[Federal Register: August 20, 2004 (Volume 69, Number 161)]
[Rules and Regulations]
[Page 51571-51582]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au04-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0200; FRL-7673-6]
DCPA; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of DCPA, dimethyl tetrachloroterephthalate, and its metabolites in or
on basil, dried leaves; basil, fresh leaves; celeriac; chicory, roots;
chicory, tops; chive; coriander, leaves; dill; ginseng; marjoram;
parsley, leaves; parsley, dried leaves; radicchio and radish, oriental.
Interregional Research Project Number 4 (IR-4) requested these
tolerances 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 20, 2004. Objections and
requests for hearings must be received on or before October 19, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0200. 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.,
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), Rm. 119, Crystal Mall 2, 1801 S.
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: Joanne I. Miller, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address:
miller.joanne@epamail.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
[[Page 51572]]
(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 at 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 6, 2004 (69 FR 25384) (FRL-7356-8),
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 2E6442)
by Interregional Research Project Number 4 (IR-4), 681 U.S. Highway 1
South, North Brunswick, NJ 08902-3390. That notice included a summary
of the petition prepared by IR-4, the petitioner. There were no
comments received in response to the notice of filing.
The petition requested that 40 CFR 180.185 be amended by
establishing tolerances for residues of the herbicide DCPA or chlorthal
dimethyl, dimethyl tetrachloroterephthalate, in or on oriental radish,
basil, coriander, dill, marjoram, chives, ginseng, celeriac, chicory,
mradicchio, parsley (fresh) and parsley (dried) at 2.0, 5.0, 5.0, 5.0,
5.0, 5.0, 2.0, 2.0, 5.0, 2.0, 5.0 and 15 parts per million (ppm),
respectively. The proposed tolerances were corrected to conform to Food
and Feed Commodity Vocabulary database (http://www.epa.gov/pesticides/foodfeed/
) and to include its metabolites to read as follows: Combined
residues of the herbicide DCPA (or chlorthal dimethyl), dimethyl
tetrachloroterephthalate, and its metabolites monomethyl
tetrachloroterephthalate (MTP) and tetrachloroterephthalate (TPA)
(calculated as dimethyl tetrachloroterephthalate) in or on basil, dried
leaves at 5.0 ppm, basil, fresh leaves at 20.0 ppm, celeriac at 2.0
ppm, chicory, roots at 2.0 ppm, chicory, tops at 5.0 ppm, chive at 5.0
ppm, coriander, leaves at 5.0 ppm, dill at 5.0 ppm, ginseng at 2.0 ppm,
marjoram at 5.0 ppm, parsley, leaves at 5.0 ppm, parsley, dried leaves
at 20 ppm, radicchio at 5.0 ppm, and radish, oriental at 2.0 ppm.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
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 combined residues of DCPA,
dimethyl tetrachloroterephthalate, and its metabolites monomethyl
tetrachloroterephthalate (MTP) and tetrachloroterephthalate (TPA)
(calculated as dimethyl tetrachloroterephthalate) in or on basil, dried
leaves at 5.0 ppm, basil, fresh leaves at 20.0 ppm, celeriac at 2.0
ppm, chicory, roots at 2.0 ppm, chicory, tops at 5.0 ppm, chive at 5.0
ppm, coriander, leaves at 5.0 ppm, dill at 5.0 ppm, ginseng at 2.0 ppm,
marjoram at 5.0 ppm, parsley, leaves at 5.0 ppm, parsley, dried leaves
at 20 ppm, radicchio at 5.0 ppm, and radish, oriental at 2.0 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 DCPA are discussed
in Table 1 of this unit as well as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies reviewed. Data bearing on the toxicity of
tetrachloroterephthalic acid (TPA), a degradate of DCPA, is presented
in Table 2.
Table 1.--DCPA Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
870.3100 28-day oral toxicity-- NOAEL < 215 lowest dose tested (LDT)
rodents (rats) milligrams/kilogram/day (mg/kg/day)
LOAEL = 215 mg/kg/day based on hepatic
hypertrophy. At 1,720 mg/kg/day thyroid
follicular cell hyperplasia in males
----------------------------------------
870.3100 90-day oral toxicity-- NOAEL = 50 mg/kg/day
rodents (rats) LOAEL = 100 mg/kg/day based on
centrilobular hypertrophy.
At 1,000 mg/kg/day there were gross and
microscopic lesions of lungs and kidneys;
microscopic lesions in thyroids; and
increased liver weights.
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[[Page 51573]]
870.3100 13-week oral toxicity-- NOAEL = 406 mg/kg/day (males) and 1,049 mg/
rodents (mice) kg/day (females)
LOAEL = 1,235 mg/kg/day (males) and 2,198
mg/kg/day (females) based on centrilobular
hepatocyte enlargement.
----------------------------------------
870.3200 21/28-day dermal toxicity NOAEL >= 1,000 mg/kg/day highest dose
tested (HDT)
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL >= 2,000 mg/kg/day (HDT)
rodents (rats) Developmental NOAEL >= 2,000 mg/kg/day
(HDT)
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 250 mg/kg/day
nonrodents (rabbits) Maternal LOAEL = 500 mg/kg/day based on
maternal mortality
Developmental NOAEL >= 500 mg/kg/day (HDT)
----------------------------------------
870.3800 Reproduction and fertility Parental/Systemic NOAEL = 50 mg/kg/day
effects (rats) Parental/Systemic LOAEL = 250 mg/kg/day
based on body weight decrements, gross and
microscopic changes in kidneys and lungs,
and microscopic changes in liver and
thyroids.
Reproductive NOAEL >= 1,000 mg/kg/day (HDT)
Offspring NOAEL = 50 mg/kg/day
Offspring LOAEL = 250 mg/kg/day based on
pup body weight decrements during the
lactation period.
----------------------------------------
870.4300 Chronic toxicity and NOAEL = 1 mg/kg/day
Carcinogenicity--rodents LOAEL = 10 mg/kg/day based on decreased T4
(rats) hormone and thyroid and liver histological
changes.
Increases in thyroid follicular cell
adenomas and carcinomas, hepatocellular
adenomas and carcinomas, and
hepatocholangiomas in females
Q1* = 1.5 x 10-\3\ based upon the three
combined types of liver tumors in female
rats (3/4 scaling factor)
----------------------------------------
870.4300 Carcinogenicity--mice NOAEL = 510 mg/kg/day
LOAEL = 1,141 mg/kg/day based on elevated
liver enzymes and increased liver weight
in females. Increases in hepatic adenomas
(females) and carcinomas (males, females).
----------------------------------------
870.5300 Mouse lymphoma assay Negative for forward mutations
----------------------------------------
870.5375 Cytogenetic assay in CHO Negative for clastogenicity
cells
----------------------------------------
870.5550 UDS assay Negative
----------------------------------------
870.5915 SCE in CHO cells Negative
----------------------------------------
870.7485 Metabolism and In 6 separate metabolism studies, \14\C-
pharmacokinetics (rats) DCPA was given as single or multiple oral
gavage doses to rats at 1 or 1,000 mg/kg/
day. There were no significant sex
differences in any of the studies.
Absorption was rapid and essentially
complete by 48 hours. Absorption was more
efficient at 1 mg/kg/day (79%-86% of
administered dose) than at 1,000 mg/kg/day
(6-9%). Urine was the major route of
excretion. Less than 1% of radiolabel was
found in bile, so compound in feces
represents unabsorbed compound. The major
compound found in urine was the mono-
methyl metabolite, 4-carbomethoxy-2,3,5,6-
tetrachlorobenzoic acid. The di-acid
metabolite, TPA, represented approximately
1% of radioactivity in urine. No DCPA was
found in urine. Radiolabel did not
bioaccumulate in tissues following
repeated treatment. Although a high
percentage of the administered dose was
found in fat 12 hours after discontinuance
of dosing (12% of dose in low-dose
animals), radiolabel had rapidly depleted
by 168 hours (0.03%). Concentration of
radiolabel in the thyroid increased at 36
hours postdosing when compared to the 12
hour time period, however, radiolabel in
the thyroid rapidly depleted by 168 hours.
By 168 hours, highest concentration of
radiolabel in both dose groups was in the
kidney.
----------------------------------------
870.7600 Dermal penetration 22% including compound on skin at 47.5
[mu]g/cm\2\
----------------------------------------------------------------------------------------------------------------
Table 2.--TPA (tetrachloroterephthalic acid) Degradate of DCPA Subchronic Toxicity
----------------------------------------------------------------------------------------------------------------
Guideline No. Study Type Results
----------------------------------------------------------------------------------------------------------------
N/A 30-day Intubation NOAEL = 500 mg/kg/day
toxicity--rodents (rats) LOAEL = 2,000 mg/kg/day based on soft
stools and occult blood in urine.
----------------------------------------
[[Page 51574]]
870.3100 90-day oral toxicity-- NOAEL >= 500 mg/kg/day (HDT)
rodents (rats)
----------------------------------------
870.3700 Prenatal developmental-- Maternal NOAEL = 1,250 mg/kg/day
rodents (rats) Maternal LOAEL = 2,500 mg/kg/day based on
soft stools and salivation
Developmental NOAEL >= 2,500 mg/kg/day
(HDT)
----------------------------------------------------------------------------------------------------------------
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 lowest dose at which adverse effects of concern are
identified (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 or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the `` default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors 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 safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
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 uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor 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 DCPA used for human
risk assessment is shown in Table 3 of this unit:
Table 3.--Summary of Toxicological Dose and Endpoints for DCPA for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
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Acute Dietary An endpoint of concern attributable to a single dose (exposure) was not
identified from the available studies. An acute RfD was not established
--------------------------------------
Chronic Dietary (All populations) NOAEL= 1 mg/kg/day Special FQPA SF = 1X Combined chronic/
UF = 100............... cPAD = chronic RfD/ carcinogenicity study
Chronic RfD = 0.01 mg/ Special FQPA SF. in rats
kg/day. = 0.01 mg/kg/day....... LOAEL = 10 mg/kg/day
based on decreased
thyroxine levels and
liver and thyroid
histological changes
in males
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Long-Term Dermal (several months to Dermal (or oral) study LOC for MOE = Combined chronic/
lifetime) (Residential) NOAEL= 1 mg/kg/day 100 (Residential)...... carcinogenicity study
(dermal absorption in rats
rate = 22 % when LOAEL = 10 mg/kg/day
appropriate). based on decreased
thyroxine levels and
liver and thyroid
histological changes
in males
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[[Page 51575]]
Short and Intermediate-Term Inhalation (or oral) LOC for MOE = 90-day feeding study in
Inhalation (1 day to 6 months) study 100 (Residential)...... rats
(Residential) NOAEL= 50 mg/kg/day LOAEL = 100 mg/kg/day
(inhalation absorption based on based on
rate = 100%). increased incidence of
hepatocellular
hypertrophy
--------------------------------------
Long-Term Inhalation (several months Inhalation (or oral) LOC for MOE = Combined chronic/
to lifetime) (Residential) study 100 (Residential)...... carcinogenicity study
NOAEL= 1 mg/kg/day in rats
(inhalation absorption LOAEL = 10 mg/kg/day
rate = 100%). based on decreased
thyroxine levels and
liver and thyroid
histological changes
in males
--------------------------------------
DCPA Cancer (oral, dermal, Classification: Group C, possible human carcinogen. Q1* = 0.0015 (mg/kg/
inhalation) day)-\1\ based upon three combined types of liver tumors in female rats.
----------------------------------------------------------------------------------------------------------------
C. Toxicological Endpoints for TPA
A summary of the toxicological endpoints for TPA used for human
risk assessment is shown in Table 4 of this unit:
Table 4.--Summary of Toxicological Dose and Endpoints for TPA for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Special FQPA SF and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment and UFs Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary An endpoint of concern attributable to a single dose (exposure) was not
identified from the available studies. An acute RfD was not established
--------------------------------------
Chronic Dietary (All populations) NOAEL= 500 mg/kg/day Special FQPA SF = 1X 90-day feeding study in
UF = 1,000............. cPAD = chronic RfD/ rats
Chronic RfD = 0.5 mg/kg/ Special FQPA SF. NOAEL = 500 mg/kg/day
day. = 0.5 mg/kg/day........ (HDT)
--------------------------------------
Cancer (oral, dermal, inhalation) TPA is not likely to be a carcinogen for humans because no liver and
thyroid precursor events occurred after treatment with TPA at very large
doses, and because neither TPA nor DCPA are mutagens.
----------------------------------------------------------------------------------------------------------------
D. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.185) for the combined residues of DCPA,
dimethyl tetrachloroterephthalate, and its metabolites monomethyl
tetrachloroterephthalate (MTP) and tetrachloroterephthalate (TPA)
(calculated as dimethyl tetrachloroterephthalate) in or on a variety of
raw agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures from DCPA and its metabolites
tetrachloroterephthalate (MTP) and tetrachloroterephthalate (TPA)
(calculated as dimethyl tetrachloroterephthalate) 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 one-day
or single exposure.
An effect of concern attributable to a single exposure (dose) was
not identified from the oral toxicity studies including the
developmental toxicity studies in rat and rabbits.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA1989-1992 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 chronic exposure
assessments: Anticipated residues for currently registered crops and
tolerance level used for the proposed crops and the percent crop
treated (PCT) data were used for currently registered crops and 100 %
of the crop treated for the proposed uses.
iii. Cancer. In conducting this cancer risk assessment the Dietary
Exposure Evaluation Model (DEEM\TM\) analysis evaluated the individual
food consumption as reported by respondents in the USDA1989-1992
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 cancer risk assessments: Anticipated
residues for currently registered crops and tolerance level used for
the proposed crops and the percent crop treated (PCT) data were used
for currently registered crops and 100 % of the crop treated for the
proposed uses.
iv. Anticipated residue and percent crop treated (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
[[Page 51576]]
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 in Table 5 as follows:
Table 5.--Percent Crop Treated (PCT) for Registered DCPA Uses.
----------------------------------------------------------------------------------------------------------------
Crop Acreage PCT Lbs ai/A\1\ Lbs.a.i
----------------------------------------------------------------------------------------------------------------
Broccoli 145,000 24 4.6 150,000
---------------------------------
Cabbage 78,000 6 5.0 20,000
---------------------------------
Cantaloupes 100,000 1 7.7 5,000
---------------------------------
Cauliflowers 45,000 15 5.0 30,000
---------------------------------
Collards 12,000 20 8.0 20,000
---------------------------------
Cucumbers 130,000 1 8.0 1,000
---------------------------------
Dry beans 190,000 1 5.0 8,000
---------------------------------
Eggplant 5,000 1 6.9 500
---------------------------------
Onions 160,000 15 6.7 150,000
---------------------------------
Sweet peppers 39,000 5 7.41 15,000
---------------------------------
Radishes 21,000 5 7.3 5,000
---------------------------------
Summer squash 60,000 1 9.0 1,000
---------------------------------
Strawberries 55,000 2 6.4 5,000
---------------------------------
Tomatoes 415,000 1 5.0 3,000
---------------------------------
Turf 250,000 2 5.4 31,000
---------------------------------
Total 444,500
----------------------------------------------------------------------------------------------------------------
Sources: USDA, EPA 1995-2000.
\1\No reported use of DCPA on cotton. Assume 1% Crop Treated for: Green and dry beans, peach, green and
succulent peas, potato, sweet potatoes, honeydew melons, watermelons, winter squash, yams. Assume 100% Crop
Treated for: Brussels sprouts, garlic, horseradish, hot pepper, turnips, upland cress.
The Agency believes that the three conditions listed above 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. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely 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 subpopulations 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
[[Page 51577]]
DCPA 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 DCPA and its environmental
degradate TPA in drinking water. 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 DCPA and TPA.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and SCI-GROW, which predicts pesticide concentrations in ground
water. In general, EPA will use GENEEC (a tier 1 model) before using
PRZM/EXAMS (a tier 2 model) for a screening-level assessment for
surface water. The GENEEC model is a subset of the PRZM/EXAMS model
that uses a specific high-end runoff scenario for pesticides. GENEEC
incorporates a farm pond scenario, while PRZM/EXAMS incorporate an
index reservoir environment in place of the previous pond scenario. The
PRZM/EXAMS model includes 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
levels of concern.
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 DCPA they are further
discussed in the aggregate risk sections in Unit III.E.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of DCPA for
acute exposures are estimated to be 22 parts per billion (ppb) for
surface water and 0.17 ppb for ground water and of TPA for acute
exposures are estimated to be 116 parts per billion (ppb) for surface
water and 192 ppb for ground water. The EECs for chronic exposures of
DCPA are estimated to be 22 ppb for surface water and 0.17 ppb for
ground water and of TPA are estimated to be 116 ppb for surface water
and 192 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).
DCPA is currently registered for use on the following residential
non-dietary sites: Garden vegetables and turf. The risk assessment was
conducted for exposure to the active ingredient DCPA and manufacturing
impurity hexachlorobenzene (HCB) using the following residential
exposure assumptions:
1. Garden vegetables. Significant post application exposures are
not anticipated for garden vegetables because the applications are made
to freshly cultivated soil using only the granular products. The risks
of acute oral exposures due to granular ingestion by children were not
assessed because adverse effects were not seen following a single dose.
2. Turf. Significant post application exposures are anticipated for
turf because broadcast applications are made to prevent the growth of
weeds throughout the lawn. These exposures are anticipated to be short
term because only one or two applications are made per growing season
and the label recommended application interval is two months or longer.
Only incidental oral exposures were assessed for toddlers because a
dermal endpoint for short/intermediate term exposures was not selected.
A Turf Transferable Residue (TTR) study involved the application of
dacthal W-75 to Kentucky bluegrass turf plots in Ohio. Three of the
treated plots were irrigated with 0.5 water immediately following
sampling at one hour after treatment and 0.18 of rain occurred at day
after treatment (DAT) six. Irrigation reduced the residue from an
initial value of 4.2 [mu]g/cm\2\ at DAT 0.04 to 1.6 [mu]g/cm\2\ at DAT
0.08. The residue then dissipated at rate of 6.1 percent per day from
DAT 1 until the last day of the study (DAT 14).
The Margins of Exposure (MOEs) calculated for toddler post
application turf exposure are presented in Table 6.
Table 6.--Incidental Oral MOEs for Toddler Post Application Turf Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
DAT Application Rate Hand to Mouth MOE Object to Mouth MOE Soil Ingestion MOE Aggregate MOE
--------------------------------------------------------------------------------------------------------------------------------------------------------
0 15 lb ai acre 220 890 6,6000 180
--------------------------------------------------------------------------------------------------------------------------------------------------------
The cancer risks for adults exposed to treated and irrigated turf
were calculated using standard assumptions and the TTR data averaged
over 14 days. The data were normalized to an average application rate
of 12.5 lbs ai/acre. It was assumed four days of exposure to turf that
was treated within 14 days would occur per year.
The cancer risks calculated for adult post application turf
exposure are presented in Table 7.
Table 7.--Cancer Risks for Adult Post Application Turf Exposure\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Turf Transferable Residue Level\2\([mu]g/ DCPA LADD\3\ (mg/kg/ DCPA Cancer HCB LADD\3\ (mg/ HCB Cancer
cm\2\) Days Per Year Exposure day) Risk\4\ kg/day) Risk\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.64 (DCPA) 4 2.3e-04 3.4e-07 1.1e-08 1.1e-08
[[Page 51578]]
0.0026 (HCB)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Average over 14 days after an application of 12.5 lb ai/acre immediately followed by irrigation.
\2\Assuming heavy yard work with a transfer coefficient (TC) of 7300 cm\2\/hour.
\3\LADD = TTR x TC x 0.001 mg/[mu]g x DA x 2 hours exposure/day x (1/70 kg) x 4/365 x 50 years /70 years
\4\DCPA Cancer Risk = LADD x Q1* where Q1* = 0.0015 mg/kg/day-\1\for DCPA
\5\ HCB Cancer Risk = LADD x Q1* where Q1* = 1.0 mg/kg/day-\1\ for HCB
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether DCPA has a common mechanism of toxicity with other substances.
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 DCPA and any other
substances and DCPA 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 DCPA 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/
.
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 data base 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 uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. The toxicology database for DCPA is complete for FQPA purposes
and there are no residual uncertainties for pre-/post-natal toxicity.
Based on the quality of the exposure data, EPA determined that the 10X
SF to protect infants and children should be removed. The FQPA factor
is removed based on the following:
i. There is no quantitative or qualitative evidence of increased
susceptibility of rat and rabbit fetuses to in utero exposure to DCPA
in developmental toxicity studies. There is no quantitative or
qualitative evidence of increased susceptibility to DCPA following pre-
/post-natal exposure to a 2-generation reproduction study.
ii. There is no concern for developmental neurotoxicity resulting
from exposure to DCPA. A developmental neurotoxicity study (DNT) study
is not required.
iii. The toxicological database is complete for FQPA assessment.
iv. The dietary food exposure assessment is based on average field
trial values corrected by percent crop treated.
v. The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded.
vi. Submitted turf transferable residue (TTR) data will be used
along with the Residential Standard Operating Procedures to assess
post-application exposure to children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by DCPA.
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, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP 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
[[Page 51579]]
future, OPP 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. An effect of concern attributable to a single
exposure (dose) was not identified from the oral toxicity studies
including the developmental toxicity studies in rat and rabbits. No
acute risk is expected from exposure to DCPA.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to DCPA from
food will utilize 0.97 % of the cPAD for the U.S. population, 1.1 % of
the cPAD for Children (1 - 6 years old). Based on the garden and turf
use patterns, chronic residential exposure to residues of DCPA is not
expected. In addition, there is potential for chronic dietary exposure
to DCPA in drinking water. After calculating DWLOCs and comparing them
to the EECs for surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in Table 8 of
this unit:
Table 8.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to DCPA
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb), (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.01 0.97 22 0.17 350
------------------------------------------------
All Infants 0.01 0.85 22 0.17 99
------------------------------------------------
Children 1- 6 0.01 1.1 22 0.17 99
------------------------------------------------
Females 13 - 50 0.01 0.88 22 0.17 300
----------------------------------------------------------------------------------------------------------------
Using the exposure assumptions described in this unit for chronic
exposure, EPA has concluded that exposure to TPA from food will utilize
0.02% of the cPAD for the U.S. population, and all infants and children
subgroups. Based on the garden and turf use patterns, chronic
residential exposure to residues of TPA is not expected. In addition,
there is potential for chronic dietary exposure to TPA in drinking
water.After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate chronic
exposure to TPA to exceed 100% of the cPAD, as shown in Table 9 of this
unit:
Table 9.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to TPA
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.5 0.02 116 192 17,500
------------------------------------------------
All Infants 0.5 0.02 116 192 5,000
------------------------------------------------
Children 1- 6 0.5 0.02 116 192 5,000
------------------------------------------------
Females 13 - 50 0.5 0.02 116 192 15,000
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
DCPA is currently registered for use that could result in short-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic food and water and short-term
exposures for DCPA.
Short-term DWLOCs were calculated and compared to the EECs for
chronic exposure of DCPA in ground and surface water based on chronic
food exposure plus the residential handler exposure for adults and the
chronic food exposure alone for toddlers. 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 level of
concern, as shown in Table 10 of this unit:
Table 10.--Aggregate Risk Assessment for Short-Term Exposure to DCPA
----------------------------------------------------------------------------------------------------------------
Aggregate Exposure (mg/ Surface Ground
Population Subgroup kg/day) (Food + Water EEC Water EEC Short-Term
Residential) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.001697 22 0.17 17,500
-------------------------------------------------
All Infants 0.000085 22 0.17 5,000
-------------------------------------------------
Children 1- 6 0.00011 22 0.17 5,000
-------------------------------------------------
Females 13 - 50 0.001688 22 0.17 15,000
----------------------------------------------------------------------------------------------------------------
[[Page 51580]]
Short term DWLOCs for TPA were calculated based upon food alone
because there is no residential non-food exposure to TPA. 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 level of concern, as shown in Table 11 of this
unit:
Table 11.--Aggregate Risk Assessment for Short-Term Exposure to TPA
----------------------------------------------------------------------------------------------------------------
Aggregate
Exposure (mg/ Surface Ground
Population Subgroup kg/day) Water EEC Water EEC Short-Term
(Food + (ppb) (ppb) DWLOC (ppb)
Residential)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.000097 116 192 17,500
------------------------------------------------------------
All Infants 0.000085 116 192 5,000
------------------------------------------------------------
Children 1- 6 0.00011 116 192 5,000
------------------------------------------------------------
Females 13 - 50 0.000088 116 192 15,000
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Though residential exposure could occur with the use of DCPA, the
endpoints and uncertainty factors for intermediate term exposures are
identical to short term. The risks are identical to short term exposure
in Table 10. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. DWLOCs were
calculated using food alone, and together with residential exposure
data. The handler exposure scenario which resulted in the greatest risk
(Scenario 1, Hand or Shaker Can Application to Garden Vegetables) was
used in the calculation. DWLOC values were calculated and the results
are shown in Table 12. The DWLOC for food alone scenario and Food and
Home Gardener Handler (Hand Application) scenario are greater than the
EEC which means that the cancer risks are expected less than 3.0 x
10-\6\ for the aggregate exposure to food, water and
residential exposure. EPA believes that a risk estimate of this level
generally represents a negligible risk, as EPA has traditionally
applied that concept. EPA has commonly referred to a negligible risk as
one that is in the range of 1 in 1 million (1 x 10-\6\).
Quantitative cancer risk assessment is not a precise science. There are
a significant number of uncertainties in both the toxicology used to
derive the cancer potency of a substance and in the data used to
measure and calculate exposure. Thus, EPA generally considers numerical
estimates as high as 3.0 x 10-\6\ to be within the range of
1 in 1 million. Therefore, EPA considers the carcinogenic risk from
DCPA to be negligible within the meaning of that standard as it has
been traditionally applied by EPA.
Table 12.--DWLOC Calculations for DCPA (Based upon a target cancer risk of 3.0 x 10-\6\)
----------------------------------------------------------------------------------------------------------------
Food and Home Gardener Handler
Food Alone (Hand Application)
----------------------------------------------------------------------------------------------------------------
Dietary Food Exposure\A\ 0.097 [mu]g/kg/day 0.097 [mu]g/kg/day
-----------------------------------------
Residential Exposure\A\ N/A 0.35 [mu]g/kg/day
-----------------------------------------
Aggregate Cancer Exposure 0.097 [mu]g/kg/day 0.45 [mu]g/kg/day
-----------------------------------------
Target Maximum Exposure\B\ 2.0 [mu]g/kg/day 2.0 [mu]g/kg/day
-----------------------------------------
Max Water Exposure\C\ 1.9 [mu]g/kg/day 1.6 [mu]g/kg/day
-----------------------------------------
Cancer DWLOC\D\ 67 [mu]g/Liter 54 [mu]g/Liter
-----------------------------------------
acre (PCA = 0.87) 33 [mu]g/Liter (36-year mean)
-----------------------------------------
10.5 lb ai/acre (PCA = 0.87) 15 [mu]g/Liter (36-year mean)
-----------------------------------------
10.5 lb ai/acre (PCA = 0.87) 19 [mu]g/Liter (36-year mean)
-----------------------------------------
acre 0.17 [mu]g/Liter (90-day average)
-----------------------------------------
acre 0.25 [mu]g/Liter (90-day average)
----------------------------------------------------------------------------------------------------------------
\A\The food and residential exposures are expressed in ug/kg/day rather than mg/kg/day.
\B\Target Maximum Exposure (ug/kg/day) = 3.0 x 10-\6\ /Q1* X 1,000 ug/mg where Q1* = 1.5 x 10-\3\ mg/kg/day
\C\Maximum Water Exposure (ug/kg/day) = [Target Maximum Exposure - (Food Exposure + Residential Exposure)]
\D\Cancer DWLOC([mu]g/liter) = [maximum water exposure ([mu]g/kg/day) x body weight (kg)] / [water consumption
(liter)]
[[Page 51581]]
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to residues of DCPA.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: residuemethods@epa.gov.
B. International Residue Limits
There are no Codex Maximum Residue Levels (MRLs) for DCPA residues;
therefore no compatibility issues exist. There are Canadian MRLs
ranging from 1-5 ppm in or on leaf crops, cole crops, cucurbits,
legumes, root crops, fruiting vegetables, bulb vegetables and
strawberries,. The Canadian MRLs appear to only include the parent
compound, but are numerically identical to U.S. tolerances.
V. Conclusion
Therefore, tolerances are established for combined residues of the
herbicide DCPA, dimethyl tetrachloroterephthalate, and its metabolites
monomethyl tetrachloroterephthalate (MTP) and tetrachloroterephthalate
(TPA) (calculated as dimethyl tetrachloroterephthalate) in or on basil,
dried leaves at 5.0 ppm, basil, fresh leaves at 20.0 ppm, celeriac at
2.0 ppm, chicory, roots at 2.0 ppm, chicory, tops at 5.0 ppm, chive at
5.0 ppm, coriander, leaves at 5.0 ppm, dill at 5.0 ppm, ginseng at 2.0
ppm, marjoram at 5.0 ppm, parsley, leaves at 5.0 ppm, parsley, dried
leaves at 20 ppm, radicchio at 5.0 ppm, and radish, oriental at 2.0
ppm.
In addition, this regulatory action is part of the tolerance
reassessment requirements of section 408(q) of the Federal Food, Drug,
and Cosmetics Act (FFDCA) 21 U.S.C. 346a(q), as amended by the Food
Quality Protection Act (FQPA) of 1996. By law, EPA is required to
reassess all tolerances in existence on August 2, 1996 by August 2006.
This regulatory action will count for 38 reassessments toward the
August 2006 deadline.
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 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-2004-0200 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
19, 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 14th 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-2004-0200, 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 issues(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 establishes 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
[[Page 51582]]
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 established 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 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 A. 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 180.185 is amended to read as follows:
0
i. In paragraph (a), by adding a heading and by alphabetically adding
commodities to the table;
0
ii. By redesignating paragraph (b) as paragraph (c) and adding a
heading; and
0
iii. By adding and reserving with headings new paragraphs (b) and (d)
to read as follows:
Sec. 180.185 Dimethyl tetrachloroterephthalate; tolerances for
residues.
(a) General. * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Basil, dried leaves........................................ 5.0
Basil, fresh leaves........................................ 20.0
* * * * *
Celeriac................................................... 2.0
Chicory, roots............................................. 2.0
Chicory, tops.............................................. 5.0
Chive...................................................... 5.0
Coriander, leaves.......................................... 5.0
* * * * *
Dill....................................................... 5.0
* * * * *
Ginseng.................................................... 2.0
* * * * *
Marjoram................................................... 5.0
* * * * *
Parsley, leaves............................................ 5.0
Parsley, dried leaves...................................... 20.0
* * * * *
Radicchio.................................................. 5.0
Radish, oriental........................................... 2.0
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. * * *
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 04-19035 Filed 8-19-04; 8:45 am]
BILLING CODE 6560-50-S