[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Rules and Regulations]
[Pages 36335-36341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16373]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0507; FRL-9963-58]
Beta Cyclodextrin, Methyl Ethers; 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 beta cyclodextrin, methyl ethers (CAS
Reg. No. 128446-36-6) when used as an inert ingredient (stabilizer and
solvent) in pesticide formulations applied to growing crops pre-harvest
limited to a maximum concentration of 40% by weight in the pesticide
formulation. Lewis and Harrison, LLC, on behalf of Wacker Chemie AG
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 beta
cyclodextrin, methyl ethers that result from applications of pesticides
consistent with the conditions in EPA regulations.
DATES: This regulation is effective August 4, 2017. Objections and
requests for hearings must be received on or before October 3, 2017,
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-2016-0507, 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: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200
[[Page 36336]]
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 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-2016-0507 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
October 3, 2017. 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-2016-0507, 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 February 7, 2017 (82 FR 9555) (FRL-9956-
86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (IN-10964) by Lewis
and Harrison, LLC (122 C St. NW., Suite 505, Washington, DC 20001), on
behalf of Wacker Chemie AG (Hanns-Seidel-Platz 4, D-81737 Munich,
Germany). The petition requested that 40 CFR 180.920 be amended by
establishing an exemption from the requirement of a tolerance for
residues of beta cyclodextrin, methyl ethers (CAS Reg. No. 128446-36-6)
when used as an inert ingredient (stabilizer/solvent) in pesticide
formulations applied to growing crops pre-harvest, limited to 40% by
weight in the pesticide formulation. That document referenced a summary
of the petition prepared by Lewis and Harrison, LLC, on behalf of
Wacker Chemie AG, the petitioner, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
The Agency is establishing an exemption from the requirement of a
tolerance as requested, but is using the chemical abstract index name
``beta-cyclodextrin, methyl ethers'', the assigned formal name rather
than ``methyl-beta-cyclodextrin'', the common name.
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 result from
aggregate exposure to the
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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 beta cyclodextrin, methyl
ethers including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
beta cyclodextrin, methyl ethers 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 beta cyclodextrin, methyl ethers 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.
All studies are conducted with beta cyclodextrin, methyl ethers
except the developmental/reproduction toxicity studies which are
conducted with beta-cyclodextrin ([beta]-CD) and 2-hydroxypropyl-beta-
cyclodextrin (HP-[beta]-CD). These chemicals are structurally similar
to beta cyclodextrin, methyl ethers and are considered suitable
surrogates. A quantitative structural-activity relationship (QSAR)
analysis demonstrates that results are nearly identical for these
chemicals; therefore, data from the developmental/reproduction toxicity
studies conducted with [beta]-CD and HP-[beta]-CD are used to assess
potential developmental/reproduction toxicity from beta cyclodextrin,
methyl ethers exposure.
The acute oral toxicity is low in rats and mice for beta
cyclodextrin, methyl ethers. The lethal dose (LD50) is
>8,000 milligrams/kilogram (mg/kg) in acute oral toxicity studies in
the rat and mouse. Beta cyclodextrin, methyl ethers is not irritating
to the skin in the rabbit. It is moderately irritating to the eyes in
rabbits. Acute inhalation toxicity is low; the lethal concentration
(LC50) is >2.95 milligram/liter (mg/L) (equivalent to 398
mg/kg). Beta cyclodextrin, methyl ethers is not a dermal sensitizer in
the guinea pig maximization test.
Beta cyclodextrin, methyl ethers administered via the diet for 28
days causes tubular degeneration of the renal cortex at 1,000
milligrams/kilogram/day (mg/kg/day). The no-observed-adverse-effect
level (NOAEL) is 300 mg/kg/day.
No fetal susceptibility was observed in any of the developmental
and reproduction toxicity studies. Following oral administration of
beta-cyclodextrin in rats and rabbits, no developmental toxicity was
observed at doses as high as 5,000 mg/kg/day and 600 mg/kg/day,
respectively. No maternal toxicity was observed at doses as high as
2,500 mg/kg/day and 600 mg/kg/day in rats and rabbits, respectively.
Similarly, no developmental or maternal toxicity was observed in rats
following oral exposure to doses of 2-hydroxypropyl-beta-cyclodextrin
as high as 5,000 mg/kg/day and in rabbits following oral exposure to
doses as high as 500 mg/kg/day. Following intravenous administration of
2-hydroxypropyl-beta-cyclodextrin to rats, slight maternal toxicity was
observed at 400 mg/kg/day (with a NOAEL at 100 mg/kg/day), but no
developmental toxicity was observed. No maternal or developmental
toxicity was observed in rabbits exposed to doses of 2-hydroxypropyl-
beta-cyclodextrin at 400 mg/kg/day, the highest dose tested. In the
three-generation reproduction toxicity study in rats, no effects were
observed in parental or offspring animals at doses up to 1,099 mg/kg/
day beta-cyclodextrin. No reproduction effects were observed up to
2,277 mg/kg/day.
Beta cyclodextrin, methyl ethers administered for 26 weeks via
gavage causes tubular vacuolation in the kidney at 500 mg/kg/day. The
NOAEL is 100 mg/kg/day. The chronic reference dose (cRfD) is based on
this study.
Carcinogenicity studies with beta cyclodextrin, methyl ethers are
not available; however, a Deductive Estimation of Risk from Existing
Knowledge (Derek) Nexus structural alert analysis was conducted with
beta cyclodextrin, methyl ethers and indicated no structural alerts for
carcinogenicity or mutagenicity. Therefore, beta cyclodextrin, methyl
ethers is not expected to be carcinogenic.
All available mutagenicity studies (Ames tests, gene mutation,
chromosomal aberrations, unscheduled DNA synthesis and micronucleus
tests) were negative; therefore, beta cyclodextrin, methyl ethers is
not mutagenic.
Although neurotoxicity and immunotoxicity studies are not available
for review, evidence of neurotoxicity and immunotoxicity is not
observed in the submitted studies.
Beta cyclodextrin, methyl ethers is not metabolized and very little
is absorbed. Following oral exposure, it is mostly excreted in the
feces and 0.92% is excreted in the urine. 0.97-0.92% of an orally
administered dose is absorbed. A distribution study shows that beta
cyclodextrin, methyl ethers is found along the gastrointestinal tract,
in the kidney and bladder. Dermal absorption is estimated to be 0.4% in
126 hours in rats.
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 no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). 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.
A summary of the toxicological endpoints for beta cyclodextrin,
methyl ethers used for human risk assessment is shown in Table 1 of
this unit.
[[Page 36338]]
Table 1--Summary of Toxicological Doses and Endpoints for Beta Cyclodextrin, Methyl Ethers for Use in Human Risk
Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (General population An acute effect was not found in the database therefore an acute dietary
including infants and children). assessment is not necessary.
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Chronic dietary (All populations) NOAEL = 100 mg/kg/ Chronic RfD = 1.00 26-week Oral Toxicity Study-Rat
day. mg/kg/day. LOAEL = 500 mg/kg/day based on
UFA = 10x.......... cPAD = 1.00 mg/kg/ tubular degeneration in the
UFH = 10x........... day. kidneys.
FQPA SF = 1x........
Incidental oral short-term (1 to NOAEL= 300 mg/kg/day LOC for MOE = 100.. 28-Day Oral Toxicity Study-Rat
30 days). UFA = 10x.......... LOAEL = 1,000 mg/kg/day based on
UFH = 10x........... tubular vacuolation in the
FQPA SF = 1x........ kidneys.
Incidental oral intermediate-term NOAEL = 100 mg/kg/ LOC for MOE = 100.. 26-week Oral Toxicity Study-Rat
(1 to 6 months). day. LOAEL = 500 mg/kg/day based on
UFA = 10x.......... tubular degeneration in the
UFH = 10x........... kidneys.
FQPA SF = 1x........
Dermal short-term (1 to 30 days). NOAEL = 300 mg/kg/ LOC for MOE = 100.. 28-Day Oral Toxicity Study-Rat
day (dermal LOAEL = 1,000 mg/kg/day based on
absorption rate = tubular vacuolation in the
0.4%). kidneys.
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
Dermal intermediate-term (1 to 6 NOAEL= 100 mg/kg/day LOC for MOE = 100.. 26-week Oral Toxicity Study-Rat
months). (dermal absorption LOAEL = 500 mg/kg/day based on
rate = 0.4%). tubular degeneration in the
UFA = 10x........... kidneys.
UFH = 10x...........
FQPA SF = 1x........
Inhalation short-term (1 to 30 NOAEL= 300 mg/kg/day LOC for MOE = 100.. 28-Day Oral Toxicity Study-Rat
days). (inhalation LOAEL = 1,000 mg/kg/day based on
absorption rate = tubular vacuolation in the
100%). kidneys.
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
Inhalation intermediate-term (1 NOAEL = 100 mg/kg/ LOC for MOE = 100.. 26-week Oral Toxicity Study-Rat
to 6 months). day (inhalation LOAEL = 500 mg/kg/day based on
absorption rate = tubular degeneration in the
100%). kidneys.
UFA = 10x...........
UFH = 10x...........
FQPA SF = 1x........
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Cancer (Oral, dermal, inhalation) Based on a Derek structural alert analysis and the lack of mutagenicity, beta
cyclodextrin, methyl ethers 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). UFDB = to account for the absence of data or other
data deficiency. UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
risk assessment.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to beta cyclodextrin, methyl ethers, EPA considered exposure
under the requested exemption from the requirement of a tolerance. EPA
assessed dietary exposures from beta cyclodextrin, methyl ethers in
food as follows:
i. Dietary exposure (food and drinking water) to beta
cyclodextrin, methyl ethers can occur following ingestion of foods
with residues from treated crops. Because no adverse effects
attributable to a single exposure of beta cyclodextrin, methyl
ethers are seen in the toxicity databases, an acute dietary risk
assessment is not necessary. 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
beta cyclodextrin, methyl ethers. In the absence of specific residue
data, EPA has developed an approach which uses surrogate information
to derive upper
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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. One hundred percent crop treated was assumed,
default processing factors, and tolerance-level residues for all
foods and use limitations of not more than 40% by weight in
pesticide formulations. 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 beta cyclodextrin,
methyl ethers, 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).
Beta cyclodextrin, methyl ethers 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.
The Agency conducted an assessment to represent conservative
residential exposure by assessing beta cyclodextrin, methyl ethers in
pesticide formulations (outdoor scenarios) and in disinfectant-type
uses (indoor scenarios). The Agency's assessment of adult residential
exposure combines high end dermal and inhalation handler exposure from
liquids/backpack sprayer/home garden with a high end post application
dermal exposure from contact with treated lawns. The Agency's
assessment of children's residential exposure includes total post-
application exposures associated with contact with treated surfaces
(dermal and hand-to-mouth exposures).
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 beta cyclodextrin, methyl ethers to share a
common mechanism of toxicity with any other substances, and beta
cyclodextrin, methyl ethers does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that beta cyclodextrin,
methyl ethers 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 (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 toxicity database for
beta cyclodextrin, methyl ethers contains developmental and 3-
generation reproduction toxicity studies conducted with surrogate
chemicals. Increased fetal susceptibility is not observed in any of the
studies: The only fetal effects observed (slight embryotoxicity
following oral exposure in developmental toxicity study in rabbits to
2-hydroxypropyl-beta-cyclodextrin at doses of 1,000 mg/kg/day) occurred
in the presence of slight maternal toxicity (NOAEL of 500 mg/kg/day).
In other studies involving oral exposure to beta-cyclodextrin and to 2-
hydroxypropyl-beta-cyclodextrin in rats and rabbits, no adverse effects
of statistical significance were observed in fetuses. In the three-
generation reproduction toxicity study in rats, no effects were
observed in parental or offspring animals at doses up to 1,099 mg/kg/
day beta-cyclodextrin. No reproduction effects were observed up to
2,277 mg/kg/day.
3. Conclusion. The toxicity database for beta cyclodextrin, methyl
ethers contains subchronic, developmental, 3-generation reproduction
toxicity and mutagenicity studies. Although there are no neurotoxicity
or immunotoxicity studies, there is no need to retain the FQPA 10X
safety factor because there is no indication of potential neurotoxicity
or immunotoxicity in the available studies. Also, there is no need to
retain the FQPA 10X safety factor for lack of an inhalation study
because baseline inhalation margin of exposure (MOE) ranges from 86000-
1400000 and more than adequately surpass the Agency's level of concern
of MOEs<100 or MOEs<1,000 if an additional 10X were applied. In
addition, the Agency used conservative exposure estimates, with 100
percent crop treated, tolerance-level residues, conservative drinking
water modeling numbers, and a conservative assessment of potential
residential exposure for infants and children. Based on the adequacy of
the toxicity database and the conservative nature of the exposure
assessment and the lack of concern for prenatal and postnatal
sensitivity, the Agency has concluded that there is reliable data to
determine that infants and children will be safe if 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,
beta cyclodextrin, methyl ethers 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
beta
[[Page 36340]]
cyclodextrin, methyl ethers from food and water will utilize 56.6% 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 (considered to be a background exposure level).
Beta cyclodextrin, methyl ethers may be used as an inert ingredient
in pesticide products that are 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 beta cyclodextrin, methyl
ethers.
Using the exposure assumptions described above for short-term
exposures, EPA has concluded the combined short-term food, water, and
residential exposures result in aggregate MOEs of 1910 for both adult
males and females respectively. EPA has concluded the combined short-
term aggregated food, water, and residential pesticide exposures result
in an aggregate MOE of 500 for children. Because EPA's level of concern
for beta cyclodextrin, methyl ethers is a MOE of 100 or below, 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).
Beta cyclodextrin, methyl ethers may be used as an inert ingredient
in pesticide products that are 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 beta
cyclodextrin, methyl ethers.
Using the exposure assumptions described above for intermediate-
term exposures, EPA has concluded that the combined intermediate-term
food, water, and residential exposures result in aggregate MOEs of 650
for adult males and females. EPA has concluded the combined
intermediate-term aggregated food, water, and residential exposures
result in an aggregate MOE of 170 for children. Because EPA's level of
concern for beta cyclodextrin, methyl ethers is a MOE of 100 or below,
these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts in a DEREK structural alert analysis and the lack of
mutagenicity, beta cyclodextrin, methyl ethers 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 beta cyclodextrin, methyl ethers residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is not establishing a numerical tolerance for residues of
beta cyclodextrin, methyl ethers in or on any food commodities. EPA is
establishing limitations on the amount of beta cyclodextrin, methyl
ethers 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 pre-harvest for sale
or distribution that exceeds 40% by weight of beta cyclodextrin, methyl
ethers unless additional data are submitted.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for beta cyclodextrin, methyl ethers
(CAS Reg. No. 128446-36-6) when used as an inert ingredient (stabilizer
and solvent) in pesticides applied to growing crops pre-harvest limited
to a maximum concentration of 40% by weight in 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
[[Page 36341]]
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: June 22, 2017.
Michael L. Goodis,
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. 180.920, add alphabetically the entry ``Beta Cyclodextrin,
Methyl Ethers'' to the table to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Beta Cyclodextrin, Methyl Ethers 40% by weight..... Stabilizer and
(CAS Reg. No. 128446-36-6). solvent.
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2017-16373 Filed 8-3-17; 8:45 am]
BILLING CODE 6560-50-P