Paraquat; Pesticide Tolerances

[Federal Register: September 21, 2001 (Volume 66, Number 184)]
[Rules and Regulations]
[Page 48593-48601]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se01-22]

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

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301178; FRL-6799-2]
RIN 2070-AB78

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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

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

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

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

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

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

[[Page 48594]]

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

II. Background and Statutory Findings

In the Federal Register of October 7, 1998 (63 FR 53902) (FRL-6026-
3), December 3, 1999 (64 FR 67905) (FRL-6392-6), and June 21, 2000 (65
FR 38535) (FRL-6558-9), EPA issued notices pursuant to section 408 of
the FFDCA, 21 U.S.C. 346a as amended by the FQPA (Public Law 104-170)
announcing the filing of pesticide petitions (PP) for a tolerance by
the IR-4, 681 U.S. Highway # 1 South, North Brunswick, NJ 08902-3390
and Zeneca Ag. Products, 1800 Concord Pike, P.O. Box 15458, Wilmington,
DE 19850-5458. These notices included summaries of the petitions
prepared by Zeneca Ag. Products, the registrant. There were no comments
received in response to the notice of filings.
The petitions requested that 40 CFR 180.205 be amended by
establishing tolerances for residues of the desiccant, defoliant and
herbicide paraquat, 1,1'-dimethyl-4,4'-bipyridinium-ion, derived from
application of the dichloride salt (calculated as the cation), in or on
various food commodities, as follows:
1. PP 5F1625, submitted by Zeneca Ag. Products, proposed tolerances
for field corn and pop corn grain at 0.05 part per million (ppm); field
corn and pop corn forage at 3.0 ppm; field corn and pop corn stover at
10.0 ppm. The proposed tolerance for field corn and pop corn grain was
increased to 0.1 ppm to harmonize with the Codex maximum residue limit
(MRL) of 0.1 ppm for maize.
2. Food additive petition 5H5088, submitted by Zeneca Ag. Products,
proposed a food additive tolerance for corn flour at 0.1 ppm. The
proposed tolerance for corn flour was subsequently withdrawn since EPA
determined that the tolerance for field corn grain at 0.1 ppm is
adequate to cover residues in corn flour.
3. PP 1E4019, submitted by IR-4, proposed a tolerance for globe
artichoke at 0.05 ppm.
4. PP 9E6026, submitted by IR-4, proposed a tolerance for endive at
0.05 ppm.
5. PP 7E4857, submitted by IR-4, proposed a tolerance with regional
registration for dry pea at 0.3 ppm. IR-4 proposed that registration be
geographically limited based on the geographical representation of the
available residue data (residue data submitted by IR-4 for dry peas are
from Washington and Idaho). EPA concluded that there is no need to
regionally restrict the registration for dry peas since there is
available residue data for dry beans, which also have a tolerance at
0.3 ppm for a similar use of paraquat.
6. 9E6009, submitted by IR-4, proposes a tolerance for persimmon at
0.05 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of paraquat on dry pea; endive;
field corn grain, forage and stover; pop corn grain and stover; globe
artichoke; and persimmon. EPA's assessment of exposures and risks
associated with establishing the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by paraquat are
discussed in the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.

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

[[Page 48595]]

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

[[Page 48596]]

B. Toxicological Endpoints

The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the LOAEL is sometimes
used for risk assessment if no NOAEL was achieved in the toxicology
study selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for
intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-\6\ or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for paraquat used for human risk assessment is shown in the
following Table 2:

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

C. Exposure Assessment

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

[[Page 48597]]

established for corn grain, forage and fodder at 0.05 (negligible) to
cover residues from the preplant use of paraquat on corn. Risk
assessments were conducted by EPA to assess dietary exposures from
paraquat in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. The Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The following assumptions were made for the acute
exposure assessments: The acute exposures are based on tolerance level
residues and some percent crop treated (PCT) refinement.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment, the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
The chronic exposures are based on tolerance level residues and some
PCT refinement.
iii. Anticipated residue and percent crop treated information.
Section 408(b)(2)(F) states that the Agency may use data on the actual
percent of food treated for assessing chronic dietary risk only if the
Agency can make the following findings: Condition 1, that the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; Condition 2, that the exposure estimate does not underestimate
exposure for any significant subpopulation group; and Condition 3, if
data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by section 408(b)(2)(F),
EPA may require registrants to submit data on PCT.
The Agency used maximum PCT information as follows: apples 48%;
apricots 8%; asparagus 21%; avocados 3%; dry beans 3%, succulent beans
0.6%; bell peppers 40%; berry 14%; blackberry 48%; blueberry 12%;
cabbage 4%; carrot 2%; cauliflower 2%; cherries 46%; citrus 13%; cole
crops 2%; cucumber (fresh) 11%, cucumber (processed) 10%; eggplant 60%;
filbert 14%; table grape 40%, wine grape 28%, other grapes 36%;
honeydew melon 6%; leafy vegetables 0.5%; other lettuce 4%; lemon 2%;
cantaloupe 7%; melon 5%; nectarine 35%; olives 14%; onion 3%; orange
9%; green pea 0.3%; peach 38%; pear 28%; peppers 36%; pistachio 7%;
plum 47%; pome fruit 5%; potato 5%; prune 14%; pumpkins 7%; raisin 21%;
raspberry 80%; root and tuber vegetables 0.8%; squash 39%; stone fruit
12%; strawberry 15%; sunflower 2%; sweet corn 2%; tomato (fresh) 34%,
tomato (processed) 11%, tomato 25%; almonds 24%; pecan 14%; walnut 29%;
other tree nut 13%; other vegetables 21%; and watermelon 4%.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which paraquat may
be applied in a particular area.
2. Dietary exposure from drinking water. Paraquat is persistent,
but is expected to be mostly inactivated by rapid cation exchange to
binding sites on soil (especially clay) particles in the environment.
Under most circumstances paraquat is unlikely to infiltrate past the
first few centimeters of soil, or to move off-field dissolved in
runoff. However, detections were reported in household wells at
concentrations ranging up to 1.52 µg/L.
Because of its strong cation-exchange sorption to soils, modeling
is not appropriate for paraquat dichloride. It should sorb to suspended
sediment, and coagulation and flocculation processes in drinking water
treatment plants are likely to remove any paraquat residues present in
the raw water. Residues of paraquat in drinking water derived from
surface supplies can therefore be assumed to be negligible. For
residues in ground water however, EPA is using the value of 1.52
µg/L, for acute and chronic human exposure assessment, as this
represents a high-end, but not worst-case value from the available
monitoring data.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Paraquat is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether paraquat has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
paraquat does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not

[[Page 48598]]

assumed that paraquat has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the final rule for Bifenthrin
Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no indication of
quantitative or qualitative increased susceptibility of rats or mice to
in utero and/or prenatal/postnatal exposure to rats.
3. Conclusion. An FQPA safety factor is necessary for paraquat
since there is a data gap for a prenatal developmental study conducted
in a non-rodent species. The safety factor was reduced to 3x for
paraquat because: (i) There is no indication of quantitative or
qualitative increased susceptibility of rats or mice to in utero and/or
prenatal/postnatal exposure to rats; (ii) EPA determined that a
developmental neurotoxicity study is not required; (iii) the dietary
(food and drinking water) exposure assessments will not underestimate
the potential exposures for infants and children; and (iv) there are no
registered residential uses of paraquat. The FQPA safety factor for
paraquat is applicable to the females 13-50 years of age population
subgroup for acute dietary risk assessment only (there are no
residential uses). The safety factor was reduced to 1x for all other
exposures and population subgroups.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
paraquat will occupy 32% of the aPAD for the U.S. population, 55% of
the aPAD for females 13 years and older, 45% of the aPAD for infants,
and 76% of the aPAD for children 1 to 6 years of age. In addition,
there is potential for acute dietary exposure to paraquat in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the aPAD, as shown in the following Table 3:

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

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to paraquat
from food will utilize 6% of the cPAD for the U.S. population, 10% of
the cPAD for infants, and 16% of the cPAD for children 1 to 6 years of
age. There are no residential uses for paraquat that result in chronic
residential exposure. In addition, there is potential for chronic
dietary exposure to paraquat in drinking water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in the following Table 4:

[[Page 48599]]

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

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

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

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

V. Conclusion

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

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301178 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
20, 2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to

[[Page 48600]]

the purpose of this subsection.'' For additional information regarding
the waiver of these fees, you may contact James Tompkins by phone at
(703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a
request for information to Mr. Tompkins at Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301178, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes tolerances under FFDCA section 408(d)
in response to petitions submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other Agency action under
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Since tolerances and exemptions that are established on the
basis of a petition under FFDCA section 408(d), such as the tolerances
in this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final

[[Page 48601]]

rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

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

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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

Sec. 180.205 Paraquat; tolerances for residues.

(a) General. * * *

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

* * * * *

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

Notices For
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994

Paraquat; Pesticide Tolerances

Local Navigation