Document ID: EPA-HQ-OPP-2013-0098-0005
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Tetrahydrofurfuryl Alcohol
Posted Date: 2018-10-19T04:00Z

[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52996-53002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22862]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0098; FRL-9984-70]

Tetrahydrofurfuryl Alcohol; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the exemption from the requirement of a 
tolerance for residues of tetrahydrofurfuryl alcohol (THFA) (CAS Reg. 
No. 97-99-4) when used as an inert ingredient in pesticide formulations 
to add one herbicide application prior to the preboot stage on 
buckwheat, oats, rye, sorghum, triticale, rice and wild rice; extend 
use on canola to the early bolting stage; extend use on soybeans prior 
to the bloom growth stage; and allow use in herbicides with two 
applications to field corn and popcorn prior to 36 inches tall (V8 
stage). Toxcel, LLC, on behalf of Penn A Kem, LLC, submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an amendment to an existing exemption from the requirement 
of a tolerance. This regulation eliminates the need to establish a 
maximum permissible level for residues of tetrahydrofurfuryl alcohol.

DATES: This regulation is effective October 19, 2018. Objections and 
requests for hearings must be received on or before December 18, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0098, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure

[[Page 52997]]

proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2013-0098 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 December 18, 2018. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0098, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of February 27, 2013 (78 FR 13295) (FRL-
9380-2), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 2E8080) by 
Toxcel, LLC, 7140 Heritage Village Plaza, Gainsville, VA 20156 on 
behalf of Penn A Kem, LLC, 3324 Chelsea Avenue, Memphis, TN 38108. The 
petition requested amendment of the exemption from the requirement of a 
tolerance in 40 CFR 180.1263 for residues of tetrahydrofurfuryl alcohol 
(THFA) (CAS Reg. No. 97-99-4) when used as an inert ingredient 
(solvent/cosolvent) to include allowance of one herbicide application 
prior to the preboot stage to all small cereal grains; extended use on 
canola to the early bolting stage; and extended use on soybeans up to 
the bloom growth stage. That document referenced a summary of the 
petition prepared by Toxcel, LLC, on behalf of Penn A Kem, LLC, the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Toxcel, LLC, on behalf of Penn A Kem, LLC, submitted a revised 
pesticide petition to supersede the previously submitted petition. EPA 
issued a document in the Federal Register of April 6, 2015 (80 FR 
18327) (FRL-9924-00), pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of this revised petition. The revised petition 
requested that 40 CFR 180.1263 be amended to allow one herbicide 
application prior to the preboot stage for wheat, buckwheat, barley, 
oats, rye, sorghum, triticale, rice, and wild rice; extend the use on 
canola to the early bolting stage; extend the use on soybeans up to the 
bloom growth stage; and allow two herbicide applications to field corn 
and popcorn up to 36 inches tall (V8 stage). That document referenced a 
summary of the petition prepared by Toxcel, LLC, on behalf of Penn A 
Kem, LLC, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. In making this safety finding, EPA is required 
to take into account the considerations set forth in section 
408(b)(2)(C) and (D). 21 U.S.C. 346a(c)(2)(B). Section 408(b)(2)(C) of 
FFDCA requires EPA to give special consideration to exposure of infants 
and children to the pesticide chemical residue in establishing a 
tolerance and to ``ensure that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to the 
pesticide chemical residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the 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 tetrahydrofurfuryl alcohol 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with 
tetrahydrofurfuryl alcohol 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

[[Page 52998]]

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 tetrahydrofurfuryl alcohol as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Hazard Assessment for the 
Tolerance Reassessment of Tetrahydrofurfuryl alcohol (THFA)(CAS Reg. 
No. 97-99-4)'' at pp 8-12 in docket ID number EPA-HQ-OPP-2013-0098. A 
summary of the toxicity of tetrahydrofurfuryl alcohol as given in that 
document follows.
    Acute toxicity information is available for the oral route with an 
LD50 for the rat of 1.6-3.2 g/kg. Tetrahydrofurfuryl alcohol 
was not irritating to the skin of mice but was irritating to the eyes 
of rabbits. Acute dermal and inhalation toxicity, as well as dermal 
sensitization information, currently are not available. However, there 
are reports that suggest tetrahydrofurfuryl alcohol may be moderately 
irritating via the dermal and inhalation routes of exposure to humans.
    Although data on chronic effects is unavailable, subchronic studies 
indicate that systemic effects from repeated dermal and oral exposure 
to tetrahydrofurfuryl alcohol include decreased body weight and body 
weight gain. Tetrahydrofurfuryl alcohol also exhibits adverse 
reproductive and developmental effects, and potential effects on the 
endocrine system.
    Males are not only quantitatively more sensitive to the subchronic 
effects of tetrahydrofurfuryl alcohol than females, but the male 
reproductive system appears to be a target for tetrahydrofurfuryl 
alcohol. Consistent decreases in male reproductive organ weights 
(testicular, epididymal, and seminal vesicle) were observed in rats in 
the 90-day dietary (LOAEL 339 mg/kg/day), dermal (LOAEL 300 mg/kg/day), 
and inhalation (LOAEL <0.21 mg/L/day) toxicity studies. In addition, a 
90-day oral (dietary) study in dogs revealed decreased testes weights 
of males in all treated groups (1,000, 3,000, 6,000 ppm, equivalent to 
approximately 25, 75, and 150 mg/kg/day), compared to controls, with 
severe testicular atrophy in all males at the highest dose (6,000 ppm 
or 150 mg/kg/day). Decreased spermatogenic activity was noted in males 
of the 3,000 ppm group (75 mg/kg/day) and was interpreted as a 
prodromal sign of atrophy.
    A 28-day repeated oral (gavage) study in rats revealed significant 
decreases in absolute testes and epididymal weights after 28 days at a 
dose level of 600 mg/kg/day which continued through the 14-day recovery 
period. Necrosis of the seminiferous tubular epithelium of the testes 
was also observed in males of the 150 and 600 mg/kg/day group at 28 
days. Necrosis of the testes was also observed in males of the 600 mg/
kg/day group at the end of the 14-day recovery period.
    In the reproduction/developmental toxicity screening test in rats, 
no reproductive parameters were affected except slightly increased 
gestation length at the high dose of 150 mg/kg/day.
    The endocrine system may also be a target for tetrahydrofurfuryl 
alcohol. Alterations in pituitary, thymus, adrenal, and thyroid weights 
have been reported after subchronic exposure (28 days) to 600 mg/kg/day 
in male rats and pituitary weights at 150 mg/kg/day in female rats. 
Decreased absolute and relative adrenal weights were observed in males 
and females receiving 5,000 ppm (equivalent to 339 mg/kg/day males and 
401 mg/kg/day females).
    In one developmental toxicity study in rats a quantitative 
susceptibility based on decreased fetal body weights and a qualitative 
susceptibility based on increased incidence of filamentous tail was 
observed. However, in a more recent reproduction/developmental toxicity 
screening test (OECD 421 guideline study) in rats, an increased 
incidence of filamentous tail was not evident nor was there any other 
evidence of increased qualitative susceptibility. Based on the overall 
weight of evidence for developmental toxicity, it is determined that 
there is increased quantitative susceptibility but not increased 
qualitative susceptibility.
    A neurotoxicity study is not available for tetrahydrofurfuryl 
alcohol, however no neurotoxic effects were observed in the available 
subchronic oral, dermal and inhalation toxicity studies.
    Mutagenicity studies indicate tetrahydrofurfuryl alcohol is not 
mutagenic in Salmonella typhimurium or E. coli with or without 
metabolic activation. Tetrahydrofurfuryl alcohol was also negative for 
causing structural chromosomal aberrations or polyploidy with or 
without metabolic activation in cultured Chinese hamster lung cells.
    There are currently no chronic toxicity or cancer studies available 
for tetrahydrofurfuryl alcohol. The Agency used a qualitative structure 
activity relationship (SAR) database, DEREK Nexus, to determine if 
there were structural alerts for potential carcinogenicity for 
tetrahydrofurfuryl alcohol. No structural alerts for carcinogenicity 
were identified for tetrahydrofurfuryl alcohol. In the absence of any 
structural alerts and lack of mutagenicity concerns, tetrahydrofurfuryl 
alcohol is not expected to be carcinogenic.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A discussion of the toxicological 
endpoints for tetrahydrofurfuryl alcohol used for human risk assessment 
can be found at http://www.regulations.gov in the document ``Hazard 
Assessment for the Tolerance Reassessment of Tetrahydrofurfuryl alcohol 
(THFA) (CAS Reg. No. 97-99-4) at pp. 6-8 in docket ID number EPA-HQ-
OPP-2013-0098''. A summary of the toxicological dose and endpoints for 
THFA follows:

[[Page 52999]]

   Table 1--Summary of Toxicological Doses and Endpoints for Tetrahydrofurfuryl Alcohol for Use in Human Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and  uncertainty/    RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = [50] mg/kg/   Acute RfD = [0.5]    [Developmental rat].
 years of age).                     day.                  mg/kg/day.          LOAEL = [100] mg/kg/day based on
                                   UFA = [10] x........  aPAD = [0.05] mg/kg/  [decreased fetal body weight and
                                   UFH = [10]x.........   day.                 increased incidence of
                                   FQPA SF = [10]x.....                        filamentous tail, complete
                                                                               resorptions at 500 and 1,000 mg/
                                                                               kg/day].
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  None................  NA.................  No acute effects relevant to the
 including infants and children).                                              general population were observed
                                                                               in the available studies.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= [50] mg/kg/    Chronic RfD = [0.5]  [Developmental rat].
                                    day.                  mg/kg/day.          LOAEL = [100] mg/kg/day based on
                                   UFA = [10]x.........  cPAD = [0.05] mg/kg/  [decreased fetal body weight and
                                   UFH = [10]x.........   day.                 increased incidence of
                                   FQPA SF = [10]x.....                        filamentous tail, complete
                                                                               resorptions at 500 and 1,000 mg/
                                                                               kg/day].
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL= [50] mg/kg/    LOC for MOE =        [Developmental, rat].
 30 days).                          day.                  [1,000].            LOAEL = [100] mg/kg/day based on
                                   UFA = [10]x.........                        [decreased fetal body weight and
                                   UFH = [10]x.........                        increased incidence of
                                   FQPA SF = [10]x.....                        filamentous tail, complete
                                                                               resorptions at 500 and 1,000 mg/
                                                                               kg/day].
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  Dermal study NOAEL =  LOC for MOE =        [90-day dermal, rat].
                                    [100] mg/kg/day.      [1,000].            LOAEL = [300 and 1,000] mg/kg/day
                                   UFA = [10]x.........                        M/F respectively based on
                                   UFH = [10]x.........                        [decreased sperm count and sperm
                                   FQPA SF = [10]x.....                        production rate in males, lower
                                                                               body weight/gains in females].
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation study      LOC for MOE =        [90-day inhalation, rat].
 days).                             LOAEL=0.21 mg/l.      [1000].             LOAEL = [0.21] mg/L (50 ppm;
                                   UFA = [10]x.........                        approx. 60 mg/kg/day) based on.
                                   UFH = [10]x.........                        Decreased body weight of males at
                                   FQPA SF = [10]x.....                        150 and 500 ppm. Multiple effects
                                                                               on sperm number, motility, and
                                                                               morphology at interim and
                                                                               terminal necropsy of males at
                                                                               both 150 and 500 ppm].
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: No structural alerts for carcinogenicity were identified for
                                    tetrahydrofurfuryl alcohol using a qualitative structure activity
                                    relationship (SAR) database, DEREK Nexus. In the absence of any structural
                                    alerts and lack of mutagenicity concerns, tetrahydrofurfuryl alcohol is not
                                    expected to be carcinogenic.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tetrahydrofurfuryl alcohol, EPA considered exposure under 
the proposed exemption from the requirement of a tolerance. EPA 
assessed dietary exposures from tetrahydrofurfuryl alcohol in food as 
follows:
    2. Acute and chronic exposure. In conducting the acute and chronic 
dietary exposure assessments using the Dietary Exposure Evaluation 
Model DEEM-FCID\TM\, Version 3.18, 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).
    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 discussion of the general approach taken to 
assess inert ingredient risks in the absence of residue data is 
contained in the memorandum entitled ``Alkyl Amines Polyethoxylates 
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) 
Dietary Exposure and Risk Assessment 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 case of tetrahydrofurfuryl alcohol residues resulting from 
foliar applications, EPA made specific adjustments to the dietary 
exposure assessments to account for the use limitations of 
tetrahydrofurfuryl alcohol as well as some residue chemistry data 
(plant uptake data) submitted with the petition. The use of the dietary 
estimated exposure model (DEEM) for upper-bound dietary risk 
assessments as described above was modified to include only those 
commodities on which pesticide formulations containing 
tetrahydrofurfuryl alcohol are being

[[Page 53000]]

used or are proposed to be used. Specifically, the dietary exposure 
assessment considered foliar uses of tetrahydrofurfuryl alcohol on 
wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and wild 
rice, canola, cotton, field corn, and popcorn as contained in the 
existing tolerance exemption expression and that are the subject of the 
present petitions. A residue chemistry study (a radiolabeled plant 
uptake study with THFA in corn, tomato, and wheat) suggest that the 
highest reported detectable level of tetrahydrofurfuryl alcohol 
residues resulting from foliar application in these crops is 0.5 ppm 
and this value is used in the dietary exposure assessment for the 
commodities included in the tolerance exemption.
    For seed treatment use, it was conservatively assumed that all of 
the following commodities (which represent an agglomeration of all 
commodities for which seed treatment pesticide products are approved 
for use) could potentially be treated with a seed treatment pesticide 
containing tetrahydrofurfuryl alcohol: barley, corn (field, pop, sweet 
and corn for seed production), legume vegetables (dried shelled peas 
and beans), brassica and bulb vegetables, alfalfa, cucurbits, rye, 
wheat, cotton, sugar beets, and sunflowers. For seed treatment use, in 
the absence of THFA-specific data, residue chemistry data for active 
ingredients with seed treatment uses were utilized. Residue levels for 
pesticide active ingredients used for seed treatment are all below the 
limit of detection, so a highly conservative value of 0.05 ppm is used 
in the dietary exposure assessment as a residue value for THFA for all 
seed treatment commodities based on application of Agency policies for 
assigning values to nondetected/nonquantified pesticide residues.
    3. 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 tetrahydrofurfuryl 
alcohol 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.
    4. 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).
    Tetrahydrofurfuryl alcohol is contained in a pesticide currently 
registered for uses that could result in residential exposures. The use 
pattern of the product includes application to dogs. EPA assessed this 
residential exposure using the Agency's Standard Operating Procedures 
for Residential Pesticide Exposure Assessment Residential Exposure 
(Residential SOP). Based on the Treated Pets section of the Residential 
SOP, the following assumptions are made: for residential handlers, 
exposure (dermal and inhalation) is expected to be short-term only. 
Residential post-application dermal exposure (short-term only) was 
assessed for adults and children. Residential post-application 
inhalation exposure is generally not assessed for pet treatment product 
uses as such exposure is typically considered to be negligible. 
Incidental oral post-application exposure was assessed for children 1 
to 2 years old. All post-application exposures are expected to be 
short-term in duration. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    5. 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 tetrahydrofurfuryl alcohol to share a common 
mechanism of toxicity with any other substances, and tetrahydrofurfuryl 
alcohol does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that tetrahydrofurfuryl alcohol 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 Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The data available for 
evaluation suggest there is evidence of increased quantitative 
susceptibility of the offspring after in utero exposure to 
tetrahydrofurfuryl alcohol. No reproductive parameters were affected 
except slightly increased gestation length at the high dose of 150 mg/
kg/day in the OECD 421 study in rats. There is also a concern for the 
effects of tetrahydrofurfuryl alcohol on the developing male 
reproductive system. Subchronic and reproductive toxicity studies 
consistently revealed decreased testicular epididymis and seminal 
vesicle weights as well as atrophy of the epididymis and seminal 
vesicles and abnormal morphology and motility of sperm. The level at 
which tetrahydrofurfuryl alcohol may affect the reproductive system 
during development is currently not known.
    3. Conclusion. EPA has determined that based on evidence of 
quantitative and qualitative susceptibility the safety of infants and 
children would be adequately protected if the FQPA SF was retained at 
10x for all scenarios. That decision is based on the following 
findings:
    i. The toxicity database for tetrahydrofurfuryl alcohol consists of 
a 28-day and 90-day oral toxicity studies in rats, dogs, 90-day dermal 
toxicity study in rats, 90-day inhalation toxicity study in rats, 
several mutagenicity studies, developmental/reproductive toxicity 
screening study in rats, and a developmental toxicity study and 
reproductive toxicity study in rats.
    ii. Slight atrophy of thymus was seen in high dose animal groups in 
the 28-day oral toxicity study, which may be indicative of an immune 
response, however no guideline immunotoxicity study is available.
    iii. Evidence of increased quantitative susceptibility of offspring 
is seen in the developmental toxicity study.
    iv. Additionally, alterations in the male reproductive system from 
subchronic exposure to tetrahydrofurfuryl alcohol does indicate

[[Page 53001]]

a concern for effects to the developing male reproductive system.
    v. The FQPA factor of 10X is considered adequate to account for 
potential immunotoxicity and uncertainty regarding the developing 
reproductive system in males because clear NOAELs are established in 
the available database.
    vi. There are no residual uncertainties identified in the exposure 
databases. As described earlier, EPA used highly conservative 
assumptions for the dietary food exposure assessment. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to tetrahydrofurfuryl alcohol in 
drinking water. EPA used similarly conservative assumptions to assess 
residential exposures of children to tetrahydrofurfuryl alcohol. These 
assessments will not underestimate the exposure and risks.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, EPA has concluded that acute exposure to 
tetrahydrofurfuryl alcohol from food and water will utilize 8.88% of 
the aPAD for females 13-49 years old.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tetrahydrofurfuryl alcohol from food and water will utilize 8.5% of the 
cPAD for children 1-2 years old, the population group receiving the 
greatest exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
tetrahydrofurfuryl alcohol is not expected.
    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). 
Tetrahydrofurfuryl alcohol is contained in a pesticide currently 
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 tetrahydrofurfuryl alcohol.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined chronic food, water, and 
short-term residential exposures result in aggregate MOEs of 13,100 for 
adults and 9,800 for children 1-2 years old. Because EPA's level of 
concern for tetrahydrofurfuryl alcohol is a MOE of 1,000 or below, 
these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
tetrahydrofurfuryl alcohol is not contained in any pesticide products 
registered for any use patterns that would result in intermediate-term 
residential exposure. Intermediate-term risk is assessed based on 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no intermediate-term residential exposure and chronic 
dietary exposure has already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for tetrahydrofurfuryl 
alcohol.
    5. Cancer. Based on the lack of genotoxicity and a DEREK assessment 
of tetrahydrofurfuryl alcohol that revealed no structural alerts 
suggestive of carcinogenicity, tetrahydrofurfuryl alcohol is therefore 
not expected to pose a cancer risk to humans.
    6. Determination of safety. Taking into consideration all available 
information on tetrahydrofurfuryl alcohol, EPA has determined that 
there is a reasonable certainty that no harm to any population subgroup 
will result from aggregate exposure to tetrahydrofurfuryl alcohol 
resulting from the limited uses contained in 40 CFR 180.1263. 
Therefore, the amendment of the exemption from requirement of a 
tolerance at 40 CFR 180.1263 for residues of tetrahydrofurfuryl alcohol 
when used as an inert ingredient in pesticide formulations to include 
allowance of one herbicide application prior to the pre-boot stage to 
wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and wild 
rice; extended use on canola to the early bolting stage; extended use 
on soybeans up to the bloom stage; and allowance of two applications to 
field corn and popcorn up to 36 inches tall (V8 stage) is safe under 
FFDCA section 408.

V. 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. Conclusion

    Therefore, the exemption from the requirement of a tolerance under 
40 CFR 180.1263 is amended to add exemption from the requirement of a 
tolerance for residues of tetrahydrofurfuryl alcohol (CAS Reg. No. 97-
99-4) when used as an inert ingredient (solvent) in herbicides applied 
to wheat, buckwheat, barley, oats, rye, sorghum, triticale, rice and 
wild rice prior to the pre-boot stage; use on canola to the early 
bolting stage; use on soybeans up to the bloom stage; and two 
applications to field corn and popcorn up to 36 inches tall (V8 stage).

VII. Statutory and Executive Order Reviews

    This final rule establishes exemptions from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this final rule has been exempted from review 
under Executive Order 12866, this final rule is not subject to 
Executive Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This final rule 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

[[Page 53002]]

the exemptions 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 9, 2018.
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.  180.1263, revise paragraphs (d) and (e), and add paragraphs 
(f) and (g) to read as follows:

Sec.  180.1263   Tetrahydrofurfuryl alcohol; exemption from the 
requirement of a tolerance.

* * * * *
    (d) For use in herbicides with one application to wheat, buckwheat, 
barley, oats, rye, sorghum, triticale, rice, and wild rice prior to the 
pre-boot stage.
    (e) For use in herbicides with two applications to field corn and 
popcorn up to 36 inches tall (V8 stage).
    (f) For use in herbicides with two applications to canola prior to 
the early bolting stage.
    (g) For use in herbicides with two applications to soybeans prior 
to the bloom growth stage.

[FR Doc. 2018-22862 Filed 10-18-18; 8:45 am]
 BILLING CODE 6560-50-P