Document ID: EPA-HQ-OPP-2015-0214-0004
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of a Tolerance: Tetraethylene Glycol
Posted Date: 2015-09-11T04:00Z

[Federal Register Volume 80, Number 176 (Friday, September 11, 2015)]
[Rules and Regulations]
[Pages 54729-54733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22946]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0214; FRL-9933-35]

Tetraethylene Glycol; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of tetraethylene glycol (CAS Reg. No. 112-
60-7) when used as an inert ingredient (solvent) in pesticide 
formulations applied to growing crops. Exponent, Inc. on behalf of 
Drexel Chemical Company 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 tetraethylene glycol.

DATES: This regulation is effective September 11, 2015. Objections and 
requests for hearings must be received on or before November 10, 2015, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0214, 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

[[Page 54730]]

Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0214 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 
November 10, 2015. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0214, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of May 20, 2015 (80 FR 28925) (FRL-9927-
39), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10753) by 
Exponent, Inc. (1150 Connecticut Ave. Suite 1100 NW., Washington, DC 
20036) on behalf of Drexel Chemical Company, P.O. Box 13327 Memphis, TN 
38113-0327. The petition requested that 40 CFR 180.920 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of tetraethylene glycol (CAS Reg. No. 112-60-7) when used as 
an inert ingredient (solvent) in pesticide formulations applied to 
growing crops. That document referenced a summary of the petition 
prepared by Exponent on behalf of Drexel Chemical Company, the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no substantive 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 tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue . . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the

[[Page 54731]]

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 tetraethylene glycol including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with tetraethylene glycol 
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 tetraethylene glycol 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.
    Acute, subchronic and mutagenicity studies were available but 
chronic, developmental, reproduction and metabolism studies were not 
available on tetraethylene glycol. Ethylene glycol and the higher 
glycols (di-, tri-, tetra-, and pentaethylene glygol) are closely 
related in structure. Their physicochemical properties differ in a 
regular and expected way due to the increasing molecular weight and 
consistent functionality of a relatively less stable hydroxy moiety on 
each end of the molecule. Therefore, the hazard profile and dose 
response are also expected to change consistently with decreasing 
potential for adverse effect with increasing molecular weight (OECD 
SIDS SIAM 18, 2004). Based on this, toxicity data on triethylene glycol 
(which has a lower molecular weight than tetraethylene glycol and is 
likely to provide a conservative estimate of potential for adverse 
effect) was used as surrogate data to bridge chronic, developmental, 
reproduction toxicity and metabolism data for tetraethylene glycol.
    The acute oral and dermal toxicity of tetraethylene glycol is low. 
The oral and dermal LD50s are >20,000 mg/kg (milligram/
kilogram) in the rat and rabbit. Acute inhalation toxicity in rats is 
also low; the LC50 is >2.5 liter (L)/min. Tetraethylene 
glycol is mildly irritating to the eyes and to the skin in rabbits. It 
is not a dermal sensitizer.
    Tetraethylene glycol did not cause toxicity at doses up to 2,000 
milligrams/kilograms/day (mg/kg/day) in a subchronic oral toxicity 
study in rats.
    Based on developmental and reproduction toxicity studies with 
triethylene glycol, tetraethylene glycol is not expected to be a 
developmental/reproduction toxicant. Neither maternal, developmental 
nor reproduction toxicity was observed up to 3,300 mg/kg/day (greater 
than three times the limit dose).
    Available mutagenicity studies included the Ames test, mammalian 
gene mutation, sister chromatid exchange, chromosome aberrations, the 
chromatid dominant lethal test, and mouse micronucleus assays. 
Tetraethylene glycol was negative for inducing mutations and 
aberrations in all of the studies except the sister chromatid exchange 
assay which was positive. However, based on the weight of evidence 
tetraethylene glycol is not expected to be mutagenic.
    Carcinogenicity studies were not available. However, based on the 
lack of systemic toxicity and the lack of mutagenicity tetraethylene 
glycol is not expected to be carcinogenic.
    Neurotoxicity and immunotoxicity studies were not available for 
review. However, evidence of neurotoxicity and immunotoxicity was not 
observed in the available studies.
    Metabolism studies are not available on tetraethylene glycol. 
However, it is postulated that the metabolic pathway for tetraethylene 
glycol is similar to that of triethylene glycol in that it undergoes 
oxidation via alcohol dehydrogenases and aldehyde dehydrogenases to 
generate dicarboxylic acid metabolites.
    Specific information on the studies received and the nature of the 
adverse effects caused by tetraethylene glycol as well as the NOAEL and 
the LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document, ``Tetraethylene Glycol; Human 
Health Risk Assessment and Ecological Effects Assessment to Support 
Proposed Exemption from the Requirement of a Tolerance When Used as 
Inert Ingredients in Pesticide Formulations'' in docket ID number EPA-
HQ-OPP-2015-0214.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that tetraethylene glycol 
has low toxicity. No effects were observed up to 2,000 mg/kg/day 
following subchronic exposure. In the developmental and reproduction 
toxicity studies, effects were observed only at very high doses 
([gteqt]3,300 mg/kg/day). Further, the only effect observed at 3,300 
mg/kg/day was a minor decrement in bodyweight. Although, doses between 
590-3300 mg/kg/day were not tested in the developmental and 
reproduction studies in mice, the Agency is reasonably certain that no 
harm will occur to the general population or infants and children 
following the use of tetraethylene glycol at any dose below the limit 
dose given the lack of effects being found and the fact that the only 
effect seen was a minor bodyweight decrease seen at 3,300 mg/kg/day. 
Since, no other effects were observed, the Agency concluded that there 
are no endpoints of concern for tetraethylene glycol and a qualitative 
risk assessment is appropriate.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tetraethylene glycol, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from tetraethylene glycol in food as follows:
    Tetraethylene glycol will be used as a solvent in pesticide 
formulations used on agricultural crops. Additionally, it is used as an 
indirect food additive.
    For the general population, the majority of exposure to 
tetraethylene glycol occurs from the extensive use as a FDA-approved 
indirect food additive. Under this exemption from the requirement of a 
tolerance, residues of this chemical also may be found on treated 
crops. Because no hazard endpoint of concern was identified for the 
acute and chronic dietary assessment (food and drinking water), a 
quantitative dietary exposure risk assessment was not conducted.
    2. 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).
    Tetraethylene glycol is used as an inert ingredient in non-food use 
pesticide formulations and is also used as a humectant in cosmetics. 
However, based on the lack of toxicity, a quantitative exposure 
assessment from residential exposures was not performed.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether

[[Page 54732]]

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 tetraethylene glycol to share a common mechanism 
of toxicity with any other substances, and tetraethylene glycol does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this tolerance action, therefore, EPA has assumed 
that tetraethylene glycol does not have a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's Web site 
at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    As part of its qualitative assessment, the Agency did not use 
safety factors for assessing risk, and no additional safety factor is 
needed for assessing risk to infants and children. Based on an 
assessment of tetraethylene glycol and its chemical properties, EPA has 
concluded that there are no toxicological endpoints of concern for the 
U.S. population, including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that aggregate exposure to residues of tetraethylene glycol 
will not pose a risk to the U.S. population, including infants and 
children, and that no harm will result to the general population, or to 
infants and children from aggregate exposure to tetraethylene glycol 
residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
tetraethylene glycol in or on any food commodities. EPA is establishing 
a limitation on the amount of tetraethylene glycol that may be used in 
pesticide formulations applied to growing crops. That limitation will 
be enforced through the pesticide registration process under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 
136 et seq. EPA will not register any pesticide formulation for use on 
growing crops for sale or distribution that contains of tetraethylene 
glycol.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for tetraethylene glycol (CAS Reg. No. 
112-60-7) when used as an inert ingredient (solvent) in pesticide 
formulations applied to growing crops.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since exemptions that are established on the basis of a petition 
under FFDCA section 408(d), such as the exemption in this final rule, 
do not require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal 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: September 3, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

[[Page 54733]]

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, add alphabetically the inert ingredient 
``Tetraethylene glycol'' to the table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients              Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Tetraethylene glycol (CAS Reg.     ..............  Solvent
 No. 112-60-7).
 
                              * * * * * * *
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[FR Doc. 2015-22946 Filed 9-10-15; 8:45 am]
BILLING CODE 6560-50-P