responsibilities of EPA, the state(s), and DOI and DOC natural resource
trustees regarding chemical or biological agent use under Sec.
300.910(a) or (b). EPA notes that the temporary exception provision
does not affect other authorities available to an OSC under the NCP,
separate from Subpart J, to take actions to address a threat to human
life, such as ordering evacuations or repositioning equipment and
personnel.
    Many commenters expressed support for the notification requirements
in Sec.  300.910(d). A commenter stated that the notifications should
be made available to the public for awareness of the imminent threat to
human life and the use of products to address the threat. Some other
commenters cited concern regarding the notification requirement and
recommended that there should not be any limits on the OSC's ability to
make decisions protecting human life. A commenter asserted that the
requirements are inappropriate, and that the Agency has not adequately
justified the proposed notification requirements in terms of additional
benefits compared with the existing requirements. The Agency recognizes
the concerns regarding the notification requirements within the
temporary exception. The final regulatory language includes the
requirement for the OSC to notify as soon as possible, and to document
the circumstances and the reasons for use of the agent, to the EPA RRT
representative and, as appropriate, the RRT representatives from the
affected state(s) and the DOC and DOI natural resource

trustees. While the Agency had proposed ``immediate'' notification, it
believes that requiring notification ``as soon as possible'' is
adequate in conjunction with a reduction in the timeframe for which
this exception is applicable from 48 hours to 24 hours. The expectation
is that this information will be provided to those federal and state
entities with concurrence and consultation roles within a timeframe to
consider further chemical or biological agent use. While the Agency
recognizes the comment regarding limitations on the OSC's ability to
protect human life, it does not believe that the notification
requirement to the RRT members in any way hinders the OSC's ability to
make decisions to protect human life. The Agency notes the notification
provision does not apply to other authorities available to an OSC under
the NCP, separate from Subpart J, to take actions to address a threat
to human life. The Agency modified the regulatory language by changing
the ``immediate'' reporting requirement terminology to ``as soon as
possible,'' which still provides for the information to promptly be
provided to those entities with concurrence and consultation roles.
Additionally, the regulatory language was modified to add the phrase
``authorized pursuant to this paragraph'' to clarify the documentation
requirement under the temporary exception.
    Some commenters suggested that exceptions may not be protective of
human health and safety, expressing concern with the replacement of the
term ``worker safety'' with ``human life.'' These commenters indicated
that the Agency should clarify the difference between threats to worker
safety and protection of human life and indicate why the proposed
change was needed. Other commenters requested that the Agency revise
the section to clearly include worker safety, or to clarify that
``worker safety'' is considered the same as ``the protection of human
life.'' The Agency disagrees that all worker safety considerations in a
response would necessarily equate to threats to human life. EPA
recognizes that all responses present multiple health and safety
challenges. The Agency reiterates that, while all threats to human life
are worker health and safety issues, not all worker health and safety
issues pose an immediate threat to human life. The temporary exception
provision is intended to capture unforeseen and immediate life-
threatening situations. For those rare and unexpected situations which
cannot be immediately addressed by any other means, this temporary
exception provision allows the OSC to consider whether the use of an
agent is appropriate. The exception provision being amended by this
action did not previously include the term ``worker safety,'' but
rather speaks to human life. Similarly, the Agency did not include the
term ``worker safety'' in the proposed rule. The Agency is clarifying
the term relative to the temporary exception to mean a ``threat'' to
human life. While the provision before the amendment used the terms
``hazard'' and ``threat'' interchangeably, the final action replaces
``hazard'' with ``threat'' for consistency and to clearly establish the
intent not to broadly cover ``worker safety.'' Section 300.150 of the
NCP establishes worker health and safety provisions to ensure these
concerns are addressed during all response actions. Specifically, the
provisions provide for an occupational safety and health program, in
compliance with applicable worker health and safety provisions of the
Occupational Safety and Health Act of 1970 (OSH Act), to be available
for the protection of workers at the response site. Among the OSH Act
provisions are requirements for a site-specific health and safety plan
that must include, at a minimum, employee training, personal protective
equipment, medical surveillance, and air monitoring. In this amendment,
the Agency is clarifying the regulatory text to specifically state that
the exception is not to be used as a substitute for compliance with
Sec.  300.150 of this part, including the use of personal protective
equipment; Sec.  300.150 of this part is outside the scope of this
action.
    In the finalized provision, EPA also made some editorial changes to
the proposed text for increased clarity.
(e) Prohibited Agents or Substances
    Sinking Agents. The Agency is maintaining in Sec.  300.910(e)(1)
the current prohibition for the authorization of use of sinking agents
and has clarified in the regulatory text that the prohibition applies
to any chemical agent, biological agent, or any substance that is used
to directly sink the oil to the bottom of a water body. EPA believes
that the final revisions better reflect EPA's intent and avoid
potential confusion with the use of other chemical and biological
agents. The Agency believes the prohibition on sinking agents is
appropriate in all cases and is consistent with the existing
restriction in Sec.  300.310(b) of NCP Subpart D. EPA notes that the
final provision applies to sinking agents which are defined under Sec.
300.5 as ``substances,'' and not included in the definitions of
chemical or biological agents. The final action modifies the section
title to include ``substances'' to provide greater clarity to the
applicability of the section.
    Commenters recommended that the proposed rule language be further
amended to recognize the potential for some products to behave as
sinking agents depending on environmental conditions; they suggested
that the description of the prohibited agents should include those with
the potential to cause oil to sink based on the receiving environment.
Commenters also suggested that the Agency should define the difference
between ``dispersing below the surface'' and ``sinking.'' The purpose
of certain chemical agents (e.g., dispersants) is to entrain oil into
the water column; the definition of dispersants in the previous and
final rules acknowledge dispersants entrain oil ``into the water
column.'' EPA recognizes that, while these products are intended to
transfer oil into the water column, they are distinct from sinking
agents. To reflect commenter concerns, the Agency revised the proposed
text, so that the finalized amendment prohibits ``sinking agents, or
any other chemical agent, biological agent, or any substance that is
used to directly sink the oil to the bottom of a water body.'' Refer to
the section on definition of sinking agents in this preamble for
further discussion.
    Some commenters requested a requirement for a screening test or
standard functional approach to determine if an agent is a sinking
agent. A commenter noted that the prohibition of sinking agents is
undermined if a product's propensity to act as a sinking agent is only
discovered after the product has been used in a discharge event. The
commenter further suggests that a test is needed to identify products
that are otherwise categorized as dispersants or other agents, but
which have the effect of submerging and sinking oil, because these
products should also be recognized as sinking agents and be prohibited.
EPA acknowledges the commenters' request for a screening test or
standard functional approach to determine if an agent is a sinking
agent. While the Agency is not including such a test or functional
approach in this final action, the provisions finalized under Sec.
300.915(a)(12) include that product manufacturers must provide physical
and chemical properties such as specific gravity as part of the product
submission package for listing on the NCP Product Schedule. In
addition, the final rule at Sec.  300.910(g) provides that the RRT may
require available data or

information about agents be provided during planning or at the time of
a response, allowing for modifications to the response as necessary.
EPA believes responses to oil discharges are site-specific, and this
approach provides flexibility to consider site-specific conditions.
    Nonylphenol (NP) or nonylphenol ethoxylates (NPEs). The Agency had
also proposed to add a prohibition from listing on the NCP Product
Schedule and from authorizing use of any chemical or biological agents
that contain nonylphenol (NP) or nonylphenol ethoxylates (NPEs) as
components. However, the Agency has determined that chemical agents
that have either NP and NPEs as components will not be prohibited from
use under this final rule.
    EPA proposed prohibiting NP and NPE to reflect the Agency's
concerns for these substances as presented in EPA's Nonylphenol and
Nonylphenol Ethoxylates Action Plan. The Agency proposed a Significant
New Use Rule (SNUR) in September of 2014, which has not been finalized
to date. The Agency is not finalizing the 2015 Subpart J proposed
amendment on NP and NPE since final action has not been taken on the
SNUR. EPA is reserving Sec.  300.910(e)(2) in lieu of finalizing the
proposed amendments. However, EPA notes that the final provisions of
this rulemaking limit the scope of information that can be claimed as
Proprietary Business Information (PBI) as part of a product submission.
Information of product components will be available for RRTs and OSCs
to consider as appropriate when reviewing authorization of use
scenarios, including whether those products contain NP or NPE
substances.
    Other agents. Commenters on the proposed rule requested
prohibitions on the use of chemical or biological agents that are
formulated with any endocrine disrupting compounds (EDCs); that degrade
in a manner such that its byproducts contain prohibited substances;
that contain known or suspected human health hazards as listed on the
material safety data sheet (MSDS) or safety data sheet (SDS); or that
contain known or suspected carcinogens, hemolytic chemicals, mutagens,
neurotoxins, teratogens, and that demonstrate human and aquatic
toxicity. The Agency recognizes that there may be other substances
that, given their use circumstances, may be of concern. The Agency has
focused this final action on maintaining the existing prohibition of
sinking agents. The Agency recognizes that there may be environmental
and health concerns associated with any response. While the final
action includes product information requirements focused on
environmental impacts, the information may also be used by OSCs to
address broader health and welfare concerns. For example, the final
rule contains a provision to include the SDS for the product as part of
the submission package (see Sec.  300.915(a)(5)). The final rule also
includes a requirement under Sec.  300.915(a)(11) for the submitter to
provide for environmental fate information on the persistence,
bioconcentration factor, bioaccumulation factor, and biodegradability
of the product and all of its components in the environment. Further,
the final provisions at Sec.  300.950 limit the information that can be
claimed as Proprietary Business Information (PBI) as part of a product
submission for listing on the NCP Product Schedule, so that product
manufacturers will not be allowed to withhold information on product
components. Thus, product component information will be available for
RRTs and OSCs to consider as appropriate, for planning and
authorization of use within the respective Area or Regional Contingency
Plans. These considerations may include, for example, whether products
contain substances of concern to human health or aquatic hazards. The
final provision also includes updated ecotoxicity testing protocols and
the listing thresholds for ecotoxicity.
    A commenter expressed opposition to the proposal's opening language
which they believed would allow the exception clause in Sec.
300.910(d) to apply to Sec.  300.910(e) and allow the OSC to use a
prohibited product. The Agency disagrees with the commenter's
interpretation of the proposed regulatory text in Sec.  300.910(e). The
temporary exception under Sec.  300.910(d) applies to a ``chemical or
biological agent.'' While subject to the provisions under Subpart J,
the definitions of chemical or biological agents do not include sinking
agents. Therefore, sinking agents are not included in the temporary
exception under Sec.  300.910(d). Nevertheless, in the final action,
EPA is not including the proposed opening clause to the provision,
``Notwithstanding paragraph (d) of this section . . .'' because it is
unnecessary and to avoid the misunderstanding described by the
commenter.
(f) Storage and Use of Agents Listed on the NCP Product Schedule
    The Agency is adding a new provision, Sec.  300.910(f), to
complement the existing information requirements for the person or
entity submitting a product for listing (``submitter'') in Sec.
300.915. The new requirements focus on the use of this information by
the responder and the OSC. EPA has organized the final provisions into
subsections (f)(1) and (f)(2) for greater clarity. Specifically, the
provision at Sec.  300.910(f)(1) requires the OSC to only authorize for
use those products listed on the NCP Product Schedule that are
documented and certified by the responsible party or its representative
to have been stored under the conditions specified by the submitter of
the product for listing, including the maximum, minimum and optimum
temperatures, humidity and any other relevant conditions, and whose
date of use does not exceed the expiration date listed on the
container's label, unless otherwise specified for expired products as
provided in Sec.  300.910(f)(2), at the time of the incident. Under
Sec.  300.910(f)(2), the OSC may authorize for use products listed on
the NCP Product Schedule that exceed their expiration date after the
responsible party or its representative documents and certifies that
the expired product has been stored under the conditions provided by
the submitter under Sec.  300.915(a)(6) and still meets the applicable
efficacy and toxicity-listing provisions under Sec.  300.915 based on
testing of representative samples within the previous 12 months. The
title of the provision has been changed from the proposed ``Storage and
Use of Agents'' to ``Storage and Use of Agents Listed on the NCP
Product Schedule'' to provide more clarity on its scope.
    Some commenters recommended that the shelf life for biological
agents and bioremediation agents be limited to one year since living
products will degrade more quickly than chemical agents. The Agency
notes that the product shelf life provision does not provide separate
consideration for biological and bioremediation agents from chemical
agents. However, the final rule amended the proposed five-year testing
timeframe to recognize products may have shorter shelf lives as
evidenced by some products currently on the NCP Product Schedule. The
shelf life is provided by the product manufacturer based on the
inherent properties of the product. The product manufacturer is
required to submit documentation supporting the shelf life
determination. Furthermore, the final provisions include a requirement
for the responsible party or its representative to document and certify
that an expired product still meets the applicable efficacy and
toxicity provisions for listing under

Sec.  300.915 based on testing of representative samples within the
previous 12 months for an OSC to consider authorizing products beyond
their expiration dates.
    Commenters suggested that other oil spill mitigating devices and
substances should be included in this provision for consistency with
other sections. The Agency disagrees the provisions under Sec.
300.910(f) should include other oil spill mitigating devices and
substances, other than the specific product categories of chemical and
biological agents already identified for listing on the NCP Product
Schedule. The final rule amends the section title and regulatory
paragraph to clarify that the provision is applicable to agent products
``Listed on the NCP Product Schedule.''
    Commenters also suggested that the rule require disposal of expired
chemical agents. Some commenters suggested that the Agency should
require the disposal of all products once the expiration date has
passed, regardless of any testing. The Agency disagrees with the
request to include provisions addressing the disposal of expired
chemical agents in the final rule. Disposal of oil and contaminated
materials recovered in cleanup operations is addressed in Sec.  300.310
of the NCP. While the final provisions provide for the retesting of
expired products, the disposal of products, including expired products,
is outside the scope of this action.
    Some commenters recommended that no additional requirements be put
in place for product shelf life, other than what is recommended by the
manufacturer. However, EPA is finalizing re-testing provisions to
provide flexibility for chemical or biological agents to be considered
for use past their designated shelf life provided they still meet
efficacy and toxicity testing requirements. The provision under Sec.
300.910(f)(2) is voluntary in that it does not require expired products
to be retested but is an option for the responsible party if they want
an OSC to be able to authorize their use.
    Commenters suggested that there is no justification for mandating a
shelf life that could limit the use of stockpiles that remain viable
and effective. EPA did not mandate a specific shelf life for products
listed on the NCP Product Schedule. However, EPA believes that users of
products should follow the manufacturer's storage conditions and shelf
life recommendations, as submitted according to Sec.  300.915(a)(6) and
(a)(7). Based on public comments, EPA made changes to the proposed re-
testing provisions in the final amendments. The final provisions
provide the OSC with the discretion to authorize products listed on the
NCP Product Schedule that exceed their expiration date. However, this
discretion is only available after the responsible party or its
representative documents and certifies that the expired product still
meets the applicable efficacy and toxicity provisions for listing under
Sec.  300.915, based on testing of representative samples within the
previous 12 months.
    Some commenters expressed support for retesting requirements but
indicated that efficacy of the product is the only relevant endpoint
for testing regardless of age. The commenters recommended that there is
no scientific justification for toxicity re-testing, and that only
effectiveness testing should be conducted rather than all of the tests
described in Appendix C. A commenter stated that testing requirements
should allow for acceptable levels of variability in efficacy results,
recommending an allowable 10% variance in effectiveness test results.
The Agency disagrees with the commenters' concerns that effectiveness
testing is the only retesting that should be considered and that the
efficacy testing requirements need to allow for acceptable levels of
variability in efficacy results. The Agency recognizes that some
products stored over time may not obtain the same efficacy or toxicity
testing results for the product's original listing submission yet may
still meet the applicable threshold(s) that were required to list the
product on the NCP Product Schedule. However, EPA also recognizes that
some products stored over time may not meet the applicable threshold
requirements. EPA believes that products stored beyond the expiration
date listed on the container's label and that, upon retesting, do not
meet the applicable threshold(s) that were required to list the product
on the NCP Product Schedule, no longer represent the product approved
for listing on the NCP Product Schedule. A variance could allow expired
products that do not meet the applicable threshold requirements for
listing on the NCP Product Schedule to be available for authorization
upon retesting, while other products with similar results would be
denied listing on the NCP Product Schedule.
(g) Supplemental Testing, Monitoring, and Information
    The Agency is finalizing at Sec.  300.910(g) an amended provision
that maintains the RRT's authority to require supplementary toxicity
and efficacy testing, or to request available data or information that
addresses site-, area-, or ecosystem-specific concerns relative to the
use of product for both planning and authorization of use. The
amendment adds flexibility to the former requirement by removing ``When
developing preauthorization plans . . .'' and by including ``or
submission of available data and information'' to recognize that
existing data or information that addresses site-, area-, or ecosystem-
specific concerns relative to the use of a product may be available.
Additionally, in the final action, EPA modified the proposed language
to specify that this supplemental testing, monitoring, and information
may be required ``for both planning and response, including
authorization of use'' to emphasize the broad potential use of this
data. As proposed, the Agency is including the term ``ecosystem'' with
area and site-specific concerns, as RRTs may want to gather additional
information on the use of certain products when assessing the
biological communities specific to their area. In the final amendment,
EPA has modified the proposed regulatory text to streamline it to
specify that ``The product manufacturer or responsible party shall
provide, upon request of the RRT or OSC, additional monitoring or
testing data and information to inform chemical or biological agent use
decisions specific to a response.''
    Some commenters expressed opposition to the RRT's authority to
require supplemental testing, monitoring, and information, as provided
in the proposed rule. Commenters provided several reasons for the
opposition, including stating that the standard efficacy and toxicity
tests already required are more than adequate, additional testing would
cause a delay in the spill response; the current testing requirements
in the rule and/or NCP are adequate and additional data is unlikely to
provide valuable information for decision making; additional data may
create confusion; additional data collection would increase costs for
facilities; and unnecessary animal testing should be avoided. One
commenter stated that no information is provided in the rule as to what
circumstances might trigger an RRT's request for supplemental testing,
monitoring, or information. The Agency disagrees with the commenters'
opposition to recognizing that RRTs may require supplemental testing,
monitoring, and information. In addition to planning, this provision
aims to provide discharge-specific information that may assist in
decision

making during a response. The Agency notes this is a discretionary
provision for the RRT to require supplemental information, and that the
RRT may coordinate with the OSC to address any concerns related to
requiring additional information. Standard toxicity tests required in
the final rule encompass only a few species and are not necessarily
intended to be protective of site-, area- or ecosystem-specific
concerns. Decades of research show that species can vary substantially
in sensitivity, and that ecosystems contain a diversity of species of
mostly unknown sensitivity. The Agency believes retaining the option
for the RRT to require supplemental testing, monitoring, and
information that addresses incident-specific concerns for planning and
response relative to product use is reasonable and prudent. For
example, the provision provides flexibility in gathering scientific
information relevant to a given site or geographic location and allows
for better targeting chemical and biological agent use during a
response. The absence of the final provision for the RRTs to require
supplemental testing, monitoring, and information may adversely impact
the RRT's ability to provide informed concurrence and consultation
determinations. EPA also notes that the provision under Sec.
300.910(a) for preauthorizing an OSC to authorize the use of a chemical
or biological agent does not preclude the RRT from requiring additional
monitoring and information.
    A commenter opposed this provision because they asserted that the
required tests would not inform operational decision making during the
response, but rather would develop data for the Natural Resource Damage
Assessment (NRDA) process. EPA agrees with the comment that
``operational monitoring and NRDA are two different things''. This
provision is separate from NRDA monitoring, testing, and data
collection; NRDA monitoring, testing, and data collection is outside
the scope of this provision. To clarify this point, EPA has modified
the provision from the proposed language. The finalized, streamlined
provision states that the RRT or OSC may request additional monitoring
or testing data and information to ``inform chemical or biological
agent use decisions specific to a response.'' EPA notes the purpose of
the provision is to provide the OSC and RRT, if necessary, supplemental
data, including monitoring data which may not be already derived from
required monitoring plans included within ACPs.
    Some commenters opposed the RRT authority to request additional
monitoring associated with the use of a product during a discharge and
expressed concern that this provision could be potentially used during
a discharge situation to prevent or delay the use of chemical or
biological agents for non-technical reasons and thus potentially reduce
the effectiveness of the response. The Agency disagrees. This provision
aims to provide incident-specific information that may assist in
decision making during a response, not to hinder the overall response
time. The Agency does not believe these requirements would delay or
impede response actions such as the deployment of mechanical recovery
or other response related equipment. EPA disagrees with the commenters'
concern that giving the RRT authority to request additional monitoring
associated with the use of a product during a discharge could
specifically delay the use of a chemical or biological agent and reduce
the effectiveness of a response. This provision is not intended to
delay the use of an agent, but rather to inform and reduce the
uncertainties associated with a chemical or biological agent during the
response. The Agency notes this is a discretionary provision for the
RRT to request supplemental information, and that the RRT may
coordinate with the OSC to address any concerns related to the request.
    A commenter suggested that the regulation should provide that Area
Committees, in addition to RRTs, are authorized to request that the OSC
require additional monitoring, and that the OSC may independently
require this additional monitoring absent a particular request from the
RRT or Area Committee. The Agency disagrees with the commenter's
suggestion. The NCP establishes the roles and responsibilities for RRTs
and Area Committees. The Area Committees are responsible for preparing
ACPs for their designated areas as described in Sec.  300.210(c). The
RRT responsibilities under the NCP include the development and
coordination of preparedness activities before a response action is
taken, as well as coordination of assistance and advice to the OSC
during response actions, as described in Sec.  300.115. The Agency
believes it is appropriate to focus this provision on the RRTs given
their operational roles, including the role of certain RRT members in
authorizing the use of chemical or biological agents. Thus, the final
rule states the product manufacturer or responsible party shall
provide, upon request of the RRT or OSC, additional monitoring or
testing data and information to support chemical or biological agent
use decisions specific to a response.
(h) Recovery of Chemical Agents and Other Substances From the
Environment
    The Agency is adding a new provision at Sec.  300.910(h) to require
the responsible party to recover solidifiers, sorbents, and surface
washing agents from the environment following their use. The provision
requires that the responsible party shall ensure that removal actions
adequately contain, collect, store, and dispose of solidifiers, surface
washing agents, and sorbents, unless otherwise directed by the OSC. EPA
identifies each of these agents or other substances, in their
respective finalized definitions in Sec.  300.5, as needing to be
recovered from the environment to minimize any potential adverse
impact. The Agency 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, so the final
provision provides that the OSC should, at a minimum, consider factors
such as the safety of response personnel and harm to the environment in
making recovery-related determinations. Furthermore, the Agency has
modified the title of the section as ``Recovery of Chemical Agents and
Other Substances from the Environment'' to recognize that sorbents are
covered under Sec.  300.910(h).
    Commenters expressed support for the identification of the agent
categories and substances intended to be removed from the environment
following their use as described in the preamble to the proposed rule:
solidifiers, sorbents, and surface washing agents. However, other
commenters requested clarification in the regulatory text as to which
substances or agents are covered, noting that it should apply to
solidifiers, sorbents, and surface washing agents as well as other oil
spill mitigating devices, oil-product combinations, and weathered oil.
A commenter stated that the phrase ``agents that are intended to be
recovered from the environment'' is ambiguous and suggested that EPA
change the language to clarify that this provision applies to
``substances'' including sorbents, rather than solely agents. EPA
recognizes the request to clarify in the regulatory text as to which
substances or agents are covered. Based on comments, EPA amended the
final provisions in Sec.  300.910(h) relative to the proposal to
address chemical agents and other substances to be recovered from the
environment to specifically include solidifiers, surface washing
agents, and sorbents.

    Some commenters suggested additions to the proposed language to
further specify requirements. EPA recognizes a commenter's request for
additional language that would serve to quantify the term
``adequately,'' a commenter's suggestion that the language should be
modified to clarify that recovery of substances should be completed
``to the extent possible,'' and the suggestion that removal action
agents should always be recovered from the environment. Under Sec.
300.120, the OSC directs response efforts and coordinates all other
efforts at the scene of a discharge. EPA believes that it is the OSC
who will make the determination of when the recovery of agents from the
environment is adequate for the specific response. These activities are
to be done in accordance with applicable federal, state, Tribal and
local requirements. Thus, the Agency maintains in the final rule the
requirements for the responsible party to ensure that removal actions
adequately contain, collect, store, and dispose of chemical agents and
other substances that are to be recovered from the environment, unless
otherwise directed by the OSC. The Agency does not believe the final
provision should be modified to include ``to the extent possible''
since it already provides for that expectation, subject to the
direction of the OSC. The OSC should, at a minimum, consider factors
such as the safety of response personnel and harm to the environment in
making such determinations. EPA amended the final provision with the
phrase ``at a minimum'' to recognize that factors other than the
examples provided may be considered.
    The Agency acknowledges a commenter's suggestion to make it
explicitly clear in the regulatory text that the OSC has the authority
to utilize the NEBA framework. The Agency is not taking action on this
comment. The NCP continues not to require nor preclude the use of any
specific environmental tradeoff methodology to identify protective
strategies that may minimize the potential environmental impact of
hazardous substance releases or oil discharges. In addition, the NCP
continues not to define NEBA. While EPA recognizes the need to
establish specific criteria and monitoring for removal actions overall,
this section specifically focuses on actions when chemical or
biological agents are used.
    The Agency acknowledges the comment that the ability to use a given
substance in a response should be dependent on the development of a
removal/recovery plan, as well as the comment that removal action
agents should not be considered for use if safety or environmental
concerns regarding recovery of these agents exist prior to deployment.
The Agency notes that there are certain chemical agents and other
substances that are intended to be recovered from the environment; EPA
amended the final provision to acknowledge that chemical agents and
other substances to be recovered include solidifiers, surface washing
agents, and sorbents, and revised the title accordingly. EPA believes
RRTs and OSCs may consider these factors when determining under what
conditions to authorize their use, as applicable. EPA also believes
that the final provision provides stakeholders the opportunity to
develop removal/recovery plans for these agents and substances. It is
important to note that removal actions that consider the use of
chemical or biological agents and other substances must do so in
accordance with Subpart J.
    Some commenters suggested that recovered materials should be
treated as a hazardous waste so that they are not disposed of in public
landfills, as a matter of public health. Under the NCP, oil and
contaminated materials recovered in cleanup operations are to be
disposed of in accordance with the Regional Contingency Plan (RCP),
ACP, and any applicable laws, regulations, or requirements, as stated
in Sec.  300.310(c). The applicability of hazardous waste regulations
is outside the scope of this final action.
(i) Reporting of Agent Use
    The Agency is adding a new provision at Sec.  300.910(i)(1), to
require the OSC to provide to the RRT certain information for the use
of a chemical or biological agent within 30 days of completion of agent
use. The information required for any chemical or biological agent used
in response to an oil discharge includes product name, product
category, the quantity and concentration used, and the duration of use,
the locations where the agent was used, any available data collected,
and any available analyses of efficacy and environmental effects. This
information may be submitted in accordance with the OSC reporting
provisions under Sec.  300.165 of this part, as applicable, subject to
the 30-day timing requirement. While other existing notification
requirements serve to activate an immediate response to an event, this
requirement gathers information that will be useful in specifically
evaluating the use of chemical or biological agents in the response,
informing the review of preauthorization plans, and providing a basis
for any necessary changes to improve environmental protection.
Additionally, Sec.  300.910(i)(2) requires that the authorizing OSC
provide for notification to the public, to be updated during a response
as appropriate, the following information on chemical and biological
agents used in response to an oil discharge: product name, product
category, quantity and concentrations used, duration of use, and
location(s) of use.
    Several commenters recommended that timely public notification of
product use be required and that reports should be accessible to the
public. A commenter recommended initial notification of product use
within 24 hours and daily public notification thereafter, stating that
accessibility is a matter of health and government accountability. This
commenter also requested simultaneous notification of Tribal
governments, Area Committees, and Citizens' Advisory Councils. A
commenter recommended adding language requiring the responsible party
to inform nearby landowners of dispersant use impacts that may affect
natural or cultural resources. The Agency generally agrees with
commenters' recommendations of providing timely public reporting of
product use and is finalizing a new provision that will require the OSC
to provide notification to the public. Under Sec. Sec.  300.135(n) and
300.155(a), both of which are provisions outside the scope of this
action, the NCP already provides that the OSC should ensure all
appropriate public and private interests are kept informed and that
their concerns are considered throughout a response, to the extent
practicable. Based upon comments received requesting public
notification of chemical and biological agent use, the Agency is
including a new notification provision at Sec.  300.910(i)(2) that
requires the OSC to provide for public notification, updated during a
response as appropriate, regarding information on chemical and
biological agents used in response to an oil discharge to include the
following: product name, quantity and concentrations used, duration of
use, and location(s) of use. The new provision requires the OSC to
provide notification to the public in support of Sec. Sec.  300.135(n)
and 300.155(a) and (b). While EPA agrees that the OSC should provide
timely public notification, the Agency disagrees that the initial
notification should be required to be within 24 hours of product use.
EPA believes the OSC should have the flexibility to establish the
initial timeframe to avoid potential delays in addressing roles and
responsibilities under the NCP, such as obtaining the

necessary concurrences and consultations from certain RRT member
agencies on chemical and biological agent use. EPA believes that the
OSC, as the entity with overall responsibility to direct the response,
is the appropriate party to provide the public notification. Public
notification may occur, for example, through coordination with the RRT
and posting on their website, as appropriate. EPA also believes that
the public notification provision in the final rule also addresses
commenter's request that reporting include notification of Tribal
governments, Area Committees, Citizens' Advisory Councils, and
landowners.
    Some commenters suggested changes to the proposed reporting
requirements. A commenter recommended that the regulatory text clarify
that reporting is required in the case of sorbent use. Commenters
suggested that reports should include an overview of the incident,
description of how the agent applications were conducted, description
of all monitoring conducted and the results, a description of any
adverse environmental effects, water depth and proximity to shoreline,
and the amount of product and oil-product recovered. This commenter
suggested that the rule may need to include reference to consultations
under section 7 of the Endangered Species Act (ESA), depending on the
nature of environmental impacts from a given spill, and that the
reporting requirements should be mandatory, not just if requested by
the RRT or the natural resource trustee. EPA disagrees with expanding
the scope of the Reporting of Agent Use provision to include other
spill mitigating devices and substances including sorbents and other
aspects of the removal operation. The purpose of the requirement is to
gather information that will be useful in evaluating the use of
chemical or biological agents in the response. Sorbents are not
included in the definition of chemical or biological agents under
Subpart J and are not subject to the authorization of use provisions
under Sec.  300.910(a) or (b); therefore, the Agency disagrees that
reporting should be required in the case of sorbent use. The
information reported through this reporting provision is also intended
to inform the review of preauthorization plans and provide a basis for
any necessary changes to improve environmental protection. The RRT has
existing authority to require the OSC to submit a complete report under
Sec.  300.165 to obtain information that more broadly covers the
removal operation and the actions taken, which may include the
information suggested by the commenters (e.g., overview of the
incident). While the Agency recognizes that consultations under ESA
section 7 may be warranted, it is important to clarify that a purpose
of this reporting requirement is for the RRT and EPA to gather
information specific to the use of a product in a response.
3. Data and Information Requirements for Listing on the NCP Product
Schedule or Sorbent Product List
    The Agency is revising the data and information requirements in
Sec.  300.915 of Subpart J for listing products on the NCP Product
Schedule or Sorbent Product List, identifying the relevant science to
establish a national screening process for products to be listed. The
amendments revise the efficacy and toxicity testing protocols and
listing criteria for all chemical and biological agents on the NCP
Product Schedule, and requirements for listing on the Sorbent Product
List. Additionally, the Agency is revising the requirements for general
product information, Proprietary Business Information (PBI) claims,
submission package contents, EPA review and listing procedures,
requests for decision review, changes to products, transitioning
products from the current NCP Product Schedule to the new NCP Product
Schedule and for listing on the new Sorbent Product List, mandatory
product disclaimer, and removal of products from the NCP Product
Schedule or Sorbent Product List. The final action specifically
includes references to the new Sorbent Product List as clarifying
edits.
    The Agency recognizes comments that asserted that burning agents
should be added to the NCP Product Schedule and that the Agency should
require toxicity testing of burning agents, of combustion products
(e.g., smoke plumes), and of the burn residue that results from
application of burning agents to oil slicks. The Agency continues to
believe that because of the nature of burning agents and the revisions
to the authorization of use for burning agents in the final rule, it is
not necessary to require product submissions for burning agents. See
section V.C.2.c of this preamble for more information on burning
agents.
(a) General Product Information
    EPA is consolidating in paragraph (a) of Sec.  300.915 the general
submission requirements applicable to all types of agents that may be
listed on the NCP Product Schedule or Sorbent Product List. The
revisions group together and simplify the general submission
requirements applicable to all product types. EPA believes that
reorganizing the general requirements in a central location will
clarify which requirements are applicable to all submissions, and which
are specific to each product type by including them in separate
sections. The general information requirements for products are as
follows:
    Submitter. Under Sec.  300.915(a)(1), EPA is requiring the name,
physical address, email, and telephone number of the submitter. Under
Sec.  300.915(a)(2), EPA is requiring the identity of the submitter
(i.e., manufacturer, vendor, importer, distributor, designated agent
for the manufacturer), and documentation of such identity. This
requirement is intended to clearly establish the point of contact
responsible for the submission, and to avoid any conflicts or claims
from unauthorized entities on products listed or submitted for
consideration. No comments on these provisions were identified. EPA
reorganized the provision under Sec.  300.915(a)(2) to provide greater
clarity by moving the documentation requirement forward and by making
editorial changes.
    General product information. Under Sec.  300.915(a)(3), EPA is
requiring the submitter to provide all name(s), brand(s), and/or
trademark(s) under which the product is to be sold. No comments on
Sec.  300.915(a)(3) were identified.
    Supplier. Under Sec.  300.915(a)(4), EPA is requiring the names,
physical addresses, emails, and telephone numbers of the primary
distributors, vendors, importers, and/or designated agent acting on
behalf of the manufacturer. No comments on Sec.  300.915(a)(4) were
identified. EPA made editorial changes from the proposed text to
provide greater clarity.
    Safety Data Sheet. The provision at Sec.  300.915(a)(5) requires
the submitter to provide a Safety Data Sheet (SDS). EPA recognizes that
chemical and biological agents may contain substances that could
potentially cause harm to oil spill responders who, if unaware of the
product's composition, may not wear the proper personal protective
equipment. SDSs describe the hazards that may be involved with the
product and recommend safety measures that would minimize or avoid
adverse consequences that may result from exposures. The Agency
believes SDS information will be useful to both OSCs and responders
when authorizing and using the product respectively. Several commenters
suggested that the Agency should require that SDS information be
submitted for each individual product component. Agency disagrees that
that SDS information needs to be submitted for each individual product
component.

EPA believes that the SDS for the product, rather than for each
component, is more appropriate for responders to use during a response.
EPA believes that requiring an SDS for each product component would add
unnecessary burden to the submitter. The information that is required
to be included in an SDS is the responsibility of the Occupational
Safety and Health Administration (OSHA) and is outside the scope of
this rulemaking. The Hazard Communication Standard (HCS) (29 CFR
1910.1200(g)) requires that the chemical manufacturer, distributor, or
importer provide Safety Data Sheets (SDSs) for each hazardous chemical
to downstream users to communicate information on these hazards. The
SDS includes information such as the properties of each chemical; the
physical, health, and environmental health hazards; protective
measures; and safety precautions for handling, storing, and
transporting the chemical. In addition, OSHA requires that SDS
preparers provide specific minimum information as detailed in Appendix
D of 29 CFR 1910.1200. The Agency believes the SDS along with the NCP
Subpart J Technical Notebook \4\ provides useful information to OSCs,
RRTs, and responders when authorizing and using the product
respectively. EPA notes the final revisions to Sec.  300.950,
Submission of Proprietary Business Information (PBI), provide greater
awareness of product components to OSCs, other stakeholders, and the
public.
---------------------------------------------------------------------------

    \4\ The NCP Subpart J Technical Notebook presents manufacturer's
summary information on the conditions under which each of the
products is recommended to be used.
---------------------------------------------------------------------------

    Product Storage and Shelf Life. Under Sec.  300.915(a)(6), EPA is
requiring the submitter to provide the maximum, minimum, and optimum
temperature, humidity, and other relevant conditions for product
storage and a brief description of the consequences to performance if
the product is not stored within these limits. Under Sec.
300.915(a)(7), EPA is requiring the anticipated shelf life of the
product at the storage conditions noted in paragraph (a)(6) and
documentation for this determination.
    A commenter suggested requiring the submitter to identify the
method of product storage (e.g., 55-gallon drum, 200-gallon plastic
tote, etc.) and provide information on the storage container materials.
The Agency does not believe it necessary to amend the regulatory text
for this purpose. EPA notes that Sec.  300.915(a)(7) requires
documentation to support a manufacturer's determination of the
anticipated shelf life of the product at the storage conditions. EPA
believes this provision satisfies the commenter's concern regarding
information on the storage container materials and methods that are
likely to affect the product shelf life.
    Product Labels. The provision at Sec.  300.915(a)(8) requires
sample product labels for all name(s), brand(s), and/or trademark(s)
under which the product is to be sold that includes manufacture and
expiration dates, and conditions for storage, and notes that the
submitter may use an existing label provided it already contains the
required dates and storage information. This requirement is not
intended in any way to supersede any other federal labeling requirement
in place (e.g., OSHA's HAZCOM). The requirement is intended to assist
the OSC in ensuring that the product used to respond to an incident is
still viable and effective, and the oil spill removal organizations or
any other responder that is storing the product to ensure that their
stockpile is viable and available to be authorized for use. No comments
on Sec.  300.915(a)(8) were identified.
    Chemical or Biological Agent Category. The provision at Sec.
300.915(a)(9) requires the chemical or biological agent category under
which the product is to be considered for listing on the NCP Product
Schedule, including detailed information on the specific process(es)
through which the product affects the oil, and the specific
environment(s) on which it is intended to be used (e.g., waters and/or
adjoining shorelines). If the product meets the definition of more than
one chemical or biological agent category, submitters must identify all
applicable categories and provide the test data to meet the listing
criteria appropriate to each category. A commenter suggested revising
Sec.  300.915(a)(9) to allow the manufacturer to indicate the primary
and other non-primary functions to help the response team determine
whether a product is best suited for a given response situation.
Another commenter suggested that bioremediation agent formulas should
be restricted to only those components necessary for the proposed
primary use of any listed product, noting, for example, that
bioremediation agents formulated for land-based settings may not need
components such as surfactants to be effective, whereas the product may
not need other components such as sugars and nutrients to be effective
for use in or near water. EPA does not believe such a revision is
necessary in Sec.  300.915(a)(9) because the final rule includes a
requirement under Sec.  300.915(a)(13) for the product submitter to
provide information on the intended function of each component. The
Agency believes these provisions will help OSCs determine whether a
product is appropriate for any given response situation. EPA notes that
some components other than those components necessary for the primary
use may still serve to support the product's function. However, EPA
also recognizes concerns that a product (e.g., bioremediation agents)
may contain components that may support an alternate mechanism of
action (e.g., surfactants) and could potentially meet the definition of
another product category (e.g., dispersants). Based on comments, EPA
amended the final provision under Sec.  300.915(a)(9) to remove the
phrase ``. . . and you want it considered for listing on the NCP
Product Schedule in more than one category . . .'' to ensure that
product manufacturers identify all applicable chemical or biological
agent categories. If a product meets the definition of more than one
chemical or biological agent category, the product manufacturers must
provide the test data appropriate to each category. The final provision
ensures that the Agency will receive the information necessary to
evaluate the product for listing on the NCP Product Schedule in all
categories in which the product may be listed, regardless of whether
the submitter requests it to be listed in a specific product category.
    In these finalized provisions, EPA also made some editorial changes
to the proposed text for increased clarity and consistency.
    Recommended Product Use Procedures. Under Sec.  300.915(a)(10), EPA
is requiring the submission of recommended product use procedures,
including product concentrations, use ratios, types of application
equipment, conditions for use, any application restrictions; and, as
applicable, for product and oil containment, collection, recovery, and
disposal procedures. These procedures must address, as appropriate,
variables such as weather, water salinity, water temperature, types and
weathering states of oils or other pollutants. The procedures must
include supporting documentation and current applicable standard
methods used to determine them. EPA believes that providing detailed
information on the recommended product use procedures is necessary to
inform the OSC when authorizing these products. This supporting
documentation and specific information on the methods and standards
used to establish them will inform OSCs and other response personnel in
selecting products that can be effectively used under the operating

conditions encountered for any given incident.
    The Agency recognizes the commenter that recommended that EPA
require turbidity measurement in Sec.  300.915(a)(10); however, EPA did
not make this change because the regulatory text in Sec.
300.915(a)(10) for variables (e.g., weather, water salinity, water
temperature, types and weathering states of oils or other pollutants,
and product and oil containment, collection) that the product use
procedures must address is not an exhaustive set of variables. In
addition, the provisions under Sec.  300.915(a) apply to all product
categories, unless otherwise specified, such as bioremediation agents
that are typically used on shorelines. The provisions under Sec.
300.915(a)(10) provide flexibility for product manufacturers to submit
information relevant to their product and this final action does not
preclude the submitter from measuring turbidity of its product or
including turbidity measurements in its submission for listing on the
NCP Product Schedule, where appropriate. Furthermore, the monitoring
requirements for dispersant use in response to major oil discharges
include a requirement at Sec.  300.913 to measure ambient background,
baseline, and dispersed oil plume water column samples for turbidity.
    EPA also acknowledges the commenter who suggested that EPA require
the following in a submission: training and personal protective
equipment (PPE) needs of the workers applying the product, health
monitoring for the workers, whether the product requires special waste
disposal, and whether the product is safe to use in sensitive areas
such as near communities or water supplies. EPA believes that various
NCP provisions already address this request. This final action includes
the requirement at Sec.  300.915(a)(5) to provide a SDS for the
product, which includes PPE information. Furthermore, EPA notes that
the NCP addresses worker health and safety under Sec.  300.150,
including compliance with applicable OSHA regulations and addresses
availability of adequately trained operators under Sec.  300.910(a) and
(b), respectively. Additionally, Sec.  300.915(a)(10) requires
recommended product use procedures, including product concentrations,
use ratios, types of application equipment, conditions for use, and any
application restrictions; and, as applicable, for product and oil
containment, collection, recovery, and disposal procedures. The NCP
addresses the disposal of oil and contaminated materials recovered in
cleanup operations in accordance with the RCP, ACP, and any applicable
laws, regulations, or requirements under Sec.  300.310(c). Waste
disposal is outside the scope of this final action.
    In the final action, EPA reorganized the provision under Sec.
300.915(a)(10) including moving forward the phrase regarding procedures
for product and oil containment, collection, recovery, and disposal
procedures to provide greater clarity and adding the term ``as
applicable,'' to recognize that not all products may be collected and
recovered. EPA also made other editorial changes for greater clarity.
    Environmental Fate. Under Sec.  300.915(a)(11), EPA is requiring
environmental fate information, including any known measured data,
methodologies, and supporting documentation, on the persistence,
bioconcentration factor, bioaccumulation factor, and biodegradability
of the product and all of its components in the environment. EPA
believes environmental fate information is necessary to inform the OSCs
when authorizing these products for use, given the potential for their
extended use in significant quantities. However, given that these
factors can be estimated, the final action is only requiring that
available information or data be submitted on the product rather than
specific product testing, as specific product testing for these factors
can add significantly to the testing cost for each product.
    Regarding the Agency's request for comment on whether testing for
products' bioconcentration, bioaccumulation, and biodegradation should
be required for listing purposes, some commenters stated that testing
should be required, and one expressed concern that reliance on existing
data, rather than specifying a core required data package, may result
in variable and incomplete understanding of these key factors which in
turn influence chemical fate and biological effects of the product. EPA
notes that the final provision provides flexibility to submit the
required information with supporting documentation and also does not
preclude submitting results from product-specific testing of these
parameters. The submitter may use estimation techniques/models, such as
the EPA model EPI Suite\TM\, to estimate environmental fate properties.
Based on comments, EPA amended Sec.  300.915(a)(11) for product
submissions to include the test methodologies used to obtain the
environmental fate information, providing additional context on the
data. EPA notes that the Agency reserves the right to request
clarification or additional information, as necessary (see Sec.
300.955(c)(1)).
    Regarding the Agency's request for comment on whether thresholds
for bioconcentration factors and bioaccumulation factors should be
established for listing a product on the NCP Product Schedule, some
commenters recommended that EPA should set thresholds for a product's
persistence, bioaccumulation, and biodegradability for listing a
product on the NCP Product Schedule, and to assist the OSC in
authorizing use and establishing safe application rates. Another
commenter suggested having minimum ``pass or fail requirements'' with
added optional information fields for NCP listing. EPA recognizes that
environmental fate information informs OSCs when authorizing these
products for use, given the potential for their extended use in
significant quantities. The new provisions will assist EPA in
evaluating a product's persistence, bioaccumulation, and
biodegradability. However, for oil spill response products, the Agency
does not have sufficient information to establish thresholds for all
environmental conditions that may be potentially encountered. The
Agency did not propose, nor did it identify any relevant information to
establish, thresholds beyond those already included in the final
action. While EPA is not establishing thresholds for environmental fate
information of chemical and biological agents, the final provisions
require the submission of available environmental fate information to
the Agency for listing a product on the NCP Product Schedule. The
Agency intends to make the submitted information available to the
public and other interested stakeholders (e.g., natural resource
trustees).
    The Agency amended the final provision to replace the phrase
``Environmental fate information . . .'' with ``Available information
on environmental fate . . .'' to address the comment that environmental
fate data should be reported only if it is already available and
included the phrase ``current applicable'' to avoid the submission of
data based on test methodologies that have been superseded by later
updates. EPA also reorganized the paragraph to clarify the
requirements.
    Physical and Chemical Properties. Under Sec.  300.915(a)(12), EPA
is requiring that the submitter provide the physical and chemical
properties of the product, as appropriate, and a citation for the
current applicable standard methods used to determine them, including:
(i) Physical state and appearance; (ii) vapor

pressure; (iii) flash point; (iv) pour point; (v) viscosity; (vi)
specific gravity; (vii) particle size for solid components; and (viii)
pH. Three of these elements are new physical or chemical property
requirements under this final rule: physical state and appearance;
vapor pressure; and particle size for solid components. The Agency
believes these basic data requirements will provide added context when
evaluating the products for listing determinations. These, in
combination with the other general product information requirements,
will assist the Agency in evaluating the expected product behavior, and
the process through which it would affect the oil when used in the
intended water and/or shoreline environment.
    Additionally, the Agency has removed the incorporation by reference
of specific standards to determine physical and chemical properties and
replaced this with a requirement for a citation of the current
applicable standard methodology used to determine these values. EPA
believes that citing the current applicable standard methodology used
to determine the required values is sufficient in lieu of specifying
commonly recognized standard methodologies. Furthermore, EPA did not
incorporate by reference specific test methodologies in the regulation
to avoid the administrative burden of updating the NCP every time a
test methodology is updated to a newer version. The Agency believes it
is appropriate to make this change given the added requirement for
accredited laboratories to conduct the testing (Sec.  300.915(a)(17)).
EPA amended this provision relative to the proposed text to qualify
``standard methods'' by adding the term ``current applicable'' to
address comments regarding additional specificity about the standard
methods used to derive physical and chemical properties. EPA included
the qualifier ``current applicable'' to provide for updates to test
methodologies and avoid the submission of data based on test
methodologies that have been superseded by later updates. EPA also made
other editorial changes to the paragraph relative to the proposed text
for greater clarity.
    Under Sec.  300.915(a)(13), EPA is requiring that the submitter
provide the identity and concentration of all components in the
product, including each specific component name; corresponding Chemical
Abstract Service (CAS) Registry Number; the maximum, minimum, and
average weight percent of each component in the product; and the
intended function of each component (e.g., solvent, surfactant).
    A commenter suggested that product vendors should not be required
to report the concentration of product components to the Agency, noting
that this reporting requirement may threaten a proprietary advantage.
EPA notes that the requirement to submit the identity and concentration
of all components in the product is consistent with the previous rule.
EPA believes that when chemical and biological agents are used on oil
discharges, it is important for OSCs, RRTs, and the public to have
information regarding the chemicals being added to the environment. EPA
also believes that the concentration of the product components provides
EPA with an understanding of how the product is intended to function
that cannot be provided by the submission of the identity of the
product components only. In addition, information on the concentration
of product components assists EPA in evaluating on the listing of
product on the NCP Product Schedule and under which category. The final
rule specifies what information submitters are allowed to claim as PBI
to balance public access to information with proprietary business
needs. When a company submits a product for listing on the NCP Product
Schedule, then it will be allowed to claim certain information
identified in Sec.  300.915(a)(13) or (14) as PBI.
    Microorganisms, enzymes, and/or nutrients. For products that
contain microorganisms, enzymes, and/or nutrients under Sec.
300.915(a)(14), EPA is requiring that the submitter provide the
following along with a citation or a description of the methodology
used to determine: (i) The name of all microorganisms by current genus
and species, including any reclassifications, and any physical,
chemical, or biological manipulation of the genetic composition and the
weight percent of each genus in the product; (ii) the name of all
enzymes and their International Union of Biochemistry (I.U.B.)
number(s); Enzyme Classification (EC) code numbers; the source of each
enzyme; units; and specific oil-degrading activity; (iii) the name(s),
maximum, minimum, and average weight percent of the nutrients contained
in the product; and (iv) data, methodology, and supporting
documentation for the levels of bacterial, fungal, or viral pathogens
or opportunistic pathogens including, but not limited to: enteric
bacteria such as Salmonella, fecal coliforms, Shigella, coagulase
positive Staphylococci, and beta hemolytic Streptococci and
enterococci. As noted above, the final rule specifies what information
submitters are allowed to claim as PBI to balance public access to
information with proprietary business needs. When a company submits a
product for listing on the NCP Product Schedule, then it will be
allowed to claim certain information identified in Sec.  300.915(a)(13)
or (14) as PBI.
    To support product screening, this final rule includes a provision
under Sec.  300.915(a)(14)(iv) to address whether products that contain
microorganisms, enzymes, and/or nutrients also contain bacterial,
fungal, or viral pathogens or opportunistic pathogens to compare to
existing applicable criteria. The Agency reconsidered, based on
comments, whether it should establish listing thresholds for products
based on National Ambient Water Quality Criteria, and whether the
levels selected for certification are appropriate for this purpose.
Comments received noted that states may develop standards that may be
more stringent than national criteria. EPA recommends that states and
authorized tribes consider the Agency's national recommended water
quality criteria when developing their criteria. However, states and
authorized tribes may adopt, where appropriate, other scientifically
defensible criteria that differ from the EPA's recommendations. In
addition, both national recommended water quality criteria and state
water quality standards may be revised from time to time. The final
provision under Sec.  300.915(a)(14)(iv) requires that products
submitters provide data, methodology, and supporting documentation for
these pathogen levels to provide relevant information, but the
provision does not require a certification that they do not exceed
recommended National Ambient Water Quality Criteria, as applicable. The
final provisions for listing products on the NCP Product Schedule or
Sorbent Product List under Sec.  300.955 allow the Agency to make
listing determinations based on a technical evaluation of all data and
information submitted in accordance with the requirements for each
product category and the relevant information on impacts or potential
impacts of the product. The Agency believes that this information is
necessary to determine if a product is suitable for listing,
particularly for bioremediation agents, which could potentially be used
at recreational beaches. EPA amended the final provision to better
reflect this approach. EPA may include information related to national
recommended ambient water quality criteria, applicable state water
quality standards, and other relevant

environmental screening information (e.g., aquatic life benchmarks) in
the NCP Product Schedule Technical Notebook for the RRTs, Area
Committees, and OSCs to consider when planning for and responding to
oil discharges.
    A commenter suggested that Sec.  300.915(a)(14)(iv) should only
apply to bioremediation agents that fall into the microbiological
cultures category, because categories of bioremediation agents that do
not contain live cultures have completely different mechanisms of
action. The Agency disagrees that the submission requirements in Sec.
300.915(a)(14)(iv) should only apply to microbiological cultures. This
provision applies to all bioremediation agents, which include
microorganisms, enzymes, and nutrient additives, irrespective of a
classification, to ensure all bioremediation agents (not just those
that the product submitters characterize as microbiological cultures)
are subject to the requirements under Sec.  300.915(a)(14)(iv).
    National Water Quality Standard Contaminants (NWQS). Under Sec.
300.915(a)(15), EPA is requiring that the submitter provide data,
methodology, and supporting documentation for the levels of the
following: (i) Arsenic, cadmium, chromium, copper, lead, mercury,
nickel, vanadium, zinc, and any other heavy metal reasonably expected
to be in the product; (ii) cyanide; (iii) chlorinated hydrocarbons;
(iv) pesticides; (v) polychlorinated biphenyls (PCBs); and (vi)
polycyclic aromatic hydrocarbons (PAHs). The Agency may consider how
these levels compare to recommended National Ambient Water Quality
Standards, as applicable. Providing information (i.e., upper limit/
concentration, detailed analytical methods, and sample preparation) on
most of these contaminants was previously required for all products,
but with no established threshold levels for product listing. The
Agency will continue to require information on the methodology and the
data and supporting documentation used to determine the levels of these
contaminants in a product. The Agency, however, is not specifying what
analytical testing method the submitter should use to make these
determinations, as it did for chlorinated hydrocarbons, allowing the
submitter flexibility in testing their product. Additionally, the
Agency is now requiring data on several additional contaminants:
pesticides, PCBs, and PAHs. The Agency's concern with pesticides as
contaminants is mostly due to their potential use on organic sorbents
(e.g., peat moss, corn cobs, and cellulose fibers). The concern for
PCBs is for their toxicity and classification as persistent organic
pollutants, having toxic effects such as endocrine disruption. PAHs are
potent atmospheric pollutants, of concern because some compounds have
been identified as carcinogenic, mutagenic, and teratogenic. The
requirements for these contaminants are intended to provide information
for listing decisions that ensure the use of any product considers
established these recommended levels.
    Some commenters suggested that the proposed requirement in Sec.
300.915(a)(15) to certify that the product does not exceed NWQS
standards is not appropriate for this use because NWQS are defined as
concentrations in the water column, not in formulated products.
Commenters argue that the requirement assumes exposure to full-strength
product, but due to the dilution that occurs when a product is used in
an oil spill situation, the requirements are unnecessary. Commenters
also assert that the existing requirements to communicate hazardous
impurities on product SDSs are sufficient. A commenter suggested that
the Agency should establish a listing threshold for products based on
the National Water Quality Criteria for both acute and chronic
standards and should rank products based on their ability to not add
additional contaminants to the water. A commenter also suggested that
the Agency consider whether there are any state water quality standards
that are more stringent than the national recommended water quality
criteria. After considering comments, EPA amended the regulatory text
in Sec.  300.915(a)(15) to require the submitter to include data,
methodology, and supporting documentation on the levels of substances
identified in Sec.  300.915(a)(15). The Agency recognizes that states
may develop water quality standards that may be more or less stringent
than national criteria and that those standards may vary from state to
state. EPA recommends that states and authorized tribes consider the
Agency's national recommended water quality criteria when developing
their criteria. However, states and authorized tribes may adopt, where
appropriate, other scientifically defensible criteria that differ from
the EPA's recommendations. In addition, both national recommended water
quality criteria and state water quality standards may be revised from
time to time. While EPA is maintaining the requirements for product
submitters to include data, methodology, and supporting documentation
on the levels of substances identified in Sec.  300.915(a)(15) in their
product, the final provision does not require a certification related
to National Recommended Water Quality Criteria or applicable State
water quality standards. EPA may include information related to
national recommended ambient water quality criteria, applicable state
water quality standards, and other relevant environmental screening
information (e.g., aquatic life benchmarks) in the NCP Product Schedule
Technical Notebook for the RRTs, Area Committees, and OSCs to consider
when planning for and responding to oil discharges. To allow the
submitter flexibility in testing their product, the Agency does not
specify which analytical testing method the submitter should use to
make these contaminant level determinations for purposes of product
submission for listing on the NCP Product Schedule. The Agency notes
that the previous rule does not specify thresholds for contaminants.
Gathering data, methodology, and supporting documentation for
substances identified in Sec.  300.915(a)(15) provides a reasonable
approach to inform RRTs, Area Committees, and OSCs on the potential
addition of these substances into the environment and to address
concerns on the potential detection of these substances during a
response. EPA also notes that the final provisions include thresholds
for listing on the NCP Product Schedule based on subchronic toxicity
for dispersants. EPA included subchronic toxicity testing for
dispersants because of EPA's experience with dispersant use, including
the quantities and duration, and because dispersants are designed to
transfer oil into the water column and are not intended to be recovered
from the environment. The fact that dispersants cause oil to enter the
water column is sufficient reason to test for the subchronic
toxicological effects of dispersed oil. Based on past spill response
activities, dispersants have the potential for use over extended
durations and in larger quantities relative to other chemical and
biological agents.
    No prohibited agents or substances. Under Sec.  300.915(a)(16), EPA
is requiring that the submitter provide certification, including data,
methodology, and supporting documentation, indicating that the product
does not contain any of the prohibited agents or substances identified
in Sec.  300.910(e). No comments on this provision were identified. EPA
is finalizing the provision with changes

to reflect the updated title to Sec.  300.910(e) ``Prohibited Agents or
Substances.''
    Testing Laboratory Information and Data. Under Sec.
300.915(a)(17), EPA is requiring that the submitter provide information
about the laboratory that conducted the required tests, including: (i)
Name of the laboratory, address, contact name, email, and phone number;
and (ii) the national and/or international accreditations held by the
laboratory. At Sec.  300.915(a)(18), EPA provides the list of all test
data and calculations that are required to be submitted, including: (i)
Raw data and replicates, including positive controls; (ii) notes and
observations collected during tests; (iii) calculated mean values and
standard deviations; (iv) reports, including a summary of stock
solution preparation; (v) source and preparation of test organisms;
(vi) test conditions; and (vii) chain of custody forms.
    In this final action, EPA is removing the previous requirement for
laboratories performing the efficacy and toxicity testing to have prior
experience specific to the required methodology. The Agency believes
that it is more appropriate to require that laboratories be nationally
or internationally accredited. Accredited laboratories are expected to
be capable of following a prescribed testing protocol and good general
practices, providing assurance that the test results will be reliable.
National and international accreditation organizations include, for
example, the International Organization for Standardization (ISO), and
the Laboratory Accreditation Bureau (recognized in the U.S. through the
National Cooperation for Laboratory Accreditation (NACLA) and the
International Laboratory Accreditation Cooperation (ILAC)). Commenters
expressed both support and opposition for this change. Various
commenters noted that qualified laboratories should not be barred from
conducting these analytical tests due to lack of prior experience with
a specific methodology if it has been accredited by an appropriate
authoritative body, and on the other hand that the removal of this
requirement may lead to inaccurate results being submitted to the
Agency because conducting these tests requires skilled and
knowledgeable technical resources, and that by themselves, general
accreditations do not guarantee a particular institution would have the
resources and/or expertise to conduct the necessary efficacy and
toxicity testing. The Agency believes that having no prior experience
with a specific methodology should not disqualify a laboratory that has
been accredited by an appropriate authoritative body. Therefore, the
final provisions do not include a requirement to have prior experience
specific to the required methodology. However, the Agency reserves the
right to not accept data from a laboratory should EPA find cause to
doubt the quality and integrity of the work. EPA also reserves the
right to conduct its own testing of any product.
    A commenter requested that the Agency be more specific regarding
laboratory accreditation requirements. For example, a laboratory that
is accredited to perform chemical analyses may not have a similar
accreditation to conduct toxicity testing. The Agency understands that
a laboratory may be accredited to perform some of the required testing
but may not have accreditation to conduct all the required tests. A
primary laboratory selected to conduct efficacy and/or toxicity testing
may subcontract that test out to another laboratory with the required
accreditation for testing if they do not have the requisite
accreditation or capability. The final provisions require laboratories
to have accreditation applicable to the test(s) they perform. EPA is
finalizing these provisions with clarifying edits.
    Production Capacity. Under Sec.  300.915(a)(19), EPA is requiring
that the submitter provide an estimate of the annual product production
volume, the average and maximum amount that could be produced per day,
and the time frame needed to reach that maximum production rate in
days. In the final provision, EPA made editorial changes to provide
greater clarity by specifying the time frame needed to reach maximum
production rate ``in days'' in lieu of ``(days).'' There was previously
no requirement for production capability information, and the Agency
believes it is important for the OSCs and responders to have this
information. The availability of a product may impact decisions of
authorization of use, depending on inventory or production
capabilities. This would prove to be of key importance, for example, in
the event of a major environmental disaster (e.g., a SONS event).
    A commenter suggested that this requirement should be removed
because production capacity is not fixed, but varies with available
blending tankage, existing business demands, other product orders, and
component supplies/shipping constraints, so the information provided at
the time of the application would not be relevant to a future time when
product manufacturing could be required during a response. The
commenter suggested that the Agency alternatively modify the language
to require product manufacturers to provide production capability
within 24 hours of a request from an OSC. The Agency disagrees. It is
important to have an estimate of product capacity in the event of a
spill of any size to better understand product availability to inform
OSCs and RRTs. EPA has no previous record of product capacity for the
dispersants, or any other product, on the NCP Product Schedule. The EPA
Inspector General Report entitled Revisions Needed to National
Contingency Plan Based on Deepwater Horizon Oil Spill recommended the
need to capture and maintain dispersant manufacturer production
capacities.
    Finally, EPA made editorial changes to this provision to provide
greater clarity.
    Recognition Received from EPA's Design for the Environment/Safer
Choice Program. Under Sec.  300.915(a)(20), EPA is requiring that the
submitter provide recognition received from EPA's Design for the
Environment (DfE) or Safer Choice programs, as applicable. In 2015, the
Safer Choice label replaced the DfE product label. Therefore, in the
finalized provision, EPA has added reference to the Safer Choice
program. (The ``DfE'' certification is still used in some cases.
Specifically, it is used on antimicrobial products (disinfectants and
sanitizers) registered under FIFRA.) A manufacturer's participation in
the Safer Choice program is voluntary. The Safer Choice label means
that EPA scientists have evaluated all chemical ingredients, regardless
of their percentage in the product. Every ingredient must meet strict
safety criteria for both human health and the environment, including
carcinogenicity, reproductive/developmental toxicity, toxicity to
aquatic life, and persistence in the environment. For more information
on the EPA's Safer Choice program, see: https://www.epa.gov/saferchoice.
    A commenter suggested that submitting this information should not
be required because the DfE certification is a voluntary program and
therefore not required. EPA disagrees; the Agency provides the
submitter with the opportunity to identify products that have met and
are labeled DfE or Safer Choice certified as part of the general
information submission, as applicable. This information may be included
in the NCP Product Schedule Technical Notebook.
    International product testing, data, or certifications. Under Sec.
300.915(a)(21), EPA is requiring that the submitter provide
international product testing or use data or certifications, if
available,

informing the performance capabilities or environmental impacts of the
product.
    A commenter suggested that the Agency clarify the ability to use
results from laboratories outside of the United States. The commenter
also requested that the Agency clarify its statements regarding
``International Product Certifications, testing or use data informing
the performance capabilities or environmental benefits of the
product;'' the commenter stated that it is not clear whether the Agency
would accept this information or whether it would be used to waive
certain efficacy or toxicity requirements. Another commenter suggested
that decision makers may benefit from knowing which products have been
denied registrations in other countries, or been banned for use in
other counties, including the reason(s) why the product was denied
registration. The Agency believes that any additional data available
from other countries may help identify the benefits or concerns for the
listing and/or the authorization of use of a product. The Agency,
however, is not associating any specific listing criterion or threshold
with this broad information request, as some products may not have data
available. The international product certifications data provision
supplements but does not waive or replace toxicity and efficacy
requirements in the listing requirements of the Subpart J final rule.
    A commenter suggested that the Agency revise the use of the term
``environmental benefits'' in this section related to product
information to a discussion of potential ``benefits and drawbacks.''
The commenter noted that their revised language would allow responders
to make more informed decisions. The Agency agrees with the comment to
revise the term ``environmental benefits.'' EPA amended the final
provisions by replacing ``environmental benefits'' with ``environmental
impacts'' to provide a neutral characterization. EPA believes the
amended terminology avoids the potential misinterpretation associated
with the term ``benefits.''
(b) Dispersant Testing and Listing Requirements
    The Agency is revising the efficacy and toxicity testing protocols,
as well as establishing new thresholds for listing dispersants on the
NCP Product Schedule in Sec.  300.915(b). As defined in Sec.  300.5 of
the final rule, dispersants are substances that emulsify, disperse, or
solubilize oil by promoting the formation of small droplets or
particles of oil in the water column. These droplets are typically
driven into the water column by wave action. Emergency response
personnel need to know whether a dispersant or any other type of
chemical or biological agent on the NCP Product Schedule could have
negative environmental impacts relative to the oil before decisions are
made about its use in a particular oil discharge situation.
Consequently, it is essential to consider comparative information about
the efficacy and the toxicity of these products. The finalized
revisions are in response to concerns not only for an increase in the
frequency of planning for the use of these agents, but also for their
potential use in large quantities, such as when responding to oil
discharges from oil tanker accidents and offshore well blowouts, as
evidenced during the Deepwater Horizon incident in 2010.
    A commenter stated that there is no need for additional testing of
chemical dispersants because it is well known that they contain toxic
constituents. Another commenter asserted that the toxicity and
effectiveness test requirements in the previous rule already allow for
discrimination between good products and poorly performing dispersants,
and it is not clear that the proposed revisions provide significant
value with respect to protecting the environment in the event of an oil
spill. EPA disagrees that there is no need for additional dispersant
testing. Subpart J not only includes an NCP Product Schedule
identifying chemical and biological agents, but also authorization of
use procedures that, when taken together, identify the waters and
quantities in which such chemical and biological agents may be used
safely. The toxicity testing and listing threshold requirements for
dispersant alone for listing on the NCP Product Schedule serve to
screen dispersant products for hazard, while the authorization of use
procedures provide for consideration of the conditions surrounding the
specific oil discharge situation. In addition, the provisions under
Sec.  300.910(g) in this final action allow for new information,
including specific to environmental toxicity, to be considered for
planning and response activities. EPA believes that when chemical and
biological agents are used on oil discharges, it is important for the
OSCs and RRTs to have information regarding the chemicals being added
to the environment, along with information about their toxicity. The
NCP provides a framework for efficient, coordinated, and effective
response to discharges of oil. This final action is consistent with
that approach.
    A commenter urged the Agency to consider regional differences in
testing requirements for NCP Product Schedule listings. The commenter
specified that some issues are better addressed at the regional level
including dispersant effects in varying environmental contexts, such as
colder versus warmer waters, changing water depths and distance,
differing sensitive species and/or habitats and shoreline
characteristics. The Agency recognizes regional differences in
requirements and that some issues may be addressed at a regional level.
EPA notes that the NCP Product Schedule is established on a national
level, and that regional considerations are integrated into Subpart J
through the authorization of use process during response activities,
and also through the RRT's and Area Committee's regional and area
planning activities. This final action provides for regional-level
consideration opportunities under the authorization of use provisions
codified at 40 CFR 300.910. For example, Sec.  300.910(a)(1) provides
for RRT and Area Committee consideration of the existence and location
of environmentally sensitive resources during preauthorization planning
development. Further, Sec.  300.910(g), Supplemental Testing,
Monitoring, and Information, provides for supplemental toxicity and
efficacy testing and information to address site, area, and ecosystem-
specific concerns. Finally, the NCP provides for national, regional and
area contingency planning under Sec.  300.210.
    A commenter stated that it is unclear whether the thresholds for
efficacy and toxicity will limit dispersant stockpiles to such a small
level as to essentially eliminate their use and suggested that this
potential issue be addressed in the analysis of the rule to provide
supporting information for the Agency in making regulatory decisions
for this rule. Another commenter also stated that the proposed revision
of the rule under Sec.  300.915(b)(1) Dispersant Testing and Listing
Requirements; Dispersant Efficacy Test and Listing Criteria that
increase the dispersant efficacy requirements for listing on the NCP
Product Schedule will make it unlikely that any dispersants currently
stockpiled in the United States would pass both the proposed efficacy
and toxicity tests. Neither the previous nor final rule requires
stakeholders to stockpile dispersants or other chemical or biological
agents, nor removes them from consideration as a response option. The
Agency notes that dispersants are not the only response option
available during a response; there are other

response options (e.g., mechanical recovery) available to consider that
may lower overall environmental damage depending on the incident-
specific nature of the response. Decisions on the authorization of use
of dispersants and other agents during a response are to be made in
accordance with the NCP and all applicable statutes and regulations.
This final action includes provisions to transition products currently
on the NCP Product Schedule through the revised listing process. This
final action allows a grace period of 24 months for any product
currently listed on the NCP Product Schedule to be authorized for use
(see Sec.  300.955(f) Transitioning Listed Products to the New NCP
Product Schedule or Sorbent Product List.) Products on the NCP Product
Schedule for which a new submission is not received or that do not meet
the revised listing criteria will be removed from the NCP Product
Schedule at the end of the 24-month transition period. This transition
period provides time for retesting, production of additional products,
and the continued ability of currently listed products to be offered
and available in the event of a response.
(1) Dispersant Efficacy
    The Agency is changing the testing protocol for measuring efficacy
and revising the efficacy listing criteria for dispersants to be
listed. Specifically, a dispersant must demonstrate that the Dispersant
Effectiveness at the 95% lower confidence level (LCL95)
meets the new proposed efficacy listing criteria at two test
temperatures. EPA is also replacing the reference oil with a new test
oil: Strategic Petroleum Reserve (SPR) Bryan Mound.
    Testing Protocol. Under Sec.  300.915(b)(1), the Agency is adopting
the Baffled Flask Test (BFT) method as the testing protocol for
dispersant efficacy and providing this method in AppendixC to part 300.
This testing protocol replaces the Swirling Flask Test (SFT) that was
formerly listed in Appendix C to part 300 of the NCP. The BFT procedure
incorporates a redesign of the testing flask by eliminating the side
arm, incorporating baffles in the wall of the flask, and adding a
stopcock at the bottom, which improves reproducibility in the hands of
different operators. This protocol has undergone peer review \5\ and
has been tested in several laboratories, providing reproducible and
repeatable results.
---------------------------------------------------------------------------

    \5\ Venosa, Albert D., National Risk Management Research
Laboratory, US EPA; Sorial, George A., Department of Civil &
Environmental Engineering, University of Cincinnati; King, Dennis
W., Statking Consulting; Round-Robin Testing of a New EPA Dispersant
Effectiveness Protocol, International Oil Spill Conference, 2001.
---------------------------------------------------------------------------

    Some commenters opposed switching from the SFT to the BFT. A
commenter stated that the Agency should not replace the accepted
standard Swirling Flask Test, developed by the EPA Canada, and that the
BFT is a non-standard test designed by industry. Another commenter
expressed concerns with EPA proposing a non-standard method in lieu of
one well accepted and used around the world (ASTM F2059-06; 2012). The
Agency's decision to adopt the test in the final rule is based on the
BFT method's attributes; the Agency could not identify other
potentially applicable standards that would incorporate the
considerations of the BFT. The BFT is designed to be more
representative of the moderately turbulent sea conditions where
dispersants are more likely to be successful when used. The new BFT
procedure incorporates a redesign of the testing flask by eliminating
the side arm, incorporating baffles in the wall of the flask, and
adding a stopcock at the bottom, which improves reproducibility in the
hands of different operators. Specifically, the new baffled
trypsinizing flask design, fitted with a glass stopcock positioned at
the bottom side, promotes less manipulation that could result in
erroneous re-suspension of non-dispersed oil. Additionally, the BFT
provides higher, consistent turbulent mixing energy within the flask,
resulting in the possibility of better dispersion and more repeatable
and reproducible dispersant effectiveness testing results. The BFT was
tested extensively in an iterative inter-laboratory calibration test
using commercially available dispersant products.
    Reference oils. The provision at Sec.  300.915(b)(1) specifies the
type of oil that the efficacy testing must use, SPR Bryan Mound. The
use of reference oils was proposed, in part, to ensure that testing of
the effectiveness of a dispersant product is done in a uniform manner,
across manufacturers, and is performed in a way to ensure that EPA can
be confident in the results of that testing before a dispersant product
is listed on the NCP Product Schedule for subsequent consideration for
use in a response under the NCP. The Agency proposed requiring product
manufacturers to test their dispersant products against two new
reference oils, ANS and IFO-120, or similar oils, to provide
representative information on the potential efficacy of products when
used on different types of oils. These two oils were proposed to
replace the previously required reference oils. In the proposal, EPA
considered testing requirements for dispersant products against two
reference oils; however, the final action provides for dispersant
efficacy and toxicity testing to be performed using one reference oil:
SPR Bryan Mound. The Agency and the Strategic Petroleum Reserve (SPR)
successfully identified multiple potential oil blends stored at the
SPR. After multiple rounds of testing, EPA has selected one oil, the
Bryan Mound oil blend, from the SPR, to serve as the selected reference
oil for the final action.
    While the proposal considered testing requirements for dispersant
products against two reference oils, this final action provides for
dispersant efficacy and toxicity testing to be performed using one
reference oil: SPR Bryan Mound. After confirmatory testing, the Agency
has determined that the use of SPR Bryan Mound as the sole screening
reference oil is sufficient and appropriate for use in establishing a
baseline comparison of products considered for listing on the NCP
Product Schedule. This final rule establishing a sole screening
reference oil is consistent with the purpose of product testing for NCP
Product Schedule listing. The NCP Product Schedule was created to allow
for consideration of comparative information about the efficacy and the
toxicity of products by establishing a national level screening
baseline of products that can be considered for use. The reference oil
used in Appendix C is not intended to be representative of every type
of oil or condition that may be encountered during a response where a
product may be considered for authorization of use. The reference oil
is used to establish a nationally consistent testing regime for product
listing on the NCP Product Schedule, which informs authorization of use
and planning decisions when applied to regional planning and site-
specific responses.
    Commenters had concerns and suggestions about the proposed
reference oils. A commenter noted that if only two types of oils are
tested (as under the proposal), it is unclear how results will be
extrapolated to other untested oils, particularly for those oil types
which exceed the tested range, e.g., those oils that are heavier than
IFO-120 or lighter than ANS crude oil. A commenter suggested testing
dispersants' efficacy on blended alcohol-hydrocarbon fuel, given that
alcohol-based biofuel spills are an emerging research priority. Some
commenters expressed concern about the lack of reference oils for
Unconventional Oil and Gas (UOG) and

that the use of conventional reference oils for products intended for
use on UOG will lead to erroneous and misleading information about
product toxicity and efficacy. The Agency's intent with proposing the
use of ANS and IFO-120, or similar oils that represent a wider range of
oil gravities, was that it would provide information on the efficacy of
the products that could represent their use on different types of oils.
The final action updates the reference oil used for dispersant efficacy
and toxicity testing to SPR Bryan Mound in lieu of ANS and IFO-120. The
Agency believes SPR Bryan Mound meets the needs as a screening
reference oil for a baseline comparison of products to establish the
NCP Product Schedule listing. The required reference oil is not
intended to be representative of every type of oil or condition that
may be encountered during a response where a product may be considered
for authorization. Rather, the final rule recognizes different types of
oil under the authorization of use provisions. For example, Sec.
300.910(a)(1) provides that preauthorization plans should address
likely sources and types of oil that might be discharged when
developing a preauthorization plan. The provision under Sec.
300.910(a)(1) provide RRTs with the flexibility to tailor the scope of
the preauthorization plan to account for different types of oil,
including unconventional oils. In addition, Sec.  300.910(g) provides
for, among other provisions, the supplementary efficacy testing to
provide greater flexibility to tailor testing conditions to address
area- and site-specific concerns relative to the use of a product for
planning and authorization of use. This provision provides RRTs with
the flexibility to gather additional information for different types of
oil, including unconventional oils.
    Temperature. The provision at Sec.  300.915(b)(1) requires that
efficacy testing be conducted at two different temperatures, 5 and 25
degrees Celsius ([deg]C), rather than at an ambient temperature range
of 20 to 23 [deg]C as previously required. The Agency recognizes the
current and future interest in arctic and deep water drilling, and the
continued oil production in the southern areas of the country. Given
the potential range of locations where dispersants may be used, the
Agency believes it is appropriate to have products tested at
temperatures that would reflect that range. These temperatures are
intended to capture dispersant use scenarios in a wide range of
geographic locations and under different temperatures that may occur in
the same geographical location (such as, for example, the deep sea and
surface water in the Gulf of Mexico, where the temperatures are
typically between 5 [deg]C and 25 [deg]C, respectively).
    Some commenters suggested that testing at different temperatures
will not add value for relative comparison between dispersants. A
commenter mentioned that dispersants can be effective at a range of
ambient temperatures and the requirement to perform multiple tests on
two oils at two temperatures does not provide significantly more
information than would otherwise be obtained by testing oils at a
single temperature. The commenter stated that the use of a single
temperature should be adequate for determining relative ranking of
different dispersants. A commenter recommended that a dispersant's
efficacy should only need to be tested within the temperature range of
20 +/- 3 [deg]C and this range would account for the variances in
testing that will occur when the BFT is conducted by different
laboratories and different technicians. A commenter suggested that
requiring an effectiveness test at 5 [deg]C is unnecessary, mentioning
that it is of greater importance to determine that the dispersant
itself maintains desirable rheology at cold temperatures and that it is
able to be used with the existing spray systems. Another commenter
recommended testing be conducted at 1 [deg]C instead of 5 [deg]C for
the lower test range because the Arctic waters typically range between
0 [deg]C and 4 [deg]C. Another commenter suggested that for dispersants
proposed for use in the Arctic, the Agency should consider requiring
efficacy testing under even colder water conditions, as marine waters
do not typically freeze until they reach approximately -1.8 [deg]C
(roughly 29 degrees Fahrenheit).
    The Agency acknowledges comments opposing testing at different
temperatures. The Agency recognizes the current and future interest in
crude petroleum oil exploration and production throughout the United
States. The Agency believes it is appropriate to have dispersant
products tested on a national level at temperatures that would reflect
a range of water temperatures in which dispersants might be used. The
efficacy testing criteria for temperature are intended to capture
dispersant use scenarios in a wide range of geographic locations and
under different temperatures that may occur in the same geographical
location. Water temperature may vary seasonally or with water depth
even within the same geographical location. For example, the
temperatures specified in the dispersant efficacy testing protocol span
the range of temperatures of the deep sea and surface water in the Gulf
of Mexico. Even within a geographical region, there may be seasonal
variations in temperature that could affect the dispersant use
considerations. This final rule screens dispersant products for
efficacy at two different temperatures to ensure the dispersant
products meet the efficacy thresholds provided for in the final action
and avoid uncertainty associated with listing a dispersant product
tested at only one temperature. Even if oil remains dispersible at
lower temperatures, the efficacy testing at a lower temperature screens
dispersants that may become ineffective due to changes in their
temperature-dependent physical or chemical properties (e.g., increased
viscosity). Efficacy testing at two different temperatures also avoids
potential confusion of listing dispersant products for use at specific
temperatures.
    The Agency also recognizes comments to extend the temperature
testing range below 5 [deg]C. This final rule provides for
consideration of geographically specific temperatures within the
general listing requirements under Sec.  300.915(a) and authorization
of use procedures under Sec.  300.910. For example, the final
provisions require product submissions (e.g., dispersant submission) to
provide the recommended product use procedures under Sec.
300.915(a)(10). These procedures must address, as appropriate,
variables such as water temperature, and must include supporting
documentation. The information required to be submitted to support the
listing, including testing results from multiple temperatures, provides
the OSC and RRT with relevant information that may be used to inform
authorization of use determinations. The final rule also allows for
supplemental efficacy testing under Sec.  300.910(g), Supplemental
Testing, Monitoring, and Information. The OSCs and RRTs may require
these tests to be conducted, due to site- or area-specific concerns,
using parameters other than those specified in Appendix C, including
dispersant efficacy test at different temperatures than that specified
in Appendix C. In conjunction with the required product listing
information, these supplemental testing provisions also provide OSCs
and RRTs with flexibility to gather more detailed information as needed
for authorization of use determinations.
    Confidence Level (LCL95). The provision at Sec.
300.915(b)(1) requires dispersant effectiveness testing results

to be reported in terms of 95% lower confidence level
(LCL95). This accounts for between- and within laboratory
error variability and the inherent error of the method.
    A commenter expressed support for this requirement because the
LCL95 is a lower threshold value than the average dispersant
effectiveness criteria that was previously used. Another commenter
suggested that reporting only the LCL95 reduces the amount
of information available on a product and recommended that the test
average and standard deviation also be provided for additional
information on the precision of the testing. The Agency disagrees with
the comment suggesting reporting the LCL95 reduces the
information available. As described in the Federal Register notice for
the proposed rule, only one number is reported compared to reporting a
mean and standard deviation, as the variation has already been
subtracted in the reported number (80 FR 3403-3404, January 22, 2015).
Furthermore, the final provisions require under Sec.  300.915(a)(18)
that product submission for listing on the NCP Product Schedule provide
all test data and calculations, including raw data and replicates
(including positive controls), notes and observations collected during
tests, calculated mean values and standard deviations, reports,
including a summary of stock solution preparation, source and
preparation of test organisms, test conditions, and chain of custody
forms.
    Dispersant Efficacy Thresholds. The Agency is revising the efficacy
criteria for dispersants to be listed on the NCP Product Schedule.
Specifically, the dispersant must demonstrate a Dispersant
Effectiveness (DE) at the 95% lower confidence level (LCL95)
greater than or equal to: (i) 70% for SPR Bryan Mound at 5 [deg]C; and
(ii) 75% for SPR Bryan Mound at 25 [deg]C.
    Commenters suggested that the efficacy thresholds as proposed in
Sec.  300.915(b)(1) were high, even for highly effective dispersants; a
commenter cited a BFT study suggesting that a certain dispersant
product may not be listed based on its percent effectiveness results of
69% and 61% on different oils. Other commenters suggested that the
proposed thresholds are too restrictive and do not sufficiently take
into account the variability of the BFT. A commenter stated that it
would be better to set a minimum threshold for efficacy tests of 65% at
any temperature as a minimum requirement for listing. Another commenter
recommended that the requirements for percent effectiveness at various
temperatures and oils should be changed to a single value of 45%
effectiveness. The Agency recognizes that the final provisions update
the SFT efficacy testing protocols to the new BFT efficacy testing
protocol, which is designed to be more representative of moderately
turbulent sea conditions where dispersants are more likely to be
successful when used. The revised testing protocol improves test
repeatability and reproducibility within and between laboratories, as
well as greatly reduces both the inherent error of the method and the
human error associated with the SFT protocol. In addition, reporting
the test results in terms of the product's LCL95 accounts
for between- and within laboratory error variability and the inherent
error of the method. The BFT provides higher, consistent turbulent
mixing and better enables more reproducible and repeatable dispersant.
The BFT provides such mixing and better enables more repeatable and
reproducible dispersant effectiveness than the SFT. The mixing energy
within the baffled flask is higher than the mixing energy within the
swirling flask, and, as a result of this increased mixing energy,
better dispersion is possible. The efficacy thresholds in the final
provisions are higher than the previous efficacy threshold and reflect
improvements from the BFT protocols. These higher thresholds also
reflect the Agency's intent to strengthen the requirements for listing
dispersant products on the NCP Product Schedule that are more
efficacious. The Agency believes the final action provides reasonable
thresholds for the purposes of listing a dispersant on the NCP Product
Schedule without being overly restrictive.
(2) Dispersant Toxicity
    The Agency is revising the toxicity testing requirements for
dispersants, including the testing protocols and the use of the test
results. The provision at Sec.  300.915(b)(2) requires acute toxicity
testing for the dispersant alone, and the dispersant mixed with SPR
Bryan Mound. It also requires developmental toxicity and subchronic
testing on the dispersant alone. These tests must be performed using
the methods specified in Appendix C. While the toxicity testing results
were previously used by the OSC to assist in authorization of use
determinations, the Agency will now use the testing results for the
dispersant tested alone to determine eligibility for listing on the NCP
Product Schedule.
    Commenters asserted that the Agency needs to clearly distinguish
between the requirements of the toxicity testing required to assess
which dispersants should be listed on the NCP Product Schedule, and
toxicological studies with appropriate oils, test organisms, and
exposure conditions that will inform discussions about how the listed
dispersants might cause impacts in U.S. waters under the specific
circumstances of an oil spill or release. Specifically, a commenter
suggested that the Agency clarify the objective and rationale of the
proposed acute exposure toxicity testing of dispersant-oil mixtures and
explain how this relates to the listing of a product on the NCP Product
Schedule. The Agency seeks to clarify that the toxicity testing and
listing threshold requirements for the dispersant alone, serve to
screen dispersant products for hazard. EPA is unaware of any single
toxicity testing protocol that represents every potential exposure
situation that may be encountered during an oil spill. There are
numerous factors that come into play and affect an organism's exposure
under the wide range of field conditions, which are not necessarily
represented by the commenters suggestion to use short-term exposure
durations under spiked exposure concentrations. In addition, even
short-term exposure to dispersed oil can have harmful effects to
certain species and life stages. The exposure to individual organisms
during an incident depends on many factors including, but not limited
to, the type of oil discharge (e.g., continuous discharge), proximity
of the organisms to the oil discharge, and organism mobility. The
Agency believes the protocols provide for a conservative decision
approach and establish an adequate safety margin without being overly
restrictive. The Agency also believes that testing the oil alone, as
well as the oil and dispersant mixture, will provide useful data on the
relative toxicity of the oil and the potential hazards associated with
dispersant use (i.e., data derived from the oil and dispersant mixture
test) relative to the hazards associated with non-treatment of the oil
(i.e., data derived from the oil only test). EPA believes that the
comparative nature of the data will benefit the OSCs, RRTs, and Area
Committees in their decision making and planning activities.
    Dispersant Tested Alone and/or Mixed with Reference Oil. The
provision at Sec.  300.915(b)(2) requires acute toxicity testing for
the dispersant alone, and the dispersant mixed with SPR Bryan Mound. It
also requires developmental toxicity and subchronic testing on the
dispersant alone.
    Commenters had varied opinions about whether a dispersant should be
tested alone or mixed with the reference oil. Some commenters
recommended

that toxicity testing should focus only on the dispersant alone, and
that the Agency should eliminate testing requirements for dispersant
mixed with reference oil. Another commenter stated that toxicity
testing of dispersant plus oil is more relevant than testing with the
dispersant alone because the dispersant would not be used if no spilled
oil was present and because the potential for toxic effects when
dispersants are used on spilled oil at sea is caused by the dispersed
oil, not by the dispersant. A commenter noted that screening tests
conducted in the absence of reference oils give no indication of
whether product-oil combinations are more toxic than the dispersant
alone, and a commenter stated that it is important to know whether
chemically dispersing the oil would increase or decrease toxicity of
the oil itself. Commenters noted that the relative toxicity of any
dispersant and oil mix will largely be a function of how much oil is
dispersed into the water sample being analyzed, with the greater the
quantity of oil dispersed, the more toxic the resultant oil and
dispersant mix will be. A commenter specifically opposed the proposed
dispersant-oil acute toxicity testing requirement because any concerns
about the potential for toxic effects on marine organisms resulting
from the use of modern dispersants should consider the potential
effects of dispersed oil, not the dispersant itself.
    In response to these comments, the Agency is not eliminating
toxicity testing for dispersed oil from the rule. To clarify the intent
of such testing, the Agency described the rationale for the dispersed
oil toxicity test in previous preambles published in the Federal
Register. For example, EPA notes that the current regulation includes
acute toxicity testing of dispersant-oil mixtures and provided a
rationale in the 1994 NCP final rule (59 FR 47411-47412, September 15,
1994). Dispersants are intended to increase the rate at which an oil
slick is dispersed into the water column. This dispersed oil is, by
definition, a mixture of the dispersant and the spilled oil. As a
result of this dispersion of oil, the possibility exists for organisms
dwelling in the water column to come in physical contact with the
dispersed oil. The Agency believes that it should not make any
difference whether the mortality of an organism was caused by the
effects of a dispersant in the water or due to physical contact with
the dispersed oil (e.g., dispersed oil covering the gills of a fish,
thereby inhibiting respiration). EPA believes that the fact that
dispersants cause oil to enter the water column is sufficient reason to
test for the toxicological effects of dispersed oil. The Agency also
believes that testing the oil alone, as well as the oil and dispersant
mixture, will provide useful data on the relative toxicity of the oil
and the potential hazards associated with dispersant use (i.e., data
derived from the oil and dispersant mixture test) relative to the
hazards associated with non-treatment of the oil (i.e., data derived
from the oil only test). EPA believes that the comparative nature of
the data will benefit the OSCs, RRTs, and Area Committees in their
decision making and planning activities. The final action maintains the
approach used in the previous rule for acute toxicity testing on
dispersant mixed with oil.
    Oil-only acute toxicity testing. In the Federal Register notice for
the proposed rule, the Agency requested comment on whether the
submitter should be required to conduct the oil-only acute toxicity
testing for the test oil (80 FR 3405, January 22, 2015). In response to
the Agency's request for comment, commenters stated that there should
be a requirement to conduct oil-only acute toxicity testing (in
addition to the dispersant alone and the dispersant-oil combination) to
give the Agency the opportunity to detect anomalies in the submitted
data and to provide a comparison to assist in evaluating whether a net
environmental benefit is achieved with the proposed dispersant. A
commenter also stated that the Agency should calculate toxicity
thresholds with oil alone, oil-dispersant mixed together, and
dispersant alone to assist in comparing the relative toxicity. The
Agency considered requiring submitters to conduct the oil acute
toxicity testing as it would provide an opportunity to detect anomalies
in the submitted data. However, EPA decided to conduct the oil-only
acute toxicity tests itself for the reference oil with both
Americamysis bahia (A. bahia) and Menidia. beryllina (M. beryllina) and
provide this data for comparisons to dispersant and dispersant-oil
mixture acute toxicity tests. EPA intends to make the reference oil
toxicity test results available to the public on its website, including
calculated median LC50 values. By providing this
information, the Agency is reducing the number of required toxicity
tests that the submitter would need to conduct in relation to the
previous requirement. To address concerns about detecting anomalies in
the submitted data, EPA notes that the final provisions under Sec.
300.915(a)(17) and Sec.  300.915(a)(18) require the product submission
for listing on the NCP Product Schedule to provide information about
the laboratory that conducted the required tests and to provide all
test data and calculations.
    Test species. The finalized provision at Sec.  300.915(b)(2)
requires acute toxicity testing and testing for subchronic effects
using the crustacean species A. bahia and the fish species M.
beryllina, as well as developmental toxicity testing using a sea urchin
species, either Strongylocentrotus purpuratus (S. purpuratus) or
Arbacia punctulata (A. punctulata) to facilitate further flexibility to
laboratories conducting the developmental assay based on test guidance
and organism availability. Protocols are detailed in Appendix C to part
300. The finalized provision specifies the sea urchin species to be
used for developmental toxicity, to be consistent with specifying
species in the acute and subchronic toxicity tests (A. bahia and M.
beryllina) and to provide greater clarity by replacing the proposal's
more general reference to the ``a sea urchin assay.''
    Commenters requested that the Agency consider including more
geographically or ecologically representative species in the testing
protocol. Commenters specifically suggested that the Agency select test
species that would be representative of those found in California and
Arctic/Alaskan waters. A commenter noted that anadromous or marine fish
would be ecologically relevant to arctic waters since dispersants are
only effective (and used) in marine waters. The commenter recommended
the use of Pacific herring (Ciupea pallasiz) as a model species, since
they are known to be quite sensitive to chemical disturbance and are an
ecologically and economically important species to Alaska. Another
commenter recommended testing on Arctic species, specifically in vitro
cell line studies to assess acute and chronic effects on important
Arctic species including ice seals, walrus, beluga whales, bowhead
whales, phytoplankton and zoo plankton, benthic invertebrates, and
Arctic fish species. Another commenter recommended that the Agency
require product testing on Arctic species such as Arctic copepods and
algae. The Agency notes that the required toxicity testing protocols in
Appendix C use standard test species to screen dispersant products for
hazard for listing on the NCP Product Schedule at a national level.
While the toxicity testing requirements use test species commonly used
in EPA toxicity testing methods, EPA recognizes that other species may
be more sensitive to

dispersed oil under the same test conditions. This final action
provides for consideration of regional conditions under the
authorization of use provisions under Sec.  300.910. For example, Sec.
300.910(a)(1) provides for consideration of the existence and location
of environmentally sensitive resources when developing a
preauthorization plan. In addition, Sec.  300.910(g) provides for
supplemental testing and information to address site, area, and
ecosystem-specific concerns.
    A few commenters expressed concerns about the proposed updates to
Sec.  300.915(b)(2) regarding developmental toxicity testing, stating
that the use of the purple urchin assay is arbitrary and capricious
given that this species' habitat is the shallow nearshore, tidal
environment, which is unlikely to be exposed to dispersants during a
response effort. Commenters also expressed concerns related to the lack
of experience in conducting this type of assay and the potential
difficulty in interpreting results between multiple laboratories. EPA
disagrees that the use of the purple urchin assay is arbitrary and
capricious. EPA notes that, along with the other toxicity test, the sea
urchin developmental assay and listing threshold requirements screen
dispersant products for hazard. The sea urchin developmental assay
established as part of the final rule serve as a sensitive surrogate
test for echinoderm early life stages. This test organism is intended
to expand the taxonomic diversity of species used in product hazard
assessment and is not intended to represent any particular species or
habitat in affected environments. EPA adapted an existing toxicity
testing approach to allow inclusion of this species in product hazard
assessment. To facilitate further flexibility to laboratories
conducting the developmental assay, the Agency amended the final
provisions to include the option to use the purple sea urchin A.
punctulata in lieu of S. purpuratus for the developmental assay. In
addition, EPA amended the final provision under Sec.  300.915(b)(2) to
replace the phrase ``. . . using a sea urchin assay . . .'' with the
phrase ``. . . using Strongylocentrotus purpuratus or Arbacia
punctulata . . .'' to recognize the additional species flexibility for
laboratories conducting the developmental assay based on guidance and
organism availability, and to be consistent with regulatory text for
the other toxicity tests where the organisms are identified.
    Toxicity Thresholds. In the finalized provisions at Sec.
300.915(b)(2)(i)-(iii), EPA is providing thresholds to determine
eligibility for listing on the NCP Product Schedule. Specifically, to
be listed on the NCP Product Schedule, the dispersant tested alone must
demonstrate: (i) A median lethal concentration (LC50) at the
lower 95% confidence interval greater than 10 ppm; (ii) an inhibition
concentration for 50% of the test species (IC50) at the
lower 95% confidence interval greater than 1 ppm; and (iii) a
subchronic No Observed Effect Concentration (NOEC) greater than 1 ppm.