1526 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 4, 2016. 

G. Jeffery Herndon, 

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 § 180.960, alphabetically add the 

following polymer to the table to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

*******

2-propenoic acid, 2-methyl-, polymers with tert-Bu acrylate, Me methacrylate, polyethylene glycol methacrylate C16-C18-alkyl 

ethers and vinylpyrrolidone, tert-Bu 2-ethylhexaneperoxoate-initiated, compounds with 2-amino-2-methyl-1-propanol, minimum number average molecular weight (in amu), 2,600 ......................................................................................................... 1515872–09–9 

* * * * * * * 

[FR Doc. 2016–00533 Filed 1–12–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0680; FRL–9940–90] 

Propyzamide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of propyzamide, 

also known as pronamide, in or on leaf 

lettuce. Dow AgroSciences, LLC 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

January 13, 2016. Objections and 

requests for hearings must be received 

on or before March 14, 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–2014–0680, 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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/test-guidelines-pesticidesand-toxic-substances. 

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 the request by the docket ID 

number EPA–HQ–OPP–2014–0680 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 March 14, 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 

by docket ID number EPA–HQ–OPP– 

2014–0680, 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 


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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 Wednesday, 

December 17, 2014 (79 FR 75109) (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 4F8301) by 

Dow AgroSciences, LLC, 9330 

Zionsville Rd., Indianapolis, IN 46268– 

1054. The petition requested that 40 

CFR 180.317 be amended by 

establishing a tolerance for residues of 

the herbicide pronamide (propyzamide) 

and its metabolite containing the 3,5- 

dichlorobenzoyl moiety calculated as 

3,5-dichloro-N-(1,1-dimethyl-2- 

propynyl)benzamide, in or on lettuce, 

leaf at 1.0 part per million (ppm). That 

document referenced a summary of the 

petition prepared by Dow AgroSciences, 

LLC, the registrant, which is available in 

the docket EPA–HQ–OPP–2014–0680 at 

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 propyzamide 

including exposure resulting from the 

tolerance established by this action. 

EPA’s assessment of exposures and risks 

associated with propyzamide 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. 

Propyzamide has low acute toxicity 

via the oral, dermal, and inhalation 

routes of exposure, is non-irritating to 

the eyes or skin, and is not a dermal 

sensitizer. 

The primary target organ for 

propyzamide is the liver. There are 

other target organs as well, including 

the thyroid, testes, and pituitary, but 

effects on these organs are secondary to 

primary effects on the liver. Liverrelated effects include increases in 

absolute and relative liver weights, 

hypertrophy, elevated levels of enzymes 

associated with liver damage, and 

histopathology of liver cells. Adverse 

liver effects were consistently observed 

in every animal species studied, with 

progression towards more severe effects 

over time ultimately leading to 

tumorigenesis in rats and mice. Based 

on the studies submitted, the rat is the 

most sensitive species. In most studies, 

there is no gender sensitivity in 

response to propyzamide. 

Propyzamide is a carcinogen in rats 

and mice, causing liver tumors in mice, 

thyroid tumors in male rats, and 

testicular tumors in rats. Based on MOA 

studies, tumorigenesis for all three 

tumor types has been shown to be 

mediated by liver enzymes induced in 

response to treatment with 

propyzamide. In mice, the MOA data 

clearly show rapid induction of 

Cyp2b10 associated with the 

constitutive androstane nuclear receptor 

(CAR), as well as induction of 

peroxisomes and peroxisomal enzymes 

such as Cyp4a10 associated with a 

second nuclear receptor, PPAR-a. 

Induction of the nuclear receptors leads 

to mitogenesis followed by 

hepatocellular proliferation and 

eventually, liver tumors. 

In rats, propyzamide induces Cyp2b1 

200-fold over background levels, but has 

no effect on other CYPs commonly 

associated with carcinogenic modes of 

action. In the rat Cyp2b1 is a biological 

marker for the CAR receptor. The CAR 

pathway is associated with the 

activation of uridine diphosphate 

glucuronyl transferase (UGT) which 

catalyzes the condensation of 

glucuronic acid with thyroxine (T4), 

leading to enhanced biliary excretion of 

T4. Eventually the continued stimulus 

to produce more T4 leads to the 

formation of thyroid follicular tumors. 

In male rats, the tumorigenic dose of 

propyzamide for both thyroid tumors 

and Leydig cell tumors is 1,000 ppm in 

the diet (34–75 mg/kg/day based on age 

of the rats). Tumor precursor effects 

such as decreases in T4 levels, increases 

in liver weight, liver hypertrophy, and 

elevated testosterone metabolism occur 

at doses below or equivalent to the 

tumorigenic dose. 

In nearly every oral repeated-dose 

study of propyzamide as well as in the 

28-day dermal toxicity study in rats, 

there were dose-related decreases in 

body weight, body weight gain, and 

food consumption. Typically, these 

effects on body weight occurred at or 

above effects on the liver such as 

hypertrophy or increases in liver 

weight. 

There was evidence of neurotoxicity 

in rats based on an increase in landing 

foot splay in females and decreases in 

motor activity in both genders in the 

acute neurotoxicity study. In the 

subchronic neurotoxicity study 

however, there was no evidence of 

neurotoxicity following dietary 

administration, and only body-weight 

effects were observed. There was no 

evidence of neurotoxicity in the rest of 

the toxicology database across other 

species or other strains of rat. There was 

no evidence of immunotoxicity. 

There was no evidence of quantitative 

or qualitative increased susceptibility in 

the fetuses or the offspring of rats or 

rabbits following pre- and/or postnatal 

exposure to propyzamide. In the 

prenatal developmental toxicity study 

in rabbits and the multi-generation 

reproduction study in rats, any observed 

toxicity to the fetuses or offspring 

occurred at equivalent or higher doses 

than effects to parental animals. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by propyzamide 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 

‘‘Pronamide Human Health Risk 

Assessment for Registration Review and 

to Support New Section 3 Use on Leaf 

Lettuce (Revised)’’ on pages 14–22 in 

docket ID number EPA–HQ–OPP–2014– 

0680. 


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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-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for propyzamide used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPYZAMIDE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/Scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All populations) .. LOAEL = 40 mg/kg/

day 

UFA = 10x ................

UFH = 10x ................

UFL = 10x ................

FQPA SF = 1x .........

Acute RfD = 0.04 

mg/kg/day.

aPAD = 0.04 mg/kg/

day.

Acute Neurotoxicity Rat Study 

No NOAEL established. 

LOAEL = 40 mg/kg/day based on increased landing foot splay 

and decreased motor activity. 

Acute dietary (Females 13–49 

years of age).

No endpoint attributable to a single exposure was identified, including developmental toxicity studies in rats 

and rabbits. 

Chronic dietary (All populations) LOAEL = 40 mg/kg/

day.

UFA = 10x ................

UFH = 10x ................

UFL = 10x ................

FQPA SF = 1x .........

Chronic RfD = 0.04 

mg/kg/day.

cPAD = 0.04 mg/kg/

day.

POD = 4 mg/kg/day based on a weight-of-evidence approach 

from the following rat studies: 

Acute Neurotoxicity Study. 

No NOAEL established. 

LOAEL = 40 mg/kg/day based on increased landing foot splay 

and decreased motor activity 

POD = 4 mg/kg/day (LOAEL of 40 mg/kg/day ÷10x UFL) 

Subchronic Neurotoxicity Study 

NOAEL = 2.38 mg/kg/day LOAEL = 11.28 mg/kg/day based on 

significant decreases in body weight, body weight gain, and 

food consumption in males 

Combined Chronic Toxicity/Carcinogenicity Study 

NOAEL = 8.46/10.69 mg/kg/day 

LOAEL = 42.59/55.09 mg/kg/day based on increased relative 

liver weight and histopathological lesions in the liver, thyroid, 

and ovaries 

Male Pubertal Study 

NOAEL = 2.5 mg/kg/day 

LOAEL = 10 mg/kg/day based on decreased serum T4 

Incidental oral short-term (1 to 

30 days).

LOAEL = 40 mg/kg/

day.

LOC for MOE = 

1,000.

Same as Chronic dietary section above 

UFA = 10x 

UFH = 10x 

UFL = 10x 

FQPA SF = 1x 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

NOAEL = 100 mg/

kg/day (dermal absorption rate = 

24%).

LOC for MOE = 100 Subchronic Dermal Toxicity Rat Study 

LOAEL = 500 mg/kg/day based on decreases in body weight 

and food consumption 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PROPYZAMIDE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/Scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (oral, dermal, inhalation).Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ at doses that do not result in induction of hepatic 

cell proliferation or metabolic enzymes leading to disruption of thyroid or gonadal endocrine axes. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to propyzamide, EPA 

considered exposure under the 

petitioned-for tolerance as well as all 

existing propyzamide tolerances in 40 

CFR 180.317. EPA assessed dietary 

exposures from propyzamide 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 propyzamide. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA assumed 

that propyzamide residues were present 

at tolerance levels in all commodities 

for which tolerances have been 

established or proposed, and that 100% 

of the crops were treated with 

propyzamide. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA). As to residue levels 

in food, EPA assumed that propyzamide 

residues were present at tolerance levels 

in all commodities for which tolerances 

have been established or proposed, and 

that 100% of the crops were treated 

with propyzamide. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that propyzamide does not 

pose a cancer risk to humans at doses 

that do not result in induction of 

hepatic cell proliferation or metabolic 

enzymes leading to disruption of 

thyroid or gonadal endrocrine axes. The 

MOAs were adequately supported by 

studies that clearly identified the 

sequence of key events, dose-response 

concordance and temporal relationship 

to the particular tumor type. 

Quantification of carcinogenic risk is 

not required. The chronic RfD would be 

protective of both carcinogenic and noncarcinogenic effects observed in the 

mouse and rat carcinogenicity studies 

and MOA studies conducted at higher 

doses. Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for propyzamide. Tolerance-level 

residues and 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used Tier II 

screening level water exposure models 

in the dietary exposure analysis and risk 

assessment for propyzamide in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of propyzamide. Further 

information regarding EPA drinking 

water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Tier II Surface Water 

Concentration Calculator (SWCC) and 

Pesticide Root Zone Model Ground 

Water (PRZM–GW), the estimated 

drinking water concentrations (EDWCs) 

of propyzamide for acute exposures are 

estimated to be 102 parts per billion 

(ppb) for surface water and 21 ppb for 

ground water; for chronic exposures for 

non-cancer assessments are estimated to 

be 47 ppb for surface water and 18.6 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 102 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 47 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). 

Propyzamide is currently registered for 

the following uses that could result in 

residential exposures: Turf grass and 

golf courses. EPA assessed residential 

exposure using the following 

assumptions: Post-application dermal 

and incidental oral exposures for 

children 1 to < 2 years old (physical 

activities on turf and hand-to-mouth 

ingestion of treated soil); and postapplication dermal exposure for 

children 6 to < 11 years old (golfing), 

children 11 to < 16 years old (golfing 

and mowing), and adults (golfing, 

mowing, and physical activities on turf). 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticidescience-and-assessing-pesticide-risks/

standard-operating-proceduresresidential-pesticide. 

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 propyzamide to 

share a common mechanism of toxicity 

with any other substances, and 

propyzamide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that propyzamide 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 


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1530 Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.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 evidence of quantitative 

or qualitative increased susceptibility in 

developing fetuses or in offspring of rats 

or rabbits following prenatal and/or 

postnatal exposure to propyzamide. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

was reduced to 1X. This decision is 

based on the following findings: 

i. The toxicity database for 

propyzamide is complete. 

ii. There is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity despite evidence of 

neurotoxicity in the acute study based 

on the increase in landing foot splay in 

female rats and the decrease in motor 

activity seen in both genders on day 1. 

This decision is based on no evidence 

of neurotoxicity in the subchronic study 

at dose levels tested via different routes 

of administration, and no evidence of 

neurotoxicity in the rest of the 

toxicology database across other species 

and other strains of rat. 

iii. There is no evidence that 

propyzamide results in increased 

susceptibility in in utero rabbits in the 

prenatal developmental toxicity study 

or in young rats in the two-generation 

reproduction study. 

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 propyzamide 

in drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by propyzamide. 

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 

propyzamide will occupy 46% of the 

aPAD for all infants < 1 year old, the 

population subgroup receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic dietary exposure to 

propyzamide from food and water will 

utilize 11% of the cPAD for children 1 

to 2 years old, the population subgroup 

receiving the greatest exposure. Based 

on the explanation in Unit III.C.3. 

regarding residential use patterns, 

chronic residential exposure to residues 

of propyzamide 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 background exposure 

level). Propyzamide 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. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that the 

combined short-term food, water, and 

residential exposure results in an 

aggregate MOE of 1,700 for children 1 to 

< 2 years old (chronic dietary exposure 

with post-application incidental oral 

exposure from turf use). Because EPA’s 

level of concern for propyzamide is a 

MOE of 1,000 or below, this MOE is 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 background exposure level). 

Propyzamide is currently registered for 

uses that could result in intermediateterm residential exposure. However, 

since the maximum single and yearly 

application rates are the same, the shortterm assessment is protective of 

intermediate-term incidental oral 

exposure. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit 

III.C.iii., Propyzamide is classified as 

‘‘Not Likely to be Carcinogenic to 

Humans’’ at doses that do not result in 

induction of hepatic cell proliferation or 

metabolic enzymes leading to 

disruption of thyroid or gonadal 

endocrine axes. Therefore, 

quantification of aggregate cancer risk is 

not required. 

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 propyzamide 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available to enforce the tolerance 

expression of residues in/on plant 

commodities (PAM II Method I, using 

gas-liquid chromatography with 

electron-capture detection (GLC/ECD)) 

and livestock commodities (Method 

GRM 02.21, using gas chromatography 

with negative-ion chemical ionization 

mass spectrometry detection (GC/MS)). 

These methods may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 81, No. 8 / Wednesday, January 13, 2016 / Rules and Regulations 1531 

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 not 

established any MRLs for propyzamide. 

V. Conclusion 

Therefore, tolerances are established 

for residues of propyzamide 

(pronamide), 3,5-dichloro-N-(1,1- 

dimethyl-2-propynyl)benzamide, in or 

on lettuce, leaf at 1.0 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

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 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 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 31, 2015. 

Susan Lewis, 

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 § 180.317, add alphabetically 

‘‘Lettuce, leaf’’ to the table in paragraph 

(a) to read as follows: 

§ 180.317 Propyzamide; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Lettuce, leaf .......................... 1.0 

* * * * * 

* * * * * 

[FR Doc. 2016–00534 Filed 1–12–16; 8:45 am] 

BILLING CODE 6560–50–P 

GENERAL SERVICES 

ADMINISTRATION 

48 CFR Parts 501, 504, 509, 519, 522, 

536, 537, 552, and 570 

[GSAR–TA–01; Docket No. 2015–0016; 

Sequence No. 1] 

General Services Administration 

Acquisition Regulation (GSAR); 

Technical Amendments 

AGENCY: Office of Acquisition Policy, 

General Services Administration (GSA). 

ACTION: Final rule. 

SUMMARY: General Services 

Administration (GSA) is amending the 

General Services Administration 

Acquisition Regulation (GSAR) to make 

editorial changes. This technical 

amendment includes updating 

references and links, as well as deleting 

repetitive information that is covered 

elsewhere within the General Services 

Administration Acquisition Manual 

(GSAM). Changes incorporate both 

internal acquisition guidance, and the 

regulatory acquisition policies. 

DATES: Effective: January 13, 2016. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Leah Price, Procurement Analyst, by 

phone at 703–605–2558, or email at 

leah.price@gsa.gov for clarification of 

content. For information pertaining to 

the status or publication schedules, 

contact the Regulatory Secretariat 

Division at 202–501–4755. Please cite 

GSAR–TA–01; Technical Amendments. 

SUPPLEMENTARY INFORMATION: GSA is 

amending the GSAR to make editorial 

changes throughout the GSAM. There 

are no significant content changes 

resulting from this technical 

amendment. 

Outdated references and links have 

been updated. Throughout multiple 

GSAM parts, the Central Contractor 

Registration (CCR) and the Excluded 

Parties List System (EPLS) have been 

changed to System for Award 

Management (SAM). This follows 

similar Federal Acquisition Regulation 


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