[Federal Register Volume 69, Number 161 (Friday, August 20, 2004)]
[Rules and Regulations]
[Pages 51571-51582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19035]


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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: 
[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

[[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
----------------------------------------------------------------------------------------------------------------
             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.
----------------------------------------

[[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
----------------------------------------------------------------------------------------------------------------
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
--------------------------------------
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
--------------------------------------

[[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
-----------------------------------------
Surface Water EEC - PA Turf @ 15 lb ai/
 acre (PCA = 0.87)                                             33 [mu]g/Liter (36-year mean)
-----------------------------------------
Surface Water EEC - Florida Cabbage @
 10.5 lb ai/acre (PCA = 0.87)                                  15 [mu]g/Liter (36-year mean)
-----------------------------------------
Surface Water EEC - California Onions @
 10.5 lb ai/acre (PCA = 0.87)                                  19 [mu]g/Liter (36-year mean)
-----------------------------------------
Ground Water EEC - Any Crop @ 10.5 lb ai/
 acre                                                        0.17 [mu]g/Liter (90-day average)
-----------------------------------------
Ground Water EEC - Any Crop @ 15 lb ai/
 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: [email protected].

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: [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 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]
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