37584 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

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: July 21, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR part 180 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, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*** * *

N-alkyl (C8-C18) primary amines and their acetate salts where the 

alkyl group is linear and may be saturated and/or unsaturated 

(CAS Reg. Nos. 61790–57–6, 61790–58–7, 61790–59–8, 61790– 

60–1, 61788–46–3, 61790–33–8, 68155–38–4).

Concentration in formulated enduse products not to exceed 10% 

by weight in herbicide products, 

4% by weight in insecticide products, and 4% by weight in fungicide products..

Surfactants, related adjuvants of 

surfactants 

*** * *

[FR Doc. E9–18076 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0098; FRL–8425–5] 

Sodium Salts of N-alkyl (C8-C18)-betaiminodipropionic acid; 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 sodium salts of 

N-alkyl (C8-C18)-beta-iminodipropionic 

acid where the C8-C18 is linear and may 

be saturated and/or unsaturated, herein 

referred to in this document as SSNAs 

when used as an inert ingredient for 

pre-harvest uses under 40 CFR 180.920 

at a maximum of 30% by weight in 

pesticide formulations. The Joint Inerts 

Task Force (JITF), Cluster Support Team 

Number 14, 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 SSNAs. 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 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–2009–0098. 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: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 


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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37585 

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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 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 directly 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. 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–2009–0098 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 

as required by 40 CFR part 178 on or 

before September 28, 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 this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0098, 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 

In the Federal Register of April 15, 

2009 (74 FR 17487) (FRL–8409–7), 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 9E7525) by The 

Joint Inerts Task Force, Cluster Support 

Team 14 (CST 14), c/o CropLife 

America, 1156 15th St., NW., Suite 400, 

Washington, DC, 20005. The petition 

requested that 40 CFR 180.920 be 

amended by establishing exemptions 

from the requirement of a tolerance for 

residues of the inert ingredient Sodium 

salts of N-alkyl (C8-C18)-betaiminodipropionic acid where the C8-C18

is linear and may be saturated and/or 

unsaturated. That notice referenced a 

summary of the petition prepared by 

The Joint Inerts Task Force (JITF), 

Cluster Support Team Number 14 (CST 

14), the petitioner, which is available to 

the public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the exemption requested to by 

limiting SSNAs to a maximum of 30% 

by weight in pesticide formulations. 

This limitation is based on the Agency’s 

risk assessment which can be found at 

http://www.regulations.gov in document 

‘‘Sodium Salts of N-Alkyl (C8-C18)-biminodipropionic Acid (SSNAs - JITF 

CST 14 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations’’ in docket ID number 

EPA–HQ–OPP–2009–0098. 

This petition was submitted in 

response to a final rule of August 9, 

2006, (71 FR 45415) in which the 

Agency revoked, under section 408(e)(1) 

of the Federal Food, Drug, and Cosmetic 

Act (FFDCA), the existing exemptions 

from the requirement of a tolerance for 

residues of certain inert ingredients 

because of insufficient data to make the 

determination of safety required by 

FFDCA section 408(b)(2). The expiration 

date for the tolerance exemptions 

subject to revocation was August 9, 

2008, which was later extended to 

August 9, 2009 (73 FR 45312) to allow 

for data to be submitted to support the 

establishment of tolerance exemptions 

for these inert ingredients prior to the 

effective date of the tolerance exemption 

revocation. 

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 


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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 sodium salts of 

N-alkyl (C8-C18)-beta-iminodipropionic 

acid where the C8-C18 is linear and may 

be saturated and/or unsaturated 

provided that the concentration of the 

SSNA inerts is limited to no more than 

30% by weight in pesticide 

formulations. 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 toxicity data indicate 

that the SSNAs have low acute oral and 

dermal toxicity, are potentially 

corrosive to the skin, and are also mild 

to moderate eye irritants. In the OPPTS 

Harmonized Guideline 870.3650 study 

with sodium coco b-iminodipropionate 

in rats, decreased food consumption and 

body weight gain in males and females 

at 160 and 600 miligrams/kilograms 

body weight day (mg/kg bw/day) were 

observed. Mean liver and kidney 

weights were increased at the high dose, 

while testis and epididymides were 

unaffected. Hypertrophy was found in 

the livers of males and/or females at the 

mid- and high-doses as well as renal 

histopathology in males, acanthosis of 

the non-glandular stomach in males and 

females, and inflammation of the 

glandular and non-glandular stomach in 

females. In the absence of any evidence 

of hepatic toxicity, liver hypertrophy 

was considered an adaptive effect and 

non-adverse. 

No reproduction or developmental 

effects were noted in the database and 

there was no evidence of neurotoxicity. 

In general, surfactants are surfaceactive materials that can damage the 

structural integrity of cellular 

membranes at high dose levels. Thus, 

surfactants are often corrosive and 

irritating in concentrated solutions. It is 

possible that some of the observed 

toxicity seen in the repeated studies, 

such as inflammation of the glandular 

stomach, can be attributed to the 

corrosive and irritating nature of these 

surfactants. 

There are no published metabolism 

studies for this series of surfactants. The 

SSNA mammalian metabolism pathway 

is based on analogy to well-described 

pathways for tertiary amines and fatty 

acids. Overall it is anticipated that the 

various metabolites are not systemically 

toxic and would be rapidly conjugated 

and excreted. 

The SSNA surfactants (mono and disodium propionates) may be conjugated 

and excreted directly. Alternatively, the 

tertiary amine dipropionate may be 

oxidized in the liver by monoamine 

oxidases to generate the intact tertiary 

amine dipropionate N-oxide which may 

either be conjugated and excreted or 

metabolically cleaved to a dipropionate 

oxime type metabolite that is conjugated 

and excreted. The linear fatty acid is 

metabolized via successive betaoxidation cycles to release acetic acid 

and eventually carbon dioxide and 

water. 

There are no chronic toxicity studies 

available for this series of nonionic 

surfactants. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK 

Version 11, to determine if there were 

structural alerts suggestive of 

carcinogenicity. No structural alerts 

were identified. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by the SSNAs, 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 

‘‘Sodium Salts of N-Alkyl (C8-C18)-biminodipropionic Acid (SSNAs - JITF 

CST 14 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations’’ pages 8-13 and 46-49 in 

docket ID number EPA–HQ–OPP–2009– 

0098. 

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 the SSNAs used for 


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human health risk assessment is shown 

in the Table 1 below: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THE SSNAS 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 An effect attributable to a single exposure was not identified. 

Chronic dietary NOAEL= 43 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPASF = 1x 

Chronic RfD =0.43 mg/kg/day 

cPAD = 0.43 mg/kg/day 

Combined Repeated Dose Toxicity Study with the Reproduction Developmental Toxicity 

Screening Test-Rat OPPTS 

Harmonized Guideline 

870.3650 (CAS Reg. No. 

3655–00–3) 

Parental LOAEL= 160 mg/kg/day 

based on decreased body 

weight gain in males and females during the pre-mating 

period, and an increased incidence of microscopic lesions in 

the kidneys of males and acanthosis of the glandular and 

non-glandular stomachs of females. 

Reproductive/Developmental 

LOAEL was not observed. 

Incidental Oral, Dermal and Inhalation (Short- and Intermediate-, 

and Long- Term) 

NOAEL= 43 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF =1x 

5 PCT dermal and 100 PCT inhalation absorption assumed 

Residential LOC for MOE = 100 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity 

screening Test- Rat OPPTS 

Harmonized Guideline 

870.3650 (Cas Reg. No. 3655- 

00-3). 

Parental LOAEL = 160 mg/kg/day 

based on decreased body 

weight gain in males and females during the pre-mating 

period and an increased incidence of microscopic lesions in 

the kidneys of males and acanthosis of the glandular and 

non-glandular stomachs of females. 

Reproductive/Developmental 

LOAEL was not observed. 

Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment. Based on SAR analysis, the SSNAs 

are not expected to be carcinogenic. 

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 SSNAs, EPA considered 

exposure under the petitioned-for 

exemption from the requirement of a 

tolerance. EPA assessed dietary 

exposures from SSNAs in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of the 

SSNAs was seen in the toxicity 

databases; therefore, an acute exposure 

assessment for the SSNAs is not 

necessary. 

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 SSNAs. 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 


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37588 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

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 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 is 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 the 

SSNAs, EPA made a specific adjustment 

to the dietary exposure assessment to 

account for the use limitations of the 

amount of SSNAs that may be in 

formulations (no more than 30% by 

weight in pesticide formulations) and 

assumed that the SSNAs 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 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

the highest tolerance level. In other 

words, EPA assumed 100% 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. The Agency used a 

qualitative structure activity 

relationship (SAR) database, DEREK11, 

to determine if there were structural 

alerts suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. SSNAs are not expected to be 

carcinogenic. Therefore a cancer dietary 

exposure assessment is not necessary to 

assess cancer risk. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for SSNAs. Tolerance level residues 

and/or 100% were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for SSNAs in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of SSNAs. 

Further information regarding EPA 

drinking water models used in the 

pesticide exposure assessment can be 

found at http://www.epa.gov/oppefed1/ 

models/water/index.htm. 

A screening level drinking water 

analysis, based on the Pesticide Root 

Zone Model /Exposure Analysis 

Modeling System (PRZM/EXAMS) was 

performed to calculate the estimated 

drinking water concentrations (EDWCs) 

of SSNAs. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of the SSNAs were 

conducted. Modeled acute drinking 

water values ranged from 0.001 ppb to 

41 ppb. Modeled chronic drinking water 

values ranged from 0.0002 ppb to 19 

ppb. Further details of this drinking 

water analysis can be found at http:// 

www.regulations.gov in the document 

‘‘Sodium Salts of N-Alkyl (C8-C18)-biminodipropionic Acid (SSNAs - JITF 

CST 14 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations’’ pages 13-14 and 51-53 in 

docket ID number EPA–HQ–OPP–2009– 

0098. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for the 

SSNAs, a conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for the chronic dietary risk 

assessments for parent compounds and 

for the metabolites of concern. 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). SSNAs 

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 the SSNAs as inert 

ingredients. In this assessment, 

representative scenarios, based on enduse product application methods and 

labeled application rates, were selected. 

For each of the use scenarios, the 

Agency assessed residential handler 

(applicator) inhalation and dermal 

exposure for indoor and outdoor 

scenarios with high exposure potential 

(i.e., exposure scenarios with high end 

unit exposure values) to serve as a 

screening assessment for all potential 

residential pesticides containing 

SSNAs. Similarly, residential post 

application dermal and oral exposure 

assessments were also performed 

utilizing high end indoor and outdoor 

exposure 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 


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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37589 

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.’’ 

EPA has not found SSNAs to share a 

common mechanism of toxicity with 

any other substances, and SSNAs do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that SSNAs 

do not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s 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. 

The toxicology database is adequate to 

assess risk for the SSNAs when used as 

inert ingredients in pesticide 

formulations. The toxicity data available 

on the SSNAs consists of one OPPTS 

Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/development 

toxicity screening test (rat) for the 

representative surfactant, sodium coco 

beta-iminodipropionate (CAS Reg. No. 

3655–00–3). There was no evidence of 

increased sensitivity in young animals 

because no developmental or 

reproductive toxicity was observed in 

the OPPTS Harmonized Guideline 

870.3650. No treatment related effects 

were observed on litter sizes or on the 

early development of pups. 

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 SSNAs is 

considered adequate for assessing the 

risks to infants and children (the 

available studies are described in Unit 

4.D.2. 

ii. No quantitative or qualitative 

increased susceptibility was 

demonstrated in the offspring in the 

OPPTS Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test in rats following 

in utero and post-natal exposure. 

iii. While there is no chronic toxicity 

data, the Agency has concluded that an 

additional uncertainty factor is not 

needed for the use of a subchronic study 

for a chronic exposure assessment based 

on the minor nature of effects which 

were seen only at the mid- and highdoses as well as the highly conservative 

nature of the exposure assessment. The 

conservative point of departure selected 

along with the standard uncertainty 

factor of 100X to account for inter- and 

intra-species variability is considered 

health protective. 

iv. There are no neurotoxicity studies 

available for this series of nonionic 

surfactants. However a Functional 

Observation Battery (FOB) to evaluate 

neurotoxicity was performed in the 

Combined Repeated Dose/ 

Developmental Screening study and 

only a minor decrease in temperature 

was observed in males at the mid and 

high doses. The effect was likely due to 

normal biological variation and; 

therefore, was not considered treatmentrelated. Thus, there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

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 PCT 

is assumed for all crops. EPA also made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to SSNAs in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by SSNAs. 

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 SSNAs. 

Therefore, the SSNAs 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 30% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to SSNAs 

is 27% of the cPAD for the U.S. 

population and 87% of the cPAD for 

children 1-2 yrs 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). 

SSNAs 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 

SSNAs. 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 

160 for both adult males and females 


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37590 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

respectively. EPA has concluded the 

combined short-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 100 for children. 

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). 

SSNAs 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 SSNAs. 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 430 and 450, for 

adult males and females, respectively. 

EPA has concluded the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 110 for children. 

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 SSNAs. 

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 

SSNAs. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

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. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for SSNAs 

nor have any CODEX Maximum Residue 

Levels been established for any food 

crops at this time. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of sodium salts of N-alkyl 

(C8-C18)-beta-iminodipropionic acid 

where the C8-C18 is linear and may be 

saturated and/or unsaturated when used 

as an inert ingredient for pre-harvest 

uses under 40 CFR 180.920 at a 

maximum of 30% by weight in pesticide 

formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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). 

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: July 21, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In §180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 


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Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37591 

Inert Ingredients Limits Uses 

*** * * **

sodium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid 

where the C8-C18 is linear and may be saturated and/or unsaturated (CAS Reg. Nos. 3655-00-3, 61791-56-8, 14960-06-6, 

26256-79-1, 90170-43-7, 91696-17-2, 97862-48-1) Concentration in formulated end-use 

products not to exceed 30% by 

weight in pesticide formulations 

Surfactants, related adjuvants of 

surfactants 

*** * * **

[FR Doc. E9–18064 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0725; FRL–8426–8] 

Sodium N-oleoyl-N-methyl taurine; 

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 sodium Noleoyl-N-methyl taurine (MOTS), (CAS 

Reg. No. 137–20–2), herein referred to in 

this document as MOTS, when used as 

an inert ingredient in pesticide 

formulations for pre-harvest and postharvest uses under 40 CFR 180.910, as 

well as for application to animals under 

40 CFR 180.930. The Joint Inerts Task 

Force (JITF), Cluster Support Team (CST 

24), 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 MOTS. 

DATES: This regulation is effective July 

29, 2009. Objections and requests for 

hearings must be received on or before 

September 28, 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–2008–0725. 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: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@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 those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR. 

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guideline 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. 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–2008–0725 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 

as required by 40 CFR part 178 on or 

before September 28, 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 this copy, 

identified by docket ID number EPA– 

HQ–OPP–2008–0725, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 


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