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[Federal Register: August 20, 2010 (Volume 75, Number 161)]
[Rules and Regulations]               
[Page 51388-51392]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au10-7]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2002-0185; FRL-8838-3]

 
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 in pesticide formulations 
applied to growing crops and raw agricultural commodities after 
harvest, and when used as an inert ingredient solvent and/or surfactant 
in pesticide formulations applied to animals (used for food). 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 20, 2010. Objections and 
requests for hearings must be received on or before October 19, 2010, 
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-2002-0185. 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: Keri Grinstead, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8373; e-mail address: grinstead.keri@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

[[Page 51389]]

through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

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-2002-0185 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 19, 2010. 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-2002-0185, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line 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 August 28, 2002 (67 FR 55243) (FRL-7194-
6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 2E6484) by 
Lyondell Chemical Company, 1221 McKinney Street, Suite 1600, Houston, 
TX 77253-2583. The petition requested that 40 CFR part 180 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) in or on 
all raw agricultural commodities. 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 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 section 408(c)(2)(A) of FFDCA, 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.
    Acute toxicity studies of 2-methyl-1,3-propanediol in the rat 
indicate that this compound is practically non-toxic (EPA Toxicity 
Category IV) by the oral and inhalation exposure routes. The oral 
LD50 is greater than 5,000 milligrams/kilogram (mg/kg) and 
the inhalation LC50 is greater than 5,100 mg/m3. 
It is slightly toxic by the dermal exposure route (EPA Toxicity 
Category III) with an acute dermal LD50 in rabbits of 
greater than 2,000 mg/kg. Acute irritation studies in rabbits indicate 
that 2-methyl-1,3-propanediol is not irritating to the skin and eyes. 
Based on the results of a dermal sensitization study in guinea pigs, 2-
methyl-1,3-propanediol was determined to have mild sensitizing 
potential.

[[Page 51390]]

    Repeat oral exposure produced no toxicity at doses up to and 
including 1,000 mg/kg/day. No neurotoxicity studies are available; 
however, no clinical signs of neurotoxicity or any systemic toxicity 
were observed in any of the available studies. 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. No 
developmental, reproductive, or teratogenic effects were seen in the 
available studies at doses up to and including 1,000 mg/kg/day (highest 
dose tested).
    No carcinogenicity studies are available for 2-methyl-1,3-
propanediol and it has not been evaluated by the International Agency 
for Research on Cancer (IARC). Based on available studies, there is no 
evidence of genotoxic activity. There is no evidence of systemic 
toxicity at doses up to and including 1,000 mg/kg/day in the available 
toxicity studies, such as 14-day oral gavage study in rats, 90-day oral 
gavage study in rats, developmental toxicity studies in rats and 
rabbits and 2-generation reproduction study in rats. In addition, a 
qualitative structure activity relationship database, DEREK Version 11, 
identified no structural alerts suggestive of carcinogenicity. Based on 
the weight of the evidence, the Agency has determined that 2-methyl-
1,3-propanediol 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 as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``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.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level - generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    There was no hazard identified in repeat dose toxicity and 
reproductive/developmental studies at the limit dose of 1,000 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.
    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.

C. Exposure Assessment

    No hazard was identified for the acute and chronic dietary 
assessment (food and drinking water), or for the short, intermediate, 
and long term residential assessments, and therefore no aggregate risk 
assessments were performed.
     1. Dietary exposure from food and feed uses and drinking water. 
Since an endpoint for risk assessment was not identified, an exposure 
assessment for 2-methyl-1,3-propanediol was not conducted. The primary 
route of exposure to 2-methyl-1,3-propanediol from its use as an inert 
ingredient in pesticide products would most likely be through 
consumption of food to which pesticide products containing it have been 
applied, and possibly through drinking water (from runoff).
    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). Since 
an endpoint for risk assessment was not identified, a quantitative 
residential exposure assessment for 2-methyl-1,3-propanediol was not 
conducted. Residential (dermal and inhalation) exposures from home 
garden uses are possible.
    3. 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA Safety Factor (SF). In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    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/

[[Page 51391]]

day. No developmental, reproductive, or teratogenic 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 an inert ingredient in pesticide formulations 
for pre-harvest and post-harvest uses, as well as, for application to 
animals, 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.

E. 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-propanediol 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 above, 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 at doses up to 1,000 mg/kg/day and 
a lack of any apparent developmental effects.
    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 reasonably 
foreseeable circumstances. Therefore, the establishment of an exemption 
from tolerance under 40 CFR 180.910 and 180.930 for residues of 2-
methyl-1,3-propanediol when used as an inert ingredient in pesticide 
formulations applied to growing crops, raw agricultural commodities 
after harvest, and to animals (used for food), 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 U.N. 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 180.910 and 40 CFR 180.930 for 2-methyl-1,3-
propanediol (CAS Reg. No. 2163-42-0) when used as an inert ingredient 
in pesticide formulations applied to growing crops, raw agricultural 
commodities after harvest, and to animals (used for food).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 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 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.

[[Page 51392]]

    Dated: August 10, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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, the table is amended by adding alphabetically 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
------------------------------------------------------------------------
                              * * * * * * *
2-methyl-1,3-propanediol (CAS     ..................  Solvent,
 Reg. No. 2163-42-0)                                   surfactant
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  180.930, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
2-methyl-1,3-propanediol (CAS     ..................  Solvent,
 Reg. No. 2163-42-0)                                   surfactant
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-20581 Filed 8-19-10; 8:45 am]
BILLING CODE 6560-50-S
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