Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 26141 

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: April 25, 2016. 

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 § 180.515, the table in paragraph 

(a) is revised to read as follows: 

§ 180.515 Carfentrazone-ethyl; tolerance 

for residues. 

(a) * * * 

Commodity Parts per 

million 

Acerola ........................................ 0.10 

Almond, hulls .............................. 0.20 

Animal feed, nongrass, crop 

group 18, forage ..................... 2.0 

Animal feed, nongrass, crop 

group 18, hay .......................... 5.0 

Animal feed, nongrass, crop 

group 18, seed ........................ 15.0 

Artichoke, globe .......................... 0.10 

Asparagus ................................... 0.10 

Atemoya ...................................... 0.10 

Avocado ...................................... 0.10 

Banana ....................................... 0.10 

Berry, low growing, subgroup 

13–07G ................................... 0.10 

Birida ........................................... 0.10 

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

Cacao bean, bean ...................... 0.10 

Cactus ......................................... 0.10 

Caneberry subgroup 13A1 ......... 0.1 

Caneberry subgroup 13–07A ..... 0.10 

Canistel ....................................... 0.10 

Cattle, fat .................................... 0.10 

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

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

Cherimoya .................................. 0.10 

Coffee, bean, green .................... 0.10 

Cotton, gin byproducts ............... 10 

Cotton, hulls 1 ............................. 0.60 

Cotton, meal 1 ............................. 0.35 

Cotton, refined oil 1 ..................... 1.0 

Cottonseed subgroup 20C ......... 0.20 

Custard apple ............................. 0.10 

Date, dried fruit ........................... 0.10 

Feijoa .......................................... 0.10 

Fig ............................................... 0.10 

Commodity Parts per 

million 

Fish ............................................. 0.30 

Fruit, citrus, group 10–10 ........... 0.10 

Fruit, pome, group 11–10 ........... 0.10 

Fruit, small vine climbing, subgroup 13–07F, except Fuzzy 

kiwifruit .................................... 0.10 

Fruit, stone, group 12–12 ........... 0.10 

Goat, fat ...................................... 0.10 

Goat, meat .................................. 0.10 

Goat, meat byproducts ............... 0.10 

Grain, aspirated grain fractions .. 1.8 

Grain, cereal, group 15 (except 

rice grain and sorghum grain) 0.10 

Grain, cereal, group 16, forage .. 1.0 

Grain, cereal, group 16, hay ...... 0.30 

Grain, cereal, group 16, stover .. 0.80 

Grain, cereal, group 16, straw .... 3.0 

Grass, forage .............................. 5.0 

Grass, hay .................................. 8.0 

Guava ......................................... 0.10 

Herbs and spices group 19 ........ 2.0 

Hog, fat ....................................... 0.10 

Hog, meat ................................... 0.10 

Hog, meat byproducts ................ 0.10 

Hop, dried cones ........................ 0.10 

Horse, fat .................................... 0.10 

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

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

Horseradish ................................ 0.10 

Ilama ........................................... 0.10 

Jaboticaba .................................. 0.10 

Kava, roots ................................. 0.10 

Kiwifruit ....................................... 0.10 

Longan ........................................ 0.10 

Lychee ........................................ 0.10 

Mango ......................................... 0.10 

Milk ............................................. 0.05 

Noni ............................................ 0.10 

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

Olive ............................................ 0.10 

Palm heart .................................. 0.10 

Palm heart, leaves ...................... 0.10 

Papaya ........................................ 0.10 

Passionfruit ................................. 0.10 

Pawpaw ...................................... 0.10 

Peanut ........................................ 0.10 

Peanut, hay ................................ 0.10 

Peppermint, tops ........................ 0.10 

Persimmon .................................. 0.10 

Pomegranate .............................. 0.10 

Poultry, meat byproducts ............ 0.10 

Psyllium, seed ............................ 0.10 

Pulasan ....................................... 0.10 

Quinoa, grain .............................. 0.10 

Rambutan ................................... 0.10 

Rapeseed, forage ....................... 0.10 

Rapeseed subgroup 20A ............ 0.10 

Rice, grain .................................. 1.3 

Rice, straw 1 ................................ 1.0 

Sapodilla ..................................... 0.10 

Sapote, black .............................. 0.10 

Sapote, mamey .......................... 0.10 

Sheep, fat ................................... 0.10 

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

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

Shellfish ...................................... 0.30 

Sorghum, grain ........................... 0.25 

Soursop ...................................... 0.10 

Soybean, seed ............................ 0.10 

Spanish lime ............................... 0.10 

Spearmint, tops .......................... 0.10 

Star apple ................................... 0.10 

Starfruit ....................................... 0.10 

Commodity Parts per 

million 

Stevia .......................................... 0.10 

Strawberrypear ........................... 0.10 

Sugar apple ................................ 0.10 

Sugarcane .................................. 0.15 

Sunflower, subgroup 20B ........... 0.10 

Tea, dried ................................... 0.10 

Teff, forage ................................. 1.0 

Teff, grain ................................... 0.25 

Teff, hay ...................................... 0.30 

Teff, straw ................................... 3.0 

Ti, leaves .................................... 0.10 

Ti, roots ....................................... 0.10 

Vanilla ......................................... 0.10 

Vegetable, brassica, leafy, group 

5 .............................................. 0.10 

Vegetable, bulb, group 3–07 ...... 0.10 

Vegetable, cucurbit, group 9 ...... 0.10 

Vegetable, foliage of legume, except soybean, subgroup 7A .... 0.10 

Vegetable, fruiting, group 8–10 .. 0.10 

Vegetable, leafy, except brassica, group 4 ........................... 0.10 

Vegetable, leaves of root and 

tuber, group 2 ......................... 0.10 

Vegetable, legume, group 6 ....... 0.10 

Vegetable, root and tuber, group 

1 .............................................. 0.10 

Wasaba, roots ............................ 0.10 

Wax jambu .................................. 0.10 

1Effective Date to be removed: May 18, 

2016. 

* * * * * 

[FR Doc. 2016–10235 Filed 4–29–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0524; FRL–9944–10] 

Propanamide, 2-hydroxy-N, Ndimethyl- ; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of propanamide, 

2-hydroxy-N, N-dimethyl- (CAS Reg. 

No. 35123–06–9) when used as an inert 

ingredient (solvent/co-solvent) in 

pesticides applied to growing crops and 

raw agricultural commodities after 

harvest under 40 CFR 180.910 or in 

pesticides applied to animals under 40 

CFR 180.930 limited to maximum 

concentration of 20% by weight in the 

pesticide formulation. Spring Trading 

Company, LLC on behalf of BASF 

Corporation submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

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26142 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of propanamide, 2-hydroxyN, N-dimethyl-. 

DATES: This regulation is effective May 

2, 2016. Objections and requests for 

hearings must be received on or before 

July 1, 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–2015–0524, 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 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–2015–0524 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 July 1, 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– 

2015–0524, 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. Petition for Exemption 

In the Federal Register of September 

9, 2015 (80 FR 54257) (FRL–9933–26), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP IN–10782) by Spring 

Trading Company, LLC (10805 W. 

Timberwagon Circle Spring, TX 77380) 

on behalf of BASF Corporation (100 

Campus Drive, Florham Park, NJ 07932). 

The petition requested that 40 CFR 

180.910 and 40 CFR 180.930 be 

amended by establishing exemptions 

from the requirement of a tolerance for 

residues of propanamide, 2-hydroxy-N, 

N-dimethyl- (CAS Reg. No. 35123–06–9) 

when used as an inert ingredient 

(solvent/co-solvent) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest or in pesticides applied to 

animals, respectively. That document 

referenced a summary of the petition 

prepared by Spring Trading Company, 

LLC on behalf of BASF Corporation, the 

petitioner, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has limited 

the maximum concentration of 

propanamide, 2-hydroxy-N, N-dimethyl 

to 20% by weight in pesticide 

formulations. The reasons for this 

change are explained in Unit V.B. 

below. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for 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 

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Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 26143 

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. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), 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 propanamide, 2- 

hydroxy-N, N-dimethyl- including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with propanamide, 2- 

hydroxy-N, N-dimethyl- follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by propanamide, 2-hydroxy-N, Ndimethyl- as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

Propanamide, 2-hydroxy-N, Ndimethyl- is of low acute oral, dermal 

and inhalation toxicity in rats; all lethal 

dose (LD)50s are greater than 1,000 mg/ 

kg. Dermal irritation is not observed in 

rabbits. It is mildly irritating to the eyes 

of rabbits. It is not a dermal sensitizer 

in mice in the lymph node assay. 

The toxicity studies summarized 

below were all conducted with 

propanamide, 2-hydroxy-N, N-dimethylexcept the chronic toxicity study. That 

study was conducted with N, Ndimethylacetamide, a structurally 

similar chemical. The only difference 

between the two chemicals is that N, Ndimethylacetamide is missing a 

hydroxyl group on a carbon atom. Both 

compounds are expected to undergo 

similar metabolism (in this case, Noxidation) by cytochrome P450 enzymes 

and have similar toxicological profiles; 

therefore, the Agency has determined 

the data to be suitable for evaluating 

propanamide. 

In rats, 90 days of oral exposure to 

propanamide, 2-hydroxy-N, N-dimethylresults in increased cholesterol and 

triglyceride levels, increased liver 

weights and centrilobular hypertrophy 

at 1,000 milligrams/kilogram/day (mg/

kg/day), the limit dose. The NOAEL is 

500 mg/kg/day. Reproduction 

parameters, estrus cyclicity and sperm 

parameters were also evaluated in this 

study and were found to be unaffected 

at 1,000 mg/kg/day. 

A developmental toxicity study in rats 

showed no maternal toxicity at 500 mg/ 

kg/day, the highest dose tested. 

Quantitative fetal susceptibility was 

observed as reduced body weight in 

pups at 500 mg/kg/day. The 

developmental NOAEL was 200 mg/kg/ 

day. 

Propanamide, 2-hydroxy-N, Ndimethyl- was not mutagenic in the 

Chinese hamster ovary (CHO) cells 

HGPRT locus gene mutation assay or the 

micronucleus test. 

Propanamide, 2-hydroxy-N, Ndimethyl- is not expected to be 

carcinogenic based on the absence of 

structural alerts using Deductive 

Estimation of Risk from Existing 

Knowledge (Derek) Nexus program and 

the lack of mutagenicity. It is not 

expected to be neurotoxic based on the 

functional observation battery or on 

motor activity in the 90-day oral toxicity 

study in rats. 

Immunotoxicity studies for 

propanamide, 2-hydroxy-N, N-dimethylwere not available for review. However, 

evidence of immunotoxicity was not 

observed in the submitted studies. 

Chronic studies with propanamide, 

2-hydroxy-N, N-dimethyl- are not 

available for review. However, a chronic 

study conducted for 12 months in rats 

treated with N, N-dimethylacetamide, a 

structurally similar chemical, was used 

as surrogate data. In this study toxicity 

manifested as reduced bodyweight was 

observed at 300 mg/kg/day. The NOAEL 

is 100 mg/kg/day. 

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. 

An acute effect was not found in the 

database therefore an acute dietary 

assessment is not necessary. The 

chronic reference dose (cRfD) as well as 

the toxicity endpoint applicable to all 

exposure scenarios was based on the 12- 

month chronic toxicity study in rats. In 

this study, the NOAEL was 100 mg/kg/ 

day based on reduced bodyweights at 

300 mg/kg/day, the LOAEL. This 

represents the lowest NOAEL in the 

most sensitive species in the toxicity 

database. The standard uncertainty 

factors were applied to account for 

interspecies (10x) and intraspecies (10x) 

variations. The Food Quality Protection 

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26144 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 

Act Safety Factor (FQPA SF) was 

reduced to 1x. Default values of 100% 

absorption were used in dermal and 

inhalation toxicity endpoint selection. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to propanamide, 2-hydroxy-N, 

N-dimethyl-, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

propanamide, 2-hydroxy-N, N-dimethylin food as follows: 

Dietary exposure (food and drinking 

water) to propanamide, 2-hydroxy-N, Ndimethyl- can occur following ingestion 

of foods with residues from treated 

crops and animals. Because no adverse 

effects attributable to a single exposure 

of propanamide, 2-hydroxy-N, Ndimethyl- are seen in the toxicity 

databases, an acute dietary risk 

assessment is not necessary. For the 

chronic dietary risk assessment, EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCIDTM, Version 3.16, and food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, no residue data 

were submitted for propanamide, 2- 

hydroxy-N, N-dimethyl-. In the absence 

of specific residue data, EPA has 

developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high use insecticides, 

herbicides, and fungicides. One 

hundred percent crop treated (PCT) was 

assumed, default processing factors, and 

tolerance-level residues for all foods and 

use limitations of not more than 20% by 

weight in pesticide formulations. A 

complete description of the general 

approach taken to assess inert 

ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts,’’ (D361707, 

S. Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

2. Dietary exposure from drinking 

water. For the purpose of the screeninglevel dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for 

propanamide, 2-hydroxy-N, Ndimethyl-, a conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Propanamide, 2-hydroxy-N, Ndimethyl- may be used in inert 

ingredients in products that are 

registered for specific uses that may 

result in residential exposure, such as 

pesticides used in and round the home. 

The Agency conducted an assessment to 

represent worst-case residential 

exposure by assessing propanamide, 2- 

hydroxy-N, N-dimethyl- in pesticide 

formulations (outdoor scenarios) and in 

disinfectant-type uses (indoor 

scenarios). 

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 propanamide, 2- 

hydroxy-N, N-dimethyl- to share a 

common mechanism of toxicity with 

any other substances, and propanamide, 

2-hydroxy-N, N-dimethyl- does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

propanamide, 2-hydroxy-N, N-dimethyldoes 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 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10X) margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

The toxicity database for 

propanamide, 2-hydroxy-N, N-dimethylcontains a subchronic, developmental, 

chronic and mutagenicity studies. There 

is no indication of neurotoxicity or 

immunotoxicity in the available studies; 

therefore, there is no need to require 

neurotoxicity or immunotoxicity 

studies. Quantitative fetal susceptibility 

was observed in the developmental 

study in rats. Fetal toxicity (reduced 

bodyweight) was observed at 500 mg/

kg/day, the highest dose tested, while 

toxicity was not observed in maternal 

animals. The developmental NOAEL 

was 200 mg/kg/day. However, fetal 

effects are not of concern since the cRfD 

(1mg/kg/day) will be protective of 

effects seen at 500 mg/kg/day. In 

addition, the Agency used conservative 

exposure estimates, with 100 PCT, 

tolerance-level residues, conservative 

drinking water modeling numbers, and 

a worst-case assessment of potential 

residential exposure for infants and 

children. Based on the adequacy of the 

toxicity and exposure databases and the 

lack of concern for prenatal and 

postnatal sensitivity, the Agency has 

concluded that there is reliable data to 

determine that infants and children will 

be safe if the FQPA SF of 10x is reduced 

to 1x. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

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and no acute dietary endpoint was 

selected. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to propanamide, 

2-hydroxy-N, N-dimethyl- from food 

and water will utilize 28.4% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

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). 

Propanamide, 2-hydroxy-N, Ndimethyl- may be used as an inert 

ingredient in pesticide products 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 propanamide, 2-hydroxyN, N-dimethyl-. Using the exposure 

assumptions described above, EPA has 

concluded that the combined short-term 

aggregated food, water, and residential 

exposures result in MOEs of 115 for 

both adult males and females. Adult 

residential exposure combines high-end 

dermal and inhalation handler exposure 

from liquids/trigger sprayer/home 

garden with a high-end postapplication dermal exposure from 

contact with treated lawns. Adult 

residential exposure combines high-end 

dermal and inhalation handler exposure 

from liquids/trigger sprayer/home 

garden with a high-end postapplication dermal exposure from 

contact with treated lawns. EPA has 

concluded the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

154 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the level of concern is for 

MOEs that are lower than 100, 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). 

Propanamide, 2-hydroxy-N, Ndimethyl- may be used as an inert 

ingredient in pesticide products that 

could result in intermediate-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with intermediate-term 

residential exposures to propanamide, 

2-hydroxy-N, N-dimethyl-. Using the 

exposure assumptions described above, 

EPA has concluded that the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 591 for adult 

males and females. Adult residential 

exposure combines indoor hard surface, 

wiping with a high-end post-application 

dermal exposure from contact with 

treated lawns. As the level of concern is 

for MOEs that are lower than 100, this 

MOE is not of concern. EPA has 

concluded the combined intermediateterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 214 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated surfaces (dermal and handto-mouth exposures). As the level of 

concern is for MOEs that are lower than 

100, this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on a DEREK 

structural alert analysis, the lack of 

mutagenicity and the lack of specific 

organ toxicity in the chronic toxicity 

study, propanamide, 2-hydroxy-N, Ndimethyl- is not expected to pose a 

cancer risk to humans. 

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 

propanamide, 2-hydroxy-N, Ndimethyl-. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of propanamide, 

2-hydroxy-N, N-dimethyl- in or on any 

food commodities. EPA is establishing a 

limitation on the amount of 

propanamide, 2-hydroxy-N, N-dimethylthat may be used in pesticide 

formulations applied to growing crops. 

That limitation will be enforced through 

the pesticide registration process under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (‘‘FIFRA’’), 7 U.S.C. 

136 et seq. EPA will not register any 

pesticide formulation for use on 

growing crops for sale or distribution 

that exceeds 20% by weight of 

propanamide, 2-hydroxy-N, Ndimethyl-. 

B. Revisions to Petitioned-For Tolerance 

Exemptions 

Based upon an evaluation of the data 

included in the petition, EPA is 

establishing an exemption from the 

requirement of a tolerance for residues 

of propanamide, 2-hydroxy-N, Ndimethyl when used in pesticide 

formulations as an inert ingredient 

(solvent/co-solvent), not to exceed 20% 

by weight of the formulation, instead of 

the unlimited use requested. When 

considering unlimited use resulted in 

aggregate risks of concern, the petitioner 

revised their request to seek a 20% 

limitation by weight of formulation. The 

basis for this revision can be found at 

http://www.regulations.gov in document 

‘‘Propanamide, 2-hydroxy-N, Ndimethyl-; Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption From the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations’’ in 

docket ID number EPA–HQ–OPP–2015– 

0524. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for residues of 

propanamide, 2-hydroxy-N, N-dimethyl- 

(Reg. No. 35123–06–9) when used as an 

inert ingredient (solvent/co-solvent) at a 

maximum concentration of 20% by 

weight in pesticide formulations 

applied to growing crops or raw 

agricultural commodities after harvest 

and under 40 CFR 180.930 when used 

in pesticide formulations applied to 

animals. 

VII. Statutory and Executive Order 

Reviews 

This action establishes exemptions to 

the requirement for 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 

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26146 Federal Register / Vol. 81, No. 84 / Monday, May 2, 2016 / Rules and Regulations 

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 exemptions 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). 

VIII. 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: April 21, 2016. 

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 § 180.910, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123–06–9) Not to exceed 20% by weight in 

pesticide formulation.

Solvent/co-solvent. 

* * * * * * * 

■ 3. In § 180.930, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Propanamide, 2-hydroxy-N, N-dimethyl- (CAS Reg. No. 35123–06–9) Not to exceed 20% by weight in 

pesticide formulation.

Solvent/co-solvent 

*******

[FR Doc. 2016–10227 Filed 4–29–16; 8:45 am] 

BILLING CODE 6560–50–P 

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