Document ID: EPA-HQ-OPP-2009-0610-0003
Agency: epa
Document Type: Rule
Title: Dibenzylidene Sorbitol; Exemption from the Requirement of a Tolerance
Posted Date: 2010-01-06T05:00Z

[Federal Register: January 6, 2010 (Volume 75, Number 3)]
[Rules and Regulations]               
[Page 763-767]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja10-10]                         

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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: 
fertich.elizabeth@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 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

[[Page 767]]

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.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
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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