# National Oil and Hazardous Substances Pollution Contingency Plan; Product Schedule Listing and Authorization of Use Requirements > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2023-11904 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** June 12, 2023 - **Citation:** 88 FR 38280 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 110 and 300 [EPA-HQ-OPA-2006-0090; FRL-4526-01-OLEM] RIN 2050-AE87 National Oil and Hazardous Substances Pollution Contingency Plan; Product Schedule Listing and Authorization of Use Requirements AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: The Environmental Protection Agency (EPA or the Agency) is amending the requirements in Subpart J of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) that govern the use of dispersants, other chemicals and other spill mitigating substances when responding to oil discharges into jurisdictional waters of the United States. This action addresses the efficacy and toxicity of dispersants and other chemical and biological agents, as well as public, state, local, and federal officials' concerns regarding their use. Specifically, the Agency is amending the Subpart J regulatory requirements for the NCP Product Schedule in two distinct ways. First, the Agency is adding new listing criteria, revising the efficacy and toxicity testing protocols, and clarifying the evaluation criteria for removing products from the NCP Product Schedule. Second, the Agency is amending requirements for the authorities, notifications, and data reporting when using chemical or biological agents in response to oil discharges to Clean Water Act (CWA) section 311 jurisdictional waters and adjoining shorelines. These requirements are anticipated to encourage the development of safer and more effective spill mitigating products and better target the use of these products to reduce the risks of oil discharges and response technologies to human health and the environment. Further, the amendments are intended to ensure that On-Scene Coordinators (OSCs), Regional Response Teams (RRTs), and Area Committees (ACs) have sufficient information to support agent authorization of use decisions. DATES: This final rule is effective on December 11, 2023. ADDRESSES: The EPA has established a docket for this action under Docket ID No. EPA-HQ-OPA-2006-0090. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: For general information, contact the Superfund, TRI, EPCRA, RMP, and Oil Information Center at 800-424-9346 or TDD at 800-553-7672 (hearing impaired). In the Washington, DC metropolitan area, contact the Superfund, TRI, EPCRA, RMP, and Oil Information Center at 703-412-9810 or TDD 703-412-3323. For more detailed information on this final rule contact Gregory Wilson at 202-564-7989 ( wilson.gregory@epa.gov ) or Vanessa Principe at 202-564-7913 ( principe.vanessa@epa.gov ). The contact address is U.S. Environmental Protection Agency, Office of Emergency Management, Regulations Implementation Division, 1200 Pennsylvania Avenue NW, Washington, DC 20460-0002, Mail Code 5104A, or visit the Office of Emergency Management website at http://www.epa.gov/oem/. SUPPLEMENTARY INFORMATION: The contents of this preamble are: I. General Information II. Entities Potentially Affected by This Final Rule III. Statutory Authority and Delegation of Authority IV. Background V. This Action A. Discharge of Oil B. Subpart A—Introduction 1. Definitions C. Subpart J—Use of Dispersants, and Other Chemical and Biological Agents 1. General 2. Authorization for Agent Use 3. Data and Information Requirements for Listing on the NCP Product Schedule or Sorbent Product List 4. Submission of Proprietary Business Information (PBI) 5. Addition of a Product to the NCP Product Schedule or Sorbent Product List 6. Mandatory Product Disclaimer 7. Removal of a Product From the NCP Product Schedule or the Sorbent Product List 8. Appendix C to Part 300 9. Appendix E to Part 300 VI. Summary of Final Rule Provisions VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review; Executive Order 13563: Improving Regulation and Regulatory Review; and Executive Order 14094: Modernizing Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act Part 110—Discharge of Oil Part 300—National Oil and Hazardous Substances Pollution Contingency Plan I. General Information In April 2010, the Deepwater Horizon underwater oil well blowout discharged significant quantities of oil into the Gulf of Mexico and raised questions about efficacy, toxicity, environmental tradeoffs, and the challenges of making dispersant use decisions in response operations for certain atypical dispersant use situations. In this final action, EPA is establishing new agent testing, listing, and authorization of use requirements under Subpart J of the NCP to address these challenges. These revisions to Subpart J address the use of dispersants and other chemical and biological agents to respond to oil discharges into jurisdictional waters and their adjoining shorelines as provided under section 311(b)(3) of the CWA. Specifically, the Agency is adding, amending, or removing certain regulatory definitions and updating requirements associated with the authorization of agent use (including preauthorization plan development, approval, and review; prohibited agents; storage; agent use; recovery; and reporting of use); testing of products (including efficacy and toxicity testing protocols); and listing on the NCP Product Schedule (including data and information requirements and the use of toxicity data to determine listing eligibility; processes for listing and delisting, including transitioning products to the new NCP Product Schedule; and proprietary business information (PBI)). The revisions include improved laboratory protocols for dispersant and bioremediation efficacy and toxicity, and will increase the overall scientific soundness of the data collected. These amendments to Subpart J will help to ensure that only products that perform effectively in laboratory testing will be listed on the NCP Product Schedule for use in mitigating the effects of oil discharges. EPA estimates that, to comply with the revised requirements, industry may incur a total incremental cost of approximately $283,800 to $376,500 annually. Note that the range in annualized cost reflects differences due to using 3% and 7% discount rates as well as a range (low and high) for submitter's paperwork burden. This action does not impose significant impacts on a substantial number of small entities. The Regulatory Impact Analysis, which can be found in the docket, provides more detail on the cost methodology and benefits of this action. II. Entities Potentially Affected by This Final Rule Entities affected by the final rule include manufacturers of bioremediation agents, dispersants, surface-washing agents, solidifiers, herding agents, and sorbents used as countermeasures against oil spills, and government entities. The universe of domestic product submitters ( i.e., product manufacturers) with products listed on the NCP Product Schedule provides the basis for identifying affected entities. EPA identified 89 affected domestic product manufacturers with products currently on the NCP Product Schedule and determined each manufacturer's NAICS code using Dun and Bradstreet (D&B) data. NAICS code Industrial category 213 Support Activities for Mining. 322 Paper Manufacturing. 325 Chemical Manufacturing. 326 Plastics and Rubber Products Manufacturing. 423 Merchant Wholesalers, Durable Goods. 424 Merchant Wholesalers, Nondurable Goods. 454 Nonstore Retailers. 493 Warehousing and Storage. 541 Professional, Scientific, and Technical Services. 561 Administrative and Support Services. 562 Waste Management and Remediation Services. 811 Repair and Maintenance. The Agency's goal is to provide a guide for readers to consider regarding entities that potentially could be affected by this action. However, this action may affect other entities not listed in this table. If you have questions regarding the applicability of this action to a particular entity, consult the person(s) listed in the FOR FURTHER INFORMATION CONTACT section. III. Statutory Authority and Delegation of Authority Under sections 311(d) and 311(j) of the Clean Water Act (CWA), as amended by section 4201 of the Oil Pollution Act of 1990 (OPA), Public Law 101-380, the President is directed to prepare and publish the NCP for removal of oil and hazardous substances. Specifically, section 311(d)(2)(G) directs the President to include a schedule identifying “(i) dispersants, other chemicals, and other spill mitigating devices and substances, if any, that may be used in carrying out the Plan, (ii) the waters in which such dispersants, other chemicals, and other spill mitigating devices and substances may be used, and (iii) the quantities of such dispersant, other chemicals, or other spill mitigating device or substance which can be used safely in such waters” as part of the NCP. The Agency has promulgated the NCP, see 40 CFR 300.1 et seq., including the schedule of dispersants, other chemicals, and other oil spill mitigating devices and substances (see 40 CFR 300.900 et. seq. ) as required by section 311(d)(2)(G). The President is further authorized to revise or otherwise amend the NCP from time to time, as the President deems advisable. 33 U.S.C. 1321(d)(3). The authority of the President to implement section 311(d)(2)(G) of the CWA is delegated to EPA in Executive Order 12777 (56 FR 54757, October 22, 1991). Subpart J of the NCP establishes the framework for the use of dispersants and any other chemical agents in response to oil discharges (40 CFR part 300 series 900). The Agency is further clarifying that the statutory schedule as required by CWA section 311(d)(2)(G) includes the NCP Product Schedule, the Sorbent Product List, and the Subpart J 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. IV. Background In the United States and around the world, chemical and biological agents are among the oil spill mitigation technologies available that responders may consider. Subpart J of the NCP sets forth the regulatory requirements for the use of chemical and biological agents, which includes separate provisions for product testing and listing, and for authorization of use procedures. These requirements provide the structure for the On-Scene Coordinator (OSC) to determine in each case the waters and quantities in which dispersants or other chemical agents may be safely used in such waters, if any. This determination is based on all relevant circumstances, testing and monitoring data and information, and is to be made in accordance with the authorization of use procedures, including the appropriate concurrences and consultations, found within the regulation. When taken together, the Subpart J regulatory requirements address the types of waters and the quantities of listed agents that may be authorized for use in response to oil discharges. EPA believes that the wide variability in waters, weather conditions, organisms living in the waters, and types of oil that might be discharged requires this approach. The Deepwater Horizon underwater oil well blowout in 2010 raised questions about the challenges of making chemical agent use decisions in response operations, particularly for certain atypical dispersant use situations. To address these and other challenges, the Agency proposed to amend Subpart J of the NCP to revise the existing product listing criteria, testing protocols, and authorization of use procedures, as well as to establish new provisions for dispersant monitoring (80 FR 3383, January 22, 2015). In July 2021, EPA published a final rule addressing the environmental monitoring of dispersant use in response to major discharges and to certain dispersant use situations. Specifically, the Agency established monitoring requirements for any subsurface use of dispersant in response to an oil discharge, surface use of dispersant in response to oil discharges of more than 100,000 U.S. gallons occurring within a 24-hour period, and surface use of dispersant for more than 96 hours after initial application in response to an oil discharge (86 FR 40234, July 27, 2021). This final action addresses the remaining Subpart J revisions proposed in 2015, including those associated with the product listing, testing protocols, and authorization of use procedures. V. This Action This final action amends two distinct sets of requirements under Subpart J: (1) Those related to chemical and biological agent testing and listing, and (2) those related to authorization of use. Specifically, in this action, the Agency adds, amends, or removes certain regulatory definitions associated with Subpart J, and updates requirements for the authorization of agent use (including preauthorization plan development, approval, and review; case by case authorization of prohibited agents; storage; agent use; recovery; and reporting of use); testing of products (including efficacy and toxicity testing protocols); and listing on the NCP Product Schedule (including data and information requirements, processes for adding or removing a product to or from the NCP Product Schedule, and proprietary business information.) The discussion below explains each of the amendments. It also summarizes and provides a response to highlighted public comments received on the 2015 proposal. See the Response to Comment Document for Listing and Testing of Chemical and Biological Agents, and for the Response to Comment Document on the Authorization of Use of Chemical and Biological Agents in the rulemaking docket for a complete summary and response to public comments. Sections of the NCP not identified to be revised in the proposed rule or addressed in this final rule are outside the scope of this final action. Revisions to Subpart J were under consideration prior to the Deepwater Horizon oil spill. The subsequent Deepwater Horizon oil spill resulted in recommendations to update Subpart J from the National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling Report 1 and the EPA Inspector General report titled Revisions Needed to the National Contingency Plan Based on Deepwater Horizon Oil Spill (Report #11-P-0534), 2 including that EPA review and update dispersant testing protocols for product listing. The Agency's final action addresses those recommendations. 1 See https://www.govinfo.gov/content/pkg/GPO-OILCOMMISSION/pdf/GPO-OILCOMMISSION.pdf. 2 See https://www.epa.gov/office-inspector-general/report-revisions-needed-national-contingency-plan-based-deepwater-horizon. This final action reflects relevant science and research that supports the specific provisions and their intent. The Agency considered the over 81,000 comments received that offered a wide range of perspectives and scientific information. Those comments remain relevant to the rulemaking, which will modernize and enhance the Subpart J regulatory provisions. The Agency is updating the process for listing products on the NCP Product Schedule, including expanded testing and listing thresholds. In doing so, EPA identified the relevant science to establish a national screening process for products to be listed on the NCP Product Schedule. Specifically, in amending the NCP Product Schedule listing provisions, EPA considered relevant science related to efficacy and toxicity testing and has determined it supports both establishing new protocols and updating existing protocols under Subpart J for testing chemical and biological agent products for listing on the NCP Product Schedule. These product testing protocols, along with additional requirements for data and information, serve as the basis for a national level screening of chemical and biological agent products, and include procedures that commercial laboratories are already familiar with or can readily adopt. EPA is not aware of changes to the relevant science since the proposed rulemaking and is proceeding with taking final action on the proposal. Furthermore, the final action builds upon the existing NCP framework, providing expanded opportunities for decisionmakers to consider any advancements in science beyond efficacy and toxicity valuations as part of listing, planning and response activities. The Agency is also updating the provisions for authorization of use by building upon the existing framework, providing further opportunities to consider advancements in science as part of the planning and authorization of use processes for chemical and biological agents. This performance-based approach provides flexibility in gathering, and allowing for the consideration of, scientific information relevant to a given site or geographic location. This allows for better targeting chemical and biological agent use during a response and is consistent with the broader NCP framework. A. Discharge of Oil The Agency is revising the text at 40 CFR 110.4 to harmonize it with the definitions for chemical and biological agents that are also being finalized for Subpart J. The revision replaces the terms “dispersants and emulsifiers” in § 110.4 with the broader term “any chemical or biological agent, or any other substance.” The revised definition in § 300.5 for chemical agents, as finalized in this action, includes elements, compounds, or mixtures designed to facilitate the removal of oil from a contaminated environment and mitigate any deleterious effects. The new definition for biological agents, also finalized in this action, includes microorganisms (typically bacteria, fungi, or algae) or biological catalysts, such as enzymes, able to enhance the biodegradation of a contaminated environment. By revising the provision at § 110.4, the Agency is clarifying that any chemical or biological agent or any other substance added to a discharge of oil with the intent to circumvent any provision of 40 CFR part 110 is prohibited. The final action replaces the specific qualifier “as defined in § 300.5 of this title” with the broader “or any other substance” to emphasize the intent of this provision is ultimately to prohibit circumventing part 110 requirements. The Agency has also amended the section title to “Chemical or biological agents.” Commenters on the 2015 proposal noted that the rule change would ensure no unintended or deliberate circumvention of § 110.4 through any inconsistencies with Subpart J definitions. EPA agrees and has finalized the rule as described above to refer to the terms “chemical and biological agents” as opposed to specifically “emulsifiers” and “dispersants.” In the finalized provision, EPA also made some editorial changes relative to the proposed text for increased clarity. B. Subpart A—Introduction 1. Definitions EPA is finalizing revisions to § 300.5 to amend the definitions for bioremediation agents, burning agents, chemical agents, dispersants, sinking agents, sorbents, and surface washing agents. Additionally, the Agency is finalizing new definitions for bioaccumulation, bioconcentration, biodegradation, biological agents, bioremediation, herding agents, products, and solidifiers. Finally, the Agency is removing the definitions for miscellaneous oil spill control agents (MOSCA) and surface collecting agents. (a) Revised Definitions Bioremediation agents —The Agency is revising the definition of bioremediation agents as proposed, to clarify the previous definition and add examples of bioremediation agents. Specifically, the final rule defines bioremediation agents as biological agents and/or nutrient additives deliberately introduced into a contaminated environment to increase the rate of biodegradation and mitigate any deleterious effects caused by the contaminant constituents. The definition identifies microorganisms and enzymes as bioremediation agents, as well as nutrient additives such as fertilizers containing bio-available forms of nitrogen, phosphorus, and potassium. This clarification will help manufacturers of products to identify the type of product, and hence, what testing requirements they will need to comply with to have a product listed on the NCP Product Schedule. A commenter expressed concerns about grouping all bioremediation agents in the revised definition. The commenter stated that the definition for bioremediation agent should be broken down for the three types of bioremediation because there are significant differences in applicability and appropriateness for the application of each type. EPA disagrees that the definition of bioremediation agent must explicitly include a classification for different types of bioremediation. The definition for bioremediation agents in the final action includes microorganisms, enzymes, and nutrients, to capture their different mechanisms of action ( e.g., amending rate limiting nutrients vs. adding microbial cultures). The final revisions do not prevent EPA from grouping similar bioremediation agents together on the NCP Product Schedule, if appropriate. A commenter suggested that the definition of bioremediation agents should include language prohibiting the use of biological agents that could result in non-indigenous species colonization. EPA is not prohibiting the use of non-indigenous species, because the addition of cultured microorganisms, which may include non-indigenous species, may enhance biodegradation of a contaminant in certain situations. EPA notes that decisions to use bioremediation agents are subject to § 300.910, Authorization of Use, and expects the OSC to utilize available resources to determine the most appropriate bioremediation agent, if any, for use in a response in light of incident and site-specific factors. Burning agents —The Agency is revising the definition of burning agents as proposed, to identify as such those additives that improve the combustibility of the materials to which they are applied. This could be achieved through either physical or chemical means. A commenter interpreted that the proposed definition combines burning agents (materials that actually change the combustibility of the material they are added to) and ignition agents (ignition devices or materials used to start combustion). The commenter recommended that the Agency adopt separate definitions for burning and ignition agents for clarity. Some commenters suggested that the Agency should either include ignition devices within the definition of “burning agents” or create a separate category for ignition devices. The Agency agrees with commenters that ignition devices are distinct from burning agents. The final provisions do not include ignition devices in the definition of burning agent. The Agency believes that the intent of ignition devices is to provide the initial energy to start a burn and typically do not enter the water column. While ignition devices provide the initial energy to start a burn, these devices are incidental to burning agents, which are intended to improve the combustibility of the oil. EPA is exercising its discretionary authority and not including ignition devices on the NCP Product Schedule given their intended use. Furthermore, EPA disagrees with a commenter's statement that burning agents are necessarily applied “prior to ignition;” EPA believes that burning agents could be added after ignition to improve combustibility. The definition of burning agents in the final action does not specifically state when during an in situ burning cycle a burning agent is to be applied. The Agency is finalizing the definition of burning agents from the proposed rule without any changes. EPA notes that burning agents remain subject to Subpart J authorization of use requirements, even though EPA is not requiring specific product information and data about burning agents to be submitted to EPA under § 300.955. Chemical agents —The Agency is revising the definition of chemical agents to identify as such those elements, compounds, or mixtures that are designed to facilitate the removal of oil from a contaminated environment and to mitigate deleterious effects. The chemical agent category includes burning agents, dispersants, herding agents, solidifiers, surface washing agents, and those bioremediation agents that consist of nutrient additives. This revised definition reflects the Agency's distinction between chemical and biological agents, allowing product manufacturers to better target the testing requirements and OSCs to better inform their authorization in specific situations. The finalized language also removes from the definition certain agent categories that are being eliminated, prohibited, or amended, to conform to these changes. Several commenters expressed concern with the Agency's proposed wording “designed to facilitate the removal of oil from a contaminated environment.” Commenters indicated that the definition of “chemical agent” does not make it clear that sinking agents, along with dispersants, do not remove or detoxify oil, but rather treat it. Commenters also stated that dispersants do not facilitate the removal of oil or mitigate deleterious effects. EPA notes that the NCP incorporates into § 300.5 the CWA section 311 statutory definition of “remove.” Under the NCP, “remove” or “removal” refers to containment and removal of oil or hazardous substances from the water and shorelines or the taking of such other actions as may be necessary to minimize or mitigate damage to the public health or welfare of the United States (including, but not limited to, fish, shellfish, wildlife, public and private property, and shorelines and beaches) or to the environment (40 CFR 300.5). Under the NCP, the term also includes monitoring of action to remove a discharge (40 CFR 300.5). Dispersants are substances that emulsify, disperse, or solubilize oil by promoting the formation of small droplets or particles of oil in the water column. The primary purpose of using dispersants is to facilitate dispersal of the oil into the water column, where the oil is then subject to several fate and transport processes ( e.g., dissolution). Thus, dispersant use may alter the behavior of oil to which it is applied and may result in an action that minimizes or mitigates damage, as described in the statutory definition of “remove.” In addition, depending on the oil composition, certain fractions of the dispersed oil may biodegrade over time. Dispersants are appropriately defined as chemical agents since they are designed to facilitate the removal of oil or mitigate oil's deleterious effects. Furthermore, EPA notes that the final provisions maintain the previous approach that chemical agents “. . . facilitate the mitigation of deleterious effects or the removal of the pollutant from the water.” A commenter stated that the definition of chemical agents should clearly delineate between chemical agents that are intended to be removed from the environment and those that are not. EPA believes that the NCP, as revised under this amendment, sufficiently delineates between chemical agents that are intended to be recovered from the environment and those that are not. The NCP addresses recovery of agents from the environment in multiple chemical agent and substances definitions ( e.g., surface washing agents, sorbents) and under § 300.910(h) Recovery of Agents from the Environment. Commenters recommended that sinking agents be removed from the proposed definition of chemical agents. A commenter suggested that including a definition for sinking agents in the context of other agents that may be put on the NCP Product Schedule contradicts the Agency's stated policy against the use of sinking agents to treat oil spills. EPA agrees that sinking agents do not remove oil from the environment and that sinking agents should not be included in the definition of chemical agents. The finalized definition of chemical agents has been modified relative to the proposed version to remove sinking agents. Dispersants —The Agency is revising the definition of dispersants to identify as such those substances that emulsify, disperse, or solubilize oil by promoting the formation of small droplets or particles of oil in the water column. The Agency acknowledges that the primary purpose of dispersants is to facilitate oil transfer from one area to another ( e.g., oil transferred from the water surface into the water column) or to maintain entrainment within the water column ( e.g., oil maintained in the water column from a subsurface discharge). Dispersed oil is then subject to transport by water currents and other fate and transport processes ( e.g., dissolution, biodegradation), which involves many site- and incident-specific factors. Irrespective of dispersant use, oil droplets may interact with suspended particulate material in the water column. For example, oil naturally dispersed in the water column ( i.e., untreated dispersed oil) may also interact with suspended particulate material. A commenter stated that the proposed definition should not identify what dispersants are “typically” composed of because formula components will vary by intended primary use setting. EPA agrees that the definition of dispersants should not identify the typical composition of dispersants ( e.g., solvents, surfactants), not necessarily because formula components will vary by intended primary use setting, but to avoid the potential misinterpretation that dispersants are necessarily comprised of these components. Thus, EPA is amending the definition of “dispersant” in this final rule by adding “. . . substances that emulsify, disperse, or solubilize oil by promoting . . .” and removing “. . . typically mixtures comprised of solvents, surfactants, and additives that promote . . .” The final provision maintains the general approach in the current definition to recognize that dispersants are substances “. . . that emulsify, disperse, or solubilize oil . . .” by promoting the formation of small droplets or particles of oil in the water column. Furthermore, based on other comments regarding oil-mineral aggregates on the proposed sorbent definition, EPA is amending the definition of dispersants to add “. . . or particles . . .” to indicate that certain particulate materials may also act as dispersants. EPA also removed the phrase “. . . by reducing the oil-water interfacial tension” in order not to identify any specific process and to recognize that other processes may also result in dispersion of oil. Sinking agents —The Agency is revising the definition of sinking agents to identify them as those substances introduced into an oil discharge to submerge the oil to the bottom of a water body. The former definition was ambiguous in distinguishing chemical agents ( e.g., dispersants) that may submerge oil below the water surface from substances that would sink oil to the bottom of the water body. The revision clarifies the distinction between sinking agents and other agents, such as dispersants, that do not intend to sink oil to the bottom of a water body but may have the incidental effect of causing some of the discharged oil to settle to the bottom of a water body. The Agency believes it is critical to distinguish between sinking agents, which are intended to sink oil as the primary mechanism of response, and dispersants, which are primarily intended to promote the formation of small droplets or particles of oil in the water column. The Agency continues to prohibit the use of sinking agents in the remediation of oil discharges in water because of their potential for causing adverse effects on benthic organisms vital to the food chain of the aquatic environment. Commenters expressed concerns with the way that the proposed definition distinguished between submersion and sinking. The commenters stated that both submersion and sinking could cause harm to benthic organisms and make oil more difficult to remove; several commenters suggested a broader definition of sinking agents to include any agent that causes oil to submerge below the water surface in a given waterbody, retains oil beneath the water surface, and/or increases aggregation of oil-sediment particles beneath the water surface, even if the treating agents also qualify for other categories ( e.g., dispersants, solidifiers, sorbents). The Agency disagrees with the recommendations to modify the sinking agent definition as this would conflate the definitions of dispersants and sinking agents and would effectively work to prohibit the use of dispersants. The final action balances the potential for deleterious effects from dispersant use against their potential for reducing or mitigating the environmental impacts of an oil spill, through the consideration of site-specific conditions and within the context of all response options. Adding language that characterizes sinking agents as facilitating the transfer of oil from the water surface into the water column or retention of oil below the water surface would cause confusion with the definition of dispersants. A commenter provided specific recommended language to edit the definition of sinking agents, which included removing the proposed phrase “. . . deliberately for the purpose of submerging . . .”. Additionally, another commenter suggested that the Agency's use of the term “deliberately” in the definition is unworkable because it fails to specify whose intent is relevant. EPA agrees that the term “deliberately” presents challenges to interpreting intent. Therefore, based on public comment, EPA is removing the term “deliberately” from the sinking agent definition in this final rule. Sorbents —Under the revised definition of sorbents, EPA identifies sorbents as inert and insoluble substances that readily absorb and/or adsorb oil or hazardous substances and that are not combined with or act as a chemical agent, biological agent, or sinking agent. Sorbents may be used in their natural bulk form or as manufactured products in for example particulate form, sheets, rolls, pillows, or booms. Sorbents are generally collected and recovered from the environment. The definition also includes a list of materials of which sorbents may consist. These revisions simplify the definition by removing the definitions of absorption and adsorption that were embedded in the former definition of sorbents; this is appropriate because absorption and adsorption are generally recognized scientific terms and sorbents are not distinguished or restricted under Subpart J based on whether they absorb or adsorb oil. The revised definition also adds the qualifier “natural” to organic substances, indicating that organic substances that have been treated with other substances do not necessarily fall under this category of agents and should not be considered a sorbent absent being listed on the Sorbent Product List as provided in this rule. It also expands on and simplifies the examples by removing the references to the type of birds that feathers could come from, by adding bagasse to the examples for natural organic substances, and by adding clay to the examples for inorganic/mineral compounds. While sorbents are not listed on the NCP Product Schedule, a list characterizing these materials is included in § 300.915(g) and EPA considers the Sorbent Product List in § 300.915(g) to be a part of the statutory schedule addressed in 33 U.S.C. 1321(d)(2)(G). Commenters replied to the Agency's request for comments on the qualifier phrase, “that are generally collected and recovered from the environment.” Some commenters requested that EPA remove the term “generally” or remove the phrase that sorbents are “generally collected and recovered from the environment.” Other commenters requested that sorbents be used with the intent of collecting and removing them from the environment. A commenter requested that the Agency clearly require that all sorbent materials must be recovered from the environment, and that sorbent use is not authorized in the event that the sorbents cannot be removed from the environment. EPA disagrees with comments that the phrase “generally collected and recovered from the environment” should be removed from the definition. EPA believes that the phrase recognizes and captures the expectation that sorbents are not intended to be left in the environment. EPA recognizes that on very limited occasions an OSC may make the determination to not recover a sorbent after consideration of factors such as the safety of response personnel and potential for greater harm to the environment if the sorbent material is recovered rather than left in place. Therefore, EPA retained the sentence “Sorbents are generally collected and recovered from the environment” in the amended definition but did move it to later in the provision in order to improve editorial flow and clarity. The OSC retains discretion not to authorize or direct the use sorbents if the OSC believes that sorbent use is inappropriate in light of incident-specific determinations. EPA received a range of comments regarding particulate materials ( e.g., clay) and the definitions of sorbent, sinking agents, and dispersants. EPA recognizes that some materials may behave differently in the environment based, in part, on the size or configuration of the substance. EPA disagrees with comments that clay necessarily behaves like a sinking agent in all cases. To address concerns regarding particulate materials, EPA is amending the definition of sorbents to recognize potentially differing behaviors and to distinguish between sorbents and sinking agents. The final revisions to the definition of sorbents includes that these substances are “. . . not combined with or act as . . . sinking agents.” EPA recognizes that substances such as clay may be used as a sorbent, but also agrees with commenters that they should not act as a sinking agent. EPA believes it is appropriate to continue to allow substances such as clay to be listed as sorbents and used as a sorbent during a response, provided that they are done so in manner that prevents them from acting as a sinking agent ( e.g., contained in a buoyant boom). The Agency expects that the Administrative Record for a response would provide the basis for continued sorbent use under OSC oversight or direction, and the Administrative Record should address any potential concerns with sorbents being used as a sinking agent. EPA also recognizes that particulate materials may be manufactured of such configuration ( e.g., micro- or nanosized) that they are, or are near, neutrally buoyant and remain in the water column over an extended time period. EPA recognizes comments that particulate materials may promote dispersion by forming oil-mineral aggregates (OMAs) and agrees with commenters that such substances should be addressed as dispersants rather than sorbents. Substances intended for use in a manner similar to a chemical or biological agent listed on the NCP Product Schedule ( e.g., dispersants) should be classified similarly and subject to the same authorization of use procedures. The final rule clarifies that dispersants are substances that emulsify, disperse, or solubilize oil by promoting the formation of small droplets or particles of oil in the water column. This revised definition clarifies that substances that emulsify, disperse, or solubilize oil include particulate materials because they promote the formation of particles of oil ( e.g., OMAs). Particulate materials that are used in a manner similar to chemical dispersants are appropriately categorized as dispersants on the NCP Product Schedule and are subject to the same dispersant authorization of use procedures under § 300.910. Surface washing agents —The Agency is revising the term “surface washing agent” to “surface washing agents” and modifying the definition. EPA changed the term from singular to plural to be consistent with the other agent definitions. The revised definition identifies surface washing agents as those substances that separate oil from solid surfaces ( e.g., beaches, rocks, metals, or concrete) through a detergency mechanism. The revised definition specifies that detergency mechanism lifts and floats the oil. The final definition is modified slightly from the proposed phrasing to clarify that the product and oil are generally to be collected and recovered from the environment with minimal dissolution, dispersion, or transfer into the water column to be consistent with similar phrases included in the sorbents and solidifiers definitions. EPA recognizes that on occasion an OSC may make the determination to not recover a surface washing agent after consideration of factors such as the safety of response personnel and potential for greater harm to the environment if the surface washing agent material is recovered rather than left in place (see 40 CFR 300.910(h)). A commenter suggested that surface washing agents used in fully self-contained structures ( e.g., tank farms, dry-dock vessels, sand-cleaning machines) or in a manner that prevents run-off to water ( e.g., cleaning/wiping of vessel hulls by hand) need not be listed on the NCP Product Schedule or require approvals from the OSC or RRT before use. A commenter suggested including the phrase “that are not likely to cause additional harm, either alone or in combination with oil, to public health or welfare or to the environment” in the definition. EPA is not revising the definition to include this phrase. EPA believes that the NCP must retain flexibility to allow for environmental tradeoffs that take into consideration incident-specific conditions when determining what actions should be taken to immediately and effectively address an oil discharge. (b) New Definitions The Agency is adding several new definitions for terms that are used in the amendments to Subpart J. These definitions include basic terminology and are consistent with how the terms are generally understood by the scientific community. Bioaccumulation —The Agency is establishing the definition of bioaccumulation, as proposed, to mean the process of accumulation of chemicals in the tissue of organisms through any route, including respiration, ingestion, or direct contact with the ambient or contaminated medium. The Agency is finalizing the definition of bioaccumulation from the proposed rule without any changes. A commenter expressed support for separate definitions of bioaccumulation and bioconcentration. The Agency appreciates and recognizes the commenter's perspective that bioaccumulation includes multiple routes of exposures to pollutants ( e.g., including dietary or food chain), whereas bioconcentration only includes water-borne routes of exposure ( e.g., absorption across the gills). Bioconcentration —The Agency is establishing the definition of bioconcentration, as proposed, to mean the accumulation of chemicals in the tissues of organisms from water alone. A commenter expressed support for separate definitions of bioaccumulation and bioconcentration, as described above. The Agency is finalizing the definition of bioconcentration from the proposed rule without any changes. Biodegradation —The Agency is establishing the definition of biodegradation to mean the process by which microorganisms metabolically decompose contaminants into biomass and smaller molecular compounds such as carbon dioxide, water, and end products. Commenters suggested expanding the definition of biodegradation to include the possibility of partial biodegradation, which can result in more toxic intermediate products. The commenters stated that partial biodegradation is likely to occur in the environment versus controlled laboratory conditions. EPA recognizes that partial biodegradation may occur in the environment. Therefore, the Agency amended the definition of biodegradation in the final rule to replace the phrase “. . . simpler compounds . . .” with “. . . smaller molecular compounds . . .”. EPA also removed the term “innocuous” in the final action to recognize that not all end products may be innocuous. Biological agents —The Agency is establishing the definition of biological agents to mean microorganisms (typically bacteria, fungi, or algae) or biological catalysts, such as enzymes, that can enhance the biodegradation of a contaminated environment. EPA has slightly amended the definition of biological agent in this rulemaking to replace the phrase “. . . able to . . .” with “. . . that can . . .” to better reflect the intent of the definition. A commenter recommended that the definition of bioremediation agents include a ban on agents that may result in the colonization of non-indigenous species. While EPA understands that microorganisms capable of degrading oil are ubiquitous in nature, the Agency is maintaining its prior approach in this rulemaking to recognize the addition of microorganisms as a potential bioremediation process. In general, the addition of cultured microorganisms, which may include non-indigenous species, may enhance biodegradation of a contaminant. Bioremediation —The Agency is establishing the definition of bioremediation to mean the process of enhancing the ability of microorganisms to convert contaminants into biomass and smaller molecular end products by the addition of materials into a contaminated environment to accelerate the natural biodegradation process. Commenters suggested expanding the definition to include the possibility of partial bioremediation, which can result in more toxic intermediate products. The commenters stated that partial bioremediation is likely to occur in the environment versus controlled laboratory conditions. EPA recognizes that partial biodegradation may lead to the formation of intermediate products. The Agency is amending the definition of bioremediation in this final rule to replace the phrase “. . . simpler compounds . . .” with “. . . smaller molecular compounds . . .”. EPA also removed the term “innocuous” to recognize that not all end products may be innocuous. Herding agents —The Agency is establishing the definition of herding agents to mean substances that form a film on the water surface to control the spreading of the oil to allow for oil removal. The definition for surface collecting agent was removed and replaced with the definition for herding agent to better reflect the common terminology used in industry for these agents. A commenter stated that the Agency should add language to the “herding agents” definition which includes that they are not likely to cause harm, either alone or in combination with oil, to public health or the environment and that they are intended to be collected and recovered from the environment. EPA disagrees with these suggested edits to the definition of herding agents. The NCP addresses discharges of oil to the environment and response authorities must retain flexibility to allow for environmental tradeoffs that consider incident-specific conditions when determining what actions should be taken to immediately and effectively address the discharge. EPA is amending the definition of herding agents in the final rule by replacing the proposed phrase “. . . across the water surface.” with the phrase “. . . form a film on the water surface . . .” and adding the phrase “. . . allow for oil removal.” to better reflect the mechanism of action of herding agents. Products —The Agency is establishing the definition of products to mean chemical or biological agents or other substances manufactured using a unique composition or formulation. A commenter suggested that the proposed definition of products is incomplete because it only includes agents that may be listed on the NCP Product Schedule. Other commenters suggested that the definition of products should include anything that may be used to mitigate oil spills ( e.g., burning agents, ignition devices, synthetic sorbents, organic or inorganic substances that may be used in bulk form, and substances that are manufactured using a unique composition or formulation). EPA's definition for products is intended to clarify the difference between a specific product and an agent type or category under the NCP Product Schedule and the Sorbent Product List. EPA agrees that the definition of a product should recognize sorbents by adding the term “other substances.” The finalized definition clarifies the distinction between an agent category ( e.g., surface washing agent) or substance ( e.g., sorbent) from a product for which a manufacturer submits an application to the Agency for listing on the NCP Product Schedule or the Sorbent Product List. The Agency is not revising the definition of “product” to specifically include burning agents since they are already included in the definition of chemical agents. Furthermore, the Agency disagrees to add “other spill mitigating devices” as it would not accurately reflect the applicability of the regulatory provisions for the purposes of the NCP Product Schedule or the Sorbent Product List in this final action. Solidifiers —The Agency is establishing the definition of solidifiers to mean substances that through a chemical reaction cause oil to become a cohesive mass, preventing oil from dissolving or dispersing into the water column. Solidifiers are generally collected and recovered from the environment. Solidifiers was not previously a specific product category on the NCP Product Schedule. The final rule amends the definition to recognize that solidifiers are “generally” to be collected, to recognize that the OSC has flexibility to consider factors such as the safety of response personnel and harm to the environment in making recovery determinations (see 40 CFR 300.910(h)). A commenter requested that the Agency add language to the definition to explain that solidifiers have no real advantage over sorbents or mechanical recovery and that they have limited practicality, may cross-link or react with other substances, and require immediate removal from the environment. The commenter mentioned that there has been very limited effectiveness testing or recent studies on solidifiers. The commenter requested that the definition of “solidifiers” include additional limitations to specify conditions under which solidifiers may be used such as proximity to shore and quantity of oil. The Agency acknowledges the commenter's concerns; however, the Agency disagrees with the suggested edits. The definition is intended to convey the mechanism of action and to distinguish solidifiers from other chemical or biological agents. Subpart J does not state or imply that chemical or biological agents are preferred over other response options such as mechanical recovery devices. EPA notes that mechanical recovery devices, including skimmers, are outside the scope of this action. EPA believes that the circumstances surrounding oil discharges and the factors influencing the choice of response methods are many. In addition, the final revisions under § 300.910(g) provide that RRTs may require supplementary toxicity and efficacy testing, or to obtain data or information to address site, area, or ecosystem-specific concerns relative to the use of any chemical or biological agent. The Agency believes that the specific conditions under which solidifiers may be used, such as proximity to shore and quantity of oil, are better addressed through the authorization of use process found at § 300.910 Authorization of Use. (c) Removed Definitions Miscellaneous Oil Spill Control Agent (MOSCA) —The Agency is removing the definition for miscellaneous oil spill control agent (MOSCA). The MOSCA category was used as a catchall for all types of products that did not meet other agent definitions; it is being replaced with a number of new and/or revised definitions for types of agents. As the Agency adds new, more stringent testing requirements for listing products on the NCP Product Schedule, there is a need for more specific category definitions to assist manufacturers in determining which of those testing requirements apply to their products. Commenters supported the removal of the definition for MOSCA. A commenter specifically expressed support for the removal of the MOSCA category provided that a subcategory is included in the “sorbents” definition to account for the uniqueness of certain products among the other sorbents. The Agency agrees with comments supporting the removal of the MOSCA category and the final action removes the category and definition of MOSCAs from the NCP. The Agency has identified product categories to be listed on the NCP Product Schedule and revised it accordingly. The MOSCA category is no longer necessary or appropriate and is being removed from the NCP through this final action. EPA does not believe that removing the MOSCA definition results in listed products automatically being reassigned to fall under the definition of another chemical or biological agent, or substance. The final revisions provide for the process to transition listed products from the current NCP Product Schedule to the new NCP Product Schedule as described in § 300.955(f). Surface collecting agents —The Agency is removing the definition for surface collecting agent and replacing it with a new herding agent definition to better reflect the common terminology used in industry for these agents. EPA did not identify comments on the proposed amendment specific to removing the definition for surface collecting agents. C. Subpart J—Use of Dispersants, and Other Chemical and Biological Agents 1. General EPA is amending § 300.900 by revising the title and paragraphs (a) and (c), and by adding paragraph (d) to reserve for later use. The revisions clarify that Subpart J addresses not only chemical agents, but also those agents that now fall under the new biological agent category. The revisions reaffirm the notion that Subpart J is not only comprised of an NCP Product Schedule of chemical and biological agents, but also includes testing requirements and authorization of use procedures. Consistent with current Subpart J regulatory requirements, the Agency is reserving a section for “Releases of Hazardous Substances” to take place of the current placeholder in § 300.905, which is being removed. Some commenters on the proposed rule expressed support for the update to § 300.900, which clarifies the Agency's duties under the CWA, but noted that the Agency should specify waters and quantities where products can be used safely, highlighting the importance of the word “safely.” The Agency recognizes support to clarify that Subpart J includes the identification of the waters and quantities in which chemical and biological agents may be safely used. In this final action, EPA is amending the last sentence of the proposed regulatory text under § 300.900 to include the term “safely” as provided in CWA section 311(d)(2)(G)(iii) based on the comment received. In addition, the Agency is clarifying that the statutory schedule as required by CWA section 311(d)(2)(G) includes the NCP Product Schedule, the Sorbents Product List, and 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. EPA is amending the regulation text at § 300.900, and throughout Subpart J, to clarify that it is the “NCP Product Schedule” which EPA updates periodically, in order to avoid confusion with the statutory use of the term “schedule” referred to in CWA section 311(d)(2)(G). Some commenters requested additional clarification related to Administrator authority and expressed uncertainty regarding federal authority. Specifically, these commenters indicated a need for additional clarity regarding the role of the Agency versus that of the U.S. Coast Guard or other public or private entities involved in spill response. While CWA section 311(c) provides statutory authority for certain removal actions and identifies the agencies that are to provide the federal OSC (which may include EPA or U.S. Coast Guard), it does not provide authority to revise the NCP and does not govern how the NCP regulates response actions. The authority to establish, revise, and maintain the NCP is addressed in CWA section 311(d), which has been delegated to the EPA Administrator in Executive Order 12777 (56 FR 54757, October 22, 1991). EPA will continue to exercise its authority over the NCP, and CWA section 311(c) responses remain subject to NCP provisions as per Congressional direction at CWA section 311(c)(1), which provides that the President “shall, in accordance with the National Contingency Plan and any appropriate Area Contingency Plan, ensure effective and immediate removal of a discharge . . . .” (emphasis added). 2. Authorization for Agent Use Section 300.910 sets forth the provisions for the authorization of use of products on the NCP Product Schedule in response to oil discharges. EPA is adding an introductory paragraph to § 300.910 that confirms, consistent with the intent of the NCP, that use of chemical or biological agents in response to oil discharges must be authorized by an OSC in accordance with Subpart J. In the final rule, EPA did not include the phrase “. . . to waters of the U.S. or adjoining shorelines . . .” under the opening clause to § 300.910 Authorization for agent use since the scope of Subpart J is already addressed under § 300.900. Unauthorized use can result in violations of sections 301 and 311 of the CWA. Section 301(a) makes unlawful “the discharge of any pollutant by any person,” except in compliance with certain provisions of the CWA. In addition, section 311(b) establishes penalties for persons who fail or refuse to comply with any regulation issued under section 311(j) of the CWA. Commenters suggested that the Agency is already required by Congress to establish a list of products that may be used for response within navigable waters of the United States and EPA is therefore required to approve these products for use in response activities. EPA disagrees with the characterization that the Agency is required by Congress to establish a list of products such that those products are automatically authorized for use within the jurisdictional waters of the United States by their listing. The CWA provides the President with the authority to determine what products, if any, may be used in what waters, and in what quantities. The NCP Product Schedule addresses the chemical and biological agents that may be authorized for use upon consideration of both the appropriateness of their use in the impacted waters and the amount of product that may be used safely in response to the unique nature of each oil discharge. EPA does not believe a “one size fits all” approach to emergency response is appropriate or prudent. A “one size fits all” approach could lead to significant under- and over-use of products that could exacerbate oil discharges absent consideration of all the specific conditions of each individual discharge. The final action provides for flexibility to evaluate the specific nature of an oil discharge when considering the authorization of a chemical or biological agents. (a) Use of Agents Identified on the NCP Product Schedule or Use of Burning Agents on Oil Discharges Addressed by a Preauthorization Plan The Agency is revising § 300.910(a) to address the preauthorized use of chemical and biological agents identified on the NCP Product Schedule. The Agency reorganized paragraph (a) to provide greater clarity about RRT and Area Committee responsibilities. The revisions to § 300.910(a) clarify the process for preauthorization, the responsibilities of all involved parties, and the factors to consider during the preauthorization process, including the authorization for the use of agents by the OSC at the time of a discharge. The reorganized paragraph (a) also makes the regulatory text easier to read and follow. The Agency added procedure and review requirements at § 300.910(a)(3) intended to ensure preauthorization plans are maintained so they are up to date. The finalized provisions also address recommendations from the National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling report and EPA's Inspector General report titled Revisions Needed to National Contingency Plan Based on Deepwater Horizon Oil Spill (Report #11-P-0534). The final revisions do not change the NCP's fundamental policies regarding roles of Federal, state, and local representatives involved in planning for and responding to an oil discharge, but rather clarify the regulatory requirements and further explain the responsibilities for each party. Some commenters expressed concerns that the proposed rule focused on preauthorization and suggested that the focus should instead be on consultation and concurrence. The Agency recognizes that the RRTs and/or Area Committees must consider whether preauthorization of chemical and biological agents is appropriate, while maintaining the existing concurrence and consultation roles on authorization of use. The revised preauthorization provisions provide greater clarity on the factors the RRT must address and those factors they should consider in developing a preauthorization plan. Department of the Interior (DOI) and Department of Commerce (DOC) natural resource trustees retain their concurrence role when approving preauthorization plans. DOI and DOC natural resource trustee concurrence is appropriate as preauthorization plans are developed during the contingency planning phase, when there is sufficient time to identify and resolve natural resource concerns. A commenter advocated for clarification of “mixed use” products, indicating that some of the products on the NCP Product Schedule have multiple uses and that during preauthorization planning all potential uses of an agent or product should be factored into the planning decisions. EPA recognizes that a “mixed use” product that meets the definition of more than one chemical or biological agent category may raise authorization of use issues when (1) listed under more than one chemical or biological agent category or (2) listed under one chemical or biological agent category but still meets the definition of another product category because of an alternate mechanism of action. The listing of a product on the NCP Product Schedule should not cause confusion on how that product is authorized at the time of an incident. Noting these concerns, the final action allows for the evaluation of products on an individual basis and informs the decision on whether and under which category to list a product on the NCP Product Schedule. Some commenters expressed concern or requested clarification on the roles and authorities of RRTs and Area Committees in preauthorization planning. Area Committees' roles and authorities under CWA section 311(j)(4) are outside the scope of this rulemaking. Nonetheless, CWA section 311(j)(4) provides the roles of the Area Committees in planning for the use of dispersants, including for Area Contingency Plans to list the equipment (including firefighting equipment), dispersants or other mitigating substances and devices, and personnel available to an owner or operator, Federal, State, and local agencies, and tribal governments, to ensure an effective and immediate removal of a discharge, and to ensure mitigation or prevention of a substantial threat of a discharge. EPA notes that not all spill mitigating equipment, substances or devices may be available or appropriate in certain planning areas. EPA believes that to create the best possible response system, it is important that the regional-level and area-level contingency planning efforts of the RRTs and Area Committees, respectively, are closely coordinated. RRTs and Area Committees should work together to develop mutually acceptable preauthorization plans, as appropriate. The standing RRTs also have responsibilities for oil spill contingency planning on a regional basis and can facilitate consistency among Area Committees. In instances where the RRT and Area Committees exist as separate entities, several RRT representatives likely also serve on the Area Committees for that region, allowing for familiarity with the roles and responsibilities of each entity. In instances ( e.g., in the inland zone) where RRTs fulfill the role of the Area Committees, they are thus responsible for both regional and area-level contingency planning (see 57 FR 15197, April 24, 1992). EPA agrees that in the development of preauthorization plans, RRTs should either provide Area Committees with an opportunity to provide input or should consider relevant information in Area Contingency Plans (ACPs) ( e.g., Fish and Wildlife and Sensitive Environments Annex). The RRTs and Area Committees should identify all potentially affected biological resources and their habitats likely to be negatively impacted, and not only those that are expected to benefit. Another commenter noted that not all regions have a use for preauthorization planning, suggesting that only regions with use for these plans should be required to develop planning materials. While RRTs and ACs must consider whether having a preauthorization plan is appropriate, the final action does not mandate preauthorization plans to be developed or preauthorization of any chemical or biological agents. EPA modified the proposed text to remove the phrase “in a preauthorization plan” to avoid a misinterpretation that § 300.910(a) requires that RRTs develop preauthorization plans. EPA also amended the final action under § 300.910(a) to further clarify the provision is to consider whether “preauthorization of” the use of chemical and biological agents is appropriate. The final action provides that an 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 § 300.910(b). Some commenters supported approval of preauthorization plans by natural resource trustees. EPA amended the final provision to clarify that the OSC does not need to obtain the incident-specific natural resource trustees consultations described in paragraph (b) of this section when authorizing the use of certain agents under § 300.910(a) by adding the phrase “. . . and without the natural resource trustees' consultations . . .” described in paragraph (b) of this section. The final provisions provide for DOI and DOC natural resource trustees concurrence on preauthorization plans rather than consultations. EPA continues to believe that DOI and DOC natural resource trustee concurrence is more appropriate than consultation during the contingency planning phase, when there is sufficient time to identify and resolve natural resource concerns while considering whether preauthorization is appropriate. Consistent with previous preauthorization approval requirements, the final revisions provide for DOI and DOC natural resource trustee approval, approval with modification, or disapproval of preauthorization plans. The final action provides that chemical or biological agents on the NCP Product Schedule may only be authorized for the purpose for which they were specifically listed. EPA amended the final provision to replace the phrase “. . . intended purpose . . .” with “. . . for the purpose for which they were specifically listed . . .” for greater clarity. This revision was made in response to a commenter's concern that chemical or biological agents may only be used for their intended use within a specific category ( e.g., an agent that is listed as a surface washing agent cannot be authorized for use as a dispersant). In the finalized provision, EPA also made some editorial changes to the proposed text for increased clarity. Preauthorization Plan Development. At § 300.910(a)(1), EPA is finalizing requirements for the preauthorization plan's site-specific factors. While the revisions simplify the language and clarify the requirements, the Agency kept in place the fundamental elements that were contained in the former § 300.910(a) text. The provision states that preauthorization plans must, at a minimum, specify limits for the quantities and duration of use, and use parameters for water depth, distance to shoreline, and proximity to populated areas for discharge situations identified in which agents may be used. The Agency believes that clearly stating the use parameters in a preauthorization plan will make it easier for planners to address concerns of preauthorizing agent use and in turn for responders to authorize their use. In meeting these provisions, the preauthorization plans should document how both regional and logistical factors were addressed when establishing use limits and parameters for chemical and biological agents. Regional factors include the likely sources and types of oil that might be discharged, various potential discharge scenarios, and the existence and location of environmentally sensitive resources or restricted areas that might be impacted by discharged oil. Logistical factors include inventory, storage locations and manufacturing capability of available agents, availability of equipment needed for agent use, availability of adequately trained operators, and the availability of appropriate means to monitor agent use in the environment. Several commenters requested clarification on the need to specify limits to the quantities and duration of agent use and the proposed use parameters for water depth, distance from shoreline, and proximity to populated areas; commenters noted that it is not realistic to predict all scenarios. EPA recognizes that oil discharges may occur under various scenarios. EPA does not envision that preauthorization plans would address every scenario imaginable, but instead will only address those specific circumstances under which RRT member agencies with roles and responsibilities under the NCP agree that an OSC does not need to obtain specific concurrence and consultations under § 300.910(b) in effectuating a preauthorized action. For example, a potential oil discharge scenario may involve a response that occurs over several days. The use of a chemical or biological agent ( e.g., surface dispersant use) during the initial response phase may be preauthorized in a manner such that any use beyond that initial response phase would be subject to § 300.910(b) and in limited circumstances subject to § 300.910(b). While the preauthorization plan must specify limits for the quantities and the duration of use, and use parameters for water depth, distance to shoreline, and proximity to populated areas, RRTs may wish to include other criteria in defining the scope of the preauthorization plan. Based on public comments, EPA is amending the final provisions to reflect that the limits for the quantities and the duration of use, and use parameters for water depth, distance to shoreline, and proximity to populated areas are the minimum criteria that RRTs must specify by inserting the phrase “at a minimum” before the specific criteria in the regulatory text. Commenters supported considering environmental tradeoffs in determining response options that provide the greatest environmental protection by identifying the affected biological resources and their habitats likely to be negatively impacted, as well as those that are expected to benefit. For example, a commenter suggested that the Agency rely upon the Net Environmental Benefit Analysis (NEBA) framework as a foundation for preauthorization planning, as opposed to artificially setting limits on dispersant use. EPA's understanding is that “NEBA” is a term used by some stakeholders in the response community to engage with various interested parties to consider available response options, including mechanical recovery. EPA also acknowledges that different stakeholders have varying perspectives on what factors beyond environmental considerations ( e.g., economic, health, and safety) are included in a NEBA, or what response options may provide the “greatest environmental protection.” While there is no prohibition on the use of environmental tradeoff methodologies, the use of such methodologies must conform with all applicable statutory and regulatory authorities. A commenter disagreed with the use of the word “likely” in reference to the sources and types of oil that may be spilled and suggested keeping “potential” instead, as a more conservative term that is more appropriate for preauthorization planning. EPA believes the phrase “likely sources and types of oil” better focuses on the sources and types of oil specific to the preauthorization plan for which agents may be used. While RRTs and Area Committees should consider “likely sources and types of oil” in developing preauthorization plans, the Agency believes they should also have the flexibility to consider other potential sources and types of oil, as appropriate, and the final revisions do not preclude RRTs and Area Committees from considering them. In considering the use of the term “potential” as offered by the commenter, EPA decided to clarify the phrase “various discharge scenarios” as used in the proposed rule. EPA recognizes that when developing a preauthorization plan, Area Committees and RRTs should not misinterpret “various discharge scenarios” to only mean past incidences but should also consider potential discharges scenarios. While RRTs and Area Committees should consider past discharge scenarios, the Agency believes they should also have the flexibility to consider potential discharge scenarios. In this respect, EPA agrees with the commenter that the term “potential” is more appropriate and is amending the phrase in the regulatory text to include “potential”. EPA believes the revised phrase “various potential discharge scenarios” more accurately reflects EPA's intent. Some commenters expressed concern or requested clarification on the roles and authorities of RRTs and Area Committees in preauthorization planning. EPA agrees that in the development of preauthorization plans, RRTs should either provide Area Committees with an opportunity to provide input or should consider relevant information in ACPs ( e.g., Fish and Wildlife and Sensitive Environments Annex). The RRTs and Area Committees should identify all potentially affected biological resources and their habitats likely to be negatively impacted, and not only those that are expected to benefit. EPA amended the final provision to ensure that Area Committees are involved in preauthorization plan development. EPA notes that the broader area contingency planning provisions are established under § 300.210(c) and are outside the scope of this action. Preauthorization Plan Approval. At § 300.910(a)(2), EPA is finalizing requirements related to the roles and responsibilities involved in reviewing and approving preauthorization plans, and procedures if preauthorization plan approval is withdrawn. The final action retains the concurrence requirement for preauthorization plans from the former version of the rule; given that preauthorization plans are developed during the contingency planning phase, DOC and DOI natural resource trustee concurrence is preferred over just consultation because it provides for sufficient time to identify and resolve natural resource concerns. Commenters suggested that the preauthorization planning process be completed under mandatory timelines, including a suggestion that plans must be reviewed within a 90-day time frame, or that the Agency otherwise stipulate that the plan cannot be blocked from being used by an Area or Region. EPA does not believe that it is appropriate to establish specific deadlines for the review and approval of preauthorization plans because both the Area Committees and RRTs coordinate their approach to reviewing and revising existing preauthorization plans and determine what information they may need to amend their preauthorization plan, as appropriate. EPA believes RRTs and ACs should begin their reviews as expeditiously as possible where preauthorization plans exist, but they also must be afforded flexibility in implementing the final revisions to ensure preauthorization plans are up-to-date when implemented in the event of a discharge. To be consistent with terminology for preauthorization plan approvals, EPA is revising the provision in the final action to substitute the phrase “withdrawal of approval from a preauthorization plan . . .” for “withdrawal of concurrence . . .” The amended rule offers specific procedures to follow should an authorizing agency decide to withdraw their approval from a preauthorization plan: the Area Committees and RRTs must address the withdrawal of approval from the preauthorization plan within 30 days of the withdrawal, allowing an opportunity to address the concerns. Additionally, the RRT must notify the National Response Team (NRT) of the final status of the preauthorization plan within 30 days from withdrawal. The absence of an approved preauthorization plan means authorizations for agent use are to be conducted in accordance with paragraph § 300.910(b) or in limited circumstances under § 300.910(d). Therefore, the Agency believes that the phrase “the preauthorization plan becomes invalid and the authorization of use for chemical or biological agents must be performed according to paragraph (b)” is unnecessary and redundant and is striking it from the final provision. The Agency continues to believe that preauthorization plans serve as a valuable advanced planning tool that supports decision making, and strongly encourages the resolution of any withdrawal of approval in a manner that addresses concerns raised. Commenters expressed concerns over the potential impact of allowing for withdrawal of preauthorization plan approval. EPA disagrees that the ability to withdraw may incentivize the development of preauthorization plans with no intent of maintaining concurrence during a response. EPA also disagrees that the withdrawal of approval from a preauthorization plan subverts the OSC's authority to use dispersants and that this provision should be removed. RRT member agencies who have responsibilities in approving preauthorization plans have always had the discretion to withdraw their approval at any time. An OSC may still authorize the use of dispersants and other agents outside of an approved preauthorization plan in accordance with § 300.910(b) or in limited circumstances under § 300.910(d). Case-by-case authorization of use under § 300.910(b) is an appropriate and timely process to authorize the use of dispersants and other agents and should not delay response operations such as the deployment of mechanical recovery. In contrast, restricting the flexibility to withdraw approval from a preauthorization plan could serve as a disincentive to approve a preauthorization plan or result in limiting the plan's scope and lead to more frequent requests for authorization by OSCs under § 300.910(b). EPA disagrees that the preauthorization plan should stay in effect for 30 days after withdrawal of approval while allowing RRTs and Area Committees to address the withdrawal. A withdrawal likely signals concerns amongst at least one of the approving bodies with actions or activities that had been preauthorized. The final provisions provide a 30-day timeframe for the RRT to notify the NRT of the status of the preauthorization plan after any such withdrawal. EPA believes that RRTs and Area Committees are likely to be aware of concerns prior to withdrawal of approval from a preauthorization plan, can work to resolve any perceived differences prior to any withdrawal, and are not prohibited from entering into new preauthorization plans addressing the same or similar areas in the future. For an active incident where chemical and biological agents have been authorized for use under a preauthorization plan, EPA encourages RRT member agencies with approval roles to work with the RRT to promptly resolve concerns and avoid potential withdrawal of plan approval during a response. Several commenters suggested a need for public input and notification during the preauthorization plan approval process, including a requirement for public notification following the withdrawal of concurrence. Another commenter recommended a formal public review and comment period on each preauthorization decision, recommending that the RRTs and Area Committees should be required to provide a written peer-reviewed scientific and technical study to support any preauthorization plan, and provide a 60-day public review and comment period. EPA disagrees that the RRTs and Area Committees should be required to provide a written peer-reviewed scientific and technical study to support any preauthorization plan, or that they should provide a 60-day public review and comment period or formal public review and comment period on each preauthorization decision. The Agency believes that the RRTs and Area Committees should have the flexibility to tailor preauthorization plans to their regional needs. While EPA recognizes the benefits of public feedback on preauthorization plans including independent scientific input, the Agency does not believe it should be a mandatory requirement. Subjecting preauthorization plans to an external peer-review process may limit RRTs' and Area Committees' ability to utilize preauthorization plans. Nonetheless, public and private stakeholders may provide input, such as relevant scientific data and information, in area and regional contingency planning activities that are open to public participation, and RRTs and Area Committees retain flexibility to seek public comment or input on any preauthorization plan in accordance with applicable statutes and regulations if they believe such participation is warranted. EPA notes that the amendments to Subpart J include a public notification provision under § 300.910(i) Reporting of Agent Use to notify the public on chemical and biological agents used during a response and to provide certain required information. In the finalized provision, EPA also made some editorial changes to the proposed text for increased clarity in addition to the specific changes described above. Preauthorization Plan Reviews. At § 300.910(a)(3), EPA is finalizing new requirements related to the review and revision, if needed, of preauthorization plans. The review requirement is intended to ensure that preauthorization plans are actively maintained and updated to reflect revisions to the NCP Product Schedule. A periodic review, following a regular timeframe, is expected to ensure that the preauthorization plan is consistent with any revisions to the NCP Product Schedule, and also with revisions to ACPs, facility, and vessel response plans. The provision specifically requires reviews to be conducted at a minimum, after a major discharge (a “major discharge” means a discharge of more than 10,000 gallons of oil to the inland waters or more than 100,000 gallons of oil to the coastal waters) 3 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. Review is to be done by the EPA RRT representative, the DOC and DOI 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. 3 See 40 CFR 300.5 “Size classes”. Several commenters recommended that additional entities should be able to participate in the review or comment process during the preauthorization plan review cycle ( e.g., local and tribal governments, the Occupational Safety and Health Administration (OSHA), Department of Health and Human Services (DHHS), and the public). EPA reiterates that all members of the ACs and RRTs will be afforded an opportunity to provide input during a review of a preauthorization plan. However, only the RRT representatives from EPA, the state(s) with jurisdiction over the waters of the area to which the plan applies, and the DOC and DOI natural resource trustees will have the authority to approve, disapprove, or approve with modification any revisions to an existing preauthorization plan. This approval process is consistent with the authorization procedures contained in the former § 300.910(a) and should minimize the time necessary for RRT approval of any amendments to an existing preauthorization plan. EPA amended the final provision by adding the phrase “The RRT in consultation with the Area Committee(s) . . .” to provide that review of preauthorization plans are coordinated with the applicable ACs so that ACs may amend relevant ACPs, as appropriate. The proposal would have required plans to be reviewed at least every five years. Commenters provided a range of feedback on this proposed timeframe. EPA recognizes that some commenters supported a five-year review cycle, while others suggested shorter, longer, or no timeframes. As stated in the preamble to the proposed rule, a five-year review cycle is consistent with facility response planning requirements. EPA believes the five-year review process has worked well for facility response planning and believes preauthorization plans should be reviewed and revised in a similar fashion. While EPA still believes that a five-year review cycle is a reasonable time frame, the Agency also agrees with commenters that an alternative timeframe may be appropriate based on regional circumstances. Based on comments, EPA is amending the timeframe for preauthorization plan from five years to a regular timeframe established by the RRT and documented in the plan. Under the revised provision, the Area Committees and RRTs must still periodically review, and revise as needed, preauthorization plans. However, the Area Committees and RRTs are to establish the timeframe and document that timeframe in the plan. The Area Committees and RRTs should also provide to the public the rationale for establishing said timeframe. EPA believes the revised provision is consistent with recommendations in the National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling report and EPA Inspector General report: Revisions Needed to National Contingency Plan Based on Deepwater Horizon Oil Spill (Report No. 11-P-0534) for periodic reviews of contingency plans. The Agency recognizes that development of preauthorization plans can be resource intensive; however, once developed, a periodic review, and revision as needed, should require much less effort. EPA disagrees that it is overly burdensome for RRTs to periodically review, especially with the revised provision to provide additional flexibility to the RRTs to establish and document their own review schedule. EPA also made other changes to the proposed text based on comments received. Several commenters suggested additional triggering events for preauthorization plan review. The Agency agrees that changes other than the trigger events specifically listed in the revised rule may impact the conditions under which the use of chemical and biological agents is preauthorized. EPA amended the final provision to clarify that the triggering events are minimum criteria by including the phrase “Reviews must also be conducted in any affected region, at a minimum . . .”. Some other commenters stated that reviews should be required only after major NCP Product Schedule listing changes to agents that may be used in the preauthorization plan area, as opposed to smaller less significant administrative changes in the NCP Product Schedule. The final provisions provide for preauthorization plans to be reviewed to address revisions to the NCP Product Schedule “impacting chemical or biological agents that may be individually listed within a preauthorization plan.” The revision is intended to avoid confusion with other, non-substantive changes to the NCP Product Schedule. EPA also amended the final provision to add the phrase “. . . relevant to the preauthorization plan area; . . .” to clarify the provision applies to the relevant RRT. The amendment also avoids misinterpretation that an RRT not impacted by a major discharge or by a Spill of National Significance (SONS) would be required to review their preauthorization plan as a result of events outside their region. Similarly, EPA amended the final provision by adding the phrase “. . . applicable to the preauthorization plan area” to clarify the applicability of the provision to the relevant RRT and to avoid confusion that new listings of threatened and/or endangered species in one or more regions requires all RRTs to review their 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 The Agency is revising § 300.910(b) to address the use of chemical or biological agents identified on the NCP Product Schedule or the use of burning agents in spill situations that have not been addressed in preauthorization plans. The revisions clarify the authorities and responsibilities of relevant parties and the factors to consider when authorizing the use of agents in these situations. The revisions also clarify that the provision applies to burning agents as well as products that are listed on the NCP Product Schedule. The revisions to Subpart J do not change, from the former rule provisions, the Agency's fundamental policies regarding the roles of Federal, state, Tribal, and local representatives involved in an oil discharge response. The revisions maintain from the former rule the OSC's authority to authorize the use of chemical or biological agents on the oil discharge; the concurrence of the EPA representative to the RRT and, as appropriate, the concurrence of the RRT representatives from jurisdictional states; and the requirement for consultation with the DOC and DOI natural resource trustees. As with paragraph (a), the final provisions under paragraph (b) specify the parameters that must be considered by the OSC for authorizing agent use on a case-by-case basis. Similar to preauthorization plans, the scope of the case-by-case authorization may include other criteria. EPA is amending the final provisions, relative to the proposal, to reflect that 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, are the minimum criteria OSCs must specify by inserting the phrase “for their authorization request to the RRT, at a minimum” in the final regulatory text. The Agency is also replacing the phrase “. . . to be used . . .” with “. . . requested to be authorized . . .” to avoid confusion that the OSC must use the entirety of the requested quantities, rather than not exceeding the quantities authorized by the RRT. The Agency also specifies that OSCs should address 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. Some commenters, for various reasons, opposed the use of any agents if the agents were not approved in a preauthorization process, even if they are listed on the NCP Product Schedule. EPA disagrees with commenters that agents should not be authorized for use if they are not covered under an approved preauthorization plan. EPA also disagrees that case-by-case authorization under § 300.910(b) provides a lesser standard for authorization. EPA notes the time critical nature of oil discharge responses and that the circumstances surrounding every potential discharge situation are not foreseeable or lend themselves to pre-planning. Not having a preauthorization plan approved by relevant RRT Agencies does not preclude the RRT or OSC from considering chemical or biological agent use for response during planning discussions. However, neither an approved preauthorization plan under § 300.910(a) nor case-by-case authorization under § 300.910(b) provide for a specific authorization outcome. Authorization of use determinations regarding chemical or biological agents are made for each individual discharge with consideration of the incident specific conditions and must be consistent with CWA section 311(d)(2)(G) and the Subpart J regulations. EPA believes there are multiple opportunities through regional and area contingency planning and from provisions included in the final action that RRTs may use to support case-by-case decision making. Contingency planning processes ( e.g., RCPs, ACPs, and vessel and facility response plans) may inform whether the use of chemical or biological agents is appropriate, including during case-by-case authorization under § 300.910(b). Separate from the regional and area contingency planning requirements described in the NCP, EPA acknowledges the benefits from advanced planning to support expedited decision making. The Agency recognizes that incident-specific authorization ( i.e., case-by-case authorization) for discharge situations not covered by preauthorization plans may benefit from planning in advance to support expedited decision making. The final action supports contingency planning efforts by establishing provisions for RRTs to gather supplementary toxicity and efficacy testing, monitoring, or to obtain available data or information relative to the use of a chemical or biological agent (see § 300.910(g)). RRTs may need additional testing or information for situations that fall under § 300.910(b). Some commenters advocated for EPA to require concurrence from natural resource trustees rather than consultation under § 300.910(b). Section 1011 of the Oil Pollution Act (OPA) states that “ The President shall consult with the affected trustees designated under section 1006 on the appropriate removal action to be taken in connection with any discharge of oil. ” Executive Order 12777 delegates this responsibility to the OSC. EPA believes the consultation requirement under § 300.910(b) is consistent with statutory requirements under OPA and maintains the approach of consultations with DOI and DOC natural resource trustees in the final provisions. It is important to note that consultation with the trustees does not mean that the OSC must obtain the concurrence of the trustees. EPA recognizes the decision to use a chemical or biological agent is highly dependent upon specific circumstances, locations, and conditions which must be assessed by the OSC and relevant RRT member agencies. The EPA and the state RRT representative(s), and DOC and DOI natural resource trustees, are in a unique position to understand local conditions and to collect and coordinate quickly the necessary local information. Several commenters addressed the proposed removal of the term “when practicable” from the former rule text regarding consultation with the DOC and DOI. Some supported the removal of this language, stating that consultation and concurrence should always be pursued during case-by-case response decision making, since the situations may present unique challenges. Other commenters opposed the removal of the term “when practicable” and recommended leaving the language as is, asserting that it has worked well for years and that continued flexibility in the approval process is warranted. Commenters suggested that delays in discharge mitigation may occur when waiting for consultations, and that EPA should establish a consultation time limit. The Agency believes that the case-by-case decision making should include consultations with natural resource trustees since these discharge situations may present unique challenges when selecting a response option that involves chemical or biological agents. EPA also notes that OPA 1011 (33 U.S.C. 2711) provides for consultations with the affected trustees on the appropriate removal action to be taken in connection with an oil discharge. Furthermore, § 300.305(e) provides that the OSC shall consult with the affected trustees on the appropriate removal action to be taken. EPA disagrees with concerns that seeking natural resource trustee input could result in delays in the use of a chemical or biological agent. While EPA supports timely decision making, it does not interpret timely decision making to necessarily mean concurring with an OSC request to authorize the use of a chemical or biological agent; consultation can allow for a more immediate exchange of information and ideas when addressing a time-critical response. EPA disagrees with establishing a consultation timeframe ( e.g., 36 or 48 hours) for natural resource trustees and notes that it is contrary to the intent of seeking input on a removal action ( e.g., chemical agent use) prior to its use. While the Agency recognizes the time-critical nature of decision making during a response, advances in communication technology ( e.g., smart phones, email) provide OSCs with increased capabilities to communicate quickly. The Agency believes it is reasonable to expect an OSC to be able to notify and explain the circumstances requiring use of the certain agents to natural resource trustees in a timely manner. The final revisions to § 300.910(b) include removing the phrase “when practicable” with respect to consultation with the DOC and DOI natural resource trustees. EPA believes that the final revisions to Subpart J better align with the statutory and regulatory provisions. A commenter supported the provision to authorize only products that are appropriate and used for their intended purpose under § 300.910(b). To provide additional editorial clarity, the revised provision replaces “. . . chemical or biological agents identified on the Schedule for their intended purpose . . .” with “. . . for the specific purpose for which they were listed . . .” A commenter expressed opposition to the requirement in § 300.910(b) to document the parameters for use of agents when there is not a preauthorization plan, emphasizing the need for quick decision making, noting that the information is already required elsewhere (33 CFR parts 154 and 155) or unnecessary at the time when action is required. Another commenter recommended revisions to the rule text which would increase the specificity of these parameters. While EPA supports timely decision making, EPA does not interpret timely decision making to be inhibited by documentation requirements that both inform RRT Agencies with roles and responsibilities under the NRT for chemical and biological agent use and support the OSC's decision making. Furthermore, EPA recognizes the request that § 300.910(b) increase the specificity of the parameters for the use of products. EPA agrees that site-specific factors are an important consideration when authorizing the use of a chemical or biological agent. For example, environmental characteristics such as local ocean water circulation patterns may affect oil transport and therefore influence whether dispersants are authorized for use, and if so, to what extent. Even within a chemical agent category ( e.g., dispersants), environmental conditions may vary locally, if not seasonally. EPA agrees that such information, if available, should be documented during case-by-case authorization of use. However, there may be several site-specific factors to consider where such information may be unavailable; the fact that information is unavailable, including assumptions used in lieu of unavailable information, should also be documented. EPA believes the relevant Agencies should be afforded flexibility in considering relevant factors when authorizing chemical and biological agents and to tailor the scope of the authorization with consideration of site-specific conditions. EPA does not believe that it is appropriate or feasible to include all potential site-specific information within the regulation. Rather, relevant site-specific factors to consider during case-by-case authorization are more appropriately addressed through development of guidance materials as appropriate, as well as through informed decision making. A commenter requested that EPA provide notification within 24 hours of spills and product use to health care providers and the public, in the language(s) spoken in the impacted region. The final action includes new provision under § 300.910(i)(2) that requires the OSC to provide notification to the public in support of §§ 300.135(n) and 300.155(a) and (b). Under §§ 300.135(n) and 300.155(a) of the NCP, the OSC should ensure all appropriate public and private interests are kept informed and that their concerns are considered throughout a response, to the extent practicable. However, EPA did not include a specific requirement to provide the notification in the language(s) spoken in the impacted region. The reporting provision does not preclude including public notification in different languages and EPA encourages consideration of impacted communities when communicating response actions, including developing materials in languages understood by local communities. However, it is impractical to require an OSC to provide notification in all language(s) spoken in the impacted region during an emergency response where chemical or biological agents may be authorized as the Agency cannot predict where and when an oil discharge occurs. The OSC retains discretion to provide public notification in additional languages if the OSC determines it to be appropriate. A commenter stated that changing the language in this section, from “navigable waters threatened” to “waters and adjoining shorelines threatened” creates additional barriers to use dispersants and limits OSC actions. Another commenter stated that the proposed updates conflict with E.O. 12777 and the CWA because they do not distinguish between coastal and inland zones for planning and operational decision making reserved for the area where the OSC is directing the response. EPA believes that the amended provision provides consistency with the provisions in § 300.910(a); the Agency is not limiting the jurisdictional scope of the NCP as provided under section 311(b)(3) of the CWA. In the final rule provision, EPA also made some editorial changes to the proposed text for increased clarity in addition to the changes described above. (c) Burning Agents EPA proposed to replace the current authorization of use for burning agents in § 300.910(c) to provide greater flexibility to OSCs for authorizing the use of burning agents. Specifically, the Agency proposed that OSCs may authorize the use of burning agents for authorized in-situ burns. EPA received comments that supported the proposed amendments, that requested clarification of the proposed changes, and that raised concerns regarding the consultation and concurrence role of the RRT. Based on public comments received, EPA is not revising § 300.910(c) as proposed, but is instead reserving § 300.910(c) and is amending the regulatory text in § 300.910(a) and (b) to specifically clarify that § 300.910(a) and (b) apply to the authorization of use of burning agents. For preauthorization requirements under the § 300.910(a), the final provisions maintain the previous approach to address burning agents. Under § 300.910(b), the final revisions incorporate burning agents in the case-by-case authorization, along with chemical and biological agents listed on the NCP Product Schedule. This approach eliminates the need to have a separate regulatory requirement for burning agents for case-by-case authorizations. To maintain consistency with the regulation's previous structural organization familiar within the response community, EPA is reserving § 300.910(c). Several commenters expressed general concern about or opposition to the use of burning agents and the use of in-situ burning as a spill response method. Additionally, several commenters expressed concern regarding various environmental impacts, particularly the impacts to aquatic and benthic environments and to air quality, from the use of burning agents and in-situ burns. While burning agents are used in de minimis quantities relative to the discharged oil they would be applied to, and when considering the response as a whole, EPA recognizes that the use of burning agents and in-situ burning may have environmental impacts. However, Subpart J does not state or imply that chemical or biological agents are preferred over other response options. Neither the current nor final rule mandates the use of chemical or biological agents, nor removes them from consideration as a response option. Rather, the Subpart J regulations provide a framework for authorizing their use, as appropriate. EPA believes that the circumstances surrounding oil discharges may vary and therefore there are many factors influencing the choice of response methods. During a response, in-situ burning may be considered along with other response options. Burning agents may be used as part of the in-situ burning process. Depending on incident-specific conditions, timely deployment of several response options may occur while tradeoffs are evaluated to determine which response option (or combination thereof) addresses response objectives. In-situ burning may reduce the need for collection, storage, transport, and disposal of recovered material by converting a fraction of the oil to gaseous combustion products. However, the Agency also recognizes that combustion products may include smoke or soot in addition to carbon dioxide and water. Monitoring of in-situ burns through information collection can inform decision making during a response. EPA recognizes comments regarding air quality concerns, including generation of particulates and toxic gases (specifically VOCs and PAHs) and potential impacts on communities. Beyond Subpart J, the NCP includes provisions for OSCs to address health and safety concerns of workers under § 300.150. The NCP recognizes that the OSC may call upon DHHS to assist in determining public health threats throughout any response action (see § 300.135(h)). In addition, the OSC may monitor air quality to identify potential public health concerns from air residues from in-situ burning. EPA also recognizes that in-situ burning of crude petroleum oil may result in residues that are not only emitted to the air, but are also entrained in the water column. In-situ burning that is initiated using burning agents may lead to the possibility for organisms dwelling in the water column to come in physical contact with residues from the combusted oil. While the burning agent itself is expected to be consumed through combustion, the Agency believes that the harmful impact to an organism caused by physical contact ( e.g., ingestion by fish) with the residue from combusted oil from an in-situ burn initiated by a burning agent is just as concerning as the effects of any residual burning agent. Subpart J does not mandate the use of burning agents. Rather, it provides a framework to consider their authorization by RRTs and OSCs. EPA recognizes the commenters' concerns regarding potential environmental impacts from in-situ burning initiated by burning agents. The final provisions under § 300.910(a) and (b) maintain the current approach that keeps RRTs, including state(s) and natural resource trustees, actively involved in the authorization of burning agents for in-situ burns. EPA believes that the fact that an in-situ burn initiated by a burning agent may cause oil to enter the water column is sufficient reason for RRTs or OSCs to consider whether supplemental monitoring of in-situ burn residue is appropriate. In-situ burning operations are subject to OSC oversight, with OSC authorization required for burning agent use. Some commenters supported not listing burning agents on the NCP Product Schedule, and several other commenters disagreed, stating that burning agents, like other spill response agents, should be listed on the schedule and be regulated with the same efficacy, toxicity, and public ingredient disclosure standards as other listed agents. EPA recognizes comments supporting and opposing the listing of burning agent products on the NCP Product Schedule. EPA recognizes burning agents as a type of chemical agent that must be authorized for use in accordance with the provision under § 300.910. EPA disagrees with the comment that the increasing frequency of burning agent use contradicts the argument that the small quantities make listing considerations unnecessary. The Agency believes that burning agents are used in de minimis quantities relative to the discharged oil they would be applied to, and when considering the response as a whole, and are expected to rapidly burn off during use, which serves to remove them from the water. Burning agents are generally added to an oil slick to initiate an in-situ burn after which the oil slick itself is expected to maintain the burn. Although EPA is maintaining the current approach of not specifically listing burning agent products on the NCP Product Schedule, RRTs may still gather additional information on burning agents and monitor their use under § 300.910(g) Supplemental Testing, Monitoring, and Information. EPA agrees with comments that an in-situ burn may raise concerns regarding environmental impacts and believes that maintaining the current approach keeps RRTs appropriately and actively involved in the decision making to authorize the use of burning agents used in in-situ burning. Furthermore, provisions within the NCP but outside the scope of this rulemaking include requirements for OSCs to address health and safety concerns of workers and the public. For example, § 300.150 provides requirements to address worker health and safety. (d) Temporary Exception EPA is revising § 300.910(d) to clarify the intent of the existing exception to the preauthorization and case-by-case authorization of use regulations. The Agency is including the term “temporary” as a qualifier to the final provision's title, to reflect that there is a time limitation for operating under this provision during a response. The temporary exception provision provides that the OSC may authorize the 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. That is, it allows OSCs to authorize the use of any agent when it is determined that the use of the agent is necessary 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 Agency believes that the protection of human life is the primary consideration in responding to an oil discharge. Accordingly, the OSC must have the ability to use any agents that would effectively and expeditiously mitigate the threat to human life, particularly in situations where chemical agents on the NCP Product Schedule are not immediately available. The final provision includes the phrase “and without consultation with the Department of Commerce and the Department of the Interior natural resource trustees” to further clarify the OSC authority under this provision relative to concurrences and consultations otherwise required for the authorization of chemical and biological agent use under § 300.910(a) or (b). However, this exception cannot be used as a substitute for compliance with § 300.150, including the use of personal protective equipment, or when there is sufficient time to seek authorization in accordance with § 300.910(a) or (b). EPA notes that the temporary exception does not affect other authorities available to an OSC under the NCP, separate from Subpart J, to take actions to address a threat to human life, such as ordering evacuations or repositioning equipment and personnel. The exception provides for authorization of agent use to occur, within a limited timeframe and for the specific purpose of preventing or substantially reducing an imminent threat to human life, if there is insufficient time to obtain the required concurrences for preauthorization or authorization of use for products on the NCP Product Schedule under paragraphs (a) and (b) respectively. To more clearly describe when the exception must not be used, EPA amended the final provision to add the phrase “. . . or when there is sufficient time to seek authorization in accordance with paragraphs (a) or (b) of this section.” The provision is not intended for the OSC to override an authorization decision of an RRT on chemical and biological agent use for the specific incident conditions. The revision in the final action is consistent with the intent of the provision as described in previous NCP final rulemakings (see 55 FR 8808, March 8, 1990). The Agency recognizes oil discharges generally will not pose threats to human life of an immediacy or magnitude that would warrant invoking the temporary exception provision. However, EPA believes that there may be unforeseen circumstances where an oil discharge poses an immediate life-threatening situation, and for which an OSC must have the ability to use agents that could effectively and expeditiously mitigate the imminent threat to human life. The Agency interprets a situation that poses an imminent threat to human life to be one which could reasonably be expected to cause death or serious physical harm such that a part of the body would be severely damaged. Further, the Agency also interprets that this imminent threat to human life must be immediate for this exception provision to be applicable, meaning that it is expected that death or serious physical harm could occur immediately or before any other action can be otherwise implemented. The former language in § 300.910(d) used the terms “hazard” and “threat” interchangeably. The amended regulatory language replaces “hazard” with “threat” for consistency and to establish the intent and expectation of the use of the exception more clearly. Several commenters recommended that the Agency remove the exception provision. These commenters claimed that it is unclear what circumstances would occur requiring the OSC to decide to apply dispersants to protect human health; the exceptions are not necessary; and that the rarity of use of this exemption is evidence that most oil discharges do not pose threats to human life of an immediacy and magnitude that warrant the exception provision. Some commenters suggested that without more direction, strict guidelines, or guidance from the Agency regarding when this provision could be invoked, the proposed rule allows for potential overreach in the use of the exception authority. The Agency recognizes the comments opposing the exception provision and the selection of spill response agents to focus on human health risks. Nonetheless, the Agency reiterates that protection of human life is the primary consideration in responding to an oil discharge. EPA notes that the other authorities available to an OSC under the NCP to take actions to address a threat to human life, such as ordering evacuations or repositioning equipment and personnel, are not affected by the revisions to the temporary exception provision in this final action. The Agency is maintaining the exception provision and is finalizing the proposed amendments with modifications to further clarify the provision's intent and address the concerns regarding potential overreach. The finalized exception provision provides the OSC this authority only in circumstances to prevent or substantially reduce an unforeseeable threat to human life that cannot be immediately addressed by other procedures or provisions of the NCP. Additionally, the Agency added the term “individual circumstances” to provide the OSC flexibility to address one or more separate unforeseen threats to human life at any time during a response. The intent behind this temporary exception provision is to eliminate potential delays in responding to life-threatening situations. The modifications finalized in this action do not change previous policy but rather clarify the intent and scope of the exception. While the Agency expects this temporary exception to be rarely needed, it continues to believe it is appropriate that the NCP include a temporary exception provision to capture unforeseen and immediate life-threatening situations. However, it is important to note that, while all threats to human life are health and safety issues, not all health and safety issues in turn pose an immediate threat to human life. The Agency stresses the intent is for this temporary exception to be applicable only to those imminent life-threatening situations which cannot be addressed through the implementation of other procedures or provisions in the NCP and has amended the final provision accordingly. The final provision also clarifies that the exception must not be used as a substitute for compliance with § 300.150 of this part, including the use of personal protective equipment. Some commenters suggested that the OSC should only be allowed to use products that are listed on the NCP Product Schedule under the exception; a commenter stated that use of products not on the NCP Product Schedule negates the purpose of contingency planning, and that the OSC should only be able to authorize the use of agents listed on the NCP Product Schedule when the agent is necessary to protect human life. Some commenters expressed concerns regarding use of agents without peer-reviewed scientific or technical evidence to show that the dispersant chemical is safe for humans, wildlife, or the ecosystem. A commenter noted that if the work required to add a product to the NCP Product Schedule was not complete prior to a spill then responders should not have the option of bypassing the process by using the [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2023-11904. Public record. Not legal advice.