Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 / Rules and Regulations 47539 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraphs (c)(381)(i) (J), 

(c)(388)(i)(F), (c)(404)(i)(B), and (c)(411) 

to read as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(381) * * * 

(i) * * * 

(J) San Diego Air Pollution Control 

District. 

(1) Rule 66.1, ‘‘Miscellaneous Surface 

Coating Operations and Other Processes 

Emitting Volatile Organic Compounds,’’ 

adopted on February 24, 2010. 

* * * * * 

(388) * * * 

(i) * * * 

(F) Mojave Desert Air Quality 

Management District. 

(1) Rule 1116, ‘‘Automotive 

Refinishing Operations,’’ amended on 

August 23, 2010. 

* * * * * 

(404) * * * 

(i) * * * 

(B) Northern Sierra Air Quality 

Management District. 

(1) Rule 228, ‘‘Surface Coating of 

Metal Parts and Products,’’ amended on 

April 25, 2011. 

* * * * * 

(411) New and amended regulations 

for the following APCDs were submitted 

on February 23, 2012. 

(i) Incorporation by reference. 

(A) Sacramento Metropolitan Air 

Quality Management District. 

(1) Rule 459, ‘‘Automotive, Mobile 

Equipment, and Associated Parts and 

Components Coating Operations,’’ 

amended August 25, 2011. 

[FR Doc. 2012–19318 Filed 8–8–12; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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, 

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47540 Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 / Rules and Regulations 

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-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Paraquat Dichloride. Human Health 

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Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 / Rules and Regulations 47541 

Risk Assessment for the Request to Add 

Uses on Perennial Tropical and SubTropical 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

Exposure/Scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment 

(in mg/kg/day) 

Study and toxicological effects 

Acute dietary (all populations) ................ NOAEL = 1.25 mg/ 

kg/day.

UFA = 10xUFH = 

10xFQPA 

SF = 1x 

aRfD = 0.0125 ......

aPAD = .0125 

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.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cRfD = 0.0045 ......

cPAD = .0045 

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. 

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%; 

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47542 Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 / Rules and Regulations 

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 nonguideline 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. 14C-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 14C-paraquat 

to approximate or below the limit of 

detection of approximately 0.15 

microgram/per liter (mg/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 nonoccupational, 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 

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Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 / Rules and Regulations 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 intermediateterm 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, 

mstockstill on DSK4VPTVN1PROD with RULES

47544 Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.205 is amended by 

alphabetically adding the following new 

entries to the table in paragraph (a) to 

read as follows: 

§ 180.205 Paraquat; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

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 

Commodity Parts per 

million 

* * * * * 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Part 2 

[Docket No. USCG–2007–27668] 

RIN 1625–AB35 

Approval of Classification Societies 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: Federal law requires that 

classification societies conducting 

certain work in the United States be 

approved by the Coast Guard. In this 

rule, we finalize application procedures 

and performance standards that 

classification societies must meet in 

order to obtain approval by the Coast 

Guard. Through this final rule, we seek 

to improve marine safety and 

environmental protection by assuring 

the consistency and quality of work 

conducted by classification societies 

that review, examine, survey, or certify 

the construction, repair, or alteration of 

a vessel in the United States. 

DATES: This final rule is effective 

September 10, 2012. 

The incorporation by reference of 

certain publications listed in the rule is 

approved by the Director of the Federal 

Register on September 10, 2012. 

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