[Federal Register Volume 74, Number 149 (Wednesday, August 5, 2009)]
[Rules and Regulations]
[Pages 38962-38970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18702]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0099; FRL-8428-6]
Sodium Alkyl Naphthalenesulfonate; 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 alkyl naphthalenesulfonate,
herein referred to in this document as SANS, when used as an inert
ingredient at a maximum of 30% by weight in pesticide formulations for
pre-harvest and post-harvest uses, as well as, for application to
animals. The Joint Inerts Task Force (JITF), Cluster Support Team
Number 10, submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of SANS.
DATES: This regulation is effective August 5, 2009. Objections and
requests for hearings must be received on or before October 5, 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-2009-0099. All documents in the
docket are listed in the docket index
[[Page 38963]]
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 those
engaged in the following activities:
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 to
provide 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.
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. 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-2009-0099 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 as required by 40 CFR part 178
on or October 5, 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 this copy, identified by docket ID number
EPA-HQ-OPP-2009-0099, 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 April 15, 2009 (74 FR 17487) (FRL-8409-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
9E7524) by The Joint Inerts Task Force (JITF), Cluster Support Team 10
(CST 10), c/o CropLife America, 1156 15th Street, NW., Suite 400,
Washington, DC 20005. The petition requested that 40 CFR 180.910 and 40
CFR 180.930 be amended by establishing exemptions from the requirement
of a tolerance for residues of the inert ingredient sodium alkyl
naphthalenesulfonate (SANS). That notice referenced a summary of the
petition prepared by JITF (CST 10), the petitioner, which is available
to the public in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the exemptions requested by adding a use limitation of not
more than 30% by weight in pesticide formulations applied pre-and post-
harvest and in pesticide formulations applied to animals. This
limitation is based on the Agency's risk assessment which can be found
at http://www.regulations.gov in document Sodium Alkyl
Naphthalenesulfonate (SANS) - JITF CST 10 Inert Ingredients). Human
Health Risk Assessment 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-2009-0099.
This petition was submitted in response to a final rule of August
9, 2006, (71 FR 45415) (FRL-8084-1) in which the Agency revoked, under
section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
the existing exemptions from the requirement of a tolerance for
residues of certain inert ingredients because of insufficient data to
make the determination of safety required by section 408(b)(2) of
FFDCA. The expiration date for the tolerance exemptions subject to
revocation was August 9, 2008, which was later extended to August 9,
2009 by a final rule published in the Federal Register of August 4,
2008 (73 FR 45312) (FRL-8372-7) to allow for data to be submitted to
support the establishment of tolerance exemptions for these inert
ingredients prior to the effective date of the tolerance exemption
revocation.
[[Page 38964]]
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 polymers 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.
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 SANS,
when used as an inert ingredient in pesticide formulations for pre-
harvest and post-harvest uses, as well as for application to animals
provided that the concentration of the SANS inerts is limited to no
more than 30% by weight in pesticide formulations. 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 representative test compounds for the SANS cluster group
include (1) an aqueous mixture containing 80% 3-butyl-naphthalene- 1
sulfonate (CAS Reg. No. 25638-17-9) and 20% sodium di-3, 6-dibutyl
naphthalene-1-sulfonate (CAS Reg. No. 25417-20-3); (2) a complex
mixture from a boiling distillate from petroleum catalytic reformer
fractionator residue that includes C9-rich C8-
C10-alkyl-sodium naphthalenesulfonate (CAS Reg. No. 908356-
16-1); and (3) naphthalenesulfonic acid, sodium salt, isopropylate (CAS
Reg. No. 68442-09-1), which is a mixture containing sodium diisopropyl
and triisopropyl-2-naphthalenesulfonates in a 40:60 ratio, with 6% of
mono-isopropyl-2-naphthalenesulfonates. The existing toxicology
database for the SANS inerts consists of an OPPTS Harmonized Guideline
870.3650 (combined repeated dose toxicity study with the reproduction/
developmental toxicity screening studies in rats) on each of the
representative SANS, and several publicly-available studies on acute
toxicity. These data are adequate to apply to the SANS inerts when used
as inert ingredients in pesticide formulations and to characterize the
potential toxic effects of these surfactants.
The sodium alkyl naphthalenesulfonates have low acute oral and
inhalation toxicity but are irritating to the skin and eye. No
mutagenicity data are available. The OPPTS Harmonized Guideline
870.3650 combined repeated dose toxicity study with the reproduction/
developmental toxicity screening tests on three representative
surfactants demonstrate local irritation effects on the forestomach/
stomach, reduced body-weight gain during mating (males), and/or
decrease in thymus weight and thymus atrophy and microscopic lesions in
the kidney (females) in the parental animals. No evidence of
neurotoxicity was observed in any of the studies.
There was evidence of increased susceptibility to the offspring of
rats following prenatal or postnatal exposure to naphthalenesulfonic
acid, sodium salt, isopropylate. Increased post-implantation and
postnatal losses and reduced pup body weights were observed at 120 and
288 milligrams/kilograms/day (mg/kg/day), whereas maternal toxicity was
observed only at 288 mg/kg/day, as evidenced by mortality, and increase
in liver enzymes and creatinine, increased kidney weight, and
histopathological lesions in the kidney (tubular cell necrosis),
stomach (inflammatory submucosal infiltrates and mucosal ulceration)
and liver (hepatic fatty change). Based on the fact that there is a
clear NOAEL for the pup effects, the point of departure is based on
this endpoint (increased post-implantation and postnatal losses and
reduced pup weight) and is protective of the effects seen in the study,
and because of the highly conservative inputs used in both the hazard
and exposure assessments, there is no residual concern for this
finding.
No evidence of increased susceptibility was observed following
prenatal or postnatal exposure to the other representative inerts.
Following exposure to an aqueous mixture containing 3-butyl-
naphthalene-1 sulfonate and sodium di-3, 6-dibutyl naphthalene-1-
sulfonate, parental toxicity manifested as microscopic forestomach
lesions, and developmental toxicity manifested as decreased pup body
weight ([darr]7-8%). No other developmental effects or reproductive
effects were observed, and there was no evidence of neurotoxicity in
the adult animal. Following exposure to a complex mixture from a
boiling distillate from petroleum catalytic reformer fractionator
residue that includes C9-rich C8-C10-
alkyl-sodium naphthalenesulfonate, parental toxicity manifested as
decreased body-weight gain during premating (males), decreased testes
weight, increased incidence of hematopoiesis in the liver (females),
and an increased incidence of erosion in the glandular stomach (both
sexes) at the limit dose. No developmental or reproductive effects were
observed, and there was no
[[Page 38965]]
evidence of neurotoxicity in the adult animal at the limit dose.
The SANS metabolism and elimination are contingent on both the
nature of the alkyl groups and the nature and extent of naphthalene
ring substituents. The Agency's August 1998 ``Toxicological Review of
Naphthalene (CAS Reg. No. 91-20-3)'' states that the in vivo and in
vitro metabolism of the parent unsubstituted naphthalene has been
studied extensively in mammalian systems. Without a functional group
for conjugation, it is expected that the majority of absorbed
unsubstituted naphthalene is eliminated and will proceed through
microsome cytochrome P-450 oxygenases to 1- and 2-napthols.
However, in the case of the CST 10 SANS surfactants, in addition to
microsome cytochrome P-450 oxygenases, the 1- or 2-sulfonic acid sodium
salt moieties on the naphthalene ring may provide a handle by which
these compounds can be readily conjugated and eliminated.
There is no evidence that the SANS inerts are carcinogenic. The
Agency used a qualitative structure activity relationship (SAR)
database, DEREK Version 11, to determine if there were structural
alerts. No structural alerts were identified. In addition, there was
little concern that any of the postulated metabolites would have
greater toxicity than the parent compounds.
Specific information on the studies received and the nature of the
adverse effects caused by the SANS, 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 document Sodium Alkyl Naphthalenesulfonate
(SANS) - JITF CST 10 Inert Ingredients). Human Health Risk Assessment
to Support Proposed Exemption from the Requirement of a Tolerance When
Used as Inert Ingredients in Pesticide Formulations, pages 9-13 and 46-
53 in docket ID number EPA-HQ-OPP-2009-0099.
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-, intermediate-
, 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 SANS used for human
health risk assessment is shown in the following Table 1.
Table 1.--Summary of Toxicological Doses and Endpoints for SANS for Use in Human Health 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) No appropriate endpoints identified for acute dietary assessment.
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Chronic dietary (all populations) NOAEL = 50 mg/kg/day Chronic RfD = 0.5 mg/kg/ OPPTS Harmonized
UFA = 10x.............. day Guideline 870.3650
UFH = 10x.............. cPAD = 0.5 mg/kg/day... Combined Repeated Dose
FQPA SF = 1x........... Toxicity Study with
the Reproduction/
Developmental Toxicity
Screen in Rats
LOAEL = 120 mg/kg/day,
based on increased
postnatal loss,
reduced viability,
decreased birth index
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Incidental Oral, (Short- and NOAEL = 50 mg/kg/day Residential LOC for MOE OPPTS Harmonized
Intermediate-Term), Dermal and UFA = 10x.............. = 100 Guideline 870.3650
Inhalation (Short, Intermediate-, UFH = 10x.............. Combined Repeated Dose
and Long-term) FQPA SF = 1x........... Toxicity Study with
(5% dermal absorption; the Reproduction/
inhalation hazard Developmental Toxicity
assumed to be Screen in Rats
equivalent to oral LOAEL = 120 mg/kg/day,
hazard). based on increased
postnatal loss,
reduced viability,
decreased birth index.
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[[Page 38966]]
Cancer (oral, dermal, inhalation) Classification: No animal toxicity data available for an assessment.
Based on SAR analysis, SANS are 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. N/A = not applicable.
C. Exposure Assessment
Very limited information is available for the sodium alkyl
naphthalenesulfonates (SANS) with respect to plant and animal
metabolism or environmental degradation. The Agency relied collectively
on information provided on the representative chemical structures, the
submitted physicochemical data, structure-activity relationship
information, as well as information on other surfactants and chemicals
of similar size and functionality to determine the residues of concern
for these inert ingredients. Based on SAR analysis the SANS inerts are
unlikely to degrade in the environment to compounds that are more toxic
than the parent compounds; therefore, the parent compounds SANS are the
residues of concern.
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to SANS, EPA considered exposure under the petitioned-for
exemptions from the requirement of a tolerance. EPA assessed dietary
exposures from SANS in food as follows:
i. Acute exposure. No adverse effects attributable to a single
exposure of SANS was seen in the toxicity databases. Therefore, an
acute dietary risk assessment for SANS 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 SANS. 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 contained in the memorandum entitled Alkyl Amines
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov 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.
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
concentrations of active ingredient 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 which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient. In the case of SANS, EPA made a specific
adjustment to the dietary exposure assessment to account for the use
limitations of the amount of SANS that may be in formulations (no more
than 30% by weight in pesticide formulations) and assumed that the SANS
are present at the maximum limitations rather than at equal quantities
with the active ingredient. This remains a very conservative assumption
because surfactants are generally used at levels far below this
percentage.
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 what level of inert
residue 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 shows that tolerance level residues 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. The Agency used a qualitative structure activity
relationship (SAR) database, DEREK11, to determine if there were
structural
[[Page 38967]]
alerts suggestive of carcinogenicity. No structural alerts for
carcinogenicity were identified. SANS are not expected to be
carcinogenic. Therefore, a cancer dietary exposure assessment is not
necessary to assess cancer risk.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for SANS. 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 SANS in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of SANS. 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 SANS. Modeling runs on four surrogate inert ingredients
using a range of physical chemical properties that would bracket those
of SANS 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 Alkyl Naphthalenesulfonate (SANS) - JITF CST 10
Inert Ingredients. Human Health Risk Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations, pages 14-15 and 56-58 in docket
ID number EPA-HQ-OPP-2009-0099.
For the purpose of the screening level dietary risk assessment to
support this request for an exemption from the requirement of a
tolerance for SANS, 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). SANS may be used as
inert ingredients 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 SANS as inert ingredients. In
this assessment, representative scenarios based on end-use product
application methods and labeled application rates were selected. The
SANS may be used as inert ingredients in pesticide formulations that
are used in and around the home. Additionally, uses are possible in
household cleaning products. For each of the use scenarios, the Agency
assessed residential handler (applicator) inhalation and dermal
exposure for indoor and outdoor scenarios with high exposure potential
(i.e., exposure scenarios with high end unit exposure values) to serve
as a screening assessment for all potential residential pesticides
containing SANS. Similarly, residential post application dermal and
oral exposure assessments were also performed utilizing high end indoor
and outdoor exposure scenarios. Further details of this residential
exposure and risk analysis can be found at http://www.regulations.gov
in the memorandum entitled 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 (D364751, 5/7/09, Lloyd/LaMay 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 the SANS to share a common mechanism of toxicity
with any other substances, and the SANS do not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that the SANS do 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 representative test
compounds for the SANS cluster group includes:
i. An aqueous mixture containing 80% 3-butyl-naphthalene-1
sulfonate (CAS Reg. No. 25638-17-9) and 20% sodium di-3, 6-dibutyl
naphthalene-1-sulfonate (CAS Reg. No. 25417-20-3);
ii. A complex mixture from a boiling distillate from petroleum
catalytic reformer fractionator residue that includes C9-
rich C8-C10-alkyl-sodium naphthalenesulfonate
(CAS Reg. No. 908356-16-1); and
iii. Naphthalenesulfonic acid, sodium salt, isopropylate (CAS Reg.
No. 68442-09-1), which is a mixture containing sodium diisopropyl and
triisopropyl-2-naphthalenesulfonates in a 40:60 ratio, with 6% of mono-
isopropyl-2-naphthalenesulfonates. The existing toxicology database for
the SANS inerts consists of an OPPTS Harmonized Guideline 870.3650
combined repeated dose toxicity study with the reproduction/
developmental toxicity screening studies in rats on each of the
representative SANS.
In the case of the SANS inerts, there was no increased
susceptibility to the offspring of rats following prenatal and
postnatal exposure in two of the three OPPTS Harmonized Guideline
870.3650 studies. There were no developmental effects at any dose level
up to the limit dose following exposure to (CAS Reg. No. 908356-16-1).
In that study, maternal toxicity was manifested as mortality, an
increase in liver enzymes and creatinine, increased kidney weight, and
histopathological lesions in the kidney (tubular cell necrosis),
stomach (inflammatory submucosal infiltrates
[[Page 38968]]
and mucosal ulceration), and liver (hepatic fatty change) at 1,000 mg/
kg/day. Following exposure to (CAS Reg. No. 25638-17-9) and (CAS Reg.
No. 25417-20-3), developmental toxicity (decreased pup body weight;
[darr]7-8%) was observed at the same dose level where maternal/paternal
toxicity was observed, as evidenced by microscopic lesions in the
stomach at 540 mg/kg/day.
Developmental toxicity was observed following exposure to (CAS Reg.
No. 68442-09-1) at a dose level where no significant effects were
observed in the parental animals. Offspring effects included increases
in post-implantation loss and postnatal loss and lower pup body weights
at dose levels of 120 and 288 mg/kg/day. Parental toxicity was observed
at 288 mg/kg/day, as evidenced by mortality, increased kidney weight
and histopathological lesions in the kidney (tubular cell necrosis),
stomach (inflammatory submucosal infiltrates and mucosal ulceration),
and liver (hepatic fatty change), and increase in liver enzymes and
creatinine in females. Based on the fact that there is a clear NOAEL
(50 mg/kg/day), the point of departure is based on this endpoint
(increased postnatal loss, decreased pup viability, reduced birth
index) and is protective of the effects seen in the study, and because
of the highly conservative inputs used in both the hazard and exposure
assessments, there is no residual concern for this finding.
3. Conclusion. EPA has determined that reliable data show that 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 SANS is considered adequate for
assessing the risks to infants and children (the available studies are
described in unit IV.D.2.). The Agency noted changes in thymus weight
and thymus atrophy. However, these were determined to be non-specific
changes not indicative of immunotoxicity. In addition, no blood
parameters were affected. Furthermore, these compounds do not belong to
a class of chemicals that would be expected to be immunotoxic.
Therefore, the Agency does not believe that an additional uncertainty
factor (UFdb) for database uncertainties needs to be applied. In
addition, this effect was not observed in the pups.
ii. No increased susceptibility of the offspring or reproductive
toxicity was demonstrated in the OPPTS Harmonized Guideline 870.3650
reproductive/developmental toxicity studies in rats following prenatal
and postnatal exposure to two of the three representative compounds
(540 and 1,000 mg/kg/day). Increased susceptibility was demonstrated in
the rat offspring following prenatal and postnatal exposure to one of
the three representative compounds. Decreased pup body weight,
increased pup mortality, and a lower viability index were observed (120
and 288 mg/kg/day) at a dose level where no parental toxicity was
observed. A clear NOAEL was established for these effects, and the
point of departure is based on this endpoint. Reproductive toxicity was
observed following exposure to one of the representative inerts (120
and 288 mg/kg/day), as evidenced by the reduction in birth index. A
clear NOAEL was established for this effect and the point of departure
for risk assessment is significantly below the NOAEL for this effect.
The selected point of departure for the dietary, dermal and inhalation
risk assessments is protective of these offspring effects, thus there
are no residual concerns.
iii. There is no indication that SANS are neurotoxic chemicals and
thus there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iv. While there is no chronic toxicity data, the Agency has
concluded that an additional uncertainty factor is not needed for the
use of a subchronic study for a chronic exposure assessment because the
adverse effects observed in the available toxicity studies are
attributable to the irritant nature of surfactants and would not be
expected to increase in severity from subchronic to chronic exposure
scenarios. Based on the lack of progression of severity of effects with
time, along with the considerable similarities of effects across the
species tested, the observation that the vast majority of the effects
observed are related to local irritation and corrosive effects, and the
highly conservative nature of the exposure assessment, EPA concludes
that an additional UF for extrapolation from subchronic toxicity study
to a chronic exposure scenario is not needed.
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 100%
crop treated is assumed for all crops. EPA also made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to SANS 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
SANS.
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-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk.There was no hazard attributable to a single exposure
seen in the toxicity database for SANS. Therefore, the SANS are 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, and the use limitations of not more than 30% by
weight in pesticide formulations, the chronic dietary exposure from
food and water to SANS is 23% of the cPAD for the U.S. population and
75% 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).
SANS are used as inert ingredients 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 SANS. Using the exposure
assumptions described in this unit, EPA has concluded that the combined
short-term food, water, and residential exposures aggregated result in
aggregate MOEs of
[[Page 38969]]
120 for both adult males and females, respectively. Adult residential
exposure combines high end dermal and inhalation handler 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 120 for children. Children's residential
exposure combines 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).
SANS are 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 SANS. 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 520 for both adult males and
females, respectively. Adult residential exposure includes high end
post application dermal exposures. EPA has concluded that the combined
intermediate-term aggregated food, water, and residential exposures
result in an aggregate MOE of 130 for children. Children's residential
exposure combines 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 SANS.
6. 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 residues of SANS.
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
SANS 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 alkyl naphthalenesulfonates when
used as inert ingredients applied to crops pre-harvest and post-
harvest, and to animals at a maximum of 30% by weight in pesticide
formulations.
VII. Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of
tolerances under section 408(d) of FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this final rule has been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, 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 exemptions 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: July 29, 2009.
Lois Rossi,
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. 180.910, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
[[Page 38970]]
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Sodium alkyl Limited to no more Surfactants,
naphthalenesulfonates (CAS Reg. than 30% by related adjuvants
Nos. 68909-83-1, 68909-84-2, weight in of surfactants
68909-82-0, 27213-90-7, 26264- pesticide end-use
58-4, 27178-87-6, 111163-74-7, products.
908356-16-1, 25417-20-3, 25638-
17-9, 145578-88-7, 1322-93-6,
1323-19-9, 7403-47-6, 68442-09-
1, 127646-44-0, 908356-18-3).
* * * * * * *
------------------------------------------------------------------------
0
4. In Sec. 180.930, the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Sodium alkyl Limited to no more Surfactants,
naphthalenesulfonates (CAS Reg. than 30% by related adjuvants
Nos. 68909-83-1, 68909-84-2, weight in of surfactants
68909-82-0, 27213-90-7, 26264- pesticide end-use
58-4, 27178-87-6, 111163-74-7, products.
908356-16-1, 25417-20-3, 25638-
17-9, 145578-88-7, 1322-93-6,
1323-19-9, 7403-47-6, 68442-09-
1, 127646-44-0, 908356-18-3).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. E9-18702 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-S