38956 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

[FR Doc. E9–18725 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0042; FRL–8424–4] 

Methyl Poly(Oxyethylene)C8–C18

Alkylammonium Chlorides; 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 methyl 

poly(oxyethylene)C8–C18

alkylammonium chlorides where the 

poly(oxyethylene) content is n=2–15 

and where C8–C18 alkyl is linear and 

may be saturated or unsaturated, herein 

referred to in this document as methyl 

poly(oxyethylene)C8–C18

alkylammonium chlorides (MPOACs), 

when used as an inert ingredient in 

pesticide formulations for pre-harvest 

uses under 40 CFR 180.920 at a 

maximum of 10% by weight in 

herbicide formulations and 5% by 

weight in all other formulations. The 

Joint Inerts Task Force (JITF), Cluster 

Support Team (CST No. 7), 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 MPOACs. 

DATES: This regulation is effective 

August 5, 2009. Objections and requests 

for hearings must be received on or 

before October 5, 2009, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0042. 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. 

To access the OPPTS Hamonized 

Guidlines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gpo/opptsfrs/home/ 

suidelin.htm. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0042 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 October 5, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2009–0042, 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 March 4, 

2009 (74 FR 9397) (FRL–8401–8), 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 9E7518) by The 

JITF, CST No. 7, c/o CropLife America, 

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

Washington, DC 20005. The petition 

requested that 40 CFR 180.920 be 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38957 

amended by establishing exemptions 

from the requirement of a tolerance for 

residues of the inert ingredient methyl 

poly(oxyethylene)C8–C18

alkylammonium chlorides where the 

poly(oxyethylene) content is n=2–15 

and where C8–C18 alkyl is linear and 

may be saturated or unsaturated 

(MPOACs) for pre-harvest uses at a 

maximum of 10% by weight in 

herbicide formulations and 5% by 

weight in all other formulations. That 

notice referenced a summary of the 

petition prepared by The JITF, CST No. 

7, the petitioner, which is available to 

the public in the docket, http:// 

www.regulations.gov. 

The Agency received two comments 

in response to the notice of filing. Both 

comments was received from private 

citizens who opposed the authorization 

to sell any pesticide that leaves a 

residue on food. The Agency 

understands the commenters’ 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 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 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 

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

expiration date for the tolerance 

exemptions subject to revocation was 

August 9, 2008, which was later 

extended August 9, 2009 by a final rule 

published in the Federal Register of 

August 4, 2008. (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 MPOACs when 

used as inert ingredients in pesticide 

formulations for pre-harvest uses at a 

maximum of 10% by weight in 

herbicide formulations and 5% by 

weight in all other formulations. EPA’s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The toxicity data available on the 

MPOACs consists of acute toxicity 

studies, mutagenicity studies, and an 

OPPTS Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test. The majority of 

the MPOAC compounds are reported as 

‘‘not acutely toxic’’ for lethality by the 

oral and dermal routes of exposure 

(Toxicity Category III). However, CAS 

Reg. No. 70750–47–9, the representative 

test compound, is more toxic by the oral 

and dermal routes (Toxicity Category II). 

All MPOACs are severely irritating to 

the eye (Toxicity Category I), and the 

MPOAC identified by CAS Reg. 

No.70750–47–9 (quatenary ammonium 

compounds, coco 

alkylbis(hydroxyethyl)methy1, 

chlorides) is severely irritating to the 

skin. Inhalation data on two of the 

MPOACs indicate irritation at high 

doses. 

The OPPTS Harmonized Guideline 

870.3650 study on the representative 

surfactant, (CAS Reg. No. 70750–47–9) 

demonstrated severe toxicity in rats, as 

evidenced by deaths of all test subjects 

at 100 milligrams/kilogram/day (mg/kg/ 

day) after 5 days, and deaths of 5 out of 

10 females at 50 mg/kg/day after 6–8 

days of exposure. Given the extremely 

corrosive nature of the test material, the 

Agency believes that the high mortality 

rate is secondary to the forestomach 

lesions seen in the rats. Further, the 

Agency notes that the severity of the 

effects may be related to the unique 

anatomy of the rats. Humans do not 

have a forestomach which serves as a 

storage reservoir in rodents; therefore, 

effects seen in the rat forestomach are 

likely to be significantly more severe 

than what would be expected from the 

compound in the glandular stomachs in 

humans and therefore, have less 

relevance to humans. 

The no observed adverse effect level 

(NOAEL) for developmental and 

reproductive toxicity is 25 mg/kg/day, 

the lowest dose tested (LDT). Although 

no reproductive or developmental 

effects were observed at the next higher 

dose of 50 mg/kg/day, the evaluation at 


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this dose level included only 5 

surviving female animals. While the 

actual lowest observed adverse effect 

level (LOAEL) for reproductive 

developmental effects may be higher, or 

reproductive developmental effects may 

not occur at all as a result of exposure 

to this chemical, in the absence of a 

sufficient number of animals to assess, 

the Agency has conservatively assumed 

that if more animals had been available 

at the mid-dose, developmental or 

reproductive toxicity might have been 

observed. There are no concerns for 

sensitivity of offspring. 

There was no evidence of 

neurotoxicity in this study; functionalobservational battery and motor-activity 

data were similar in all the treatment 

groups. Liver enzymes were elevated 

but were not accompanied by 

microscopic lesions or increased organ 

weight and were not considered 

adverse. No carcinogenicity studies are 

available for the MPOACs. A qualitative 

structure activity relationship database, 

DEREK Version 11, identified no 

structural alerts suggestive of 

carcinogenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by MPOACs as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

MPOACs–JITF CST No. 7 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 9–13 and pages 25–26 in docket 

ID number EPA–HQ–OPP–2009–0042. 

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 tested (HDT) at which 

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 

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 MPOACs used for human 

health risk assessment is shown in 

Table 1 of this unit. 

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

Acute toxicity was not identified. 

Chronic dietary 

(all populations) 

NOAEL = 25 mg/kg/day 

UFA = 10x 

UFH = 10x 

Food quality protection act 

(FQPA) SF = 1x 

Chronic RfD = 0.25 mg/kg/day 

cPAD = 0.25 mg/kg/day 

LOAEL = 50 mg/kg/day based on stomach inflammation and mortality associated with the forestomach 

inflammation 

Incidental oral 

(short-term and 

intermediateterm) 

NOAEL= 25 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for MOE = 100 LOAEL = 50 mg/kg/day based on stomach inflammation and mortality associated with the forestomach 

inflammation. 

Dermal and inhalation (all durations) Quantitative assessment not required: Cluster is corrosive irritating and exposure will be self limiting; expected low-dermal 

and inhalation absorptions; product is used in low percentages in household products (i.e., low exposure). 

Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment. Based on SAR analysis, MPOACs is not expected to 

be carcinogenic. 

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 

Sufficient data were provided on the 

chemical identity of the MPOACs; 

however, limited data are available on 

the metabolism and environmental 

degradation of these compounds. The 

Agency relied collectively on 

information provided on the 

representative chemical structures, the 

generic cluster structures, the submitted 

physicochemical data, structure-activity 

relationship information, as well as 


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information on other surfactants and 

chemicals of similar size and 

functionality to determine the residues 

of concern for these inert ingredients. 

The residues of concern for risk 

assessment purposes are the parent 

compounds only. 

The registrant selected CAS Reg. No. 

70750–47–9, as the test compound 

because the coco alkyl encompasses the 

broad range of C8–C18 alkyl chain 

included in the descriptor. The Agency 

concluded that the cluster grouping was 

appropriate. Further, the Agency also 

concluded that it is unlikely that any 

potential environmental degradates that 

would be found in food and water will 

be more toxic than the parent 

compound. Residue estimates used in 

the dietary risk assessment were chosen 

to represent an upper bound on the 

combined residues of parent and any 

potential metabolite or degradate of 

concern. 

Quantitative dermal or inhalation risk 

assessments were not be performed for 

residential exposures because the 

MPOACs are highly corrosive irritating, 

and therefore, exposure will be selflimiting and will be regulated based on 

labeling of the formulations. There is 

not a significant concern for dermal or 

inhalation exposures due to expected 

low dermal and inhalation absorptions 

and the fact that the product is used in 

low percentages in household products 

(i.e., low exposure). An aggregate 

assessment need only be conducted for 

food, water, and incidental oral 

exposures. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to MPOACs, EPA considered 

exposure under the petitioned-for 

exemptions from the requirement of a 

tolerance. EPA assessed dietary 

exposures from MPOACs in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

MPOACs was seen in the toxicity 

databases. Therefore, acute dietary risk 

assessments for MPOACs is not 

necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, no residue data 

were submitted for MPOACs. In the 

absence of specific residue data, EPA 

has developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts. 

(D361707, S. Piper, 2/25/09) and can be 

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

docket ID number EPA–HQ–OPP–2008– 

0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest 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% 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 

MPOACs, EPA made a specific 

adjustment to the dietary exposure 

assessment to account for the use 

limitations of the amount of MPOACs 

that may be in formulations (no more 

than 10% by weight in herbicide 

formulations) and assumed that the 

MPOACs 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% 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 SAR database, DEREK11, to 

determine if there were structural alerts 

suggestive of carcinogenicity. No 

structural alerts for carcinogenicity were 

identified. MPOACs are not expected to 

be carcinogenic. Therefore, a cancer 

dietary exposure assessment is not 

necessary to assess cancer risk. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and PCT 

information in the dietary assessment 

for MPOACs. Tolerance level residues 

and 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 MPOACs in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate 

transport characteristics of MPOACs. 

Further information regarding EPA 

drinking water models used in the 

pesticide exposure assessment can be 


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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 MPOACs. Modeling runs on four 

surrogate inert ingredients using a range 

of physical chemical properties that 

would bracket those of MPOACs 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 the document 

MPOACs– JITF, (CST No. 7 Inert 

Ingredients). Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations, 

pages 13–14 and 28–46 in docket ID 

number EPA–HQ–OPP–2009–0042. 

For the purpose of the screening level 

dietary risk assessment to support this 

request for an exemption from the 

requirement of a tolerance for MPOACs, 

a conservative drinking water 

concentration value of 100 ppb based on 

screening level modeling was used to 

assess the contribution to drinking 

water for chronic dietary risk 

assessments for the parent compounds 

and for the metabolites of concern. 

These values were directly entered into 

the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). MPOACs 

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 

MPOACs as inert ingredients. In this 

assessment, representative scenarios, 

based on end-use product application 

methods and labeled application rates, 

were selected. The MPOACs may be 

used as inert ingredients in pesticide 

formulations that are used in and 

around the home. Additionally, uses are 

possible in household cleaning products 

and in personal care products. The 

Agency has not selected endpoints for 

dermal or inhalation risk assessmenst; 

therefore, only exposure scenarios 

which will result in oral exposures have 

been assessed for the MPOACs. The 

Agency conducted an assessment to 

represent worst-case residential 

exposure by assessing postapplication 

exposures and risks from MPOACs in 

pesticide formulations (outdoor 

scenarios) and MPOACs in disinfectanttype uses (indoor scenarios). Further 

details of this residential exposure and 

risk analysis can be found at http:// 

www.regulations.gov in the 

memorandum 9entitled 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 MPOACs to share 

a common mechanism of toxicity with 

any other substances, and the MPOACs 

do not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that the MPOACs 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 SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional SF 

when reliable data available to EPA 

support the choice of a different factor. 

2. Prenatal and postnatal sensitivity. 

The toxicity data available on the 

MPOACs consists of acute toxicity 

studies, mutagenicity studies, and an 

OPPTS Harmonized Guideline 870.3650 

combined repeated dose toxicity study 

with the reproduction developmental 

toxicity screening test. 

There was no evidence of increased 

sensitivity in young animals because no 

developmental or reproductive toxicity 

occurred in the lowest dose group 

(doses of 25 mg/kg/day) in the 

reproductive developmental toxicity 

screening test. Additionally, no 

developmental or reproductive toxicity 

was noted in the mid-dose group (doses 

of 50 mg/kg/day); however, since there 

were only five surviving female animals 

in this group, which is considered an 

insufficient number of animals, the 

study LOAEL was set at the mid-dose 

level. The mortality in rats that occurred 

in the study was associated with 

forestomach inflammation. Given the 

extremely corrosive nature of the test 

material, the Agency believes that the 

high mortality rate is secondary to the 

forestomach lesions seen in the rats. 

Further, the Agency notes that the 

severity of the effects may be related to 

the unique anatomy of the rats. Humans 

do not have a forestomach which serves 

as a storage reservoir in rodents; 

therefore effects seen in the rat 

forestomach are likely to be significantly 

more severe than what would be 

expected from the compound in the 

glandular stomachs in humans, and 

therefore, have less relevance to 

humans. 

There was no evidence of 

neurotoxicity in the OPPTS Harmonized 

Guideline 870.3650 study; functionalobservational battery and motor-activity 

data were similar in all the treatment 

groups. 

There are no residual uncertainties 

identified in the exposure databases. 

The dietary (food and water) exposure 

assessment is not likely to 

underestimate exposure to any 

subpopulation, including those 

comprised of infants and children. 

3. Conclusion. EPA has determined 

that reliable data show that the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for MPOACs 

is considered adequate for assessing the 

risks to infants and children (the 

available studies are described in Unit 

IV.D.2). 

ii. No quantitative or qualitative 

increased susceptibility was 

demonstrated in the offspring in the 

OPPTS Harmonized Guideline 870.3650 


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Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 38961 

combined repeated dose toxicity study 

with the reproduction developmental 

toxicity screening test in rats following 

in utero and post-natal exposure. 

iii. Although mortality occurred in the 

OPPTS Harmonized Guideline 870.3650 

study that was associated with 

forestomach inflammation, the Agency 

believes that, given the extremely 

corrosive nature of the test material, the 

high mortality rate is secondary to the 

forestomach lesions seen in the rats. 

Further, the Agency notes that the 

severity of the effects may be related to 

the unique anatomy of the rats. Humans 

do not have a forestomach which serves 

as a storage reservoir in rodents; 

therefore effects seen in the rat 

forestomach are likely to be significantly 

more severe than what would be 

expected from the compound in the 

glandular stomachs in humans and 

therefore, have less relevance to 

humans. 

iv. There was no evidence of 

neurotoxicity in the OPPTS Harmonized 

Guideline 870.3650 study. Functionalobservational battery and motor-activity 

data were similar in all the treatment 

groups. Thus, no additional 

neurotoxicity data are required. 

v. While there is no chronic toxicity 

study, the Agency has concluded that 

since endpoint risk assessment is based 

on the forestomach lesions in rats, a 

very conservative hazard endpoint, 

coupled with the highly conservative 

exposure assessment and an absence of 

evidence of increased sensitivity, or 

neurotoxicity, the use of the standard 

100X inter-species and intra-species UF 

are adequate to protect infants and 

children, and no additional UF is 

needed for extrapolating from 

subchronic to chronic exposure. 

vi. 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 MPOACs 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 MPOACs. 

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. 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. 

1. Acute risk. There was no hazard 

attributable to a single exposure seen in 

the toxicity database for MPOACs. 

Therefore, the MPOACs 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 MPOACs is 16% 

of the cPAD for the U.S. population and 

51% 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). 

MPOACs are used as an 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 MPOACs. Using the 

exposure assumptions described in this 

unit, EPA has concluded the combined 

short-term aggregated food, water, and 

residential exposures result in an 

aggregate MOE of 190 for children. 

Children’s residential exposure includes 

hand-to-mouth exposures. As the LOC is 

for MOEs that are lower than 100, this 

MOE is 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). 

MPOACs are currently registered for 

uses that could result in intermediateterm residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to MPOACs. Using the exposure 

assumptions described in this unit, EPA 

has concluded the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 190 for children. 

Children’s residential exposure includes 

hand-to-mouth exposures. As the LOC is 

for MOEs that are lower than 100, this 

MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to MPOACs. 

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 

MPOACs. 

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 

MPOACs 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 methyl 

poly(oxyethylene)C8–C18

alkylammonium chlorides where the 

poly(oxyethylene) content is n=2–15 

and where C8–C18 alkyl is linear and 

may be saturated or unsaturated 

(MPOACs) for pre-harvest uses at a 

maximum of 10% by weight in 

herbicide formulations and 5% by 

weight in all other formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 


srobinson on DSKHWCL6B1PROD with RULES
38962 Federal Register / Vol. 74, No. 149 / Wednesday, August 5, 2009 / Rules and Regulations 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

VIII. Congressional Review Act 

The Congressional Review Act, 5 

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

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

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

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 21, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In §180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

*******

Methyl poly(oxyethylene)C8–C18 alkylammonium 

chlorides where the poly(oxyethylene) content is 

n=2–15 and where C8–C18 alkyl is linear and may be 

saturated or unsaturated (CAS Reg. Nos. 3010–24– 

0, 18448–65–2, 70750–47–9, 22340–01–8, 67784– 

77–4, 64755–05–1, 61791–10–4, 28724–32–5, 

28880–55–9, 68187–69–9, 68607–27–2, 60687–90– 

3. 

Concentration in formulated end use products not to 

exceed 10% by weight in herbicide products and 5% 

by weight in all other pesticide products. 

Surfactants, related adjuvants of surfactants 

*******

[FR Doc. E9–18348 Filed 8–4–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0099; FRL–8428–6] 

Sodium Alkyl Naphthalenesulfonate; 

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 alkyl 

naphthalenesulfonate, herein referred to 

in this document as SANS, when used 

as an inert ingredient at a maximum of 

30% by weight in pesticide 

formulations for pre-harvest and postharvest uses, as well as, for application 

to animals. The Joint Inerts Task Force 

(JITF), Cluster Support Team Number 

10, 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 SANS. 

DATES: This regulation is effective 

August 5, 2009. Objections and requests 

for hearings must be received on or 

before October 5, 2009, and must be 

filed in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0099. All documents in the 

docket are listed in the docket index 


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