[Federal Register Volume 74, Number 154 (Wednesday, August 12, 2009)]
[Rules and Regulations]
[Pages 40503-40509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19314]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0041; FRL-8430-5]


Sodium Lauryl Sulfate; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of sodium lauryl sulfate (CAS Reg. No. 151-
21-3) when used as a component of food contact sanitizing solutions 
applied to all food contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils at a 
maximum level in the end-use concentration of 350 parts per million 
(ppm). ETI H2O submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the 
requirement of a

[[Page 40504]]

tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of sodium lauryl sulfate.

DATES: This regulation is effective August 12, 2009. Objections and 
requests for hearings must be received on or before October 13, 2009, 
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-2008-0041. All documents in the 
docket are listed in the docket index available at http://www.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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open 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: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: <a href="/cdn-cgi/l/email-protection#2f434a46494a5d01444a5d5d566f4a5f4e01484059"><span class="__cf_email__" data-cfemail="fa969f939c9f88d4919f888883ba9f8a9bd49d958c">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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. 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 electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0041 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before October 13, 2009.
    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-2008-0041, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 Facility'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. Background

    In the Federal Register of February 6, 2008 (73 FR 6964) (FRL-8350-
9), EPA issued a notice pursuant to section 408 (d)(3) of FFDCA, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP 7F7179) 
by ETI H2O, 1725 Gillespie Way, El Cajon, CA 92020. The petition 
requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of sodium 
lauryl sulfate (CAS Reg. No. 151-21-3) as a component of food contact 
sanitizing solutions applied to all food contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils which increases the maximum level in the end-use 
concentration from 3 ppm to 350 ppm. That notice included a summary of 
the petition prepared by the petitioner. There were no comments 
received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene ploymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

[[Page 40505]]

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of 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(b)(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. Section 408(b)(2)(C) of FFDCA 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.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) 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 of a tolerance for residues of sodium 
lauryl sulfate when used as a component of food contact sanitizing 
solutions applied to all food contact surfaces in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils 
at a maximum level in the end-use concentration of 350 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances 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.
    The toxicology database is adequate to support the use of sodium 
lauryl sulfate as an inert ingredient in pesticide formulations as well 
as its use as a component of food contact sanitizing solutions.
    Sodium lauryl sulfate has low acute oral and dermal toxicity but is 
irritating to the skin and eye at high doses. Sodium lauryl sulfate is 
not a skin sensitizer. Sodium lauryl sulfate was negative in tests for 
genotoxicity. The repeated dose toxicity data on alkyl sulfates 
including sodium lauryl sulfate demonstrate effects consistent with 
surfactant-mediated irritant effects. The common target organs of 
toxicity following repeated-dose oral exposure were the forestomach in 
gavage studies, and the liver and kidneys in dietary studies. No 
evidence of neurotoxicity was observed in any of the available studies. 
Chronic toxicity data on sodium lauryl sulfate is available in limited, 
summary form. A developmental toxicity study with sodium lauryl sulfate 
in rats, rabbits and mice demonstrated developmental toxicity at 
maternally toxic doses at a dose level of 600 milligrams/kilogram/day 
(mg/kg/day). A 2-generation reproductive toxicity study conducted with 
a related chemical, [alpha]-alkyl (C<INF>12</INF>) olefin sulfonate, 
showed no treatment-related adverse reproductive effects.
    Specific information on the studies received and the nature of the 
adverse effects caused by sodium lauryl sulfate 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 in the document Sodium Lauryl Sulfate. Human Health 
Risk Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as an Inert Ingredient in Pesticide Formulations. 
pages 6-9 in docket ID number EPA-HQ-OPP-2008-0041.

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. 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-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the level of 
concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sodium lauryl sulfate 
used for human risk assessment is shown in the following Table.

Table 1--Summary of Toxicological Doses and Endpoints for Sodium Lauryl Sulfate for Use in Human Risk Assessment
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                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
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Acute dietary (all populations)            An endpoint attributable to a single exposure was not seen in the
                                               database; therefore, a point of departure was not selected.
----------------------------------------------------------------------------------------------------------------

[[Page 40506]]

 
Chronic dietary (all populations)      NOAEL= 100 mg/kg/day     Chronic RfD = 1 mg/kg/   28-Day oral (gavage)
                                       UFA = 10x..............   day                      toxicity study in rats
                                       UFH = 10x..............  cPAD = 1 mg/kg/day.....  LOAEL = 200 mg/kg/
                                       FQPA SF = 1x...........                            day,based on decreased
                                                                                          body weight gain
----------------------------------------------------------------------------------------------------------------
Incidental oral, dermal and            NOAEL= 100 mg/kg/day     Residential/             28-Day oral (gavage)
 inhalation (short-term and            Dermal absorption of 1%   occupational LOC for     toxicity study in rats
 intermediate-term)                     inhalation exposure is   MOE = 100                LOAEL = 200 mg/kg/day,
                                        assumed to be                                     based on decreased
                                        equivalent to oral                                body weight gain
                                        exposure.
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)          Classification: Based on limted data sodium lauryl sulfate is not
                                                              expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). PAD = population adjusted dose
  (a=acute, c=chronic). FQPA SF = FQPA Safety Factor. RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sodium lauryl sulfate, EPA considered exposure under the 
petitioned-for exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from sodium lauryl sulfate in food as 
follows:
     i. Acute exposure. No adverse effects attributable to a single 
exposure of sodium lauryl sulfate were seen in the toxicity databases; 
therefore, an acute dietary exposure assessment for sodium lauryl 
sulfate is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, no residue data were submitted for sodium lauryl 
sulfate. In the absence of specific residue data, EPA has developed an 
approach which uses surrogate information to derive upper bound 
exposure estimates for the subject inert ingredient. Upper bound 
exposure estimates are based on the highest tolerance for a given 
commodity from a list of high-use insecticides, herbicides, and 
fungicides. A complete description of the general approach taken to 
assess inert ingredient risks in the absence of residue data is found 
at http://www.regulations.gov in the document Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts in 
docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest of tolerances 
would be no higher than the concentration of the active ingredient.
    In addition to dietary exposures resulting from use of sodium 
lauryl sulfate as an inert ingredient in pesticide formulation 
application to crops, a conservative dietary exposure estimate of 
residues of sodium lauryl sulfate in food as a result of its use as a 
component in food contact sanitizing solution was also performed. This 
estimate also utilizes conservative assumptions related to the amount 
of residues that can be transferred to foods as a result of use of food 
contact sanitizing products.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms. First, assuming that the 
level of residue for an inert ingredient is equal to the level of 
residue for the active ingredient will overstate exposure. The 
concentration of active ingredients in agricultural products is 
generally at least 50 percent of the product and often can be much 
higher. Further, pesticide products rarely have a single inert 
ingredient; rather, there is generally a combination of different inert 
ingredients used thereby further reducing the concentration of any 
single inert ingredient in the pesticide product in relation to that of 
the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100 percent of all foods are treated with the 
inert ingredient at the rate and manner necessary to produce the 
highest residue legally possible for an active ingredient. In summary, 
EPA chose a very conservative method for estimating the level of inert 
residue that could be on food, then used this methodology to choose the 
highest possible residue that could be found on food and assumed that 
all food contained this residue. No consideration was given to 
potential degradation between harvest and consumption even though 
monitoring data show that tolerance level residues

[[Page 40507]]

are typically one to two orders of magnitude higher than actual 
residues in food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    iii. Cancer. There is no evidence that sodium lauryl sulfate is 
carcinogenic. While the full study reports are not available, summary 
data on two carcinogenicity studies with sodium (C<INF>12</INF>-
C<INF>15</INF>) alkyl sulfate show no increase in tumor incidence, nor 
any impact on tumor type at levels up to up to 1.5% highest dose tested 
(HDT) in the diet.
    Since the Agency has not identified any concerns for 
carcinogenicity relating to sodium lauryl sulfate, a cancer dietary 
exposure assessment was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for sodium lauryl sulfate. Tolerance level residues 
and/or 100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sodium lauryl sulfate in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of sodium lauryl sulfate. Further 
information regarding EPA drinking water models used in the pesticide 
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    A screening level drinking water analysis, based on the Pesticide 
Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) was 
performed to calculate the estimated drinking water concentrations 
(EDWCs) of sodium lauryl sulfate. Modeling runs on four surrogate inert 
ingredients using a range of physical chemical properties that would 
bracket those of sodium lauryl sulfate were conducted. Modeled acute 
drinking water values ranged from 0.001 parts per billion (ppb) to 41 
ppb. Modeled chronic drinking water values ranged from 0.0002 ppb to 19 
ppb. Further details of this drinking water analysis can be found at 
http://www.regulations.gov in the document Sodium Lauryl Sulfate. Human 
Health Risk Assessment to Support Proposed Exemption from the 
Requirement of a Tolerance When Used as an Inert Ingredients in 
Pesticide Formulations, pages 10 and 25-27 in docket ID number EPA-HQ-
OPP-2008-0041.
    For the purpose of the screening level dietary risk assessment to 
support this request for an exemption from the requirement of a 
tolerance for sodium lauryl sulfate, a conservative drinking water 
concentration value of 100 ppb based on screening level modeling was 
used to assess the contribution to drinking water for chronic dietary 
risk assessments for the parent compounds and for the metabolites of 
concern. These values were directly entered into the dietary exposure 
model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Sodium lauryl sulfate 
may be used as an inert ingredient in pesticide products that are 
registered for specific uses that may result in both indoor and outdoor 
residential exposures. A screening level residential exposure and risk 
assessment was completed for products containing sodium lauryl sulfate. 
The Agency conducted an assessment to represent worst-case residential 
exposure by assessing sodium lauryl sulfate in pesticide formulations 
resulting in the highest residential exposures, including both 
residential handler exposures and residential post-application 
exposures. Further details of this residential exposure and risk 
analysis can be found at http://www.regulations.gov in the document 
Joint Insert Task Force (JITF) Inert Ingredients. Residential and 
Occupational Exposure Assessment Algorithms and Assumptions Appendix 
for the Human Health Risk Assessments to Support Proposed Exemption 
from the Requirement of a Tolerance When Used as Inert Ingredients in 
Pesticide Formulations, in docket ID number EPA-HQ-OPP-2008-0710.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' EPA has not found sodium 
lauryl sulfate to share a common mechanism of toxicity with any other 
substances, and sodium lauryl sulfate does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that sodium lauryl sulfate 
does not have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) 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 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 safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for sodium lauryl sulfate includes a prenatal 
developmental toxicity study in rats, rabbits, and mice as well as a 2-
generation reproduction toxicity study in rats on a closely related 
compound. There was no evidence of increased quantitative or 
qualitative susceptibility following in utero exposure of rats, rabbits 
or mice in the developmental toxicity study and no evidence of 
increased quantitative or qualitative susceptibility of offspring in 
the reproduction study. Developmental toxicity was not observed in the 
developmental toxicity study at doses below that which maternal 
toxicity was also observed. In the reproduction study, no offspring or 
maternal toxicity was observed at the highest dose tested (HDT) of 285 
mg/kg/day. There is no evidence of neurotoxicity in the toxicity 
database for sodium lauryl sulfate.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for sodium lauryl sulfate is considered 
adequate for assessing the risks to infants and children (the available 
studies are described in Unit IV.D.2.).
     ii. No evidence of quantitative or qualitative increased 
susceptibility was demonstrated in the offspring in a

[[Page 40508]]

developmental toxicity study in rats, rabbits, and mice following in 
utero and prenatal exposure or in young rats in the 2-generation 
reproduction study.
    iii. There is no indication that sodium lauryl sulfate is a 
neurotoxic chemical and thus there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iv. The Agency has concluded that an additional uncertainty factor 
is not needed for the use of a subchronic study for a chronic exposure 
assessment as reported NOAELs in two chronic rat studies were at the 
same levels as the POD derived from a subchronic toxicity study.
     v. There are no residual uncertainties identified in the exposure 
databases. The food and drinking water assessment is not likely to 
underestimate exposure to any subpopulation, including those comprised 
of infants and children. The food exposure assessments are considered 
to be highly conservative as they are based on the use of the highest 
tolerance level from the surrogate pesticides for every food and the 
assumption that for all crops, 100% of the crop is treated as well as 
similarly conservative assumptions related to the transfer of residues 
of sodium lauryl sulfate into food from its use in food contact 
sanitizing solutions. EPA also made conservative (protective) 
assumptions in the ground water and surface water modeling used to 
assess exposure to sodium lauryl sulfate in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
sodium lauryl sulfate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    1. Acute risk. There was no hazard attributable to a single 
exposure seen in the toxicity database for sodium lauryl sulfate. 
Therefore, sodium lauryl sulfate is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for chronic exposure, the chronic dietary exposure from food and water 
to sodium lauryl sulfate is 19% of the cPAD for the U.S. population and 
67% of the cPAD for children 1 to 2 years old, the most highly exposed 
population subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Sodium lauryl sulfate is used in pesticide products that are 
currently registered for uses that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to sodium lauryl sulfate. Using the 
exposure assumptions described in this unit, EPA has concluded that the 
combined short-term aggregated food, water, and residential exposures 
result in aggregate MOEs of 500, for both adult males and females, 
respectively. Adult residential exposure combines high end dermal and 
inhalation handler indoor and outdoor exposure with a high end post 
application dermal exposure. EPA has concluded that the combined short-
term aggregated food, water, and residential exposures result in an 
aggregate MOE of 147 for children. Children's residential exposure 
combines outdoor and indoor dermal and hand-to-mouth exposures. As the 
level of concern is for MOEs that are lower than 100, these MOEs are 
not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Sodium lauryl sulfate is used in products currently registered for 
uses that could result in intermediate-term residential exposure and 
the Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with intermediate-term residential 
exposures to sodium lauryl sulfate. Using the exposure assumptions 
described in this unit, EPA has concluded that the combined 
intermediate-term aggregated food, water, and residential exposures 
result in aggregate MOEs of 660 for both adult males and females, 
respectively. Adult residential exposure includes high end post 
application dermal exposure from contact with treated lawns. EPA has 
concluded that the combined intermediate-term aggregated food, water, 
and residential exposures result in an aggregate MOE of 148 for 
children. Children's residential exposure combines outdoor and indoor 
dermal and hand-to-mouth exposures. As the level of concern is for MOEs 
that are lower than 100, these MOEs are not of concern.
     5.  Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to sodium lauryl 
sulfate.
    6. Determination of safety. Based on these risk assessments and the 
limitation imposed in the exemption, EPA concludes that, with respect 
to the exemption, there is a reasonable certainty that no harm will 
result to the general population, or to infants and children from 
aggregate exposure to residues of sodium lauryl sulfate under 
reasonably foreseeable circumstances.

V. Other Considerations

A. Analytical Enforcement Methodology

     An analytical method is not required for enforcement purposes 
since the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 
sodium lauryl sulfate nor have any CODEX Maximum Residue Levels been 
established for any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of sodium lauryl sulfate as a component of 
food contact sanitizing solutions applied to all food contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils at a maximum level in the end-use 
concentration of 350 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemtpion from the requirement of 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

[[Page 40509]]

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, 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 exemption 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).

VIII. 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, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: August 6, 2009.
G. Jeffrey Herndon,
Acting Director, Registration 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. In Sec. 180.940(a), the table is amended by revising the following 
entry 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
------------------------------------------------------------------------
 
                              * * * * * * *
Sulfuric acid monododecyl ester,  151-21-3            When ready for
 sodium salt (sodium lauryl                            use, the end-use
 sulfate).                                             concentration is
                                                       not to exceed 350
                                                       ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
 [FR Doc. E9-19314 Filed 8-11-09 8:45 am]
BILLING CODE 6560-50-S


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