Sodium Ferric Ethylenediaminetetraacetate; Exemption From the Requirement of a Tolerance, 17556-17561 [2011-7465]

Download as PDF WReier-Aviles on DSKGBLS3C1PROD with RULES 17556 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations beginning actual construction) whether a significant net emissions increase will occur at the major stationary source (i.e., the second step of the process) is contained in the definition in paragraph (b)(3) of this section. Regardless of any such preconstruction projections, a major modification results if the project causes a significant emissions increase and a significant net emissions increase. * * * * * (b) * * * (3) * * * (iii) * * * (b) The increase or decrease in emissions did not occur at a Clean Unit except as provided in paragraphs (x)(8) and (y)(10) of this section. * * * * * (20) Fugitive emissions means those emissions which could not reasonably pass through a stack, chimney, vent, or other functionally equivalent opening. * * * * * (41) * * * (ii) * * * (b) Shall include fugitive emissions to the extent quantifiable, and emissions associated with startups, shutdowns, and malfunctions; and * * * * * (d) In lieu of using the method set out in paragraphs (a)(41)(ii)(a) through (c) of this section, may elect to use the emissions unit’s potential to emit, in tons per year, as defined under paragraph (b)(4) of this section. * * * * * (48) * * * (i) * * * (a) The average rate shall include fugitive emissions to the extent quantifiable, and emissions associated with startups, shutdowns, and malfunctions. * * * * * (ii) * * * (a) The average rate shall include fugitive emissions to the extent quantifiable, and emissions associated with startups, shutdowns, and malfunctions. * * * * * (iii) For a new emissions unit, the baseline actual emissions for purposes of determining the emissions increase that will result from the initial construction and operation of such unit shall equal zero; and thereafter, for all other purposes, shall equal the unit’s potential to emit. (iv) For a PAL for a stationary source, the baseline actual emissions shall be calculated for existing electric utility steam generating units in accordance with the procedures contained in paragraph (b)(48)(i) of this section, for VerDate Mar<15>2010 12:55 Mar 29, 2011 Jkt 223001 other existing emissions units in accordance with the procedures contained in paragraph (b)(48)(ii) of this section, and for a new emissions unit in accordance with the procedures contained in paragraph (b)(48)(iii) of this section. * * * * * (i) * * * (1) * * * (vii) The source or modification would be a major stationary source or major modification only if fugitive emissions, to the extent quantifiable, are considered in calculating the potential to emit of the stationary source or modification and the source does not belong to any of the following categories: (a) Coal cleaning plants (with thermal dryers); (b) Kraft pulp mills; (c) Portland cement plants; (d) Primary zinc smelters; (e) Iron and steel mills; (f) Primary aluminum ore reduction plants; (g) Primary copper smelters; (h) Municipal incinerators capable of charging more than 250 tons of refuse per day; (i) Hydrofluoric, sulfuric, or nitric acid plants; (j) Petroleum refineries; (k) Lime plants; (l) Phosphate rock processing plants; (m) Coke oven batteries; (n) Sulfur recovery plants; (o) Carbon black plants (furnace process); (p) Primary lead smelters; (q) Fuel conversion plants; (r) Sintering plants; (s) Secondary metal production plants; (t) Chemical process plants—The term chemical processing plant shall not include ethanol production facilities that produce ethanol by natural fermentation included in NAICS codes 325193 or 312140; (u) Fossil-fuel boilers (or combination thereof) totaling more than 250 million British thermal units per hour heat input; (v) Petroleum storage and transfer units with a total storage capacity exceeding 300,000 barrels; (w) Taconite ore processing plants; (x) Glass fiber processing plants; (y) Charcoal production plants; (z) Fossil fuel-fired steam electric plants of more than 250 million British thermal units per hour heat input; (aa) Any other stationary source category which, as of August 7, 1980, is being regulated under section 111 or 112 of the Act; or * * * * * PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 (r) * * * (6) * * * (iii) The owner or operator shall monitor the emissions of any regulated NSR pollutant that could increase as a result of the project and that is emitted by any emissions unit identified in paragraph (r)(6)(i)(b) of this section; and calculate and maintain a record of the annual emissions, in tons per year on a calendar year basis, for a period of 5 years following resumption of regular operations after the change, or for a period of 10 years following resumption of regular operations after the change if the project increases the design capacity or potential to emit that regulated NSR pollutant at such emissions unit. (iv) If the unit is an existing electric utility steam generating unit, the owner or operator shall submit a report to the Administrator within 60 days after the end of each year during which records must be generated under paragraph (r)(6)(iii) of this section setting out the unit’s annual emissions during the calendar year that preceded submission of the report. * * * * * (aa) * * * (4) * * * (i) * * * (d) The PAL shall include fugitive emissions, to the extent quantifiable, from all emissions units that emit or have the potential to emit the PAL pollutant at the major stationary source. * * * * * [FR Doc. 2011–6670 Filed 3–29–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2010–0097; FRL–8867–7] Sodium Ferric Ethylenediaminetetraacetate; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of sodium ferric ethylenediaminetetraacetate (EDTA) in or on all food commodities when applied as a molluscicide and used in accordance with good agricultural practices. W. Neudorff GmbH KG submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from SUMMARY: E:\FR\FM\30MRR1.SGM 30MRR1 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium ferric EDTA under the FFDCA. DATES: This regulation is effective March 30, 2011. Objections and requests for hearings must be received on or before May 31, 2011, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). 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. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2010–0097. 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 Office of Pesticide Programs (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: John Fournier, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–0169; e-mail address: fournier.john@epa.gov. 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 site at http:// www.gpoaccess.gov/ecfr. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/oscpp and select ‘‘Test Methods and Guidelines.’’ ADDRESSES: SUPPLEMENTARY INFORMATION: I. General Information WReier-Aviles on DSKGBLS3C1PROD with RULES 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 VerDate Mar<15>2010 12:55 Mar 29, 2011 Jkt 223001 C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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–2010–0097 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 31, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). 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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2010–0097, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 17557 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 30, 2010 (75 FR 60452) (FRL–8837–2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 9F7668) by W. Neudorff GmbH KG, An der ¨ Muhle 3, Postfach 1209, 31860 Emmerthal, Germany (c/o Walter G. Talarek, P.C., 1008 Riva Ridge Dr., Great Falls, VA 22066–1620). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of sodium ferric EDTA. This notice referenced a summary of the petition prepared by the petitioner, W. Neudorff GmbH KG, which is available in the docket, http:// www.regulations.gov. There were no comments received in response to the notice of filing. Section 408(c)(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 exemption is ‘‘safe.’’ Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require 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.’’ Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider ‘‘available information E:\FR\FM\30MRR1.SGM 30MRR1 17558 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations concerning the cumulative effects of a particular pesticide’s residues’’ and ‘‘other substances that have a common mechanism of toxicity.’’ 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. WReier-Aviles on DSKGBLS3C1PROD with RULES III. 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. A. Overview of Sodium Ferric EDTA The pesticidal active ingredient, sodium ferric EDTA, is a molluscicide that has historically been used to control terrestrial slugs and snails in agriculture and on ornamental landscaping. The compound is comprised of iron in a sodium chelate. This chelate forms a soluble, complex molecule with iron ions, inactivating the ions so that they cannot normally react with other elements or ions to produce precipitates or scale. In this form, the iron is more bioavailable than in other mineral sources (Ref. 1). Bioavailability of iron is an essential quality of sodium ferric EDTA as the iron in this compound is responsible for controlling slugs and snails. That is, when slugs or snails ingest sodium ferric EDTA, the iron in the compound interacts with hemocyanin, a copperbased respiratory protein common to the blood of mollusks and responsible for their oxygen transport. This interaction with hemocyanin causes suffocation and eventually results in the death of slugs and snails. Iron does not have this interaction, however, in organisms that do not use hemocyanin for oxygen transport (e.g., mammals). Iron is a necessary nutrient for all mammals and other vertebrates because it is a component of hemoglobin, the oxygen transport protein found in red blood cells of vertebrates. It is the most abundant element on Earth and, as such, can be found in most soil and water. It is an essential nutrient listed as Generally Recognized as Safe (GRAS) by the Food and Drug Administration VerDate Mar<15>2010 12:55 Mar 29, 2011 Jkt 223001 (FDA) for direct addition to food (21 CFR 184.1375) and is added to commonly consumed, fortified foods such as enriched flour, bread, pasta, and grains. Sodium Ferric EDTA is allowed as a direct food additive by the FDA and is used as a source of iron for nutritional fortification in foods such as powdered meal replacements, flavored milk, and fruit-flavored beverages (Ref. 2), as well as soy, fish, teriyaki, and hoisin sauces (Ref. 3). The compound is also a common constituent of many cosmetic products and, despite being present at much higher concentrations than those found in sodium ferric EDTA end-use pesticide products used for control of slugs and snails, has an extensive history of safe use as an agricultural fertilizer. In 2008, EPA registered the first sodium ferric EDTA-containing product for control of slugs and snails. EPA assessed the risks to human health and concluded that, when sodium ferric EDTA was used in accordance with widespread and commonly recognized practices, no unreasonable adverse effects on the environment were expected (Ref. 4). At the time of this initial sodium ferric EDTA registration, the applicant did not petition EPA to establish a tolerance or tolerance exemption because all uses were nonfood. On December 6, 2009, however, EPA was petitioned by W. Neudorff GmbH KG to establish an exemption from the requirement of a tolerance for residues of sodium ferric EDTA in or on all food commodities. Accordingly, EPA has completed a risk assessment of mammalian toxicology data submitted in support of this request. The overall conclusions from these data are described in Unit III.B., while more indepth synopses of the study results can be found in the risk assessment and Biopesticides Registration Action Document provided as references in Unit IX. (Refs. 5 and 6). B. Biochemical Pesticide Human Health Assessment Data Requirements 1. Acute toxicity. Tier I acute toxicity studies of technical grade sodium ferric EDTA (Slugkil MP, containing 71.42% sodium ferric EDTA) showed that the active ingredient is a Toxicity Category III (slightly toxic) compound via the oral and dermal routes of exposure, a Toxicity Category III (slightly irritating) compound via the dermal and eye routes of exposure, and a Toxicity Category IV (practically nontoxic) compound for inhalation exposure. Moreover, sodium ferric EDTA is not a dermal sensitizer. Given the results of these studies, no additional toxicity (i.e., Tiers II or III) or residue data are PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 required to support food uses of this biochemical active ingredient. These acute toxicity studies confirm sodium ferric EDTA’s low toxicity profile. i. The acute oral median lethal dose (LD50) for sodium ferric EDTA in rats was greater than 2,000 milligrams per kilogram (mg/kg) and confirmed low toxicity through oral exposure (Master Record Identification Number (MRID No.) 47942507). Sodium Ferric EDTA is classified as Toxicity Category III for acute oral toxicity. ii. The acute dermal LD50 for sodium ferric EDTA in rats was greater than 2,000 mg/kg, which confirmed low dermal toxicity (MRID No. 47942508). Sodium Ferric EDTA is classified as Toxicity Category III for acute dermal toxicity. iii. The acute inhalation median lethal concentration (LC50) for sodium ferric EDTA in rats was greater than 2.75 milligrams per liter (mg/L) and showed practically no inhalation toxicity (MRID No. 47942512). Sodium Ferric EDTA is classified as Toxicity Category IV for acute inhalation toxicity. iv. A primary eye irritation study showed that exposure to sodium ferric EDTA will cause temporary, mild eye irritation (MRID No. 47942509). Accordingly, EPA has determined that sodium ferric EDTA is Toxicity Category III for primary eye irritation. v. A primary dermal irritation study showed that exposure to sodium ferric EDTA is slightly irritating (MRID No. 47942510) and a skin sensitization study showed that sodium ferric EDTA is not a sensitizer to the skin (MRID No. 47942511). Accordingly, EPA has determined that sodium ferric EDTA is Toxicity Category III for dermal irritation. 2. Subchronic toxicity.—i. Submission of 90-day oral toxicity data was waived by EPA because the acute oral toxicity study demonstrated sodium ferric EDTA’s low toxicity (LD50 >2,000 .mg/ kg). In their waiver rationale, the petitioner also cited information from EPA’s 2008 sodium ferric EDTA Biopesticides Registration Action Document (BRAD): No references for feeding studies using sodium ferric EDTA were located in the published literature. Rats fed low mineral diets with or without calcium disodium EDTA for four months had reduced weight gain, but their general condition was comparable to that of controls (Ref. 7). Rats fed 1%, 5%, or 10% disodium salt of EDTA for 90 days had significantly lower food consumption and weight gain than controls (Ref. 8). Hematology was comparable among all groups, except that prothrombin time was increased in the 10% group. The only significant necropsy finding was pale livers in the 10% group. E:\FR\FM\30MRR1.SGM 30MRR1 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations WReier-Aviles on DSKGBLS3C1PROD with RULES Mice fed 3,750 or 7,500 ppm trisodium EDTA for 103 weeks had no treatment-related clinical signs, and gross and microscopic pathology were unremarkable (Ref. 9). A companion study conducted by NCI using rats produced the same results (Ref. 9). In a 12-month feeding study using dogs, Oser et al (1963) found no significant changes in hematology or urinalysis parameters, and no abnormal gross or microscopic findings in groups receiving up to 250 mg/kg body weight/day of calcium disodium EDTA (Ref. 10). The information cited above refers to feeding studies using sodium EDTA and calcium disodium EDTA. The Agency has assessed the toxicity profile of these and other EDTA salts (Refs. 11 and 12), and concluded that they are closely related. This information sufficed for the assessment of toxicological risk characterization of sodium ferric EDTA. Additionally, iron is an essential nutrient listed as GRAS by the FDA, and both iron and sodium ferric EDTA are allowed as direct food additives to increase the nutritional content of food and food supplements. Sodium Ferric EDTA is also used in agriculture as a fertilizer. Given all of this information, EPA concluded that no subchronic oral toxicity is expected when this compound is used in accordance with good agricultural practices. ii. Submission of 90-day dermal toxicity data was waived by EPA because acute guideline studies demonstrated that sodium ferric EDTA has low dermal toxicity (LD50 >2,000 mg/kg), is a slight dermal irritant, and is not a dermal sensitizer. Repeated dermal exposure, under conditions of product use at a concentration that could be toxic, is not anticipated. iii. Submission of 90-day inhalation data was waived by EPA because the acute inhalation toxicity study demonstrated sodium ferric EDTA’s lack of toxicity (Toxicity Category IV). Repeated inhalation exposure, under conditions of product use at a concentration that could be toxic, is not anticipated. 3. Developmental toxicity and mutagenicity. Acceptable waiver requests were submitted to address the data requirements for Developmental toxicity and Mutagenicity (OPPTS 870.3700). The Agency concluded that humans are regularly exposed to iron found abundantly in nature and from the use of sodium ferric EDTA as fertilizer. No negative effects of sodium ferric EDTA have been reported because of its low toxicity and low water solubility, which decreases its absorption in the intestine. Moreover, the active ingredient is not a mutagen nor is it related to any known classes of mutagens. After considering the VerDate Mar<15>2010 12:55 Mar 29, 2011 Jkt 223001 aforementioned information and the extensive history of use of sodium ferric EDTA in agriculture and food without deleterious effects, EPA waived the requirement to submit developmental toxicity and mutagenicity data. IV. 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 nonoccupational 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). A. Dietary Exposure 1. Food. The primary route of sodium ferric EDTA exposure to the general population will be through consumption of food; however, there is no reason to expect that practical use of sodium ferric EDTA, in accordance with good agricultural practices, will constitute any significant hazard. Sodium Ferric EDTA is comprised of iron in a sodium chelate. Iron is abundant in nature, an essential nutrient, and listed as GRAS for direct addition to food (21 CFR 184.1375). Sodium Ferric EDTA is regarded as safe for use as a dietary supplement to increase iron bioavailability and prevent iron deficiency. In humans, iron is an essential nutrient that is vital to the processes by which cells generate energy. It is available to animals from food derived from other animals and plants. When sodium ferric EDTA is ingested, the chelate holds the iron in the stomach until pH rises in the upper small intestine. As pH rises, the strength of the complex progressively diminishes, allowing exchange with other metals and iron for absorption. Iron dissociates from the EDTA moiety and is released in the duodenum prior to absorption. Only a very small fraction of the sodium ferric EDTA complex (less than 1%) is absorbed intact. Intact EDTA metal complexes are rapidly excreted; they do not accumulate or undergo biotransformation (Ref. 13). European Food Safety Authority Panel on Food Additives and Nutrient Sources added to Food (2010) concluded that, when sodium ferric EDTA is used in food supplements at levels that provide 22.3 milligrams (mg) of iron/day for adults and 11.1 mg of iron/day for children, the use of sodium ferric EDTA as a source of iron in foods is of no safety concern as long as it does PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 17559 not lead to an exposure of EDTA above 1.9 mg/kg/day. Exposure to EDTA and salts of EDTA already occurs through certain FDAapproved uses as food additives, in sanitizing solutions, and in pharmaceutical products, or through their use in soaps, shampoos, or cosmetics. EDTA has also been administered safely under medical supervision as treatment for heavy metal poisoning. The results of toxicity testing and information found in public literature indicate that there is no risk to human health from residues of sodium ferric EDTA in food crops. Furthermore, residues from the formulations in agricultural use sites (certified limits <4% by weight) and residential use sites (<1% of typical formulations) are not likely to exceed levels currently consumed in commonly eaten foods. In addition, the use of EDTA and EDTA salts in pesticide products is expected to result in much lower exposure than the FDA-regulated use of these compounds, as well as lower exposure than their use in pharmaceuticals or cosmetic products. The concentration of iron needed for good plant growth is below the concentration needed by animals for good cellular functioning. In agriculture, iron sodium chelate is used as micronutrient fertilizer at much higher concentrations than those present in sodium ferric EDTA-containing pesticide products, which are labeled for maximum application rates of below 25 mg of sodium ferric EDTA per square foot. The use of sodium ferric EDTA in pesticides is expected to result in much lower exposure than through its use in plant fertilizers, pharmaceutical products, or cosmetic products. Based on review and evaluation of available information, EPA concludes that there is a reasonable certainty of no harm from residues of sodium ferric EDTA when applied as a molluscicide and used in accordance with good agricultural practices. 2. Drinking water exposure. No significant drinking water exposure or residues are expected to result from the use of sodium ferric EDTA as a molluscicide. The active ingredient is intended for use directly on food commodities or the soil around crops and is not to be applied directly to water. If used in accordance with EPAapproved labeling and good agricultural practices, sodium ferric EDTA is not likely to accumulate in drinking water. Overall, exposures from residues in drinking water are unlikely and are not expected to pose a quantifiable risk due to environmental fate of sodium ferric E:\FR\FM\30MRR1.SGM 30MRR1 17560 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations EDTA and lack of residues of toxicological concerns. B. Other Non-Occupational Exposure The potential for non-dietary exposure of the general population, including infants and children, is limited based on the use patterns of sodium ferric EDTA. The end use products containing sodium ferric EDTA are granules or pellets that do not produce any dust and are applied directly to the ground. Therefore, it is unlikely that there will be any dermal or inhalation exposure when the product is applied according to the label use directions. Furthermore, sodium ferric EDTA was demonstrated to be practically non-toxic (Toxicity Category IV) to rats in an acute dermal toxicity guideline study (MRID 45848104) and practically non-toxic (Toxicity Category IV) to rats in an acute inhalation toxicity guideline study (MRID 45848105). Nondietary exposures are not expected to pose any quantifiable risk to the general population. WReier-Aviles on DSKGBLS3C1PROD with RULES V. Cumulative Effects From Substances With a Common Mechanism of Toxicity 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.’’ EPA has not found sodium ferric EDTA to share a common mechanism of toxicity with any other substances, and sodium ferric EDTA does not appear to produce a toxic metabolite as its mode of action against the target pests. For the purposes of this tolerance action, therefore, EPA has assumed that sodium ferric EDTA does not 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 EPA’s Web site at http:// www.epa.gov/pesticides/cumulative. VI. Determination of Safety for U.S. Population, Infants and Children FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section VerDate Mar<15>2010 12:55 Mar 29, 2011 Jkt 223001 408(b)(2)(C) provides that EPA shall apply an additional tenfold 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 unless EPA determines that a different margin of safety will be safe for infants and children. Margins of exposure (safety), which are often referred to as uncertainty factors, are incorporated into EPA risk assessments either directly or through the use of a margin of exposure analysis, or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk. Based on the results of the toxicological data discussed in Unit III.B., as well as all other available information, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of sodium ferric EDTA. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion based on the low level of toxicity of the compound, the minimal exposure from application/use of sodium ferric EDTA as a molluscicide, and the already widespread exposure through use as a fertilizer and food additive without any reported adverse effects on human health. Thus, there are no threshold effects of concern and, as a result, an additional margin of safety is not necessary. VII. Other Considerations A. Analytical Enforcement Methodology 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. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for sodium ferric EDTA. VIII. Conclusions EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of sodium ferric EDTA. Therefore, an exemption is established for residues of sodium ferric EDTA in or on all food commodities when applied as a molluscicide and used in accordance with good agricultural practices. IX. References 1. Heimbach J, Rieth S, Mohamedshah F, Slesinski R, Samuel-Fernando P, Sheehan T, Dickmann R, Borzelleca J. 2000. Safety assessment of iron EDTA sodium ion (Fe(3+)) ethylenediaminetetraacetic acid: Summary of toxicological, fortification and exposure data. Food Chemical Toxicology 38(1):99–111. 2. U.S. FDA. 2006 Agency Response Letter GRAS Notice No. GRN 000178 (Sodium Iron EDTA). Available from: http:// www.fda.gov/Food/ FoodIngredientsPackaging/ GenerallyRecognizedasSafeGRAS/ GRASListings/ucm154622.htm. 3. U.S. FDA. 2004. Agency Response Letter GRAS Notice No. GRN 000152 (Sodium Iron EDTA). Available from: http:// www.fda.gov/Food/ FoodIngredientsPackaging/ GenerallyRecognizedasSafeGRAS/ GRASListings/ucm154378.htm. 4. U.S. EPA. 2008. Sodium Ferric EDTA Biopesticides Registration Action document dated November 20, 2008. 5. U.S. EPA. 2011. Dietary Risk Assessment (Ferric Sodium EDTA). Memorandum from C. Fuentes, PhD to J. Fournier dated January 5, 2011. 6. U.S. EPA. 2011. Sodium Ferric EDTA Biopesticides Registration Action Document dated February 7, 2011 (available as ‘‘Supporting & Related Materials’’ within Docket Number EPA– HQ–OPP–2010–0144 at http:// www.regulations.gov). 7. Yang SS. 1964. Toxicology of EDTA. Food Cosmetics Toxicology 2:763–765. 8. Wynn JE, Van’t Riet B, Borzelleca JF. 1970. The toxicity and pharmacodynamics of EGTA: oral administration to rats and comparisons with EDTA. Toxicology Applied Pharmacology 16(3):807–817. 9. National Cancer Institute. 1977. Bioassay of trisodium ethylenediaminetetraacetate trihydrate (EDTA) for possible carcinogenicity: CAS No. 150–38–9. Bethesda (MD): National Cancer Institute, Carcinogenesis Program/ Research Triangle Park (NC): National E:\FR\FM\30MRR1.SGM 30MRR1 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations Toxicology Program (NTP); Technical Report Series No. 11. 10. Oser BL, Oser M, Spencer HC. 1963. Safety evaluation studies of calcium EDTA. Toxicology Applied Pharmacology 5:142–162. 11. U.S. EPA. 2004. Recommendation for Tolerance Reassessment for Ethylenediaminetetraacetic Acid (EDTA) and various ammonium, calcium, copper, iron, potassium, manganese, sodium and zinc salts of EDTA. Memorandum from K. Boyle to B. Shackleford dated January 28, 2004. 12. U.S. EPA. 2004. Ethylenediaminetetraacetic acid (EDTA) and the salts of EDTA: Science Assessment Document for Tolerance Reassessment. Memorandum from E. Reaves to K. Boyle dated January 26, 2004. 13. European Food Safety Authority Panel on Food Additives and Nutrient Sources added to Food 2010. Scientific opinion on the use of ferric sodium EDTA as a source of iron added for nutritional purposes to foods for the general population (including food supplements) and to foods for particular nutritional uses. EFSA Journal 8(1):1414. WReier-Aviles on DSKGBLS3C1PROD with RULES X. 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. VerDate Mar<15>2010 12:55 Mar 29, 2011 Jkt 223001 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) (Pub. L. 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). XI. 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: March 17, 2011. Steven Bradbury, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 17561 PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.1302 is added to subpart D to read as follows: ■ § 180.1302 Sodium Ferric Ethylenediaminetetraacetate (EDTA); exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of sodium ferric EDTA in or on all food commodities when applied as a molluscicide and used in accordance with good agricultural practices. [FR Doc. 2011–7465 Filed 3–29–11; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 46 CFR Part 160 [USCG–2011–0076] RIN 1625–AB60 Inflatable Personal Flotation Devices Coast Guard, DHS. Direct final rule; request for comments. AGENCY: ACTION: By this direct final rule, the Coast Guard is harmonizing structural and performance standards for inflatable recreational personal flotation devices (PFDs) with current voluntary industry consensus standards. This direct final rule also slightly modifies regulatory text in anticipation of a future rulemaking addressing the population for which inflatable recreational PFDs are approved, but does not change the current affected population. DATES: This rule is effective September 26, 2011 unless an adverse comment, or notice of intent to submit an adverse comment, is either submitted to our online docket via http:// www.regulations.gov on or before May 31, 2011 or reaches the Docket Management Facility by that date. If an adverse comment, or notice to submit an adverse comment, is received by May 31, 2011, we will withdraw this direct final rule and publish a timely notice of withdrawal in the Federal Register. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register on September 26, 2011. ADDRESSES: You may submit comments identified by docket number USCG– SUMMARY: E:\FR\FM\30MRR1.SGM 30MRR1

Agencies

[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Rules and Regulations]
[Pages 17556-17561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7465]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0097; FRL-8867-7]


Sodium Ferric Ethylenediaminetetraacetate; 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 sodium ferric 
ethylenediaminetetraacetate (EDTA) in or on all food commodities when 
applied as a molluscicide and used in accordance with good agricultural 
practices. W. Neudorff GmbH KG submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption 
from

[[Page 17557]]

the requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of sodium ferric 
EDTA under the FFDCA.

DATES: This regulation is effective March 30, 2011. Objections and 
requests for hearings must be received on or before May 31, 2011, 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-2010-0097. 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 Office of Pesticide Programs (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: John Fournier, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0169; e-mail address: fournier.john@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 site at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/oscpp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2010-0097 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 31, 2011. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0097, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: 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 30, 2010 (75 FR 60452) (FRL-
8837-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 9F7668) by W. Neudorff GmbH KG, An der M[uuml]hle 3, 
Postfach 1209, 31860 Emmerthal, Germany (c/o Walter G. Talarek, P.C., 
1008 Riva Ridge Dr., Great Falls, VA 22066-1620). The petition 
requested that 40 CFR part 180 be amended by establishing an exemption 
from the requirement of a tolerance for residues of sodium ferric EDTA. 
This notice referenced a summary of the petition prepared by the 
petitioner, W. Neudorff GmbH KG, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Section 408(c)(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 exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which require 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.'' 
Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency 
consider ``available information

[[Page 17558]]

concerning the cumulative effects of a particular pesticide's 
residues'' and ``other substances that have a common mechanism of 
toxicity.''
    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. 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.

A. Overview of Sodium Ferric EDTA

    The pesticidal active ingredient, sodium ferric EDTA, is a 
molluscicide that has historically been used to control terrestrial 
slugs and snails in agriculture and on ornamental landscaping. The 
compound is comprised of iron in a sodium chelate. This chelate forms a 
soluble, complex molecule with iron ions, inactivating the ions so that 
they cannot normally react with other elements or ions to produce 
precipitates or scale. In this form, the iron is more bioavailable than 
in other mineral sources (Ref. 1). Bioavailability of iron is an 
essential quality of sodium ferric EDTA as the iron in this compound is 
responsible for controlling slugs and snails. That is, when slugs or 
snails ingest sodium ferric EDTA, the iron in the compound interacts 
with hemocyanin, a copper-based respiratory protein common to the blood 
of mollusks and responsible for their oxygen transport. This 
interaction with hemocyanin causes suffocation and eventually results 
in the death of slugs and snails. Iron does not have this interaction, 
however, in organisms that do not use hemocyanin for oxygen transport 
(e.g., mammals).
    Iron is a necessary nutrient for all mammals and other vertebrates 
because it is a component of hemoglobin, the oxygen transport protein 
found in red blood cells of vertebrates. It is the most abundant 
element on Earth and, as such, can be found in most soil and water. It 
is an essential nutrient listed as Generally Recognized as Safe (GRAS) 
by the Food and Drug Administration (FDA) for direct addition to food 
(21 CFR 184.1375) and is added to commonly consumed, fortified foods 
such as enriched flour, bread, pasta, and grains. Sodium Ferric EDTA is 
allowed as a direct food additive by the FDA and is used as a source of 
iron for nutritional fortification in foods such as powdered meal 
replacements, flavored milk, and fruit-flavored beverages (Ref. 2), as 
well as soy, fish, teriyaki, and hoisin sauces (Ref. 3). The compound 
is also a common constituent of many cosmetic products and, despite 
being present at much higher concentrations than those found in sodium 
ferric EDTA end-use pesticide products used for control of slugs and 
snails, has an extensive history of safe use as an agricultural 
fertilizer.
    In 2008, EPA registered the first sodium ferric EDTA-containing 
product for control of slugs and snails. EPA assessed the risks to 
human health and concluded that, when sodium ferric EDTA was used in 
accordance with widespread and commonly recognized practices, no 
unreasonable adverse effects on the environment were expected (Ref. 4). 
At the time of this initial sodium ferric EDTA registration, the 
applicant did not petition EPA to establish a tolerance or tolerance 
exemption because all uses were non-food. On December 6, 2009, however, 
EPA was petitioned by W. Neudorff GmbH KG to establish an exemption 
from the requirement of a tolerance for residues of sodium ferric EDTA 
in or on all food commodities. Accordingly, EPA has completed a risk 
assessment of mammalian toxicology data submitted in support of this 
request. The overall conclusions from these data are described in Unit 
III.B., while more in-depth synopses of the study results can be found 
in the risk assessment and Biopesticides Registration Action Document 
provided as references in Unit IX. (Refs. 5 and 6).

B. Biochemical Pesticide Human Health Assessment Data Requirements

    1. Acute toxicity. Tier I acute toxicity studies of technical grade 
sodium ferric EDTA (Slugkil MP, containing 71.42% sodium ferric EDTA) 
showed that the active ingredient is a Toxicity Category III (slightly 
toxic) compound via the oral and dermal routes of exposure, a Toxicity 
Category III (slightly irritating) compound via the dermal and eye 
routes of exposure, and a Toxicity Category IV (practically nontoxic) 
compound for inhalation exposure. Moreover, sodium ferric EDTA is not a 
dermal sensitizer. Given the results of these studies, no additional 
toxicity (i.e., Tiers II or III) or residue data are required to 
support food uses of this biochemical active ingredient. These acute 
toxicity studies confirm sodium ferric EDTA's low toxicity profile.
    i. The acute oral median lethal dose (LD50) for sodium 
ferric EDTA in rats was greater than 2,000 milligrams per kilogram (mg/
kg) and confirmed low toxicity through oral exposure (Master Record 
Identification Number (MRID No.) 47942507). Sodium Ferric EDTA is 
classified as Toxicity Category III for acute oral toxicity.
    ii. The acute dermal LD50 for sodium ferric EDTA in rats 
was greater than 2,000 mg/kg, which confirmed low dermal toxicity (MRID 
No. 47942508). Sodium Ferric EDTA is classified as Toxicity Category 
III for acute dermal toxicity.
    iii. The acute inhalation median lethal concentration 
(LC50) for sodium ferric EDTA in rats was greater than 2.75 
milligrams per liter (mg/L) and showed practically no inhalation 
toxicity (MRID No. 47942512). Sodium Ferric EDTA is classified as 
Toxicity Category IV for acute inhalation toxicity.
    iv. A primary eye irritation study showed that exposure to sodium 
ferric EDTA will cause temporary, mild eye irritation (MRID No. 
47942509). Accordingly, EPA has determined that sodium ferric EDTA is 
Toxicity Category III for primary eye irritation.
    v. A primary dermal irritation study showed that exposure to sodium 
ferric EDTA is slightly irritating (MRID No. 47942510) and a skin 
sensitization study showed that sodium ferric EDTA is not a sensitizer 
to the skin (MRID No. 47942511). Accordingly, EPA has determined that 
sodium ferric EDTA is Toxicity Category III for dermal irritation.
    2. Subchronic toxicity.--i. Submission of 90-day oral toxicity data 
was waived by EPA because the acute oral toxicity study demonstrated 
sodium ferric EDTA's low toxicity (LD50 >2,000 .mg/kg). In 
their waiver rationale, the petitioner also cited information from 
EPA's 2008 sodium ferric EDTA Biopesticides Registration Action 
Document (BRAD):

    No references for feeding studies using sodium ferric EDTA were 
located in the published literature. Rats fed low mineral diets with 
or without calcium disodium EDTA for four months had reduced weight 
gain, but their general condition was comparable to that of controls 
(Ref. 7). Rats fed 1%, 5%, or 10% disodium salt of EDTA for 90 days 
had significantly lower food consumption and weight gain than 
controls (Ref. 8). Hematology was comparable among all groups, 
except that prothrombin time was increased in the 10% group. The 
only significant necropsy finding was pale livers in the 10% group.

[[Page 17559]]

    Mice fed 3,750 or 7,500 ppm trisodium EDTA for 103 weeks had no 
treatment-related clinical signs, and gross and microscopic 
pathology were unremarkable (Ref. 9). A companion study conducted by 
NCI using rats produced the same results (Ref. 9). In a 12-month 
feeding study using dogs, Oser et al (1963) found no significant 
changes in hematology or urinalysis parameters, and no abnormal 
gross or microscopic findings in groups receiving up to 250 mg/kg 
body weight/day of calcium disodium EDTA (Ref. 10).
    The information cited above refers to feeding studies using 
sodium EDTA and calcium disodium EDTA. The Agency has assessed the 
toxicity profile of these and other EDTA salts (Refs. 11 and 12), 
and concluded that they are closely related. This information 
sufficed for the assessment of toxicological risk characterization 
of sodium ferric EDTA.

    Additionally, iron is an essential nutrient listed as GRAS by the 
FDA, and both iron and sodium ferric EDTA are allowed as direct food 
additives to increase the nutritional content of food and food 
supplements. Sodium Ferric EDTA is also used in agriculture as a 
fertilizer. Given all of this information, EPA concluded that no 
subchronic oral toxicity is expected when this compound is used in 
accordance with good agricultural practices.
    ii. Submission of 90-day dermal toxicity data was waived by EPA 
because acute guideline studies demonstrated that sodium ferric EDTA 
has low dermal toxicity (LD50 >2,000 mg/kg), is a slight 
dermal irritant, and is not a dermal sensitizer. Repeated dermal 
exposure, under conditions of product use at a concentration that could 
be toxic, is not anticipated.
    iii. Submission of 90-day inhalation data was waived by EPA because 
the acute inhalation toxicity study demonstrated sodium ferric EDTA's 
lack of toxicity (Toxicity Category IV). Repeated inhalation exposure, 
under conditions of product use at a concentration that could be toxic, 
is not anticipated.
    3. Developmental toxicity and mutagenicity. Acceptable waiver 
requests were submitted to address the data requirements for 
Developmental toxicity and Mutagenicity (OPPTS 870.3700). The Agency 
concluded that humans are regularly exposed to iron found abundantly in 
nature and from the use of sodium ferric EDTA as fertilizer. No 
negative effects of sodium ferric EDTA have been reported because of 
its low toxicity and low water solubility, which decreases its 
absorption in the intestine. Moreover, the active ingredient is not a 
mutagen nor is it related to any known classes of mutagens. After 
considering the aforementioned information and the extensive history of 
use of sodium ferric EDTA in agriculture and food without deleterious 
effects, EPA waived the requirement to submit developmental toxicity 
and mutagenicity data.

IV. 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).

A. Dietary Exposure

    1. Food. The primary route of sodium ferric EDTA exposure to the 
general population will be through consumption of food; however, there 
is no reason to expect that practical use of sodium ferric EDTA, in 
accordance with good agricultural practices, will constitute any 
significant hazard.
    Sodium Ferric EDTA is comprised of iron in a sodium chelate. Iron 
is abundant in nature, an essential nutrient, and listed as GRAS for 
direct addition to food (21 CFR 184.1375). Sodium Ferric EDTA is 
regarded as safe for use as a dietary supplement to increase iron 
bioavailability and prevent iron deficiency. In humans, iron is an 
essential nutrient that is vital to the processes by which cells 
generate energy. It is available to animals from food derived from 
other animals and plants.
    When sodium ferric EDTA is ingested, the chelate holds the iron in 
the stomach until pH rises in the upper small intestine. As pH rises, 
the strength of the complex progressively diminishes, allowing exchange 
with other metals and iron for absorption. Iron dissociates from the 
EDTA moiety and is released in the duodenum prior to absorption. Only a 
very small fraction of the sodium ferric EDTA complex (less than 1%) is 
absorbed intact. Intact EDTA metal complexes are rapidly excreted; they 
do not accumulate or undergo biotransformation (Ref. 13).
    European Food Safety Authority Panel on Food Additives and Nutrient 
Sources added to Food (2010) concluded that, when sodium ferric EDTA is 
used in food supplements at levels that provide 22.3 milligrams (mg) of 
iron/day for adults and 11.1 mg of iron/day for children, the use of 
sodium ferric EDTA as a source of iron in foods is of no safety concern 
as long as it does not lead to an exposure of EDTA above 1.9 mg/kg/day.
    Exposure to EDTA and salts of EDTA already occurs through certain 
FDA-approved uses as food additives, in sanitizing solutions, and in 
pharmaceutical products, or through their use in soaps, shampoos, or 
cosmetics. EDTA has also been administered safely under medical 
supervision as treatment for heavy metal poisoning. The results of 
toxicity testing and information found in public literature indicate 
that there is no risk to human health from residues of sodium ferric 
EDTA in food crops. Furthermore, residues from the formulations in 
agricultural use sites (certified limits <4% by weight) and residential 
use sites (<1% of typical formulations) are not likely to exceed levels 
currently consumed in commonly eaten foods. In addition, the use of 
EDTA and EDTA salts in pesticide products is expected to result in much 
lower exposure than the FDA-regulated use of these compounds, as well 
as lower exposure than their use in pharmaceuticals or cosmetic 
products.
    The concentration of iron needed for good plant growth is below the 
concentration needed by animals for good cellular functioning. In 
agriculture, iron sodium chelate is used as micronutrient fertilizer at 
much higher concentrations than those present in sodium ferric EDTA-
containing pesticide products, which are labeled for maximum 
application rates of below 25 mg of sodium ferric EDTA per square foot. 
The use of sodium ferric EDTA in pesticides is expected to result in 
much lower exposure than through its use in plant fertilizers, 
pharmaceutical products, or cosmetic products. Based on review and 
evaluation of available information, EPA concludes that there is a 
reasonable certainty of no harm from residues of sodium ferric EDTA 
when applied as a molluscicide and used in accordance with good 
agricultural practices.
    2. Drinking water exposure. No significant drinking water exposure 
or residues are expected to result from the use of sodium ferric EDTA 
as a molluscicide. The active ingredient is intended for use directly 
on food commodities or the soil around crops and is not to be applied 
directly to water. If used in accordance with EPA-approved labeling and 
good agricultural practices, sodium ferric EDTA is not likely to 
accumulate in drinking water. Overall, exposures from residues in 
drinking water are unlikely and are not expected to pose a quantifiable 
risk due to environmental fate of sodium ferric

[[Page 17560]]

EDTA and lack of residues of toxicological concerns.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure of the general population, 
including infants and children, is limited based on the use patterns of 
sodium ferric EDTA. The end use products containing sodium ferric EDTA 
are granules or pellets that do not produce any dust and are applied 
directly to the ground. Therefore, it is unlikely that there will be 
any dermal or inhalation exposure when the product is applied according 
to the label use directions. Furthermore, sodium ferric EDTA was 
demonstrated to be practically non-toxic (Toxicity Category IV) to rats 
in an acute dermal toxicity guideline study (MRID 45848104) and 
practically non-toxic (Toxicity Category IV) to rats in an acute 
inhalation toxicity guideline study (MRID 45848105). Non-dietary 
exposures are not expected to pose any quantifiable risk to the general 
population.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    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.''
    EPA has not found sodium ferric EDTA to share a common mechanism of 
toxicity with any other substances, and sodium ferric EDTA does not 
appear to produce a toxic metabolite as its mode of action against the 
target pests. For the purposes of this tolerance action, therefore, EPA 
has assumed that sodium ferric EDTA does not 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 EPA's Web site 
at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the 
available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues, and the cumulative effects on infants and children 
of the residues and other substances with a common mechanism of 
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA 
shall apply an additional tenfold 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 unless EPA 
determines that a different margin of safety will be safe for infants 
and children. Margins of exposure (safety), which are often referred to 
as uncertainty factors, are incorporated into EPA risk assessments 
either directly or through the use of a margin of exposure analysis, or 
by using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk.
    Based on the results of the toxicological data discussed in Unit 
III.B., as well as all other available information, EPA concludes that 
there is a reasonable certainty that no harm will result to the U.S. 
population, including infants and children, from aggregate exposure to 
the residues of sodium ferric EDTA. This includes all anticipated 
dietary exposures and all other exposures for which there is reliable 
information. EPA has arrived at this conclusion based on the low level 
of toxicity of the compound, the minimal exposure from application/use 
of sodium ferric EDTA as a molluscicide, and the already widespread 
exposure through use as a fertilizer and food additive without any 
reported adverse effects on human health. Thus, there are no threshold 
effects of concern and, as a result, an additional margin of safety is 
not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    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. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for sodium ferric EDTA.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm 
will result to the U.S. population, including infants and children, 
from aggregate exposure to residues of sodium ferric EDTA. Therefore, 
an exemption is established for residues of sodium ferric EDTA in or on 
all food commodities when applied as a molluscicide and used in 
accordance with good agricultural practices.

IX. References

1. Heimbach J, Rieth S, Mohamedshah F, Slesinski R, Samuel-Fernando 
P, Sheehan T, Dickmann R, Borzelleca J. 2000. Safety assessment of 
iron EDTA sodium ion (Fe(3+)) ethylenediaminetetraacetic acid: 
Summary of toxicological, fortification and exposure data. Food 
Chemical Toxicology 38(1):99-111.
2. U.S. FDA. 2006 Agency Response Letter GRAS Notice No. GRN 000178 
(Sodium Iron EDTA). Available from: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154622.htm.
3. U.S. FDA. 2004. Agency Response Letter GRAS Notice No. GRN 000152 
(Sodium Iron EDTA). Available from: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154378.htm.
4. U.S. EPA. 2008. Sodium Ferric EDTA Biopesticides Registration 
Action document dated November 20, 2008.
5. U.S. EPA. 2011. Dietary Risk Assessment (Ferric Sodium EDTA). 
Memorandum from C. Fuentes, PhD to J. Fournier dated January 5, 
2011.
6. U.S. EPA. 2011. Sodium Ferric EDTA Biopesticides Registration 
Action Document dated February 7, 2011 (available as ``Supporting & 
Related Materials'' within Docket Number EPA-HQ-OPP-2010-0144 at 
http://www.regulations.gov).
7. Yang SS. 1964. Toxicology of EDTA. Food Cosmetics Toxicology 
2:763-765.
8. Wynn JE, Van't Riet B, Borzelleca JF. 1970. The toxicity and 
pharmacodynamics of EGTA: oral administration to rats and 
comparisons with EDTA. Toxicology Applied Pharmacology 16(3):807-
817.
9. National Cancer Institute. 1977. Bioassay of trisodium 
ethylenediaminetetraacetate trihydrate (EDTA) for possible 
carcinogenicity: CAS No. 150-38-9. Bethesda (MD): National Cancer 
Institute, Carcinogenesis Program/Research Triangle Park (NC): 
National

[[Page 17561]]

Toxicology Program (NTP); Technical Report Series No. 11.
10. Oser BL, Oser M, Spencer HC. 1963. Safety evaluation studies of 
calcium EDTA. Toxicology Applied Pharmacology 5:142-162.
11. U.S. EPA. 2004. Recommendation for Tolerance Reassessment for 
Ethylenediaminetetraacetic Acid (EDTA) and various ammonium, 
calcium, copper, iron, potassium, manganese, sodium and zinc salts 
of EDTA. Memorandum from K. Boyle to B. Shackleford dated January 
28, 2004.
12. U.S. EPA. 2004. Ethylenediaminetetraacetic acid (EDTA) and the 
salts of EDTA: Science Assessment Document for Tolerance 
Reassessment. Memorandum from E. Reaves to K. Boyle dated January 
26, 2004.
13. European Food Safety Authority Panel on Food Additives and 
Nutrient Sources added to Food 2010. Scientific opinion on the use 
of ferric sodium EDTA as a source of iron added for nutritional 
purposes to foods for the general population (including food 
supplements) and to foods for particular nutritional uses. EFSA 
Journal 8(1):1414.

X. 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) (Pub. L. 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).

XI. 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: March 17, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    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. Section 180.1302 is added to subpart D to read as follows:


Sec.  180.1302  Sodium Ferric Ethylenediaminetetraacetate (EDTA); 
exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sodium ferric EDTA in or on all food commodities when 
applied as a molluscicide and used in accordance with good agricultural 
practices.

[FR Doc. 2011-7465 Filed 3-29-11; 8:45 am]
BILLING CODE 6560-50-P