[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Rules and Regulations]
[Pages 763-767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31281]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0610; FRL-8802-5]
Dibenzylidene Sorbitol; 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 dibenzylidene sorbitol (CAS Reg. No.
32647-67-9) under 40 CFR 180.920 when used as the inert ingredient in
pesticdes formulations applied in or on growing crops. Dow Agrosciences
LLC submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of dibenzylidene sorbitol.
DATES: This regulation is effective January 6, 2010. Objections and
requests for hearings must be received on or before March 8, 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-2009-0610. 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
[[Page 764]]
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: Elizabeth Fertich, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 347-8560; e-mail address:
[email protected].
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 cite at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2009-0610 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before March 8, 2010.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2009-0610, 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. Background and Statutory Findings
In the Federal Register of September 4, 2009 (71 FR 45848) (FRL-
8434-4), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP 9E7581)
by Dow Agrosciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-
1054. The petition requested that 40 CFR 180.920 be amended by
establishing an exemption from the requirement of a tolerance for
residues of dibenzylidene sorbitol. That notice included a summary of
the petition prepared by the petitioner. No substantive comments were
received in response to the notice of filing.
Section 408(b)(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 performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
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. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information 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. The
[[Page 765]]
nature of the toxic effects caused by dibenzylidene sorbitol (DBS) are
discussed in this unit.
Some of the toxicological studies available in the database were
conducted with Millad[reg] 3905. Millad[reg] 3905 is a tradename for
the inert ingredient DBS and contains a minimum of 96% DBS.
DBS is not expected to pose a hazard when used for its proposed use
pattern. A skin sensitization study in guinea pigs determined that DBS
is not a sensitizer. A primary dermal irritation study in rats
determined that DBS is not irritating. The combined LD50 of
DBS in an acute oral toxicity study in mice was 12,800 mg/kg/day. The
dermal LD50 in mice (males only) was 6400 mg/kg/day.
In a 90-day subchronic oral toxicity study in mice and rats, the
no-observed-adverse-effect-level (NOAEL) was determined to be 3200 mg/
kg/day for mice and 2000 mg/kg/day for rats. No treatment-related
clinical signs of toxicity or systemic toxicity were noted during the
90-day test period at the highest dose tested. In a separate 13-week
oral toxicity with recovery phase assessment study in rats there were
no significant treatment-related effects noted and the NOAEL was
determined to be 20,000 parts per million (ppm) (1261.3 mg/kg/day for
males and 1479.2 mg/kg/day for females). In a 90-day subchronic oral
toxicity study in dogs the NOAEL was determined to be 92.1 mg/kg/day
for males and 91.5 mg/kg/day for females. No evidence of systemic
toxicity was observed at doses as high as 2500 ppm (92.1 and 91.5 mg/
kg/day in males and females, respectively; the highest dose tested).
In a mammalian cell gene mutation assay at the TK locus, mouse
lymphoma L5178Y cells cultured in vitro were exposed to Millad[reg]
3905. The study concluded that Millad[reg] 3905 was negative in the in
vitro mammalian cells in culture gene mutation assay in mouse lymphoma
L5178Y cells, both with and without S9-mix under the conditions of
testing.
In a mouse bone marrow micronucleus assay mice were treated orally
by gavage with Millad[reg] 3905. There were no signs of toxicity during
the study and the test substance is considered negative in the mouse
bone marrow micronucleus test.
In a reverse gene mutation assay in bacteria of S. typhimurium were
exposed to Millad[reg] 3905. It was negative for mutagenicity both in
the presence and absence of metabolic activations.
Based on the results from these studies, EPA concluded that DBS is
not likely to be genotoxic. No carcinogenicity studies are available on
DBS. Based on the lack of any systemic toxicity at high doses in rats
and mice in a 90-day study and the lack of mutagenicity, EPA concluded
that DBS is not likely to be carcinogenic. It is also likely that DBS
will metabolized into sorbitol and benzaldehyde in the body. Sorbitol
is a natural constituent and is considered non-carcinogenic and
benzaldehyde has been shown to be non-carcinogenic in rats at doses up
to 400 mg/kg/day. (Bishop, 1990)
No neurotoxicity studies are available on DBS, however, there were
no clinical signs of neurotoxicity were observed in the database.
V. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
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.
The primary route of exposure to DBS 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).
In addition to pesticide use, DBS has reported uses in personal
care products, such as antiperspirants, shampoos, conditioners, and
moisturizers. There is a potential exposure via dermal and inhalation
routes based on its use pattern in personal care products.
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.
VI. Cumulative Effects
Section 408(b)(2)(D)(v) of FFFDCA 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.''
Unlike other pesticide ingredients for which EPA has followed as
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to DBS and any
other substances and, DBS does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that DBS has 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
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.
VII. Additional Safety Factor for the Protection of Infants and
Children
Section 408 of the 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 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 to EPA supports the choice
of a different factor. The toxicity database is sufficient for DBS and
potential exposure is adequately characterized given the low toxicity
of the chemical. In terms of hazard, there are low concerns and no
residual uncertainties regarding prenatal and/or postnatal toxicity.
DBS has low subchronic
[[Page 766]]
toxicity. Although no developmental or reproductive studies, per se,
were identified, subchronic 90-day studies in dogs, rats and mice have
not demonstrated any systemic toxicity or effects on the reproductive
organs. No acute or subchronic neurotoxicity studies are available, but
there were no signs of neurological effects observed in the database at
high doses. Therefore, the Agency concluded that the developmental
neurotoxicity study is not required. No immunotoxicity study is
available, however, no systemic toxicity was observed in mice, rats and
dogs at high doses. In addition, no hazard has been identified
following exposure to DBS. Based on this information, there is no
concern at this time for increased sensitivity to infants and children
to DBS when used as an inert ingredient in pesticide formulations 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.
VIII. Determination of Safety
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be 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.
Residues of concern are not anticipated for dietary exposure (food
and drinking water) or for residential exposure from the use of DBS for
the proposed use pattern as an inert ingredient in pesticide products.
As discussed elsewhere, EPA expects aggregate exposure to DBS to pose
no appreciable dietary risk given that the data on DBS show a lack of
any systemic toxicity at high doses in mice and rats.
Taking into consideration all available information on DBS, 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 DBS. Therefore, the establishment of an exemption from
tolerance under 40 CFR 180.920 for residues of DBS when used as an
inert ingredient in pesticide formulations applied pre-harvest can be
considered safe under section 408 of the FFDCA. Dow Agrosciences
submitted a petition (9E7581) proposing to establish an
exemption from the requirement of a tolerance under 40 CFR 180.920
(pre-harvest only) for residues of DBS when used as a pesticide inert
ingredient, limited to herbicide use only with a 3% formulation cap.
Based upon review of the data supporting the petition, EPA has modified
the requested exemption. No limitations are necessary because no hazard
was identified.
IX. Other Considerations
A. Endocrine Disruptors
EPA is required under the Federal Food, Drug and Cosmetic Act
(FFDCA), as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active
and other ingredients) ``may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen, or other such
endocrine effects as the Administrator may designate.'' Following
recommendations of its Endocrine Disruptor and Testing Advisory
Committee (EDSTAC), EPA determined that there was a scientific basis
for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. EPA also adopted
EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use
FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA authority to
require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the
Endocrine Disruptor Screening Program (EDSP).
When additional appropriate screening and/or testing protocols
being considered under the Agency's EDSP have been developed, DBS may
be subjected to further screening and/or testing to better characterize
effects related to endocrine disruption.
B. Analytical Method(s)
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.
X. Conclusions
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues of dibenzylidene sorbitol. Accordingly, EPA finds that
exempting dibenzylidene sorbitol from the requirement of a tolerance
will be safe.
XI. 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
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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).
XII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 24, 2009.
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. 180.920, the table is amended by adding alphabetically the
following inert ingredient to read as follows:
Sec. 180.920 Inert Ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
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dibenzylidene sorbitol (32647-67- Thinning agent
9)
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* * * * *
[FR Doc. E9-31281 Filed 1-5-10; 8:45 am]
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