Document ID: EPA-HQ-OPP-2009-0213-0003
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: 1,2,3-Propanetriol, Homopolymer Diisooctadecanoate
Posted Date: 2010-02-25T05:00Z

[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Rules and Regulations]               
[Page 8500-8504]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe10-19]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0213; FRL-8813-8]

 
1,2,3-Propanetriol, Homopolymer Diisooctadecanoate; 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 1,2,3-propanetriol, homopolymer 
diisooctadecanoate, herein referred to as triglycerol diisostearate, 
when used as an inert ingredient (emulsifier) when applied to animals. 
Valent Biosciences Corporation 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 
triglycerol diisostearate.

DATES: This regulation is effective February 25, 2010. Objections and 
requests for hearings must be received on or before April 26, 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-2009-0213. 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: 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

[[Page 8501]]

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-2009-0213 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 April 26, 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-2009-0213, 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 May 6, 2009 (74 FR 20947) (FRL-8412-7), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
announcing the filing of a pesticide petition (PP 8E7354) by Valent 
Biosciences Corporation, 870 Technology Way, Libertyville, IL 60048. 
The petition requested that 40 CFR 180.930 be amended by establishing 
an exemption from the requirement of a tolerance for residues of 1,2,3-
propanetriol, homopolymer diisooctadecanoate, herein referred to as 
triglycerol diisostearate. That notice included a summary of the 
petition prepared by the petitioner. There were no comments 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 nature of the toxic effects caused by 
triglycerol diisostearate are discussed in this unit.
    The Agency has determined that triglycerol diisostearate is 
represented by the group of chemicals known as polyglycerol esters of 
fatty acids. Where specific information on triglycerol diisostearate is 
not available, information on polyglycerol esters of fatty acids is 
used to assess toxicity.
    The polyglycerol esters of fatty acids represent a large group of 
closely related compounds with complex compositions. The individual 
components are found as normal constituents of the human diet, i.e. 
glycerol, glycerol mono-, di- and tri-fatty acid esters and individual 
fatty acids. Hydrolysis by enzymes or gastric juices to form esters and 
carbon dioxide is the main pathway for metabolic degradation for 
polyglycerol esters of fatty acids.
    Acute toxicity studies conducted with polyglycerol esters of fatty 
acids in rats and rabbits show no adverse effects at doses up to 29 
grams/kilogram (g/kg) body weight. Repeated dose testing in rats over 5 
days did not result in any deaths at doses up to 10 g/kg body weight..
    In a short-term study, rats were maintained on 9% polyglycerol 
ester (equivalent to 4,500 milligrams/kilogram/day (mg/kg/day)) and 1% 
ground-nut oil for 17 weeks. No

[[Page 8502]]

systemic toxicity was observed in the study. There were also no adverse 
effects noted in a study where rats were maintained on a diet of 10% 
polyglycerol ester (equivalent to 5,000 mg/kg/day) for 90 days. In a 
third study, rats were fed a diet containing 15% polyglycerol ester 
(equivalent to 7,500 mg/kg/day) of fatty acids for 5 weeks. No adverse 
effects were reported during this study.
    In a long-term study, mice were fed a diet of either 5% 
polyglycerol ester (equivalent to 2,500 mg/kg/day) or ground-nut oil 
for 80 weeks. All animals survived the study and no adverse effects 
were reported on body weight, food consumption or peripheral blood 
picture. Microscopic examination of all major organs showed nothing 
remarkable. Similar results were exhibited in a study with rats fed the 
same diet for 2 years. In a third study, mice were maintained on a diet 
of 1% polyglycerol ester (equivalent to 500 mg/kg/day) for 15.5 months. 
There were no adverse effects noted in this study.
    In a reproductive study, rats were fed a diet containing 1.5% 
polyglycerol ester (equivalent to 750 mg/kg/day) for three generations. 
There were no significant effects on fertility or reproductive 
performance during the first year. There were also no consistent, 
compound-related abnormalities noted after gross and histological 
examination of the third generation.
    No carcinogenicity studies are available on triglycerol 
diisostearate, however, there was no systemic toxicity observed in mice 
and rats at doses up to 2,500 mg/kg/day for 80 weeks and 2 years, 
respectively.
    No neurotoxicity studies are available in the database; however, 
there was no systemic toxicity in mice and rats at doses up to 2,500 
mg/kg/day during prolonged exposure.
    No mutagenicity studies are available, however, polyglycerol esters 
of fatty acids are normal constituents in the diet. Therefore, there is 
no concern for mutagenic effects.

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 triglycerol diisostearate 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, triglycerol diisostearate has 
reported uses in personal care products, such as lipstick, lip gloss, 
sunscreen, makeup, skin cream and cleanser. 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 triglycerol 
diisostearate and any other substances and, triglycerol diisostearate 
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 triglycerol diisostearate 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. Safety Factor for 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 Agency has determined that triglycerol diisostearate is 
represented by the group of chemicals known as polyglycerol esters of 
fatty acids. Where specific information on triglycerol diisostearate is 
not available, information on polyglycerol esters of fatty acids is 
used to assess toxicity. The toxicity database is sufficient for 
polyglycerol esters of fatty acids 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. Polyglycerol esters of fatty acids 
have low subchronic and chronic toxicity. There was no systemic 
toxicity in mice and rats at very high doses for 80 weeks and 2 years 
respectively. In a reproductive study with rats, there were no 
significant effects on fertility or reproductive performance for three 
generations. There were also no consistent, compound-related 
abnormalities noted after gross and histological examination of the 
third generation. No 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 and rats 
at high doses. In addition, no hazard has been identified following 
exposure to

[[Page 8503]]

triglycerol diisostearate. Based on this information, there is no 
concern at this time for increased sensitivity to infants and children 
to triglycerol diisostearate 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 from dietary exposure (food 
and drinking water) or for residential exposure from the use of 
triglycerol diisostearate for the proposed use pattern as an inert 
ingredient (emulsifier) in pesticide formulations applied to animals. A 
quantitative dietary risk or residential risk assessment was not 
performed since no endpoint of concern was identified in the database.
    Taking into consideration all available information on triglycerol 
diisostearate, 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 triglycerol diisostearate. 
Therefore, the establishment of an exemption from the requirement of a 
tolerance under 40 CFR 180.930 for residues of triglycerol 
diisostearate when used as an inert ingredient (emulsifier) in 
pesticide formulations applied to animals can be considered safe under 
section 408 of the FFDCA.

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, 
triglycerol diisostearate may be subjected to further screening and/or 
testing to better characterize effects related to endocrine disruption.

B. Analytical Method

    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.

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
triglycerol diisostearate nor have any CODEX Maximum Residue Levels 
(MRLs) been established for any food crops at this time.

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 triglycerol diisostearate. Accordingly, EPA finds that 
exempting triglycerol diisostearate 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 
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

[[Page 8504]]

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: February 19, 2010.
Meredith F. Laws,
Acting 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. 180.930, 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
------------------------------------------------------------------------
                                * * * * *
1,2,3-Propanetriol, homopolymer                       Emulsifier
 diisooctadecanoate (CAS Reg.
 No. 63705-03-3)
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-3859 Filed 2-24-10; 8:45 am]
BILLING CODE 6560-50-S