[Federal Register: September 6, 2006 (Volume 71, Number 172)]
[Rules and Regulations]
[Page 52487-52494]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se06-23]
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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: johnson.hope@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (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/
[fxsp0]EPA-PEST/1997/November/[fxsp0]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
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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
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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
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[[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
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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
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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
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Cancer (oral, dermal, inhalation) Classification: Category E (evidence of non-carcinogenicity to humans)
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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:
residuemethods@epa.gov.
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