[Federal Register Volume 59, Number 69 (Monday, April 11, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-8465] [[Page Unknown]] [Federal Register: April 11, 1994] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 750 and 761 [OPPTS-66011A; FRL 4766-5] RIN 2070-AB20 Polychlorinated Biphenyls; Exemptions From Prohibition Against Manufacturing, Processing, and Distribution in Commerce, and Use Authorization AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: Section 6(e) of the Toxic Substances Control Act (TSCA) bans the manufacture, processing, distribution in commerce, and the use of PCBs unless the PCBs are totally enclosed. Section 6(e) gives EPA authority, however, to authorize these activities if the Administrator finds that they will not present an unreasonable risk of injury to health and the environment. This final rule addresses six individual petitions under TSCA section 6(e)(3)(B) for exemptions from the prohibition against the manufacture, processing and distribution in commerce of polychlorinated biphenyls (PCBs). In this final rule, EPA denies two petitions and grants three petitions; the sixth petition has been withdrawn by the petitioner. EPA is also promulgating one use authorization under TSCA section 6(e)(2)(B). In addition, EPA is amending the Interim Procedural Rules at 40 CFR part 750 to require certain petitioners to reapply for EPA approval to continue PCB activities that EPA has previously approved. DATES: This final rule shall become effective May 25, 1994. In accordance with 40 CFR 23.5 (50 FR 7271), this rule shall be promulgated for purposes of judicial review at 1 p.m. eastern daylight time on April 25, 1994. FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Rm. E-543B, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551, FAX: (202) 554-5603 (document requests only). SUPPLEMENTARY INFORMATION: Section 6(e) of the Toxic Substances Control Act (TSCA) bans the manufacture, processing, distribution in commerce, and the use of PCBs unless the PCBs are totally enclosed. Section 6(e) gives EPA authority, however, to authorize these PCB activities if the Administrator finds that they will not present an unreasonable risk of injury to health or the environment. TSCA provides that EPA may set terms and conditions, including recordkeeping and reporting requirements, for granting an exemption. I. Background A. Statutory Authority Section 6(e) of TSCA, 15 U.S.C. 2605(e), generally prohibits the manufacture of PCBs after January 1, 1979, the processing and distribution in commerce of PCBs after July 1, 1979, and the use of PCBs after October 11, 1977, unless otherwise authorized. While, section 6(e)(2)(A) of TSCA bans the use of PCBs in any manner other than a totally enclosed manner, section 6(e)(2)(B) provides that the Administrator may by rule authorize the use of PCBs if such use will not present an unreasonable risk of injury to health or the environment. Section 6(e)(3)(A) of TSCA prohibits the manufacture, processing, and distribution in commerce of PCBs in a manner other than totally enclosed. Section 6(e)(3)(B) provides that any person may petition the Administrator for an exemption from the prohibition on the manufacture, processing, and distribution in commerce of PCBs. The Administrator may by rule grant an exemption if the Administrator finds that ``(i) an unreasonable risk of injury to health or the environment would not result, and (ii) good faith efforts have been made to develop a chemical substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for such polychlorinated biphenyl'' (15 U.S.C. 2605(e)(3)(B)(i) - (ii)). The Administrator may set terms and conditions for an exemption and may grant an exemption for not more than 1 year. B. Regulatory Authority EPA's Interim Procedural Rule for Manufacturing, Processing, and Distribution in Commerce Exemptions describes the required content for the manufacturing, processing, and distribution in commerce exemption petitions and the procedures EPA follows in rulemaking on exemption petitions. Those rules were published initially in the Federal Register of November 1, 1978 (43 FR 50905), and of May 31, 1979 (44 FR 31558) and are codified at 40 CFR 750.10 through 750.41. EPA's Procedural Rule for rulemaking under section 6 of TSCA, which governs use authorizations for PCBs, is found at 40 CFR 750.1 through 750.9. C. History of this Rulemaking EPA received for consideration six new exemption petitions under TSCA section 6(e)(3)(B) which are the subject of this final rule. The requests for exemption are as follows: 1. Petition for approval to distribute in commerce for export small quantities of PCBs for the purpose of research and development (ManTech Environmental Technology Inc., petitioner). 2. Petition for approval to process and distribute in commerce for export small quantities of PCBs for the purpose of research and development (Restek Corporation, petitioner). 3. Petition for approval to import from Canada, PCBs in oil and soil for laboratory analysis, and to export the unused portions of these samples following their analysis (National Chem Lab, petitioner). 4. Petition for approval to import capacitors and voltage transformers, which were inadvertently shipped into Canada, back to the United States for the purpose of disposal (General Motors, petitioner). The General Motors' petition was subsequently withdrawn. 5. Petition for approval to distribute in commerce for export PCB- Contaminated Transformers for salvage to the Far East (Joseph Simon Sons, petitioner). 6. Petition for approval to process and distribute in commerce analytical reference samples derived from actual waste materials (R.T. Corporation, petitioner). The proposed rule for these exemption petitions and the amendment to the Interim Procedural Rules were published on March 2, 1992 (57 FR 7349). No substantive comments were received on the proposal that would impact EPA's decision to grant or deny a particular exemption petition. However, the Small Business Administration commented on whether EPA had properly exercised its certification authority under the Regulatory Flexibility Act (RFA) and had fully articulated its reasons for certifying there was no significant impact on a substantial number of small entities. This comment resulted in changes to the language under unit VIII.B. of the preamble to this final rule, where the authority to make the certification under the RFA and EPA's rationale for the certification is stated more precisely. In addition, comments were received concerning the Interim Procedural Rules. (See unit VII - Changes to the Interim Procedural Rules). II. Unreasonable Risk Finding Section 6(e)(3)(B)(i) of TSCA requires a petitioner to demonstrate that granting an exemption would not result in an unreasonable risk of injury to health or the environment. To determine whether a risk is unreasonable, EPA balances the probability that harm will occur to health or the environment against the benefits to society from granting or denying each petition. Specifically, EPA considers the following factors: A. Effects of PCBs on Human Health and the Environment In deciding whether to grant an exemption, EPA considers the magnitude of exposure and the effects of PCBs on humans and the environment. 1. Health effects. EPA has determined that PCBs are toxic and persistent. PCBs can enter the body through the lungs, gastrointestinal tract, and skin, can circulate throughout the body, and can be stored in the fatty tissue. 2. Environmental effects. Certain PCB congeners are among the most stable chemicals known, which decompose very slowly once they are released in the environment. PCBs are absorbed and stored in the fatty tissue of higher organisms as they bioaccumulate up the food chain through invertebrates, fish, and mammals. This ultimately results in human exposure through consumption of PCB-containing food sources. 3. Risks. Toxicity and exposure are the two basic components of risk. Based on animal data, EPA concluded that in addition to chloracne, PCBs may cause developmental toxicity, reproductive effects, and oncogenicity in humans. EPA also concluded that PCBs present a hazard to the environment. A lengthy discussion of these factors is provided in the preamble to the August 24, 1988 proposed exemption rule (53 FR 32327) (Docket No. OPTS 66008F). B. Benefits and Costs The benefits to society of granting an exemption vary, depending on the activity for which the exemption is requested. The reasonably ascertainable costs of denying an exemption vary, depending on the individual petitioner. EPA has taken benefits and costs into consideration when evaluating each exemption petition. III. Good Faith Efforts Finding Section 6(e)(3)(B)(ii) of TSCA requires petitioners to demonstrate a good faith effort to develop a chemical substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for PCBs. EPA considers several factors in determining whether a petitioner has demonstrated good faith efforts. For each petition, EPA considers the kind of exemption the petitioner is requesting and whether the petitioner expended time and effort to develop or search for a substitute. In each case, the burden is on the petitioner to show specifically what it did to substitute non-PCB material for PCBs or to show why it was not feasible to substitute non- PCBs for PCBs. To satisfy this finding for requests for an exemption to import PCBs, a petitioner must show why such activity must occur in the United States and what steps will be taken to eliminate the need to import PCBs in the future. IV. Explanation of Class Exemption for Research and Development Distinct from its authority to exempt PCBs from the ban on manufacturing, processing, and distribution in commerce, EPA may also authorize the use of PCBs. EPA authorized, indefinitely, the use of PCBs in small quantities for research and development in the Use Authorization Rule, 40 CFR 761.30(j), published in the Federal Register of July 10, 1984 (Docket No. OPTS 66008B). ``Small quantities for research and development'' is defined at 40 CFR 761.3 as ``any quantity of PCBs (1) that is originally packaged in one or more hermetically sealed containers of a volume of no more than five (5.0) milliliters, and (2) that is used only for purposes of scientific experimentation or analysis, or chemical research on, or analysis of PCBs, but not for research or analysis for the development of a PCB product.'' The processing and distribution in commerce of PCBs in small quantities for use in research and development is allowed via a class exemption in the PCB Exemptions Rule, 40 CFR 761.80(g), published in the Federal Register of August 8, 1986 (51 FR 28556) (Docket No. OPTS 66008E). This rule eliminated the need for each person who processes and distributes PCBs in commerce to file an individual exemption petition. EPA placed the following terms and conditions on the class exemption: (a) That all processors and distributors maintain records of their PCB activities for a period of 5 years; and (b) that any person or company that expects to distribute in commerce 100 grams (0.22 lb.) or more of PCBs for research and development in 1 year must report to EPA and identify the sites of PCB activities and the quantities of PCBs to be distributed in commerce. At that time EPA stated it would automatically renew the class exemption unless the petitioner changed the quantity of PCBs or manner of processing and distributing PCBs in commerce. In granting a class exemption, EPA retains the authority to terminate the class exemption, or to exclude any distributor from the class exemption, upon determining that the activities allowed in the class exemption will pose an unreasonable risk of injury to health or the environment. Any changes in the disposition of the class exemption, or the status of individuals within the class exemption, will be published in a notice of proposed rulemaking; and members of the class will be allowed to continue activities until a final rule is promulgated. V. Disposition of Pending Exemption Petitions A. Import EPA received one exemption petition to import PCBs. General Motors Corp. (GMC). On August 31, 1987, GMC requested an exemption to import PCBs into the United States from Canada, solely for the purpose of disposal, in indoor constant voltage transformers. On February 14, 1991, GMC withdrew this petition. As a result, no action was taken by EPA on the GMC exemption petition. B. Import and Export EPA received one exemption petition to import and export PCBs. National Chem Lab. On December 3, 1987, EPA received a petition from National Chem Lab to import small test samples of oil and soil from Canadian Electric Utilities, and to export these samples following their analysis. a. Current petition. The sample sizes would be less than 6 milliliters per sample of oil and less than 4 ounces of soil. These samples would then be analyzed for PCB content. Following their analysis these small laboratory test samples would be exported back to the utility that submitted them. National Chem Lab estimates that 5.072 ounces by volume or 0.283 pounds by weight of PCBs would be utilized per year. These figures were based on a sample submittal rate of 10,000 per year with 15 percent of the submitted samples containing PCB concentrations over 50 ppm. The residue that evolves from distillation of the solvent used in the extraction process would be packaged in a common Department of Transportation (DOT) approved container and sent to an incinerator for disposal as required by the PCB disposal rules of 40 CFR 761.60. The extremely small amounts of PCBs that would be retained by National Chem Lab in testing for a contamination level would be disposed of in the United States as required in the PCB disposal rules. The economic consequences of denial would cost National Chem Lab an estimated income of $150,000 per year and result in a staffing level of three fewer employees. National Chem Lab also maintained that this exemption would enable it to expand its facilities and generate jobs in an area of Eastern Washington which badly needs jobs in non-agricultural enterprises. b. Decision on petition. EPA has determined to deny this exemption petition. EPA has determined that the import (manufacture) of PCBs into the United States and the distribution in commerce of PCBs present an unreasonable risk of injury to health and the environment (See 40 CFR 761.20 and 44 FR 31514, 31537, May 31, 1979). EPA has also stated that ``[i]t is the clear intent of TSCA to minimize the addition of PCBs to the environment of the United States.'' Id. In 1980, EPA closed the border to encourage foreign countries to develop their own capacity for properly handling and disposing of PCB waste. (See 45 FR 29115, May 1, 1980, filed at Docket No. OPTS 66008). Also, National Chem Lab has failed to provide evidence that both Canadian and provincial border officials will accept the PCBs when they are returned to Canada upon completion of the PCB analysis. Further, EPA has determined that the petitioner has not met the good faith efforts criterion. Although no non-PCB substitutes for PCB analytical standards currently exist, the petitioner has not demonstrated or provided any convincing rationale as to why there is a necessity for the PCBs to be imported into the United States, solely for the purpose of analysis. According to the Canadian Association for Environmental Analytical Laboratories, there are analytical laboratories within Canada for conducting PCB analysis (See Docket No. OPTS 66011). EPA does not want to encourage the expansion of PCB products or PCB services for companies when there are feasible alternatives already in place. Implied in the petitioner's exemption application is a request to export the samples after analysis. Since EPA is denying the request to import, it is not addressing the request to export the samples back to their site of generation after analysis. No comments were submitted to EPA for further consideration during the comment period. C. Export EPA received two petitions relating to PCBs involved in research and development. Also, the same petitioners requested to export the PCBs. These petitions are discussed in this section. In addition, this section addresses the petition to export and distribute in commerce drained PCB-Contaminated Transformers. 1. ManTech Environmental Technology, Inc. and Subsidiary (ManTech). On November 16, 1987, NSIT (formerly known as Northrop Services, Inc.) submitted an exemption petition to export small quantities of PCBs for research and development to the international monitoring community for use in the identification and quantification of environmental contaminants. The annual export amount is estimated to be less than 500 grams of PCBs. On February 12, 1991, NSIT amended its petition and notified EPA that the company name had been changed to ManTech. a. Current petition. ManTech obtains PCBs for environmental monitoring purposes and prepares analytical reference standards which are provided for a charge to laboratories engaged in monitoring activities. The PCB standards will be available in solution (1.5 ml each) or in neat, essentially pure form in 50 to 100 mg aliquots. PCBs in the form of Aroclor mixtures as well as individual isomers, will be distributed in sealed 2-ml ampuls in accordance with the class exemption requirements. The total amount of PCBs to be exported in 1 year will not exceed 500 grams. The standards will be packaged in sealed, glass primary ampules, labeled and placed in heat-sealed bags with appropriate labelling. The neat standards will then be wrapped individually in several layers of absorbent packaging material, placed in a secondary heat-sealed bag, and then in a standard corrugated cardboard container which will be filled with cushioning material and sealed with reinforced paper tape. Solution standards will be placed in the first heat-sealed bag, then placed in form-fitting styrofoam containers which are wrapped in cellucrepe material and placed in a secondary heat-sealed bag. They will then be inserted into a padded mailer and sealed with fiberglass tape. According to the letter submitted by ManTech on February 21, 1991, there is a charge for the standards which should accrue an estimated amount of $60,000 per year in sales from the foreign distribution of the analytical samples. In its petition ManTech also states that it will support and encourage good quality assurance practices to several thousand laboratories in 93 foreign countries. b. Decision on petition. EPA has determined to grant the ManTech petition. The Agency generally treats petitions for exemption to export PCBs more stringently than petitions to distribute PCBs within the United States. This is because once the PCBs cross beyond our borders, the United States loses its ability to monitor the handling and distribution activities, to inspect the receiving facilities for any regulatory violations, or to protect health or the environment from releases of those PCBs that might lead to additional PCB contamination in this country. However, EPA believes that those concerns are mitigated in the export of PCBs in small quantities for research and development particularly given the viscosity, quantity, marking, and packaging of the PCBs, as well as the careful handling of the PCBs by trained personnel as described in the petition. Since there are no substitutes for PCB analytical samples, the good faith efforts finding has been met. No comments were submitted to EPA for further consideration during the comment period. ManTech is prohibited from exporting PCBs in excess of the amounts and quantities specified in its petition (i.e., less than 500 grams/ year), and will be required to petition EPA and obtain an exemption prior to an increase in the quantity or a change in the manner of handling PCBs under the ManTech exemption. EPA will consider any such change as a new exemption petition and address the request by rulemaking. If ManTech wishes to continue its export activities beyond the 1-year timeframe, according to the EPA approved exemption, a certified letter, pursuant to the amended Interim Procedural Rules promulgated in this rule, must be submitted to EPA at least 6 months prior to the expiration of the exemption. 2. Restek Corporation. On June 8, 1990, Restek requested an exemption to process and distribute in commerce for export small quantities of PCBs for research and development to calibrate analytical instruments. a. Current petition. Restek seeks to process and distribute small quantities (less than 100 grams/year) of PCBs for research and development under 40 CFR 761.80. The PCBs will be purchased from companies already exempted by EPA, then diluted to a concentration of 1,000g/mL in solvent. The only processing will be to prepare gravimetric standards of the PCBs. The concentration of these standards will be verified by gas chromatography. Once verified, these solutions will be packaged in a flame-sealed, amber glass ampul in volumes of 1 milliliter. The sealed ampuls will be overwrapped in a plastic tube with adequate cushioning to prevent damage during shipment. These solutions will be shipped via common carrier domestically and exported to foreign customers. Restek will comply with all relevant DOT and overseas shipping regulations. All processing and distribution will be performed at the Restek facility at 110 Benner Circle, Bellefonte, PA. The estimated amount of PCBs to be processed and distributed in commerce, both domestic and foreign, will not exceed 100 grams per year. Restek states that the small amounts of laboratory waste generated during the production procedures will be collected and disposed of in accordance with all Federal, State, and local regulations, and the total amount of waste will be less than 1 gram per year. Restek states that all PCBs will be handled by qualified organic chemists. There are no substitutes available which can be used to calibrate analytical instrumentation for PCBs. Restek estimates that the cost of denial of this petition could cause a loss of business amounting to $280,000 per year. b. Decision on petition. EPA has determined to grant the Restek petition. As stated above, EPA generally treats petitions for exemption to export PCBs more stringently than petitions to distribute PCBs within the United States. This is because once the PCBs cross beyond our borders, the United States loses its ability to monitor the handling and the distribution activities, to inspect the receiving facilities for any regulatory violations, or to protect health or the environment from releases of those PCBs that might lead to additional PCB contamination in this country. However, EPA believes that those concerns are mitigated in the export of PCBs in small quantities for research and development particularly given the viscosity, quantity, marking, and packaging of the PCBs involved, as well as the careful handling of the PCBs by trained personnel as described in the petition. Further, since no PCB substitutes exist for analytical standards of PCBs, the good faith efforts criterion has been met. No comments were submitted to EPA for further consideration during the comment period. Restek is prohibited from exporting PCBs in excess of the amounts and quantities specified in their exemption petition (less than 100 grams/year), and will be required to petition EPA to obtain an exemption prior to an increase in the quantity or a change in the manner of handling PCBs under the Restek exemption. EPA will consider any such change as a new exemption petition and address the request by rulemaking. If Restek wishes to continue its export activities beyond the 1-year timeframe, according to the EPA approved exemption, a certified letter, pursuant to the amended Interim Procedural Rules promulgated in this rule, must be submitted at least 6 months prior to the expiration of the exemption. 3. Joseph Simon Sons, Inc.. On April 9, 1987, Joseph Simon Sons, Inc. requested an exemption to distribute in commerce and export for disposal PCB-Contaminated Transformers that have been drained of all free-flowing liquids. a. Current petition. The drained electrical transformers would be packaged in shipping containers at locations in the states of Utah, California, and Washington and then shipped to the Far East for salvage. To ensure that all the drained electrical transformers being exported had contained fluid with a PCB concentration of less than 500 ppm, Joseph Simon Sons would require its customers to provide analytical reports showing the serial number of each unit and the PCB concentration. The estimated pounds of drained electrical transformers to be processed from each of the 3 states identified would be 1 million pounds. b. Decision on petition. EPA has determined to deny this request for an exemption. EPA has determined, due to the large amounts of PCBs and the availability of an alternative option, namely reclassifying the transformers to non-PCB status, that this petition fails the unreasonable risk and good faith efforts criteria as required in TSCA section 6(e)(3)(B). EPA is very stringent regarding the export of PCBs because once the PCBs cross beyond our borders, the United States loses its ability to monitor the handling and distribution activities, to inspect the receiving facilities for any regulatory violations, or to protect health or the environment from releases of those PCBs. Thus, EPA has found that the manufacturing, processing and distribution in commerce of PCBs and PCB Items for export in concentrations of 50 ppm or greater present an unreasonable risk of injury to health and the environment within the United States (40 CFR 761.20). This petition requests to export a large amount, approximately 3 million pounds, of drained PCB-Contaminated Electric Equipment to the Far East for salvage. Generally, EPA does not allow export of PCB- contaminated equipment for disposal because some countries have failed to develop safe methods of PCB disposal and salvaging, and because EPA has limited ability to ensure that such activities, including reuse of the salvaged material, does not present an unreasonable risk of injury to health and the environment in the United States. The Agency has previously recognized that PCB contamination is a global problem, and that use and other activities connected with PCBs outside the United States may lead to additional PCB contamination of this country. EPA concluded in 1979 that the distribution in commerce of certain PCBs for export constitutes an unreasonable risk of injury to health and the environment in the United States (44 FR 31514, May 31, 1979) and maintains that the activities proposed by the petitioner would present an unreasonable risk. Further, in determining whether good faith efforts have been taken to develop a substitute for PCBs, EPA considers whether alternatives are available to the person requesting an exemption. In this case, there is a safer alternative available to petitioners, namely that the transformer be reclassified to non-PCB status through a drain, flush, and refill process according to 40 CFR 761.30(a)(2)(v). Such non-PCB transformers could then be exported for any purpose according to 40 CFR 761.20(b)(2). Because a readily available substitute for PCB- contaminated equipment exists, namely decontaminated equipment, the good faith efforts criterion has not been met. No comments were submitted to EPA for further consideration during the comment period. D. Processing and Distribution in Commerce EPA received one petition requesting an exemption to allow the processing and/or distribution in commerce of PCBs. R.T. Corporation (RT Corp.). On March 31, 1989, RT Corp. requested an exemption to process and distribute in commerce PCBs as analytical reference samples derived from actual waste materials. Even if RT Corp. obtains such an exemption, use of such samples is banned unless authorized by rule. EPA is creating such a use authorization in this rule. (See unit VI. of this preamble for a further discussion.) a. Current petition. RT Corp. seeks to blend samples containing PCBs in various materials that have been taken from spills and Superfund sites, duplicating real world laboratory situations. These samples will provide EPA, contract labs, and other facilities with interlaboratory comparability and access to real world references. RT Corp. states that these procedures will be done under controlled conditions by trained and experienced personnel using practices that are designed to minimize human and environmental exposure to hazardous substances. An estimated annual amount of approximately .5 pound of PCB samples will be distributed in commerce to environmental analytical laboratories in small quantities for inhouse Quality Assurance/Quality Control programs by Federal, State and municipal governments, and other clients wanting to ensure the accuracy of their analytical results. These reference samples, which average 50 grams in weight, will be blended to homogeneity, packaged into 10 to 50 gram aliquots, and then marketed exclusively to laboratories. The total estimated annual amount of PCB-Contaminated material at <500 ppm concentration levels to be allowed under the exemption will be between 500 to 1,000 pounds. This equates to approximately .5 pound of pure PCBs. The values of the analytes of interest are determined by a round-robin analysis by as many laboratories as necessary to attain a 95 percent level of confidence. RT Corp. states that these samples will be shipped in accordance with all DOT shipping requirements and that they will be packaged in hermetically sealed containers bearing the PCB warning label. Once the PCBs are distributed in commerce, the risk of exposure to humans and the environment will be minimized by the small quantities of PCBs used in most applications, by the matrix containing the PCBs, and by the careful handling procedures typical of laboratory work. b. Decision on petition. EPA has determined to grant the RT Corp. petition. EPA believes that, due to the small quantities of PCBs in these reference samples as well as the careful handling of the PCBs by trained personnel, there is no unreasonable risk presented by granting this exemption petition request. The good faith efforts criterion has been met because there are no substitutes for the ``real world'' waste samples of PCB material associated with this activity. RT Corp. must comply with all Federal, State, and local laws governing the handling of these samples. In addition, once the use of the samples is complete, all of the disposal requirements contained in 40 CFR part 761 apply. One commenter to the proposal expressed support for issuing this use authorization. However, it was also suggested by this commenter that EPA broaden this authorization to include samples processed and distributed in connection with R&D activities. As noted by the commenter, EPA has already solicited comments on this revision in the June 10, 1991 Advance Notice of Proposed Rulemaking (ANPRM) with respect to amendments to the PCB disposal rules. A broader application of this use authorization is more appropriately addressed by the proposed Disposal Amendments in that the Agency will be able to obtain more extensive public comment and conduct a more comprehensive review of this issue. RT Corp. is prohibited from distributing in commerce PCBs in excess of the amounts and quantities specified in this petition (i.e., less than .5 pound of PCBs), and will be required to petition EPA and obtain an exemption prior to an increase in the quantity or a change in the manner of handling PCBs under the RT Corp. exemption. EPA will consider any such change a new exemption petition and address the request by rulemaking. If RT Corp. wishes to continue its processing and distribution activities beyond the 1-year timeframe, according to the EPA approved exemption, a certified letter, pursuant to the amended Interim Procedural Rules promulgated in this rule, must be submitted at least 6 months prior to the expiration of the exemption. VI. Use Authorization for Analytical Reference Samples Derived from Waste Materials EPA is granting a use authorization for analytical reference samples that contain PCBs and are derived from waste materials provided that the samples have been processed and distributed in commerce pursuant to an exemption granted under TSCA section 6(e)(3)(B). As discussed above, EPA has already granted an authorization for the use of PCBs in small quantities for research and development (40 CFR 761.30(j)). Also discussed above are the reasons EPA is granting an exemption for analytical reference samples derived from waste materials. These samples do not fit the definition for the use authorization granted under 40 CFR 761.30(j), and therefore, use of these samples requires an authorization. EPA has determined to authorize the use of PCB analytical reference samples derived from waste materials when the samples have been processed and distributed in commerce pursuant to an exemption granted under TSCA section 6(e)(3)(B). EPA has determined that the use of such samples will not present an unreasonable risk of injury to health or the environment because such samples will be handled by laboratories that have established procedures for handling PCBs. Further, EPA has determined that the use of such samples will further efforts to implement, comply with, and enforce the requirements for PCBs under TSCA. Once the use of such samples is over, persons who have used the samples are subject to any Federal, State, and local law governing the disposal of the PCBs, including the rules found in 40 CFR part 761. VII. Changes to Interim Procedural Rule In this rule, EPA is adopting procedures for renewing exemptions. A petitioner granted an exemption in this rule or in any future rule, and who wishes to renew that exemption, must submit a letter by certified mail to EPA stating that a renewal is desired and certifying that the specific type(s) of PCB activities, the procedures for handling the PCBs, the amount of PCBs handled, and all other activities specified in the original exemption request have not been changed. To provide EPA with sufficient time to include the renewal submission in the next PCB exemption rulemaking, the request and certification must be sent by certified mail and received by EPA at least 6 months prior to the expiration date of the existing exemption. If the renewal submission is not received at least 6 months prior to the expiration date, the original exemption activities must cease at the 1-year expiration date. If there are any increases from the original petition in the amounts of PCBs or any changes in the manner in which they are handled, EPA will consider the submission to be a petition for a new exemption. This amendment does not affect exemption petitions granted under Sec. 761.80(g) or petitions granted by EPA prior to the effective date of this final rule, provided the type of activities, the procedures for handling the PCBs, and any other terms of the exemption have not changed. However, any petitioner granted an exemption in a prior rule who wishes to alter the activities as previously approved by the Agency in granting the exemption must submit a new petition and must refrain from any of the new activities until EPA makes a determination on that petition by rulemaking. EPA will review the new petition during the next rulemaking process and determine whether to grant or deny the exemption. A commenter suggested EPA refine its procedures and the time it takes to respond to an exemption petition. Ideally, EPA would like to respond to exemption petitions more expeditiously; however, this is not practical. Several factors influence the review and processing of exemptions, such as, the complexity of issues, the number of petitions and the structure of the rulemaking process. Although the schedule for responding to exemption petitions may not be aggressive enough for some, in this rulemaking, EPA has, to the extent possible, modified the filing procedures for the exemption rulemaking process. One commenter suggested that to relieve the resource burden necessary to carry out the rulemaking process, EPA should also automatically renew petitions that are based on a renewal letter, and that involve minor changes that do not present an unreasonable risk to health and the environment. EPA agrees that allowing automatic renewal for minor changes would provide more flexibility. However, TSCA only authorizes the Administrator to grant exemptions by rule, if he/she determines the activity in question does not present an unreasonable risk to health and the environment and that the petitioner has met the good faith effort criteria (15 U.S.C. 6(e)(3)(B)). Consequently, the Administrator cannot forego rulemaking and renew all exemptions automatically without an analysis of risk as suggested by the commenter. VIII. Regulatory Assessment Requirements A. Executive Order 12866 Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also referred to as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of this Executive Order, it has been determined that this rule is not ``significant'' and is therefore not subject to OMB review. B. Regulatory Flexibility Act Pursuant to the Regulatory Flexibility Act (the Act), 5 U.S.C. 603, EPA prepared an initial regulatory flexibility analysis, which describes the impacts of the rule on small business entities in connection with the proposed rulemaking. In this analysis, EPA tried to estimate the cost of this proposed rule on the small businesses whose petitions EPA has denied. For purposes of this regulatory flexibility analysis, EPA considers a small business to be one whose annual sales revenues were less than $40 million. This cutoff is in accordance with EPA's definition of a small business for purposes of reporting under section 8(a) of TSCA, which was published in the Federal Register of November 16, 1984 (49 FR 45430). Pursuant to section 605(b) of the Regulatory Flexibility Act, which provides that section 603 of the Act ``shall not apply to any proposed or final rule if the Agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities,'' the Administrator certifies that this rule will not have a significant impact on a substantial number of small entities. In addition, EPA is sending a copy of this rule to the Chief Counsel for Advocacy of the Small Business Administration. EPA further notes that section 606 of the Act states that the requirements of section 603 do not alter in any manner standards otherwise applicable by law to Agency action. Current law, section 6(e)(3)(A) and (B) of TSCA and EPA's PCB Ban Rule, 40 CFR part 761, prohibits the manufacture, processing, and distribution in commerce of PCBs. This rule, under section 6(e)(3)(B) of TSCA, would exempt persons from these prohibitions where petitioners have demonstrated that granting an exemption would not result in an unreasonable risk of injury to health or the environment and that they have made good faith efforts to develop substitutes for PCBs. Both small and large businesses must meet the same statutory standard. Thus, even if EPA believed that it was an economically desirable policy to grant an exemption petition for a small business, it could do so only if the small business met the requirements set forth in TSCA. This rule would not add to the burden placed on small businesses, it would only remove the prohibition placed on such businesses through granting an exemption. Owners of individual small businesses who elect to petition the Administrator to engage in activities otherwise banned by the statute have already considered the economic consequences of conducting these activities, and nonetheless have opted to pursue an authorization for these activities. Finally, because this rule basically would benefit some small entities, without imposing direct economic costs on others, EPA believes that it is appropriate to certify that this rule will not have a significant economic impact on a substantial number of small entities. C. Paperwork Reduction Act The Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq., authorizes the Director of OMB to review certain information collection requests by Federal Agencies. Under OMB Control Number 2070-0021, OMB has approved a general information collection request submitted by EPA for purposes of collecting information for rulemakings on PCB exemption petitions, and for any recordkeeping or reporting conditions to PCB exemption petitions granted by EPA. Public reporting burden for this collection of information is estimated to average 5 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. IX. Official Rulemaking Record For the convenience of the public and EPA, all of the information originally submitted and filed in dockets number OPTS-66001, 66002, 66008-66008K (manufacturing, processing, and distribution in commerce exemptions) is being consolidated into this docket (docket number OPTS- 66011). Public comments are not listed because these documents are exempt from Federal Register listing under TSCA section 19(a)(3). A public record, along with a complete index, is available for inspection in the Non-Confidential Information Center, Monday through Friday (excluding holidays) from 12 noon to 4 p.m. in Room G-102 (401 M St., SW., Washington, DC). Previous Rulemaking Record Previous rulemaking related to exemptions are cited in the Index to the Rulemaking Record for Polychlorinated Biphenyls, Manufacturing, Processing, and Distribution in Commerce; Exemptions, Docket Number OPTS 66011 at A2-File. List of Subjects 40 CFR Part 750 Adminstrative practice and procedure, chemicals, Environmental protection, Hazardous substances. 40 CFR Part 761 Environmental protection, Hazardous substances, Labeling, Polychlorinated biphenyls, Reporting and recordkeeping requirements. Dated: March 30, 1994. Lynn R. Goldman, Assistant Administrator for Prevention, Pesticides and Toxic Substances. Therefore, 40 CFR Chapter I, Subchapter R is amended as follows: PART 750--[AMENDED] 1. In part 750. a. The authority citation for part 750 continues to read as follows: Authority: 15 U.S.C. 2605. b. In Sec. 750.11 by removing paragraph (b), by redesignating paragraphs (c) and (d) as paragraphs (b) and (c), respectively, by revising newly designated paragraph (b), by designating the undesignated text appearing at the end of the section as paragraph (d) and revising it, and by adding new paragraph (e) to read as follows: Sec. 750.11 Filing of petitions for exemption. * * * * * (b) Where to file. All petitions must be submitted to the following location: OPPT Document Control Officer (7407), Environmental Protection Agency, 401 M St., SW., Washington, D.C. 20460. * * * * * (d) Request for further information. The Agency reserves the right to request further information as to each petition prior to or after publication of the notice of proposed rulemaking required by Sec. 750.13. (e) Renewal requests. (1) Any petitioner who has been granted an exemption under section 6(e)(3)(B) of TSCA, on or after May 25, 1994, and who seeks to renew that exemption without changing its terms, must submit a letter by certified mail to EPA requesting that the exemption be granted for the following year. (i) This letter must contain a certification by the petitioner that the type of activities, the procedures for handling the PCBs, the amount of PCBs handled, and any other aspect of the exemption have not changed from the original exemption petition request. (ii) This letter must be received by EPA at least 6 months prior to the expiration of the existing exemption. (iii) If a petitioner fails to make a submission or the submission is not timely under this section, the exemption will expire 1 year from the effective date of granting that exemption. (iv) EPA will address a timely submission of a renewal request by rulemaking and either grant or deny the request. (2) Any petitioner who has been granted an exemption on or after May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the current exemption approved by EPA, and the petitioner complies with the conditions of paragraph (e)(1) of this section. (3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) exemption in a rule prior to May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the original exemption approved by EPA. Secs. 750.13 and 750.14 [Amended] c. In Secs. 750.13 and 750.14 change the reference ``Sec. 750.11(d)'' to read ``Sec. 750.11(c)''. d. Section 750.31 is amended by removing paragraph (b), by redesignating paragraphs (c), (d) and (e) as paragraphs (b), (c) and (d), respectively, by revising newly designated paragraph (b), and by adding a new paragraph (e) to read as follows: Sec. 750.31 Filing of petitions for exemption. * * * * * (b) Where to file. All petitions must be submitted to the following location: OPPT Document Control Officer (7407), East Tower, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. * * * * * (e) Renewal requests. (1) Any petitioner who has been granted an exemption under 40 CFR 761.80, except paragraph (g) of 40 CFR 761.80, on or after May 25, 1994, and who seeks to renew that exemption without changing its terms, must submit a letter by certified mail to EPA requesting that the exemption be granted for the following year. (i) This letter must contain a certification by the petitioner that the type of activities, the procedures for handling the PCBs, the amount of PCBs handled, and any other aspect of the exemption have not changed from the original exemption petition request. (ii) This letter must be received by EPA at least 6 months prior to the expiration of the existing exemption. (iii) If a petitioner fails to make a submission or the submission is not timely under this section, the exemption will expire 1 year from the effective date of granting that exemption. (iv) EPA will address a timely submission of a renewal request by rulemaking and either grant or deny the request. (2) Any petitioner who has been granted an exemption on or after May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the current exemption approved by EPA, and the petitioner complies with the conditions of paragraph (e)(1) of this section. (3) Any petitioner who has been granted a TSCA section 6(e)(3)(B) exemption in a rule prior to May 25, 1994, and who seeks to increase the amount of PCBs handled or to change the type of activities, the procedures for handling the PCBs, and any other aspect of their existing exemption must submit a new exemption petition to EPA. The existing exemption activity may continue until the new submission is addressed by rulemaking, provided the activity conforms to the terms of the original exemption approved by EPA. PART 761--[AMENDED] 2. In part 761 a. The authority citation for part 761 continues to read as follows: Authority: 15 U.S.C. 2605, 2607, 2611, 2614 and 2616. b. In Sec. 761.30 by adding paragraph (p) to read as follows: Sec. 761.30 Authorizations. * * * * * (p) Analytical reference samples. PCBs in analytical reference samples derived from waste materials may be used only when the samples originated from a person who has been granted an exemption to process and distribute in commerce such samples under TSCA section 6(e)(3)(B). Once the use of such samples is completed, disposal of such samples is governed by all applicable Federal, State, and local laws, including the rules contained in this part. c. In Sec. 761.80 by adding paragraphs (c)(2) and (m)(7) and by revising paragraphs (h) and (n) to read as follows: Sec. 761.80 Manufacturing, processing and distribution in commerce exemptions. * * * * * (c) * * * (2) ManTech, Research Triangle Park, NC 27709. * * * * * (h) The Administrator grants the following petitioners an exemption for 1 year to process and distribute in commerce PCBs for analytical reference samples derived from actual waste materials: (1) R.T. Corporation, Laramie, WY 82070. (2) [Reserved] * * * * * (m) * * * (7) Restek Corporation, Bellefonte, PA 16823. (n) The 1-year exemption granted to petitioners in paragraphs (a) through (c)(1), (d), (f), and (m)(1) through (m)(6) of this section shall be renewed automatically as long as there is no increase in the amount of PCBs to be processed and distributed, imported (manufactured), or exported, nor any change in the manner of processing and distributing, importing (manufacturing), or exporting of PCBs. If there is such a change, a new exemption petition must be submitted to EPA and it will be addressed through an exemption rulemaking. In such a case, the activities granted under the existing exemption may continue until the new petition is addressed by rulemaking, but must conform to the terms of the existing exemption approved by EPA. The 1-year exemption granted to petitioners in paragraphs (c)(2), (h) and (m)(7) of this section may be extended pursuant to 40 CFR 750.11(e) or 750.31(e). * * * * * [FR Doc. 94-8465 Filed 4-8-94; 8:45 am] BILLING CODE 6560-50-F