# National Oil and Hazardous Substances Pollution Contingency Plan > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2015-00544 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** January 22, 2015 - **Citation:** 80 FR 3380 ## Text ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 110 and 300 [EPA-HQ-OPA-2006-0090; FRL-9689-9-OSWER] RIN 2050-AE87 National Oil and Hazardous Substances Pollution Contingency Plan AGENCY: U.S. Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: The Environmental Protection Agency (EPA or the Agency) proposes to amend the requirements in Subpart J of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) that govern the use of dispersants, other chemical and biological agents, and other spill mitigating substances when responding to oil discharges into waters of the United States (U.S.). The proposal addresses the efficacy, toxicity, environmental monitoring of dispersants, and other chemical and biological agents, as well as public, state, local, and federal officials' concerns regarding their use. Specifically, the proposal amends the Subpart J regulatory requirements for the NCP Product Schedule (Schedule) by adding new listing criteria, revising the efficacy and toxicity testing protocols, and clarifying the evaluation criteria for removing products from the Schedule. The Agency also proposes amended requirements for the authorities, notifications, monitoring, and data reporting when using chemical or biological agents in response to oil discharges to the navigable waters of the United States and adjoining shorelines, the waters of the contiguous zone, and the high seas beyond the contiguous zone in connection with activities under the Outer Continental Shelf Lands Act, activities under the Deepwater Port Act of 1974, or activities that may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States, including resources under the Magnuson Fishery Conservation and Management Act of 1976. These requirements are anticipated to encourage the development of safer and more effective spill mitigating products, and would better target the use of these products to reduce the risks 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 have sufficient information to support agent preauthorization or authorization of use decisions. DATES: Comments must be received on or before April 22, 2015. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OPA-2006-0090, by one of the following methods: • Federal Rulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments. • Mail: The mailing address of the docket for this rulemaking is EPA Docket Center (EPA/DC), Docket ID No. EPA-HQ-OPA-2006-0090, 1200 Pennsylvania Avenue NW., Washington, DC 20460. • Hand Delivery: Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA-HQ-OPA-2006-0090. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of the comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Comments and suggestions regarding the scope of any future rulemaking should be clearly differentiated from comments specific to this proposal ( e.g., label Suggestions for Future Rulemaking and Comments on Current Proposal). Docket: All documents in the docket are listed in the http://www.regulations.gov index. 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, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the EPA Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202-566-1744 to make an appointment to view the docket. 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 proposed rule contact Gregory Wilson at 202-564-7989 ( wilson.gregory@epa.gov ) or Vanessa Principe at 202-564-7913 ( principe.vanessa@epa.gov ). The contacts 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 Web site at http://www.epa.gov/oem/. SUPPLEMENTARY INFORMATION: The contents of this preamble are: I. General Information II. Entities Potentially Affected by This Proposed Rule III. Statutory Authority and Delegation of Authority IV. Background A. Historical Background B. Current Statute and Regulation C. Advanced Response Planning 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 of Use 3. Monitoring the Use of Dispersants 4. Data and Information Requirements for Product Schedule Listing 5. Submission of Confidential Business Information (CBI) 6. Addition of a Product to the Schedule 7. Mandatory Product Disclaimer 8. Removal of a Product From the Schedule 9. Appendix C to Part 300 10. Appendix E to Part 300 VI. Summary of Proposed Rule Provisions VII. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and 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: Environmental Justice I. General Information In April 2010, the Deepwater Horizon underwater oil well blowout discharged significant quantities of oil into the Gulf of Mexico. The blowout discharged oil from one mile below the sea surface. Approximately one million gallons of dispersants over a three-month period were deployed on surface slicks over thousands of square miles of the Gulf, and approximately three quarters of a million gallons of dispersants were, for the first time, injected directly into the oil gushing from the well riser. This use of dispersants raised many questions about efficacy, toxicity, environmental trade-offs, and monitoring challenges that EPA seeks to address through the proposed revisions to Subpart J. The proposed revisions to Subpart J address the use of dispersants and other chemical and biological agents to respond to oil discharges into waters of the U.S. Over the past several years, EPA's Office of Research and Development (ORD) has conducted research on improved laboratory protocols for dispersant and bioremediation efficacy, and revisions to Subpart J to address these new protocols were under consideration. As a result of this research and the Deepwater Horizon event, the new protocols in the proposed revisions, in addition to increasing the overall scientific soundness of the data, take into consideration not only the efficacy but also the toxicity, long-term environmental impacts, endangered species protection, and human health concerns raised during responses to oil discharges, including the Deepwater Horizon blowout. Additionally, area planning requirements for dispersant use authorization, toxicity thresholds and advanced monitoring techniques are also proposed. The proposed amendments are a major component of EPA's effort to inform the use of dispersants and other chemical or biological agents when responding to oil discharges. They incorporate lessons learned from the federal government's experiences in the Gulf, and address recommendations specific to agent testing and use in response to oil discharges from the National Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling Report to the President. The proposed amendments would help to ensure that only products that perform effectively in laboratory testing would be listed on the NCP Product Schedule (Schedule) for use in mitigating the effects of oil discharges in the environment. Manufacturers would be required to provide more detailed product application materials, ecological toxicity data, and human health and safety information, including more detailed instructions for product application in the field. Prohibitions on using products in certain areas under certain conditions determined by On-Scene Coordinators (OSCs), Regional Response Teams (RRTs), and EPA would help ensure that first responders are better able to mitigate environmental effects when spills occur. The required submission of additional product toxicity information would aid OSCs and RRTs when evaluating specific product information and when deciding whether and which products to use to mitigate hazards to the environment and human health caused by discharges or threatened discharges of oil. Specifically in this action, the Agency proposes, for the following areas: • Definitions. Amend definitions for Bioremediation agents, Burning agents, Chemical agents, Dispersants, Sinking agents, Sorbents, and Surface washing agents; add new definitions for Bioaccumulation, Bioconcentration, Biodegradation, Biological agents, Bioremediation, Herding agents, Products, and Solidifiers; and remove definitions for Miscellaneous Oil Spill Control Agents (MOSCA) and Surface collecting agents. • General Requirements. Revise to reflect new and amended regulatory definitions. • Authorization of Use. Revise to clarify planning and preauthorization responsibilities, establish limitations and prohibitions on the use of certain agents, establish requirements for storage and use of agents, clarify authorities for requiring supplemental testing, monitoring and information on agents, establish requirements for agent recovery from the environment, and establish reporting requirements for agent use. • Monitoring the Use of Dispersant. Establish monitoring requirements for dispersant use in response to major discharges and/or certain dispersant use situations. • General Product Information for Schedule Listing. Revise and establish requirements, including designation of and testing for all product categories under which the listing is requested, Safety Data Sheets, sample product labels, shelf life, collection and recovery, persistence in the environment, storage and use conditions, physical and chemical properties, component identities, concentration limits on National Water Quality Criteria and Standards contaminants, laboratory accreditations, submission of all testing data and calculations, production capabilities, and any other data or certification informing the product's performance capabilities or environmental benefits. • Dispersant Testing and Listing Requirements. Revise the efficacy testing methodology using a baffled flask test, establish new developmental and sub-chronic toxicity testing requirements, revise the acute toxicity testing methodologies, revise the listing criteria, and establish use limitations to saltwater environments. • Surface Washing Agent Testing and Listing Requirements. Revise the acute toxicity testing methodology and listing requirements, establish efficacy testing requirements and listing criteria, and establish use limitations based on product testing for salt and/or freshwater environments. • Bioremediation Agent Testing and Listing Requirements. Revise the efficacy and acute toxicity testing methodologies and listing criteria, establish exceptions for specified non-proprietary products, and establish use limitations based on product testing for salt and/or freshwater environments. • Solidifier and Herding Agent Testing and Listing Requirements. Revise the acute toxicity testing methodology and listing criteria, and establish use limitations based on product testing for salt and/or freshwater environments. • Sorbent Requirements. Establish a list of known, non-proprietary sorbents to be made publicly available in lieu of listing sorbents on the Schedule, and requirements for data and information for sorbent products with components other than those specifically identified in the rule. • Submissions of Confidential Business Information. Revise the allowable confidential business information claims and reporting procedures. • Addition of a Product to the Schedule. Revise the submission requirements including the package contents, EPA's review of submission package, request for review of decision, changes to a product listing, and transitioning of listed products from the current Schedule to the new Schedule. • Mandatory Product Disclaimer. Revise the product disclaimer requirements. • Removal of a Product from the Schedule. Revise the basis for removal and appeals process. • Appendix C to part 300. Revise the requirements for product testing protocols and summary test data including new dispersant baffled flask efficacy and toxicity tests; new standard acute toxicity tests for bioremediation agents, surface washing agents, herding agents, and solidifiers; and revised bioremediation agent efficacy test. • Appendix E to Part 300—Oil Spill Response. Remove this appendix from the NCP. EPA estimates industry may incur total incremental costs of approximately $668,000 to $694,000 annually. The benefits of the Subpart J amendments are assessed qualitatively. Such benefits include, for example, greater clarity of regulatory requirements, as well as less toxic products. This action does not pose 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. Cost of the Proposed Rule Annualized costs, 20 years Annualized at 3% Annualized at 7% Costs $667,610 $694,343 II. Entities Potentially Affected by This Proposed Rule Industrial category NAICS code Chemical Manufacturing 325 Merchant Wholesalers, Nondurable Goods 424 Professional, Scientific, and Technical Services 541 Waste Management and Remediation Services 562 Oil and Gas Extraction 211 The list of potentially affected entities in the above table includes manufacturers and users of chemical and biological agents, and other oil spill mitigating devices and substances used as countermeasures against oil discharges. 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 preceding section entitled FOR FURTHER INFORMATION CONTACT . 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 National Oil and Hazardous Substances Pollution Contingency Plan (NCP) for removal of oil and hazardous substances. Specifically, section 311(d)(2)(G) requires the President to include a schedule identifying “dispersants, other chemicals, and other spill mitigating devices and substances, if any, that may be used in carrying out” the NCP. The authority of the President to implement this portion of the CWA is currently delegated to EPA in Executive Order 12777 (56 FR 54757, October 22, 1991). Subpart J of the NCP governs the use of dispersants, and any other chemical or biological agent to respond to oil discharges (40 CFR part 300 series 900). IV. Background A. Historical Background The Council on Environmental Quality (CEQ) first published the National Oil and Hazardous Materials Pollution Contingency Plan in 1970 (35 FR 8508). Among its elements was Annex X—Schedule of Dispersants and other Chemicals to Treat Oil Spills. Annex X provided a basic regulatory framework that included authorization of use, restrictions, and information requirements to be submitted to the Federal Water Quality Administration (FWQA). This initial schedule advocated mechanical and other control methods, and the removal and proper disposal of oil from the environment. It also specified that dispersants might be used in accordance with the schedule if other control methods are judged to be inadequate or infeasible, and if certain information requirements and usage requirements were met. As a listing requirement, manufacturers had to provide the FWQA with methods for analyzing the chemical components in fresh and salt water, or reasons why such analytical methods could not be provided. Except to prevent or substantially reduce the hazard to human life or limb, or substantial hazard of fire to property, dispersants were restricted from use on or in any: Distillate fuel oil; spill of oil less than 200 barrels in quantity; shoreline; waters less than 100 feet deep; waters containing major populations or breeding or passage for species of fish or marine life which may be damaged or rendered commercially less marketable by exposure to the dispersant or dispersed oil; waters where the winds and/or currents are of such velocity and direction that the dispersed oil mixtures would likely, in the judgment of the FWQA, be carried to shore areas within 24 hours; and waters where such use may affect surface water supplies. The CEQ revised the National Oil and Hazardous Materials Pollution Contingency Plan, renaming it the National Oil and Hazardous Substances Pollution Contingency Plan (NCP) in 1971 (36 FR 16215). The NCP was amended again in 1971 (36 FR 18411) and 1972 (37 FR 28208), with no substantive changes to Annex X. As a result of the Federal Water Pollution Control Act (Pub. L. 92-500) of 1972, CEQ again revised the NCP, including revisions to Annex X (38 FR 21887, August 13, 1973). The title of Annex X changed to the “ Schedule of Chemicals to Remove Oil & Hazardous Substances Discharges. ” While the Schedule still advocated mechanical and other control methods, and the removal and proper disposal of oil from the environment, it broadened its applicability to chemical agents, including dispersants. It also recognized separate authorizations of use for chemical agents on minor, medium and major discharges. In addition, the revised schedule required an official report from a recognized laboratory with a description of the analytical methods employed and results obtained in determining the chemical and biological characteristics of the chemical agent, but no longer required the submission of those analytical methods. Biological and burning agents were not part of the Schedule, which expressed caution on their use. In 1975 CEQ again revised the NCP, including Annex X (40 FR 6282). Annex X was now the “ Schedule of Chemicals and Other Additives to Remove Oil & Hazardous Substances Discharges, ” and it was “. . . revised and expanded to provide more precise and definitive information, concerning substances which may be employed to remove discharges.” Additionally, Executive Order 11735 (38 FR 21243, August 3, 1973) made EPA responsible for Annex X. Chemical agents or any other substance not specifically defined in the Schedule were to be considered for use on a case-by-case basis. The Schedule advocated the development and utilization of mechanical control methods to remove or mitigate oil, and to remove, mitigate, or neutralize hazardous substances discharges from the environment, with subsequent proper disposal. The Schedule intended that no harmful quantities of any substance were to be applied to waters to remove or mitigate the effects of oil or hazardous substances discharges. The Schedule also provided procedures for authorization of use for different agent categories, and separate regulatory authorization of use for dispersants or other chemical agents was established for minor, medium, and major discharges. Product shelf life, toxicity and effectiveness, and analytical methods needed to obtain such data were among the technical data requirements. Similar provisions were tailored to surface collecting agents and biological additives. In 1982, EPA amended the NCP; the revision included rewriting of Annex X as Subpart H of 40 CFR part 300 of the revised Plan (47 FR 31180). The Agency allowed OSCs to authorize the use of dispersants or other chemicals to treat discharges of oil, provided they were listed in the previous Annex X, with the following limitations: • Authorization applies only to discharges of oil, not to releases of hazardous substances. • OSCs may only authorize the use of dispersant or other chemicals on EPA's Acceptance list, which included the twenty-eight products tested and found acceptable for their intended purpose in the previous Annex X. • State consultation provisions regarding the use of any dispersant or other chemicals in its waters required the OSC to obtain concurrence from the EPA representative to the RRT. The new Subpart H of 40 CFR part 300 also provided for a case-by-case authorization by the EPA Administrator (“Administrator”) or designee of the use of dispersants or other chemicals not on EPA's Acceptance list in treating oil discharges or hazardous substances releases. However, EPA did not include testing procedures or a process for designation of dispersants or other chemicals as acceptable for use. In 1984, EPA published amendments to Subpart H, including adding Appendix C (49 FR 29192). The amendments specified testing and data requirements for listing of dispersants, surface collecting agents, or biological additives on the Schedule to ensure sufficient data was available for the OSC. Standardized testing procedures generated comparable data regarding the products' effectiveness and toxicity. Appendix C detailed the methods and types of apparatus to be used in carrying out the revised standard dispersant effectiveness and toxicity tests, as well as the format required for summary presentation of product test data. Listing of a product on the Schedule was neither a recommendation nor authorization for use on an oil discharge, but rather a confirmation that data submission requirements had been satisfied. EPA's listing on the Schedule did not confirm its safety or effectiveness or constitute an endorsement; in fact, a new requirement was established that either a written disclaimer to this effect or EPA's written disclaimer be included in all product technical literature or advertisements. Products previously listed under Annex X were included on the new Schedule as the previous data requirements were sufficient to permit OSCs to make informed decisions about product use. The amendments also provided for OSC authorization for use of burning agents on a case-by-case basis with the concurrence of the EPA RRT representative and the States, and prohibited the use of sinking agents in waters of the United States. They encouraged advance planning by allowing the OSC to act without the concurrence of the RRT and affected States if these parties have approved a plan identifying the products that may be used in specific contexts. The amendments also allowed the OSC to authorize the use of any product (including products not on the Schedule) without obtaining the concurrence of the EPA representative to the RRT or the affected States if the use of a dispersant, surface collecting agent, or biological additive is necessary to prevent or substantially reduce hazard to human life, and there is not sufficient time to obtain concurrence. However, the OSC was to inform the EPA RRT representative and the affected States of the use of a product as soon as possible, and obtain their concurrences for the product's continued use in the situation once the threat to human life had subsided. These provisions were designed to eliminate delays in life threatening situations, such as spills of highly flammable petroleum products in harbors or near inhabited areas. Subpart H was re-designated as Subpart J with minor changes in 1990 (55 FR 8666), with those definitions present in Subpart H moved to Subpart A, and a new definition and data requirements for miscellaneous spill control agents added. In 1994, EPA revised the NCP in response to the passage of the Oil Pollution Act in 1990 (59 FR 47384). The final rule significantly revised Subpart J to its current regulatory requirements with respect to authorization of use, data requirements, dispersant effectiveness and toxicity testing protocols, surface washing agent toxicity testing protocol, bioremediation agent effectiveness testing protocol, and requirements for adding products to the Schedule. As a result, several dispersants were re-classified as surface washing agents because they did not pass the dispersant efficacy test threshold, but were effective in removing oil from solid surfaces. B. Current Statute and Regulation Section 300.910 of Subpart J addresses the authorization of the use of products on the Schedule and specifies the conditions under which OSCs may authorize the use of dispersants, other chemicals, and other spill mitigating substances. Sections 300.915 and 300.920 describe the data requirements and the process for adding products to the Schedule. To list a product on the Schedule, Subpart J currently requires the submission of technical data on the product to EPA. Data on dispersants, surface collecting agents, surface washing agents, and miscellaneous oil spill control agents must include the results of the toxicity test set for these products in Appendix C of the NCP. Data on dispersants must also include the results of the dispersant effectiveness test, while bioremediation agents must include results of the bioremediation effectiveness test, also set forth in Appendix C. These tests are conducted at the expense of the product manufacturers and must be performed by laboratories experienced with Appendix C protocols. The raw data and a summary of the results from these tests are then submitted to EPA, where they are reviewed to confirm that the data are complete and that the specified procedures were followed. The data requirements for placement of a product on the Schedule are designed to provide sufficient data for the OSCs to judge whether and in what quantities a product may be used to control a particular discharge. Inclusion of a product on the Schedule means only that the data submission requirements have been satisfied. The listing of a product on the Schedule does not mean that the product is recommended or authorized for use on any specific oil discharge nor does it imply that EPA has in any other way endorsed the product for the use listed or for other uses. The standardized testing procedures set forth in Appendix C provide OSCs comparable data regarding the toxicity, effectiveness, and other characteristics of different products. C. Advanced Response Planning Under the current 300.910(a) regulation, RRTs and the Area Committees (ACs) are required to address, as part of their planning activities, the desirability of using appropriate dispersants, and other chemical or biological agents. The RRTs and ACs generally develop “preauthorization plans” which address the specific context in which products can be used under OSC direction. Preauthorization plans are approved with concurrences from EPA, Department of Interior (DOI) and Department of Commerce (DOC) natural resource trustees, and the state(s) with jurisdiction over the water to the area, which they apply. When a preauthorization plan approves in advance the use of certain products under specified circumstances, the OSC may authorize the use of the products without obtaining the specific concurrences described elsewhere in that section of the regulation. The use of chemical or biological agents is only one approach of many available, such as mechanical collection or in-situ burning, and decisions about their use should be weighed to achieve greater overall environmental protection. To facilitate the best possible response, it is important that the regional-level and area-level contingency planning efforts of the RRTs and ACs, respectively, are coordinated closely with each other and are consistent. Section 300.910(a) authorizes the RRTs to review and either approve, disapprove, or approve with modification the preauthorization plans developed by Area Committees that addresses dispersants or other spill mitigating substances. This advanced planning has allowed the OSC to authorize the use of products without obtaining the specific concurrences, if the RRT representatives from EPA and the states with jurisdiction over waters to which a preauthorization plan applies, and DOC and DOI natural resource trustees approve their use in advance. The OSC primarily uses the Schedule to confirm if a product is listed, analyze toxicity and efficacy data, note worker health and safety precautions, understand proper product application, and compare one product to another in order to make the most informed decision on how to mitigate an oil discharge. AC responsibilities include enhancing contingency planning; ensuring preplanning of joint federal, state, and local response efforts; and expediting decisions on the use of dispersants and other spill mitigating devices and substances. The Area Contingency Plan (ACP) must list the equipment, dispersants or other spill mitigating substances, and personnel available to ensure effective and immediate removal of a discharge. ACPs must also ensure the mitigation or prevention of a substantial threat of a discharge; provide a description of the procedures to be followed for obtaining an expedited decision regarding the use of dispersants (which may be addressed in applicable preauthorization plans); and identify the means to monitor use of chemical countermeasures. Many coastal ACPs include some type of preauthorization zones for dispersants, while most Regional Contingency Plans (RCPs) address other product categories, such as bioremediation and surface washing agents. RRTs, in cooperation with the states and federal agencies, have addressed the requirements for the conduct of in-situ burns (ISB) of oil discharges in their RCPs. This planning has allowed consideration of chemical agent use on oil discharges as a viable response tool in combination with other mitigation measures. These agents have increasingly been considered and used in the field, as evidenced by research and case studies presented at national and international oil spill conferences, research and development funding from private and government stakeholders, RRT efforts to plan for their use, requests for EPA and other federal experts to advise field personnel on the use of such products, and by the response to the Deepwater Horizon oil spill. While many research efforts have helped to clarify issues and added information on the toxicity, efficacy, proper use, and human health impacts of these response technologies, uncertainties still arise. The Agency has an interest in resolving the issues that arise from the use of chemical and biological agents in spill responses, as its representatives are asked to concur with chemical and biological agent use for marine and freshwater spills. The use of non-mechanical oil spill mitigating technologies, such as dispersants, surface washing agents, sorbents, solidifiers, bioremediation agents, and others are among the available oil response options that responders may consider in the United States and the world. The National Academies' National Research Council report titled “Oil Spill Dispersants: Efficacy and Effects” (2005), recommends that steps be taken to better support policymakers and spill responders faced with making choices regarding the use of dispersants as part of spill contingency planning efforts or during actual spills. The United States Coast Guard has promulgated new requirements for certain vessels to have only Schedule listed dispersant response capabilities while operating in designated dispersant preauthorization zones (74 FR 45004, August 31, 2009). The proposed amendments are aimed at ensuring that chemical and biological agents have met efficacy and toxicity requirements, that product manufacturers provide important use and safety information, and that the planning and response community is equipped with the proper information to authorize and use the products in a judicious and effective manner. V. This Action This proposal addresses the efficacy, toxicity, environmental monitoring of dispersants, other chemical and biological agents, and other spill mitigating substances, as well as public, state, local, and federal officials concerns on their authorization and use. The sections below explain the proposed requirements and revisions, and EPA is requesting comments by section. Alternatives offered should include rationale and supporting information in order for the Agency to include the alternative in any final rule. A. Discharge of Oil The Agency is proposing revisions to harmonize 40 CFR part 110.4 with the definitions for chemical and biological agents proposed for Subpart J. The current language in § 110.4 is specific to dispersants and emulsifiers. The proposal replaces the terms “dispersants and emulsifiers” with the broader terms of “chemical agent” and “biological agent” as proposed to be amended in § 300.5. The proposed definition for chemical agents includes elements, compounds, or mixtures designed to facilitate the removal of oil from a contaminated environment and mitigate any deleterious effects. The proposed definition for biological agents includes microorganisms (typically bacteria, fungi, or algae) or biological catalysts, such as enzymes, able to enhance the biodegradation of a contaminated environment. Chemical and biological agents would include both the dispersants and emulsifiers cited in § 110.4. By revising 40 CFR part 110, the Agency is clarifying that any chemical or biological agent added to a discharge of oil with the intent to circumvent any provision of 40 CFR part 110 is prohibited. To further reflect the proposed revisions, the Agency is proposing to also amend the section title to “Chemical or biological agents.” EPA believes the proposed amendment is consistent with U.S. Coast Guard (USCG) regulations, which prohibit the discharge of chemicals or other substances into the sea that circumvent discharge conditions specified in their regulation (33 CFR 151.10(g)). EPA requests comment on these revisions. B. Subpart A—Introduction 1. Definitions The Agency is proposing revisions to § 300.5 that amend the definitions for Bioremediation agents, Burning agents, Chemical agents, Dispersants, Sinking agents, and Sorbents. The Agency proposes to revise the term Surface washing agent and amend its definition. Additionally, the proposal includes 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 Agent (MOSCA) and Surface collecting agents. (a) Revised Definitions Bioremediation agent —The Agency is proposing to revise the definition of bioremediation agents to identify as such biological agents and/or nutrient additives. These agents would be deliberately introduced into a contaminated environment to increase the rate of biodegradation, which in turn would assist in mitigating deleterious effects caused by contaminants. The proposed definition identifies as bioremediation agents microorganisms and enzymes. It also identifies nutrient additives such as fertilizers containing bio-available forms of nitrogen, phosphorus, and potassium. The proposed definition clarifies the current definition and adds specific examples of bioremediation agents. This clarification will help manufacturers of products in identifying the type of product, and hence, what testing requirements they will need to comply with to have a product listed on the Schedule. Burning agents —The Agency proposes to revise the definition of burning agents 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. Burning agents include inorganic compounds in the form of gelling agents, such as aluminum soap. For example, the fuel used in helitorch systems is a mixture of powdered gelling agents with either gasoline, jet fuel, or a diesel/gas mixture, which are organic compounds. 1 The Agency believes both the inorganic gelling agent and the organic fuel ( e.g., gasoline) meet the burning agent definition by improving the combustibility of the materials to which they are applied through physical or chemical means. The Agency considered including ignition devices in the definition of burning agent because improving the combustibility of oil and igniting that oil could be considered one and the same. The intent would be to clarify the potential that not only substances, but also the devices holding those substances, be considered in the case-by-case authorization of use of such agents. The Agency rejected this approach since many devices either deliver the agent to the oil to be burned and do not enter the water, or are consumed in the burn along with the agent. The Agency requests comment on whether it should add ignition devices to the definition of a burning agent. 1 Fingas, Mervin, (Ed) (2011), Oil Spill Science and Technology, Gulf Professional Publishing, pp. 836, ISBN: 978-1-85617-943-0. Chemical agents —The Agency proposes to revise the definition of chemical agents to identify as such those elements, compounds, or mixtures that are designed to facilitate the removal of oil. These agents may be used to mitigate deleterious effects of the oil on a contaminated environment. The proposed definition would include under the chemical agent category burning agents, dispersants, herding agents, sinking agents, solidifiers, surface washing agents, and those bioremediation agents that consist of nutrient additives. The proposed language reflects the distinction the Agency is now making between chemical and biological agents, allowing product manufacturers to better target the testing requirements and OSCs to better inform their authorization of agent use in specific situations. The proposal also removes from the definition agent categories that are either being eliminated, prohibited or amended to conform to the changes, as discussed below. Dispersants —The Agency is proposing to revise the definition of dispersants to identify them as those agents that promote the formation of small droplets of oil in the water column by reducing the oil-water interfacial tension. Dispersants are proposed to be defined as typically mixtures of solvents, surfactants (including biosurfactants), and additives. The proposed definition specifically addresses the process through which these agents assist in mitigating the consequences of a discharge, clarifying for manufacturers which testing requirements they will be subject to when seeking to list a product on the Schedule. Sinking agents —The Agency is proposing to revise the definition of sinking agents to identify them as those substances deliberately introduced into an oil discharge to submerge the oil to the bottom of a water body. The current definition is ambiguous in regards to how much sinking below the water surface would qualify as a sinking agent, as some submersion below the surface but generally not to the bottom of the water body can also be associated with other agents, such as dispersants. The proposed definition specifies these agents purposely sink the oil to the bottom of a water body. The Agency is prohibiting 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. Sorbents —The Agency is proposing to revise the definition of sorbents to identify them as inert, insoluble substances that readily absorb and/or adsorb oil or hazardous substances. The proposed definition specifies that sorbents are not combined with or act as any other chemical or biological agent. The proposed definition also specifies that sorbents are generally collected and recovered from the environment and that they may be used in their natural bulk form, or as manufactured products in particulate form, sheets, rolls, pillows, or booms. The proposed definition identifies sorbents as substances consisting of: (1) Natural organic substances ( e.g., feathers, cork, peat moss, and cellulose fibers such as bagasse, corncobs, and straw); (2) inorganic/mineral compounds ( e.g., volcanic ash, perlite, vermiculite, zeolite, clay); and (3) synthetic compounds ( e.g., polypropylene, polyethylene, polyurethane, polyester). The proposed changes simplify the definition by removing the definitions of absorption and adsorption that are embedded in the current definition of sorbents. The Agency believes this is appropriate given these are generally recognized scientific terms and the proposal does not distinguish sorbents or in any way restrict their use based on whether they absorb or adsorb the oil. The definition also adds the “natural” qualifier to organic substances, indicating that organic substances that have been treated with other substances would not necessarily fall under this category of agents and should not immediately be considered a sorbent. 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. The Agency requests comments on whether the definition is appropriate or if there are other materials that should also be included. Additionally, the Agency requests comments on particulate materials ( e.g., clay) as sorbents. There is concern that particulate materials with densities greater than the seawater (or freshwater depending on where they may be used) have the potential to become sinking agents, settling to the seabed and posing potential risks to benthic organisms. This question is also relevant when considering emerging response technologies such as the use of particulate materials to form oil-mineral aggregates (OMAs) to promote dispersion. OMAs are stable microscopic entities formed when particulate materials interact with the oil droplets resulting in distinct oil and mineral phases. These fine mineral particles could be intentionally introduced by themselves to promote physical dispersion by preventing the oil to re-coalesce, or can also be used in conjunction with dispersants to enhance chemical dispersion. However, any particulate material that by itself, or when combined with oil ( e.g., OMA), results in overall densities less than the waters where it may be used, would not be prohibited as a sinking agent. The Agency requests comment on whether the use of sorbent materials in particulate form should be specified for use only in booms or other contained manufactured products, and whether there should be limitations on the authorization of use on water for sorbents in loose particulate form. Alternatively, the Agency also requests comment and supporting rationale on other approaches, including whether particulate materials in loose form, or specifically OMA technologies, should be excluded from the regulatory definition of sorbents. Finally, EPA also requests comments on the qualifier phrase “that are generally collected and recovered from the environment.” For example, a natural organic and biodegradable sorbent ( e.g., bagasse) may not necessarily need to be removed after it has absorbed/adsorbed the oil when used in a wetland or salt marsh. Such removal may cause more harm than the oil itself due to trampling in the wetland or salt marsh. Once the oil is brought to the surface by the sorbent, biodegradation of both the oil and the sorbent can take place, especially if nutrients are added to enhance biodegradation. Another example would be the use of OMA technology to promote dispersion, which might not lend itself to collect or remove the aggregates from the environment. Thus, the Agency is requesting comment on whether testing and/or authorization of use requirements should be considered for particulate materials in loose form or OMA technologies that may be used in discharge situations where they would not be collected and recovered from the environment. Surface washing agents— The Agency is proposing to revise the term surface washing agent and the definition for surface washing agents. The proposed definition would identify surface washing agents as those substances that separate oil from solid surfaces ( e.g., beaches, rocks, metals, or concrete) through a detergency mechanism. This detergency mechanism would lift and float the oil for collection and recovery from the environment. The use of these agents results in minimal dissolution, dispersion, or transfer of oil into the water column. The proposed changes revise the term from singular to plural to be consistent with the other agent definitions and clarifies that these agents are to be recovered from the environment along with the oil being treated. (b) New Definitions The Agency is proposing to add several new definitions that serve as the foundation for the new proposed biological agent classification: Bioaccumulation, Bioconcentration, Biodegradation, Biological agents, and Bioremediation. The proposed definitions include basic terminology and are consistent with definitions of these terms generally understood by the scientific community. The Agency is also proposing new definitions for the terms herding agents and solidifiers. The proposed definitions address types of agents originally captured under the surface collecting agent or the miscellaneous oil spill control agent categories respectively, and are terms that are more commonly used in industry. The definitions more specifically describe the specific process through which the product affects the oil for the categories and are consistent with definitions of these terms generally understood by the scientific community. Finally, the Agency is proposing a new definition for the term product to clarify the difference between a specific product and an agent type or category. All of the proposed new definitions can be found in the § 300.5 of this action. (c) Removed Definitions The Agency is proposing to remove the definitions for surface collecting agent and for miscellaneous oil spill control agent (MOSCA). The surface collecting agent definition is being removed and replaced with a new herding agent definition to better reflect the common terminology used in industry for these agents. The MOSCA definition is being removed and replaced with a number of new and/or revised definitions for types of agents. The original MOSCA category was used as a catchall for all types of products that did not meet other agent definitions. As the Agency adds new, more stringent testing requirements for listing products on the Schedule, there is a need for more specific category definitions to assist manufacturers in determining which of those testing requirements apply to their products. The Agency believes it has identified categories that capture all products to be listed on the Schedule; we request comment on whether the MOSCA category should be retained, and whether the proposed categories are appropriate, including sufficient information and rationale to support the addition of any new categories. C. Subpart J—Use of Dispersants, and Other Chemical and Biological Agents 1. General EPA is proposing to amend § 300.900 by revising paragraphs (a) and (c), and by adding paragraph (d) to reserve for “Releases of Hazardous Substances”. The proposed revisions clarify that Subpart J addresses not only chemical agents, but also those agents that now fall under the newly proposed biological agent category. The revisions reaffirms the notion that Subpart J is not only comprised of a 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 proposing to reserve a section for “Releases of Hazardous Substances” to take place of the current placeholder in § 300.905, which is proposed to be removed. Based on all relevant circumstances, testing data and information, and in accordance with the authorization of use procedures (including the appropriate concurrences and consultations), the waters and quantities in which a dispersant, or other chemical or biological agents may be safely used are to be determined in each case by the OSC. When taken together, these testing requirements, listing of agents and authorization of use procedures address the types of waters and the quantities of listed agents that may be used in response to discharges of oil or hazardous substances. The wide variability in waters, weather conditions, organisms living in the waters, and types of oil that might be discharged requires this approach. 2. Authorization of Use Section 300.910 sets forth the provisions for the authorization of use of products on the Schedule in response to oil discharges. Subpart J does not state or imply that chemical or biological agents are preferred over other response options such as mechanical recovery devices. EPA believes that the circumstances surrounding oil discharges and the factors influencing the choice of response methods are many. During the DWH response, a priority countermeasures scheme was established to first use mechanical recovery via skimming/booming or in-situ burning followed by subsea dispersant and lastly surface dispersant use. Following DWH, EPA and the NRT issued Interim Actions regarding the use of dispersants on oil spills to NRT members and RRT co-chairs 2 and to EPA Regional Administrators 3 for consideration during response planning. While response actions are incident specific, the availability of response methods that address the specific discharge situation depends largely on contingency planning activities and on how these requirements are implemented through the RCPs, ACPs and vessel and facility response plans. In order for a response to be effective, the NCP requires coordination between the regulatory and planning entities responsible for all these response plans. The Agency believes that preauthorization or expedited decision making plans are critical elements of contingency planning activities. Regularly reviewing or revising preauthorization or expedited decision making plans provides those agencies in charge of preparedness planning the opportunity to identify and resolve concerns in advance, leading to quick and effective operations during removal actions. The Agency believes these proposed revisions to the authorization of use provisions will assist OSCs, RRTs, and ACs in their advanced planning activities as they consider response methods that result in the greatest environmental protection. The goal is to ensure that preauthorization or expedited decision making plans are developed and maintained to effectively support decisions by OSCs during removal actions. In carrying out advanced planning activities, the Agency believes the NRT can assist RRTs by providing guidance on national level issues that may arise during planning activities. 2 Tulis, Dana S., EPA Chair and Caplis, Captain John, USCG Vice-Chair, National Response Team, “Use of Dispersants on Oil Spills—Interim Actions;” Memorandum to NRT Members and RRT Co-Chairs; December 16, 2010. 3 Stanislaus, Mathy; Assistant Administrator, OSWER EPA; “Revision of Area Contingency Plans/Regional Contingency Plans Regarding Use of Dispersants on Oil Spills—Interim Actions;” Memorandum to EPA Regional Administrators, November 2, 2010. EPA is amending § 300.910 by revising paragraphs (a) through (f); and by adding paragraphs (g), (h) and (i). EPA is not proposing major changes to the current authorities granted to OSCs, RRT representatives to the RRTs, States, DOC, DOI, or other National Response Team decision makers with regards to the authorization and application of chemical or biological agents. However, EPA recognizes that the planning for and prolonged use and monitoring of chemical agents, especially dispersants, may require additional planning activities and monitoring requirements. Thus, the Agency is proposing to reorganize this section; to add titles to the paragraphs for ease of use; to add several requirements addressing the storage and use of agents, notification of agent use and recovery from the environment; and to revise language to clarify established EPA policy. The proposed revisions and clarifications are highlighted for each paragraph under § 300.910. EPA is also confirming, consistent with the intent of the NCP, that use of chemical or biological agents in response to oil discharges to waters of the U.S. or its adjoining shorelines must be authorized by an OSC in accordance with Subpart J. The unauthorized use can result in violations of section 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. (a) Use of Agents Identified on the Schedule on Oil Discharges Addressed by a Preauthorization Plan The Agency is proposing revisions to § 300.910(a) of Subpart J to address the preauthorized use of chemical and biological agents identified on the Schedule. The proposed revisions 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. EPA is also proposing to reorganize paragraph (a) to provide greater clarity by making the regulatory text easier to read and follow. The Agency believes that the proposed revisions do not change its fundamental policies regarding roles of Federal, state and local representatives involved in planning for and responding to an oil discharge, but rather clarify the current requirements and further explain the responsibilities for each party. The Agency is also proposing added procedures and review requirements intended to ensure preauthorization plans are up-to-date so they are most effective when implemented in case of a discharge. EPA believes RRTs and ACs must work together in order to effectively and successfully manage contingency planning. Thus, the proposed revisions continue to require that, as part of their planning activities, RRTs and ACs address in the preauthorization plan whether the use of chemical and biological agents listed on the Schedule on certain oil discharges is appropriate. The Agency believes that the proposed revision clarifies the meaning of the desirability of using appropriate chemical or biological agents. The Agency is removing “. . . the desirability of using appropriate burning agents.” from paragraph (a) and addressing the use of burning agents under paragraph (c) to provide greater flexibility to OSCs for authorization of use. Under the current paragraph (a), ACs are responsible for developing preauthorization plans. ACs are also responsible for developing ACPs, providing a forum to evaluate the environments within a jurisdiction and establishing protection priorities. The information gathered during the ACP development process should inform the development of preauthorization plans. Identified representatives from the RRTs are responsible for approving or requesting modifications of preauthorization plans developed by the ACs. ACs can advocate for local concerns to be reflected in the preauthorization plans they develop, and the RRTs will decide if the plans are adequate and address region-wide and cross-regional issues. Since the RRTs should be in a position to provide guidance to ACs on common attributes within a region, EPA continues to believe RRTs and ACs should work together to develop preauthorization plans, particularly when identifying discharge situations where chemical or biological agents may be used. There may be circumstances where it is appropriate to allow either the RRTs and/or ACs to develop preauthorization plans. Preauthorization plans developed by an RRT would allow for these plans to better reflect overarching regional circumstances. Therefore, the Agency is proposing to include RRTs as another planning entity with responsibility for developing preauthorization plans, and is requesting comment on this change, and on the advantages or disadvantages of keeping the development of these plans at the AC level. ACPs generally describe discharge situations for the geographical area for which they apply. Discharge situations developed as part of area contingency planning activities may consider likely scenarios from vessels, and onshore or offshore facilities. While RRTs and ACs should consider the discharge scenarios described in ACPs when identifying discharge situations in developing preauthorization plans, the Agency believes they should also have the flexibility to consider other discharge scenarios. The proposed language states preauthorization plans must 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 dispersant use limits and parameters. Regional factors include the likely sources and types of oil that might be discharged, various 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. While the proposed revisions simplify the language and clarify the requirements, the Agency believes it is necessary to keep in place the fundamental elements that should be considered. The proposed factors generally parallel those under the current 300.910(a) regulation. Several revisions include identifying some factors as “regional” and others “logistical.” The Agency is identifying “logistical” factors to ensure the availability of chemical and biological agents to address discharge situations identified in the preauthorization plan. The Agency added “various discharge scenarios” as a regional factor to be considered because preauthorization plans may cover more than one ACP with multiple discharge scenarios that RRTs and/or ACs may want to consider. The Agency also added the existence and location of “restricted areas” along with “environmentally sensitive resources” as a factor to consider. Environmentally sensitive resources would include fish, wildlife and their habitats, and other special areas of ecological sensitivity that may be adversely affected by a discharge. While “restricted areas” may include “environmentally sensitive resources” some areas may be restricted from certain activities because of biologically sensitive topographic features or critical habitats, such as submerged rock formations colonized by species ( e.g., coral) and the organisms they interact with and support. NOAA's Environmental Sensitivity Index maps, the Fish and Wildlife and Sensitive (FWS) Environments Plan in ACPs, or environmental impact statements, may contain relevant information on “environmentally sensitive resources” for the RRTs and ACs to consider. The proposal revises the phrase “potential sources and types of oil that might be spilled” to “likely sources and types of oil that might be discharged.” 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. In addition, the proposal revises “spill” to “discharge” to be consistent with terminology in the NCP. The proposal also revises the phrase “the available means to monitor product application and effectiveness” to “means to monitor agent use in the environment” as the Agency believes it provides for additional flexibility for the RRTs and/or the ACs to consider the scope of the monitoring, and to include other endpoints beyond product application and effectiveness. The Agency is proposing to eliminate the “available” qualifier, as it believes it is unnecessary. Likewise, the Agency proposes to eliminate the “available” qualifier before “product and storage locations” and revise the phrase “product and storage location” to the broader “inventory, storage locations and manufacturing capability of available agents” to address lessons learned from the Deepwater Horizon incident, including the challenges posed by the potential sustained use of dispersants. When developing preauthorization plans, RRTs and ACs should use the best available scientific information to assess environmental trade-offs, including those identified by conducting an ecological risk assessment. Environmental trade-offs should be considered in determining response options that provide the greatest environmental protection. The RRTs and ACs should identify the affected biological resources and their habitats likely to be negatively impacted, as well as those that are expected to benefit. The natural resource trustees are critical partners that can assist in conducting these analyses. As previously stated, all members of the RRT are afforded an opportunity to review and provide input on a draft preauthorization plan. However, only the RRT representatives from EPA and the state(s) with jurisdiction over the waters and adjoining shorelines within the preauthorization plan area and the DOC and DOI natural resource trustees may approve, disapprove, or approve with modification the draft preauthorization plan. The Agency believes this remains the correct approach. Given preauthorization plans are developed during the contingency planning phase, the Agency believes that 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. As noted in the 1994 NCP final rule, the requirement for concurrence during the advanced planning phase ensures trustee involvement in decision-making (59 FR 47398). Addressing in advance concerns that might otherwise slow the action ensures that operations during a removal action can be carried out quickly and effectively. EPA believes natural resource trustee concurrence with preauthorization plans satisfies the consultation obligation since the preauthorization plans specify the use parameters for chemical or biological agents. Thus, the Agency is retaining this concurrence requirement for preauthorization plans. The Agency is proposing to revise the “Approved preauthorization plans shall be included in the appropriate RCPs and ACPs” in the current § 300.910(a) regulation to “RRTs and ACs shall, as appropriate, include applicable approved preauthorization plans in RCPs and ACPs.” The Agency is proposing to modify the qualifier “approved” with “applicable” to clarify that RRTs and ACs need to include the preauthorization plans only in those RCPs and ACPs to which they apply, and remains consistent with current requirements. The Agency considered adding specifically the EPA Administrator and the senior EPA representative to the NRT ( e.g. NRT Chair) to § 300.910(a) and other paragraphs to make clear the EPA Administrator's and senior EPA NRT representative's existing authority under section 311(d)(2)(G) of FWPCA and Executive Order 12777, along with the OSC to authorize any chemical or biological agent use. The Agency is clarifying that if the preauthorization plan is approved in advance for chemical or biological agent use under specified discharge circumstances, then the OSC may authorize the use of the agents on the Schedule for their intended purpose without the incident specific concurrences and consultations described in paragraphs (b) of this section unless otherwise directed by the Administrator in accordance with current concurrence authority. The Agency believes this clarification would not impede rapid decision-making on the part of the OSC, and that for the majority of discharge situations, the OSC will remain as the sole authorizing entity for discharge situations covered by preauthorization plans. Note that in situations like a spill of national significance (SONS) or an event of extended duration, the Administrator already has the authority for, and is likely to have a more direct role in chemical or biological agent use decisions. The authority, jurisdiction, and implementation provisions in the NCP flow from section 311 of the Clean Water Act and are reflected in Executive Order 12777. All authorities under CWA 311 are delegated either directly to the Administrator by Congress, or by Executive Order 12777 from the President to the Administrator. While the Administrator's authority may be further delegated through senior management on down to the RRT representative, the Administrator (and other delegatees) retain the authority to act. The mere delegation of authority does not prohibit the delegator from exercising said authority. However, given these situations are rare and that this is an existing authority, the Agency is not proposing a regulatory amendment to clarify the Administrator's authority at this time. We request comment on this issue. The Agency is clarifying that chemical or biological agents may only be used for their intended use, given the different listing requirements proposed for the various categories of chemical or biological agents. For example, a chemical agent that is listed on the Schedule solely as a surface washing agent cannot be authorized for use as a dispersant, nor can a chemical agent that is listed on the Schedule solely as a dispersant for use under saltwater conditions be used in freshwater. The Agency is proposing specific procedures for concurrence withdrawals, allowing agencies to do so if they believe the preauthorization plan no longer addresses or reflects existing situations if it were to be implemented. While an agency with concurrence authority may now decide to withdraw concurrence from an approved preauthorization plan, there are currently no set procedures to promptly address those situations. The proposal would require the RRT and the ACs to address the withdrawal of approval of the preauthorization plan within 30 days of the withdrawal, allowing an opportunity to address the concerns. The proposal also calls for the RRT to notify the NRT of the final status of the preauthorization plan within 30 days from the withdrawal. The Agency requests comments on whether this 30 day notification requirement should also include notification to the public. In the event of an Agency withdrawing its concurrence from an approved preauthorization plan, EPA believes the advanced planning process should continue with consideration for all the elements specified in paragraph (a) of this section. While the absence of a preauthorization plan requires that authorizations for agent use be conducted according to paragraph (b) of this section, the Agency continues to believe that preauthorization plans serve as a valuable advanced planning tool that provides a strong foundation to support decision-making and strongly encourages the resolution of any withdrawal. Finally, EPA proposes a new requirement for RRTs and/or ACs to review, and revise as needed, preauthorization plans: (a) At least every 5 years to address revisions of the Schedule; (b) after a major discharge or a spill of national significance (SONS); (c) to reflect new listings of threatened and/or endangered species or; (d) after any other change such as a new or revised worst case discharge estimate that may impact the conditions under which the use of chemical and biological agents is preauthorized. A 5-year review cycle is consistent with facility response planning requirements; as those plans are revised and updated, it seems reasonable that preauthorization plans should be reviewed and revised accordingly. 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 welcomes comment on this timeframe and suggestions with supporting information for alternatives. This review requirement is intended to ensure that preauthorization plans are actively maintained and updated to reflect revisions to the Schedule. Preauthorization plans, as well as the facility and vessel response plans reflected in them, may include information on products listed on the Schedule. A review at least every 5 years is expected to provide greater consistency not only between any Schedule revisions, but also between any ACPs, facility, and vessel response plans. For example, an ACP revision that results in a change in the worst-case discharge scenario could trigger a preauthorization plan review. Additionally, the requirement specifically includes plan review and revision requirements as appropriate to reflect new listings of threatened and/or endangered species that may occur. The EPA RRT representative, the DOC and DOI natural resource trustees, and, as appropriate, the RRT representative from the state(s) with jurisdiction over the waters of the area to which a preauthorization plan applies must review and either approve, approve with modification, or disapprove any revisions to the preauthorization plans. This review and approval is intended to focus on any revisions, and is not intended as a requirement for review and approval for those portions that do not require modifications. (b) Use of Agents Identified on the Schedule on Oil Discharges Not Addressed by a Preauthorization Plan The Agency is proposing revisions to § 300.910(b) of Subpart J to address use of chemical or biological agents identified on the Schedule for discharge situations that have not been addressed in preauthorization plans. The proposed revisions clarify the authorities and responsibilities of all involved parties, and the factors to consider when authorizing the use of listed chemical or biological agents in these situations. The Agency believes the proposed revisions do not change its fundamental policies regarding the roles of Federal, state and local representatives involved in an oil discharge response. The proposed revisions maintain, with the appropriate concurrences and consultations, the OSC's authority to authorize the use of chemical or biological agents on the oil discharge, provided that the agents are listed on the NCP Product Schedule. The concurrence of the EPA representative to the RRT and, as appropriate, the concurrence of the RRT representatives from the states with jurisdiction over the waters and adjoining shorelines threatened by the release or discharge is maintained. The requirement for consultation with the DOC and DOI natural resource trustees is also maintained. However, the language is amended by removing “when practicable” with respect to consultation with the DOC and DOI natural resource trustees. 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. 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. Therefore, 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. Of note, while consultation with the trustees on removal actions as required by OPA does not equate to a concurrence requirement, the Agency believes that such concurrence is highly desirable. The Agency is also proposing to revise the term “navigable waters threatened” to “waters and adjoining shorelines threatened” to be consistent with the provisions in paragraph (a) of this section. The preauthorization plan requirements in paragraph (a) proposes to remove the term “specific context” currently used and instead clearly establish what the term refers to. The proposal specifically identifies the parameters that must be considered by the OSC for authorizing agent use. Similar requirements are proposed under paragraph (b). Thus, in meeting the provisions of § 300.910(b), the OSC must consider and document the parameters for the use of agents including, but not limited to, quantities to be used, the duration of use, the depth of water, the distance to shoreline and proximity to populated areas, and 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. These considerations are parallel to those proposed under paragraph (a) for preauthorization and planning purposes. While the Agency is not including other factors that may inform preauthorization planning development, such as various discharge scenarios, this does not mean these factors cannot or should not be considered if RRTs and/or ACs choose to develop expedited decision making plans. The Agency believes these are fundamental elements that would inform an assessment of the overall ecological risks for the OSC to consider when authorizing the use of chemical or biological agents. Finally, while not required, EPA strongly recommends advanced planning for expedited decision making for cases where the discharge situation is not addressed in the preauthorization plans. Some RRTs have developed expedited approval guidelines that are not part of the preauthorization plans, but that offer an opportunity for advanced contingency planning by gathering information on the key parameters discussed above. Because discharge situations not covered by preauthorization plans need incident specific ( i.e., case-by-case) authorization concurrence, 4 expedited approval guidelines can be used to support expedited incident specific authorizations. For chemical or biological agents listed on the Schedule that are not authorized for use under a preauthorization plan, the ACs and RRTs should work together to outline the process for expedited authorization decisions regarding their use. It is important to note that while the NCP requires that the ACPs include procedures for expedited decisions, these procedures can include disapproving the use of agents, or approving the use of agents with certain operational conditions. For example, areas may be designated in which the use of certain agents or other discharge mitigating devices is prohibited, situations where limits are placed on the quantities of agents used, or situations that require certain monitoring requirements be in place. 4 http://www.epaosc.org/sites/5083/files/rrt6_nearshore_dispersant_eap_031605.pdf. (c) Burning Agents The Agency is proposing to replace the current authorization of use for burning agents in § 300.910(c) with a provision that provides greater flexibility to OSCs for authorizing the use of burning agents. Specifically, the Agency proposes that OSCs may authorize the use of burning agents for authorized in-situ burns. The proposed amendments recognize that relatively small quantities of burning agents are ignited prior to or immediately after they are introduced to an oil discharge. Furthermore, they are composed of substances that are expected to rapidly burn off during use, which serves to remove them from the water. The Agency also recognizes that ISB has become an important response option that is used more frequently and the proposed revisions would allow OSCs to authorize the use of burning agents for authorized burns. For example, a significant number of ISBs were conducted during the Deepwater Horizon oil spill, 5 and ISBs appear to be gaining a more prominent role as a response option in federal waters in remote locations, such as the Arctic. Therefore the Agency believes the proposed revisions better address OSC authorities for these situations, without compromising environmental concerns. Further, because of the nature of burning agents and the proposed revisions to the authorization of use for these products, the Agency continues to believe it is not necessary to require product submissions for burning agents. Thus, the proposal removes the provisions for burning agents under the current data requirements. The Agency requests comments on this approach. 5 http://www.restorethegulf.gov/release/2011/08/19/operations-and-ongoing-response-august-17-2011. (d) Exceptions The proposed rule maintains the provision allowing OSCs to authorize the use of any agent, including products not on the Schedule, when it is determined that the use of the agent is necessary to prevent or substantially reduce a threat to human life. The proposed revisions do not change previous policy, but rather clarify the intent of the exception. The Agency believes that the protection of human life is the primary consideration in responding to an oil discharge. Life- threatening oil discharges ( e.g., spills of highly flammable petroleum products in harbors or near inhabited areas) may occur at locations where chemical agents on the Schedule are not immediately available. The Agency believes that in such cases, an OSC must have the ability to use agents that, in his professional judgment, would effectively and expeditiously mitigate the threat to human life. Allowing this authorization to occur without the required concurrences for preauthorization or authorization of use for products on the Schedule under paragraphs (a) and (b) respectively, eliminates delays in responding to potentially life-threatening situations. The Agency is proposing to include “without obtaining the immediate concurrence” to clarify the scope of the exception. The proposed revisions are consistent with the intent of the current regulation which recognizes that once the threat to human life has subsided, the continued use of a product shall be in accordance with authorization of use paragraphs (a) and (b) of the section. In addition, this exception is intended for those extraordinary situations in which time is of the essence to mitigate the threat to human life; revising the language to replace “hazard” with “threat” clearly establishes this. The Agency emphasizes this authority is not intended to circumvent the authorization of use provisions in paragraphs (a) and (b) of this section, which serve to address all other situations. The proposed revisions also specify that the OSC immediately notify, and document the reasons for the use of an agent to the EPA RRT representative and the affected states as soon as possible, and must obtain their concurrences where continued use of chemical or biological agents extends beyond 48 hours. The Agency believes that advances in communication technologies ( e.g., smart phones, email) provide OSCs the increased capabilities to communicate quickly. Therefore, it is reasonable to expect that the OSC notify and explain the circumstances requiring use of the agent to the designated EPA RRT representative and, as appropriate, the RRT representatives from the affected states and the DOC/DOI natural resources trustees within 48 hours. The Agency is requesting comments on these revisions, and specifically on the 48 hour timeframe within which the OSC shall be operating in accordance with authorization of use paragraphs (a) and (b) of the section. (e) Prohibited Agents The Agency is maintaining the current prohibition for the authorization of use of sinking agents, and is clarifying that this prohibition also applies to any other chemical agent, biological agent, or any substance that acts as a sinking agent when mixed with oil. While certain chemical and biological agents may submerge oil below the water surface ( e.g. dispersants are designed to break up oil into small, near neutrally buoyant particles that are entrained in the water column between the surface and the bottom), they would not be considered “sinking agents” for purposes of the proposed definition and this prohibition, given that they do not completely submerge oil to the bottom of the water body when applied to an oil discharge. Sinking agents, when applied to oil discharges, function by sinking floating oil to the bottom of any body of water where used, potentially causing adverse effects on benthic organisms vital to the food chain of the aquatic environment. Additionally, the oil and these agents are very difficult to remove. The Agency has similar concerns regarding substances that could directly cause the oil to submerge to the bottom of the water body when used in an oil spill response, and thus it is specifically proposing to exclude their use. The Agency is also proposing to add a prohibition from listing on the Schedule and from authorizing use of any chemical or biological agents that contain nonylphenol (NP) or nonylphenol ethoxylates (NPEs) as components. This prohibition reflects the Agency's concern for these substances, as presented in the EPA Nonylphenol and Nonylphenol Ethoxylates Action Plan, released August 18, 2010. The Action Plan specifically addresses nonylphenol (NP) and nonylphenol ethoxylates (NPEs). NP and NPEs are produced in large volumes, with uses that currently lead to widespread release to the aquatic environment. NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms. NP's main use is in the manufacture of NPEs. NPEs are nonionic surfactants that are used in a wide variety of industrial applications and consumer products. Many of these, such as laundry detergents, are “down-the-drain” applications. Some others, such as dust-control agents and deicers, lead to direct release to the environment. NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP. Both NP and NPEs have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota. NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents. EPA has encouraged the ongoing voluntary phase-out of NPEs in industrial laundry detergents, and intends to evaluate how releases and exposures are mitigated through the phase-out action prior to taking any final regulatory action under the Toxic Substances Control Act. 6 The Agency believes this prohibition would not adversely affect product manufacturers given there are viable alternatives to the use of NP and NPEs in product formulations. However, we are requesting comment on the potential impacts of modifying existing products to meet this new requirement, including cost. 6 For more information, refer to http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/np-npe.html . Alternatively, EPA considered a broader prohibition from listing and from authorizing the use of chemical or biological agents formulated with any endocrine disrupting compounds (EDC). EDCs impact exposed organisms by altering the hormonal and homeostatic systems that allow them to interact with and respond to their environment. The group of molecules identified as potential endocrine disruptors is highly varied and may be present in chemicals used as industrial solvents or surfactants that can be found in dispersants and surface washing agents. Because of the common properties of these compounds and the similarities of the receptors and enzymes involved in the synthesis, release, and degradation of hormones, no endocrine system is immune to endocrine disrupting compounds. 7 7 For more background information on endocrine disrupting compounds and their human health and environmental effects, please see http://www.epa.gov/endo/pubs/edspoverview/index.htm . The 1996 Food Quality Protection Act directed EPA to develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have hormonal effects in humans; the 1996 amendments to the Safe Drinking Water Act authorized EPA to screen substances that may be found in sources of drinking water for endocrine disruption potential. In response to these mandates, the Agency's Endocrine Disruptor Screening Program is developing requirements for the screening and testing of pesticides, commercial chemicals, and environmental contaminants for their potential to disrupt the endocrine system. 8 The science related to measuring and demonstrating endocrine disruption is relatively new and validated testing methods are still being developed. When complete, EPA will use these validated methods or assays to identify and characterize the endocrine activity of pesticides, commercial chemicals, and environmental contaminants, specifically in relation to estrogen, androgen, and thyroid hormones. EPA plans to use the assays in a two-tiered screening and testing process: Tier 1 will serve to identify chemicals that have the potential to interact with the endocrine system; and Tier 2 will determine the endocrine-related effects caused by each chemical and obtain information about effects at various doses. With this two-tiered approach, the Agency will gather information needed to identify endocrine-active substances and take appropriate action, as mandated by Congress. To date, EPA has developed and validated 11 assays that comprise the Tier 1 Screening Battery. EPA's validation effort continues with the current focus on Tier 2 tests and potential replacement assays for Tier 1. 9 When all tests are finalized and chemical information begins to be collected, EPA may further consider how to incorporate that information into the Subpart J NCP requirements, including additional testing and listing requirements. Because validated testing methods are still being developed, the agency is not proposing any test requirements with respect to endocrine disruption for products to be listed on the Schedule. 8 http://www.epa.gov/endo/pubs/edspoverview/background.htm. 9 http://www.epa.gov/endo/pubs/assayvalidation/index.htm . However, because NP and the NPE are extremely or highly toxic to aquatic organisms, the Agency is proposing a prohibition specific to Subpart J products containing NP and NPE as components. The Agency is not proposing to include a broad prohibition on Subpart J products that contain substances in which at least part of the toxic mode of action may include disruption of the organism's endocrine system, but is requesting comments on prohibiting similar substances that may be found in products/agents that could be listed on the Schedule, or to what the criteria should be in order to make that determination. As an alternative, the Agency could require that all product components be tested for a toxic mode of action that includes disruption of the organism's endocrine system and is requesting comment on this approach as well. The Agency believes the proposed prohibitions are appropriate in all cases, notwithstanding the proposed provisions for case-by-case use authorization of burning agents under § 300.910(c), or for authorization of use of any chemical or biological agent when it is necessary to prevent or substantially reduce an immediate threat to human life under § 300.910(d). There are chemical and biological agent alternatives to sinking agents and to agents containing NP or NPE, as well as mechanical methods for responding to oil discharges, including those situations that pose extreme threats or are time critical. (f) Storage and Use of Agents Section 300.915 currently requires that information be provided on recommended conditions of storage and use for each product at the time an application for listing a product under Subpart J is submitted to the Agency. This information is summarized in EPA's NCP Product Schedule Technical Notebook. Specifically, this information includes: Special handling and worker precautions for storage and field application; maximum and minimum storage temperatures (optimum ranges and temperatures that will cause phase separations, chemical changes, or other alterations to product efficacy); shelf life of the product; recommended application rates and procedures, concentrations and conditions (considering water temperatures, salinity, types and ages of the oil); and any other application restrictions. The Agency proposes to add a new paragraph (f) to this section that complements the existing information requirements for the person or entity submitting a product for listing (“submitter”). The proposed requirements focus on the use of this information by the responder and the OSC. Specifically, the revised provisions require the OSC to only authorize for use those products that are stored under the conditions specified by the submitter of the product for listing, including the maximum, minimum and optimum temperatures, humidity and any other relevant conditions. Additionally, the Agency proposes to require that the OSC only authorize for use those products whose date of use does not exceed the expiration date listed on the container's label at the time of an incident, unless the responsible party 10 provides the OSC documentation, developed in consultation with the submitter of the product for listing, prior to product use, affirming the product has maintained its integrity, including no changes in the composition, storage conditions, efficacy, and toxicity of any product. In such cases where the product expiration date has passed but the owner or operator of the facility/vessel storing the product still wants to be able to use the product inventory, EPA proposes that samples of the expired product lot representative of all storage conditions at any end user location be tested following the applicable testing protocols in Appendix C. The testing documentation is to include laboratory information ( i.e., contacts, accreditations) and all test data and calculations ( i.e., raw data and replicates, notes and observations, calculated means and standard deviations, stock solution preparations, source and preparations of test organisms, test conditions, chain of custody forms, and summary reports). Only if the owner or operator can demonstrate that the product has maintained its integrity is the OSC allowed to authorize the use of that product inventory. The owner or operator of the facility/vessel, or their representative, must re-label the tested product lots and maintain documentation of the test results until those lots are used or discarded, and must retest the expired product lot representative of the product at least once every 5 years to ensure efficacy and to allow an OSC to authorize the product for use. The intent of these proposed revisions is to ensure that products being authorized and used have maintained their efficacy, even though storage beyond the products' original shelf life may have occurred. The Agency believes it is the owner or operator's responsibility to ensure that any product it stockpiles for future use has maintained its efficacy and has not changed from its listed composition, including the possibility of degrading into more toxic byproducts, once the manufacturer's expiration date has passed. This retesting provision is supported by the proposed requirements that the submitter of the product for listing provide not only the recommended storage conditions, but the anticipated shelf life of a product at those conditions, and that the product label include both the manufacture and expiration dates, and conditions for storage. The flexibility in this proposed revision allows for the use of available product inventory that may still be viable. To alleviate concerns that applications are submitted that establish an extended or indefinite shelf life for a product, the Agency is requesting comments on whether any additional data or information requirements should be included for product listing determinations specific to a product's shelf life, or whether alternative approaches, such as limiting the shelf life for product categories to a given timeframe, should be considered. 10 Responsible party is defined in the NCP under 40 CFR 300.5. (g) Supplemental Testing, Monitoring, and Information This proposal maintains RRT authority in that they may require supplementary toxicity and efficacy testing, or available data or information that addresses site, area, or ecosystem specific concerns relative to the use of a product for both planning and authorization of use. While parallel to the current provisions, the proposed revisions provide added flexibility. The current provisions allow RRTs to require supplementary toxicity and efficacy testing of products, in addition to those specified as technical requirements following the test methods described in Appendix C to part 300, due to existing site-specific or area-specific concerns when developing preauthorization plans. EPA proposes to remove the qualifier “When developing preauthorization plans” to provide greater flexibility for RRTs to require supplementary toxicity and efficacy testing, or available data or information that addresses site, area, or ecosystem specific concerns relative to the use of a product for situations even when preauthorization plans are not being developed. For example, RRTs may need additional testing or information for situations that fall under paragraph (b) of this section, including when developing an expedited decision making plan. The proposed revision also allows for RRTs to require supplementary product toxicity and efficacy testing, or available data or information for both planning and authorization of use situations, and based on that information may consider establishing limitations for the use of products in certain areas. The Agency is including “available data and information” to compliment the supplementary toxicity and efficacy testing provision recognizing that existing data or information that addresses site, area, or ecosystem specific concerns relative to the use of a product may be available. The Agency is also proposing to include “ecosystem” with area and site specific concerns, as RRTs may want to gather additional information on the use of certain products when assessing the use of a product relative to the biological communities specific to their area. The proposal removes “in addition to the test methods specified in § 300.915 and described in appendix C to part 300.” While RRTs may want to use the efficacy and toxicity testing protocols specified in Appendix C of the NCP for comparative purposes, the proposed revisions clearly establish the RRTs authority to require tests using parameters beyond those specified in Appendix C. Furthermore, there may be supplementary toxicity and efficacy testing information based on recognized standard testing methods already available that RRTs may want to consider when addressing site, area, or ecosystem specific concerns. This proposal also provides the RRT authority to request that the OSC require a responsible party to conduct additional monitoring associated with the use of a product during a discharge incident. The proposed revision compliments the proposed monitoring requirements for dispersant use, but also including other chemical or biological agents, or other testing endpoints. The Agency believes the RRT must be afforded the ability to request that the OSC direct the responsible party to conduct additional monitoring under Subpart J for the use of a product in the environment. The RRT may request that the OSC consider additional monitoring during an oil discharge response to support operational decisions on dispersant use. For example, the RRT may want to monitor the exposure of marine mammals to oil constituents, including dispersed oil, or to monitor toxicity in the water column using biological assays. The Agency requests comments on these proposed revisions. (h) Recovery of Agents From the Environment The proposal identifies certain agent categories and substances intended to be removed from the environment following their use: Solidifiers, sorbents and surface washing agents. For those categories, the Agency expects the agents to be recovered from the environment to minimize any potential adverse impact. The proposal adds a new requirement that charges the responsible party, under OSC oversight, to recover these products from the environment. Recovery activities after the use of these agents would include containment of the agents in the water, collection of the agents mixed with oil or any residual agent, storage of the oil-agent waste prior to disposal, and disposal of that oil-agent waste. The Agency also recognizes there may be situations where the safety of response personnel is threatened, or where additional harm to the environment could occur during recovery operations. Consequently, we are proposing these factors be considered when initiating recovery actions. While it is appropriate to have the OSC ensure these activities take place, it is ultimately the responsibility of the responsible party to conduct these activities and ensure that the agents are recovered from the environment. The Agency requests comments on this proposed requirement. (i) Reporting of Agent Use The proposal includes a new requirement for the OSC to provide to the RRT certain information after the use of a chemical or biological agent within 30 days of completion of agent operations. The information required in this report includes the information on any chemical or biological agent used, including product name, the quantity and concentration of the agent used during the response, the duration of use, the locations where the agent was used, and any data collected and analysis of efficacy or environmental effects. The proposal allows this information to be provided in the OSC report to the NRT or RRT as required under section 300.165 of the NCP, if such a report has been requested. While other existing notification requirements serve to activate an immediate response to an event, the proposed requirement gathers information that will be useful in specifically evaluating the use of chemical or biological agents in the response. It will also inform the review of preauthorization plans and provide a basis for any necessary changes to improve environmental protection. Given that response and removal actions can greatly vary depending on the discharge situation, the Agency requests comments on whether it would be appropriate to allow the timeframe for submitting the report to be agreed upon by the RRT, rather than establishing a set timeframe. The Agency is requesting comments on this proposed new requirement, including on the proposed timeframe. 3. Monitoring the Use of Dispersants The goal of establishing a Schedule under the NCP is to protect the environment from possible damage related to spill mitigating products used in response to oil discharges. The proposal establishes a regulatory approach under Subpart J that includes test data and information requirements for certain chemical and biological agents, procedures for authorizing the use of those agents, and monitoring requirements for certain discharge situations. Each oil discharge represents a unique situation with distinct conditions, which may require various response methods. When dispersants are applied to an oil discharge, field monitoring can be used to inform operational decisions by gathering site-specific information on the overall effectiveness, including the transport and environmental effects of the dispersant and the dispersed oil. The revisions to product test data and information requirements are intended to provide OSCs, RRTs, and ACs with the best information available when selecting products for use on an oil discharge. While laboratory test protocols allow for comparison between different products under standardized laboratory conditions and may be useful during the monitoring and assessment of a discharge event and/or for selection of the agents used in the response, they do not necessarily reflect field conditions. Monitoring of agents in the field informs the OSC and other agencies on the overall effectiveness of dispersant use, including the environmental effects and transport of dispersed oil. The Agency believes that comprehensive monitoring in certain discharge situations is necessary to determine the overall effectiveness of dispersants and should transcend from the initial dispersant application to include the transport and environmental effects of the dispersant and dispersed oil in the water column. Monitoring the overall effectiveness of dispersant use in the field provides those Agencies with responsibility for authorizing the use of dispersant product information for decision-making during subsurface or prolonged surface dispersant applications. Adverse effects on ecological receptors from exposures to dispersed oil depend on the length of time and concentration of the exposure, which in turn is dependent on the transport of dispersed oil. Because these exposures may vary depending on the discharge situation, the Agency believes comprehensive monitoring is important for certain discharge situations. This monitoring data will enhance the information needed for an effective response without delaying the use of agents under these conditions. Equipment is being contemplated to inject dispersants subsurface, directly into the oil near the source of the discharge. 11 This type of application is intended to minimize dispersant dilution in the water before the dispersant has had an opportunity to interact with the oil. 12 This application approach that is closer to the source is expected to reduce potential adverse environmental consequences from the use of excessive quantities of dispersants. 13 However, applying dispersant to an oil discharge does not result in the physical recovery of oil from the environment. Instead, dispersing oil increases the potential exposure of aquatic organisms to the dispersant-oil mixture, at least transiently, and subsurface application has the potential to more immediately and effectively increase these exposures near the discharge. The Agency believes this new subsurface application approach requires new environmental monitoring capabilities to support operational decision-making. These new monitoring capabilities must be able to meet the operational conditions ( e.g., water depths, temperatures) and be supported by knowledgeable personnel familiar with them. 11 http://marinewellcontainment.com/expanded_system.php . 12 NRC, (2005), Oil Spill Dispersants: Efficacy and Effects, The National Academies Press, pp. 138, http://www.nap.edu/catalog.php?record_id=11283 . 13 Ibid. The proposed rule adds § 300.913 establishing requirements for the responsible party to monitor any subsurface use of dispersant in response to an oil discharge, surface use of dispersants in response to oil discharges of more than 100,000 U.S. gallons occurring within 24 hours, and surface use of dispersants for more than 96 hours in response to an oil discharge, as directed by the OSC. The purpose of monitoring subsurface application is to characterize the dispersed oil, follow the plume integrity and transport with the underwater current, and identify and assess the potential adverse effects from the dispersed oil. The proposal requires the responsible party to implement monitoring for any subsurface dispersant use in response to an oil discharge upon initiation and for the duration of subsurface dispersant use. The Agency believes monitoring subsurface use of dispersants is critical to inform response actions to minimize potential environmental effects. While surface application of dispersants is not a new approach and understood for small, short duration discharges, the Agency believes it is appropriate to require comprehensive monitoring for situations where dispersants are used for an extended period of time or in cases of major oil discharges. The Agency chose 100,000 U.S. gallons as a threshold criterion for a major oil discharge because the NCP classifies a discharge of more than this quantity to coastal waters as major. In addition, EPA is proposing to this quantity monitoring of dispersant use in response to major oil discharges occurring within 24 hours since a larger quantity of dispersant may be required in a short time frame for an incident of this scale. The Agency also believes comprehensive monitoring should be required when surface dispersant is used for more than 96 hours because of potentially longer exposures of biological aquatic resources to dispersant and dispersed oil. Further, many acute toxicity studies use 96-hour exposure durations, including the acute toxicity tests using Menidia beryllina described in this proposal. While other toxicity tests have shorter exposure durations ( e.g., 24, 48, or 72 hours), the Agency believes 96 hours is a reasonable threshold given its commonality of use in the toxicology field. Therefore, the proposal requires a responsible party to implement monitoring for surface dispersant use in response to an oil discharge under these discharge conditions and for the duration of dispersant use. The proposal also requires the submission of a Quality Assurance Project Plan for approval to the OSC covering the collection of all environmental data to ensure and maximize its quality, objectivity, utility, and integrity. The Agency welcomes comments on the proposed monitoring requirements, including the thresholds. Specifically, the Agency requests comments on whether it should also consider a threshold for surface use of dispersants that is based on the quantity of dispersant used within a given timeframe. Alternative thresholds must include a rationale in order for the EPA to consider them for final action. (a) Dispersant Application The proposal requires the responsible party to document the characteristics of the source oil; best estimate of the oil discharge flow rate, periodically reevaluated as conditions dictate, including a description of the method, associated uncertainties, and materials; dispersant(s) product used, rationale for dispersant choice(s), including the results of any efficacy and toxicity tests, recommended dispersant-to-oil ratio; and the application method and procedures, including a description of the equipment to be used, hourly application rates, capacities, and total amount of dispersant needed. For subsurface discharges, the proposal also requires the responsible party to document the best estimate of the discharge flow rate of any associated volatile petroleum hydrocarbons, periodically reevaluated as conditions dictate, including as description of the method, associated uncertainties, and materials. This would provide the OSC with the necessary information for operational decision-making and coordination of the dispersant application monitoring. Because of the many factors that influence the selection of a dispersant product ( e.g., its availability, the type of oil it will be used on, the prevalent weather conditions, and the particular discharge situations) the Agency proposes that the responsible party document its product choice and selection rationale. Documenting the characteristics of the source oil provides specific chemical data to identify the oil associated with discharge and to inform decisions on dispersant use. Documenting application methods and procedures ensures that dispersant use is consistent with the dispersant manufacturer's recommended concentrations, and conditions provided as part of the data requirements for listing the product on the Schedule. Documenting results of any additional efficacy and toxicity testing, or available data or information specific to the area or site conditions will assist the OSC in establishing the appropriateness of the dispersant choice. Documentation and clear understanding of the estimated daily oil discharge flow rate and the recommended dispersant-to-oil ratio (DOR) allows a dispersant rate to be established that would aid the OSC in determining the adequate dispersant usage. The OSC can compare the recommended DOR to the manufacturer's recommended application concentration to ensure it is within the recommended range or to provide an opportunity for the responsible party to explain any deviations that may arise due to operational considerations. The biodegradation of petroleum constituents may result in a reduction in the dissolved oxygen concentration in the water column that could lead to hypoxia, which could be detrimental to marine organisms. The best estimate of the oil discharge flow rate, periodically reevaluated as conditions dictate, is an important consideration for monitoring dispersant use since the estimated amount of oil discharged may be used to provide insight into the potential oxygen demand exerted on the water column and to characterize the potential oil distribution. The proposal would also require the responsible party to document the best estimate of the discharge flow rate of any associated volatile petroleum hydrocarbons for subsurface applications. Volatile petroleum hydrocarbons ( e.g., methane, and low molecular weight alkanes such as ethane, propane, and butane) associated with the discharge could contribute to a reduction in dissolved oxygen as a result of microbial degradation. The Agency is not proposing this requirement for surface applications given these compounds are expected to readily evaporate, making it unlikely they would be incorporated into the water column in quantities that would result in hypoxia. The proposal requires the documentation of the dispersant application method and procedures to include a description of the equipment to be used, including hourly application rates, capacities, and total amount of dispersant needed. Dispersant and equipment should be available to maintain the hourly dispersant application rate without significant deviation from the set rate. The Agency believes this information will assist in ensuring a consistent dispersant application rate. Dispersant application rates outside of established parameters may result in their over or under use, altering their effectiveness. Significant fluctuations in dispersant application rates could also indicate equipment malfunctions, requiring a reassessment of the response technique. EPA welcomes comment on the proposed requirements for dispersant application. Alternatives must include a rationale in order for the Agency to consider them for final action. (b) Water Column Sampling The proposal requires the responsible party to collect representative background samples from the water column at the closest safe distance determined by the OSC from the discharge, and in any direction of likely transport. The sampling should consider surface and subsurface currents and oil properties. Establishing background information prior to oil contamination from the discharge source provides reference data to compare against the results from water samples taken during the response. In establishing the background information, the responsible party should consider other potential sources of petroleum hydrocarbons ( e.g., natural seeps) in the water column. The background samples would be collected in areas not affected by the discharge of oil throughout the water column upon initiation of dispersant use, at the closest safe distance as determined by the OSC from the oil discharge. Sampling would be conducted in any direction of likely transport considering surface and subsurface currents and the oil properties in those areas. The responsible party should consider using trajectory models that incorporate relevant factors such as oil type to determine the likely direction of the dispersed oil to inform where the water samples should be collected. The Agency is requiring that sample collection follow established standard operating and quality assurance procedures that are reliable and defensible. An accurate assessment of environmental data depends on the reliability, timeliness, and integrity of the data collected. Standard operating procedures should describe the appropriateness of the sampling method; the equipment needed for sample collection; a description of potential interferences, problems that may be encountered and corrective actions that would be taken; the sample collection procedure, including the preparation steps, representative sampling considerations, and sampling steps for each sampling device used; sample preservation, containers, handling, and storage; decontamination of sampling equipment; and record keeping and quality control procedures. These elements are generally described in various guidance documents on standard operating and quality assurance procedures for environmental sampling. 14 15 14 http://www.epa.gov/quality/qa_docs.html. 15 http://www2.epa.gov/region8/environmental-sampling. In addition to the background water sample collection, the proposal requires the responsible party to collect water column samples daily in the dispersed oil plume at such depths and locations where dispersed oil is likely to be present. EPA believes the dispersed oil plume captures the presence of oil from either the subsurface or the surface application of dispersant, including where oil could be rising to the surface from a subsurface discharge or the dispersed oil plume at the water surface as a result of surface dispersant application. The responsible party also would need to analyze for: • In-situ oil droplet size distribution analysis, including the mass or volume mean diameters between droplet sizes ranging from 2.5 to 2000 μm, with the majority of data collected between the 2.5 and 100 μm sizes. Droplet size distribution, which is an important component to understanding the chemical and hydrodynamic effectiveness of dispersants, can be measured with devices such as the Laser In-Situ Scattering and Transmissometry (LISST) instrument or other similar instruments. Small oil droplets ( e.g., diameters in the tens of μm range) have such low rise velocities that they tend to remain suspended in the water column (neutrally buoyant), where they can become widely dispersed by advective forces, turbulent motion, and to a lesser extent diffusion. These small droplets are more readily amenable to biodegradation due to their higher surface area to volume ratio. In contrast, large oil droplets ( e.g., diameters >100 µm) will tend to recoalesce and rise faster to the surface. 16 Effective application of dispersants is expected to generate a larger number of small droplets, reducing the average droplet size. 17 This will change the trajectory of rising oil that is subjected to stratified horizontal subsurface currents. Near the water surface, hydrodynamic and other environmental factors also influence the oil droplet size distribution. Mixing energy, especially from breaking waves, dictates the breakup of large oil droplets into smaller droplets and the depth of submergence of the droplets. Plunging breaking waves under experimental conditions produced the smallest oil droplets. 13 14 Additionally, studies indicate that the type of chemical dispersant used is an important factor in controlling the dispersed oil droplet size distributions. Further, wave tank studies have shown that the chemically dispersed oil may result in a droplet size distribution that has not been observed without the use of dispersants ( i.e., physically dispersed oil), both in terms of a smaller volumetric mean diameter and a bimodal distribution for droplet size diameters below 100 μm. 18 EPA recognizes that the aforementioned studies were conducted under conditions characteristic of surface waters. However, the effect of the high velocities of oil that may occur from a discharge from a subsurface oil well on the oil droplet size distribution requires further scientific investigation to understand the contribution of physically dispersed oil relative to chemically dispersed oil. In either event, it is clear droplet size distribution analysis provides important data useful in optimizing operational guidelines and decision making, modeling transport and fate, and potentially evaluating biological effects of chemic [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%3A2015-00544. Public record. Not legal advice.