U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jul 23, 2024

§ 300.915 - Data and information requirements for listing on the NCP Product Schedule or Sorbent Product List.

If you are submitting an application for listing a product to the NCP Product Schedule or Sorbent Product List, you must provide EPA the information required under § 300.955. Technical product data submissions are not required for burning agents. Your submission for each product must contain:

(a) General information for any product category. (1) Your name, physical address, email, and telephone number;

(2) Your identity and documentation of that identity, as the manufacturer of the product, vendor, importer, distributor of the product, and/or a designated agent acting on behalf of the manufacturer.

(3) All name(s), brand(s), and/or trademark(s) under which the product is to be sold;

(4) Names, physical addresses, emails, and telephone numbers of the primary distributors, vendors, importers and/or designated agent acting on behalf of the manufacturer;

(5) The Safety Data Sheet (SDS) for the product;

(6) The maximum, minimum, and optimum temperature, humidity, and other relevant conditions for product storage and a brief description of the consequences to performance if the product is not stored within these limits;

(7) The anticipated shelf life of the product at the storage conditions noted in paragraph (a)(6) of this section and documentation for this determination;

(8) A sample product label for all name(s), brand(s), and/or trademark(s) under which the product is to be sold that includes manufacture and expiration dates, and conditions for storage. You may use an existing label provided it already contains the required dates and storage information;

(9) The chemical or biological agent category under which you want the product to be considered for listing on the NCP Product Schedule, including detailed information on the specific process(es) through which the product affects the oil, and the specific environment(s) on which it is intended to be used (e.g., waters and/or adjoining shorelines). If your product meets the definition of more than one chemical or biological agent category, you must identify all applicable categories and provide the test data to meet the listing criteria appropriate to each;

(10) Recommended product use procedures, including product concentrations, use ratios, types of application equipment, conditions for use, any application restrictions; and, as applicable, procedures for product and oil containment, collection, recovery, and disposal. These procedures must address, as appropriate, variables such as weather, water salinity, water temperature, types and weathering states of oils or other pollutants. The procedures must include supporting documentation and current applicable standard methods used to determine them;

(11) Available information on environmental fate, including any known measured data, methodologies, and supporting documentation, on the persistence, bioconcentration factor, bioaccumulation factor, and biodegradability of the product and all of its components in the environment;

(12) The physical and chemical properties of the product, as appropriate, and a citation for the current applicable standard methods used to determine them, including:

(i) Physical state and appearance;

(ii) Vapor pressure;

(iii) Flash point;

(iv) Pour point;

(v) Viscosity;

(vi) Specific gravity;

(vii) Particle size for solid components; and

(viii) pH;

(13) The identity and concentration of all components in the product, including each specific component name; corresponding Chemical Abstract Service (CAS) Registry Number; the maximum, minimum, and average weight percent of each component in the product; and the intended function of each component (e.g., solvent, surfactant);

(14) For products that also contain microorganisms, enzymes, and/or nutrients, provide the following along with a citation or a description of the methodology used to determine:

(i) The name of all microorganisms by current genus and species, including any reclassifications, and any physical, chemical, or biological manipulation of the genetic composition and the weight percent of each genus in the product;

(ii) The name of all enzymes and their International Union of Biochemistry (I.U.B.) number(s); Enzyme Classification (EC) code numbers; the source of each enzyme; units; and specific oil-degrading activity;

(iii) The name(s), maximum, minimum, and average weight percent of the nutrients contained in the product; and

(iv) Data, methodology, and supporting documentation, for the levels of bacterial, fungal, or viral pathogens or opportunistic pathogens including, but not limited to: enteric bacteria such as Salmonella, fecal coliforms, Shigella, coagulase positive Staphylococci, and beta hemolytic Streptococci and enterococci;

(15) Data, methodology, and supporting documentation for the levels of the following:

(i) Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and any other heavy metal reasonably expected to be in the product;

(ii) Cyanide;

(iii) Chlorinated hydrocarbons;

(iv) Pesticides;

(v) Polychlorinated Biphenyls (PCBs); and

(vi) Polycyclic aromatic hydrocarbons (PAHs).

(16) Certification, including data, methodology, and supporting documentation, indicating that the product does not contain any of the prohibited agents or substances identified in § 300.910(e);

(17) Information about the accredited laboratory that conducted the required tests, including:

(i) Name of the laboratory, address, contact name, email, and phone number; and

(ii) The national and/or international accreditations held by the laboratory that are applicable to the test(s) performed;

(18) All test data and calculations, including:

(i) Raw data and replicates, including positive controls;

(ii) Notes and observations collected during tests;

(iii) Calculated mean values and standard deviations;

(iv) Reports, including a summary of stock solution preparation;

(v) Source and preparation of test organisms;

(vi) Test conditions; and

(vii) Chain of custody forms;

(19) An estimate of the annual product production volume, the average and maximum amount that could be produced per day, and the time frame needed to reach that maximum production rate in days;

(20) Recognition received from EPA's Design for the Environment (DfE) or Safer Choice programs, as applicable; and

(21) International product testing or use data or certifications, if available, informing the performance capabilities or environmental impacts of the product.

(b) Dispersant testing and listing requirements—(1) Dispersant efficacy test and listing criteria. Test the dispersant product for efficacy using the Baffled Flask Test (BFT) method in Appendix C to part 300. To be listed on the NCP Product Schedule, the dispersant must demonstrate for each temperature a Dispersant Effectiveness (DE) at the 95% lower confidence level (LCL95) greater than or equal to:

(i) ≥70% for Strategic Petroleum Reserve Bryan Mound at 5 °C;

(ii) ≥75% for Strategic Petroleum Reserve Bryan Mound at 25 °C;

(2) Dispersant toxicity tests and listing criteria. Use the methods specified in Appendix C to part 300 to test the dispersant alone, and the dispersant mixed with Strategic Petroleum Reserve Bryan Mound for acute toxicity, using Americamysis bahia and Menidia beryllina. Use the methods specified in Appendix C to part 300 to test the dispersant alone for developmental toxicity using Strongylocentrotus purpuratus or Arbacia punctulata and for subchronic effects using Americamysis bahia and Menidia beryllina. To be listed on the NCP Product Schedule, the dispersant alone must demonstrate:

(i) A median lethal concentration (LC50) at the lower 95% confidence interval greater than 10 ppm;

(ii) An inhibition concentration for 50% of the test species (IC50) at the lower 95% confidence interval greater than 1 ppm; and

(iii) A subchronic No Observed Effect Concentration (NOEC) greater than 1 ppm.

(3) Limitations. A dispersant may only be listed on the NCP Product Schedule for use in saltwater environments for which it meets the efficacy and toxicity listing criteria.

(c) Surface washing agent testing and listing requirements—(1) Surface washing agent efficacy test and listing criteria. To be listed on the NCP Product Schedule, using an applicable standard methodology, the surface washing agent must meet an efficacy of greater than or equal to 30% in either freshwater or saltwater, or both, depending on the intended product use.

(2) Surface washing agent toxicity test and listing criteria. Using the toxicity test methodology in Appendix C to part 300, test the surface washing agent for acute toxicity against freshwater species Ceriodaphnia dubia and Pimephales promelas, or saltwater species Americamysis bahia and Menidia beryllina, or both, depending on the intended product use. To be listed on the NCP Product Schedule, the surface washing agent must demonstrate an LC50 at the lower 95% confidence interval greater than 10 ppm in either freshwater or saltwater for all tested species.

(3) Limitations. Surface washing agent listing would be for use only in freshwater and/or saltwater environments for which it was tested and for which it met the efficacy and toxicity listing criteria.

(d) Bioremediation agent testing and listing requirements—(1) Bioremediation agent efficacy test and listing criteria. To be listed on the NCP Product Schedule, a bioremediation agent must successfully degrade both alkanes and aromatics as determined by gas chromatography/mass spectrometry (GC/MS) in freshwater or saltwater, or both, depending on the intended product use, following the test method specified in Appendix C to part 300. The percentage reduction of total alkanes (aliphatic fraction) from the GC/MS analysis must be greater than or equal to 85% at day 28, based on the ninety-fifth (95th) percentile Upper Confidence Limit (UCL95) for both freshwater and saltwater. The percentage reduction of total aromatics (aromatic fraction) must be greater than or equal to 35% at day 28 for both saltwater and freshwater based on the UCL95.

(2) Bioremediation agent toxicity test and listing criteria. The bioremediation agent must be tested for acute toxicity in freshwater or saltwater, or both, depending on the intended product use, following the method specified in Appendix C to part 300. To be listed on the NCP Product Schedule, the bioremediation agent must demonstrate an LC50 at the lower 95% confidence interval greater than 10 ppm in either freshwater or saltwater for all tested species.

(3) Limitations. Bioremediation agent listing would be for use only in the freshwater and/or saltwater environments for which it was tested and for which it met the efficacy and toxicity listing criteria.

(4) Generic listing. If the product consists solely of: ammonium nitrate, ammonium phosphate, ammonium sulfate, calcium ammonium nitrate, sodium nitrate, potassium nitrate, synthetically-derived urea, sodium triphosphate (or tripolyphosphate), sodium phosphate, potassium phosphate (mono- or dibasic), triple super phosphate, potassium sulphate, or any combination thereof, no technical product data are required. The product will be generically listed as non-proprietary nutrients on the NCP Product Schedule, and no further action is necessary.

(e) Solidifier testing and listing requirements. (1) Solidifiers must be tested for acute toxicity in freshwater or saltwater, or both, depending on the intended product use, following the method specified in Appendix C to part 300. To be listed on the NCP Product Schedule, the solidifier must demonstrate an LC50 at the lower 95% confidence interval greater than 10 ppm in either freshwater or saltwater for all tested species.

(2) Limitations. Solidifier listing would be for use only in the freshwater and/or saltwater environments for which it was tested and for which it met the toxicity listing criteria.

(f) Herding agent testing and listing requirements. (1) Herding agents must be tested for acute toxicity in freshwater or saltwater, or both, depending on the intended product use, following the method specified in Appendix C to part 300. To be listed on the NCP Product Schedule, the herding agent must demonstrate an LC50 at the lower 95% confidence interval greater than 10 ppm in either freshwater or saltwater for all tested species.

(2) Limitations. Herding agent listing would be for use only in freshwater and/or saltwater environments for which it was tested and for which it met the toxicity listing criteria.

(g) Sorbent requirements. Known sorbent materials and products will be identified on a publicly available Sorbent Product List for the use of such products when responding to an oil discharge as follows:

(1) For sorbent products that consist solely of the following materials, or any combination thereof, no technical data are required to be submitted for listing on the Sorbent Product List, and no further action is necessary for use as a sorbent:

(i) Feathers, cork, peat moss, and cellulose fibers such as bagasse, corncobs, and straw;

(ii) Volcanic ash, perlite, vermiculite, zeolite, and clay; and

(iii) Polypropylene, polyethylene, polyurethane, and polyester.

(2) If the product consists of one or more natural organic substances, inorganic/mineral compounds, and/or synthetic compounds not specifically identified in paragraph (g)(1) of this section but you believe the product meets the definition of a sorbent then, as applicable under § 300.955(a) and (b), you must submit the following information for consideration for listing it as a sorbent on the Sorbent Product List:

(i) The information required under paragraphs (a)(1) through (a)(8), and paragraph (a)(13) through (a)(15) of this section;

(ii) The certification required under paragraph (a)(16) of this section; and

(iii) Information, including data, to support the claim your product meets the sorbent definition under § 300.5.

[88 FR 38334, June 12, 2023]