Fomesafen; Pesticide Tolerances, 65565-65570 [2013-25984]
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formulations (i.e., food contact surface
sanitizing solutions) applied to foodcontact surfaces in public eating places,
dairy-processing equipment, and foodprocessing equipment and utensils.
VII. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the requirement of 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 final rule has been exempted from
review under Executive Order 12866,
this final rule is not subject to Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VIII. 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: October 22, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.940, add alphabetically the
following entry to the table in paragraph
(a) to read as follows:
■
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
Pesticide chemical
*
*
*
*
*
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Part 180
[EPA–HQ–OPP–2012–0589; FRL–9401–8]
Fomesafen; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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*
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This regulation establishes
tolerances for residues of fomesafen in
or on multiple commodities which are
identified and discussed later in this
document. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
November 1, 2013. Objections and
requests for hearings must be received
on or before December 31, 2013, 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:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0589, 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), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
ADDRESSES:
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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: Lois
Rossi, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&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–2012–0589 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 December 31, 2013. 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
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as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2012–0589, 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 September
28, 2012 (77 FR 59578) (FRL–9364–6)
and June 5, 2013 (78 FR 33785) (FRL–
9386–2), EPA issued documents
pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing
of pesticide petitions (PP 2E8061 and
3E8167) by IR–4, IR–4 Project
Headquarters, 500 College Road East,
Suite 201W, Princeton, NJ 08540. The
petitions requested that 40 CFR 180.433
be amended by establishing tolerances
for residues of the herbicide fomesafen,
5-[2-chloro-4-(trifluoromethyl)phenoxy]N-(methylsulfonyl)-2-nitrobenzamide,
in or on cantaloupe; cucumber; pea,
succulent; pumpkin; squash, summer;
squash, winter; and watermelon all at
0.025 parts per million (ppm); and
soybean, vegetable, succulent at 0.05
ppm (2E8061); and bean, lima,
succulent at 0.05 ppm (3E8167). The
documents referenced a summary of
each petition prepared by Syngenta
Crop Protections, LLC, the registrant,
which are available in the docket,
https://www.regulations.gov. One public
comment was received on the notice of
filing for PP 3E8167. EPA’s response to
the comment is discussed in Unit IV.C.
Based upon review of data supporting
the petition, EPA corrected the
commodity name for certain crops for
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which a tolerance was proposed as
explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue.* * *’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for fomesafen
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fomesafen follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
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.
In the subchronic and chronic
fomesafen toxicity studies in rats and
mice, food consumption, food
efficiency, body weight, body weight
gain, and histopathological changes in
the liver were parameters that were
most often affected. In addition, dogs
and mice also showed hematological
changes (e.g., decreased erythrocyte
count, hemoglobin, or hematocrit).
In the developmental studies, postimplantation loss was noted but no
quantitative or qualitative evidence of
increased susceptibility to fomesafen
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was seen following in utero exposure to
rat or rabbit fetuses in prenatal
developmental studies or postnatally in
rat 2-generation reproduction study.
Acute neurotoxicity studies indicate
fomesafen may cause neurotoxicity
(decreased motor activity) at the same
dose level as systemic toxicity.
Although suppression of anti-sheep red
blood cell immunoglobulin (SRBC IgM)
response was noted in the
immunotoxicity study, the selected
endpoints for risk assessment are
protective of this effect.
Carcinogenicity was not observed in
the rat chronic toxicity/carcinogenicity
study. Although liver tumors were seen
in the mouse carcinogenicity study, EPA
classified fomesafen as ‘‘Not Likely to be
Carcinogenic to Humans’’ because the
mode of action for fomesafen-induced
hepatocarcinogenesis in mice is
unlikely to take place in humans.
Fomesafen was not considered to be
mutagenic.
Specific information on the studies
received and the nature of the adverse
effects caused by fomesafen, 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 https://
www.regulations.gov in document:
‘‘Fomesafen Sodium: Human Health
Risk Assessment for the Section 3
Registration Action on Cantaloupe,
Cucumber, Pea (Succulent), Pumpkin,
Summer Squash, Winter Squash,
Watermelon, Soybean (Succulent) and
Lima Bean (Succulent),’’ dated July 18,
2013 at page 27 in docket ID number
EPA–HQ–OPP–2012–0589.
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
65567
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for fomesafen used for human
risk assessment is shown in Table 1. of
this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOMESAFEN FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (General population including infants and
children).
NOAEL = 100 mg/
kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 1 mg/
kg/day
aPAD = 1 mg/kg/day
Acute neurotoxicity test in the rat.
LOAEL = 250 mg/kg/day based on decreased body weight and
motor activity (horizontal and vertical activity and time in central quadrant) in males.
Chronic dietary (All populations)
NOAEL= 0.25 mg/
kg/day UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD =
0.0025 mg/kg/day
cPAD = 0.0025 mg/
kg/day
Chronic toxicity/carcinogenicity in the rat.
LOAEL = 5 mg/kg/day based on hyalinization of the liver in
males.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. 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).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fomesafen, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
fomesafen tolerances in 40 CFR 180.433.
EPA assessed dietary exposures from
fomesafen 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
fomesafen. In estimating acute dietary
exposure, EPA used Dietary Exposure
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Evaluation Model—Food Consumption
Intake Database (DEEM–FCID), ver. 3.16
which incorporates consumption data
from the United States Department of
Agriculture (USDA) 2003—2008
National Health and Nutrition
Examination Survey, What We Eat in
America (NHANES/WWEA). Acute
analysis assumed 100 percent crop
treated (PCT), DEEM 7.81 default
concentration factors, tolerance-level
residues for all existing and proposed
crop uses.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used DEEM–FCID, ver. 3.16 which
incorporates consumption data from
USDA 2003—2008 NHANES/WWEA.
As to residue levels in food, EPA
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analysis assumed 100 PCT and
tolerance-level residues for all existing
and proposed crop uses.
iii. Cancer. Based on the data
summarized in Unit III.A., a dietary
exposure assessment for the purpose of
assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue or PCT information
in the dietary assessment for fomesafen.
Tolerance level residues and 100 PCT
were assumed for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for fomesafen in drinking water. These
simulation models take into account
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data on the physical, chemical, and fate/
transport characteristics of fomesafen.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Screening model Tier II Pesticide Root
Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) was
used to calculate surface water
estimated drinking water concentrations
(EDWCs). Groundwater EDWCs for
fomesafen were calculated using Tier 1
Pesticide Root Zone Model Ground
Water (PRZM GW). Acute exposures are
estimated to be 34.8 parts per billion
(ppb) for surface water and 51.8 ppb for
ground water.
Chronic exposures for non-cancer
assessments are estimated to be 13.1
ppb for surface water and 32.3 ppb for
ground water.
Modeled estimates of drinking water
concentrations are based on ground
water EDWCs, which were highest
among surface water and ground water
EDWCs (representing worst case), were
directly entered into the dietary
exposure model.
For acute dietary risk assessment, the
water concentration value of 51.8 ppb
was used to assess the contribution to
drinking water.
For chronic dietary risk assessment,
the water concentration of value 32.3
ppb was used to assess the contribution
to drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Fomesafen 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 fomesafen to share
a common mechanism of toxicity with
any other substances, and fomesafen
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that fomesafen does not have
a common mechanism of toxicity with
other substances. For information
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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
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.
The pre- and postnatal database for
fomesafen includes a prenatal
developmental toxicity study in rabbits,
two prenatal developmental toxicity
studies in rats, and a 2-generation
reproduction toxicity study in rats. The
rabbit developmental study was
classified as unacceptable because of
bacterial infection in the colony;
however, the study provided
information to assess potential
developmental toxicity in rabbits. There
was no significant difference between
the treated and control animals for
developmental abnormalities in the
rabbit study. In the two rat
developmental studies (considered
together), developmental effects
(postimplantation loss) occurred at the
same dose causing maternal toxicity
(staining of the ventral fur and
significantly decreased body weight
gain (>10%)). In the rat reproduction
study, offspring effects (increased
incidence of liver hyalinization in
males) occurred at the same dose
causing parental effects (liver
histopathology in males and females of
both generations).
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 fomesafen
is complete. The developmental toxicity
study in rabbits, classified unacceptable
due to mortality from bacterial
infections, showed no evidence of
increased susceptibility of rabbit fetuses
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due to the treatment with fomesafen.
Therefore, the lack of an acceptable
developmental toxicity study in nonrodents was not considered a data gap.
ii. There is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity. In an acute neurotoxicity
screening battery in rats, decreased
motor activity (horizontal and vertical
activity and time in central quadrant)
was observed at the same dose that
resulted in general systemic toxicity. In
the subchronic neurotoxicity test,
neither general systemic toxicity nor
neurotoxicity was observed at the
highest dose tested. All points of
departure used in the risk assessment
are protective of any potential
neurotoxicity.
iii. There is no evidence that
fomesafen 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. The 2-generation
reproduction study in rats did not show
evidence of increased susceptibility to
fomesafen.
iv. There are no residual uncertainties
identified in the exposure databases.
Tolerance level residues and 100 PCT
were assumed for all food commodities.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to fomesafen in drinking water. These
assessments will not underestimate the
exposure and risks posed by fomesafen.
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
fomesafen will occupy < 1% of the
aPAD for all population subgroups,
including all infants (< 1 year 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 fomesafen from
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food and water will utilize 77% of the
cPAD for all infants (< 1 year old) the
population group receiving the greatest
exposure. There are no residential uses
for fomesafen.
3. Short- and intermediate-term risk.
Short- and intermediate-term aggregate
exposure takes into account short- or
intermediate-term residential exposure
plus chronic exposure from food and
water (considered to be a background
exposure level). Short- and
intermediate-term adverse effects were
identified; however, fomesafen is not
registered for any use patterns that
would result in short- and intermediateterm residential exposure. Because there
is no short- or 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 short-term risk),
no further assessment of short- or
intermediate-term risk is necessary, and
EPA relies on the chronic dietary risk
assessment for evaluating short- and
intermediate-term risk for fomesafen.
4. Aggregate cancer risk for U.S.
population. Based on the data
summarized in Unit III.A., fomesafen is
not expected to pose a cancer risk to
humans.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to fomesafen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high performance liquid
chromatography method with tandem
mass spectrometry detection (LC/MS/
MS) method (GRM045.01A) is available
to enforce the tolerance expression. The
validated limit of quantitation (LOQ) of
the method is 0.02 ppm.
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.
ehiers on DSK2VPTVN1PROD with RULES
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
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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.
Codex has not established maximum
residue limits (MRLs) for residues of
fomesafen.
C. Response to Comments
The Agency received an anonymous
public comment objecting to the
proposed fomesafen tolerance on lima
bean because of the amounts of
pesticides already consumed and
carried by the American population.
The Agency understands the
commenter’s concerns and recognizes
that some individuals believe that
pesticides should be banned
completely. However, under the existing
legal framework provided by section
408 of the FFDCA, EPA is authorized to
establish pesticide tolerances or
exemptions where persons seeking such
tolerances or exemptions have
demonstrated that the pesticide meets
the safety standard imposed by that
statute.
D. Revisions to Petitioned-For
Tolerances
Petitioned-for tolerance levels in or on
commodities were unchanged, however,
the commodity name of certain
proposed crops was changed to comply
with current EPA commodity
definitions, as follows: Winter, squash
changed to squash, winter; vegetable,
soybean, succulent to soybean,
vegetable, succulent; and lima, bean to
bean, lima, succulent.
V. Conclusion
Therefore, tolerances are established
for residues of the herbicide fomesafen,
including its metabolites and
degradates, in or on cantaloupe;
cucumber; pea, succulent; pumpkin;
squash, summer; squash, winter; and
watermelon all at 0.025 ppm; soybean,
vegetable, succulent at 0.05 ppm; and
bean, lima, succulent at 0.05 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
PO 00000
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65569
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerances in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
Tribes. Thus, the Agency has
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this final rule.
In addition, this final rule does not
impose any enforceable duty or contain
any unfunded mandate as described
under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
E:\FR\FM\01NOR1.SGM
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65570
Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Rules and Regulations
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
ehiers on DSK2VPTVN1PROD with RULES
Dated: October 17, 2013.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Washington, DC 20460–0001; telephone
number: (202) 564–8974; email address:
alwood.jim@epa.gov.
*
*
*
*
*
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
Watermelon ..............................
0.025
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
*
*
*
*
*
1404; email address: TSCA-Hotline@
[FR Doc. 2013–25984 Filed 10–31–13; 8:45 am]
epa.gov.
BILLING CODE 6560–50–P
Parts per
million
Commodity
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2008–0918; FRL–9901–97]
RIN 2070–AB27
Modification of Significant New Uses
of 1-Propene, 2,3,3,3-tetrafluoroEnvironmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
Under the Toxic Substances
Control Act (TSCA), EPA is finalizing an
amendment to the significant new use
Therefore, 40 CFR chapter I is
rule (SNUR) for the chemical substance
amended as follows:
identified as 1-Propene, 2,3,3,3tetrafluoro-, which was the subject of
PART 180—[AMENDED]
premanufacture notice (PMN) P–07–
601. This action amends the SNUR to
■ 1. The authority citation for part 180
allow the manufacture and processing
continues to read as follows:
for certain uses without requiring a
Authority: 21 U.S.C. 321(q), 346a and 371.
significant new use notice (SNUN). EPA
■ 2. In § 180.433, add alphabetically the
is finalizing this amendment based on
following commodities to the table in
review of newly submitted exposure
paragraph (a) to read as follows:
and toxicity data.
DATES: This final rule is effective
§ 180.433 Fomesafen; tolerance for
December 2, 2013.
residues.
ADDRESSES: The docket for this action,
(a) General. * * *
identified by docket identification (ID)
Parts per
number EPA–HQ–OPPT–2008–0918 is
Commodity
million
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
*
*
*
*
*
Environmental Protection Agency
Bean, lima, succulent ...............
0.05 Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC. The Public
*
*
*
*
*
Reading Room is open from 8:30 a.m. to
Cantaloupe ...............................
0.025 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
Cucumber .................................
0.025
Pea, succulent ..........................
0.025 number for the OPPT Docket is (202)
566–0280. Please review the visitor
instructions and additional information
*
*
*
*
*
about the docket available at https://
Pumpkin ....................................
0.025 www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
*
*
*
*
*
technical information contact: Jim
Soybean, vegetable, succulent
0.05 Alwood, Chemical Control Division
Squash, summer ......................
0.025 (7405M), Office of Pollution Prevention
Squash, winter ..........................
0.025 and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
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15:07 Oct 31, 2013
Jkt 232001
SUMMARY:
PO 00000
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Fmt 4700
Sfmt 4700
I. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substance identified
as 1-Propene, 2,3,3,3-tetrafluoro- (PMN
P–07–601). Potentially affected entities
may include, but are not limited to:
• Manufacturers or processors of the
subject chemical substance (NAICS
codes 325 and 324110), e.g., chemical
manufacturers and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
§ 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127, and 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to a SNUR must
certify their compliance with the SNUR
requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export the chemical substance
that is the subject of a proposed or final
SNUR are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 721.20),
and must comply with the export
notification requirements in 40 CFR part
707, subpart D.
E:\FR\FM\01NOR1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Rules and Regulations]
[Pages 65565-65570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25984]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2012-0589; FRL-9401-8]
Fomesafen; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fomesafen in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective November 1, 2013. Objections and
requests for hearings must be received on or before December 31, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0589, 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), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP
[[Page 65566]]
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: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0589 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
December 31, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0589, 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 September 28, 2012 (77 FR 59578) (FRL-
9364-6) and June 5, 2013 (78 FR 33785) (FRL-9386-2), EPA issued
documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of pesticide petitions (PP 2E8061 and 3E8167) by
IR-4, IR-4 Project Headquarters, 500 College Road East, Suite 201W,
Princeton, NJ 08540. The petitions requested that 40 CFR 180.433 be
amended by establishing tolerances for residues of the herbicide
fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-
2-nitrobenzamide, in or on cantaloupe; cucumber; pea, succulent;
pumpkin; squash, summer; squash, winter; and watermelon all at 0.025
parts per million (ppm); and soybean, vegetable, succulent at 0.05 ppm
(2E8061); and bean, lima, succulent at 0.05 ppm (3E8167). The documents
referenced a summary of each petition prepared by Syngenta Crop
Protections, LLC, the registrant, which are available in the docket,
https://www.regulations.gov. One public comment was received on the
notice of filing for PP 3E8167. EPA's response to the comment is
discussed in Unit IV.C.
Based upon review of data supporting the petition, EPA corrected
the commodity name for certain crops for which a tolerance was proposed
as explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.* *
*''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fomesafen including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fomesafen follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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.
In the subchronic and chronic fomesafen toxicity studies in rats
and mice, food consumption, food efficiency, body weight, body weight
gain, and histopathological changes in the liver were parameters that
were most often affected. In addition, dogs and mice also showed
hematological changes (e.g., decreased erythrocyte count, hemoglobin,
or hematocrit).
In the developmental studies, post-implantation loss was noted but
no quantitative or qualitative evidence of increased susceptibility to
fomesafen
[[Page 65567]]
was seen following in utero exposure to rat or rabbit fetuses in
prenatal developmental studies or postnatally in rat 2-generation
reproduction study.
Acute neurotoxicity studies indicate fomesafen may cause
neurotoxicity (decreased motor activity) at the same dose level as
systemic toxicity. Although suppression of anti-sheep red blood cell
immunoglobulin (SRBC IgM) response was noted in the immunotoxicity
study, the selected endpoints for risk assessment are protective of
this effect.
Carcinogenicity was not observed in the rat chronic toxicity/
carcinogenicity study. Although liver tumors were seen in the mouse
carcinogenicity study, EPA classified fomesafen as ``Not Likely to be
Carcinogenic to Humans'' because the mode of action for fomesafen-
induced hepatocarcinogenesis in mice is unlikely to take place in
humans. Fomesafen was not considered to be mutagenic.
Specific information on the studies received and the nature of the
adverse effects caused by fomesafen, 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 https://www.regulations.gov in document: ``Fomesafen Sodium: Human Health Risk
Assessment for the Section 3 Registration Action on Cantaloupe,
Cucumber, Pea (Succulent), Pumpkin, Summer Squash, Winter Squash,
Watermelon, Soybean (Succulent) and Lima Bean (Succulent),'' dated July
18, 2013 at page 27 in docket ID number EPA-HQ-OPP-2012-0589.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fomesafen used for
human risk assessment is shown in Table 1. of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Fomesafen for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 100 mg/kg/ Acute RfD = 1 mg/kg/ Acute neurotoxicity test in the
including infants and children). day day rat.
UFA = 10x........... aPAD = 1 mg/kg/day. LOAEL = 250 mg/kg/day based on
UFH = 10x........... decreased body weight and motor
FQPA SF = 1x........ activity (horizontal and vertical
activity and time in central
quadrant) in males.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 0.25 mg/kg/ Chronic RfD = Chronic toxicity/carcinogenicity
day UFA = 10x 0.0025 mg/kg/day in the rat.
UFH = 10x........... cPAD = 0.0025 mg/kg/ LOAEL = 5 mg/kg/day based on
FQPA SF = 1x........ day. hyalinization of the liver in
males.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. 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).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fomesafen, EPA considered exposure under the petitioned-for
tolerances as well as all existing fomesafen tolerances in 40 CFR
180.433. EPA assessed dietary exposures from fomesafen 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 fomesafen. In estimating acute
dietary exposure, EPA used Dietary Exposure Evaluation Model--Food
Consumption Intake Database (DEEM-FCID), ver. 3.16 which incorporates
consumption data from the United States Department of Agriculture
(USDA) 2003--2008 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEA). Acute analysis assumed 100
percent crop treated (PCT), DEEM 7.81 default concentration factors,
tolerance-level residues for all existing and proposed crop uses.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID, ver. 3.16 which incorporates consumption
data from USDA 2003--2008 NHANES/WWEA. As to residue levels in food,
EPA analysis assumed 100 PCT and tolerance-level residues for all
existing and proposed crop uses.
iii. Cancer. Based on the data summarized in Unit III.A., a dietary
exposure assessment for the purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
fomesafen. Tolerance level residues and 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fomesafen in drinking water. These simulation models
take into account
[[Page 65568]]
data on the physical, chemical, and fate/transport characteristics of
fomesafen. Further information regarding EPA drinking water models used
in pesticide exposure assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
Screening model Tier II Pesticide Root Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) was used to calculate surface water
estimated drinking water concentrations (EDWCs). Groundwater EDWCs for
fomesafen were calculated using Tier 1 Pesticide Root Zone Model Ground
Water (PRZM GW). Acute exposures are estimated to be 34.8 parts per
billion (ppb) for surface water and 51.8 ppb for ground water.
Chronic exposures for non-cancer assessments are estimated to be
13.1 ppb for surface water and 32.3 ppb for ground water.
Modeled estimates of drinking water concentrations are based on
ground water EDWCs, which were highest among surface water and ground
water EDWCs (representing worst case), were directly entered into the
dietary exposure model.
For acute dietary risk assessment, the water concentration value of
51.8 ppb was used to assess the contribution to drinking water.
For chronic dietary risk assessment, the water concentration of
value 32.3 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Fomesafen 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 fomesafen to share a common mechanism of toxicity
with any other substances, and fomesafen does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fomesafen 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 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. The pre- and postnatal
database for fomesafen includes a prenatal developmental toxicity study
in rabbits, two prenatal developmental toxicity studies in rats, and a
2-generation reproduction toxicity study in rats. The rabbit
developmental study was classified as unacceptable because of bacterial
infection in the colony; however, the study provided information to
assess potential developmental toxicity in rabbits. There was no
significant difference between the treated and control animals for
developmental abnormalities in the rabbit study. In the two rat
developmental studies (considered together), developmental effects
(postimplantation loss) occurred at the same dose causing maternal
toxicity (staining of the ventral fur and significantly decreased body
weight gain (>10%)). In the rat reproduction study, offspring effects
(increased incidence of liver hyalinization in males) occurred at the
same dose causing parental effects (liver histopathology in males and
females of both generations).
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 fomesafen is complete. The
developmental toxicity study in rabbits, classified unacceptable due to
mortality from bacterial infections, showed no evidence of increased
susceptibility of rabbit fetuses due to the treatment with fomesafen.
Therefore, the lack of an acceptable developmental toxicity study in
non-rodents was not considered a data gap.
ii. There is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity. In an acute neurotoxicity
screening battery in rats, decreased motor activity (horizontal and
vertical activity and time in central quadrant) was observed at the
same dose that resulted in general systemic toxicity. In the subchronic
neurotoxicity test, neither general systemic toxicity nor neurotoxicity
was observed at the highest dose tested. All points of departure used
in the risk assessment are protective of any potential neurotoxicity.
iii. There is no evidence that fomesafen 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. The 2-generation reproduction study in rats did not show
evidence of increased susceptibility to fomesafen.
iv. There are no residual uncertainties identified in the exposure
databases. Tolerance level residues and 100 PCT were assumed for all
food commodities. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to fomesafen
in drinking water. These assessments will not underestimate the
exposure and risks posed by fomesafen.
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 fomesafen will occupy < 1% of the aPAD for all population subgroups,
including all infants (< 1 year 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
fomesafen from
[[Page 65569]]
food and water will utilize 77% of the cPAD for all infants (< 1 year
old) the population group receiving the greatest exposure. There are no
residential uses for fomesafen.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- or intermediate-term
residential exposure plus chronic exposure from food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, fomesafen
is not registered for any use patterns that would result in short- and
intermediate-term residential exposure. Because there is no short- or
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 short-term risk), no
further assessment of short- or intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
short- and intermediate-term risk for fomesafen.
4. Aggregate cancer risk for U.S. population. Based on the data
summarized in Unit III.A., fomesafen is not expected to pose a cancer
risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fomesafen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography method with tandem mass spectrometry detection (LC/MS/
MS) method (GRM045.01A) is available to enforce the tolerance
expression. The validated limit of quantitation (LOQ) of the method is
0.02 ppm.
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.
Codex has not established maximum residue limits (MRLs) for
residues of fomesafen.
C. Response to Comments
The Agency received an anonymous public comment objecting to the
proposed fomesafen tolerance on lima bean because of the amounts of
pesticides already consumed and carried by the American population.
The Agency understands the commenter's concerns and recognizes that
some individuals believe that pesticides should be banned completely.
However, under the existing legal framework provided by section 408 of
the FFDCA, EPA is authorized to establish pesticide tolerances or
exemptions where persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute.
D. Revisions to Petitioned-For Tolerances
Petitioned-for tolerance levels in or on commodities were
unchanged, however, the commodity name of certain proposed crops was
changed to comply with current EPA commodity definitions, as follows:
Winter, squash changed to squash, winter; vegetable, soybean, succulent
to soybean, vegetable, succulent; and lima, bean to bean, lima,
succulent.
V. Conclusion
Therefore, tolerances are established for residues of the herbicide
fomesafen, including its metabolites and degradates, in or on
cantaloupe; cucumber; pea, succulent; pumpkin; squash, summer; squash,
winter; and watermelon all at 0.025 ppm; soybean, vegetable, succulent
at 0.05 ppm; and bean, lima, succulent at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require
[[Page 65570]]
Agency consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 17, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.433, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:
Sec. 180.433 Fomesafen; tolerance for residues.
(a) General. * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Bean, lima, succulent...................................... 0.05
* * * * *
Cantaloupe................................................. 0.025
* * * * *
Cucumber................................................... 0.025
Pea, succulent............................................. 0.025
* * * * *
Pumpkin.................................................... 0.025
* * * * *
Soybean, vegetable, succulent.............................. 0.05
Squash, summer............................................. 0.025
Squash, winter............................................. 0.025
* * * * *
Watermelon................................................. 0.025
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-25984 Filed 10-31-13; 8:45 am]
BILLING CODE 6560-50-P
