§ 761.80 - Manufacturing, processing and distribution in commerce exemptions.

§ 761.80 Manufacturing, processing and distribution in commerce exemptions.

(a) The Administrator grants the following petitioner(s) an exemption for 1 year to process and distribute in commerce PCBs for use as a mounting medium in microscopy:

(1) McCrone Accessories Components, Division of Walter C. McCrone Associates, Inc., 2820 South Michigan Avenue, Chicago, IL. 60616.

(2) [Reserved]

(b) The Administrator grants the following petitioner(s) an exemption for 1 year to process and distribute in commerce PCBs for use as a mounting medium in microscopy, an immersion oil in low fluorescence microscopy and an optical liquid:

(1) R.P. Cargille Laboratories, Inc., 55 Commerce Road, Cedar Grove, N.J. 07009.

(2) [Reserved]

(c) The Administrator grants the following petitioner(s) an exemption for 1 year to export PCBs for use in small quantities for research and development:

(1) Accu-Standard, New Haven, CT. 06503.

(2) ManTech, Research Triangle Park, NC 27709.

(d) The Administrator grants the following petitioner(s) an exemption for 1 year to import (manufacture) into the United States, small quantities of existing PCB fluids from electrical equipment for analysis:

(1) Unison Transformer Services, Inc., Tarrytown, N.Y. 10591, provided each of the following conditions are met:

(i) The samples must be shipped in 5.0 ml or less, hermetically sealed vials.

(ii) The exemption is limited to no more than 250 total samples per year.

(iii) Unison makes quarterly inspections of its laboratories to ensure that proper safety procedures are being followed.

(iv) Unison annually notifies and describes to EPA its attempts to have samples analyzed abroad.

(2) [Reserved]

(e) The Administrator grants a class exemption to all research and development (R&D) facilities for a period of 1 year to manufacture or import PCBs for use solely in the manufacturer or importer's own research for the development of PCB disposal technologies. Each person that wishes to be part of the exemption must meet the following conditions:

(1) A petition for an exemption from the PCB prohibition on manufacturing PCBs must be received by EPA 60 days prior to engaging in these activities.

(2) Requests for renewal must be filed pursuant to § 750.11 of this chapter. EPA will deem any properly filed request for the renewal of the exemption by any member of the class as a renewal request for the entire class.

(3) The quantity of the PCBs manufactured annually must not exceed 500 grams by total weight of pure PCBs. Any person who wishes to manufacture or import more than 500 grams of PCBs in 1 year must receive written approval from the Director, National Program Chemicals Division to exceed the limitations established by this provision. The Director, National Program Chemicals Division may grant approval without further rulemaking. Any increase granted will be in writing and will extend only for a maximum of the time remaining in a specific exemption year.

(4) The owner or operator of the facility must notify the EPA Regional Administrator in writing 30 days prior to the commencement of R&D activities that include the manufacture or import of PCBs under the exemption, unless the facility has obtained a PCB R&D approval from EPA pursuant to § 761.60(e), § 761.60(i)(2), § 761.70(a), or § 761.70(b) and the approval contains a provision allowing the manufacture of PCBs.

(5) Records are maintained of their PCB activities for a period of 3 years after ceasing operations. The records must include the sources and the annual amounts of PCBs received if imported and the type and annual amount of PCBs that were manufactured.

(6) All PCBs and materials containing PCBs, regardless of concentration, remaining from the disposal-related studies must be disposed of according to § 761.60(j)(1)(vi), or decontaminated pursuant to § 761.79, based on the original PCB concentration.

(f) The Administrator grants the following petitioner(s) an exemption for 1 year to manufacture PCBs for use in small quantities for research and development:

(1) California Bionuclear Corp., Sun Valley, CA 91352 (ME-13).

(2) Foxboro Co., North Haven, CT 06473 (ME-6).

(3) ULTRA-Scientific, Inc.,Hope, RI 02831 (ME-99.1).

(4) Midwest Research Institute, Kansas City, MO 64110 (ME-70.1).

(5) Pathfinder Laboratories, St. Louis, MO 63146 (A division of Sigma Aldridge Corporation, St. Louis, MO, 63178 (ME-76).

(6) Radian Corp., Austin, TX 78766 (ME-81.2).

(7) Wellington Sciences USA, College Station, TX 77840 (ME-104.1).

(8) Accu-Standard, 25 Science Park, New Haven, CT. 06503.

(g) The Administrator grants a class exemption to all processors and distributors of PCBs in small quantities for research and development provided that the following conditions are met:

(1) All processors and distributors must maintain records of their PCB activities for a period of 5 years.

(2) Any person or company which expects to process or distribute in commerce 100 grams (.22 lb) or more PCBs in 1 year must report to EPA identifying the sites of PCB activities and the quantity of PCBs to be processed or distributed in commerce.

(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]

(i) The Administrator grants a class exemption to all persons who manufacture, import, process, distribute in commerce, or export PCBs, or analytical reference samples derived from PCB waste material, provided the PCBs are manufactured, imported, processed, distributed in commerce, or exported solely for the purpose of R&D and the following conditions are met:

(1) Notification in the form of a petition for an exemption from the PCB prohibitions on manufacture, import, processing, distribution in commerce, or export is received by EPA 60 days prior to engaging in these activities.

(2) Requests for renewal are filed pursuant to §§ 750.11 and 750.31 of this chapter. EPA will deem any properly filed request for the renewal of the exemption by any member of the class as a renewal request for the entire class.

(3) The PCBs are packaged in one or more hermetically sealed containers of a volume of no more than 5.0 ml each. Analytical reference samples derived from PCB waste material may be packaged in a container larger than 5.0 ml when packaged pursuant to applicable DOT performance standards.

(4) The quantity of PCBs manufactured, imported, processed, distributed in commerce, or exported annually must not exceed 500 grams by total weight of pure PCBs. Any person who expects to manufacture, import, process, distribute in commerce, or export more than 500 grams of PCBs in 1 year or to exceed the 5.0 ml packaging requirement must obtain a written approval from the Director, National Program Chemicals Division and must identify the sites of PCB activities and the quantity of PCBs to be manufactured, imported, processed, distributed in commerce, or exported. Each request must include a justification. The Director, National Program Chemicals Division, may grant approval without further rulemaking. Any increase granted will be in writing and will extend only for a maximum of the time remaining in a specific exemption year.

(5) All treated and untreated PCB regulated material and material coming into contact with regulated material must be stored and disposed of according to subpart D of this part, or decontaminated pursuant to § 761.79.

(6) All PCB materials must be distributed in DOT-authorized packaging.

(7) Records are maintained of their PCB activities for a period of 3 years after ceasing operations. The records must include the sources and the annual amounts of PCBs received if imported, the annual amount of PCBs that were manufactured, the annual amount of PCBs that were processed and/or distributed in commerce (to include export), and the persons to whom the PCBs were shipped.

(j) The Administrator grants the United States Defense Logistics Agency's April 23, 2013 petition for an exemption for 1 year beginning on October 1, 2014, to import up to 1,014,222 pounds of PCBs and PCB Items stored or in use in Japan as identified in its petition for disposal.

(k)-(l) [Reserved]

(m) The Administrator grants the following petitioner(s) an exemption for 1 year to process and export small quantities of PCBs for research and development:

(1) Chem Service, Inc., West Chester, PA 19380 (PDE-41).

(2) Foxboro Co., North Haven, CT 06473 (ME-6).

(3) PolyScience Corp., Niles, IL 60648 (PDE-178).

(4) ULTRA-Scientific, Inc., Hope, RI 02831 (PDE-282.1).

(5) Supelco, Inc., Bellefonte, PA 16823-0048 (PDE-41.2).

(6) Radian Corp., Austin, TX 78766 (PDE-182.1).

(7) Restek Corporation, Bellefonte, PA

(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).

(o) The 1-year class exemption granted to all processors and distributors of PCBs in small quantities for research and development in paragraph (g) of this section shall be renewed automatically unless information is submitted affecting EPA's conclusion that the class exemption, or the activities of any individual or company included in the exemption, will not pose an unreasonable risk of injury to health or the environment. EPA will evaluate the information, issue a proposed rule for public comment, and issue a final rule affecting the class exemption or individuals or companies included in the class exemption. Until EPA issues a final rule, individuals and companies included in the class exemption will be allowed to continue processing and distributing PCBs in small quantities for research and development.

[55 FR 38999, Sept. 24, 1990, as amended at 59 FR 16998, Apr. 11, 1994; 63 FR 35460, June 29, 1998; 68 FR 4941, Jan. 31, 2003; 72 FR 53158, Sept. 18, 2007; 79 FR 58270, Sept. 29, 2014]