Document ID: EPA-HQ-OPP-2012-0921-0003
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of a Tolerance: 1,3-Propanediol
Posted Date: 2013-06-12T04:00Z

[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Rules and Regulations]
[Pages 35143-35147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13823]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0921; FRL-9386-8]

1,3-Propanediol; Exemptions From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance for residues of 1,3-propanediol (CAS Reg. No. 504-63-2) 
when used as an inert ingredient solvent, co-solvent, diluent, or 
freeze-point depressant in pesticide formulations applied to growing 
crops and to raw agricultural crops after harvest and in antimicrobial 
pesticide formulations applied to food-contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils. DuPont Tate & Lyle BioProducts submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting establishment of exemptions from the requirement of a 
tolerance. These regulations eliminate the need to establish a maximum 
permissible level for residues of 1,3-propanediol.

DATES: This regulation is effective June 12, 2013. Objections and 
requests for hearings must be received on or before August 12, 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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0921, 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), EPA West 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: David Lieu, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0079; email address: lieu.david@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. To access the OCSPP test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

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-2012-0921 in the subject line on

[[Page 35144]]

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 August 12, 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 (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-2012-0921, 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 January 16, 2013 (78 FR 3377) (FRL-9375-
4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 2E8091) by 
DuPont Tate & Lyle BioProducts, LLC, 198 Blair Bend Dr., Loudon, TN 
37774. The petition requested two exemptions from the requirement of a 
tolerance be established for residues of 1,3-propanediol (CAS Reg. No. 
504-63-2) when used as an inert ingredient under 40 CFR 180.910 for its 
use as a solvent, co-solvent, diluent, or freeze-point depressant in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest and under 40 CFR 180.940(a) for its use in 
antimicrobial pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. That document referenced a summary 
of the petition prepared by DuPont Tate & Lyle BioProducts, 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 non-
toxicity; 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 1,3-propanediol including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with 1,3-propanediol 
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 1,3-propanediol 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 1,3-propanediol in rodents, expressed as 
an LD50 ranges from 10,500 to 15,789 milligram/kilogram body 
weight (mg/kg bw). No acute dermal toxicity studies for 1,3-propanediol 
were available in the toxicity database. The acute inhalation toxicity 
of 1,3-propanediol in rats produced a LC50 was > 5.0 mg/
liter (L). It is minimally irritating to the eyes of rabbits. It is 
mildly irritating to the skin of rabbits. Dermal sensitization studies 
on guinea pigs showed that 1,3-propanediol is not a sensitizer.
    In a 14-day inhalation toxicity study, three groups of 10 male 
Crl:CD (SD) IGS BR rats each were exposed by inhalation to either vapor 
only or a vapor/aerosol mixture of 1,3-propanediol in air at 
concentrations targeted to 60, 600, or 1,800 mg/meter cubed (m\3\) 
(0.06, 0.60,

[[Page 35145]]

or 1.80 mg/L) for 6 hours/day, 4 or 5 days/week for a total of 9 
exposures. A procedural control group of 10 male rats were exposed 
simultaneously to air only. There were no clinical signs of toxicity, 
body weight effects, clinical chemistry parameters, hematology 
measurements, and histopathological findings. The NOAEL for repeated 
inhalation exposure to 1,3-propanediol in male rats was considered to 
be 1,800 mg/m\3\ or 1.8 mg/L (the highest dose tested) and no LOAEL was 
identified.
    In a 90-day oral toxicity study, 1,3-propanediol was administered 
to 10 Crl:CD[supreg](SD)BR rats/sex/dose by gavage at dosages of 0, 
100, 300, or 1,000 mg/kg/day. No treatment-related effects were 
observed on clinical signs, mortality, body weights and body weight 
gain, food consumption, ophthalmoscopic examination, sperm 
abnormalities, organ weights and macroscopic, and microscopic 
examinations at doses up to and including 1,000 mg/kg/day. The NOAEL 
for systemic toxicity of 1,3-propanediol administered orally via gavage 
to male and female rats for 91 or 92 consecutive days was 1,000 mg/kg/
day (the highest dose tested) and no LOAEL was identified.
    The mutagenic potential of 1,3-propanediol was evaluated in a 
bacterial reverse mutation test, an in vitro mammalian cell gene 
mutation test, an in vitro chromosome aberration assay, an in vitro 
mammalian cell chromosome aberration assay, and an in vivo mammalian 
erythrocyte micronucleus test. Although the in vitro mammalian cell 
chromosome aberration assay in the V79 Chinese hamster cell line 
indicated some chromosomal aberrations, the remainders of the studies 
including the in vivo mouse micronucleus assay were negative; 
therefore, there are no concerns for clastogenicity. Based on the 
results of these studies, 1,3-propanediol is not considered to be 
mutagenic.
    No carcinogenicity studies on 1,3-propanediol were available in the 
toxicity database, however based on the lack of mutagenicity concerns, 
lack of any systemic toxicity at the limit dose, and lack of any 
structural alerts for carcinogenicity in the Derek analysis, there are 
no concerns for carcinogenicity for 1,3-propanediol.
    In a developmental toxicity study, 1,3-propanediol was administered 
to 20 pregnant female Sprague-Dawley (Hag:SD) rats/dose by gavage in 
0.8% aqueous hydroxypropyl-methylcellulose gel (with constant dose 
volume of 10 milliliter (mL)/kg bw) at dose levels of 0, 250, or 1,000 
mg/kg bw/day on gestation days (GDs) 6 through 15. Dams were sacrificed 
and necropsied on gestation day (GD) 20. There were no treatment-
related effects on maternal survival, clinical signs, body weight, food 
consumption, or gross pathology. The maternal LOAEL is not identified, 
and the maternal NOAEL is greater than or equal to 1,000 mg/kg bw/day 
(the highest dose tested). There were no treatment-related effects on 
live litter size, fetal deaths, fetal weights, early or late 
resorptions, or the fetal sex ratio. The developmental LOAEL is not 
identified, and the developmental NOAEL is greater than or equal to 
1,000 mg/kg bw/day (the highest dose tested).
    There were no immunotoxicity or neurotoxicity studies on 1,3-
propanediol available in the toxicity database. However, there was no 
evidence of clinical signs of neurotoxicity or immunotoxicity triggers 
in the available database up to the limit dose.
    The proposed metabolic pathway for 1,3-propanediol follows that for 
other simple alcohols, where alcohol and aldehyde dehydrogenase enzymes 
sequentially break down this substance to aldehydes and acids used in 
intermediary metabolism. 1,3-propanediol is metabolized to 3-
hydroxypropionaldehyde, malondialdehyde, or 3-hydroxypropionic acid, 
malonic semi-aldehyde, malonic acid, and ultimately, carbon dioxide and 
water.

B. Toxicological Points of Departure/Levels of Concern

    There was no hazard identified in repeat dose toxicity and 
developmental studies with 1,3-propanediol at the limit dose of 1,000 
mg/kg/day to either parental animals or their offspring. Based on the 
available mutagenicity studies, EPA concluded that 1,3-propanediol is 
not likely to be genotoxic. In addition, there were no structural 
alerts for carcinogenicity in the Derek analysis. Thus, due to its low 
potential hazard and lack of hazard endpoint, the Agency has determined 
that a quantitative risk assessment using safety factors applied to a 
point of departure protective of an identified hazard endpoint is not 
appropriate for 1,3-propanediol.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 1,3-propanediol, EPA considered exposure under the proposed 
exemptions from the requirement of a tolerance. Dietary exposure to 
1,3-propanediol can occur eating food treated with pesticide 
formulation containing this inert ingredient. In addition, dietary 
exposure to 1,3-propanediol could occur via residues from treated food 
contact surfaces. Since an endpoint for risk assessment was not 
identified, a quantitative dietary exposure assessment for 1,3-
propanediol was not conducted.
    2. Dietary exposure from drinking water. Dietary exposure from 
drinking water to 1,3-propanediol can occur by drinking water that has 
been contaminated by run-off from a pesticide treated area and from 
antimicrobial formulations used in food-contact surface sanitizing 
solutions. Since an endpoint for risk assessment was not identified, a 
quantitative dietary exposure assessment from drinking water for 1,3-
propanediol was not conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, and tables).
    Residential (oral, dermal, and inhalation) exposure from food-
contact surface sanitizing solutions for public eating places, dairy-
processing equipment, and food-processing equipment and utensils are 
possible. In addition, residential exposure through other potential 
agricultural uses is also possible. Since an endpoint for risk 
assessment was not identified, a quantitative residential exposure 
assessment for 1,3-propanediol was not conducted.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found 1,3-propanediol to share a common mechanism of 
toxicity with any other substances, and 1,3-propanediol does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 1,3-
propanediol 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

[[Page 35146]]

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 1,3-propanediol contains several acute and subchronic 
studies, mutagenic studies, and a developmental toxicity study. No 
hazard was identified based on those studies. The toxicity database 
does not contain a carcinogenicity study and an immunotoxicity study, 
but for the reasons stated in Unit IV.A., the Agency has concluded that 
there are no concerns for carcinogenicity or immunotoxicity for this 
chemical. No acute or subchronic neurotoxicity studies are available, 
but there were no clinical signs of neurotoxicity or any systemic 
toxicity observed with 1,3-propanediol in the available database at 
doses up to 1,000 mg/kg/day. No developmental or reproductive effects 
were seen in the available studies at doses of 1,3-propanediol up to 
and including 1,000 mg/kg/day. Thus, there is no residual uncertainty 
regarding prenatal and/or postnatal toxicity of 1,3-propanediol.
    Based on this information, there is no concern at this time for 
increased sensitivity to infants and children to 1,3-propanediol when 
used as an inert ingredient in pesticide formulations applied to 
growing crops, raw agricultural commodities after harvest, and for 
food-contact surface sanitizing applications.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on 1,3-
propanediol, EPA has determined that there is a reasonable certainty 
that no harm to any population subgroup will result from aggregate 
exposure to 1,3-propanediol under reasonable foreseeable circumstances. 
Therefore, the establishment of exemptions from tolerance under 40 CFR 
180.910 for residues of 1,3-propanediol when used as an inert 
ingredient in pesticide formulations applied to growing crops and raw 
agricultural commodities after harvest and under 40 CFR 180.940(a) for 
residues of 1,3-propanediol when used as an inert ingredient in food-
contact surface sanitizing solutions for public eating places, dairy-
processing equipment, and food-processing equipment and utensils is 
safe under FFDCA section 408.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
1,3-propanediol is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account chronic exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a chronic oral 
exposure was identified, and no chronic dietary endpoint was selected. 
Therefore, 1,3-propanediol is not expected to pose a chronic risk.
    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). Because no 
short-term adverse effect was identified, 1,3-propanediol is not 
expected to pose a short-term risk.
    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). Because no intermediate-term adverse effect was identified, 
1,3-propanediol is not expected to pose a intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. As discussed in Unit 
IV.A., 1,3-propanediol is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to 1,3-propanediol residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing exemptions 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 1,3-propanediol.

VI. Conclusions

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of 1,3-propanediol (CAS Reg. No. 504-63-2) 
under 40 CFR 180.910 when used as an inert ingredient (solvent, co-
solvent, diluent, or freeze point depressant) in pesticide formulations 
applied to growing crops and raw agricultural commodities after harvest 
and under 40 CFR 180.940(a) when used as an inert ingredient in food-
contact surface sanitizing solutions for public eating places, dairy-
processing equipment, and food-processing equipment and utensils.

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 35147]]

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: June 3, 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.  180.910, add to the table, after the entry ``Propane,'' the 
following inert ingredient to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients            Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
1,3-Propanediol (CAS Reg. No. 504-  .........  Solvent, co-solvent,
 63-2).                                         diluent, or freeze-point
                                                depressant.
 
                              * * * * * * *
------------------------------------------------------------------------

0
3. In Sec.  180.940, add to the table in paragraph (a), after the entry 
``potassium iodide,'' 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) * * *

------------------------------------------------------------------------
        Pesticide chemical           CAS Reg. No.          Limits
------------------------------------------------------------------------
 
                              * * * * * * *
1,3-Propanediol...................        504-63-2  None.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-13823 Filed 6-11-13; 8:45 am]
BILLING CODE 6560-50-P