Environmental Protection Agency (EPA).
This regulation establishes an exemption from the requirement of a tolerance for residues of ammonium salts of fatty acids (C8-C18 saturated) applied pre- and post-harvest on all raw agricultural commodities when applied/used as a surfactant. Falcon Lab, 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 ammonium salts of fatty acids (C8-C18 saturated).
This regulation is effective March 24, 2010. Objections and requests for hearings must be received on or before May 24, 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).
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0652. 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Deirdre Sunderland, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 603-0851; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
SUPPLEMENTARY INFORMATION:Start Printed Page 14083
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 Access Electronic Copies of This Document?
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-2008-0652 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 May 24, 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-2008-0652, 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 5, 2008 (73 FR 51817) (FRL-8380-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by the Food Quality Protection ACT (FQPA) (Public Law 104-170), announcing the filing of a pesticide petition (PP 8E7402) by Falcon Lab, LLC, 1103 Norbee Drive, Wilmington, DE 19803. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of ammonium salts of fatty acids (C8-C18 saturated) when used as an inert ingredient in pesticide formulations applied pre- and post-harvest. A request for a tolerance exemption under 40 CFR 180.950 was withdrawn by the company. 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 ploymers 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 ammonium salts of fatty acids (C8-C18 saturated) are discussed in this unit. The following provides a brief summary of the risk assessment and conclusions for the Agency's review of ammonium salts of fatty acids (C8-C18 saturated). The Agency's full decision document for this action is available in the Agency's electronic docket (regulations.gov) under the docket ID number EPA-HQ-OPP-2008-0652.Start Printed Page 14084
Ammonium salts of fatty acids are mineral salts of naturally occurring fatty acids found in the environment. Fatty acids play a significant role in the normal diet of humans, animals, and plants and currently have Food and Drug Administration and EPA approved uses in food products. They are naturally present in commonly eaten fats and oils, accounting for approximately 30 to 40% of the caloric intake in the U.S. diet (~ 90 grams/day). They are also found in cosmetics and household cleaning products.
Ammonium salts of fatty acids have shown to be of low toxicity via the oral and dermal routes of exposure, Toxicity category IV and III, respectively (40 CFR 156.62). When applied for long periods of time, they have the potential to be dermal irritants. In addition, ammonium salts of fatty acids are eye irritants and have the potential to cause permanent eye injury. Limited data are available regarding the inhalation toxicity of soap salts; however, they are anticipated to be irritating via the inhalation route of exposure.
A subchronic range finding study did not see any significant systemic toxicity from nonanoic acid (C9 saturated) given to rats at doses up to 1,834 milligrams/kilograms/day (mg/kg/day). Ammonium salts of fatty acids are not believed to be mutagenic or carcinogenic. When used at very high doses, potassium salts of fatty acids (a chemical belonging to the same chemical group) caused reproductive effects (post-implantation mortality at 6,000 mg/kg/day (6 times the limit dose of 1,000 mg/kg/day) on days 2 to 13 of pregnancy and musculo-skeletal abnormalities observed at 600 mg/kg/day); however, studies on ammonium salts of fatty acids did not show developmental or mutagenic effects in rats at doses up to 1,500 mg/kg/day. In addition, no signs of neurotoxicity or carcinogencity were observed. Although reproductive/developmental effects were seen at very high doses in a study on a structurally similar chemical, these effects were not observed in studies on the actual inert ingredient at doses up to 1,500 mg/kg/day. Based on the available evidence the Agency does not believe that ammonium salt of fatty acids (C8-C18 saturated) when used as an inert ingredient in pesticide products will cause reproductive or developmental effects. Due to the low toxicity of ammonium soap salts and the natural occurrence of fatty acids in the environment and food products, a chronic study was not required.
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.
Fatty acids are an essential component of the mammalian diet and the body is able to metabolize these soap salts and use them as an energy source. Due to the self-limiting nature of these chemicals (e.g. unpleasant taste and odor, herbicidal properties), their natural occurrence in the environment, their rapid environmental degradation and low toxicity, and their presence in commonly eaten foods (both naturally and intentionally added), a quantitative exposure assessment was not performed. The anticipated exposure from the use of ammonium salts of fatty acids as inert ingredients in pesticide products is expected to be minimal and is not anticipated to significantly increase the overall exposure to all populations including infants and children.
Because of their strong soil adsorption and the rapid degradation of ammonium salts of fatty acids they are not expected to reach surface water via runoff nor are they expected to leach into ground water. Based on the physical/chemical properties, volatilization from soils and water is not expected. There is no expected translocation into plants. Ammonium salts of fatty acid are not likely to persist in the environment and are expected to be indistinguishable from naturally occurring ammonium ions and fatty acids already present in the environment as a result of plant metabolism and formation by soil microbes.
VI. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ammonium salts of fatty acids (C8-C18 saturated) and any other substances, and these chemicals do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that these chemicals have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see 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 of toxicity on EPA's website at http://ww.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 margin of exposure (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of exposure (safety) will be safe for infants and children. There was no evidence of systemic toxicity or developmental toxicity in rats at doses up to 1,500 mg/kg/day in a developmental toxicity study (Master Record Identification Number 43843508) on pelargonic acid (nonanoate acid). The study showed no adverse effect of treatment on clinical signs, body weights, weight gain, or food/water consumption. No fetal toxicity attributed to the effects of treatment was observed between the Start Printed Page 14085treated (1,500 mg/kg/day) or the untreated controls. Similarly, no systemic toxicity was observed at doses up to and including 1,837 mg/kg/day in a 14-day toxicity study in rats. No clinical signs of neurotoxicity were seen in any of the repeat dose studies. Since there was no hazard identified to adults and developing fetuses EPA did not use a safety factor analysis in assessing risks to ammonium salts of fatty acids (C8-C18 saturated). For similar reasons, EPA determined that an additional safety factor to protect infants and children is not needed.
VIII. Determination of Safety for U.S. Population
As noted in Unit IV, ammonium salts of fatty acids are not expected to pose an acute risk. Because of the low oral and dermal toxicity, the rapid degradation of the chemical, and the natural presence of fatty acids in the environment, the Agency concluded that aggregate exposure will result in minimal risk to all subpopulations, including infants and children. Since the inhalation route is not a likely exposure pathway the anticipated risk from inhalation exposure is also considered minimal.
Taking into consideration all available information on ammonium salts of fatty acids (C8-C18 saturated), it has been determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to this chemical. Therefore, the exemption from the requirement of a tolerance for residues of ammonium salts of fatty acids (C8-C18 saturated) (CAS Reg. No. 5972-76-9, 63718-65-0, 16530-70-4, 32582-95-9, 2437-23-2, 191799-95-8, 16530-71-5, 93917-76-1, 5297-93-8, 94266-36-1, 1002-89-7), when used as inert ingredient in pre- and post-harvest applications, under 40 CFR 180.910 can be considered safe under section 408(q) of the FFDCA.
IX. Other Considerations
A. 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.
B. Existing Exemptions
Ammonium stearate (C18 saturated; CAS Reg. No. 1002-89-7), one of the soap salts, has been approved as an inert ingredient under 40 CFR 180.910. In addition, 40 CFR 180.1284 established an exemption from the requirement of a tolerance for residues of the active ingredient ammonium salts of higher fatty acids (C8-C18 saturated; C8-C12 unsaturated) in or on all food commodities when applied for the suppression and control of a wide variety of grasses and weeds.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for ammonium salts of fatty acids (C8-C18 saturated) nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.
Therefore, a tolerance exemption is established for Ammonium salts of fatty acids (C8-C18 saturated) (CAS Reg. No. 5972-76-9, 63718-65-0, 16530-70-4, 32582-95-9, 2437-23-2, 191799-95-8, 16530-71-5, 93917-76-1, 5297-93-8, 94266-36-1, 1002-89-7) when used as inert ingredient in pesticide formulations applied to pre- and post-harvest crops only.
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 exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 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).Start List of Subjects
List of Subjects in 40 CFR Part 180
- Environmental protection
- Administrative practice and procedure
- Agricultural commodities
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: March 11, 2010.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:End Amendment Part Start Part
PART 180—[AMENDED]End Part Start Amendment Part
1. The authority citation for part 180 continues to read as follows:End Amendment Part Start Amendment Part
2. In §180.910, in the table add alphabetically the following inert ingredient to read as follows:End Amendment Part
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|Ammonium salts of fatty acids (C8-C18 saturated) (CAS Reg. No. 5972-76-9, 63718-65-0, 16530-70-4, 32582-95-9, 2437-23-2, 191799-95-8, 16530-71-5, 93917-76-1, 5297-93-8, 94266-36-1, 1002-89-7)||Surfactant|
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[FR Doc. 2010-6495 Filed 3-23-10; 8:45 am]
BILLING CODE 6560-50-S