(12) The technical product data submission shall include the identity of the laboratory that performed the required tests, the qualifications of the laboratory staff, including professional biographical information for individuals responsible for any tests, and laboratory experience with similar tests. Laboratories performing toxicity tests for dispersant toxicity must demonstrate previous toxicity test experience in order for their results to be accepted. It is the responsibility of the submitter to select competent analytical laboratories based on the guidelines contained herein. EPA reserves the right to refuse to accept a submission of technical product data because of lack of qualification of the analytical laboratory, significant variance between submitted data and any laboratory confirmation performed by EPA, or other circumstances that would result in inadequate or inaccurate information on the dispersing agent. (b) Surface washing agents. (1) Name, brand, or trademark, if any, under which the surface washing agent is sold. (2) Name, address, and telephone number of the manufacturer, importer, or vendor. (3) Name, address, and telephone number of primary distributors or sales outlets. (4) Special handling and worker precautions for storage and field application. Maximum and minimum storage temperatures, to include optimum ranges as well as temperatures that will cause phase separations, chemical changes, or other alterations to the effectiveness of the product. (5) Shelf life. (6) Recommended application procedures, concentrations, and conditions for use depending upon water salinity, water temperature, types and ages of the pollutants, and any other application restrictions. (7) Toxicity. Use standard toxicity test methods described in appendix C to part 300. Washington, DC, or at the Office of the Federal Register, 1100 L Street, NW., Room 8401, Washington, DC 20408. (8) Follow the data requirement specifications in paragraph (a)(9) of this section. (9) Surface Washing Agent Components. Itemize by chemical name and percentage by weight each component of the total formulation. The percentages will include maximum, minimum, and average weights in order to reflect quality control variations in manufacture or formulation. In addition to the chemical information provided in response to the first two sentences, identify the major components in at least the following categories: surface active agents, solvents, and additives. (10) Heavy Metals, Cyanide, and Chlorinated Hydrocarbons. Follow specifications in paragraph (a)(11) of this section. (11) Analytical Laboratory Requirements for Technical Product Data. Follow specifications in paragraph (a)(12) of this section. (c) Surface collecting agents. (1) Name, brand, or trademark, if any, under which the product is sold. (2) Name, address, and telephone number of the manufacturer, importer, or vendor. (3) Name, address, and telephone number of primary distributors or sales outlets. (4) Special handling and worker precautions for storage and field application. Maximum and minimum storage temperatures, to include optimum ranges as well as temperatures that will cause phase separations, chemical changes, or other alterations to the effectiveness of the product. (5) Shelf life. (6) Recommended application procedures, concentrations, and conditions for use depending upon water salinity, water temperature, types and ages of the pollutants, and any other application restrictions. (7) Toxicity. Use standard toxicity test methods described in appendix C to part 300. (8) Follow the data requirement specifications in paragraph (a)(9) of this section. (9) Test to Distinguish Between Surface Collecting Agents and Other Chemical Agents. (i) Method Summary-Five milliliters of the chemical under test are mixed with 95 milliliters of distilled water and allowed to stand undisturbed for one hour. Then the volume of the upper phase is determined to the nearest one milliliter. (ii) Apparatus. (A) Mixing Cylinder: 100 milliliter subdivisions and fitted with a glass stopper. (B) Pipettes: Volumetric pipette, 5.0 milliliter. (C) Timers. (iii) Procedure-Add 95 milliliters of distilled water at 22° C, plus or minus 3° C, to a 100 milliliter mixing cylinder. To the surface of the water in the mixing cylinder, add 5.0 milliliters of the chemical under test. Insert the stopper and invert the cylinder five times in ten seconds. Set upright for one hour at 22° C, plus or minus 3° C, and then measure the chemical layer at the surface of the water. If the major portion of the chemical added (75 percent) is at the water surface as a separate and easily distinguished layer, the product is a surface collecting agent. (10) Surface Collecting Agent Components. Itemize by chemical name and percentage by weight each component of the total formulation. The percentages should include maximum, minimum, and average weights in order to reflect quality control variations in manufacture or formulation. In addition to the chemical information provided in response to the first two sentences, identify the major components in at least the following categories: surface action agents, solvents, and additives. (11) Heavy Metals, Cyanide, and Chlorinated Hydrocarbons. Follow specifications in paragraph (a)(11) of this section. (12) Analytical Laboratory Requirements for Technical Product Data. Follow specifications in paragraph (a)(12) of this section. (d) Bioremediation Agents. (1) Name, brand, or trademark, if any, under which the agent is sold. (2) Name, address, and telephone number of the manufacturer, importer, or vendor. (3) Name, address, and telephone number of primary distributors or sales outlets. (4) Special handling and worker precautions for storage and field application. Maximum and minimum storage temperatures. (5) Shelf life. (6) Recommended application procedures, concentrations, and conditions for use depending upon water salinity, water temperature, types and ages of the pollutants, and any other application restrictions. (7) Bioremediation Agent Effectiveness. Use bioremediation agent effectiveness test methods described in appendix C to part 300. (8) Bioremediation Agent Toxicity [Reserved]. (9) Biological additives. (i) For microbiological cultures, furnish the following information: (A) Listing of each component of the total formulation, other than microorganisms, by chemical name and percentage by weight. (B) Listing of all microorganisms by species. (C) Percentage of each species in the composition of the additive. (D) Optimum pH, temperature, and salinity ranges for use of the additive, and maximum and minimum pH, temperature, and salinity levels above or below which the effectiveness of the additive is reduced to half its optimum capacity. (E) Special nutrient requirements, if any. (F) Separate listing of the following, and test methods for such determinations: Salmonella, fecal coliform, Shigella, Staphylococcus Coagulase positive, and Beta Hemolytic Streptococci. (ii) For enzyme additives, furnish the following information: (A) Listing of each component of the total formulation, other than enzymes, by chemical name and percentage by weight. (B) Enzyme name(s). (C) International Union of Biochemistry (I.U.B.) number(s). (D) Source of the enzyme. (E) Units. (F) Specific Activity. (G) Optimum pH, temperature, and salinity ranges for use of the additive, and maximum and minimum pH, temperature, and salinity levels above or below which the effectiveness of the additive is reduced to half its optimum capacity. (H) Enzyme shelf life. (I) Enzyme optimum storage conditions. (10) For nutrient additives, furnish the following information: (i) Listing of each component of the total formulation by chemical name and percentage by weight. (ii) Nutrient additive optimum storage conditions. (11) Analytical Laboratory Requirements for Technical Product Data. Follow specifications in paragraph (a)(12) of this section. (e) Burning Agents. EPA does not require technical product data submissions for burning agents and does not include burning agents on the NCP Product Schedule. (f) Miscellaneous Oil Spill Control Agents. (1) Name, brand, or trademark, if any, under which the miscellaneous oil spill control agent is sold. (2) Name, address, and telephone number of the manufacturer, importer, or vendor. (3) Name, address, and telephone number of primary distributors or sales outlets. (4) Brief description of recommended uses of the product and how the product works. (5) Special handling and worker precautions for storage and field application. Maximum and minimum storage temperatures, to include optimum ranges as well as temperatures that will cause phase separations, chemical changes, or other alternatives to the effectiveness of the product. (6) Shelf life. (7) Recommended application procedures, concentrations, and conditions for use depending upon water salinity, water temperature, types and ages of the pollutants, and any other application restrictions. (8) Toxicity. Use standard toxicity test methods described in appendix C to part 300. (9) Follow the data requirement specifications in paragraph (a)(9) of this section. (10) Miscellaneous Oil Spill Control Agent Components. Itemize by chemical name and percentage by weight each component of the total formulation. The percentages should include maximum, minimum, and average weights in order to reflect quality control variations in manufacture or formulation. In addition to the chemical information provided in response to the first two sentences, identify the major components in at least the following categories: surface active agents, solvents, and additives. (11) Heavy Metals, Cyanide, and Chlorinated Hydrocarbons. Follow specifications in paragraph (a)(11) of this section. (12) For any miscellaneous oil spill control agent that contains microbiological cultures, enzyme additives, or nutrient additives, furnish the information specified in paragraphs (d)(9) and (d)(10) of this section, as appropriate. (13) Analytical Laboratory Requirements for Technical Product Data. Follow specifications in paragraph (a)(12) of this section. (g) Sorbents. (1) Sorbent material may consist of, but is not limited to, the following materials: (i) Organic products- (B) Cellulose fibers or cork; (D) Chicken, duck, or other bird feathers. (ii) Mineral compounds- (2) EPA does not require technical product data submissions for sorbents and does not include sorbents on the NCP Product Schedule. (3) Manufacturers that produce sorbent materials that consist of materials other than those listed in paragraph (g)(1) of this section shall submit to EPA the technical product data specified for miscellaneous oil spill control agents in paragraph (f) of this section and EPA will consider listing those products on the NCP Product Schedule under the miscellaneous oil spill control agent category. EPA will inform the submitter in writing, within 60 days of the receipt of technical product data, of its decision on adding the product to the Schedule. (4) Certification. OSCs may request a written certification from manufacturers that produce sorbent materials that consist solely of the materials listed in paragraph (g)(1) of this section prior to making a decision on the use of a particular sorbent material. The certification at a minimum shall state that the sorbent consists solely of the materials listed in §300.915(g)(1) of the NCP. The following statement, when completed, dated, and signed by a sorbent manufacturer, is sufficient to meet the written certification requirement: [SORBENT NAME] is a sorbent material and consists solely of the materials listed in §300.915(g)(1) of the NCP. (h) Mixed products. Manufacturers of products that consist of materials that meet the definitions of two or more of the product categories contained on the NCP Product Schedule shall submit to EPA the technical product data specified in this section for each of those product categories. After review of the submitted technical product data, and the performance of required dispersant effectiveness and toxicity tests, if appropriate, EPA will make a determination on whether and under which category the mixed product should be listed on the Schedule. §300.920 Addition of products to Schedule. (a) Dispersants. (1) To add a dispersant to the NCP Product Schedule, submit the technical product data specified in §300.915(a) to the Emergency Response Division (5202–G), U.S. Environmental Protection Agency, 401 M Street, SW, Washington, DC 20460. A dispersant must attain an effectiveness value of 45 percent or greater in order to be added to the Schedule. (2) EPA reserves the right to request further documentation of the manufacturers' test results. EPA also reserves the right to verify test results and consider the results of EPA's verification testing in determining whether the dispersant meets listing criteria. EPA will, within 60 days of receiving a complete application as specified in §300.915(a) of this part, notify the manufacturer of its decision to list the product on the Schedule, or request additional information and/or a sample of the product in order to review and/or conduct validation sampling. If EPA requests additional information and/or a product sample, within 60 days of receiving such additional information or sample, EPA will then notify the manufacturer in writing of its decision to list or not list the product. (3) Request for review of decision. (i) A manufacturer whose product was determined to be ineligible for listing on the NCP Product Schedule may request EPA's Administrator to review the determination. The request must be made in writing within 30 days of receiving notification of EPA's decision to not list the dispersant on the Schedule. The request shall contain a clear and concise statement with supporting facts and technical analysis demonstrating that EPA's decision was incorrect. (ii) The Administrator or his designee may request additional information from the manufacturer, or from any other person, and may provide for a conference between EPA and the manufacturer, if appropriate. The Administrator or his designee shall render a decision within 60 days of receiving the request, or within 60 days of receiving requested additional information, if appropriate, and shall notify the manufacturer of his decision in writ ing. (b) Surface washing agents, surface collecting agents, bioremediation agents, and miscellaneous oil spill control agents. (1) To add a surface washing agent, surface collecting agent, bioremediation agent, or miscellaneous oil spill control agent to the NCP Product Schedule, the technical product data specified in §300.915 must be submitted to the Emergency Response Division (5202-G), U.S. Environmental Protection Agency, 401 M Street, SW., Washington, DC 20460. If EPA determines that the required data were submitted, EPA will add the product to the Schedule. (2) EPA will inform the submitter in writing, within 60 days of the receipt of technical product data, of its decision on adding the product to the Schedule. (c) The submitter may assert that certain information in the technical product data submissions, including technical product data submissions for sorbents pursuant to §300.915(g)(3), is confidential business information. EPA will handle such claims pursuant to the provisions in 40 CFR part 2, subpart B. Such information must be submitted separately from non-confidential information, clearly identified, and clearly marked "Confidential Business Information." If the submitter fails to make such a claim at the time of submittal, EPA may make the information available to the public without further notice. (d) The submitter must notify EPA of any changes in the composition, formulation, or application of the dispersant, surface washing agent, surface collecting agent, bioremediation agent, or miscellaneous oil spill control agent. On the basis of this data, EPA may require retesting of the product if the change is likely to affect the effectiveness or toxicity of the product. or (e) The listing of a product on the NCP Product Schedule does not constitute approval of the product. To avoid possible misinterpretation misrepresentation, any label, advertisement, or technical literature that refers to the placement of the product on the NCP Product Schedule must either reproduce in its entirety EPA's written statement that it will add the product to the NCP Product Schedule under §300.920(a)(2) or (b)(2), or include the disclaimer shown below. If the disclaimer is used, it must be conspicuous and must be fully reproduced. Failure to comply with these restrictions or any other improper attempt to demonstrate the approval of the product by any NRT or other U.S. Government agency shall constitute grounds for removing the product from the NCP Product Schedule. DISCLAIMER [PRODUCT NAME] is on the U.S. Environmental Protection Agency's NCP Product Schedule. This listing does NOT mean that EPA approves, recommends, licenses, certifies, or authorizes the use of [PRODUCT NAME] on an oil discharge. This listing means only that data have been submitted to EPA as required by subpart J of the National Contingency Plan, §300.915. |