[Federal Register Volume 69, Number 164 (Wednesday, August 25, 2004)]
[Rules and Regulations]
[Pages 52182-52192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19036]


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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: [email protected].

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: 
[email protected].

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: [email protected]. 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