C1, 43510-43517 [2019-17993]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[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 https://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 https://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 
https://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: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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, https://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 https://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 https://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 https://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 https://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