Document ID: EPA-HQ-OPP-2006-0573-0002
Agency: epa
Document Type: Rule
Title: Residues of Quaternary Ammonium Compounds, N-Alkyl (C12-18) dimethyl benzyl ammonium chloride on Food Contact Surfaces; Exemption from the Requirement of a Tolerance
Posted Date: 2008-08-20T04:00Z

[Federal Register: August 20, 2008 (Volume 73, Number 162)]
[Rules and Regulations]               
[Page 49101-49107]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au08-10]                         

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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.

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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 end-use 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

[[Page 49102]]

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 no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (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 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 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

[[Page 49103]]

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
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General pop., females         An acute dietary endpoint was not identified in the database.
 13+, infants and children)
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL = 44 mg/kg/day     Chronic RfD = 0.44 mg/   Chronic toxicity/
                                       UFA = 10x..............   kg/day                   carcinogencity-rat
                                       UFH = 10x..............  cPAD = 0.44 mg/kg/day..   MRID 41947501
                                       FQPA SF = 1x...........                           LOAEL = 88 mg/kg/day
                                                                                          based on decreased
                                                                                          body weight and weight
                                                                                          gain
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to 30    NOAEL = 10 mg/kg/day     LOC for MOE = 100        Developmental Toxicity-
 days)                                 UFA = 10x..............                            Rat MRID 42351501
                                       UFH = 10x..............                           LOAEL = 30 mg/kg/day
                                       FQPA SF = 1x...........                            based on clinical
                                                                                          signs and decrease
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term (1   NOAEL = 10 mg/kg/day     LOC for MOE = 100        Developmental Toxicity-
 to 6 months)                          UFA = 10x..............                            Rat MRID 42351501
                                       UFH = 10x..............                           LOAEL = 30 mg/kg/day
                                       FQPA SF = 1x...........                            based on clinical
                                                                                          signs and decrease
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)       Dermal study             LOC for MOE = 10 d       21-day dermal toxicity-
 (Formulated product (4% ai.))         NOAEL = 20 mg/kg/day...                            guinea pigs MRID
                                       (333 [mu]g/cm2)b.......                            41105801
                                       UFA = 3 x..............                           LOAEL = 40 mg/kg/day
                                       UFH = 3x...............                            based on denuded non-
                                       FQPA SF = 1x...........                            vascularized epidermal
                                                                                          layer
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term (technical    Dermal study             LOC for MOE = 10 d       90-day dermal in rats
 grade a.i.) (1 to 6 months)           NOAEL = 20 mg/kg/day...                            MRID 41499601
                                       (80 [mu]g/cm2)c........                           LOAEL = 20 mg/kg/day
                                       UFA = 3 x..............                            based on highest doest
                                       UFH = 3x...............                            tested before
                                       FQPA SF = 1x...........                            irritation became
                                                                                          significant.
                                                                                          Irritation not
                                                                                          observed until day 43
----------------------------------------------------------------------------------------------------------------
Dermal Short-term (technical grade        No endpoint identified from the available data on dermal irritation.
 a.i)                                     Dermal irritation in the 90-day dermal toxicity study was not evident
                                                              until day 43 (MRID 41499601)d
----------------------------------------------------------------------------------------------------------------
 Long-Term Dermal (technical grade     No appropriate endpoint identified. No systemic effects observed up to 20
 a.i.)                                      mg/kg/day, highest dose of technical that could be tested without
                                                                  irritation effects.d
----------------------------------------------------------------------------------------------------------------

[[Page 49104]]

Inhalation (all exposures)             Oral study NOAEL = 3 mg/ LOC for MOE = 1,000      Developmental Toxicity-
                                        kg/day 100%)                                      rabbit MRID 42392801
                                       UFA = 10x..............                           LOAEL = 9 mg/kg/day
                                       UFH = 10 x.............                            based on clinical
                                       UF =10xa...............                            signs of toxicity in
                                       FQPA SF = 1x...........                            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 [mu]g/mg)/ 25.8 cm2 area
  of guinea pig dosed = 33 [mu]g/cm2.
c TGAI-based dermal endpoint = (20 mg/kg rat x 0.2 kg rat x 1,000 [mu]g/mg)/ 50 cm2 area of rate dosed = 80
  [mu]g/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

[[Page 49105]]

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 ([mu]g/L) and ground water is 5.4 
[mu]g/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 non-occupational, 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 post-application 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

[[Page 49106]]

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 short-term aggregate is 
presented here because the endpoints for incidental oral as well as 
inhalation are identical for the short- and 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 co-occurrence 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 end-use 
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: N-alkyl (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

[[Page 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, Food-Contact Sanitizers Pesticides and 
pests, Reporting and recordkeeping requirements.

    Dated: August 7, 2008.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.940 is amended by alphabetically adding a new entry in 
the table in paragraph (a) to read as follows:

Sec.  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- 68424-85-1          When ready for
 alkyl (C12-18) dimethyl benzyl                        use, the end-use
 ammonium chloride                                     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