Proposed Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes, 2854-2859 [E8-681]

Download as PDF 2854 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules evidence of a causal association satisfies the standard for inclusion in the labeling under § 201.57(c) of this chapter; * * * * * (5) For purposes of paragraph (f)(2) of this section, information will be considered newly acquired if it consists of data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events of a different type or greater severity or frequency than previously included in submissions to FDA, or new analyses of previously submitted data (e.g., metaanalyses). * * * * * Dated: December 4, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–702 Filed 1–15–08; 8:45 am] PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES AGENCY: 6. The authority citation for 21 CFR part 814 continues to read as follows: Authority: 21 U.S.C. 351, 352, 353, 360, 360c–360j, 371, 372, 373, 374, 375, 379, 379e, 381. 7. Section 814.3 is amended by adding paragraph (o) to read as follows: § 814.3 Definitions. * * * * * (o) Newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events of a different type or greater severity or frequency than previously included in submissions to FDA, or new analyses of previously submitted data (e.g., metaanalyses). 8. Section 814.39 is amended by revising paragraphs (d)(1) introductory text and (d)(2)(i) to read as follows: § 814.39 PMA supplements. ebenthall on PRODPC61 with PROPOSALS * * * * * (d)(1) After FDA approves a PMA, any change described in paragraph (d)(2) of this section to reflect newly acquired information that enhances the safety of the device or the safety in the use of the device may be placed into effect by the applicant prior to the receipt under § 814.17 of a written FDA order approving the PMA supplement provided that: * * * * * (2) * * * (i) Labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there is reasonable evidence of a causal association. * * * * * VerDate Aug<31>2005 15:31 Jan 15, 2008 Jkt 214001 BILLING CODE 4160–01–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 704, 720, 721, and 723 [EPA–HQ–OPPT–2007–0392; FRL–8131–8] RIN 2070–AJ21 Proposed Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes Environmental Protection Agency (EPA). ACTION: Proposed clarification. SUMMARY: This document proposes a clarification under which activated phosphors that are not on the Toxic Substances Control Act (TSCA) section 8(b) Chemical Substance Inventory (TSCA Inventory) would be considered to be new chemical substances under TSCA section 5, thus would be subject to the notification requirements under TSCA section 5(a) new chemical notification requirements. In certain letters and other interpretations issued by EPA from 1978 to 2003, it appears that the Agency erroneously indicated that activated phosphors constitute solid mixtures for purposes of the TSCA Inventory, and thus that they were not separately reportable as chemical substances under TSCA section 5(a) new chemical notification requirements. This proposed clarification is necessary because EPA’s interpretations in this area have not been consistent. Given this past inconsistency, EPA is seeking comment on its proposed clarfication. DATES: Comments must be received on or before March 17, 2008. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2007–0392, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001. • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 Number EPA–HQ–OPPT–2007–0392. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA–HQ–OPPT– 2007–0392. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at http:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov website is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket, visit the EPA Docket Center homepage at http:// www.epa.gov/epahome/dockets.htm. Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket E:\FR\FM\16JAP1.SGM 16JAP1 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. FOR FURTHER INFORMATION CONTACT: For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 554–1404; e-mail address: TSCA-Hotline@epa.gov. For technical information contact: David Schutz, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (202) 564– 9262; e-mail address: schutz.david@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information ebenthall on PRODPC61 with PROPOSALS A. Does this Action Apply to Me? You may be affected by this action if you are, or may in the future be, a manufacturer or importer of an activated phosphor that requires submission of a premanufacture notification (PMN) or exemption request under TSCA section 5. Special procedures would apply to persons who manufactured these chemicals after the publication of the Initial TSCA Inventory and before a date 12 months following the publication of a final chemical identification clarification document in the Federal Register. Potentially affected entities may include, but are not limited to: • Chemical manufacturers or importers (NAICS codes 325, 3251), e.g., anyone who manufactures or imports, or who plans to manufacture or import, an activated phosphor for a non-exempt commercial purpose. VerDate Aug<31>2005 15:31 Jan 15, 2008 Jkt 214001 • Electric Lighting Equipment Manufacturing, Electric Lamp Bulb and Part Manufacturing (NAICS codes 3351, 33511), e.g., anyone who manufactures or imports, or who plans to manufacture or import, lighting equipment containing an activated phosphor for a non-exempt commercial purpose. 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 technical person listed under FOR FURTHER INFORMATION CONTACT. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 2855 vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background A. What Action is the Agency Taking? This action proposes a clarification in the approach used for the chemical identification of activated (doped) phosphors for purposes of listing on the TSCA Inventory. A doped or activated phosphor is a substance resulting from the chemical combination of a mixture of metal oxides, carbonates, phosphates or acid phosphates, chlorides, and/or fluorides, most frequently by sintering, along with a small amount of one or more dopants. Dopants can include such chemical substances as antimony, europium, gallium, germanium, magnesium, manganese, strontium, or yttrium. When this material is electrically excited, it emits light. The color and electrical efficiency of light emission is a function of the parent phosphor and of the dopant which is present. EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep current an inventory of chemical substances manufactured, imported, or processed for commercial purposes in the United States. This inventory is known as the TSCA Chemical Substances Inventory (TSCA Inventory). In 1977, EPA promulgated a rule published in the Federal Register issue of December 23, 1977 (42 FR 64572) under TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of chemical substances in commerce at that time. In 1983, and building on several earlier interim policies, EPA promulgated a rule published in the Federal Register issue of May 13, 1983 (48 FR 21722) under TSCA section 5, 15 U.S.C. 2604, to keep the TSCA Inventory up-to-date through a procedure for the submission, receipt, and health and safety review of PMNs covering chemical substances not yet in commerce from their intending manufacturers and importers. Manufacturing, importing, or processing of a new chemical is illegal prior to the expiration of the PMN review period. Once EPA receives a PMN, the Agency has 90 days to review the notice (unless for good cause EPA extends the review period). During the review period, EPA may act under TSCA section 5(e) or 5(f) to regulate the E:\FR\FM\16JAP1.SGM 16JAP1 ebenthall on PRODPC61 with PROPOSALS 2856 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules new chemical substance. If EPA has not prohibited manufacture or import of the chemical substance during the review period, these activities may begin subject to any restrictions or testing requirements imposed upon the submitter during the review period (these restrictions may be imposed upon others via a Significant New Use Rule (SNUR) and subsequent action under TSCA section 5(e) or 5(f) taken in follow-up to a significant new use notification (SNUN)). When manufacture or import begins, the notice submitter must provide a notice of commencement, after which EPA adds the chemical substance to the TSCA Inventory. If the Agency receives a PMN submission for a chemical substance which EPA determines is excluded from consideration as a chemical substance under TSCA (generally because it meets the criteria for one of the excepted categories at TSCA section 3(2)(B), which include mixtures, pesticides, tobacco, food, drugs, etc.) it will not accept the PMN. A similar practice was followed as well during the period 1978–1979, when the EPA was accepting submissions for the Initial TSCA Inventory, and during 1979–1983, prior to promulgation of the May 13, 1983 PMN rule. Partly as a result of the Agency’s incomplete information and understanding of the chemistry involved in manufacturing activated phosphors, from 1978 through 2003 EPA has been inconsistent in its interpretation to potential submitters and in its actions regarding whether activated phosphors are considered distinct chemical substances for purposes of the TSCA Inventory. During the period 1978–1979, when EPA received submissions for the Initial TSCA Inventory, it accepted a number of doped phosphors for listing, but in other cases it sent ‘‘problem letters’’ to the manufacturers of doped phosphors indicating that they were mixtures. In October 1979, the Agency wrote to a lighting manufacturer and stated that such listings could be ‘‘unnecessary’’ and that their continued inclusion on the TSCA Inventory would be ‘‘closely examined.’’ In January 1980, a lighting manufacturer wrote to the Agency to challenge problem letters it had received. The manufacturer stated that the materials it manufactured should be excluded from mixture status because they had characteristic crystal structures and that volatile reaction products given off during their manufacture showed that chemical synthesis was occurring. In March 1982, the Agency wrote to a lighting manufacturer and suggested that activated phosphors could be VerDate Aug<31>2005 15:31 Jan 15, 2008 Jkt 214001 regarded either as physically altered chlorophosphates or as mixtures, thus not subject to PMN. In August 1983, the Agency wrote to the lighting manufacturer which had challenged the problem letters and informed it that the materials had, in fact, been placed on the TSCA Inventory, and in addition that a PMN was appropriate for another activated phosphor but that ‘‘low levels’’ of an activator would not require separate PMN. In January 1993, a lighting manufacturer submitted a Low Volume Exemption (LVE) Application for an activated phosphor with a letter referencing much of the history as described in this unit and asserting that, based on Agency positions, no submission should be necessary, but the Agency did accept the application and granted the LVE. After that LVE was granted, the manufacturer submitted a letter making the case that activated phosphors should, in fact, be considered to be mixtures and requesting that the Agency issue a clarifying statement. In response, the Agency met with the manufacturer on the issue and indicated that activated phosphors should be considered chemical substances instead of mixtures, but did not issue a written clarification. In 1995, EPA issued the publication entitled Toxic Substances Control Act Inventory Representation for Products Containing Two or More Substances: Formulated and Statutory Mixtures (Formulated and Statutory Mixtures), available at http://www.epa.gov/ opptintr/newchems/pubs/mixtures.txt), which interpreted the mixture definition given at 40 CFR 710.3(d) and 720.3(u): Mixture means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except ‘‘mixture’’ does include (1) any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined, and if all of the chemical substances comprising the combination are not new chemical substances, and (2) hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water, so long as the nonhydrated form is itself not a new chemical substance. Formulated and Statutory Mixtures discusses common examples of mixtures, including paints, blended fuels, and solvent combinations. ‘‘Mixture’’ can include, as well, solid solutions—homogeneous crystalline phases composed of several distinct chemical species. Alloys are solid PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 solutions, and are considered mixtures. For the purposes of TSCA, multicomponent blends or formulations of chemical substances, or certain reaction product combinations which can be completely characterized as consistently formed sets of their constituent chemical substances, are considered to be mixtures of chemical substances. Mixtures are not reportable, although their constituent chemical substances are. Most important in the context of this clarification, a mixture can often provide its function over some range of constituent ratios, consequently it is unusual if the ratios of chemical substances which comprise a mixture are necessarily definite or stoichiometric, and if the mixture components are deliberately reacted together to manufacture a chemical substance, this reaction product cannot be considered a mixture for TSCA purposes except in very specialized circumstances which are not present in the case of the activated phosphors. In June 1998, a lighting manufacturer wrote to the Agency and stated that, in the absence of any negative response by the Agency within 60 days of the letter, it intended to rely on the interpretation in Formulated and Statutory Mixtures, and that it believed that that interpretation precluded TSCA Inventory listing for activated phosphors. The Agency did not respond to that letter. Based on a 2003 request from a lighting manufacturer, and cognizant of the history described in this unit, EPA held a meeting with the manufacturer in September 2003 and as a result has reexamined some earlier assumptions—particularly about nonstoichiometry and non-reaction between chemical substances used to make activated phosphors—which may have led it to believe that activated phosphors could be considered mixtures. The result of this reexamination is this clarification that individual activated phosphors should be considered to be distinct chemical substances under TSCA. EPA’s clarification on the potential need to report activated phosphor materials is based on its updated understanding about reactions and stoichiometry in activated phosphors, as follows: Activated phosphors are in general synthesized by means of a solid state reaction at high temperature and using precise quantities of the precursor chemical substances, both for the base materials and for the dopants which control the quality of light emitted. Precise ratios of component materials are used to maintain strict stoichiometry in the end product, and component E:\FR\FM\16JAP1.SGM 16JAP1 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules materials are thoroughly blended before reaction for uniformity of the product. Heat may be absorbed or released by the reactant mixture at certain temperatures, typically by the release of water: This is generally an indication of chemical substance synthesis. During the manufacture of activated phosphors, other volatile reaction products are often emitted, another indication that chemical substances are being formed. The phosphor and the amount of dopant added need to be controlled with high precision, and during sintering the doped phosphor undergoes oxidation state changes. Consequently, EPA believes that activated phosphors cannot be manufactured for commercial purposes without chemical reaction. Additionally, activated phosphor products have a different function from the material which would be produced by the same synthetic process in the absence of dopant, and which would not emit the characteristic light, which is the primary property sought. Because dopants provide the primary property sought from these materials, small or even trace amounts of dopant must be considered to be reactants which must be included in the chemical identity. These factors preclude these materials from being considered as ‘‘mixtures.’’ ebenthall on PRODPC61 with PROPOSALS B. What is the Agency’s Authority for Taking this Action? Section 5 of TSCA requires any person who intends to manufacture (defined by statute to include import) a new chemical substance (i.e., a chemical substance not on the TSCA Inventory) to notify EPA at least 90 days in advance and comply with the statutory provisions pertaining to the manufacture of new chemical substances for non-exempt commercial purposes. Section 8(b) of TSCA requires EPA to compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the United States (the TSCA Inventory). This requirement includes defining the scope of the listings on the TSCA Inventory. C. Why is this Proposed Chemical Identity Clarification Necessary? Because activated phosphors are precluded by the factors identified in the last paragraph of Unit II.A. from being considered to be formulated or statutory mixtures, some previous EPA interpretations that such materials need not be reviewed through the new chemicals process were incorrect. As a result of certain past EPA interpretations, some manufacturers of activated phosphors have not submitted new chemical notifications under TSCA VerDate Aug<31>2005 15:31 Jan 15, 2008 Jkt 214001 section 5 because those interpretations incorrectly indicated that activated phosphors were covered for TSCA purposes if the substances used in their manufacture were already on the TSCA Inventory. Other manufacturers have submitted notices for these materials, and they have been given TSCA Inventory listings in some cases. Several industry representatives have asked EPA to clarify the Agency’s chemical identity policy for activated phosphors. EPA now agrees that it is necessary to add listings to the TSCA Inventory for activated phosphors which have been manufactured but not listed, and that it is possible that some existing listings should be altered to describe certain metal components as dopants. This document proposes a clarification to previous interpretations on chemical identity for activated phosphors. With this proposed clarification, activated phosphors that are not on the TSCA Inventory would be considered new chemical substances under TSCA section 5. Because some of the interpretations provided by the agency prior to 2003 led some manufacturers to believe that the products they manufactured were already on the TSCA Inventory if their precursor substances were on the TSCA Inventory, some manufacturers of activated phosphor products have not submitted PMNs required under TSCA section 5. This chemical identification problem is similar to one involving monomer acid and its derivatives, which was resolved through Agencyindustry dialog and a period for submission of new notices (Correction to Chemical Nomenclature for Monomer Acid and Derivatives for TSCA Inventory Purpose published in the Federal Register issue of June 27, 2001 (66 FR 34193) (FRL–6784–6). The Agency is proposing to address this activated phosphor situation in a similar manner. III. Proposed TSCA New Chemicals Program Policy for Activated Phosphor Chemical Identity EPA is proposing that the portion of EPA’s earlier interpretations indicating that activated phosphors are mixtures rather than chemical substances in their own right was erroneous, and that TSCA Inventory listing would be required for these materials. Under this proposal, PMNs would be required for activated phosphors not on the TSCA Inventory (and for which a TSCA section 5(h)(4) exemption has not been granted) and which are manufactured on or after the effective date of the final clarification. In accordance with TSCA Inventory correction guidelines published in the PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 2857 Federal Register issue of July 29, 1980 (45 FR 50544), activated phosphors that were never reported for the Initial TSCA Inventory are not eligible for TSCA Inventory correction as an alternative to PMN submission. A. What is the Basis for and Scope of this Proposed Chemical Identification Clarification? EPA no longer considers to be valid the chemical identity interpretation that activated phosphors are mixtures rather than chemical substances in their own right. Thus listing on the TSCA Inventory established at TSCA section 8(b) is required for these chemical substances. The proposed chemical identity clarification would affect anyone who manufactures or imports, or who plans to manufacture or import, an activated phosphor not now listed on the TSCA Inventory. B. What Are the Key Dates and Provisions of this Proposed Chemical Identification Clarification? The effective date for this proposed new chemical identity clarification, described in Unit II.B. would be 12 months following the date of publication of the final chemical identification clarification document in the Federal Register. Prior to this effective date, companies would be allowed to continue commercial production of non-TSCA Inventory listed activated phosphors under the old, incorrect chemical identity interpretation. After the effective date, any manufacturer making non-TSCA Inventory listed activated phosphors for non-exempt commercial purposes would no longer be in compliance with TSCA section 5. Therefore, companies would need to submit PMNs or exemption applications at least 90 days before the effective date to ensure that Agency review is completed before this chemical identification clarification takes effect. Continued commercial production prior to expiration of the applicable review period would be allowed if it were during the year following the date of publication of the final chemical identification clarification document in the Federal Register and applies only to activated phosphor materials already being made. EPA will work closely with chemical manufacturers and importers to resolve chemical identity issues for any specific material for which the manufacturer believes the incorrect activated phosphor interpretations may still have applicability. To facilitate the PMN process for activated phosphors currently using the incorrect chemical identification, EPA E:\FR\FM\16JAP1.SGM 16JAP1 2858 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules would allow an exception to its TSCA new chemicals program policy of a limit of six chemical substances per consolidation notice for these chemical substances. However, consistent with the Agency’s chemical identification requirements for consolidated notices, submitters must use the Chemical Abstracts Service (CAS) Inventory Expert Service to develop correct Chemical Abstracts (CA) names for all of their reported chemical substances, in accordance with Method 1 as described in the Premanufacture Notification regulations, 40 CFR 720.45(a)(3)(i). EPA encourages persons intending to manufacture activated phosphors to file PMNs using the proper chemical identity immediately instead of delaying their submissions to near the effective date of this proposed document. PMNs filed in response to this chemical identification clarification should, as specified in 40 CFR 720.50, include all information normally included with a PMN submission, such as toxicity data on the PMN chemical substance that are in the possession or control of the PMN submitter, or known to or reasonably ascertainable by the PMN submitter. ebenthall on PRODPC61 with PROPOSALS C. What Are the Consequences of Not Submitting a PMN and Completing PMN Review on an Activated Phosphor Before the Effective Date of this Proposed Chemical Identification Clarification? Starting on the effective date of the final chemical identification clarification document, anyone manufacturing (includes import) for a non–exempt commercial purpose an activated phosphor that is not specifically listed on the TSCA Inventory would be in violation of TSCA. Penalties of $32,500 per violation per day are possible. D. Would a PMN Be Required for Persons Who Did Not Submit One Due to an Incorrect EPA Interpretation, Regardless of Whether They Still Manufacture the Chemical Substance? A PMN would have to be submitted by any person who intends to manufacture or import an activated phosphor not on the TSCA Inventory for a non–exempt commercial purpose on or after the effective date of the final chemical identification clarification document. If future manufacture is not intended, no PMN need be submitted. For example, if you manufactured such a phosphor in 1986 but are not currently manufacturing nor intending to resume manufacture, you would not be required to submit a PMN at this time. However, if you later form an intention to VerDate Aug<31>2005 15:31 Jan 15, 2008 Jkt 214001 manufacture the activated phosphor after the effective date of the final chemical identification clarification document, you would need to submit a PMN 90 days before commencing manufacture. IV. Do Certain Statutory and Executive Order Reviews Apply to this Action? No. This document presents the Agency’s clarification of the TSCA Inventory chemical identification principles. This action is not a regulatory action or significant guidance document under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), as amended by Executive Order 13422 (72 FR 2763, January 23, 2007). As such, this action does not require review by the Office of Management and Budget (OMB) under Executive Order 12866. In addition, Executive Orders 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997) and 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), do not apply to this action because it is not ‘‘economically significant’’ as defined by section 3(f) of Executive Order 12866. Nor does this action establish an environmental standard that may have a negatively disproportionate effect on children, or otherwise have any significant adverse effect on the supply, distribution, or use of energy. This document does not contain any new information collection requirements that would require additional review and approval by OMB under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). The information collection activities related to the submission of information pursuant to TSCA section 5 are already approved by OMB under OMB Control No. 2070–0012 (EPA Information Collection Request [ICR] No.574). The burden for that ICR is estimated to average 100 hours per respondent, including time for reading the regulations, processing, compiling, and reviewing the requested data, generating the request, storing, filing, and maintaining the data. Under PRA, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number, or is otherwise required to submit the specific information by a statute. The OMB control numbers for the EPA regulations that are codified in 40 CFR chapter I, after appearing in the preamble of the final rule, are further displayed either by publication in the PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in a list at 40 CFR 9.1. As indicated previously, this action is not subject to the notice–and–comment requirements under the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.) or any other statute. As such, it is not subject to the provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). Further, this action is expected to only have a limited impact because only entities which are now manufacturing such a chemical substance, and which have not already prepared and submitted a PMN to EPA, must submit a PMN as a result of this action if they intend to continue manufacturing it. Based on EPA’s experience with review of PMNs, State, local, and Tribal governments have not been impacted by these activities, and EPA does not have any reason to believe that any State, local, or Tribal government would be impacted by this action. As such, this action will not have substantial direct effects on the States or on the relationship between the national government and the States or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Nor does this action significantly or uniquely affect the communities of tribal governments as specified by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000). In addition, EPA has determined that this regulatory action would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). This action does not involve any technical standards that require the Agency’s 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). This action will not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and E:\FR\FM\16JAP1.SGM 16JAP1 Federal Register / Vol. 73, No. 11 / Wednesday, January 16, 2008 / Proposed Rules Low-Income Populations (59 FR 7629, February 16, 1994), the Agency is not required to and has not considered environmental justice-related issues. List of Subjects 40 CFR Part 704 Environmental protection, Chemicals, Confidential business information, Hazardous substances, Imports, Reporting and recordkeeping requirements. 40 CFR Part 720 Environmental protection, Chemicals, Hazardous substances, Imports, Reporting and recordkeeping requirements. 40 CFR Part 721 Environmental protection, Administrative practice and procedure, Chemicals, Hazardous substances, Imports, Labeling, Occupational safety and health, Reporting and recordkeeping requirements. 40 CFR Part 723 Environmental protection, Chemicals, Hazardous substances, Photographic industry, Reporting and recordkeeping requirements. Dated: January 10, 2008. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E8–681 Filed 1–15–08; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 67 [Docket No. FEMA–B–7756] Proposed Flood Elevation Determinations Federal Emergency Management Agency, DHS. ACTION: Proposed rule. ebenthall on PRODPC61 with PROPOSALS AGENCY: SUMMARY: Comments are requested on the proposed Base (1 percent annualchance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the VerDate Aug<31>2005 15:31 Jan 15, 2008 Jkt 214001 downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings. DATES: Comments are to be submitted on or before April 15, 2008. ADDRESSES: The corresponding preliminary Flood Insurance Rate Map (FIRM) for the proposed BFEs for each community are available for inspection at the community’s map repository. The respective addresses are listed in the table below. You may submit comments, identified by Docket No. FEMA–B–7756, to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3151, or (e-mail) bill.blanton@dhs.gov. FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3151 or (e-mail) bill.blanton@dhs.gov. SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency (FEMA) proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a). These proposed BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 2859 buildings built after these elevations are made final, and for the contents in these buildings. Comments on any aspect of the Flood Insurance Study and FIRM, other than the proposed BFEs, will be considered. A letter acknowledging receipt of any comments will not be sent. Administrative Procedure Act Statement. This matter is not a rulemaking governed by the Administrative Procedure Act (APA), 5 U.S.C. 553. FEMA publishes flood elevation determinations for notice and comment; however, they are governed by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and the National Flood Insurance Act of 1968, 42 U.S.C. 4001, et seq., and do not fall under the APA. National Environmental Policy Act. This proposed rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601–612, a regulatory flexibility analysis is not required. Executive Order 12866, Regulatory Planning and Review. This proposed rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866, as amended. Executive Order 13132, Federalism. This proposed rule involves no policies that have federalism implications under Executive Order 13132. Executive Order 12988, Civil Justice Reform. This proposed rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 67 Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements. Accordingly, 44 CFR part 67 is proposed to be amended as follows: PART 67—[AMENDED] 1. The authority citation for part 67 continues to read as follows: Authority: 42 U.S.C. 4001, et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. § 67.4 [Amended] 2. The tables published under the authority of § 67.4 are proposed to be amended as follows: E:\FR\FM\16JAP1.SGM 16JAP1

Agencies

[Federal Register Volume 73, Number 11 (Wednesday, January 16, 2008)]
[Proposed Rules]
[Pages 2854-2859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-681]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 704, 720, 721, and 723

[EPA-HQ-OPPT-2007-0392; FRL-8131-8]
RIN 2070-AJ21


Proposed Clarification for Chemical Identification Describing 
Activated Phosphors for TSCA Inventory Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed clarification.

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SUMMARY: This document proposes a clarification under which activated 
phosphors that are not on the Toxic Substances Control Act (TSCA) 
section 8(b) Chemical Substance Inventory (TSCA Inventory) would be 
considered to be new chemical substances under TSCA section 5, thus 
would be subject to the notification requirements under TSCA section 
5(a) new chemical notification requirements. In certain letters and 
other interpretations issued by EPA from 1978 to 2003, it appears that 
the Agency erroneously indicated that activated phosphors constitute 
solid mixtures for purposes of the TSCA Inventory, and thus that they 
were not separately reportable as chemical substances under TSCA 
section 5(a) new chemical notification requirements. This proposed 
clarification is necessary because EPA's interpretations in this area 
have not been consistent. Given this past inconsistency, EPA is seeking 
comment on its proposed clarfication.

DATES: Comments must be received on or before March 17, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2007-0392, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2007-0392. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0392. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, will be publicly available only in hard copy. Publicly 
available docket

[[Page 2855]]

materials are available electronically at http://www.regulations.gov, 
or, if only available in hard copy, at the OPPT Docket. The OPPT Docket 
is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West 
Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public 
Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding Federal holidays. The telephone number of the 
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number 
for the OPPT Docket is (202) 566-0280. Docket visitors are required to 
show photographic identification, pass through a metal detector, and 
sign the EPA visitor log. All visitor bags are processed through an X-
ray machine and subject to search. Visitors will be provided an EPA/DC 
badge that must be visible at all times in the building and returned 
upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: David Schutz, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9262; e-mail 
address: schutz.david@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are, or may in the future 
be, a manufacturer or importer of an activated phosphor that requires 
submission of a premanufacture notification (PMN) or exemption request 
under TSCA section 5. Special procedures would apply to persons who 
manufactured these chemicals after the publication of the Initial TSCA 
Inventory and before a date 12 months following the publication of a 
final chemical identification clarification document in the Federal 
Register. Potentially affected entities may include, but are not 
limited to:
     Chemical manufacturers or importers (NAICS codes 325, 
3251), e.g., anyone who manufactures or imports, or who plans to 
manufacture or import, an activated phosphor for a non-exempt 
commercial purpose.
     Electric Lighting Equipment Manufacturing, Electric Lamp 
Bulb and Part Manufacturing (NAICS codes 3351, 33511), e.g., anyone who 
manufactures or imports, or who plans to manufacture or import, 
lighting equipment containing an activated phosphor for a non-exempt 
commercial purpose.
    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 technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM 
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and 
then identify electronically within the disk or CD-ROM the specific 
information that is claimed as CBI. In addition to one complete version 
of the comment that includes information claimed as CBI, a copy of the 
comment that does not contain the information claimed as CBI must be 
submitted for inclusion in the public docket. Information so marked 
will not be disclosed except in accordance with procedures set forth in 
40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    This action proposes a clarification in the approach used for the 
chemical identification of activated (doped) phosphors for purposes of 
listing on the TSCA Inventory. A doped or activated phosphor is a 
substance resulting from the chemical combination of a mixture of metal 
oxides, carbonates, phosphates or acid phosphates, chlorides, and/or 
fluorides, most frequently by sintering, along with a small amount of 
one or more dopants. Dopants can include such chemical substances as 
antimony, europium, gallium, germanium, magnesium, manganese, 
strontium, or yttrium. When this material is electrically excited, it 
emits light. The color and electrical efficiency of light emission is a 
function of the parent phosphor and of the dopant which is present.
    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to 
compile and keep current an inventory of chemical substances 
manufactured, imported, or processed for commercial purposes in the 
United States. This inventory is known as the TSCA Chemical Substances 
Inventory (TSCA Inventory). In 1977, EPA promulgated a rule published 
in the Federal Register issue of December 23, 1977 (42 FR 64572) under 
TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of 
chemical substances in commerce at that time. In 1983, and building on 
several earlier interim policies, EPA promulgated a rule published in 
the Federal Register issue of May 13, 1983 (48 FR 21722) under TSCA 
section 5, 15 U.S.C. 2604, to keep the TSCA Inventory up-to-date 
through a procedure for the submission, receipt, and health and safety 
review of PMNs covering chemical substances not yet in commerce from 
their intending manufacturers and importers.
    Manufacturing, importing, or processing of a new chemical is 
illegal prior to the expiration of the PMN review period. Once EPA 
receives a PMN, the Agency has 90 days to review the notice (unless for 
good cause EPA extends the review period). During the review period, 
EPA may act under TSCA section 5(e) or 5(f) to regulate the

[[Page 2856]]

new chemical substance. If EPA has not prohibited manufacture or import 
of the chemical substance during the review period, these activities 
may begin subject to any restrictions or testing requirements imposed 
upon the submitter during the review period (these restrictions may be 
imposed upon others via a Significant New Use Rule (SNUR) and 
subsequent action under TSCA section 5(e) or 5(f) taken in follow-up to 
a significant new use notification (SNUN)). When manufacture or import 
begins, the notice submitter must provide a notice of commencement, 
after which EPA adds the chemical substance to the TSCA Inventory. If 
the Agency receives a PMN submission for a chemical substance which EPA 
determines is excluded from consideration as a chemical substance under 
TSCA (generally because it meets the criteria for one of the excepted 
categories at TSCA section 3(2)(B), which include mixtures, pesticides, 
tobacco, food, drugs, etc.) it will not accept the PMN. A similar 
practice was followed as well during the period 1978-1979, when the EPA 
was accepting submissions for the Initial TSCA Inventory, and during 
1979-1983, prior to promulgation of the May 13, 1983 PMN rule.
    Partly as a result of the Agency's incomplete information and 
understanding of the chemistry involved in manufacturing activated 
phosphors, from 1978 through 2003 EPA has been inconsistent in its 
interpretation to potential submitters and in its actions regarding 
whether activated phosphors are considered distinct chemical substances 
for purposes of the TSCA Inventory. During the period 1978-1979, when 
EPA received submissions for the Initial TSCA Inventory, it accepted a 
number of doped phosphors for listing, but in other cases it sent 
``problem letters'' to the manufacturers of doped phosphors indicating 
that they were mixtures.
    In October 1979, the Agency wrote to a lighting manufacturer and 
stated that such listings could be ``unnecessary'' and that their 
continued inclusion on the TSCA Inventory would be ``closely 
examined.'' In January 1980, a lighting manufacturer wrote to the 
Agency to challenge problem letters it had received. The manufacturer 
stated that the materials it manufactured should be excluded from 
mixture status because they had characteristic crystal structures and 
that volatile reaction products given off during their manufacture 
showed that chemical synthesis was occurring. In March 1982, the Agency 
wrote to a lighting manufacturer and suggested that activated phosphors 
could be regarded either as physically altered chlorophosphates or as 
mixtures, thus not subject to PMN. In August 1983, the Agency wrote to 
the lighting manufacturer which had challenged the problem letters and 
informed it that the materials had, in fact, been placed on the TSCA 
Inventory, and in addition that a PMN was appropriate for another 
activated phosphor but that ``low levels'' of an activator would not 
require separate PMN.
    In January 1993, a lighting manufacturer submitted a Low Volume 
Exemption (LVE) Application for an activated phosphor with a letter 
referencing much of the history as described in this unit and asserting 
that, based on Agency positions, no submission should be necessary, but 
the Agency did accept the application and granted the LVE. After that 
LVE was granted, the manufacturer submitted a letter making the case 
that activated phosphors should, in fact, be considered to be mixtures 
and requesting that the Agency issue a clarifying statement. In 
response, the Agency met with the manufacturer on the issue and 
indicated that activated phosphors should be considered chemical 
substances instead of mixtures, but did not issue a written 
clarification.
    In 1995, EPA issued the publication entitled Toxic Substances 
Control Act Inventory Representation for Products Containing Two or 
More Substances: Formulated and Statutory Mixtures (Formulated and 
Statutory Mixtures), available at http://www.epa.gov/opptintr/newchems/
pubs/mixtures.txt), which interpreted the mixture definition given at 
40 CFR 710.3(d) and 720.3(u):

    Mixture means any combination of two or more chemical substances 
if the combination does not occur in nature and is not, in whole or 
in part, the result of a chemical reaction; except ``mixture'' does 
include (1) any combination which occurs, in whole or in part, as a 
result of a chemical reaction if the combination could have been 
manufactured for commercial purposes without a chemical reaction at 
the time the chemical substances comprising the combination were 
combined, and if all of the chemical substances comprising the 
combination are not new chemical substances, and (2) hydrates of a 
chemical substance or hydrated ions formed by association of a 
chemical substance with water, so long as the nonhydrated form is 
itself not a new chemical substance.

    Formulated and Statutory Mixtures discusses common examples of 
mixtures, including paints, blended fuels, and solvent combinations. 
``Mixture'' can include, as well, solid solutions--homogeneous 
crystalline phases composed of several distinct chemical species. 
Alloys are solid solutions, and are considered mixtures. For the 
purposes of TSCA, multi-component blends or formulations of chemical 
substances, or certain reaction product combinations which can be 
completely characterized as consistently formed sets of their 
constituent chemical substances, are considered to be mixtures of 
chemical substances. Mixtures are not reportable, although their 
constituent chemical substances are. Most important in the context of 
this clarification, a mixture can often provide its function over some 
range of constituent ratios, consequently it is unusual if the ratios 
of chemical substances which comprise a mixture are necessarily 
definite or stoichiometric, and if the mixture components are 
deliberately reacted together to manufacture a chemical substance, this 
reaction product cannot be considered a mixture for TSCA purposes 
except in very specialized circumstances which are not present in the 
case of the activated phosphors.
    In June 1998, a lighting manufacturer wrote to the Agency and 
stated that, in the absence of any negative response by the Agency 
within 60 days of the letter, it intended to rely on the interpretation 
in Formulated and Statutory Mixtures, and that it believed that that 
interpretation precluded TSCA Inventory listing for activated 
phosphors. The Agency did not respond to that letter. Based on a 2003 
request from a lighting manufacturer, and cognizant of the history 
described in this unit, EPA held a meeting with the manufacturer in 
September 2003 and as a result has reexamined some earlier 
assumptions--particularly about non-stoichiometry and non-reaction 
between chemical substances used to make activated phosphors--which may 
have led it to believe that activated phosphors could be considered 
mixtures.
    The result of this reexamination is this clarification that 
individual activated phosphors should be considered to be distinct 
chemical substances under TSCA. EPA's clarification on the potential 
need to report activated phosphor materials is based on its updated 
understanding about reactions and stoichiometry in activated phosphors, 
as follows: Activated phosphors are in general synthesized by means of 
a solid state reaction at high temperature and using precise quantities 
of the precursor chemical substances, both for the base materials and 
for the dopants which control the quality of light emitted. Precise 
ratios of component materials are used to maintain strict stoichiometry 
in the end product, and component

[[Page 2857]]

materials are thoroughly blended before reaction for uniformity of the 
product. Heat may be absorbed or released by the reactant mixture at 
certain temperatures, typically by the release of water: This is 
generally an indication of chemical substance synthesis. During the 
manufacture of activated phosphors, other volatile reaction products 
are often emitted, another indication that chemical substances are 
being formed. The phosphor and the amount of dopant added need to be 
controlled with high precision, and during sintering the doped phosphor 
undergoes oxidation state changes. Consequently, EPA believes that 
activated phosphors cannot be manufactured for commercial purposes 
without chemical reaction. Additionally, activated phosphor products 
have a different function from the material which would be produced by 
the same synthetic process in the absence of dopant, and which would 
not emit the characteristic light, which is the primary property 
sought. Because dopants provide the primary property sought from these 
materials, small or even trace amounts of dopant must be considered to 
be reactants which must be included in the chemical identity. These 
factors preclude these materials from being considered as ``mixtures.''

B. What is the Agency's Authority for Taking this Action?

    Section 5 of TSCA requires any person who intends to manufacture 
(defined by statute to include import) a new chemical substance (i.e., 
a chemical substance not on the TSCA Inventory) to notify EPA at least 
90 days in advance and comply with the statutory provisions pertaining 
to the manufacture of new chemical substances for non-exempt commercial 
purposes. Section 8(b) of TSCA requires EPA to compile, keep current, 
and publish a list of each chemical substance which is manufactured or 
processed in the United States (the TSCA Inventory). This requirement 
includes defining the scope of the listings on the TSCA Inventory.

C. Why is this Proposed Chemical Identity Clarification Necessary?

    Because activated phosphors are precluded by the factors identified 
in the last paragraph of Unit II.A. from being considered to be 
formulated or statutory mixtures, some previous EPA interpretations 
that such materials need not be reviewed through the new chemicals 
process were incorrect. As a result of certain past EPA 
interpretations, some manufacturers of activated phosphors have not 
submitted new chemical notifications under TSCA section 5 because those 
interpretations incorrectly indicated that activated phosphors were 
covered for TSCA purposes if the substances used in their manufacture 
were already on the TSCA Inventory. Other manufacturers have submitted 
notices for these materials, and they have been given TSCA Inventory 
listings in some cases. Several industry representatives have asked EPA 
to clarify the Agency's chemical identity policy for activated 
phosphors. EPA now agrees that it is necessary to add listings to the 
TSCA Inventory for activated phosphors which have been manufactured but 
not listed, and that it is possible that some existing listings should 
be altered to describe certain metal components as dopants. This 
document proposes a clarification to previous interpretations on 
chemical identity for activated phosphors. With this proposed 
clarification, activated phosphors that are not on the TSCA Inventory 
would be considered new chemical substances under TSCA section 5.
    Because some of the interpretations provided by the agency prior to 
2003 led some manufacturers to believe that the products they 
manufactured were already on the TSCA Inventory if their precursor 
substances were on the TSCA Inventory, some manufacturers of activated 
phosphor products have not submitted PMNs required under TSCA section 
5. This chemical identification problem is similar to one involving 
monomer acid and its derivatives, which was resolved through Agency-
industry dialog and a period for submission of new notices (Correction 
to Chemical Nomenclature for Monomer Acid and Derivatives for TSCA 
Inventory Purpose published in the Federal Register issue of June 27, 
2001 (66 FR 34193) (FRL-6784-6). The Agency is proposing to address 
this activated phosphor situation in a similar manner.

III. Proposed TSCA New Chemicals Program Policy for Activated Phosphor 
Chemical Identity

    EPA is proposing that the portion of EPA's earlier interpretations 
indicating that activated phosphors are mixtures rather than chemical 
substances in their own right was erroneous, and that TSCA Inventory 
listing would be required for these materials. Under this proposal, 
PMNs would be required for activated phosphors not on the TSCA 
Inventory (and for which a TSCA section 5(h)(4) exemption has not been 
granted) and which are manufactured on or after the effective date of 
the final clarification. In accordance with TSCA Inventory correction 
guidelines published in the Federal Register issue of July 29, 1980 (45 
FR 50544), activated phosphors that were never reported for the Initial 
TSCA Inventory are not eligible for TSCA Inventory correction as an 
alternative to PMN submission.

A. What is the Basis for and Scope of this Proposed Chemical 
Identification Clarification?

    EPA no longer considers to be valid the chemical identity 
interpretation that activated phosphors are mixtures rather than 
chemical substances in their own right. Thus listing on the TSCA 
Inventory established at TSCA section 8(b) is required for these 
chemical substances. The proposed chemical identity clarification would 
affect anyone who manufactures or imports, or who plans to manufacture 
or import, an activated phosphor not now listed on the TSCA Inventory.

B. What Are the Key Dates and Provisions of this Proposed Chemical 
Identification Clarification?

    The effective date for this proposed new chemical identity 
clarification, described in Unit II.B. would be 12 months following the 
date of publication of the final chemical identification clarification 
document in the Federal Register. Prior to this effective date, 
companies would be allowed to continue commercial production of non-
TSCA Inventory listed activated phosphors under the old, incorrect 
chemical identity interpretation. After the effective date, any 
manufacturer making non-TSCA Inventory listed activated phosphors for 
non-exempt commercial purposes would no longer be in compliance with 
TSCA section 5. Therefore, companies would need to submit PMNs or 
exemption applications at least 90 days before the effective date to 
ensure that Agency review is completed before this chemical 
identification clarification takes effect. Continued commercial 
production prior to expiration of the applicable review period would be 
allowed if it were during the year following the date of publication of 
the final chemical identification clarification document in the Federal 
Register and applies only to activated phosphor materials already being 
made.
    EPA will work closely with chemical manufacturers and importers to 
resolve chemical identity issues for any specific material for which 
the manufacturer believes the incorrect activated phosphor 
interpretations may still have applicability.
    To facilitate the PMN process for activated phosphors currently 
using the incorrect chemical identification, EPA

[[Page 2858]]

would allow an exception to its TSCA new chemicals program policy of a 
limit of six chemical substances per consolidation notice for these 
chemical substances. However, consistent with the Agency's chemical 
identification requirements for consolidated notices, submitters must 
use the Chemical Abstracts Service (CAS) Inventory Expert Service to 
develop correct Chemical Abstracts (CA) names for all of their reported 
chemical substances, in accordance with Method 1 as described in the 
Premanufacture Notification regulations, 40 CFR 720.45(a)(3)(i). EPA 
encourages persons intending to manufacture activated phosphors to file 
PMNs using the proper chemical identity immediately instead of delaying 
their submissions to near the effective date of this proposed document.
    PMNs filed in response to this chemical identification 
clarification should, as specified in 40 CFR 720.50, include all 
information normally included with a PMN submission, such as toxicity 
data on the PMN chemical substance that are in the possession or 
control of the PMN submitter, or known to or reasonably ascertainable 
by the PMN submitter.

C. What Are the Consequences of Not Submitting a PMN and Completing PMN 
Review on an Activated Phosphor Before the Effective Date of this 
Proposed Chemical Identification Clarification?

    Starting on the effective date of the final chemical identification 
clarification document, anyone manufacturing (includes import) for a 
non-exempt commercial purpose an activated phosphor that is not 
specifically listed on the TSCA Inventory would be in violation of 
TSCA. Penalties of $32,500 per violation per day are possible.

D. Would a PMN Be Required for Persons Who Did Not Submit One Due to an 
Incorrect EPA Interpretation, Regardless of Whether They Still 
Manufacture the Chemical Substance?

    A PMN would have to be submitted by any person who intends to 
manufacture or import an activated phosphor not on the TSCA Inventory 
for a non-exempt commercial purpose on or after the effective date of 
the final chemical identification clarification document. If future 
manufacture is not intended, no PMN need be submitted. For example, if 
you manufactured such a phosphor in 1986 but are not currently 
manufacturing nor intending to resume manufacture, you would not be 
required to submit a PMN at this time. However, if you later form an 
intention to manufacture the activated phosphor after the effective 
date of the final chemical identification clarification document, you 
would need to submit a PMN 90 days before commencing manufacture.

IV. Do Certain Statutory and Executive Order Reviews Apply to this 
Action?

    No. This document presents the Agency's clarification of the TSCA 
Inventory chemical identification principles. This action is not a 
regulatory action or significant guidance document under Executive 
Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 
October 4, 1993), as amended by Executive Order 13422 (72 FR 2763, 
January 23, 2007). As such, this action does not require review by the 
Office of Management and Budget (OMB) under Executive Order 12866. In 
addition, Executive Orders 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997) and 13211, entitled Actions Concerning Regulations that 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001), do not apply to this action because it is not 
``economically significant'' as defined by section 3(f) of Executive 
Order 12866. Nor does this action establish an environmental standard 
that may have a negatively disproportionate effect on children, or 
otherwise have any significant adverse effect on the supply, 
distribution, or use of energy.
    This document does not contain any new information collection 
requirements that would require additional review and approval by OMB 
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). The 
information collection activities related to the submission of 
information pursuant to TSCA section 5 are already approved by OMB 
under OMB Control No. 2070-0012 (EPA Information Collection Request 
[ICR] No.574). The burden for that ICR is estimated to average 100 
hours per respondent, including time for reading the regulations, 
processing, compiling, and reviewing the requested data, generating the 
request, storing, filing, and maintaining the data. Under PRA, an 
agency may not conduct or sponsor, and a person is not required to 
respond to a collection of information unless it displays a currently 
valid OMB control number, or is otherwise required to submit the 
specific information by a statute. The OMB control numbers for the EPA 
regulations that are codified in 40 CFR chapter I, after appearing in 
the preamble of the final rule, are further displayed either by 
publication in the Federal Register or by other appropriate means, such 
as on the related collection instrument or form, if applicable. The 
display of OMB control numbers for certain EPA regulations is 
consolidated in a list at 40 CFR 9.1.
    As indicated previously, this action is not subject to the notice-
and-comment requirements under the Administrative Procedure Act (APA) 
(5 U.S.C. 551 et seq.) or any other statute. As such, it is not subject 
to the provisions of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.). Further, this action is expected to only have a limited 
impact because only entities which are now manufacturing such a 
chemical substance, and which have not already prepared and submitted a 
PMN to EPA, must submit a PMN as a result of this action if they intend 
to continue manufacturing it.
    Based on EPA's experience with review of PMNs, State, local, and 
Tribal governments have not been impacted by these activities, and EPA 
does not have any reason to believe that any State, local, or Tribal 
government would be impacted by this action. As such, this action will 
not have substantial direct effects on the States or on the 
relationship between the national government and the States or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Nor does this action significantly or 
uniquely affect the communities of tribal governments as specified by 
Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 9, 2000). In addition, 
EPA has determined that this regulatory action would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4).
    This action does not involve any technical standards that require 
the Agency's 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).
    This action will not have an adverse impact on the environmental 
and health conditions in low-income and minority communities. 
Therefore, under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and

[[Page 2859]]

Low-Income Populations (59 FR 7629, February 16, 1994), the Agency is 
not required to and has not considered environmental justice-related 
issues.

List of Subjects

40 CFR Part 704

    Environmental protection, Chemicals, Confidential business 
information, Hazardous substances, Imports, Reporting and recordkeeping 
requirements.

40 CFR Part 720

    Environmental protection, Chemicals, Hazardous substances, Imports, 
Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Administrative practice and procedure, 
Chemicals, Hazardous substances, Imports, Labeling, Occupational safety 
and health, Reporting and recordkeeping requirements.

40 CFR Part 723

    Environmental protection, Chemicals, Hazardous substances, 
Photographic industry, Reporting and recordkeeping requirements.


    Dated: January 10, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E8-681 Filed 1-15-08; 8:45 am]
BILLING CODE 6560-50-S