Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19261 

[FR Doc. 2010–8526 Filed 4–13–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0479; FRL–8816–5] 

Alkyl (C12-C16) Dimethyl Ammonio 

Acetate; 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 Alkyl (C12-C16) 

dimethyl ammonio acetate, herein 

referred to in this document as ADAA, 

when used as an inert ingredient 

(surfactant) in pesticide formulations for 

pre-harvest uses under 40 CFR 180.920 

or applied to animals under 40 CFR 

180.930 at a maxiumum concentration 

of 20% in pesticide product 

formulations. Technology Sciences 

Group, Inc., on behalf of Rhodia, Inc., 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of ADAA. 

DATES: This regulation is effective April 

14, 2010. Objections and requests for 

hearings must be received on or before 

June 14, 2010, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0479. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS harmonized test quidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2009–0479 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before June 14, 2010. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009–0479, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of August 19, 

2009 (74 FR 41895) (FRL–8429–9), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

9E7557) by Rhodia, Inc., 5171 

Glenwood Avenue, Suite 402, Raleigh, 

NC 27612. The petition requested that 

40 CFR 180.920 and 40 CFR 180.930 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Alkyl (C12-C16) dimethyl 

ammonio acetate, herein referred to in 

this document as ADAA. That notice 

included a summary of the petition 

prepared by the petitioner. There were 

no comments received in response to 

the notice of filing. 


jlentini on DSKJ8SOYB1PROD with RULES
19262 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

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(b)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement of 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. . . .’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 

exemption from the requirement of a 

tolerance for residues of ADAA when 

used as inert ingredients in pesticide 

formulations for pre-harvest uses and on 

animals at a maximum of 20% by 

weight in pesticide formulations. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information 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 

nature of the toxic effects caused by 

ADAA are discussed in this unit. 

Acute oral toxicity studies were 

performed using C12-ADAA and C16- 

ADAA. ADAA has moderate to low 

acute toxicity via the oral and dermal 

routes of exposure. Low acute toxicity is 

generally associated with C16-ADAA 

while moderate acute toxicity is 

associated with C12-ADAA. In acute 

dermal and eye irritation studies, C12- 

ADAA was severely irritating to the skin 

and eyes. A mixture of C12-C16 ADAA 

was used in a local lymph node assay 

(LLNA) to evaluate the potential to 

cause skin sensitization, C12-C16 ADAA 

was found to be a sensitizer; however, 

it gave a negative response for skin 

sensitization in in vivo guinea pigs as 

determined by Magnusson-Kligman test. 

Two developmental studies were 

available; an oral toxicity study in the 

rat and a screening level developmental 

dermal toxicity study in the rabbit. In 

the developmental toxicity study in the 

rat, maternal toxicity was manifested as 

reduced body weight gain, stained and 

matted haircoats, and respiratory rates 

at 50 milligrams/kilograms/day (mg/kg/ 

day) and above. Offspring toxicity was 

manifested as reduced or absent 

ossification of the skull, sternebrae #5 

and/or #6, and other sternebrae at 250 

mg/kg/day. The NOAEL for 

developmental toxicity in rats was 150 

mg/kg/day. In the screening level 

developmental dermal toxicity study in 

rabbits, maternal toxicity manifested as 

skin irritation, inhibition of body weight 

gain, decreased food consumption and 

resorptions at doses of 100 mg/kg/day 

and above while offspring toxicity was 

manifested as increased incidence of 

resorptions and decreased average litter 

size at ≥ 100 mg/kg/day. The NOAEL for 

systemic and developmental toxicity in 

rabbits via dermal route was 40 mg/kg/ 

day. 

A dose range-finding and a main 

study of Combined Repeated Dose 

Toxicity Study with the Reproduction/ 

Developmental Toxicity Screening Test 

according to the OPPTS Harmonized 

Test Guideline 870.3650 study were 

available in the rat. In the range-finding 

study, at ≥ 100 mg/kg/day, a reduction 

was observed in mean food 

consumption, body weight, and body 

weight gain during the pre-pairing 

period in all animals. Also, animals 

pushed their heads through the bedding 

throughout the treatment period at 

doses ≥ 100 mg/kg/day. At 1,000 mg/kg/ 

day, mortality was observed in all 

animals within 24 hours. In the main 

OPPTS Harmonized Test Guideline 

870.3650 study, parental toxicity was 

manifested as microscopic lesions 

(squamous hyperplasia, hyperkeratosis, 

submucosal inflammation and edema) 

in the forestomach at the lowest dose 

tested (50 mg/kg/day). Reproductive and 

developmental toxicity was manifested 

as increased implantation losses, 

decreased birth and viability indices, 

and decreased pup weight at 300 mg/kg/ 

day (highest dose tested). The NOAEL 

for reproductive/developmental toxicity 

was 150 mg/kg/day. 

Several mutagenicity studies (two 

Ames assays and chromosome 

aberration assay) were available for 

review. The results for these studies 

were negative. No animal 

carcinogenicity studies are available in 

the database. Based on Structure 

Activity Relationship (SAR) analysis, no 

structural alerts for carcinogenicity were 

identified. 

Two in vitro dermal absorption 

studies were available in hairless mice. 

The dermal absorption factor of C12- 

ADAA and C16-ADAA was estimated to 

be <1%. 

The Agency notes the surfactants are 

surface-active materials that can damage 

the structural integrity of cellular 

membranes at high dose levels. Thus, 

surfactants are often corrosive and 

irritating in concentrated solutions. The 

observed toxicity seen in the repeated 

dose studies, such as microscopic 

stomach lesions or decreased body 

weight gain, are attributed to the 

corrosive and irritating nature of these 

surfactants. 

There are no published or 

unpublished ADAA metabolism studies. 

However, ADAA are expected to 

metabolized via three potential 

metabolic pathways: 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19263 

1. Omega oxidation followed by beta 

oxidation of the carbon chain, 

2. Conjugation of ADAA at the 

carboxylic acid portion of the molecule 

by any of a number of amino acids, or 

3. Glucuronidation at the same site on 

ADAA, followed by elimination. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ADAA, 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 

‘‘Decision Document for Alkyl (C12-C16) 

dimethyl ammonio acetate (CAS Reg. 

Nos. 683–10–3, 2601–33–4 and 693–33– 

4),’’ pages 8-16 in docket ID number 

EPA–HQ–OPP–2009–0479. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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. 

For the purpose of this risk 

assessment, a protective overall NOAEL 

of 40 mg/kg/day was selected for all 

exposure scenarios based on weight-ofevidence from three studies in which 

systemic toxicity was observed at doses 

of 100 mg/kg/day or above. The 

different NOAELs observed in these 

studies are due to the dose selection 

process. For example, a NOAEL of 33 

mg/kg/day and LOAEL of 100 mg/kg/ 

day (based on pushing head through 

bedding, decreased food consumption 

and weight gain) were established in a 

range finding study for a combined 

reproduction/ developmental toxicity 

screening test. In the main study, 

Organization for Economic Cooperation 

and Development (OECD) combined 

repeated dose toxicity study with the 

reproduction/developmental toxicity 

screening test, the LOAEL was 

established at 50 mg/kg/day (lowest 

dose tested). However, the LOAEL was 

based on irritation in the forestomach of 

rats due to the physical/chemical 

properties of ADAA, which was not 

considered relevant for human risk 

assessments. Also the NOAEL of 40 mg/ 

kg/day is considered to be protective of 

marginal decreases in body weights seen 

at the LOAEL of 50 mg/kg/day in the 

oral development toxicity study in rats 

because body weight effects were not 

observed in the OECD 422 study (main 

study) at a dose level of 150 mg/kg/day. 

Additionally, this NOAEL is supported 

by the developmental dermal toxicity 

study in the rabbit. In this study, a 

NOAEL of 40 was established based on 

the effects (uncoordinated movement, 

partial paralysis and increased 

incidence of resorptions) observed at 

100 mg/kg/day in the presence of severe 

skin irritation. 

A summary of the toxicological 

endpoints for ADAA used for human 

risk assessment is shown in the Table of 

this unit. 

TABLE.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADAA 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) 

The Agency notes the surfactants are surface-active materials that can damage the structural integrity of cellular membranes at high dose levels. Moderate acute toxicity is associated with C12- 

ADAA. However, these effects are considered local irritations rather than systemic toxicity. Therefore this endpoint is not appropriate for risk assessment. In addition, no endpoint of concern attributed to a single dose was identified in the database. 

Chronic dietary 

(all populations) 

NOAEL = 40 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.40 mg/kg/day 

cPAD = 0.40 mg/kg/day 

Overall NOAEL based on three 

studies 

OECD 422 range finding and 

main study 

Developmental toxicity study in 

rabbits via dermal route, 

Oral developmental toxicity 

study in rats 

Incidental Oral, dermal and inhalation 

(Short- and Intermediate-Term) 

NOAEL= 40 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Overall NOAEL based on three 

studies 

OECD 422 range finding and 

main study 

Developmental toxicity study in 

rabbits via dermal route, 

Oral developmental toxicity 

study in rats 


jlentini on DSKJ8SOYB1PROD with RULES
19264 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

TABLE.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADAA 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 

Dermal short- and intermediate term (1 

to 30 days) (1 to 6 months) 

NOAEL= 40 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

10% dermal absorption factor 

LOC for MOE = 100 Overall NOAEL based on three 

studies 

OECD 422 range finding and 

main study 

Developmental toxicity study in 

rabbits via dermal route, 

Oral developmental toxicity 

study in rats 

Inhalation short- and intermediate term 

(1 to 30 days) (1 to 6 months) 

100% inhalation absorption LOC for MOE = 100 Overall NOAEL based on three 

studies 

OECD 422 range finding and 

main study 

Developmental toxicity study in 

rabbits via dermal route, 

Oral developmental toxicity 

study in rats 

Cancer (oral, dermal, inhalation) Not necessary. No cancer concerns were identified. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose (a=acute, c=chronic). 

FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

V. Aggregate Exposures 

A. Dietary Exposure 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to the ADAA, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from ADAA in food as 

follows: 

i. Acute exposure. The Agency notes 

the surfactants are surface-active 

materials that can damage the structural 

integrity of cellular membranes at high 

dose levels. Moderate acute toxicity is 

associated with C12-ADAA. However, 

these effects are considered local 

irritations rather than systemic toxicity. 

Therefore this endpoint is not 

appropriate for risk assessment. In 

addition, no endpoint of concern 

attributed to a single dose was identified 

in the database. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, no residue data 

were submitted for ADAA. 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. 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. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest levels of tolerances would 

be no higher than the concentration of 

the active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentrations 

of active ingredient in agricultural 

products are generally at least 50 

percent of the product and often can be 

much higher. Further, pesticide 

products rarely have a single inert 

ingredient; rather there is generally a 

combination of different inert 

ingredients used which additionally 

reduces the concentration of any single 

inert ingredient in the pesticide product 

in relation to that of the active 

ingredient. In the case of ADAA, EPA 

made a specific adjustment to the 

dietary exposure assessment to account 

for the use limitations of the amount of 

ADAA that may be in formulations (to 

no more than 20% by weight in 

pesticide products) and assumed that 

the ADAA are present at the maximum 

limitation rather than at equal quantities 

with the active ingredient. This remains 

a very conservative assumption because 

surfactants are generally used at levels 

far below this percentage. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19265 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100 percent of all 

foods are treated with the inert 

ingredient at the rate and manner 

necessary to produce the highest residue 

legally possible for an active ingredient. 

In summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data shows that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. ADAA is not expected to 

be carcinogenic since there was no 

evidence of carcinogenicity in the 

available studies. Since the Agency has 

not identified any concerns for 

carcinogenicity relating to ADAA, a 

cancer dietary exposure assessment was 

not conducted. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for ADAA, a 

conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for chronic dietary risk 

assessments for ADAA. 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., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). ADAA 

may be used as inert ingredients in 

pesticide products that are registered for 

specific uses that may result in both 

indoor and outdoor residential 

exposures. A screening level residential 

exposure and risk assessment was 

completed for products containing 

ADAA as inert ingredients. The ADAA 

inerts are used in pesticide formulations 

that may be used around the home in 

pesticide formulations used on lawn, 

turf, or gardens. In addition, these inerts 

may be present in personal care 

products. The Agency selected 

representative scenarios and conducted 

an assessment to represent worst-case 

residential exposure by assessing ADAA 

in pesticide formulations (outdoor 

scenarios) and ADAA in disinfectanttype uses (indoor scenarios). Based on 

information contained in the petition, 

ADAA can be present in personal care 

products (maximum concentration 5%). 

Therefore, the Agency assessed the 

personal care products containing 

ADAA using exposure scenarios used by 

OPP’s Antimicrobials Division to 

represent worst-case residential handler 

exposure. The Agency conducted an 

assessment to represent worst-case 

residential exposure by assessing post 

application exposures and risks from 

ADAA in pesticide formulations 

(Outdoor Scenarios) and ADAA in 

disinfectant-type uses (Indoor 

Scenarios). Further details of this 

residential exposure and risk analysis 

can be found at http:// 

www.regulations.gov in the 

memorandum entitled ‘‘JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations’’ (D364751, 5/7/09, Lloyd/ 

LaMay in docket ID number EPA–HQ– 

OPP–2008–0710. 

VI. Cumulative Effects 

Section 408(b)(2)(D)(v) of FFFDCA 

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.’’ 

Unlike other pesticide ingredients for 

which EPA has followed as cumulative 

risk approach based on a common 

mechanism of toxicity, EPA has not 

made a common mechanism of toxicity 

finding as to ADAA acetate and any 

other substances and, ADAA does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

ADAA has 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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s website at http:// 

www.epa.gov/pesticides/cumulative/. 

VII. Additional Safety Factor for the 

Protection of Infants and Children 

1. In general. Section 408(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (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 is available to EPA support the 

choice of a different factor. EPA 

concluded that the FQPA safety factor 

should be reduced to 1X for ADAA. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility of infants and children in 

the available developmental toxicity 

studies via dermal and oral routes of 

exposure. In these studies 

developmental toxicity was observed in 

the presence of maternal toxicity and/or 

at one dose level higher. There was no 

evidence of increased susceptibility of 

infants and children in the OPPTS 

870.3650 study (OECD 422) study. In 

this study, the maternal toxicity was 

manifested as body weight changes and 

microscopic changes, while the fetal 

toxicity was manifested as increased 

implantation losses and decreased pup 

weight. The maternal and 

developmental NOAEL was 150 mg/kg/ 

day. 

3. Conclusion. EPA has determined 

that reliable data show that 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 database is considered adequate 

for FQPA assessment. The following 

acceptable studies are available: 

Developmental toxicity study in rats 

(1) 

Developmental dermal toxicity study 

in rabbits 

Combined development/reproduction 

repeated dose toxicity study (1) 

ii. Fetal susceptibility was not 

observed in the oral developmental 

toxicity study in the rat, the 


jlentini on DSKJ8SOYB1PROD with RULES
19266 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

developmental dermal toxicity study in 

the rabbit or in the OPPTS Harmonized 

Test Guideline 870.3650 study. In these 

studies fetal toxicity was observed at 

doses that were higher than the dose 

that caused maternal toxicity. Therefore, 

there are low concerns and no residual 

uncertainties concerning prenatal and 

postnatal toxicity. 

iii. Clinical signs of neurotoxicity 

(uncoordinated movement, partial 

paralysis) were observed in the 

developmental dermal study in the 

rabbit. However, no effects on 

Functional Observation Battery (FOB) 

parameters were observed at doses up to 

and including 300 mg/kg/day in the 

OPPTS 870.3650 study (OECD 422 

study). Therefore, EPA concluded that 

the developmental neurotoxicity study 

is not required. 

iv. No evidence of immunotoxicity 

was observed in the database. 

v. No chronic toxicity or 

carcinogenicity studies are available in 

the database, however the Agency notes 

that surfactants are surface-active 

materials that can damage the structural 

integrity of cellular membranes at high 

dose levels. Thus, surfactants are often 

corrosive and irritating in concentrated 

solutions. The observed toxicity seen in 

the repeated dose studies, such as 

microscopic lesions or decreased body 

weight gain, are attributed to the 

corrosive and irritating nature of these 

surfactants. The Agency has 

considerable toxicity information on 

surfactants which indicates that the 

effects do not progressively increase in 

severity over time. In addition, use of 

the full 10X interspecies factor will 

actually provide an additional margin of 

safety because it is not expected that 

humans’ response to local irritation/ 

corrosiveness effects would be markedly 

different from animals. The database on 

ADAA indicates that the target organ 

toxicity is occurring at relatively high 

doses. Based on the consideration in 

this unit, the Agency concluded that an 

additional FQPA safety factor for the 

lack of a chronic study is not necessary. 

vi. The dietary food exposure 

assessment utilizes highly conservative 

default assumptions and would not 

underestimate the dietary risk to all 

populations. For the purpose of the 

screening level dietary risk assessment 

to support this request for an exemption 

from the requirement of a tolerance for 

ADAA, a value of 100 ppb based on 

screening level modeling was used for 

the chronic dietary risk assessment. The 

value of 100 ppb is considered to be a 

high end, conservative assumption that 

is not likely to underestimate drinking 

water risks. 

Taking into consideration the 

available information, EPA concludes 

the additional 10X FQPA safety factor 

can be reduced to 1X. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. The Agency notes the 

surfactants are surface-active materials 

that can damage the structural integrity 

of cellular membranes at high dose 

levels. Moderate acute toxicity is 

associated with C12-ADAA. However, 

these effects are considered local 

irritations rather than systemic toxicity. 

Therefore this endpoint is not 

appropriate for risk assessment. In 

addition, no endpoint of concern 

attributed to a single dose was identified 

in the database. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for chronic 

exposure and the use limitation of not 

more than 20% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to ADAA 

is 19.5% of the cPAD for the U.S. 

population and 62.9% of the cPAD for 

children 1-2 years old, the most highly 

exposed population subgroup. 

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). 

ADAA are used as inert ingredients in 

pesticide products that are 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 

ADAA. Using the exposure assumptions 

described in this unit, EPA has 

concluded that the combined short-term 

aggregated food, water, and residential 

exposures result in aggregate MOEs of 

110 for adult males and adult females. 

Adult residential exposure combines 

high end dermal and inhalation handler 

exposure from indoor hard surface 

wiping with a high end post application 

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 130 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth 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). 

ADAA are currently registered for 

uses that could result in intermediateterm 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 ADAA. Using the exposure 

assumptions described in this unit, EPA 

has concluded that the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in aggregate MOEs of 450 for adult 

males and adult females. Adult 

residential exposure includes high end 

post application dermal exposure from 

contact with treated lawns. EPA has 

concluded the combined intermediateterm aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 150 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth 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. The Agency has not 

identified any concerns for 

carcinogenicity relating to ADAA. 

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 residues of 

ADAA when used as inert ingredients in 

pesticide formulations for pre-harvest 

uses and on animals at a maximum of 

20% by weight in pesticide 

formulations. 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19267 

VIII. Other Considerations 

A. Endocrine Disruptors 

EPA is required under the Federal 

Food, Drug and Cosmetic Act (FFDCA), 

as amended by FQPA, to develop a 

screening program to determine whether 

certain substances (including all 

pesticide active and other ingredients) 

‘‘may have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen, or other 

such endocrine effects as the 

Administrator may designate.’’ 

Following recommendations of its 

Endocrine Disruptor and Testing 

Advisory Committee (EDSTAC), EPA 

determined that there was a scientific 

basis for including, as part of the 

program, the androgen and thyroid 

hormone systems, in addition to the 

estrogen hormone system. EPA also 

adopted EDSTAC’s recommendation 

that the Program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use 

FIFRA and, to the extent that effects in 

wildlife may help determine whether a 

substance may have an effect in 

humans, FFDCA authority to require the 

wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). 

When additional appropriate 

screening and/or testing protocols being 

considered under the Agency’s EDSP 

have been developed, ADAA may be 

subjected to further screening and/or 

testing to better characterize effects 

related to endocrine disruption. 

B. Analytical Method 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

C. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for ADAA 

nor have any CODEX Maximum Residue 

Levels (MRLs) been established for any 

food crops at this time. 

IX. Conclusions 

Based on the information in this 

preamble, EPA concludes that there is a 

reasonable certainty of no harm from 

aggregate exposure to residues of 

ADAA. Accordingly, EPA finds that 

exempting ADAA (at a maximum of 

20% by weight in formulation) from the 

requirement of a tolerance will be safe. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 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 section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 1, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In §180.920, in the table add 

alphabetically the following inert 

ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 


jlentini on DSKJ8SOYB1PROD with RULES
19268 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

Inert ingredients Limits Uses 

* * * * * * * 

Alkyl (C12-C16) dimethyl ammonio acetate (CAS Reg. Nos. 683–10– 

3, 2601–33–4 and 693–33–4 

20% by weight in pesticide formulation Surfactant 

* * * * * * * 

■ 3. In §180.930, in the table add 

alphabetically the following inert 

ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

Alkyl (C12-C16) dimethyl ammonio acetate (CAS Reg. Nos. 683–10– 

3, 2601–33–4 and 693–33–4 

20% by weight in pesticide formulation Surfactant 

* * * * * * * 

[FR Doc. 2010–8298 Filed 4–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0695; FRL–8808–7] 

Kasugamycin; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

kasugamycin, 3-O-[2-amino-4- 

[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol in or on apples. This 

action is in response to EPA’s granting 

of an emergency exemption under 

section 18 of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

authorizing use of the agricultural 

bactericide on apples. This regulation 

establishes a maximum permissible 

level for residues of kasugamycin in this 

food commodity. The time-limited 

tolerance expires and is revoked on 

December 31, 2012. 

DATES: This regulation is effective April 

14, 2010. Objections and requests for 

hearings must be received on or before 

June 14, 2010, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0695. All documents in the 

docket are listed in the docket index 

available in http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS harmonized test guidelines 

referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2008–0695 in the subject line on 

the first page of your submission. All 


jlentini on DSKJ8SOYB1PROD with RULES