Propamocarb; Pesticide Tolerances, 33731-33736 [2013-13190]
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country, and EPA notes that it will not
impose substantial direct costs on tribal
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file an immediate petition for judicial
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EPA can withdraw this direct final rule
and address the comment in the
proposed rulemaking. This action may
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enforce its requirements. See section
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Dated: May 22, 2013.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
40 CFR part 52 is amended as follows:
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[FR Doc. 2013–13186 Filed 6–4–13; 8:45 am]
Unit I.C. of the SUPPLEMENTARY
BILLING CODE 6560–50–P
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2008–0887, 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
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:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0887; FRL–9388–1]
Propamocarb; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of propamocarb in
or on succulent lima bean. Interregional
Research Project Number 4 (IR–4)
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective June
5, 2013. Objections and requests for
hearings must be received on or before
August 5, 2013, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
DATES:
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Explanation
*
(703) 305–7390; email address:
nollen.laura@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).
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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. To access the OCSPP test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0887 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 August 5, 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–
2008–0887, 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
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available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of April 13,
2009 (74 FR 16866) (FRL–8396–6), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 8E7473) by IR–4, Rutgers
University, 500 College Rd. East, Suite
201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.499 be
amended by establishing a tolerance for
residues of the fungicide propamocarb
hydrochloride (propamocarb HCl),
propyl[3(dimethylamino)propyl]carbamate
monohydrochloride, in or on succulent
lima bean at 2.0 parts per million (ppm).
That document referenced a summary of
the petition prepared on behalf of IR–4
by Bayer CropScience, the registrant,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petition, EPA has revised
the tolerance expression for all
established commodities to be
consistent with current Agency policy.
The reason for this change is explained
in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
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sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for propamocarb
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with propamocarb 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.
In all species tested for toxicity to
propamocarb, decreased body weights,
body-weight gains, and food
consumption were observed following
subchronic and chronic durations of
exposure. Effects indicative of toxicity
were noted in the digestive and
gastrointestinal (GI) tracts in dogs,
including chronic erosive gastritis and
vacuolization of the salivary glands,
stomach, and duodenum. Ocular effects
were noted in rats (opacity of the eye
and yellow colored eyes in females) and
in dogs (vacuolization of the lacrimal
gland, retinal degeneration, and
hyporeflectivity of the inner eye tissue
below the lens). Respiratory tract effects
were also noted in dogs, including
vacuolization of the cells of the trachea
and lung. In rats, there were signs of
neurotoxicity including decreased
motor activities in females following
acute exposure and vacuolization of the
ventricles of the brain that produce
cerebral spinal fluid noted for
subchronic and chronic durations.
There were no signs of immunotoxicity
in the guideline immunotoxicity study
for propamocarb.
Fetal effects due to propamocarb
treatment were noted at doses which
also caused maternal toxicity. Effects in
the rat included increased fetal death
and post-implantation loss, increases in
minor skeletal anomalies, and increased
incidences of small fetuses. There were
also inter-atrial septal defects, and
hemorrhage in the ears, upper GI tract,
and nasopharynx/sinuses. Maternal
effects consisted of decreased absolute
body weights, body-weight gains and
food consumption, and mortality. In
rabbits, the only developmental effect
was an increase in post-implantation
loss. Maternal effects consisted of
increased abortions, and body-weight
decrements.
Additionally, in the rat 2-generation
reproduction studies, parental and
offspring effects occurred at the same
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dose. Parental effects were similar to the
effects observed in the rat subchronic
and chronic studies in addition to
clinical signs including salivation,
reddish material around the mouth, and
urine staining. Offspring effects
consisted of pup deaths, decreased
viability and lactation indices and litter
size, and decreased pup body weights
and body weight gains. Reproductive
effects consisted of increased
vacuolization and decreased weight of
the epididymides, decreased sperm
counts and motility, and abnormal
sperm morphology.
Propamocarb has been classified as
‘‘not likely to be carcinogenic to
humans’’ by all routes of exposure,
based upon lack of evidence of
carcinogenicity in rats and mice.
Specific information on the studies
received and the nature of the adverse
effects caused by propamocarb as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
entitled ‘‘Propamocarb Hydrochloride
(Propamocarb-HCl). Section 3 Request
for use on Lima Beans (Succulent).
Human-Health Risk Assessment’’ at pp.
32–37 in docket ID number EPA–HQ–
OPP–2008–0887.
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
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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 propamocarb used for
human-health risk assessment is shown
in Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPAMOCARB FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (Females
years of age).
RfD, PAD, LOC for risk assessment
POD and UFs/SFs
Study and toxicological effects
13–49
NOAEL = 150 mg/kg/day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Acute RfD = 1.5 mg/kg/day. .........
aPAD = 1.5 mg/kg/day.
Developmental Toxicity Study—
Rabbit.
LOAEL = 300 mg/kg/day based
on decreased body weight gain
and decreased motor activity.
Acute dietary (General population
including infants and children).
NOAEL = 200 mg/kg/day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Acute RfD = 2 mg/kg/day. ............
aPAD = 2 mg/kg/day.
Acute Neurotoxicity Screening
Battery—Rat.
LOAEL = 2,000 mg/kg/day based
on decreased body weight gain
and decreased motor activity.
Chronic dietary (All populations) ....
NOAEL = 12 mg/kg/day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Chronic RfD = 0.12 mg/kg/day. ....
cPAD = 0.12 mg/kg/day.
Carcinogenicity Study—Mouse.
LOAEL = 95 mg/kg/day based on
decreased body weight and
body weight gain in females.
Dermal short-term (1 to 30 days) ..
Dermal (or oral) study
NOAEL = 150 mg/kg/day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
LOC for MOE = 100 .....................
2-Generation Reproduction Toxicity Study—Rat.
LOAEL = 406.69 mg/kg/day for
males and 467.13 mg/kg/day
for females based on decreased body weights.
Cancer (Oral, dermal, inhalation) ..
Classification: ‘‘Not likely to be carcinogenic to humans.’’
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). POD = points of departure. 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 propamocarb, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing propamocarb tolerances in 40
CFR 180.499. EPA assessed dietary
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exposures from propamocarb 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
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exposure. Such effects were identified
for propamocarb. In estimating acute
dietary exposure, EPA used Dietary
Exposure Evaluation Model software
with the Food Commodity Intake
Database (DEEM–FCID) Version 3.16,
which uses food consumption data from
the U.S. Department of Agriculture’s
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National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA),
conducted from 2003–2008. As to
residue levels in food, EPA assumed 100
percent crop treated (PCT) and
tolerance-level residues for all
commodities. In addition, DEEM
version 7.81 default processing factors
were used, when appropriate.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used DEEM–FCID Version 3.16. As
to residue levels in food, EPA assumed
100 PCT and tolerance-level residues for
all commodities. In addition, DEEM
version 7.81 default processing factors
were used, when appropriate.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that propamocarb does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for propamocarb. Tolerance level
residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for propamocarb in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
propamocarb. 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.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
Concentration in Ground Water (SCI–
GROW) models, the estimated drinking
water concentrations (EDWCs) of
propamocarb for surface water are
estimated to be 8,762 parts per billion
(ppb) for acute exposures and 1,067 ppb
for chronic exposures for non-cancer
assessments. For ground water, the
EDWC is estimated to be 15.6 ppb for
acute and chronic exposures for noncancer assessments.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 8,762 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 1,067 ppb was used to assess the
contribution to drinking water.
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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).
Propamocarb is currently registered for
use on golf course turf, which may
result in residential exposure. EPA
assessed residential exposure using the
following assumptions: Chemicalspecific turf transferable residue (TTR)
data for propamocarb were used to
assess potential short-term dermal postapplication exposures to adult and
youth golfers. Post-application oral and
inhalation exposures, as well as
residential handler exposures, are not
expected based on the current use
patterns for propamocarb. Intermediateterm residential exposures are not
expected based on the current use
patterns; however, the short-term
aggregate assessment would be
protective of any potential intermediateterm exposures, as the short- and
intermediate-term PODs are the same.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’ Although a
carbamate, propamocarb is not an Nmethyl carbamate and does not cause
cholinesterase inhibition. Therefore, it
was not included in the N-methyl
carbamate cumulative risk assessment.
EPA has not found propamocarb to
share a common mechanism of toxicity
with any other substances, and
propamocarb does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that propamocarb 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.
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D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional SF when reliable data
available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity.
There was no increased quantitative
prenatal sensitivity due to propamocarb
treatment. Effects in developing rats
occurred at the same dose as maternal
effects and included increased fetal
death and post-implantation loss,
increases in minor skeletal anomalies,
and an increased incidence of small
fetus. Effects in maternal rats at that
dose consisted of decreased absolute
body weights, body weight gains, food
consumption, and mortality. In rabbits,
the only developmental effect was an
increase in post-implantation loss in the
presence of maternal effects (increased
abortions, and body weight decrements).
In the rat 2-generation reproduction
studies, parental effects were similar to
the effects observed in the rat
subchronic and chronic studies, in
addition to clinical signs including
salivation, reddish material around the
mouth, and urine staining. Offspring
effects consisted of pup deaths,
decreased viability and lactation indices
and litter size, and decreased pup body
weights and body weight gains.
Reproductive effects at the same dose as
parental effects consisted of increased
vacuolization and decreased weight of
the epididymides, decreased sperm
counts and motility, and abnormal
sperm morphology.
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
propamocarb is complete.
ii. There are two guideline acute
neurotoxicity studies and two
subchronic neurotoxicity studies for
propamocarb HCl. The effects of these
studies are well characterized, and
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include decreased motor activities in
females following acute exposure.
However, the endpoints selected are
protective of these effects, as the rat
acute oral neurotoxicity study was used
to select the endpoint for the aRfD of 2.0
mg/kg/day for the general U.S.
population, including infants and
children. The lack of quantitative
increased fetal sensitivity should
remove concern for a developmental
neurotoxicity study (DNT).
iii. There is no evidence that
propamocarb results in increased
quantitative susceptibility in in utero
rats or rabbits in the prenatal
developmental studies or in young rats
in the 2-generation reproduction study.
Although there are qualitative effects
observed in both developmental studies,
as well as in one of the 2-generation
reproduction studies, EPA has
determined that no additional UF is
necessary to account for these effects
because:
a. The effects are well characterized.
b. Clear NOAELs were established.
c. The developmental rabbit and rat 2generation reproduction studies are
being used in endpoint selection.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to propamocarb
in drinking water. EPA used similarly
conservative assumptions to assess
postapplication exposure of children.
Incidental oral exposure is not expected
for children. These assessments will not
underestimate the exposure and risks
posed by propamocarb.
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 exposures, the acute dietary
exposure from food and water to
propamocarb will occupy 34% of the
aPAD selected for females 13–49 years
old; and 75% of the aPAD for infants
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Jkt 229001
less than 1 year old, the population
group receiving the greatest exposure for
the general U.S. population, including
infants and children.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to propamocarb
from food and water will utilize 50% of
the cPAD for infants less than 1 year
old, the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
propamocarb is not expected.
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). Propamocarb is
currently registered for uses that could
result in short-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to propamocarb.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures result in aggregate
MOEs of 310 for adult male golfers, 280
for golfers aged 11 to less than 16 years
old, and 240 for golfers aged 6 to less
than 11 years old. Because EPA’s level
of concern for propamocarb is a MOE of
100 or below, these MOEs are not of
concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). An
intermediate-term adverse effect was
identified; however, propamocarb 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
propamocarb.
5. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
PO 00000
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Fmt 4700
Sfmt 4700
33735
adequate rodent carcinogenicity studies,
propamocarb 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 propamocarb
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography with
nitrogen-phosphorus detection (GC/
NPD) method (Analytical Method No.
XAM–34) is available to enforce
tolerance expression on plant
commodities. The method may be found
in the Pesticide Analytical Method
(PAM) Vol. II.
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 propamocarb.
C. Revisions to Petitioned-For
Tolerances
The Agency has revised the tolerance
expression to clarify that:
1. As provided in FFDCA section
408(a)(3), the tolerance covers
metabolites and degradates of
propamocarb not specifically
mentioned.
2. Compliance with the specified
tolerance levels is to be determined by
measuring only the specific compounds
mentioned in the tolerance expression.
V. Conclusion
Therefore, tolerances are established
for residues of propamocarb (propyl N[3-(dimethylamino)propyl]carbamate) in
or on bean, lima, succulent at 2.0 ppm.
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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Rules and Regulations
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 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 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
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16:07 Jun 04, 2013
Jkt 229001
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 28, 2013.
Daniel J. Rosenblatt,
Acting 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 § 180.499, revise the section
heading, paragraph (a) introductory text,
and paragraph (c) to read as follows:
■
§ 180.499 Propamocarb; tolerances for
residues.
(a) General. Tolerances are
established for the residues of
propamocarb, including its metabolites
and degradates, in or on the
commodities specified in the following
table resulting from the application of
the hydrochloride salt of propamocarb.
Compliance with the following
tolerance levels is to be determined by
measuring only propamocarb (propyl N[3-(dimethylamino)propyl]carbamate):
*
*
*
*
*
(c) Tolerance with regional
registrations. Tolerances with regional
registrations are established for the
residues of propamocarb, including its
metabolites and degradates, in or on the
commodities specified in the following
table resulting from the application of
the hydrochloride salt of propamocarb.
Compliance with the following
PO 00000
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Fmt 4700
Sfmt 4700
tolerance levels is to be determined by
measuring only propamocarb (propyl N[3-(dimethylamino)propyl]carbamate):
Commodity
Parts per
million
Bean, lima, succulent ...........
2.0
*
*
*
*
*
[FR Doc. 2013–13190 Filed 6–4–13; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2012–0204; FRL–9387–9]
Imidacloprid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for residues of imidacloprid in
or on fish and fish-shellfish, mollusc
requested by the Interregional Research
Project Number 4 (IR–4) under the
Federal Food, Drug, and Cosmetic Act
(FFDCA). In addition, this regulation
establishes time-limited tolerances for
residues of imidacloprid in or on
sugarcane, cane and sugarcane,
molasses. This action is associated with
the use of the pesticide on sugarcane
under a crisis exemption granted by
EPA under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA). The time-limited
tolerances expire on December 31, 2015.
DATES: This regulation is effective June
5, 2013. Objections and requests for
hearings must be received on or before
August 5, 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).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2012–0204, 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
Docket is (703) 305–5805. Please review
the visitor instructions and additional
ADDRESSES:
E:\FR\FM\05JNR1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33731-33736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13190]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0887; FRL-9388-1]
Propamocarb; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
propamocarb in or on succulent lima bean. Interregional Research
Project Number 4 (IR-4) requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective June 5, 2013. Objections and
requests for hearings must be received on or before August 5, 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-2008-0887, 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 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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; email address: nollen.laura@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).
[[Page 33732]]
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0887 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
August 5, 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-2008-0887, 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 April 13, 2009 (74 FR 16866) (FRL-8396-
6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E7473) by IR-4, Rutgers University, 500 College Rd. East, Suite 201W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.499 be
amended by establishing a tolerance for residues of the fungicide
propamocarb hydrochloride (propamocarb HCl), propyl[3-
(dimethylamino)propyl]carbamate monohydrochloride, in or on succulent
lima bean at 2.0 parts per million (ppm). That document referenced a
summary of the petition prepared on behalf of IR-4 by Bayer
CropScience, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the tolerance expression for all established commodities to be
consistent with current Agency policy. The reason for this change is
explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for propamocarb including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with propamocarb 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.
In all species tested for toxicity to propamocarb, decreased body
weights, body-weight gains, and food consumption were observed
following subchronic and chronic durations of exposure. Effects
indicative of toxicity were noted in the digestive and gastrointestinal
(GI) tracts in dogs, including chronic erosive gastritis and
vacuolization of the salivary glands, stomach, and duodenum. Ocular
effects were noted in rats (opacity of the eye and yellow colored eyes
in females) and in dogs (vacuolization of the lacrimal gland, retinal
degeneration, and hyporeflectivity of the inner eye tissue below the
lens). Respiratory tract effects were also noted in dogs, including
vacuolization of the cells of the trachea and lung. In rats, there were
signs of neurotoxicity including decreased motor activities in females
following acute exposure and vacuolization of the ventricles of the
brain that produce cerebral spinal fluid noted for subchronic and
chronic durations. There were no signs of immunotoxicity in the
guideline immunotoxicity study for propamocarb.
Fetal effects due to propamocarb treatment were noted at doses
which also caused maternal toxicity. Effects in the rat included
increased fetal death and post-implantation loss, increases in minor
skeletal anomalies, and increased incidences of small fetuses. There
were also inter-atrial septal defects, and hemorrhage in the ears,
upper GI tract, and nasopharynx/sinuses. Maternal effects consisted of
decreased absolute body weights, body-weight gains and food
consumption, and mortality. In rabbits, the only developmental effect
was an increase in post-implantation loss. Maternal effects consisted
of increased abortions, and body-weight decrements.
Additionally, in the rat 2-generation reproduction studies,
parental and offspring effects occurred at the same
[[Page 33733]]
dose. Parental effects were similar to the effects observed in the rat
subchronic and chronic studies in addition to clinical signs including
salivation, reddish material around the mouth, and urine staining.
Offspring effects consisted of pup deaths, decreased viability and
lactation indices and litter size, and decreased pup body weights and
body weight gains. Reproductive effects consisted of increased
vacuolization and decreased weight of the epididymides, decreased sperm
counts and motility, and abnormal sperm morphology.
Propamocarb has been classified as ``not likely to be carcinogenic
to humans'' by all routes of exposure, based upon lack of evidence of
carcinogenicity in rats and mice.
Specific information on the studies received and the nature of the
adverse effects caused by propamocarb 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 the document entitled ``Propamocarb
Hydrochloride (Propamocarb-HCl). Section 3 Request for use on Lima
Beans (Succulent). Human-Health Risk Assessment'' at pp. 32-37 in
docket ID number EPA-HQ-OPP-2008-0887.
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 propamocarb used for
human-health risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Propamocarb for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
RfD, PAD, LOC for risk Study and toxicological
Exposure/scenario POD and UFs/SFs assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years of NOAEL = 150 mg/kg/day. Acute RfD = 1.5 mg/kg/ Developmental Toxicity
age). UFA = 10X.............. day.. Study--Rabbit.
UFH = 10X.............. aPAD = 1.5 mg/kg/day... LOAEL = 300 mg/kg/day
FQPA SF = 1X........... based on decreased
body weight gain and
decreased motor
activity.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 200 mg/kg/day. Acute RfD = 2 mg/kg/ Acute Neurotoxicity
including infants and children). UFA = 10X.............. day.. Screening Battery--
UFH = 10X.............. aPAD = 2 mg/kg/day..... Rat.
FQPA SF = 1X........... LOAEL = 2,000 mg/kg/day
based on decreased
body weight gain and
decreased motor
activity.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations).... NOAEL = 12 mg/kg/day. Chronic RfD = 0.12 mg/ Carcinogenicity Study--
UFA = 10X.............. kg/day.. Mouse.
UFH = 10X.............. cPAD = 0.12 mg/kg/day.. LOAEL = 95 mg/kg/day
FQPA SF = 1X........... based on decreased
body weight and body
weight gain in
females.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)..... Dermal (or oral) study LOC for MOE = 100...... 2-Generation
NOAEL = 150 mg/kg/day.. Reproduction Toxicity
UFA = 10X.............. Study--Rat.
UFH = 10X.............. LOAEL = 406.69 mg/kg/
FQPA SF = 1X........... day for males and
467.13 mg/kg/day for
females based on
decreased body
weights.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).... Classification: ``Not likely to be carcinogenic to humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). POD = points of departure. 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 propamocarb, EPA considered exposure under the petitioned-
for tolerances as well as all existing propamocarb tolerances in 40 CFR
180.499. EPA assessed dietary exposures from propamocarb 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 propamocarb. In estimating acute dietary exposure, EPA used Dietary
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID) Version 3.16, which uses food consumption data
from the U.S. Department of Agriculture's
[[Page 33734]]
National Health and Nutrition Examination Survey, What We Eat in
America, (NHANES/WWEIA), conducted from 2003-2008. As to residue levels
in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level
residues for all commodities. In addition, DEEM version 7.81 default
processing factors were used, when appropriate.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used DEEM-FCID Version 3.16. As to residue levels in
food, EPA assumed 100 PCT and tolerance-level residues for all
commodities. In addition, DEEM version 7.81 default processing factors
were used, when appropriate.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that propamocarb does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for propamocarb. Tolerance level residues and/or 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for propamocarb in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of propamocarb. 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.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
propamocarb for surface water are estimated to be 8,762 parts per
billion (ppb) for acute exposures and 1,067 ppb for chronic exposures
for non-cancer assessments. For ground water, the EDWC is estimated to
be 15.6 ppb for acute and chronic exposures for non-cancer assessments.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 8,762 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 1,067 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). Propamocarb is
currently registered for use on golf course turf, which may result in
residential exposure. EPA assessed residential exposure using the
following assumptions: Chemical-specific turf transferable residue
(TTR) data for propamocarb were used to assess potential short-term
dermal post-application exposures to adult and youth golfers. Post-
application oral and inhalation exposures, as well as residential
handler exposures, are not expected based on the current use patterns
for propamocarb. Intermediate-term residential exposures are not
expected based on the current use patterns; however, the short-term
aggregate assessment would be protective of any potential intermediate-
term exposures, as the short- and intermediate-term PODs are the same.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Although a carbamate,
propamocarb is not an N-methyl carbamate and does not cause
cholinesterase inhibition. Therefore, it was not included in the N-
methyl carbamate cumulative risk assessment. EPA has not found
propamocarb to share a common mechanism of toxicity with any other
substances, and propamocarb does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that propamocarb 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
SF when reliable data available to EPA support the choice of a
different factor.
2. Prenatal and postnatal sensitivity. There was no increased
quantitative prenatal sensitivity due to propamocarb treatment. Effects
in developing rats occurred at the same dose as maternal effects and
included increased fetal death and post-implantation loss, increases in
minor skeletal anomalies, and an increased incidence of small fetus.
Effects in maternal rats at that dose consisted of decreased absolute
body weights, body weight gains, food consumption, and mortality. In
rabbits, the only developmental effect was an increase in post-
implantation loss in the presence of maternal effects (increased
abortions, and body weight decrements). In the rat 2-generation
reproduction studies, parental effects were similar to the effects
observed in the rat subchronic and chronic studies, in addition to
clinical signs including salivation, reddish material around the mouth,
and urine staining. Offspring effects consisted of pup deaths,
decreased viability and lactation indices and litter size, and
decreased pup body weights and body weight gains. Reproductive effects
at the same dose as parental effects consisted of increased
vacuolization and decreased weight of the epididymides, decreased sperm
counts and motility, and abnormal sperm morphology.
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 propamocarb is complete.
ii. There are two guideline acute neurotoxicity studies and two
subchronic neurotoxicity studies for propamocarb HCl. The effects of
these studies are well characterized, and
[[Page 33735]]
include decreased motor activities in females following acute exposure.
However, the endpoints selected are protective of these effects, as the
rat acute oral neurotoxicity study was used to select the endpoint for
the aRfD of 2.0 mg/kg/day for the general U.S. population, including
infants and children. The lack of quantitative increased fetal
sensitivity should remove concern for a developmental neurotoxicity
study (DNT).
iii. There is no evidence that propamocarb results in increased
quantitative susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. Although there are qualitative effects observed in both
developmental studies, as well as in one of the 2-generation
reproduction studies, EPA has determined that no additional UF is
necessary to account for these effects because:
a. The effects are well characterized.
b. Clear NOAELs were established.
c. The developmental rabbit and rat 2-generation reproduction
studies are being used in endpoint selection.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to propamocarb in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of
children. Incidental oral exposure is not expected for children. These
assessments will not underestimate the exposure and risks posed by
propamocarb.
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 exposures, the acute dietary exposure from food and
water to propamocarb will occupy 34% of the aPAD selected for females
13-49 years old; and 75% of the aPAD for infants less than 1 year old,
the population group receiving the greatest exposure for the general
U.S. population, including infants and children.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
propamocarb from food and water will utilize 50% of the cPAD for
infants less than 1 year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
propamocarb is not expected.
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). Propamocarb
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to propamocarb.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 310 for adult
male golfers, 280 for golfers aged 11 to less than 16 years old, and
240 for golfers aged 6 to less than 11 years old. Because EPA's level
of concern for propamocarb is a MOE of 100 or below, these MOEs are not
of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
propamocarb 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
propamocarb.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, propamocarb 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 propamocarb residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromatography with nitrogen-phosphorus detection
(GC/NPD) method (Analytical Method No. XAM-34) is available to enforce
tolerance expression on plant commodities. The method may be found in
the Pesticide Analytical Method (PAM) Vol. II.
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 propamocarb.
C. Revisions to Petitioned-For Tolerances
The Agency has revised the tolerance expression to clarify that:
1. As provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of propamocarb not specifically mentioned.
2. Compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of propamocarb
(propyl N-[3-(dimethylamino)propyl]carbamate) in or on bean, lima,
succulent at 2.0 ppm.
[[Page 33736]]
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 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 final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 28, 2013.
Daniel J. Rosenblatt,
Acting 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. 180.499, revise the section heading, paragraph (a)
introductory text, and paragraph (c) to read as follows:
Sec. 180.499 Propamocarb; tolerances for residues.
(a) General. Tolerances are established for the residues of
propamocarb, including its metabolites and degradates, in or on the
commodities specified in the following table resulting from the
application of the hydrochloride salt of propamocarb. Compliance with
the following tolerance levels is to be determined by measuring only
propamocarb (propyl N-[3-(dimethylamino)propyl]carbamate):
* * * * *
(c) Tolerance with regional registrations. Tolerances with regional
registrations are established for the residues of propamocarb,
including its metabolites and degradates, in or on the commodities
specified in the following table resulting from the application of the
hydrochloride salt of propamocarb. Compliance with the following
tolerance levels is to be determined by measuring only propamocarb
(propyl N-[3-(dimethylamino)propyl]carbamate):
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Bean, lima, succulent.................................. 2.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-13190 Filed 6-4-13; 8:45 am]
BILLING CODE 6560-50-P
