[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
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Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
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Acute dietary (General pop., females An acute dietary endpoint was not identified in the database.
13+, infants and children)
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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
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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
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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
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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
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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
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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
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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
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[[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
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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