Exemption from the Requirement of a Tolerance: 1,2,3-Propanetriol, Homopolymer Diisooctadecanoate
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
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.
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:
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General Information
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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
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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/.
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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
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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.
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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.
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Other Considerations
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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.
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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.
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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.
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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.
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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
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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).
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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
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