The finalized regulatory text has been modified from that proposed to
list these requirements in subsections (i) through (iii), to provide
greater clarity.
    Commenters expressed concern that the proposed dispersed oil
toxicity test and its threshold could result in the elimination of many
dispersants (and potential future dispersants) from the NCP Product
Schedule. A commenter stated that it might be difficult for any
effective dispersant, mixed with crude oil, to meet the Agency's 10 ppm
LC50 concentration requirement. The commenter noted that a
significant fraction of the toxicity reported from these tests can be
attributed to the crude oil alone, masking the dispersant toxicity.
Another commenter explained that, based on a toxicity study, a specific
product would not pass the proposed toxicity limit, and that given the
reported LC50 of ANS oil alone, it is unlikely that any of
the current dispersants on the NCP Product Schedule would meet the
proposed toxicity limit. The commenter notes that this is consistent
with the results of a study using Louisiana sweet crude oil in which
all of the nine investigated dispersants currently included on the NCP
Product Schedule failed a toxicity threshold requirement of 10 ppm.
Furthermore, commenters suggested it is not clear whether any
dispersant will be approved for the NCP Product Schedule when both
toxicity and effectiveness tests are required, and that the standard
static acute toxicity testing of dispersant-oil mixtures do not
represent real world exposures. The Agency recognizes comments
regarding establishing a listing threshold for the dispersant-oil
mixture toxicity test for the purposes of being listed on the NCP
Product Schedule. The final provisions establish that the listing
threshold for acute toxicity testing applies to the results from the
dispersant-only toxicity test and not the results from the dispersant-
oil mixture toxicity test. Nonetheless, the results from toxicity
testing for dispersant alone and dispersant-oil mixture as required
under Sec.  300.915 are to be made available in the NCP Product
Schedule Technical Notebook for OSCs, ACs, and RRTs to consider in
planning for and responding to an oil discharge.
(3) Limitations
    In the finalized provision at Sec.  300.915(b)(3), EPA specifies
that a dispersant may only be listed on the NCP Product Schedule for
use in saltwater environments for which it meets the efficacy and
toxicity listing criteria. Dispersants are typically designed and
traditionally used for responding to oil discharges in saltwater in the
United States. In general, the effectiveness of dispersants decreases
as the salinity of the water decreases. In waters with no salinity,
many dispersants have shown a very low effectiveness or are sometimes
completely ineffective.\6\ The Agency is also concerned with using
dispersants in freshwater environments because of the limited dilution
typically available as compared with the open sea and because of the
existence of water intakes in rivers, streams, and lakes for use in
drinking water supplies. Using dispersants in freshwater has the
potential for compounding the impacts caused by already discharged
petroleum products, particularly near potable and non-potable
subsurface water intakes.
---------------------------------------------------------------------------

    \6\ Fingas, M., (Ed.), 2011, Oil Spill Science and Technology,
Gulf Professional Publishing, pp. 513-518.
---------------------------------------------------------------------------

    Several commenters suggested explicit temperature and salinity
limits for dispersant use. A commenter noted that it is not clear
whether dispersants could be used in estuaries, or other saltwater/
freshwater mixing zones, and therefore a salinity threshold is needed.
Commenters suggested that dispersant use should be restricted to
saltwater with a salinity of greater than 20 ppt and temperatures
greater than 10 [deg]C or 50 [deg]F. The Agency is not amending the
rule to require specific salinity or temperature limits for dispersant
use. The Agency believes it is more appropriate to address water
salinities regionally rather than in a definition applicable at a
national level and is not including a definition of ``saltwater'' in
the final rule. Dispersants are typically designed and traditionally
used for responding to oil discharges in saltwater in the United
States. In general, the effectiveness of dispersants used in marine
waters decreases as the salinity of the water decreases. EPA agrees
that dispersants may be effective in brackish waters that have
salinities lower than typical ocean water (e.g., 35 ppt). EPA also
believes that dispersants may be effective in water with salinities
greater

than typical ocean water. However, dispersant effectiveness may vary
depending upon factors such as product formulation and mixing energy.
Water temperature is also an important variable that may influence the
effectiveness of dispersant applications. For example, cold
temperatures may, among other environmental factors, impact the
effectiveness of dispersants as it affects certain oil properties
(e.g., viscosity). Colder temperatures also may affect the degree of
oil weathering (e.g., evaporation), and the amount of dispersant-oil
mixing energy (wave action) needed to effectively disperse oil relative
to warmer temperatures. 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 salinity, water
temperature, types and weathering states of oils or other pollutants,
and must include supporting documentation. EPA believes that the
information on salinity and water temperature from the product
submission provides flexibility to OSCs, RRTs, and other interested
parties when considering dispersant products for use on an oil
discharge.
    In the finalized provisions, EPA made some editorial changes to the
proposed text for increased clarity. EPA also added the phrase ``for
which it meets the efficacy and toxicity listing criteria'' to be
consistent with the requirements in Sec.  300.915(b)(1) and (2).
(c) Surface Washing Agent Testing and Listing Requirements
    In Sec.  300.915(c), the Agency is revising the toxicity testing
protocols for surface washing agents (SWAs), establishing efficacy
testing protocols, and establishing both toxicity and efficacy listing
thresholds. As defined in Sec.  300.5 in the final action, surface
washing agents are substances that separate oil from solid surfaces,
such as beaches, rocks, metals, or concrete, through a detergency
mechanism that lifts and floats oil. Product and oil are generally to
be collected and recovered from the environment with minimal
dissolution, dispersion, or transfer into the water column. The
finalized revisions in Sec.  300.915(c) respond to concerns regarding
surface washing agents' frequent use and the potential for residual
impacts after their use.
(1) Surface Washing Agent Efficacy
    Under Sec.  300.915(c)(1), the Agency is establishing a surface
washing agent efficacy testing requirement. Specifically, EPA is
requiring that to be listed on the NCP Product Schedule, the surface
washing agent must meet an efficacy of greater than or equal to 30% in
either freshwater or saltwater, or both, depending on the intended
product use. The Agency is allowing the use of standard recognized
efficacy testing methodologies for surface washing agents. An example
of such a standard recognized methodology is the American Society for
Testing and Materials (ASTM) Standard Test Method for Evaluating the
Effectiveness of Cleaning Agents.\7\ Another methodology is Environment
Canada's Test Method.\8\ The capability of a particular surface washing
agent depends upon the application procedures and the characteristics
of the surface being cleaned, such as size, shape, and material. The
ASTM test method in particular covers a procedure for evaluating the
capability of the agents, providing a relatively rough surface to which
the oil can adhere. The Environment Canada method uses a stainless-
steel `trough' which is placed at a specified angle. The target oil is
placed on an area on the trough. The treating agent is then applied in
droplets to the surface of the oil and after 10 minutes at 5-minute
intervals, rinses of water are applied to the trough. After drying, the
trough is weighed, and the removal calculated from the weight loss.
Repeatability is within 5 percent.
---------------------------------------------------------------------------

    \7\ ASTM Standard Test Method for Evaluating the Effectiveness
of Cleaning Agents. Designation: G122--96 (Reapproved 2008). ASTM
International, 100 Barr Harbour Dr., P.O. Box C-700 West
Conshohocken, Pennsylvania 19428-2959, United States.
    \8\ Fingas, Merv and Fieldhouse, Ben; ``Surface Washing Agents
or Beach Cleaners'' (2010). Chapter 21 Surface-Washing Agents or
Beach Cleaners. In Oil Spill Science and Technology (p716). London:
Gulf Professional Publishing.
---------------------------------------------------------------------------

    Commenters expressed support for the use of the Environment Canada
efficacy protocol, which EPA provided as an example of a standard
recognized efficacy testing methodology in the preamble to the proposed
rule. Commenters recommending the use of the Environment Canada
efficacy protocol cited the availability of a large database of testing
results from this protocol and indications that test results are
thoroughly reviewed and thought to be highly reliable. EPA acknowledges
the commenters' support for the proposed requirements at Sec.
300.915(c) and the use of the Environment Canada efficacy protocol.
There are no requirements for the submitter to use a specific efficacy
testing methodology in the NCP Subpart J for surface washing agents to
determine listing eligibility on the NCP Product Schedule. The final
rule requires that the submitter use an applicable standard methodology
to meet the surface washing agent efficacy testing and listing
requirements. The Agency continues to develop a laboratory testing
protocol to evaluate the efficacy of surface washing agents.
    A commenter suggested that the Agency should not require efficacy
testing until a standard protocol is developed. The commenter expressed
concern that the results from the ASTM and Environment Canada tests may
not be comparable and suggested that within-test variability is already
large. The commenter also noted that in the published data, Environment
Canada tests were performed only on a Canadian oil using only one test.
While the Agency's goal is to develop a standard bench-scale testing
protocol for surface washing agent product evaluation, the Agency
believes that using existing applicable protocols provides useful
information that would otherwise be unavailable to screen products. The
Agency continues to develop a laboratory testing protocol to evaluate
the efficacy of surface washing agents and would propose this protocol
in the Federal Register through notice and comment before adopting it
as part of the Subpart J requirements. The EPA surface washing agent
protocol is outside the scope of this rulemaking. Nonetheless, the
final rule provides for the use of standard efficacy testing
methodologies for surface washing agents. To clarify the provision, EPA
amended the final provision to replace the term ``. . . recognized
standard methodology . . .'' with ``. . . applicable standard
methodology . . .'' to better reflect the applicability of the
methodology to surface washing agents. While EPA recognizes the
potential for test variability, the Agency agrees that there may be
other potential benefits to these methodologies. The Agency believes
that general surface washing agent efficacy tests that are currently
available will develop efficacy results that can be measured against
the efficacy threshold of 30% in either freshwater or saltwater or
both, depending on the intended product use.
    EPA also made some editorial changes to the proposed text for
increased clarity.
(2) Surface Washing Agent Toxicity
    Under Sec.  300.915(c)(2), the Agency is revising the toxicity
testing requirements for surface washing agents, including the testing
protocol. While the toxicity testing results were previously used by
the OSC to assist in authorization of use determinations, the Agency
will now use these toxicity

testing results to determine listing eligibility on the NCP Product
Schedule. The Agency requires the use of the toxicity test methodology
in Appendix C to part 300 to test the surface washing agent for acute
toxicity against freshwater species Ceriodaphnia dubia and Pimephales
promelas, or saltwater species Americamysis bahia and Menidia
beryllina, or both, depending on the intended product use. The
revisions to the testing protocols for surface washing agents are
detailed in Appendix C to part 300. The protocol is based on EPA's
Methods for Measuring the Acute Toxicity of Effluents and Receiving
Waters for Freshwater and Marine Organisms.\9\ To be listed on the NCP
Product Schedule, the surface washing agent must demonstrate an
LC50 at the lower 95% confidence interval of greater than 10
ppm in either freshwater or saltwater for all tested species. EPA
believes that with this threshold level, the Agency is establishing an
adequate safety margin without being overly restrictive.
---------------------------------------------------------------------------

    \9\ http://water.epa.gov/scitech/methods/cwa/wet/upload/2007_07_10_methods_wet_disk2_atx1-6.pdf.
---------------------------------------------------------------------------

    In addition to testing the surface washing agent alone, some
commenters suggested that the Agency require toxicity testing with
surface washing agent-oil mixtures, to determine whether the addition
of the surface washing agent may enhance or alter toxicity of the oil.
Commenters asserted that this would better approximate conditions that
organisms may encounter in the natural environment. EPA believes the
final rule provisions for acute toxicity testing for surface washing
agents is adequate given these products are not likely to be used in
the same quantities or durations as dispersants. EPA notes surface
washing agents are intended to be recovered from the environment,
unlike dispersants. In addition, while the Agency requested comment on
a protocol for preparation of product/oil mixtures for toxicity
testing, the Agency did not identify comments or sufficient information
to tailor the exposure solutions for oil-SWA mixtures. Nonetheless, EPA
believes the final provisions will help the Agency gather additional
technical information specific to the product category. In addition,
EPA may request clarification or additional information as necessary
under Sec.  300.955(c)(1) to inform the Agency's evaluation of a
product.
    In the finalized provisions, EPA made only editorial changes to the
proposed text for increased clarity.
(3) Limitations
    At Sec.  300.915(c)(3), the Agency specifies that surface washing
agents may only be used in those water environments (freshwater and/or
saltwater) for which the product was tested and for which it met the
efficacy and toxicity listing threshold criteria. The Agency recognizes
that products may yield effective results in certain environments and
not in others. Products that may be effective in freshwater
environments may not necessarily be so in saltwater environments, and
vice versa. Product manufacturers maintain flexibility to select which
environment the product is to be tested and authorized for use within
these limitations.
    No comments on this provision were identified. EPA made editorial
changes to the final provisions to provide greater clarity.
(d) Bioremediation Agent Testing and Listing Requirements
    The Agency is establishing toxicity testing protocols, revising the
efficacy testing protocols, and establishing both efficacy and toxicity
listing thresholds for bioremediation agents in Sec.  300.915(d). As
now defined in Sec.  300.5, bioremediation agents are biological agents
and/or nutrient additives deliberately introduced into a contaminated
environment to increase the rate of biodegradation and mitigate any
deleterious effects caused by the contaminant constituents.
Bioremediation agents include microorganisms, enzymes, and nutrient
additives such as fertilizers containing bioavailable forms of
nitrogen, phosphorus, and potassium.
    A 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. This final rule requires product listing submissions to
provide information on the intended function of each component (e.g.,
solvent, surfactant) under Sec.  300.915(a)(13). 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). 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 manufacturer must provide the test data
appropriate to each category. The final provision ensures that the
Agency has the information necessary to evaluate the product for
listing on the NCP Product Schedule regardless of whether the submitter
requests it to be listed in a specific product category.
    A commenter expressed concern related to the use of nonindigenous
or genetically modified bioremediation agents, stating that they may
colonize areas where they are being applied. The commenter suggested
that the Agency should not allow use of genetically modified agents in
response activities. The Agency disagrees that the NCP should
completely prohibit the use of nonindigenous or genetically modified
agents in response activities. The final action establishes
requirements for submitters to disclose bioremediation agent product
information under Sec.  300.915(a)(13) and (14), including components
and any physical, chemical, or biological manipulation of the genetic
composition. In addition, Sec.  300.950, Submission of Proprietary
Business Information (PBI), specifies that only certain information as
identified in Sec.  300.915(a)(13) and (14) may be claimed as PBI. All
other information submitted to EPA for listing on the NCP Product
Schedule as required under Sec.  300.915 and Sec.  300.955 cannot be
claimed as PBI and will be available for public disclosure upon
submission without further notice to the submitter. The Agency believes
that the final provisions afford OSCs, Area Committees, and RRTs with
the flexibility to establish the appropriate agent to use during
response and response planning activities.
(1) Bioremediation Agent Efficacy
    The final provisions reflect a series of changes from the previous
requirements for the efficacy testing protocol for bioremediation
agents. The new protocol includes freshwater testing in addition to the
updated saltwater-based test and uses artificial water for both
freshwater and saltwater testing, replacing the natural seawater

previously used. The protocol also eliminates several gravimetric and
microbiological analyses and testing endpoints not used in the proposed
listing determinations. Additionally, the protocol limits the levels at
which external nutrients may be added, which allows the addition for
product formulations without nutrients, or for product formulations
that have nutrient concentrations at insufficient levels for the
experimental setup. Finally, the methodology streamlines the
statistical analysis. The revisions address concerns with the existing
methodology (as discussed in detail in the Federal Register notice for
the proposed rule, 80 FR 3408, January 22, 2015), expanding its
application to include freshwater environments, improving the
consistency and comparability of the test results, and generally
streamlining the protocol.
    Bioremediation Efficacy Threshold. Under Sec.  300.915(d)(1), to be
listed on the NCP Product Schedule, a bioremediation agent must
successfully degrade both alkanes and aromatics as determined by gas
chromatography/mass spectrometry (GC/MS) in freshwater or saltwater, or
both, depending on the intended product use, following the test method
specified in Appendix C to part 300. The percentage reduction of total
alkanes (aliphatic fraction) from the GC/MS analysis must be greater
than or equal to 85% at day 28, based on the ninety-fifth (95th)
percentile Upper Confidence Limit (UCL95) for both
freshwater and saltwater. The percentage reduction of total aromatics
(aromatic fraction) must be greater than or equal to 35% at day 28 for
both saltwater and freshwater based on the UCL95.
    Some commenters suggested that the proposed efficacy threshold
requirements are unattainably high (originally proposed as a 95%
reduction of aliphatic and 70% reduction in aromatics for saltwater)
and are significantly higher than the efficacy standards for
dispersants. The commenters were concerned that these thresholds would
essentially exclude bioremediation products. Commenters suggested
amending the efficacy standard to 50% reduction in 28 days of both
aliphatics and aromatics in both freshwater and saltwater. The Agency
disagrees with these comments. EPA did not receive information to
conclude that the revised thresholds would exclude a large portion of
bioremediation products currently available. While the Agency disagrees
with these comments, it recognizes that a reduction in percent
thresholds would appropriately address the inherent variability of
microbial consortium to degrade oil, also accounting for the different
types of bioremediation agents.
    After review of the proposed bioremediation agent thresholds and
protocol, the Agency is amending the efficacy thresholds at 28 days to
be greater than or equal to 85% for total alkanes and 35% for total
aromatics in both saltwater and freshwater. While maintaining the
efficacy protocol's approach as proposed, the Agency believes the final
action provides reasonable thresholds for the purposes of listing a
bioremediation agents on the NCP Product Schedule without being overly
restrictive. The efficacy criteria finalized in this action demonstrate
that the product can cause a substantial degradation of the alkane and
aromatic fractions of weathered crude oil compared to a control, as
determined by GC/MS analysis. The Agency disagrees that an equally high
efficacy threshold is needed for dispersants. The efficacy thresholds
for bioremediation agents are unrelated to and established separately
from dispersants. EPA based the efficacy thresholds on individual
assessments of the bioremediation agents and dispersant product
categories, including consideration of their modes of action.
Furthermore, efficacy for dispersant and bioremediation agents are
evaluated using different analytical techniques. For example, the
bioremediation agent efficacy test protocol described efficacy in terms
of reduction in total alkanes and total aromatics of a weathered crude
oil, ANS 521, using high-resolution gas chromatograph/mass spectrometer
(GC/MS) over a 28-day period. Of note, the total alkanes and total
aromatics described in the bioremediation agent efficacy testing
protocol do not represent all of the components in crude petroleum oil.
Dispersant efficacy is evaluated using a different test oil, non-
weathered SPR Bryan Mound, using a UV-visible spectrophotometer. In the
finalized provisions, EPA made only editorial changes to the proposed
text for increased clarity.
    Protocol Specific to Products Containing Enzymes Only. Regarding
EPA's request for comment on whether an additional protocol specific to
products containing enzymes only would be appropriate, commenters
suggested that a testing protocol specific to products containing
enzymes would be useful, because effectiveness data would help
determine whether the technology would be beneficial during a response.
Commenters recommended that testing of these products should consist of
water exposure, weathered oil, and enzymatic product in the
concentrations specified by the manufacturer. The intent of the
protocol including specified concentrations is to provide a consistent,
standardized approach that will allow the Agency to screen products for
listing on the NCP Product Schedule; having each manufacturer
specifying their own test parameters is contrary to this. EPA notes the
final action does not restrict products with enzymes to testing under
only one bioremediation agent procedure. The final rule includes a
specific procedure within the bioremediation efficacy protocol in
Appendix C that captures bioremediation agent products containing
enzymes. Table 15 in Appendix C describes the summary of experimental
setup for the bioremediation efficacy test and includes the treatment
for products (such as an enzyme) containing no live microorganisms and
no nutrients. (See: Test Type 3 in Table 15 in Appendix C). In
addition, section 5.4.9 of Appendix C provides the entry for the
experimental setup and procedure for non-living products (e.g.,
enzymes) other than nutrients.
(2) Bioremediation Agent Toxicity
    Prior to this amendment, there were no bioremediation agent
toxicity testing requirements for purposes of listing these agents on
the NCP Product Schedule. The Agency is finalizing an acute toxicity
testing protocol for bioremediation agents to include both freshwater
and saltwater. The Agency will use these testing results to determine
listing eligibility on the NCP Product Schedule. The required testing
protocols for bioremediation agents, detailed in Appendix C, are based
on EPA's protocol, Methods for Measuring the Acute Toxicity of
Effluents and Receiving Waters for Freshwater and Marine Organisms.
    Toxicity Threshold. Under Sec.  300.915(d)(2), the bioremediation
agent must be tested for acute toxicity in freshwater or saltwater, or
both, depending on the intended product use, following the method
specified in Appendix C to part 300. To be listed on the NCP Product
Schedule, the bioremediation agent must demonstrate an LC50
at the lower 95% confidence interval of greater than 10 ppm in either
freshwater or saltwater for all tested species.
    A commenter suggested that it is unclear why the proposed toxicity
testing appears to be more stringent for bioremediation products than
for chemical dispersants. The commenter asserted that all agents, no
matter their type, should be required to meet toxicity standards before
being listed on the NCP

Schedule and suggested a threshold of 100 ppm, rather than the Agency's
proposed threshold of 10 ppm. The Agency notes that all chemical and
biological agent categories have acute toxicity testing and associated
threshold criteria to be considered for listing on the NCP Product
Schedule. The Agency disagrees that the listing threshold for acute
toxicity tests should be set to 100 ppm. The final provisions establish
a listing threshold for 10 ppm for acute toxicity testing under Sec.
300.915(d) for bioremediation agents, which is the same threshold as
for other product categories. EPA's toxicity classification scheme
classifies LC50 values ranging from 10 ppm to 100 ppm as
slightly toxic and values above 100 ppm substances are considered
practically nontoxic to aquatic organisms. This threshold level
establishes an adequate safety margin without being overly restrictive.
    A commenter stated that the Agency should establish thresholds
where agents that contain known pathogens, bacteria, or fungi, that are
harmful to humans or the environment, should be ineligible for listing.
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. The
final provision under Sec.  300.915(a)(14)(iv) requires that product
submitters provide data, methodology, and supporting documentation for
the levels of these pathogens, to provide relevant information. The
Agency may consider how these levels compare against recommended
National Ambient Water Quality Criteria, as applicable. The final
provisions for listing products on the NCP Product Schedule 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.
Thus, the Agency can determine not to list the product on the NCP
Product Schedule based on information received on contaminants that may
raise concerns.
    Bioremediation agent-oil mixtures. Regarding EPA's request for
comment on the need for acute toxicity tests conducted with
bioremediation agents-reference oil mixtures, commenters stated that
toxicity testing should be conducted with mixtures of oil and products.
Commenters expressed concern about the potential for toxicity from the
partial degradation products of bioremediation and the potential for
toxicity from agent-oil combinations that may not be captured if
products are tested alone. The final action balances gathering the
information necessary to support responses and response planning
against the burden to conduct additional tests to list a product on the
NCP Product Schedule, with the understanding that additional
information may be incorporated at the regional level. Unlike
dispersants that emulsify, disperse, or solubilize oil by promoting the
formation of small droplets or particles of oil in the water column,
bioremediation agents are introduced into a contaminated environment to
increase the rate of biodegradation and mitigate any deleterious
effects caused by the contaminant constituents. EPA believes the final
rule provisions for acute toxicity testing for bioremediation agents
are adequate, given these products are not likely to have the potential
to be used in the same quantities or durations as dispersants based on
past experience with spill response activities.
    Subchronic toxicity testing. A commenter suggested that EPA require
subchronic toxicity testing in addition to the proposed acute testing,
because bioremediation products are expected to remain in the
environment for at least 28 days. EPA did not take this suggestion. EPA
believes the final rule balances the information necessary against the
burden to conduct additional tests to list a product on the NCP Product
Schedule at a national level, with the understanding that additional
information may be incorporated at the regional level. According to the
finalized provisions of Sec.  300.910(g), RRTs may require
supplementary toxicity and efficacy testing to address site, area, or
ecosystem-specific concerns relative to the use of a product for
planning and authorization of use.
    In the finalized provisions, EPA made only editorial changes to the
proposed text for increased clarity.
(3) Limitations
    At Sec.  300.915(c)(3), the Agency specifies that bioremediation
agent listing would be for use only in the freshwater and/or saltwater
environments for which the product was tested and for which it met the
efficacy and toxicity listing criteria.
    No comments on the provision were identified. EPA made only
editorial changes to the final provision for greater clarity. EPA
removed the phrase ``Based on testing . . .'' because it was
unnecessary. EPA also replaced the term ``product'' with
``Bioremediation agents'' and the term ``fresh'' with ``freshwater''
for clarity.
(4) Generic Listing
    The Agency recognizes that there may be oil discharge situations
where it is determined that the addition of nutrients in the form of
salts of nitrogen, phosphorus and potassium (i.e., fertilizers) to
stimulate or enhance bioremediation may be an effective and
environmentally favorable mitigation method. However, nonproprietary
commercially available formulations of nutrients are not specifically
listed on the NCP Product Schedule, even though as nutrient additives
they are subject to Subpart J requirements. Therefore, the Agency is
finalizing at Sec.  300.915(d)(4) a provision providing that if the
product consists solely of: ammonium nitrate, ammonium phosphate,
ammonium sulfate, calcium ammonium nitrate, sodium nitrate, potassium
nitrate, synthetically-derived urea, sodium triphosphate (or
tripolyphosphate), sodium phosphate, potassium phosphate (mono- or
dibasic), triple super phosphate, potassium sulphate, or any
combination thereof, then no technical product data are required. The
product will be generically listed as non-proprietary nutrients on the
NCP Product Schedule, and no further action is necessary under Sec.
300.955. For these nonproprietary commercial nutrients, the Agency
believes there is no need for submission of readily available
information. In the proposal, this provision was titled ``Exceptions.''
EPA changed the name in the final amendment to ``Generic Listing'' to
better describe the purpose of the provision and to avoid confusion
with the provision under Sec.  300.910(d).
    Commenters recommended that products that require nutrient
additions and additional proprietary components should have to follow
toxicity and efficacy testing protocols. A commenter suggested that few
if any of the listed fertilizers would pass the 10 ppm acute toxicity
threshold that is proposed for other bioremediation agents, and that
the requirement should be that the commercial formulations be no more
toxic than their inorganic components. For these non-proprietary
commercial nutrients, the Agency believes there is

no need for submission of readily available information. The Agency
notes that the generic listing applies to substances comprised solely
of those specifically identified in Sec.  300.915(d)(4). The generic
listing applies only to products commonly formulated entirely of those
mineral nutrients and synthetically derived urea listed. The final
action requires no technical product data submission or further action
on the part of a manufacturer prior for the purposes of listing
products commonly formulated of said materials on the NCP Product
Schedule. However, the Agency notes that the use of such substances
remain subject to the authorization of use provisions under Sec.
300.910. For products that may contain components not specifically
identified in Sec.  300.915(d)(4), the requirements under Sec.  300.955
Addition of a Product to the NCP Product Schedule or Sorbent Product
List apply, including the bioremediation agents testing and listing
provisions under Sec.  300.915(d).
    In the finalized provisions, EPA made only editorial changes to the
proposed text for increased clarity.
(e) Solidifier Testing and Listing Requirements
    The Agency is revising the toxicity testing protocol and
establishing a toxicity listing threshold for solidifiers in Sec.
300.915(e). As now defined in Sec.  300.5, solidifiers are substances
that through a chemical reaction cause oil to become a cohesive mass,
preventing oil from dissolving or dispersing into the water column, and
which are collected and recovered from the environment. Although
solidifiers are intended to be recovered from the environment, the
revisions and new toxicity listing threshold respond to concerns
regarding the general increase in the use of chemical and biological
agents as tools available for oil discharge responses.
    Commenters recommended removing solidifiers from the NCP Product
Schedule because they preclude the use of other mechanical
countermeasures, noting that once a solidifier is applied to the slick,
it becomes too heavy and viscous for mechanical recovery. A commenter
asserted that solidifiers offer no measurable advantage over sorbents
or mechanical recovery, have limited practicality, may cross-link or
react with other substances, and require immediate removal from the
environment. The commenter stated that there has been relatively few
studies and tests on the effectiveness of solidifiers and referenced
several reports supporting their position. The Agency disagrees that
solidifiers should be removed from the NCP Product Schedule. The final
action under Sec.  300.915(a)(10) requires that information be provided
on solidifier use procedures, including application equipment,
conditions for use, any application restrictions, and as applicable,
procedures for product and oil containment, collection, recovery, and
disposal. This information will be available to the OSC and the RRT
when making agent authorization of use determinations; agent
authorization of use determinations are subject to OSC direction under
the NCP. Further, the final action provides requirements under Sec.
300.910(h) for the recovery of chemical agents and other substances
from the environment. The final action provisions establish that the
responsible party shall ensure that removal actions adequately contain,
collect, store, and dispose of chemical agents and of other substances
that are to be recovered from the environment, unless otherwise
directed by the OSC. The requirements in Sec.  300.910(h) apply to
solidifiers. Finally, these requirements are reinforced by the
definition provided for under Sec.  300.5 for solidifiers, which
specifies these agents are generally collected and recovered from the
environment. The Agency believes these provisions sufficiently address
solidifier recovery from the environment.
(1) Solidifier Efficacy
    The Agency did not propose nor is it finalizing an efficacy testing
requirement for solidifiers. EPA's focus has been on reviewing the
protocols for dispersants and bioremediation agents, given that their
specific process for affecting the oil allows them to be left in the
environment, whereas solidifiers are intended for removal from the
environment.
    A commenter expressed support for the adoption of efficacy testing
requirements, suggesting that the Agency should rely on recommendations
from the experts. Another commenter suggested that while they did not
have a specific methodology to propose, the Agency should consider
performance criteria when adopting an efficacy standard including
buoyancy of the product (to ensure that the oil-solidifier mixture does
not sink) and ease of collection and removal from the environment. The
Agency acknowledges the comments supporting efficacy testing
requirements for solidifiers, and it notes that no specific methodology
was suggested. EPA does not have sufficient information to establish an
efficacy protocol for solidifiers at this time. While the final action
does not establish efficacy testing requirements for solidifiers for
the purposes of listing products on the NCP Product Schedule, these
agents are subject to the data and information provisions under Sec.
300.915(a), which specifically includes specific gravity as one of the
data points for physical and chemical properties of the product, and
the toxicity testing provisions under Sec.  300.915(e). The new data
and information provisions, including the new classification of
solidifiers as chemical agents, will assist EPA in evaluating
solidifier agent products and gather additional technical information
specific to the product category. Additionally, EPA may request
clarification or additional information as necessary under Sec.
300.955(c)(1) to inform the Agency's evaluation.
(2) Solidifier Toxicity
    EPA is revising the acute toxicity testing requirements for
solidifiers, including the testing protocol. While the Agency
previously provided the acute toxicity testing results to the OSC to
assist in authorization of use determinations, it will now use these
results to determine listing eligibility on the NCP Product Schedule.
The revisions to the testing protocols for solidifiers are detailed in
Appendix C to part 300. The acute toxicity test protocol for
solidifiers is based on EPA's protocol, Methods for Measuring the Acute
Toxicity of Effluents and Receiving Waters for Freshwater and Marine
Organisms. According to Sec.  300.915(e)(1), solidifiers must now be
tested for acute toxicity in freshwater or saltwater, or both,
depending on the intended product use, following the method specified
in Appendix C to part 300. To be listed on the NCP Product Schedule,
the solidifier must demonstrate an LC50 at the lower 95%
confidence interval of greater than 10 ppm in either freshwater or
saltwater for all tested species.
    Similar to surface washing agents, the Agency is not requiring
submitters to conduct acute toxicity tests with solidifier-oil
mixtures. Regarding the Agency's request for comment on the need for
acute toxicity tests conducted with solidifier-oil mixtures, a
commenter noted that toxicity tests with oil may help to evaluate the
efficiency of solidifiers in retaining water soluble hydrocarbons and
preventing them from leaching into water, whereas simple efficiency
tests may not provide such data. However, the Agency is unaware of
information to tailor the acute toxicity protocol for the exposure
solution for oil-product mixtures for solidifiers for the purpose of
listing a product on the NCP Product Schedule.

EPA has experience with preparing oil-product combination for certain
product categories and the final rule incorporates these updates where
applicable. For solidifier products, the Agency does not have
sufficient information to tailor the acute toxicity protocol for oil-
solidifier mixtures, and the final action requires toxicity testing of
solidifier products in conjunction with new toxicity thresholds for
listing on the NCP Product Schedule. The final action also provides for
the Agency to request clarification or additional information as
necessary under Sec.  300.955(c)(1) to inform the product submission
evaluation.
    In the finalized provision at Sec.  300.915(e)(1), EPA made only
editorial changes to the proposed text for increased clarity.
(3) Limitations
    The Agency recognizes that products may yield effective results in
certain environments and not in others. Products that may be effective
in freshwater may not necessarily be so in saltwater, and vice versa.
The Agency is specifying at Sec.  300.915(e)(2) that the listing of
solidifiers is limited to use only in those water environments
(freshwater and/or saltwater) for which the product was tested and for
which it met the listing threshold criteria. Product manufacturers
maintain the flexibility to select which environment the product is to
be tested and could be authorized for use, either saltwater,
freshwater, or both within these limitations.
    EPA made editorial changes to this provision to provide greater
clarity.
(f) Herding Agent Testing and Listing Requirements
    The Agency is revising the toxicity testing protocol and
establishing a listing threshold for toxicity for herding agents in
Sec.  300.915(f). As defined in Sec.  300.5 in the final rule, herding
agents are substances that are used to control the spreading of oil
across the water surface. The revisions and new toxicity listing
threshold respond to concerns regarding the general increase in the use
of chemical and biological agents as tools available for responses to
oil discharges.
    Because the final action eliminates surface collecting agents as a
category and redefines herding agents to better reflect their specific
process for affecting the oil, and because the agents will need to be
identified in order for the required testing to be submitted, the
Agency has eliminated the test requirement for distinguishing surface
collecting agents from other chemical agents.
(1) Herding Agent Efficacy
    There were previously no efficacy testing requirements for herding
agents to determine listing eligibility on the NCP Product Schedule.
These agents would have been included in the former surface collecting
agent category, which had no efficacy testing requirements, and which
the rule amendment eliminates. The Agency did not propose, nor is it
finalizing, an efficacy testing methodology for herding agents.
    Commenters expressed general support to establish a herding agent
efficacy threshold. One commenter suggested that EPA rely on expert
guidance and recommendations related to the adoption of efficacy
protocols. Another commenter suggested considering performance
criteria, including buoyancy of the product (to ensure oil-herder agent
mixtures do not sink) and some measure of the ease of collection and
removal from the environment. The commenter also indicated concern
related to how OSCs will evaluate the utility of the agents without the
use of efficacy testing. The Agency does not have sufficient
information to establish an efficacy protocol for herding agents at
this time. While the final action does not establish efficacy testing
requirements for herding agents for listing on the NCP Product
Schedule, herding agents are subject to the data and information
provisions under Sec.  300.915(a) and the toxicity testing provisions
under Sec.  300.915(f). The revised classification will assist EPA in
evaluating herding agent products and gather additional technical
information specific to the product category.
(2) Herding Agent Toxicity
    EPA is revising the acute toxicity testing requirements for herding
agents, including the testing protocol. While the Agency previously
provided the acute toxicity testing results to the OSC to assist in
authorization of use determinations, these results will now be used to
determine listing eligibility on the NCP Product Schedule. According to
Sec.  300.915(f)(1), herding agents must now be tested for acute
toxicity in freshwater or saltwater, or both, depending on the intended
product use, following the method specified in Appendix C to part 300.
Furthermore, to be listed on the NCP Product Schedule, the herding
agent must demonstrate an LC50 at the lower 95% confidence
interval greater than 10 ppm in either freshwater or saltwater for all
tested species.
    A commenter expressed opposition to toxicity testing as an NCP
Product Schedule listing criteria for herding agents, stating that
since herding agents are used in very limited quantities, they should
not be held to the same toxicity standards as dispersants. The
commenter stated that during actual response activities, dilution and
mixing in the natural environment would decrease concentrations of
herding agents immediately following application to levels below 0.15
ppm, which is below the toxic threshold. The Agency disagrees with this
comment. Toxicity testing results assist in determining listing
eligibility on the NCP Product Schedule. Toxicity testing results may
also be used by RRTs and OSCs for comparative purposes between products
when authorizing their use.
    In the finalized provisions, EPA made editorial changes to the
proposed text for increased clarity. EPA added the qualifier ``To be
listed on the NCP Product Schedule'' for clarity and consistency with
other provisions.
(3) Limitations
    The Agency recognizes that herding agent products may yield
effective results in certain environments and not in others. Products
that may be effective in freshwater may not necessarily be so in
saltwater, and vice versa. The Agency is specifying at Sec.
300.915(f)(2) that the listing of herding agents is limited to use only
in those water environments (freshwater and/or saltwater) for which the
product was tested and for which it met the listing threshold criteria.
Product manufacturers maintain the flexibility to select which
environment the product is to be tested and could be authorized for
use, either saltwater, freshwater, or both within these limitations.
    In the finalized provisions, EPA made only editorial changes to the
proposed text for increased clarity.
(g) Sorbent Requirements
    The statutory schedule as required by CWA section 311(d)(2)(G)
includes the NCP Product Schedule, the Sorbent Product List, and
authorization of use procedures that, when taken together, identify the
waters and quantities in which such dispersants, other chemicals, or
other spill mitigating devices and substances may be used safely.
Sorbents are not listed on the NCP Product Schedule. Rather, the Agency
proposed to establish a separate Sorbent Product List from the NCP
Product Schedule and to include sorbent materials and products on
Sorbent Product List that meets the definition of a sorbent.
Previously, a list that characterized sorbent materials was included in
Sec.  300.915(g). Under the

finalized revisions to Sec.  300.915(g), EPA is establishing a publicly
available Sorbent Product List identifying known sorbent materials and
products for emergency responders to use when responding to an oil
discharge. The Sorbent Product List is separate from the NCP Product
Schedule. Sorbents, as now defined in Sec.  300.5, are inert and
insoluble substances that readily absorb and/or adsorb oil or hazardous
substances, and that are not combined with or act as a chemical agent,
biological agent, or sinking agent. Sorbents may be used in their
natural bulk form or as manufactured products in particulate form,
sheets, rolls, pillows, or booms. Sorbents are generally collected and
recovered from the environment. The list of sorbent materials provided
in the definition includes natural organic substances (e.g., feathers,
cork, peat moss, and cellulose fibers such as bagasse, corncobs, and
straw); inorganic/mineral compounds (e.g., volcanic ash, perlite,
vermiculite, zeolite, clay); and synthetic compounds (e.g.,
polypropylene, polyethylene, polyurethane, polyester).
    According to Sec.  300.915(g)(1), if a sorbent product that
consists solely of a material or any combination of the materials found
in the definition of sorbent (also listed in Sec.  300.915(g)(1)(i)-
(iii)), then no technical data are required to be submitted for listing
on the Sorbent Products List, and no further action is necessary for
use as a sorbent. EPA added the phrase ``to be submitted on the Sorbent
Products List'' in the final action, for clarity.
    The Agency recognizes that a sorbent material may consist of one or
more substances not specifically identified in the non-proprietary list
in Sec.  300.915(g)(1)(i)-(iii). The final action includes a process
for submitters to request to include other products as sorbents if they
can certify they meet the inert, insoluble criteria. For sorbent
products consisting of one or more substances not specifically
identified in Sec.  300.915(g)(1)(i)-(iii), a manufacturer may submit
information for consideration for listing it as a sorbent on the
Sorbent Product List. The required information includes: the
information required under Sec.  300.915 (a)(1) through (8), and
(a)(13) through (a)(15); the certification required under Sec.
300.915(a)(16); and information, including data, to support the claim
that the product meets the sorbent definition under Sec.  300.5.
    A commenter opposed the establishment of a separate list for
sorbents and indicated that these products should be added to the NCP
Product Schedule with all of the other potential agents used in spill
responses activities. Along similar lines, another commenter suggested
that NCP Product Schedule listing should be required for all
synthetically manufactured sorbent products. EPA disagrees that
sorbents should be added to the NCP Product Schedule. For the purposes
of Subpart J, EPA's 1994 final rule noted that the use of sorbents, by
themselves, will not create deleterious effects on the environment
because sorbent materials are essentially inert and insoluble in water
and because the basic components of sorbents are non-toxic. (59 FR
47407; September 15, 1994). The rule previously provided that, prior to
deciding on the use of a particular sorbent material, an OSC could
request a written certification from the manufacturers that their
sorbent product is comprised solely of those sorbent materials
identified in the rule. Furthermore, for sorbents that consist of
materials that are not specifically listed in the rule, the Agency
issued written notification of its decision to add the product to the
NCP Product Schedule under the miscellaneous oil spill control agent
category if it met the definition of a sorbent. In this final rule, the
Agency is maintaining the same overarching approach but offering an
alternative administrative structure by establishing a publicly
available Sorbent Product List in lieu of providing written
certifications to sorbent manufacturers. EPA notes that the sorbent
definition under Sec.  300.5 specifically includes synthetic compounds
(e.g., polypropylene, polyethylene, polyurethane, polyester).
    A commenter stated that EPA should require certain General
Information listing requirements for sorbents, including the
requirements in Sec.  300.915(a)(1)-(8), (10), (11), (12)(i), (iv), and
(vii), (19), and (20). The final action requires under Sec.
300.915(g)(2) sorbent product submissions to include information
required under Sec.  300.915(a)(1) through (8), and (a)(13) through
(a)(15), the certification required under Sec.  300.915(a)(16), and
information, including data, to support the claim the product meets the
definition of sorbent under Sec.  300.5. EPA does not believe that the
information under Sec.  300.915(a)(10) Recommended product use
procedures, (11) Environmental fate information, (12) The physical and
chemical properties, (19) Annual product production volume, and (20)
Design for the Environment is necessary to determine whether the
product meets the definitions of a sorbent to be placed on the Sorbent
Product List. The Agency believes the Sorbent Product List will be
helpful during preparedness planning and response to assist
stakeholders, OSCs, and other responders in understanding what sorbents
have been reviewed by EPA and are available for oil spills. EPA notes
that the Sorbent Product List is separate from the NCP Product Schedule
and is not subject to the preauthorization process under Sec.
300.910(a). However, response actions, including the use of sorbents,
are subject to OSC oversight under the NCP.
    A commenter suggested that the Agency develop efficacy tests for
sorbents based on expert recommendations that include parameters such
as absorption amounts and rates. Another commenter expressed concerns
related to the use of synthetic sorbent products and suggested that
additional discussion of known toxicity of these compounds should be
added to determine whether or not additional toxicity testing is
warranted. The final provisions do not include sorbent efficacy or
toxicity testing requirements. Under Sec.  300.5, sorbents are defined
as inert and insoluble substances that readily absorb and/or adsorb oil
or hazardous substances, and that are not combined with or act as a
chemical agent, biological agent, or sinking agent. Therefore, the
Agency believes that sorbents are inert and insoluble substances that
are removed from the environment, so the submission requirements for
inclusion on the Sorbent Product List is a reasonable approach.
Nonetheless, EPA notes that their use is subject to OSC oversight under
the NCP. The definition also states that sorbents are generally
collected and recovered from the environment. As noted above, for the
purposes of Subpart J, EPA's 1994 final rule noted that the use of
sorbents, by themselves, will not create deleterious effects on the
environment because sorbent materials are essentially inert and
insoluble in water and because the basic components of sorbents are
non-toxic (59 FR 47407; September 15, 1994).
4. Submission of Proprietary Business Information (PBI)
    EPA notes that the Agency has updated the terminology from
``Confidential Business Information (CBI)'' to ``Proprietary Business
Information (PBI)'' in the title and throughout the provision. The
final provisions reflect EPA policy to implement Executive Order 13556
(November 4, 2010) on the terminology used for certain types of
information. The final action addresses the PBI

provisions for product submission under Subpart J in Sec.  300.950.
    Previously, manufacturers were able to assert a claim of
confidential business information (CBI) for any information in their
product package submissions to EPA. Typically, manufacturers claimed as
CBI the chemical identity (e.g., chemical name and chemical abstracts
number [CASRN]), the chemical components, and the concentration (weight
percent) of each chemical component in the product. However, EPA
believes that when chemical and biological agents are used on oil
discharges, it is critically important for the public and all other
stakeholders to have information regarding the components, including
the chemicals, being added to the environment, along with information
about their toxicity and fate. This is particularly true for major
discharge events where larger quantities of chemical or biological
agents may be authorized for use. Prompt and accurate information will
allow the public to evaluate and understand the potential human and
environmental effects of these chemical agents. The Agency is
establishing limitations to what submitters are allowed to claim as PBI
in an effort to balance public access to information with proprietary
business needs. The final action provides that product manufacturers
submitting a product for listing on the NCP Product Schedule or the
Sorbent Product List may only assert, and the Agency will only
consider, PBI claims covering the following information contained in
product submissions: concentration, maximum, minimum, and average
weight percent, and units of each component in the product as
identified in Sec.  300.915(a)(13) and (14). All other information
submitted to EPA for listing a product on the NCP Product Schedule or
the Sorbent Product List as required under Sec.  300.915 and Sec.
300.955 will not be considered PBI and will be available for public
disclosure upon submission without further notice to the submitter. The
final rule provides public access to the identity of components and
relevant health and environmental effects information submitted by the
product manufacturer while providing confidential treatment for the
concentrations of product components.
    In the final action, EPA modified the proposed language in Sec.
300.950(a) to replace the term ``disclosed to the public'' with
``available for public disclosure upon submission without further
notice to the submitter'' to maintain the focus of information in the
NCP Product Schedule Technical Notebook by providing OSCs and RRTs the
most relevant information to consider for planning and response. EPA
also amended the final provision by replacing the phrase ``You may only
claim the concentration and the maximum, minimum, and average weight
percent of each chemical component or microorganism in your product, as
identified in Sec.  300.915(a)(13) or (14), to be CBI'' with ``You may
only claim as PBI the concentration; the maximum, minimum, and average
weight percent; and the units of each component as identified in Sec.
300.915(a)(13) and (14) and as applicable.'' EPA included the phrase
``. . . as applicable'' to recognize that product reporting
requirements may vary depending on the type of component (e.g.,
chemical, microorganism). EPA modified the regulatory text in Sec.
300.950(b)(1) to include the term ``or Sorbent Product List'' to
clarify this requirement also applies to submissions for listing
sorbent products. Finally, EPA modified the language in Sec.
300.950(b)(2) from that proposed, to more clearly explain the process
for submitting PBI; the information does not need to be redacted but
included in a separate marked inner envelope in the submission package.
    Some commenters expressed concerns related to the public disclosure
of proprietary information. A commenter suggested that while EPA may
require disclosures of product formulas, this information does not need
to be made public. The commenter noted that this disclosure could put
the manufacturer at a competitive disadvantage. The commenter also
suggested that this rule may have the unintended consequence of
discouraging companies from listing products which in turn could
decrease the number of products available for response activities in
the United States. Another commenter suggested that the disclosure
requirement would allow competitors to develop ``copycats'' of existing
products with the release of proprietary trade secrets. Other
commenters expressed concerns related to the potential impacts of the
proposed rule on innovation for manufacturers, with some emphasizing
impacts to small businesses. The Agency acknowledges the opposition to
the final rule amendments relating to those elements identified in
Sec.  300.915(a)(13) and (14) in the product to be claimed as PBI.
While providing submitters the ability to claim the concentrations,
weight percentages, and units of all chemical components,
microbiological cultures, enzymes, or nutrients as identified in Sec.
300.915(a)(13) and (14) as PBI, the final rule allows greater public
access to other information (that is, all the information required
under Sec.  300.915 and Sec.  300.955 except for specific data as per
Sec.  300.950) submitted by the product manufacturer to EPA for listing
on the NCP Product Schedule, including the identity of chemical
components and relevant health and environmental effects information.
EPA recognizes the need to balance a product manufacturer's interest in
keeping as much information about a product confidential as possible
with the general public's interest to be informed about products that
may be used during a response under CWA section 311 authorities. As
such, EPA believes the approach in the final action provides the
appropriate balance between the public interest in knowing the
constituents of products being used during a response and a product
manufacturer's interest in protecting the product's formulation. The
Agency also recognizes the concern with disclosure of product formulas,
which some commenters argue would allow the development of ``copycats''
of existing products, thereby impacting manufacturers and small
businesses, their incentive to develop products, and the ability of
small, disadvantaged businesses to compete and innovate. The final
action balances public access to information with proprietary business
needs. The final rule allows product manufacturers to assert a claim of
PBI for the concentrations, weight percentages, and units of all
chemical components, microbiological cultures, enzymes, or nutrients as
identified in Sec.  300.915(a)(13) when submitting a product for
listing on the NCP Products Schedule. The remainder of the information
submitted as required under Sec.  300.915 and Sec.  300.955 will be
available for public disclosure upon submission without further notice
to the submitter.
    Another commenter suggested that the EPA's duty under the Clean
Water Act mandates that all ingredients for products listed on the NCP
Product Schedule be disclosed, including precise formulations, in order
to assess potential exposure and toxicity. Some commenters suggested
that applications for agents that have claimed specific ingredients as
CBI should not be listed on the NCP Product Schedule, and thus
precluded from use. The Agency does not agree that mandatory disclosure
of ingredients is required by the Clean Water Act and has chosen a
balanced approach to ensure that relevant information is available to
the public while maintaining important

confidentiality protections for product manufacturers. This final
action allows only for the concentrations, weight percentages, and
units of all chemical components, microbiological cultures, enzymes, or
nutrients as identified in Sec.  300.915(a)(13) and (14) to be claimed
as PBI. All other information submitted to EPA for listing on the NCP
Product Schedule as required under Sec. Sec.  300.915 and 300.955
cannot be claimed PBI and will be available for public disclosure upon
submission without further notice to the submitter.
    A commenter requested clarification on what and how product
components or confidential business information would be disclosed
publicly. PBI claims associated with a product for listing on the NCP
Product Schedule are limited to the concentrations, weight percentages,
and units of all chemical components, microbiological cultures,
enzymes, or nutrients as identified in Sec.  300.915(a)(13) and (14);
all other information submitted to EPA for listing a product on the NCP
Product Schedule as required under Sec.  300.915 and Sec.  300.955 will
not be considered PBI and will be available for public disclosure upon
submission without further notice to the submitter. EPA does not
disclose PBI to the public; EPA safeguards this information under the
requirements in 40 CFR part 2, subpart B. EPA intends to publish non-
PBI product component information in the NCP Product Schedule Technical
Notebook, which is publicly available on EPA's NCP Product Schedule web
page.
5. Addition of a Product to the NCP Product Schedule or Sorbent Product
List
    The final action at Sec.  300.955 establishes the requirements for
submitters to request a product to be listed on the NCP Product
Schedule or the Sorbent Product List. These provisions provide
administrative information, such as the address where to submit the
package, as well as details of the requirements for a complete
submission package. Additionally, they address how a submitter may
request a listing determination review and the requirements when there
are changes in a listed product. Finally, these provisions address the
process the Agency will follow to review all new submissions, requests
for review of decisions and product changes, as well as how it will
transition from the current NCP Product Schedule to a new one that
reflects the new and amended testing and data requirement.
    EPA revised the title for Sec.  300.955 relative to the proposal
from ``Addition of a Product to the Schedule'' to ``Addition of a
Product to the NCP Product Schedule or Sorbent Product List'' to
clarify the applicability under Sec.  300.955(a) and (b) of
requirements as described in Sec.  300.915(g), Sorbent Requirements,
for adding sorbents to the Sorbent Product List.
(a) Submission
    At Sec.  300.955(a), the Agency has updated the address where the
package is to be submitted. No comments on the proposed changes at
Sec.  300.955(a) were identified. EPA is finalizing this provision as
proposed.
(b) Package Contents
    The provision at Sec.  300.955(b) specifies what a complete package
must include. Because of their intended function in responding to oil
discharges, products listed on the NCP Product Schedule will certainly
impact the environment. It is important that the information provided
by the submitter is true and accurate, as it serves as the basis for
evaluating those potential environmental impacts. The Agency believes
that it is appropriate for the submitter to be held accountable for the
technical data and information provided to make these listing
determinations. The final action requires the submitter to certify the
accuracy of the information submitted, and EPA will reject any
submission that is determined to be incomplete or noncompliant,
misleading, or inaccurate.
    No comments on the proposal at Sec.  300.955(b) were identified.
EPA amended the proposed phrase ``Your package shall include in this
order:'' to include the term ``as applicable'' to recognize that those
provisions under Sec.  300.955 apply to sorbents submission as
described in Sec.  300.915(g), Sorbent Requirements. The term ``as
applicable'' was also added to Sec.  300.955(b)(2) for the same reason.
Finally, EPA also made other editorial changes to provide greater
clarity.
(c) EPA Review
    The final action maintains most of the previous Agency process for
reviewing product submissions. The final action increases the number of
days allowed for the Agency to complete its product review from 60 days
to 90 days from the date of receipt. This change, as described in the
proposal, considers the additional amount of technical data and
information required under the revised rule, as well as the Agency's
past experience with submission packages.
    As described in Sec.  300.955(c), EPA will first review the package
for completeness and compliance with all data and information
requirements. EPA will contact the submitter to verify information, or
to request clarification or additional information, including a product
sample, as necessary. The Agency will make product listing
determinations based on a technical evaluation of all data and
information submitted in accordance with the requirements for each
product category, any relevant information on impacts or potential
impacts of the product or any of its components on human health or the
environment, and on the intended use of the product. Within the 90-day
timeframe, the Agency will notify the submitter, in writing, of its
decision to either list the product on the NCP Product Schedule, or of
its decision and supporting rationale to reject the submission.
Submitters may revise submission packages to address test results,
data, or information deficiencies and resubmit them. Because the Agency
will need a complete set of data and technical information to make a
listing determination, the 90-day review time period will start anew
once a complete package is resubmitted.
    A commenter stated that the listing process should be as
transparent as possible, and that the Agency does not explain the
standard that a dispersant must meet to be listed. The commenter
suggested that the Agency clearly explain how it will evaluate studies
that show sub-lethal impacts to humans and wildlife--particularly,
information other than toxicity and efficacy tests. EPA reiterates that
for a dispersant to be listed on the NCP Product Schedule, it must meet
the specific dispersant testing and listing requirements in Sec.
300.915(b), in addition to the general information requirements under
Sec.  300.915(a). The Agency will evaluate a submission package in
accordance with the provisions under Sec.  300.955(c) of this final
rule. The Agency's product listing determination will be based on a
technical evaluation of all data and information submitted, in
accordance with the requirements for each product category, relevant
information on impacts or potential impacts of the product or any of
its components on human health or the environment, and the intended use
of the product. EPA amended the provision to include the phrase ``. . .
in accordance with the requirements for each product category . . .''
to clarify the applicability for each product category.
    In the final action, EPA removed the proposed sentence ``EPA
reserves the right to make a determination on whether the product will
be listed, and under which category'' because it is unnecessary.
Likewise, the final action

under Sec.  300.955(c)(3) does not include the phrase ``. . . and in
which category or categories. . .'' because it too is unnecessary. The
provision under Sec.  300.955(c)(3) already states that EPA will
provide notification of the Agency's decision to list (or not) a
product on the NCP Product Schedule, which will include how the product
is listed, as applicable. EPA reorganized the sentence under Sec.
300.955(c)(3)(i) for greater clarity to read ``You may revise and
resubmit a complete package to . . .''. Finally, EPA also made other
editorial changes to provide greater clarity.
(d) Request for Review of Decision
    The final action does not substantively change the process for a
submitter to request that the Agency review its determination on a
product. If the Agency rejects a product for listing on the NCP Product
Schedule, the rule at Sec.  300.955(d) continues to allow for a
submitter to appeal to the EPA Administrator to review its
determination to reject the product listing. Such a request must be
made in writing, within 30 days of receipt of the written notification
of EPA's decision. The request to review the Agency's determination
must include a clear and concise statement with supporting facts and
technical analysis that demonstrates why the submitter believes the
product meets the listing requirements. The Administrator or designee
may request additional information or a meeting opportunity. Within 60
days of receipt of any such request, or within 60 days of receipt of
any requested additional information, the Administrator or designee
must notify the submitter in writing of the review decision.
    No comments on the proposed provision at Sec.  300.955(d) were
identified. In the final provision, EPA replaces the phrase ``. . . why
you believe EPA's decision was incorrect.'' with ``. . . why the
product meets the listing requirements.'' to better reflect the intent
of the provision. EPA also made other editorial changes to provide
greater clarity and consistency.
(e) Changes to a Product Listing
    The Agency is revising the provisions for notification of changes
to a product listing. Under the final action at Sec.  300.955(e),
submitters must notify EPA in writing within 30 days of any changes to
the general product information submitted for listing on the NCP
Product Schedule so the OSCs have timely updated information. Changes
applicable to this provision are any changes to information submitted
under Sec.  300.915(a)(1) through (8), and (a)(19) through (21), for a
product on the NCP Product Schedule. Submitters must provide the
reasons for such changes and the supporting data and information. EPA
maintains the ability to request additional information and
clarification regarding these changes. For any changes to the
components and/or their concentrations, the final action requires
retesting of the reformulated product according to the requirements for
the product category, and the resubmission of a new complete package in
accordance with Sec.  300.955(b) for review and consideration for a
listing determination by the Agency. In the final action, EPA split the
proposed paragraph into two subparagraphs, that is Sec.  300.955(e)(1)
and (2), to distinguish requirements for administrative changes from
those for when a listed product is reformulated.
    Some commenters expressed support of the 30-day written
notification requirement for changes to listed product information. The
commenters suggested expanding the requirement to provide a mechanism
for the RRT to request retesting where field performance falls short of
expectations. EPA acknowledges that there may be instances when a
product performs differently in the field than when it was tested. The
final rule contains provisions at Sec.  300.910(g) that allow the RRT
or OSC, during a discharge response, to require a responsible party to
conduct additional monitoring associated with the use of a product. For
any changes to the components and/or their concentrations, the final
rule requires retesting of the product according to the requirements
for the product category, and the resubmission of a new, complete
package for review and consideration for a listing determination of the
reformulated product by the Agency. The Agency believes that when the
components or concentrations of a product change, an automatic
retesting requirement is merited.
    EPA modified the final provision by deleting the proposed term
``chemical'' to clarify that the provision applies to changes to non-
chemical components in biological agents, such as microorganisms and
enzymes. EPA also added the qualifier ``in accordance with Sec.
300.955(b)'' to clarify the procedure for submission of a new package
for review and consideration for reformulated products. Finally, EPA
amended the final provision by adding the phrase ``. . . a new complete
package under a new, distinct name . . .'' to clarify the submission
requirements for reformulated products. Providing a new, distinct name
for the reformulated product avoids potential confusion with existing
products listed on the NCP Product Schedule and helps to distinguish
products with the previous formulation that may be stockpiled. EPA also
made additional editorial changes to this provision from the proposed
text to provide greater clarity.
(f) Transitioning Listed Products to the New NCP Product Schedule or
Sorbent Product List
    The Agency believes it important that products on the current NCP
Product Schedule continue to be available during the transition period
to a new NCP Product Schedule that reflects the amended requirements.
Therefore, according to Sec.  300.955(f), during this transition
period, all products on the current NCP Product Schedule as of December
11, 2023 will remain conditionally listed and available for planning
and response activities. Because of the finalized revisions to test
protocols and listing criteria, and because of the additional test
requirements, all products currently on the NCP Product Schedule must
be retested, and the new data and information be submitted to the
Agency for reevaluation of the current listings by December 12, 2025.
The Agency believes that this 24-month transition period starting on
the effective date of the final action provides adequate time for
submitters to prepare and submit new packages to EPA and for the Agency
to review and make decisions on these products. For a product to be
transitioned to the new NCP Product Schedule, manufacturers would be
required to submit a new, complete package according to the amended
test and listing criteria, and EPA would need to make a favorable
finding to list the product on the new NCP Product Schedule, either as
currently listed or with modifications. Products on the current NCP
Product Schedule for which a new submission is not received, or that
upon review of their submissions do not meet the revised listing
criteria, will be removed from the NCP Product Schedule at the end of
the 24-month transition period. Likewise, it is important that all
products that have previously received EPA letters identifying them as
sorbents remain available for use until December 12, 2025. Similar to
the 24-month transition period allowed for products listed on the NCP
Product Schedule, the Agency believes this provides an adequate
timeframe for sorbent product manufacturers, as appropriate, to prepare
and submit new packages to EPA and for the Agency to review and

make decisions on listing these products on the Sorbent Product List.
Under the new Sec.  300.955(f) provisions, all sorbent products must
have submitted information as applicable under Sec.  300.955(a) and (b)
and be listed in the new Sorbent Product List at the end of the 24-
month transition period to be considered for use. Known sorbent
materials identified under Sec.  300.915(g)(1), or any combination
thereof, for which no technical data are required to be submitted for
listing on the Sorbent Product List, are not subject to relisting
review.
    Some commenters suggested that the transition period should be
shortened from two years to one, due to an increased risk of harm from
products listed on the old Schedule. A commenter noted that a one-year
timeframe would be adequate for manufacturers to perform all required
product retesting and recertification. Some commenters expressed
concern that the proposed transition timeframe is too short. A few
commenters stated that the 24-month transition period is inadequate to
allow for the depth of technical work required for the recertification
and relisting of products on the new NCP Product Schedule. Another
commenter suggested extending the transition period to the lesser of
five years, the product expiration date, or until a suitable
replacement is available and listed on the Schedule. Another commenter
suggested that the proposed transition timeframe is unreasonable
because the Agency is overestimating the number of laboratories capable
of performing the required testing (specifically, bioremediation
testing). The Agency believes that the 24-month transition period
provides adequate time for submitters to prepare and submit new,
complete packages to EPA and for the Agency to review and make
decisions on these products. EPA updates the NCP Product Schedule when
new products are listed. EPA has identified laboratories with
sufficient capability to conduct testing for bioremediation agents to
meet the expected demand under the revised rule.
    Several commenters provided suggestions related to keeping products
that are currently on the NCP Product Schedule, without requiring
further retesting or recertification. Several commenters expressed
concern that the updates to the rule would invalidate the significant
amount of time and effort previously spent to obtain Schedule listing
and suggested that products on the existing Schedule should be
grandfathered into the new listing. Some commenters expressed concern
related to potential impacts on small businesses, including advocating
for additional transition time for small businesses to complete testing
and for short-term extensions for small businesses with products that
have been recently added to the Schedule. On the other hand, a
commenter expressed concern that grandfathering products on the current
NCP Product Schedule would undermine efforts to ensure all listed
products meet the most up-to-date toxicity and efficacy standards. EPA
acknowledges the comments requesting both shorter and longer timeframes
for the transition period. EPA believes the 24-month transition period
provides adequate 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. Furthermore, the
Agency believes that the 24-month transition period provides adequate
time for submitters to prepare and submit new, complete packages to EPA
and for the Agency to review and make decisions on these products
regardless of entity size. Finally, EPA agrees with commenters that
opposed grandfathering of existing products on the Product Schedule.
The final provisions ensure that all products transitioned to the new
NCP Product Schedule meet the updated efficacy and toxicity listing
criteria, follow the amended testing protocols, and have submitted
updated data and information to the Agency.
    In the final provision, EPA replaced ``. . . according to the
amended test and listing criteria . . .'' with ``in accordance with
Sec.  300.955(b)'' to avoid confusion by clarifying the procedure for
submission of a new, complete package for review and consideration. EPA
also added specific regulatory language clarifying the transition
period is applicable to listing products on the Sorbent Product List.
Finally, EPA made additional editorial changes to the provisions in
Sec.  300.955(f) relative to the proposed text to provide greater
clarity, and to specifically address the transition period for sorbent
products.
6. Mandatory Product Disclaimer
    It remains the Agency's position that listing a product on the NCP
Product Schedule does not constitute approval or endorsement of that
product, nor a recommendation of its use. The Agency continues to
believe that it is important to avoid any possible misinterpretation or
misrepresentation of this policy. Thus, the requirement for a
disclaimer to be included on any label, advertisement, or technical
literature for the product is maintained at Sec.  300.965. As proposed,
the final action removes the alternative to reproduce in its entirety
EPA's written notification that it will add the product to the NCP
Product Schedule. The Agency believes it will be able to update the NCP
Product Schedule list within a reasonable timeframe given the advances
in information technology, and thus the option of producing the EPA
letter of notification for a product listing should no longer be
necessary. The Agency is modifying the previously required disclaimer
language to include the sentence ``Only a Federal On-Scene Coordinator
(OSC) may authorize use of this product in accordance with Subpart J of
the NCP in response to an oil discharge.'' This revision is intended to
clarify that the use of these products is conditional to OSC
authorization following the requirements set forth under the NCP
regulations. The disclaimer language must continue to be conspicuously
displayed in its entirety, and must be fully reproduced on all product
literatures, labels, and electronic media, including website pages.
    A commenter suggested a change to the last sentence in the
disclaimer language related to decision authority as follows, ``Only a
Federal On-Scene Coordinator, using pre-authorizations or incident-
specific approvals issued by the Regional Response Team (RRT), may
authorize . . .'' Another commenter suggested further clarification to
the disclaimer language to indicate that NCP Product Schedule listing
is only approval to be on the NCP Product Schedule, not approval for
use or application during a response. EPA did not adopt the commenter's
recommended disclaimer language because authorization of use is already
addressed under Subpart J. However, the Agency did modify the last
sentence of the proposed regulatory text in Sec.  300.965 to clarify an
OSC's authority to authorize a product for use in accordance with
Subpart J of the NCP. The amended disclaimer language clarifies that
only a Federal On-Scene Coordinator (OSC) may authorize use of this
product by replacing the phrase ``according to the NCP'' with ``in
accordance with Subpart J of the NCP in response to an oil discharge.''
The Agency acknowledges the commenter's suggestion to add further
clarification to indicate that the NCP Product Schedule listing is only
approval to be on the NCP Product Schedule but disagrees that this
clarification is necessary. The Agency believes the mandatory product
disclaimer language in this final action already clearly indicates that
a product's

listing on the NCP Product Schedule does not constitute approval or
recommendation of the product. However, the final provision under Sec.
300.965 includes the phrase ``. . . listed on the NCP Product Schedule
. . .'' to read ``To avoid possible misinterpretation or
misrepresentation, any label, advertisement, or technical literature
for products listed on the NCP Product Schedule must display in its
entirety the disclaimer shown below.'' for greater clarity.
    EPA also made additional editorial changes to the provisions in
Sec.  300.965 relative to the proposed text to provide greater clarity.
7. Removal of a Product From the NCP Product Schedule or the Sorbent
Product List
    Products that are not properly used in the field may cause harm to
human health and the environment, and may constitute violations of the
CWA, and other federal, state, Tribal, or local laws. Misleading,
inaccurate, or incorrect statements within a product submittal package
or within language that refers to the listing of a product on the NCP
Product Schedule or the Sorbent Product List may result in their
improper or incorrect use. Falsification of federal documents,
unsupported toxicity or efficacy claims, submission of incorrect
product composition or use information, or withholding technical
product data are some examples of these acts. For these reasons, EPA is
providing explicit criteria and process for the removal of a product
from the NCP Product Schedule or the Sorbent Product List at Sec.
300.970. In the final action, EPA is modifying the title from that
which was proposed, to include ``or the Sorbent Product List'' to
clarify that sorbents placed on the Sorbents Product List may also be
removed. EPA made similar modifications throughout the paragraph of
Sec.  300.970.
(a) Removal Reasons
    To minimize potential misuse of listed products, the Agency
believes it is appropriate to clarify the criteria for the removal of a
product from the NCP Product Schedule or Sorbent Product List. In Sec.
300.970(a), EPA specifically includes, but does not limit, as causes
for removal from the NCP Product Schedule or Sorbent Product List:
statements or information that are misleading, inaccurate, outdated, or
incorrect regarding the composition or use of the product to remove or
control oil discharges made to any person, or private or public entity,
including on labels, advertisements, technical literature, or
electronic media, or within the product submission to EPA; any
alterations to the components, concentrations, or use conditions of the
product without proper notification to EPA as required by Sec.
300.955(e); failure to print the disclaimer provided in Sec.  300.965
on all labels, advertisements, technical literature, or electronic
media; or any new or relevant information not previously considered
concerning the impacts or potential impacts of the product to human
health or the environment.
    Commenters suggested the need for public input in the removal
process, e.g., for the public to request product removal from the NCP
Product Schedule, such as following a decrease in rating of Tribe or
community acceptance criteria for product use. The final provisions
provide that misleading, inaccurate, or incorrect information provided
to any private or public entity is a reason for removal from the NCP
Product Schedule. However, the Agency disagrees that the listing of
products on the NCP Product Schedule on a national level should include
criteria developed by outside entities. Section 311(d)(2)(G) of the CWA
solely delegates authority to EPA to prepare a schedule identifying
dispersants, other chemicals, other spill mitigating devices and
substances if any, that may be used in carrying out the NCP; and the
waters and quantities in which they may be used safely. Thus, the final
action does not allow for entities other than EPA to remove a product
from the NCP Product Schedule, nor is the removal of a product based on
ratings from a non-EPA entity. The final rule does not preclude any
person or private or public entity to bring to EPA's attention
information, including relevant scientific data, that they believe may
warrant consideration for EPA to remove a product from the NCP Product
Schedule.
    Other commenters requested explicit clarification that changes to
product chemical components or reformulation would result in removal
from the NCP Product Schedule and would require product retesting and
recertification, since changes to the composition can change impacts on
human health or the environment. As provided in Sec.  300.970 of the
final rule, the EPA Administrator or designee may remove a listed
product from the NCP Product Schedule for alterations to the
components, concentrations, or use conditions of the product without
proper notification to EPA as required by Sec.  300.955(e). If the
manufacturer changes the components and/or concentrations, then the
manufacturer must retest the reformulated product according to the
requirements for the product category and submit a new, complete
package for a review and EPA's consideration for listing on the NCP
Product Schedule.
    A commenter suggested that the Agency should set a threshold for
product impact levels that would necessitate list removal. The final
action includes thresholds in the testing and listing protocols for
each product category in Sec.  300.915, as applicable, to screen
products at a national level. However, EPA believes potential impacts
from chemical and biological agent use is situational and more
appropriately considered when authorizing their use and overseen by the
OSC. The final action includes authorization of use provisions that
provide for consideration of potential impacts. Further, the final
action also includes provisions for RRTs to consider supplemental
testing, monitoring and information under Sec.  300.910(g) to address
site, area, and/or ecosystem-specific concerns relative to the
potential impact from the use of a chemical or biological agent.
    In the final action, EPA has included ``information'' and added
``outdated'' to the list of types of statements and information that
could be reasons for removal from the NCP Product Schedule. EPA has
also updated the proposed text by including ``electronic media'' to the
methods by which statements or information and disclaimers may be
disseminated. The final action removes the qualifier ``chemical''
before the term ``component'' to clarify that the provision applies to
``non-chemical'' components (e.g., microorganisms) and to be consistent
with similar changes under Sec.  300.955(e). The final action also
replaces the term ``previously unknown'' with ``not previously
considered'' to clarify what information the Agency may consider when
removing a product from the NCP Product Schedule. EPA also made
additional editorial changes to the provisions in Sec.  300.970(a)
relative to the proposed text to provide greater clarity.
(b) Notification and Appeals
    The final action also establishes a process for removal if the
Agency obtains evidence of cause for removal. As per Sec.  300.970(b),
EPA will notify the submitter in writing, at the address of record, of
its reasons for removal of the product from the NCP Product Schedule.
The provision at Sec.  300.970(c) allows for an appeals process similar
to the one set forth for listing determinations. Appeals must be
received within 30 days of receipt of

EPA's removal notification and must contain a clear and concise
statement with supporting facts and technical analysis demonstrating
why the product should not be removed. Written notification from the
Administrator or designee will be sent to the submitter within 60 days
of any appeal, or within 60 days of receipt of any requested additional
information. If no appeal is received within the 30 days of receipt of
EPA's removal notification, the product will be delisted without
further notice.
    EPA did not identify any comments specifically related to the
provisions at Sec.  300.970(b) and (c). In the final action, EPA
revised Sec.  300.970(c) to replace the phrase ``. . . demonstrating
why you believe EPA's decision was incorrect.'' This phrase is replaced
with ``. . . demonstrating why the product should not be removed'' to
better describe the appeal process. EPA also made other editorial
changes to these provisions from the proposed text to provide greater
clarity.
8. Appendix C to Part 300
    The Agency is revising Appendix C to change its title to Appendix
C--Requirements for Product Testing Protocols and Summary Test Data:
Dispersant Baffled Flask Efficacy and Toxicity Tests; Standard Acute
Toxicity Test for Bioremediation Agents, Surface Washing Agents,
Herding Agents, and Solidifiers; and Bioremediation Agent Efficacy
Test. Revisions to this appendix reflect the new and revised testing
protocols for listing agents on the NCP Product Schedule as finalized
in this action. A description of the technical changes and rationale
are discussed for each agent in section V.C.3 of this preamble--Data
and Information Requirements for NCP Product Schedule Listing. The
appendix reflects the technical considerations and listing
requirements.
    Commenters expressed general concern regarding the potential
limitations of screening tests relative to field performance, and
specifically to product performance in marine environments. EPA
reiterates that the product efficacy and toxicity testing protocols
provide essential information for listing chemical and biological agent
products on the NCP Product Schedule. These laboratory testing
protocols provide testing procedures for evaluating product efficacy
for dispersant and bioremediation agents and product toxicity for all
chemical and biological agent product categories, allowing for a
comparative screening of products to be listed. The Agency acknowledges
that tests like the BFT, under the parameters set in the protocol,
cannot simulate the range of parameters and processes that may
potentially influence dispersant effectiveness under actual spill
discharge conditions. The Agency reiterates that the testing protocols
are to provide data and information in support of screening for product
listing at the national level. Nonetheless, the final action still
adopts the BFT for screening products for the NCP Product Schedule
because the BFT screening process not only improves test repeatability
and reproducibility within and between laboratories, but also reduces
both inherent and human error associated with the SFT. The Agency
recognizes field performance may not be directly reflected for each
product and spill situation by the testing results based on the
protocols used for listing products on the NCP Product Schedule.
Nonetheless, the testing protocols finalized in this action account for
relevant oil spill parameters, including salinity, mixing energy, and
temperature. These protocols provide a measure of efficacy for products
that serves to establish a comparative screening baseline for a
national level listing on the NCP Product Schedule. For example, the
revised BFT testing protocol for dispersant effectiveness is designed
to be more representative of moderately turbulent sea conditions where
dispersants are more likely to be successfully used. Additionally, the
final action provides for testing products at temperatures reflective
of the potential range of locations where dispersants may be used. The
final action also provides for product listing on the NCP Product
Schedule to reflect testing for the specific salinity environments
where the product could be considered for use.
    Commenters requested that the Agency audit or independently vet all
tests with third-party scientists or peer review to ensure fairness and
transparency, as well as recommended using independent science as
opposed to government or industry, to review all studies conducted by
the spiller, product vendor, or manufacturer. Commenters recommended
that toxicity tests and efficacy tests be required to be conducted with
certified chemists and scientists working in certified laboratories
using certified procedures and best available technology. The Agency
acknowledges the comments regarding laboratory certification. The final
rule specifies in Appendix C the procedures for efficacy and toxicity
tests that all laboratories must follow for each product category to
maintain consistency and provide comparative information and data. The
Appendix C procedures include a quality assurance (QA) provision. For
example, the dispersant toxicity test under section 3 of Appendix C
includes verification of laboratory accreditation, including
subcontractor facilities (see Appendix C section 3.8.8) and analytical
method summary including Limit of Detection (LOD)/Limit of Quantitation
(LOQ) and QA summary (including calibration curves, method blank and
surrogate recovery, analytical results summary) (see Appendix C section
3.8.10). Furthermore, the final provisions under Sec.  300.915(a)(17)
require the product submission for listing on the NCP Product Schedule
to provide information about the laboratory that conducted the required
tests, including the name of the laboratory, address, contact name,
email, and phone number and the national and/or international
accreditations held by the laboratory. The final provisions under Sec.
300.915(a)(18) require the submission to 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. The final provisions under
Sec.  300.915(a)(21) provide for the submission of international
product testing or use data or certifications, if available, informing
the performance capabilities or environmental impacts of the product.
EPA believes these requirements sufficiently address informational
needs concerning laboratory certification and independent science.
    Dispersant Baffled Flask Efficacy Tests. A commenter questioned how
realistic the turbulent mixing associated with the Baffled Flask Test
would be, relative to the range of ambient conditions and sea-states
that might be expected during operational use of dispersants. The
commenter recommended that the Agency explore other methods that would
replicate mixing of oil and dispersants under moderate to low-energy
sea conditions. The commenter stated that dispersion is much less
effective in nonbreaking wave conditions relative to breaking wave
conditions, citing a study. While the BFT is designed to be more
representative of moderately turbulent sea conditions where dispersants
are more likely to be successful when used, the Agency reiterates that
laboratory efficacy and toxicity testing protocols provide relatively
rapid and simple

testing procedures for evaluating product efficacy and toxicity,
allowing for a comparative screening of products at a national level to
be listed on the NCP Product Schedule. The final BFT methodology is
modified to remove the step to test a dispersant as a positive control
as the final action includes sufficient quality assurance and quality
control procedures specific to the updated dispersant efficacy
protocol, as well as the submittal of raw data and information for
product testing, that make this requirement unnecessary.
    Dispersant Toxicity Tests. A commenter recommended that wherever
practicable, dispersant toxicity test species should either be
indigenous to the spill area or have been shown to be appropriate
surrogates for species from the area. EPA selected the final rule test
species because of their general acceptability in applicable toxicity
testing methods. 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 Arbacia
punctulata (A. punctulata) in lieu of Strongylocentrotus purpuratus (S.
purpuratus) for the developmental assay. Separately, the final rule
allows for species- or region-specific toxicity testing to be required
by the RRT and/or OSC under Sec.  300.910(g). EPA considers the
toxicity tests being finalized in this rule to be the most practical
for judging product hazard. Additional comments on specific protocol
considerations were summarized and answered in the Response to Comments
document. EPA also updated the reference oil used for the acute
toxicity testing of the dispersant product-oil mixture. Finally, the
final action does not include phrase ``. . . (iii) egg production must
occur in 50% of female Americamysis bahia in the replicate control
treatments.'' under section 3.7.5. EPA determined that excluding the
fecundity endpoint was unlikely to influence the sensitivity of the
test, while having the practical advantage of simplifying the test
method.
    Standard Acute Toxicity Test for Bioremediation Agents, Surface
Washing Agents, Herding Agents, and Solidifiers. Prior to this
amendment, the rule did not include any requirements for toxicity
testing for bioremediation agents. The final provisions establish acute
toxicity testing requirements for all product categories, including
bioremediation agents. The acute toxicity testing protocols for all
product categories use the same test species for saltwater
environments. Likewise, the acute toxicity testing protocols for all
product categories, except for dispersants, use the same test species
for freshwater environments; a dispersant may only be listed on the NCP
Product Schedule for use in saltwater environments and therefore do not
have acute toxicity testing requirements for freshwater. Finally,
dispersant toxicity testing requirements include a developmental
toxicity test and a subchronic toxicity test that are not required for
bioremediation agents.
    No substantive changes were made to the proposed text to this
section of the Appendix. A commenter recommended including toxicity
testing for species that are representative of in-shore and/or
nearshore environments as well as longer term monitoring that reflects
toxicity during continuous/long term application. A commenter noted
that toxicity testing involving intertidal and estuarine species would
be particularly appropriate for surface washing agents. A commenter
asked for clarification regarding why the Agency test species required
for bioremediation agents have changed from previous requirements and
are different than those required for dispersant tests. The Agency
recognizes the comments regarding the specific test species the Agency
specifies for use in the protocols included in the final action. The
laboratory efficacy and toxicity testing protocols in the final action
provide relatively rapid and simple testing procedures for evaluating
product efficacy and toxicity, allowing for a comparative screening of
products at a national level; this applies to the selection of test
species. Test species are generally chosen because they are easily
cultured in the laboratory and tend to be sensitive to a wide variety
of pollutants, serving as good indicators of chemical hazards. These
species are also small enough to be easily tested in groups in
relatively small containers under laboratory conditions. The species
included in the protocols have been identified to be aquatic species
commonly used in laboratory tests, and consistent with EPA standard
methods. While the data and information from laboratory testing results
in the final action may broadly inform potential field performance or
impacts, they are intended for the Agency's screening of agent products
for listing on the NCP Product Schedule.
    Bioremediation Agent Efficacy Test. No substantive changes were
made to the proposed text to this section of the Appendix. A commenter
stated that all testing should be conducted with the original medium
(i.e., seawater and/or freshwater), and that all bioremediation types
should be tested in aqueous solutions closest to the original
environment in which these products were intended for use. They
recommended that test procedures involving bioremediation agents should
allow for microbes or nutrients, which are naturally occurring in
nature, to be added at the manufacturer's discretion. The protocol
required by the final action uses a standardized artificial saltwater
formula called GP2, whose components and concentrations are generally
recognized, and which is easily made. Requiring standardized artificial
saltwater avoids the potential for variable results due to the
compositional variability of natural seawater both chemically and
microbiologically, resulting in better test reproducibility.
Additionally, the protocol also provides for efficacy testing in
freshwater, which allows for a better screening of the use of these
agents in this environment.
9. Appendix E to Part 300
    The 1994 revisions to the NCP established Appendix E, Oil Spill
Response, which separates the oil spill response requirements of the
NCP from the hazardous substance release requirements (59 FR 47414).
The purpose of creating this appendix was to compile general oil
discharge response requirements into one document to aid responsible
parties and responders with their duties under the national response
system. The Agency's intent was to provide guidance, and not to alter
in any way the meaning or policy stated in other sections or subparts
of the NCP. However, some minor variations between the Appendix E
provisions and the analogous provisions of the NCP rule language were
necessary to ensure that the appendix addressed only oil discharges;
hazardous substance releases continue to be addressed in the NCP rule
but were not addressed in Appendix E. The Agency is removing Appendix E
in this final action. While having all of the information pertaining to
oil discharges compiled in one location may offer useful guidance, it
is not necessary that this guidance be codified as a regulatory
appendix to the NCP. Because all requirements in Appendix E are part of
the NCP, any revisions to the NCP necessitate revisions to this
appendix. This adds burden not only for the Agency in revising and
ensuring consistency, but also for the regulated community in reviewing
redundant and duplicative requirements.
    A commenter suggested that the Agency continue to provide guidance
on response activities through other formats. EPA agrees that it is
more appropriate to provide guidance on

response activities through other formats. In this action, EPA is
finalizing revisions to remove Appendix E. EPA will consider what
additional guidance, if any, may be appropriate.

VI. Summary of Final Rule Provisions

    This section summarizes the final changes to 40 CFR parts 110 and
300. Subpart J has been renumbered to include new, consolidated, and
revised sections. Some of the rule sections have been retained,
removed, or moved in their entirety. The Table below provides an
overview of the formerly existing rule and final rule citations for a
quick reference of the final changes.
    Section 110.4 was revised to reflect the new and amended regulatory
definitions for Subpart J product categories.
    Section 300.5, Definitions, was revised to include new, amended,
and deleted definitions.
    Subpart J--heading was revised as Use of Dispersants, and Other
Chemical and Biological Agents, to reflect new and amended regulatory
definitions for product categories.
    Section 300.900, General, paragraphs (a) and (c) were revised to
reflect new and amended regulatory definitions for product categories.
Paragraph (d) has been added to reserve for later use.
    Section 300.905, NCP Product Schedule, was removed.
    Section 300.910 was renamed Authorization for Agent Use, was
revised, and new paragraphs were added to clarify the provisions for
the authorization of use of products on the NCP Product Schedule.
     Paragraph (a) was revised to clarify the process for
preauthorization, the responsibilities of all involved parties, and the
factors to consider during the preauthorization process. Subparagraphs
(1) through (3) were added to clarify the development, approval, and
review of a preauthorization plan.
     Paragraph (b) was revised to clarify the requirements for
using a listed product or a burning agent on an oil discharge not
addressed by a preauthorization plan and add new parameters for use
considerations.
     Paragraph (c) was deleted and reserved for later use.
     Paragraph (d) was revised to clarify the exception
requirements, emphasize its temporary nature, and add specific time
frames for notification of continued agent use.
     Paragraph (e) was revised to maintain the prohibition on
the authorization of use of sinking agents and reorganized to clarify
and specifically include substances.
     Paragraph (f) was revised to add new regulatory
requirements for agent storage and use. Former paragraph (f)
requirements were moved to new paragraph (g), Supplemental Testing,
Monitoring, and Information.
     New paragraph (g) Supplemental Testing, Monitoring, and
Information, was added to clarify the requirements for supplemental
testing, monitoring and information and their applicability.
     New paragraph (h), Recovery of Chemical Agents and other
Substances from the Environment, adds regulatory requirements for
recovery of agents and other substances during removal actions.
     New Paragraph (i), Reporting of Agent Use, adds regulatory
requirements for notification of agent use on an oil discharge to both
the RRT and to the public.
    Section 300.915 was renamed Data and information requirements for
listing on the NCP Product Schedule or Sorbent Product List. This
section was revised to consolidate general submission requirements
applicable to all product categories and was restructured to include
new testing and listing requirements for specific product categories.
     Paragraph (a) was revised to consolidate general
information requirements from former paragraphs (a), (b), (d), and (f).
The paragraph includes revisions and new requirements for the
identification of and testing for all product categories designated for
listing. Former paragraph (a) requirements specific to dispersants were
moved to new section 300.915(b), Dispersant Testing and Listing
Requirements. The paragraph was also revised to add new toxicity and
efficacy testing requirements, limitations for use, and new criteria
for listing a dispersant on the NCP Product Schedule.
     Former paragraph (b) was moved to new paragraph (c),
Surface Washing Agent Testing and Listing Requirements. The paragraph
was revised to add new toxicity and efficacy testing requirements,
limitations for use, and new criteria for listing a surface washing
agent on the NCP Product Schedule.
     Former paragraph (c), Surface Collecting Agents, was
deleted.
     Paragraph (d) was renamed Bioremediation Agent Testing and
Listing Requirements. The paragraph was revised to add new toxicity and
efficacy testing requirements, limitations for use, and new criteria
for listing a bioremediation agent to the NCP Product Schedule. Former
paragraphs (d)(9) and (10) were moved to new paragraph (a), General
Product Information.
     Former paragraph (e), Burning Agents, was deleted.
     New paragraph (e), Solidifier Testing and Listing
Requirements, was added to provide new regulatory requirements for
submission and listing of a solidifier.
     Former paragraph (f), Miscellaneous Oil Spill Control
Agents, was deleted.
     New paragraph (f), Herding Agent Testing and Listing
Requirements, adds new toxicity testing requirements, limitations of
use, and criteria for listing a herding agent on the NCP Product
Schedule.
     Paragraph (g) was renamed Sorbent Requirements and revised
to add new provisions for listing a sorbent to the Sorbent Product
List.
    Section 300.920, Addition of Products to Schedule, was moved to new
Sec.  300.955, Addition of a Product to the NCP Product Schedule or
Sorbent Product List.
     Paragraph (a) was revised to include submission
instructions for all product categories. Former paragraphs (a)(1)
through (3), regulatory text specific to dispersant applications, was
moved to new Sec. Sec.  300.915(b) and 300.955(c) and (d).
     Paragraph (b) was revised to add new regulatory text for
preparation of complete submission packages. Former paragraph (b)
regulatory text was moved to new Sec.  300.955(c) and (d).
     Paragraph (c) was revised to add regulatory text for EPA's
review of submission packages and decision criteria for listing. Former
paragraph (c) was moved to new Sec.  300.950, Submission of Proprietary
Business Information (PBI). The term Confidential was changed to
Proprietary to reflect updated nomenclature.
     Paragraph (d) was revised to add regulatory text for
requesting a listing decision review. Former paragraph (d) was moved to
new Sec.  300.955(e), Changes to a Listed Product.
     Paragraph (e) was revised to add new regulatory text for
notification of changes to a listed product. Former paragraph (e) was
moved to new Sec.  300.965, Mandatory Product Disclaimer.
     New paragraph (f) adds new regulatory requirements for
transitioning products to the new NCP Product Schedule or Sorbent
Product List.
    New Sec.  300.950, Proprietary Business Information (PBI), revises
and clarifies the allowable PBI claims in a submission package.
    New Sec.  300.965, Mandatory Product Disclaimer, clarifies the
regulatory text

for including a disclaimer statement on all product labels and
literature for products listed on the NCP Product Schedule.
    New Sec.  300.970, Removal of a Product from the NCP Product
Schedule or Sorbent Product List, adds basis for removal of products
from the NCP Product Schedule or Sorbent Product List, EPA notification
of decision, and appeals process.
    Appendix C to Part 300--Requirements for Product Testing Protocols
and Summary Test Data: Dispersant Baffled Flask Efficacy and Toxicity
Tests; Standard Acute Toxicity Test for Bioremediation Agents, Surface
Washing Agents, Herding Agents, and Solidifiers; and Bioremediation
Agent Efficacy Test was revised to update and add test methodology.
    Appendix E to Part 300--Oil Spill Response was removed.

          40 CFR Part 100 Discharge of Oil--Distribution Table
------------------------------------------------------------------------
             Current citation                    Final rule citation
------------------------------------------------------------------------
110.4 Dispersants.........................  110.4 Chemical or biological
                                             agents.
------------------------------------------------------------------------

    40 CFR Part 300--National Oil and Hazardous Substances Pollution
                  Contingency Plan--Distribution Table
------------------------------------------------------------------------
           Current citations                   Final rule citations
------------------------------------------------------------------------
300.5 Definitions......................  300.5 Definitions.
Subpart J--Use of Dispersants and Other  Subpart J--Use of Dispersants,
 Chemicals.                               and Other Chemical and
                                          Biological Agents.
300.900 General........................  300.900 General.
300.900(a).............................  300.900(a).
300.900(c).............................  300.900(c).
[new]..................................  300.900(d) Reserved.
300.905 NCP Product Schedule...........  Deleted.
300.910 Authorization of use...........  300.910 Authorization for agent
                                          use.
300.910(a).............................  300.910(a) Use of Agents
                                          Identified on the NCP Product
                                          Schedule or Use of Burning
                                          Agents on Oil Discharges
                                          Addressed by a
                                          Preauthorization Plan.
300.910(b).............................  300.910(b) Use of Agents
                                          Identified on the NCP Product
                                          Schedule or Use of Burning
                                          Agents on Oil Discharges Not
                                          Addressed by a
                                          Preauthorization Plan.
300.910(c).............................  300.910(c) Reserved.
300.910(d).............................  300.910(d) Temporary Exception.
300.910(e).............................  300.910(e) Prohibited Agents or
                                          Substances.
300.910(f).............................  300.910(g) Supplemental
                                          Testing, Monitoring, and
                                          Information.
[new]..................................  300.910(f) Storage and Use of
                                          Agents Listed on the NCP
                                          Product Schedule.
[new]..................................  300.910(h) Recovery of Chemical
                                          Agents and Other Substances
                                          from the Environment.
[new]..................................  300.910(i) Reporting of Agent
                                          Use.
300.915 Data requirements..............  300.915 Data and information
                                          requirements for listing on
                                          the NCP Product Schedule or
                                          Sorbent Product List.
300.915(a) Dispersants.................  300.915(a)(1) through (21)
                                          General Information for any
                                          Product Category; and
                                         300.915(b) Dispersant Testing
                                          and Listing Requirements.
300.915(b) Surface washing agents......  300.915(a)(1) through (21)
                                          General Information for any
                                          Product Category; and
                                         300.915(c) Surface Washing
                                          Agent Testing and Listing
                                          Requirements.
300.915(c) Surface collecting agents...  Deleted.
300.915(d) Bioremediation Agents.......  300.915(a)(1) through (21)
                                          General Information for any
                                          Product Category; and
                                         300.915(d) Bioremediation Agent
                                          Testing and Listing
                                          Requirements.
300.915(e) Burning Agents..............  Deleted.
300.915(f) Miscellaneous Oil Spill       Deleted.
 Control Agents.
300.915(g) Sorbents....................  300.915(g) Sorbent
                                          Requirements.
300.915(h) Mixed products..............  Deleted.
[new]..................................  300.915(e) Solidifier Testing
                                          and Listing Requirements;
                                          300.915(a)(1) through (21)
                                          General Information for any
                                          Product Category.
[new]..................................  300.915(f) Herding Agent
                                          Testing and Listing
                                          Requirements; 300.915(a)(1)
                                          through (21) General
                                          Information for any Product
                                          Category.
300.920 Addition of products to          300.955 Addition of a Product
 Schedule.                                to the NCP Product Schedule or
                                          Sorbent Product List.
300.920(a)(1) Dispersants..............  300.955(a) Submission.
300.920(a)(2)..........................  300.955(c) EPA Review.
300.920(a)(3)..........................  300.955(d) Request for review
                                          of decision.
300.920(b)(1) Surface washing agents,    300.955(a) Submission.
 surface collecting Agents,
 bioremediation agents, and
 miscellaneous oil spill control agents.
300.920(b)(2)..........................  300.955(c) EPA Review.
[new]..................................  300.955(b) Package contents.
300.920(c).............................  300.950 Submission of
                                          Proprietary Business
                                          Information (PBI).
300.920(d).............................  300.955(e) Changes to a product
                                          listing.
[new]..................................  300.955(f) Transitioning Listed
                                          Products to the New NCP
                                          Product Schedule or Sorbent
                                          Product List.
300.920(e).............................  300.965 Mandatory Product
                                          Disclaimer.

[new]..................................  300.970 Removal of a Product
                                          from the NCP Product Schedule
                                          or Sorbent Product List.
------------------------------------------------------------------------

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review; Executive
Order 13563: Improving Regulation and Regulatory Review; and Executive
Order 14094: Modernizing Regulatory Review

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review. Any changes
made in response to OMB recommendations have been documented in the
docket for this action. In addition, EPA prepared an analysis of the
potential costs and benefits associated with this action. This
analysis, Regulatory Impact Analysis, Final Revisions to the National
Oil and Hazardous Substances Pollution Contingency Plan Regulations (40
CFR part 300 Subpart J), is available in the docket for this action.