[Federal Register Volume 66, Number 184 (Friday, September 21, 2001)]
[Rules and Regulations]
[Pages 48593-48601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23606]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301178; FRL-6799-2]
RIN 2070-AB78


Paraquat; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
paraquat in or on dry pea; endive; field corn grain, forage and stover; 
pop corn grain and stover; globe artichoke; and persimmon. The 
Interregional Research Project Number 4 (IR-4) and Zeneca Ag. Products 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA). This final rule establishes permanent tolerances for paraquat 
and as part of that process the Agency has reassessed existing 
tolerances. By law, EPA is required to reassess 66% of the tolerances 
in existence on August 2, 1996, by August 2002, or about 6,400 
tolerances. All permanent tolerances for paraquat that existed on 
August 2, 1996, were previously reassessed by the Paraquat Dichloride 
Reregistration Eligibility Document signed September 30, 1996. 
Consequently, regarding the actions in this final rule, no tolerance 
reassessments are counted toward the August 2002 review deadline of 
FFDCA section 408(q).

DATES: This regulation is effective September 21, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301178, 
must be received by EPA on or before November 20, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301178 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9368; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules'', and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to theFederal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/

[[Page 48594]]

opptsfrs/home/guidelin.htm. A frequently updated electronic version of 
40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under 
development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301178. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of October 7, 1998 (63 FR 53902) (FRL-6026-
3), December 3, 1999 (64 FR 67905) (FRL-6392-6), and June 21, 2000 (65 
FR 38535) (FRL-6558-9), EPA issued notices pursuant to section 408 of 
the FFDCA, 21 U.S.C. 346a as amended by the FQPA (Public Law 104-170) 
announcing the filing of pesticide petitions (PP) for a tolerance by 
the IR-4, 681 U.S. Highway # 1 South, North Brunswick, NJ 08902-3390 
and Zeneca Ag. Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, 
DE 19850-5458. These notices included summaries of the petitions 
prepared by Zeneca Ag. Products, the registrant. There were no comments 
received in response to the notice of filings.
    The petitions requested that 40 CFR 180.205 be amended by 
establishing tolerances for residues of the desiccant, defoliant and 
herbicide paraquat, 1,1'-dimethyl-4,4'-bipyridinium-ion, derived from 
application of the dichloride salt (calculated as the cation), in or on 
various food commodities, as follows:
    1. PP 5F1625, submitted by Zeneca Ag. Products, proposed tolerances 
for field corn and pop corn grain at 0.05 part per million (ppm); field 
corn and pop corn forage at 3.0 ppm; field corn and pop corn stover at 
10.0 ppm. The proposed tolerance for field corn and pop corn grain was 
increased to 0.1 ppm to harmonize with the Codex maximum residue limit 
(MRL) of 0.1 ppm for maize.
    2. Food additive petition 5H5088, submitted by Zeneca Ag. Products, 
proposed a food additive tolerance for corn flour at 0.1 ppm. The 
proposed tolerance for corn flour was subsequently withdrawn since EPA 
determined that the tolerance for field corn grain at 0.1 ppm is 
adequate to cover residues in corn flour.
    3. PP 1E4019, submitted by IR-4, proposed a tolerance for globe 
artichoke at 0.05 ppm.
    4. PP 9E6026, submitted by IR-4, proposed a tolerance for endive at 
0.05 ppm.
    5. PP 7E4857, submitted by IR-4, proposed a tolerance with regional 
registration for dry pea at 0.3 ppm. IR-4 proposed that registration be 
geographically limited based on the geographical representation of the 
available residue data (residue data submitted by IR-4 for dry peas are 
from Washington and Idaho). EPA concluded that there is no need to 
regionally restrict the registration for dry peas since there is 
available residue data for dry beans, which also have a tolerance at 
0.3 ppm for a similar use of paraquat.
    6. 9E6009, submitted by IR-4, proposes a tolerance for persimmon at 
0.05 ppm.
    Section 408(b)(2)(A)(i) of the 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) 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) 
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 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), 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), for tolerances for residues of paraquat on dry pea; endive; 
field corn grain, forage and stover; pop corn grain and stover; globe 
artichoke; and persimmon. EPA's assessment of exposures and risks 
associated with establishing the tolerances 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 paraquat are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3150                          Subchronic in       NOAEL = 0.5 mg/kg/
                                   nonrodents (dogs)   day
                                                      LOAEL = 1.5 mg/kg/
                                                       day based on
                                                       increased
                                                       absolute and
                                                       relative lung
                                                       weight,
                                                       alveolitis and
                                                       alveolar
                                                       collapse.
------------------------------------------------------------------------

[[Page 48595]]

 
870.3250                          Subchronic dermal   NOAEL = 1.15 mg/kg/
                                   toxicity            day
                                   (rabbits)          LOAEL = 2.6 mg/kg/
                                                       day based on
                                                       scabbing at the
                                                       dosing site.
------------------------------------------------------------------------
870.3465                          Subchronic          NOAEL = 0.01
                                   inhalation          g/L
                                   toxicity (rats)    LOAEL = 0.1 g/L based on
                                                       nasal discharge
                                                       and squamous
                                                       keratinizing
                                                       metaplasia, and/
                                                       or hyperplasia of
                                                       the epithelium of
                                                       the larynx.
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL = 3
                                   developmental in    mg/kg/day
                                   rodents (rats)     Maternal LOAEL = 5
                                                       mg/kg/day based
                                                       on death occurred
                                                       in 2 of 30 rats
                                                       at 5 mg/kg/day
                                                       and 6 of 30 at 10
                                                       mg/kg/day.
                                                      Developmental
                                                       NOAEL = 1 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 5 mg/kg/
                                                       day based on
                                                       delayed
                                                       ossification.
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL = 1
                                   developmental in    mg/kg/day
                                   rodents (Alderley  Maternal LOAEL = 5
                                   Park mice)          mg/kg/day based
                                                       on reduction in
                                                       body weight gain.
                                                      Developmental
                                                       NOAEL = 1 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 5 mg/kg/
                                                       day based on
                                                       based on partial
                                                       ossified 4th
                                                       sternebrae.
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 1.25 mg/
                                   (Wistar-derived     kg/day
                                   Alderley Park      Parental/Systemic
                                   strain of rats)     LOAEL = 3.75 mg/
                                                       kg/day based on
                                                       increased
                                                       incidence of
                                                       alveolar
                                                       histiocytes .
                                                      Reproductive NOAEL
                                                        7.5
                                                       mg/kg/day
------------------------------------------------------------------------
870.4100                          Chronic toxicity/   NOAEL = 1.25 mg/kg/
                                   carcinogenicity     day
                                   rodents (Fisher    LOAEL = 3.75 mg/kg/
                                   344 rats)           day based on
                                                       increased
                                                       incidence of
                                                       opacities/
                                                       cataracts in
                                                       males, ptosis/
                                                       swollen eyelids
                                                       in females, and
                                                       non-neoplastic
                                                       lung lesions in
                                                       male non-
                                                       survivors.
------------------------------------------------------------------------
870.4100                          Chronic toxicity/   NOAEL = 4.15 mg/kg/
                                   carcinogenicity     day
                                   rodents (Wistar    LOAEL = 12.25 mg/
                                   rats)               kg/day based on
                                                       increased
                                                       mortality in
                                                       males and
                                                       females;
                                                       decreased
                                                       erythrocytes,
                                                       hemoglobin, and
                                                       serum protein in
                                                       males and
                                                       females;
                                                       decreased
                                                       hematocrit,
                                                       glucose and
                                                       corpuscular
                                                       cholinesterase
                                                       activity in
                                                       males; decreased
                                                       leucocytes,
                                                       albumin/globulin
                                                       ratio and
                                                       alkaline
                                                       phosphatase,
                                                       glutamic-
                                                       oxaloacetic
                                                       transaninase, and
                                                       glutamic-pyruvic
                                                       transaminase
                                                       activities in
                                                       females;
                                                       increased
                                                       polymorphonucleoc
                                                       ytes in males;
                                                       increased
                                                       potassium and
                                                       glucose in
                                                       females;
                                                       decreased
                                                       absolute and/or
                                                       relative weights
                                                       of heart in males
                                                       and females, and
                                                       liver and brain
                                                       in females; and
                                                       decreased
                                                       absolute weights
                                                       of kidneys in
                                                       males and females
                                                       and ovaries.
------------------------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL = 0.45 mg/kg/
                                   (dogs)              day
                                                      LOAEL = 0.93 mg/kg/
                                                       day based on a
                                                       dose-related
                                                       increase in
                                                       severity and
                                                       extent of chronic
                                                       pneumonitis.
------------------------------------------------------------------------
870.1000                          Gene mutation       Not mutagenic in
                                                       Salmonella
                                                       typhimurium assay
                                                       or genotoxic in
                                                       the Unscheduled
                                                       DNA synthesis
                                                       assay in vivo or
                                                       in vitro.
------------------------------------------------------------------------
870.5375                          Cytogenetics        In structural
                                                       chromosomal
                                                       aberration tesing
                                                       using human
                                                       lymphocytes, the
                                                       results were
                                                       weakly positive
                                                       and the sister
                                                       chromatid
                                                       exchange assay
                                                       was positive.
                                                       Paraquat was
                                                       negative for
                                                       chromasomal
                                                       aberration in the
                                                       bone marrow test
                                                       system and there
                                                       was no evidence
                                                       of suppress
                                                       fertility or
                                                       dominant lethal
                                                       mutagenicity in
                                                       mice.
------------------------------------------------------------------------


[[Page 48596]]

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    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 the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, 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 FQPA 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 is expressed as 1 x 10-\6\ or one in a million). 
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 paraquat used for human risk assessment is shown in the 
following Table 2:

       Table 2.--Summary of Toxicological Dose and Endpoints for Paraquat for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk       FQPA SF* and LOC for   Study and Toxicological
          Exposure Scenario                 Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of  NOAEL = 1.25 mg/kg/day   FQPA SF = 3X             3-Generation
 age)                                  UF = 100...............  aPAD = acute RfD          reproduction study in
                                       Acute RfD = 0.0125 mg/     FQPA SF.        rats
                                        kg/day.                 = 0.0042 mg/kg/day.....  LOAEL = 3.75 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of alveolar
                                                                                          histiocytes.
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population      NOAEL = 1.25 mg/kg/day   FQPA SF = 1X             3-Generation
 including infants and children)       UF = 100...............  aPAD = acute RfD          reproduction study in
                                       Acute RfD = 0.0125 mg/     FQPA SF.        rats
                                        kg/day.                 = 0.0125 mg/kg/day.....  LOAEL = 3.75 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of alveolar
                                                                                          histiocytes
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 0.45 mg/kg/day   FQPA SF = 1X             1-Year feeding study in
                                       UF = 100...............  cPAD = chronic RfD        dogs
                                       Chronic RfD = 0.0045 mg/   FQPA SF.       LOAEL = 0.93 mg/kg/day
                                        kg/day.                 = 0.0045 mg/kg/day.....   based on increase in
                                                                                          severity and extent of
                                                                                          chronic pneumontis
----------------------------------------------------------------------------------------------------------------
Short- and intermediate - term dermal  Oral study NOAEL = 1.25  LOC for MOE = 100        3-Generation
                                        mg/kg/day (dermal        (residential)            reproduction study in
                                        absorption rate =                                 rats
                                        0.3%)                                            LOAEL = 3.75 mg/kg/day
                                                                                          based on increased
                                                                                          incidence of alveolar
                                                                                          histiocytes
----------------------------------------------------------------------------------------------------------------
Long-term dermal (several months to    Oral study NOAEL = 0.45  LOC for MOE = 100        1-Year feeding study in
 lifetime)                              mg/kg/day (dermal        (residential)            dogs
                                        absorption rate = 0.3%                           LOAEL = 0.93 mg/kg/day
                                        when appropriate)                                 based on increase in
                                                                                          severity and extent of
                                                                                          chronic pneumonitis
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period)           Inhalation study NOAEL   LOC for MOE = 100        21-Day inhalation study
                                        = 0.01 mg/kg/day         (residential)           LOAEL = 0.1 mg/kg/day
                                        (respirable particle)                             based on squamous
                                                                                          keratinizing
                                                                                          metaplasia and/or
                                                                                          hyperlasia of the
                                                                                          epithelium of the
                                                                                          larynx; increased
                                                                                          incidence of alveolar
                                                                                          histocytes.
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period)           Oral study NOAEL = 1.25  LOC for MOE = 100        3-Generation
                                        mg/kg/day                (residential)            reproduction study
                                        (nonrespirable                                   LOAEL = 3.75 mg/kg/day
                                        particles)                                        based on increased
                                                                                          incidence of alveolar
                                                                                          histiocytes
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Not applicable           Classified as not
                                                                 likely to be a human
                                                                 carcinogen
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.205) for the residues of paraquat in or on a 
variety of raw agricultural commodities, including the meat, fat, and 
meat by-products of cattle, goats, hogs, horses and sheep and milk. 
Tolerances are

[[Page 48597]]

established for corn grain, forage and fodder at 0.05 (negligible) to 
cover residues from the preplant use of paraquat on corn. Risk 
assessments were conducted by EPA to assess dietary exposures from 
paraquat in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 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 acute 
exposure assessments: The acute exposures are based on tolerance level 
residues and some percent crop treated (PCT) refinement.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: 
The chronic exposures are based on tolerance level residues and some 
PCT refinement.
    iii. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(F) 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), 
EPA may require registrants to submit data on PCT.
    The Agency used maximum PCT information as follows: apples 48%; 
apricots 8%; asparagus 21%; avocados 3%; dry beans 3%, succulent beans 
0.6%; bell peppers 40%; berry 14%; blackberry 48%; blueberry 12%; 
cabbage 4%; carrot 2%; cauliflower 2%; cherries 46%; citrus 13%; cole 
crops 2%; cucumber (fresh) 11%, cucumber (processed) 10%; eggplant 60%; 
filbert 14%; table grape 40%, wine grape 28%, other grapes 36%; 
honeydew melon 6%; leafy vegetables 0.5%; other lettuce 4%; lemon 2%; 
cantaloupe 7%; melon 5%; nectarine 35%; olives 14%; onion 3%; orange 
9%; green pea 0.3%; peach 38%; pear 28%; peppers 36%; pistachio 7%; 
plum 47%; pome fruit 5%; potato 5%; prune 14%; pumpkins 7%; raisin 21%; 
raspberry 80%; root and tuber vegetables 0.8%; squash 39%; stone fruit 
12%; strawberry 15%; sunflower 2%; sweet corn 2%; tomato (fresh) 34%, 
tomato (processed) 11%, tomato 25%; almonds 24%; pecan 14%; walnut 29%; 
other tree nut 13%; other vegetables 21%; and watermelon 4%.
    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 paraquat may 
be applied in a particular area.
    2. Dietary exposure from drinking water. Paraquat is persistent, 
but is expected to be mostly inactivated by rapid cation exchange to 
binding sites on soil (especially clay) particles in the environment. 
Under most circumstances paraquat is unlikely to infiltrate past the 
first few centimeters of soil, or to move off-field dissolved in 
runoff. However, detections were reported in household wells at 
concentrations ranging up to 1.52 g/L.
    Because of its strong cation-exchange sorption to soils, modeling 
is not appropriate for paraquat dichloride. It should sorb to suspended 
sediment, and coagulation and flocculation processes in drinking water 
treatment plants are likely to remove any paraquat residues present in 
the raw water. Residues of paraquat in drinking water derived from 
surface supplies can therefore be assumed to be negligible. For 
residues in ground water however, EPA is using the value of 1.52 
g/L, for acute and chronic human exposure assessment, as this 
represents a high-end, but not worst-case value from the available 
monitoring data.
    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). Paraquat is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 paraquat has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
paraquat does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not

[[Page 48598]]

assumed that paraquat 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 final rule for Bifenthrin 
Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 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 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.
    2. Prenatal and postnatal sensitivity. There is no indication of 
quantitative or qualitative increased susceptibility of rats or mice to 
in utero and/or prenatal/postnatal exposure to rats.
    3. Conclusion. An FQPA safety factor is necessary for paraquat 
since there is a data gap for a prenatal developmental study conducted 
in a non-rodent species. The safety factor was reduced to 3x for 
paraquat because: (i) There is no indication of quantitative or 
qualitative increased susceptibility of rats or mice to in utero and/or 
prenatal/postnatal exposure to rats; (ii) EPA determined that a 
developmental neurotoxicity study is not required; (iii) the dietary 
(food and drinking water) exposure assessments will not underestimate 
the potential exposures for infants and children; and (iv) there are no 
registered residential uses of paraquat. The FQPA safety factor for 
paraquat is applicable to the females 13-50 years of age population 
subgroup for acute dietary risk assessment only (there are no 
residential uses). The safety factor was reduced to 1x for all other 
exposures and population subgroups.

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 the model estimates of 
a pesticide's concentration in water (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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
paraquat will occupy 32% of the aPAD for the U.S. population, 55% of 
the aPAD for females 13 years and older, 45% of the aPAD for infants, 
and 76% of the aPAD for children 1 to 6 years of age. In addition, 
there is potential for acute dietary exposure to paraquat 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 aPAD, as shown in the following Table 3:

                       Table 3.--Aggregate Risk Assessment for Acute Exposure to Paraquat
----------------------------------------------------------------------------------------------------------------
                                                                                           Ground
                     Population Subgroup                       aPAD (mg/      %aPAD      Water EEC   Acute DWLOC
                                                                  kg)         (Food)       (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                                    0.0125           32         1.52          300
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years of age)                                    0.0042           55         1.52           57
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years of age)                                     0.0125           76         1.52           30
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to paraquat 
from food will utilize 6% of the cPAD for the U.S. population, 10% of 
the cPAD for infants, and 16% of the cPAD for children 1 to 6 years of 
age. There are no residential uses for paraquat that result in chronic 
residential exposure. In addition, there is potential for chronic 
dietary exposure to paraquat 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 the following Table 4:

[[Page 48599]]



                Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Paraquat
----------------------------------------------------------------------------------------------------------------
                                                                                           Ground
                     Population Subgroup                      cPAD mg/kg/     %cPAD      Water EEC     Chronic
                                                                  day         (Food)       (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                                    0.0045            6         1.52          150
----------------------------------------------------------------------------------------------------------------
Females (13 to 50 years of age)                                    0.0045            4         1.52          130
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years of age)                                     0.0045           16         1.52           38
----------------------------------------------------------------------------------------------------------------

    3. Short-, intermediate-, and long-term risk. Short- intermediate-, 
and long-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Paraquat is not registered for use on any 
sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Paraquat has been 
classified as ``not likely to be carcinogenic in humans'' based on the 
results of carcinogenicity studies in animals. Therefore, paraquat is 
not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to paraquat residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. Method I of Pesticide Analytical Manual (PAM), 
Volume II (spectrophotometric), is adequate for plant tolerance 
enforcement purposes. In addition, Method 1B (spectrophotometric) has 
also been found to adequately recover paraquat cation residues.

B. International Residue Limits

    There are no Codex, Canadian or Mexican MRLs for residues of 
paraquat on dry peas. There is a Codex MRL for ``vegetable (except as 
otherwise listed)'' at 0.05 ppm and there is a Canadian MRL on peas at 
0.1 ppm. Based on the residue observed in dry peas from the proposed 
use, the U.S. tolerance cannot be harmonized with the Codex vegetable 
MRL.
    There is a Codex MRL for maize at 0.1 ppm defined as the paraquat 
cation (generally available as dichloride), a Canadian MRL for corn at 
0.1 ppm defined as the 1,1'-dimethyl-4,4'-bipyridinium salt, and a 
Mexican MRL for maize at 0.05 ppm defined as paraquat. The field corn 
grain tolerance recommended in this assessment matches the 0.1 ppm 
Codex maize MRL. Domestic tolerances are defined as the paraquat ion, 
which is in harmonization with international definitions. There are no 
Codex, Canadian or Mexican MRLs for paraquat on endive, persimmons, or 
globe artichokes.

V. Conclusion

    Therefore, the tolerances are established for residues of paraquat 
in or on, dry pea at 0.3 ppm; field and pop corn grain at 0.1 ppm; 
field corn forage at 3.0 ppm; field and pop corn stover at 10.0 ppm; 
endive at 0.05 ppm; globe artichoke at 0.05 ppm; and persimmon at 0.05 
ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301178 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 November 
20, 2001.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to

[[Page 48600]]

the purpose of this subsection.'' For additional information regarding 
the waiver of these fees, you may contact James Tompkins by phone at 
(703) 305-5697, by e-mail at [email protected], or by mailing a 
request for information to Mr. Tompkins at Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. 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 Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301178, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. 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. Regulatory Assessment Requirements

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to petitions submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any other 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 FFDCA section 408(d), such as the tolerances 
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 FFDCA section 408(n)(4). 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. Submission to Congress and the Comptroller General

    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

[[Page 48601]]

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: September 10, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:


    Authority: 21 U.S.C. 321(q), 346(a) and 371.


    2. Section 180.205 is amended as follows:
    i. By alphabetically adding the commodities artichoke, globe; corn, 
field, forage; corn, field grain; corn, field stover; corn, pop, grain; 
corn, pop, stover; endive; pea, dry; and persimmon to the table in 
paragraph (a).
    ii. By removing the entries for corn grain, corn fodder, and corn 
forage from the table in paragraph (a).
    iii. By removing the entries for corn flour, corn fodder, corn 
forage, corn grain and peas (dry) from the table in paragraph (b).


Sec. 180.205  Paraquat; tolerances for residues.

    (a) General.   *    *    *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                      *      *      *      *      *
Artichoke, globe..........................                          0.05
                      *      *      *      *      *
Corn, field, forage.......................                           3.0
Corn, field, grain........................                           0.1
Corn, field, stover.......................                          10.0
                      *      *      *      *      *
Corn, pop, grain..........................                           0.1
Corn, pop, stover.........................                          10.0
                      *      *      *      *      *
Endive....................................                          0.05
                      *      *      *      *      *
Pea, dry..................................                           0.3
                      *      *      *      *      *
Persimmon.................................                          0.05
                      *      *      *      *      *
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-23606 Filed 9-20-01; 8:45 am]
BILLING CODE 6560-50-S