[Federal Register Volume 84, Number 162 (Wednesday, August 21, 2019)]
[Rules and Regulations]
[Pages 43510-43517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17993]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2018-0201; FRL-9997-14]
C1-C4 Linear and Branched Chain Alkyl D-
Glucitol Dianhydro Alkyl Ethers; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of pesticide inert ingredients within the
C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers (AD-GDAE) cluster. These exemptions are being
established with the following terms: When used as an inert ingredient
(solvent, co-solvent, viscosity modifier and adjuvant) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest, on animals, and in antimicrobial formulations applied to
food-contact surfaces in public-eating places, dairy-processing
equipment, and food-processing equipment, and utensils, and in
antimicrobial formulations used for dairy processing equipment, and
food-processing equipment and utensils. Exponent, Inc., on behalf of
Croda, 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 C1-
C4 linear and branched chain alkyl d-glucitol dianhydro
alkyl ethers cluster when used in accordance with the terms of these
exemptions.
DATES: This regulation is effective August 21, 2019. Objections and
requests for hearings must be received on or before October 21, 2019,
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-2018-0201, 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 L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:
[[Page 43511]]
(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 Publishing 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-2018-0201 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 21, 2019. 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-2018-0201, 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 October 18, 2018 (83 FR 52787) (FRL-
9984-21), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11109) by Exponent, Inc. (1150 Connecticut Ave, Suite 1100, NW,
Washington, DC 20036), on behalf of Croda, Inc. (315 Cherry Lane New
Castle, DE 19720). The petition requested that 40 CFR be amended by
establishing exemptions from the requirement of a tolerance for
residues of C1-C4 linear and branched chain alkyl d-glucitol dianhydro
alkyl ethers (C1-C4 Linear and Branched Chain AD-GDAE) cluster--d-
glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-(CAS Reg. No. 5306-85-4);
d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-ethyl- (CAS Reg. No. 30915-81-
2); d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-propyl) (CAS Reg. No.
107644-13-3); d-glucitol, 1,4:3,6-dianhydro-2,5-bis-O-(1-methylethyl)-
,(iso-propyl diether) (CAS Reg. No. 103594-41-8); d-glucitol, 1,4:3,6-
dianhydro-2,5-di-O-butyl- (CAS Reg. No. 103594-42-9); d-glucitol,
1,4:3,6-dianhydro-2,5-di-O-(1-methylpropyl)-, (CAS Reg. No. not
assigned); and d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-(2-methylpropyl)-
, (CAS Reg. No. not assigned) when used as an inert ingredient
(solvent, co-solvent, viscosity modifier and adjuvant) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest under 40 CFR 180.910, applied in or on animals under 40
CFR 180.930, in antimicrobial formulations used in food-contact
surfaces in public-eating places, dairy-processing equipment, and food-
processing equipment and utensils under 40 CFR 180.940(a) and in
antimicrobial formulations used for dairy-processing equipment, and
food-processing equipment and utensils under 40 CFR 180.940(b). That
document referenced a summary of the petition prepared by Exponent,
Inc. on behalf of Croda, Inc., the petitioner, which is available in
the docket, http://www.regulations.gov. Although one comment was
submitted in response to the relating to notice of filing regarding the
use of pesticides generally, it was not specific to tolerances or this
rulemaking.
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. . . .''
[[Page 43512]]
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 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 C1-C4
linear and branched chain alkyl d-glucitol dianhydro alkyl ethers
cluster including exposure resulting from the exemption established by
this action. EPA's assessment of exposures and risks associated with
C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers cluster 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 C1-C4 linear and
branched chain alkyl d-glucitol dianhydro alkyl ethers cluster 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 seven compounds included in the cluster are C1-
C4 linear and branched chain glucitol, 1,4:3,6-dianhydro
ether congeners of isosorbide, which is described as a fused ring
furo[3,2-b]furan, d-glucitol heterocycle. These chemicals are similar
in structure and are expected to be similar in regard to toxicity
profile. Therefore, d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl- was
selected as a suitable analogue to represent toxicity due to exposure
to the seven compounds included in the cluster and all toxicological
studies were conducted with d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-
methyl-.
The acute oral and dermal toxicities are low in rats and rabbits,
respectively. C1-C4 linear and branched chain
alkyl d-glucitol dianhydro alkyl ethers are not irritating to the skin
or eyes in the rabbit. Acute inhalation and sensitization studies are
not available for review.
New Zealand white rabbits exposed for 8 days via gavage to doses as
high as 300 mg/kg/day of d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-
do not exhibit adverse effects. No adverse effects are observed up to
375 mg/kg/day in rats following 13 weeks of exposure via gavage to d-
glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-. Conversely, adverse
effects are observed in the dog following 13 weeks of exposure via
capsule to d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-. Decreased
mean body weight, body weight gain, food consumption, changes in
clinical biochemistry, lower levels of red blood cells (RBCs),
hemoglobin and hematocrit and decreased relative liver weights are
observed in dogs at 700 mg/kg/day. The no-observed-adverse-effect level
(NOAEL) is 100 mg/kg/day.
No fetal susceptibility is observed in the developmental toxicity
studies in rats and rabbits. Developmental studies with d-glucitol,
1,4:3,6-dianhydro-2,5-di-O-methyl-in the rat and rabbit show no
maternal or developmental adverse effects up to 375 and 300 mg/kg/day,
respectively, the highest doses tested. No reproduction toxicity
studies are available for review, however, no evidence of toxicity to
reproductive organs is observed in the 13-week oral toxicity studies in
the rat or dog up to 375 and 700 mg/kg/day, respectively.
The Ames test and chromosomal aberrations assay in human
lymphocytes are negative. Therefore, d-glucitol, 1,4:3,6-dianhydro-2,5-
di-O-methyl- is not considered mutagenic.
D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl- is not expected to
be carcinogenic based on a Derek Nexus structural alert analysis. No
structural alerts for carcinogenicity or mutagenicity are indicated in
the analysis.
Neurotoxicity and immunotoxicity studies are not available for
review. However, no evidence of neurotoxicity and immunotoxicity is
observed in the submitted studies.
Metabolism studies are not available for the C1-
C4 linear and branched chain alkyl d-glucitol dianhydro
alkyl ethers cluster. However, based on the classical metabolic
pathways for the alkyl and aryl etherases, it is expected that the
C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers cluster would be metabolized to monoethers,
isosorbide (the common and major metabolite), and sorbitol.
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.
The 13-week oral toxicity study in dogs is selected for the chronic
dietary exposure scenario as well as intermediate-term incidental oral,
dermal and inhalation exposure scenarios. The NOAEL is 100 mg/kg/day,
and the LOAEL is 700 mg/kg/day based on decreased mean body weight,
body weight gain and food consumption, changes in clinical
biochemistry, lower levels of RBCs, hemoglobin and hematocrit and
decreased relative liver weights. This represents the lowest NOAEL in
the database in the most sensitive species. The developmental studies
in rats and rabbits are selected for short-term exposure scenarios.
These studies are considered co-critical, the NOAEL is 300 mg/kg/day,
the highest dose tested.
[[Page 43513]]
The standard inter- and intra-species uncertainty factors of 10x are
applied; as discussed below in Unit IV.D., the Agency applied a 1x Food
Quality Protection Act (FQPA) Safety Factor (SF). The default factor of
100% is applied for the dermal absorption rate and the inhalation
absorption rate.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to C1-C4 linear and branched chain alkyl
d-glucitol dianhydro alkyl ethers cluster, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from C1-C4 linear and
branched chain alkyl d-glucitol dianhydro alkyl ethers cluster in food
as follows:
No adverse effects attributable to a single exposure of endpoint
was identified for d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-;
therefore, an acute dietary exposure assessment was not conducted.
In conducting the chronic dietary exposure assessment using the
Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, EPA used
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 d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-
methyl-. In the absence of specific residue data, EPA has developed an
approach which uses surrogate information to derive upper bound
exposure estimates for the subject inert ingredient. Upper bound
exposure estimates are based on the highest tolerance for a given
commodity from a list of high use insecticides, herbicides, and
fungicides. A complete description of the general approach taken to
assess inert ingredient risks in the absence of residue data is
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water)
Dietary Exposure and Risk Assessments for the Inerts,'' (D361707, S.
Piper, 2/25/09) and can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2008-0738.
In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest levels of
tolerances would be no higher than the concentration of the active
ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentrations of active ingredient in agricultural products are
generally at least 50 percent of the product and often can be much
higher. Further, pesticide products rarely have a single inert
ingredient; rather there is generally a combination of different inert
ingredients used which additionally reduces the concentration of any
single inert ingredient in the pesticide product in relation to that of
the active ingredient.
Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain residues of the inert ingredient at the highest tolerance
level. In other words, EPA assumed 100 percent of all foods are treated
with the inert ingredient at the rate and manner necessary to produce
the highest residue legally possible for an active ingredient. In
summary, EPA chose a very conservative method for estimating what level
of inert residue could be on food, then used this methodology to choose
the highest possible residue that could be found on food and assumed
that all food contained this residue. No consideration was given to
potential degradation between harvest and consumption even though
monitoring data shows that tolerance level residues are typically one
to two orders of magnitude higher than actual residues in food when
distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
To assess dietary exposure due to its use in antimicrobial
products, EPA calculated the daily dietary dose (DDD) and the estimated
daily intake (EDI) as described in the Food Drug Administration (FDA)
model. The assessment considered: Application rates, residual solution
or quantity of solution remaining on the treated surface without
rinsing with potable water, surface area of the treated surface which
comes into contact with food, pesticide migration fraction, and body
weight. These assumptions are based on FDA guidelines (2003). Dietary
exposures due to antimicrobial uses are aggregated with the
aforementioned dietary exposures.
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 C1-
C4 linear and branched chain alkyl d-glucitol dianhydro
alkyl ethers, a conservative drinking water concentration value of 100
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).
The term ``residential exposure'' is used in this document to refer
to non-occupational, non-dietary exposure (e.g., for lawn and garden
pest control, indoor pest control, termiticides, and flea and tick
control on pets). D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl- may be
used as an inert ingredient in pesticide products that are registered
for specific uses that may result in residential exposure. A
conservative residential exposure and risk assessments were completed
for pesticide products containing d-glucitol, 1,4:3,6-dianhydro-2,5-di-
O-methyl- as inert ingredients. The Agency assessed pesticide products
containing d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl- using
exposure scenarios (treated lawns, mopping, wiping and aerosol spray)
to represent conservative residential handler exposure. Further details
of this residential exposure and risk analysis can be found at http://www.regulations.gov in the
[[Page 43514]]
memorandum entitled: ``JITF Inert Ingredients. Residential and
Occupational Exposure Assessment Algorithms and Assumptions Appendix
for the Human Health Risk Assessments to Support Proposed Exemption
from the Requirement of a Tolerance When Used as Inert Ingredients in
Pesticide Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID
number EPA-HQ-OPP-2008-0710. D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-
methyl- is also present in some anti-acne and anti-aging topically
applied pharmaceuticals products. The typical use levels of d-glucitol,
1,4:3,6-dianhydro-2,5-di-O-methyl- in these products are limited to
less than 5.44% to 15% weight/weight (w/w). These products are used
sparingly and applied selectively to limited areas of the skin.
The Agency does not have sufficient data to quantitatively assess
exposures to d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl- that result
from these non-pesticidal uses. However, the Agency believes the
assessments of exposures due to pesticide uses are protective of these
non-pesticidal uses. Based on the available data on the typical
reported concentration ranges of d-glucitol, 1,4:3,6-dianhydro-2,5-di-
O-methyl- topically applied pharmaceuticals as well as the specific use
and limited exposures resulting from such uses, the Agency anticipates
that exposures to d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl- that
might result from anti-acne and anti-aging topically applied
pharmaceutical products uses are likely to be markedly less than the
conservatively-estimated exposures resulting from pesticide use.
Therefore, the Agency believes that any contribution to the estimated
pesticide exposure resulting from topically applied pharmaceuticals
products is likely to be insignificant in comparison to the estimates
for exposure from pesticide use and these exposures have not been
aggregated with other non-residential 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 C1-C4 linear and branched
chain alkyl d-glucitol dianhydro alkyl ethers cluster to share a common
mechanism of toxicity with any other substances, and C1-
C4 linear and branched chain alkyl d-glucitol dianhydro
alkyl ethers cluster does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that C1-C4
linear and branched chain alkyl d-glucitol dianhydro alkyl ethers
cluster does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA 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.
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 for the chronic dietary assessment for the following reasons. The
toxicity database for C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers cluster contains subchronic, developmental and
mutagenicity studies. There is no indication of immunotoxicity or
neurotoxicity in the available studies; therefore, there is no need to
require an immunotoxicity or neurotoxicity study. Fetal susceptibility
is not observed in developmental toxicity studies in the rat and
rabbit. No maternal or developmental toxicity is observed in either
study up to 300 mg/kg/day. A reproduction toxicity is not available;
however, reproduction parameters were not affected in the submitted
studies at doses as high as 375 and 700 mg/kg/day in the rat and dog,
respectively. Based on the adequacy of the toxicity database, 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,
C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers cluster 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
C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers cluster from food and water will utilize 70.6%
of the cPAD for children 1 to 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).
C1-C4 linear and branched chain alkyl d-
glucitol dianhydro alkyl ethers cluster is currently 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 C1-
C4 linear and branched chain alkyl d-glucitol dianhydro
alkyl ethers cluster.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 148 for adult
males and females. Adult residential exposure combines high-end dermal
and inhalation handler exposure from indoor hard surface, aerosol spray
with a high-end post application dermal exposure from contact with
treated lawns. The combined short-term
[[Page 43515]]
aggregated food, water, and residential pesticide exposures result in
an aggregate MOE of 122 for children. Children's residential exposure
includes total exposures associated with contact with treated surfaces
(dermal and hand-to-mouth exposures). Because EPA's level of concern
for C1-C4 linear and branched chain alkyl d-
glucitol dianhydro alkyl ethers cluster is an MOE of less 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).
C1-C4 linear and branched chain alkyl d-
glucitol dianhydro alkyl ethers cluster is currently 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
C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers cluster.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 434 for adult males and females. Adult residential
exposure includes high end post application dermal exposure from
contact with treated lawns. The combined intermediate-term aggregated
food, water, and residential exposures result in an aggregate MOE of
125 for children. Children's residential exposure includes total
exposures associated with contact with treated surfaces (dermal and
hand-to-mouth exposures). Because EPA's level of concern for
C1-C4 linear and branched chain alkyl d-glucitol
dianhydro alkyl ethers cluster is an MOE of less than 100, these MOEs
are not of concern.
5. Aggregate cancer risk for U.S. population. Based on a DEREK
structural alert analysis, the lack of mutagenicity, and the lack of
specific organ toxicity in the chronic toxicity study, C1-C4 linear and
branched chain alkyl d-glucitol dianhydro alkyl ethers cluster 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 C1-C4 linear and branched chain alkyl
d-glucitol dianhydro alkyl ethers cluster residues.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
VI. Conclusions
Therefore, exemptions from the requirement of a tolerance are
established for residues of the following seven compounds within the
C1-C4 linear and branched chain alkyl d-glucitol dianhydro alkyl ethers
(AD-GDAE) cluster: (1) d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-methyl-
(CAS Reg. No. 5306-85-4); (2) d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-
ethyl- (CAS Reg. No. 30915-81-2); (3) d-glucitol, 1,4:3,6-dianhydro-
2,5-di-O-propyl) (CAS Reg. No.107644-13-3); (4) d-glucitol, 1,4:3,6-
dianhydro-2,5-bis-O-(1-methylethyl)-,(iso-propyl diether) (CAS Reg. No.
103594-41-8); (5) d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-butyl- (CAS
Reg. No. 103594-42-9); (6) d-glucitol, 1,4:3,6-dianhydro-2,5-di-O-(1-
methylpropyl)-, (CAS Reg. No. not assigned); and (7) d-glucitol,
1,4:3,6-dianhydro-2,5-di-O-(2-methylpropyl)-, (CAS Reg. No. not
assigned) when used as an inert ingredient (solvent, co-solvent,
viscosity modifier and adjuvant) in pesticide formulations applied to
growing crops and raw agricultural commodities after harvest under 40
CFR 180.910; applied in or on animals under 40 CFR 180.930; when used
in antimicrobial formulations applied to food-contact surfaces in
public-eating places, dairy-processing equipment, and food-processing
equipment and utensils under 40 CFR 180.940(a) limited to 500 ppm; and
in antimicrobial formulations used for dairy-processing equipment, and
food-processing equipment and utensils under 40 CFR 180.940(b) limited
to 1,000 ppm.
VII. Statutory and Executive Order Reviews
This action establishes a tolerance exemption 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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
[[Page 43516]]
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: August 8, 2019.
Michael 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. 180.910, add alphabetically the following inert ingredients
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
----------------------------------------------------------------------------------------------------------------
* * * * * * *
D-glucitol, 1,4:3,6-dianhydro-2,5-di-O- ......................................... solvent, co-solvent,
methyl- (CAS Reg. No. 5306-85-4); D- viscosity modifier, and
glucitol, 1,4:3,6-dianhydro-2,5-di-O- adjuvant.
ethyl- (CAS Reg. No. 30915-81-2); D-
glucitol, 1,4:3,6-dianhydro-2,5-di-O-
propyl) (CAS Reg. No.107644-13-3); D-
glucitol, 1,4:3,6-dianhydro-2,5-bis-O-(1-
methylethyl)-,(iso-propyl diether) (CAS
Reg. No. 103594-41-8); D-glucitol,
1,4:3,6-dianhydro-2,5-di-O-butyl- (CAS
Reg. No. 103594-42-9); D-glucitol,
1,4:3,6-dianhydro-2,5-di-O-(1-
methylpropyl)-, (CAS Reg. No. not
assigned); and D-glucitol, 1,4:3,6-
dianhydro-2,5-di-O-(2-methylpropyl)-,
(CAS Reg. No. not assigned).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
3. In Sec. 180.930, add alphabetically the following inert ingredients
to the table to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
----------------------------------------------------------------------------------------------------------------
Inert ingredients Limits Uses
----------------------------------------------------------------------------------------------------------------
* * * * * * *
D-glucitol, 1,4:3,6-dianhydro-2,5-di-O- ......................................... solvent, co-solvent,
methyl-(CAS Reg. No. 5306-85-4); D- viscosity modifier, and
glucitol, 1,4:3,6-dianhydro-2,5-di-O- adjuvant.
ethyl- (CAS Reg. No. 30915-81-2); D-
glucitol, 1,4:3,6-dianhydro-2,5-di-O-
propyl) (CAS Reg. No.107644-13-3); D-
glucitol, 1,4:3,6-dianhydro-2,5-bis-O-(1-
methylethyl)-,(iso-propyl diether) (CAS
Reg. No. 103594-41-8); D-glucitol,
1,4:3,6-dianhydro-2,5-di-O-butyl- (CAS
Reg. No. 103594-42-9); D-glucitol,
1,4:3,6-dianhydro-2,5-di-O-(1-
methylpropyl)-, (CAS Reg. No. not
assigned); and D-glucitol, 1,4:3,6-
dianhydro-2,5-di-O-(2-methylpropyl)-,
(CAS Reg. No. not assigned).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
0
4. In Sec. 180.940, add alphabetically the following inert
ingredients to the tables in paragraphs (a) and (b) to read as follows:
Sec. 180. 940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
* * * * *
[[Page 43517]]
(a) * * *
----------------------------------------------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------
* * * * * * *
C1-C4 linear and branched chain alkyl d- 5306-85-4; 30915-81-2; 107644-13-3; 103594- When ready for use, the
glucitol dianhydro alkyl ethers cluster. 41-8; 103594-42-9. end-use concentration is
not to exceed 500 ppm.
D-glucitol, 1,4:3,6-dianhydro-2,5-di-O- None....................................... .........................
(1-methylpropyl)-,.
D-glucitol, 1,4:3,6-dianhydro-2,5-di-O- None....................................... .........................
(2-methylpropyl)-, (CAS Reg. No. not
assigned).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(b) * * *
----------------------------------------------------------------------------------------------------------------
Pesticide chemical CAS Reg. No. Limits
----------------------------------------------------------------------------------------------------------------
* * * * * * *
C1-C4 linear and branched chain alkyl d- 5306-85-4; 30915-81-2; 107644-13-3; When ready for use, the
glucitol dianhydro alkyl ethers cluster. 103594-41-8; 103594-42-9. end-use concentration is
not to exceed 1,000 ppm.
D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-(1- None..................................... ..........................
methylpropyl)-,.
D-glucitol, 1,4:3,6-dianhydro-2,5-di-O-(2- None..................................... ..........................
methylpropyl)-, (CAS Reg. No. not
assigned).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 2019-17993 Filed 8-20-19; 8:45 am]
BILLING CODE 6560-50-P