Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Rules and Regulations 49101 

rule, we also requested comments on its 

collection of information provisions. 

The rule’s § 169.215 of 33 CFR 

requires ships to transmit position 

reports using long range identification 

and tracking (LRIT) equipment that has 

been type-approved by their 

Administration. Its § 169.230 of the 

same title requires ships’ LRIT 

equipment to transmit position reports 

at 6-hour intervals unless a more 

frequent interval is requested remotely 

by an LRIT Data Center. And its 

§ 169.245 requires a ship’s master to 

inform his or her Flag Administration 

without undue delay if LRIT equipment 

is switched off or fails to operate. The 

master must also make an entry in the 

ship’s logbook that states his or her 

reason for switching the LRIT 

equipment off, or an entry that the 

equipment has failed to operate, and the 

period during which the LRIT 

equipment was switched off or nonoperational. 

The LRIT NPRM and final rule are 

available electronically through the 

docket (USCG–2005–22612) at 

www.regulations.gov. On August 12, 

2008, under 44 U.S.C. 3505(c), OMB 

approved the collection of information 

associated with the requirements in 

§§ 169.215, 169.230, and 169.245 of the 

LRIT final rule under OMB control 

number 1625–0112. A copy of the OMB 

notice of action is available in our 

online docket. 

Dated: August 15, 2008. 

Howard L. Hime, 

Acting Director of Commercial Regulations 

and Standards, U.S. Coast Guard. 

[FR Doc. E8–19307 Filed 8–19–08; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0573; FRL–8376–9] 

Residues of Quaternary Ammonium 

Compounds, N-Alkyl (C12-18) dimethyl 

benzyl ammonium chloride on Food 

Contact Surfaces; 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 n-alkyl (C12-18) 

dimethyl benzyl ammonium chloride 

(CAS No. 68424–85–1) 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 ppm. 

DATES: This regulation is effective 

August 20, 2008. Objections and 

requests for hearings must be received 

on or before October 20, 2008, 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–2006–0573. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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 either in the electronic docket 

at http://www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

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) 308–6416; 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 Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket 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 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, 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–2006–0573. 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 

on or before October 20, 2008. 

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 


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may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0573., 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’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. Petition 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 6F7071) 

by Edwards-Councilor Co., Inc, 1427 

Baker Road Virginia Beach, VA 23455. 

The petition requested that 40 CFR 

180.940(a) be amended by increasing 

concentration limits for n-alkyl (C12-18) 

dimethyl benzyl ammonium chloride in 

end-use solutions eligible for tolerance 

exemption. That notice referenced a 

summary of the petition prepared by 

Edwards-Councilor Co., Inc, the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has created 

a new exemption n-alkyl (C12-18) 

dimethyl benzyl ammonium chloride 

(CAS No. 68424–85–1) instead of 

amending the current exemption for the 

sake of clarity. The reason for this 

change is explained in Unit IV.B. 

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 tolerance 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 the petitioned-for 

exemption from the requirement for a 

tolerance for residues of alkyl (C12-18) 

dimethyl benzyl 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 alkyl (C12-18) dimethyl benzyl 

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 quaternary 

ammonium compounds (quats) that are 

characterized by having a positively 

charged nitrogen 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 (i.e. Alkyl (50% 

C14, 40% C12, 10% C16) dimethyl benzyl 

ammonium chloride. In finished form, 

these quats are salts with the positively 

charged nitrogen (cation) balanced by a 

negatively charged anion. The most 

common anion for the quats 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 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 nontoxic 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 Group II, 

ADBAC, and the toxicology database for 

PC code 069105 is being considered 

representative of the hazard for the 

ADBAC class of quaternary ammonium 

compounds. 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 

percent of the surfaces authorized on 

the label that could result in human 

exposure and summing the percent 

active ingredients (a.i.) on the labels for 

all of the ADBAC compounds when 

used in combination. 

ADBACs are corrosive, highly 

irritating to the eye and skin, with 

moderate acute toxicity by oral, dermal, 

and inhalation routes of exposure. 

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 


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Endpoint Committee (ADTC) and the 

Hazard Identification Assessment 

Review Committee (HIARC). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. 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 

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 the Table in 

this unit. 

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADBAC FOR USE IN HUMAN RISK ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary (General pop., 

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 = 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 

Dermal short-term (1 to 30 

days) (Formulated product 

(4% ai.)) 

Dermal study 

NOAEL = 20 mg/kg/day 

(333 μg/cm2)b

UFA = 3 x 

UFH = 3x 

FQPA SF = 1x 

LOC for MOE = 10 d 21–day dermal toxicity-guinea pigs MRID 41105801 

LOAEL = 40 mg/kg/day 

based on denuded nonvascularized epidermal 

layer 

Dermal intermediate-term 

(technical grade a.i.) (1 to 

6 months) 

Dermal study 

NOAEL = 20 mg/kg/day 

(80 μg/cm2)c

UFA = 3 x 

UFH = 3x 

FQPA SF = 1x 

LOC for MOE = 10 d 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 Short-term (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


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SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ADBAC FOR USE IN HUMAN RISK ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Inhalation (all exposures) Oral study NOAEL = 3 mg/kg/day 

100%) 

UFA = 10x 

UFH = 10 x 

UF =10xa

FQPA SF = 1x 

LOC for MOE = 1,000 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). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. a An additional uncertainity factor of 10x is applied for use of an oral endpoint for route-to-route extrapolation to determine if a confirmatory inhalation toxicity study is warranted. b Formulated-based dermal endpoint = (20 mg/kg guinea pig x 0.43 kg guinea pig x 1,000 μg/mg)/ 25.8 cm2 area of guinea pig dosed = 33 μg/ 

cm2. 

c TGAI-based dermal endpoint = (20 mg/kg rat x 0.2 kg rat x 1,000 μg/mg)/ 50 cm2 area of rate dosed = 80 μg/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 (C12-18) Dimethyl 

Benzyl 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 FDA 

methodologies for utensils and Indirect 

Dietary Residential Exposure Model 

software (IDREAM) for countertops. 

IDREAM incorporates consumption data 

from USDA’s 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 two 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 milligram (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 three dimensional 

approach, Tier 2, was utilized for this 

assessment. This conservative approach 

uses food consumption and preparation 

patterns as well as data and 

assumptions that are not chemical 

specific. 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 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 


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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. The 

calculated % cPADs for all population 

subgroups do not exceed 100% and 

therefore are not of a concern. 

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 ground water 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 three 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 microgram/Liter (μg/L) and 

ground water is 5.4 μg/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 I surface and ground water model. 

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 pounds/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) and 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 

percent 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 chemicals, 

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 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 

pertaining to the risks to infants and 

childrenis 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 


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49106 Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Rules and Regulations 

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 water 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 

respective cPADs. 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. 

Moreover, EPA has not identified that 

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, 

1,200 for the dermal route, and no cooccurrence for the inhalation route), and 

thus are not of concern. 

Based on the toxicological and 

exposure data discussed in this 

preamble, EPA concludes that ADBAC 

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 for enforcement purposes. 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 enduse solution that is applied to the food 

contact surface is analyzed, rather than 

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. Revisions to Petitioned-For 

Exemption 

EPA has revised the exemption as 

proposed in the notice of filing. The 

petitioner proposed to amend the 

exemption for Quaternary Ammonium 

Compounds: N-alkyl (C12-18) dimethyl 

benzyl ammonium chloride by 

increasing the amount of quaternary 

chemicals that may be in end-use 

concentrations from 200 ppm to 400 

ppm. There presently exists an 

exemption for Quaternary Ammonium 

Compounds: Alkyl (C12-18) dimethyl 

benzyl ammonium chloride (CAS Reg. 

No. 8001–54–5) that limits the 

concentration of quaternary chemicals 

to 200 ppm; however, because the 

petitioner specifically sought an 

exemption for Quaternary Ammonium 

Compounds: N-alkyl (C12-18) dimethyl 

benzyl ammonium chloride (CAS Reg. 

No. 68424–85–1) with a limit for the 

concentration of quaternary chemicals 

at 400 ppm, EPA has not amended the 

existing exemptions but instead 

established a new exemption for 

Quaternary Ammonium Compounds: Nalkyl (C12-18) dimethyl benzyl 

ammonium chloride (CAS Reg. No. 

68424–85–1). 

V. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance under section 

408 of FFDCA is established for residues 

of n-alkyl (C12-18) dimethyl benzyl 

ammonium chloride (CAS No. 68424–

85–1), on food contact surfaces resulting 

from use as an antimicrobial pesticide 

formulation applied to food-contact 

surfaces in public eating places, dairy 

processing equipment, and food 

processing equipment and utensils, 

provided that the end-use concentration 

of all quaternary chemicals in solution 

does not exceed 400 ppm of active 

quaternary compound. 

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, 

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 


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Federal Register / Vol. 73, No. 162 / Wednesday, August 20, 2008 / Rules and Regulations 49107 

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, Alkyl 

Dimethyl Benzyl Ammonium Chloride 

Quaternaries, Food Additives, FoodContact Sanitizers Pesticides and pests, 

Reporting and recordkeeping 

requirements. 

Dated: August 7, 2008. 

Frank Sanders, 

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 

alphabetically adding a new 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 

(C12-18) 

dimethyl 

benzyl 

ammonium 

chloride 

68424–

85–1 

When ready for 

use, the enduse concentration of all quaternary chemicals in solution 

is not to exceed 

400 ppm of active quaternary 

compound. 

*****

* * * * * 

[FR Doc. E8–19070 Filed 8–19–08; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 071106673–8011–02] 

RIN 0648–XJ81 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Greenland Turbot in 

the Aleutian Islands Subarea of the 

Bering Sea and Aleutian Islands 

Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is prohibiting directed 

fishing for Greenland turbot in the 

Aleutian Islands subarea of the Bering 

Sea and Aleutian Islands management 

area (BSAI). This action is necessary to 

prevent exceeding the 2008 Greenland 

turbot total allowable catch (TAC) in the 

Aleutian Islands subarea of the BSAI. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), August 15, 2008, through 

2400 hrs, A.l.t., December 31, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Hogan, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI according to the Fishery 

Management Plan for Groundfish of the 

Bering Sea and Aleutian Islands 

Management Area (FMP) prepared by 

the North Pacific Fishery Management 

Council under authority of the 

Magnuson-Stevens Fishery 

Conservation and Management Act. 

Regulations governing fishing by U.S. 

vessels in accordance with the FMP 

appear at subpart H of 50 CFR part 600 

and 50 CFR part 679. 

The 2008 Greenland turbot TAC in 

the Aleutian Islands subarea of the BSAI 

is 790 metric tons (mt) as established by 

the 2008 and 2009 final harvest 

specifications for groundfish in the 

BSAI (73 FR 10160, February 26, 2008) 

and the allocation from the nonspecified reserves (73 FR 40193, July 14, 

2008). 

In accordance with § 679.20(d)(1)(i), 

the Administrator, Alaska Region, 

NMFS, has determined that the 2008 

Greenland turbot TAC in the Aleutian 

Islands subarea of the BSAI will soon be 

reached. Therefore, the Regional 

Administrator is establishing a directed 

fishing allowance of 540 mt, and is 

setting aside the remaining 250 mt as 

bycatch to support other anticipated 

groundfish fisheries. In accordance with 

§ 679.20(d)(1)(iii), the Regional 

Administrator finds that this directed 

fishing allowance has been reached. 

Consequently, NMFS is prohibiting 

directed fishing for Greenland turbot in 

the Aleutian Islands subarea of the 

BSAI. 

After the effective date of this closure 

the maximum retainable amounts at 

§ 679.20(e) and (f) apply at any time 

during a trip. 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Assistant 

Administrator for Fisheries, NOAA 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 5 

U.S.C. 553(b)(B) as such requirement is 

impracticable and contrary to the public 

interest. This requirement is 

impracticable and contrary to the public 

interest as it would prevent NMFS from 

responding to the most recent fisheries 

data in a timely fashion and would 

delay the closure of Greenland turbot in 

the Aleutian Islands subarea of the 

BSAI. NMFS was unable to publish a 

notice providing time for public 

comment because the most recent, 

relevant data only became available as 

of August 14, 2008. 

The AA also finds good cause to 

waive the 30-day delay in the effective 

date of this action under 5 U.S.C. 

553(d)(3). This finding is based upon 

the reasons provided above for waiver of 

prior notice and opportunity for public 

comment. 

This action is required by § 679.20 

and is exempt from review under 

Executive Order 12866. 

Authority: 16 U.S.C. 1801 et seq. 


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