Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 37605 

Inert Ingredients Limits Uses 

*** * *

Sodium monoalkyl and dialkyl (C6-C16) 

phenoxy benzenedisulfonates and related 

acids (CAS Reg. Nos. 147732-59-0, 

147732-60-3, 169662-22-0, 70191-75-2, 

36445-71-3, 39354-74-0, 70146-13-3, 

119345-03-8, 149119-20-0, 149119-19-7, 

119345-04-9, 28519-02-0, 25167-32-2, 

30260-73-2, 65143-89-7, 70191-76-3) 

Not to exceed 20% in pesticide formulations Surfactants, related adjuvants of surfactants 

*** * *

■ 3. In §180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

*** * *

Sodium monoalkyl and dialkyl (C6-C16) 

phenoxy benzenedisulfonates and related 

acids (CAS Reg. Nos. 147732-59-0, 

147732-60-3, 169662-22-0, 70191-75-2, 

36445-71-3, 39354-74-0, 70146-13-3, 

119345-03-8, 149119-20-0, 149119-19-7, 

119345-04-9, 28519-02-0, 25167-32-2, 

30260-73-2, 65143-89-7, 70191-76-3) 

Not to exceed 20% in pesticide formulations Surfactants, related adjuvants of surfactants 

*** * *

[FR Doc. E9–17957 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0710; FRL–8425–7] 

Ethylene oxide adducts of 2,4,7,9- 

tetramethyl-5-decynediol, the ethylene 

oxide content averages 3.5, 10, or 30 

moles; 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 ethylene oxide 

adducts of 2,4,7,9-tetramethyl-5- 

decynediol, the ethylene oxide content 

averages 3.5, 10, or 30 moles, herein 

referred to in this document as 

ethoxylated acetylenic diols, when used 

as inert ingredients 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 

Number 19, 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 the 

ethoxylated acetylenic diols. 

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–2008–0710. 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 


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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. 

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–2008–0710 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–2008–0710, 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 December 3, 

2008 (73 FR 73640) (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 8E7374) by The 

Joint Inerts Task Force, Cluster Support 

Team 19 (CST 19), c/o CropLife 

America, 1156 15th Street, NW., Suite 

400, Washington, DC 20005. The 

petition requested that 40 CFR 180.910 

and 40 CFR 180.930 be amended by 

establishing exemptions from the 

requirement of a tolerance for residues 

of the inert ingredients ethoxylated 

acetylenic diols. That notice referenced 

a summary of the petition prepared by 

the Joint Inerts Task Force (JITF), 

Cluster Support Team Number 19 (CST 

19), 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. 

This petition was submitted in 

response to a final rule of August 9, 

2006, (71 FR 45415) (FRL–8084–1), 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) (FRL– 

8372–7), 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 

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 the ethoxylated 

acetylenic diols when used as inert 

ingredients in pesticide formulations for 

pre-harvest and post-harvest uses, as 

well as for application to animals. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 


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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 mammalian toxicology 

database includes acute, subchronic (rat 

and dog) repeat dose, and reproductive 

toxicity studies (rat) via the oral route 

for a representative ethoxylated 

compound for the series of 

polyethoxylated 2,4,7,9-tetramethyl-5- 

decyne-4,7-diols and the proposed 

major unethoxylated metabolite, and 

mutagenicity data for the unethoxylated 

compound. The available toxicology 

data are adequate to support the 

requested exemption from the 

requirement of tolerance when used in 

pesticide formulations for these 

ethoxylated acetylenic diols. In addition 

to concern for the parent compounds, 

the Agency has identified the 

unethoxylated metabolite, 2,4,7,9- 

tetramethyl-5-decyne-4,7-diol, to be of 

concern. Unethoxylated and ethoxylated 

acetylenic diols are expected to follow 

a similar metabolic pathway. This 

would include hydrolytic or oxidative 

removal of the polyethoxylate chain to 

generate a common acetylenic diol 

primary metabolite and polyethoxylated 

moieties, which would vary in size 

depending on the extent of ethoxylation 

in the parent molecule. The primary 

acetylenic diol metabolite would be 

analogous to a related surfactant (CAS 

Reg. No. 126–86–3). Both the diol and 

polyethoxylate moieties would undergo 

rapid oxidative degradation and 

excretion likely as conjugates. The 

unethoxylated diol metabolite is of 

concern in food and water only. The 

Agency has concluded that the available 

data on the ethoxylated compound and 

unethoxylated metabolite (CAS Reg. 

Nos. 9014–85–1 and 126–86–3) are 

representative of the chemicals in the 

polyethoxylated 2,4,7,9-tetramethyl-5- 

decyne-4,7-diols cluster. Further, the 

Agency has concluded that the currently 

available toxicity dataset is adequate to 

apply to the cluster and to characterize 

the potential toxic effects of these 

surfactants. 

The ethoxylated compounds are not 

acutely toxic by the oral, dermal and 

inhalation routes of exposure, but are 

slight to severe eye and mild skin 

irritants. The unethoxylated metabolite 

demonstrates low to medium acute 

toxicity by the oral and dermal routes of 

exposure, with the greatest concerns 

being eye and skin irritation. There is no 

evidence that the unethoxylated 

metabolite is mutagenic, and no 

increases in polyploidy or chromosome 

aberrations were observed in the 

presence and absence of metabolic 

activation. 

There is no clear target organ 

identified for the ethoxylated compound 

or the unethoxylated metabolite, 

although increased liver weight 

(without histopathology) was a 

consistent finding. Following 

subchronic exposure to the ethoxylated 

compound, no specific target organ 

toxicity or neurotoxicity was observed 

in rats and dogs. In a 1–generation 

reproduction study, decreased pup body 

weights were observed at weaning 

following exposure to the ethoxylated 

and unethoxylated compounds at dose 

levels at and greater than the limit dose. 

Following subchronic exposure to the 

unethoxylated metabolite, compoundrelated neurological disturbances 

(convulsions and tremors) were 

observed in the dog. However, the 

concern for this finding is low based on 

the following considerations: 

1. The clinical signs were sporadic. 

2. There was no neuropathology at 

any dose. 

3. No neurotoxic clinical signs were 

seen following subchronic exposures to 

the parent compound. 

4. This endpoint is used as the point 

of departure in conjunction with highly 

conservative exposure inputs for 

assessing chronic dietary risks for the 

diol metabolite. 

5. There was no evidence with either 

the parent or metabolite of neurotoxicity 

in rats, the species of choice for 

conducting neurotoxicity studies. 

There was evidence of increased 

susceptibility following pre- and postnatal exposures to rats for 1–generation 

where decreases in body weights of the 

offspring were seen at high doses (1,000 

or 2,000 milligrams/kilogram/day (mg/ 

kg/day)) that did not cause any parental/ 

systemic toxicity. It should be noted 

that the offspring effects were seen at 

and above the limit dose. Similarly, 

following exposure to the unethoxylated 

compound, there was a decrease in pup 

body weight at dose levels of 1,000 and 

2,000 mg/kg/day, whereas the parental 

animals displayed body-weight effects 

only at the 2,000 mg/kg/day dose level. 

Based on the fact that the effect 

(decreased body weight) was observed 

only at the limit dose and above and 

there is a clear NOAEL, there is no 

residual concern for this finding. 

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. Based on the negative 

response for mutagenicity, the fact that 

no specific target organs have been 

identified in the rat and dog subchronic 

studies at the limit dose, the lack of any 

alerts in model predictions, and SAR 

analysis, the Agency concluded that the 

ethoxylated acetylenic diol inerts or 

their unethoxylated diol metabolite are 

not likely to be carcinogenic. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ethoxylated acetylenic 

diols or the unethoxylated diol 

metabolite as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov 

in document ‘‘Ethoxylated Acetylenic 

Diols (JITF CST 19 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 10–15 and pages 

50–57 in docket ID number EPA–HQ– 

OPP–2008–0710. 

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-term, intermediate-term, 

and chronic-term risks are evaluated by 

comparing food, water, and residential 


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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 ethoxylated acetylenic 

diols used for human health risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHOXYLATED ACETYLENIC DIOLS 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) Parent and Diol 

Metabolite 

No appropriate endpoints were identified for acute dietary risk assessment. 

Chronic dietary (all populations) Parent Compound NOAEL= 500 mg inert/kg/day UFA = 

10x UFH = 10x FQPA SF = 1x 

Chronic RfD = 5 mg/kg/ 

daycPAD = 5 mg/kg/day 

1–generation reproduction/subchronic 

oral toxicity study - rat (CAS Reg. 

No. 9014–85–1) Offspring LOAEL = 

1,000 mg/kg/day, based on decreased pup body weight (11% 

lower than control) at weaning (only 

time assessed); BW decreased 21– 

22% lower than control at 2,000 mg/ 

dg/day. 

Chronic Dietary (all populations) Diol Metabolite NOAEL = 200 mg/kg/day UFA = 10x 

UFH = 10x FQPA SF = 1x 

Chronic RfD = 2 mg/kg/ 

daycPAD = 2 mg/kg/day 

Subchronic oral toxicity study - dog 

(CAS Reg. No. 126–86–3) LOAEL = 

250 mg/kg/day, based on sporadic 

compound-related neurological disturbances (convulsions and tremors; 

time of occurrence unknown) 

Incidental Oral Short- and Intermediate Term Dermal 

and Inhalation (All Durations) Parent Compound 

NOAEL= 500 mg/kg/day UFA = 10 x 

UFH = 10 x FQPA SF = 1x (20% 

Dermal absorption; inhalation and 

oral toxicity assumed equivalent) 

Residential/Occupational 

LOC for MOE = 100 

1–generation reproduction/subchronic 

oral toxicity study - rat (CAS Reg. 

No. 9014–85–1) Offspring LOAEL = 

1,000 mg/kg/day, based on decreased pup body weight (11% 

lower than control) at weaning (only 

time assessed); BW decreased 21– 

22% lower than control at 2,000 mg/ 

kg/day. 

Cancer (oral, dermal, inhalation) Parent and Diol Metabolite Classification: No animal toxicitydata available for an assessment. Based on SAR analysis, the ethoxylated 

acetylenic diols and the diol metabolite 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 ethoxylated acetylenic 

diols and the unethoxylated diol 

metabolite, EPA considered exposure 

under the petitioned-for exemptions 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

ethoxylated acetylenic diols in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of ether 

the parent ethoxylated acetylenic diol 

inerts or the unethoxylated diol 

metabolite were seen in the toxicity 

databases; Therefore, acute dietary risk 

assessments for the parent compound 

and the unethoxylated diol metabolite 

are 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 the ethoxylated 

acetylenic diol inert ingredients or the 

unethoxylated diol metabolite. 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 ingredients. 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 


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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 

ethoxylated acetylenic diols, a 

conservative screening level chronic 

dietary (food and water) assessment was 

conducted for both the parent 

ethoxylated acetylenic diol inerts and 

for the 2,4,7,9-tetramethyl-5-decyne-4,7- 

diol metabolite. 

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 

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. Based on the negative 

response for mutagenicity, the fact that 

no specific target organs have been 

identified in the rat and dog subchronic 

studies at the limit dose, the lack of any 

alerts in model predictions, and SAR 

analysis, the Agency concluded that the 

ethoxylated acetylenic diol inerts or 

their unethoxylated diol metabolite are 

not likely to be carcinogenic. Since the 

Agency has not identified any concerns 

for carcinogenicity relating to the 

ethoxylated acetylenic diol inerts or 

their unethoxylated diol metabolite, 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 the ethoxylated acetylenic diols or 

their unethoxylated diol metabolite. 

Tolerance level residues and/or 100 PCT 

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 the ethoxylated acetylenic diols and 

unethoxylated diol metabolite in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of the ethoxylated 

acetylenic diols and unethoxylated diol 

metabolite. Further information 

regarding EPA drinking water models 

used in 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 the ethoxylated acetylenic diols and 

unethoxylated diol metabolite. 

Modeling runs on four surrogate inert 

ingredients using a range of physical 

chemical properties that would bracket 

those of the the ethoxylated acetylenic 

diols and unethoxylated diol metabolite 

were conducted. Modeled acute 

drinking water values ranged from 0.001 

parts per billion (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 document 

‘‘Ethoxylated Acetylenic Diols (JITF 

CST 19 Inert Ingredients). Human 

Health Risk Assessment to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide’’, at 

pages 15–16 and 59–61 in docket ID 

number EPA–HQ–OPP–2008–0710. 

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 

ethoxylated acetylenic diols and 

unethoxylated diol metabolite, 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 the parent compounds 

and for the metabolite 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). The 

ethoxylated acetylenic diols 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. The 

ethoxylated acetylenic diol inerts are 

used in pesticide formulations that may 

be used around the home. In addition, 

these inerts may be used in pesticide 

products applied to pets as dust 

formulations and aerosol sprays 

intended for flea control on carpeted 

surfaces and bedding. Lastly, these inert 

surfactants may be present in home 

cleaning products. The ethoxylated 

acetylenic diols inerts do not have 

utility in personal care products. A 

screening level residential exposure and 

risk assessment was completed for 

products containing ethoxylated 

acetylenic diols as inert ingredients. In 


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this assessment, representative 

scenarios, based on end-use product 

application methods and labeled 

application rates, were selected. The 

Agency conducted an assessment to 

represent worst-case residential 

exposure by assessing ethoxylated 

acetylenic diols in pesticide 

formulations (Outdoor Scenarios); 

ethoxylated acetylenic diols in 

disinfectant-type uses; (Indoor 

Scenarios) and ethoxylated acetylenic 

diols in pet products; (Pet Product 

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.’’ 

EPA has not found ethoxylated 

acetylenic diols to share a common 

mechanism of toxicity with any other 

substances, and ethoxylated acetylenic 

diols do not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that ethoxylated acetylenic 

diols 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 toxicity database consists of a 1– 

generation reproductive toxicity study 

on the ethoxylated compound and a 1– 

generation reproductive toxicity study 

on the unethoxylated compound. 

The Agency performed a Degree of 

Concern Analysis because the rat 

reproduction studies provided evidence 

of increased susceptibility in the 

offspring relative to the parents. The 

purpose of the Degree of Concern 

analysis was: 

i. To determine the level of concern 

for the effects observed when 

considered in the context of all available 

toxicity data; and 

ii. Identify any residual uncertainties 

after establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment. 

In the case of the ethoxylated 

acetylenic diols and unethoxylated diol 

metabolite, there was evidence of 

increased susceptibility in the 1– 

generation reproduction toxicity studies 

in rats. Although there is some 

increased susceptibility in the rat 

reproductive toxicity studies (where the 

offspring NOAEL of 500 mg/kg/day was 

lower than the paternal NOAELs of 

1,000 and 2,000 mg/kg/day), the effects 

(decreased body weight) were observed 

only at the limit and twice the limit 

dose. The dose-response for this effect 

has been adequately characterized, and 

the NOAEL selected as a point of 

departure for the chronic dietary, 

dermal and inhalation risk assessment is 

protective of the adverse offspring 

effects. Thus, there are no residual 

concerns. 

There was some evidence of clinical 

signs indicative of neurotoxicity 

following subchronic exposures to the 

diol metabolite in dogs. However, the 

concern for this finding is low based on 

the following considerations: 

a. The clinical signs were sporadic; 

b. There was no neuropathology at 

any dose; 

c. No neurotoxic clinical signs were 

seen following subchronic exposures to 

the parent compound; 

d. This endpoint is used as the point 

of departure in conjunction with highly 

conservative exposure inputs for 

assessing chronic dietary risks for the 

diol metabolite; and 

e. There was no evidence with either 

the parent or metabolite of neurotoxicity 

in rats, the species of choice for 

conducting neurotoxicity studies. 

Therefore, additional neurotoxicity data, 

including developmental neurotoxicity 

studies are not required. 

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 

ethoxylated acetylenic diols and 

unethoxylated diol metabolite is 

considered adequate for assessing the 

risks to infants and children (the 

available studies are described in Unit 

IV.D.2.). 

ii. There are no concerns or residual 

uncertainties concerning pre- and 

postnatal toxicity for the reasons given 

in this Unit. 

iii. No additional neurotoxicity data 

are required. 

iv. While there is no chronic toxicity 

study, the Agency has concluded that 

based on the very conservative exposure 

assessment and the fact that the toxicity 

endpoint is also very conservative 

(effects were only seen at and above the 

limit dose), the 10X interspecies and 

10X intraspecies uncertainty factor 

would be adequately protective, and no 

additional uncertainty factor is needed 

for extrapolating from subchronic to 

chronic exposure. 

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 the 

ethoxylated acetylenic diols or their diol 

metabolite in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by the ethoxylated 

acetylenic diols. 

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 


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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. Shortterm, intermediate-term, and chronicterm 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. 

The Agency has conducted aggregate 

risk assessments to support the 

proposed uses of the ethoxylated 

acetylenic diols as inert ingredients in 

pesticide formulations. As noted 

previously, the ethoxylated acetylenic 

diols assessment includes not only 

parent compounds, but also 2,4,7,9- 

tetramethyl-5-decyne-4,7-diol. The 

Agency notes that concern for this 

degradate is for residues in food and 

water only. Additionally, the Agency 

has selected endpoints and doses for 

risk assessment separately for the parent 

compound and diol metabolite. 

Therefore, separate parent compound 

and diol metabolite aggregate risk 

assessments are appropriate. The 

aggregate risk assessment for the diol 

metabolite includes residues in food 

and water only. 

1. Acute risk. There was no hazard 

attributable to a single dietary exposure 

seen in the toxicity database for the 

parent ethoxylated acetylenic diols or 

the unethoxylated diol metabolite. 

Therefore, the parent ethoxylated 

acetylenic diols or the unethoxylated 

diol metabolite 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, the chronic dietary exposure 

from food and water to the parent 

ethoxylated acetylenic diol is 4% of the 

cPAD for the U.S. population and 13% 

of the cPAD for children 1–2 yrs old, the 

most highly exposed population 

subgroup. The chronic dietary (food and 

water) exposure for the unethoxylated 

diol metabolite resulted in a risk 

estimate of 10% of the cPAD for the U.S. 

population and 31% of the cPAD for 

children 1–2 yrs old, the most highly 

exposured 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). 

Ethoxylated acetylenic diol inerts 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 the ethoxylated acetylenic 

diols. 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 

670, 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 

600 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the LOC 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). 

Ethoxylated acetylenic diol inerts are 

used as inert ingredients in pesticide 

products that 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 ethoxylated acetylenic diols. 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 2,500 for 

both adult males and females 

respectively. Adult residential exposure 

includes high end post application 

dermal exposure from contact with 

treated lawns. EPA has concluded that 

the combined intermediate-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

690 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to-mouth 

exposures). As the LOC is for MOEs that 

are lower than 100, these MOEs are not 

of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to the parent 

ethoxylated acetylenic diol inerts or the 

degradate of concern. 

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 

the ethoxylated acetylenic diol inerts. 

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 the 

ethoxylated acetylenic diol inerts 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 Ethylene oxide adducts 

of 2,4,7,9-tetramethyl-5-decynediol, the 

ethylene oxide content averages 3.5, 10, 

or 30 moles, when used as inert 

ingredients applied to crops pre-harvest 

and post-harvest, or to animals. 

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 


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37612 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from 

the requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

***** * *

Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, 

the ethylene oxide content averages 3.5, 10 or 30 moles 

(CAS Reg. No. 9014–85–1) 

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

* * * * * ■ 3. In §180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

***** * *

Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, 

the ethylene oxide content averages 3.5, 10 or 30 moles 

(CAS Reg. No. 9014–85–1) 

..................................................... Surfactants, related adjuvants of surfactants 

***** * *

* * * * * 

[FR Doc. E9–17958 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0556; FRL–8420–6] 

Fenpyroximate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

fenpyroximate in or on raw agricultural 

commodities (RAC): Vegetables, 

fruiting, group 8 at 0.20 ppm; okra at 

0.20 ppm; melon subgroup 9A at 0.10 

ppm; and cucumber at 0.10 ppm. The 

Interregional Research Project Number 4 

(IR-4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

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 


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