[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Rules and Regulations]
[Pages 45495-45498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18506]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0031; FRL-9352-6]


2-Methyl-1,3-propanediol; 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 2-methyl-1,3-propanediol (CAS Reg. No. 
2163-42-0) when used as an inert ingredient component of food contact 
sanitizing solutions applied to all food contact surfaces in public 
eating places, dairy-processing equipment, and food-processing 
equipment and utensils. Lyondell 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 2-methyl-1,3-propanediol.

DATES: This regulation is effective August 1, 2012. Objections and 
requests for hearings must be received on or before October 1, 2012, 
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-2012-0031, is available either 
electronically through http://www.regulations.gov or in hard copy at 
the OPP Docket in the Environmental Protection Agency Docket Center 
(EPA/DC), located in EPA West, 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. 
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-2012-0031 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 1, 2012. 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-2012-0031, 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 Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 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.htm.
    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 2, 2012 (77 FR 25954) (FRL-9346-1), 
EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 1E7946) by Lyondell 
Chemical Company, 1221 McKinney Street, Houston, Texas 77010. The 
petition requested that 40 CFR 180.940(a) be amended by establishing an 
exemption from the requirement of a tolerance for residues of 2-methyl-
1,3-propanediol (CAS Reg. No. 2163-42-0) when used as a component of 
food contact sanitizing solutions applied to all 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 Lyondell Chemical Company, 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

[[Page 45496]]

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 2-methyl-1,3-propanediol 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with 2-
methyl-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 2-methyl-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 
the final rule published in the Federal Register of August 20, 2010 (75 
FR 51388) (FRL-8838-3).

B. Toxicological Points of Departure/Levels of Concern

    There was no hazard identified in repeat dose toxicity and 
reproductive/developmental studies with 2-methyl-1,3-propanediol at the 
limit dose of 1,000 milligram/kilogram/day (mg/kg/day) to either 
parental animals or their offspring. Thus, due to its low potential 
hazard and lack of a 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 2-methyl-1,3-propanediol.
    2-Methyl-1,3-propanediol was not mutagenic in an in vitro 
chromosome aberration test, bacterial gene mutation test, and mammalian 
cell gene mutation assay and based on the available information, it is 
not anticipated to be carcinogenic. Specific information on the studies 
received and the nature of the adverse effects caused by 2-methyl-1,3-
propanediol are discussed in the final rule published in the Federal 
Register of August 20, 2010 (75 FR 51388) and can be found at http://www.regulations.gov in the document ``Decision Document for Petition 
Number 2E6484; 2-methyl-1,3-propanediol [CAS Reg No. 2163-42-0], 
requesting the establishment of an inert ingredient exemption from the 
requirement of a tolerance'' in docket ID number EPA-HQ-OPP-2002-0185.

C. Exposure Assessment

    No hazard endpoint of concern was identified for the acute and 
chronic dietary assessment (food and drinking water), or for the short, 
intermediate, and long term residential assessments (via all exposure 
routes), therefore, acute and chronic dietary and short-, intermediate-
, and long-term residential exposure assessments were not performed.

D. 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 2-methyl-1,3-propanediol to share a common 
mechanism of toxicity with any other substances, and 2-methyl-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 2-methyl-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 http://www.epa.gov/pesticides/cumulative.

E. Safety Factor for Infants and Children

    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

[[Page 45497]]

additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    The toxicity database for 2-methyl-1,3-propanediol is adequate for 
FQPA assessment and the potential exposure is adequately characterized 
given the low toxicity of the chemical. No hazard was identified and 
there is no residual uncertainty regarding prenatal and/or postnatal 
toxicity. No acute or subchronic neurotoxicity studies are available, 
but there were no clinical signs of neurotoxicity or any systemic 
toxicity observed 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 up to and including 1,000 mg/kg/day.
    Based on this information, there is no concern, at this time, for 
increased sensitivity to infants and children to 2-methyl-1,3-
propanediol when used as a component of food contact sanitizing 
solutions applied to all food contact surfaces and a safety factor 
analysis has not been used to assess risk. For the same reason, EPA has 
determined that an additional safety factor is not needed to protect 
the safety of infants and children.

F. Aggregate Risks and Determination of Safety

    Given the lack of concern for hazard posed by 2-methyl-1,3-
propanediol, EPA concludes that there are no dietary or aggregate 
dietary/non-dietary risks of concern as a result of exposure to 2-
methyl-1,3-propnaediol in food and water or from residential exposure. 
Residues of concern are not anticipated for dietary exposure (food and 
drinking water) or for residential exposure from the use of 2-methyl-
1,3-propanediol as an inert ingredient in pesticide products. As 
discussed in this unit, EPA expects aggregate exposure to 2-methyl-1,3-
propanediol to pose no appreciable dietary risk given that the data 
show a lack of any systemic toxicity or adverse developmental/
reproductive effects at doses up to 1,000 mg/kg/day.
    Taking into consideration all available information on 2-methyl-
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 2-methyl-1,3-propanediol under reasonable 
foreseeable circumstances. Therefore, the establishment of an exemption 
from tolerance under 40 CFR 180.940(a) for residues of 2-methyl-1,3-
propanediol when used as a component of food contact sanitizing 
solutions applied to all food contact surface in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils, 
is safe under FFDCA section 408.

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 2-methyl-1,3-propanediol.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for residues of 2-methyl-1,3-
propanediol (CAS Reg. No. 2163-42-0) when used as a component of food 
contact sanitizing solutions applied to all 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 establishes 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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This 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 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

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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 18, 2012.
G. Jeffery Herndon,
Acting 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(a), the table is amended by adding alphabetically 
the following inert ingredient after the entry for ``Magnesium oxide'' 
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) * * *

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       Pesticide chemical            CAS Reg. No.            Limits
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                              * * * * * * *
2-Methyl-1,3-propanediol.......             2163-42-0  None.
 
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[FR Doc. 2012-18506 Filed 7-31-12; 8:45 am]
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