[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Rules and Regulations]
[Pages 27025-27030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10582]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0213; FRL-9945-58]
Butanedioic Acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
Disodium Salts; 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 butanedioic acid, 2-sulfo-, C-C9-11-
isoalkyl esters, C10-rich, disodium salts (CAS Reg. No. 815583-91-6)
when used as an inert ingredient (surfactant) in pesticides applied to
growing crops and raw agricultural commodities after harvest under 40
CFR 180.910 limited to maximum concentration of 10% by weight in
pesticide formulations. Keller and Heckman LLP on behalf of Cytec
Industries, Inc. 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 butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-
rich, disodium salts.
DATES: This regulation is effective May 5, 2016. Objections and
requests for hearings must be received on or before July 5, 2016, 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-2015-0213, 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: [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.
The following
[[Page 27026]]
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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
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 Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-2015-0213 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
July 5, 2016. 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-2015-0213, by one of
the following methods:
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.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
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 http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927-
39), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-10760) by
Keller and Heckman LLP, (1001 G Street NW., Suite 500, Washington, DC
20001) on behalf of Cytec Industries, Inc. (5 Garret Mountain Plaza,
Woodland Park, NJ 07424). The petition requested that 40 CFR 180.910 be
amended by establishing an exemption from the requirement of a
tolerance for residues of butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl
esters, C10-rich, disodium salts (CAS Reg. No. 815583-91-6) when used
as an inert ingredient (surfactant) in pesticide formulations applied
to growing crops and raw agricultural commodities after harvest. That
document referenced a summary of the petition prepared by Keller and
Heckman LLP, on behalf of Cytec Industries, Inc., 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 has
limited the maximum concentration of butanedioic acid, 2-sulfo-, C-C9-
11-isoalkyl esters, C10-rich, disodium salts to 10% by weight in
pesticide formulations. This limitation is based on the Agency's risk
assessment which can be found at http://www.regulations.gov in document
``Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts (CAS Reg No. 815583-91-6); 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
Pesticide Formulations'' in docket ID number EPA-HQ-OPP-2015-0213.
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 exemption is ``safe.'' Section 408(c)(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 or exemption 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 ingredient 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 result from aggregate
[[Page 27027]]
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 butanedioic acid, 2-sulfo-, C-
C9-11-isoalkyl esters, C10-rich, disodium salts including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with butanedioic acid, 2-
sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts 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 butanedioic acid, 2-sulfo-, C-C9-11-
isoalkyl esters, C10-rich, disodium salts 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.
Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts is of low acute oral and dermal toxicity in rats. The
acute oral and dermal LD50s are >1,600 milligram/kilogram
(mg/kg). It is irritating to the eyes but not the skin of rabbits.
Neither inhalation nor sensitization studies are available.
90-day oral toxicity studies are available in rats and dogs. In the
rat, toxicity is manifested as decreased body weight and food
efficiency at 4% (equivalent to 3,080 milligram/kilogram/day (mg/kg/
day)) of butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts. In dogs, toxicity is manifested as testicular atrophy
at 0.5% (equivalent to 125 mg/kg/day). The NOAEL in this study is 0.12%
(equivalent to 30 mg/kg/day). The chronic reference dose (cRfD) is
based on this study.
A combined reproductive and developmental study on rats is
available with butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters,
C10-rich, disodium salts. Quantitative fetal susceptibility is observed
as reduced pup weight at 1% (equivalent to 750 mg/kg/day). Maternal
toxicity is reported only with regard to reproduction toxicity and
included a reduced number of viable embryos and live-born per litter,
and reduced fertility, viability and lactation indices at 4%
(equivalent to 3,000 mg/kg/day).
Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts is not expected to be carcinogenic based on the absence
of structural alerts using the Derek Nexus program and the lack of
mutagenicity in two Ames tests.
Neurotoxicity and immunotoxicity studies with butanedioic acid, 2-
sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts are not
available for review. However, no evidence of potential neurotoxicity
or immunotoxicity is observed in the submitted studies.
Metabolism studies with butanedioic acid, 2-sulfo-, C-C9-11-
isoalkyl esters, C10-rich, disodium salts are not available for review.
However, it is expected that these salts will readily hydrolyze
(primarily in the intestine, blood and liver) by carboxylesterases
resulting in the corresponding alcohol (C9-C l1 isoalkyl, Cl0 rich).
The fatty alcohol is expected to be metabolized via normal metabolic
pathways (oxidation, followed by normal fatty acid metabolism).
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 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.
An acute effect was not found in the database therefore an acute
dietary assessment was not conducted. The cRfD as well as all exposure
scenarios was based on the 90-day oral toxicity study in the dog. In
this study, the LOAEL was 0.5% (equivalent to 125 mg/kg/day) based on
testicular atrophy in males. The NOAEL was 0.12% (equivalent to 30 mg/
kg/day). This represents the lowest NOAEL in the most sensitive species
in the toxicity database. The standard uncertainty factors were applied
to account for interspecies (10x) and intraspecies (10x) variations.
Default values of 100% absorption were used for the dermal and
inhalation factors.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-
rich, disodium salts, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters,
C10-rich, disodium salts in food as follows:
Dietary exposure (food and drinking water) to butanedioic acid, 2-
sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts can occur
following ingestion of foods with residues from treated crops. Because
no adverse effects attributable to a single exposure of butanedioic
acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts are
seen in the toxicity databases, an acute dietary risk assessment was
not conducted. For the chronic dietary risk assessment, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM, Version 3.16, and food
consumption information from the U.S. Department of Agriculture's
(USDA's) 2003-2008 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no
residue data were submitted for butanedioic acid, 2-sulfo-, C-C9-11-
isoalkyl esters, C10-rich, disodium salts. 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. 100 percent crop treated
(PCT), default processing
[[Page 27028]]
factors, and tolerance-level residues were assumed for all foods, and
the assessment incorporated the use limitation that the ingredient will
be present in pesticide formulations at a concentration of not more
than 10% by weight. 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.
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 butanedioic acid, 2-
sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts, 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).
Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts may be used in inert ingredients in products that are
registered for specific uses that may result in residential exposure,
such as pesticides used in and around the home. Based on the available
data for products registered for residential use, the Agency concluded
that products containing inert chemicals similar to butanedioic acid,
2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts (ie
surfactant) usually comprise no more than 2-5% of the inert ingredient
in the final product. Therefore, the Agency conducted an assessment to
represent conservative residential exposure by assessing butanedioic
acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts in
pesticide formulations (outdoor scenarios) and in disinfectant-type
uses (indoor scenarios) at no more than 5% in the final formulation.
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 butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl
esters, C10-rich, disodium salts to share a common mechanism of
toxicity with any other substances, and butanedioic acid, 2-sulfo-, C-
C9-11-isoalkyl esters, C10-rich, disodium salts does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium
salts 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 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. The toxicity database for
butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium
salts contains subchronic, combined reproduction/teratology and
mutagenicity studies. There is no indication of potential neurotoxicity
or immunotoxicity in the available studies. Quantitative increased
fetal susceptibility was observed in the combined reproduction/
teratology study in rats. Fetal toxicity (reduced pup weight) was
observed at the lowest dose tested, 750 mg/kg/day. Maternal/
reproduction toxicity was observed at 3,000 mg/kg/day and manifested as
a reduction in the number of viable embryos, live-born per litter,
fertility, viability, and lactation indices. The addition of a 10x FQPA
safety factor to account for quantitative susceptibility and LOAEL to
NOAEL extrapolation is not necessary because it would result in a cRfD
of 0.75 mg/kg/day and the established cRfD is 0.30 mg/kg/day. The cRfD
is considerably lower and will be protective of fetal susceptibility
and effects observed at 750 mg/kg/day. Therefore, retention of the FQPA
safety factor is unnecessary. There is low concern for reproduction
toxicity since the aforementioned effects occurred above the limit dose
of 1,000 mg/kg/day and a clear NOAEL of 750 mg/kg/day was established.
Therefore, the established cRfD will be protective of these effects. In
addition, the Agency used the most conservative (highest) exposure
estimates and assumptions, including 100 PCT and tolerance-level
residues for all foods, conservative estimates of drinking water
exposure, and a conservative assessment of potential residential
exposure for infants and children. Therefore, the FQPA SF of 10x is
reduced to 1x.
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 and no acute dietary endpoint was selected. Therefore,
butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium
salts is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium
salts from food and water will utilize 47.9% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water
[[Page 27029]]
(considered to be a background exposure level).
Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts may be used as inert ingredients in pesticide products
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
butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium
salts. Using the exposure assumptions described above, EPA has
concluded that the combined short-term aggregated food, water, and
residential exposures result in MOEs of 126 for both adult males and
females. Adult residential exposure combines high end dermal and
inhalation handler exposure from liquids/trigger sprayer/home garden
use with a high end post application dermal exposure from contact with
treated lawns. Also, EPA has concluded the combined short-term
aggregated food, water, and residential exposures result in an
aggregate MOE of 135 for children. Children's residential exposure
includes total exposures associated with contact with treated lawns
(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).
Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts may be used as inert ingredients in pesticide products
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 butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-
rich, disodium salts. Using the exposure assumptions described above,
EPA has concluded that the combined intermediate-term food, water, and
residential exposures result in aggregate MOEs of 480 for adult males
and females. Adult residential exposure combines liquids/trigger
sprayer/home garden use with a high end post application dermal
exposure from contact with treated lawns. As the level of concern is
for MOEs that are lower than 100, this MOE is not of concern. EPA has
concluded the combined intermediate-term aggregated food, water, and
residential exposures result in an aggregate MOE of 158 for children.
Children's residential exposure includes total exposures associated
with contact with treated surfaces (dermal and hand-to-mouth
exposures). As the level of concern is for MOEs that are lower than
100, this MOE is not of concern.
5. Aggregate cancer risk for U.S. population. Based on a DEREK
structural alert analysis and the lack of mutagenicity, butanedioic
acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts is
not expected to pose a cancer risk to humans.
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 butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-
rich, disodium salts residues.
V. Other Considerations
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium
salts in or on any food commodities. EPA is establishing limitations on
the amount of butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-
rich, disodium salts that may be used in pesticide formulations applied
to growing crops. These limitations 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 formulation for use on growing crops or
raw agricultural commodities after harvest for sale or distribution
that exceeds 10% by weight of butanedioic acid, 2-sulfo-, C-C9-11-
isoalkyl esters, C10-rich, disodium salts unless additional data are
submitted.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180. 910 for of butanedioic acid, 2-sulfo-, C-
C9-11-isoalkyl esters, C10-rich, disodium salts (CAS Reg. No. 815583-
91-6) when used as inert ingredients (surfactant) at a maximum
concentration of 10% by weight in pesticide formulations applied to
growing crops or to raw agricultural commodities after harvest.
VII. Statutory and Executive Order Reviews
This action establishes 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This 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
[[Page 27030]]
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: April 26, 2016.
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 Sec. 180.910, add alphabetically the inert ingredient
``Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich,
disodium salts (CAS Reg. No. 815583-91-6)'' to the table to read as
follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Butanedioic acid, 2-sulfo-, C- Not to exceed 10% by Surfactant.
C9-11-isoalkyl esters, C10- weight in pesticide
rich, disodium salts (CAS formulation for
Reg. No. 815583-91-6). agricultural use.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2016-10582 Filed 5-4-16; 8:45 am]
BILLING CODE 6560-50-P