Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Rules and Regulations 40729 

(1) Rule 1144, ‘‘Vanishing Oils and 

Rust Inhibitors,’’ adopted on March 6, 

2009. 

(2) Rule 1145, ‘‘Plastic, Rubber, 

Leather, and Glass Coatings,’’ amended 

on December 4, 2009. 

* * * * * 

[FR Doc. 2010–17077 Filed 7–13–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0533; FRL–8833–2] 

Residues of Quaternary Ammonium 

Compounds, N-Alkyl (C12-14) Dimethyl 

Ethylbenzyl Ammonium Chloride; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

existing exemption from the 

requirement of a tolerance for residues 

of n-alkyl (C12-14) dimethyl ethylbenzyl 

ammonium chloride on food contact 

surfaces when applied/used in public 

eating places, dairy processing 

equipment, and/or food processing 

equipment and utensils. The regulation 

will exempt from the requirement of 

tolerance residues in food resulting from 

contact with surfaces treated with 

antimicrobial solutions where the enduse concentration of active quaternary 

compound does not exceed 400 parts 

per million (ppm). 

DATES: This regulation is effective July 

14, 2010. Objections and requests for 

hearings must be received on or before 

September 13, 2010, 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–2008–0533. 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: 

Velma Noble, Antimicrobials Division 

(7510P), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–6233; e-mail address: 

noble.velma@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 dairy cattle milk 

producer, food manufacturer, or 

beverage manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Dairy cattle milk production 

(NAICS code 11212). 

• Food manufacturing (NAICS code 

311). 

• Beverage manufacturing (NAICS 

code 3121). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 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–2008–0533 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 13, 2010. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2008–0533, 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. Summary of Petitioned-For 

Exemption 

In the Federal Register of November 

28, 2007 (72 FR 67299) (FRL–8141–1), 

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 tolerance petition (PP 8F7323) 

by Stepan Company, 22 West Frontage 

Rd., Northfield, IL 60093. The petition 

requested that 40 CFR 180.940(a) be 

amended by increasing concentration 

limits for n-alkyl (C12-14) dimethyl 

ethylbenzyl ammonium chloride in enduse solutions eligible for tolerance 

exemption. That notice referenced a 

summary of the petition prepared by 

Stepan Company, the registrant, which 

is available in the docket, http:// 

www.regulations.gov. 


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III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which 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.’’ 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

section 408(c)(2)(B) 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 residues of nalkyl (C12-14) dimethyl ethylbenzyl 

ammonium chloride on food contact 

surfaces when applied/used in public 

eating places, dairy processing 

equipment, and/or food processing 

equipment and utensils. EPA’s 

assessment of exposures and risks 

associated with amending the 

exemption from the requirement for a 

tolerance 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by n-alkyl (C12-14) dimethyl ethylbenzyl 

ammonium chloride as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

The alkyl dimethyl benzyl ammonium 

chlorides (ADBAC) chemical case is 

comprised of 24 compounds that are 

structurally similar and are a subgroup 

of the class of chemicals known as 

quaternary ammonium compounds. 

Quaternary ammonium compounds are 

a class of salts derived from ammonium 

in which nitrogen atom is attached to 

four organic groups. ADBAC is 

characterized by having a positively 

charged nitrogen atom covalently 

bonded to three alkyl group substituents 

(two methyls and R component) and a 

benzyl substituent. The R component 

represents the different number of 

hydrocarbon carbon moieties delineated 

by different percentages (e.g., Alkyl 

(50% C14, 40% C12, 10% C16) dimethyl 

benzyl ammonium chloride). In finished 

form, these quaternary ammonium 

compounds are salts with the positively 

charged nitrogen (cation) balanced by a 

negatively charged anion. The most 

common anion for the quaternary 

ammonium compounds in this cluster is 

chloride. However, other anions, such 

as saccharide and bromide are also 

used. The Agency clustered these 

chemicals together because variance in 

the length and conformation of alkyl 

carbon chains between 12 and 18 does 

not appear to significantly affect the 

toxicity or fate of the ADBAC 

compound. In all ADBACs, it is the 

positive entity (quaternized nitrogen) 

that is of relevance from toxicology and 

exposure perspectives. The negative 

part of ADBAC (counter ion) is a 

relatively non-toxic entity (chloride). 

Alkyl (50% C14, 40% C12, 10% C16) 

dimethyl benzyl ammonium chloride 

(PC code 069105) was chosen by the 

Agency as the representative chemical 

for the ADBAC subgroup of quaternary 

ammonium compounds, and the 

toxicology database for alkyl (50% C14, 

40% C12, 10% C16) dimethyl benzyl 

ammonium chloride is considered 

representative of the hazard for the 

ADBAC subgroup. The individual 

exposure scenarios in the ADBAC 

assessments (as well as the aggregate 

assessment in the RED) were developed 

by assuming that an ADBAC compound 

was used on 100% of the surfaces 

authorized on the label that could result 

in human exposure and summing the 

percent active ingredients on the labels 

for all of the ADBAC compounds when 

used in combination. 

Quaternary ammonium compounds 

are corrosive on contact with the skin 

and eyes. They typically cause highlyirritating localized effects which occur 

at the portals of entry. On the other 

hand, ADBACs are only moderately 

toxic systemically by oral, dermal, and 

inhalation routes of exposure. Systemic 

toxicity occurs after absorption and 

distribution of the chemical to tissues in 

the body. Such toxicity is dependent on 

physiological factors within the tissue/ 

organ, and also how the body eliminates 

the chemical (Kinetics). These 

chemicals are classified as ‘‘not likely’’ 

to be human carcinogens based on 

negative carcinogenicity studies in both 

rats and mice. There is no evidence of 

these chemicals being associated with 

increased susceptibility to 

developmental toxicity or reproductive 

toxicity based on two developmental 

toxicity studies and a 2–generation 

reproductive study. Lastly, they are 

negative for mutagenicity and 

neurotoxicity. Specific information on 

the studies received and the nature of 

the toxic effects caused by ADBAC, can 

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

Docket ID Number EPA–HQ–OPP– 

2005–0339, Alkyl dimethyl benzyl 

ammonium chloride (ADBAC)- Report 

of Antimicrobials Division Toxicity 

Endpoint Committee (ADTC) and the 

Hazard Identification Assessment 

Review Committee (HIARC). 

B. Toxicological Points of Departure/ 

Levels of Concern 

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. The Level of Concern (LOC) 

is a reference value expressed as either 

a reference dose/population adjusted 

dose (RfD/PAD) or margin of exposure 

(MOE). 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 


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dividing the POD by all applicable 

uncertainty/safety factors. Aggregate 

short-, intermediate-, and chronic-term 

risks are evaluated by comparing 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. For non-threshold risks, 

the Agency assumes that any amount of 

exposure will lead to some degree of 

risk and estimates risk in terms of the 

probability of a cancer occurrence 

greater than that expected in a lifetime. 

Generally, cancer risks are considered 

non-threshold. 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 ADBAC used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADBAC 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 

(general 

population, 

females 13+, 

infants and 

children) 

An acute dietary endpoint was not identified 

in the database. 

Chronic dietary 

(all populations) 

NOAEL = 44 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.44 mg/kg/day 

cPAD = 0.44 mg/kg/day 

Chronic toxicity/carcinogencity-rat 

MRID 41947501 

LOAEL = 88 mg/kg/day based on decreased body weight and weight 

gain 

Incidental oral 

short-term (1 

to 30 days) 

NOAEL = 10 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental Toxicity-Rat MRID 

42351501 

LOAEL = 30 mg/kg/day based on 

clinical signs and decrease body 

weight gain 

Incidental oral 

intermediateterm (1 to 6 

months) 

NOAEL = 10 mg/kg/day 

UFA = 10x 

UFH = 10 x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental Toxicity-Rat MRID 

42351501 

LOAEL = 30 mg/kg/day based on 

clinical signs and decrease body 

weight gain 

Dermal shortterm (1 to 

30 days) 

(Formulated 

product (4% 

ai.)) 

Dermal study NOAEL = 20 mg/kg/day (333 

ug/cm2)b

UFA = 3x 

UFH = 3x 

FQPA SF = 1x 

LOC for MOE = 10d 21-day dermal toxicity-guinea pigs 

MRID 41105801 

LOAEL = 40 mg/kg/day based on 

denuded non-vascularized epidermal layer 

Dermal intermediateterm (technical grade 

a.i.) (1 to 6 

months) 

Dermal study NOAEL= 20 mg/kg/day (80 ug/ 

cm2)c

UFA = 3x 

UFH = 3x 

FQPA SF = 1x 

LOC for MOE = 10d 90-day dermal in rats MRID 

41499601 

LOAEL = 20 mg/kg/day based on 

highest doest tested before irritation became significant. Irritation 

not observed until day 43 

Dermal Shortterm (technical grade 

a.i) 

No endpoint identified from the available 

data on dermal irritation. Dermal irritation 

in the 90-day dermal toxicity study was not 

evident until day 43 (MRID 41499601)d

Long-term 

Dermal 

(technical 

grade a.i.) 

No appropriate endpoint identified. No systemic effects observed up to 20 mg/kg/ 

day, highest dose of technical that could 

be tested without irritation effects.d

Inhalation (all 

exposures) 

Oral study NOAEL = 3 mg/kg/day 100% 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x 

(UFdb)a

LOC for MOE = 1000 Developmental Toxicity-rabbit MRID 

42392801 

LOAEL = 9 mg/kg/day based on clinical signs of toxicity in maternal 

animals 

UFA = extrapolation from animal to human (interspecies). 

UFH = potential variation in sensitivity among members of the human population (intraspecies). 

FQPA SF = FQPA Safety Factor. 

PAD = population adjusted dose (a = acute, c = chronic). 

RfD = reference dose. 

MOE = margin of exposure. 


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a An additional uncertainity factor of 10x is applied for use of an oral endpoint for route-to-route extrapolation in the absence of an inhalation 

toxicity study. b Formulated-based dermal endpoint = (20 mg/kg guinea pig x 0.43 kg guinea pig x 1,000 ug/mg)/25.8cm2 area of guinea pig dosed = 33 ug/ 

cm2. 

c TGAI-based dermal endpoint = (20 mg/kg rat x 0.2 kg rat x 1000 ug/mg)/ 50 cm2 area of rate dosed = 80 ug/cm2. d For dermal exposures, irritation as the effect was selected for the short-term endpoint and a reduced margin of exposure (MOE) was used to 

characterize the risk. The use of irritation as a toxic endpoint for assessment of dermal risk is appropriate in this case, as dermal exposure that 

results in primarily an irritation response is considered a self-limiting type of exposure that is not expected to last for any length of time, and variability in the response is not expected to be as great as systemic toxic responses. For ADBAC, the MOE for short-term dermal risk is reduced to 

a total factor of 10x (3x for interspecies extrapolation, 3x for intraspecies variation.) 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to n-alkyl (C12-14) dimethyl 

ethylbenzyl ammonium chloride, EPA 

considered exposure under the 

petitioned-for exemption as well as all 

existing ADBAC exemptions or 

tolerances in 40 CFR 180.940(a), and (c). 

EPA assessed dietary exposures from 

ADBAC in food as follows: 

ADBACs are to be used as a sanitizer 

on counter tops, utensils, appliances, 

tables, refrigerators, food packaging, and 

beverage bottling. The use of these 

actives in antimicrobial products for use 

on food or feed contact surfaces, 

agricultural commodities, and 

application to food-grade eggs may 

result in pesticide residues in human 

food. Residues from treated surfaces, 

such as utensils, countertops, 

equipment, and appliances can migrate 

to food coming into contact with the 

treated and rinsed surfaces and can be 

ingested by humans. 

The Agency assessed chronic dietary 

exposures from the use of ADBAC as a 

disinfectant and food contact sanitizer 

on utensils, countertops, and in food/ 

beverage processing facilities. The 

assessment calculated the Daily Dietary 

Dose (DDD) and the Estimated Daily 

Intake (EDI) using modified Food and 

Drug Administration (FDA) 

methodologies for utensils and Indirect 

Dietary Residential Exposure Model 

software (IDREAM) for countertops. 

IDREAM incorporates consumption data 

from U.S. Department of Agriculture 

(USDA) Continuing Surface of Food 

Intakes by Individuals (CSFII) for 1994– 

1996, and 1998. The 1994–1996, and 

1998 data are based on the reported 

consumption of more than 20,000 

individuals over 2 non-consecutive 

survey days. 

The Estimated Daily Intake (EDI) 

calculations presented in this 

assessment for treated indirect dietary 

exposures resulting from sanitizing 

utensils assumed that food would 

contact 4,000 cm2 (which represents 

contact with treated silverware, china, 

and glass used by an individual who 

regularly eats three meals per day at an 

institutional or public facility) and that 

the residual solution remaining on the 

surface or pesticide migration fraction is 

1 mg per square centimeter of treated 

area. The body weights used for this 

assessment were 70 kilogram (kg) for an 

adult male, 60 kg for an adult woman, 

and 10 kg for an infant. Based on data 

provided in a new residue study, 

Transferability Equivalence among 

Quats and Measured Food Surrogate 

Transfer Efficiency (MRID 46870703), a 

conservative transfer rate of 43% was 

used to estimate the amount of residues 

on the surface that will be transferred to 

food and subsequently ingested. The 

maximum application rate for ADBAC 

on utensils is 0.0033 lbs a.i per gallon 

of treatment solution. 

There are two levels of refinement for 

assessing dietary exposure to 

antimicrobial products used on 

countertops. The Tier 2 approach, a 

refined exposure estimate in 

comparison to the Tier 1, was utilized 

for this assessment. This conservative 

approach uses food consumption and 

preparation patterns as well as data and 

assumptions that are not chemicalspecific. Food ingredients are separated 

into nine categories based on food 

preparation, food physical properties, 

and potential, or likelihood of contact 

with treated countertops. The nine food 

categories are liquids, fruit, bread, 

cheese, vegetable, meat, purees (e.g., 

pudding, oatmeal), pieces (foods 

normally consumed in small pieces), 

and powders (foods normally used in 

powder/granular forms). Assumed 

countertop residues are converted to 

estimated residues contacting the 

countertops using a translation factor for 

each food category, and default residue 

transfer efficiency for a representative 

food. Therefore, IDREAM combines the 

estimated countertop residues for 

surface treatment products, CSFII 

consumption data, food-specific 

conversion factors that relate the surface 

area contacting a countertop with 

corresponding weight of the food item, 

and the transfer efficiency of residues 

from countertops to food. Conservative 

assumptions for these analyses include: 

All disinfectants registered to disinfect 

kitchen countertops are included; all 

foods are prepared on treated 

countertops; all prepared foods will 

come in contact with treated 

countertops at the maximum active 

ingredient (a.i.) residues; these residues 

will not diminish over time (i.e., residue 

reduction will not occur from cooking 

or preparation processes); there is a 

100% likelihood of contact to account 

for both commercial and residential 

scenarios; all commercial facilities and 

households use the same disinfectant 

product; all foods are prepared and 

consumed. 

When assessing the food bottling/ 

packaging use, EPA assumed a 100% 

transfer rate because the food is 

potentially in contact with the treated 

surfaces for very long periods of time. 

The maximum application rate for 

ADBAC for bottling/packing of food is 

0.0103 lbs a.i per gallon of treatment 

solution. EDI values were calculated 

using an approach similar to that used 

for treated food utensils. Exposure was 

assumed to occur through the ingestion 

of three food products that might be 

packaged in treated material: milk, egg 

products, and beverages (alcoholic and 

non-alcoholic). A calorie intake 

modification factor of 0.64 was applied 

to the EDI for a child to account for the 

differences between intake values 

among children and adults. 

2. Dietary exposure from drinking 

water. ADBAC is applied to nursery 

ornamentals and turf as an bactericide 

and fungicide. The Tier 1 surface water 

and groundwater model was used to 

assess Estimated Drinking Water 

Concentrations (EDWCs). EPA modeled 

the ornamental plant use because this 

use has the highest application rate of 

all labeled uses — 302 lbs. a.i/Acre, and 

a maximum of 3 applications per year. 

The EDWCs determined for the nursery 

ornamental use are also protective of all 

other uses with lower application rates. 

The EDWC for surface water is 331 ug/ 

L and groundwater is 5.4 ug/L. There 

were no major degradates of ADBAC in 

the laboratory studies. 

ADBAC is also used for mosquito 

control and as an algaecide in 

decorative ponds and pools. Because the 

mosquito control and algaecide uses are 

both periodic in nature and are 

restricted to a limited use area, EPA 

expects drinking water exposures from 

these uses to be minimal in comparison 

to the ornamental plant exposure 

estimate for drinking water using the 

Tier 1 surface and ground water model. 


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Additionally, antisapstain and cooling 

water tower uses for ADBAC are 

potential exposures to drinking water. 

These uses are also expected to result in 

minimal exposure in comparison to the 

modeled EDWCs for the ornamental use 

taking into account that the Tier 1 

model assumed that ADBAC was 

applied at 302 lbs./Acre across the 

entire watershed. 

Specific information on the dietary 

and drinking water exposure 

assessments for ADBAC can be found at 

http://www.regulations.gov. Docket ID 

Number EPA–HQ–OPP–2006–0339, 

Dietary Risk Assessment on ADBAC and 

Tier 1 Drinking Water Assessment for 

Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) & Didecyl Dimethyl 

Ammonium Chloride (DDAC). 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

ADBAC is currently registered for the 

following residential non-dietary sites: 

Homes, swimming pools, humidifiers. 

EPA assessed residential exposure using 

the following assumptions: Residential 

exposure may occur during the 

application as well as post application 

of ADBAC to indoor hard surfaces (e.g., 

mopping, wiping, trigger pump sprays), 

carpets, swimming pools, wood as a 

preservative, textiles (e.g., diaper treated 

during washing and clothes treated with 

fabric spray), and humidifiers. The 

residential handler scenarios were 

assessed to determine dermal and 

inhalation exposures. Residential post 

application scenarios such as children 

exposure to treated toys and floors were 

also assessed to determine dermal and 

incidental oral exposures. Surrogate 

dermal and inhalation unit exposure 

values were estimated using Pesticide 

Handler Exposure Database (PHED) data 

and the Chemical Manufactures 

Association Antimicrobial Exposure 

Assessment Study (USEPA, 1999), and 

the SWIMODEL 3.0 was utilized to 

conduct exposure assessments of 

pesticides found in swimming pools 

and spas (Versar, 2003). Note that for 

this assessment, EPA assumed that 

residential users complete all elements 

of an application (mix/load/apply) 

without the use of personal protective 

equipment. 

The duration for most residential 

exposures is believed to be best 

represented by the short-term duration 

(1 to 30 days). The short-term duration 

was chosen for this assessment because 

the residential handler and postapplication scenarios are assumed to be 

performed on an episodic, not daily 

basis. 

Specific information on the 

residential exposure assessment for 

ADBAC Quaternaries can be found at 

http://www.regulations.gov. Docket ID 

Number EPA–HQ–OPP–2006–0339 

Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC) Occupational and 

Residential Exposure Assessment. 

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’s risk assessment for any 

individual ADBAC is based on an 

assessment of the cumulative exposure 

to all ADBACs. The individual exposure 

scenarios in the ADBAC assessments (as 

well as the aggregate assessment in the 

RED) were developed by assuming that 

an ADBAC compound was used on 

100% of the surfaces authorized on the 

label that could result in human 

exposure and summing the percent 

active ingredients on the labels for all of 

the ADBACs when used in combination. 

Thus, because the risk assessment for 

ADBAC accounts for exposures to all of 

the ADBACs, there is no need for a 

separate cumulative risk assessment for 

those compounds. The Agency has not 

identified any other substances as 

sharing a common mode of toxicity with 

ADBAC. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemical, see 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional (10X) tenfold 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 when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional FQPA 

SF value based on the use of traditional 

UFs and/or FQPA SFs, as appropriate. 

2. Prenatal and postnatal sensitivity. 

There is no evidence that ADBAC result 

in increased susceptibility in in utero 

rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2–generation reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA SF to 1X. That decision is 

based on the following findings: 

i. The toxicity database for ADBAC is 

complete. 

ii. There is no indication that ADBAC 

is a neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that ADBAC 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 2–generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

Conservative ground and surface water 

modeling estimates were used. Similarly 

conservative residential standard 

operating procedures (SOPs) were used 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by ADBAC. 

E. Aggregate Risks and Determination of 

Safety 

The chronic dietary aggregate risk 

assessment includes direct and indirect 

food contact uses as well as drinking 

water exposures. Based on the results of 

the chronic aggregate assessment, the 

estimated chronic risks for adults and 

children are 8.4% and 40.9% of the 

cPAD. Therefore, the chronic dietary 

aggregate risks are not of concern (i.e., 

less than 100% of cPAD). 

Short-term and intermediate-term 

aggregate risks were calculated using the 

total MOE approach. Only the shortterm aggregate is presented here because 

the endpoints for incidental oral as well 

as inhalation are identical for the shortand intermediate-term durations. The 

aggregate risks are not of concern for 

adults for any of the three routes of 

exposure. The aggregate adult MOEs are 

1,200 for oral, 480 for dermal, and 2,000 

for inhalation, which are greater than 

the target MOE of 100 for the oral, 1,000 

for inhalation, and 10 for dermal. For 

children, the aggregate risk estimate for 

each of the routes of exposure are also 

above the target MOEs of 100 for the 

oral, 1,000 for inhalation, and 10 for 

dermal (MOE=140 for the oral route, 


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1,200 for the dermal route, and are thus 

not of concern). There were no 

inhalation risks identified. 

Based on the toxicological and 

exposure data discussed in this 

preamble, EPA concludes that will not 

pose a risk under reasonably foreseeable 

circumstances. Accordingly, EPA finds 

that there is a reasonable certainty of no 

harm will result to the general 

population, or to infants and children 

from aggregate exposure to ADBAC 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method for food is not 

needed. Food contact sanitizers are 

typically regulated by the State health 

departments to ensure that the food 

industry is using products in 

compliance with the regulations in 40 

CFR 180.940. The end-use solution that 

is applied to the food contact surface is 

analyzed not food items that may come 

into contact with treated surface. An 

analytical method is available to analyze 

the use dilution that is applied to food 

contact surfaces. A titration method is 

used to determine the total amount of 

quaternary compound. If the use 

solution is a mixture of ADBAC and 

didecyl dimethyl ammonium chloride 

(DDAC), then High Pressure Liquid 

Chromatogram–Ultraviolet Visible 

(HPLC-UV) is used to determine the 

amount of ADBAC. The amount of 

DDAC is determined by calculating the 

difference between the total amount of 

quaternary compounds and ADBAC. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for n-alkyl (C12-14) dimethyl ethylbenzyl 

ammonium chloride. 

C. Response to Comments 

EPA received no comments in 

response to the notice of filing for the 

petition to amend the tolerance 

exemption for the ADBAC compound 

addressed in this rulemaking, n-alkyl 

(C12-14) dimethyl ethylbenzyl 

ammonium chloride. However, in 

October, 2008, EPA received comments 

on a final rule amending the tolerance 

exemption for a similar ADBAC 

compound, n-alkyl (C12-18) dimethyl 

benzyl ammonium chloride. (73 FR 

49101) (August 20, 2008). The 

commenter mistakenly assumed that 

this final rule was a ‘‘proposed EPA 

action’’ and urged that EPA require 

submission of new data on ADBAC, 

review studies that have recently 

become available on ADBAC, and 

conduct a revised risk assessment for 

the chemical. Because the petition for 

the current action was pending at the 

time that the comments on the related 

final rule were received, EPA 

considered those comments in ruling on 

the petition addressed in this action. 

The commenter raised several 

concerns with regard to the earlier 

tolerance action as to an ADBAC 

compound: (1) ADBAC and other 

quaternary ammonium compounds may 

be reproductive and genetic toxicants; 

(2) quaternary ammonium compounds 

are linked with increased occupational 

asthma and immune system 

sensitization; and (3) quaternary 

ammonium compounds are persistent in 

the environment. The commenter also 

raised various environmental concerns 

with the quaternary ammonium 

compounds but these concerns are 

relevant only to EPA’s decision to 

register ADBAC under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (‘‘FIFRA’’), 7 U.S.C. 136 et seq., and 

not tolerance actions under section 408 

of the FFDCA. EPA has prepared a 

detailed response to each of the 

commenter’s arguments and included 

that document in the record for this 

action. EPA’s response as to the FFDCArelated comments is summarized below. 

EPA does not believe that ADBAC 

poses unacceptable reproductive risks. 

In the ADBAC risk assessment, the 

Agency relied on available, reliable, 

quantitative animal data to characterize 

hazards associated with uses of ADBAC 

including reproductive function and 

effects on the developing mammalian 

fetus. In the developmental studies with 

rats (range-finding MRID 42645101 and 

main study MRID 42351501) and rabbits 

(range-finding MRID 42734401 and 

main study MRID 42392801), there was 

no increased sensitivity of developing 

fetuses to ADBAC compared to adult 

animals. In a 2–generation reproductive 

toxicity study (MRID 41385001), effects 

on rat pups were observed in the 

absence of statistically significant 

maternal toxicity, but only at the highest 

dose (160 mg/kg/day). The effects 

observed were considered to be 

nonspecific (decreased pup body weight 

and weight gain during lactation) and 

there were no effects of ADBAC on 

reproductive indices. It is important to 

note that the endpoints selected from 

the rat oral developmental toxicity 

study (NOAEL = 10 mg/kg/day) or the 

21–day dermal toxicity studies (NOAEL 

= 20 mg/kg/day) are well below the dose 

causing these nonspecific effects. 

Therefore, the endpoints used in risk 

assessment are protective of infants and 

children. The commenter relied on a 

scientific literature article in which a 

researcher speculated that a severe 

decline in the fertility of the researcher’s 

laboratory mouse population was due to 

exposure to quaternary ammonium 

compounds. EPA concludes that the 

results of the specific studies designed 

to examine the reproductive effects of 

pesticides outweigh the speculative 

article. 

EPA does not believe ADBAC is a 

genetic toxicant. In evaluating ADBAC’s 

potential mutagenicity, EPA relied on 

testing results in a battery of 

mutagenicity studies, including an 

HGPRT/CHO forward mutation assay 

(MRID 42290801, reformat of MRID 

41012701), an in vivo bone marrow 

chromosomal aberration assay (MRID 

40311101, supplement MRID 

43037701), and an unscheduled DNA 

synthesis (UDS) assay (MRID 42290802, 

reformat of 41012601), all of which 

demonstrated that ADBAC did not 

induce mutagenic effects. Further 

support for this conclusion is provided 

by carcinogenicity testing in long-term 

studies using both rats (MRID 41947501) 

and mice (MRID 41765201). In both 

studies, ADBAC was tested at adequate 

dose levels and found to be negative for 

induction of tumors. In contrast, the 

commenter relies on the result in an in 

vitro mutagenicity test. The weight of 

the evidence clearly supports EPA’s 

conclusion. In vivo mutagenicity testing 

(as does carcinogenicity testing in 

rodents) carries far greater weight than 

in vitro testing because in vivo testing is 

much more likely to simulate the 

detoxifying effects present in the living 

animal. 

Finally, although EPA would agree 

that the chemical properties of ADBAC 

indicate that it will only degrade slowly 

in the environment, these properties 

were taken into account in estimating 

exposure to humans to ADBAC in 

drinking water in assessing ADBAC 


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Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Rules and Regulations 40735 

risks. Accordingly, ADBAC’s 

persistence does not render it unsafe. 

V. Conclusion 

Therefore, the exemption from the 

requirement of a tolerance in 40 CFR 

180.940(a) for Quaternary Ammonium 

Compounds: n-alkyl (C 12-14) dimethyl 

ethylbenzyl ammonium chloride (CAS 

Reg. No. 85409–23–0) is amended to 

increase from 200 ppm to 400 ppm the 

level of the end-use concentration of all 

quaternary chemicals that may be 

present in solution when the solution is 

ready for use. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the 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). 

VII. 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 8, 2010. 

Joan Harrigan-Farrelly, 

Director, Antimicrobials 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. Section 180.940 is amended by 

revising the following entry in the table 

in paragraph (a) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide Chemical CAS Reg. No. Limits 

*** * *

Quaternary Ammonium Compounds: n-alkyl 

(C 12-14) dimethyl ethylbenzyl ammonium chloride, 

average molecular weight 

(in amu), 377 

to 384.

85409–23–0 When ready for use, the end-use concentration of all quaternary chemicals in solution is not to exceed 400 ppm of 

active quaternary compound. 

*** * *


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
40736 Federal Register / Vol. 75, No. 134 / Wednesday, July 14, 2010 / Rules and Regulations 

[FR Doc. 2010–17156 Filed 7–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0561;FRL–8833–8] 

Acetic Acid; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends the 

existing tolerance exemption for acetic 

acid by establishing an exemption from 

the requirement of a tolerance for 

residues of acetic acid, also known as 

vinegar in or on all food crops resulting 

from unintentional spray and drift to 

non-target vegetation including nonfood, food and feed crops when used as 

a non-selective contact herbicide spray. 

SummerSet Products c/o SciReg, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of acetic acid, also known 

as vinegar. 

DATES: This regulation is effective July 

14, 2010. Objections and requests for 

hearings must be received on or before 

September 13, 2010, 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–2010–0561. 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: 

Cheryl Greene, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0352; e-mail address: 

greene.cheryl@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site 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(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2010–0561 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 13, 2010. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2010–0561, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of November 

19, 2008, (FR 69635) (FRL–8389–6), 

EPA issued a notice pursuant to section 

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

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

pesticide tolerance petition (PP 8F7319) 

by SummerSet Products c/o SciReg, 

Inc., 130 Columbia Court, Chaska, MN 

55318. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of acetic acid. This notice referenced a 

summary of the petition prepared by the 

petitioner SummerSet Products, which 

is available in the docket, http:// 

www.regulations.gov. One anonymous 

comment was received on the notice of 

filing. However, EPA was unable to 

address the comment because it was not 

specific to this action, focusing instead 

on the registration of pesticides 

generally, and therefore was not a 

significant comment. 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1