Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 79267 

November 9, 2000), nor will it impose 

substantial direct costs on tribal 

governments or preempt tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. The EPA will 

submit a report containing this action 

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. A major rule cannot take effect 

until 60 days after it is published in the 

Federal Register. This action is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by February 19, 2016. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Ozone, Reporting and recordkeeping 

requirements. 

Dated: December 8, 2015. 

Dennis J. McLerran, 

Regional Administrator, Region 10. 

For the reasons set forth in the 

preamble, 40 CFR part 52 is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart MM—Oregon 

■ 2. Section 52.1991 is amended by 

adding paragraph (d) to read as follows: 

§ 52.1991 Section 110(a)(2) infrastructure 

requirements. 

* * * * * 

(d) The EPA approves Oregon’s June 

28, 2010 submittal as meeting the 

requirements of CAA section 

110(a)(2)(D)(i)(I) for the 2008 ozone 

NAAQS. 

[FR Doc. 2015–31915 Filed 12–18–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0397; FRL–9937–18] 

Pendimethalin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pendimethalin 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested the 

tolerances associated with pesticide 

petition number (PP) 4E8282, and BASF 

requested the tolerances associated with 

(PP) 4F8261, under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 21, 2015. Objections and 

requests for hearings must be received 

on or before February 19, 2016, 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–2014–0397, 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 

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–2014–0397 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 February 19, 2016. 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 


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79268 Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 

by docket ID number EPA–HQ–OPP– 

2014–0397, 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 

17, 2014 (79 FR 75107) (FRL–9918–90), 

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) 4E8282 by 

Interregional Research Project Number 4 

(IR–4), 500 College Road East, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.361 be 

amended by establishing tolerances for 

residues of the herbicide pendimethalin, 

[N-(1-ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine], and its metabolite, 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol, in or on 

caneberry subgroup 13–07A at 0.10 

parts per million (ppm) and bushberry 

subgroup 13–07B at 0.10 ppm, and 

amending the existing crop group 

tolerance for nut, tree, group 14 to nut, 

tree, group 14–12. That document 

referenced a summary of the petition 

prepared on behalf of IR–4 by BASF, the 

registrant, which is available in the 

docket EPA–HQ–OPP–2014–0397 at 

http://www.regulations.gov. 

In the Federal Register of August 26, 

2015 (80 FR 51759) (FRL–9931–74), 

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) 4F8261 by BASF 

Corp., 26 Davis Drive, Research Triangle 

Park, NC 27709. The petition requested 

that 40 CFR 180.361 be amended by 

establishing tolerances for residues of 

the herbicide pendimethalin, [N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine], and its metabolite, 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol, in or on milk at 

0.04 parts per million (ppm); cattle, fat 

at 0.30 ppm; cattle, liver at 1.5 ppm; 

cattle, meat at 0.1 ppm; cattle, meat 

byproducts, except liver at 3.0 ppm; 

goat, fat at 0.30 ppm; goat, liver at 1.5 

ppm; goat, meat at 0.10 ppm; goat, meat 

byproducts, except liver at 3.0 ppm; 

horse, fat at 0.30 ppm; horse, liver at 1.5 

ppm; horse, meat at 0.10 ppm; horse, 

meat byproducts, except liver at 3.0 

ppm; sheep, fat at 0.30 ppm; sheep, liver 

at 1.5 ppm; sheep, meat at 0.10 ppm; 

and sheep, meat byproducts, except 

liver at 3.0 ppm. This petition 

additionally requested that 40 CFR 

180.361 be amended by revising the 

existing tolerance in or on grass forage, 

fodder, and hay crop group 17, forage at 

1,000 ppm and grass forage, fodder, and 

hay crop group 17, hay at 2,000 ppm. 

That document referenced a summary of 

the petition prepared on behalf of IR–4 

by BASF, the registrant, which is 

available in the docket EPA–HQ–OPP– 

2014–0397 at http://

www.regulations.gov. 

Two comments were received on 

these notices of filing. EPA’s response to 

these comments is discussed in Unit 

IV.C. 

Based upon review of the data 

supporting the petition, EPA has revised 

the petitioned-for tolerance in or on 

cattle, meat byproduct, meat byproduct 

except liver, and liver; goat, meat 

byproduct, meat byproduct except liver, 

and liver; horse, meat byproduct, meat 

byproduct except liver, and liver; and 

sheep, meat byproduct, meat byproduct 

except liver, and liver. The Agency has 

determined that the tolerance 

expression for the ruminant 

commodities is different than that for 

plant commodities. Additionally, the 

EPA is removing existing tolerances for 

Juneberry; nut, tree, group 14; and 

pistachio since they are superseded by 

this action. The reason for these changes 

are explained in Unit IV.D. 

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 pendimethalin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pendimethalin 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 target organ 

for pendimethalin is the thyroid. 

Thyroid toxicity in chronic and 

subchronic rat and mouse studies was 

manifested as alterations in thyroid 

hormones (decreased total T4, and T3, 

increased percent of free T4 and T3), 

increased thyroid weight, and 

microscopic thyroid lesions (including 

increased thyroid follicular cell height, 

follicular cell hyperplasia, as well as 

follicular cell adenomas). Due to these 

effects, the Agency required that a 

developmental thyroid assay be 

conducted to evaluate the impact of 

pendimethalin on thyroid hormones, 

structure, and/or thyroid hormone 

homeostasis during development. A 

developmental thyroid study was 

submitted and demonstrated that there 

is no potential thyroid toxicity 

following pre- and/or post-natal 

exposure to pendimethalin. 

The points of departure (PODs) used 

for the chronic and short-term risk 

assessments were based on co-critical 

studies of a 92-day thyroid function 

study in rats, a 56-day thyroid study in 

rats, and a 14-day intra thyroid 

metabolism study in rats. An 

uncertainty factor (UF) of 30X (3X for 

interspecies extrapolation and 10X for 

intraspecies variation) is applied for the 

chronic and short-term risk assessments. 

The interspecies UF which used to 

account for animal to human differences 

in toxicokinetics and toxicodynamics 


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was reduced to 3X due to several 

important quantitative dynamic 

differences between rats and humans 

with respect to thyroid function. A UF 

of 100X (10X for interspecies 

extrapolation and 10X for intraspecies 

variation) was used in the acute risk 

assessment because the POD was based 

on an acute neurotoxicity study, not a 

thyroid study. 

There is no evidence that 

pendimethalin is a developmental, 

reproductive, neurotoxic, or 

immunotoxic chemical. There is no 

evidence of increased qualitative or 

quantitative susceptibility in the young. 

EPA classified pendimethalin as a 

‘‘Group C’’, possible human carcinogen 

based on a statistically significant 

increased trend and pair-wise 

comparison between the high-dose 

group and controls for thyroid follicular 

cell adenomas in male and female rats. 

A non-quantitative approach (i.e., nonlinear, reference dose (RfD) approach) 

was used to assess cancer risk since 

mode-of-action studies are available to 

demonstrate that the thyroid tumors are 

due to a thyroid-pituitary imbalance, 

and also since pendimethalin was 

shown to be non-mutagenic in 

mammalian somatic cells and germ 

cells. Specific information on the 

studies received and the nature of the 

adverse effects caused by pendimethalin 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

at http://www.regulations.gov in 

document, ‘‘Pendimethalin—Human 

Health Risk Assessment to Support the 

Proposed New Uses on the Caneberry 

Subgroup 13–07A, and the Bushberry 

Subgroup 13–07B, Amended Use on 

Grasses and Establishment of Tolerances 

for Pendimethalin in/on Grass Forage, 

Fodder, and Hay (Crop Group 17) with 

New Ruminant Tolerances; Crop Group 

Conversion for Tree Nut Crop Group 

14.’’ in pages 14–20 in docket ID 

number EPA–HQ–OPP–2014–0397. 

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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for Pendimethalin used for 

human risk assessment is discussed in 

the final rule published in the Federal 

Register of August 29, 2012 (77 FR 

52240) (FRL–9360–5). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pendimethalin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pendimethalin tolerances in 40 

CFR 180.361. EPA assessed dietary 

exposures from pendimethalin 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 

pendimethalin. In estimating acute 

dietary exposure, EPA Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCID) Version 3.16. This 

software uses 2003–2008 food 

consumption data 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, EPA used 

tolerance-level residues, and 100 

percent crop treated (PCT) for all 

commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the DEEM–FCID, Version 3.16 

software with 2003–2008 food 

consumption data from the USDA’s 

NHANES/WWEIA. As to residue levels 

in food, EPA used tolerance-level 

residues, and 100 percent crop treated 

(PCT) for all commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to pendimethalin. Cancer 

risk was assessed using the same 

exposure estimates as discussed in Unit 

III.C.1.ii., chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for pendimethalin. Tolerance-level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. In drinking water, the residue of 

concern is pendimethalin parent only. 

The Agency used screening-level water 

exposure models in the dietary exposure 

analysis and risk assessment for 

pendimethalin in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of 

pendimethalin. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Based on the Pesticide Root Zone 

Model Ground Water (PRZM GW) and 

Surface Water Concentration Calculator 

(SWCC) models, the estimated drinking 

water concentrations (EDWCs) of 

pendimethalin for acute exposures are 

estimated to be 96.4 parts per billion 

(ppb) for surface water and 4.38 × 10¥9

ppb for ground water. For chronic 

exposures for non-cancer assessments, 

they are estimated to be 9.73 ppb for 

surface water. 

For acute dietary risk assessment, the 

water concentration value of 96.4 ppb 

was used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 9.73 ppb was used to assess the 

contribution to drinking water. 

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). 

Pendimethalin is currently registered 

for the following uses that could result 

in residential exposures: Turf, home 

gardens, and ornamentals. EPA assessed 

residential exposure using the following 

assumptions: 

• For handlers, it is assumed that 

residential use will result in short-term 


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79270 Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 

(1 to 30 days) duration dermal and 

inhalation exposures. 

• Residential post-application 

exposure is also assumed to be shortterm (1–30 days) in duration, resulting 

from the following exposure scenarios: 

Æ Gardening: Adults (dermal) and 

children 6 < 11 years old (dermal); 

Æ Physical activities on turf: Adults 

(dermal) and children 1–2 years old 

(dermal and incidental oral); 

Æ Mowing turf: Adults (dermal) and 

children 11 < 16 years old (dermal); and 

Æ Exposure to golf courses during 

golfing: Adults (dermal), children 11 < 

16 years old (dermal), and children 6 < 

11 years old (dermal). 

EPA did not combine exposure 

resulting from adult handler and postapplication exposure resulting from 

treated gardens, lawns, and/or golfing 

because of the conservative assumptions 

and inputs within each estimated 

exposure scenario. The Agency believes 

that combining exposures resulting from 

handler and post-application activities 

would result in an overestimate of adult 

exposure. EPA selected the most 

conservative adult residential scenario 

(adult dermal post-application exposure 

from gardening) as the contributing 

source of residential exposure to be 

combined with the dietary exposure for 

the aggregate assessment. The children’s 

oral exposure is based on postapplication hand-to-mouth exposures. 

To include exposure from object-tomouth and soil ingestion in addition to 

hand-to-mouth would overestimate the 

potential for oral exposure. However, 

there is the potential for co-occurrence 

of dermal and oral exposure, since the 

toxicological effects from the dermal 

and oral routes of exposure are the 

same. As a result, the children’s 

aggregate assessment combines postapplication dermal and oral exposure 

along with dietary exposure from food 

and water. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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 pendimethalin to share a 

common mechanism of toxicity with 

any other substances, and 

pendimethalin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pendimethalin 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://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/

cumulative-assessment-risk-pesticides. 

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 Safety Factor (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. 

There was no indication of pre- and/or 

post-natal qualitative or quantitative 

increased susceptibility in the 

developmental studies in rats and 

rabbits or the 2-generation reproduction 

studies in rats. A developmental thyroid 

toxicity study demonstrated that there is 

no potential thyroid toxicity following 

pre- and/or post-natal exposure to 

pendimethalin. 

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 

pendimethalin is complete. Although a 

subchronic inhalation study was not 

available in the database, EPA 

determined that one is not needed at 

this time based on a weight-of-evidence 

analysis, considering the following: (1) 

All relevant hazard and exposure 

information, which indicates its low 

acute inhalation toxicity; (2) its 

physical/chemical properties, which 

indicate its low volatility; and (3) the 

use of an oral POD that results in a 

residential inhalation margin of 

exposure (MOE) more than 10X the 

level of concern (in the case of 

pendimethalin MOE = 30 based on 

thyroid POD). 

ii. There is no indication that 

pendimethalin 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 

pendimethalin 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. In addition, a 

developmental thyroid toxicity study 

demonstrated that there is no potential 

thyroid toxicity following pre- and/or 

post-natal exposure to pendimethalin. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

pendimethalin in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by pendimethalin. 

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 

pendimethalin will occupy 2% of the 

aPAD for all infants less than 1 year 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 pendimethalin 

from food and water will utilize 2.4% of 

the cPAD for children 1 to 2 years old, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 


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Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 79271 

residential exposure to residues of 

pendimethalin is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Pendimethalin is currently registered 

for uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to pendimethalin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 130 for adults and 92 for 

children 1 to 2 years old, the two 

population subgroups receiving the 

greatest combined dietary and nondietary exposure. Because EPA’s level of 

concern for pendimethalin is a MOE of 

30 or below, these MOEs are not of 

concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, pendimethalin 

is not registered for any use patterns 

that would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

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 intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

pendimethalin. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III.A., 

EPA has determined that an RfD 

approach based on the chronic point of 

departure is appropriate for evaluating 

cancer risk. As there are not chronic 

aggregate risks of concern, there are no 

cancer aggregate risk concerns. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

pendimethalin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

gas chromatography with electron 

capture detection (GC/ECD), is available 

to enforce the tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

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. 

There are currently no established 

Codex MRLs for the residues of 

pendimethalin. 

C. Response to Comments 

Two comments were received to the 

Notices of Filing for PP 4E8282 and PP 

4F8261. One commenter stated: 

‘‘Pesticide/Herbicide contents must be 

made available to the public due to 

allergies. Labeling foods that have been 

exposed to Pesticides/Herbicides 

protects the public from potentially 

ingesting a known allergen. This safe 

practice allows health care professionals 

to determine the cause of a life 

threatening severe reaction to avoid 

these products in the future. I am a 

nurse hence my concern.’’ The second 

commenter stated that no residue 

should be allowed for pendimethalin 

and that they do not support 

manufacture or use of this product. The 

Agency understands the commenters’ 

concerns and recognizes that some 

individuals believe that pesticides 

should be banned on agricultural crops. 

However, the existing legal framework 

provided by Section 408 of the Federal 

Food, Drug and Cosmetic Act (FFDCA) 

states that tolerances may be set when 

persons seeking such tolerances or 

exemptions have demonstrated that the 

pesticide meets the safety standard 

imposed by that statute. These 

comments appear to be directed at the 

underlying statute and not EPA’s 

implementation of it; the citizens have 

made no contention that EPA has acted 

in violation of the statutory framework. 

EPA has found that there is a reasonable 

certainty of no harm to humans after 

considering the toxicological studies 

and the exposure levels of humans to 

pendimethalin. 

D. Revisions to Petitioned-for 

Tolerances 

Based on review of the data 

supporting the petitions, EPA has 

revised the petitioned-for tolerance in or 

on ‘‘meat byproduct’’ (at 3.0 ppm) based 

on anticipated residues in kidney which 

contained the highest residue amongst 

all ruminant tissues and will therefore 

cover anticipated residues in liver and 

fat. BASF, proposed setting a tolerance 

on ‘‘meat byproduct except liver’’, also 

at 3.0 ppm based on anticipated 

residues in kidney with a separate lower 

tolerance on liver at 1.5 ppm. However, 

the anticipated residues in liver versus 

kidney, on which the tolerance for meat 

byproduct is based on, are not 

significantly different given the limited 

number of data for those tissues and that 

both are greater than LOQ and within 1 

ppm of each other. Therefore, a single 

tolerance on ‘‘meat byproduct’’ without 

a separate tolerance on liver is adequate. 

Additionally, the current tolerance 

expression for pendimethalin for plant 

commodities includes the combined 

residues of pendimethalin and its 3,5- 

dinitrobenzyl alcohol metabolite (CL 

202,347). EPA has determined, based on 

the review of the ruminant feeding 

study, that the residues of concern for 

setting tolerances and assessing risks in 

ruminants is the parent compound, 

pendimethalin, and its metabolite, 1-(1- 

ethylpropyl)-5, 6-dimethyl-7-nitro-1Hbenzimidazole (also known as 

metabolite 6). 

Finally, the Agency is removing 

Juneberry at 0.1 ppm as it is superseded 

by fruit, bushberry, subgroup 13–07B; as 

well as nut, tree, group 14 and pistachio 

at 0.1 ppm to account for an updated 

crop group conversion. 

V. Conclusion 

Therefore, tolerances are established 

for plant residues by measuring only the 

sum of pendimethalin, [N-(1- 

ethylpropyl)-3,4-dimethyl-2,6- 

dinitrobenzenamine], and its metabolite, 

4-[(1-ethylpropyl)amino]-2-methyl-3,5- 

dinitrobenzyl alcohol calculated as the 


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79272 Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 

stoichiometric equivalent of 

pendimethalin, in or on bushberry 

subgroup 13–07B at 0.10 ppm; 

caneberry subgroup 13–07A at 0.10 

ppm; grass forage, fodder, and hay crop 

group 17, forage at 1,000 ppm; grass 

forage, fodder, and hay crop group 17, 

hay at 2,000 ppm; and nut, tree group 

14–12 at 0.1 ppm. Tolerances are 

established for livestock commodities is 

by measuring only the sum of 

pendimethalin, [N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine], and 

its metabolite, 1-[(1-ethylpropyl)-5,6- 

dimethyl-7-nitro-1H-benzimidazole 

(metabolite 6), calculated as the 

stoichiometric equivalent of 

pendimethalin in or on cattle, fat at 0.30 

ppm; cattle, meat at 0.10 ppm; cattle, 

meat byproduct 3.0 ppm; goat, fat at 

0.30 ppm; goat, meat at 0.10 ppm; goat, 

meat byproduct at 3.0 ppm; horse, fat at 

0.30 ppm; horse, meat at 0.10 ppm; 

horse, byproduct at 3.0 ppm; milk at 

0.04 ppm; sheep, fat at 0.30 ppm; sheep, 

meat at 0.10 ppm; and sheep, meat 

byproduct at 3.0 ppm. Additionally, the 

existing tolerances for Juneberry; nut, 

tree, group 14; and pistachio are 

removed. 

VI. Statutory and Executive Order 

Reviews 

This action 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (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 

(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: December 7, 2015. 

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 § 180.361: 

■ a. Redesignate paragraph (a) as (a)(1). 

■ b. In the newly redesignated 

paragraph (a)(1): 

■ i. Remove the entries in the table for 

‘‘Grass forage, fodder, and hay crop 

group 17, straw’’; ‘‘Juneberry’’; ‘‘Nut, 

tree group 14’’; and ‘‘Pistachio’’. 

■ ii. Revise the entries in the table for 

‘‘Grass, forage, fodder, and hay crop 

group 17, forage’’ and ‘‘Grass, forage, 

fodder, and hay crop group 17, hay’’. 

■ iii. Add alphabetically the entries 

‘‘Bushberry subgroup 13–07B’’ and 

‘‘Caneberry subgroup 13–07A’’ to the 

table. 

■ c. Add paragraph (a)(2). 

The additions and revisions read as 

follows: 

§ 180.361 Pendimethalin; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity 

Parts 

per 

million 

* * * * * 

Bushberry subgroup 13–07B .......... 0.10 

Caneberry subgroup 13–07A ......... 0.10 

* * * * * 

Grass, forage, fodder, and hay 

crop group 17, forage ................. 1,000 

Grass, forage, fodder, and hay 

crop group 17, hay ...................... 2,000 

* * * * * 

Nut, tree, group 14–12 ................... 0.10 

* * * * * 

(2) Tolerances are established for 

residues of the herbicide pendimethalin, 

including its metabolites and 

degradates, in or on commodities listed 

in the following table. Compliance with 

the tolerance levels is to be determined 

by measuring only the sum of 

pendimethalin (N-(1-ethylpropyl)-3,4- 

dimethyl-2,6-dinitrobenzenamine)) and 

its metabolite, 1-(1-ethylpropyl)-5, 6- 

dimethyl-7-nitro-1H-benzimidazole 

(metabolite 6), calculated as the 

stoichiometric equivalent of 

pendimethalin, in or on the commodity. 

Commodity 

Parts 

per 

million 

Cattle, fat ........................................ 0.30 

Cattle, meat .................................... 0.10 

Cattle, meat byproduct ................... 3.0 

Goats, fat ........................................ 0.30 


Lhorne on DSK5TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Rules and Regulations 79273 

1https://www.fmcsa.dot.gov/medical/drivermedical-requirements/medical-applications-andforms. 

Commodity 

Parts 

per 

million 

Goats, meat .................................... 0.10 

Goats, meat byproduct ................... 3.0 

Horse, fat ........................................ 0.30 

Horse, meat .................................... 0.10 

Horse, byproduct ............................ 3.0 

Milk ................................................. 0.04 

Sheep, fat ....................................... 0.30 

Sheep, meat ................................... 0.10 

Sheep, meat byproduct .................. 3.0 

* * * * * 

[FR Doc. 2015–31655 Filed 12–18–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 391 

[Docket No. FMCSA–2012–0178] 

RIN 2126–AB40 

Guidance on Medical Examiner’s 

Certification Integration Final Rule 

Regarding Use of Driver Examination 

Forms 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Guidance. 

SUMMARY: The FMCSA announces a 120- 

day grace period during which Medical 

Examiners may use either the current or 

the newly revised versions of the 

Medical Examination Report (MER) 

Form and Medical Examiner’s 

Certificate (MEC). This period is from 

December 22, 2015, until April 20, 2016. 

This action is being taken to ensure that 

Medical Examiners have sufficient time 

to become familiar with the new forms 

and to program electronic medical 

records systems. 

DATES: This guidance is effective 

December 21, 2015. 

ADDRESSES: You may search background 

documents or comments to the docket 

for this rule, identified by docket 

number FMCSA–2012–0178, by visiting 

the: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for reviewing documents 

and comments. Regulations.gov is 

available electronically 24 hours each 

day, 365 days a year; or 

• DOT Docket Management Facility 

(M–30): U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., West Building, Ground 

Floor, Room 12–140, Washington, DC 

20590–0001. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Christine Hydock, Chief, Medical 

Programs Division, Office of Policy, 

Federal Motor Carrier Safety 

Administration, 1200 New Jersey 

Avenue SE., Washington, DC 20590 or 

by telephone (202) 366–4001. If you 

have questions on viewing material in 

the docket, contract Docket services, 

telephone (202) 366–9826. 

SUPPLEMENTARY INFORMATION: 

I. Legal Basis 

On April, 23, 2015, FMCSA published 

a final rule adopting regulations to 

facilitate the electronic transmission of 

MEC information from FMCSA’s 

National Registry to the State driver’s 

license agencies (SDLA) for holders of 

Commercial Driver’s Licenses (CDL) and 

Commercial Learner’s Permits (CLP). (80 

FR 22790). On June 22, 2015, FMCSA 

published a document correcting the 

effective date for use of new forms 

prescribed in the final rule to December 

22, 2015. (80 FR 35577). See 49 CFR 

391.43(f)(1) and (2) and 391.43(h)(1) and 

(2). 

The final rule, as corrected, requires 

certified MEs performing physical 

examinations of CMV drivers to use a 

newly developed MER Form, MCSA– 

5875, in place of the current MER form, 

and for use of the newly developed MEC 

Form MCSA–5876 for the current MEC 

form, beginning on December 22, 2015. 

II. Availability of New Forms 

On December 14, FMCSA posted the 

fillable pdf versions of the new driver 

examination forms. The Agency had 

planned to make the forms available 

prior to this date but experienced 

technical difficulties. As a result, 

FMCSA has received numerous requests 

from the public asking to have the 

effective date for use of the MER Form, 

MCSA–5875, and the MEC, MCSA– 

5876, to be delayed. FMCSA 

acknowledges that enforcement of this 

December 22, 2015, compliance date 

would not provide sufficient time for 

Medical Examiners to become familiar 

with the new driver examination forms 

and/or program electronic medical 

records systems. For this reason, 

FMCSA will provide a 120-day grace 

period during which Medical Examiners 

may use either the current or the newly 

revised versions of the Medical 

Examination Report Form and Medical 

Examiner’s Certificate, which will be 

from December 22, 2015, until April 20, 

2016. Both sets of forms have been 

posted on the FMCSA Web site,1 and 

Medical Examiners have the option to 

use either set of forms from December 

22, 2015 until April 20, 2016. 

Issued on: December 16, 2015. 

T.F. Scott Darling, III, 

Acting Administrator. 

[FR Doc. 2015–32001 Filed 12–18–15; 8:45 am] 

BILLING CODE 4910–EX–P 


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