Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Proposed Rules 11563

MAJOR MILESTONES IN NAAQS REVIEW—Continued

Major milestones Completed/future target date(s)

Second Draft SP and Second Draft Human Health and Ecological Risk Assessment Reports for Mid-June 2007. CASAC and Public Comment. CASAC Meeting on Second Draft SP and Second Draft Human Health and Ecological Risk Assess- Late July 2007. ment Reports. Complete Final SP and Final Human Health and Ecological Risk Assessment Reports ...... Late September 2007. Publish Proposal Notice in FEDERAL REGISTER ...... Late February 2008. Final Promulgation Notice Signed by Administrator ...... September 1, 2008.

List of Subjects in 40 CFR Part 50 Corporation, and the thermal coal dryers ENVIRONMENTAL PROTECTION Environmental protection, Air at EME Homer City, LP. These three AGENCY control, Carbon monoxide, formerly RACT-subject sources have Lead, Nitrogen dioxide, Ozone, been permanently shut down and the 40 CFR Part 180 Particulate matter, Sulfur oxides. Pennsylvania DEP has indicated to EPA [EPA–HQ–OPP–2005–0325; FRL–7750–8] Dated: February 23, 2006. that no RACT need be approved for them. Ethylenediaminetetraacetic Acid Jeffrey S. Clark, Chemicals: Exemptions from the Acting Director, Office of Air Quality Planning DATES: Effective Date: The proposed rule Requirement of a Tolerance and Standards. for Doverspike Brothers Coal Co., [FR Doc. E6–3225 Filed 3–7–06; 8:45 am] Hedstrom Corporation, and the thermal AGENCY: Environmental Protection BILLING CODE 6560–50–P coal dryers at EME Homer City Agency (EPA). published at 65 FR 20788 is withdrawn ACTION: Proposed rule. ENVIRONMENTAL PROTECTION as of March 8, 2006. SUMMARY: The Agency is proposing to AGENCY FOR FURTHER INFORMATION CONTACT: establish 16 new and amend three Marcia L. Spink, (215) 814–2104, or by existing exemptions from the 40 CFR Part 52 e-mail at [email protected]. requirement of a tolerance for residues [PA–4091; FRL–8042–4] of various ethylenediaminetetraacetic SUPPLEMENTARY INFORMATION: See the acid (EDTA) chemicals in or on raw Approval and Promulgation of Air information provided in the proposed agricultural commodities when used as Quality Implementation Plans; rule located in the Proposed Rules inert ingredients in Pennsylvania; VOC and NOX RACT section of the April 18, 2000 Federal formulations applied to growing crops Determinations for Twenty-Six Register (65 FR 20788). EPA is or to raw agricultural commodities after Individual Sources; Partial Withdrawal withdrawing the proposed rule for only harvest under the Federal Food, Drug, of Proposed Rule for Three Sources three sources, namely, Doverspike and Cosmetic Act (FFDCA), as amended Brothers Coal Co., Hedstrom by the Food Quality Protection Act of AGENCY: Environmental Protection Corporation and the thermal coal dryers 1996 (FQPA). This regulation eliminates Agency (EPA). at EME Homer City, LP. These formerly the need to establish a maximum ACTION: Partial withdrawal of proposed RACT-subject sources have been permissible level for residues of these rule. permanently shut down and the EDTA chemicals. SUMMARY: On April 18, 2000, EPA Pennsylvania DEP has indicated to EPA DATES: Comments, identified by docket published a proposed rule (65 FR that no RACT need be approved for identification (ID) number EPA–HQ– 20788) to approve reasonably available them. The other actions in the April 18, OPP–2005–0325, must be received on or control technology (RACT) 2000 Federal Register are not affected. before May 8, 2006. determinations submitted by the ADDRESSES: Submit your comments, Pennsylvania Department of List of Subjects in 40 CFR Part 52 identified by docket identification (ID) Environmental Protection (DEP) for Environmental protection, Air number EPA–HQ–OPP–2005–0325, by twenty-six major sources of nitrogen pollution control, Incorporation by one of the following methods: oxides (NO ) and/or volatile organic • X reference, Nitrogen dioxide, Ozone, Federal eRulemaking Portal: http:// compounds (VOC). In separate final www.regulations.gov/. Follow the on- Reporting and recordkeeping rules, EPA has already approved the line instructions for submitting requirements, Volatile organic RACT determinations for ten of the comments. twenty-six sources covered by the April compounds. • Agency Website: EDOCKET, EPA’s 18, 2000 proposed rule. In the rules Dated: February 28, 2006. electronic public and comment system portion of today’s Federal Register, EPA William Early, was replaced on November 25, 2005, by is approving the RACT determinations Acting Regional Administrator, Region III. an enhanced federal-wide electronic for an additional thirteen of twenty-six [FR Doc. 06–2149 Filed 3–7–06; 8:45 am] docket management and comment sources covered by the April 18, 2000 system located at http:// proposed rule. EPA is hereby BILLING CODE 6560–50–P www.regulations.gov/. Follow the on- withdrawing its April 18, 2000 line instructions. proposed rule with regard to the • Mail: Public Information and remaining three sources. The April 18, Records Integrity Branch (PIRIB) 2000 (65 FR 20788) proposed rule is (7502C), Office of Pesticide Programs being withdrawn with regard to (OPP), Environmental Protection Doverspike Brothers Coal Co., Hedstrom Agency, 1200 Pennsylvania Ave., NW.,

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Washington, DC 20460–0001, Attention: Public Information and Records that you claim to be CBI. For CBI Docket ID Number EPA–HQ–OPP– Integrity Branch (PIRIB), Rm. 119, information in a disk or CD ROM that 2005–0325. Crystal Mall #2, 1801 S. Bell St., you mail to EPA, mark the outside of the • Hand Delivery: Public Information Arlington, VA. This Docket Facility is disk or CD ROM as CBI and then and Records Integrity Branch (PIRIB), open from 8:30 a.m. to 4 p.m., Monday identify electronically within the disk or Office of Pesticide Programs (OPP), through Friday, excluding legal CD ROM the specific information that is Environmental Protection Agency, Rm. holidays. The Docket telephone number claimed as CBI. In addition to one 119, Crystal Mall #2, 1801 S. Bell St., is (703) 305–5805. complete version of the comment that Arlington, VA, Attention: Docket ID FOR FURTHER INFORMATION CONTACT: includes information claimed as CBI, a Number EPA–HQ–OPP–2005–0325. Kathryn Boyle, Registration Division copy of the comment that does not Such deliveries are only accepted (7505C), Office of Pesticide Programs, contain the information claimed as CBI during the Docket’s normal hours of Environmental Protection Agency, 1200 must be submitted for inclusion in the operation, and special arrangements Pennsylvania Ave, NW., Washington, public docket. Information so marked should be made for deliveries of boxed DC 20460–0001; telephone number: will not be disclosed except in information. (703) 305–6304; e-mail address: accordance with procedures set forth in Instructions: Direct your comments to [email protected]. 40 CFR part 2. docket ID number EPA–HQ–OPP–2005– 2. Tips for preparing your comments. SUPPLEMENTARY INFORMATION: 0325. EPA’s policy is that all comments When submitting comments, remember received will be included in the public I. General Information to: docket without change and may be i. Identify the rulemaking by docket made available online at http:// A. Does this Action Apply to Me? number and other identifying www.regulations.gov/, including any You may be potentially affected by information (subject heading, Federal personal information provided, unless this action if you are an agricultural Register date, and page number). the comment includes information producer, food manufacturer, or ii. Follow directions. The agency may claimed to be Confidential Business pesticide manufacturer. Potentially ask you to respond to specific questions Information (CBI) or other information affected entities may include, but are or organize comments by referencing a whose disclosure is restricted by statute. not limited to: Code of Federal Regulations (CFR) part Do not submit information that you • Crop production (NAICS code 111) or section number. consider to be CBI or otherwise • Animal production (NAICS code iii. Explain why you agree or disagree; protected through regulations.gov or e- 112) suggest alternatives and substitute mail. The regulations.gov website is an • Food manufacturing (NAICS code language for your requested changes. ‘‘anonymous access’’ system, which 311) iv. Describe any assumptions and means EPA will not know your identity • Pesticide manufacturing (NAICS provide any technical information and/ or contact information unless you code 32532) or data that you used. provide it in the body of your comment. This listing is not intended to be v. If you estimate potential costs or If you send an e-mail comment directly exhaustive, but rather provides a guide burdens, explain how you arrived at to EPA without going through for readers regarding entities likely to be your estimate in sufficient detail to regulations.gov your e-mail address will affected by this action. Other types of allow for it to be reproduced. be automatically captured and included entities not listed in this unit could also vi. Provide specific examples to as part of the comment that is placed in be affected. The North American illustrate your concerns, and suggest the public docket and made available on Industrial Classification System alternatives. the Internet. If you submit an electronic (NAICS) codes have been provided to vii. Explain your views as clearly as comment, EPA recommends that you assist you and others in determining possible, avoiding the use of profanity include your name and other contact whether this action might apply to or personal threats. information in the body of your certain entities. If you have any viii. Make sure to submit your comment and with any disk or CD ROM questions regarding the applicability of comments by the comment period you submit. If EPA cannot read your this action to a particular entity, consult deadline identified. comment due to technical difficulties the person listed under FOR FURTHER II. What is the Agency’s Authority for and cannot contact you for clarification, INFORMATION CONTACT. EPA may not be able to consider your Taking this Action? comment. Electronic files should avoid B. How Can I Access Electronic Copies This proposed rule is issued under the use of special characters, any form of this Document and Other Related section 408 of FFDCA, 21 U.S.C. 346a, of encryption, and be free of any defects Information? as amended by the Food Quality or viruses. For additional information In addition to using regulations.gov, Protection Act of 1996 (FQPA) (Public about EPA’s public docket visit the EPA you may access this Federal Register Law 104–170). Section 408(e) of FFDCA Docket Center homepage athttp:// document electronically through the authorizes EPA to establish, modify, or www.epa.gov/epahome/dockets.html. EPA Internet under the ‘‘Federal revoke tolerances, or exemptions from Docket: All documents in the docket Register’’ listings at http:// the requirement of a tolerance for are listed in the www.regulations.gov www.epa.gov/fedrgstr/. A frequently residues of pesticide chemicals in or on index. Although listed in the index, updated electronic version of 40 CFR raw agricultural commodities and some information is not publicly part 180 is available on E-CFR Beta Site processed foods. available, i.e., CBI or other information Two at http://www.gpoaccess.gov/ecfr/. whose disclosure is restricted by statute. III. What Action is the Agency Taking? Certain other material, such as C. What Should I Consider as I Prepare The Agency is proposing to establish copyrighted material, will be publicly My Comments for EPA? 16 new and amend three existing available only in hard copy form. 1. Submitting CBI. Do not submit this tolerance exemptions for several EDTA Publicly available docket materials are information to EPA through chemicals. Currently, there are three available either electronically in www.regulations.gov or e-mail. Clearly tolerance exemptions for EDTA www.regulations.gov or hard copy at the mark the part or all of the information chemicals in 40 CFR 180.910: Disodium

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zinc ethylenediaminetetraacetate are for the hydrated forms of the EDTA (or one of its salts) function to dihydride, ethylenediaminetetraacetic tetrasodium salt and the disodium zinc scavenge the heavy metals from the acid, and ethylenediaminetetraacetic salt. body. EDTA preferentially binds with acid, tetrasodium salt. These The EDTA chemicals are a group of the heavy metal present with the exemptions are being amended to reflect man-made chelating (binding) agents resultant complex then being excreted. a common nomenclature, add CAS Reg. with a preferred affinity for heavier The EDTA chemicals which are the Nos., and/or a 5% limitation of all metals such as lead, mercury, cadmium, EDTA chemicals in the pesticide zinc, and aluminum. EDTA’s ability to subject of this proposed rule, the product. complex, bind, and remove such metals nomenclature which will be used and The tolerance exemptions for the is used commercially to either promote the CAS Reg. Nos. are in the Table tetrasodium salt and the disodium zinc or inhibit chemical reactions, depending below. These chemicals were selected are considered to be for both the on the application. EDTA has also been based on information in the Agency’s hydrated and anhydrous forms. Thus, used under medical supervision to treat files which indicate use in pesticide three of the new tolerance exemptions heavy metal poisoning. Large doses of products applied to food-use sites.

EDTA Chemical CAS Reg. No.

Ethylenediaminetetraacetic acid (EDTA) 60–00–4

Ethylenediaminetetraacetic acid (EDTA) calcium disodium salt 62–33–9

Ethylenediaminetetraacetic acid (EDTA) disodium (II) salt 14025–15–1

Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt, dihydrate 61916–40–3

Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt, trihydrate 73637–19–1

Ethylenediaminetetraacetic acid (EDTA) disodium manganese (II) salt 15375–84–5

Ethylenediaminetetraacetic acid (EDTA) disodium manganese (I) salt, dihydrate 73637–20–4

Ethylenediaminetetraacetic acid (EDTA) disodium salt 139–33–3

Ethylenediaminetetraacetic acid (EDTA) disodium salt, dihydrate 6381–92–6

Ethylenediaminetetraacetic acid (EDTA) disodium zinc salt 14025–21–9

Ethylenediaminetetraacetic acid (EDTA) disodium zinc salt, dihydrate 73513–47–0

Ethylenediaminetetraacetic acid (EDTA) monosodium salt 17421–79–3

Ethylenediaminetetraacetic acid (EDTA) sodium (III) salt 15708–41–5

Ethylenediaminetetraacetic acid (EDTA) sodium salt 7379–28–4

Ethylenediaminetetraacetic acid (EDTA) tetrapotassium salt 5964–35–2

Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt 64–02–8

Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt, tetrahydrate 13235–36–4

Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt, trihydrate 67401–50–7

Ethylenediaminetetraacetic acid (EDTA) tripotassium salt 17572–97–3

IV. Toxicological Profile The data considered in this action (see http://www.regulations.gov/). assessment included information It is noted that the Agency’s review and Consistent with section 408(b)(2)(D) located by the Office of Pesticide evaluation covered a large group of 25 of FFDCA, EPA has reviewed the Programs on the internet, studies EDTA chemicals in which the available available scientific data and other conducted by the National Toxicology data from all of the chemicals was relevant information in support of this Program (NTP) and the National Cancer ‘‘pooled’’ for use as surrogate data. action and considered its validity, Institute (NCI), several work products As a group, the EDTA chemicals are completeness and reliability and the produced by the Cosmetic Ingredient not acutely toxic via the oral route of relationship of this information to Review, several evaluations by the exposure. They are mild skin irritants human risk. EPA has also considered World Health Organization, and articles and severe eye irritants. available information concerning the from open literature. The Agency’s variability of the sensitivities of major overall conclusions are as follows; Mutagenicity studies such as the identifiable subgroups of consumers, however, greater detail on the Agency’s mouse lymphoma study were negative including infants and children. The review and evaluation of these EDTA for EDTA and its salts except for a few nature of the toxic effects caused by chemicals are in the EDTA Science positive tests when administered with these EDTA chemicals are summarized Assessment, which is posted as a sterile distilled water. Genotoxicity in this unit. support document in the docket for this studies for EDTA and its salts were

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mixed positive and negative results, developmental toxicity studies were For sodium iron EDTA, a provisional depending on assay type and cell type. performed using disodium EDTA. The maximum tolerance daily intake of 0.8 Trisodium EDTA was tested in a 2– Agency has reviewed the toxicological mg/kg/bodyweight was established by year carcinogenicity study by the NCI. literature on both of these studies. In the Joint FAO/WHO Committee. Their conclusions indicated that there one study, rats were maintained on de- In 1981, an article in a toxicology were no compound-related signs of ionized water (water containing no trace journal reported that the maximum chemical toxicity, and tumor incidence minerals) and a semi-purified diet, and human consumption of EDTA and its was not related to treatment. This study housed in nonmetallic caging. The test salts in foods was on the order of 0.4 was re-evaluated in 2003 with the animals displayed both maternal and mg/kg/day. conclusion that ‘‘there is no concern for developmental effects. In another very 2. Food contact surface sanitizing EDTA with regard to carcinogenicity.’’ similar study, rats that were maintained solutions. The disodium and The Agency has evaluated 15 of the on tap water displayed no such effects. tetrasodium salts of EDTA are used in EDTA chemicals through the use of Thus, the availability of trace metals, food contact surface sanitizing structure-activity-relationship (SAR) particularly zinc, in the diet and solutions, as specified in 40 CFR assessments. With one exception, these drinking water work to prevent 180.940. A screening-level exposure evaluations indicate no absorption of deficiencies. estimate of this use was performed for the EDTA chemicals through the skin, Thus, test animals can consume large the tetrasodium salt. The estimated but predicted good absorption through amounts of EDTA (up to 5% of the diet) exposure is 0.005 mg/kg/day. 3. In pesticide products applied to the lungs and GI tract. The exception with no adverse effects, provided that agricultural crops. The Agency is was EDTA, per se, which is expected to the trace metals needed by the body, are proposing to place a limitation of 5% of be absorbed through all routes of also included in the diet. exposure. The Team performing the total EDTA in pesticide products. This SARs indicated a low to moderate V. Aggregate Exposures limit was based on information in the Agency’s files. To account for possible concern for human health effects. All In examining aggregate exposure, food residues as a result of application concerns noted were considered to be section 408 of FFDCA directs EPA to of an inert ingredient in a pesticide due to the and eventual consider available information excretion of metals such as calcium, product, the Agency has developed a concerning exposures from the pesticide magnesium, iron, and zinc in the screening-level model for predicting residue in food and all other non- mammalian body. dietary exposure to inert ingredients. Other reviews indicate that EDTA is occupational exposures, including The model assumes that the inert not totally absorbed when ingested. drinking water from ground water or ingredients are used on all crops and Various sources rate the absorption as surface water and exposure through 100% of all crops are ‘‘treated’’ with the poor to good with the upper limit on pesticide use in gardens, lawns, or inert ingredient. The results of the absorption being defined numerically as buildings (residential and other indoor model are considered to over-estimate 20%. Elimination occurs mainly by the uses). exposure to an inert ingredient in a kidneys (95%) with some (5%) via the A. Dietary exposure pesticide product. The model is scalable bile. and can be adjusted to account for lower Various EDTA chemicals have been 1. Food additive uses. EDTA is used percent in formulations. The scaled tested in repeated dose toxicity studies extensively as a food additive to estimate for use of EDTA chemicals which included doses of up to 5% of the sequester trace metals that catalyze the with a limitation of 5% in the diet. Only diarrhea and lowered food oxidation of oils, vitamins, and formulation is 0.006 mg/kg/day. consumption were reported in animals unsaturated fats that cause rancidity, given 5% disodium EDTA. Taken changes, and discoloration. For B. Drinking Water together, all of the repeated dose the calcium disodium salt of EDTA an EDTA is a strong organic acid toxicity studies reviewed indicate that of 2.5 milligram/ (approximately 1,000 times stronger the greatest risk in the mammalian body kilogram (mg/kg) was established by the than acetic acid). It has a high affinity will occur when the EDTA attempts to Joint FAO/WHO Expert Committee on for alkaline-earth ions (for example, scavenge the trace metals used and Food Additives (JECFA) in 1973. calcium and magnesium) and heavy- required by the body. The repeated In the U.S., in food the permissible metal ions (for example, lead and conclusion of the various studies is that levels of the calcium disodium salt of mercury). This affinity generally results rats fed a low percent of an EDTA EDTA, as specified in 21 CFR 172.120, in the formation of highly stable and chemical in the diet with adequate range from 25 to 800 ppm. Use of soluble complexes. The EDTA minerals showed no signs of toxicity. calcium disodium EDTA as a food chemicals are soluble in water, have low The various developmental studies additive is permitted for direct addition sorption to soil and sediments, have no indicate that developmental effects will to food for human consumption, as long significant vapor pressure, and have a occur if the EDTA chemicals remove the as (1) the quantity of the substance biodegradation half-life of weeks to necessary trace metals from the added to food does not exceed the months. While EDTA chemicals are maternal body, so that none are amount reasonably required to slow to degrade, aerobic biodegradation available for the developing fetus. accomplish its intended physical, (mineralization to carbon dioxide and The Agency’s review and evaluation nutritive, or other technical effect in water) is the dominant mechanism. The of EDTA and its various salts indicates food, and (2) any substance intended for rate of biodegradation of EDTA in soils that adverse effects occur only in the use in or on food is of appropriate food is reported to vary depending upon presence of mineral deficiencies. In fact, grade, and is prepared and handled as environmental factors such as pH, the toxic effects of EDTA are considered a food ingredient. temperature, soil classification, organic to be related to metal deficiencies, Disodium EDTA can also be used as matter, and types and population of especially a deficiency of zinc. a food additive for direct addition to microbes. However, two critical pieces of food for human consumption in There are significant releases of EDTA information informed the Agency’s specified foods, as specified under 21 to the environment in domestic sewage evaluation of EDTA. Two CFR 172.135. (from use in detergents, soaps, and

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cleaning products) and industrial • For a typical cleaning product, the the mammalian body in trace amounts effluents (bleaching of textiles and estimated exposure estimate is 0.028 for proper functioning of the paper; processing of photographic mg/kg/day mammalian body. Lack of these metals, material; electroplating; bottle cleaning; • For a typical laundry detergent, the and most particularly zinc, can lead to and industrial cleaning of pipe and tank estimated exposure estimate is 0.0088 severe effects. systems). Detergent preparations are mg/kg/day Various salts of EDTA have been probably the predominant source of • For a cosmetic product, the tested in several developmental toxicity EDTA found in domestic sewage, estimated exposure is 0.0008 mg/kg/day studies. Based on developmental studies contributing an estimated 100 These modeled exposure estimates in lab rodents, EDTA and salts should micrograms/Liter (µg/L) to the total indicate that the exposures that could not posed a developmental concern. concentration of EDTA in average occur from the use of these EDTA Results of a developmental study sewage streams, with smaller amounts chemicals in either residential indicate no developmental effects are probably originating from food and pesticidal or consumer non-pesticidal likely in rodents at doses up to 1,000 other consumer products. products are less than the levels at mg/kg/day. Adequate minerals in the After treatment, the effluent from which an adverse effect could occur. diet and administration of tap water prevented possible developmental sewage treatment plants is released to VI. Cumulative Effects streams, rivers, and lakes, and is further effects of EDTA during pregnancy. In a Section 408 (b)(2)(D)(v) of FFDCA diluted by the receiving waters. different developmental toxicity study, requires that, when considering whether According to Toxnet (see http:// developmental effects observed in lab to establish, modify, or revoke a toxnet.nlm.nih.gov) ethylenediamine rodents were likely due to animals tolerance or tolerance exemption, the tetraacetic acid has been detected in maintained on deionized water and a Agency consider ‘‘available ground water (ranging from 5 to 25 µg/ semi-purified diet, and housed in information’’ concerning the cumulative L), and drinking water derived from nonmetallic caging. It is unlikely that effects of a particular chemical’s surface water (10 to 45 µg/L). infants and children would be exposed residues and ‘‘other substances that to concentrations as high as the lab Using 45 µg/L, the estimated exposure have a common mechanism of toxicity.’’ rodents studied. The maximum human via drinking water is 1.5 µg/kg/day or Unlike other pesticide chemicals for consumption of EDTA and its salts in 0.0015 mg/kg/day for adult females and which EPA has followed a cumulative foods was reported to be on the order of 4.5 µg/kg/day or 0.0045 mg/kg/day for risk approach based on a common 0.4 mg/kg/day. Infants and children, children. mechanism of toxicity, EPA has not also, generally drink tap water instead C. Other Non-Occupational made a common mechanism of toxicity of deionized or distilled water. finding as to ethylene EDTA is also used therapeutically in Several EDTA chemicals are used as diaminetetraacetic acid and its various adults and pregnant women. A chelating agents in cosmetics. Examples salts. The EDTA chemicals are a therapeutic dose of 1.2 to 2.0 grams per of products containing EDTA chemicals structurally-related group of chemicals, day is generally given to adults. include: bubble baths, bath soaps and that travel through the mammalian body Information is also available indicating detergents, deodorants, facial makeups and are excreted. For the purposes of EDTA treatment of pregnant women is and lotions, colognes and toilet waters, this tolerance action, therefore, EPA has possible without affecting the hair products (shampoos, rinses, not assumed that these chemical development of the fetus. Treatments of conditioners, dyes and colors), nail substances have a common mechanism EDTA to pregnant women include 75 basecoats and undercoats, and nail of toxicity with other substances. For mg/kg/day calcium disodium EDTA for creams and lotions. EDTA chemicals are information regarding EPA’s efforts to 7 days and 1 gram twice a day for 3 also used in cleaning products and determine which chemicals have a days, under medical supervision. laundry detergents and to control the common mechanism of toxicity and to Healthy, normal infants were delivered interactions of trace metals in evaluate the cumulative effects of such 4 weeks and 8 days after chelation pharmaceuticals, metal working, pulp chemicals, see the policy statements therapy, respectively. and paper processing, rubber and released by EPA’s Office of Pesticide EPA also believes there would be a polymer chemistry, and textile Programs concerning common very low exposure of infants to EDTA. processing and dyeing.The available mechanism determinations and First, premature or very young infants information indicates that the non-food procedures for cumulating effects from ingest only formula or breast milk. (It is uses of EDTA are more prevalent than substances found to have a common generally recommended that infants not the food-uses. The information in the mechanism on EPA’s website at http:// consume solid food until 4 to 6 months Agency’s files indicates that pesticide www.epa.gov/pesticides/cumulative/. of age). Regulation of infant formulas is products applied to residential use sites under the purview of the FDA generally contain less than 1% of EDTA VII. Safety Factor for Infants and (www.fda.gov/fdac/features/ in the formulated product. Children 596lbaby.html). Calcium disodium Using this information on percents in FFDCA section 408 provides that EPA EDTA, disodium EDTA, and formulation, the Agency has estimated shall apply an additional tenfold margin tetrasodium EDTA are used as direct short-term screening level dermal of safety for infants and children in the food additives (21 CFR 172.120, exposure estimates for EDTA chemicals case of threshold effects to account for 172.135, and 178.1010, respectively). using both EDTA, per se, and the prenatal and postnatal toxicity and the However, all manufacturers of infant tetrasodium salt of EDTA. Since the completeness of the database unless formula must begin with safe food screening level estimates were identical EPA concluded that a different margin ingredients, which are approved either for both of these chemicals, they can of safety will be safe for infants and generally as safe or approved as food serve as surrogate estimates for all the children. additives for use in infant formula. EDTA chemicals. Note that inhalation EDTA chemicals are chelating agents Neither EDTA nor the salts of EDTA are exposure estimates are not used since or scavengers. Their function is to locate currently approved by the FDA for use the vapor pressure of EDTA chemicals and then bind to metals. Many metals in infant formula. Therefore, infants is so low. (iron, zinc, manganese) are required in consuming only infant formula or breast

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milk would be exposed to very low in humans that is similar to an effect and Budget (OMB) has exempted these amounts of EDTA. Second, even if produced by a naturally occurring types of actions from review under young infants were to be fed some solid estrogen, or such other endocrine effect. Executive Order 12866, entitled food, given the characteristics of EDTA . .’’ EPA has been working with Regulatory Planning and Review (58 FR and its salts, residues are not likely to interested stakeholders to develop a 51735, October 4, 1993). Because this be present at concentrations for screening and testing program as well as proposed rule has been exempted from potential sensitivity. Once past this a priority setting scheme. As the Agency review under Executive Order 12866 several month time-period, there is no proceeds with implementation of this due to its lack of significance, this longer a concern for potential sensitivity program, further testing of products proposed rule is not subject to Executive to infants and children. Older infants, containing ethylenediaminetetraacetic Order 13211, Actions Concerning like adults, process EDTA through well acid and its various salts for endocrine Regulations That Significantly Affect understood metabolic pathways. effects may be required. Energy Supply, Distribution, or Use (66 The comparison of two B. Analytical Method(s) FR 28355, May 22, 2001). This proposed developmental toxicity studies rule does not contain any information performed using disodium EDTA clearly An analytical method is not required collections subject to OMB approval indicates that the presence of trace for enforcement purposes since the under the Paperwork Reduction Act metals in the drinking water and diet, Agency is establishing an exemption (PRA), 44 U.S.C. 3501 et seq., or impose particularly zinc, work to prevent from the requirement of a tolerance any enforceable duty or contain any deficiencies. Based on this information without any numerical limitation. unfunded mandate as described under concerning both toxicity and exposure, C. Existing Exemptions Title II of the Unfunded Mandates a safety factor analysis has not been Reform Act of 1995 (UMRA) (Public There are three existing tolerance used to assess the risk of Law 104–4). Nor does it require any exemptions for ethylenediaminetetraacetic acid (EDTA) special considerations under Executive ethylenediaminetetraacetic acid, and its various salts. For the same Order 12898, entitled Federal Actions to disodium zinc reasons, the additional tenfold safety Address Environmental Justice in ethylenediaminetetraacetate dihydride, factor for the protection of infants and Minority Populations and Low-Income and ethylenediaminetetraacetic acid, children is unnecessary. Populations (59 FR 7629, February 16, tetrasodium salt in 40 CFR 180.910. 1994); or OMB review or any Agency VIII. Determination of Safety for U.S. These are the tolerance exemptions action under Executive Order 13045, Population, and Infants and Children proposed for amendment as a result of entitled Protection of Children from this action. There are four existing Based on the available toxicity data Environmental Health Risks and Safety tolerance exemptions for the disodium on ethylenediaminetetraacetic acid Risks (62 FR 19885, April 23, 1997). and tetrasodium EDTA salts in 40 CFR (EDTA) and its various salts, with This action does not involve any 180.940. These four exemptions are not particular emphasis on the comparison technical standards that would require the subject of this action. of the findings in the two Agency consideration of voluntary developmental toxicity studies; the D. International Tolerances consensus standards pursuant to section reviews and evaluations conducted by 12(d) of the National Technology NTP, NCI, and WHO; the knowledge The Agency is not aware of any country requiring a tolerance or Transfer and Advancement Act of 1995 that trace metal supplementation occurs (NTTAA), Public Law 104–113, section via the food and drinking water tolerance exemption for ethylenediamine tetraacetic acid and its 12(d) (15 U.S.C. 272 note). The consumed by human beings; and Regulatory Flexibility Act (RFA) (5 considering the estimated exposures of various salts, nor have any CODEX Maximum Residue Levels (MRLs) been U.S.C. 601 et seq.) Generally requires an the wide-spread existing uses of agency to prepare a regulatory flexibility ethylenediaminetetraacetic acid (EDTA) established for any food crops at this time. analysis of any rule subject to notice and its various salts which are less than and comment rulemaking requirements levels at which adverse effects were X. Conclusions under the Administrative Procedure Act noted, EPA concludes that there is a Accordingly, EPA proposes to or any other statute unless the agency reasonable certainty of no harm from establish 16 new and amend three certifies that the rule will not have a aggregate exposure to residues of existing exemptions from the significant impact on a substantial ethylenediaminetetraacetic acid (EDTA) requirement of a tolerance for residues number of small entities. The Agency and its various salts. EPA finds that of various ethylenediaminetetraacetic hereby certifies that this proposed establishing exemptions from the acid (EDTA) chemicals in or on raw action will not have significant negative requirement of a tolerance for agricultural commodities when used as economic impact on a substantial ethylenediaminetetraacetic acid (EDTA) inert ingredients in pesticide number of small entities. Establishing and its various salts with the following formulations applied to growing crops exemptions from the requirement of a limitation ‘‘The concentration of all or to raw agricultural commodities after pesticide tolerance, as is proposed, is in EDTA chemicals is not to exceed 5% in harvest. The concentration of all EDTA effect the removal of a regulatory the formulated pesticide product’’ will chemicals is not to exceed 5% in the restriction on pesticide residues in food be safe for the general population formulated pesticide product. and thus such an action will not have including infants and children. any negative economic impact on any XI. Statutory and Executive Order IX. Other Considerations entities, including small entities. In Reviews addition, the Agency has determined A. Endocrine Disruptors This rule proposes to amend three that this action will not have a FQPA requires EPA to develop a existing and establish 16 new substantial direct effect on States, on the screening program to determine whether exemptions from the requirement of a relationship between the national certain substances, including all tolerance under section 408(e) of government and the States, or on the pesticide chemicals (both inert and FFDCA. The Agency is acting on its own distribution of power and active ingredients), ‘‘may have an effect initiative. The Office of Management responsibilities among the various

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levels of government, as specified in Coordination with Indian Tribal Agricultural commodities, Executive Order 13132, entitled Governments (65 FR 67249, November and pests, Reporting and recordkeeping Federalism (64 FR 43255, August 10, 6, 2000). Executive Order 13175, requirements. requires EPA to develop an accountable 1999). Executive Order 13132 requires Dated: February 27, 2006. EPA to develop an accountable process process to ensure ‘‘meaningful and Lois Ross, to ensure ‘‘meaningful and timely input timely input by tribal officials in the by State and local officials in the development of regulatory policies that Director, Registration Division, Office of development of regulatory policies that have tribal implications.’’ ‘‘Policies that Pesticide Programs. have federalism implications.’’ ‘‘Policies have tribal implications’’ is defined in Therefore, it is proposed that 40 CFR that have federalism implications’’ is the Executive Order to include chapter I be amended as follows: defined in the Executive Order to regulations that have ‘‘substantial direct include regulations that have effects on one or more Indian tribes, on PART 180—[AMENDED] ‘‘substantial direct effects on the States, the relationship between the Federal on the relationship between the national Government and the Indian tribes, or on 1. The authority citation for part 180 government and the States, or on the the distribution of power and continues to read as follows: responsibilities between the Federal distribution of power and Authority: 21 U.S.C. 321(q), 346a and 371. Government and Indian tribes.’’ This responsibilities among the various proposed rule will not have substantial levels of government.’’ This proposed 2. Section 180.910, in the table, is direct effects on tribal governments, on rule directly regulates growers, food amended by removing the entry for the relationship between the Federal Disodium zinc processors, food handlers and food Government and Indian tribes, or on the retailers, not States. This action does not ethylenediaminetetraacetate dihydride; distribution of power and by revising the entries for alter the relationships or distribution of responsibilities between the Federal power and responsibilities established ethylenediaminetetraacetic acid and Government and Indian tribes, as ethylenediaminetetraacetic acid (EDTA) by Congress in the preemption specified in Executive Order 13175. provisions of section 408(n)(4) of tetrasodium salt and adding Thus, Executive Order 13175 does not alphabetically the remaining entries as FFDCA. For these same reasons, the apply to this proposed rule. Agency has determined that this set forth below to read as follows: List of Subjects in 40 CFR Part 180 proposed rule does not have any ‘‘tribal § 180.910 Inert ingredients used pre-and implications’’ as described in Executive Environmental protection, post-harvest; exemptions from the Order 13175, entitled Consultation and Administrative practice and procedure, requirement of a tolerance.

Inert Ingredient Limits Uses

******* Ethylenediaminetetraacetic acid (EDTA) (CAS Reg. No.60–00–4) The concentration of all Sequestrant EDTA chemicals is not to exceed 5% in the for- mulated pesticide prod- uct. Ethylenediaminetetraaceticacid (EDTA) calcium disodium salt (CAS Reg. No.62–33–9) Do...... Do. Ethylenediaminetetraacetic acid (EDTA) disodiumcopper (II) salt (CAS Reg. No. 14025–15– Do...... Do. 1) Ethylenediaminetetraaceticacid (EDTA) disodiumcopper (II) salt, dihydrate(CAS Reg. No. Do...... Do. 61916–40–3) Ethylenediaminetetraaceticacid (EDTA) disodium copper (II) salt, trihydrate(CAS Reg. No. Do...... Do. 73637–19–1) Ethylenediaminetetraacetic acid (EDTA) disodiummanganese (II) salt (CAS Reg. No. Do...... Do. 15375–84–5) Ethylenediaminetetraacetic acid (EDTA) disodiummanganese (I) salt, dihydrate (CAS Reg. Do...... Do. No. 73637–20–4) Ethylenediaminetetraacetic acid (EDTA) disodium salt(CAS Reg. No. 139–33–3) Do...... Do. Ethylenediaminetetraaceticacid (EDTA) disodium salt, dihydrate (CAS Reg. No. 6381–92–6) Do...... Do. Ethylenediaminetetraacetic acid (EDTA) disodium zincsalt (CAS Reg. No. 14025–21–9) Do...... Do. Ethylenediaminetetraacetic acid (EDTA) disodium zinc salt, dihydrate (CAS Reg. No.73513– Do...... Do. 47–0) Ethylenediaminetetraacetic acid (EDTA) monosodiumsalt (CAS Reg. No. 17421–79–3) Do...... Do. Ethylenediaminetetraacetic acid (EDTA) sodium iron(III) salt (CAS Reg. No. 15708–41–5) Do...... Do. Ethylenediaminetetraacetic acid (EDTA) sodium salt(CAS Reg. No. 7379–28–4) Do...... Do. Ethylenediaminetetraaceticacid (EDTA) tetrapotassiumsalt (CAS Reg. No. 5964–35–2) Do...... Do. Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt(CAS Reg. No. 64–02–8) Do...... Do. Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt, tetrahydrate (CAS Reg. No. Do...... Do. 13235–36–4) Ethylenediaminetetraaceticacid (EDTA) tetrasodium salt, trihydrate (CAS Reg. No.67401– Do...... Do. 50–7) Ethylenediaminetetraacetic acid (EDTA) tripotassium salt (CAS Reg. No. 17572–97–3) The concentration of all Sequestrant EDTA chemicals is not to exceed 5% in the for- mulated pesticide prod- uct. *******

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[FR Doc. 06–2106 Filed 3–7–06; 8:45 am] Monday through Friday, excluding legal Reading Room telephone number is BILLING CODE 6560–50–S holidays. The telephone number for the (202) 566–1744, and the telephone DCO is (202) 564–8930. Such deliveries number for the OPPT Docket, which is are only accepted during the Docket’s located in the EPA Docket Center, is ENVIRONMENTAL PROTECTION normal hours of operation, and special (202) 566–0280. AGENCY arrangements should be made for FOR FURTHER INFORMATION CONTACT: For deliveries of boxed information. general information contact: Colby 40 CFR Part 745 Instructions: Direct your comments to Lintner, Regulatory Coordinator, [EPA–HQ–OPPT–2004–0126; FRL–7690–8] docket ID number EPA–HQ–OPPT– Environmental Assistance Division 2004–0126. EPA’s policy is that all (7408M), Office of Pollution Prevention Lead Hazard Information Pamphlet; comments received will be included in and Toxics, Environmental Protection Notice of Availability the public docket without change and Agency, 1200 Pennsylvania Ave., NW., may be made available in the on-line Washington, DC 20460–0001; telephone AGENCY: Environmental Protection docket at http://www.regulations.gov, Agency (EPA). number: (202) 554–1404; e-mail address: including any personal information [email protected]. ACTION: Notice of availability. provided, unless the comment includes For technical information contact: information claimed to be Confidential SUMMARY: This notice announces the Joshua B. Novikoff, National Program availability of EPA’s new lead hazard Business Information (CBI) or other Chemicals Division (7404T), Office of information whose disclosure is information pamphlet for renovation Pollution Prevention and Toxics, restricted by statute. Do not submit activities, Protect Your Family from Environmental Protection Agency, 1200 information that you consider to be CBI Lead During Renovation, Repair & Pennsylvania Ave., NW., Washington, or otherwise protected through Painting, for review and comment. DC 20460–0001; telephone number: regulations.gov, or e-mail. The There is an increased risk of lead-based (202) 566–0502; e-mail address: regulations.gov Web site is an paint poisoning during renovation [email protected]. ‘‘anonymous access’’ system, which activities, particularly to children under SUPPLEMENTARY INFORMATION: means EPA will not know your identity 6 years of age. To better inform families or contact information unless you I. General Information about the risks and to encourage greater provide it in the body of your comment. public health and safety during If you send an e-mail comment directly A. Does This Action Apply to Me? renovation activities in target housing, to EPA without going through You may be potentially affected by EPA has developed a renovation- regulations.gov, your e-mail address this action if you perform renovations in specific information pamphlet for will be automatically captured and target housing for compensation. Target families. This new pamphlet gives included as part of the comment that is housing is defined as any housing information on lead-based paint hazards placed in the public docket and made constructed prior to 1978, except in a home, lead testing, how to select a available on the Internet. If you submit housing for the elderly or persons with contractor, what precautions to take an electronic comment, EPA disabilities (unless any child who is less during the renovation, and proper recommends that you include your than 6 years of age resides or is expected cleanup activities. EPA is seeking name and other contact information in to reside in such housing) or any 0- comment on all aspects of the the body of your comment and with any bedroom dwelling (40 CFR 745.103). pamphlet’s content and design. After disk or CD ROM you submit. If EPA Potentially affected entities may reviewing the comments, EPA will cannot read your comment due to include, but are not limited to: publish a final version of the pamphlet technical difficulties and cannot contact • Renovators (NAICS 236118), e.g., that may be used to comply with the you for clarification, EPA may not be general building contractors/operative requirements of section 406(b) of the able to consider your comment. builders, renovation firms, individual Toxic Substances Control Act (TSCA). Electronic files should avoid the use of contractors. DATES: Comments, identified by docket special characters, any form of • Special trade contractors, e.g., identification (ID) number EPA–HQ– encryption, and be free of any defects or carpenters (NAICS 38350), painters OPPT–2004–0126, must be received on viruses. (NAICS 238320), drywall workers and or before April 7, 2006. Docket: All documents in the docket lathers (NAICS 238310), home ADDRESSES: Submit your comments, are listed in the docket index at http:// improvement contractors. identified by docket ID number EPA– www.regulations.gov/. Although listed • Landlords (NAICS 561110), e.g., HQ–OPPT–2004–0126, by one of the in the index, some information is not multi-family housing property following methods: publicly available, i.e., CBI or other management firms and owners. • Federal eRulemaking Portal: http:// information whose disclosure is This listing is not intended to be www.regulations.gov/. Follow the on- restricted by statute. Certain other exhaustive, but rather provides a guide line instructions for submitting material, such as copyrighted material, for readers regarding entities likely to be comments. is not placed on the Internet and will be affected by this action. Other types of • Mail: Document Control Office publicly available only in hard copy entities not listed in this unit could also (7407M), Office of Pollution Prevention form. Publicly available docket be affected. The North American and Toxics (OPPT), Environmental materials are available either Industrial Classification System Protection Agency, 1200 Pennsylvania electronically in the online docket at (NAICS) codes have been provided to Ave., NW., Washington, DC 20460– http://www.regulations.gov/ or in hard assist you and others in determining 0001. copy at the OPPT Docket, EPA Docket whether this action might apply to • Hand Delivery: OPPT Document Center, EPA West, Rm. B102, 1301 certain entities. To determine whether Control Office (DCO), EPA East Bldg., Constitution Ave., NW., Washington, you or your business may be affected by Rm. 6428, 1201 Constitution Ave., NW., DC. The Public Reading Room is open this action, you should carefully Washington, DC. Attention: Docket ID from 8:30 a.m. to 4:30 p.m., Monday examine the applicability provisions in number EPA–HQ–OPPT–2004–0126. through Friday, excluding legal 40 CFR 745.82. If you have any The DCO is open from 8 a.m. to 4 p.m., holidays. The EPA Docket Center questions regarding the applicability of

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