance Without U.S. Registration
for Papaya on page 9 within the docket
ID number EPA–HQ–OPP–2014–0483.
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 the NOAEL and the
LOAEL at which adverse effects of
concern are identified. Uncertainty/
safety factors (U/SF) 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 nonthreshold 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 dimethomorph used for
human risk assessment is shown in the
Table of this unit.
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DIMETHOMORPH FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Acute dietary (Females 13–49
years of age).
No appropriate endpoint was identified including developmental toxicity studies in rats
and rabbits.
Not applicable ..........
No study selected.
Acute dietary (General population).
LOAEL = 250 mg/kg/
day UFA.
UFH = 10x ................
FQPA SFL = 10x .....
Acute RfD = 0.25
mg/kg/day.
aPAD = 0.25 mg/kg/
day.
Acute Neurotoxicity Study.
LOAEL = 250 mg/kg/day based on reduced motor activity in
both sexes.
Chronic dietary (All populations)
NOAEL = 11 mg/kg/
day UFA = 10x.
UFH = 10x ................
FQPA SF = 1x .........
Chronic RfD = 0.1
mg/kg/day.
cPAD = 0.1 mg/kg/
day.
Carcinogenicity study in rats.
LOAEL = 46.3 mg/kg/day based on decreased body weight
and increases in liver lesions in female rats.
Cancer (Oral, dermal, inhalation).
Classification: ‘‘Not likely’’ to be a human carcinogen.
Exposure/scenario
Study and toxicological effects
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, 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). UFL = use of a LOAEL to extrapolate a NOAEL.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to dimethomorph, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing dimethomorph tolerances in 40
CFR 180.493. EPA assessed dietary
exposures from dimethomorph in food
as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
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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. Such effects were identified
for dimethomorph. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) Nationwide Health and
Nutrition Examination Survey, What We
Eat In America (NHANES/WWEIA)
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conducted from 2003–2008. As to
residue levels in food, EPA made the
following assumptions for the acute
exposure assessment: tolerance-level
residues for all commodities, 100
percent crop treated (PCT) for all
commodities and Dietary Exposure
Evaluation Model (DEEM) (ver. 7.81)
default processing factors or empirical
processing factors.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
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from the USDA’s (NHANES/WWEIA)
conducted from 2003–2008 as well. As
to residue levels in food, EPA made the
following assumptions for the chronic
exposure assessment: Tolerance-level
residues for all commodities, 100 PCT
for all commodities and DEEM (ver.
7.81) default processing factors or
empirical processing factors.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that dimethomorph should
be classified as ‘‘not likely’’ to be a
human carcinogen based upon lack of
evidence of carcinogenicity in rats and
mice. Therefore a cancer risk assessment
was not necessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for dimethomorph. Tolerance level
residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The drinking water
concentrations have not changed since
the last assessment. The Agency utilized
a maximum application rate of 1.4
pound active ingredient/acre/season (lb
ai/A/season) for broccoli (which is the
use with the most exposure and highest
PCT area). The groundwater value was
generated using the Screening
Concentration in Groundwater (SCI–
GROW) Model and the surface water
values were generated using a Tier 1
broccoli model. The surface water
estimate was used for both acute and
chronic assessment (81.1 parts per
billion (ppb) for acute and 24.7 ppb for
chronic) because these values were
higher than the groundwater value.
Since the current petition is for a
tolerance in/on imported papaya, an
assessment of the impacts of that use on
drinking water was not required.
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).
Dimethomorph 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.’’
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EPA has not found dimethomorph to
share a common mechanism of toxicity
with any other substances, and
dimethomorph does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that dimethomorph 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
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.
The available data did not provide
evidence of increased sensitivity in the
offspring based on the results from
developmental studies conducted with
rats and rabbits as well as a 2-generation
reproduction study conducted with rats.
There were no toxic effects observed in
either the rat developmental toxicity or
the rat 2-generation reproductive
toxicity studies at doses that were lower
than doses which produced toxic effects
in the parents. Additionally, no
developmental toxicity was
demonstrated in the rabbit
developmental toxicity 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 reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
dimethomorph is complete.
ii. The available data do not support
a determination that dimethomorph is a
neurotoxic chemical and there is no
need for a developmental neurotoxicity
study or additional UFs to account for
neurotoxicity.
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iii. There is no evidence that
dimethomorph results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The unrefined acute and chronic dietary
risk assessments used tolerance level
residues, included modeled drinking
water estimates, assumed 100 PCT, and
incorporated DEEM default processing
factors. EPA made conservative
(protective) assumptions in the
groundwater and surface water
modeling used to assess exposure to
dimethomorph in drinking water. These
assessments will not underestimate the
exposure and risks posed by
dimethomorph.
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 and water to
dimethomorph will occupy 39% of the
aPAD for children 3–5 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 dimethomorph
from food and water will utilize 25% of
the cPAD for children 1–2 years the
population group receiving the greatest
exposure. There are no residential uses
for dimethomorph.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Because no short-term
adverse effect was identified,
dimethomorph is not expected to pose
a short-term risk.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
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to be a background exposure level). An
intermediate-term adverse effect was
identified; however, dimethomorph is
not registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
dimethomorph.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
dimethomorph 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
dimethomorph residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
FAMS–002–04 which utilizes high
performance liquid chromatography
with ultraviolet detection (HPLC/UV) 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.
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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
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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 residues of dimethomorph in/on
papaya.
V. Conclusion
Therefore, tolerances are established
for residues of dimethomorph, in or on
papaya at 1.5 ppm. While no pesticides
containing dimethomorph have been
registered in the United States for use
on papaya, this tolerance allows
importation of papaya containing
permissible residues of dimethomorph
under the FFDCA.
VI. Statutory and Executive Order
Reviews
This action establishes a tolerance
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
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
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: March 9, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.493 alphabetically add the
commodity ‘‘papaya’’ to the table in
paragraph (a) to read as follows:
■
§ 180.493 Dimethomorph; tolerances for
residues.
(a) General. * * *
E:\FR\FM\18MRR1.SGM
18MRR1
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Rules and Regulations
2014–0610. All documents in the docket
are listed on the www.regulations.gov
Web site. Although listed in the index,
some information is not publicly
* * *
* * * available, i.e., Confidential Business
Papaya 1 ...............................
1.5
Information or other information whose
* * *
* * * disclosure is restricted by statute.
Certain other material, such as
1 There are no U.S. registrations as of Janucopyrighted material, is not placed on
ary 20, 2015.
the Internet and will be publicly
*
*
*
*
*
available only in hard copy form.
[FR Doc. 2015–06106 Filed 3–17–15; 8:45 am]
Publicly available docket materials are
BILLING CODE 6560–50–P
available either electronically through
www.regulations.gov or in hard copy at
the Air Regulatory Management Section
ENVIRONMENTAL PROTECTION
(formerly Regulatory Development
AGENCY
Section), Air Planning and
Implementation Branch, Air, Pesticides
40 CFR Part 52
and Toxics Management Division, U.S.
[EPA–R04–OAR–2014–0610; FRL–9924–47– Environmental Protection Agency,
Region 4]
Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960. EPA
Approval and Promulgation of
requests that if at all possible, you
Implementation Plans; Region 4
contact the person listed in the FOR
States; 2008 Lead, 2008 Ozone and
FURTHER INFORMATION CONTACT section to
2010 Nitrogen Dioxide Prevention of
schedule your inspection. The Regional
Significant Deterioration Infrastructure
Office’s official hours of business are
Plans
Monday through Friday 8:30 a.m. to
4:30 p.m., excluding Federal holidays.
AGENCY: Environmental Protection
Agency.
FOR FURTHER INFORMATION CONTACT:
Sean Lakeman, Air Regulatory
ACTION: Final rule.
Management Section, Air Planning and
SUMMARY: The Environmental Protection Implementation Branch, Air, Pesticides
Agency (EPA) is approving portions of
and Toxics Management Division, U.S.
submissions from Alabama, Florida,
Environmental Protection Agency,
Georgia, Kentucky, Mississippi, South
Region 4, 61 Forsyth Street SW.,
Carolina and Tennessee for inclusion
Atlanta, Georgia 30303–8960. The
into each State’s implementation plan.
telephone number is (404) 562–9043.
This action pertains to the Clean Air Act Mr. Lakeman can be reached via
(CAA or Act) infrastructure
electronic mail at lakeman.sean@
requirements for the 2008 Lead, 2008
epa.gov.
Ozone and 2010 Nitrogen Dioxide (NO2)
National Ambient Air Quality Standards SUPPLEMENTARY INFORMATION:
(NAAQS). The CAA requires that each
I. Background
state adopt and submit a state
By statute, SIPs meeting the
implementation plan (SIP) for the
requirements of sections 110(a)(1) and
implementation, maintenance, and
(2) are to be submitted by states within
enforcement of each NAAQS
three years after promulgation of a new
promulgated by EPA. These plans are
or revised NAAQS to provide for the
commonly referred to as
implementation, maintenance, and
‘‘infrastructure’’ SIPs. Specifically, EPA
enforcement of the new or revised
is approving the portions of the
NAAQS. EPA has historically referred to
submissions from Alabama, Florida,
these SIP submissions made for the
Georgia, Kentucky, Mississippi, South
purpose of satisfying the requirements
Carolina and Tennessee that relate to
of CAA sections 110(a)(1) and 110(a)(2)
the infrastructure SIP prevention of
as ‘‘infrastructure SIP’’ submissions.
significant deterioration (PSD)
Sections 110(a)(1) and (2) require states
requirements. All other applicable
to address basic SIP elements such as
infrastructure requirements for the 2008
for monitoring, basic program
Lead, 2008 Ozone and 2010 NO2
requirements and legal authority that
NAAQS associated with these States are
are designed to assure attainment and
being addressed in separate
maintenance of the newly established or
rulemakings.
revised NAAQS. More specifically,
DATES: This rule is effective on April 17, section 110(a)(1) provides the
2015.
procedural and timing requirements for
ADDRESSES: EPA has established a
SIPs. Section 110(a)(2) lists specific
docket for this action under Docket
elements that states must meet for the
Identification No. EPA–R04–OAR–
‘‘infrastructure’’ SIP requirements
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related to a newly established or revised
NAAQS. The contents of an
infrastructure SIP submission may vary
depending upon the data and analytical
tools available to the state, as well as the
provisions already contained in the
state’s implementation plan at the time
in which the state develops and submits
the submission for a new or revised
NAAQS.
Through this action, EPA is approving
the PSD requirements of sections
110(a)(2)(C), 110(a)(2)(D)(i)(II) (prong 3)
and 110(a)(2)(J) (hereafter ‘‘PSD
Elements’’) for various infrastructure
SIP submissions from the states of
Alabama, Florida, Georgia, Kentucky,
Mississippi, South Carolina and
Tennessee. As described further below,
for some of these states, EPA is
approving the PSD Elements in the
infrastructure SIP submissions for the
2008 Lead, 2008 Ozone and 2010 NO2
NAAQS; whereas for other states, EPA
is only approving the PSD Elements of
the infrastructure SIP submissions for a
subset of these NAAQS. All other
applicable infrastructure requirements
for the 2008 Lead, 2008 Ozone and 2010
NO2 NAAQS associated with these
States are being addressed in separate
rulemakings.
a. 2008 Lead NAAQS
For the 2008 Lead NAAQS, EPA is
only approving the PSD Elements of the
infrastructure SIP submissions from
Alabama (received November 4, 2011),
Florida (received October 14, 2011),
Georgia (received May 14, 2012),
Kentucky (received July 17, 2012),
Mississippi (received November 17,
2011), and South Carolina (received
September 20, 2011). EPA notes that the
Agency approved the PSD Elements of
Tennessee’s 2008 Lead infrastructure
SIP submission on August 12, 2013 (78
FR 48806).
b. 2008 Ozone NAAQS
For the 2008 Ozone NAAQS, EPA is
only approving the PSD Elements of the
infrastructure SIP submissions from
Alabama (received August 20, 2012),
Georgia (received March 6, 2012),
Mississippi (received May 29, 2012; and
resubmitted July 26, 2012), and South
Carolina (received on July 17, 2012).
EPA notes that the Agency approved the
PSD Elements of the infrastructure SIP
submissions for the 2008 Ozone NAAQS
for Kentucky on March 7, 2013 (78 FR
14691) and November 3, 2014 (79 FR
65143), and Tennessee on March 6,
2013 (78 FR 14450) and January 9, 2014
(79 FR 1593).
E:\FR\FM\18MRR1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Rules and Regulations]
[Pages 14014-14019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06106]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0483; FRL-9923-59]
Dimethomorph; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
dimethomorph in or on papaya at 1.5 parts per million (ppm). BASF
Corporation requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA) to cover residues of dimethomorph in papaya
imported into the United States; there are currently no U.S.
registrations for pesticides containing dimethomorph that are used on
papaya.
DATES: This regulation is effective March 18, 2015. Objections and
requests for hearings must be received on or before May 18, 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-2014-0483, 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
[[Page 14015]]
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
Publishing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under 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-2014-0483 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
May 18, 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-2014-0483, 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 December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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
3E8218) by BASF Corporation, P.O. Box, 13528, Research Triangle Park,
North Carolina 27709. The petition requested that 40 CFR part 180 be
amended by establishing a tolerance for residues of the fungicide
dimethomorph, in or on papaya at 1.5 ppm. That document referenced a
summary of the petition prepared by BASF Corporation, the registrant,
which is available in the docket, https://www.regulations.gov. No
comments were received on the notice of filing.
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 dimethomorph including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with dimethomorph 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.
Dimethomorph has low acute toxicity by the oral, dermal, or
inhalation route of exposure. It is not an eye or skin irritant, and is
not a skin sensitizer. There is no evidence that dimethomorph is a
developmental, reproductive, carcinogenic, mutagenic or immunotoxic
chemical. Dimethomorph is classified as ``not likely to be carcinogenic
to humans'' based upon lack of evidence of carcinogenicity in rats and
mice.
No biologically significant effect was observed in the rat
subchronic oral toxicity study while decreased body weight and
increased incidence of arteritis in male rats and decreased body
weights and increased incidence of ``ground-glass'' foci in livers of
female rats were observed in the rat chronic toxicity study. In the dog
subchronic oral toxicity study, decreased absolute and relative
prostate weights, and slight liver effects were observed. No toxicity
was observed at the limit dose in the rat 28-day dermal toxicity study.
The developmental toxicity studies showed no increased sensitivity to
offspring of either rats or rabbits as demonstrated by
[[Page 14016]]
no-observed-adverse-effect-level's (NOAEL) equal to or higher than
those producing toxicity in the maternal animals. Likewise, in the 2-
generation reproduction study, there was no toxicity to the offspring
at doses lower than that causing parental toxicity.
In an acute neurotoxicity study, functional observational battery
(FOB) findings and reduced motor activity were observed. However, these
findings were considered an impairment of the overall condition of the
animals following treatment, rather than direct neurotoxic effects of
the dimethomorph exposure. No neurotoxic effects were observed in the
subchronic neurotoxicity study in rats and there is no evidence of
neurotoxicity throughout the dimethomorph toxicity database. There was
no evidence of immunotoxicity in the immunotoxicity study.
Specific information on the studies received and the nature of the
adverse effects caused by dimethomorph 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 Dimethomorph:
Human Health Risk Assessment to Support Establishment of a Tolerance
Without U.S. Registration for Papaya on page 9 within the docket ID
number EPA-HQ-OPP-2014-0483.
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 the NOAEL and the LOAEL at which adverse
effects of concern are identified. Uncertainty/safety factors (U/SF)
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 dimethomorph used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Dimethomorph 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 (Females 13-49 No appropriate Not applicable..... No study selected.
years of age). endpoint was
identified
including
developmental
toxicity studies in
rats and rabbits.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General LOAEL = 250 mg/kg/ Acute RfD = 0.25 mg/ Acute Neurotoxicity Study.
population). day UFA. kg/day. LOAEL = 250 mg/kg/day based on
UFH = 10x........... aPAD = 0.25 mg/kg/ reduced motor activity in both
FQPA SFL = 10x...... day. sexes.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 11 mg/kg/day Chronic RfD = 0.1 Carcinogenicity study in rats.
UFA = 10x. mg/kg/day. LOAEL = 46.3 mg/kg/day based on
UFH = 10x........... cPAD = 0.1 mg/kg/ decreased body weight and
FQPA SF = 1x........ day. increases in liver lesions in
female rats.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not likely'' to be a human carcinogen.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population
adjusted dose (a = acute, 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). UFL = use of a LOAEL to extrapolate a NOAEL.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dimethomorph, EPA considered exposure under the petitioned-
for tolerances as well as all existing dimethomorph tolerances in 40
CFR 180.493. EPA assessed dietary exposures from dimethomorph 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. Such effects were identified
for dimethomorph. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) Nationwide Health and Nutrition Examination Survey,
What We Eat In America (NHANES/WWEIA) conducted from 2003-2008. As to
residue levels in food, EPA made the following assumptions for the
acute exposure assessment: tolerance-level residues for all
commodities, 100 percent crop treated (PCT) for all commodities and
Dietary Exposure Evaluation Model (DEEM) (ver. 7.81) default processing
factors or empirical processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data
[[Page 14017]]
from the USDA's (NHANES/WWEIA) conducted from 2003-2008 as well. As to
residue levels in food, EPA made the following assumptions for the
chronic exposure assessment: Tolerance-level residues for all
commodities, 100 PCT for all commodities and DEEM (ver. 7.81) default
processing factors or empirical processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that dimethomorph should be classified as ``not likely'' to
be a human carcinogen based upon lack of evidence of carcinogenicity in
rats and mice. Therefore a cancer risk assessment was not necessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for dimethomorph. Tolerance level residues and/or
100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The drinking water
concentrations have not changed since the last assessment. The Agency
utilized a maximum application rate of 1.4 pound active ingredient/
acre/season (lb ai/A/season) for broccoli (which is the use with the
most exposure and highest PCT area). The groundwater value was
generated using the Screening Concentration in Groundwater (SCI-GROW)
Model and the surface water values were generated using a Tier 1
broccoli model. The surface water estimate was used for both acute and
chronic assessment (81.1 parts per billion (ppb) for acute and 24.7 ppb
for chronic) because these values were higher than the groundwater
value. Since the current petition is for a tolerance in/on imported
papaya, an assessment of the impacts of that use on drinking water was
not required.
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). Dimethomorph 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 dimethomorph to share a common mechanism of
toxicity with any other substances, and dimethomorph does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
dimethomorph 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
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. The available data did not
provide evidence of increased sensitivity in the offspring based on the
results from developmental studies conducted with rats and rabbits as
well as a 2-generation reproduction study conducted with rats. There
were no toxic effects observed in either the rat developmental toxicity
or the rat 2-generation reproductive toxicity studies at doses that
were lower than doses which produced toxic effects in the parents.
Additionally, no developmental toxicity was demonstrated in the rabbit
developmental toxicity 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 reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for dimethomorph is complete.
ii. The available data do not support a determination that
dimethomorph 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 dimethomorph results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The unrefined acute and chronic dietary risk assessments
used tolerance level residues, included modeled drinking water
estimates, assumed 100 PCT, and incorporated DEEM default processing
factors. EPA made conservative (protective) assumptions in the
groundwater and surface water modeling used to assess exposure to
dimethomorph in drinking water. These assessments will not
underestimate the exposure and risks posed by dimethomorph.
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 and water
to dimethomorph will occupy 39% of the aPAD for children 3-5 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
dimethomorph from food and water will utilize 25% of the cPAD for
children 1-2 years the population group receiving the greatest
exposure. There are no residential uses for dimethomorph.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Because no
short-term adverse effect was identified, dimethomorph is not expected
to pose a short-term risk.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered
[[Page 14018]]
to be a background exposure level). An intermediate-term adverse effect
was identified; however, dimethomorph is not registered for any use
patterns that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for dimethomorph.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, dimethomorph 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 dimethomorph residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
FAMS-002-04 which utilizes high performance liquid chromatography
with ultraviolet detection (HPLC/UV) 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 not established a MRL for residues of dimethomorph
in/on papaya.
V. Conclusion
Therefore, tolerances are established for residues of dimethomorph,
in or on papaya at 1.5 ppm. While no pesticides containing dimethomorph
have been registered in the United States for use on papaya, this
tolerance allows importation of papaya containing permissible residues
of dimethomorph under the FFDCA.
VI. Statutory and Executive Order Reviews
This action establishes a tolerance 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: March 9, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.493 alphabetically add the commodity ``papaya'' to the
table in paragraph (a) to read as follows:
Sec. 180.493 Dimethomorph; tolerances for residues.
(a) General. * * *
[[Page 14019]]
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * *
Papaya \1\.............................................. 1.5
* * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of January 20, 2015.
* * * * *
[FR Doc. 2015-06106 Filed 3-17-15; 8:45 am]
BILLING CODE 6560-50-P
