[Federal Register Volume 80, Number 14 (Thursday, January 22, 2015)]
[Proposed Rules]
[Pages 3379-3446]
[FR Doc No: 2015-00544]

Vol. 80

Thursday,

No. 14

January 22, 2015

Part III

Environmental Protection Agency

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40 CFR Parts 110 and 300

National Oil and Hazardous Substances Pollution Contingency Plan;
Proposed Rule

Federal Register / Vol. 80 , No. 14 / Thursday, January 22, 2015 /
Proposed Rules

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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.

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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<PHONE_NUMBER> 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<PHONE_NUMBER>
or TDD at<PHONE_NUMBER> (hearing impaired). In the Washington, DC
metropolitan area, contact the Superfund, TRI, EPCRA, RMP, and Oil
Information Center at<PHONE_NUMBER> or TDD<PHONE_NUMBER>. For more
detailed information on this proposed rule contact Gregory Wilson at
202-564-7989<EMAIL_ADDRESS>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
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                                           Annualized costs, 20 years
                                       ---------------------------------
                                         Annualized at    Annualized at
                                               3%               7%
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Costs.................................        $667,610         $694,343
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II. Entities Potentially Affected by This Proposed Rule

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                   Industrial category                      NAICS code
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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
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    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 Sec.  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 Sec.
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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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
Sec.  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 Sec.  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 Sec.  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 Sec.
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 Sec.  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 Sec.  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 Sec.  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.
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    \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.
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    \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 Sec.  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 Sec.  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
Sec.  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.
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    \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.
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    The proposed rule adds Sec.  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
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    \14\ http://www.epa.gov/quality/qa_docs.html.
    \15\ http://www2.epa.gov/region8/environmental-sampling.
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    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 [mu]m, with the majority of data collected between the 2.5
and 100 [mu]m 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
[mu]m 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 [micro]m) 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 [mu]m.\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 chemically dispersed oil. The proposal also
includes larger oil droplet sizes of up to 2000 [mu]m, intended to
provide information that can inform the oil distribution using
trajectory modeling analysis.
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    \16\ Li, M. and Garrett, C., (1998) The Relationship Between Oil
Droplet Size and Upper Ocean Turbulence, Mar. Poll. Bull., Vol. 36,
pp. 961-970.
    \17\ Li, Z., Lee, K., King, T., Boufadel, M.C., Venosa, A.D.,
(2008) Assessment of Chemical Dispersant Effectiveness in a Wave
Tank under Regular Non-Breaking and Breaking Wave Conditions, Mar
Pollut Bull, Vol. 56, pp. 903-912.
    \18\ Li, Z., Lee, K., King, T., Boufadel, M.C., Venosa, A.D.,
(2009) Evaluating Chemical Dispersant Efficacy in an Experimental
Wave Tank: 2--Significant Factors Determining In Situ Oil Droplet
Size Distribution, Env Eng Scien, Vol. 26, pp 1407-1418.
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     In-situ fluorometry. When exposed to ultraviolet (UV)
light, certain compounds absorb energy that can elevate electrons into
an excited higher energy level. The wavelength that excites electrons
into a higher energy state is typically referred to as the excitation
wavelength. Electrons unstable at the higher energy state return to a
lower energy state, emitting energy at longer emission wavelengths
resulting in fluorescence.\19\ Many organic compounds fluoresce at
specific excitation and emission wavelengths that allow for identifying
many of the components of dissolved organic matter and other compounds
(e.g., crude oil) in seawater.\20\ For crude petroleum oils, the
aromatic fraction is responsible for the fluorescence property of
petroleum, and these compounds are used to determine the specific
excitation and emission wavelengths for monitoring. When subject to
excitation at certain wavelengths in the near ultraviolet spectrum,
polycyclic aromatic hydrocarbons (PAH) fluoresce over a range of higher
wavelengths, depending on the number of aromatic rings in the
structure.\21\ Fluorometers can be targeted to the type of oil
discharged, and the excitation and emission wavelengths chosen should
match the aromatic properties of the oil discharged. Although this
measure does not include all oil constituents, fluorescence is a
valuable screening tool deployed during a response,\22\ providing a
rapid indication of potential dispersed oil in the water column, as
well as an indicator of dispersion effectiveness as discussed in the