Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 64317 

2015. The rules of section 7502 and 

§ 301.7502–1 of this chapter (relating to 

timely mailing treated as timely filing) 

determine when an application for 

registration is considered to be received 

by a State. For rules applicable to 

applications before that date, see 26 CFR 

41.6001–2 (revised as of April 1, 2014). 

§ 41.6001–2T [Removed] 

■ Par. 8. Section 41.6001–2T is 

removed. 

■ Par. 9. Section 41.6011(a)–1 is 

amended by adding paragraphs (a)(4), 

(c) and (d) to read as follows: 

§ 41.6011(a)–1 Returns. 

(a) * * * 

(4) A person that is liable for tax 

under § 41.4481–2(a)(1)(i)(A), (B), (C), or 

(D), after taking into account the 

modification required under § 41.4481– 

2(a)(2), is treated as liable for tax by the 

same provision of § 41.4481–2(a)(1)(i) 

for purposes of this section and must 

file a return. 

* * * * * 

(c) Required use of electronic filing— 

(1) In general. A person that files any 

return reporting 25 or more vehicles 

must file the return electronically, as 

prescribed by the Commissioner. For 

this purpose, the number of vehicles 

reported on a return is the total number 

of vehicles for which tax is reported and 

does not include vehicles for which a 

suspension of tax is claimed. 

(2) Examples. The application of this 

paragraph (c) may be illustrated by the 

following examples: 

Example 1. A has 100 vehicles registered 

in its name, all of which have a taxable gross 

weight in excess of 55,000 pounds. Seventyfive of the vehicles are in use on July 1. 

Twenty-five are in dead storage as described 

in § 41.4482(c)–1(c). The vehicles in dead 

storage are not in use and they are not listed 

on the Schedule 1. A files Form 2290 

electronically for the 75 vehicles in use on 

July 1 and receives a receipted Schedule 1. 

On August 23 of the same calendar year, A 

uses the remaining 25 vehicles. A does not 

file Form 2290 electronically but uses a paper 

Form 2290. A has failed to meet the 

requirements of section 4481(e) for the 

remaining 25 vehicles. 

Example 2. Assume the same facts as in 

Example 1 except that on August 23, A uses 

15 of the vehicles that were not used in July. 

The remaining 10 vehicles are not used in 

August. A does not file Form 2290 

electronically but uses a paper Form 2290. A 

has correctly filed a return as required by 

section 4481(e). 

(d) Effective/applicability date. 

Paragraphs (a)(4) and (c) of this section 

apply to returns filed on and after July 

1, 2015. For rules applicable before that 

date, see 26 CFR 41.6011(a)–1 (revised 

as of April 1, 2014). 

■ Par. 10. Section 41.6071(a)–1 is 

amended as follows: 

■ 1. In paragraph (a) introductory text, 

the language ‘‘paragraph (b) or 

paragraph (c)’’ is removed and 

‘‘paragraph (b)’’ is added in its place. 

■ 2. Revising paragraph (c). 

■ 3. Adding paragraph (d). 

The additions and revision read as 

follows: 

§ 41.6071(a)–1 Time for filing returns. 

* * * * * 

(c) Effect of sale during taxable 

period. A person that is liable for tax 

under § 41.4481–2(a)(1)(i)(A), (B), (C), or 

(D) after taking into account the 

modification required under § 41.4481– 

2(a)(2) is treated as liable for tax under 

the same provision of § 41.4481– 

2(a)(1)(i) for purposes of this section. 

(d) Effective/applicability date. 

Paragraph (c) of this section applies on 

and after July 1, 2015. For rules 

applicable before that date, see 26 CFR 

41.6071(a)–1 (revised as of April 1, 

2014). 

§ 41.6071(a)–1T [Removed] 

■ Par. 11. Section 41.6071(a)–1T is 

removed. 

§ 41.6151(a)–1 [Revised] 

■ Par. 12. Section 41.6151(a)–1 is 

revised to read as follows: 

§ 41.6151(a)–1 Time and place for paying 

tax. 

(a) In general. The tax must be paid 

at the time prescribed in § 41.6071(a)–1 

for filing the return and at the place 

prescribed in § 41.6091–1 for filing the 

return. 

(b) Effective/applicability date. This 

section applies on and after July 1, 2015. 

For rules applicable before that date, see 

26 CFR 41.6151(a)–1 and 41.6151(a)–1T 

(revised as of April 1, 2014). 

§ 41.6151(a)–1T [Removed] 

■ Par. 13. Section 41.6151(a)–1T is 

removed. 

§ 41.6156–1 [Removed] 

■ Par. 14. Section 41.6156–1 is 

removed. 

John Dalrymple, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: September 9, 2014. 

Mark J. Mazur, 

Assistant Secretary of the Treasury (Tax 

Policy). 

[FR Doc. 2014–25558 Filed 10–28–14; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0729; FRL–9917–15] 

Paraquat Dichloride; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of paraquat 

dichloride in or on the tuberous and 

corm vegetables subgroup 1C. 

Interregional Research Project Number 4 

(IR–4) requested this tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective 

October 29, 2014. Objections and 

requests for hearings must be received 

on or before December 29, 2014, 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–2013–0729, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 


rmajette on DSK2TPTVN1PROD with RULES
64318 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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://www.ecfr.gov/cgi-bin/textidx?&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–2013–0729 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 December 29, 2014. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0729, 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 CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (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.html. 

Additional instructions on commenting 

or visiting the docket, 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 December 

30, 2013 (78 FR 79359) (FRL–9903–69), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 3E8201) by IR–4, 

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 desiccant, defoliant, and 

herbicide paraquat dichloride (1,1′- 

dimethyl-4,4′-bipyridinium-ion) 

(hereafter in this document referred to 

solely as paraquat) derived from 

application of the dichloride salt 

(calculated as the cation) in or on 

tuberous and corm vegetables subgroup 

(Crop subgroup 1C) at 0.5 parts per 

million (ppm). That document 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

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. 

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 (independent of route 

of exposure (oral, dermal, inhalation)) 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 


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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. 

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. HED Human 

Health Risk Assessment for the 

Expansion of Representative 

Commodity Use on Potato to Tuberous 

and Corm Vegetables Subgroup 1C’’ on 

pages 28–32 in docket ID number EPA– 

HQ–OPP–2013–0729. 

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 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 discussed in Unit B. 

of the final rule published in the 

Federal Register of August 9, 2012 (77 

FR 47539) (FRL–9357–1). 

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 U.S. Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). 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 percent crop treated 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’s NHANES/WWEIA. 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 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: 

• 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 

acute dietary risk assessment for 

existing uses as follows: 

Almond, 35%; apple, 30%; apricot, 

30%; artichoke, 70%; asparagus, 20%; 

avocado, 5%; barley, 2.5%; green beans, 

2.5%; blueberries, 20%; broccoli, 2.5%; 

cabbage, 10%; caneberries, 70%; 

cantaloupe, 10%; carrots, 2.5%; 

cauliflower, 2.5%; celery, 2.5%; cherry, 

30%; corn, 2.5%; cotton, 40%; 

cucumber, 10%; dry beans/peas, 5%; 

figs, 5%; garlic, 2.5%; grapefruit, 15%; 

grapes, 30%; hazelnut, 70%; kiwifruit, 

30%; lemon, 5%; lettuce, 2.5%; 

nectarine, 20%; olive, 2.5%; onion, 

10%; orange, 15%; peach, 45%; peanut, 

45%; pear, 20%; green peas, 2.5%; 

pecan, 10%; peppers, 15%; pistachio, 

35%; plum/prune, 20%; potato, 10%; 

pumpkin, 10%; rice, 2.5%; sorghum, 

2.5%; soybean, 2.5%; spinach, 5%; 

squash, 20%; strawberry, 20%; sugar 

beet, 2.5%; sugarcane, 10%; sunflower, 

2.5%; sweet corn, 2.5%; tangelos, 10%; 

tangerine, 5%; tomato, 30%; walnut, 

20%; watermelon, 15%; and wheat, 

2.5%. 

The Agency estimated the PCT in the 

chronic dietary risk assessment for 

existing uses as follows: 

Almond, 25%; apple, 20%; apricot, 

10%; artichoke, 30%; asparagus, 10%; 

avocado, 5%; barley, 1%; green beans, 

1%; blueberries, 15%; broccoli, 1%; 

cabbage, 2.5%; caneberries, 45%; 


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cantaloupe, 5%; carrots, 1%; 

cauliflower, 1%; celery, 1%; cherry, 

20%; corn, 2.5%; cotton, 20%; 

cucumber, 5%; dry beans/peas, 2.5%; 

figs, 5%; garlic, 1%; grapefruit, 5%; 

grapes, 15%; hazelnut, 55%; kiwifruit, 

30%; lemon, 2.5%; lettuce, 1%; 

nectarine, 10%; olive, 2.5%; onion, 5%; 

orange, 5%; peach, 30%; peanut, 25%; 

pear, 10%; green peas, 1%; pecan, 5%; 

peppers, 10%; pistachio, 25%; plum/

prune, 10%; potato, 5%; pumpkin, 5%; 

rice, 1%; sorghum, 1%; soybean, 1%; 

spinach, 2.5%; squash, 5%; strawberry, 

5%; sugar beet, 1%; sugarcane, 5%; 

sunflower, 1%; sweet corn, 1%; tangelo, 

10%; tangerine, 5%; tomato, 10%; 

walnut, 15%; watermelon, 5%; and 

wheat, 1%. 

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 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 paraquat 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 around 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 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 

Food Quality Protection Act Safety 

Factor (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. 


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Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 64321 

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, which are 

considered lesser in severity than the 

effects observed in maternal animals. 

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 percent crop 

treated. The chronic analysis is based on 

tolerance level residues and average 

estimates of PCT. 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 75% 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 27% 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. 

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 root and tuber 

vegetables at 0.05 ppm. These MRLs are 

different than the tolerance of 5.0 ppm 

that will be established for the tuberous 

and corm vegetables subgroup 1C for 

residues of paraquat in the United 

States. The Agency cannot harmonize 

with the Codex MRL because available 

residue data demonstrates that 

application of paraquat in accordance 

with approved label directions could 

result in residues that exceed 0.05 ppm. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of paraquat, including its 

metabolites and degradates, in or on the 

tuberous and corm vegetables subgroup 

1C at 0.50 ppm. 

In addition, EPA is removing the 

separate tolerances for cassava, ginger, 

potato, tanier, and true yam tuber 

because those are subsumed within the 

new tolerance for subgroup 1C. 

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, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 


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64322 Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Rules and Regulations 

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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: October 16, 2014. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.205: 

■ a. In the table for paragraph (a), 

remove the entries for ‘‘Ginger’’ and 

‘‘Potato’’ and add alphabetically the 

entry ‘‘Vegetable, tuberous and corm, 

subgroup 1C’’; 

■ b. In the table for paragraph (c), 

remove the entries for and ‘‘Cassava,’’ 

‘‘Tanier,’’ and ‘‘Yam, true, tuber’’. 

The addition reads as follows: 

§ 180.205 Paraquat; tolerances for 

residues. 

(a) * * * 

Commodity Parts 

per million 

* * * * * 

Vegetable, tuberous and 

corn, subgroup 1C ............ 0.50 

* * * * * 

* * * * * 

[FR Doc. 2014–25592 Filed 10–28–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0659; FRL–9917–30] 

Prallethrin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of the insecticide 

prallethrin, including its metabolites 

and degradates, in or on all food 

commodities from use of prallethrin in 

food handling establishments where 

food and food products are held, 

processed, prepared and/or served, or as 

a wide-area mosquito adulticide at 1.0 

part per million (ppm). McLaughlin 

Gormley King Company requested these 

tolerances under the Federal Food, Drug 

and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 29, 2014. Objections and 

requests for hearings must be received 

on or before December 29, 2014, 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–2013–0659, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., 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: 

Daniel J. Rosenblatt, Registration 

Division (RD) (7505P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

telephone number: (703) 305–7090; 

email address: RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 


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