Document ID: EPA-HQ-OPP-2012-0901-0004
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: Propylene Glycol
Posted Date: 2013-08-09T04:00Z

[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Rules and Regulations]
[Pages 48618-48621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19025]

[[Page 48618]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0901; FRL-9394-5]

Propylene 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 propylene glycol (CAS Reg. No. 57-55-6) 
when used as an inert ingredient in antimicrobial formulations applied 
to food-contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils under our 
regulations. Exponent on behalf of Ecolab, 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 propylene glycol.

DATES: This regulation is effective August 9, 2013. Objections and 
requests for hearings must be received on or before October 8, 2013, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2012-0901. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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://ecfr.gpoaccess.gov/cgi/t/text/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-2012-0901 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 8, 2013. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2012-0901, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Exemption

    In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP IN-10525) by 
Exponent[supreg], 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 
20036 on behalf of Ecolab, Inc., 370 N. Wabasha Street, St. Paul, MN 
55102. The petition requested that 40 CFR 180.940(a) be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of propylene glycol (CAS Reg. No. 57-55-6) when used as an 
inert ingredient in antimicrobial formulations applied to food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. That notice referenced a summary of 
the petition prepared by Ecolab, 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

[[Page 48619]]

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 
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 propylene glycol including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with propylene 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 propylene 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.
    The acute oral toxicity of propylene glycol is low propylene glycol 
did not cause dermal or eye irritation in rabbits. It was not a dermal 
sensitizer.
    Propylene glycol administered via the oral route did not cause 
systemic toxicity in rats or dogs in studies conducted for up to 2 
years at doses as high as 2,500 mg/kg/day. Neither maternal, 
developmental, offspring nor reproduction toxicity was observed at 
doses up to approximately 10,000 mg/kg/day in a teratology screening 
and a continuous breeding study in mice.
    Also, dermal exposure to propylene glycol did not cause systemic 
toxicity nor increased skin tumor incidence at concentrations up to 
100% (~100,000 mg/kg/day) propylene glycol in mice.
    Propylene glycol was not mutagenic or genotoxic on the basis of a 
battery of studies that included the bacterial gene mutation assay 
using Salmonella typhimurium (AMES) in vitro assay, in vitro Chinese 
hamster ovary (CHO) mutation assay, Chinese hamster ovary (CHO) 
chromosomal aberration assays, and an in vitro sister chromatid 
exchange assay. In addition, EPA concluded that propylene glycol was 
negative for carcinogenicity in studies conducted up to the testing 
limit doses established by the Agency.
    Although no neurotoxicity or immunotoxicity studies on propylene 
glycol are available, there is no evidence of neurotoxicity or 
immunotoxicity in the available studies.
    Propylene glycol should be readily metabolized to lactic acid at 
the typical low-level exposures. At higher concentrations (absorbed 
doses), propylene glycol is primarily excreted unchanged in the urine.

B. Toxicological Points of Departure/Levels of Concern

    EPA has concluded that there are no toxicity endpoints of concern 
for oral, dermal, or inhalation exposure to propylene glycol. This 
conclusion is based on the results of toxicity testing of propylene 
glycol at dose levels near or above testing limits (as established in 
the OPPTS 870 series harmonized test guidelines). Since signs of 
toxicity were not observed, a toxicological endpoint of concern for use 
in risk assessment was not identified. Therefore, EPA has determined 
that a quantitative risk assessment, which would use safety factors 
applied to a point of departure that is protective of an identified 
hazard endpoint, for propylene glycol is not appropriate.

C. Exposure Assessment

    1. Dietary exposure from food, feed, drinking water and non-dietary 
exposures. In evaluating dietary exposure to propylene glycol, EPA 
considered exposure under the proposed exemption from the requirement 
of a tolerance. For purposes of this action, EPA qualitatively assessed 
dietary and non-dietary exposures from propylene glycol as follows:
    Dietary exposure (food and drinking water) could potentially occur 
from the use of propylene glycol as a food additive, from food 
packaging, from its use as an inert ingredient in pesticide 
formulations. In addition, dietary exposure to propylene glycol could 
occur as a result of contact with treated surfaces or food- or dairy-
processing equipment or food utensils. Residential exposure could also 
potentially occur as a result of the use of propylene glycol in and 
around the home as a sanitizer, disinfectant, and pet treatment. Since 
an endpoint for risk assessment was not identified, a quantitative 
dietary exposure assessment for propylene glycol was not conducted.
    2. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether

[[Page 48620]]

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 propylene glycol to share a common mechanism of 
toxicity with any other substances, and propylene 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 
propylene 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

    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. The toxicity 
database for propylene glycol contains several acute, subchronic, and 
chronic, developmental, and reproductive toxicity studies, as well as 
carcinogenicity, mutagenicity, metabolism/pharmacokinetics, and dermal 
toxicity studies. No hazard was identified based on those studies. 
Although the toxicity database does not contain any neurotoxicity or 
immunotoxicity studies, no evidence of neurotoxicity or immunotoxicity 
effects was present in any of the available studies. Thus, there is no 
residual uncertainty regarding prenatal and/or postnatal toxicity of 
propylene glycol.
    Based on this information, there is no concern at this time for 
increased sensitivity to infants and children to propylene glycol when 
used as an inert ingredient in pesticide formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment, 
and food-processing equipment and utensils.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on propylene 
glycol, EPA concludes that there are no dietary or aggregate dietary/
non-dietary risks of concern as a result of exposure to propylene 
glycol in food and water or from residential exposure. As discussed in 
this unit, EPA expects aggregate exposure to propylene glycol to pose 
no appreciable dietary risk given that the data show a lack of systemic 
toxicity at doses < 2500 mg/kg/day and a lack of any increased 
susceptibility of infants and children. Taking into consideration of 
all available information on propylene glycol, 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 
propylene glycol residues.

V. Other Considerations

A. 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.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food 
and Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for propylene glycol.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for propylene glycol (CAS Reg. No. 
57-55-6) when used as an inert ingredient in antimicrobial pesticide 
formulations applied to food-contact surfaces in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils.

VII. Statutory and Executive Order Reviews

    This final rule exempts certain pesticide residues 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 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 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) (Pub. L. 104-4).
    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

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Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 
section 12(d) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: July 29, 2013.
Lois Rossi,
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.  180.940, the table in paragraph (a) is amended by adding, 
alphabetically, the following inert ingredient to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
                                          CAS Reg.
           Pesticide chemical               No.            Limits
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                                * * * * *
Propylene glycol.......................    57-55-6  None.
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2013-19025 Filed 8-8-13; 8:45 am]
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