U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jul 16, 2024

§ 300.900 - General.

(a) Section 311(d)(2)(G) of the Clean Water Act (CWA) requires EPA to prepare a schedule identifying dispersants, other chemicals, other spill mitigating devices and substances, if any, that may be used in carrying out the NCP; and the waters and quantities in which they may be used safely. This subpart establishes a schedule that includes the NCP Product Schedule identifying chemical and biological agents, the Sorbents Product List, and the authorization of use procedures that, when taken together, identify the waters and quantities in which such dispersants, other chemicals, or other spill mitigating devices and substances may be used safely.

(b) This subpart applies to the navigable waters of the United States and adjoining shorelines, the waters of the contiguous zone, and the high seas beyond the contiguous zone in connection with activities under the Outer Continental Shelf Lands Act, activities under the Deepwater Port Act of 1974, or activities that may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States, including resources under the Magnuson Fishery Conservation and Management Act of 1976.

(c) This subpart applies to the use of chemical and biological agents as defined in Subpart A of this part, or other substances that may be used to remove, control, or otherwise mitigate oil discharges.

(d) [Reserved]

[59 FR 47453, Sept. 15, 1994, as amended at 88 FR 38333, June 12, 2023]

§ 300.910 - Authorization for agent use.

Use of chemical or biological agents in response to oil discharges must be authorized by the OSC in accordance with the provisions of this section.

(a) Use of agents identified on the NCP Product Schedule or use of burning agents on oil discharges addressed by a preauthorization plan. Area Committees and RRTs shall address, as part of their planning activities, whether preauthorization of the use of chemical and biological agents listed on the NCP Product Schedule or the use of burning agents on certain oil discharges is appropriate. Area Committees and RRTs shall, as appropriate, include applicable approved preauthorization plans in ACPs and RCPs. When a preauthorization plan is approved in advance for the use of certain agents under specified discharge situations, then the OSC may authorize the use of agents listed on the NCP Product Schedule, or the use of burning agents, for the purpose for which they were specifically listed without obtaining the incident-specific concurrences and without the natural resource trustees consultations described in paragraph (b) of this section.

(1) Preauthorization plan development. For discharge situations identified where such agents may be used, the preauthorization plan must, at a minimum, specify limits for the quantities and the duration of use, and use parameters for water depth, distance to shoreline, and proximity to populated areas. In meeting the provisions of this paragraph, preauthorization plans should document how regional factors are addressed including likely sources and types of oil that might be discharged, various potential discharge scenarios, the existence and location of environmentally sensitive resources or restricted areas that might be impacted by discharged oil, and logistical factors including inventory, storage locations and manufacturing capability of available agents, availability of equipment needed for agent use, availability of adequately trained operators, and means to monitor agent use in the environment. Preauthorization plans are to be developed by the Area Committees or the RRT in consultation with the Area Committee(s).

(2) Preauthorization plan approval. The EPA representative to the RRT, the Department of Commerce and the Department of the Interior natural resource trustees and, as appropriate the RRT representative from the state(s) with jurisdiction over waters and adjoining shorelines within the preauthorization plan area shall review and either approve, approve with modification, or disapprove the preauthorization plans. The Area Committees and RRTs shall address the withdrawal of approval from a preauthorization plan, and the RRT shall notify the NRT of the status of the preauthorization plan within 30 days from any such withdrawal.

(3) Preauthorization plan reviews. The RRT in consultation with the Area Committee(s) must review, and revise, as needed, approved preauthorization plans. These reviews must be conducted following a regular timeframe, established by the RRT and documented in the plan, to address changes that may impact the conditions under which the use of chemical and biological agents have been preauthorized. Reviews must also be conducted in any affected region, at a minimum, after a major discharge or after a Spill of National Significance (SONS) relevant to the preauthorization plan area; to address revisions of the NCP Product Schedule impacting chemical or biological agents that may be individually listed within a preauthorization plan; and to reflect new listings of threatened and/or endangered species applicable to the preauthorization plan area. The EPA RRT representative, the Department of Commerce and Department of the Interior natural resource trustees, and the RRT representative from the state(s) with jurisdiction over the waters of the area to which a preauthorization plan applies shall review and either approve, approve with modification, or disapprove any revisions to the preauthorization plans.

(b) Use of agents identified on the NCP Product Schedule or use of burning agents on oil discharges not addressed by a preauthorization plan. For discharge situations that are not addressed by a preauthorization plan developed pursuant to paragraph (a) of this section, the OSC may authorize the use of chemical or biological agents identified on the NCP Product Schedule on an oil discharge, or the use of burning agents, for the specific purpose for which they were listed with the concurrence of the EPA RRT representative and, as appropriate, the concurrence of the RRT representatives from the state(s) with jurisdiction over the waters and adjoining shorelines threatened by the release or discharge, and in consultation with the Department of Commerce and Department of the Interior natural resource trustees. In meeting the provisions of this paragraph, the OSC must consider and document for their authorization request to the RRT, at a minimum, the parameters for the use of agents including the quantities requested to be authorized, the duration of use, the depth of water, the distance to shoreline and proximity to populated areas, and should consider and document factors such as environmentally sensitive resources or restricted areas that might be impacted, agent inventory and storage locations, agent manufacturing capability, availability of equipment needed for agent use, availability of adequately trained operators and appropriate means to monitor agent use in the environment.

(c) [Reserved]

(d) Temporary exception. In circumstances to prevent or substantially reduce an imminent threat to human life that cannot be immediately addressed by other procedures or provisions of the NCP, the OSC may authorize the provisional use of any chemical or biological agent, whether it is identified or not on the NCP Product Schedule, without obtaining the concurrence of the EPA RRT representative and, as appropriate, the RRT representatives from the state(s) with jurisdiction over the waters and adjoining shorelines threatened by the release or discharge, and without consultation with the Department of Commerce and the Department of the Interior natural resource trustees. This exception shall not be used as a substitute for compliance with § 300.150 of this part, including the use of personal protective equipment, or when there is sufficient time to seek authorization in accordance with paragraphs (a) or (b) of this section. If an agent is authorized for use pursuant to this paragraph, the OSC shall notify as soon as possible the EPA RRT representative and as appropriate, the RRT representatives from the affected state(s) and the Department of Commerce and Department of the Interior natural resource trustees. The OSC shall document the circumstances and the reasons for use of the agent authorized pursuant to this paragraph. Agent use for individual circumstances under this exception shall be in accordance with paragraphs (a) or (b) of this section no later than 24 hours after initial application.

(e) Prohibited agents or substances. The OSC may not authorize the use of the following:

(1) Sinking agents, or any other chemical agent, biological agent, or any substance that is used to directly sink the oil to the bottom of a water body.

(2) [Reserved]

(f) Storage and use of agents listed on the NCP Product Schedule. (1) The OSC may authorize for use only products listed on the NCP Product Schedule that are documented and certified by the responsible party or its representative to have been stored under the conditions provided by the submitter under § 300.915(a)(6), and whose date of use does not exceed the expiration date listed on the container's label unless otherwise specified for expired products as provided in § 300.910(f)(2), at the time of the incident.

(2) The OSC may authorize for use products listed on the NCP Product Schedule that exceed their expiration date after the responsible party or its representative documents and certifies that the expired product has been stored under the conditions provided by the submitter under § 300.915(a)(6) and still meets the applicable efficacy and toxicity listing provisions under § 300.915, based on testing of representative samples within the previous 12 months.

(g) Supplemental testing, monitoring, and information. The RRT may require, for both planning and response, including authorization of use, supplemental toxicity and efficacy testing, or submission of available data and information that addresses site, area, and ecosystem-specific concerns relative to the use of any chemical or biological agent. The product manufacturer or responsible party shall provide, upon request of the RRT or OSC, additional monitoring or testing data and information to inform chemical or biological agent use decisions specific to a response.

(h) Recovery of chemical agents and other substances from the environment. The responsible party shall ensure that removal actions adequately contain, collect, store, and dispose of chemical agents and other substances that are to be recovered from the environment, unless otherwise directed by the OSC. Chemical agents and other substances to be recovered include solidifiers, surface washing agents, and sorbents. The OSC should, at a minimum, consider factors such as the safety of response personnel and harm to the environment in making determinations pursuant to this paragraph.

(i) Reporting of agent use. (1) The authorizing OSC shall provide the RRT the following information on chemical and biological agents used in response to an oil discharge: product name, product category, quantity and concentrations used, duration of use, location(s) of use, any available data collected, and any available analyses of efficacy and environmental effects. This information must be provided within 30 days of completion of agent use. This information may be submitted in accordance with the OSC reporting provisions under § 300.165 of this part, as applicable, subject to the 30-day timing requirement.

(2) In support of sections 300.135(n) and 300.155(a) and (b) of this part, the authorizing OSC shall provide for notification to the public, updated during a response as appropriate, the following information on chemical and biological agents used in response to an oil discharge: product name, product category, quantity and concentrations used, duration of use, and location(s) of use.

[88 FR 38333, June 12, 2023]

§ 300.913 - Monitoring the use of dispersants.

The responsible party shall monitor any subsurface use of dispersant in response to an oil discharge, any surface use of dispersant for more than 96 hours after initial application in response to an oil discharge, and any surface use of dispersant in response to oil discharges of more than 100,000 U.S. gallons occurring within a 24-hour period, and shall submit a Dispersant Monitoring Quality Assurance Project Plan (DMQAPP) covering the collection of environmental data within this section to the OSC. When any dispersant is used subsurface in response to an oil discharge, the responsible party shall implement paragraphs (a) through (g) of this section for the entire duration of the subsurface dispersant use. When any dispersant is used on the surface in response to oil discharges of greater than 100,000 U.S. gallons occurring within a 24-hour period, the responsible party shall implement paragraphs (a) through (g) of this section as soon as possible for the entire or remaining duration of surface dispersant use, as applicable. When any dispersant is used on the surface in response to an oil discharge for more than 96 hours after initial application, the responsible party shall implement paragraphs (a) through (g) of this section for the remaining duration of surface dispersant use.

(a) Document:

(1) The characteristics of the source oil.

(2) The best estimate of the oil discharge volume or flow rate, periodically reevaluated as conditions dictate, including a description of the method, associated uncertainties, and materials.

(3) The dispersant used, rationale for dispersant choice(s) including the results of any efficacy and toxicity tests specific to area or site conditions, recommended dispersant-to-oil ratio (DOR).

(4) The application method(s) and procedures, including a description of the equipment to be used, hourly application rates, capacities, and total amount of dispersant.

(5) For subsurface discharges, the best estimate of the discharge flow rate of any associated volatile petroleum hydrocarbons, periodically reevaluated as conditions dictate, including a description of the method, associated uncertainties, and materials.

(b) Collect a representative set of ambient background water column samples in areas not affected by the discharge of oil, at the closest safe distance from the discharge as determined by the OSC, and in all directions of likely oil transport considering surface and subsurface currents. Collect a representative set of baseline water column samples absent dispersant application at such depths and locations affected by the oil discharge, considering surface and subsurface currents, oil properties, and other relevant discharge conditions. On a daily basis, collect dispersed oil plume water column samples at such depths and locations where dispersed oil is likely to be present, considering surface and subsurface currents, oil properties, and other relevant discharge conditions. Collect these ambient background, baseline, and dispersed oil plume water column samples following standard operating and quality assurance procedures. Analyze the collected ambient background, baseline, and dispersed oil plume water column samples for:

(1) In-situ oil droplet size distribution, including mass or volume mean diameter for droplet sizes ranging from 2.5 to 2,000 µm, with the majority of data collected between the 2.5 and 100 µm size.

(2) In-situ fluorometry and fluorescence signatures targeted to the type of oil discharged and referenced against the source oil.

(3) Dissolved oxygen (DO) (subsurface only).

(4) Total petroleum hydrocarbons, individual resolvable constituents including volatile organic compounds, aliphatic hydrocarbons, monocyclic, polycyclic, and other aromatic hydrocarbons including alkylated homologs, and hopane and sterane biomarker compounds.

(5) Methane, if present (subsurface only).

(6) Heavy metals, including nickel and vanadium.

(7) Turbidity.

(8) Water temperature.

(9) pH.

(10) Conductivity.

(c) Considering available technologies, characterize the dispersant effectiveness and oil distribution including trajectory, accounting for the condition of oil, dispersant, and dispersed oil components from the discharge location, and describing associated uncertainties.

(d) Characterize the ecological receptors (e.g., aquatic species, wildlife, and/or other biological resources) and their habitats that may be present in the discharge area and their exposure pathways. The characterization shall include, but is not limited to, those species that may be in sensitive life stages, transient or migratory species, breeding or breeding-related activities (e.g., embryo and larvae development), and threatened and/or endangered species that may be exposed to the oil that is not dispersed, the dispersed oil, and the dispersant alone. The responsible party shall also estimate an acute toxicity level of concern for the dispersed oil using available dose-response information relevant to potentially exposed species following a species sensitivity distribution.

(e) Immediately report to the OSC any:

(1) Deviation of more than 10 percent from the mean hourly dispersant use rate for subsurface application, based on the dispersant volume authorized for 24 hours use, and the reason for the deviation.

(2) Ecological receptors of environmental importance, and any other ecological receptors as identified by the OSC or the Natural Resource Trustees, including any threatened or endangered species that may be exposed based on dispersed plume trajectory modeling and level of concern information.

(f) Report daily to the OSC water sampling and data analyses collected in paragraph (b) of this section and include:

(1) For each application platform, the actual amount of dispersant used for each one-hour period and the total amount of dispersant used for the previous 24-hour reporting period.

(2) All collected data and analyses of those data within a time frame necessary to make operational decisions (e.g., within 24 hours of collection), including documented observations, photographs, video, and any other information related to dispersant use, unless an alternate time frame is authorized by the OSC.

(3) For analyses that take more than 24 hours due to analytical methods, provide such data and results as available but no later than five days, unless an alternate time frame is authorized by the OSC.

(4) Estimates of the daily transport of dispersed oil, non-dispersed oil, the associated volatile petroleum hydrocarbons, and dispersants, using available technology as described in paragraph (c) of this section.

(g) Report all information provided to the OSC under paragraphs (e) and (f) of this section to the applicable RRT(s).

[86 FR 40263, July 27, 2021]

§ 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]

§ 300.950 - Submission of Proprietary Business Information (PBI).

(a) Except as provided in paragraph (b) of this section, all product information submitted to EPA as required under § 300.915 and § 300.955 will be available for public disclosure upon submission, without further notice to the submitter.

(b) You may only claim as PBI the concentration; the maximum, minimum, and average weight percent; and the units of each component as identified in § 300.915(a)(13) and (14) and as applicable. EPA will handle such claims in accordance with 40 CFR part 2, subpart B Confidentiality of Business Information.

(1) You must make your PBI claim at the time you submit your information to EPA to be listed on the NCP Product Schedule or Sorbent Product List.

(2) You must separate the PBI from all other submitted information. Include all PBI separately with your submission package, marking it as “Proprietary Business Information” and placing it in a separate inner envelope labeled with “PROPRIETARY BUSINESS INFORMATION—TO BE OPENED BY THE PRODUCT SCHEDULE MANAGER ONLY.”

[88 FR 38336, June 12, 2023]

§ 300.955 - Addition of a product to the NCP Product Schedule or Sorbent ProductLlist.

(a) Submission. Submit your complete package to: U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Mail Code: 5104A, Room 1448, William J. Clinton North, Washington, DC 20460, Attention: Product Schedule Manager.

(b) Package contents. Your package shall include, as applicable, in this order:

(1) A cover letter on company letterhead signed and dated by you certifying that:

(i) All testing was conducted on representative product samples;

(ii) Testing was conducted at a nationally or internationally accredited laboratory in accordance with the methods specified in Appendix C to part 300, and other applicable methods as appropriate; and

(iii) All test results and product technical data and information are true and accurate.

(2) A page numbered Table of Contents showing the information and data submitted under § 300.915(a) through (g), as applicable;

(3) All required data and information arranged in the same order as specified in § 300.915(a) through (g); and

(4) A separate envelope containing and labeled Proprietary Business Information as specified in § 300.950(b), if applicable.

(c) EPA Review. EPA shall, within 90 days of receiving a submission package:

(1) Review the package for completeness and compliance with all data and information requirements in §§ 300.915, 300.950, and this section; verify information; and request clarification or additional information, including testing as necessary;

(2) Make a product listing determination based on a technical evaluation of all data and information submitted in accordance with the requirements for each product category, relevant information on impacts or potential impacts of the product or any of its components on human health or the environment, and the intended use of the product; and

(3) Notify you in writing of its decision to list the product on the NCP Product Schedule or the Sorbent Product List, or of its decision and supporting rationale to reject the submission. If your submission is rejected:

(i) You may revise and resubmit a complete package to address test results, data, or information deficiencies.

(ii) EPA's 90-day review will not start until a complete package is resubmitted.

(d) Request for review of decision. If your product is rejected for listing on the NCP Product Schedule or the Sorbent Product List, you may request that the EPA Administrator or designee review the determination. Your request must be in writing within 30 days of receipt of notification of EPA's decision not to list the product on the NCP Product Schedule or the Sorbent Product List. Your request must contain a clear and concise statement with supporting facts and technical analysis demonstrating why the product meets the listing requirements.

(1) The EPA Administrator or designee may request additional information from you and may offer an opportunity for you to meet with EPA.

(2) The EPA Administrator or designee will notify you in writing of the decision within 60 days of receipt of your request, or within 60 days of receipt of requested additional information.

(e) Changes to a product listing—(1) Administrative change. You must notify EPA in writing within 30 days of any changes to information submitted under § 300.915(a)(1) through (8) and § 300.915(a)(19) through (21) for a product on the NCP Product Schedule. In the notification, you must detail the specific changes, the reasons for such changes and supporting data and information. EPA may request additional information and clarification regarding these changes.

(2) Reformulation. If you change the components and/or concentrations, you must retest the reformulated product according to the requirements for the product category and submit a new complete package under a new, distinct name in accordance with § 300.955(b) for review and consideration for listing on the NCP Product Schedule or Sorbent Product List by EPA.

(f) Transitioning Listed Products to the New NCP Product Schedule or Sorbent Product List. All products on the current NCP Product Schedule as of December 11, 2023 will remain conditionally listed until December 12, 2025 at which time all products that have not been submitted and listed in the new NCP Product Schedule based on the amended test and listing criteria will be removed. Your product will be transitioned from the current NCP Product Schedule to the new NCP Product Schedule prior to December 12, 2025 after you submit a new complete package in accordance with § 300.955(b), and EPA makes a determination to list the product on the new NCP Product Schedule. All products previously identified as sorbents by EPA will remain available for use until December 12, 2025, at which time all sorbent products must have submitted information as applicable under § 300.955(a) and (b) and be listed in the new Sorbent Product List.

[88 FR 38337, June 12, 2023]

§ 300.965 - Mandatory Product Disclaimer.

The listing of a product on the NCP Product Schedule does not constitute approval or recommendation of the product. To avoid possible misinterpretation or misrepresentation, any label, advertisement, or technical literature for products listed on the NCP Product Schedule must display in its entirety the disclaimer shown below. The disclaimer must be conspicuous and must be fully reproduced on all product literatures, labels, and electronic media including website pages.

Disclaimer

[PRODUCT NAME] is listed on the National Contingency Plan (NCP) Product Schedule. This listing does NOT mean that EPA approves, recommends, licenses, or certifies 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 NCP. Only a Federal On-Scene Coordinator (OSC) may authorize use of this product in accordance with Subpart J of the NCP in response to an oil discharge.

[88 FR 38337, June 12, 2023]

§ 300.970 - Removal of a product from the NCP Product Schedule or Sorbent Product List.

(a) The EPA Administrator or designee may remove your product from the NCP Product Schedule or the Sorbent Product List for reasons including, but not limited to:

(1) Statements or information that are misleading, inaccurate, outdated, or incorrect regarding the composition or use of the product to remove or control oil discharges made to any person, or private or public entity, including on labels, advertisements, technical literature, electronic media, or within the product submission to EPA; or

(2) Alterations to the components, concentrations, or use conditions of the product without proper notification to EPA as required by § 300.955(e); or

(3) Failure to print the disclaimer provided in § 300.965 on all labels, advertisements, technical literature, or electronic media for products listed on the NCP Product Schedule; or

(4) New or relevant information not previously considered concerning the impacts or potential impacts of the product to human health or the environment.

(b) EPA will notify you in writing, at your address of record, of its reasons for deciding to remove the product from the NCP Product Schedule. If EPA receives no appeal from you in 30 days, the product will be removed from the NCP Product Schedule without further notice to you.

(c) You may appeal the decision to remove your product from the NCP Product Schedule within 30 days of receipt of EPA's notification. Your appeal must contain a clear and concise statement with supporting facts and technical analysis demonstrating why the product should not be removed. The EPA Administrator or designee will notify you in writing of the decision within 60 days of your appeal, or within 60 days of receipt of any requested additional information.

[88 FR 38337, June 12, 2023]