[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Rules and Regulations]
[Pages 19226-19231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08218]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0756; FRL-9923-64]
Secondary (C13-C17) Alkane Sulfonates;
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 two secondary alkane (C13-
C17) sulfonates (CAS Reg. Nos. 85711-69-9 and
97489-15-1) when used as inert ingredients (surfactant) in
pesticide formulations applied to growing crops at a maximum
concentration not to exceed 40% by weight. Exponent, on behalf of
Clariant Corporation, submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of secondary alkane (C13-C17)
sulfonates.
DATES: This regulation is effective April 10, 2015. Objections and
requests for hearings must be received on or before June 9, 2015, 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: The docket for this action, identified by docket
identification (ID) number
EPA-HQ-OPP-2013-0756, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the
OPP Docket is (703) 305-5805. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main
telephone number: (703) 305-7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following
[[Page 19227]]
list of North American Industrial Classification System (NAICS) codes
is not intended to be exhaustive, but rather provides a guide to help
readers determine whether this document applies to them. Potentially
affected entities may include:
&sbull; Crop production (NAICS code 111).
&sbull; Animal production (NAICS code 112).
&sbull; Food manufacturing (NAICS code 311).
&sbull; Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the OCSPP test guidelines
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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-2013-0756 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing, and must be received by the
Hearing Clerk on or before June 9, 2015. Addresses for mail and hand
delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number
EPA-HQ-OPP-2013-0756, by one of the following
methods:
&sbull; Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be CBI or other information whose disclosure is restricted by statute.
&sbull; Mail: OPP Docket, Environmental Protection Agency
Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.
&sbull; Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at
&fnl;http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of February 21, 2014 (79 FR 9870)
(FRL-9904-98), EPA issued a document pursuant to FFDCA
section 408, 21 U.S.C. 346a, announcing the filing of a pesticide
petition (PP IN-10630) by Exponent, 1150 Connecticut Ave. NW.,
Washington, DC 20036 on behalf of Clariant Corporation, 4000 Monroe
Rd., Charlotte, NC 28205. The petition requested that 40 CFR 180.920 be
amended by establishing an exemption from the requirement of a
tolerance for residues of two inert ingredients, collectively referred
to as secondary alkane (C13-C17) sulfonates
(SAS): Sulfonic acids, C13-17-sec-alkane, sodium
salts (CAS Reg. No. 85711-69-9) and sulfonic acids,
C14-17-sec-alkane, sodium salts (CAS Reg. No.
97489-15-1) when used as surfactants in pesticide
formulations applied to growing crops. That document referenced a
summary of the petition prepared by Exponent, the petitioner, which is
available 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 is
limiting the tolerance exemption to pesticide formulations in which the
maximum concentration of the secondary alkane sulfonates is 40% by
weight. This limitation is based on the Agency's risk assessment which
can be found at &fnl;http://www.regulations.gov in document
“Secondary Alkane (C13-C17) Sulfonates
(SAS); Human Health Risk Assessment and Ecological Effects Assessment
to Support Proposed Exemption from the Requirement of a Tolerance When
Used as an Inert Ingredient in Pre-harvest Pesticide Products Under 40
CFR 180.920” in docket ID number
EPA-HQ-OPP-2013-0756.
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(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is “safe.” Section 408(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 establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will
[[Page 19228]]
result from aggregate exposure to the inert ingredient, an exemption
from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 secondary alkane
(C13-C17) sulfonates including exposure resulting
from the exemption established by this action. EPA's assessment of
exposures and risks associated with secondary alkane (C13-
C17) sulfonates follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by secondary alkane (C13-
C17) sulfonates (also referred to as SAS) as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
The Agency relied on data on CAS Reg. No. 85711-69-9
(sulfonic acids (C13-C17 secondary alkane) to
assess both inert ingredients. Bridging data in this manner is
appropriate because CAS Reg. No. 97489-15-1 (sulfonic
acids, C14-C17 secondary alkane) has an alkyl
carbon chain length that falls within the carbon chain length range of
CAS Reg. No. 85711-69-9 (sulfonic acids, C13-
C17 secondary alkane) and toxic effects attributable to the
C14-C17 secondary alkane sulfonate would be
observed in toxicity testing of the C13-C17
secondary alkane sulfonate.
The acute oral lethal dose (LD50) for SAS in rats is
>500 milligram/kilogram (mg/kg). The acute dermal LD50 in
mice is >200 mg/kg. Secondary alkane (C13-C17)
sulfonate is not a dermal irritant based on primary skin irritation
study in rabbits and it is not a dermal sensitizer in guinea pigs.
A chronic toxicity study was conducted on SAS in rats and
demonstrated a NOAEL of 4,000 parts per million (ppm) (equivalent to
168 milligram/kilogram body weight/day (mg/kg bw/day) in males and 227
mg/kg bw/day in females), and a LOAEL of 20,000 ppm (equivalent to 920
mg/kg bw/day in males and 1,281 mg/kg bw/day in females) based on
reduced body weight, body weight gain, and the clinical signs of
reduced grooming in males and females.
In a 2-generation reproduction study in rats dosed with SAS, there
was no indication that offspring were more susceptible than the
parental adults. The parental systemic LOAEL was 3,000 ppm (equivalent
to 177 mg/kg bw/day in males and 181 mg/kg bw/day in females), based on
decreased body weight gain during premating and on reduced organ
weight. The parental NOAEL was 1,000 ppm (equivalent to 58.2 mg/kg bw/
day for males and 66 mg/kg bw/day for females). The offspring LOAEL was
3,000 ppm (equivalent to 177 mg/kg bw/day) based on decreased pre- and
post-implantation loss and decreased weight gain in offspring. The
offspring NOAEL was 1,000 ppm (equivalent to 58.2 mg/kg bw/day).
Secondary alkane (C13-C17) sulfonates were
not mutagenic when tested in the in vitro mammalian cell gene mutation
assay and in the Salmonella typhimurium reverse mutation assay.
In a combined oral (dietary) chronic toxicity/carcinogenicity study
of SAS in rats, there were no treatment-related neoplastic or non-
neoplastic microscopic findings observed up to 2.0% (equivalent to 805
mg/kg bw/day in males and 1,032 mg/kg bw/day in females), the highest
dose tested. A LOAEL was not identified. Although body weight of high-
dose males and females were lower by about 20% relative to controls
throughout most of the study, decreased body weight was not viewed as
an adverse effect since higher survival rates were observed in this
group compared to controls.
In a dermal carcinogenicity study of SAS in mice, no indication of
increased incidence relative to controls of malignant neoplasms was
observed. No LOAEL was demonstrated. The NOAEL was 1.0% (equivalent to
0.6 mg/treatment), the highest concentration applied to the skin.
Secondary alkane (C13-C17) sulfonates are
rapidly absorbed and excreted in the urine and feces. Secondary alkane
(C13-C17) sulfonates have a low potential for
dermal absorption based on a dermal penetration study in rats.
Although no immunotoxicity or neurotoxicity studies on SAS were
available in the database, no evidence of immunotoxicity or
neurotoxicity was observed in the submitted studies.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors (UF) are used in conjunction with the POD to
calculate a safe exposure level-generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)—and a
safe margin of exposure (MOE). 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 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 secondary alkane
(C13-C17) sulfonates used for human risk
assessment is shown in Table 1 of this unit.
The 2-generation reproductive toxicity study in rats was selected
for oral, dietary, dermal, and inhalation exposure scenarios (all
durations) for this risk assessment. The parental systemic NOAEL in
this study was 1,000 ppm (equivalent to 58.2 mg/kg bw/day for males)
based on reduced body weight gain during premating and on reduced organ
weight seen at the LOAEL of 3,000 ppm (equivalent to 177 mg/kg bw/day).
The rationale for selecting this study for the dietary, dermal, and
inhalation exposure scenario is based on the fact that this study
provided the lowest and most conservative toxicity endpoint and route-
specific studies are available.
A default 100% inhalation absorption will be used for inhalation
exposure scenarios. A 50% dermal absorption rate will be used for
dermal exposure scenarios based on the toxicokinetic dermal absorption
study.
[[Page 19229]]
Table 1-Summary of Toxicological Doses and Endpoints for Secondary Alkane (C13-C17) Sulfonates for Use in
Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Chronic dietary (All populations) NOAEL = 58.2 mg/kg Chronic RfD = 0.582 Rat reproductive toxicity study.
bw/day. mg/kg bw/day. LOAEL = 177 mg/kg bw/day based on
UFA = 10x........... cPAD = 0.58 mg/kg decreased weight gain during
UFH = 10x........... bw/day. premating and reduced organ
FQPA SF = 1x........ weight.
Cancer (Oral, dermal, inhalation) Based on the lack of
increased incidence
of tumor formation
compared to
controls in
multiple
carcinogenicity
studies and the
lack of
mutagenicity, SAS
is considered not
likely to be
carcinogenic.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to secondary alkane (C13-C17)
sulfonates, EPA considered exposure under the proposed exemption from
the requirement of a tolerance. EPA assessed dietary exposures from
secondary alkane (C13-C17) sulfonates in food as
follows:
i. Acute Exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide chemical, if a
toxicological study has indicated the possibility of an effect of
concern occurring as a result of a 1-day or single exposure. No such
effects were identified in the toxicological studies for SAS;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. The chronic dietary exposure assessment for
this inert ingredient utilizes the Dietary Exposure Evaluation Model
Food Commodity Intake Database (DEEM-FCID), Version 3.16, EPA,
which includes food consumption information from the U.S. Department of
Agriculture's National Health and Nutrition Examination Survey,
“What We Eat In America”, (NHANES/WWEIA). This dietary
survey was conducted from 2003 to 2008. In the absence of actual
residue data, the inert ingredient evaluation is based on a highly
conservative model which assumes that the residue level of the inert
ingredient would be no higher than the highest established tolerance
for an active ingredient on a given commodity. Implicit in this
assumption is that there would be similar rates of degradation between
the active and inert ingredient (if any) 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 model assumes 100 percent crop treated (PCT) for all
crops and that every food eaten by a person each day has tolerance-
level residues. 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.
iii Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that SAS does not pose a cancer risk to humans. Therefore, a
dietary exposure assessment for the purpose of assessing cancer risk is
unnecessary.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for secondary alkane
(C13-C17) sulfonates, a conservative drinking
water concentration value of 100 parts per billion (ppb) based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. 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., textiles (clothing and diapers), carpets,
swimming pools, and hard surface disinfection on walls, floors,
tables).
Based on the use pattern for pesticide products containing SAS as
an inert ingredient, there are no residential uses and thus no
residential exposures are expected.
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 secondary alkane (C13-C17)
sulfonates to share a common mechanism of toxicity with any other
substances, and secondary alkane (C13-C17)
sulfonates do not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that secondary alkane (C13-C17)
sulfonates do not have a common mechanism of toxicity with other
[[Page 19230]]
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 Web site 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 Food Quality
Protection Act Safety Factor (FQPA 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. In a 2-generation
reproduction toxicity study, there was no evidence of susceptibility of
infants and children to SAS. In this study, the offspring and parental
toxicity NOAEL was 1,000 ppm (equivalent to 58.2 mg/kg bw/day) based
decreased pre- and post-implantation loss and decreased weight gain in
offspring and decreased body weight gain during premating and on
reduced organ weight in parental animals seen at the LOAEL was 3,000
ppm (equivalent to 177 mg/kg bw/day).
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 secondary alkane (C13-
C17) sulfonates includes a subchronic toxicity study, a 2-
generation reproduction study, chronic/carcinogenicity studies, several
mutagenicity studies, and two toxicokinetic studies. The Agency
concludes that for this ingredient, the results of these studies
provide a reliable basis for assessing the range of potential effects
to infants and children, such that the Agency has determined that no
additional data are necessary at this time to evaluate effects to
infants and children.
ii. There is no indication that SAS is a neurotoxic chemical and
there is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity.
iii. There is no evidence of increased susceptibility due to pre-or
post-natal exposure to SAS in infants and children.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 percent crop treated (PCT) and tolerance-level residues. EPA
made conservative (protective) assumptions utilizing a 100 ppb default
value in the ground and surface water modeling used to assess exposure
to secondary alkane (C13-C17) sulfonates in
drinking water. These assessments will not underestimate the exposure
and risks posed by secondary alkane (C13-C17)
sulfonates.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified, therefore, an acute dietary exposure assessment was not
conducted.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
SAS from food and water will utilize 97.1% of the cPAD for children
1-2 years old, the population group receiving the greatest
exposure.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). A short-term/
intermediate-term adverse effect was identified; however, SAS is not
used as inert ingredient in any pesticide product registered for any
use patterns that would result in short-term or intermediate-term
residential exposure. Because there is no short-term or intermediate-
term residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for SAS.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two rodent carcinogenicity studies,
secondary alkane (C13-C17) sulfonates are not
expected to pose a cancer risk to humans.
5. 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 secondary alkane (C13-C17) sulfonates
residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Although EPA is establishing a limitation on the amount of SAS that
may be used in pesticide formulations, an analytical enforcement
methodology is not necessary for this exemption. The limitation will be
enforced through the pesticide registration process under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. EPA will not register any pesticide for sale or distribution for
use on growing crops with concentrations of SAS exceeding 40% by weight
of the formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for secondary alkane
(C13-C17) sulfonates.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established
[[Page 19231]]
under 40 CFR 180.920 for sulfonic acids, C13-17-
sec-alkane, sodium salts (CAS Reg. No. 85711-69-9) and
sulfonic acids, C14-17-sec-alkane, sodium salts
(CAS Reg. No. 97489-15-1) when used as inert ingredients
(surfactant) in pesticide formulations applied to growing crops at not
more than 40% by weight of the pesticide formulation.
VII. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) 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 action has been exempted from
review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
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 (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: March 10, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
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 §&thnsp;180.920, add alphabetically the following inert
ingredients to the table to read as follows:
§&thnsp;180.920 Inert ingredients used pre-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * &ems
p; * &em
sp; * &e
msp;* *
*
Sulfonic acids, C13-17-sec- Not to exceed 40% by Surfactant.
alkane, sodium salts (CAS weight in non-
Reg. No. residential use
85711-69-9). pesticide
formulation only.
Sulfonic acids, C14-17-sec- Not to exceed 40% by Surfactant.
alkane, sodium salts (CAS weight in non-
Reg. No. residential
97489-15-1). pesticide
formulation only.
* * &ems
p; * &em
sp; * &e
msp;* *
*
------------------------------------------------------------------------
[FR Doc. 2015-08218 Filed 4-9-15; 8:45 am]
BILLING CODE 6560-50-P