[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: [email protected].
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. 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:
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
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 (C12) 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.
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[[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
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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...........
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Cancer (oral, dermal, inhalation) Classification: Based on limted data sodium lauryl sulfate is not
expected to be carcinogenic.
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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 (C12-
C15) 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