Residues of Quaternary Ammonium Compounds di-n-Alkyl (C8, 51180-51187 [E7-17634]
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Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Rules and Regulations
determined that it does not have
implications for federalism.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
Federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 or more in any one year.
Though this rule will not result in such
an expenditure, we do discuss the
effects of this rule elsewhere in this
preamble.
Taking of Private Property
This rule will not affect a taking of
private property or otherwise have
taking implications under Executive
Order 12630, Governmental Actions and
Interference with Constitutionally
Protected Property Rights.
Civil Justice Reform
This rule meets applicable standards
in sections 3(a) and 3(b)(2) of Executive
Order 12988, Civil Justice Reform, to
minimize litigation, eliminate
ambiguity, and reduce burden.
Protection of Children
We have analyzed this rule under
Executive Order 13045, Protection of
Children from Environmental Health
Risks and Safety Risks. This rule is not
an economically significant rule and
does not concern an environmental risk
to health or risk to safety that may
disproportionately affect children.
Indian Tribal Governments
This final rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does not have substantial
direct effect on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes.
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Energy Effects
We have analyzed this rule under
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use. We have
determined that it is not a ‘‘significant
energy action’’ under that order because
it is not a ‘‘significant regulatory action’’
under Executive Order 12866 and is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy. The Administrator of the Office
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of Information and Regulatory Affairs
has not designated it as a significant
energy action. Therefore, it does not
require a Statement of Energy Effects
under Executive Order 13211.
Technical Standards
The National Technology Transfer
and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use
voluntary consensus standards in their
regulatory activities unless the agency
provides Congress, through the Office of
Management and Budget, with an
explanation of why using these
standards would be inconsistent with
applicable law or otherwise impractical.
Voluntary consensus standards are
technical standards (e.g., specifications
of materials, performance, design, or
operation; test methods; sampling
procedures; and related management
systems practices) that are developed or
adopted by voluntary consensus
standards bodies.
This rule does not use technical
standards. Therefore, we did not
consider the use of voluntary consensus
standards.
Environment
We have analyzed this rule under
Commandant Instruction M16475.1D,
which guides the Coast Guard in
complying with the National
Environmental Policy Act of 1969
(NEPA) (42 U.S.C. 4321–4370f), and
have concluded that there are no factors
in this case that would limit the use of
a categorical exclusion under section
2.B.2 of the Instruction. Therefore, this
rule is categorically excluded, under
figure 2–1, paragraph (32)(e), of the
Instruction, from further environmental
documentation considering that it
relates to the promulgation of operating
regulations or procedures for
drawbridges. Under figure 2–1,
paragraph (32)(e), of the instruction, an
‘‘Environmental Analysis Check List’’
and a ‘‘Categorical Exclusion
Determination’’ are not required for this
rule.
List of Subjects in 33 CFR Part 117
Bridges.
I For the reasons set out in the
preamble, the Coast Guard amends 33
CFR part 117 as follows:
PART 117—DRAWBRIDGE
OPERATION REGULATIONS
1. The authority citation for part 117
continues to read as follows:
I
Authority: 33 U.S.C. 499; 33 CFR 1.05–1;
and Department of Homeland Security
Delegation No. 0170.1.
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2. Section 117.217 is amended by
revising paragraph (a) to read as follows:
I
§ 117.217
Norwalk River.
(a) The draw of the Washington Street
S136 Bridge, mile 0.0, at Norwalk, shall
operate as follows:
(1) The draw shall open on signal;
except that, from 7 a.m. to 8:45 a.m.,
11:45 a.m. to 1:15 p.m., and 4 p.m. to
6 p.m., Monday through Friday, except
holidays, the draw need not be opened
for the passage of vessels that draw less
than 14 feet of water.
(2) The draw need not open for the
passage of vessel traffic, from 10 a.m. to
12 p.m., on the first Saturday in
December, to facilitate the running of
the annual Norwalk River Fun Run.
Should inclement weather force the
postponement of the race the above
bridge closure shall be implemented the
next day, the first Sunday after the first
Saturday in December, from 10 a.m. to
12 p.m.
(3) The bridge opening signal is three
short blasts. Vessels drawing 14 feet of
water or more shall add one prolonged
blast after the three short blasts.
*
*
*
*
*
Dated: August 20, 2007.
Timothy S. Sullivan,
Rear Admiral, U.S. Coast Guard, Commander,
First Coast Guard District.
[FR Doc. E7–17567 Filed 9–5–07; 8:45 am]
BILLING CODE 4910–15–P
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
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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,
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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 enduse concentration of all quaternary
chemicals in the solution does not
exceed 400 ppm of active quaternary
compound.
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 https://
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 https://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:
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DATES:
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(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 (Foodcontact 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 https://
www.regulations.gov, you my access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
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
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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:
https://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: Din-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
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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
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.
for Didecyl Dimethyl Ammonium
Chloride (DDAC).
III. Toxicological Profile
B. Toxic Endpoints
A. Toxic Effects
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.
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 https://
www.regulations.gov; Docket ID Number
EPA–HQ–OPP–2005–0338; Toxicology
Disciplinary Chapter for the
Reregistration Eligibility Decision (RED)
TABLE 1.—SUMMARY OF TOXICOLOGICAL ENDPOINTS FOR DDAC
Dose Used in Risk Assessment (mg/kg/day)
Target MOE/UF, Special
FQPA SF for Risk Assessment
Acute Dietary (Females 13–
50)
NOAEL (developmental) = 10
mg/kg/day
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Exposure Scenario
FQPA SF = 1
UF = 100 (10x inter-species extrapolation, 10x
intra-species variation)
Parenatal Developmental
Toxicity - Rat MRID
41886701
LOAEL = 20 mg/kg/day
based on increased incidence of skeletal variations.
Study and Toxicological Effects
Acute RfD = 0.1 mg/kg/day (for Females age 13–50)
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TABLE 1.—SUMMARY OF TOXICOLOGICAL ENDPOINTS FOR DDAC—Continued
Exposure Scenario
Acute Dietary(general population)
Chronic Dietary (general population)
Target MOE/UF, Special
FQPA SF for Risk Assessment
Dose Used in Risk Assessment (mg/kg/day)
Study and Toxicological Effects
An acute dietary endpoint was not identified in the data base. This risk assessment is not required
NOAEL = 10 mg/kg/day
FQPA SF = 1
UF = 100 (10x inter-species
extrapolation, 10x intra-species variation
Chronic Toxicity Study - Dog MRID 41970401
LOAEL = 20 mg/kg/day based on increased incidence of clinical signs in males and females
and decreased total cholesterol levels in females
Chronic RfD = 0.1 mg/kg/day
Incidental Oral (Short-Term)
NOAEL (developmental)
= 10 mg/kg/day
Target MOE = 100 (10x interspecies extrapolation, 10x
intra-species variation)
FQPA SF = 1
Prenatal Developmental Toxicity - Rat MRID
41886701
LOAEL = 20 mg/kg/day based on increased incidence of skeletal variations.
Incidental Oral (IntermediateTerm)
NOAEL = 10 mg/kg/day
Target MOE = 100 (10x interspecies extrapolation, 10x
intra-species variation)
FQPA SF = 1
Chronic Toxicity Study - Dog MRID 41970401
LOAEL = 20 mg/kg/day based on increased incidence of clinical signs in males and females
and decreased total cholesterol levels in females.
Dermal, Short-term (formulated product 0.13% a.i.)
Dermal, Short-terma
No endpoint identified. No dermal or systemic effects identified in the 21–day dermal toxicity study (MRID
45656601) up to and including the limit dose of 1,000 mg/kg/day
NOAEL (dermal) = 2 mg/
kg/day(8 µg/cm2)
Target MOE = 10 (3x interspecies extrapolation, 3x
intra-species variation)
Dermal, Intermediate- and
Long-term
90–day Dermal Toxicity - Rat MRID 41305901
LOAEL = 6 mg/kg/day based on increased clinical
and gross findings (erythema, edema, exfoliation, excoriation, and ulceration)
No appropriate endpoint identified
Inhalation, Short-Term
NOAELb = 10 mg/kg/day
Target MOE = 100 (10x interspecies extrapolation, 10x
intra-species variation)
FQPA SF = 1
Prenatal Developmental Toxicity - Rat MRID
41886701
LOAEL = 20 mg/kg/day based on increased incidence of skeletal variations.
Inhalation, Intermediate- and
Long-Term
NOAELb = 10 mg/kg/day
Target MOE = 100 (10x interspecies extrapolation, 10x
intra-species variation)
FQPA SF = 1
Chronic Toxicity Study - Dog MRID 41970401
LOAEL = 20 mg/kg/day based on increased incidence of clinical signs males and females and
decreased total cholesterol levels in females.
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 µg/mg) ÷ 50 cm2 area of rat dosed = 8 µg/cm2.
bAn additional UF of 10x is used for route extrapolation from an oral endpoint to determine if a confirmatory study is warranted.
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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 nonoccupational 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
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an antimicrobial product on food or feed
contact surfaces, agricultural
commodities, and application to foodgrade 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
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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,
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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 https://
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).
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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 postapplication 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 https://www.regulations.gov;
Docket ID Number EPA–HQ–OPP–
2006–0338; Didecyl Dimethyl
Ammonium Chloride (DDAC)
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Fmt 4700
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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
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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 twogeneration 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
VerDate Aug<31>2005
18:26 Sep 05, 2007
Jkt 211001
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 https://
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 nonoccupational 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
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Fmt 4700
Sfmt 4700
51185
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
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Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Rules and Regulations
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
Pesticide Chemical
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*
18:26 Sep 05, 2007
Jkt 211001
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.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.940 is amended by
revising the following entry to the table
in paragraph (a):
I
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
CAS Reg. No.
*
Quaternary Ammonium Compounds, Di-n-Alkyl (C8-10)
dimethyl ammonium chloride, average molecular
weight (in amu) 332 to 361
VerDate Aug<31>2005
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).
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None
*
Frm 00028
*
*
*
*
Fmt 4700
*
*
Limits
*
*
*
When ready for use, the end-use concentration of these specific
in quaternary ammonium 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.
*
*
*
Sfmt 4700
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Federal Register / Vol. 72, No. 172 / Thursday, September 6, 2007 / Rules and Regulations
*
*
*
*
because the rule is a compilation of
existing authorities, and makes no
change to DoD contracting policy.
*
[FR Doc. E7–17634 Filed 9–5–07; 8:45 am]
BILLING CODE 6560–50–S
C. Paperwork Reduction Act
48 CFR Chapter 2
The Paperwork Reduction Act does
not apply, because the rule does not
impose any information collection
requirements that require the approval
of the Office of Management and Budget
under 44 U.S.C. 3501, et seq.
RIN 0750–AF56
List of Subjects in 48 CFR Chapter 2
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
Defense Federal Acquisition
Regulation Supplement; Emergency
Acquisitions (DFARS Case 2006–D036)
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
AGENCY:
Interim Rule Adopted as Final Without
Change
DoD published an interim rule at 72
FR 2631 on January 22, 2007, to provide
a single reference to the acquisition
flexibilities that may be used to
facilitate and expedite DoD acquisitions
of supplies and services during
emergency situations. The rule
supplements the Governmentwide
acquisition flexibilities found in Part 18
of the Federal Acquisition Regulation.
DoD received no comments on the
interim rule. Therefore, DoD has
adopted the interim rule as a final rule
without change.
This rule was not subject to Office of
Management and Budget review under
Executive Order 12866, dated
September 30, 1993.
B. Regulatory Flexibility Act
pwalker on PROD1PC71 with RULES
Accordingly, the interim rule
amending 48 CFR Chapter 2, which was
published at 72 FR 2631 on January 22,
2007, is adopted as a final rule without
change.
I
[FR Doc. E7–17432 Filed 9–5–07; 8:45 am]
BILLING CODE 5001–08–P
DEPARTMENT OF DEFENSE
Defense Acquisition Regulations
System
48 CFR Parts 202 and 252
DoD certifies that this final rule will
not have a significant economic impact
on a substantial number of small entities
within the meaning of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq.,
Jkt 211001
Defense Federal Acquisition
Regulation Supplement; Technical
Amendments
Defense Acquisition
Regulations System, Department of
Defense (DoD).
ACTION: Final rule.
SUMMARY: DoD is making technical
amendments to the Defense Federal
Acquisition Regulation Supplement
(DFARS) to update the list of Air Force
and Navy contracting activities and to
remove obsolete text.
EFFECTIVE DATE: September 6, 2007.
FOR FURTHER INFORMATION CONTACT: Ms.
Michele Peterson, Defense Acquisition
Regulations System, OUSD (AT&L)
DPAP (DARS), IMD 3D139, 3062
Defense Pentagon, Washington, DC
20301–3062. Telephone (703) 602–0311;
facsimile (703) 602–7887.
SUPPLEMENTARY INFORMATION: This final
rule amends DFARS text as follows:
Æ Section 202.101. Updates the list of
Air Force and Navy contracting
activities.
Æ Section 252.219–7009. Removes an
obsolete date within a reference to a
PO 00000
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Fmt 4700
Sfmt 4700
partnership agreement between DoD
and the Small Business Administration.
List of Subjects in 48 CFR Parts 202 and
252
Government procurement.
Michele P. Peterson,
Editor, Defense Acquisition Regulations
System.
Therefore, 48 CFR Parts 202 and 252
are amended as follows:
I 1. The authority citation for 48 CFR
Parts 202 and 252 continues to read as
follows:
I
Authority: 41 U.S.C. 421 and 48 CFR
chapter 1.
PART 202—DEFINITIONS OF WORDS
AND TERMS
2. Section 202.101 is amended in the
definition of ‘‘Contracting activity’’ as
follows:
I a. In the list with the heading
‘‘NAVY’’, by removing ‘‘Deputy,
Acquisition Management, Office of the
Assistant Secretary of the Navy
(Research, Development, and
Acquisition)’’ and adding in its place
‘‘Office of the Deputy Assistant
Secretary of the Navy (Acquisition &
Logistics Management)’’; and
I b. By revising the list with the heading
‘‘AIR FORCE’’.
The revised list reads as follows:
I
202.101
AGENCY:
A. Background
18:26 Sep 05, 2007
Michele P. Peterson,
Editor, Defense Acquisition Regulations
System.
Chapter 2—Amended
SUMMARY: DoD has adopted as final,
without change, an interim rule
amending the Defense Federal
Acquisition Regulation Supplement
(DFARS) to provide a single reference to
DoD-unique acquisition flexibilities that
may be used to facilitate and expedite
acquisitions of supplies and services
during emergency situations.
EFFECTIVE DATE: September 6, 2007.
FOR FURTHER INFORMATION CONTACT: Mr.
Michael Benavides, Defense Acquisition
Regulations System, OUSD (AT&L)
DPAP (DARS), IMD 3D139, 3062
Defense Pentagon, Washington, DC
20301–3062. Telephone (703) 602–1302;
facsimile (703) 602–7887. Please cite
DFARS Case 2006–D036.
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
Government procurement.
51187
*
*
Definitions.
*
*
*
AIR FORCE
Office of the Assistant Secretary of the
Air Force (Acquisition)
Office of the Deputy Assistant Secretary
(Contracting)
Air Force District of Washington
Air Force Operational Test & Evaluation
Center
Air Force Special Operations Command
United States Air Force Academy
Air Force Materiel Command
Air Force Reserve Command
Air Combat Command
Air Mobility Command
Air Education and Training Command
Pacific Air Forces
United States Air Forces in Europe
Air Force Space Command
Program Executive Office for Aircraft
Systems
Program Executive Office for Command
and Control & Combat Support
Systems
Program Executive Office for Combat
and Mission Support
Program Executive Office for F/A–22
Programs
Program Executive Office for Joint Strike
Fighter
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]]>Agencies
[Federal Register Volume 72, Number 172 (Thursday, September 6, 2007)]
[Rules and Regulations]
[Pages 51180-51187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17634]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://
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 https://
www.regulations.gov, you my access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
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: https://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
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 https://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
----------------------------------------------------------------------------------------------------------------
Target MOE/UF, Special
Exposure Scenario Dose Used in Risk FQPA SF for Risk Study and Toxicological
Assessment (mg/kg/day) Assessment Effects
----------------------------------------------------------------------------------------------------------------
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..
----------------------------------------------------------------------------
Acute RfD = 0.1 mg/kg/day (for Females age 13-50)
----------------------------------------------------------------------------------------------------------------
[[Page 51183]]
Acute Dietary(general population) An acute dietary endpoint was not identified in the data base. This risk
assessment is not required
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Chronic RfD = 0.1 mg/kg/day
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
Dermal, Intermediate- and Long-term No appropriate endpoint identified
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 https://
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 https://
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 https://
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.
* * * * * * *
------------------------------------------------------------------------
[[Page 51187]]
* * * * *
[FR Doc. E7-17634 Filed 9-5-07; 8:45 am]
BILLING CODE 6560-50-S
