Residues of Quaternany Ammonium Compounds, Didecyl Dimethyl Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate; Exemption from the Requirement of a Tolerance, 37852-37858 [E8-14880]
Download as PDF
<![CDATA[
37852
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
mstockstill on PROD1PC66 with RULES
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
VerDate Aug<31>2005
17:12 Jul 01, 2008
Jkt 214001
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 23, 2008.
Lois Rossi,
Director, Registration 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 180.220 is amended by
adding text to paragraph (d) to read as
follows:
I
§ 180.220 Atrazine; tolerances for
residues.
*
*
*
*
*
(d) Indirect or inadvertant residues.
Tolerances are established for indirect
or inadvertant residues of atrazine, 2chloro-4-ethylamino-6-isopropylaminos-triazine, in or on the following raw
agricultural commodity when present
therein as a result of application of
atrazine to the growing crops in
paragraph (a) of this section:
applied/used in public eating places,
dairy processing equipment, and/or
food processing equipment and utensils.
Lonza, Inc., submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA), requesting to establish
concentration limits of DDACB in enduse products eligible for the exemption
from the requirement of a tolerance. As
amended, the regulation will exempt
solutions from the requirement of
tolerance residues resulting from
contact with surfaces treated with
solutions where the end-use
concentration of DDACB does not
exceed 240 parts per million (ppm).
DATES: This regulation is effective July
2, 2008. Objections and requests for
hearings must be received on or before
September 2, 2008, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–1024. 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
Commodity
Parts per million
the instructions on the regulations.gov
website to view the docket index or
Vegetable, leafy, except
brassica, group 4 ........
0.25 access available documents. All
documents in the docket are listed in
[FR Doc. E8–15010 Filed 7–1–08; 8:45 am]
the docket index available in
regulations.gov. Although listed in the
BILLING CODE 6560–50–S
index, some information is not publicly
available, e.g., Confidential Business
ENVIRONMENTAL PROTECTION
Information (CBI) or other information
AGENCY
whose disclosure is restricted by statute.
Certain other material, such as
40 CFR Part 180
copyrighted material, is not placed on
the Internet and will be publicly
[EPA–HQ–OPP–2006–1024; FRL–8368–1]
available only in hard copy form.
Residues of Quaternany Ammonium
Publicly available docket materials are
Compounds, Didecyl Dimethyl
available either in the electronic docket
Ammonium Carbonate and Didecyl
at https://www.regulations.gov, or, if only
Dimethyl Ammonium Bicarbonate;
available in hard copy, at the Office of
Exemption from the Requirement of a
Pesticide Programs (OPP) Regulatory
Tolerance
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
AGENCY: Environmental Protection
Crystal Dr., Arlington, VA. The hours of
Agency (EPA).
operation of this Docket Facility are
ACTION: Final rule.
from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
SUMMARY: This regulation establishes an
holidays. The Docket Facility telephone
exemption from the requirement of a
tolerance for residues of the quaternany number is (703) 305–5805.
ammonium compounds, didecyl
FOR FURTHER INFORMATION CONTACT:
dimethyl ammonium carbonate and
Velma Noble, Antimicrobials Division
didecyl dimethyl ammonium
(7510P), Environmental Protection
bicarbonate (hereinafter cited jointly as
Agency, 1200 Pennsylvania Ave., NW.,
DDACB), on food-contact surfaces when Washington, DC 20460–0001; telephone
PO 00000
Frm 00078
Fmt 4700
Sfmt 4700
ADDRESSES:
E:\FR\FM\02JYR1.SGM
02JYR1
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
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 dairy cattle milk
producer, food manufacturer, or
beverage manufacturer. Potentially
affected entities may include, but are
not limited to:
• Dairy Cattle Milk Production
(NAICS code 11212).
• Food manufacturing (NAICS code
311).
• Beverage Manufacturing (NAICS
code 3121).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may 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.
mstockstill on PROD1PC66 with RULES
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by FQPA, any person may file
an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–1024 in the subject line on
the first page of your submission. All
VerDate Aug<31>2005
17:12 Jul 01, 2008
Jkt 214001
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before September 2, 2008.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2006–1024, 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 Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Exemption
In the Federal Register of November
28, 2007 (72 FR 67300) (FRL–8141–2),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 6F7131)
by Lonza, Inc., 90 Boroline Rd.,
Allendale, NJ 07401. The petition
requested that 40 CFR 180.190(a) be
amended by establishing concentration
limits for DDACB in end-use solutions
eligible for tolerance exemption. That
notice referenced a summary of the
petition prepared by Lonza, Inc., the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
PO 00000
Frm 00079
Fmt 4700
Sfmt 4700
37853
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of FFDCA, which requires
EPA to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance and to ‘‘ensure
that there is a reasonable certainty that
no harm will result to infants and
children from aggregate exposure to the
pesticide chemical residue ....’’
Consistent with section 408(c)(2)(A)
of FFDCA, and the factors specified in
section 408(c)(2)(B) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
exemption from the requirement for a
tolerance for residues of DDACB on
food-contact surfaces in public eating
places, dairy processing equipment, and
food processing equipment and utensils.
EPA’s assessment of exposures and risks
associated with establishing the
exemption from the requirement for a
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by DDACB as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are
discussed in this unit.
DDACB is a part of the aliphatic alkyl
quaternaries chemical case which is
comprised of six compounds that are
structurally similar quaternary
ammonium compounds (quats). This
group of chemicals are characterized by
having a positively charged nitrogen
covalently bonded to two alkyl group
substituents (at least one C8 or longer)
E:\FR\FM\02JYR1.SGM
02JYR1
mstockstill on PROD1PC66 with RULES
37854
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
and two methyl substituents. In finished
form, these quats are salts with
positively charged nitrogen (cation)
balanced by a negatively charged
molecule (anion). The anion for the
quats in this group are chlorine,
carbonate, bicarbonate, or bromine.
In 1988, EPA issued PR Notice 88–2
outlining ‘‘Clustering of Quaternary
Ammonium Compounds.’’ In that PR
Notice, quats were clustered into 4
groups as follows:
Group I: The alkyl or hydroxyalkyl
(straight chain) substituted quats;
otherwise referred to as the aliphatic
alkyl quaternaries.
Group II: The non-halogenated benzyl
substituted quats (including alkyl
benzyl, dodecyhlbenzyl, hydroxybenzyl,
hydroxyethylbenzyl, and
naphylmethyl).
Group III: The di- and trichlorobenzyl substituted quats.
Group IV: Quats with unusual
substitutes (charged heterocyclic
compounds).
In all types of aliphatic alkyl
ammonium chloride quaternaries, it is
the positive entity (quaternized nitrogen
containing the aliphatic alkyl and/or
aromatic alkyl groups) that is of
relevance from toxicology and exposure
perspectives. The negative part of the
aliphatic alkyl ammonium chloride
quaternaries (counter ion) is relatively
non-toxic entities (bicarbonate,
carbonate, chloride). Aliphatic alkyl
ammonium chloride quaternaries were
originally formulated with chloride as
the negative or the counter ion.
However, one negative ion in the
aliphatic alkyl ammonium chloride
quaternaries can be replaced with
another without disrupting the
structural integrity of the chemical (i.e.,
quaternized nitrogen) and thereby
without having a significant effect on
toxicity. Accordingly, the toxicological
profiles of the aliphatic alkyl
ammonium chloride quaternaries are
very similar and a toxicological
assessment of any of the aliphatic alkyl
ammonium chloride quaternaries is
representative of the group. Didecyl
dimethyl ammonium chloride (DDAC),
was chosen as the representative
chemical for aliphatic alkyl ammonium
chloride quaternaries because it was
registered first. On this basis, the
toxicology database for DDAC is
accepted as representative of the hazard
for this class of quaternary ammonium
compounds.
The aliphatic alkyl ammonium
chloride quaternaries are corrosive,
VerDate Aug<31>2005
17:12 Jul 01, 2008
Jkt 214001
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 negative
carcinogenicity studies in rats and mice
feeding studies using doses above limit
dose. There is no evidence of these
chemicals being associated with
increased susceptibility to
developmental toxicity or reproductive
toxicity based on two developmental
toxicity studies and a 2–generation
reproductive study. Lastly, they are
negative for mutagenicity and
neurotoxicity.
Specific information on the studies
received and the nature of the toxic
effects caused by aliphatic alkyl
quaternaries can be found at https://
www.regulations.gov. Docket ID Number
EPA–HQ–OPP–2006–0338, Didecyl
Dimethyl Ammonium Chloride
(DDAC)—Report of Antimicrobials
Division Toxicity Endpoint Committee
(ADTC) and the Hazard Identification
Assessment Review Committee
(HIARC).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. The Level of Concern (LOC)
is a reference value expressed as either
a reference dose/population adjusted
dose (RfD/PAD) or margin of exposure
(MOE). Safety is assessed for acute and
chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
PO 00000
Frm 00080
Fmt 4700
Sfmt 4700
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
MOE called for by the product of all
applicable UFs is not exceeded.
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk and
estimates risk in terms of the probability
of a cancer occurrence greater than that
expected in a lifetime. Generally, cancer
risks are considered non-threshold. For
more information on the general
principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
The Agency’s LOC for aliphatic alkyl
ammonium chloride quaternaries’
inhalation and oral exposures is 100
(i.e., a MOE less than 100 exceeds the
Agency’s level of concern). The LOC is
based on an UF of 10x for interspecies
extrapolation and 10x UF for
intraspecies extrapolation. For dermal
exposures, irritation as the effect was
selected for the short-term endpoint and
a reduced MOE was used to characterize
the risk. The use of irritation as a toxic
endpoint for assessment of dermal risk
is appropriate in this case, as dermal
exposure that results in primarily an
irritation response is considered a selflimiting type of exposure that is not
expected to last for any length of time,
and variability in the response is not
expected to be as great as systemic toxic
responses. For aliphatic alkyl
quaternaries, the MOE for short-term
dermal risk is reduced to a total factor
of 10x (3x for interspecies extrapolation,
3x for intraspecies variation).
A summary of the toxicological
endpoints for aliphatic alkyl
quaternaries used for human risk
assessment is shown in Table 1 of this
unit. Specific information on the studies
received such as the NOAEL and the
LOAEL from the toxicity studies caused
by aliphatic alkyl quaternaries can be
found at https://www.regulations.gov.
Docket ID Number EPA–HQ–OPP–
2006–0338, Didecyl Dimethyl
Ammonium Chloride (DDBAC)—Report
of Antimicrobials Division Toxicity
Endpoint Committee (ADTC) and the
Hazard Identification Assessment
Review Committee (HIARC).
E:\FR\FM\02JYR1.SGM
02JYR1
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
37855
TABLE 1. —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ALIPHATIC ALKYL AMMONIUM CHLORIDE
QUATERNARIES FOR USE IN HUMAN RISK ASSESSMENT
Exposure/Scenario
Point of Departure and
Uncertainty/Safety Factors
RfD, PAD, LOC for Risk Assessment
Study and Toxicological Effects
Acute dietary
(Females 13–50 years of
age)
NOAEL = 10 milligrams/
kilograms/day (mg/kg/
day) UFA = 10x
UFH = 10 x
FQPA SF = 1x
Acute RfD = 0.1 mg/kg/day
aPAD = 0.1 mg/kg/day
Prenatal Developmental Toxicity—Rat
(MRID 41886701)
LOAEL = 20 mg/kg/day based on increased incidence of skeletal variations.
Chronic dietary
(All populations)
NOAEL= 10 mg/kg/day
UFA = 10x
UFH = 10 x
FQPA SF = 1x
Chronic RfD =0.1 mg/kg/day
cPAD = 0.1 mg/kg/day
Chronic Toxicity—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.
Incidental oral short-term
(1 to 30 days)
NOAEL= 10 mg/kg/day
UFA = 10x
UFH = 10 x
FQPA SF = 1x
LOC for MOE = 100
Prenatal Developmental Toxicity—Rat
(MRID 41886701)
LOAEL = 20 mg/kg/day based on increased incidence of skeletal variations.
Incidental oral intermediate-term
(1 to 6 months)
NOAEL= 10 mg/kg/day
UFA= 10x.
UFH= 10x
FQPA SF =1x
LOC for MOE = 100
Chronic Toxicity—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-term
(1 to 6 months)
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.
Dermal study NOAEL= 2
mg/kg/day ( (8
micrograms (ug)/centimeters (cm)2)a %when
appropriate)
UFA = 3 x
UFH = 3x
FQPA SF = 1x
LOC for MOE = 10
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 endpoint identified.
Inhalation short-term
(1 to 30 days)
Oral study NOAELb= 10
mg/kg/day (inhalation
absorption rate = 100%)
UFA = 10 x
UFH = 10 x
FQPA SF = 1x
LOC for MOE = 100
Prenatal Developmental Toxicity
(MRID 41886701)
LOAEL = 20 mg/kg/day based on increased incidence of skeletal variations.
Inhalation
(1 to 6 months)
Oral) study NOAELb = 10
mg/kg/day (inhalation
absorption rate = 100%)
UFA = 10x
UFH = 10x
FQPA SF = 1x
LOC for MOE = 100
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.
mstockstill on PROD1PC66 with RULES
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.
a Short-term dermal endpoint = (2 mg/kg rat x 0.2 kg rat x 1,000 ug/mg)/50 cm2 area of rat dosed = 8 ug/cm2.
b An additional UF of 10x is used for route extrapolation from an oral endpoint to determine, if a confirmatory study is warranted.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to DDACB, EPA considered
exposure under the petitioned-for
VerDate Aug<31>2005
17:12 Jul 01, 2008
Jkt 214001
exemption as well as all existing
aliphatic alkyl quaternaries exemptions
or tolerances in (40 CFR 180.940(a)).
EPA assessed dietary exposures from
DDACB in food as follows:
PO 00000
Frm 00081
Fmt 4700
Sfmt 4700
Aliphatic alkyl quaternaries are to be
used as a sanitizer on appliances,
beverage bottling, counter tops, food
packaging, refrigerators, tables, and
utensils. The use of these actives in
antimicrobial products for use on food
E:\FR\FM\02JYR1.SGM
02JYR1
mstockstill on PROD1PC66 with RULES
37856
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
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 appliances,
countertops, equipment, and utensils
can migrate to food coming into contact
with the treated and rinsed surfaces and
can be ingested by humans.
The Agency assessed acute and
chronic dietary exposures from the use
of DDACB as a disinfectant and foodcontact sanitizer on utensils,
countertops, and in food/beverage
processing facilities. The assessment
calculated the Daily Dietary Dose (DDD)
and the Estimated Daily Intake (EDI)
using modified Food and Drug
Administration (FDA) methodologies for
utensils and Indirect Dietary Residential
Exposure Model software (IDREAM) for
countertops. IDREAM incorporates
consumption data from United States
Department of Agriculture (USDA)
Continuing Survey of Food Intakes by
Individuals (CSFII) for 1994–1996 and
1998. The USDA CSFII 1994–1996 and
1998 data are based on the reported
consumption of more than 20,000
individuals over two non-consecutive
survey days.
The EDI calculations presented in this
assessment for treated indirect dietary
exposures resulting from sanitizing
utensils assumed that food would
contact 4,000 cm2 (which represents
contact with treated china, glass, and
silverware used by an individual who
regularly eats three meals per day at an
institutional or public facility) and that
the residual solution remaining on the
surface or pesticide migration fraction is
1 mg/cm2 of treated area. The body
weights used for this assessment were
70 kg for an adult male, 60 kg for an
adult woman, and 10 kg for an infant.
Based on data provided in a new
residue study, Transferability
Equivalence among Quats and Measured
Food Surrogate Transfer Efficiency
(MRID 46870703), a conservative
transfer rate of 43% was used to
demonstrate the amount of residues on
the surface that will be transferred to
food and subsequently ingested. The
maximum application rate for DDACB
on utensils is 0.0020 lbs active
ingredient (a.i) per gallon of treatment
solution.
There are two levels of refinement for
assessing dietary exposure to
antimicrobial products used on
countertops. The three dimensional
approach, Tier 2, was utilized for this
assessment. This conservative approach
uses food consumption and preparation
patterns as well as data and
assumptions that are not chemical
specific. Food ingredients are separated
VerDate Aug<31>2005
17:12 Jul 01, 2008
Jkt 214001
into nine categories based on food
preparation, food physical properties,
and potential, or likelihood of contact
with treated countertops. The nine food
categories are liquids, fruit, bread,
cheese, vegetable, meat, purees (e.g.,
oatmeal, pudding), pieces (foods
normally consumed in small pieces),
and powders (foods normally used in
powder/granular forms). Assumed
countertop residues are converted to
estimated residues contacting the
countertops using a translation factor for
each food category, and default residue
transfer efficiency for a representative
food. Therefore, IDREAM combines the
estimated countertop residues for
surface treatment products, CSFII
consumption data, food-specific
conversion factors that relate the surface
area contacting a countertop with
corresponding weight of the food item,
and the transfer efficiency of residues
from countertops to food. Conservative
assumptions for these analyses include:
All disinfectants registered to disinfect
kitchen countertops are included; all
foods are prepared on those
countertops; all prepared foods will
come in contact with treated
countertops at the maximum
application rate and transfer residues do
not diminish over time (i.e., residue
reduction will not occur from cooking
or preparation processes); there is a
100% likelihood of contact to account
for both commercial and residential
scenarios: All commercial and
households use the same active
ingredients; all foods are prepared and
consumed.
When assessing the food bottling/
packaging use, EPA assumed a 100%
transfer rate because the food is
potentially in contact with the treated
surfaces for very long periods of time.
The maximum application rate for
DDACB for bottling/packing of food is
0.0020 lbs a.i. per gallon of treatment
solution. EDI values were calculated
using an approach similar to that used
for treated food utensils. Exposure was
assumed to occur through the ingestion
of three food products that might be
packaged with treated material:
Beverages (alcoholic and non-alcoholic),
egg products, and milk. A calorie intake
modification factor of 0.64 was applied
to the EDI for a child to account for the
differences between intake values
among children and adults. The
calculated percent of an aPAD and a
cPAD do not exceed 100% and therefore
are not of a concern.
2. Dietary exposure from drinking
water. DDACB outdoor uses are as an
algaecide in wood preservative
treatment and a slimicide in secondary
oil field uses. The oil field uses are
PO 00000
Frm 00082
Fmt 4700
Sfmt 4700
considered to be contained. The other
uses are not expected to significantly
contaminate drinking water sources.
Therefore, the DDACB contributions for
drinking water exposure are considered
to be negligible and are not quantified.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
tables).
DDACB is currently registered for the
following residential non-dietary sites:
Homes and day-care nurseries. EPA
assessed residential exposure using the
following assumptions:
Residential exposure may occur
during the application as well as post
application of DDACB to indoor hard
surfaces (e.g., mopping, trigger pump
sprays, wiping). The residential handler
scenarios were assessed to determine
dermal and inhalation exposures.
Residential post application scenarios
such as children exposure to treated
toys and floors were also assessed to
determine dermal and incidental oral
exposures. Surrogate dermal, inhalation,
and incidental oral unit exposure values
were estimated using Pesticide Handler
Exposure Database (PHED) data and the
Chemical Manufactures Association
Antimicrobial Exposure Assessment
Study (EPA, 1999). Note that for this
assessment, EPA assumed that
residential users complete all elements
of an application (mix/load/apply)
without the use of personal protective
equipment.
The duration for most residential
exposures is believed to be best
represented by the short-term duration
(1 to 30 days). The short-term duration
was chosen for this assessment because
the residential handler and postapplication scenarios are assumed to be
performed on an episodic, not daily
basis.
Specific information on the
residential exposure assessment for
DDACB can be found at https://
www.regulations.gov. Docket ID Number
EPA–HQ–OPP–2006–1024, Review of
Petition to Amend 40 CFR 180.940 to
add Didecyl Dimethyl Ammonium
Carbonate/Bicarbonate.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
E:\FR\FM\02JYR1.SGM
02JYR1
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
mstockstill on PROD1PC66 with RULES
substances that have a common
mechanism of toxicity.’’
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 Aliphatic
Alkyl Quaternary (DDAC) Reregistration
Eligibility Decision (RED)) were
developed by assuming that a DDAC
compound was used on 100% 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.
D. Safety Factor for Infants and
Children
1. In general. Section 408 of FFDCA
provides that EPA shall apply an
additional (10x) tenfold margin of safety
for infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10x when reliable data do not support
the choice of a different factor, or, if
reliable data are available, EPA uses a
different additional FQPA SF value
based on the use of traditional UFs and/
or FQPA SFs, as appropriate.
2. Prenatal and postnatal sensitivity.
Given the data on the aliphatic alkyl
ammonium chloride quaternaries, there
is no evidence that DDACB result in
increased susceptibility in in utero rats
or rabbits in the prenatal developmental
studies or in young rats in the 2–
generation reproduction study.
3. Conclusion. EPA has determined
that reliable data show that it would be
safe for infants and children to reduce
the FQPA SF to 1x. That decision is
based on the following findings:
i. The toxicity database for aliphatic
alkyl ammonium chloride quaternaries
is complete.
ii. There is no indication that
aliphatic alkyl ammonium chloride
quaternaries are a neurotoxic chemical
VerDate Aug<31>2005
17:12 Jul 01, 2008
Jkt 214001
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that aliphatic
alkyl ammonium chloride quaternaries
result in increased susceptibility in in
utero rats or rabbits in the prenatal
developmental studies or in young rats
in the 2–generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
Although EPA may, in the future, refine
exposure estimates for aliphatic alkyl
ammonium chloride 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 ammonium chloride
quaternaries.
E. Aggregate Risks and Determination of
Safety
1. Dietary risks from food and feed
uses. EPA compares the estimated
dietary exposures to an aPAD and a
cPAD, 0.1 mg/kg/day, which are the
same value for DDACB. Generally, a
dietary exposure estimate that is less
than 100% of the aPAD or the cPAD
does not exceed the Agency’s LOC.
The antimicrobial indirect food use
acute and chronic risk estimates from
exposure to treated utensils and
countertops are below the Agency’s
LOC. For adult males, the acute and
chronic dietary exposure risk estimates
are 5.9% for utensils and 1. 92% for
countertops. The aPAD and cPAD for
adult females of child bearing age (13–
49), the highly exposed group, is 6.9%
for utensils and 1. 79% for countertops.
For children ages 1–2, the most highly
exposed population subgroup, the acute
and chronic dietary risk estimates are
41. 3% for utensils and 6.21% for
countertops. Therefore, dietary exposure
estimates are below the Agency’s LOC
for all population subgroups. The
antimicrobial indirect food use chronic
risk estimates from exposure to treated
food packaging and beverage bottles are
below the Agency’s LOC. The percent
cPAD values exceeded 100% and are
not of concern.
Specific information on the dietary
exposure assessment for DDACB can be
found at https://www.regulations.gov.
Docket ID Number EPA–HQ–2006–
1024, Review of Petition to Amend 40
CFR 180.940 to add Didecyl Dimethyl
Ammonium Carbonate/Bicarbonate.
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
PO 00000
Frm 00083
Fmt 4700
Sfmt 4700
37857
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.
Based on the toxicological and
exposure data discussed in this
preamble, EPA concludes that DDACB
will not pose a risk under reasonably
foreseeable circumstances. Accordingly,
EPA finds that there is a reasonable
certainty that no harm will result to the
general population, or to infants and
children from aggregate exposure to
DDACB residues.
IV. Other Considerations
An analytical method for food is not
needed. Food-contact sanitizers are
typically regulated by the State health
departments to ensure that the food
industry is using products in
compliance with the regulations in 40
CFR 180.940. The end-use solution that
is applied to the food-contact surface is
analyzed not food items that may come
into contact with treated surface. An
analytical method is available to analyze
the use dilution that is applied to foodcontact surfaces. A titration method is
used to determine the total amount of
quaternary compound. If the use
solution is a mixture of ADBAC and
DDACB, then high pressure liquid
chromatogram with ultraviolet visible
(HPLC-UV) is used to determine the
amount of ADBAC. The amount of
DDACB is determined by calculating the
difference between the total amount of
quaternary compounds and ADBAC.
V. Conclusion
Therefore, an exemption is
established for residues of DDACB,
regulated chemical, on food-contact
surfaces in public eating establishments,
on dairy processing equipment, and
food processing equipment and utensils.
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
E:\FR\FM\02JYR1.SGM
02JYR1
37858
Federal Register / Vol. 73, No. 128 / Wednesday, July 2, 2008 / Rules and Regulations
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
Pesticide Chemical
*
*
*
*
148788–55–0/148812–654–1
*
*
*
*
*
*
ACTION:
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 261 and 266
mstockstill on PROD1PC66 with RULES
[FRL–8687–6]
RIN 2090–AA15
US Filter Recovery Services, Inc.,
Under Project XL
Environmental Protection
Agency (EPA).
AGENCY:
18:15 Jul 01, 2008
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Aliphatic
alkyl quaternaries, Food-contact
sanitizers, Pesticides and pests,
Quaternary ammonium compounds,
Reporting and recordkeeping
requirements.
Dated: June 10, 2008.
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
alphabetically adding an entry to the
table in paragraph (a) to read as follows:
I
§ 180.940 Tolerance exemptions for active
and inert ingredients for use in
antimicrobial formulations (Food-contact
surface sanitizing solutions).
*
*
*
(a) * * *
*
Jkt 214001
*
*
*
When ready for use, the end-use concentration of
these specific ammonium compounds is not to exceed 240 ppm of active quaternary ammonium
compound.
*
Final rule.
SUMMARY: The Environmental Protection
Agency (EPA) is withdrawing a final
rule published on May 22, 2001 which
modified the regulations under the
Resource, Conservation and Recovery
Act (RCRA) to enable the
implementation of the US Filter
Recovery Services, Inc. (USFRS) project
that was developed under EPA’s Project
eXcellence in Leadership (Project XL)
program. Project XL was a national pilot
program that allowed state and local
governments, businesses and federal
facilities to work with EPA to develop
more cost-effective ways of achieving
environmental and public health
PO 00000
Frm 00084
Fmt 4700
Sfmt 4700
*
Limits
[FR Doc. E8–14880 Filed 7–1–08; 8:45 am]
VerDate Aug<31>2005
List of Subjects in 40 CFR Part 180
CAS Reg. No.
*
*
Quaternary ammonium compounds, didecyl
dimethyl ammonium carbonate/didecyl dimethyl ammonium bicarbonate
*
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).
*
*
protection. In exchange, EPA provided
regulatory, policy or procedural
flexibilities to conduct the pilot
experiments.
The final rule is effective August
1, 2008.
DATES:
FOR FURTHER INFORMATION CONTACT:
Sandra Panetta, Mail Code 1870T, U.S.
Environmental Protection Agency,
Office of Policy, Economics and
Innovation, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460. Ms.
Panetta’s telephone number is (202)
566–2184 and her e-mail address is
panetta.sandra@epa.gov. Further
information on today’s action may also
be obtained on the Internet at https://
E:\FR\FM\02JYR1.SGM
02JYR1
]]>Agencies
[Federal Register Volume 73, Number 128 (Wednesday, July 2, 2008)]
[Rules and Regulations]
[Pages 37852-37858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14880]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-1024; FRL-8368-1]
Residues of Quaternany Ammonium Compounds, Didecyl Dimethyl
Ammonium Carbonate and Didecyl Dimethyl Ammonium Bicarbonate; Exemption
from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the quaternany ammonium compounds,
didecyl dimethyl ammonium carbonate and didecyl dimethyl ammonium
bicarbonate (hereinafter cited jointly as DDACB), on food-contact
surfaces when applied/used in public eating places, dairy processing
equipment, and/or food processing equipment and utensils. Lonza, Inc.,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting to establish concentration limits of DDACB in end-
use products eligible for the exemption from the requirement of a
tolerance. As amended, the regulation will exempt solutions from the
requirement of tolerance residues resulting from contact with surfaces
treated with solutions where the end-use concentration of DDACB does
not exceed 240 parts per million (ppm).
DATES: This regulation is effective July 2, 2008. Objections and
requests for hearings must be received on or before September 2, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-1024. 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 website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone
[[Page 37853]]
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 dairy
cattle milk producer, food manufacturer, or beverage manufacturer.
Potentially affected entities may include, but are not limited to:
Dairy Cattle Milk Production (NAICS code 11212).
Food manufacturing (NAICS code 311).
Beverage Manufacturing (NAICS code 3121).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may 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 FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-1024 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 September 2, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-1024, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
II. Petition for Exemption
In the Federal Register of November 28, 2007 (72 FR 67300) (FRL-
8141-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F7131) by Lonza, Inc., 90 Boroline Rd., Allendale, NJ
07401. The petition requested that 40 CFR 180.190(a) be amended by
establishing concentration limits for DDACB in end-use solutions
eligible for tolerance exemption. That notice referenced a summary of
the petition prepared by Lonza, Inc., the registrant, which is
available to the public in the docket, https://www.regulations.gov.
There were no comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue
....''
Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in section 408(c)(2)(B) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
exemption from the requirement for a tolerance for residues of DDACB on
food-contact surfaces in public eating places, dairy processing
equipment, and food processing equipment and utensils. EPA's assessment
of exposures and risks associated with establishing the exemption from
the requirement for a tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by DDACB as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in this unit.
DDACB is a part of the aliphatic alkyl quaternaries chemical case
which is comprised of six compounds that are structurally similar
quaternary ammonium compounds (quats). This group of chemicals are
characterized by having a positively charged nitrogen covalently bonded
to two alkyl group substituents (at least one C8 or longer)
[[Page 37854]]
and two methyl substituents. In finished form, these quats are salts
with positively charged nitrogen (cation) balanced by a negatively
charged molecule (anion). The anion for the quats in this group are
chlorine, carbonate, bicarbonate, or bromine.
In 1988, EPA issued PR Notice 88-2 outlining ``Clustering of
Quaternary Ammonium Compounds.'' In that PR Notice, quats were
clustered into 4 groups as follows:
Group I: The alkyl or hydroxyalkyl (straight chain) substituted
quats; otherwise referred to as the aliphatic alkyl quaternaries.
Group II: The non-halogenated benzyl substituted quats (including
alkyl benzyl, dodecyhlbenzyl, hydroxybenzyl, hydroxyethylbenzyl, and
naphylmethyl).
Group III: The di- and tri-chlorobenzyl substituted quats.
Group IV: Quats with unusual substitutes (charged heterocyclic
compounds).
In all types of aliphatic alkyl ammonium chloride quaternaries, it
is the positive entity (quaternized nitrogen containing the aliphatic
alkyl and/or aromatic alkyl groups) that is of relevance from
toxicology and exposure perspectives. The negative part of the
aliphatic alkyl ammonium chloride quaternaries (counter ion) is
relatively non-toxic entities (bicarbonate, carbonate, chloride).
Aliphatic alkyl ammonium chloride quaternaries were originally
formulated with chloride as the negative or the counter ion. However,
one negative ion in the aliphatic alkyl ammonium chloride quaternaries
can be replaced with another without disrupting the structural
integrity of the chemical (i.e., quaternized nitrogen) and thereby
without having a significant effect on toxicity. Accordingly, the
toxicological profiles of the aliphatic alkyl ammonium chloride
quaternaries are very similar and a toxicological assessment of any of
the aliphatic alkyl ammonium chloride quaternaries is representative of
the group. Didecyl dimethyl ammonium chloride (DDAC), was chosen as the
representative chemical for aliphatic alkyl ammonium chloride
quaternaries because it was registered first. On this basis, the
toxicology database for DDAC is accepted as representative of the
hazard for this class of quaternary ammonium compounds.
The aliphatic alkyl ammonium chloride 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 negative
carcinogenicity studies in rats and mice feeding studies using doses
above limit dose. There is no evidence of these chemicals being
associated with increased susceptibility to developmental toxicity or
reproductive toxicity based on two developmental toxicity studies and a
2-generation reproductive study. Lastly, they are negative for
mutagenicity and neurotoxicity.
Specific information on the studies received and the nature of the
toxic effects caused by aliphatic alkyl quaternaries can be found at
https://www.regulations.gov. Docket ID Number EPA-HQ-OPP-2006-0338,
Didecyl Dimethyl Ammonium Chloride (DDAC)--Report of Antimicrobials
Division Toxicity Endpoint Committee (ADTC) and the Hazard
Identification Assessment Review Committee (HIARC).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. The Level of Concern (LOC) is a reference
value expressed as either a reference dose/population adjusted dose
(RfD/PAD) or margin of exposure (MOE). Safety is assessed for acute and
chronic dietary risks by comparing aggregate food and water exposure to
the pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the MOE called for by
the product of all applicable UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of a cancer occurrence greater than that expected in
a lifetime. Generally, cancer risks are considered non-threshold. For
more information on the general principles EPA uses in risk
characterization and a complete description of the risk assessment
process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
The Agency's LOC for aliphatic alkyl ammonium chloride
quaternaries' inhalation and oral exposures is 100 (i.e., a MOE less
than 100 exceeds the Agency's level of concern). The LOC is based on an
UF of 10x for interspecies extrapolation and 10x UF for intraspecies
extrapolation. For dermal exposures, irritation as the effect was
selected for the short-term endpoint and a reduced MOE was used to
characterize the risk. The use of irritation as a toxic endpoint for
assessment of dermal risk is appropriate in this case, as dermal
exposure that results in primarily an irritation response is considered
a self-limiting type of exposure that is not expected to last for any
length of time, and variability in the response is not expected to be
as great as systemic toxic responses. For aliphatic alkyl quaternaries,
the MOE for short-term dermal risk is reduced to a total factor of 10x
(3x for interspecies extrapolation, 3x for intraspecies variation).
A summary of the toxicological endpoints for aliphatic alkyl
quaternaries used for human risk assessment is shown in Table 1 of this
unit. Specific information on the studies received such as the NOAEL
and the LOAEL from the toxicity studies caused by aliphatic alkyl
quaternaries can be found at https://www.regulations.gov. Docket ID
Number EPA-HQ-OPP-2006-0338, Didecyl Dimethyl Ammonium Chloride
(DDBAC)--Report of Antimicrobials Division Toxicity Endpoint Committee
(ADTC) and the Hazard Identification Assessment Review Committee
(HIARC).
[[Page 37855]]
Table 1. --Summary of Toxicological Doses and Endpoints for Aliphatic Alkyl Ammonium Chloride Quaternaries for
Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 10 milligrams/ Acute RfD = 0.1 mg/kg/ Prenatal Developmental
(Females 13-50 years of age)........ kilograms/day (mg/kg/ day Toxicity--Rat
day) UFA = 10x aPAD = 0.1 mg/kg/day... (MRID 41886701)
UFH = 10 x............. LOAEL = 20 mg/kg/day
FQPA SF = 1x........... based on increased
incidence of skeletal
variations.
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL= 10 mg/kg/day UFA Chronic RfD =0.1 mg/kg/ Chronic Toxicity--Dog
(All populations).................... = 10x day (MRID 41970401)
UFH = 10 x............. cPAD = 0.1 mg/kg/day... LOAEL = 20 mg/kg/day
FQPA SF = 1x........... based on increased
incidence of clinical
signs in males and
females and decreased
total cholesterol
levels in females.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term NOAEL= 10 mg/kg/day UFA LOC for MOE = 100 Prenatal Developmental
(1 to 30 days)....................... = 10x Toxicity--Rat
UFH = 10 x............. (MRID 41886701)
FQPA SF = 1x........... LOAEL = 20 mg/kg/day
based on increased
incidence of skeletal
variations.
----------------------------------------------------------------------------------------------------------------
Incidental oral intermediate-term NOAEL= 10 mg/kg/day LOC for MOE = 100 Chronic Toxicity--Dog
(1 to 6 months)...................... UFA= 10x. (MRID 41970401)
UFH= 10x............... LOAEL = 20 mg/kg/day
FQPA SF =1x............ based on increased
incidence of clinical
signs in males and
females and decreased
total cholesterol
levels in females
----------------------------------------------------------------------------------------------------------------
Dermal short-term No endpoint identified. No dermal or systemic effects identified in the
(formulated product 0.13% a.i.)...... 21-day dermal toxicity study (MRID 45656601) up to and including the
limit dose of 1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Dermal short-term Dermal study NOAEL= 2 LOC for MOE = 10 90-Day Dermal Toxicity--
(1 to 6 months)...................... mg/kg/day ( (8 Rat
micrograms (ug)/ (MRID 41305901)
centimeters LOAEL = 6 mg/kg/day
(cm)\2\)\a\ %when based on increased
appropriate) clinical and gross
UFA = 3 x.............. findings (erythema,
UFH = 3x............... edema, exfoliation,
FQPA SF = 1x........... excoriation, and
ulceration.
----------------------------------------------------------------------------------------------------------------
Dermal intermediate- and Long-term... No endpoint identified.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term Oral study NOAEL\b\= LOC for MOE = 100 Prenatal Developmental
(1 to 30 days)....................... 10 mg/kg/day Toxicity
(inhalation absorption (MRID 41886701)
rate = 100%) LOAEL = 20 mg/kg/day
UFA = 10 x............. based on increased
UFH = 10 x............. incidence of skeletal
FQPA SF = 1x........... variations.
----------------------------------------------------------------------------------------------------------------
Inhalation Oral) study NOAEL\b\ = LOC for MOE = 100 Chronic Toxicity Study--
(1 to 6 months)...................... 10 mg/kg/day Dog
(inhalation absorption (MRID 41970401)
rate = 100%) LOAEL = 20 mg/kg/day
UFA = 10x.............. based on increased
UFH = 10x.............. incidence of clinical
FQPA SF = 1x........... signs males and
females and decreased
total cholesterol
levels in females.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE =
margin of exposure. LOC = level of concern.
\a\ Short-term dermal endpoint = (2 mg/kg rat x 0.2 kg rat x 1,000 ug/mg)/50 cm\2\ area of rat dosed = 8 ug/
cm\2\.
\b\ An additional UF of 10x is used for route extrapolation from an oral endpoint to determine, if a
confirmatory study is warranted.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to DDACB, EPA considered exposure under the petitioned-for
exemption as well as all existing aliphatic alkyl quaternaries
exemptions or tolerances in (40 CFR 180.940(a)). EPA assessed dietary
exposures from DDACB in food as follows:
Aliphatic alkyl quaternaries are to be used as a sanitizer on
appliances, beverage bottling, counter tops, food packaging,
refrigerators, tables, and utensils. The use of these actives in
antimicrobial products for use on food
[[Page 37856]]
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 appliances, countertops,
equipment, and utensils can migrate to food coming into contact with
the treated and rinsed surfaces and can be ingested by humans.
The Agency assessed acute and chronic dietary exposures from the
use of DDACB as a disinfectant and food-contact sanitizer on utensils,
countertops, and in food/beverage processing facilities. The assessment
calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake
(EDI) using modified Food and Drug Administration (FDA) methodologies
for utensils and Indirect Dietary Residential Exposure Model software
(IDREAM) for countertops. IDREAM incorporates consumption data from
United States Department of Agriculture (USDA) Continuing Survey of
Food Intakes by Individuals (CSFII) for 1994-1996 and 1998. The USDA
CSFII 1994-1996 and 1998 data are based on the reported consumption of
more than 20,000 individuals over two non-consecutive survey days.
The EDI calculations presented in this assessment for treated
indirect dietary exposures resulting from sanitizing utensils assumed
that food would contact 4,000 cm\2\ (which represents contact with
treated china, glass, and silverware used by an individual who
regularly eats three meals per day at an institutional or public
facility) and that the residual solution remaining on the surface or
pesticide migration fraction is 1 mg/cm\2\ of treated area. The body
weights used for this assessment were 70 kg for an adult male, 60 kg
for an adult woman, and 10 kg for an infant. Based on data provided in
a new residue study, Transferability Equivalence among Quats and
Measured Food Surrogate Transfer Efficiency (MRID 46870703), a
conservative transfer rate of 43% was used to demonstrate the amount of
residues on the surface that will be transferred to food and
subsequently ingested. The maximum application rate for DDACB on
utensils is 0.0020 lbs active ingredient (a.i) per gallon of treatment
solution.
There are two levels of refinement for assessing dietary exposure
to antimicrobial products used on countertops. The three dimensional
approach, Tier 2, was utilized for this assessment. This conservative
approach uses food consumption and preparation patterns as well as data
and assumptions that are not chemical specific. Food ingredients are
separated into nine categories based on food preparation, food physical
properties, and potential, or likelihood of contact with treated
countertops. The nine food categories are liquids, fruit, bread,
cheese, vegetable, meat, purees (e.g., oatmeal, pudding), pieces (foods
normally consumed in small pieces), and powders (foods normally used in
powder/granular forms). Assumed countertop residues are converted to
estimated residues contacting the countertops using a translation
factor for each food category, and default residue transfer efficiency
for a representative food. Therefore, IDREAM combines the estimated
countertop residues for surface treatment products, CSFII consumption
data, food-specific conversion factors that relate the surface area
contacting a countertop with corresponding weight of the food item, and
the transfer efficiency of residues from countertops to food.
Conservative assumptions for these analyses include: All disinfectants
registered to disinfect kitchen countertops are included; all foods are
prepared on those countertops; all prepared foods will come in contact
with treated countertops at the maximum application rate and transfer
residues do not diminish over time (i.e., residue reduction will not
occur from cooking or preparation processes); there is a 100%
likelihood of contact to account for both commercial and residential
scenarios: All commercial and households use the same active
ingredients; all foods are prepared and consumed.
When assessing the food bottling/packaging use, EPA assumed a 100%
transfer rate because the food is potentially in contact with the
treated surfaces for very long periods of time. The maximum application
rate for DDACB for bottling/packing of food is 0.0020 lbs a.i. per
gallon of treatment solution. EDI values were calculated using an
approach similar to that used for treated food utensils. Exposure was
assumed to occur through the ingestion of three food products that
might be packaged with treated material: Beverages (alcoholic and non-
alcoholic), egg products, and milk. A calorie intake modification
factor of 0.64 was applied to the EDI for a child to account for the
differences between intake values among children and adults. The
calculated percent of an aPAD and a cPAD do not exceed 100% and
therefore are not of a concern.
2. Dietary exposure from drinking water. DDACB outdoor uses are as
an algaecide in wood preservative treatment and a slimicide in
secondary oil field uses. The oil field uses are considered to be
contained. The other uses are not expected to significantly contaminate
drinking water sources. Therefore, the DDACB contributions for drinking
water exposure are considered to be negligible and are not quantified.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
DDACB is currently registered for the following residential non-
dietary sites: Homes and day-care nurseries. EPA assessed residential
exposure using the following assumptions:
Residential exposure may occur during the application as well as
post application of DDACB to indoor hard surfaces (e.g., mopping,
trigger pump sprays, wiping). The residential handler scenarios were
assessed to determine dermal and inhalation exposures. Residential post
application scenarios such as children exposure to treated toys and
floors were also assessed to determine dermal and incidental oral
exposures. Surrogate dermal, inhalation, and incidental oral unit
exposure values were estimated using Pesticide Handler Exposure
Database (PHED) data and the Chemical Manufactures Association
Antimicrobial Exposure Assessment Study (EPA, 1999). Note that for this
assessment, EPA assumed that residential users complete all elements of
an application (mix/load/apply) without the use of personal protective
equipment.
The duration for most residential exposures is believed to be best
represented by the short-term duration (1 to 30 days). The short-term
duration was chosen for this assessment because the residential handler
and post-application scenarios are assumed to be performed on an
episodic, not daily basis.
Specific information on the residential exposure assessment for
DDACB can be found at https://www.regulations.gov. Docket ID Number EPA-
HQ-OPP-2006-1024, Review of Petition to Amend 40 CFR 180.940 to add
Didecyl Dimethyl Ammonium Carbonate/Bicarbonate.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other
[[Page 37857]]
substances that have a common mechanism of toxicity.''
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 Aliphatic Alkyl Quaternary
(DDAC) Reregistration Eligibility Decision (RED)) were developed by
assuming that a DDAC compound was used on 100% 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.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (10x) tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA SF. In applying this
provision, EPA either retains the default value of 10x when reliable
data do not support the choice of a different factor, or, if reliable
data are available, EPA uses a different additional FQPA SF value based
on the use of traditional UFs and/or FQPA SFs, as appropriate.
2. Prenatal and postnatal sensitivity. Given the data on the
aliphatic alkyl ammonium chloride quaternaries, there is no evidence
that DDACB result in increased susceptibility in in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA SF to 1x.
That decision is based on the following findings:
i. The toxicity database for aliphatic alkyl ammonium chloride
quaternaries is complete.
ii. There is no indication that aliphatic alkyl ammonium chloride
quaternaries are a neurotoxic chemical and there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. There is no evidence that aliphatic alkyl ammonium chloride
quaternaries result in increased susceptibility in in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. Although EPA may, in the future, refine exposure estimates
for aliphatic alkyl ammonium chloride 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 ammonium chloride
quaternaries.
E. Aggregate Risks and Determination of Safety
1. Dietary risks from food and feed uses. EPA compares the
estimated dietary exposures to an aPAD and a cPAD, 0.1 mg/kg/day, which
are the same value for DDACB. Generally, a dietary exposure estimate
that is less than 100% of the aPAD or the cPAD does not exceed the
Agency's LOC.
The antimicrobial indirect food use acute and chronic risk
estimates from exposure to treated utensils and countertops are below
the Agency's LOC. For adult males, the acute and chronic dietary
exposure risk estimates are 5.9% for utensils and 1. 92% for
countertops. The aPAD and cPAD for adult females of child bearing age
(13-49), the highly exposed group, is 6.9% for utensils and 1. 79% for
countertops. For children ages 1-2, the most highly exposed population
subgroup, the acute and chronic dietary risk estimates are 41. 3% for
utensils and 6.21% for countertops. Therefore, dietary exposure
estimates are below the Agency's LOC for all population subgroups. The
antimicrobial indirect food use chronic risk estimates from exposure to
treated food packaging and beverage bottles are below the Agency's LOC.
The percent cPAD values exceeded 100% and are not of concern.
Specific information on the dietary exposure assessment for DDACB
can be found at https://www.regulations.gov. Docket ID Number EPA-HQ-
2006-1024, Review of Petition to Amend 40 CFR 180.940 to add Didecyl
Dimethyl Ammonium Carbonate/Bicarbonate.
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.
Based on the toxicological and exposure data discussed in this
preamble, EPA concludes that DDACB will not pose a risk under
reasonably foreseeable circumstances. Accordingly, EPA finds that there
is a reasonable certainty that no harm will result to the general
population, or to infants and children from aggregate exposure to DDACB
residues.
IV. Other Considerations
An analytical method for food is not needed. Food-contact
sanitizers are typically regulated by the State health departments to
ensure that the food industry is using products in compliance with the
regulations in 40 CFR 180.940. The end-use solution that is applied to
the food-contact surface is analyzed not food items that may come into
contact with treated surface. An analytical method is available to
analyze the use dilution that is applied to food-contact surfaces. A
titration method is used to determine the total amount of quaternary
compound. If the use solution is a mixture of ADBAC and DDACB, then
high pressure liquid chromatogram with ultraviolet visible (HPLC-UV) is
used to determine the amount of ADBAC. The amount of DDACB is
determined by calculating the difference between the total amount of
quaternary compounds and ADBAC.
V. Conclusion
Therefore, an exemption is established for residues of DDACB,
regulated chemical, on food-contact surfaces in public eating
establishments, on dairy processing equipment, and food processing
equipment and utensils.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply,
[[Page 37858]]
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Aliphatic alkyl quaternaries, Food-contact
sanitizers, Pesticides and pests, Quaternary ammonium compounds,
Reporting and recordkeeping requirements.
Dated: June 10, 2008.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDed]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.940 is amended by alphabetically adding an entry to the
table in paragraph (a) to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
(a) * * *
------------------------------------------------------------------------
Pesticide Chemical CAS Reg. No. Limits
------------------------------------------------------------------------
* * * * * * *
Quaternary ammonium compounds, 148788-55-0/148812- When ready for
didecyl dimethyl ammonium 654-1 use, the end-use
carbonate/didecyl dimethyl concentration of
ammonium bicarbonate these specific
ammonium
compounds is not
to exceed 240 ppm
of active
quaternary
ammonium
compound.
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-14880 Filed 7-1-08; 8:45 am]
BILLING CODE 6560-50-S
