[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Rules and Regulations]
[Pages 52487-52494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14642]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0664; FRL-8089-3]


Paraquat Dichloride; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
paraquat dichloride in or on various food and feed commodities. The 
tolerances were requestd by Syngenta Crop Protection Inc. through 
submission of several pesticide petitions. Syngenta Crop Protection 
Inc. 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 September 6, 2006. Objections and 
requests for hearings must be received on or before November 6, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0664. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information

[[Page 52488]]

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 in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP 
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. The 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: Hope Johnson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-305-5410; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    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. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0664 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 6, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0664, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 29, 2005 (70 FR 124) (FRL-7718-8), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of pesticide petitions (PP 1E6332, PP 
1E6319, PP 1E6223, PP 2F6433, PP 3E6763) by Syngenta Crop Protection 
Inc, P.O. Box 18300, Greensboro, NC 27419-8300. The petitions requested 
that 40 CFR 180.205 be amended by establishing tolerances for residues 
of the herbicide paraquat dichloride as follows: In or on okra at 0.05 
ppm (PP 1E6332); onion (dry bulb) at 0.1 ppm (PP 1E6319); tanier at 
0.05 ppm (PP 1E6223); animal feed, nongrass, group at 5.0; barley, hay 
at 3.0 ppm; barley, straw at 1.0 ppm; beet, sugar, tops at 0.05 ppm ; 
berry group at 0.05 ppm; cattle, kidney at 0.3 ppm; cotton gin 
byproducts at 82.0 ppm; cotton, seed at 5.0 ppm; cranberry at 0.05 ppm; 
; fruit, pome, group at 0.05 ppm; fruit, stone, group at 0.05 ppm; 
goat, kidney at 0.3 ppm; grape at 0.05 ppm; hog, kidney at 0.3 ppm; 
hops, cone, dry at 0.5 ppm; horse, kidney at 0.3 ppm; nut, tree, group 
at 0.05 ppm; pea and bean, dried shelled, except soybean, subgroup at 
0.30 ppm; pea and bean, succulent, shelled, subgroup at 0.05 ppm; 
sheep, kidney at 0.3 ppm; sorghum, forage at 0.1 ppm; soybean, seed at 
0.70 ppm; soybean, forage at 0.40 ppm; soybean, hay at 6.0 ppm; 
soybean, aspirated grain fractions at 60.0 ppm; vegetable, brassica 
leafy, group at 0.05 ppm; vegetable, cucurbit, group at 0.05 ppm; 
vegetable, fruiting, group at 0.05 ppm; vegetable, legume, edible-
podded, subgroup at 0.05 ppm; wheat, grain at 1.5 ppm; wheat, forage at 
0.40 ppm; wheat, hay at 3.0 ppm; wheat, straw at 40.0 ppm; wheat, 
aspirated grain fractions at 65.0 ppm (PP 2F6433); ginger at 0.1 ppm 
(PP 3E6763). That notice included a summary of the petition prepared by 
Syngenta Crop Protection Inc., the registrant. As a result of the 
review of the residue field trials, the proposed tolerance level for 
barley, hay was subsequently revised to 3.5 ppm. One comment was 
received on the notice of filing. EPA's response to this comment is 
discussed in Unit IV (C) below.
    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

[[Page 52489]]

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 the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of paraquat dichloride 
on animal feed, nongrass, group 18, forage at 75 ppm; animal feed, 
nongrass, group 18, hay at 210 ppm; barley, hay at 3.5 ppm; barley, 
straw at 1.0 ppm; beet, sugar, tops at 0.05 ppm; berry group 13 at 0.05 
ppm; cattle, kidney at 0.50 ppm; cotton, gin byproducts at 110 ppm; 
cotton, undelinted seed at 3.5 ppm; cranberry at 0.05 ppm; fruit, pome, 
group 11 at 0.05 ppm; fruit, stone, group 12 at 0.05 ppm; ginger at 
0.10 ppm; goat, kidney at 0.50 ppm; grain, aspirated fractions at 65 
ppm; grape at 0.05 ppm; hog, kidney at 0.50 ppm; hop, dried cones at 
0.50 ppm; horse, kidney at 0.50 ppm; nut, tree, group 14 at 0.05 ppm; 
okra at 0.05 ppm; onion, bulb at 0.10 ppm; pea and bean, dried shelled, 
except soybean, subgroup 6C, except guar bean at 0.30 ppm; pea and 
bean, succulent shelled, subgroup 6B at 0.05 ppm; sheep, kidney at 0.50 
ppm; sorghum, forage, forage at 0.10 ppm; sorghum, grain, forage at 
0.10 ppm; soybean, forage at 0.40 ppm; soybean, hay at 10 ppm; soybean, 
hulls at 4.5 ppm; soybean, seed at 0.70 ppm; vegetable, Brassica leafy, 
group 5 at 0.05 ppm; vegetable, cucurbit, group 9 at 0.05 ppm; 
vegetable, fruiting, group 8 at 0.05 ppm; vegetable, legume, edible 
podded, subgroup 6A at 0.05 ppm; wheat, forage at 0.50 ppm; wheat, 
grain at 1.1 ppm; wheat, hay at 3.5 ppm; and wheat, straw at 50 ppm. 
Additionally, EPA has determined that the current tolerance with 
regional registrations for residues of paraquat dichloride on tanier at 
0.05 ppm may be extended to the State of Florida. 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. Specific information on the studies received and the nature 
of the toxic effects caused by paraquat dichloride as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the index of docket ID number EPA-HQ-OPP-2006-
0664.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for dichloride used for 
human risk assessment is shown in Table 1 of this unit:

 Table 1.--Summary of Toxicological Dose and Endpoints for paraquat dichloride for Use in Human Risk Assessment
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                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
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Acute Dietary (Females 13-50 years of  NOAEL = 1.25 mg/kg/day   Special FQPA SF = 1X     Multi-generation rat
 age)                                  UF = 300...............  aPAD = 0.0042 mg/kg/day   study LOAEL = 3.75 mg/
                                       Acute RfD = 0.0125 mg/                             kg/day based on
                                        kg/day.                                           increased invidences
                                                                                          of alveolar
                                                                                          histiocytes in both
                                                                                          sexes
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      NOAEL = 1.25 mg/kg/day   Special FQPA SF = 1X     Multi-generation rat
 including infants and children)       UF = 100...............  aPAD = 0.0125 mg/kg/day   study LOAEL = 3.75 mg/
                                       Acute RfD = 0.0125 mg/                             kg/day based on
                                        kg/day.                                           increased incidences
                                                                                          of alveolar
                                                                                          histiocytes in both
                                                                                          sexes
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 0.45 mg/kg/day    Special FQPA SF = 1X     Chronic toxicity in
                                       UF = 100...............  cPAD = 0.0045 mg/kg/day   dogs LOAEL = 0.93 mg/
                                       Chronic RfD = 0.0045 mg/                           kg/day based on
                                        kg/day.                                           increased severity of
                                                                                          chronic pneumonitis
                                                                                          and gross lung lesions
                                                                                          in both sexes, and
                                                                                          focal pulmonary
                                                                                          granulomas in males
----------------------------------------------------------------------------------------------------------------

[[Page 52490]]

 
Short-Term/Intermediate-Term Dermal    NOAEL = 1.25 mg/kg/day   LOC = MOE = 100          Multi-generation rat
 (1 day to 6 months)                    (dermal absorption                                study LOAEL = 3.75 mg/
                                        factor = 0.3%)                                    kg/day based on
                                                                                          increased incidences
                                                                                          of alveolar
                                                                                          histiocytes in both
                                                                                          sexes
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (> 6 months)          NOAEL= 0.45 mg/kg/day    LOC = MOE = 100          Chronic toxicity in
                                        (dermal absorption                                dogs LOAEL = 0.93 mg/
                                        factor = 0.3%)                                    kg/day based on
                                                                                          increased severity of
                                                                                          chronic pneumonitis
                                                                                          and gross lung lesions
                                                                                          in both sexes, and
                                                                                          focal pulmonary
                                                                                          granulomas in males
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term, Long-   NOAEL= 0.01 [mu]g/L      LOC = MOE = 100          21-day inhalation
 TermInhalation (1 to > 6 months)       (inhalation absorption                            toxicity study LOAEL =
                                        factor = 100%)                                    0.10 [mu]g/L based on
                                                                                          squamous keratinizing
                                                                                          metaplasia and
                                                                                          hyperplasia of the
                                                                                          epithelium of the
                                                                                          larynx
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)        Classification: Category E (evidence of non-carcinogenicity to humans)
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
previously established (40 CFR 180.205) for the residues of paraquat 
dichloride, in or on a variety of raw agricultural commodities, 
including egg, milk, and the meat, fat and meat by-products of cattle, 
goats, hogs, horses, and sheep. Risk assessments were conducted by EPA 
to assess dietary exposures from paraquat dichloride in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    The Dietary Exposure Evaluation Model (DEEM-FCID\TM\, Version 2.03) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 Nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and a supplemental children's survey 
conducted in 1998 and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the acute exposure 
assessments: A partially refined, probabilistic acute dietary exposure 
assessment using tolerance-level residues for all registered and 
proposed commodities, maximum estimates of percent crop treated 
information for some registered commodities, and DEEM default 
processing factors for some commodities, was conducted for the general 
U.S. population and various population subgroups. Drinking water was 
incorporated directly into the dietary assessment using a high-end 
monitoring value of 1.52 ppb.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\, Version 2.03), which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII), and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: A partially refined, chronic dietary exposure assessment 
using tolerance-level residues for all registered and proposed 
commodities, average estimates of percent crop treated information for 
some registered commodities, and DEEM default processing factors for 
some commodities, was conducted for the general U.S. population and 
various population subgroups. Drinking water was incorporated directly 
into the dietary assessment using a high-end monitoring value of 1.52 
ppb.
    iii. Cancer. Paraquat dichloride is a Category E chemical (evidence 
of non-carcinogenicity to humans).
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on 
the actual percent of food treated for assessing chronic dietary risk 
only if the Agency can make the following findings: Condition 1, that 
the data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows:
    For the acute assessment, maximum percent crop treated information 
was used on the following commodities: alfalfa 2.5%, almonds 30%, 
apples 30%, apricots 20%, artichokes 40%, asparagus 15%, avocados 5%, 
barley 2.5%, green beans 3%, blackberries 40%, blueberries 15%, 
broccoli 3%, Brussels sprouts 3%, cabbage 3%, cantaloupes 3%, carrots 
3%, cherries 30%, corn 5%, cotton 20%, cucumbers 30%, dry beans/peas 
5%, eggplant 20%, figs 10%, garlic 5%, grapefruit 5%, grapes 55%, 
hazelnuts (filberts) 70%, kiwifruit 3%, lemons 3%, lettuce 3%, 
nectarines 25%, olives 10%, onions 5%, oranges 10%, peaches 40%, 
peanuts 35%, pears 15%, green peas 3%, pecans 15%, peppers 30%, 
pistachios 45%, potatoes 5%, prunes and plums 20%, pumpkins 5%, 
raspberries 75%, rice 2.5%, safflower 2.5%, sorghum 2.5%, soybeans 
2.5%, squash 10%, strawberries 25%, sugar beets 2.5%, sugarcane 5%, 
sunflowers 2.5%, sweet corn 5%, tangelos 30%, tangerines 10%, tomatoes 
15%, walnuts 20%, watermelons 10%, and wheat 2.5%.
    For the chronic assessment, average percent crop treated 
information was

[[Page 52491]]

used on the following commodities: alfalfa 1%, almonds 30%, apples 20%, 
apricots 10%, artichokes 30%, asparagus 10%, avocados 1%, barley 1%, 
green beans 1%, blackberries 30%, blueberries 10%, broccoli 1%, cabbage 
1%, cantaloupes 1%, carrots 1%, cherries 20%, corn 1%, cotton 20%, 
cucumbers 5%, dry beans/peas 1%, eggplant 20%, figs 10%, garlic 1%, 
grapefruit 5%, grapes 20%, hazelnuts (filberts) 55%, hops 80%, 
kiwifruit 1%, lemons 1%, lettuce 1%, nectarines 15%, olives 5%, onions 
1%, oranges 5%, peaches 30%, peanuts 25%, pears 10%, green peas 1%, 
pecans 10%, peppers 10%, pistachios 30%, potatoes 5%, prunes and plums 
15%, pumpkins 5%, raspberries 70%, rice 1%, safflower 1%, sorghum 1%, 
soybeans 1%, squash 5%, strawberries 15%, sugar beets 1%, sugarcane 5%, 
sunflowers 1%, sweet corn 1%, tangelos 20%, tangerines 5%, tomatoes 5%, 
walnuts 15%, watermelons 5%, and wheat 1%.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available Federal, State, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of 5% except for those situations in which the average 
PCT is less than one. In those cases 1% is used as the average. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the single maximum value reported overall from available 
Federal, State, and private market survey data on the existing use, 
across all years, and rounded up to the nearest multiple of 5%, except 
for those situations in which the maximum PCT is 2.5%. In those cases, 
2.5% is used as the maximum. In most cases, EPA uses available data 
from United States Department of Agriculture/National Agricultural 
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the 
National Center for Food and Agriculture Policy (NCFAP) for the most 
recent 6 years.
    2. Dietary exposure from drinking water. Paraquat dichloride 
undergoes minimal degradation in the environment, and thus is very 
persistent (as parent). However, its very high propensity to bind to 
solids, particularly clay, makes it very immobile. In addition, 
paraquat dichloride does not readily appear to desorb from clay. The 
greatest cause for concern is likely to be erosion of contaminated 
sediments off-site and subsequent redeposition onto non-target areas 
(especially surface water bodies). There is an additional (minor) 
concern for the one proposed new usage (wheat) that includes aerial 
spray; however, this use entails very small amounts (relative to all 
other uses), so spray drift onto nearby surface water drinking water 
sources should be fairly limited. Because of its very low mobility and 
strong tendency to bind tightly to soils, paraquat dichloride 
contamination of drinking water supplies derived from groundwater is 
expected to be highly unlikely. In addition, the strong binding 
characteristics of paraquat dichloride are likely to render most 
residues in raw drinking water sources removable through sedimentation 
processes, which are typically included as part of standard drinking 
water treatments.
    Because of its strong cation-exchange sorption to soils, modeling 
is not appropriate for paraquat dichloride. In most circumstances, the 
levels of paraquat dichloride residues in surface or ground water are 
expected to be insignificant. Because it should sorb to suspended 
sediment, coagulation and flocculation processes in drinking water 
treatment plants are likely to remove any paraquat dichloride residues 
present in the raw water. Residues of paraquat dichloride in drinking 
water derived from surface supplies can therefore be assumed to be 
negligible. For residues in ground water however, the EPA used the 
value of 1.52 ppb reported in Virginia, for human exposure assessment, 
as this represents a high-end, but not worst-case value from the 
available monitoring data. As a result, the groundwater monitoring 
value of 1.52 ppb was used for both the acute and chronic analyses. 
This estimate of drinking water concentration was directly entered into 
the dietary exposure model (DEEM-FCID\TM\).
    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 dichloride is not registered for use on any sites that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to paraquat dichloride and 
any other substances and paraquat dichloride 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 paraquat 
dichloride 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 
Office of Pesticide Programs concerning common mechanism determinations 
and procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website 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 database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Prenatal developmental 
studies in rats and mice show that developmental effects only occur in 
the presence of maternal toxicity. No effect on reproduction was 
observed. Fetal effects were limited to delayed ossification and 
decreased body weights. There was no indication from these studies that 
paraquat dichloride is involved in endocrine disruption.
    3. Conclusion. The toxicological database for paraquat dichloride 
is incomplete, lacking an acceptable prenatal developmental study in a 
non-rodent species. However, four acceptable developmental studies in 
rats and mice have been submitted for paraquat dichloride, and the 
Agency

[[Page 52492]]

considers the toxicology database adequate for hazard characterization, 
and to address FQPA concerns. The Agency is retaining a 3x uncertainty 
factor for the acute dietary subpopulation Females 13-49 years old 
because of residual concerns for developing fetuses. All other 
populations will have a 1x safety factor. The FQPA safety factor was 
reduced to (1x) for the following reasons:
    (i) There is no evidence of neurotoxicity;
    (ii) There is no indication of quantitative or qualitative 
increased susceptibility of rats or mice to in utero and/or prenatal/
postnatal exposure of rats;
    (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 
dichloride.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
paraquat dichloride will occupy 33% of the aPAD for the U.S. 
population, 54% of the aPAD for females 13-49 years old, 52% of the 
aPAD for all infants (<1 year old), and 66% of the aPAD for children 1-
2 years old. Acute aggregate risk consists of risks resulting from 
exposure to residues in food and drink water only. The acute dietary 
exposure analysis included both food and drinking water, and as a 
result, the acute aggregate risk assessment is equivalent to the acute 
dietary analysis.

   Table 2.--Aggregate Risk Assessment for Acute Exposure to paraquat
                               dichloride
------------------------------------------------------------------------
                                               Dietary
           Population Subgroup             Exposure(mg/kg/      % aPAD
                                                 day)
------------------------------------------------------------------------
General U.S. Population                            0.004064           33
------------------------------------------------------------------------
All Infants (<1 year old)                          0.006550           52
------------------------------------------------------------------------
Children 1-2 years old                             0.008240           66
------------------------------------------------------------------------
Females 13-49 years old                            0.002284           54
------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to paraquat 
dichloride from food will utilize 8% of the cPAD for the U.S. 
population, 13% of the cPAD for all infants (<1 year old), and 26% of 
the cPAD for children 1-2 years old. There are no residential uses for 
paraquat dichloride that result in chronic residential exposure to 
paraquat dichloride. Chronic aggregate risk consists of risks resulting 
from exposure to residues in food and drink water only. The chronic 
dietary exposure analysis included both food and drinking water, and as 
a result, the chronic aggregate risk assessment is equivalent to the 
chronic dietary analysis.

Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to
                           paraquat dichloride
------------------------------------------------------------------------
                                           Dietary Exposure
           Population/Subgroup               (mg/kg/day)        %/cPAD
------------------------------------------------------------------------
General U.S. Population                            0.000353            8
------------------------------------------------------------------------
All Infants (<1 year old)                          0.000584           13
------------------------------------------------------------------------
Children 1-2 years old                             0.001175           26
------------------------------------------------------------------------
Females 13-49 years old                            0.000250            6
------------------------------------------------------------------------

    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).
    Paraquat dichloride 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 does not exceed the 
Agency's level of concern.
    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).
    Paraquat dichloride 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 does not exceed the 
Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Paraquat dichloride 
is a Category E chemical (evidence of non-carcinogenicity in humans). 
As a result, an aggregate cancer risk assessment was not conducted.
    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 paraquat dichloride 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. Method 
IA of PAM Volume II (spectrophotometric) is available for animal 
tolerance enforcement purposes. Method 4B of PAM Volume II (HPLC) is 
also available for animal tolerance enforcement purposes.

[[Page 52493]]

    Adequate enforcement methodology (specify method; example--gas 
chromatography) 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

    The Codex Alimentarius Commission has established several maximum 
residue limits (MRLs) for paraquat dichloride residues in various 
commodities. The Codex and U.S. tolerances are in harmony with respect 
to MRL/tolerance expression; both regulate the parent paraquat cation 
only. Compatibility between U.S. tolerances and Codex MRLs exists for 
eggs, passion fruit, sunflower seed, and vegetables [including Brassica 
leafy vegetables, carrots, cassava, corn (sweet), edible podded legume 
vegetables, fruiting vegetables, lettuce, onions (green), pigeon peas, 
turnips (roots and tops), and yams], milk and ruminant tissue, and 
poultry eggs. Incompatibilities of U.S. tolerances and Codex MRLs on 
the following raw plant commodities remain because of differences in 
agricultural practices: cotton seed, dry hops, maize, olives, sorghum, 
dry soya bean and certain vegetables (such as bulb onion). No Canadian 
or Mexican MRLs have been established for paraquat dichloride.

C. Response to Comments

    Several comments were received from a private citizen objecting to 
pesticide body load, IR-4 profiteering, animal testing, establishing 
tolerances, and pesticide residues. The Agency has received these same 
comments from this commenter on numerous previous occasions. Refer to 
the following Federal Register cites: 70 FR 37686, June 30, 2005; 70 FR 
1354, January 7, 2005;, 69 FR 63096-63098, October 29, 2004; for the 
Agency's response to these objections.

V. Conclusion

    Therefore, tolerances are established for residues of paraquat 
dichloride in or on animal feed, nongrass, group 18, forage at 75 ppm; 
animal feed, nongrass, group 18, hay at 210 ppm; barley, hay at 3.5 
ppm; barley, straw at 1.0 ppm; beet, sugar, tops at 0.05 ppm; berry 
group 13 at 0.05 ppm; cattle, kidney at 0.50 ppm; cotton, gin 
byproducts at 110 ppm; cotton, undelinted seed at 3.5 ppm; cranberry at 
0.05 ppm; fruit, pome, group 11 at 0.05 ppm; fruit, stone, group 12 at 
0.05 ppm; ginger at 0.10 ppm; goat, kidney at 0.50 ppm; grain, 
aspirated fractions at 65 ppm; grape at 0.05 ppm; hog, kidney at 0.50 
ppm; hop, dried cones at 0.50 ppm; horse, kidney at 0.50 ppm; nut, 
tree, group 14 at 0.05 ppm; okra at 0.05 ppm; onion, bulb at 0.10 ppm; 
pea and bean, dried shelled, except soybean, subgroup 6C, except guar 
bean at 0.30 ppm; pea and bean, succulent shelled, subgroup 6B at 0.05 
ppm; sheep, kidney at 0.50 ppm; sorghum, forage, forage at 0.10 ppm; 
sorghum, grain, forage at 0.10 ppm; soybean, forage at 0.40 ppm; 
soybean, hay at 10 ppm; soybean, hulls at 4.50 ppm; soybean, seed at 
0.70 ppm; vegetable, Brassica leafy, group 5 at 0.05 ppm; vegetable, 
cucurbit, group 9 at 0.05 ppm; vegetable, fruiting, group 8 at 0.05 
ppm; vegetable, legume, edible podded, subgroup 6A at 0.05 ppm; wheat, 
forage at 0.50 ppm; wheat, grain at 1.1 ppm; wheat, hay at 3.5 ppm; and 
wheat, straw at 50 ppm..

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 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

[[Page 52494]]

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.

VII. 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 25, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.205, the table to paragraph (a) is amended as follows:
0
a. By adding entries for animal feed, nongrass, group 18, forage; 
animal feed, nongrass, group 18, hay; barley, hay; barley, straw; 
berry, group 13; cotton, gin byproducts; cranberry; fruit, pome group 
11; fruit, pome group 12; grain, aspirated fractions; ginger; grape; 
okra; nut, tree, group 14; onion, bulb; pea and bean, dried shelled, 
except soybean, subgroup 6C, except guar bean; pea and bean, succulent 
shelled, subgroup 6B; sorghum, forage, forage; sorghum, grain, forage; 
soybean, hay; soybean, hulls; soybean, seed; vegetable, Brassica leafy, 
group 5; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; 
vegetable, legume, edible podded, subgroup 6A; wheat, forage; wheat, 
hay; and wheat, straw.
0
b. By revising the entries for beet, sugar, tops; cattle, kidney; 
cotton, undelinted seed; goat, kidney; hog, kidney; hop, dried cone; 
horse, kidney; sheep, kidney; soybean, forage; and wheat, grain.
0
c. By removing from the table in paragraph (a) the entries for onion, 
dry bulb; sorghum, forage; and vegetable, fruiting.


Sec.  180.205  Paraquat; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Animal feed, nongrass, group 18, forage....................           75
Animal feed, nongrass, group 18, hay.......................          210
                                * * * * *
Barley, hay................................................          3.5
Barley, straw..............................................          1.0
                                * * * * *
Beet, sugar, tops..........................................         0.05
Berry group 13.............................................         0.05
                                * * * * *
Cattle, kidney.............................................         0.50
                                * * * * *
Cotton, gin byproducts.....................................          110
Cotton, undelinted seed....................................          3.5
Cranberry..................................................         0.05
                                * * * * *
Fruit, pome, group 11......................................         0.05
Fruit, pome, group 12......................................         0.05
Ginger.....................................................         0.10
Goat, kidney...............................................         0.50
                                * * * * *
Grain, aspirated fractions.................................           65
Grape......................................................         0.05
                                * * * * *
Hog, kidney................................................         0.50
                                * * * * *
Hop, dried cones...........................................         0.50
                                * * * * *
Horse, kidney..............................................         0.50
                                * * * * *
Nut, tree, group 14........................................         0.05
Okra.......................................................         0.05
                                * * * * *
Onion, bulb................................................         0.10
                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C,           0.30
 except guar bean..........................................
Pea and bean, succulent shelled, subgroup 6B...............         0.05
                                * * * * *
Sheep, kidney..............................................         0.50
                                * * * * *
Sorghum, forage, forage....................................         0.10
                                * * * * *
Sorghum, grain, forage.....................................         0.10
                                * * * * *
Soybean, forage............................................         0.40
Soybean, hay...............................................           10
Soybean, hulls.............................................          4.5
Soybean, seed..............................................         0.70
                                * * * * *
Vegetable, Brassica leafy, group 5.........................         0.05
Vegetable, cucurbit, group 9...............................         0.05
                                * * * * *
Vegetable, fruiting, group 8...............................         0.05
Vegetable, legume, edible podded, subgroup 6A..............         0.05
                                * * * * *
Wheat, forage..............................................         0.50
Wheat, grain...............................................          1.1
Wheat, hay.................................................          3.5
Wheat, straw...............................................           50
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-14642 Filed 9-5-06; 8:45 am]
BILLING CODE 6560-50-S