[Federal Register: August 25, 2004 (Volume 69, Number 164)]
[Rules and Regulations]
[Page 52182-52192]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au04-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0168; FRL-7369-1]
Folpet; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the tolerance for residues of folpet in
or on hops to delete the footnote stating that there are no
registrations for the use of folpet on hops in the United States. The
Interregional Research Project Number 4 (IR-4), requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 25 2004. Objections and
requests for hearings, identified by docket identification (ID) number
OPP-2004-0168, must be received on or before October 25, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
ID number OPP-2004-0168. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket/. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Crystal Mall
2, Rm. 1801, South Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
FOR FURTHER INFORMATION CONTACT: Cynthia Giles-Parker, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-7740; e-mail address:
giles-parker.cynthia@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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of May 7, 2003 (68 FR 24467) (FRL-7305-1),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E6310)
by IR-4, Center for Minor Crop Pest Management, Rutgers, The State
University of New Jersey, 681 U.S. Highway 1 South, North
Brunswick, NJ 08902-3390. That notice included a summary of the
petition prepared by IR-4, the registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR 180.191 be amended by
establishing a tolerance for residues of the fungicide folpet, N-
(trichloromethylthio)phthalimide, in or on U.S. grown hop, dried cones
at 120 parts per million (ppm). EPA has
[[Page 52183]]
previously established a tolerance for folpet on hops in the Federal
Register of March 5, 2003 (68 FR 10377) (FRL-7296-2). That tolerance
applies to all hops in interstate commerce in the U. S. no matter what
country the hops originate from. Nonetheless, because at the time that
tolerance was established there was no registration under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq., for use of folpet on hops, that fact was noted, as is EPA's
general practice, in the tolerance regulation. A FIFRA registration has
since been applied for and EPA plans to approve that registration
simultaneous with promulgation of this final rule. This final rule
amends the folpet tolerance to delete the statement regarding the lack
of a FIFRA registration. Further, this action re-examines the safety
determination for folpet because the prior action assumed that folpet
would not be used on hops in the United States.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish or amend 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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of folpet on hop,
dried cones at 120 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance 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. The nature of the toxic effects caused by folpet as well as
the no observed adverse effect level (NOAEL) and the lowest observed
adverse effect level (LOAEL) from the toxicity studies reviewed are
discussed in the March 5, 2003 Federal Register document (OPP-2003-
0075). There have been no changes in the toxicological profile since
the March 5, 2003 Federal Register document (OPP-2003-0075) and,
therefore, the Agency will not repeat the entire table in this final
rule but refers to the original document.
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the LOAEL is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety factors (SF) or UFs may be used:
``Traditional UFs;'' the ``special FQPA safety factor;'' and the
``default FQPA safety factor.'' By the term ``traditional uncertainty
factor,'' EPA is referring to those additional UFs used prior to FQPA
passage to account for database deficiencies. These traditional UFs
have been incorporated by the FQPA into the additional safety factor
for the protection of infants and children. The term ``special FQPA
safety factor'' refers to those safety factors that are deemed
necessary for the protection of infants and children primarily as a
result of the FQPA. The ``default FQPA safety factor'' is the
additional 10X SF that is mandated by the statute unless it is decided
that there are reliable data to choose a different additional factor
(potentially a traditional UF or a special FQPA SF).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional UF factors deemed appropriate (RfD = NOAEL/UF). Where a
special FQPA SF or the default FQPA SF is used, this additional factor
is applied to the RfD by dividing the RfD by such additional factor.
The acute or chronic population adjusted dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for folpet used for human
risk assessment is shown in Table 1 of this unit:
[[Page 52184]]
Table 1.--Summary of Toxicological Dose and Endpoints for Folpet for Use in Human Risk Assessment
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Dose Used in Risk
Assessment,
Exposure Scenario Interspecies and Special FQPA SF and LOC Study and Toxicological
Intraspecies and any for Risk Assessment Effects
Traditional UF
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Acute dietary (females 13-50 years of NOAEL = 10 milligrams/ Special FQPA SF = 1X Rabbit developmental
age) kilograms/day (mg/kg/ aPAD = acute RfD / toxicity
day) Special FQPA SF = 0.1 LOAEL = 20 mg/kg/day
UF = 100............... mg/kg/day. based on increase in
Acute RfD = 0.1 mg/kg/ number of fetuses and
day. litters with
hydrocephaly and
related malformations.
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Acute dietary (general population An appropriate endpoint attributable to a single dose was not identified
including infants and children) for the general population including infants and children for this risk
assessment in the toxicological database.
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Chronic dietary (all populations) NOAEL = 9 mg/kg/day Special FQPA SF = 1X Combined chronic
UF = 100............... cPAD = chronic RfD / toxicity/
Chronic RfD = 0.09 mg/ Special FQPA SF = 0.09 carcinogenicity study
kg/day. mg/kg/day. in rats
LOAEL = 35 mg/kg/day
based on
hyperkeratosis/
acanthosis and
ulceration/erosion of
the non-glandular
stomach in males and
females.
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Short-term dermal (1 to 30 days) Dermal (or oral) study LOC for MOE = 100 Rabbit development
NOAEL = 10 mg/kg/day. (Occupational and toxicity
(dermal absorption rate residential). LOAEL = 20 mg/kg/day
= 2.7%). based on increase in
number of fetuses and
litters with
hydrocephaly and
related malformations.
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Intermediate-term dermal (1 to 6 NOAEL (developmental) = LOC for MOE = 100 Rabbit developmental
months) 10 mg/kg/day (Occupational and study
(dermal absorption rate residential). LOAEL = 20 mg/kg/day
= 2.7%. based on increase in
number of fetuses and
litters with
hydrocephaly and
related malformations.
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Long-term dermal (> 6 months) Dermal (or oral) study LOC for MOE = 100 Combined chronic
NOAEL = 9 mg/kg/day (Occupational and toxicity/
(dermal absorption rate residential). carcinogenicity study
= 2.7% when in rats
appropriate). LOAEL = 35 mg/kg/day
based on
hyperkeratosis/
acanthosis and
ulceration/erosion of
the non-glandular
stomach in males and
females.
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Short-term inhalation** NOAEL (developmental) = LOC for MOE = 100 Rabbit developmental
(1 to 30 days)....................... 10 mg/kg/day (Occupational and study
residential). LOAEL = 20 mg/kg/day
based on increase in
number of fetuses and
litters with
hydrocephaly and
related malformations.
** Assume inhalation
absorption rate = 100%
of oral absorption.
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Intermediate-term inhalation** NOAEL (developmental) = LOC for MOE = 100 Rabbit Developmental
(1 week to several months)........... 10 mg/kg/day (Occupational and Study
Residential). LOAEL = 20 mg/kg/day
based on increase in
number of fetuses and
litters with
hydrocephaly and
related malformations.
** Assume inhalation
absorption rate = 100%
of oral absorption.
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Long-term inhalation** NOAEL = 9 mg/kg/day LOC for MOE = Combined chronic
(several months to lifetime)......... ....................... 100 (Occupational and toxicity/
residential). carcinogenicity study
in rats
LOAEL = 35 mg/kg/day
based on
hyperkeratosis/
acanthosis and
ulceration/erosion of
the non-glandular
stomach in males and
females.
** Assume inhalation
absorption rate = 100%
of oral absorption.
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Cancer (oral, dermal, inhalation) Folpet is a B2 carcinogen (probable human carcinogen) based on the
increased incidences of adenomas and carcinomas in the duodenum of male
and female mice in two strains (CD-1 and B6C3F1). The Q1* is 1.86 x
10 \3\ (mg/kg/day).
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C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.191) for residues of folpet, in or on a variety
of raw agricultural commodities. Risk assessments were conducted by EPA
to assess dietary exposures from folpet in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide, if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID\TM\), which
[[Page 52185]]
incorporates food consumption data as reported by respondents in the
(United States Department of Agriculture) (USDA) 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII),
and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the acute exposure assessments: A
Tier 3 acute probabilistic dietary exposure analysis was performed. The
assumptions for most commodities (apple and apple juice; cranberries;
cucumbers; grapes, grape juice, wine, raisins; lettuce; melons; onions;
strawberries; and tomatoes) were anticipated residue levels
(incorporated into residue distribution files) and the percent crop
treated (PCT) estimate for imported crops consumed in the U.S. PCT for
imported commodities is estimated at a maximum of 1%, based on
information derived through an analysis of import and domestic
production data available from the USDA for the years 1995 through
1999, adjusted for the countries in which folpet is registered. For
avocados, the assumptions of the acute dietary exposure analysis were
anticipated residue levels and 11 PCT (Florida avocado acreage is 11%
of the total U.S. avocado acreage as reported by USDA and assuming all
the crop in Florida is treated is considered very conservative). For
hops, the assumptions of the acute dietary analysis were tolerance
level residues (120 ppm) and 100 PCT.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: A Tier 3 chronic (non-cancer) dietary exposure
analysis was performed. The assumptions for most commodities (apple and
apple juice; cranberries; cucumbers; grapes, grape juice, wine,
raisins; lettuce; melons; onions; strawberries; and tomatoes) were
anticipated residue levels (incorporated into residue distribution
files) and the PCT estimate for imported crops consumed in the U.S.
(which is a maximum of 1%, based on information derived through an
analysis of import and domestic production data available from the USDA
for the years 1995 through 1999, adjusted for the countries in which
folpet is registered). For avocados, the assumptions of the chronic
dietary exposure analysis were anticipated residue levels and 11 PCT
(because Florida avocado acreage is 11% of the total U.S. avocado
acreage as reported by USDA). For hops, the assumptions of the chronic
dietary analysis were tolerance level residues (120 ppm) and 100 PCT.
iii. Cancer. A Tier 3 chronic dietary exposure analysis was
performed. The assumptions for most commodities (apple and apple juice;
cranberries; cucumbers; grapes, grape juice, wine, raisins; lettuce;
melons; onions; strawberries; and tomatoes) were anticipated residue
levels (incorporated into residue distribution files) and the PCT
estimate for imported crops consumed in the U.S. (which is a maximum of
1%, based on information derived through an analysis of import and
domestic production data available from the USDA for the years 1995
through 1999, adjusted for the countries in which folpet is
registered). For avocados, the assumptions of the chronic dietary
exposure analysis were anticipated residue levels and 11 PCT (because
Florida avocado acreage is 11% of the total U.S. avocado acreage as
reported by USDA). For hops, the assumptions of the chronic dietary
analysis were tolerance level residues (120 ppm) and 100 PCT.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide chemicals that have been measured in food. If EPA
relies on such information, EPA must require that data be provided 5
years after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. As
required by section 408(b)(2)(E) of FFDCA, EPA will issue a data call-
in for information relating to anticipated residues to be submitted no
later than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used PCT information as follows. As discussed in the
Agency's March 5, 2003 final rule for folpet the only registered use of
folpet in the United States is avocados grown in Florida. According to
data available from the USDA's National Agricultural Statistics
Service, California accounted for 89% of avocado production in the U.S.
followed by Florida at nearly 11% and Hawaii at 0.1 %. Therefore, the
Agency has assumed that only 11% of the U.S. avocado crop is treated
with folpet (100% of the Florida grown avocados). For hops the Agency
assumed 100 PCT (U.S. product and imported hops). For all other
commodities (i.e., apple, cranberry, cucumber, grape, lettuce, melon,
onion, strawberry, and tomato) based upon information derived through
an analysis of import and domestic production data available from the
USDA for the years 1995 through 1999 and adjusted for the countries in
which folpet is registered.
The Agency believes that the three conditions listed Unit
III.1.C.iv. have been met. With respect to Condition 1, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. In using these data, the Agency took
into account the specific countries where folpet is registered. In the
case of avocados, the Agency based it's PCT estimate on the volume of
crop grown in Florida based on data from the USDA. Therefore, the
Agency has assumed that only 11% of the U.S. avocado crop is treated
with folpet. For all other commodities (except hops and avocados), the
Agency has assumed (see March 5, 2003 folpet final rule) a maximum PCT
of 1% for each commodity (i.e., apple, cranberry, cucumber, grape,
lettuce, melon, onion, strawberry, and tomato) based upon information
derived through an analysis of import and domestic production data
available from the USDA for the years 1995 through 1999 and adjusted
for the countries in which folpet is registered.
For all potentially treated commodities the Agency used estimated
maximum PCT assumptions in conducting both the acute and chronic
dietary exposure assessments. The exposure estimates from this approach
the Agency is reasonably certain,
[[Page 52186]]
represent the highest levels to which individuals could be exposed, and
are unlikely to be an underestimation. As to Conditions 2 and 3,
regional consumption information and consumption information for
significant subpopulations is taken into account through EPA's
computer-based model for evaluating the exposure of significant
Subpopulation including several regional groups. Use of this
consumption information in EPA's risk assessment process ensures that
EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which folpet may be
applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for folpet in drinking water
(other than avocados in Florida all tolerances reflect imported
commodities and monitoring data other than from Florida would probably
not be useful). Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of folpet.
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The screening concentration in ground water (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water EPA will use FIRST
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
LOC.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to folpet they are
further discussed in the aggregate risk Unit III.E.
Based on the Tier 1 FIRST and SCI-GROW models, the EECs of folpet
for acute exposures are estimated to be 309 parts per billion (ppb) for
surface water and 0.06 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.62 ppb for surface water and 0.06 ppb
for ground 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).
Folpet is currently registered for use on the following residential
non-dietary sites: Fungicide/preservative in wood sealants for use on
exterior wood surfaces including residential/recreational decks and
playsets, as well as siding, shingles, and fences. There are two wood
preservative product registered that have residential use sites. The
risk assessment was conducted using the following residential exposure
assumptions: Residential handlers may receive short-term dermal and
inhalation exposure to folpet when applying the ready-to-use
formulations. Adults and children may be exposed to folpet residues
from dermal contact with treated wood during post-application
activities. In addition, toddlers may receive short- and intermediate-
term oral exposure from incidental ingestion (i.e., hand-to-mouth)
during post-application activities on treated decks or playsets.
Exposure and risk estimates of dermal and inhalation exposure for
residential handlers were assessed using: An oral NOAEL of 10 mg/kg/day
(LOAEL = 20 mg/kg/day based on the increase in number of fetuses and
litters with hydrocephaly and related malformations). Because the
endpoints are based on an oral study, the estimated dermal exposures
were adjusted by applying a 2.7% dermal absorption rate, while
absorption in the lung was assumed to be 100%. In addition, these
endpoints are applicable to females 13+ years old; therefore, a 60-kg
body weight was used in the calculations. The endpoints are the same
for both dermal and inhalation exposure therefore, the individual
dermal and inhalation MOEs were combined into a total MOE. The dermal
endpoint used in the adult post-application exposure assessment is the
same as that for residential handlers. To assess toddler incidental
ingestion and dermal exposure, the maternal NOAEL (10 mg/kg/day) from
the rabbit developmental toxicity study; based on a decrease in food
consumption at the LOAEL of 20 mg/kg/day, was used for risk assessment
purposes because it occurs at the same dose level as the developmental
NOAEL (i.e., protective of developmental effects), is from the same
study, and is more applicable to toddlers than hydrocephaly effects,
which apply only to females of child-bearing age. In addition, using
the maternal NOAEL for the toddler dermal assessment is more protective
in that it allows for combination with the toddler incidental oral
assessment, because they are compared to the same endpoint. The FQPA
safety factor was reduced to 1X for the U.S. population and all
population subgroups and for all exposure scenarios, thus, the target
MOE for risk assessment purposes is 100.
To quantify cancer risk, the Q1* of 1.86 x 10-\3\ mg/kg/
day-\1\ was multiplied by the estimated lifetime average
daily doses from handler and post-application exposure. As with the
non-cancer assessment, dermal doses were first adjusted for dermal
absorption (i.e., 2.7%) because the Q1* is based on an oral study,
while inhalation doses were assumed to be 100% absorbed. Cancer risks
for residential handler and postapplication that exceed the range of 1
in 1 million are indicative of concern.
Handler exposures were previously assessed in the 1999
Reregistration Eligibility Decision (RED) for folpet. However, the
assessment has been revised in this document to account for the
possibility of the residential handler wearing short sleeves and short
pants,
[[Page 52187]]
rather than the long sleeves/pants assumed for both occupational and
residential handlers in the RED.
Dermal and inhalation daily doses for residential handlers were
calculated for the wood sealant formulation using data for applying a
paint or stain. The following handler scenarios were evaluated:
1. Application of ready-to-use wood sealant with a paint brush.
2. Application of ready-to-use wood sealant using an airless
sprayer.
The calculated non-occupational handler MOEs are greater than the
target of 100, and therefore, are not of concern to the Agency. The
handler cancer risks range from 7.6E-08 to 1.0E-07, which also do not
exceed the Agency's LOC.
Table 2.--Exposure and Risk for Residential Handlers
--------------------------------------------------------------------------------------------------------------------------------------------------------
Scenarios for Residential Folpet
Uses Amount Used Short-Term MOE Intermediate-Term MOE Total /MOE Cancer Risk
--------------------------------------------------------------------------------------------------------------------------------------------------------
Apply sealant with a paint brush 5 gal/day 430 9,400 410 7.6E-08
-------------------------------------------------------------
Apply sealant with an airless 15 gal/day 420 1,100 300 1.0E-07
sprayer
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to folpet and any other
substances and folpet does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that folpet has 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
the policy statements released by EPA's OPP concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/
.
Captan and folpet share a common metabolite, thiophosgene, which
the Agency believes to be responsible for the carcinogenic effects of
these compounds. Thiophosgene is a highly reactive, short-lived
compound. Studies indicate that thiophosgene causes local irritation of
the site with which it comes in contact, and is believed to cause
tumors through irritation of the duodenum. Because they are so short-
lived, thiophosgene residues cannot be quantified. Without measurable
residues of the common metabolite, it is difficult to relate exposures
of captan to those of folpet since the formation of thiophosgene may be
different for both compounds. However, assuming that the carcinogenic
effects observed in both pesticides are due solely to the metabolite
thiophosgene, the Agency believes it is reasonable to add the estimated
cancer risks from the individual aggregate risks from both folpet and
captan to obtain a worst-case estimate.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional UFs and/or special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity--a. The Agency made a
determination of susceptibility, as well as performed a degree of
concern analysis regarding pre- and/or postnatal toxicity resulting
from exposure to folpet. The Agency recommended that the FQPA safety
factor be reduced to 1X based upon the following:
i. There was no quantitative or qualitative evidence of increased
susceptibility following in utero exposure in two developmental
toxicity studies in the rat.
ii. There was no quantitative or qualitative evidence of enhanced
susceptibility to the pups in two different two-generation reproduction
studies in the rat.
iii. Although there was qualitative evidence of susceptibility in
one developmental study in the rabbit (hydrocephaly (developmental
LOAEL = 20 mg/kg/day; developmental NOAEL = 10 mg/kg/day)), and
quantitative evidence of susceptibility in the other developmental
study in the rabbit (delayed ossification (developmental LOAEL = 40 mg/
kg/day; developmental NOAEL = 10 mg/kg/day)), the Agency determined
that there is low concern for the observed susceptibility because:
Clear NOAELs/LOAELs were established in these studies.
There were inconsistencies in the results seen between
these studies (hydrocephaly seen in one study was not seen in the other
study).
A conservative determination was made to use hydrocephaly
as the endpoint for acute dietary, and short- and intermediate-term
dermal and inhalation exposure scenarios, in spite of lack of
replication of this effect.
The dose selected for overall risk assessment would
address the concerns for developmental toxicity seen in this species.
The structure-activity relationship analysis showed that
there was not evidence of increased susceptibility in rabbits following
in utero exposure to captan, a structural analog of folpet.
There are no other signs from the available toxicology
database of a concern for neurotoxic effects.
b. Therefore, the Agency concluded that there is no residual
uncertainty for prenatal and/or postnatal toxicity. The Agency also
determined that a developmental neurotoxicity (DNT) study for folpet is
not warranted based upon the following considerations:
[[Page 52188]]
i. The hydrocephalus seen in one fetus/1 litter at 20 mg kg/day in
the presence of maternal toxicity was not seen at higher doses (40 or
160 mg/kg/day) in another study in the same strain of rabbit.
ii. No alterations to the fetal nervous system were seen in the
developmental rat study at the same doses that induced hydrocephaly in
the rabbits.
iii. Although there are no acute or subchronic neurotoxicity
studies, there is no evidence of neurotoxicity or neuropathology in
adult animals in any of the studies.
iv. The available data indicate that the DNT study would have to be
tested at dose levels higher than 150 mg/kg/day, because no
developmental toxicity was observed in rats at 2,000 mg/kg/day. In
addition, given the results in the 2-generation reproduction study
(NOAEL of 168 mg/kg/day), it is anticipated that in order to elicit any
fetal nervous system abnormalities in the DNT study, the selected dose
levels would have to be higher than 160 mg/kg/day.
v. Since the dose level selections for the DNT study would be
greater than 160 mg/kg/day, the resultant NOAEL would be either
comparable to, or higher than, the doses currently used in the risk
assessment. The NOAEL of 10 mg/kg/day selected for the acute RfD and
the residential exposure assessment are 17 times lower than the
offspring NOAEL in the reproduction study. The NOAEL of 9 mg/kg/day
selected for the chronic RfD is 19 times lower than the offspring NOAEL
in the reproduction study. Therefore, it is unlikely that the DNT study
would change the current doses used for overall risk assessments.
3. Conclusion. There is a complete toxicity database for folpet and
exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. The Agency has determined
that the FQPA safety factor can be reduced to 1X based on the weight of
the evidence considerations.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. The Agency identified an aPAD for females 13 to 50
years old based on an increase in number of fetuses and litters with
Hydrocephaly and related malformations in the rabbit developmental
toxicity study at a LOAEL of 20 mg/kg/day (NOAEL = 10 mg/kg/day, UF =
100X, FQPA SF = 1X). An aPAD was not identified for the general
population. Using the exposure assumptions discussed in this unit for
acute exposure, the acute dietary exposure from food to folpet will
occupy 6.4% of the aPAD for females 13 to 50. In addition, there is
potential for acute dietary exposure to folpet in drinking water. No
drinking water monitoring data are available for folpet, in fact it is
only used in Florida on avocados. SCI-GROW and FIRST models were used
to calculated EECs for this fungicide. Tier 1 (SCI-GROW) modeling
estimates that folpet residues in ground water are not likely to exceed
0.06 ppb. Tier 1 (FIRST) surface water modeling for folpet residues
predicts the peak (acute) EEC is not likely to exceed 309 ppb. After
calculating DWLOCs for acute exposure to females 13-50 years old and
comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
Table 3 of this unit:
Table 3.--Aggregate Risk Assessment for Acute Exposure to folpet for females 13-50 years old (An aPAD was not identified for the general population.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
% aPAD/mg/kg//day/ Surface Water EEC/ Ground Water EEC/
Population Subgroup/ aPAD (mg/kg/day) (Food) (ppb) (ppb) Acute DWLOC/(ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13 to 50 years 0.10 0.0064 309 0.094 2800
--------------------------------------------------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to folpet
from food will utilize < 1% of the cPAD for the U.S. population and all
population subgroups. Based the use pattern, chronic residential
exposure to residues of folpet is not expected. In addition, there is
potential for chronic dietary exposure to folpet in drinking water.
After calculating DWLOCs and comparing them to the EECs for surface
water and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in Table 4 of this unit:
[[Page 52189]]
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to folpet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC/ Ground Water EEC/
Population/Subgroup cPAD/mg/kg/day mg/kg/day/(Food) (ppb) (ppb) Chronic/DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.09 0.000039 0.62 0.06 3,100
-------------------------------------------------------------
All infants 0.09 0.000045 0.62 0.06 900
-------------------------------------------------------------
Children 1-2 0.09 0.000107 0.62 0.06 900
-------------------------------------------------------------
Children 3-5 0.09 0.00009 0.62 0.06 900
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Folpet is currently registered for uses that could result in short-
term and intermediate-term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic food and water
and short-term exposures for folpet.
Dermal NOAELs are based on a developmental effect (an increased
number of fetuses and litters with hydrocephaly and related skull
malformations), and the incidental oral NOAEL is based on a maternal
effect (a decrease in food consumption). These effects were observed at
the maternal or developmental LOAEL of 20 mg/kg/day (NOAEL = 10 mg/kg/
day, UF = 100, FQPA SF = 1X) in the developmental toxicity study in
rabbits. However, as in the post-application assessment, to assess
toddler incidental ingestion and dermal exposure, the NOAEL based on
the maternal decrease in food consumption was used because this effect
is relevant to the population being assessed and the dose level is
numerically equivalent to the dose level for the developmental NOAEL.
In the residential assessment, the highest adult exposure scenario
(inhalation and dermal) was a residential handler applying a wood
preservative with 0.66% active ingredient (ai) (EPA Reg. No. 577-539)
to a deck or playset. The highest child exposure scenario (dermal and
incidental oral) is a toddler being exposed while mulling around on the
deck/playset after the wood preservative formulation has dried (24
hours after application). Exposure from these scenarios, in addition to
background exposure from food and water, were used to estimate the
short- and intermediate-term aggregate risk to adults and children from
folpet. For adults and children, all exposure routes were combined.
An average food exposure was also used to estimate the short- and
intermediate-term aggregate risk to adults and children from folpet.
The highest average food exposures from the respective subpopulation
groups were used, i.e. 0.000107 mg/kg/day for children (children 1-2
years), and 0.000039 mg/kg/day for adults (general U.S. population).
The average food exposure for females 13 to 50 years (0.000032 mg/kg/
day) was also considered, because the short- and intermediate-term
dermal and inhalation developmental endpoint is particularly relevant
to this subpopulation.
No drinking water monitoring data are available for folpet. SCI-
GROW and FIRST models were used to calculate EECs for this fungicide.
Tier 1 (SCI-GROW) modeling estimates that folpet residues in ground
water are not likely to exceed 0.06 ppb micrograms ([mu]g)/L).
Additionally, Tier 1 (FIRST) surface water modeling for folpet residues
predicts the annual average EEC is not likely to exceed 0.62 ppb.
Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 300. These
aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to
food and residential uses. In addition, short-term DWLOCs were
calculated and compared to the EECs for chronic exposure of folpet in
ground surface and surface water. After calculating DWLOCs and
comparing them to the EECs for surface and ground water, EPA does not
expect short-term aggregate exposure to exceed the Agency's LOC, as
shown in Table 5 of this unit:
Table 5.--Aggregate Risk Assessment for Short-Term and Intermediate-Term Exposure to folpet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate/MOE/(Food + Surface Water EEC/ Ground Water EEC/ Short-Term DWLOC
Population/Subgroup Residential) Aggregate LOC (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. population 300 100 0.62 0.06 2,300
-------------------------------------------------------------
Females 13 to 50 years 300 100 0.62 0.06 2,000
-------------------------------------------------------------
Children 1-2 years 160 100 0.62 0.06 3,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. Aggregate cancer risk for U.S. population. Chronic dietary and
residential exposure are included in the aggregate cancer risk
estimate. The residential exposure was calculated, as previously
discussed, by averaging expected residential exposure over a lifetime
(both handler dermal and inhalation and post-application dermal
activities were included) as discussed in Unit III.C. Folpet and captan
share a common metabolite, thiophosgene. Thiophosgene is highly
reactive and severely irritating to mucus membranes and tissues it
comes in contact with. Thiophosgene is believed to be responsible for
the carcinogenic effects of these compounds. The carcinogenic effect of
concern is gastrointestinal (GI) tract tumors from oral exposure to
both folpet and captan. Therefore, the EPA believes it is reasonable to
add the estimated cancer risks from the individual aggregate oral risks
from both
[[Page 52190]]
folpet and captan to obtain a worst-case scenario. The Agency in fact
used this approach when establishing the tolerance for hops previously
(March 5, 2003 final rule). Dietary risks from both folpet and captan
have not changed since the last risk assessment, and therefore the
aggregate cancer assessment performed in the previous risk assessment
has not changed (although the folpet EECs to which the aggregate cancer
assessment is compared have changed, they do not impact the
calculation, nor the conclusion).
Drinking water monitoring data are not available for folpet. SCI-
GROW and FIRST models were used to calculate EECs for folpet in water.
Tier 1 (SCI-GROW) modeling estimates that folpet residues in ground
water, from the only U.S. registered use on avocados in Florida, are
not likely to exceed 0.06 ppb ([mu]g/L). Additionally, Tier 1 (FIRST)
surface water modeling for folpet residues predicts the average annual
(chronic-term) EEC is not likely to exceed 0.62 ppb ([mu]g/L).
Table 6.--Cancer DWLOC Calculations (using the Q* Approach) for Folpet
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Food/ Residential/ Total. cancer
Population Exposure/(mg/kg/ Exposure/(mg/kg/ exposure/(mg/kg/ Ground Water EEC/ Surface Water EEC/ Cancer/DWLOC/
day) day) day) ([mu]g/L) ([mu]g/L) ([mu]g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.000039 0.00017 0.00021 0.06 0.62 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
The dietary cancer risk estimate for folpet (food only) for the
U.S. population is 7.2 x 10-\8\ and the cancer risk
resulting from residential exposure is 3.1 x 10-\7\. As
shown in Table 6 of this unit, the DWLOC for assessing chronic (cancer)
aggregate dietary risk is 12 [mu]g/L. The SCI-GROW and FIRST chronic
(cancer) EECs are less than the cancer DWLOC for folpet. Therefore,
residues of folpet in drinking water will not contribute significantly
to the aggregate chronic (cancer) human health risk, and thus, that the
aggregate cancer risk from exposure to folpet is not of concern.
The cancer risk estimate (food only) for the U.S. population
(total) is 7.2 x 10-\8\ for folpet (food exposure = 0.000039
mg/kg/day) and 1.3 x 10-\7\ for captan (food exposure =
0.000053 mg/kg/day). The EECs for assessing chronic (cancer) aggregate
dietary risk for folpet are 0.06 [mu]g/L (for ground water) and 0.62
[mu]g/L (for surface water). The EECs for assessing chronic (cancer)
aggregate dietary risk for captan are 1 [mu]g/L (for ground water) and
4 [mu]g/L (for surface water).
Table 7.--Cancer DWLOC for Aggregate Exposure to Folpet and Captan
--------------------------------------------------------------------------------------------------------------------------------------------------------
Max Water/Exposure\1\/ Ground Water EEC/ Surface Water EEC/ Cancer/DWLOC\2\/
Population Aggregate/Cancer Risk (mg/kg/day) ([mu]g/L) ([mu]g/L) ([mu]g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 2.0 x 10 \7\ 0.00032 0.06 (folpet) 0.62 (folpet) 11
1 (captan)........... 4 (captan)...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Chronic Food Exposure).
2 Cancer DWLOC ([mu]g/L) = maximum water exposure (mg/kg/day) x body weight (kg), a 70 kg body weight and 2L water consumption were assumed. Water
consumption (L) x 10 \3\ mg/[mu]g.
The calculated DWLOC (calculated using the Q1* for captan 2.4 x
10-\3\ as this value is higher than that for folpet and
results in a worst-case estimate of risk) for assessing chronic
(cancer) aggregate dietary risk is 11 [mu]g/L. The chronic (cancer)
EECs are less than the EPA's level of comparison for folpet and captan
residues in drinking water as a contribution to chronic (cancer)
aggregate exposure. Therefore the Agency concludes with reasonable
certainty that residues of folpet and captan in drinking water will not
contribute significantly to the aggregate cancer human health risk from
exposure to folpet and captan; and, that the aggregate exposure from
folpet and captan residues in food and drinking water will not exceed
the EPA's LOC for cancer risk for the U.S. population.
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, and to infants and children from aggregate
exposure to folpet residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate gas chromotography/electron capture detector (GC/ECD)
is available to enforce tolerances for folpet on plant commodities. 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; e-mail address:
Residuemethods@epa.gov.
B. International Residue Limits
No CODEX Maximum Residue Level (MRL) exist for folpet on hops. A
German MRL exists for folpet on hops at 120 ppm.
V. Conclusion
Therefore, the tolerance for residues of folpet, in or on hop,
dried cone at 120 ppm is amended to delete the footnote stating that
there are no registrations for use of folpet on hops in the United
States.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for
[[Page 52191]]
filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0168 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before October
25, 2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0168, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule amends a tolerance under section 408(d) of FFDCA 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are amended on the basis of a petition
under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal
[[Page 52192]]
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 this final rule in the Federal Register. This final
rule 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: August 12, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. Section 180.191 is amended by revising the entry for ``Hops, dried
cones'' in the table in paragraph (a) as follows:
Sec. 180.191 Folpet; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Hop, dried cones.......................... 120
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-19036 Filed 8-24-04; 8:45 am]
BILLING CODE 6560-50-S