[Federal Register Volume 75, Number 161 (Friday, August 20, 2010)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20581]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
2-methyl-1,3-propanediol; Exemption from the Requirement of a
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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)
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: firstname.lastname@example.org.
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
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of 40 CFR
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
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
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-
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
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
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
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/
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
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.
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: August 10, 2010.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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
* * * * * * *
* * * * *
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]
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