51474 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

■ 2. In §180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * ***

Mono-, di-, and trimethylnapthalenesulfonic acids and napthalenesulfonic 

acids formaldehyde condensates, ammonium and sodium salts (CAS Reg. 

Nos 9008–63–3, 9069–80–1, 9084–06–4, 36290–04–7, 91078–68–1, 

141959–43–5, 68425–94–5) 

Surfactants, related adjuvants of surfactants 

* * * *** *

[FR Doc. E9–24160 Filed 10–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0690; FRL–8437–3] 

C10-C18-Alkyl dimethyl amine oxides; 

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 C10-C18-Alkyl 

dimethyl amine oxides (ADAO) when 

used as the inert ingredient in pesticide 

formulations applied to raw agricultural 

commodities pre- and post-harvest. 

Exponent on behalf of Stepan Company 

and Rhodia submitted petitions 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 

ADAOs. 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, 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–2009–0690. All documents in the 

dockets 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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 Guidelines 

referenced in this document, go to the 

guidelines at http://www.epa.gov/ 

opptsfrs/home/guidelin.htm. 

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–2009–0690 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 December 7, 2009. 

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 


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Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51475 

EPA–HQ–OPP–2009–0690, 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 

EPA received two petitions requesting 

that 40 CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of ADAOs. These two petitions are 

grouped together because they fall 

under the same general chemical 

description criteria. 

In the Federal Register of February 1, 

2006 (71 FR 5322) (FRL–7756–5), EPA 

issued a notice pursuant to section 408 

(d)(3)of FFDCA, 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP #5E7003) by Stepan 

Company, 951 Bankhead Hwy., Winder, 

GA 30680. The petition requested that 

40 CFR 180.920 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of ADAOs (CAS Reg. Nos. 1643–20–5, 

2571–88–2, 2605–79–0, 3332–27–2, 

61788–90–7, 68955–55–5, 70592–80–2, 

7128–91–8, 85408–48–6, and 85408–49– 

7). Also, in the Federal Register of 

December 3, 2008 (73 FR 73644) (FRL– 

8390–4), EPA issued a notice pursuant 

to section 408 (d)(3) of FFDCA, 21 

U.S.C. 346a(d)(3), announcing the filing 

of a pesticide petition (PP #5E7003) by 

Stepan Company, 951 Bankhead Hwy., 

Winder, GA 30680. This petition is an 

addendum to PP #5E7003 and included 

the submission of new data only. Both 

notices included a summary of the 

petition prepared by the petitioner. 

There were no comments received in 

response to the notices of filing. 

Also, in the Federal Register of April 

13, 2009 (74 FR 16869) (FRL–8396–6), 

EPA issued a notice pursuant to section 

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

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

pesticide petition (PP #8E7316) by 

Rhodia Inc. c/o SciReg, Inc., 12733 

Director’s Loop, Woodbridge, VA 22192. 

The petition requested that 40 CFR 

180.920 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of ADAOs. The 

notice included a summary of the 

petition prepared by the petitioner. 

There were no substantial comments 

received in response to the notice of 

filing. 

Based upon review of the data 

supporting the petitions (#5E7003 and 

#8E7316), EPA has modified the 

exemptions requested by limiting 

ADAOs to a maximum of 15% by 

weight in pesticide formulations. In 

addition, the risk assessment supports 

the expansion of the exemptions from a 

requirement of tolerance to include use 

in pesticide formulations intended for 

post– harvest as well as pre–harvest 

application under 40 CFR 180.910. 

Further details can be found at http:// 

www.regulations.gov in document 

Decision Document for Petition 

Numbers #5E7003 and 8E7316 (C10–16); 

C10–C18–Alkyldimethylamine oxides 

CAS Reg. No. 1643–20–5, 2571–88–2, 

2605–79–0, 3332–27–2, 61788–90–7, 

68955–55–5, 70592–80–2, 7128–91–8, 

85408–48–6, 85408–49–7) in docket ID 

numbers EPA–HQ–OPP–2005–0310 and 

EPA–HQ–OPP–2008–0858. 

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 ploymers 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 ADAOs is 

limited to no more than 15% by weight 

in pesticide formulations when used as 

an inert ingredient in pesticide 

formulations for pre- and post-harvest 

uses. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The available toxicology database 

includes an acute, subchronic (rat and 

rabbit), 21 and 90 day dermal toxicity 

(rabbit), developmental (rat and rabbit), 

reproduction and fertility effects study, 

an OPPTS Harmonized Guideline 

870.3650 combined repeated dose 

toxicity studies with the reproduction/ 

developmental toxicity screening tests, 

chronic dermal toxicity (mouse), 

chronic/carcinogenicity (rat), 

mutagenicity, and metabolism studies. 


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ADAOs have moderate acute toxicity 

via the oral routes and low toxicity via 

the dermal and inhalation routes. It is 

moderately irritating to the skin and 

severely irritating to the eye. It is not a 

skin sensitizer. 

Subchronic studies were available in 

the rat and rabbit. Following subchronic 

exposure to rats via the diet, a decrease 

in body weight was observed in females 

only while cataracts were observed in 

males only. In the rabbit, subchronic 

exposure via the diet resulted in 

decreased alkaline phosphatase levels 

and increased liver/body weight ratio. 

A 21/28 day study and 91–day dermal 

toxicity studies were available in 

rabbits. Systemic toxicity was not 

observed at the limit dose in the 21/28 

day study and was not observed at the 

highest dose (2.5 milligrams/kilogram/ 

day (mg/kg bw/day)) tested in the 91– 

day study. 

Three developmental studies were 

available for review (2–rat, 1–rabbit). In 

one developmental toxicity study in the 

rat (Sprague-Dawley), maternal 

(decreased body weight gain) and 

offspring (skeletal variation-bifid 

centrum) toxicity were manifested at 

100 mg/kg/day. The NOAEL in this 

study was 25 mg/kg/day. In a second 

developmental toxicity study in the rat 

(CD), maternal and offspring toxicity 

occurred at the same dose (200 mg/kg/ 

day), the highest dose tested. Effects 

similar to the previous study were 

observed. Maternal toxicity was 

manifested as decreased body weight, 

food intake and water consumption and 

offspring toxicity was manifested as a 

slight reduction in fetal ossification. The 

NOAEL in this study was 100 mg/kg/ 

day. In the rabbit, maternal and 

offspring toxicity were not observed at 

doses up to 160 mg/kg/day (highest dose 

tested, HDT). In a reproduction and 

fertility effects study in the rat, neither 

maternal nor offspring systemic toxicity 

was not observed at doses up to 40 mg/ 

kg bw/day (HDT). No treatment-related 

effects were observed on reproductive 

parameters. 

In an OPPTS Harmonized Test 

Guideline 870.3650 study designed to 

evaluate developmental, reproduction 

and neurological parameters, maternal 

toxicity in the rat [HanRcc:WIST(SPF)] 

was manifested as hyperkeratosis, 

parakeratosis, squamous cell 

hyperplasia, submucosal inflammation 

and submucosal edema in the 

forestomach at 100 mg/kg/day (mid dose 

tested, MDT). Mortality and decreased 

body weight were observed in the 

offspring at 250 mg/kg/day (HDT). 

Reproductive toxicity (decreased 

gestation index) was also manifested at 

250 mg/kg/day. Reduced total locomotor 

activity was observed in females at 250 

mg/kg/day. However, this effect was 

considered a result of systemic toxicity 

rather than a result of neurological 

toxicity since it was transient, occurred 

at the high dose in one gender only, it 

was not observed at the lower doses, 

neuropathologic lesions were not 

observed and signs of neurotoxicity 

were not observed in other studies. 

Changes in absolute and relative thymus 

weights and atrophy were observed in 

males at the 250 mg/kg/d (HDT). These 

were determined to be non-specific 

changes not indicative of 

immunotoxicity. In addition, no blood 

parameters were affected. Furthermore, 

these compounds do not belong to a 

class of chemicals that would be 

expected to be immunotoxic. 

Several mutagenicity studies (Ames, 

chromosome aberration, micronucleus 

assay, cell transformation, and cell 

dominant lethal assay) were available 

for review. The results for these studies 

were negative. 

There were two chronic studies 

available, a chronic dermal toxicity 

study in the mouse, and a chronic/ 

carcinogenicity study in the rat. In the 

dermal toxicity study in the mouse, 

systemic toxicity and evidence of 

increased tumors were not observed at 

the HDT (5.6 mg/kg/day). In the chronic 

carcinogenicity study in the rat, 

systemic toxicity was manifested as 

decreased body weight and cataracts at 

107 mg/kg/day (HDT). Evidence of 

increased tumors was not observed. 

Based on the lack of evidence of 

carcinogenicity in these studies and the 

negative response for mutagenicity 

ADAOs are not expected to be 

carcinogenic. 

Metabolism studies demonstrated that 

C12 ADAO was absorbed in rats and 

extensively and rapidly excreted. The 

distribution of C12 ADMO was similar 

between males and females. Among all 

the tissues analyzed, the largest amount 

and the highest concentration of 

radioactivity were found in the liver. 

The fractions of dosed radioactivity 

appearing in the liver, kidney, and 

blood reached maxima within 1 hour 

after the oral dose. The excretion of 

radioactivity was rapid with 

approximately 70% and greater excreted 

within 24 hours. The major excretory 

pathway was urine followed by expired 

CO2 with much less found in feces and 

bile. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ADAOs, 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 the document 

Decision Document for Petition 

Numbers #5E7003 and 8E7316 (C10–16); 

C10-C18-Alkyldimethylamine oxides 

CAS Reg. No. 1643–20–5, 2571–88–2, 

2605–79–0, 3332–27–2, 61788–90–7, 

68955–55–5, 70592–80–2, 7128–91–8, 

85408–48–6, 85408–49–7) at pp 7–18 in 

docket ID numbers EPA–HQ–OPP– 

2005–0310 and EPA–HQ–OPP–2008– 

0858. 

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. 

A summary of the toxicological 

endpoints for ADAOs used for human 

health risk assessment is shown in 

Table 1 of this unit. 


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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADAOS 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) 

No appropriate endpoints were identified for acute dietary risk assessment. 

Chronic dietary (all populations) NOAEL = 42.3 mg inert/kg/ 

day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = .42 mg/kg/ 

day 

cPAD = .42 mg/kg/day 

Chronic toxicity/oncogenicity study– rat (CAS Reg. 

No. 70592–80–2) 

LOAEL = 87.4 mg/kg/day based on decreased body 

weight and ophthalmological opacities/cataracts 

Incidental Oral Short- and 

Intermediate Term Dermal and Inhalation 

NOAEL= 42.3 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x (10% Dermal absorption; 100% 

inhalation and oral toxicity assumed equivalent) 

Residential/Occupational 

LOC for MOE = 100.

Chronic toxicity/oncogenicity study– rat (CAS Reg. 

No. 70592–80–2) 

LOAEL = 87.4 mg/kg/day based on decreased body 

weight and ophthalmological opacities/cataracts 

Cancer 

(oral, dermal, inhalation) 

Classification: ADAOs are not expected to be carcinogenic based on the lack of evidence of carcinogenicity in 

the chronic feeding study in rats or in the chronic dermal study in mice as well as the negative response for mutagenicity. 

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. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to the ADAOs, EPA 

considered exposure under the 

petitioned-for exemptions from the 

requirement of a tolerance. EPA 

assessed dietary exposures from ADAOs 

in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

ADAOs were seen in the toxicity 

databases. Therefore, acute dietary risk 

assessments for ADAOs are not 

necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the U.S. 

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 ADAOs. 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 ADAOs, EPA 

made a specific adjustment to the 

dietary exposure assessment to account 

for the use limitations of the amount of 

ADAOs that may be in formulations (to 

no more than 15% by weight in 

pesticide products) and assumed that 

the ADAOs are present at the maximum 

limitation rather than at equal quantities 

with the active ingredient. 

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 

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 


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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. ADAOs are not expected 

to be carcinogenic since there was no 

evidence of carcinogenicity in the 

chronic feeding studies in mice and rats 

or in the chronic dermal study in mice 

as well as the negative response for 

mutagenicity. Since the Agency has not 

identified any concerns for 

carcinogenicity relating to ADAOs, a 

cancer dietary exposure assessment was 

not performed. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for ADAOs. Tolerance level residues 

and/or 100% CT were assumed for all 

food commodities. 

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 ADAOs, 

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 

chronic dietary risk assessments for 

ADAOs. 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). ADAOs 

may be used in 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 

ADAOs as inert ingredients. The ADAO 

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 home cleaning 

products. The Agency selected 

representative scenarios, based on enduse product application methods and 

labeled application rates. The Agency 

conducted an assessment to represent 

worst-case residential exposure by 

assessing ADAOs in pesticide 

formulations (Outdoor Scenarios) and 

ADAOs in disinfectant-type uses 

(Indoor Scenarios). Based on 

information contained in the petition, 

ADAOs can be present in consumer 

cleaning products (maximum 

concentration 4%). Therefore, the 

Agency assessed the disinfectant-type 

products containing ADAOs 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 ADAOs in 

pesticide formulations (Outdoor 

Scenarios) and ADAOs in disinfectanttype 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. 

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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

ADAOs and any other substances and, 

this material 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 ADAOs 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 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/. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA safety factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

Qualitative susceptibility was observed 

in the developmental toxicity studies in 

the rat. Skeletal variations were 

observed in rat fetuses at a dose (100 

mg/kg/day) that caused maternal 

toxicity (decreased body weight gain). In 

a second developmental study in the rat, 

increased incidence of bifid centrum 

occurred in fetuses at a dose (100 mg/ 

kg/day) that caused maternal toxicity 

(decreased body weight gain). However, 

the concern for qualitative fetal 

susceptibility is low because NOAELs 

are well established in these two studies 

and protective of fetuses. The NOAEL of 

25 mg/kg/day established in the 

developmental study in the rat 

represents the lowest NOAEL in the 

database. However, the NOAEL of 42.3 

mg/kg/day was selected from the 

chronic/carcinogenicity study for use in 

risk assessment. This decision was 

based on the conclusion that the 

NOAEL of 25 mg/kg/day is an artifact of 

dose spread. The doses tested in the 

developmental study in the rat were 0, 

25, 100, and 200 mg/kg/day. The 

LOAEL for this study was 100 mg/kg/ 

day. In a second rat developmental 

study and a 2–generation reproduction 

study, fetal and maternal effects were 

consistently seen at doses >100 mg/kg/ 

day, the maternal and fetal NOAELs 


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were established at 100 mg/kg/day 

(developmental study) and >40 mg/kg/ 

day (2–generation reproduction study, 

highest dose tested). In a recently 

conducted combined developmental/ 

reproduction screening study (OPPTS 

Harmonized Guideline 870.3650), the 

maternal and offspring NOAELs were 40 

and 100 mg/kg/day, respectively, and 

effects were seen at doses >100 mg/kg/ 

day further supporting the higher 

NOAEL. Additionally, in the chronic/ 

carcinogenicity study, the NOAEL was 

42.3 mg/kg/day, effects (decreased body 

weight and cataracts) were observed at 

87.4 mg/kg/day which is consistent with 

the dose at which other effects were 

seen. Given this weight-of-evidence, it 

was concluded that the NOAEL of 42.3 

mg/kg/day most accurately reflected the 

true NOAEL. Therefore, the established 

Chronic Reference Dose (cRfD) (0.42 

mg/kg/day) is protective of any 

developmental effects observed at doses 

as low as 100 mg/kg/day in these 

studies. There are low concerns for 

residual uncertainties concerning 

prenatal and postnatal toxicity. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for the 

ADAOs inerts is considered adequate 

for assessing the risks to infants and 

children. The toxicity data available on 

the ADAOs is summarized in Unit IV.A. 

ii. Although qualitative susceptibility 

was observed in the developmental 

toxicity studies in the rat, the concern 

for qualitative fetal susceptibility is low 

for the reasons noted in Unit IV.D.2. 

iii. Evidence of neurotoxicity was 

noted in the combined developmental/ 

reproduction screening test in rats. Total 

locomotor activity was reduced at the 

high dose (250 mg/kg/day) in females 

only. However, EPA concluded that the 

reduction in locomotor activity was due 

to excessive systemic toxicity at the 

high dose rather than due to 

neurological origin. This conclusion is 

based on the following: effects were 

seen only in one sex at the high dose, 

the effect was transient, neurotoxicity 

was not observed at the lower doses in 

this study, there were no 

neuropathological lesions in the study 

and clinical signs of neurotoxicity and 

neuropathology were not observed in 

any other studies in the database. Thus 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iv. The Agency noted changes in 

thymus weight and thymus atrophy 

were observed in males at the high dose 

(250 mg/kg/day) only. These were 

determined to be non-specific changes 

not indicative of immunotoxicity. In 

addition, no blood parameters were 

affected. Furthermore, these compounds 

do not belong to a class of chemicals 

that would be expected to be 

immunotoxic. Therefore, these 

identified effects do not raise a concern 

necessitating an additional uncertainty. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The food and drinking water assessment 

is not likely to underestimate exposure 

to any subpopulation, including those 

comprised of infants and children. The 

food exposure assessments are 

considered to be highly conservative as 

they are based on the use of the highest 

tolerance level from the surrogate 

pesticides for every food and 100% crop 

treated is assumed for all crops. EPA 

also made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to ADAOs in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by ADAOs. 

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.There was no hazard 

attributable to a single exposure seen in 

the toxicity database for ADAOs. 

Therefore, the ADAOs are not expected 

to pose an acute risk. 

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 limitations of not 

more than 15% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to ADAO 

is 14% of the cPAD for the U.S. 

population and 45% of the cPAD for 

children 1 to 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). 

ADAOs 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 

ADAOs. Using the exposure 

assumptions described in this unit, EPA 

has concluded that the combined shortterm aggregated food, water, and 

residential exposures result in aggregate 

MOEs of 250 for both adult males and 

females respectively. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

indoor hand 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 

200 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). 

ADAOs are currently registered for 

uses 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 ADAOs. 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 840 for adult 

males and 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 210 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. 


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51480 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to ADAOs. 

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 

ADAOs. 

V. 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, ADAOs may be 

subjected to further screening and/or 

testing to better characterize effects 

related to endocrine disruption. 

B. Analytical Method(s) 

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 ADAOs 

nor have any CODEX Maximum Residue 

Levels (MRLs) been established for any 

food crops at this time. 

VI. 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 

ADAOs. Accordingly, EPA finds that 

exempting ADAOs from the requirement 

of a tolerance when used as an inert 

ingredient in pesticide formulations 

applied to growing crops will be safe. 

VII. 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 exemption 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). 

VIII. 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: September 25, 2009. 

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 §180.910, the table is amended 

by adding alphabetically the following 

inert ingredients: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 


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Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51481 

Inert ingredients Limits Uses 

* * * * * * * 

C10-C18-Alkyl dimethyl amine oxides (CAS Reg. Nos. 1643–20–5, 2571–88–2, 2605–79–0, 3332–27– 

2, 61788–90–7, 68955–55–5, 70592–80–2, 7128–91–8, 85408–48–6, and 85408–49–7) 

15% by weight in pesticide formulation Surfactant 

* * * * * * * 

[FR Doc. E9–24055 Filed 10–06–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0407; FRL–8438–1] 

Ammonium chloride; 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 ammonium 

chloride (CAS Reg. No. 12125–02–9) 

applied pre-harvest on all raw 

agricultural commodities when applied/ 

used as a carrier/nutrient. SciReg, 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 ammonium chloride. 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, 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–2008–0407. 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: 

Deirdre Sunderland, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0851; e-mail address: 

sunderland.deirdre@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also 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. 

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–2008–0407 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 December 7, 2009. 

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–2008–0407, 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 June 13, 

2008 (73 FR 33814) (FRL–8367–3), EPA 

issued a notice pursuant to section 408 


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