Document ID: EPA-HQ-OPP-2010-0637-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Paraquat Dichloride
Posted Date: 2012-08-09T04:00Z

[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Rules and Regulations]
[Pages 47539-47544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19320]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0637; FRL-9357-1]

Paraquat Dichloride; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
paraquat dichloride (hereafter in this document referred to solely as 
paraquat) in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 9, 2012. Objections and 
requests for hearings must be received on or before October 9, 2012, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2010-0637, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: 703-308-9367; email address: ertman.andrew@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 those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2010-0637 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 9, 2012. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0637, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

    Additional instructions on commenting or visiting the docket,

[[Page 47540]]

along with more information about dockets generally, is available at 
http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 27, 2010 (75 FR 66092) (FRL-
9218-2), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0E7748) by IR-4 Project Headquarters, Rutgers, the State University of 
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. 
The petition requested that 40 CFR 180.205 be amended by establishing 
tolerances for residues of the dessicant, defoliant, and herbicide 
paraquat dichloride, (1,1'-dimethyl-4,4'-bipyridinium-ion) derived from 
application of either the bis(methyl sulfate) or the dichloride salt 
(both calculated as the cation), in or on the following perennial 
tropical and subtropical fruit trees: Sugar apple, cherimoya, atemoya, 
custard apple, ilama, soursop, biriba, lychee, longan, Spanish lime, 
rambutan, pulasan, star apple, black sapote, mango, sapodilla, 
canistel, mamey sapote, feijoa, jaboticaba, wax jambu, starfruit 
(carambola), pawpaw, pomegranate, and white sapote at 0.05 parts per 
million (ppm). That notice referenced a summary of the petition 
prepared by Syngenta, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    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 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. * * 
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for paraquat including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with paraquat 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.
    Paraquat is severely toxic following acute exposure via the dermal 
and inhalation routes and only slightly less toxic by the oral route of 
exposure. It is a dermal and ocular irritant but is not a skin 
sensitizer.
    The primary target organ of paraquat is the lung. Evidence of lung 
inflammation, scarring, and compromised lung function in response to 
paraquat are observed throughout the toxicity database in different 
species (rats, mice, and dogs). Effects in the respiratory tract are 
observed after acute, subchronic, and chronic exposures regardless of 
the route of exposure (oral or inhalation). However, inhalation was a 
more sensitive route of exposure than the oral route. With increasing 
durations of exposure, effects of paraquat in other organ systems are 
observed. These effects include liver inflammation and necrosis in rats 
and inflammation and necrosis of the kidneys in rats and mice. 
Lenticular changes in the eyes of rats were also observed with 
increasing durations of exposure. Importantly, the lung effects occur 
at doses lower than effects in these other organs systems, and so 
protecting for lung effects protects for all other adverse effects of 
paraquat.
    The effects of paraquat in lungs are considered systemic effects. 
There are no dermal toxicity studies suitable for evaluation of 
systemic lung effects in the toxicity database for paraquat. Therefore, 
the Agency is using a dermal absorption factor of 0.3%, which was 
derived from dermal absorption studies conducted in humans and monkeys 
and an oral endpoint for dermal risk assessments.
    Paraquat does not cause reproductive toxicity. Developmental 
toxicity in response to paraquat, when observed, always occurred in the 
presence of maternal toxicity. Four developmental toxicity studies (two 
in rats and two in mice) are available. Since effects in the offspring 
(e.g., reduced body weight/gain and delayed skeletal ossification), 
when present, were lesser in severity than those observed in maternal 
animals (e.g., respiratory distress, reduced body weight, lesions in 
the lungs and kidneys) and were also consistent with those commonly 
observed as secondary to maternal toxicity, the Agency has concluded 
that there was no evidence of qualitative susceptibility in the young.
    Previously, the Agency had required that a developmental toxicity 
study in rabbits be conducted for paraquat. As a result, the Food 
Quality Protection Act (FQPA) Safety Factor (SF) had been retained as a 
3X database uncertainty factor for Females 13-39 years old for the 
acute dietary risk assessment only. The Agency recently reviewed the 
toxicity database for paraquat and concluded that a developmental 
toxicity study in rabbits was not likely to add information that would 
impact the paraquat risk assessment. Therefore, this study is no longer 
required and the FQPA Safety Factor has been reduced to 1X for this 
population.
    No evidence of neurotoxicity was observed in acute and subchronic 
neurotoxicity studies conducted with paraquat up to the doses at which 
respiratory effects were observed (e.g. the maximum tolerated dose). 
There was also no evidence of immunotoxicity in response to paraquat.
    Based on the lack of evidence of carcinogenicity in mice and rats, 
the Agency has concluded that there is no concern for the carcinogenic 
potential of paraquat. Paraquat was not mutagenic in the Salmonella 
typhimurium assay, was not genotoxic in the unscheduled DNA synthesis 
assay in vitro or in vivo, was negative for chromosomal aberration in 
the bone marrow test, and no evidence was found for suppressed 
fertility or dominant lethal mutagenicity in mice. Conversely, paraquat 
was found to be weakly positive in the mouse lymphoma assay and human 
lymphocyte cytogenetic assay, and was positive in the sister chromatid 
exchange assay.
    Specific information on the studies received and the nature of the 
adverse effects caused by paraquat as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Paraquat Dichloride. Human Health

[[Page 47541]]

Risk Assessment for the Request to Add Uses on Perennial Tropical and 
Sub-Tropical Fruit Trees'' on pps. 31-35 in docket ID number EPA-HQ-
OPP-2010-0637.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for paraquat used for 
human risk assessment is shown in the following table.

    Table--Summary of Toxicological Doses and Endpoints for Paraquat for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure    RfD, PAD, LOC for
        Exposure/Scenario            and uncertainty/      risk assessment      Study and toxicological effects
                                      safety factors        (in mg/kg/day)
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)..  NOAEL = 1.25 mg/kg/   aRfD = 0.0125......  Multi-generation rat study.
                                    day.                 aPAD = .0125.......  LOAEL = 3.75 mg/kg/day, based on
                                   UFA = 10xUFH =                              increased incidences of alveolar
                                    10xFQPA.                                   histiocytes in both sexes.
                                   SF = 1x.............
Chronic dietary (All populations)  NOAEL = 0.45 mg/kg/   cRfD = 0.0045......  Chronic toxicity in dogs.
                                    day.                 cPAD = .0045.......  LOAEL = 0.93 mg/kg/day, based on
                                   UFA = 10x...........                        increased severity of chronic
                                   UFH = 10x...........                        pneumonitis and gross lung
                                   FQPA SF = 1x........                        lesions in both sexes, and focal
                                                                               pulmonary granulomas in males.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to paraquat, EPA considered exposure under the petitioned-for 
tolerances as well as all existing paraquat tolerances in 40 CFR 
180.205. EPA assessed dietary exposures from paraquat 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 1-day or single exposure.
    Such effects were identified for paraquat. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, the acute analysis assumed a distribution of residues 
based on tolerance level residues. Empirical and Dietary Exposure 
Evaluation Model (DEEM) default processing factors were used to modify 
the field trial data. Maximum screening-level percent crop treated 
(PCT) estimates were used for commodities for which data were 
available. If no PCT data were available, 100 PCT was assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance 
level residues and average estimates of PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that paraquat does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and 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:
     Condition a: 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 the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit 
data on PCT.
    The Agency estimated the PCT in the chronic dietary risk assessment 
for existing uses as follows: Alfalfa, 1%; almonds, 25%; apples, 20%; 
apricots, 10%; artichokes, 25%; asparagus, 10%; avocados, 2.5%; barley, 
1%; green beans, 1%; blackberries, 30%; blueberries, 10%; broccoli, 1%; 
cabbage, 2.5%; caneberries, 45%; cantaloupes, 5%; carrots, 2.5%; 
celery, 1%; cherries, 20%; corn, 2.5%; cotton, 15%; cucumbers, 5%; dry 
beans/peas, 2.5%; summer fallow, 1%; garlic, 1%; grapefruit, 2.5%; 
grapes, 20%; kiwifruit, 30%; lemons, 2.5%; lettuce, 1%;

[[Page 47542]]

nectarines, 10%; olives, 5%; onions, 5%; oranges, 5%; pasture, 1%; 
pastureland, 1%; peaches, 30%; peanuts, 20%; pears, 10%; green peas, 
1%; pecans, 5%; peppers, 10%; pistachios, 25%; plums, 15%; potatoes, 
5%; prunes, 10%; pumpkins, 5%; raspberries, 70%; rice, 1%; sorghum, 1%; 
soybeans, 1%; spinach, 5%; squash, 5%; strawberries, 10%; sugar beets, 
1%; sugarcane, 5%; sunflowers, 1%; sweet corn, 2.5%; tangelos, 10%; 
tangerines, 10%; tobacco, 1%; tomatoes, 5%; walnuts, 15%; watermelons, 
5%; wheat, 1%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6-7 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which may be applied in a particular area.
    2. Dietary exposure from drinking water. In the past the EPA has 
concluded that though paraquat undergoes minimal degradation in the 
environment, and thus is very persistent (as parent), paraquat residues 
are not expected in surface or ground water. Paraquat has a very high 
propensity to bind to solids, particularly clay, which makes it very 
immobile. In addition, paraquat 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). Because of its very low 
mobility and strong tendency to bind tightly to soils, paraquat 
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. In most circumstances, the levels of 
paraquat 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.
    In order to determine the most appropriate and realistic drinking 
water numbers to use in the human health risk assessment, the Agency 
reviewed a non-guideline supplemental mobility study that was conducted 
to evaluate the effects of traditional water treatment processes on 
paraquat and to determine the mobility of paraquat through soil 
filtration column. \14\C-paraquat, spiked at ~30 parts per billion 
(ppb) into the raw surface water samples from five representative U.S. 
community water supply facilities, was effectively removed by a 
combination of typical water treatment processes conducted on a 
laboratory-scale: The ``laboratory jar test'' (coagulation using alum 
with either lime or soda ash, flocculation and sedimentation), followed 
by duel media filtration (anthracite atop of filtering sand). The 
combination process was able to reduce the level of \14\C-paraquat to 
approximate or below the limit of detection of approximately 0.15 
microgram/per liter ([mu]g/L) ppb. The level of paraquat in the 
finished water of 0.15 ppb was used in both the acute and chronic 
assessments.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Paraquat is not registered for any specific use patterns that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found paraquat to share a common mechanism of toxicity 
with any other substances, and paraquat does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that paraquat does not 
have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    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

[[Page 47543]]

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. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for paraquat is complete.
    ii. There is no indication that paraquat is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that paraquat results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary exposure analysis is based on tolerance 
level residues and maximum estimates of PCT. The chronic analysis is 
based on tolerance level residues and average estimates of percent crop 
treated. For estimating levels of paraquat in drinking water, the 
Agency relied on a study that evaluated the effects of traditional 
water treatment processes on paraquat. These assessments will not 
underestimate the exposure and risks posed by paraquat.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to paraquat will occupy 21% of the aPAD for children 1-2 years old, the 
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
paraquat from food and water will utilize 14% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for paraquat.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). A short- and 
intermediate-term adverse effect was identified; however, paraquat is 
not registered for any use patterns that would result in short- and/or 
intermediate-term residential exposure. Short- and intermediate-term 
risk is assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure. Because there is no short- and 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short- and 
intermediate-term risk), no further assessment of short- and 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for paraquat.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, paraquat is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to paraquat residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate spectrophotometric method, Method I of the Pesticide 
Analytical Manual (PAM) Vol. II, is available for enforcing tolerances 
for residues of paraquat in/on plant commodities.
    The methods 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for paraquat in or on assorted 
tropical and subtropical fruits-inedible peel (includes all except 
atemoya, biriba, jaboticaba, starfruit, and wax jambu) at 0.01 ppm. 
These MRLs are different from the tolerances being established for 
paraquat in the United States. The Agency cannot harmonize with the 
Codex MRL because there were residues greater than 0.01 ppm in some of 
the data on which the proposed U.S tolerances are based.

V. Conclusion

    Therefore, tolerances are established for residues of paraquat 
dichloride, (1,1'-dimethyl-4,4'-bipyridinium-ion) derived from 
application of either the bis(methylsulfate) or the dichloride salt 
(both calculated as the cation), in or on the following: Sugar apple, 
cherimoya, atemoya, custard apple, ilama, soursop, biriba, lychee, 
longan, Spanish lime, rambutan, pulasan, star apple, black sapote, 
mango, sapodilla, canistel, mamey sapote, feijoa, jaboticaba, wax 
jambu, starfruit (carambola), pawpaw, pomegranate, and white sapote at 
0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885,

[[Page 47544]]

April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: July 27, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. Section 180.205 is amended by alphabetically adding the following 
new entries to the table in paragraph (a) to read as follows:

Sec.  180.205  Paraquat; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Atemoya.....................................................        0.05
 
                                * * * * *
Biriba......................................................        0.05
 
                                * * * * *
Canistel....................................................        0.05
 
                                * * * * *
Cherimoya...................................................        0.05
 
                                * * * * *
Custard apple...............................................        0.05
 
                                * * * * *
Feijoa......................................................        0.05
 
                                * * * * *
Ilama.......................................................        0.05
Jaboticaba..................................................        0.05
 
                                * * * * *
Longan......................................................        0.05
Lychee......................................................        0.05
Mango.......................................................        0.05
 
                                * * * * *
Pawpaw......................................................        0.05
 
                                * * * * *
Pomegranate.................................................        0.05
 
                                * * * * *
Pulasan.....................................................        0.05
Rambutan....................................................        0.05
 
                                * * * * *
Sapodilla...................................................        0.05
Sapote, black...............................................        0.05
Sapote, mamey...............................................        0.05
Sapote, white...............................................        0.05
 
                                * * * * *
Soursop.....................................................        0.05
 
                                * * * * *
Spanish lime................................................        0.05
 
                                * * * * *
Star apple..................................................        0.05
Starfruit...................................................        0.05
 
                                * * * * *
Sugar apple.................................................        0.05
 
                                * * * * *
Wax jambu...................................................        0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-19320 Filed 8-8-12; 8:45 am]
BILLING CODE 6560-50-P