Paraquat Dichloride; Pesticide Tolerance, 52487-52494 [E6-14642]
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Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 / Rules and Regulations
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
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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.
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).
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 28, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.600 is amended by
revising the tolerance levels for wheat,
forage in the table in paragraph (a)(1)
and for cattle, meat byproducts; goat,
meat byproducts; horse, meat
byproducts; milk; and sheep, meat
byproducts in the table in paragraph
(a)(2) to read as follows:
I
§ 180.600 Propoxycarbazone; tolerances
for residues.
(a) General. (1) * * *
Parts per million
Wheat, forage .................
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*
*
Parts per million
*
*
*
(2) * * *
Commodity
*
*
Parts per million
*
*
*
Cattle, meat byproducts
*
*
*
*
0.3
*
Goat, meat byproducts ...
*
*
*
*
0.3
*
*
0.3
0.03
*
Horse, meat byproducts
Milk .................................
*
*
*
Sheep, meat byproducts
*
*
*
*
0.3
*
[FR Doc. E6–14641 Filed 9–5–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0664; FRL–8089–3]
Paraquat Dichloride; Pesticide
Tolerance
List of Subjects in 40 CFR Part 180
Commodity
Commodity
52487
17
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
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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
https://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
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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.
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
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: https://
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
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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
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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 https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for residues of
paraquat dichloride on animal feed,
nongrass, group 18, forage at 75 ppm;
animal feed, nongrass, group 18, hay at
210 ppm; barley, hay at 3.5 ppm; barley,
straw at 1.0 ppm; beet, sugar, tops at
0.05 ppm; berry group 13 at 0.05 ppm;
cattle, kidney at 0.50 ppm; cotton, gin
byproducts at 110 ppm; cotton,
undelinted seed at 3.5 ppm; cranberry at
0.05 ppm; fruit, pome, group 11 at 0.05
ppm; fruit, stone, group 12 at 0.05 ppm;
ginger at 0.10 ppm; goat, kidney at 0.50
ppm; grain, aspirated fractions at 65
ppm; grape at 0.05 ppm; hog, kidney at
0.50 ppm; hop, dried cones at 0.50 ppm;
horse, kidney at 0.50 ppm; nut, tree,
group 14 at 0.05 ppm; okra at 0.05 ppm;
onion, bulb at 0.10 ppm; pea and bean,
dried shelled, except soybean, subgroup
6C, except guar bean at 0.30 ppm; pea
and bean, succulent shelled, subgroup
6B at 0.05 ppm; sheep, kidney at 0.50
ppm; sorghum, forage, forage at 0.10
ppm; sorghum, grain, forage at 0.10
ppm; soybean, forage at 0.40 ppm;
soybean, hay at 10 ppm; soybean, hulls
at 4.5 ppm; soybean, seed at 0.70 ppm;
vegetable, Brassica leafy, group 5 at 0.05
ppm; vegetable, cucurbit, group 9 at
0.05 ppm; vegetable, fruiting, group 8 at
0.05 ppm; vegetable, legume, edible
podded, subgroup 6A at 0.05 ppm;
wheat, forage at 0.50 ppm; wheat, grain
at 1.1 ppm; wheat, hay at 3.5 ppm; and
wheat, straw at 50 ppm. Additionally,
EPA has determined that the current
tolerance with regional registrations for
residues of paraquat dichloride on
tanier at 0.05 ppm may be extended to
the State of Florida. EPA’s assessment of
exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
52489
paraquat dichloride as well as the noobserved-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies
can be found at https://
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 nonthreshold 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 https://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
Exposure/Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
Level of Concern for Risk
Assessment
Study and Toxicological Effects
NOAEL = 1.25 mg/kg/day
UF = 300
Acute RfD = 0.0125 mg/kg/
day
Special FQPA SF = 1X
aPAD = 0.0042 mg/kg/
day
Multi-generation rat study LOAEL = 3.75 mg/kg/
day based on increased invidences of alveolar
histiocytes in both sexes
Acute Dietary (General population including infants and
children)
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Acute Dietary (Females 13–
50 years of age)
NOAEL = 1.25 mg/kg/day
UF = 100
Acute RfD = 0.0125 mg/kg/
day
Special FQPA SF = 1X
aPAD = 0.0125 mg/kg/
day
Multi-generation rat study LOAEL = 3.75 mg/kg/
day based on increased incidences of alveolar
histiocytes in both sexes
Chronic Dietary (All populations)
NOAEL= 0.45 mg/kg/day
UF = 100
Chronic RfD = 0.0045 mg/
kg/day
Special FQPA SF = 1X
cPAD = 0.0045 mg/kg/
day
Chronic toxicity in dogs LOAEL = 0.93 mg/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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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PARAQUAT DICHLORIDE FOR USE IN HUMAN RISK
ASSESSMENT—Continued
Exposure/Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and
Level of Concern for Risk
Assessment
Study and Toxicological Effects
Short-Term/Intermediate-Term
Dermal (1 day to 6 months)
NOAEL = 1.25 mg/kg/day
(dermal absorption factor
= 0.3%)
LOC = MOE = 100
Multi-generation rat study LOAEL = 3.75 mg/kg/
day based on increased incidences of alveolar
histiocytes in both sexes
Long-Term Dermal (> 6
months)
NOAEL= 0.45 mg/kg/day
(dermal absorption factor
= 0.3%)
LOC = MOE = 100
Chronic toxicity in dogs LOAEL = 0.93 mg/kg/day
based on increased severity of chronic pneumonitis and gross lung lesions in both sexes, and
focal pulmonary granulomas in males
Short-Term, IntermediateTerm, Long-TermInhalation
(1 to > 6 months)
NOAEL= 0.01 µg/L (inhalation absorption factor =
100%)
LOC = MOE = 100
21–day inhalation toxicity study LOAEL = 0.10 µg/
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)
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-FCIDTM, 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.
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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-FCIDTM, 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 noncarcinogenicity 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
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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
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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 offsite 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
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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-FCIDTM).
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, 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
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52491
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 https://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 nonrodent species. However, four
acceptable developmental studies in rats
and mice have been submitted for
paraquat dichloride, and the Agency
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Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 / Rules and Regulations
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 Exposure(mg/kg/day)
Population Subgroup
% aPAD
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
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
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
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
(mg/kg/day)
Population/Subgroup
%/cPAD
0.000353
8
All Infants (<1 year old)
0.000584
13
Children 1–2 years old
0.001175
26
Females 13–49 years old
jlentini on PROD1PC65 with RULES
General U.S. Population
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
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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 noncarcinogenicity 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.
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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.
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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; email 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.
jlentini on PROD1PC65 with RULES
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,
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Jkt 205001
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
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52493
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
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Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006 / Rules and Regulations
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.205, the table to paragraph
(a) is amended as follows:
I 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.
I b. By revising the entries for beet,
sugar, tops; cattle, kidney; cotton,
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I
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Jkt 205001
undelinted seed; goat, kidney; hog,
kidney; hop, dried cone; horse, kidney;
sheep, kidney; soybean, forage; and
wheat, grain.
I c. By removing from the table in
paragraph (a) the entries for onion, dry
bulb; sorghum, forage; and vegetable,
fruiting.
§ 180.205 Paraquat; tolerances for
residues.
Parts per
million
*
*
*
*
Animal feed, nongrass, group
18, forage ..............................
Animal feed, nongrass, group
18, hay ..................................
*
*
*
*
Barley, hay ................................
Barley, straw .............................
*
*
*
*
Beet, sugar, tops ......................
Berry group 13 ..........................
*
*
*
*
Cattle, kidney ............................
*
*
*
*
Cotton, gin byproducts .............
Cotton, undelinted seed ...........
Cranberry ..................................
*
*
*
*
Fruit, pome, group 11 ...............
Fruit, pome, group 12 ...............
Ginger .......................................
Goat, kidney .............................
*
*
*
*
Grain, aspirated fractions .........
Grape ........................................
*
*
*
*
Hog, kidney ...............................
*
*
*
*
Hop, dried cones ......................
*
*
*
*
Horse, kidney ............................
*
*
*
*
Nut, tree, group 14 ...................
Okra ..........................................
*
*
*
*
Onion, bulb ...............................
*
*
*
*
Pea and bean, dried shelled,
except soybean, subgroup
6C, except guar bean ...........
Pea and bean, succulent
shelled, subgroup 6B ............
*
*
*
*
Sheep, kidney ...........................
*
*
*
*
Sorghum, forage, forage ..........
*
*
*
*
Sorghum, grain, forage .............
*
*
*
*
Soybean, forage .......................
Soybean, hay ............................
Soybean, hulls ..........................
Soybean, seed ..........................
*
*
*
*
Vegetable, Brassica leafy,
group 5 ..................................
Vegetable, cucurbit, group 9 ....
*
*
*
*
Vegetable, fruiting, group 8 ......
Frm 00092
*
*
*
0.05
*
0.50
1.1
3.5
50
*
[FR Doc. E6–14642 Filed 9–5–06; 8:45 am]
Commodity
PO 00000
Vegetable, legume, edible podded, subgroup 6A .................
*
*
*
*
Wheat, forage ...........................
Wheat, grain .............................
Wheat, hay ...............................
Wheat, straw .............................
*
(a) * * *
Parts per
million
Commodity
Fmt 4700
Sfmt 4700
*
75
210
3.5
1.0
*
0.05
0.05
40 CFR Part 710
RIN 2070–AC61
TSCA Inventory Update Reporting
Rule; Electronic Reporting
Environmental Protection
Agency (EPA).
110 ACTION: Direct final rule.
0.50
*
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2005–0059; FRL–7752–8]
*
*
BILLING CODE 6560–50–S
3.5
0.05
*
0.05
0.05
0.10
0.50
*
65
0.05
*
0.50
*
0.50
*
0.50
*
0.05
0.05
*
0.10
*
0.30
0.05
*
0.50
*
0.10
*
0.10
*
0.40
10
4.5
0.70
*
0.05
0.05
*
0.05
AGENCY:
SUMMARY: EPA is taking direct final
action to amend the Toxic Substances
Control Act (TSCA) section 8(a)
Inventory Update Reporting (IUR)
regulations to allow the electronic
submission of information and to make
several minor corrections. For the first
time, in 2006, reporters of IUR data will
be able to use the Internet, through
EPA’s Central Data Exchange (CDX), to
submit information on their chemicals
to EPA. In addition, EPA will continue
to allow IUR submissions either on CD
ROM or on paper. EPA is also correcting
two paragraph cross-references and a
section heading. Additionally, EPA is
clarifying requirements for the reporting
of company identification information.
DATES: This direct final rule is effective
on November 6, 2006 without further
notice, unless EPA receives adverse
comment by October 6, 2006. If,
however, EPA receives adverse
comment, EPA will publish aFederal
Register document to withdraw the
portion of the rule that relates to the
specific comment that was made before
the effective date of the direct final rule.
The remainder of the rule will become
effective on November 6, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2005–0059, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
E:\FR\FM\06SER1.SGM
06SER1
]]>Agencies
[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Rules and Regulations]
[Pages 52487-52494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14642]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
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: https://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 https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of paraquat dichloride
on animal feed, nongrass, group 18, forage at 75 ppm; animal feed,
nongrass, group 18, hay at 210 ppm; barley, hay at 3.5 ppm; barley,
straw at 1.0 ppm; beet, sugar, tops at 0.05 ppm; berry group 13 at 0.05
ppm; cattle, kidney at 0.50 ppm; cotton, gin byproducts at 110 ppm;
cotton, undelinted seed at 3.5 ppm; cranberry at 0.05 ppm; fruit, pome,
group 11 at 0.05 ppm; fruit, stone, group 12 at 0.05 ppm; ginger at
0.10 ppm; goat, kidney at 0.50 ppm; grain, aspirated fractions at 65
ppm; grape at 0.05 ppm; hog, kidney at 0.50 ppm; hop, dried cones at
0.50 ppm; horse, kidney at 0.50 ppm; nut, tree, group 14 at 0.05 ppm;
okra at 0.05 ppm; onion, bulb at 0.10 ppm; pea and bean, dried shelled,
except soybean, subgroup 6C, except guar bean at 0.30 ppm; pea and
bean, succulent shelled, subgroup 6B at 0.05 ppm; sheep, kidney at 0.50
ppm; sorghum, forage, forage at 0.10 ppm; sorghum, grain, forage at
0.10 ppm; soybean, forage at 0.40 ppm; soybean, hay at 10 ppm; soybean,
hulls at 4.5 ppm; soybean, seed at 0.70 ppm; vegetable, Brassica leafy,
group 5 at 0.05 ppm; vegetable, cucurbit, group 9 at 0.05 ppm;
vegetable, fruiting, group 8 at 0.05 ppm; vegetable, legume, edible
podded, subgroup 6A at 0.05 ppm; wheat, forage at 0.50 ppm; wheat,
grain at 1.1 ppm; wheat, hay at 3.5 ppm; and wheat, straw at 50 ppm.
Additionally, EPA has determined that the current tolerance with
regional registrations for residues of paraquat dichloride on tanier at
0.05 ppm may be extended to the State of Florida. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by paraquat dichloride as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at https://
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 https://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
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of NOAEL = 1.25 mg/kg/day Special FQPA SF = 1X Multi-generation rat
age) UF = 300............... aPAD = 0.0042 mg/kg/day study LOAEL = 3.75 mg/
Acute RfD = 0.0125 mg/ kg/day based on
kg/day. increased invidences
of alveolar
histiocytes in both
sexes
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population NOAEL = 1.25 mg/kg/day Special FQPA SF = 1X Multi-generation rat
including infants and children) UF = 100............... aPAD = 0.0125 mg/kg/day study LOAEL = 3.75 mg/
Acute RfD = 0.0125 mg/ kg/day based on
kg/day. increased incidences
of alveolar
histiocytes in both
sexes
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL= 0.45 mg/kg/day Special FQPA SF = 1X Chronic toxicity in
UF = 100............... cPAD = 0.0045 mg/kg/day dogs LOAEL = 0.93 mg/
Chronic RfD = 0.0045 mg/ kg/day based on
kg/day. increased severity of
chronic pneumonitis
and gross lung lesions
in both sexes, and
focal pulmonary
granulomas in males
----------------------------------------------------------------------------------------------------------------
[[Page 52490]]
Short-Term/Intermediate-Term Dermal NOAEL = 1.25 mg/kg/day LOC = MOE = 100 Multi-generation rat
(1 day to 6 months) (dermal absorption study LOAEL = 3.75 mg/
factor = 0.3%) kg/day based on
increased incidences
of alveolar
histiocytes in both
sexes
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (> 6 months) NOAEL= 0.45 mg/kg/day LOC = MOE = 100 Chronic toxicity in
(dermal absorption dogs LOAEL = 0.93 mg/
factor = 0.3%) kg/day based on
increased severity of
chronic pneumonitis
and gross lung lesions
in both sexes, and
focal pulmonary
granulomas in males
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term, Long- NOAEL= 0.01 [mu]g/L LOC = MOE = 100 21-day inhalation
TermInhalation (1 to > 6 months) (inhalation absorption toxicity study LOAEL =
factor = 100%) 0.10 [mu]g/L based on
squamous keratinizing
metaplasia and
hyperplasia of the
epithelium of the
larynx
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: Category E (evidence of non-carcinogenicity to humans)
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
previously established (40 CFR 180.205) for the residues of paraquat
dichloride, in or on a variety of raw agricultural commodities,
including egg, milk, and the meat, fat and meat by-products of cattle,
goats, hogs, horses, and sheep. Risk assessments were conducted by EPA
to assess dietary exposures from paraquat dichloride in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
The Dietary Exposure Evaluation Model (DEEM-FCID\TM\, Version 2.03)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and a supplemental children's survey
conducted in 1998 and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute exposure
assessments: A partially refined, probabilistic acute dietary exposure
assessment using tolerance-level residues for all registered and
proposed commodities, maximum estimates of percent crop treated
information for some registered commodities, and DEEM default
processing factors for some commodities, was conducted for the general
U.S. population and various population subgroups. Drinking water was
incorporated directly into the dietary assessment using a high-end
monitoring value of 1.52 ppb.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\, Version 2.03), which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: A partially refined, chronic dietary exposure assessment
using tolerance-level residues for all registered and proposed
commodities, average estimates of percent crop treated information for
some registered commodities, and DEEM default processing factors for
some commodities, was conducted for the general U.S. population and
various population subgroups. Drinking water was incorporated directly
into the dietary assessment using a high-end monitoring value of 1.52
ppb.
iii. Cancer. Paraquat dichloride is a Category E chemical (evidence
of non-carcinogenicity to humans).
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on
the actual percent of food treated for assessing chronic dietary risk
only if the Agency can make the following findings: Condition 1, that
the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used PCT information as follows:
For the acute assessment, maximum percent crop treated information
was used on the following commodities: alfalfa 2.5%, almonds 30%,
apples 30%, apricots 20%, artichokes 40%, asparagus 15%, avocados 5%,
barley 2.5%, green beans 3%, blackberries 40%, blueberries 15%,
broccoli 3%, Brussels sprouts 3%, cabbage 3%, cantaloupes 3%, carrots
3%, cherries 30%, corn 5%, cotton 20%, cucumbers 30%, dry beans/peas
5%, eggplant 20%, figs 10%, garlic 5%, grapefruit 5%, grapes 55%,
hazelnuts (filberts) 70%, kiwifruit 3%, lemons 3%, lettuce 3%,
nectarines 25%, olives 10%, onions 5%, oranges 10%, peaches 40%,
peanuts 35%, pears 15%, green peas 3%, pecans 15%, peppers 30%,
pistachios 45%, potatoes 5%, prunes and plums 20%, pumpkins 5%,
raspberries 75%, rice 2.5%, safflower 2.5%, sorghum 2.5%, soybeans
2.5%, squash 10%, strawberries 25%, sugar beets 2.5%, sugarcane 5%,
sunflowers 2.5%, sweet corn 5%, tangelos 30%, tangerines 10%, tomatoes
15%, walnuts 20%, watermelons 10%, and wheat 2.5%.
For the chronic assessment, average percent crop treated
information was
[[Page 52491]]
used on the following commodities: alfalfa 1%, almonds 30%, apples 20%,
apricots 10%, artichokes 30%, asparagus 10%, avocados 1%, barley 1%,
green beans 1%, blackberries 30%, blueberries 10%, broccoli 1%, cabbage
1%, cantaloupes 1%, carrots 1%, cherries 20%, corn 1%, cotton 20%,
cucumbers 5%, dry beans/peas 1%, eggplant 20%, figs 10%, garlic 1%,
grapefruit 5%, grapes 20%, hazelnuts (filberts) 55%, hops 80%,
kiwifruit 1%, lemons 1%, lettuce 1%, nectarines 15%, olives 5%, onions
1%, oranges 5%, peaches 30%, peanuts 25%, pears 10%, green peas 1%,
pecans 10%, peppers 10%, pistachios 30%, potatoes 5%, prunes and plums
15%, pumpkins 5%, raspberries 70%, rice 1%, safflower 1%, sorghum 1%,
soybeans 1%, squash 5%, strawberries 15%, sugar beets 1%, sugarcane 5%,
sunflowers 1%, sweet corn 1%, tangelos 20%, tangerines 5%, tomatoes 5%,
walnuts 15%, watermelons 5%, and wheat 1%.
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, State, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of 5% except for those situations in which the average
PCT is less than one. In those cases 1% is used as the average. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the single maximum value reported overall from available
Federal, State, and private market survey data on the existing use,
across all years, and rounded up to the nearest multiple of 5%, except
for those situations in which the maximum PCT is 2.5%. In those cases,
2.5% is used as the maximum. In most cases, EPA uses available data
from United States Department of Agriculture/National Agricultural
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the
National Center for Food and Agriculture Policy (NCFAP) for the most
recent 6 years.
2. Dietary exposure from drinking water. Paraquat dichloride
undergoes minimal degradation in the environment, and thus is very
persistent (as parent). However, its very high propensity to bind to
solids, particularly clay, makes it very immobile. In addition,
paraquat dichloride does not readily appear to desorb from clay. The
greatest cause for concern is likely to be erosion of contaminated
sediments off-site and subsequent redeposition onto non-target areas
(especially surface water bodies). There is an additional (minor)
concern for the one proposed new usage (wheat) that includes aerial
spray; however, this use entails very small amounts (relative to all
other uses), so spray drift onto nearby surface water drinking water
sources should be fairly limited. Because of its very low mobility and
strong tendency to bind tightly to soils, paraquat dichloride
contamination of drinking water supplies derived from groundwater is
expected to be highly unlikely. In addition, the strong binding
characteristics of paraquat dichloride are likely to render most
residues in raw drinking water sources removable through sedimentation
processes, which are typically included as part of standard drinking
water treatments.
Because of its strong cation-exchange sorption to soils, modeling
is not appropriate for paraquat dichloride. In most circumstances, the
levels of paraquat dichloride residues in surface or ground water are
expected to be insignificant. Because it should sorb to suspended
sediment, coagulation and flocculation processes in drinking water
treatment plants are likely to remove any paraquat dichloride residues
present in the raw water. Residues of paraquat dichloride in drinking
water derived from surface supplies can therefore be assumed to be
negligible. For residues in ground water however, the EPA used the
value of 1.52 ppb reported in Virginia, for human exposure assessment,
as this represents a high-end, but not worst-case value from the
available monitoring data. As a result, the groundwater monitoring
value of 1.52 ppb was used for both the acute and chronic analyses.
This estimate of drinking water concentration was directly entered into
the dietary exposure model (DEEM-FCID\TM\).
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Paraquat dichloride is not registered for use on any sites that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to paraquat dichloride and
any other substances and paraquat dichloride does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has not assumed that paraquat
dichloride has a common mechanism of toxicity with other substances.
For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations
and procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at https://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
