Federal Register / Vol. 65, No. 183 / Wednesday, September 20, 2000 / Notices 56901 absorbed amount were calculated using D. Cumulative Effects dishes or use dandruff shampoo on a methods recommended by EPA. It is 3M's position that zinc pyrithione regular basis, eliminating these routes of ii. Per cutaneous absorption from should not be expected to have any exposure. Maximum possible aggregate dandruff shampoo. Information on the effects cumulative with any other dietary exposure for non-nursing infants ¥6 absorption of zinc pyrithione from the substances. It is EPA's position that the is calculated to be 1.92 x 10 mg/kg/ use of dandruff shampoos was obtained Agency ``does not at this time have the day, yielding an MOE of 260,000, far in from FDA's docket supporting formal methodology to resolve scientific issues excess of the 1,000 fold safety factor rulemaking leading to a monograph concerning common mechanisms of applied by EPA in its assessment to calculate an RfD. The use of sponges for establishing conditions under which toxicity.'' Hence, for the time being EPA teething for a lifetime, which EPA over-the-counter drug products for the has not assumed that zinc pyrithione included in its assessments, was not control of dandruff, seborrheic has a common mechanism of toxicity considered. dermatitis, and psoriasis are ``generally with other substances. recognized as safe and effective.'' In a E. Safety Determination F. International Tolerances study involving 30 human subjects, a 1. U.S. population. EPA has No international tolerances have been shampoo containing radio labeled zinc issued for the use of zinc pyrithione as pyrithione (14C in the 2- and 6- established an oral NOAEL for zinc pyrithione of 0.5 mg/kg/day based upon a preservative in cellulose sponges. positions) was applied in both a sink [FR Doc. 00±24210 Filed 9±19±00; 8:45 am] shampoo procedure (head exposure a chronic rat study. This value is BILLING CODE 6560±50±F only) and a shower shampoo (total body confirmed in the NOAEL for a exposure). All wash water and towels, subchronic neurotoxicity study and a 2± generation reproduction study. Using a etc. were retained and biological substantial number of high exposure ENVIRONMENTAL PROTECTION samples of skin, hair, blood and urine assumptions, the absolute upper limit AGENCY collected for a period of ten days exposure to zinc pyrithione was following application. Recovery of radio [PF±974; FRL±6742±7] calculated for all uses in the realistic label was essentially 100%. adverse case presented above. When Notice of Filing a Pesticide Petition to An average upper level systemic load exposure to zinc pyrithione through Establish a Tolerance for a Certain of zinc pyrithione was calculated from daily lifetime use of dandruff shampoo Pesticide Chemical in or on Food the urinary output data to be 1 µg/kg/ is included, a minimum adult MOE of day. Absorption was greatest for 128,000 was found, with total aggregate AGENCY: Environmental Protection subjects with seborrheic dermatitis, and exposure at 7.81 x 10¥4 mg/kg/day. The Agency (EPA). the absorbed material was derived from exposure from the assumed daily use of ACTION: Notice. solid zinc pyrithione deposited on the dandruff shampoo is huge compared to SUMMARY: head, rather than from the soluble zinc the aggregate adult exposure from use of This notice announces the initial filing of a pesticide petition pyrithione complexed with detergent in zinc pyrithione in sponges. Total adult proposing the establishment of the commercial shampoo. exposure (oral + dermal) not counting shampoo is 1.20 x 10¥6 mg/kg/day. The regulations for residues of a certain For this aggregate exposure analysis, pesticide chemical in or on various food in the realistic adverse case it was maximum possible daily intake of zinc pyrithione for all uses other than commodities. assumed that all persons have chronic DATES: Comments, identified by docket dandruff and use a dandruff shampoo shampoo was calculated to yield an aggregate adult MOE of over 400,000, control number PF±974, must be every day, absorbing the maximum dose received on or before October 20, 2000. of the active ingredient. In the worst assuming an individual does not ADDRESSES: case and exaggerated worst case, it is routinely (i.e., daily) use dandruff Comments may be submitted by mail, electronically, or in assumed that all persons have shampoo (see Table 2). person. Please follow the detailed seborrheic dermatitis and use the 2. Infants and children. Aggregate exposure to children was determined by instructions for each method as dandruff shampoo every day for life adjusting the assumptions used for provided in Unit I.C. of the (i.e., the treatment has no curative effect adults. The assessment was designed to SUPPLEMENTARY INFORMATION. To ensure on the seborrheic dermatitis). It was also examine exposure for non-nursing proper receipt by EPA, it is imperative assumed that infants and small children infants, the subpopulation that most that you identify docket control number do not use dandruff shampoo on a often is calculated to have the highest PF±974 in the subject line on the first regular basis. Using these assumptions, exposure to pesticides in the diet in page of your response. exposure from use of zinc pyrithione in EPA's own assessments for most dandruff shampoo was found to be three FOR FURTHER INFORMATION CONTACT: By chemicals. orders of magnitude higher than mail: James Tompkins, Herbicide In this assessment, it was assumed Branch, Registration Division (7505W), exposure from all other uses of zinc that the dietary consumption of food pyrithione. Office of Pesticide Programs, and water by infants was 2.5 times more Environmental Protection Agency, 1200 EPA assumed 3% dermal absorption per kg of body weight than for adults. Pennsylvania Ave., NW., Washington, of zinc pyrithione for non-dietary Because a large portion of an infant's DC 20460; telephone number: (703) exposures. In contrast, for assessments diet is liquids, the additional 305±5697; e-mail address: involving dermal exposure to sodium assumption was made that a smaller [email protected]. pyrithione, the Agency has used an portion of the diet for infants than absorption value of 0.1% in risk adults would be exposed to counters SUPPLEMENTARY INFORMATION: assessments. In its assessment of and other surfaces washed with I. General Information aggregate risk for the sponge, EPA did dishwater. Therefore, absorption of zinc not consider exposures through the use pyrithione from washed surfaces would A. Does this Action Apply to Me? of dandruff shampoos containing zinc be expected to be less. Non-nursing You may be affected by this action if pyrithione. infants are also not expected to wash you are an agricultural producer, food VerDate 11<MAY>2000 19:59 Sep 19, 2000 Jkt 190000 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\20SEN1.SGM pfrm03 PsN: 20SEN1 56902 Federal Register / Vol. 65, No. 183 / Wednesday, September 20, 2000 / Notices manufacturer or pesticide manufacturer. electronic comments submitted during information claimed as CBI, a copy of Potentially affected categories and an applicable comment period, is the comment that does not contain the entities may include, but are not limited available for inspection in the Public information claimed as CBI must be to: Information and Records Integrity submitted for inclusion in the public Branch (PIRIB), Rm. 119, Crystal Mall version of the official record. #2, 1921 Jefferson Davis Highway, Information not marked confidential Arlington, VA, from 8:30 a.m. to 4 p.m., will be included in the public version Examples of poten- Monday through Friday, excluding legal of the official record without prior Categories NAICS tially affected enti- holidays. The PIRIB telephone number ties notice. If you have any questions about is (703) 305±5805. CBI or the procedures for claiming CBI, Industry 111 Crop production C. How and to Whom Do I Submit please consult the person identified 112 Animal production Comments? under FOR FURTHER INFORMATION 311 Food manufacturing CONTACT. 32532 Pesticide manufac- You may submit comments through turing the mail, in person, or electronically. To E. What Should I Consider as I Prepare ensure proper receipt by EPA, it is My Comments for EPA? This listing is not intended to be imperative that you identify docket You may find the following exhaustive, but rather provides a guide control number PF±974 in the subject suggestions helpful for preparing your for readers regarding entities likely to be line on the first page of your response. affected by this action. Other types of 1. By mail. Submit your comments to: comments: entities not listed in the table could also Public Information and Records 1. Explain your views as clearly as be affected. The North American Integrity Branch (PIRIB), Information possible. Industrial Classification System Resources and Services Division 2. Describe any assumptions that you (NAICS) codes have been provided to (7502C), Office of Pesticide Programs used. assist you and others in determining (OPP), Environmental Protection 3. Provide copies of any technical whether or not this action might apply Agency, 1200 Pennsylvania Ave., NW., information and/or data you used that to certain entities. If you have questions Washington, DC 20460. support your views. regarding the applicability of this action 2. In person or by courier. Deliver to a particular entity, consult the person your comments to: Public Information 4. If you estimate potential burden or listed under FOR FURTHER INFORMATION and Records Integrity Branch (PIRIB), costs, explain how you arrived at the CONTACT. Information Resources and Services estimate that you provide. 5. Provide specific examples to B. How Can I Get Additional Division (7502C), Office of Pesticide illustrate your concerns.