

[Federal Register: September 6, 2007 (Volume 72, Number 172)]
[Rules and Regulations]               
[Page 51180-51187]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se07-9]                         

=======================================================================
-----------------------------------------------------------------------

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 http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office 

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division 
(7510P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-6233; e-mail address: noble.velma@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR 180.940 
Tolerance exemptions for active and inert ingredients for use in 
antimicrobial formulations (Food-contact surface sanitizing solutions), 
paragraph (a). If you have any questions regarding the applicability of 
this action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you my access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.


C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the Food Quality 
Protection Act (FQPA), any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
The EPA procedural regulations which govern the submission of 
objections and requests for hearings appear in 40 CFR part 178. You 
must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2006-0572 in the subject line on the first page of your submission. All 
requests must be in writing, and must be mailed or delivered to the 
Hearing Clerk on or before November 5, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0572, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
      Mail: Office of Pesticide Programs (OPP) Regulatory 
Public Docket (7502P), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
      Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of October 25, 2006 (71 FR 62458) (FRL-
8099-6), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 6F7045) by Lonza, Inc, 90 Boroline Rd, 
Allendale, NJ 07401. The petition requested that 40 CFR 180.940(a) be 
amended by increasing concentration limits for aliphatic alkyl 
quaternary compounds in end-use solutions eligible for the tolerance 
exemption for Quaternary Ammonium compounds: Di-n-Alkyl (C8-
10) dimethyl ammonium chloride, average molecular weight (in 
amu) 332 to 361) on food contact surfaces in public eating places, 
dairy processing equipment, and food

[[Page 51182]]

processing equipment and utensils from 150 ppm to 240 ppm and the total 
end use concentration of all quaternary chemicals in solution from 200 
ppm to 400 ppm. The notice referenced a summary of the petition 
prepared by Lonza Inc., 90 Boroline Rd Allendale, NJ 07401, the 
registrant, which is available to the public in the docket at 
http://www.regulations.gov, Docket ID Number EPA-HQ-OPP -2006-0572. There were 

no comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which requires EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

A. Toxic Effects

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by the 
Aliphatic Alkyl Quaternaries are discussed in this unit.
    The Aliphatic Alkyl Quaternaries are corrosive, highly irritating 
to the eye and skin, with moderate acute toxicity by oral, dermal, and 
inhalation routes of exposure. These chemicals are classified as ``not 
likely'' to be a human carcinogen based on a negative carcinogenicity 
study in rats and mice feeding studies using doses above the limit. 
There is no evidence of these chemicals being associated with increased 
susceptibility to developmental toxicity or reproductive toxicity based 
on two developmental toxicity studies and a two-generation reproductive 
study. Lastly, they are negative for mutagenicity and neurotoxicity. 
Specific information on the studies received and the nature of the 
toxic effects caused by Di-n-Alkyl (C8-10) 
dimethyl ammonium chloride, average molecular weight (in amu) 332 to 
361) (DDAC) as well as the no observed adverse effect level (NOAEL) and 
the lowest observed adverse effect level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov; Docket ID Number 

EPA-HQ-OPP-2005-0338; Toxicology Disciplinary Chapter for the 
Reregistration Eligibility Decision (RED) for Didecyl Dimethyl Ammonium 
Chloride (DDAC).

B. Toxic Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(NOAEL) from the toxicology study identified as appropriate for the 
risk assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in variations 
in sensitivity among members of the human population as well as other 
unknowns.
    The Agency's level of concern (LOC) for residential Aliphatic Alkyl 
Quaternaries' inhalation and oral exposures is 100 (i.e., a margin of 
exposure (MOE) less than 100 exceeds the Agency's level of concern). 
The level of concern is based on 10x for interspecies extrapolation and 
10x for intraspecies extrapolation. However, the uncertainty factor or 
``target'' MOE for Aliphatic Alkyl Quaternaries' dermal exposures is 10 
for residential scenarios. The target MOE was chosen because the 
established endpoint is for dermal irritation, not a systemic toxic 
effect. In addition, dermal irritation is considered a reversible and 
short-term effect, thus supporting a 10x uncertainty factor (half a log 
(10.5) or approximately 3x for interspecies extrapolation and half log 
(10.5) or approximately 3x for intraspecies variation). It should be 
noted that the determination to reduce the 100x UF to 10X UF for 
irritation endpoints is made on a case-by-case basis.
    Aliphatic Alkyl Quaternaries toxicological endpoint summary is 
listed in the following table.

                              Table 1.--Summary of Toxicological Endpoints for DDAC
----------------------------------------------------------------------------------------------------------------
                                                             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 http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary 

Risk Assessment on DDAC and Tier 1 Drinking Water Assessment for Alkyl 
Dimethyl Benzyl Ammonium Chloride (ADBAC); Didecyl Dimethyl Ammonium 
Chloride (DDAC).

B. Other Non-Occupational Exposure

    The residential exposure assessment considers all potential non-
occupational pesticide exposure, other than exposure due to residues in 
food or in drinking water. Exposures may occur during and after 
application as a hard surfaces disinfectant (e.g., walls, floors, 
tables, fixtures), to textiles (e.g., clothing, diapers) to swimming 
pools and to carpets. Each route of exposure (oral, dermal, inhalation) 
is assessed, where appropriate, and risk is expressed as a MOE, which 
is the ratio of estimated exposure to an appropriate NOAEL
    Residential exposure may occur during the application of Aliphatic 
Alkyl Quaternaries to indoor hard surfaces (e.g., mopping, wiping, 
trigger pump sprays), carpets, swimming pools, wood as a preservative, 
textiles (e.g., diapers treated during washing and clothes treated with 
fabric spray), and humidifiers. The residential handler scenarios were 
assessed to determine dermal and inhalation exposures. Surrogate dermal 
and inhalation unit exposure values were estimated using data from the 
Pesticide Handler Exposure Database (PHED) and the Chemical 
Manufactures Association Antimicrobial Exposure Assessment Study 
(USEPA, 1999), and the SWIMODEL 3.0 was utilized to conduct exposure 
assessments of pesticides found in swimming pools and spas (Versar, 
2003). Note that for this assessment, EPA assumed that residential 
users complete all elements of an application (mix/load/apply) without 
the use of personal protective equipment.
    The duration for most residential exposures is believed to be best 
represented by the short-term duration (1 to 30 days). The short-term 
duration was chosen for this assessment because the residential handler 
and post-application scenarios are assumed to be performed on an 
episodic, not daily basis.
    Based on toxicological criteria and the potential for exposure, the 
Agency has conducted dermal and inhalation exposure assessments for 
Aliphatic Alkyl Quaternaries residential use. As noted previously, MOEs 
greater than or equal to 100 for the inhalation route of exposure and 
10 for dermal exposure are considered adequately protective for the 
residential exposure assessment.
    Specific information on the residential exposure assessment for 
Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Didecyl 

Dimethyl Ammonium Chloride (DDAC) Occupational and Residential Exposure 
Assessment.

V. Cumulative Effects

    Another factor EPA must consider in making a section 408 reasonable 
certainty of no harm determination is any ``available information'' 
concerning the cumulative effects of a particular pesticide's residues 
and ``other substances that have a common mechanism of toxicity.''
    The Aliphatic Alkyl Quaternaries are a group of structurally 
similar quaternary ammonium compounds that are characterized by having 
a positively charged nitrogen covalently bonded to two alkyl group 
substituents (at least one C8 or longer) and two methyl 
substituents. In finished form, these quats are salts with the 
positively charged nitrogen (cation) balanced by a negatively charged 
molecule (anion). The anion for the quats in this cluster is chloride 
or bromide. Didecyl dimethyl ammonium chloride, or DDAC, was chosen as 
the representative chemical for this class in PR notice 88-2. On that 
basis, the toxicology database for DDAC is accepted as representative 
of the hazard for this class of quaternary ammonium compounds. However, 
the toxicologic responses observed from animal toxicity studies with 
DDAC are generalized responses to treatment and are difficult to 
attribute to any one mechanism.
    EPA's risk assessment for the Group I Cluster is based on an 
assessment of the cumulative exposure to all aliphatic alkyl quaternary 
compounds. The individual exposure scenarios in the DDAC assessments 
(as well as the aggregate assessment in the RED) were developed by 
assuming that a DDAC compound was used on 100 percent of the surfaces 
authorized on the label that could result in human exposure and summing 
the percent active ingredients on the labels for all of the aliphatic 
alkyl quaternary compounds when used in combination. Thus, because the 
risk assessment for DDAC accounts for exposures to all of the aliphatic 
alkyl quaternary compounds, there is no need for a separate cumulative 
risk assessment for those compounds. The Agency has not identified any 
other substances as sharing a common mode of toxicity with DDAC.

VI. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold (``10X'') margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the

[[Page 51185]]

completeness of the data base on toxicity and exposure unless EPA 
determines based on reliable data that a different margin of safety 
will be safe for infants and children. This additional margin of safety 
is commonly referred to as the FQPA safety factor. In applying this 
provision, EPA either retains the default value of 10X when reliable 
data do not support the choice of a different factor, or, if reliable 
data are available, EPA uses a different additional FQPA safety factor 
value based on the use of traditional uncertainty/safety factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence that 
Aliphatic Alkyl Quaternaries result in increased susceptibility in in 
utero rats or rabbits in the prenatal developmental studies or in young 
rats in the two-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for Aliphatic Alkyl Quaternaries is 
complete for assessing risk to infants and children under the FFDCA.
    ii. There is no indication that Aliphatic Alkyl Quaternaries are 
neurotoxic chemicals and there is no need for a developmental 
neurotoxicity study or additional uncertainty factors to account for 
neurotoxicity.
    iii. There is no evidence that Aliphatic Alkyl Quaternaries result 
in increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. Although EPA may, in the future, refine exposure estimates 
for Aliphatic Alkyl Quaternaries based on more sophisticated modeling 
techniques, the current exposure assessment is based on a combination 
of conservative assumptions that is likely to overstate exposure from 
food to Aliphatic Alkyl Quaternaries.

VII. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the acute population adjusted 
dose (``aPAD'') and chronic population adjusted dose (``cPAD''). The 
aPAD and cPAD are calculated by dividing the LOC by all applicable 
uncertainty/safety factors. For linear cancer risks, EPA calculates the 
probability of additional cancer cases given aggregate exposure. Short-
, intermediate, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the MOE called for by the 
product of all applicable uncertainty/safety factors is not exceeded.
    1. Acute and chronic risk. EPA compares the estimated dietary 
exposures to an aPAD and a cPAD, 0.1 mg/kg/day, which are the same 
value for the aliphatic alkyl quaternaries. Generally, a dietary 
exposure estimate that is less than 100% of the aPAD or cPAD does not 
exceed the Agency's levels of concern.
    The antimicrobial indirect food use acute/chronic risk estimates 
from exposure to treated utensils and countertops are below the 
Agency's level of concern. For adults, the acute and chronic dietary 
exposure risk estimates are 3.32% of the aPAD and cPAD for adult 
females of child bearing age (13 to 50), the highly exposed adult 
group. For children ages 3 to 5, the most highly exposed population 
subgroup, the acute and chronic dietary risk estimates are 13.3% of the 
aPAD and cPAD. Therefore, dietary exposure estimates are below the 
Agency's level of concern for all population subgroups. The 
antimicrobial indirect food use acute/chronic risk estimates from 
exposure to treated food packaging and beverage bottles are below the 
the Agency's level of concern. Neither the percent aPAD or percent cPAD 
values exceeded 100% and are not of concern.
    Specific information on the dietary exposure assessment for 
Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov
; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary 

Risk Assessment on DDAC.
    2. Non-occupational risk. Aggregate exposure takes into account 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Using the exposure assumptions described in this unit for other 
non-occupational exposures, EPA has concluded that food, water, and 
residential exposures aggregated result in aggregate MOEs greater than 
or equal to 100 for the inhalation route of exposure and 10 for dermal 
exposure; therefore, are not of concern.
    3. Aggregate cancer risk for U.S. population. Based on the 
carcinogenic data, the EPA concludes that there is reasonable certainty 
that Aliphatic Alkyl Quaternaries doe not pose an aggregate cancer risk 
to the U. S. population.
    4. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to Aliphatic Alkyl Quaternaries residues.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA is required under the FFDCA, as amended by FQPA, to develop a 
screening program to determine whether certain substances (including 
all pesticide active and other ingredients) ``may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen, or other such endocrine effects as the Administrator may 
designate.'' Following recommendations of its Endocrine Disruptor and 
Testing Advisory Committee (EDSTAC), EPA determined that there was a 
scientific basis for including, as part of the program, the androgen 
and thyroid hormone systems, in addition to the estrogen hormone 
system. EPA also adopted EDSTAC's recommendation that the Program 
include evaluations of potential effects in wildlife. For pesticide 
chemicals, EPA will use FIFRA and, to the extent that effects in 
wildlife may help determine whether a substance may have an effect in 
humans, FFDCA authority to require the wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP). When appropriate screening and/or testing protocols being 
considered under the Agency's Endocrine Disruption Screening Program 
(EDSP) have been developed, the Aliphatic Alkyl Quaternaries (DDAC) may 
be subjected to additional screening and/or testing to better 
characterize effects related to endocrine disruption.

B. Analytical Method(s)

    An analytical method for food is not needed. Food contact 
sanitizers are typically regulated by state health departments to 
ensure that the food industry is using these products in compliance 
with the regulations in 40 CFR 180.940. The end use solution that is 
applied to the food contact surface is analyzed not food items that may 
come into contact with the treated surface. An analytical method is 
available to analyze the use dilution that is applied to food contact 
surfaces. A titration method is used to determine the total amount of 
quaternary compound. If the use solution is a mixture of DDAC and alkyl 
dimethyl benzyl ammonium chloride (ADBAC), then High Performance Liquid 
Chromatography using Ultra

[[Page 51186]]

Violet Detection (HPLC-UV) is used to determine the amount of ADBAC. 
The amount of DDAC is determined by calculating the difference between 
the total amount of quaternary compounds and ADBAC.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of FFDCA in response to a petition submitted to the Agency. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). Because this rule 
has been exempted from review under Executive Order 12866, this rule is 
not subject to Executive Order 13211, Actions Concerning Regulations 
That Significantly Affect Energy Supply, Distribution, or Use (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Food contact sanitizers, Food additives, Pesticides and pests, 
Reporting and recordkeeping requirements.

    Dated: August 29, 2007.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.940 is amended by revising the following entry to the 
table in paragraph (a):


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
      Pesticide Chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------
                              * * * * * * *
Quaternary Ammonium            None             When ready for use, the
 Compounds, Di-n-Alkyl (C8-                      end-use concentration
 10) dimethyl ammonium                           of these specific in
 chloride, average molecular                     quaternary ammonium
 weight (in amu) 332 to 361                      compounds is not to
                                                 exceed 240 ppm of
                                                 active quaternary
                                                 ammonium compound; the
                                                 end-use concentration
                                                 of all quaternary
                                                 chemicals in the
                                                 solution is not to
                                                 exceed 400 ppm of
                                                 active quaternary
                                                 compound.
                              * * * * * * *
------------------------------------------------------------------------


[[Page 51187]]

* * * * *
[FR Doc. E7-17634 Filed 9-5-07; 8:45 am]

BILLING CODE 6560-50-S
