37598 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Rules and Regulations 

Inert Ingredients Limits Uses 

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Sodium N-oleoyl-N-methyl taurine (CAS Reg. No. 137–20–2) Surfactants, related adjuvants of surfactants 

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[FR Doc. E9–17960 Filed 7–28–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0665; FRL–8421–7] 

Sodium monoalkyl and dialkyl (C6-C16) 

phenoxybenzenedisulfonates and 

related acids; 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 

monoalkyl and dialkyl (C6-C16) 

phenoxybenzenedisulfonates and 

related acids, often known as the 

‘‘alkyldiphenyl oxide sulfnates’’, herein 

referred to in this document as ADPOS, 

when used as inert ingredients at a 

maximum of 20% by weight in pesticide 

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

well as for application to animals under 

40 CFR 180.930. Dow AgroSciences, 

LLC, 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 ADPOS. 

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–2008–0665. 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 

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–2008–0665 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–2008–0665, 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. 


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II. Background 

In the Federal Register of October 8, 

2008 (73 FR 58962) (FRL–8383-7), 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 8E7372) by Dow 

AgroSciences, LLC, 9330 Zionsville Rd., 

Indianapolis, IN 46268. 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 ingredient ADPOS at a 

maximum of 20% by weight in pesticide 

formulations. That notice referenced a 

summary of the petition prepared by 

Dow AgroSciences, LLC, the petitioner, 

which is available to the public in the 

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

The Agency received only one 

comment in response to the notice of 

filing. One comment was received from 

a private citizen who opposed the 

authorization to sell any pesticide that 

leaves a residue on food. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that no residue of pesticides 

should be allowed. However, under the 

existing legal framework provided by 

section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA), EPA is 

authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

that statute. 

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) 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 ADPOS when 

used as inert ingredients at a maximum 

of 20% by weight in pesticide 

formulations for pre-harvest and postharvest use, as well as for application to 

animals. 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 mammalian toxicology 

database includes acute, subchronic 

repeat dose oral, reproductive/ 

developmental screening tests, chronic 

rat and dog studies and mutagenicity 

data for four representative compounds 

of the C6 to C16 ADPOS group. The 

Agency concluded that the four 

surrogate chemicals (CAS Reg. Nos. 

147732–60–3, 39354–74–0, 119345–04– 

9 (alternate CAS Reg. No. 28519–02–0), 

and 70191-76-3) are representative of all 

the chemicals in the ADPOS cluster. 

Additionally, the Agency concluded 

that the currently available toxicity 

dataset is adequate to apply to the 

ADPOS inerts and to characterize these 

surfactants. Further, the Agency noted 

that there was sufficient bracketing of 

the range of molecular weights expected 

from the inerts in this grouping. 

The ADPOS inerts are not acutely 

toxic by the oral, dermal, and inhalation 

routes of exposure, and are moderately 

irritating to the skin and eyes. 

Respiratory irritation is possible with 

mists. The ADPOS inerts, like all 

surfactants, are surface-active materials 

that can damage the structural integrity 

of cellular membranes at high dose 

levels. Thus, surfactants are often 

corrosive and irritating in concentrated 

solutions, as indicated by the acute 

toxicity studies for these inert materials. 

It is possible that some of the observed 

toxicity seen in the repeated studies, 

such as diarrhea, gastrointestinal tract 

effects or decreased body weight gain, 

can be attributed to the corrosive and 

irritating nature of these surfactants. 

The liver and possibly kidney appear to 

be the primary target organs. Following 

subchronic exposures to ADPOS inerts, 

the most sensitive effects include 

increased liver enzymes (alanine and 

aspartate aminotransferase), increased 

prothrombin time and soft/decreased 

feces in males and significant decreases 

in body weight gain in both sexes after 

47–54 days of dosing at doses between 

28 and 92 mg/kg/day. In comparison, in 

most of the other studies, no effects 

were observed in the range of 100 to 500 


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mg/kg/day, even following chronic 

exposures. There is some evidence of 

neurotoxicity in a 28–day rat study, 

including high-stepping gait, ataxia and 

salivation; however, these effects are 

seen at the highest dose tested (HDT). 

The Agency considered these effects to 

be the result of a high dose rather than 

a neurotoxic condition. No quantitative 

or qualitative increased susceptibility 

was demonstrated in the offspring in the 

two reproductive/developmental 

toxicity studies in rats following in 

utero and postnatal exposure. In one 

OPPTS Harmonized Guideline 870.3650 

study there were no developmental 

effects at the HDT in the presence of 

maternal toxicity such as increased liver 

enzymes and prothrombin time. In a 

second OPPTS Harmonized Guideline 

870.3650 study with test substance 

(CAS Reg. No. 147732–60–3) the 

developmental effects were manifested 

as statistically significantly decrease in 

body weight and clinical signs at 1,000 

mg/kg which was in the presence severe 

maternal toxicity which manifested as 

mortality, clinical signs, and decrease in 

body weight were observed. 

There is no evidence that the ADPOS 

inerts are mutagenic, but there is some 

evidence of potential clastogenicity for 

a C6 inert formulation. In vitro data for 

genotoxicity are available for the range 

of alkyl chains of the lower (C6) and 

upper (C16) compounds in this group. 

The Ames tests were negative for the C6

and C16 inerts. The C16 analogue was 

negative in the CHO/HGPRT forward 

mutation assay. In chromosomal 

aberration tests that evaluate 

clastogenicity, C6 (CAS Reg. No. 

147732–60–3) was clastogenic in human 

lymphocytes in the absence of metabolic 

activation (S9), but was negative in rat 

lymphocytes. The registrants attributed 

this positive response to peroxide as an 

unwanted constituent, and no longer 

use peroxide in the ADPOS process. C16

was negative in both human and rat 

lymphocytes, although the human 

lymphocyte study was not acceptable. 

In vivo, there was no evidence of a 

cytogenetic response in rat bone marrow 

cells for C16 (CAS Reg. No. 70191–76– 

3) in an unacceptable study that lacked 

positive controls, which limits the 

confidence of this finding. Based on 

these studies and the overall weight of 

the evidence, the Agency concluded 

that the ADPOS inerts are not likely to 

be mutagenic. There is no evidence of 

carcinogenicity in the chronic/ 

carcinogenicity rat study at does up to 

500 mg/kg/day. In addition, no tumors 

were observed in the two year toxicity 

study in dogs. Based on the negative 

response for carcinogenicity in the 

carcinogenicity study in rats and two 

year dog study, negative response for 

mutagenicity, lack of any alerts in 

model predictions, and SAR analysis, 

the Agency concluded that the ADPOS 

inerts are not likely to be carcinogenic. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ADPOS 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 

‘‘Alkyl Diphenyl Oxide Sulfonates (JITF 

CST 18 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 9-15 in docket ID 

number EPA–HQ–OPP–2008–0665. 

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 ADPOS used for human 

health risk assessment is shown in the 

Table of this unit. 

TABLE —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADPOS FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure Scenerio Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk 

Assesment Study and Toxicological Effects 

Acute Dietary 

(General Population, including Infants and Children) 

NOAEL=115 milligrams/ kilograms/day (mg/kg/day) 

UFA=10x 

UFH=10x 

FQPA SF=1x 

Acute RfD=1.15 mg/kg/day 

aPAD=1.15 mg/kg/day 

28-day oral toxicity study- rats 

(CAS No. 70191-76-3) 

LOAEL= 367 mg/kg/day, based 

on Post-dosing salivation (day 

1 post-dose in 3/5 male and 2/ 

5 female rats; 2-28 all rats.) 


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TABLE —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADPOS FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure Scenerio Point of Departure and Uncertainty/Safety Factors 

RfD, PAD, LOC for Risk 

Assesment Study and Toxicological Effects 

Chronic Dietary 

(all populations) 

NOAEL=28 mg/kg/day UFA=10x 

UFH=10x 

FQPA SF=1x 

Chronic RfD=0.28 mg/kg/day 

cPAD=0.28 mg/kg/day 

Reproductive/developmentalrat(CAS No. 70191-76-3) 

LOAEL= 92 mg/kg/day, based on 

increasted ALT and AST in females, increased prothrombin 

time and soft/decrease feces in 

males and significant decreased feces in males and 

significant decreased in body 

weight gain in both sexes after 

47-54 days of dosing. 

Short-Term 

(1-30 days Incidental Oral/Dermal/ 

Inhalation) 

NOAEL=115 mg/kg/day UFA=10x 

UFH=10x 

FQPA SF=1x 

Residential/Occupational LOC for 

MOE=100 

28-day oral toxicity studyrats(CAS No. 70191-76-3) 

LOAEL= 367 mg/kg/day, based 

on ost-dosing salvation (day 1 

post-dose in 3/5 male and 2/5 

female rats; days 2-28 all rats). 

Intermediate and Long-Term (1-6 

months/≤6months 

Incidental Oral/Dermal/Inhalation 

NOAEL=28 mg/kg/day UFA=10x 

UFH=10x 

FQPA SF=1x 

Residential/Occupational LOC for 

MOE= 100 

Reproductive/developmentalrat(CAS No. 70191-76-3) 

LOAEL= 92 mg/kg/day, based on 

increasted ALT and AST in females, increased prothrombin 

time and soft/decreased feces 

in males and significant decreased feces in males and 

significant decreased in body 

weight gain in both sexes after 

47-54 days of dosing. 

Cancer (oral, dermal, inhalation) Classification: no edivence of carcinogenicity in available studies 

1The LOAEL of 367 mg/kg/day was used from MRID 46989217 and NOAEL of 115 mg/kg/day was used from MRID 46989216 due to artifact 

of dose selection. 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 ADPOS, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from ADPOS in food as 

follows: 

i. Acute and chronic exposure. In 

conducting the acute and chronic 

dietary exposure assessments, 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 ADPOS inert 

ingredients. 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 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 

ADPOS, EPA made a specific 

adjustment to the dietary exposure 

assessment to account for the use 

limitations of the amount of ADPOS that 


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may be in formulations (no more than 

20% by weight) and assumed that the 

ADPOS are present at the maximum 

limitations 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 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. 

ii. 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. There is no evidence of 

carcinogenicity in the chronic/ 

carcinogenicity study in rats at doe up 

to 500 mg/kg/day. In addition, no 

tumors were observed in the two year 

toxicity study in dogs. Based on the 

negative response of the carcinogenicity 

study in rats and two year dog study, 

negative response for mutagenicity, lack 

of any alerts in model predictions, and 

SAR analysis, the Agency concluded 

that the ADPOS inerts are not likely to 

be carcinogenic. Since the Agency has 

not identified any concerns for 

carcinogenicity relating to the ADPOS 

inerts, a cancer dietary exposure 

assessment was not performed. 

iii. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for ADPOS. 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 ADPOS in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of ADPOS. 

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 ADPOS. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of the ADPOS 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 

‘‘Alkyl Diphenyl Oxide Sulfonates (JITF 

CST 18 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 16 and 71-73 in 

docket ID number EPA–HQ–OPP–2008– 

0665. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for ADPOS, 

a conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for both the acute and chronic 

dietary risk assessments. 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). ADPOS 

may be used in inert ingredients in 

pesticide products that are registered for 

specific uses that may result in both 

indoor and outdoor residential 

exposures. A screening level residential 

exposure and risk assessment was 

completed for products containing 

ADPOS as inert ingredients. In this 

assessment, representative scenarios, 

based on end-use product application 

methods and labeled application rates, 

were selected.The ADPOS inerts are not 

added to any insecticidal products 

intended for pet use and are not likely 

to be used in personal care products. 

The Agency conducted an assessment to 

represent worst-case residential 

exposure by assessing ADPOS in 

pesticide formulations (outdoor 

scenarios) and ADPOS in disinfectant 

type uses (indoor scenarios). Based on 

information contained in the petition, 

the ADPOS inerts can be present in 

consumer cleaning products. Therefore, 

the Agency assessed the disinfectanttype products containing ADPOS using 

several anti-microbial scenarios to 

represent worst-case residential handler 

exposure. Standard methodologies 

based on the Agency’s Residential SOPs 

were used to assess residential post 

application exposure to hard surfance 

cleaners. 

Further details of this residential 

exposure and risk analysis can be found 

at http://www.regulations.gov in ‘‘Alkyl 

Diphenyl Oxide Sulfonates (JITF CST 18 

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 20-28 and 94-110 in docket ID 

number EPA–HQ–OPP–2008–0665. 

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 ADPOS to share a 

common mechanism of toxicity with 

any other substances, and ADPOS do 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that ADPOS 


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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 two rat 

reproductive/developmental screening 

studies. There was no increased 

susceptibility to the offspring of rats 

following in utero or postnatal exposure 

in the two reproductive/developmental 

toxicity screening tests, In one study, 

there were no adverse effects to 

offspring, while decreased pup body 

weight and clinical signs were noted in 

the presence of maternal/parental 

toxicity at the limit dose of 1,000 mg/ 

kg/day in a second study. 

There are no neurotoxicity studies 

available for the ADPOS, however, there 

is some evidence of neurotoxicity in a 

subchronic rat study at 367 mg inert/kg/ 

day (1,000 mg product/kg/day), 

including high-stepping gait, ataxia and 

salivation. However, since the effects 

noted occurred at doses significantly 

higher than the current points of 

departure for risk assessment, additional 

neurotoxicity data is 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 ADPOS is 

considered adequate for assessing the 

risks to infants and children (the 

available studies are described in Unit 

iv.D.2. 

ii. There is some evidence of 

neurotoxicity in a 28–day rat study, 

including high-stepping gait, ataxia and 

salivation; however, these effects are 

seen at the HDT. Since these effects 

occurred at dose levels significantly 

higher than the current points of 

departure used for regulation, the 

Agency determined that the points of 

departure selected for this risk 

assessment are protective of any 

neurotoxicity effects. Therefore, 

additional neurotoxicity data and other 

toxicity data are not required. 

iii. No quantitative or qualitative 

increased susceptibility was 

demonstrated in the offspring in the two 

reproductive/developmental toxicity 

studies in rats following in utero and 

postnatal exposure. 

iv. The Agency has concluded that an 

additional UF for extrapolation from 

subchronic toxicity study to a chronic 

exposure scenario would not be needed 

since toxicity is not expected to increase 

with a longer duration of exposure for 

the ADPOS inerts. This is because for 

the most sensitive endpoint, 

prothrombin time (PT), the clotting 

factor proteins evaluated by the PT test 

have short plasma half-lives, ranging 

from 4 hours for factor VII to a 

maximum of 96 hours for fibrinogen. 

The clotting factors are being 

continually synthesized by the liver and 

by 47 days of exposure would have 

reached steady state and further 

exposure is not expected to result in any 

further increase in prothrombin time. 

Therefore, the Agency concluded that 

the 10X interspecies and 10X 

intraspecies UF would be adequately 

protective. 

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 ADPOS 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 ADPOS. 

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. 

In conducting this aggregate risk 

assessment, the Agency has 

incorporated the petitioner’s requested 

use limitations of ADPOS as inert 

ingredients in pesticide product 

formulations into its exposure 

assessment. Specifically, the petition 

includes a use limitation of ADPOS at 

not more than 20% by weight in 

pesticide formulations. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for acute 

exposure, and the use limitations of not 

more than 20% by weight in pesticide 

formulations, the acute dietary exposure 

from food and water to ADPOS at the 

95th percentile for food and drinking 

water is 20% of the aPAD for the U.S. 

population and 55% of the aPAD for 

children 1-2 yrs old, the population 

group receiving the greatest exposure. 

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 20% by weight in pesticide 

formulations, the chronic dietary 

exposure from food and water to 

ADPOS is 28% of the cPAD for the U.S. 

population and 90% 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). 

ADPOS 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 ADPOS. Using the 

exposure assumptions described in this 


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unit, EPA has concluded the combined 

short-term food, water, and residential 

exposures aggregated result in aggregate 

MOEs of 490 and 530, for adult males 

and females respectively, for a 

combined high end dermal and 

inhalation handler exposure with a high 

end post application dermal exposure 

and an aggregate MOE of 380 for 

children for a combined dermal 

exposure with hand-to-mouth exposure. 

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). 

ADPOS 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 ADPOS. 

Using the exposure assumptions 

described in this unit, EPA has 

concluded the combined intermediateterm food, water, and residential 

exposures aggregated result in aggregate 

MOEs of 320 and 400, for adult males 

and females respectively, and 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. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to the ADPOS 

inerts. 

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 

ADPOS. 

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 ADPOS 

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 monoalkyl and 

dialkyl (C6-C16) 

phenoxybenzenedisulfonates and 

related acids, when used as inert 

ingredients at a maximum of 20% by 

weight in pesticide formulations 

applied to crops pre-harvest and postharvest, 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 

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 pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 


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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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