[Federal Register: September 6, 2007 (Volume 72, Number 172)]
[Rules and Regulations]
[Page 51180-51187]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se07-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0572; FRL-8146-7]
Residues of Quaternary Ammonium Compounds di-n-Alkyl
(C8-10) dimethyl Ammonium chloride, Exemption
from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends 40 CFR 180.940(a), the exemption from
the requirement of a tolerance for residues of Quaternary Ammonium
Compounds, di-n-Alkyl (C8-10) dimethyl ammonium
chloride, average molecular weight (in amu) 332 to 361 on food contact
surfaces when applied/used in public eating places, dairy processing
equipment, and food-processing equipment and utensils by increasing the
allowable use solution concentrations of quaternary compounds. Lonza
Inc. submitted a petition to EPA under the Federal Food,
[[Page 51181]]
Drug, and Cosmetic Act requesting an increase in the concentrations of
quaternary compounds in end-use products eligible for the exemption. As
amended, the regulation will exempt solutions from the requirement of a
tolerance residues resulting from contact with surfaces treated with
solutions where the end use concentration of the specific quaternary
compounds does not exceed 240 parts per million (ppm) of active
quaternary ammonium compounds, and the end-use concentration of all
quaternary chemicals in the solution does not exceed 400 ppm of active
quaternary compound.
DATES: This regulation is effective September 6, 2007. Objections and
requests for hearings must be received on or before November 5, 2007,
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-2006-0572. 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 web site 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 Building), 2777 S. Crystal Drive 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
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-6233; e-mail address: noble.velma@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 180.940
Tolerance exemptions for active and inert ingredients for use in
antimicrobial formulations (Food-contact surface sanitizing solutions),
paragraph (a). 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 my 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 the FFDCA, as amended by the Food Quality
Protection Act (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-
2006-0572 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 November 5, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0572, 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of October 25, 2006 (71 FR 62458) (FRL-
8099-6), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 6F7045) by Lonza, Inc, 90 Boroline Rd,
Allendale, NJ 07401. The petition requested that 40 CFR 180.940(a) be
amended by increasing concentration limits for aliphatic alkyl
quaternary compounds in end-use solutions eligible for the tolerance
exemption for Quaternary Ammonium compounds: Di-n-Alkyl (C8-
10) dimethyl ammonium chloride, average molecular weight (in
amu) 332 to 361) on food contact surfaces in public eating places,
dairy processing equipment, and food
[[Page 51182]]
processing equipment and utensils from 150 ppm to 240 ppm and the total
end use concentration of all quaternary chemicals in solution from 200
ppm to 400 ppm. The notice referenced a summary of the petition
prepared by Lonza Inc., 90 Boroline Rd Allendale, NJ 07401, the
registrant, which is available to the public in the docket at
http://www.regulations.gov, Docket ID Number EPA-HQ-OPP -2006-0572. There were
no comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of the 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) 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), 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), 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....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
A. Toxic Effects
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by the
Aliphatic Alkyl Quaternaries are discussed in this unit.
The Aliphatic Alkyl Quaternaries 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 a human carcinogen based on a negative carcinogenicity
study in rats and mice feeding studies using doses above the limit.
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 two-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 Di-n-Alkyl (C8-10)
dimethyl ammonium chloride, average molecular weight (in amu) 332 to
361) (DDAC) as well as the no observed adverse effect level (NOAEL) and
the lowest observed adverse effect level (LOAEL) from the toxicity
studies can be found at http://www.regulations.gov; Docket ID Number
EPA-HQ-OPP-2005-0338; Toxicology Disciplinary Chapter for the
Reregistration Eligibility Decision (RED) for Didecyl Dimethyl Ammonium
Chloride (DDAC).
B. Toxic Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(NOAEL) from the toxicology study identified as appropriate for the
risk assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in variations
in sensitivity among members of the human population as well as other
unknowns.
The Agency's level of concern (LOC) for residential Aliphatic Alkyl
Quaternaries' inhalation and oral exposures is 100 (i.e., a margin of
exposure (MOE) less than 100 exceeds the Agency's level of concern).
The level of concern is based on 10x for interspecies extrapolation and
10x for intraspecies extrapolation. However, the uncertainty factor or
``target'' MOE for Aliphatic Alkyl Quaternaries' dermal exposures is 10
for residential scenarios. The target MOE was chosen because the
established endpoint is for dermal irritation, not a systemic toxic
effect. In addition, dermal irritation is considered a reversible and
short-term effect, thus supporting a 10x uncertainty factor (half a log
(10.5) or approximately 3x for interspecies extrapolation and half log
(10.5) or approximately 3x for intraspecies variation). It should be
noted that the determination to reduce the 100x UF to 10X UF for
irritation endpoints is made on a case-by-case basis.
Aliphatic Alkyl Quaternaries toxicological endpoint summary is
listed in the following table.
Table 1.--Summary of Toxicological Endpoints for DDAC
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Target MOE/UF, Special
Exposure Scenario Dose Used in Risk FQPA SF for Risk Study and Toxicological
Assessment (mg/kg/day) Assessment Effects
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Acute Dietary (Females 13-50) FQPA SF = 1 Parenatal
NOAEL (developmental) = 10 mg/kg/ UF = 100 (10x inter- Developmental
day. species Toxicity - Rat MRID
extrapolation, 10x 41886701
intra-species LOAEL = 20 mg/kg/day
variation). based on increased
incidence of skeletal
variations..
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Acute RfD = 0.1 mg/kg/day (for Females age 13-50)
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[[Page 51183]]
Acute Dietary(general population) An acute dietary endpoint was not identified in the data base. This risk
assessment is not required
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Chronic Dietary (general NOAEL = 10 mg/kg/day FQPA SF = 1 Chronic Toxicity Study -
population) UF = 100 (10x inter- Dog MRID 41970401
species LOAEL = 20 mg/kg/day based
extrapolation, 10x on increased incidence of
intra-species clinical signs in males
variation. and females and decreased
total cholesterol levels
in females
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Chronic RfD = 0.1 mg/kg/day
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Incidental Oral (Short-Term) NOAEL (developmental) Target MOE = 100 (10x Prenatal Developmental
= 10 mg/kg/day inter-species Toxicity - Rat MRID
extrapolation, 10x 41886701
intra-species LOAEL = 20 mg/kg/day based
variation) on increased incidence of
FQPA SF = 1........... skeletal variations.
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Incidental Oral (Intermediate-Term) NOAEL = 10 mg/kg/day Target MOE = 100 (10x Chronic Toxicity Study -
inter-species Dog MRID 41970401
extrapolation, 10x LOAEL = 20 mg/kg/day based
intra-species on increased incidence of
variation) clinical signs in males
FQPA SF = 1........... and females and decreased
total cholesterol levels
in females.
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Dermal, Short-term (formulated No endpoint identified. No dermal or systemic effects identified in the 21-
product 0.13% a.i.) day dermal toxicity study (MRID 45656601) up to and including the limit
dose of 1,000 mg/kg/day
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Dermal, Short-term\a\ NOAEL (dermal) = 2 mg/ Target MOE = 10 (3x 90-day Dermal Toxicity -
kg/day(8 [mu]g/cm2) inter-species Rat MRID 41305901
extrapolation, 3x LOAEL = 6 mg/kg/day based
intra-species on increased clinical and
variation) gross findings (erythema,
edema, exfoliation,
excoriation, and
ulceration)
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Dermal, Intermediate- and Long-term No appropriate endpoint identified
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Inhalation, Short-Term NOAEL\b\ = 10 mg/kg/ Target MOE = 100 (10x Prenatal Developmental
day inter-species Toxicity - Rat MRID
extrapolation, 10x 41886701
intra-species LOAEL = 20 mg/kg/day based
variation) on increased incidence of
FQPA SF = 1........... skeletal variations.
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Inhalation, Intermediate- and Long- NOAEL\b\ = 10 mg/kg/ Target MOE = 100 (10x Chronic Toxicity Study -
Term day inter-species Dog MRID 41970401
extrapolation, 10x LOAEL = 20 mg/kg/day based
intra-species on increased incidence of
variation) clinical signs males and
FQPA SF = 1........... females and decreased
total cholesterol levels
in females.
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UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference
dose, MOE = margin of exposure, LOC = Level of concern, NA = Not Applicable.
\a\ Short-term dermal endpoint = (2 mg/kg rat x 0.2 kg rat x 1,000 [mu]g/mg) / 50 cm2 area of rat dosed = 8
[mu]g/cm2.
\b\An additional UF of 10x is used for route extrapolation from an oral endpoint to determine if a confirmatory
study is warranted.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
A. Dietary Exposure
Aliphatic Alkyl Quaternaries are used as a sanitizer on counter
tops, utensils, appliances, tables, refrigerators, food packaging, and
beverage bottling. The use of Aliphatic Alkyl Quaternaries as an
antimicrobial product 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.
1. Food. The Agency assessed acute and chronic dietary exposure
from the use of Aliphatic Alkyl Quaternaries as a disinfectant and food
contact sanitizer on direct and indirect food-contact surfaces. This
assessment calculated the Daily Dietary Dose (DDD) and the Estimated
Daily Intake (EDI) using an FDA model (2003). The FDA model takes into
account application rates, residual solution, area of the treated
surface which comes into contact with food, pesticide migration
fraction, and body weight.
The EDI calculations presented in this assessment are based on the
assumption that food can contact 2,000 cm2 of treated
surface per day (which represents contact with a treated countertop
surface area), 4,000 cm2 of treated surface per day (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 ), or 6,000 cm2 of treated surface per
day (which represents treated countertops, silverware, china,
[[Page 51184]]
and glass by an individual who regularly eats three meals per day at an
institutional or public facility). It also assumes that 10% of the
pesticide would migrate to food.
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 Aliphatic Alkyl Quaternaries for bottling/packaging of food is
0.0020 lbs active ingredient (a.i) per gallon of treatment solution.
EDI values were calculated using an approach similar to that used for
treated food-contact surfaces and food utensils. Exposure was assumed
to occur through the ingestion of three food products that might be
packaged with treated material: milk, egg products, and beverages
(alcoholic and non-alcoholic). A calorie intake modification factor of
0.64 was applied to the EDI for a child to account for the differences
between intake values among children and adults.
2. Drinking water exposure. The only Aliphatic Alkyl Quaternaries
outdoor uses are an algaecide in decorative/swimming pools,
antisapstain wood preservative treatment, once-through cooling tower
treatment, and oil field uses. The pond and oil field uses are
considered to be contained. The other uses are not expected to
significantly contaminate drinking water sources. Therefore, the
Aliphatic Alkyl Quaternaries contributions for drinking water exposure
are considered to be negligible and are not quantified.
It should be noted that the Agency estimated concentrations for
exposure to aquatic animals resulting from the antisapstain and cooling
tower uses. These levels were not considered appropriate for use in the
drinking water assessment due to the very conservative nature of the
models used, that the model estimates runoff/point source
concentrations and not water body concentrations, and the fact that the
models does not account for dilution.
Specific information on the dietary and drinking water exposure
assessments for Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary
Risk Assessment on DDAC and Tier 1 Drinking Water Assessment for Alkyl
Dimethyl Benzyl Ammonium Chloride (ADBAC); Didecyl Dimethyl Ammonium
Chloride (DDAC).
B. Other Non-Occupational Exposure
The residential exposure assessment considers all potential non-
occupational pesticide exposure, other than exposure due to residues in
food or in drinking water. Exposures may occur during and after
application as a hard surfaces disinfectant (e.g., walls, floors,
tables, fixtures), to textiles (e.g., clothing, diapers) to swimming
pools and to carpets. Each route of exposure (oral, dermal, inhalation)
is assessed, where appropriate, and risk is expressed as a MOE, which
is the ratio of estimated exposure to an appropriate NOAEL
Residential exposure may occur during the application of Aliphatic
Alkyl Quaternaries to indoor hard surfaces (e.g., mopping, wiping,
trigger pump sprays), carpets, swimming pools, wood as a preservative,
textiles (e.g., diapers treated during washing and clothes treated with
fabric spray), and humidifiers. The residential handler scenarios were
assessed to determine dermal and inhalation exposures. Surrogate dermal
and inhalation unit exposure values were estimated using data from the
Pesticide Handler Exposure Database (PHED) 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.
Based on toxicological criteria and the potential for exposure, the
Agency has conducted dermal and inhalation exposure assessments for
Aliphatic Alkyl Quaternaries residential use. As noted previously, MOEs
greater than or equal to 100 for the inhalation route of exposure and
10 for dermal exposure are considered adequately protective for the
residential exposure assessment.
Specific information on the residential exposure assessment for
Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Didecyl
Dimethyl Ammonium Chloride (DDAC) Occupational and Residential Exposure
Assessment.
V. Cumulative Effects
Another factor EPA must consider in making a section 408 reasonable
certainty of no harm determination is any ``available information''
concerning the cumulative effects of a particular pesticide's residues
and ``other substances that have a common mechanism of toxicity.''
The Aliphatic Alkyl Quaternaries are a group of structurally
similar quaternary ammonium compounds that are characterized by having
a positively charged nitrogen covalently bonded to two alkyl group
substituents (at least one C8 or longer) and two methyl
substituents. In finished form, these quats are salts with the
positively charged nitrogen (cation) balanced by a negatively charged
molecule (anion). The anion for the quats in this cluster is chloride
or bromide. Didecyl dimethyl ammonium chloride, or DDAC, was chosen as
the representative chemical for this class in PR notice 88-2. On that
basis, the toxicology database for DDAC is accepted as representative
of the hazard for this class of quaternary ammonium compounds. However,
the toxicologic responses observed from animal toxicity studies with
DDAC are generalized responses to treatment and are difficult to
attribute to any one mechanism.
EPA's risk assessment for the Group I Cluster is based on an
assessment of the cumulative exposure to all aliphatic alkyl quaternary
compounds. The individual exposure scenarios in the DDAC assessments
(as well as the aggregate assessment in the RED) were developed by
assuming that a DDAC 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 aliphatic
alkyl quaternary compounds when used in combination. Thus, because the
risk assessment for DDAC accounts for exposures to all of the aliphatic
alkyl quaternary compounds, 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 DDAC.
VI. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold (``10X'') margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the
[[Page 51185]]
completeness of the data base on toxicity and exposure unless EPA
determines based on reliable data that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the FQPA safety factor. 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 safety factor
value based on the use of traditional uncertainty/safety factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no evidence that
Aliphatic Alkyl Quaternaries result in increased susceptibility in in
utero rats or rabbits in the prenatal developmental studies or in young
rats in the two-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 safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for Aliphatic Alkyl Quaternaries is
complete for assessing risk to infants and children under the FFDCA.
ii. There is no indication that Aliphatic Alkyl Quaternaries are
neurotoxic chemicals and there is no need for a developmental
neurotoxicity study or additional uncertainty factors to account for
neurotoxicity.
iii. There is no evidence that Aliphatic Alkyl Quaternaries result
in increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. Although EPA may, in the future, refine exposure estimates
for Aliphatic Alkyl Quaternaries based on more sophisticated modeling
techniques, the current exposure assessment is based on a combination
of conservative assumptions that is likely to overstate exposure from
food to Aliphatic Alkyl Quaternaries.
VII. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate 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 LOC by all applicable
uncertainty/safety factors. For linear cancer risks, EPA calculates the
probability of additional cancer cases given aggregate exposure. Short-
, intermediate, and long-term risks are evaluated by comparing
aggregate exposure to the LOC to ensure that the MOE called for by the
product of all applicable uncertainty/safety factors is not exceeded.
1. Acute and chronic risk. EPA compares the estimated dietary
exposures to an aPAD and a cPAD, 0.1 mg/kg/day, which are the same
value for the aliphatic alkyl quaternaries. Generally, a dietary
exposure estimate that is less than 100% of the aPAD or cPAD does not
exceed the Agency's levels of concern.
The antimicrobial indirect food use acute/chronic risk estimates
from exposure to treated utensils and countertops are below the
Agency's level of concern. For adults, the acute and chronic dietary
exposure risk estimates are 3.32% of the aPAD and cPAD for adult
females of child bearing age (13 to 50), the highly exposed adult
group. For children ages 3 to 5, the most highly exposed population
subgroup, the acute and chronic dietary risk estimates are 13.3% of the
aPAD and cPAD. Therefore, dietary exposure estimates are below the
Agency's level of concern for all population subgroups. The
antimicrobial indirect food use acute/chronic risk estimates from
exposure to treated food packaging and beverage bottles are below the
the Agency's level of concern. Neither the percent aPAD or percent cPAD
values exceeded 100% and are not of concern.
Specific information on the dietary exposure assessment for
Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary
Risk Assessment on DDAC.
2. Non-occupational risk. Aggregate exposure takes into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Using the exposure assumptions described in this unit for other
non-occupational exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs greater than
or equal to 100 for the inhalation route of exposure and 10 for dermal
exposure; therefore, are not of concern.
3. Aggregate cancer risk for U.S. population. Based on the
carcinogenic data, the EPA concludes that there is reasonable certainty
that Aliphatic Alkyl Quaternaries doe not pose an aggregate cancer risk
to the U. S. population.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to Aliphatic Alkyl Quaternaries residues.
VIII. Other Considerations
A. Endocrine Disruptors
EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following recommendations of its Endocrine Disruptor and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen
and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program
include evaluations of potential effects in wildlife. For pesticide
chemicals, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in
humans, FFDCA authority to require the wildlife evaluations. As the
science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disruptor Screening Program
(EDSP). When appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disruption Screening Program
(EDSP) have been developed, the Aliphatic Alkyl Quaternaries (DDAC) may
be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
B. Analytical Method(s)
An analytical method for food is not needed. Food contact
sanitizers are typically regulated by state health departments to
ensure that the food industry is using these products in compliance
with the regulations in 40 CFR 180.940. The end use solution that is
applied to the food contact surface is analyzed not food items that may
come into contact with the 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 DDAC and alkyl
dimethyl benzyl ammonium chloride (ADBAC), then High Performance Liquid
Chromatography using Ultra
[[Page 51186]]
Violet Detection (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.
IX. Statutory and Executive Order Reviews
This final rule establishes a tolerance exemption 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 rule
has been exempted from review under Executive Order 12866, this 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 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
X. 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,
Food contact sanitizers, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: August 29, 2007.
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 revising the following entry to the
table in paragraph (a):
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 None When ready for use, the
Compounds, Di-n-Alkyl (C8- end-use concentration
10) dimethyl ammonium of these specific in
chloride, average molecular quaternary ammonium
weight (in amu) 332 to 361 compounds is not to
exceed 240 ppm of
active quaternary
ammonium compound; the
end-use concentration
of all quaternary
chemicals in the
solution is not to
exceed 400 ppm of
active quaternary
compound.
* * * * * * *
------------------------------------------------------------------------
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* * * * *
[FR Doc. E7-17634 Filed 9-5-07; 8:45 am]
BILLING CODE 6560-50-S