[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Rules and Regulations]
[Pages 38280-38356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11904]
[[Page 38279]]
Vol. 88
Monday,
No. 112
June 12, 2023
Part III
Environmental Protection Agency
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40 CFR Parts 110 and 300
National Oil and Hazardous Substances Pollution Contingency Plan;
Product Schedule Listing and Authorization of Use Requirements; Final
Rule
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Rules
and Regulations
[[Page 38280]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 110 and 300
[EPA-HQ-OPA-2006-0090; FRL-4526-01-OLEM]
RIN 2050-AE87
National Oil and Hazardous Substances Pollution Contingency Plan;
Product Schedule Listing and Authorization of Use Requirements
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is
amending the requirements in Subpart J of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP) that govern the
use of dispersants, other chemicals and other spill mitigating
substances when responding to oil discharges into jurisdictional waters
of the United States. This action addresses the efficacy and toxicity
of dispersants and other chemical and biological agents, as well as
public, state, local, and federal officials' concerns regarding their
use. Specifically, the Agency is amending the Subpart J regulatory
requirements for the NCP Product Schedule in two distinct ways. First,
the Agency is adding new listing criteria, revising the efficacy and
toxicity testing protocols, and clarifying the evaluation criteria for
removing products from the NCP Product Schedule. Second, the Agency is
amending requirements for the authorities, notifications, and data
reporting when using chemical or biological agents in response to oil
discharges to Clean Water Act (CWA) section 311 jurisdictional waters
and adjoining shorelines. These requirements are anticipated to
encourage the development of safer and more effective spill mitigating
products and better target the use of these products to reduce the
risks of oil discharges and response technologies to human health and
the environment. Further, the amendments are intended to ensure that
On-Scene Coordinators (OSCs), Regional Response Teams (RRTs), and Area
Committees (ACs) have sufficient information to support agent
authorization of use decisions.
DATES: This final rule is effective on December 11, 2023.
ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OPA-2006-0090. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available electronically
through http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For general information, contact the
Superfund, TRI, EPCRA, RMP, and Oil Information Center at 800-424-9346
or TDD at 800-553-7672 (hearing impaired). In the Washington, DC
metropolitan area, contact the Superfund, TRI, EPCRA, RMP, and Oil
Information Center at 703-412-9810 or TDD 703-412-3323. For more
detailed information on this final rule contact Gregory Wilson at 202-
564-7989 ([email protected]) or Vanessa Principe at 202-564-7913
([email protected]). The contact address is U.S. Environmental
Protection Agency, Office of Emergency Management, Regulations
Implementation Division, 1200 Pennsylvania Avenue NW, Washington, DC
20460-0002, Mail Code 5104A, or visit the Office of Emergency
Management website at http://www.epa.gov/oem/.
SUPPLEMENTARY INFORMATION: The contents of this preamble are:
I. General Information
II. Entities Potentially Affected by This Final Rule
III. Statutory Authority and Delegation of Authority
IV. Background
V. This Action
A. Discharge of Oil
B. Subpart A--Introduction
1. Definitions
C. Subpart J--Use of Dispersants, and Other Chemical and
Biological Agents
1. General
2. Authorization for Agent Use
3. Data and Information Requirements for Listing on the NCP
Product Schedule or Sorbent Product List
4. Submission of Proprietary Business Information (PBI)
5. Addition of a Product to the NCP Product Schedule or Sorbent
Product List
6. Mandatory Product Disclaimer
7. Removal of a Product From the NCP Product Schedule or the
Sorbent Product List
8. Appendix C to Part 300
9. Appendix E to Part 300
VI. Summary of Final Rule Provisions
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review;
Executive Order 13563: Improving Regulation and Regulatory Review;
and Executive Order 14094: Modernizing Regulatory Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act
Part 110--Discharge of Oil
Part 300--National Oil and Hazardous Substances Pollution
Contingency Plan
I. General Information
In April 2010, the Deepwater Horizon underwater oil well blowout
discharged significant quantities of oil into the Gulf of Mexico and
raised questions about efficacy, toxicity, environmental tradeoffs, and
the challenges of making dispersant use decisions in response
operations for certain atypical dispersant use situations.
In this final action, EPA is establishing new agent testing,
listing, and authorization of use requirements under Subpart J of the
NCP to address these challenges. These revisions to Subpart J address
the use of dispersants and other chemical and biological agents to
respond to oil discharges into jurisdictional waters and their
adjoining shorelines as provided under section 311(b)(3) of the CWA.
Specifically, the Agency is adding, amending, or removing certain
regulatory definitions and updating requirements associated with the
authorization of agent use (including preauthorization plan
development, approval, and review; prohibited agents; storage; agent
use; recovery; and reporting of use); testing of products (including
efficacy and toxicity testing protocols); and listing on the NCP
Product Schedule (including data and information requirements and the
use of toxicity data to determine listing eligibility; processes for
listing and delisting, including transitioning products to the new NCP
Product Schedule; and proprietary business information (PBI)). The
revisions include improved laboratory protocols for dispersant and
bioremediation efficacy and toxicity, and will increase the overall
scientific soundness of the data collected. These amendments to Subpart
J will help to ensure that only
[[Page 38281]]
products that perform effectively in laboratory testing will be listed
on the NCP Product Schedule for use in mitigating the effects of oil
discharges.
EPA estimates that, to comply with the revised requirements,
industry may incur a total incremental cost of approximately $283,800
to $376,500 annually. Note that the range in annualized cost reflects
differences due to using 3% and 7% discount rates as well as a range
(low and high) for submitter's paperwork burden. This action does not
impose significant impacts on a substantial number of small entities.
The Regulatory Impact Analysis, which can be found in the docket,
provides more detail on the cost methodology and benefits of this
action.
II. Entities Potentially Affected by This Final Rule
Entities affected by the final rule include manufacturers of
bioremediation agents, dispersants, surface-washing agents,
solidifiers, herding agents, and sorbents used as countermeasures
against oil spills, and government entities. The universe of domestic
product submitters (i.e., product manufacturers) with products listed
on the NCP Product Schedule provides the basis for identifying affected
entities. EPA identified 89 affected domestic product manufacturers
with products currently on the NCP Product Schedule and determined each
manufacturer's NAICS code using Dun and Bradstreet (D&B) data.
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NAICS code Industrial category
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213................................. Support Activities for Mining.
322................................. Paper Manufacturing.
325................................. Chemical Manufacturing.
326................................. Plastics and Rubber Products Manufacturing.
423................................. Merchant Wholesalers, Durable Goods.
424................................. Merchant Wholesalers, Nondurable Goods.
454................................. Nonstore Retailers.
493................................. Warehousing and Storage.
541................................. Professional, Scientific, and Technical Services.
561................................. Administrative and Support Services.
562................................. Waste Management and Remediation Services.
811................................. Repair and Maintenance.
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The Agency's goal is to provide a guide for readers to consider
regarding entities that potentially could be affected by this action.
However, this action may affect other entities not listed in this
table. If you have questions regarding the applicability of this action
to a particular entity, consult the person(s) listed in the FOR FURTHER
INFORMATION CONTACT section.
III. Statutory Authority and Delegation of Authority
Under sections 311(d) and 311(j) of the Clean Water Act (CWA), as
amended by section 4201 of the Oil Pollution Act of 1990 (OPA), Public
Law 101-380, the President is directed to prepare and publish the NCP
for removal of oil and hazardous substances. Specifically, section
311(d)(2)(G) directs the President to include a schedule identifying
``(i) dispersants, other chemicals, and other spill mitigating devices
and substances, if any, that may be used in carrying out the Plan, (ii)
the waters in which such dispersants, other chemicals, and other spill
mitigating devices and substances may be used, and (iii) the quantities
of such dispersant, other chemicals, or other spill mitigating device
or substance which can be used safely in such waters'' as part of the
NCP. The Agency has promulgated the NCP, see 40 CFR 300.1 et seq.,
including the schedule of dispersants, other chemicals, and other oil
spill mitigating devices and substances (see 40 CFR 300.900 et. seq.)
as required by section 311(d)(2)(G). The President is further
authorized to revise or otherwise amend the NCP from time to time, as
the President deems advisable. 33 U.S.C. 1321(d)(3). The authority of
the President to implement section 311(d)(2)(G) of the CWA is delegated
to EPA in Executive Order 12777 (56 FR 54757, October 22, 1991).
Subpart J of the NCP establishes the framework for the use of
dispersants and any other chemical agents in response to oil discharges
(40 CFR part 300 series 900). The Agency is further clarifying that the
statutory schedule as required by CWA section 311(d)(2)(G) includes the
NCP Product Schedule, the Sorbent Product List, and the Subpart J
authorization of use procedures that, when taken together, identify the
waters and quantities in which such dispersants, other chemicals, or
other spill mitigating devices and substances may be used safely.
IV. Background
In the United States and around the world, chemical and biological
agents are among the oil spill mitigation technologies available that
responders may consider. Subpart J of the NCP sets forth the regulatory
requirements for the use of chemical and biological agents, which
includes separate provisions for product testing and listing, and for
authorization of use procedures. These requirements provide the
structure for the On-Scene Coordinator (OSC) to determine in each case
the waters and quantities in which dispersants or other chemical agents
may be safely used in such waters, if any. This determination is based
on all relevant circumstances, testing and monitoring data and
information, and is to be made in accordance with the authorization of
use procedures, including the appropriate concurrences and
consultations, found within the regulation. When taken together, the
Subpart J regulatory requirements address the types of waters and the
quantities of listed agents that may be authorized for use in response
to oil discharges. EPA believes that the wide variability in waters,
weather conditions, organisms living in the waters, and types of oil
that might be discharged requires this approach.
The Deepwater Horizon underwater oil well blowout in 2010 raised
questions about the challenges of making chemical agent use decisions
in response operations, particularly for certain atypical dispersant
use situations. To address these and other challenges, the Agency
proposed to amend Subpart J of the NCP to revise the existing product
listing criteria, testing protocols, and authorization of use
procedures, as well as to establish new provisions for dispersant
monitoring (80 FR 3383, January 22, 2015). In July 2021, EPA published
a final rule addressing the environmental monitoring of dispersant use
in response to major discharges and to certain dispersant use
situations.
[[Page 38282]]
Specifically, the Agency established monitoring requirements for any
subsurface use of dispersant in response to an oil discharge, surface
use of dispersant in response to oil discharges of more than 100,000
U.S. gallons occurring within a 24-hour period, and surface use of
dispersant for more than 96 hours after initial application in response
to an oil discharge (86 FR 40234, July 27, 2021). This final action
addresses the remaining Subpart J revisions proposed in 2015, including
those associated with the product listing, testing protocols, and
authorization of use procedures.
V. This Action
This final action amends two distinct sets of requirements under
Subpart J: (1) Those related to chemical and biological agent testing
and listing, and (2) those related to authorization of use.
Specifically, in this action, the Agency adds, amends, or removes
certain regulatory definitions associated with Subpart J, and updates
requirements for the authorization of agent use (including
preauthorization plan development, approval, and review; case by case
authorization of prohibited agents; storage; agent use; recovery; and
reporting of use); testing of products (including efficacy and toxicity
testing protocols); and listing on the NCP Product Schedule (including
data and information requirements, processes for adding or removing a
product to or from the NCP Product Schedule, and proprietary business
information.) The discussion below explains each of the amendments. It
also summarizes and provides a response to highlighted public comments
received on the 2015 proposal. See the Response to Comment Document for
Listing and Testing of Chemical and Biological Agents, and for the
Response to Comment Document on the Authorization of Use of Chemical
and Biological Agents in the rulemaking docket for a complete summary
and response to public comments. Sections of the NCP not identified to
be revised in the proposed rule or addressed in this final rule are
outside the scope of this final action.
Revisions to Subpart J were under consideration prior to the
Deepwater Horizon oil spill. The subsequent Deepwater Horizon oil spill
resulted in recommendations to update Subpart J from the National
Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling
Report \1\ and the EPA Inspector General report titled Revisions Needed
to the National Contingency Plan Based on Deepwater Horizon Oil Spill
(Report #11-P-0534),\2\ including that EPA review and update dispersant
testing protocols for product listing. The Agency's final action
addresses those recommendations.
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\1\ See https://www.govinfo.gov/content/pkg/GPO-OILCOMMISSION/pdf/GPO-OILCOMMISSION.pdf.
\2\ See https://www.epa.gov/office-inspector-general/report-revisions-needed-national-contingency-plan-based-deepwater-horizon.
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This final action reflects relevant science and research that
supports the specific provisions and their intent. The Agency
considered the over 81,000 comments received that offered a wide range
of perspectives and scientific information. Those comments remain
relevant to the rulemaking, which will modernize and enhance the
Subpart J regulatory provisions.
The Agency is updating the process for listing products on the NCP
Product Schedule, including expanded testing and listing thresholds. In
doing so, EPA identified the relevant science to establish a national
screening process for products to be listed on the NCP Product
Schedule. Specifically, in amending the NCP Product Schedule listing
provisions, EPA considered relevant science related to efficacy and
toxicity testing and has determined it supports both establishing new
protocols and updating existing protocols under Subpart J for testing
chemical and biological agent products for listing on the NCP Product
Schedule. These product testing protocols, along with additional
requirements for data and information, serve as the basis for a
national level screening of chemical and biological agent products, and
include procedures that commercial laboratories are already familiar
with or can readily adopt. EPA is not aware of changes to the relevant
science since the proposed rulemaking and is proceeding with taking
final action on the proposal. Furthermore, the final action builds upon
the existing NCP framework, providing expanded opportunities for
decisionmakers to consider any advancements in science beyond efficacy
and toxicity valuations as part of listing, planning and response
activities.
The Agency is also updating the provisions for authorization of use
by building upon the existing framework, providing further
opportunities to consider advancements in science as part of the
planning and authorization of use processes for chemical and biological
agents. This performance-based approach provides flexibility in
gathering, and allowing for the consideration of, scientific
information relevant to a given site or geographic location. This
allows for better targeting chemical and biological agent use during a
response and is consistent with the broader NCP framework.
A. Discharge of Oil
The Agency is revising the text at 40 CFR 110.4 to harmonize it
with the definitions for chemical and biological agents that are also
being finalized for Subpart J. The revision replaces the terms
``dispersants and emulsifiers'' in Sec. 110.4 with the broader term
``any chemical or biological agent, or any other substance.'' The
revised definition in Sec. 300.5 for chemical agents, as finalized in
this action, includes elements, compounds, or mixtures designed to
facilitate the removal of oil from a contaminated environment and
mitigate any deleterious effects. The new definition for biological
agents, also finalized in this action, includes microorganisms
(typically bacteria, fungi, or algae) or biological catalysts, such as
enzymes, able to enhance the biodegradation of a contaminated
environment. By revising the provision at Sec. 110.4, the Agency is
clarifying that any chemical or biological agent or any other substance
added to a discharge of oil with the intent to circumvent any provision
of 40 CFR part 110 is prohibited. The final action replaces the
specific qualifier ``as defined in Sec. 300.5 of this title'' with the
broader ``or any other substance'' to emphasize the intent of this
provision is ultimately to prohibit circumventing part 110
requirements. The Agency has also amended the section title to
``Chemical or biological agents.''
Commenters on the 2015 proposal noted that the rule change would
ensure no unintended or deliberate circumvention of Sec. 110.4 through
any inconsistencies with Subpart J definitions. EPA agrees and has
finalized the rule as described above to refer to the terms ``chemical
and biological agents'' as opposed to specifically ``emulsifiers'' and
``dispersants.'' In the finalized provision, EPA also made some
editorial changes relative to the proposed text for increased clarity.
B. Subpart A--Introduction
1. Definitions
EPA is finalizing revisions to Sec. 300.5 to amend the definitions
for bioremediation agents, burning agents, chemical agents,
dispersants, sinking agents, sorbents, and surface washing agents.
Additionally, the Agency is finalizing new definitions for
bioaccumulation, bioconcentration, biodegradation, biological agents,
bioremediation, herding agents,
[[Page 38283]]
products, and solidifiers. Finally, the Agency is removing the
definitions for miscellaneous oil spill control agents (MOSCA) and
surface collecting agents.
(a) Revised Definitions
Bioremediation agents--The Agency is revising the definition of
bioremediation agents as proposed, to clarify the previous definition
and add examples of bioremediation agents. Specifically, the final rule
defines bioremediation agents as biological agents and/or nutrient
additives deliberately introduced into a contaminated environment to
increase the rate of biodegradation and mitigate any deleterious
effects caused by the contaminant constituents. The definition
identifies microorganisms and enzymes as bioremediation agents, as well
as nutrient additives such as fertilizers containing bio-available
forms of nitrogen, phosphorus, and potassium. This clarification will
help manufacturers of products to identify the type of product, and
hence, what testing requirements they will need to comply with to have
a product listed on the NCP Product Schedule.
A commenter expressed concerns about grouping all bioremediation
agents in the revised definition. The commenter stated that the
definition for bioremediation agent should be broken down for the three
types of bioremediation because there are significant differences in
applicability and appropriateness for the application of each type. EPA
disagrees that the definition of bioremediation agent must explicitly
include a classification for different types of bioremediation. The
definition for bioremediation agents in the final action includes
microorganisms, enzymes, and nutrients, to capture their different
mechanisms of action (e.g., amending rate limiting nutrients vs. adding
microbial cultures). The final revisions do not prevent EPA from
grouping similar bioremediation agents together on the NCP Product
Schedule, if appropriate.
A commenter suggested that the definition of bioremediation agents
should include language prohibiting the use of biological agents that
could result in non-indigenous species colonization. EPA is not
prohibiting the use of non-indigenous species, because the addition of
cultured microorganisms, which may include non-indigenous species, may
enhance biodegradation of a contaminant in certain situations. EPA
notes that decisions to use bioremediation agents are subject to Sec.
300.910, Authorization of Use, and expects the OSC to utilize available
resources to determine the most appropriate bioremediation agent, if
any, for use in a response in light of incident and site-specific
factors.
Burning agents--The Agency is revising the definition of burning
agents as proposed, to identify as such those additives that improve
the combustibility of the materials to which they are applied. This
could be achieved through either physical or chemical means.
A commenter interpreted that the proposed definition combines
burning agents (materials that actually change the combustibility of
the material they are added to) and ignition agents (ignition devices
or materials used to start combustion). The commenter recommended that
the Agency adopt separate definitions for burning and ignition agents
for clarity. Some commenters suggested that the Agency should either
include ignition devices within the definition of ``burning agents'' or
create a separate category for ignition devices. The Agency agrees with
commenters that ignition devices are distinct from burning agents. The
final provisions do not include ignition devices in the definition of
burning agent. The Agency believes that the intent of ignition devices
is to provide the initial energy to start a burn and typically do not
enter the water column. While ignition devices provide the initial
energy to start a burn, these devices are incidental to burning agents,
which are intended to improve the combustibility of the oil. EPA is
exercising its discretionary authority and not including ignition
devices on the NCP Product Schedule given their intended use.
Furthermore, EPA disagrees with a commenter's statement that burning
agents are necessarily applied ``prior to ignition;'' EPA believes that
burning agents could be added after ignition to improve combustibility.
The definition of burning agents in the final action does not
specifically state when during an in situ burning cycle a burning agent
is to be applied. The Agency is finalizing the definition of burning
agents from the proposed rule without any changes. EPA notes that
burning agents remain subject to Subpart J authorization of use
requirements, even though EPA is not requiring specific product
information and data about burning agents to be submitted to EPA under
Sec. 300.955.
Chemical agents--The Agency is revising the definition of chemical
agents to identify as such those elements, compounds, or mixtures that
are designed to facilitate the removal of oil from a contaminated
environment and to mitigate deleterious effects. The chemical agent
category includes burning agents, dispersants, herding agents,
solidifiers, surface washing agents, and those bioremediation agents
that consist of nutrient additives. This revised definition reflects
the Agency's distinction between chemical and biological agents,
allowing product manufacturers to better target the testing
requirements and OSCs to better inform their authorization in specific
situations. The finalized language also removes from the definition
certain agent categories that are being eliminated, prohibited, or
amended, to conform to these changes.
Several commenters expressed concern with the Agency's proposed
wording ``designed to facilitate the removal of oil from a contaminated
environment.'' Commenters indicated that the definition of ``chemical
agent'' does not make it clear that sinking agents, along with
dispersants, do not remove or detoxify oil, but rather treat it.
Commenters also stated that dispersants do not facilitate the removal
of oil or mitigate deleterious effects. EPA notes that the NCP
incorporates into Sec. 300.5 the CWA section 311 statutory definition
of ``remove.'' Under the NCP, ``remove'' or ``removal'' refers to
containment and removal of oil or hazardous substances from the water
and shorelines or the taking of such other actions as may be necessary
to minimize or mitigate damage to the public health or welfare of the
United States (including, but not limited to, fish, shellfish,
wildlife, public and private property, and shorelines and beaches) or
to the environment (40 CFR 300.5). Under the NCP, the term also
includes monitoring of action to remove a discharge (40 CFR 300.5).
Dispersants are substances that emulsify, disperse, or solubilize oil
by promoting the formation of small droplets or particles of oil in the
water column. The primary purpose of using dispersants is to facilitate
dispersal of the oil into the water column, where the oil is then
subject to several fate and transport processes (e.g., dissolution).
Thus, dispersant use may alter the behavior of oil to which it is
applied and may result in an action that minimizes or mitigates damage,
as described in the statutory definition of ``remove.'' In addition,
depending on the oil composition, certain fractions of the dispersed
oil may biodegrade over time. Dispersants are appropriately defined as
chemical agents since they are designed to facilitate the removal of
oil or mitigate oil's deleterious effects. Furthermore, EPA notes that
the final provisions maintain the previous approach that
[[Page 38284]]
chemical agents ``. . . facilitate the mitigation of deleterious
effects or the removal of the pollutant from the water.''
A commenter stated that the definition of chemical agents should
clearly delineate between chemical agents that are intended to be
removed from the environment and those that are not. EPA believes that
the NCP, as revised under this amendment, sufficiently delineates
between chemical agents that are intended to be recovered from the
environment and those that are not. The NCP addresses recovery of
agents from the environment in multiple chemical agent and substances
definitions (e.g., surface washing agents, sorbents) and under Sec.
300.910(h) Recovery of Agents from the Environment.
Commenters recommended that sinking agents be removed from the
proposed definition of chemical agents. A commenter suggested that
including a definition for sinking agents in the context of other
agents that may be put on the NCP Product Schedule contradicts the
Agency's stated policy against the use of sinking agents to treat oil
spills. EPA agrees that sinking agents do not remove oil from the
environment and that sinking agents should not be included in the
definition of chemical agents. The finalized definition of chemical
agents has been modified relative to the proposed version to remove
sinking agents.
Dispersants--The Agency is revising the definition of dispersants
to identify as such those substances that emulsify, disperse, or
solubilize oil by promoting the formation of small droplets or
particles of oil in the water column. The Agency acknowledges that the
primary purpose of dispersants is to facilitate oil transfer from one
area to another (e.g., oil transferred from the water surface into the
water column) or to maintain entrainment within the water column (e.g.,
oil maintained in the water column from a subsurface discharge).
Dispersed oil is then subject to transport by water currents and other
fate and transport processes (e.g., dissolution, biodegradation), which
involves many site- and incident-specific factors. Irrespective of
dispersant use, oil droplets may interact with suspended particulate
material in the water column. For example, oil naturally dispersed in
the water column (i.e., untreated dispersed oil) may also interact with
suspended particulate material.
A commenter stated that the proposed definition should not identify
what dispersants are ``typically'' composed of because formula
components will vary by intended primary use setting. EPA agrees that
the definition of dispersants should not identify the typical
composition of dispersants (e.g., solvents, surfactants), not
necessarily because formula components will vary by intended primary
use setting, but to avoid the potential misinterpretation that
dispersants are necessarily comprised of these components. Thus, EPA is
amending the definition of ``dispersant'' in this final rule by adding
``. . . substances that emulsify, disperse, or solubilize oil by
promoting . . .'' and removing ``. . . typically mixtures comprised of
solvents, surfactants, and additives that promote . . .'' The final
provision maintains the general approach in the current definition to
recognize that dispersants are substances ``. . . that emulsify,
disperse, or solubilize oil . . .'' by promoting the formation of small
droplets or particles of oil in the water column. Furthermore, based on
other comments regarding oil-mineral aggregates on the proposed sorbent
definition, EPA is amending the definition of dispersants to add ``. .
. or particles . . .'' to indicate that certain particulate materials
may also act as dispersants. EPA also removed the phrase ``. . . by
reducing the oil-water interfacial tension'' in order not to identify
any specific process and to recognize that other processes may also
result in dispersion of oil.
Sinking agents--The Agency is revising the definition of sinking
agents to identify them as those substances introduced into an oil
discharge to submerge the oil to the bottom of a water body. The former
definition was ambiguous in distinguishing chemical agents (e.g.,
dispersants) that may submerge oil below the water surface from
substances that would sink oil to the bottom of the water body. The
revision clarifies the distinction between sinking agents and other
agents, such as dispersants, that do not intend to sink oil to the
bottom of a water body but may have the incidental effect of causing
some of the discharged oil to settle to the bottom of a water body. The
Agency believes it is critical to distinguish between sinking agents,
which are intended to sink oil as the primary mechanism of response,
and dispersants, which are primarily intended to promote the formation
of small droplets or particles of oil in the water column. The Agency
continues to prohibit the use of sinking agents in the remediation of
oil discharges in water because of their potential for causing adverse
effects on benthic organisms vital to the food chain of the aquatic
environment.
Commenters expressed concerns with the way that the proposed
definition distinguished between submersion and sinking. The commenters
stated that both submersion and sinking could cause harm to benthic
organisms and make oil more difficult to remove; several commenters
suggested a broader definition of sinking agents to include any agent
that causes oil to submerge below the water surface in a given
waterbody, retains oil beneath the water surface, and/or increases
aggregation of oil-sediment particles beneath the water surface, even
if the treating agents also qualify for other categories (e.g.,
dispersants, solidifiers, sorbents). The Agency disagrees with the
recommendations to modify the sinking agent definition as this would
conflate the definitions of dispersants and sinking agents and would
effectively work to prohibit the use of dispersants. The final action
balances the potential for deleterious effects from dispersant use
against their potential for reducing or mitigating the environmental
impacts of an oil spill, through the consideration of site-specific
conditions and within the context of all response options. Adding
language that characterizes sinking agents as facilitating the transfer
of oil from the water surface into the water column or retention of oil
below the water surface would cause confusion with the definition of
dispersants.
A commenter provided specific recommended language to edit the
definition of sinking agents, which included removing the proposed
phrase ``. . . deliberately for the purpose of submerging . . .''.
Additionally, another commenter suggested that the Agency's use of the
term ``deliberately'' in the definition is unworkable because it fails
to specify whose intent is relevant. EPA agrees that the term
``deliberately'' presents challenges to interpreting intent. Therefore,
based on public comment, EPA is removing the term ``deliberately'' from
the sinking agent definition in this final rule.
Sorbents--Under the revised definition of sorbents, EPA identifies
sorbents as inert and insoluble substances that readily absorb and/or
adsorb oil or hazardous substances and that are not combined with or
act as a chemical agent, biological agent, or sinking agent. Sorbents
may be used in their natural bulk form or as manufactured products in
for example particulate form, sheets, rolls, pillows, or booms.
Sorbents are generally collected and recovered from the environment.
The definition also
[[Page 38285]]
includes a list of materials of which sorbents may consist. These
revisions simplify the definition by removing the definitions of
absorption and adsorption that were embedded in the former definition
of sorbents; this is appropriate because absorption and adsorption are
generally recognized scientific terms and sorbents are not
distinguished or restricted under Subpart J based on whether they
absorb or adsorb oil. The revised definition also adds the qualifier
``natural'' to organic substances, indicating that organic substances
that have been treated with other substances do not necessarily fall
under this category of agents and should not be considered a sorbent
absent being listed on the Sorbent Product List as provided in this
rule. It also expands on and simplifies the examples by removing the
references to the type of birds that feathers could come from, by
adding bagasse to the examples for natural organic substances, and by
adding clay to the examples for inorganic/mineral compounds. While
sorbents are not listed on the NCP Product Schedule, a list
characterizing these materials is included in Sec. 300.915(g) and EPA
considers the Sorbent Product List in Sec. 300.915(g) to be a part of
the statutory schedule addressed in 33 U.S.C. 1321(d)(2)(G).
Commenters replied to the Agency's request for comments on the
qualifier phrase, ``that are generally collected and recovered from the
environment.'' Some commenters requested that EPA remove the term
``generally'' or remove the phrase that sorbents are ``generally
collected and recovered from the environment.'' Other commenters
requested that sorbents be used with the intent of collecting and
removing them from the environment. A commenter requested that the
Agency clearly require that all sorbent materials must be recovered
from the environment, and that sorbent use is not authorized in the
event that the sorbents cannot be removed from the environment. EPA
disagrees with comments that the phrase ``generally collected and
recovered from the environment'' should be removed from the definition.
EPA believes that the phrase recognizes and captures the expectation
that sorbents are not intended to be left in the environment. EPA
recognizes that on very limited occasions an OSC may make the
determination to not recover a sorbent after consideration of factors
such as the safety of response personnel and potential for greater harm
to the environment if the sorbent material is recovered rather than
left in place. Therefore, EPA retained the sentence ``Sorbents are
generally collected and recovered from the environment'' in the amended
definition but did move it to later in the provision in order to
improve editorial flow and clarity. The OSC retains discretion not to
authorize or direct the use sorbents if the OSC believes that sorbent
use is inappropriate in light of incident-specific determinations.
EPA received a range of comments regarding particulate materials
(e.g., clay) and the definitions of sorbent, sinking agents, and
dispersants. EPA recognizes that some materials may behave differently
in the environment based, in part, on the size or configuration of the
substance. EPA disagrees with comments that clay necessarily behaves
like a sinking agent in all cases. To address concerns regarding
particulate materials, EPA is amending the definition of sorbents to
recognize potentially differing behaviors and to distinguish between
sorbents and sinking agents. The final revisions to the definition of
sorbents includes that these substances are ``. . . not combined with
or act as . . . sinking agents.'' EPA recognizes that substances such
as clay may be used as a sorbent, but also agrees with commenters that
they should not act as a sinking agent. EPA believes it is appropriate
to continue to allow substances such as clay to be listed as sorbents
and used as a sorbent during a response, provided that they are done so
in manner that prevents them from acting as a sinking agent (e.g.,
contained in a buoyant boom). The Agency expects that the
Administrative Record for a response would provide the basis for
continued sorbent use under OSC oversight or direction, and the
Administrative Record should address any potential concerns with
sorbents being used as a sinking agent. EPA also recognizes that
particulate materials may be manufactured of such configuration (e.g.,
micro- or nanosized) that they are, or are near, neutrally buoyant and
remain in the water column over an extended time period. EPA recognizes
comments that particulate materials may promote dispersion by forming
oil-mineral aggregates (OMAs) and agrees with commenters that such
substances should be addressed as dispersants rather than sorbents.
Substances intended for use in a manner similar to a chemical or
biological agent listed on the NCP Product Schedule (e.g., dispersants)
should be classified similarly and subject to the same authorization of
use procedures. The final rule clarifies that dispersants are
substances that emulsify, disperse, or solubilize oil by promoting the
formation of small droplets or particles of oil in the water column.
This revised definition clarifies that substances that emulsify,
disperse, or solubilize oil include particulate materials because they
promote the formation of particles of oil (e.g., OMAs). Particulate
materials that are used in a manner similar to chemical dispersants are
appropriately categorized as dispersants on the NCP Product Schedule
and are subject to the same dispersant authorization of use procedures
under Sec. 300.910.
Surface washing agents--The Agency is revising the term ``surface
washing agent'' to ``surface washing agents'' and modifying the
definition. EPA changed the term from singular to plural to be
consistent with the other agent definitions. The revised definition
identifies surface washing agents as those substances that separate oil
from solid surfaces (e.g., beaches, rocks, metals, or concrete) through
a detergency mechanism. The revised definition specifies that
detergency mechanism lifts and floats the oil. The final definition is
modified slightly from the proposed phrasing to clarify that the
product and oil are generally to be collected and recovered from the
environment with minimal dissolution, dispersion, or transfer into the
water column to be consistent with similar phrases included in the
sorbents and solidifiers definitions. EPA recognizes that on occasion
an OSC may make the determination to not recover a surface washing
agent after consideration of factors such as the safety of response
personnel and potential for greater harm to the environment if the
surface washing agent material is recovered rather than left in place
(see 40 CFR 300.910(h)).
A commenter suggested that surface washing agents used in fully
self-contained structures (e.g., tank farms, dry-dock vessels, sand-
cleaning machines) or in a manner that prevents run-off to water (e.g.,
cleaning/wiping of vessel hulls by hand) need not be listed on the NCP
Product Schedule or require approvals from the OSC or RRT before use. A
commenter suggested including the phrase ``that are not likely to cause
additional harm, either alone or in combination with oil, to public
health or welfare or to the environment'' in the definition. EPA is not
revising the definition to include this phrase. EPA believes that the
NCP must retain flexibility to allow for environmental tradeoffs that
take into consideration incident-specific conditions when determining
what actions should be taken to immediately and effectively address an
oil discharge.
[[Page 38286]]
(b) New Definitions
The Agency is adding several new definitions for terms that are
used in the amendments to Subpart J. These definitions include basic
terminology and are consistent with how the terms are generally
understood by the scientific community.
Bioaccumulation--The Agency is establishing the definition of
bioaccumulation, as proposed, to mean the process of accumulation of
chemicals in the tissue of organisms through any route, including
respiration, ingestion, or direct contact with the ambient or
contaminated medium. The Agency is finalizing the definition of
bioaccumulation from the proposed rule without any changes.
A commenter expressed support for separate definitions of
bioaccumulation and bioconcentration. The Agency appreciates and
recognizes the commenter's perspective that bioaccumulation includes
multiple routes of exposures to pollutants (e.g., including dietary or
food chain), whereas bioconcentration only includes water-borne routes
of exposure (e.g., absorption across the gills).
Bioconcentration--The Agency is establishing the definition of
bioconcentration, as proposed, to mean the accumulation of chemicals in
the tissues of organisms from water alone.
A commenter expressed support for separate definitions of
bioaccumulation and bioconcentration, as described above. The Agency is
finalizing the definition of bioconcentration from the proposed rule
without any changes.
Biodegradation--The Agency is establishing the definition of
biodegradation to mean the process by which microorganisms
metabolically decompose contaminants into biomass and smaller molecular
compounds such as carbon dioxide, water, and end products.
Commenters suggested expanding the definition of biodegradation to
include the possibility of partial biodegradation, which can result in
more toxic intermediate products. The commenters stated that partial
biodegradation is likely to occur in the environment versus controlled
laboratory conditions. EPA recognizes that partial biodegradation may
occur in the environment. Therefore, the Agency amended the definition
of biodegradation in the final rule to replace the phrase ``. . .
simpler compounds . . .'' with ``. . . smaller molecular compounds . .
.''. EPA also removed the term ``innocuous'' in the final action to
recognize that not all end products may be innocuous.
Biological agents--The Agency is establishing the definition of
biological agents to mean microorganisms (typically bacteria, fungi, or
algae) or biological catalysts, such as enzymes, that can enhance the
biodegradation of a contaminated environment. EPA has slightly amended
the definition of biological agent in this rulemaking to replace the
phrase ``. . . able to . . .'' with ``. . . that can . . .'' to better
reflect the intent of the definition.
A commenter recommended that the definition of bioremediation
agents include a ban on agents that may result in the colonization of
non-indigenous species. While EPA understands that microorganisms
capable of degrading oil are ubiquitous in nature, the Agency is
maintaining its prior approach in this rulemaking to recognize the
addition of microorganisms as a potential bioremediation process. In
general, the addition of cultured microorganisms, which may include
non-indigenous species, may enhance biodegradation of a contaminant.
Bioremediation--The Agency is establishing the definition of
bioremediation to mean the process of enhancing the ability of
microorganisms to convert contaminants into biomass and smaller
molecular end products by the addition of materials into a contaminated
environment to accelerate the natural biodegradation process.
Commenters suggested expanding the definition to include the
possibility of partial bioremediation, which can result in more toxic
intermediate products. The commenters stated that partial
bioremediation is likely to occur in the environment versus controlled
laboratory conditions. EPA recognizes that partial biodegradation may
lead to the formation of intermediate products. The Agency is amending
the definition of bioremediation in this final rule to replace the
phrase ``. . . simpler compounds . . .'' with ``. . . smaller molecular
compounds . . .''. EPA also removed the term ``innocuous'' to recognize
that not all end products may be innocuous.
Herding agents--The Agency is establishing the definition of
herding agents to mean substances that form a film on the water surface
to control the spreading of the oil to allow for oil removal. The
definition for surface collecting agent was removed and replaced with
the definition for herding agent to better reflect the common
terminology used in industry for these agents.
A commenter stated that the Agency should add language to the
``herding agents'' definition which includes that they are not likely
to cause harm, either alone or in combination with oil, to public
health or the environment and that they are intended to be collected
and recovered from the environment. EPA disagrees with these suggested
edits to the definition of herding agents. The NCP addresses discharges
of oil to the environment and response authorities must retain
flexibility to allow for environmental tradeoffs that consider
incident-specific conditions when determining what actions should be
taken to immediately and effectively address the discharge. EPA is
amending the definition of herding agents in the final rule by
replacing the proposed phrase ``. . . across the water surface.'' with
the phrase ``. . . form a film on the water surface . . .'' and adding
the phrase ``. . . allow for oil removal.'' to better reflect the
mechanism of action of herding agents.
Products--The Agency is establishing the definition of products to
mean chemical or biological agents or other substances manufactured
using a unique composition or formulation.
A commenter suggested that the proposed definition of products is
incomplete because it only includes agents that may be listed on the
NCP Product Schedule. Other commenters suggested that the definition of
products should include anything that may be used to mitigate oil
spills (e.g., burning agents, ignition devices, synthetic sorbents,
organic or inorganic substances that may be used in bulk form, and
substances that are manufactured using a unique composition or
formulation). EPA's definition for products is intended to clarify the
difference between a specific product and an agent type or category
under the NCP Product Schedule and the Sorbent Product List. EPA agrees
that the definition of a product should recognize sorbents by adding
the term ``other substances.'' The finalized definition clarifies the
distinction between an agent category (e.g., surface washing agent) or
substance (e.g., sorbent) from a product for which a manufacturer
submits an application to the Agency for listing on the NCP Product
Schedule or the Sorbent Product List. The Agency is not revising the
definition of ``product'' to specifically include burning agents since
they are already included in the definition of chemical agents.
Furthermore, the Agency disagrees to add ``other spill mitigating
devices'' as it would not accurately reflect the applicability of the
regulatory provisions for the purposes of the NCP Product Schedule or
the Sorbent Product List in this final action.
[[Page 38287]]
Solidifiers--The Agency is establishing the definition of
solidifiers to mean substances that through a chemical reaction cause
oil to become a cohesive mass, preventing oil from dissolving or
dispersing into the water column. Solidifiers are generally collected
and recovered from the environment. Solidifiers was not previously a
specific product category on the NCP Product Schedule. The final rule
amends the definition to recognize that solidifiers are ``generally''
to be collected, to recognize that the OSC has flexibility to consider
factors such as the safety of response personnel and harm to the
environment in making recovery determinations (see 40 CFR 300.910(h)).
A commenter requested that the Agency add language to the
definition to explain that solidifiers have no real advantage over
sorbents or mechanical recovery and that they have limited
practicality, may cross-link or react with other substances, and
require immediate removal from the environment. The commenter mentioned
that there has been very limited effectiveness testing or recent
studies on solidifiers. The commenter requested that the definition of
``solidifiers'' include additional limitations to specify conditions
under which solidifiers may be used such as proximity to shore and
quantity of oil. The Agency acknowledges the commenter's concerns;
however, the Agency disagrees with the suggested edits. The definition
is intended to convey the mechanism of action and to distinguish
solidifiers from other chemical or biological agents. Subpart J does
not state or imply that chemical or biological agents are preferred
over other response options such as mechanical recovery devices. EPA
notes that mechanical recovery devices, including skimmers, are outside
the scope of this action. EPA believes that the circumstances
surrounding oil discharges and the factors influencing the choice of
response methods are many. In addition, the final revisions under Sec.
300.910(g) provide that RRTs may require supplementary toxicity and
efficacy testing, or to obtain data or information to address site,
area, or ecosystem-specific concerns relative to the use of any
chemical or biological agent. The Agency believes that the specific
conditions under which solidifiers may be used, such as proximity to
shore and quantity of oil, are better addressed through the
authorization of use process found at Sec. 300.910 Authorization of
Use.
(c) Removed Definitions
Miscellaneous Oil Spill Control Agent (MOSCA)--The Agency is
removing the definition for miscellaneous oil spill control agent
(MOSCA). The MOSCA category was used as a catchall for all types of
products that did not meet other agent definitions; it is being
replaced with a number of new and/or revised definitions for types of
agents. As the Agency adds new, more stringent testing requirements for
listing products on the NCP Product Schedule, there is a need for more
specific category definitions to assist manufacturers in determining
which of those testing requirements apply to their products. Commenters
supported the removal of the definition for MOSCA. A commenter
specifically expressed support for the removal of the MOSCA category
provided that a subcategory is included in the ``sorbents'' definition
to account for the uniqueness of certain products among the other
sorbents.
The Agency agrees with comments supporting the removal of the MOSCA
category and the final action removes the category and definition of
MOSCAs from the NCP. The Agency has identified product categories to be
listed on the NCP Product Schedule and revised it accordingly. The
MOSCA category is no longer necessary or appropriate and is being
removed from the NCP through this final action. EPA does not believe
that removing the MOSCA definition results in listed products
automatically being reassigned to fall under the definition of another
chemical or biological agent, or substance. The final revisions provide
for the process to transition listed products from the current NCP
Product Schedule to the new NCP Product Schedule as described in Sec.
300.955(f).
Surface collecting agents--The Agency is removing the definition
for surface collecting agent and replacing it with a new herding agent
definition to better reflect the common terminology used in industry
for these agents.
EPA did not identify comments on the proposed amendment specific to
removing the definition for surface collecting agents.
C. Subpart J--Use of Dispersants, and Other Chemical and Biological
Agents
1. General
EPA is amending Sec. 300.900 by revising the title and paragraphs
(a) and (c), and by adding paragraph (d) to reserve for later use. The
revisions clarify that Subpart J addresses not only chemical agents,
but also those agents that now fall under the new biological agent
category. The revisions reaffirm the notion that Subpart J is not only
comprised of an NCP Product Schedule of chemical and biological agents,
but also includes testing requirements and authorization of use
procedures. Consistent with current Subpart J regulatory requirements,
the Agency is reserving a section for ``Releases of Hazardous
Substances'' to take place of the current placeholder in Sec. 300.905,
which is being removed.
Some commenters on the proposed rule expressed support for the
update to Sec. 300.900, which clarifies the Agency's duties under the
CWA, but noted that the Agency should specify waters and quantities
where products can be used safely, highlighting the importance of the
word ``safely.'' The Agency recognizes support to clarify that Subpart
J includes the identification of the waters and quantities in which
chemical and biological agents may be safely used. In this final
action, EPA is amending the last sentence of the proposed regulatory
text under Sec. 300.900 to include the term ``safely'' as provided in
CWA section 311(d)(2)(G)(iii) based on the comment received.
In addition, the Agency is clarifying that the statutory schedule
as required by CWA section 311(d)(2)(G) includes the NCP Product
Schedule, the Sorbents Product List, and authorization of use
procedures that, when taken together, identify the waters and
quantities in which such dispersants, other chemicals, or other spill
mitigating devices and substances may be used safely. EPA is amending
the regulation text at Sec. 300.900, and throughout Subpart J, to
clarify that it is the ``NCP Product Schedule'' which EPA updates
periodically, in order to avoid confusion with the statutory use of the
term ``schedule'' referred to in CWA section 311(d)(2)(G).
Some commenters requested additional clarification related to
Administrator authority and expressed uncertainty regarding federal
authority. Specifically, these commenters indicated a need for
additional clarity regarding the role of the Agency versus that of the
U.S. Coast Guard or other public or private entities involved in spill
response. While CWA section 311(c) provides statutory authority for
certain removal actions and identifies the agencies that are to provide
the federal OSC (which may include EPA or U.S. Coast Guard), it does
not provide authority to revise the NCP and does not govern how the NCP
regulates response actions. The authority to establish, revise, and
maintain the NCP is addressed in CWA section 311(d), which has been
delegated to the EPA Administrator in Executive Order 12777 (56 FR
54757, October 22, 1991). EPA will continue to exercise its authority
[[Page 38288]]
over the NCP, and CWA section 311(c) responses remain subject to NCP
provisions as per Congressional direction at CWA section 311(c)(1),
which provides that the President ``shall, in accordance with the
National Contingency Plan and any appropriate Area Contingency Plan,
ensure effective and immediate removal of a discharge . . . .''
(emphasis added).
2. Authorization for Agent Use
Section 300.910 sets forth the provisions for the authorization of
use of products on the NCP Product Schedule in response to oil
discharges. EPA is adding an introductory paragraph to Sec. 300.910
that confirms, consistent with the intent of the NCP, that use of
chemical or biological agents in response to oil discharges must be
authorized by an OSC in accordance with Subpart J. In the final rule,
EPA did not include the phrase ``. . . to waters of the U.S. or
adjoining shorelines . . .'' under the opening clause to Sec. 300.910
Authorization for agent use since the scope of Subpart J is already
addressed under Sec. 300.900. Unauthorized use can result in
violations of sections 301 and 311 of the CWA. Section 301(a) makes
unlawful ``the discharge of any pollutant by any person,'' except in
compliance with certain provisions of the CWA. In addition, section
311(b) establishes penalties for persons who fail or refuse to comply
with any regulation issued under section 311(j) of the CWA.
Commenters suggested that the Agency is already required by
Congress to establish a list of products that may be used for response
within navigable waters of the United States and EPA is therefore
required to approve these products for use in response activities. EPA
disagrees with the characterization that the Agency is required by
Congress to establish a list of products such that those products are
automatically authorized for use within the jurisdictional waters of
the United States by their listing. The CWA provides the President with
the authority to determine what products, if any, may be used in what
waters, and in what quantities. The NCP Product Schedule addresses the
chemical and biological agents that may be authorized for use upon
consideration of both the appropriateness of their use in the impacted
waters and the amount of product that may be used safely in response to
the unique nature of each oil discharge. EPA does not believe a ``one
size fits all'' approach to emergency response is appropriate or
prudent. A ``one size fits all'' approach could lead to significant
under- and over-use of products that could exacerbate oil discharges
absent consideration of all the specific conditions of each individual
discharge. The final action provides for flexibility to evaluate the
specific nature of an oil discharge when considering the authorization
of a chemical or biological agents.
(a) Use of Agents Identified on the NCP Product Schedule or Use of
Burning Agents on Oil Discharges Addressed by a Preauthorization Plan
The Agency is revising Sec. 300.910(a) to address the
preauthorized use of chemical and biological agents identified on the
NCP Product Schedule. The Agency reorganized paragraph (a) to provide
greater clarity about RRT and Area Committee responsibilities. The
revisions to Sec. 300.910(a) clarify the process for preauthorization,
the responsibilities of all involved parties, and the factors to
consider during the preauthorization process, including the
authorization for the use of agents by the OSC at the time of a
discharge. The reorganized paragraph (a) also makes the regulatory text
easier to read and follow. The Agency added procedure and review
requirements at Sec. 300.910(a)(3) intended to ensure preauthorization
plans are maintained so they are up to date. The finalized provisions
also address recommendations from the National Commission on the BP
Deepwater Horizon Oil Spill and Offshore Drilling report and EPA's
Inspector General report titled Revisions Needed to National
Contingency Plan Based on Deepwater Horizon Oil Spill (Report #11-P-
0534). The final revisions do not change the NCP's fundamental policies
regarding roles of Federal, state, and local representatives involved
in planning for and responding to an oil discharge, but rather clarify
the regulatory requirements and further explain the responsibilities
for each party.
Some commenters expressed concerns that the proposed rule focused
on preauthorization and suggested that the focus should instead be on
consultation and concurrence. The Agency recognizes that the RRTs and/
or Area Committees must consider whether preauthorization of chemical
and biological agents is appropriate, while maintaining the existing
concurrence and consultation roles on authorization of use. The revised
preauthorization provisions provide greater clarity on the factors the
RRT must address and those factors they should consider in developing a
preauthorization plan. Department of the Interior (DOI) and Department
of Commerce (DOC) natural resource trustees retain their concurrence
role when approving preauthorization plans. DOI and DOC natural
resource trustee concurrence is appropriate as preauthorization plans
are developed during the contingency planning phase, when there is
sufficient time to identify and resolve natural resource concerns.
A commenter advocated for clarification of ``mixed use'' products,
indicating that some of the products on the NCP Product Schedule have
multiple uses and that during preauthorization planning all potential
uses of an agent or product should be factored into the planning
decisions. EPA recognizes that a ``mixed use'' product that meets the
definition of more than one chemical or biological agent category may
raise authorization of use issues when (1) listed under more than one
chemical or biological agent category or (2) listed under one chemical
or biological agent category but still meets the definition of another
product category because of an alternate mechanism of action. The
listing of a product on the NCP Product Schedule should not cause
confusion on how that product is authorized at the time of an incident.
Noting these concerns, the final action allows for the evaluation of
products on an individual basis and informs the decision on whether and
under which category to list a product on the NCP Product Schedule.
Some commenters expressed concern or requested clarification on the
roles and authorities of RRTs and Area Committees in preauthorization
planning. Area Committees' roles and authorities under CWA section
311(j)(4) are outside the scope of this rulemaking. Nonetheless, CWA
section 311(j)(4) provides the roles of the Area Committees in planning
for the use of dispersants, including for Area Contingency Plans to
list the equipment (including firefighting equipment), dispersants or
other mitigating substances and devices, and personnel available to an
owner or operator, Federal, State, and local agencies, and tribal
governments, to ensure an effective and immediate removal of a
discharge, and to ensure mitigation or prevention of a substantial
threat of a discharge. EPA notes that not all spill mitigating
equipment, substances or devices may be available or appropriate in
certain planning areas. EPA believes that to create the best possible
response system, it is important that the regional-level and area-level
contingency planning efforts of the RRTs and Area Committees,
respectively, are closely coordinated. RRTs and Area Committees
[[Page 38289]]
should work together to develop mutually acceptable preauthorization
plans, as appropriate. The standing RRTs also have responsibilities for
oil spill contingency planning on a regional basis and can facilitate
consistency among Area Committees. In instances where the RRT and Area
Committees exist as separate entities, several RRT representatives
likely also serve on the Area Committees for that region, allowing for
familiarity with the roles and responsibilities of each entity. In
instances (e.g., in the inland zone) where RRTs fulfill the role of the
Area Committees, they are thus responsible for both regional and area-
level contingency planning (see 57 FR 15197, April 24, 1992). EPA
agrees that in the development of preauthorization plans, RRTs should
either provide Area Committees with an opportunity to provide input or
should consider relevant information in Area Contingency Plans (ACPs)
(e.g., Fish and Wildlife and Sensitive Environments Annex). The RRTs
and Area Committees should identify all potentially affected biological
resources and their habitats likely to be negatively impacted, and not
only those that are expected to benefit.
Another commenter noted that not all regions have a use for
preauthorization planning, suggesting that only regions with use for
these plans should be required to develop planning materials. While
RRTs and ACs must consider whether having a preauthorization plan is
appropriate, the final action does not mandate preauthorization plans
to be developed or preauthorization of any chemical or biological
agents. EPA modified the proposed text to remove the phrase ``in a
preauthorization plan'' to avoid a misinterpretation that Sec.
300.910(a) requires that RRTs develop preauthorization plans. EPA also
amended the final action under Sec. 300.910(a) to further clarify the
provision is to consider whether ``preauthorization of'' the use of
chemical and biological agents is appropriate.
The final action provides that an OSC may authorize the use of
agents listed on the NCP Product Schedule, or the use of burning
agents, for the purpose for which they were specifically listed without
obtaining the incident-specific concurrences and without the natural
resource trustees consultations described in Sec. 300.910(b). Some
commenters supported approval of preauthorization plans by natural
resource trustees. EPA amended the final provision to clarify that the
OSC does not need to obtain the incident-specific natural resource
trustees consultations described in paragraph (b) of this section when
authorizing the use of certain agents under Sec. 300.910(a) by adding
the phrase ``. . . and without the natural resource trustees'
consultations . . .'' described in paragraph (b) of this section. The
final provisions provide for DOI and DOC natural resource trustees
concurrence on preauthorization plans rather than consultations. EPA
continues to believe that DOI and DOC natural resource trustee
concurrence is more appropriate than consultation during the
contingency planning phase, when there is sufficient time to identify
and resolve natural resource concerns while considering whether
preauthorization is appropriate. Consistent with previous
preauthorization approval requirements, the final revisions provide for
DOI and DOC natural resource trustee approval, approval with
modification, or disapproval of preauthorization plans.
The final action provides that chemical or biological agents on the
NCP Product Schedule may only be authorized for the purpose for which
they were specifically listed. EPA amended the final provision to
replace the phrase ``. . . intended purpose . . .'' with ``. . . for
the purpose for which they were specifically listed . . .'' for greater
clarity. This revision was made in response to a commenter's concern
that chemical or biological agents may only be used for their intended
use within a specific category (e.g., an agent that is listed as a
surface washing agent cannot be authorized for use as a dispersant).
In the finalized provision, EPA also made some editorial changes to
the proposed text for increased clarity.
Preauthorization Plan Development. At Sec. 300.910(a)(1), EPA is
finalizing requirements for the preauthorization plan's site-specific
factors. While the revisions simplify the language and clarify the
requirements, the Agency kept in place the fundamental elements that
were contained in the former Sec. 300.910(a) text. The provision
states that preauthorization plans must, at a minimum, specify limits
for the quantities and duration of use, and use parameters for water
depth, distance to shoreline, and proximity to populated areas for
discharge situations identified in which agents may be used. The Agency
believes that clearly stating the use parameters in a preauthorization
plan will make it easier for planners to address concerns of
preauthorizing agent use and in turn for responders to authorize their
use. In meeting these provisions, the preauthorization plans should
document how both regional and logistical factors were addressed when
establishing use limits and parameters for chemical and biological
agents. Regional factors include the likely sources and types of oil
that might be discharged, various potential discharge scenarios, and
the existence and location of environmentally sensitive resources or
restricted areas that might be impacted by discharged oil. Logistical
factors include inventory, storage locations and manufacturing
capability of available agents, availability of equipment needed for
agent use, availability of adequately trained operators, and the
availability of appropriate means to monitor agent use in the
environment.
Several commenters requested clarification on the need to specify
limits to the quantities and duration of agent use and the proposed use
parameters for water depth, distance from shoreline, and proximity to
populated areas; commenters noted that it is not realistic to predict
all scenarios. EPA recognizes that oil discharges may occur under
various scenarios. EPA does not envision that preauthorization plans
would address every scenario imaginable, but instead will only address
those specific circumstances under which RRT member agencies with roles
and responsibilities under the NCP agree that an OSC does not need to
obtain specific concurrence and consultations under Sec. 300.910(b) in
effectuating a preauthorized action. For example, a potential oil
discharge scenario may involve a response that occurs over several
days. The use of a chemical or biological agent (e.g., surface
dispersant use) during the initial response phase may be preauthorized
in a manner such that any use beyond that initial response phase would
be subject to Sec. 300.910(b) and in limited circumstances subject to
Sec. 300.910(b). While the preauthorization plan must specify limits
for the quantities and the duration of use, and use parameters for
water depth, distance to shoreline, and proximity to populated areas,
RRTs may wish to include other criteria in defining the scope of the
preauthorization plan. Based on public comments, EPA is amending the
final provisions to reflect that the limits for the quantities and the
duration of use, and use parameters for water depth, distance to
shoreline, and proximity to populated areas are the minimum criteria
that RRTs must specify by inserting the phrase ``at a minimum'' before
the specific criteria in the regulatory text.
Commenters supported considering environmental tradeoffs in
determining response options that provide the greatest environmental
protection by
[[Page 38290]]
identifying the affected biological resources and their habitats likely
to be negatively impacted, as well as those that are expected to
benefit. For example, a commenter suggested that the Agency rely upon
the Net Environmental Benefit Analysis (NEBA) framework as a foundation
for preauthorization planning, as opposed to artificially setting
limits on dispersant use. EPA's understanding is that ``NEBA'' is a
term used by some stakeholders in the response community to engage with
various interested parties to consider available response options,
including mechanical recovery. EPA also acknowledges that different
stakeholders have varying perspectives on what factors beyond
environmental considerations (e.g., economic, health, and safety) are
included in a NEBA, or what response options may provide the ``greatest
environmental protection.'' While there is no prohibition on the use of
environmental tradeoff methodologies, the use of such methodologies
must conform with all applicable statutory and regulatory authorities.
A commenter disagreed with the use of the word ``likely'' in
reference to the sources and types of oil that may be spilled and
suggested keeping ``potential'' instead, as a more conservative term
that is more appropriate for preauthorization planning. EPA believes
the phrase ``likely sources and types of oil'' better focuses on the
sources and types of oil specific to the preauthorization plan for
which agents may be used. While RRTs and Area Committees should
consider ``likely sources and types of oil'' in developing
preauthorization plans, the Agency believes they should also have the
flexibility to consider other potential sources and types of oil, as
appropriate, and the final revisions do not preclude RRTs and Area
Committees from considering them. In considering the use of the term
``potential'' as offered by the commenter, EPA decided to clarify the
phrase ``various discharge scenarios'' as used in the proposed rule.
EPA recognizes that when developing a preauthorization plan, Area
Committees and RRTs should not misinterpret ``various discharge
scenarios'' to only mean past incidences but should also consider
potential discharges scenarios. While RRTs and Area Committees should
consider past discharge scenarios, the Agency believes they should also
have the flexibility to consider potential discharge scenarios. In this
respect, EPA agrees with the commenter that the term ``potential'' is
more appropriate and is amending the phrase in the regulatory text to
include ``potential''. EPA believes the revised phrase ``various
potential discharge scenarios'' more accurately reflects EPA's intent.
Some commenters expressed concern or requested clarification on the
roles and authorities of RRTs and Area Committees in preauthorization
planning. EPA agrees that in the development of preauthorization plans,
RRTs should either provide Area Committees with an opportunity to
provide input or should consider relevant information in ACPs (e.g.,
Fish and Wildlife and Sensitive Environments Annex). The RRTs and Area
Committees should identify all potentially affected biological
resources and their habitats likely to be negatively impacted, and not
only those that are expected to benefit. EPA amended the final
provision to ensure that Area Committees are involved in
preauthorization plan development. EPA notes that the broader area
contingency planning provisions are established under Sec. 300.210(c)
and are outside the scope of this action.
Preauthorization Plan Approval. At Sec. 300.910(a)(2), EPA is
finalizing requirements related to the roles and responsibilities
involved in reviewing and approving preauthorization plans, and
procedures if preauthorization plan approval is withdrawn. The final
action retains the concurrence requirement for preauthorization plans
from the former version of the rule; given that preauthorization plans
are developed during the contingency planning phase, DOC and DOI
natural resource trustee concurrence is preferred over just
consultation because it provides for sufficient time to identify and
resolve natural resource concerns.
Commenters suggested that the preauthorization planning process be
completed under mandatory timelines, including a suggestion that plans
must be reviewed within a 90-day time frame, or that the Agency
otherwise stipulate that the plan cannot be blocked from being used by
an Area or Region. EPA does not believe that it is appropriate to
establish specific deadlines for the review and approval of
preauthorization plans because both the Area Committees and RRTs
coordinate their approach to reviewing and revising existing
preauthorization plans and determine what information they may need to
amend their preauthorization plan, as appropriate. EPA believes RRTs
and ACs should begin their reviews as expeditiously as possible where
preauthorization plans exist, but they also must be afforded
flexibility in implementing the final revisions to ensure
preauthorization plans are up-to-date when implemented in the event of
a discharge.
To be consistent with terminology for preauthorization plan
approvals, EPA is revising the provision in the final action to
substitute the phrase ``withdrawal of approval from a preauthorization
plan . . .'' for ``withdrawal of concurrence . . .'' The amended rule
offers specific procedures to follow should an authorizing agency
decide to withdraw their approval from a preauthorization plan: the
Area Committees and RRTs must address the withdrawal of approval from
the preauthorization plan within 30 days of the withdrawal, allowing an
opportunity to address the concerns. Additionally, the RRT must notify
the National Response Team (NRT) of the final status of the
preauthorization plan within 30 days from withdrawal. The absence of an
approved preauthorization plan means authorizations for agent use are
to be conducted in accordance with paragraph Sec. 300.910(b) or in
limited circumstances under Sec. 300.910(d). Therefore, the Agency
believes that the phrase ``the preauthorization plan becomes invalid
and the authorization of use for chemical or biological agents must be
performed according to paragraph (b)'' is unnecessary and redundant and
is striking it from the final provision. The Agency continues to
believe that preauthorization plans serve as a valuable advanced
planning tool that supports decision making, and strongly encourages
the resolution of any withdrawal of approval in a manner that addresses
concerns raised.
Commenters expressed concerns over the potential impact of allowing
for withdrawal of preauthorization plan approval. EPA disagrees that
the ability to withdraw may incentivize the development of
preauthorization plans with no intent of maintaining concurrence during
a response. EPA also disagrees that the withdrawal of approval from a
preauthorization plan subverts the OSC's authority to use dispersants
and that this provision should be removed. RRT member agencies who have
responsibilities in approving preauthorization plans have always had
the discretion to withdraw their approval at any time. An OSC may still
authorize the use of dispersants and other agents outside of an
approved preauthorization plan in accordance with Sec. 300.910(b) or
in limited circumstances under Sec. 300.910(d). Case-by-case
authorization of use under Sec. 300.910(b) is an appropriate and
timely process to authorize the use of dispersants and other agents and
should not delay response operations such as
[[Page 38291]]
the deployment of mechanical recovery. In contrast, restricting the
flexibility to withdraw approval from a preauthorization plan could
serve as a disincentive to approve a preauthorization plan or result in
limiting the plan's scope and lead to more frequent requests for
authorization by OSCs under Sec. 300.910(b). EPA disagrees that the
preauthorization plan should stay in effect for 30 days after
withdrawal of approval while allowing RRTs and Area Committees to
address the withdrawal. A withdrawal likely signals concerns amongst at
least one of the approving bodies with actions or activities that had
been preauthorized. The final provisions provide a 30-day timeframe for
the RRT to notify the NRT of the status of the preauthorization plan
after any such withdrawal. EPA believes that RRTs and Area Committees
are likely to be aware of concerns prior to withdrawal of approval from
a preauthorization plan, can work to resolve any perceived differences
prior to any withdrawal, and are not prohibited from entering into new
preauthorization plans addressing the same or similar areas in the
future. For an active incident where chemical and biological agents
have been authorized for use under a preauthorization plan, EPA
encourages RRT member agencies with approval roles to work with the RRT
to promptly resolve concerns and avoid potential withdrawal of plan
approval during a response.
Several commenters suggested a need for public input and
notification during the preauthorization plan approval process,
including a requirement for public notification following the
withdrawal of concurrence. Another commenter recommended a formal
public review and comment period on each preauthorization decision,
recommending that the RRTs and Area Committees should be required to
provide a written peer-reviewed scientific and technical study to
support any preauthorization plan, and provide a 60-day public review
and comment period. EPA disagrees that the RRTs and Area Committees
should be required to provide a written peer-reviewed scientific and
technical study to support any preauthorization plan, or that they
should provide a 60-day public review and comment period or formal
public review and comment period on each preauthorization decision. The
Agency believes that the RRTs and Area Committees should have the
flexibility to tailor preauthorization plans to their regional needs.
While EPA recognizes the benefits of public feedback on
preauthorization plans including independent scientific input, the
Agency does not believe it should be a mandatory requirement.
Subjecting preauthorization plans to an external peer-review process
may limit RRTs' and Area Committees' ability to utilize
preauthorization plans. Nonetheless, public and private stakeholders
may provide input, such as relevant scientific data and information, in
area and regional contingency planning activities that are open to
public participation, and RRTs and Area Committees retain flexibility
to seek public comment or input on any preauthorization plan in
accordance with applicable statutes and regulations if they believe
such participation is warranted. EPA notes that the amendments to
Subpart J include a public notification provision under Sec.
300.910(i) Reporting of Agent Use to notify the public on chemical and
biological agents used during a response and to provide certain
required information.
In the finalized provision, EPA also made some editorial changes to
the proposed text for increased clarity in addition to the specific
changes described above.
Preauthorization Plan Reviews. At Sec. 300.910(a)(3), EPA is
finalizing new requirements related to the review and revision, if
needed, of preauthorization plans. The review requirement is intended
to ensure that preauthorization plans are actively maintained and
updated to reflect revisions to the NCP Product Schedule. A periodic
review, following a regular timeframe, is expected to ensure that the
preauthorization plan is consistent with any revisions to the NCP
Product Schedule, and also with revisions to ACPs, facility, and vessel
response plans. The provision specifically requires reviews to be
conducted at a minimum, after a major discharge (a ``major discharge''
means a discharge of more than 10,000 gallons of oil to the inland
waters or more than 100,000 gallons of oil to the coastal waters) \3\
or after a Spill of National Significance (SONS) relevant to the
preauthorization plan area; to address revisions of the NCP Product
Schedule impacting chemical or biological agents that may be
individually listed within a preauthorization plan; and to reflect new
listings of threatened and/or endangered species applicable to the
preauthorization plan area. Review is to be done by the EPA RRT
representative, the DOC and DOI natural resource trustees, and the RRT
representative from the state(s) with jurisdiction over the waters of
the area to which a preauthorization plan applies.
---------------------------------------------------------------------------
\3\ See 40 CFR 300.5 ``Size classes''.
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Several commenters recommended that additional entities should be
able to participate in the review or comment process during the
preauthorization plan review cycle (e.g., local and tribal governments,
the Occupational Safety and Health Administration (OSHA), Department of
Health and Human Services (DHHS), and the public). EPA reiterates that
all members of the ACs and RRTs will be afforded an opportunity to
provide input during a review of a preauthorization plan. However, only
the RRT representatives from EPA, the state(s) with jurisdiction over
the waters of the area to which the plan applies, and the DOC and DOI
natural resource trustees will have the authority to approve,
disapprove, or approve with modification any revisions to an existing
preauthorization plan. This approval process is consistent with the
authorization procedures contained in the former Sec. 300.910(a) and
should minimize the time necessary for RRT approval of any amendments
to an existing preauthorization plan. EPA amended the final provision
by adding the phrase ``The RRT in consultation with the Area
Committee(s) . . .'' to provide that review of preauthorization plans
are coordinated with the applicable ACs so that ACs may amend relevant
ACPs, as appropriate.
The proposal would have required plans to be reviewed at least
every five years. Commenters provided a range of feedback on this
proposed timeframe. EPA recognizes that some commenters supported a
five-year review cycle, while others suggested shorter, longer, or no
timeframes. As stated in the preamble to the proposed rule, a five-year
review cycle is consistent with facility response planning
requirements. EPA believes the five-year review process has worked well
for facility response planning and believes preauthorization plans
should be reviewed and revised in a similar fashion. While EPA still
believes that a five-year review cycle is a reasonable time frame, the
Agency also agrees with commenters that an alternative timeframe may be
appropriate based on regional circumstances. Based on comments, EPA is
amending the timeframe for preauthorization plan from five years to a
regular timeframe established by the RRT and documented in the plan.
Under the revised provision, the Area Committees and RRTs must still
periodically review, and revise as needed, preauthorization plans.
However, the Area Committees and RRTs are to establish the timeframe
and document that timeframe in the
[[Page 38292]]
plan. The Area Committees and RRTs should also provide to the public
the rationale for establishing said timeframe. EPA believes the revised
provision is consistent with recommendations in the National Commission
on the BP Deepwater Horizon Oil Spill and Offshore Drilling report and
EPA Inspector General report: Revisions Needed to National Contingency
Plan Based on Deepwater Horizon Oil Spill (Report No. 11-P-0534) for
periodic reviews of contingency plans. The Agency recognizes that
development of preauthorization plans can be resource intensive;
however, once developed, a periodic review, and revision as needed,
should require much less effort. EPA disagrees that it is overly
burdensome for RRTs to periodically review, especially with the revised
provision to provide additional flexibility to the RRTs to establish
and document their own review schedule.
EPA also made other changes to the proposed text based on comments
received. Several commenters suggested additional triggering events for
preauthorization plan review. The Agency agrees that changes other than
the trigger events specifically listed in the revised rule may impact
the conditions under which the use of chemical and biological agents is
preauthorized. EPA amended the final provision to clarify that the
triggering events are minimum criteria by including the phrase
``Reviews must also be conducted in any affected region, at a minimum .
. .''. Some other commenters stated that reviews should be required
only after major NCP Product Schedule listing changes to agents that
may be used in the preauthorization plan area, as opposed to smaller
less significant administrative changes in the NCP Product Schedule.
The final provisions provide for preauthorization plans to be reviewed
to address revisions to the NCP Product Schedule ``impacting chemical
or biological agents that may be individually listed within a
preauthorization plan.'' The revision is intended to avoid confusion
with other, non-substantive changes to the NCP Product Schedule. EPA
also amended the final provision to add the phrase ``. . . relevant to
the preauthorization plan area; . . .'' to clarify the provision
applies to the relevant RRT. The amendment also avoids
misinterpretation that an RRT not impacted by a major discharge or by a
Spill of National Significance (SONS) would be required to review their
preauthorization plan as a result of events outside their region.
Similarly, EPA amended the final provision by adding the phrase ``. . .
applicable to the preauthorization plan area'' to clarify the
applicability of the provision to the relevant RRT and to avoid
confusion that new listings of threatened and/or endangered species in
one or more regions requires all RRTs to review their preauthorization
plans.
(b) Use of Agents Identified on the NCP Product Schedule or Use of
Burning Agents on Oil Discharges Not Addressed by a Preauthorization
Plan
The Agency is revising Sec. 300.910(b) to address the use of
chemical or biological agents identified on the NCP Product Schedule or
the use of burning agents in spill situations that have not been
addressed in preauthorization plans. The revisions clarify the
authorities and responsibilities of relevant parties and the factors to
consider when authorizing the use of agents in these situations. The
revisions also clarify that the provision applies to burning agents as
well as products that are listed on the NCP Product Schedule. The
revisions to Subpart J do not change, from the former rule provisions,
the Agency's fundamental policies regarding the roles of Federal,
state, Tribal, and local representatives involved in an oil discharge
response. The revisions maintain from the former rule the OSC's
authority to authorize the use of chemical or biological agents on the
oil discharge; the concurrence of the EPA representative to the RRT
and, as appropriate, the concurrence of the RRT representatives from
jurisdictional states; and the requirement for consultation with the
DOC and DOI natural resource trustees.
As with paragraph (a), the final provisions under paragraph (b)
specify the parameters that must be considered by the OSC for
authorizing agent use on a case-by-case basis. Similar to
preauthorization plans, the scope of the case-by-case authorization may
include other criteria. EPA is amending the final provisions, relative
to the proposal, to reflect that the parameters for the use of agents,
including the quantities requested to be authorized, the duration of
use, the depth of water, the distance to shoreline and proximity to
populated areas, are the minimum criteria OSCs must specify by
inserting the phrase ``for their authorization request to the RRT, at a
minimum'' in the final regulatory text. The Agency is also replacing
the phrase ``. . . to be used . . .'' with ``. . . requested to be
authorized . . .'' to avoid confusion that the OSC must use the
entirety of the requested quantities, rather than not exceeding the
quantities authorized by the RRT. The Agency also specifies that OSCs
should address factors such as environmentally sensitive resources or
restricted areas that might be impacted, agent inventory and storage
locations, agent manufacturing capability, availability of equipment
needed for agent use, availability of adequately trained operators and
appropriate means to monitor agent use in the environment.
Some commenters, for various reasons, opposed the use of any agents
if the agents were not approved in a preauthorization process, even if
they are listed on the NCP Product Schedule. EPA disagrees with
commenters that agents should not be authorized for use if they are not
covered under an approved preauthorization plan. EPA also disagrees
that case-by-case authorization under Sec. 300.910(b) provides a
lesser standard for authorization. EPA notes the time critical nature
of oil discharge responses and that the circumstances surrounding every
potential discharge situation are not foreseeable or lend themselves to
pre-planning. Not having a preauthorization plan approved by relevant
RRT Agencies does not preclude the RRT or OSC from considering chemical
or biological agent use for response during planning discussions.
However, neither an approved preauthorization plan under Sec.
300.910(a) nor case-by-case authorization under Sec. 300.910(b)
provide for a specific authorization outcome. Authorization of use
determinations regarding chemical or biological agents are made for
each individual discharge with consideration of the incident specific
conditions and must be consistent with CWA section 311(d)(2)(G) and the
Subpart J regulations. EPA believes there are multiple opportunities
through regional and area contingency planning and from provisions
included in the final action that RRTs may use to support case-by-case
decision making. Contingency planning processes (e.g., RCPs, ACPs, and
vessel and facility response plans) may inform whether the use of
chemical or biological agents is appropriate, including during case-by-
case authorization under Sec. 300.910(b). Separate from the regional
and area contingency planning requirements described in the NCP, EPA
acknowledges the benefits from advanced planning to support expedited
decision making. The Agency recognizes that incident-specific
authorization (i.e., case-by-case authorization) for discharge
situations
[[Page 38293]]
not covered by preauthorization plans may benefit from planning in
advance to support expedited decision making. The final action supports
contingency planning efforts by establishing provisions for RRTs to
gather supplementary toxicity and efficacy testing, monitoring, or to
obtain available data or information relative to the use of a chemical
or biological agent (see Sec. 300.910(g)). RRTs may need additional
testing or information for situations that fall under Sec. 300.910(b).
Some commenters advocated for EPA to require concurrence from
natural resource trustees rather than consultation under Sec.
300.910(b). Section 1011 of the Oil Pollution Act (OPA) states that
``The President shall consult with the affected trustees designated
under section 1006 on the appropriate removal action to be taken in
connection with any discharge of oil.'' Executive Order 12777 delegates
this responsibility to the OSC. EPA believes the consultation
requirement under Sec. 300.910(b) is consistent with statutory
requirements under OPA and maintains the approach of consultations with
DOI and DOC natural resource trustees in the final provisions. It is
important to note that consultation with the trustees does not mean
that the OSC must obtain the concurrence of the trustees. EPA
recognizes the decision to use a chemical or biological agent is highly
dependent upon specific circumstances, locations, and conditions which
must be assessed by the OSC and relevant RRT member agencies. The EPA
and the state RRT representative(s), and DOC and DOI natural resource
trustees, are in a unique position to understand local conditions and
to collect and coordinate quickly the necessary local information.
Several commenters addressed the proposed removal of the term
``when practicable'' from the former rule text regarding consultation
with the DOC and DOI. Some supported the removal of this language,
stating that consultation and concurrence should always be pursued
during case-by-case response decision making, since the situations may
present unique challenges. Other commenters opposed the removal of the
term ``when practicable'' and recommended leaving the language as is,
asserting that it has worked well for years and that continued
flexibility in the approval process is warranted. Commenters suggested
that delays in discharge mitigation may occur when waiting for
consultations, and that EPA should establish a consultation time limit.
The Agency believes that the case-by-case decision making should
include consultations with natural resource trustees since these
discharge situations may present unique challenges when selecting a
response option that involves chemical or biological agents. EPA also
notes that OPA 1011 (33 U.S.C. 2711) provides for consultations with
the affected trustees on the appropriate removal action to be taken in
connection with an oil discharge. Furthermore, Sec. 300.305(e)
provides that the OSC shall consult with the affected trustees on the
appropriate removal action to be taken. EPA disagrees with concerns
that seeking natural resource trustee input could result in delays in
the use of a chemical or biological agent. While EPA supports timely
decision making, it does not interpret timely decision making to
necessarily mean concurring with an OSC request to authorize the use of
a chemical or biological agent; consultation can allow for a more
immediate exchange of information and ideas when addressing a time-
critical response. EPA disagrees with establishing a consultation
timeframe (e.g., 36 or 48 hours) for natural resource trustees and
notes that it is contrary to the intent of seeking input on a removal
action (e.g., chemical agent use) prior to its use. While the Agency
recognizes the time-critical nature of decision making during a
response, advances in communication technology (e.g., smart phones,
email) provide OSCs with increased capabilities to communicate quickly.
The Agency believes it is reasonable to expect an OSC to be able to
notify and explain the circumstances requiring use of the certain
agents to natural resource trustees in a timely manner. The final
revisions to Sec. 300.910(b) include removing the phrase ``when
practicable'' with respect to consultation with the DOC and DOI natural
resource trustees. EPA believes that the final revisions to Subpart J
better align with the statutory and regulatory provisions.
A commenter supported the provision to authorize only products that
are appropriate and used for their intended purpose under Sec.
300.910(b). To provide additional editorial clarity, the revised
provision replaces ``. . . chemical or biological agents identified on
the Schedule for their intended purpose . . .'' with ``. . . for the
specific purpose for which they were listed . . .''
A commenter expressed opposition to the requirement in Sec.
300.910(b) to document the parameters for use of agents when there is
not a preauthorization plan, emphasizing the need for quick decision
making, noting that the information is already required elsewhere (33
CFR parts 154 and 155) or unnecessary at the time when action is
required. Another commenter recommended revisions to the rule text
which would increase the specificity of these parameters. While EPA
supports timely decision making, EPA does not interpret timely decision
making to be inhibited by documentation requirements that both inform
RRT Agencies with roles and responsibilities under the NRT for chemical
and biological agent use and support the OSC's decision making.
Furthermore, EPA recognizes the request that Sec. 300.910(b) increase
the specificity of the parameters for the use of products. EPA agrees
that site-specific factors are an important consideration when
authorizing the use of a chemical or biological agent. For example,
environmental characteristics such as local ocean water circulation
patterns may affect oil transport and therefore influence whether
dispersants are authorized for use, and if so, to what extent. Even
within a chemical agent category (e.g., dispersants), environmental
conditions may vary locally, if not seasonally. EPA agrees that such
information, if available, should be documented during case-by-case
authorization of use. However, there may be several site-specific
factors to consider where such information may be unavailable; the fact
that information is unavailable, including assumptions used in lieu of
unavailable information, should also be documented. EPA believes the
relevant Agencies should be afforded flexibility in considering
relevant factors when authorizing chemical and biological agents and to
tailor the scope of the authorization with consideration of site-
specific conditions. EPA does not believe that it is appropriate or
feasible to include all potential site-specific information within the
regulation. Rather, relevant site-specific factors to consider during
case-by-case authorization are more appropriately addressed through
development of guidance materials as appropriate, as well as through
informed decision making.
A commenter requested that EPA provide notification within 24 hours
of spills and product use to health care providers and the public, in
the language(s) spoken in the impacted region. The final action
includes new provision under Sec. 300.910(i)(2) that requires the OSC
to provide notification to the public in support of Sec. Sec.
300.135(n) and 300.155(a) and (b). Under Sec. Sec. 300.135(n) and
300.155(a) of the NCP, the OSC should ensure all appropriate public and
private interests are kept informed and that their
[[Page 38294]]
concerns are considered throughout a response, to the extent
practicable. However, EPA did not include a specific requirement to
provide the notification in the language(s) spoken in the impacted
region. The reporting provision does not preclude including public
notification in different languages and EPA encourages consideration of
impacted communities when communicating response actions, including
developing materials in languages understood by local communities.
However, it is impractical to require an OSC to provide notification in
all language(s) spoken in the impacted region during an emergency
response where chemical or biological agents may be authorized as the
Agency cannot predict where and when an oil discharge occurs. The OSC
retains discretion to provide public notification in additional
languages if the OSC determines it to be appropriate.
A commenter stated that changing the language in this section, from
``navigable waters threatened'' to ``waters and adjoining shorelines
threatened'' creates additional barriers to use dispersants and limits
OSC actions. Another commenter stated that the proposed updates
conflict with E.O. 12777 and the CWA because they do not distinguish
between coastal and inland zones for planning and operational decision
making reserved for the area where the OSC is directing the response.
EPA believes that the amended provision provides consistency with the
provisions in Sec. 300.910(a); the Agency is not limiting the
jurisdictional scope of the NCP as provided under section 311(b)(3) of
the CWA.
In the final rule provision, EPA also made some editorial changes
to the proposed text for increased clarity in addition to the changes
described above.
(c) Burning Agents
EPA proposed to replace the current authorization of use for
burning agents in Sec. 300.910(c) to provide greater flexibility to
OSCs for authorizing the use of burning agents. Specifically, the
Agency proposed that OSCs may authorize the use of burning agents for
authorized in-situ burns. EPA received comments that supported the
proposed amendments, that requested clarification of the proposed
changes, and that raised concerns regarding the consultation and
concurrence role of the RRT. Based on public comments received, EPA is
not revising Sec. 300.910(c) as proposed, but is instead reserving
Sec. 300.910(c) and is amending the regulatory text in Sec.
300.910(a) and (b) to specifically clarify that Sec. 300.910(a) and
(b) apply to the authorization of use of burning agents. For
preauthorization requirements under the Sec. 300.910(a), the final
provisions maintain the previous approach to address burning agents.
Under Sec. 300.910(b), the final revisions incorporate burning agents
in the case-by-case authorization, along with chemical and biological
agents listed on the NCP Product Schedule. This approach eliminates the
need to have a separate regulatory requirement for burning agents for
case-by-case authorizations. To maintain consistency with the
regulation's previous structural organization familiar within the
response community, EPA is reserving Sec. 300.910(c).
Several commenters expressed general concern about or opposition to
the use of burning agents and the use of in-situ burning as a spill
response method. Additionally, several commenters expressed concern
regarding various environmental impacts, particularly the impacts to
aquatic and benthic environments and to air quality, from the use of
burning agents and in-situ burns. While burning agents are used in de
minimis quantities relative to the discharged oil they would be applied
to, and when considering the response as a whole, EPA recognizes that
the use of burning agents and in-situ burning may have environmental
impacts. However, Subpart J does not state or imply that chemical or
biological agents are preferred over other response options. Neither
the current nor final rule mandates the use of chemical or biological
agents, nor removes them from consideration as a response option.
Rather, the Subpart J regulations provide a framework for authorizing
their use, as appropriate. EPA believes that the circumstances
surrounding oil discharges may vary and therefore there are many
factors influencing the choice of response methods. During a response,
in-situ burning may be considered along with other response options.
Burning agents may be used as part of the in-situ burning process.
Depending on incident-specific conditions, timely deployment of several
response options may occur while tradeoffs are evaluated to determine
which response option (or combination thereof) addresses response
objectives. In-situ burning may reduce the need for collection,
storage, transport, and disposal of recovered material by converting a
fraction of the oil to gaseous combustion products. However, the Agency
also recognizes that combustion products may include smoke or soot in
addition to carbon dioxide and water. Monitoring of in-situ burns
through information collection can inform decision making during a
response. EPA recognizes comments regarding air quality concerns,
including generation of particulates and toxic gases (specifically VOCs
and PAHs) and potential impacts on communities. Beyond Subpart J, the
NCP includes provisions for OSCs to address health and safety concerns
of workers under Sec. 300.150. The NCP recognizes that the OSC may
call upon DHHS to assist in determining public health threats
throughout any response action (see Sec. 300.135(h)). In addition, the
OSC may monitor air quality to identify potential public health
concerns from air residues from in-situ burning. EPA also recognizes
that in-situ burning of crude petroleum oil may result in residues that
are not only emitted to the air, but are also entrained in the water
column. In-situ burning that is initiated using burning agents may lead
to the possibility for organisms dwelling in the water column to come
in physical contact with residues from the combusted oil. While the
burning agent itself is expected to be consumed through combustion, the
Agency believes that the harmful impact to an organism caused by
physical contact (e.g., ingestion by fish) with the residue from
combusted oil from an in-situ burn initiated by a burning agent is just
as concerning as the effects of any residual burning agent. Subpart J
does not mandate the use of burning agents. Rather, it provides a
framework to consider their authorization by RRTs and OSCs. EPA
recognizes the commenters' concerns regarding potential environmental
impacts from in-situ burning initiated by burning agents. The final
provisions under Sec. 300.910(a) and (b) maintain the current approach
that keeps RRTs, including state(s) and natural resource trustees,
actively involved in the authorization of burning agents for in-situ
burns. EPA believes that the fact that an in-situ burn initiated by a
burning agent may cause oil to enter the water column is sufficient
reason for RRTs or OSCs to consider whether supplemental monitoring of
in-situ burn residue is appropriate. In-situ burning operations are
subject to OSC oversight, with OSC authorization required for burning
agent use.
Some commenters supported not listing burning agents on the NCP
Product Schedule, and several other commenters disagreed, stating that
burning agents, like other spill response agents, should be listed on
the schedule and be regulated with the same efficacy, toxicity, and
public ingredient
[[Page 38295]]
disclosure standards as other listed agents. EPA recognizes comments
supporting and opposing the listing of burning agent products on the
NCP Product Schedule. EPA recognizes burning agents as a type of
chemical agent that must be authorized for use in accordance with the
provision under Sec. 300.910. EPA disagrees with the comment that the
increasing frequency of burning agent use contradicts the argument that
the small quantities make listing considerations unnecessary. The
Agency believes that burning agents are used in de minimis quantities
relative to the discharged oil they would be applied to, and when
considering the response as a whole, and are expected to rapidly burn
off during use, which serves to remove them from the water. Burning
agents are generally added to an oil slick to initiate an in-situ burn
after which the oil slick itself is expected to maintain the burn.
Although EPA is maintaining the current approach of not specifically
listing burning agent products on the NCP Product Schedule, RRTs may
still gather additional information on burning agents and monitor their
use under Sec. 300.910(g) Supplemental Testing, Monitoring, and
Information. EPA agrees with comments that an in-situ burn may raise
concerns regarding environmental impacts and believes that maintaining
the current approach keeps RRTs appropriately and actively involved in
the decision making to authorize the use of burning agents used in in-
situ burning. Furthermore, provisions within the NCP but outside the
scope of this rulemaking include requirements for OSCs to address
health and safety concerns of workers and the public. For example,
Sec. 300.150 provides requirements to address worker health and
safety.
(d) Temporary Exception
EPA is revising Sec. 300.910(d) to clarify the intent of the
existing exception to the preauthorization and case-by-case
authorization of use regulations. The Agency is including the term
``temporary'' as a qualifier to the final provision's title, to reflect
that there is a time limitation for operating under this provision
during a response. The temporary exception provision provides that the
OSC may authorize the use of any chemical or biological agent, whether
it is identified or not on the NCP Product Schedule, without obtaining
the concurrence of the EPA RRT representative and, as appropriate, the
RRT representatives from the state(s) with jurisdiction over the waters
and adjoining shorelines threatened by the release or discharge, and
without consultation with the Department of Commerce and the Department
of the Interior natural resource trustees. That is, it allows OSCs to
authorize the use of any agent when it is determined that the use of
the agent is necessary to prevent or substantially reduce an imminent
threat to human life that cannot be immediately addressed by other
procedures or provisions of the NCP. The Agency believes that the
protection of human life is the primary consideration in responding to
an oil discharge. Accordingly, the OSC must have the ability to use any
agents that would effectively and expeditiously mitigate the threat to
human life, particularly in situations where chemical agents on the NCP
Product Schedule are not immediately available. The final provision
includes the phrase ``and without consultation with the Department of
Commerce and the Department of the Interior natural resource trustees''
to further clarify the OSC authority under this provision relative to
concurrences and consultations otherwise required for the authorization
of chemical and biological agent use under Sec. 300.910(a) or (b).
However, this exception cannot be used as a substitute for compliance
with Sec. 300.150, including the use of personal protective equipment,
or when there is sufficient time to seek authorization in accordance
with Sec. 300.910(a) or (b). EPA notes that the temporary exception
does not affect other authorities available to an OSC under the NCP,
separate from Subpart J, to take actions to address a threat to human
life, such as ordering evacuations or repositioning equipment and
personnel.
The exception provides for authorization of agent use to occur,
within a limited timeframe and for the specific purpose of preventing
or substantially reducing an imminent threat to human life, if there is
insufficient time to obtain the required concurrences for
preauthorization or authorization of use for products on the NCP
Product Schedule under paragraphs (a) and (b) respectively. To more
clearly describe when the exception must not be used, EPA amended the
final provision to add the phrase ``. . . or when there is sufficient
time to seek authorization in accordance with paragraphs (a) or (b) of
this section.'' The provision is not intended for the OSC to override
an authorization decision of an RRT on chemical and biological agent
use for the specific incident conditions. The revision in the final
action is consistent with the intent of the provision as described in
previous NCP final rulemakings (see 55 FR 8808, March 8, 1990).
The Agency recognizes oil discharges generally will not pose
threats to human life of an immediacy or magnitude that would warrant
invoking the temporary exception provision. However, EPA believes that
there may be unforeseen circumstances where an oil discharge poses an
immediate life-threatening situation, and for which an OSC must have
the ability to use agents that could effectively and expeditiously
mitigate the imminent threat to human life. The Agency interprets a
situation that poses an imminent threat to human life to be one which
could reasonably be expected to cause death or serious physical harm
such that a part of the body would be severely damaged. Further, the
Agency also interprets that this imminent threat to human life must be
immediate for this exception provision to be applicable, meaning that
it is expected that death or serious physical harm could occur
immediately or before any other action can be otherwise implemented.
The former language in Sec. 300.910(d) used the terms ``hazard'' and
``threat'' interchangeably. The amended regulatory language replaces
``hazard'' with ``threat'' for consistency and to establish the intent
and expectation of the use of the exception more clearly.
Several commenters recommended that the Agency remove the exception
provision. These commenters claimed that it is unclear what
circumstances would occur requiring the OSC to decide to apply
dispersants to protect human health; the exceptions are not necessary;
and that the rarity of use of this exemption is evidence that most oil
discharges do not pose threats to human life of an immediacy and
magnitude that warrant the exception provision. Some commenters
suggested that without more direction, strict guidelines, or guidance
from the Agency regarding when this provision could be invoked, the
proposed rule allows for potential overreach in the use of the
exception authority. The Agency recognizes the comments opposing the
exception provision and the selection of spill response agents to focus
on human health risks. Nonetheless, the Agency reiterates that
protection of human life is the primary consideration in responding to
an oil discharge. EPA notes that the other authorities available to an
OSC under the NCP to take actions to address a threat to human life,
such as ordering evacuations or repositioning equipment and personnel,
are not affected by the revisions to the temporary exception provision
in this final action. The Agency is maintaining
[[Page 38296]]
the exception provision and is finalizing the proposed amendments with
modifications to further clarify the provision's intent and address the
concerns regarding potential overreach. The finalized exception
provision provides the OSC this authority only in circumstances to
prevent or substantially reduce an unforeseeable threat to human life
that cannot be immediately addressed by other procedures or provisions
of the NCP. Additionally, the Agency added the term ``individual
circumstances'' to provide the OSC flexibility to address one or more
separate unforeseen threats to human life at any time during a
response. The intent behind this temporary exception provision is to
eliminate potential delays in responding to life-threatening
situations. The modifications finalized in this action do not change
previous policy but rather clarify the intent and scope of the
exception. While the Agency expects this temporary exception to be
rarely needed, it continues to believe it is appropriate that the NCP
include a temporary exception provision to capture unforeseen and
immediate life-threatening situations. However, it is important to note
that, while all threats to human life are health and safety issues, not
all health and safety issues in turn pose an immediate threat to human
life. The Agency stresses the intent is for this temporary exception to
be applicable only to those imminent life-threatening situations which
cannot be addressed through the implementation of other procedures or
provisions in the NCP and has amended the final provision accordingly.
The final provision also clarifies that the exception must not be used
as a substitute for compliance with Sec. 300.150 of this part,
including the use of personal protective equipment.
Some commenters suggested that the OSC should only be allowed to
use products that are listed on the NCP Product Schedule under the
exception; a commenter stated that use of products not on the NCP
Product Schedule negates the purpose of contingency planning, and that
the OSC should only be able to authorize the use of agents listed on
the NCP Product Schedule when the agent is necessary to protect human
life. Some commenters expressed concerns regarding use of agents
without peer-reviewed scientific or technical evidence to show that the
dispersant chemical is safe for humans, wildlife, or the ecosystem. A
commenter noted that if the work required to add a product to the NCP
Product Schedule was not complete prior to a spill then responders
should not have the option of bypassing the process by using the
exception clause. The Agency shares the concern for any use of chemical
or biological agent products not listed on the NCP Product Schedule.
The fact that the exception applies broadly to include chemical or
biological agents not identified on the NCP Product Schedule
necessitates the temporary nature of the exception. The Agency
reiterates that the OSC authorities provided under this temporary
exception are not intended to allow bypassing or circumventing the
processes established under Subpart J. Specifically, the temporary
exception is not intended to bypass those provisions for testing and
listing chemical and biological agent products established under Sec.
300.915. The provisions for testing and listing chemical and biological
agent products on the NCP Product Schedule are intended to ensure that
these products have met baseline efficacy and toxicity requirements,
promoting the use of safer and more effective spill mitigating
products. The limited timeframe addresses concerns regarding the extent
of the temporary exception applicability, and promptly brings back into
the decision making process the required environmental considerations
that are built into the authorization of use provisions under Sec.
300.910(a) and (b), including the use of chemical and biological agent
products only when they are listed in the NCP Product Schedule.
Several commenters requested a 24-hour (or shorter) timeframe
instead of 48 hours for OSC product use notification and concurrence.
These commenters indicated that a 48-hour window for the OSC to operate
without concurrence seemed excessive, and that members of the RRT and
natural resource trustees should be engaged in this type of decision
making as soon as is feasible, as well as OSHA and the DHHS for human
health impacts. They noted that with advances in communication
technology, a 24-hour timeframe for OSC notification should be
attainable. The Agency acknowledges the support for specifying a
timeframe for the temporary exception to best clarify the intent that
this provision is to be a temporary and limited measure. Based upon
comments, the Agency is finalizing the provision's language to modify
the proposed 48-hour timeframe for which the temporary exception would
be applicable. The Agency is finalizing a further limited timeframe of
24 hours, recognizing that those entities with concurrence and
consultation roles under Subpart J, and who bring relevant
environmental expertise to these types of decision making, should
indeed be engaged as soon as possible. Additionally, this change
acknowledges the advances in communications since the exception
provision was last revisited under the NCP in 1994. Technologies are
now available that allow the OSC to notify the EPA RRT representative,
the state(s), and natural resource trustees of this decision within the
24-hour timeframe, if not sooner. This 24-hour timeframe further
addresses concerns regarding the extent of the temporary exception's
applicability, and promptly brings back into the decision making
process the required environmental considerations that are built into
the authorization of use provisions under Sec. 300.910(a) and (b). The
final amendments also include the phrase ``after initial application''
to further clarify when the 24-hour timeframe begins. The timeframe in
the final rule balances the need to address an unforeseen imminent
threat to human life during a response with the roles and
responsibilities of EPA, the state(s), and DOI and DOC natural resource
trustees regarding chemical or biological agent use under Sec.
300.910(a) or (b). EPA notes that the temporary exception provision
does not affect other authorities available to an OSC under the NCP,
separate from Subpart J, to take actions to address a threat to human
life, such as ordering evacuations or repositioning equipment and
personnel.
Many commenters expressed support for the notification requirements
in Sec. 300.910(d). A commenter stated that the notifications should
be made available to the public for awareness of the imminent threat to
human life and the use of products to address the threat. Some other
commenters cited concern regarding the notification requirement and
recommended that there should not be any limits on the OSC's ability to
make decisions protecting human life. A commenter asserted that the
requirements are inappropriate, and that the Agency has not adequately
justified the proposed notification requirements in terms of additional
benefits compared with the existing requirements. The Agency recognizes
the concerns regarding the notification requirements within the
temporary exception. The final regulatory language includes the
requirement for the OSC to notify as soon as possible, and to document
the circumstances and the reasons for use of the agent, to the EPA RRT
representative and, as appropriate, the RRT representatives from the
affected state(s) and the DOC and DOI natural resource
[[Page 38297]]
trustees. While the Agency had proposed ``immediate'' notification, it
believes that requiring notification ``as soon as possible'' is
adequate in conjunction with a reduction in the timeframe for which
this exception is applicable from 48 hours to 24 hours. The expectation
is that this information will be provided to those federal and state
entities with concurrence and consultation roles within a timeframe to
consider further chemical or biological agent use. While the Agency
recognizes the comment regarding limitations on the OSC's ability to
protect human life, it does not believe that the notification
requirement to the RRT members in any way hinders the OSC's ability to
make decisions to protect human life. The Agency notes the notification
provision does not apply to other authorities available to an OSC under
the NCP, separate from Subpart J, to take actions to address a threat
to human life. The Agency modified the regulatory language by changing
the ``immediate'' reporting requirement terminology to ``as soon as
possible,'' which still provides for the information to promptly be
provided to those entities with concurrence and consultation roles.
Additionally, the regulatory language was modified to add the phrase
``authorized pursuant to this paragraph'' to clarify the documentation
requirement under the temporary exception.
Some commenters suggested that exceptions may not be protective of
human health and safety, expressing concern with the replacement of the
term ``worker safety'' with ``human life.'' These commenters indicated
that the Agency should clarify the difference between threats to worker
safety and protection of human life and indicate why the proposed
change was needed. Other commenters requested that the Agency revise
the section to clearly include worker safety, or to clarify that
``worker safety'' is considered the same as ``the protection of human
life.'' The Agency disagrees that all worker safety considerations in a
response would necessarily equate to threats to human life. EPA
recognizes that all responses present multiple health and safety
challenges. The Agency reiterates that, while all threats to human life
are worker health and safety issues, not all worker health and safety
issues pose an immediate threat to human life. The temporary exception
provision is intended to capture unforeseen and immediate life-
threatening situations. For those rare and unexpected situations which
cannot be immediately addressed by any other means, this temporary
exception provision allows the OSC to consider whether the use of an
agent is appropriate. The exception provision being amended by this
action did not previously include the term ``worker safety,'' but
rather speaks to human life. Similarly, the Agency did not include the
term ``worker safety'' in the proposed rule. The Agency is clarifying
the term relative to the temporary exception to mean a ``threat'' to
human life. While the provision before the amendment used the terms
``hazard'' and ``threat'' interchangeably, the final action replaces
``hazard'' with ``threat'' for consistency and to clearly establish the
intent not to broadly cover ``worker safety.'' Section 300.150 of the
NCP establishes worker health and safety provisions to ensure these
concerns are addressed during all response actions. Specifically, the
provisions provide for an occupational safety and health program, in
compliance with applicable worker health and safety provisions of the
Occupational Safety and Health Act of 1970 (OSH Act), to be available
for the protection of workers at the response site. Among the OSH Act
provisions are requirements for a site-specific health and safety plan
that must include, at a minimum, employee training, personal protective
equipment, medical surveillance, and air monitoring. In this amendment,
the Agency is clarifying the regulatory text to specifically state that
the exception is not to be used as a substitute for compliance with
Sec. 300.150 of this part, including the use of personal protective
equipment; Sec. 300.150 of this part is outside the scope of this
action.
In the finalized provision, EPA also made some editorial changes to
the proposed text for increased clarity.
(e) Prohibited Agents or Substances
Sinking Agents. The Agency is maintaining in Sec. 300.910(e)(1)
the current prohibition for the authorization of use of sinking agents
and has clarified in the regulatory text that the prohibition applies
to any chemical agent, biological agent, or any substance that is used
to directly sink the oil to the bottom of a water body. EPA believes
that the final revisions better reflect EPA's intent and avoid
potential confusion with the use of other chemical and biological
agents. The Agency believes the prohibition on sinking agents is
appropriate in all cases and is consistent with the existing
restriction in Sec. 300.310(b) of NCP Subpart D. EPA notes that the
final provision applies to sinking agents which are defined under Sec.
300.5 as ``substances,'' and not included in the definitions of
chemical or biological agents. The final action modifies the section
title to include ``substances'' to provide greater clarity to the
applicability of the section.
Commenters recommended that the proposed rule language be further
amended to recognize the potential for some products to behave as
sinking agents depending on environmental conditions; they suggested
that the description of the prohibited agents should include those with
the potential to cause oil to sink based on the receiving environment.
Commenters also suggested that the Agency should define the difference
between ``dispersing below the surface'' and ``sinking.'' The purpose
of certain chemical agents (e.g., dispersants) is to entrain oil into
the water column; the definition of dispersants in the previous and
final rules acknowledge dispersants entrain oil ``into the water
column.'' EPA recognizes that, while these products are intended to
transfer oil into the water column, they are distinct from sinking
agents. To reflect commenter concerns, the Agency revised the proposed
text, so that the finalized amendment prohibits ``sinking agents, or
any other chemical agent, biological agent, or any substance that is
used to directly sink the oil to the bottom of a water body.'' Refer to
the section on definition of sinking agents in this preamble for
further discussion.
Some commenters requested a requirement for a screening test or
standard functional approach to determine if an agent is a sinking
agent. A commenter noted that the prohibition of sinking agents is
undermined if a product's propensity to act as a sinking agent is only
discovered after the product has been used in a discharge event. The
commenter further suggests that a test is needed to identify products
that are otherwise categorized as dispersants or other agents, but
which have the effect of submerging and sinking oil, because these
products should also be recognized as sinking agents and be prohibited.
EPA acknowledges the commenters' request for a screening test or
standard functional approach to determine if an agent is a sinking
agent. While the Agency is not including such a test or functional
approach in this final action, the provisions finalized under Sec.
300.915(a)(12) include that product manufacturers must provide physical
and chemical properties such as specific gravity as part of the product
submission package for listing on the NCP Product Schedule. In
addition, the final rule at Sec. 300.910(g) provides that the RRT may
require available data or
[[Page 38298]]
information about agents be provided during planning or at the time of
a response, allowing for modifications to the response as necessary.
EPA believes responses to oil discharges are site-specific, and this
approach provides flexibility to consider site-specific conditions.
Nonylphenol (NP) or nonylphenol ethoxylates (NPEs). The Agency had
also proposed to add a prohibition from listing on the NCP Product
Schedule and from authorizing use of any chemical or biological agents
that contain nonylphenol (NP) or nonylphenol ethoxylates (NPEs) as
components. However, the Agency has determined that chemical agents
that have either NP and NPEs as components will not be prohibited from
use under this final rule.
EPA proposed prohibiting NP and NPE to reflect the Agency's
concerns for these substances as presented in EPA's Nonylphenol and
Nonylphenol Ethoxylates Action Plan. The Agency proposed a Significant
New Use Rule (SNUR) in September of 2014, which has not been finalized
to date. The Agency is not finalizing the 2015 Subpart J proposed
amendment on NP and NPE since final action has not been taken on the
SNUR. EPA is reserving Sec. 300.910(e)(2) in lieu of finalizing the
proposed amendments. However, EPA notes that the final provisions of
this rulemaking limit the scope of information that can be claimed as
Proprietary Business Information (PBI) as part of a product submission.
Information of product components will be available for RRTs and OSCs
to consider as appropriate when reviewing authorization of use
scenarios, including whether those products contain NP or NPE
substances.
Other agents. Commenters on the proposed rule requested
prohibitions on the use of chemical or biological agents that are
formulated with any endocrine disrupting compounds (EDCs); that degrade
in a manner such that its byproducts contain prohibited substances;
that contain known or suspected human health hazards as listed on the
material safety data sheet (MSDS) or safety data sheet (SDS); or that
contain known or suspected carcinogens, hemolytic chemicals, mutagens,
neurotoxins, teratogens, and that demonstrate human and aquatic
toxicity. The Agency recognizes that there may be other substances
that, given their use circumstances, may be of concern. The Agency has
focused this final action on maintaining the existing prohibition of
sinking agents. The Agency recognizes that there may be environmental
and health concerns associated with any response. While the final
action includes product information requirements focused on
environmental impacts, the information may also be used by OSCs to
address broader health and welfare concerns. For example, the final
rule contains a provision to include the SDS for the product as part of
the submission package (see Sec. 300.915(a)(5)). The final rule also
includes a requirement under Sec. 300.915(a)(11) for the submitter to
provide for environmental fate information on the persistence,
bioconcentration factor, bioaccumulation factor, and biodegradability
of the product and all of its components in the environment. Further,
the final provisions at Sec. 300.950 limit the information that can be
claimed as Proprietary Business Information (PBI) as part of a product
submission for listing on the NCP Product Schedule, so that product
manufacturers will not be allowed to withhold information on product
components. Thus, product component information will be available for
RRTs and OSCs to consider as appropriate, for planning and
authorization of use within the respective Area or Regional Contingency
Plans. These considerations may include, for example, whether products
contain substances of concern to human health or aquatic hazards. The
final provision also includes updated ecotoxicity testing protocols and
the listing thresholds for ecotoxicity.
A commenter expressed opposition to the proposal's opening language
which they believed would allow the exception clause in Sec.
300.910(d) to apply to Sec. 300.910(e) and allow the OSC to use a
prohibited product. The Agency disagrees with the commenter's
interpretation of the proposed regulatory text in Sec. 300.910(e). The
temporary exception under Sec. 300.910(d) applies to a ``chemical or
biological agent.'' While subject to the provisions under Subpart J,
the definitions of chemical or biological agents do not include sinking
agents. Therefore, sinking agents are not included in the temporary
exception under Sec. 300.910(d). Nevertheless, in the final action,
EPA is not including the proposed opening clause to the provision,
``Notwithstanding paragraph (d) of this section . . .'' because it is
unnecessary and to avoid the misunderstanding described by the
commenter.
(f) Storage and Use of Agents Listed on the NCP Product Schedule
The Agency is adding a new provision, Sec. 300.910(f), to
complement the existing information requirements for the person or
entity submitting a product for listing (``submitter'') in Sec.
300.915. The new requirements focus on the use of this information by
the responder and the OSC. EPA has organized the final provisions into
subsections (f)(1) and (f)(2) for greater clarity. Specifically, the
provision at Sec. 300.910(f)(1) requires the OSC to only authorize for
use those products listed on the NCP Product Schedule that are
documented and certified by the responsible party or its representative
to have been stored under the conditions specified by the submitter of
the product for listing, including the maximum, minimum and optimum
temperatures, humidity and any other relevant conditions, and whose
date of use does not exceed the expiration date listed on the
container's label, unless otherwise specified for expired products as
provided in Sec. 300.910(f)(2), at the time of the incident. Under
Sec. 300.910(f)(2), the OSC may authorize for use products listed on
the NCP Product Schedule that exceed their expiration date after the
responsible party or its representative documents and certifies that
the expired product has been stored under the conditions provided by
the submitter under Sec. 300.915(a)(6) and still meets the applicable
efficacy and toxicity-listing provisions under Sec. 300.915 based on
testing of representative samples within the previous 12 months. The
title of the provision has been changed from the proposed ``Storage and
Use of Agents'' to ``Storage and Use of Agents Listed on the NCP
Product Schedule'' to provide more clarity on its scope.
Some commenters recommended that the shelf life for biological
agents and bioremediation agents be limited to one year since living
products will degrade more quickly than chemical agents. The Agency
notes that the product shelf life provision does not provide separate
consideration for biological and bioremediation agents from chemical
agents. However, the final rule amended the proposed five-year testing
timeframe to recognize products may have shorter shelf lives as
evidenced by some products currently on the NCP Product Schedule. The
shelf life is provided by the product manufacturer based on the
inherent properties of the product. The product manufacturer is
required to submit documentation supporting the shelf life
determination. Furthermore, the final provisions include a requirement
for the responsible party or its representative to document and certify
that an expired product still meets the applicable efficacy and
toxicity provisions for listing under
[[Page 38299]]
Sec. 300.915 based on testing of representative samples within the
previous 12 months for an OSC to consider authorizing products beyond
their expiration dates.
Commenters suggested that other oil spill mitigating devices and
substances should be included in this provision for consistency with
other sections. The Agency disagrees the provisions under Sec.
300.910(f) should include other oil spill mitigating devices and
substances, other than the specific product categories of chemical and
biological agents already identified for listing on the NCP Product
Schedule. The final rule amends the section title and regulatory
paragraph to clarify that the provision is applicable to agent products
``Listed on the NCP Product Schedule.''
Commenters also suggested that the rule require disposal of expired
chemical agents. Some commenters suggested that the Agency should
require the disposal of all products once the expiration date has
passed, regardless of any testing. The Agency disagrees with the
request to include provisions addressing the disposal of expired
chemical agents in the final rule. Disposal of oil and contaminated
materials recovered in cleanup operations is addressed in Sec. 300.310
of the NCP. While the final provisions provide for the retesting of
expired products, the disposal of products, including expired products,
is outside the scope of this action.
Some commenters recommended that no additional requirements be put
in place for product shelf life, other than what is recommended by the
manufacturer. However, EPA is finalizing re-testing provisions to
provide flexibility for chemical or biological agents to be considered
for use past their designated shelf life provided they still meet
efficacy and toxicity testing requirements. The provision under Sec.
300.910(f)(2) is voluntary in that it does not require expired products
to be retested but is an option for the responsible party if they want
an OSC to be able to authorize their use.
Commenters suggested that there is no justification for mandating a
shelf life that could limit the use of stockpiles that remain viable
and effective. EPA did not mandate a specific shelf life for products
listed on the NCP Product Schedule. However, EPA believes that users of
products should follow the manufacturer's storage conditions and shelf
life recommendations, as submitted according to Sec. 300.915(a)(6) and
(a)(7). Based on public comments, EPA made changes to the proposed re-
testing provisions in the final amendments. The final provisions
provide the OSC with the discretion to authorize products listed on the
NCP Product Schedule that exceed their expiration date. However, this
discretion is only available after the responsible party or its
representative documents and certifies that the expired product still
meets the applicable efficacy and toxicity provisions for listing under
Sec. 300.915, based on testing of representative samples within the
previous 12 months.
Some commenters expressed support for retesting requirements but
indicated that efficacy of the product is the only relevant endpoint
for testing regardless of age. The commenters recommended that there is
no scientific justification for toxicity re-testing, and that only
effectiveness testing should be conducted rather than all of the tests
described in Appendix C. A commenter stated that testing requirements
should allow for acceptable levels of variability in efficacy results,
recommending an allowable 10% variance in effectiveness test results.
The Agency disagrees with the commenters' concerns that effectiveness
testing is the only retesting that should be considered and that the
efficacy testing requirements need to allow for acceptable levels of
variability in efficacy results. The Agency recognizes that some
products stored over time may not obtain the same efficacy or toxicity
testing results for the product's original listing submission yet may
still meet the applicable threshold(s) that were required to list the
product on the NCP Product Schedule. However, EPA also recognizes that
some products stored over time may not meet the applicable threshold
requirements. EPA believes that products stored beyond the expiration
date listed on the container's label and that, upon retesting, do not
meet the applicable threshold(s) that were required to list the product
on the NCP Product Schedule, no longer represent the product approved
for listing on the NCP Product Schedule. A variance could allow expired
products that do not meet the applicable threshold requirements for
listing on the NCP Product Schedule to be available for authorization
upon retesting, while other products with similar results would be
denied listing on the NCP Product Schedule.
(g) Supplemental Testing, Monitoring, and Information
The Agency is finalizing at Sec. 300.910(g) an amended provision
that maintains the RRT's authority to require supplementary toxicity
and efficacy testing, or to request available data or information that
addresses site-, area-, or ecosystem-specific concerns relative to the
use of product for both planning and authorization of use. The
amendment adds flexibility to the former requirement by removing ``When
developing preauthorization plans . . .'' and by including ``or
submission of available data and information'' to recognize that
existing data or information that addresses site-, area-, or ecosystem-
specific concerns relative to the use of a product may be available.
Additionally, in the final action, EPA modified the proposed language
to specify that this supplemental testing, monitoring, and information
may be required ``for both planning and response, including
authorization of use'' to emphasize the broad potential use of this
data. As proposed, the Agency is including the term ``ecosystem'' with
area and site-specific concerns, as RRTs may want to gather additional
information on the use of certain products when assessing the
biological communities specific to their area. In the final amendment,
EPA has modified the proposed regulatory text to streamline it to
specify that ``The product manufacturer or responsible party shall
provide, upon request of the RRT or OSC, additional monitoring or
testing data and information to inform chemical or biological agent use
decisions specific to a response.''
Some commenters expressed opposition to the RRT's authority to
require supplemental testing, monitoring, and information, as provided
in the proposed rule. Commenters provided several reasons for the
opposition, including stating that the standard efficacy and toxicity
tests already required are more than adequate, additional testing would
cause a delay in the spill response; the current testing requirements
in the rule and/or NCP are adequate and additional data is unlikely to
provide valuable information for decision making; additional data may
create confusion; additional data collection would increase costs for
facilities; and unnecessary animal testing should be avoided. One
commenter stated that no information is provided in the rule as to what
circumstances might trigger an RRT's request for supplemental testing,
monitoring, or information. The Agency disagrees with the commenters'
opposition to recognizing that RRTs may require supplemental testing,
monitoring, and information. In addition to planning, this provision
aims to provide discharge-specific information that may assist in
decision
[[Page 38300]]
making during a response. The Agency notes this is a discretionary
provision for the RRT to require supplemental information, and that the
RRT may coordinate with the OSC to address any concerns related to
requiring additional information. Standard toxicity tests required in
the final rule encompass only a few species and are not necessarily
intended to be protective of site-, area- or ecosystem-specific
concerns. Decades of research show that species can vary substantially
in sensitivity, and that ecosystems contain a diversity of species of
mostly unknown sensitivity. The Agency believes retaining the option
for the RRT to require supplemental testing, monitoring, and
information that addresses incident-specific concerns for planning and
response relative to product use is reasonable and prudent. For
example, the provision provides flexibility in gathering scientific
information relevant to a given site or geographic location and allows
for better targeting chemical and biological agent use during a
response. The absence of the final provision for the RRTs to require
supplemental testing, monitoring, and information may adversely impact
the RRT's ability to provide informed concurrence and consultation
determinations. EPA also notes that the provision under Sec.
300.910(a) for preauthorizing an OSC to authorize the use of a chemical
or biological agent does not preclude the RRT from requiring additional
monitoring and information.
A commenter opposed this provision because they asserted that the
required tests would not inform operational decision making during the
response, but rather would develop data for the Natural Resource Damage
Assessment (NRDA) process. EPA agrees with the comment that
``operational monitoring and NRDA are two different things''. This
provision is separate from NRDA monitoring, testing, and data
collection; NRDA monitoring, testing, and data collection is outside
the scope of this provision. To clarify this point, EPA has modified
the provision from the proposed language. The finalized, streamlined
provision states that the RRT or OSC may request additional monitoring
or testing data and information to ``inform chemical or biological
agent use decisions specific to a response.'' EPA notes the purpose of
the provision is to provide the OSC and RRT, if necessary, supplemental
data, including monitoring data which may not be already derived from
required monitoring plans included within ACPs.
Some commenters opposed the RRT authority to request additional
monitoring associated with the use of a product during a discharge and
expressed concern that this provision could be potentially used during
a discharge situation to prevent or delay the use of chemical or
biological agents for non-technical reasons and thus potentially reduce
the effectiveness of the response. The Agency disagrees. This provision
aims to provide incident-specific information that may assist in
decision making during a response, not to hinder the overall response
time. The Agency does not believe these requirements would delay or
impede response actions such as the deployment of mechanical recovery
or other response related equipment. EPA disagrees with the commenters'
concern that giving the RRT authority to request additional monitoring
associated with the use of a product during a discharge could
specifically delay the use of a chemical or biological agent and reduce
the effectiveness of a response. This provision is not intended to
delay the use of an agent, but rather to inform and reduce the
uncertainties associated with a chemical or biological agent during the
response. The Agency notes this is a discretionary provision for the
RRT to request supplemental information, and that the RRT may
coordinate with the OSC to address any concerns related to the request.
A commenter suggested that the regulation should provide that Area
Committees, in addition to RRTs, are authorized to request that the OSC
require additional monitoring, and that the OSC may independently
require this additional monitoring absent a particular request from the
RRT or Area Committee. The Agency disagrees with the commenter's
suggestion. The NCP establishes the roles and responsibilities for RRTs
and Area Committees. The Area Committees are responsible for preparing
ACPs for their designated areas as described in Sec. 300.210(c). The
RRT responsibilities under the NCP include the development and
coordination of preparedness activities before a response action is
taken, as well as coordination of assistance and advice to the OSC
during response actions, as described in Sec. 300.115. The Agency
believes it is appropriate to focus this provision on the RRTs given
their operational roles, including the role of certain RRT members in
authorizing the use of chemical or biological agents. Thus, the final
rule states the product manufacturer or responsible party shall
provide, upon request of the RRT or OSC, additional monitoring or
testing data and information to support chemical or biological agent
use decisions specific to a response.
(h) Recovery of Chemical Agents and Other Substances From the
Environment
The Agency is adding a new provision at Sec. 300.910(h) to require
the responsible party to recover solidifiers, sorbents, and surface
washing agents from the environment following their use. The provision
requires that the responsible party shall ensure that removal actions
adequately contain, collect, store, and dispose of solidifiers, surface
washing agents, and sorbents, unless otherwise directed by the OSC. EPA
identifies each of these agents or other substances, in their
respective finalized definitions in Sec. 300.5, as needing to be
recovered from the environment to minimize any potential adverse
impact. The Agency recognizes there may be situations where the safety
of response personnel is threatened, or where additional harm to the
environment could occur during recovery operations, so the final
provision provides that the OSC should, at a minimum, consider factors
such as the safety of response personnel and harm to the environment in
making recovery-related determinations. Furthermore, the Agency has
modified the title of the section as ``Recovery of Chemical Agents and
Other Substances from the Environment'' to recognize that sorbents are
covered under Sec. 300.910(h).
Commenters expressed support for the identification of the agent
categories and substances intended to be removed from the environment
following their use as described in the preamble to the proposed rule:
solidifiers, sorbents, and surface washing agents. However, other
commenters requested clarification in the regulatory text as to which
substances or agents are covered, noting that it should apply to
solidifiers, sorbents, and surface washing agents as well as other oil
spill mitigating devices, oil-product combinations, and weathered oil.
A commenter stated that the phrase ``agents that are intended to be
recovered from the environment'' is ambiguous and suggested that EPA
change the language to clarify that this provision applies to
``substances'' including sorbents, rather than solely agents. EPA
recognizes the request to clarify in the regulatory text as to which
substances or agents are covered. Based on comments, EPA amended the
final provisions in Sec. 300.910(h) relative to the proposal to
address chemical agents and other substances to be recovered from the
environment to specifically include solidifiers, surface washing
agents, and sorbents.
[[Page 38301]]
Some commenters suggested additions to the proposed language to
further specify requirements. EPA recognizes a commenter's request for
additional language that would serve to quantify the term
``adequately,'' a commenter's suggestion that the language should be
modified to clarify that recovery of substances should be completed
``to the extent possible,'' and the suggestion that removal action
agents should always be recovered from the environment. Under Sec.
300.120, the OSC directs response efforts and coordinates all other
efforts at the scene of a discharge. EPA believes that it is the OSC
who will make the determination of when the recovery of agents from the
environment is adequate for the specific response. These activities are
to be done in accordance with applicable federal, state, Tribal and
local requirements. Thus, the Agency maintains in the final rule the
requirements for the responsible party to ensure that removal actions
adequately contain, collect, store, and dispose of chemical agents and
other substances that are to be recovered from the environment, unless
otherwise directed by the OSC. The Agency does not believe the final
provision should be modified to include ``to the extent possible''
since it already provides for that expectation, subject to the
direction of the OSC. The OSC should, at a minimum, consider factors
such as the safety of response personnel and harm to the environment in
making such determinations. EPA amended the final provision with the
phrase ``at a minimum'' to recognize that factors other than the
examples provided may be considered.
The Agency acknowledges a commenter's suggestion to make it
explicitly clear in the regulatory text that the OSC has the authority
to utilize the NEBA framework. The Agency is not taking action on this
comment. The NCP continues not to require nor preclude the use of any
specific environmental tradeoff methodology to identify protective
strategies that may minimize the potential environmental impact of
hazardous substance releases or oil discharges. In addition, the NCP
continues not to define NEBA. While EPA recognizes the need to
establish specific criteria and monitoring for removal actions overall,
this section specifically focuses on actions when chemical or
biological agents are used.
The Agency acknowledges the comment that the ability to use a given
substance in a response should be dependent on the development of a
removal/recovery plan, as well as the comment that removal action
agents should not be considered for use if safety or environmental
concerns regarding recovery of these agents exist prior to deployment.
The Agency notes that there are certain chemical agents and other
substances that are intended to be recovered from the environment; EPA
amended the final provision to acknowledge that chemical agents and
other substances to be recovered include solidifiers, surface washing
agents, and sorbents, and revised the title accordingly. EPA believes
RRTs and OSCs may consider these factors when determining under what
conditions to authorize their use, as applicable. EPA also believes
that the final provision provides stakeholders the opportunity to
develop removal/recovery plans for these agents and substances. It is
important to note that removal actions that consider the use of
chemical or biological agents and other substances must do so in
accordance with Subpart J.
Some commenters suggested that recovered materials should be
treated as a hazardous waste so that they are not disposed of in public
landfills, as a matter of public health. Under the NCP, oil and
contaminated materials recovered in cleanup operations are to be
disposed of in accordance with the Regional Contingency Plan (RCP),
ACP, and any applicable laws, regulations, or requirements, as stated
in Sec. 300.310(c). The applicability of hazardous waste regulations
is outside the scope of this final action.
(i) Reporting of Agent Use
The Agency is adding a new provision at Sec. 300.910(i)(1), to
require the OSC to provide to the RRT certain information for the use
of a chemical or biological agent within 30 days of completion of agent
use. The information required for any chemical or biological agent used
in response to an oil discharge includes product name, product
category, the quantity and concentration used, and the duration of use,
the locations where the agent was used, any available data collected,
and any available analyses of efficacy and environmental effects. This
information may be submitted in accordance with the OSC reporting
provisions under Sec. 300.165 of this part, as applicable, subject to
the 30-day timing requirement. While other existing notification
requirements serve to activate an immediate response to an event, this
requirement gathers information that will be useful in specifically
evaluating the use of chemical or biological agents in the response,
informing the review of preauthorization plans, and providing a basis
for any necessary changes to improve environmental protection.
Additionally, Sec. 300.910(i)(2) requires that the authorizing OSC
provide for notification to the public, to be updated during a response
as appropriate, the following information on chemical and biological
agents used in response to an oil discharge: product name, product
category, quantity and concentrations used, duration of use, and
location(s) of use.
Several commenters recommended that timely public notification of
product use be required and that reports should be accessible to the
public. A commenter recommended initial notification of product use
within 24 hours and daily public notification thereafter, stating that
accessibility is a matter of health and government accountability. This
commenter also requested simultaneous notification of Tribal
governments, Area Committees, and Citizens' Advisory Councils. A
commenter recommended adding language requiring the responsible party
to inform nearby landowners of dispersant use impacts that may affect
natural or cultural resources. The Agency generally agrees with
commenters' recommendations of providing timely public reporting of
product use and is finalizing a new provision that will require the OSC
to provide notification to the public. Under Sec. Sec. 300.135(n) and
300.155(a), both of which are provisions outside the scope of this
action, the NCP already provides that the OSC should ensure all
appropriate public and private interests are kept informed and that
their concerns are considered throughout a response, to the extent
practicable. Based upon comments received requesting public
notification of chemical and biological agent use, the Agency is
including a new notification provision at Sec. 300.910(i)(2) that
requires the OSC to provide for public notification, updated during a
response as appropriate, regarding information on chemical and
biological agents used in response to an oil discharge to include the
following: product name, quantity and concentrations used, duration of
use, and location(s) of use. The new provision requires the OSC to
provide notification to the public in support of Sec. Sec. 300.135(n)
and 300.155(a) and (b). While EPA agrees that the OSC should provide
timely public notification, the Agency disagrees that the initial
notification should be required to be within 24 hours of product use.
EPA believes the OSC should have the flexibility to establish the
initial timeframe to avoid potential delays in addressing roles and
responsibilities under the NCP, such as obtaining the
[[Page 38302]]
necessary concurrences and consultations from certain RRT member
agencies on chemical and biological agent use. EPA believes that the
OSC, as the entity with overall responsibility to direct the response,
is the appropriate party to provide the public notification. Public
notification may occur, for example, through coordination with the RRT
and posting on their website, as appropriate. EPA also believes that
the public notification provision in the final rule also addresses
commenter's request that reporting include notification of Tribal
governments, Area Committees, Citizens' Advisory Councils, and
landowners.
Some commenters suggested changes to the proposed reporting
requirements. A commenter recommended that the regulatory text clarify
that reporting is required in the case of sorbent use. Commenters
suggested that reports should include an overview of the incident,
description of how the agent applications were conducted, description
of all monitoring conducted and the results, a description of any
adverse environmental effects, water depth and proximity to shoreline,
and the amount of product and oil-product recovered. This commenter
suggested that the rule may need to include reference to consultations
under section 7 of the Endangered Species Act (ESA), depending on the
nature of environmental impacts from a given spill, and that the
reporting requirements should be mandatory, not just if requested by
the RRT or the natural resource trustee. EPA disagrees with expanding
the scope of the Reporting of Agent Use provision to include other
spill mitigating devices and substances including sorbents and other
aspects of the removal operation. The purpose of the requirement is to
gather information that will be useful in evaluating the use of
chemical or biological agents in the response. Sorbents are not
included in the definition of chemical or biological agents under
Subpart J and are not subject to the authorization of use provisions
under Sec. 300.910(a) or (b); therefore, the Agency disagrees that
reporting should be required in the case of sorbent use. The
information reported through this reporting provision is also intended
to inform the review of preauthorization plans and provide a basis for
any necessary changes to improve environmental protection. The RRT has
existing authority to require the OSC to submit a complete report under
Sec. 300.165 to obtain information that more broadly covers the
removal operation and the actions taken, which may include the
information suggested by the commenters (e.g., overview of the
incident). While the Agency recognizes that consultations under ESA
section 7 may be warranted, it is important to clarify that a purpose
of this reporting requirement is for the RRT and EPA to gather
information specific to the use of a product in a response.
3. Data and Information Requirements for Listing on the NCP Product
Schedule or Sorbent Product List
The Agency is revising the data and information requirements in
Sec. 300.915 of Subpart J for listing products on the NCP Product
Schedule or Sorbent Product List, identifying the relevant science to
establish a national screening process for products to be listed. The
amendments revise the efficacy and toxicity testing protocols and
listing criteria for all chemical and biological agents on the NCP
Product Schedule, and requirements for listing on the Sorbent Product
List. Additionally, the Agency is revising the requirements for general
product information, Proprietary Business Information (PBI) claims,
submission package contents, EPA review and listing procedures,
requests for decision review, changes to products, transitioning
products from the current NCP Product Schedule to the new NCP Product
Schedule and for listing on the new Sorbent Product List, mandatory
product disclaimer, and removal of products from the NCP Product
Schedule or Sorbent Product List. The final action specifically
includes references to the new Sorbent Product List as clarifying
edits.
The Agency recognizes comments that asserted that burning agents
should be added to the NCP Product Schedule and that the Agency should
require toxicity testing of burning agents, of combustion products
(e.g., smoke plumes), and of the burn residue that results from
application of burning agents to oil slicks. The Agency continues to
believe that because of the nature of burning agents and the revisions
to the authorization of use for burning agents in the final rule, it is
not necessary to require product submissions for burning agents. See
section V.C.2.c of this preamble for more information on burning
agents.
(a) General Product Information
EPA is consolidating in paragraph (a) of Sec. 300.915 the general
submission requirements applicable to all types of agents that may be
listed on the NCP Product Schedule or Sorbent Product List. The
revisions group together and simplify the general submission
requirements applicable to all product types. EPA believes that
reorganizing the general requirements in a central location will
clarify which requirements are applicable to all submissions, and which
are specific to each product type by including them in separate
sections. The general information requirements for products are as
follows:
Submitter. Under Sec. 300.915(a)(1), EPA is requiring the name,
physical address, email, and telephone number of the submitter. Under
Sec. 300.915(a)(2), EPA is requiring the identity of the submitter
(i.e., manufacturer, vendor, importer, distributor, designated agent
for the manufacturer), and documentation of such identity. This
requirement is intended to clearly establish the point of contact
responsible for the submission, and to avoid any conflicts or claims
from unauthorized entities on products listed or submitted for
consideration. No comments on these provisions were identified. EPA
reorganized the provision under Sec. 300.915(a)(2) to provide greater
clarity by moving the documentation requirement forward and by making
editorial changes.
General product information. Under Sec. 300.915(a)(3), EPA is
requiring the submitter to provide all name(s), brand(s), and/or
trademark(s) under which the product is to be sold. No comments on
Sec. 300.915(a)(3) were identified.
Supplier. Under Sec. 300.915(a)(4), EPA is requiring the names,
physical addresses, emails, and telephone numbers of the primary
distributors, vendors, importers, and/or designated agent acting on
behalf of the manufacturer. No comments on Sec. 300.915(a)(4) were
identified. EPA made editorial changes from the proposed text to
provide greater clarity.
Safety Data Sheet. The provision at Sec. 300.915(a)(5) requires
the submitter to provide a Safety Data Sheet (SDS). EPA recognizes that
chemical and biological agents may contain substances that could
potentially cause harm to oil spill responders who, if unaware of the
product's composition, may not wear the proper personal protective
equipment. SDSs describe the hazards that may be involved with the
product and recommend safety measures that would minimize or avoid
adverse consequences that may result from exposures. The Agency
believes SDS information will be useful to both OSCs and responders
when authorizing and using the product respectively. Several commenters
suggested that the Agency should require that SDS information be
submitted for each individual product component. Agency disagrees that
that SDS information needs to be submitted for each individual product
component.
[[Page 38303]]
EPA believes that the SDS for the product, rather than for each
component, is more appropriate for responders to use during a response.
EPA believes that requiring an SDS for each product component would add
unnecessary burden to the submitter. The information that is required
to be included in an SDS is the responsibility of the Occupational
Safety and Health Administration (OSHA) and is outside the scope of
this rulemaking. The Hazard Communication Standard (HCS) (29 CFR
1910.1200(g)) requires that the chemical manufacturer, distributor, or
importer provide Safety Data Sheets (SDSs) for each hazardous chemical
to downstream users to communicate information on these hazards. The
SDS includes information such as the properties of each chemical; the
physical, health, and environmental health hazards; protective
measures; and safety precautions for handling, storing, and
transporting the chemical. In addition, OSHA requires that SDS
preparers provide specific minimum information as detailed in Appendix
D of 29 CFR 1910.1200. The Agency believes the SDS along with the NCP
Subpart J Technical Notebook \4\ provides useful information to OSCs,
RRTs, and responders when authorizing and using the product
respectively. EPA notes the final revisions to Sec. 300.950,
Submission of Proprietary Business Information (PBI), provide greater
awareness of product components to OSCs, other stakeholders, and the
public.
---------------------------------------------------------------------------
\4\ The NCP Subpart J Technical Notebook presents manufacturer's
summary information on the conditions under which each of the
products is recommended to be used.
---------------------------------------------------------------------------
Product Storage and Shelf Life. Under Sec. 300.915(a)(6), EPA is
requiring the submitter to provide the maximum, minimum, and optimum
temperature, humidity, and other relevant conditions for product
storage and a brief description of the consequences to performance if
the product is not stored within these limits. Under Sec.
300.915(a)(7), EPA is requiring the anticipated shelf life of the
product at the storage conditions noted in paragraph (a)(6) and
documentation for this determination.
A commenter suggested requiring the submitter to identify the
method of product storage (e.g., 55-gallon drum, 200-gallon plastic
tote, etc.) and provide information on the storage container materials.
The Agency does not believe it necessary to amend the regulatory text
for this purpose. EPA notes that Sec. 300.915(a)(7) requires
documentation to support a manufacturer's determination of the
anticipated shelf life of the product at the storage conditions. EPA
believes this provision satisfies the commenter's concern regarding
information on the storage container materials and methods that are
likely to affect the product shelf life.
Product Labels. The provision at Sec. 300.915(a)(8) requires
sample product labels for all name(s), brand(s), and/or trademark(s)
under which the product is to be sold that includes manufacture and
expiration dates, and conditions for storage, and notes that the
submitter may use an existing label provided it already contains the
required dates and storage information. This requirement is not
intended in any way to supersede any other federal labeling requirement
in place (e.g., OSHA's HAZCOM). The requirement is intended to assist
the OSC in ensuring that the product used to respond to an incident is
still viable and effective, and the oil spill removal organizations or
any other responder that is storing the product to ensure that their
stockpile is viable and available to be authorized for use. No comments
on Sec. 300.915(a)(8) were identified.
Chemical or Biological Agent Category. The provision at Sec.
300.915(a)(9) requires the chemical or biological agent category under
which the product is to be considered for listing on the NCP Product
Schedule, including detailed information on the specific process(es)
through which the product affects the oil, and the specific
environment(s) on which it is intended to be used (e.g., waters and/or
adjoining shorelines). If the product meets the definition of more than
one chemical or biological agent category, submitters must identify all
applicable categories and provide the test data to meet the listing
criteria appropriate to each category. A commenter suggested revising
Sec. 300.915(a)(9) to allow the manufacturer to indicate the primary
and other non-primary functions to help the response team determine
whether a product is best suited for a given response situation.
Another commenter suggested that bioremediation agent formulas should
be restricted to only those components necessary for the proposed
primary use of any listed product, noting, for example, that
bioremediation agents formulated for land-based settings may not need
components such as surfactants to be effective, whereas the product may
not need other components such as sugars and nutrients to be effective
for use in or near water. EPA does not believe such a revision is
necessary in Sec. 300.915(a)(9) because the final rule includes a
requirement under Sec. 300.915(a)(13) for the product submitter to
provide information on the intended function of each component. The
Agency believes these provisions will help OSCs determine whether a
product is appropriate for any given response situation. EPA notes that
some components other than those components necessary for the primary
use may still serve to support the product's function. However, EPA
also recognizes concerns that a product (e.g., bioremediation agents)
may contain components that may support an alternate mechanism of
action (e.g., surfactants) and could potentially meet the definition of
another product category (e.g., dispersants). Based on comments, EPA
amended the final provision under Sec. 300.915(a)(9) to remove the
phrase ``. . . and you want it considered for listing on the NCP
Product Schedule in more than one category . . .'' to ensure that
product manufacturers identify all applicable chemical or biological
agent categories. If a product meets the definition of more than one
chemical or biological agent category, the product manufacturers must
provide the test data appropriate to each category. The final provision
ensures that the Agency will receive the information necessary to
evaluate the product for listing on the NCP Product Schedule in all
categories in which the product may be listed, regardless of whether
the submitter requests it to be listed in a specific product category.
In these finalized provisions, EPA also made some editorial changes
to the proposed text for increased clarity and consistency.
Recommended Product Use Procedures. Under Sec. 300.915(a)(10), EPA
is requiring the submission of recommended product use procedures,
including product concentrations, use ratios, types of application
equipment, conditions for use, any application restrictions; and, as
applicable, for product and oil containment, collection, recovery, and
disposal procedures. These procedures must address, as appropriate,
variables such as weather, water salinity, water temperature, types and
weathering states of oils or other pollutants. The procedures must
include supporting documentation and current applicable standard
methods used to determine them. EPA believes that providing detailed
information on the recommended product use procedures is necessary to
inform the OSC when authorizing these products. This supporting
documentation and specific information on the methods and standards
used to establish them will inform OSCs and other response personnel in
selecting products that can be effectively used under the operating
[[Page 38304]]
conditions encountered for any given incident.
The Agency recognizes the commenter that recommended that EPA
require turbidity measurement in Sec. 300.915(a)(10); however, EPA did
not make this change because the regulatory text in Sec.
300.915(a)(10) for variables (e.g., weather, water salinity, water
temperature, types and weathering states of oils or other pollutants,
and product and oil containment, collection) that the product use
procedures must address is not an exhaustive set of variables. In
addition, the provisions under Sec. 300.915(a) apply to all product
categories, unless otherwise specified, such as bioremediation agents
that are typically used on shorelines. The provisions under Sec.
300.915(a)(10) provide flexibility for product manufacturers to submit
information relevant to their product and this final action does not
preclude the submitter from measuring turbidity of its product or
including turbidity measurements in its submission for listing on the
NCP Product Schedule, where appropriate. Furthermore, the monitoring
requirements for dispersant use in response to major oil discharges
include a requirement at Sec. 300.913 to measure ambient background,
baseline, and dispersed oil plume water column samples for turbidity.
EPA also acknowledges the commenter who suggested that EPA require
the following in a submission: training and personal protective
equipment (PPE) needs of the workers applying the product, health
monitoring for the workers, whether the product requires special waste
disposal, and whether the product is safe to use in sensitive areas
such as near communities or water supplies. EPA believes that various
NCP provisions already address this request. This final action includes
the requirement at Sec. 300.915(a)(5) to provide a SDS for the
product, which includes PPE information. Furthermore, EPA notes that
the NCP addresses worker health and safety under Sec. 300.150,
including compliance with applicable OSHA regulations and addresses
availability of adequately trained operators under Sec. 300.910(a) and
(b), respectively. Additionally, Sec. 300.915(a)(10) requires
recommended product use procedures, including product concentrations,
use ratios, types of application equipment, conditions for use, and any
application restrictions; and, as applicable, for product and oil
containment, collection, recovery, and disposal procedures. The NCP
addresses the disposal of oil and contaminated materials recovered in
cleanup operations in accordance with the RCP, ACP, and any applicable
laws, regulations, or requirements under Sec. 300.310(c). Waste
disposal is outside the scope of this final action.
In the final action, EPA reorganized the provision under Sec.
300.915(a)(10) including moving forward the phrase regarding procedures
for product and oil containment, collection, recovery, and disposal
procedures to provide greater clarity and adding the term ``as
applicable,'' to recognize that not all products may be collected and
recovered. EPA also made other editorial changes for greater clarity.
Environmental Fate. Under Sec. 300.915(a)(11), EPA is requiring
environmental fate information, including any known measured data,
methodologies, and supporting documentation, on the persistence,
bioconcentration factor, bioaccumulation factor, and biodegradability
of the product and all of its components in the environment. EPA
believes environmental fate information is necessary to inform the OSCs
when authorizing these products for use, given the potential for their
extended use in significant quantities. However, given that these
factors can be estimated, the final action is only requiring that
available information or data be submitted on the product rather than
specific product testing, as specific product testing for these factors
can add significantly to the testing cost for each product.
Regarding the Agency's request for comment on whether testing for
products' bioconcentration, bioaccumulation, and biodegradation should
be required for listing purposes, some commenters stated that testing
should be required, and one expressed concern that reliance on existing
data, rather than specifying a core required data package, may result
in variable and incomplete understanding of these key factors which in
turn influence chemical fate and biological effects of the product. EPA
notes that the final provision provides flexibility to submit the
required information with supporting documentation and also does not
preclude submitting results from product-specific testing of these
parameters. The submitter may use estimation techniques/models, such as
the EPA model EPI Suite\TM\, to estimate environmental fate properties.
Based on comments, EPA amended Sec. 300.915(a)(11) for product
submissions to include the test methodologies used to obtain the
environmental fate information, providing additional context on the
data. EPA notes that the Agency reserves the right to request
clarification or additional information, as necessary (see Sec.
300.955(c)(1)).
Regarding the Agency's request for comment on whether thresholds
for bioconcentration factors and bioaccumulation factors should be
established for listing a product on the NCP Product Schedule, some
commenters recommended that EPA should set thresholds for a product's
persistence, bioaccumulation, and biodegradability for listing a
product on the NCP Product Schedule, and to assist the OSC in
authorizing use and establishing safe application rates. Another
commenter suggested having minimum ``pass or fail requirements'' with
added optional information fields for NCP listing. EPA recognizes that
environmental fate information informs OSCs when authorizing these
products for use, given the potential for their extended use in
significant quantities. The new provisions will assist EPA in
evaluating a product's persistence, bioaccumulation, and
biodegradability. However, for oil spill response products, the Agency
does not have sufficient information to establish thresholds for all
environmental conditions that may be potentially encountered. The
Agency did not propose, nor did it identify any relevant information to
establish, thresholds beyond those already included in the final
action. While EPA is not establishing thresholds for environmental fate
information of chemical and biological agents, the final provisions
require the submission of available environmental fate information to
the Agency for listing a product on the NCP Product Schedule. The
Agency intends to make the submitted information available to the
public and other interested stakeholders (e.g., natural resource
trustees).
The Agency amended the final provision to replace the phrase
``Environmental fate information . . .'' with ``Available information
on environmental fate . . .'' to address the comment that environmental
fate data should be reported only if it is already available and
included the phrase ``current applicable'' to avoid the submission of
data based on test methodologies that have been superseded by later
updates. EPA also reorganized the paragraph to clarify the
requirements.
Physical and Chemical Properties. Under Sec. 300.915(a)(12), EPA
is requiring that the submitter provide the physical and chemical
properties of the product, as appropriate, and a citation for the
current applicable standard methods used to determine them, including:
(i) Physical state and appearance; (ii) vapor
[[Page 38305]]
pressure; (iii) flash point; (iv) pour point; (v) viscosity; (vi)
specific gravity; (vii) particle size for solid components; and (viii)
pH. Three of these elements are new physical or chemical property
requirements under this final rule: physical state and appearance;
vapor pressure; and particle size for solid components. The Agency
believes these basic data requirements will provide added context when
evaluating the products for listing determinations. These, in
combination with the other general product information requirements,
will assist the Agency in evaluating the expected product behavior, and
the process through which it would affect the oil when used in the
intended water and/or shoreline environment.
Additionally, the Agency has removed the incorporation by reference
of specific standards to determine physical and chemical properties and
replaced this with a requirement for a citation of the current
applicable standard methodology used to determine these values. EPA
believes that citing the current applicable standard methodology used
to determine the required values is sufficient in lieu of specifying
commonly recognized standard methodologies. Furthermore, EPA did not
incorporate by reference specific test methodologies in the regulation
to avoid the administrative burden of updating the NCP every time a
test methodology is updated to a newer version. The Agency believes it
is appropriate to make this change given the added requirement for
accredited laboratories to conduct the testing (Sec. 300.915(a)(17)).
EPA amended this provision relative to the proposed text to qualify
``standard methods'' by adding the term ``current applicable'' to
address comments regarding additional specificity about the standard
methods used to derive physical and chemical properties. EPA included
the qualifier ``current applicable'' to provide for updates to test
methodologies and avoid the submission of data based on test
methodologies that have been superseded by later updates. EPA also made
other editorial changes to the paragraph relative to the proposed text
for greater clarity.
Under Sec. 300.915(a)(13), EPA is requiring that the submitter
provide the identity and concentration of all components in the
product, including each specific component name; corresponding Chemical
Abstract Service (CAS) Registry Number; the maximum, minimum, and
average weight percent of each component in the product; and the
intended function of each component (e.g., solvent, surfactant).
A commenter suggested that product vendors should not be required
to report the concentration of product components to the Agency, noting
that this reporting requirement may threaten a proprietary advantage.
EPA notes that the requirement to submit the identity and concentration
of all components in the product is consistent with the previous rule.
EPA believes that when chemical and biological agents are used on oil
discharges, it is important for OSCs, RRTs, and the public to have
information regarding the chemicals being added to the environment. EPA
also believes that the concentration of the product components provides
EPA with an understanding of how the product is intended to function
that cannot be provided by the submission of the identity of the
product components only. In addition, information on the concentration
of product components assists EPA in evaluating on the listing of
product on the NCP Product Schedule and under which category. The final
rule specifies what information submitters are allowed to claim as PBI
to balance public access to information with proprietary business
needs. When a company submits a product for listing on the NCP Product
Schedule, then it will be allowed to claim certain information
identified in Sec. 300.915(a)(13) or (14) as PBI.
Microorganisms, enzymes, and/or nutrients. For products that
contain microorganisms, enzymes, and/or nutrients under Sec.
300.915(a)(14), EPA is requiring that the submitter provide the
following along with a citation or a description of the methodology
used to determine: (i) The name of all microorganisms by current genus
and species, including any reclassifications, and any physical,
chemical, or biological manipulation of the genetic composition and the
weight percent of each genus in the product; (ii) the name of all
enzymes and their International Union of Biochemistry (I.U.B.)
number(s); Enzyme Classification (EC) code numbers; the source of each
enzyme; units; and specific oil-degrading activity; (iii) the name(s),
maximum, minimum, and average weight percent of the nutrients contained
in the product; and (iv) data, methodology, and supporting
documentation for the levels of bacterial, fungal, or viral pathogens
or opportunistic pathogens including, but not limited to: enteric
bacteria such as Salmonella, fecal coliforms, Shigella, coagulase
positive Staphylococci, and beta hemolytic Streptococci and
enterococci. As noted above, the final rule specifies what information
submitters are allowed to claim as PBI to balance public access to
information with proprietary business needs. When a company submits a
product for listing on the NCP Product Schedule, then it will be
allowed to claim certain information identified in Sec. 300.915(a)(13)
or (14) as PBI.
To support product screening, this final rule includes a provision
under Sec. 300.915(a)(14)(iv) to address whether products that contain
microorganisms, enzymes, and/or nutrients also contain bacterial,
fungal, or viral pathogens or opportunistic pathogens to compare to
existing applicable criteria. The Agency reconsidered, based on
comments, whether it should establish listing thresholds for products
based on National Ambient Water Quality Criteria, and whether the
levels selected for certification are appropriate for this purpose.
Comments received noted that states may develop standards that may be
more stringent than national criteria. EPA recommends that states and
authorized tribes consider the Agency's national recommended water
quality criteria when developing their criteria. However, states and
authorized tribes may adopt, where appropriate, other scientifically
defensible criteria that differ from the EPA's recommendations. In
addition, both national recommended water quality criteria and state
water quality standards may be revised from time to time. The final
provision under Sec. 300.915(a)(14)(iv) requires that products
submitters provide data, methodology, and supporting documentation for
these pathogen levels to provide relevant information, but the
provision does not require a certification that they do not exceed
recommended National Ambient Water Quality Criteria, as applicable. The
final provisions for listing products on the NCP Product Schedule or
Sorbent Product List under Sec. 300.955 allow the Agency to make
listing determinations based on a technical evaluation of all data and
information submitted in accordance with the requirements for each
product category and the relevant information on impacts or potential
impacts of the product. The Agency believes that this information is
necessary to determine if a product is suitable for listing,
particularly for bioremediation agents, which could potentially be used
at recreational beaches. EPA amended the final provision to better
reflect this approach. EPA may include information related to national
recommended ambient water quality criteria, applicable state water
quality standards, and other relevant
[[Page 38306]]
environmental screening information (e.g., aquatic life benchmarks) in
the NCP Product Schedule Technical Notebook for the RRTs, Area
Committees, and OSCs to consider when planning for and responding to
oil discharges.
A commenter suggested that Sec. 300.915(a)(14)(iv) should only
apply to bioremediation agents that fall into the microbiological
cultures category, because categories of bioremediation agents that do
not contain live cultures have completely different mechanisms of
action. The Agency disagrees that the submission requirements in Sec.
300.915(a)(14)(iv) should only apply to microbiological cultures. This
provision applies to all bioremediation agents, which include
microorganisms, enzymes, and nutrient additives, irrespective of a
classification, to ensure all bioremediation agents (not just those
that the product submitters characterize as microbiological cultures)
are subject to the requirements under Sec. 300.915(a)(14)(iv).
National Water Quality Standard Contaminants (NWQS). Under Sec.
300.915(a)(15), EPA is requiring that the submitter provide data,
methodology, and supporting documentation for the levels of the
following: (i) Arsenic, cadmium, chromium, copper, lead, mercury,
nickel, vanadium, zinc, and any other heavy metal reasonably expected
to be in the product; (ii) cyanide; (iii) chlorinated hydrocarbons;
(iv) pesticides; (v) polychlorinated biphenyls (PCBs); and (vi)
polycyclic aromatic hydrocarbons (PAHs). The Agency may consider how
these levels compare to recommended National Ambient Water Quality
Standards, as applicable. Providing information (i.e., upper limit/
concentration, detailed analytical methods, and sample preparation) on
most of these contaminants was previously required for all products,
but with no established threshold levels for product listing. The
Agency will continue to require information on the methodology and the
data and supporting documentation used to determine the levels of these
contaminants in a product. The Agency, however, is not specifying what
analytical testing method the submitter should use to make these
determinations, as it did for chlorinated hydrocarbons, allowing the
submitter flexibility in testing their product. Additionally, the
Agency is now requiring data on several additional contaminants:
pesticides, PCBs, and PAHs. The Agency's concern with pesticides as
contaminants is mostly due to their potential use on organic sorbents
(e.g., peat moss, corn cobs, and cellulose fibers). The concern for
PCBs is for their toxicity and classification as persistent organic
pollutants, having toxic effects such as endocrine disruption. PAHs are
potent atmospheric pollutants, of concern because some compounds have
been identified as carcinogenic, mutagenic, and teratogenic. The
requirements for these contaminants are intended to provide information
for listing decisions that ensure the use of any product considers
established these recommended levels.
Some commenters suggested that the proposed requirement in Sec.
300.915(a)(15) to certify that the product does not exceed NWQS
standards is not appropriate for this use because NWQS are defined as
concentrations in the water column, not in formulated products.
Commenters argue that the requirement assumes exposure to full-strength
product, but due to the dilution that occurs when a product is used in
an oil spill situation, the requirements are unnecessary. Commenters
also assert that the existing requirements to communicate hazardous
impurities on product SDSs are sufficient. A commenter suggested that
the Agency should establish a listing threshold for products based on
the National Water Quality Criteria for both acute and chronic
standards and should rank products based on their ability to not add
additional contaminants to the water. A commenter also suggested that
the Agency consider whether there are any state water quality standards
that are more stringent than the national recommended water quality
criteria. After considering comments, EPA amended the regulatory text
in Sec. 300.915(a)(15) to require the submitter to include data,
methodology, and supporting documentation on the levels of substances
identified in Sec. 300.915(a)(15). The Agency recognizes that states
may develop water quality standards that may be more or less stringent
than national criteria and that those standards may vary from state to
state. EPA recommends that states and authorized tribes consider the
Agency's national recommended water quality criteria when developing
their criteria. However, states and authorized tribes may adopt, where
appropriate, other scientifically defensible criteria that differ from
the EPA's recommendations. In addition, both national recommended water
quality criteria and state water quality standards may be revised from
time to time. While EPA is maintaining the requirements for product
submitters to include data, methodology, and supporting documentation
on the levels of substances identified in Sec. 300.915(a)(15) in their
product, the final provision does not require a certification related
to National Recommended Water Quality Criteria or applicable State
water quality standards. EPA may include information related to
national recommended ambient water quality criteria, applicable state
water quality standards, and other relevant environmental screening
information (e.g., aquatic life benchmarks) in the NCP Product Schedule
Technical Notebook for the RRTs, Area Committees, and OSCs to consider
when planning for and responding to oil discharges. To allow the
submitter flexibility in testing their product, the Agency does not
specify which analytical testing method the submitter should use to
make these contaminant level determinations for purposes of product
submission for listing on the NCP Product Schedule. The Agency notes
that the previous rule does not specify thresholds for contaminants.
Gathering data, methodology, and supporting documentation for
substances identified in Sec. 300.915(a)(15) provides a reasonable
approach to inform RRTs, Area Committees, and OSCs on the potential
addition of these substances into the environment and to address
concerns on the potential detection of these substances during a
response. EPA also notes that the final provisions include thresholds
for listing on the NCP Product Schedule based on subchronic toxicity
for dispersants. EPA included subchronic toxicity testing for
dispersants because of EPA's experience with dispersant use, including
the quantities and duration, and because dispersants are designed to
transfer oil into the water column and are not intended to be recovered
from the environment. The fact that dispersants cause oil to enter the
water column is sufficient reason to test for the subchronic
toxicological effects of dispersed oil. Based on past spill response
activities, dispersants have the potential for use over extended
durations and in larger quantities relative to other chemical and
biological agents.
No prohibited agents or substances. Under Sec. 300.915(a)(16), EPA
is requiring that the submitter provide certification, including data,
methodology, and supporting documentation, indicating that the product
does not contain any of the prohibited agents or substances identified
in Sec. 300.910(e). No comments on this provision were identified. EPA
is finalizing the provision with changes
[[Page 38307]]
to reflect the updated title to Sec. 300.910(e) ``Prohibited Agents or
Substances.''
Testing Laboratory Information and Data. Under Sec.
300.915(a)(17), EPA is requiring that the submitter provide information
about the laboratory that conducted the required tests, including: (i)
Name of the laboratory, address, contact name, email, and phone number;
and (ii) the national and/or international accreditations held by the
laboratory. At Sec. 300.915(a)(18), EPA provides the list of all test
data and calculations that are required to be submitted, including: (i)
Raw data and replicates, including positive controls; (ii) notes and
observations collected during tests; (iii) calculated mean values and
standard deviations; (iv) reports, including a summary of stock
solution preparation; (v) source and preparation of test organisms;
(vi) test conditions; and (vii) chain of custody forms.
In this final action, EPA is removing the previous requirement for
laboratories performing the efficacy and toxicity testing to have prior
experience specific to the required methodology. The Agency believes
that it is more appropriate to require that laboratories be nationally
or internationally accredited. Accredited laboratories are expected to
be capable of following a prescribed testing protocol and good general
practices, providing assurance that the test results will be reliable.
National and international accreditation organizations include, for
example, the International Organization for Standardization (ISO), and
the Laboratory Accreditation Bureau (recognized in the U.S. through the
National Cooperation for Laboratory Accreditation (NACLA) and the
International Laboratory Accreditation Cooperation (ILAC)). Commenters
expressed both support and opposition for this change. Various
commenters noted that qualified laboratories should not be barred from
conducting these analytical tests due to lack of prior experience with
a specific methodology if it has been accredited by an appropriate
authoritative body, and on the other hand that the removal of this
requirement may lead to inaccurate results being submitted to the
Agency because conducting these tests requires skilled and
knowledgeable technical resources, and that by themselves, general
accreditations do not guarantee a particular institution would have the
resources and/or expertise to conduct the necessary efficacy and
toxicity testing. The Agency believes that having no prior experience
with a specific methodology should not disqualify a laboratory that has
been accredited by an appropriate authoritative body. Therefore, the
final provisions do not include a requirement to have prior experience
specific to the required methodology. However, the Agency reserves the
right to not accept data from a laboratory should EPA find cause to
doubt the quality and integrity of the work. EPA also reserves the
right to conduct its own testing of any product.
A commenter requested that the Agency be more specific regarding
laboratory accreditation requirements. For example, a laboratory that
is accredited to perform chemical analyses may not have a similar
accreditation to conduct toxicity testing. The Agency understands that
a laboratory may be accredited to perform some of the required testing
but may not have accreditation to conduct all the required tests. A
primary laboratory selected to conduct efficacy and/or toxicity testing
may subcontract that test out to another laboratory with the required
accreditation for testing if they do not have the requisite
accreditation or capability. The final provisions require laboratories
to have accreditation applicable to the test(s) they perform. EPA is
finalizing these provisions with clarifying edits.
Production Capacity. Under Sec. 300.915(a)(19), EPA is requiring
that the submitter provide an estimate of the annual product production
volume, the average and maximum amount that could be produced per day,
and the time frame needed to reach that maximum production rate in
days. In the final provision, EPA made editorial changes to provide
greater clarity by specifying the time frame needed to reach maximum
production rate ``in days'' in lieu of ``(days).'' There was previously
no requirement for production capability information, and the Agency
believes it is important for the OSCs and responders to have this
information. The availability of a product may impact decisions of
authorization of use, depending on inventory or production
capabilities. This would prove to be of key importance, for example, in
the event of a major environmental disaster (e.g., a SONS event).
A commenter suggested that this requirement should be removed
because production capacity is not fixed, but varies with available
blending tankage, existing business demands, other product orders, and
component supplies/shipping constraints, so the information provided at
the time of the application would not be relevant to a future time when
product manufacturing could be required during a response. The
commenter suggested that the Agency alternatively modify the language
to require product manufacturers to provide production capability
within 24 hours of a request from an OSC. The Agency disagrees. It is
important to have an estimate of product capacity in the event of a
spill of any size to better understand product availability to inform
OSCs and RRTs. EPA has no previous record of product capacity for the
dispersants, or any other product, on the NCP Product Schedule. The EPA
Inspector General Report entitled Revisions Needed to National
Contingency Plan Based on Deepwater Horizon Oil Spill recommended the
need to capture and maintain dispersant manufacturer production
capacities.
Finally, EPA made editorial changes to this provision to provide
greater clarity.
Recognition Received from EPA's Design for the Environment/Safer
Choice Program. Under Sec. 300.915(a)(20), EPA is requiring that the
submitter provide recognition received from EPA's Design for the
Environment (DfE) or Safer Choice programs, as applicable. In 2015, the
Safer Choice label replaced the DfE product label. Therefore, in the
finalized provision, EPA has added reference to the Safer Choice
program. (The ``DfE'' certification is still used in some cases.
Specifically, it is used on antimicrobial products (disinfectants and
sanitizers) registered under FIFRA.) A manufacturer's participation in
the Safer Choice program is voluntary. The Safer Choice label means
that EPA scientists have evaluated all chemical ingredients, regardless
of their percentage in the product. Every ingredient must meet strict
safety criteria for both human health and the environment, including
carcinogenicity, reproductive/developmental toxicity, toxicity to
aquatic life, and persistence in the environment. For more information
on the EPA's Safer Choice program, see: https://www.epa.gov/saferchoice.
A commenter suggested that submitting this information should not
be required because the DfE certification is a voluntary program and
therefore not required. EPA disagrees; the Agency provides the
submitter with the opportunity to identify products that have met and
are labeled DfE or Safer Choice certified as part of the general
information submission, as applicable. This information may be included
in the NCP Product Schedule Technical Notebook.
International product testing, data, or certifications. Under Sec.
300.915(a)(21), EPA is requiring that the submitter provide
international product testing or use data or certifications, if
available,
[[Page 38308]]
informing the performance capabilities or environmental impacts of the
product.
A commenter suggested that the Agency clarify the ability to use
results from laboratories outside of the United States. The commenter
also requested that the Agency clarify its statements regarding
``International Product Certifications, testing or use data informing
the performance capabilities or environmental benefits of the
product;'' the commenter stated that it is not clear whether the Agency
would accept this information or whether it would be used to waive
certain efficacy or toxicity requirements. Another commenter suggested
that decision makers may benefit from knowing which products have been
denied registrations in other countries, or been banned for use in
other counties, including the reason(s) why the product was denied
registration. The Agency believes that any additional data available
from other countries may help identify the benefits or concerns for the
listing and/or the authorization of use of a product. The Agency,
however, is not associating any specific listing criterion or threshold
with this broad information request, as some products may not have data
available. The international product certifications data provision
supplements but does not waive or replace toxicity and efficacy
requirements in the listing requirements of the Subpart J final rule.
A commenter suggested that the Agency revise the use of the term
``environmental benefits'' in this section related to product
information to a discussion of potential ``benefits and drawbacks.''
The commenter noted that their revised language would allow responders
to make more informed decisions. The Agency agrees with the comment to
revise the term ``environmental benefits.'' EPA amended the final
provisions by replacing ``environmental benefits'' with ``environmental
impacts'' to provide a neutral characterization. EPA believes the
amended terminology avoids the potential misinterpretation associated
with the term ``benefits.''
(b) Dispersant Testing and Listing Requirements
The Agency is revising the efficacy and toxicity testing protocols,
as well as establishing new thresholds for listing dispersants on the
NCP Product Schedule in Sec. 300.915(b). As defined in Sec. 300.5 of
the final rule, dispersants are substances that emulsify, disperse, or
solubilize oil by promoting the formation of small droplets or
particles of oil in the water column. These droplets are typically
driven into the water column by wave action. Emergency response
personnel need to know whether a dispersant or any other type of
chemical or biological agent on the NCP Product Schedule could have
negative environmental impacts relative to the oil before decisions are
made about its use in a particular oil discharge situation.
Consequently, it is essential to consider comparative information about
the efficacy and the toxicity of these products. The finalized
revisions are in response to concerns not only for an increase in the
frequency of planning for the use of these agents, but also for their
potential use in large quantities, such as when responding to oil
discharges from oil tanker accidents and offshore well blowouts, as
evidenced during the Deepwater Horizon incident in 2010.
A commenter stated that there is no need for additional testing of
chemical dispersants because it is well known that they contain toxic
constituents. Another commenter asserted that the toxicity and
effectiveness test requirements in the previous rule already allow for
discrimination between good products and poorly performing dispersants,
and it is not clear that the proposed revisions provide significant
value with respect to protecting the environment in the event of an oil
spill. EPA disagrees that there is no need for additional dispersant
testing. Subpart J not only includes an NCP Product Schedule
identifying chemical and biological agents, but also authorization of
use procedures that, when taken together, identify the waters and
quantities in which such chemical and biological agents may be used
safely. The toxicity testing and listing threshold requirements for
dispersant alone for listing on the NCP Product Schedule serve to
screen dispersant products for hazard, while the authorization of use
procedures provide for consideration of the conditions surrounding the
specific oil discharge situation. In addition, the provisions under
Sec. 300.910(g) in this final action allow for new information,
including specific to environmental toxicity, to be considered for
planning and response activities. EPA believes that when chemical and
biological agents are used on oil discharges, it is important for the
OSCs and RRTs to have information regarding the chemicals being added
to the environment, along with information about their toxicity. The
NCP provides a framework for efficient, coordinated, and effective
response to discharges of oil. This final action is consistent with
that approach.
A commenter urged the Agency to consider regional differences in
testing requirements for NCP Product Schedule listings. The commenter
specified that some issues are better addressed at the regional level
including dispersant effects in varying environmental contexts, such as
colder versus warmer waters, changing water depths and distance,
differing sensitive species and/or habitats and shoreline
characteristics. The Agency recognizes regional differences in
requirements and that some issues may be addressed at a regional level.
EPA notes that the NCP Product Schedule is established on a national
level, and that regional considerations are integrated into Subpart J
through the authorization of use process during response activities,
and also through the RRT's and Area Committee's regional and area
planning activities. This final action provides for regional-level
consideration opportunities under the authorization of use provisions
codified at 40 CFR 300.910. For example, Sec. 300.910(a)(1) provides
for RRT and Area Committee consideration of the existence and location
of environmentally sensitive resources during preauthorization planning
development. Further, Sec. 300.910(g), Supplemental Testing,
Monitoring, and Information, provides for supplemental toxicity and
efficacy testing and information to address site, area, and ecosystem-
specific concerns. Finally, the NCP provides for national, regional and
area contingency planning under Sec. 300.210.
A commenter stated that it is unclear whether the thresholds for
efficacy and toxicity will limit dispersant stockpiles to such a small
level as to essentially eliminate their use and suggested that this
potential issue be addressed in the analysis of the rule to provide
supporting information for the Agency in making regulatory decisions
for this rule. Another commenter also stated that the proposed revision
of the rule under Sec. 300.915(b)(1) Dispersant Testing and Listing
Requirements; Dispersant Efficacy Test and Listing Criteria that
increase the dispersant efficacy requirements for listing on the NCP
Product Schedule will make it unlikely that any dispersants currently
stockpiled in the United States would pass both the proposed efficacy
and toxicity tests. Neither the previous nor final rule requires
stakeholders to stockpile dispersants or other chemical or biological
agents, nor removes them from consideration as a response option. The
Agency notes that dispersants are not the only response option
available during a response; there are other
[[Page 38309]]
response options (e.g., mechanical recovery) available to consider that
may lower overall environmental damage depending on the incident-
specific nature of the response. Decisions on the authorization of use
of dispersants and other agents during a response are to be made in
accordance with the NCP and all applicable statutes and regulations.
This final action includes provisions to transition products currently
on the NCP Product Schedule through the revised listing process. This
final action allows a grace period of 24 months for any product
currently listed on the NCP Product Schedule to be authorized for use
(see Sec. 300.955(f) Transitioning Listed Products to the New NCP
Product Schedule or Sorbent Product List.) Products on the NCP Product
Schedule for which a new submission is not received or that do not meet
the revised listing criteria will be removed from the NCP Product
Schedule at the end of the 24-month transition period. This transition
period provides time for retesting, production of additional products,
and the continued ability of currently listed products to be offered
and available in the event of a response.
(1) Dispersant Efficacy
The Agency is changing the testing protocol for measuring efficacy
and revising the efficacy listing criteria for dispersants to be
listed. Specifically, a dispersant must demonstrate that the Dispersant
Effectiveness at the 95% lower confidence level (LCL95)
meets the new proposed efficacy listing criteria at two test
temperatures. EPA is also replacing the reference oil with a new test
oil: Strategic Petroleum Reserve (SPR) Bryan Mound.
Testing Protocol. Under Sec. 300.915(b)(1), the Agency is adopting
the Baffled Flask Test (BFT) method as the testing protocol for
dispersant efficacy and providing this method in AppendixC to part 300.
This testing protocol replaces the Swirling Flask Test (SFT) that was
formerly listed in Appendix C to part 300 of the NCP. The BFT procedure
incorporates a redesign of the testing flask by eliminating the side
arm, incorporating baffles in the wall of the flask, and adding a
stopcock at the bottom, which improves reproducibility in the hands of
different operators. This protocol has undergone peer review \5\ and
has been tested in several laboratories, providing reproducible and
repeatable results.
---------------------------------------------------------------------------
\5\ Venosa, Albert D., National Risk Management Research
Laboratory, US EPA; Sorial, George A., Department of Civil &
Environmental Engineering, University of Cincinnati; King, Dennis
W., Statking Consulting; Round-Robin Testing of a New EPA Dispersant
Effectiveness Protocol, International Oil Spill Conference, 2001.
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Some commenters opposed switching from the SFT to the BFT. A
commenter stated that the Agency should not replace the accepted
standard Swirling Flask Test, developed by the EPA Canada, and that the
BFT is a non-standard test designed by industry. Another commenter
expressed concerns with EPA proposing a non-standard method in lieu of
one well accepted and used around the world (ASTM F2059-06; 2012). The
Agency's decision to adopt the test in the final rule is based on the
BFT method's attributes; the Agency could not identify other
potentially applicable standards that would incorporate the
considerations of the BFT. The BFT is designed to be more
representative of the moderately turbulent sea conditions where
dispersants are more likely to be successful when used. The new BFT
procedure incorporates a redesign of the testing flask by eliminating
the side arm, incorporating baffles in the wall of the flask, and
adding a stopcock at the bottom, which improves reproducibility in the
hands of different operators. Specifically, the new baffled
trypsinizing flask design, fitted with a glass stopcock positioned at
the bottom side, promotes less manipulation that could result in
erroneous re-suspension of non-dispersed oil. Additionally, the BFT
provides higher, consistent turbulent mixing energy within the flask,
resulting in the possibility of better dispersion and more repeatable
and reproducible dispersant effectiveness testing results. The BFT was
tested extensively in an iterative inter-laboratory calibration test
using commercially available dispersant products.
Reference oils. The provision at Sec. 300.915(b)(1) specifies the
type of oil that the efficacy testing must use, SPR Bryan Mound. The
use of reference oils was proposed, in part, to ensure that testing of
the effectiveness of a dispersant product is done in a uniform manner,
across manufacturers, and is performed in a way to ensure that EPA can
be confident in the results of that testing before a dispersant product
is listed on the NCP Product Schedule for subsequent consideration for
use in a response under the NCP. The Agency proposed requiring product
manufacturers to test their dispersant products against two new
reference oils, ANS and IFO-120, or similar oils, to provide
representative information on the potential efficacy of products when
used on different types of oils. These two oils were proposed to
replace the previously required reference oils. In the proposal, EPA
considered testing requirements for dispersant products against two
reference oils; however, the final action provides for dispersant
efficacy and toxicity testing to be performed using one reference oil:
SPR Bryan Mound. The Agency and the Strategic Petroleum Reserve (SPR)
successfully identified multiple potential oil blends stored at the
SPR. After multiple rounds of testing, EPA has selected one oil, the
Bryan Mound oil blend, from the SPR, to serve as the selected reference
oil for the final action.
While the proposal considered testing requirements for dispersant
products against two reference oils, this final action provides for
dispersant efficacy and toxicity testing to be performed using one
reference oil: SPR Bryan Mound. After confirmatory testing, the Agency
has determined that the use of SPR Bryan Mound as the sole screening
reference oil is sufficient and appropriate for use in establishing a
baseline comparison of products considered for listing on the NCP
Product Schedule. This final rule establishing a sole screening
reference oil is consistent with the purpose of product testing for NCP
Product Schedule listing. The NCP Product Schedule was created to allow
for consideration of comparative information about the efficacy and the
toxicity of products by establishing a national level screening
baseline of products that can be considered for use. The reference oil
used in Appendix C is not intended to be representative of every type
of oil or condition that may be encountered during a response where a
product may be considered for authorization of use. The reference oil
is used to establish a nationally consistent testing regime for product
listing on the NCP Product Schedule, which informs authorization of use
and planning decisions when applied to regional planning and site-
specific responses.
Commenters had concerns and suggestions about the proposed
reference oils. A commenter noted that if only two types of oils are
tested (as under the proposal), it is unclear how results will be
extrapolated to other untested oils, particularly for those oil types
which exceed the tested range, e.g., those oils that are heavier than
IFO-120 or lighter than ANS crude oil. A commenter suggested testing
dispersants' efficacy on blended alcohol-hydrocarbon fuel, given that
alcohol-based biofuel spills are an emerging research priority. Some
commenters expressed concern about the lack of reference oils for
Unconventional Oil and Gas (UOG) and
[[Page 38310]]
that the use of conventional reference oils for products intended for
use on UOG will lead to erroneous and misleading information about
product toxicity and efficacy. The Agency's intent with proposing the
use of ANS and IFO-120, or similar oils that represent a wider range of
oil gravities, was that it would provide information on the efficacy of
the products that could represent their use on different types of oils.
The final action updates the reference oil used for dispersant efficacy
and toxicity testing to SPR Bryan Mound in lieu of ANS and IFO-120. The
Agency believes SPR Bryan Mound meets the needs as a screening
reference oil for a baseline comparison of products to establish the
NCP Product Schedule listing. The required reference oil is not
intended to be representative of every type of oil or condition that
may be encountered during a response where a product may be considered
for authorization. Rather, the final rule recognizes different types of
oil under the authorization of use provisions. For example, Sec.
300.910(a)(1) provides that preauthorization plans should address
likely sources and types of oil that might be discharged when
developing a preauthorization plan. The provision under Sec.
300.910(a)(1) provide RRTs with the flexibility to tailor the scope of
the preauthorization plan to account for different types of oil,
including unconventional oils. In addition, Sec. 300.910(g) provides
for, among other provisions, the supplementary efficacy testing to
provide greater flexibility to tailor testing conditions to address
area- and site-specific concerns relative to the use of a product for
planning and authorization of use. This provision provides RRTs with
the flexibility to gather additional information for different types of
oil, including unconventional oils.
Temperature. The provision at Sec. 300.915(b)(1) requires that
efficacy testing be conducted at two different temperatures, 5 and 25
degrees Celsius ([deg]C), rather than at an ambient temperature range
of 20 to 23 [deg]C as previously required. The Agency recognizes the
current and future interest in arctic and deep water drilling, and the
continued oil production in the southern areas of the country. Given
the potential range of locations where dispersants may be used, the
Agency believes it is appropriate to have products tested at
temperatures that would reflect that range. These temperatures are
intended to capture dispersant use scenarios in a wide range of
geographic locations and under different temperatures that may occur in
the same geographical location (such as, for example, the deep sea and
surface water in the Gulf of Mexico, where the temperatures are
typically between 5 [deg]C and 25 [deg]C, respectively).
Some commenters suggested that testing at different temperatures
will not add value for relative comparison between dispersants. A
commenter mentioned that dispersants can be effective at a range of
ambient temperatures and the requirement to perform multiple tests on
two oils at two temperatures does not provide significantly more
information than would otherwise be obtained by testing oils at a
single temperature. The commenter stated that the use of a single
temperature should be adequate for determining relative ranking of
different dispersants. A commenter recommended that a dispersant's
efficacy should only need to be tested within the temperature range of
20 +/- 3 [deg]C and this range would account for the variances in
testing that will occur when the BFT is conducted by different
laboratories and different technicians. A commenter suggested that
requiring an effectiveness test at 5 [deg]C is unnecessary, mentioning
that it is of greater importance to determine that the dispersant
itself maintains desirable rheology at cold temperatures and that it is
able to be used with the existing spray systems. Another commenter
recommended testing be conducted at 1 [deg]C instead of 5 [deg]C for
the lower test range because the Arctic waters typically range between
0 [deg]C and 4 [deg]C. Another commenter suggested that for dispersants
proposed for use in the Arctic, the Agency should consider requiring
efficacy testing under even colder water conditions, as marine waters
do not typically freeze until they reach approximately -1.8 [deg]C
(roughly 29 degrees Fahrenheit).
The Agency acknowledges comments opposing testing at different
temperatures. The Agency recognizes the current and future interest in
crude petroleum oil exploration and production throughout the United
States. The Agency believes it is appropriate to have dispersant
products tested on a national level at temperatures that would reflect
a range of water temperatures in which dispersants might be used. The
efficacy testing criteria for temperature are intended to capture
dispersant use scenarios in a wide range of geographic locations and
under different temperatures that may occur in the same geographical
location. Water temperature may vary seasonally or with water depth
even within the same geographical location. For example, the
temperatures specified in the dispersant efficacy testing protocol span
the range of temperatures of the deep sea and surface water in the Gulf
of Mexico. Even within a geographical region, there may be seasonal
variations in temperature that could affect the dispersant use
considerations. This final rule screens dispersant products for
efficacy at two different temperatures to ensure the dispersant
products meet the efficacy thresholds provided for in the final action
and avoid uncertainty associated with listing a dispersant product
tested at only one temperature. Even if oil remains dispersible at
lower temperatures, the efficacy testing at a lower temperature screens
dispersants that may become ineffective due to changes in their
temperature-dependent physical or chemical properties (e.g., increased
viscosity). Efficacy testing at two different temperatures also avoids
potential confusion of listing dispersant products for use at specific
temperatures.
The Agency also recognizes comments to extend the temperature
testing range below 5 [deg]C. This final rule provides for
consideration of geographically specific temperatures within the
general listing requirements under Sec. 300.915(a) and authorization
of use procedures under Sec. 300.910. For example, the final
provisions require product submissions (e.g., dispersant submission) to
provide the recommended product use procedures under Sec.
300.915(a)(10). These procedures must address, as appropriate,
variables such as water temperature, and must include supporting
documentation. The information required to be submitted to support the
listing, including testing results from multiple temperatures, provides
the OSC and RRT with relevant information that may be used to inform
authorization of use determinations. The final rule also allows for
supplemental efficacy testing under Sec. 300.910(g), Supplemental
Testing, Monitoring, and Information. The OSCs and RRTs may require
these tests to be conducted, due to site- or area-specific concerns,
using parameters other than those specified in Appendix C, including
dispersant efficacy test at different temperatures than that specified
in Appendix C. In conjunction with the required product listing
information, these supplemental testing provisions also provide OSCs
and RRTs with flexibility to gather more detailed information as needed
for authorization of use determinations.
Confidence Level (LCL95). The provision at Sec.
300.915(b)(1) requires dispersant effectiveness testing results
[[Page 38311]]
to be reported in terms of 95% lower confidence level
(LCL95). This accounts for between- and within laboratory
error variability and the inherent error of the method.
A commenter expressed support for this requirement because the
LCL95 is a lower threshold value than the average dispersant
effectiveness criteria that was previously used. Another commenter
suggested that reporting only the LCL95 reduces the amount
of information available on a product and recommended that the test
average and standard deviation also be provided for additional
information on the precision of the testing. The Agency disagrees with
the comment suggesting reporting the LCL95 reduces the
information available. As described in the Federal Register notice for
the proposed rule, only one number is reported compared to reporting a
mean and standard deviation, as the variation has already been
subtracted in the reported number (80 FR 3403-3404, January 22, 2015).
Furthermore, the final provisions require under Sec. 300.915(a)(18)
that product submission for listing on the NCP Product Schedule provide
all test data and calculations, including raw data and replicates
(including positive controls), notes and observations collected during
tests, calculated mean values and standard deviations, reports,
including a summary of stock solution preparation, source and
preparation of test organisms, test conditions, and chain of custody
forms.
Dispersant Efficacy Thresholds. The Agency is revising the efficacy
criteria for dispersants to be listed on the NCP Product Schedule.
Specifically, the dispersant must demonstrate a Dispersant
Effectiveness (DE) at the 95% lower confidence level (LCL95)
greater than or equal to: (i) 70% for SPR Bryan Mound at 5 [deg]C; and
(ii) 75% for SPR Bryan Mound at 25 [deg]C.
Commenters suggested that the efficacy thresholds as proposed in
Sec. 300.915(b)(1) were high, even for highly effective dispersants; a
commenter cited a BFT study suggesting that a certain dispersant
product may not be listed based on its percent effectiveness results of
69% and 61% on different oils. Other commenters suggested that the
proposed thresholds are too restrictive and do not sufficiently take
into account the variability of the BFT. A commenter stated that it
would be better to set a minimum threshold for efficacy tests of 65% at
any temperature as a minimum requirement for listing. Another commenter
recommended that the requirements for percent effectiveness at various
temperatures and oils should be changed to a single value of 45%
effectiveness. The Agency recognizes that the final provisions update
the SFT efficacy testing protocols to the new BFT efficacy testing
protocol, which is designed to be more representative of moderately
turbulent sea conditions where dispersants are more likely to be
successful when used. The revised testing protocol improves test
repeatability and reproducibility within and between laboratories, as
well as greatly reduces both the inherent error of the method and the
human error associated with the SFT protocol. In addition, reporting
the test results in terms of the product's LCL95 accounts
for between- and within laboratory error variability and the inherent
error of the method. The BFT provides higher, consistent turbulent
mixing and better enables more reproducible and repeatable dispersant.
The BFT provides such mixing and better enables more repeatable and
reproducible dispersant effectiveness than the SFT. The mixing energy
within the baffled flask is higher than the mixing energy within the
swirling flask, and, as a result of this increased mixing energy,
better dispersion is possible. The efficacy thresholds in the final
provisions are higher than the previous efficacy threshold and reflect
improvements from the BFT protocols. These higher thresholds also
reflect the Agency's intent to strengthen the requirements for listing
dispersant products on the NCP Product Schedule that are more
efficacious. The Agency believes the final action provides reasonable
thresholds for the purposes of listing a dispersant on the NCP Product
Schedule without being overly restrictive.
(2) Dispersant Toxicity
The Agency is revising the toxicity testing requirements for
dispersants, including the testing protocols and the use of the test
results. The provision at Sec. 300.915(b)(2) requires acute toxicity
testing for the dispersant alone, and the dispersant mixed with SPR
Bryan Mound. It also requires developmental toxicity and subchronic
testing on the dispersant alone. These tests must be performed using
the methods specified in Appendix C. While the toxicity testing results
were previously used by the OSC to assist in authorization of use
determinations, the Agency will now use the testing results for the
dispersant tested alone to determine eligibility for listing on the NCP
Product Schedule.
Commenters asserted that the Agency needs to clearly distinguish
between the requirements of the toxicity testing required to assess
which dispersants should be listed on the NCP Product Schedule, and
toxicological studies with appropriate oils, test organisms, and
exposure conditions that will inform discussions about how the listed
dispersants might cause impacts in U.S. waters under the specific
circumstances of an oil spill or release. Specifically, a commenter
suggested that the Agency clarify the objective and rationale of the
proposed acute exposure toxicity testing of dispersant-oil mixtures and
explain how this relates to the listing of a product on the NCP Product
Schedule. The Agency seeks to clarify that the toxicity testing and
listing threshold requirements for the dispersant alone, serve to
screen dispersant products for hazard. EPA is unaware of any single
toxicity testing protocol that represents every potential exposure
situation that may be encountered during an oil spill. There are
numerous factors that come into play and affect an organism's exposure
under the wide range of field conditions, which are not necessarily
represented by the commenters suggestion to use short-term exposure
durations under spiked exposure concentrations. In addition, even
short-term exposure to dispersed oil can have harmful effects to
certain species and life stages. The exposure to individual organisms
during an incident depends on many factors including, but not limited
to, the type of oil discharge (e.g., continuous discharge), proximity
of the organisms to the oil discharge, and organism mobility. The
Agency believes the protocols provide for a conservative decision
approach and establish an adequate safety margin without being overly
restrictive. The Agency also believes that testing the oil alone, as
well as the oil and dispersant mixture, will provide useful data on the
relative toxicity of the oil and the potential hazards associated with
dispersant use (i.e., data derived from the oil and dispersant mixture
test) relative to the hazards associated with non-treatment of the oil
(i.e., data derived from the oil only test). EPA believes that the
comparative nature of the data will benefit the OSCs, RRTs, and Area
Committees in their decision making and planning activities.
Dispersant Tested Alone and/or Mixed with Reference Oil. The
provision at Sec. 300.915(b)(2) requires acute toxicity testing for
the dispersant alone, and the dispersant mixed with SPR Bryan Mound. It
also requires developmental toxicity and subchronic testing on the
dispersant alone.
Commenters had varied opinions about whether a dispersant should be
tested alone or mixed with the reference oil. Some commenters
recommended
[[Page 38312]]
that toxicity testing should focus only on the dispersant alone, and
that the Agency should eliminate testing requirements for dispersant
mixed with reference oil. Another commenter stated that toxicity
testing of dispersant plus oil is more relevant than testing with the
dispersant alone because the dispersant would not be used if no spilled
oil was present and because the potential for toxic effects when
dispersants are used on spilled oil at sea is caused by the dispersed
oil, not by the dispersant. A commenter noted that screening tests
conducted in the absence of reference oils give no indication of
whether product-oil combinations are more toxic than the dispersant
alone, and a commenter stated that it is important to know whether
chemically dispersing the oil would increase or decrease toxicity of
the oil itself. Commenters noted that the relative toxicity of any
dispersant and oil mix will largely be a function of how much oil is
dispersed into the water sample being analyzed, with the greater the
quantity of oil dispersed, the more toxic the resultant oil and
dispersant mix will be. A commenter specifically opposed the proposed
dispersant-oil acute toxicity testing requirement because any concerns
about the potential for toxic effects on marine organisms resulting
from the use of modern dispersants should consider the potential
effects of dispersed oil, not the dispersant itself.
In response to these comments, the Agency is not eliminating
toxicity testing for dispersed oil from the rule. To clarify the intent
of such testing, the Agency described the rationale for the dispersed
oil toxicity test in previous preambles published in the Federal
Register. For example, EPA notes that the current regulation includes
acute toxicity testing of dispersant-oil mixtures and provided a
rationale in the 1994 NCP final rule (59 FR 47411-47412, September 15,
1994). Dispersants are intended to increase the rate at which an oil
slick is dispersed into the water column. This dispersed oil is, by
definition, a mixture of the dispersant and the spilled oil. As a
result of this dispersion of oil, the possibility exists for organisms
dwelling in the water column to come in physical contact with the
dispersed oil. The Agency believes that it should not make any
difference whether the mortality of an organism was caused by the
effects of a dispersant in the water or due to physical contact with
the dispersed oil (e.g., dispersed oil covering the gills of a fish,
thereby inhibiting respiration). EPA believes that the fact that
dispersants cause oil to enter the water column is sufficient reason to
test for the toxicological effects of dispersed oil. The Agency also
believes that testing the oil alone, as well as the oil and dispersant
mixture, will provide useful data on the relative toxicity of the oil
and the potential hazards associated with dispersant use (i.e., data
derived from the oil and dispersant mixture test) relative to the
hazards associated with non-treatment of the oil (i.e., data derived
from the oil only test). EPA believes that the comparative nature of
the data will benefit the OSCs, RRTs, and Area Committees in their
decision making and planning activities. The final action maintains the
approach used in the previous rule for acute toxicity testing on
dispersant mixed with oil.
Oil-only acute toxicity testing. In the Federal Register notice for
the proposed rule, the Agency requested comment on whether the
submitter should be required to conduct the oil-only acute toxicity
testing for the test oil (80 FR 3405, January 22, 2015). In response to
the Agency's request for comment, commenters stated that there should
be a requirement to conduct oil-only acute toxicity testing (in
addition to the dispersant alone and the dispersant-oil combination) to
give the Agency the opportunity to detect anomalies in the submitted
data and to provide a comparison to assist in evaluating whether a net
environmental benefit is achieved with the proposed dispersant. A
commenter also stated that the Agency should calculate toxicity
thresholds with oil alone, oil-dispersant mixed together, and
dispersant alone to assist in comparing the relative toxicity. The
Agency considered requiring submitters to conduct the oil acute
toxicity testing as it would provide an opportunity to detect anomalies
in the submitted data. However, EPA decided to conduct the oil-only
acute toxicity tests itself for the reference oil with both
Americamysis bahia (A. bahia) and Menidia. beryllina (M. beryllina) and
provide this data for comparisons to dispersant and dispersant-oil
mixture acute toxicity tests. EPA intends to make the reference oil
toxicity test results available to the public on its website, including
calculated median LC50 values. By providing this
information, the Agency is reducing the number of required toxicity
tests that the submitter would need to conduct in relation to the
previous requirement. To address concerns about detecting anomalies in
the submitted data, EPA notes that the final provisions under Sec.
300.915(a)(17) and Sec. 300.915(a)(18) require the product submission
for listing on the NCP Product Schedule to provide information about
the laboratory that conducted the required tests and to provide all
test data and calculations.
Test species. The finalized provision at Sec. 300.915(b)(2)
requires acute toxicity testing and testing for subchronic effects
using the crustacean species A. bahia and the fish species M.
beryllina, as well as developmental toxicity testing using a sea urchin
species, either Strongylocentrotus purpuratus (S. purpuratus) or
Arbacia punctulata (A. punctulata) to facilitate further flexibility to
laboratories conducting the developmental assay based on test guidance
and organism availability. Protocols are detailed in Appendix C to part
300. The finalized provision specifies the sea urchin species to be
used for developmental toxicity, to be consistent with specifying
species in the acute and subchronic toxicity tests (A. bahia and M.
beryllina) and to provide greater clarity by replacing the proposal's
more general reference to the ``a sea urchin assay.''
Commenters requested that the Agency consider including more
geographically or ecologically representative species in the testing
protocol. Commenters specifically suggested that the Agency select test
species that would be representative of those found in California and
Arctic/Alaskan waters. A commenter noted that anadromous or marine fish
would be ecologically relevant to arctic waters since dispersants are
only effective (and used) in marine waters. The commenter recommended
the use of Pacific herring (Ciupea pallasiz) as a model species, since
they are known to be quite sensitive to chemical disturbance and are an
ecologically and economically important species to Alaska. Another
commenter recommended testing on Arctic species, specifically in vitro
cell line studies to assess acute and chronic effects on important
Arctic species including ice seals, walrus, beluga whales, bowhead
whales, phytoplankton and zoo plankton, benthic invertebrates, and
Arctic fish species. Another commenter recommended that the Agency
require product testing on Arctic species such as Arctic copepods and
algae. The Agency notes that the required toxicity testing protocols in
Appendix C use standard test species to screen dispersant products for
hazard for listing on the NCP Product Schedule at a national level.
While the toxicity testing requirements use test species commonly used
in EPA toxicity testing methods, EPA recognizes that other species may
be more sensitive to
[[Page 38313]]
dispersed oil under the same test conditions. This final action
provides for consideration of regional conditions under the
authorization of use provisions under Sec. 300.910. For example, Sec.
300.910(a)(1) provides for consideration of the existence and location
of environmentally sensitive resources when developing a
preauthorization plan. In addition, Sec. 300.910(g) provides for
supplemental testing and information to address site, area, and
ecosystem-specific concerns.
A few commenters expressed concerns about the proposed updates to
Sec. 300.915(b)(2) regarding developmental toxicity testing, stating
that the use of the purple urchin assay is arbitrary and capricious
given that this species' habitat is the shallow nearshore, tidal
environment, which is unlikely to be exposed to dispersants during a
response effort. Commenters also expressed concerns related to the lack
of experience in conducting this type of assay and the potential
difficulty in interpreting results between multiple laboratories. EPA
disagrees that the use of the purple urchin assay is arbitrary and
capricious. EPA notes that, along with the other toxicity test, the sea
urchin developmental assay and listing threshold requirements screen
dispersant products for hazard. The sea urchin developmental assay
established as part of the final rule serve as a sensitive surrogate
test for echinoderm early life stages. This test organism is intended
to expand the taxonomic diversity of species used in product hazard
assessment and is not intended to represent any particular species or
habitat in affected environments. EPA adapted an existing toxicity
testing approach to allow inclusion of this species in product hazard
assessment. To facilitate further flexibility to laboratories
conducting the developmental assay, the Agency amended the final
provisions to include the option to use the purple sea urchin A.
punctulata in lieu of S. purpuratus for the developmental assay. In
addition, EPA amended the final provision under Sec. 300.915(b)(2) to
replace the phrase ``. . . using a sea urchin assay . . .'' with the
phrase ``. . . using Strongylocentrotus purpuratus or Arbacia
punctulata . . .'' to recognize the additional species flexibility for
laboratories conducting the developmental assay based on guidance and
organism availability, and to be consistent with regulatory text for
the other toxicity tests where the organisms are identified.
Toxicity Thresholds. In the finalized provisions at Sec.
300.915(b)(2)(i)-(iii), EPA is providing thresholds to determine
eligibility for listing on the NCP Product Schedule. Specifically, to
be listed on the NCP Product Schedule, the dispersant tested alone must
demonstrate: (i) A median lethal concentration (LC50) at the
lower 95% confidence interval greater than 10 ppm; (ii) an inhibition
concentration for 50% of the test species (IC50) at the
lower 95% confidence interval greater than 1 ppm; and (iii) a
subchronic No Observed Effect Concentration (NOEC) greater than 1 ppm.
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.
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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
[[Page 38314]]
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.
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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
[[Page 38315]]
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
[[Page 38316]]
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
[[Page 38317]]
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
[[Page 38318]]
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.
[[Page 38319]]
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
[[Page 38320]]
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
[[Page 38321]]
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
[[Page 38322]]
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
[[Page 38323]]
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
[[Page 38324]]
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
[[Page 38325]]
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
[[Page 38326]]
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
[[Page 38327]]
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
[[Page 38328]]
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
[[Page 38329]]
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.
[[Page 38330]]
[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.
B. Paperwork Reduction Act
The information collection activities in this final action will be
submitted for approval to the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA). The Information Collection
Request (ICR) document prepared by EPA has been assigned EPA ICR No.
1664.14. You can find a copy of the ICR in the docket for this rule,
and it is briefly summarized here. The information collection
requirements are not enforceable until OMB approves them.
The NCP Product Schedule listing and authorization of use
provisions of the final rule include requirements for submission of
general product information and documentation of information related to
product testing. For this ICR, EPA has estimated an average annual
total burden for respondents of 487 to 1,165 hours per year in the
first three years, and average annual labor and O&M costs of $1,040,969
to $1,088,123. EPA has carefully considered the burden imposed upon the
regulated community by the regulations. EPA believes that the
activities required are necessary and, to the extent possible, has
attempted to minimize the burden imposed. The minimum requirements
specified in the final rule are intended to encourage the development
of safer and more effective spill mitigating products, and to better
target the use of these products to reduce the risks to human health
and the environment.
Respondents/affected entities: Manufacturers of dispersants, other
chemical and biological agents, other spill mitigating devices and
substances.
Respondent's obligation to respond: Mandatory if manufacturer
wishes to have a product listed on the NCP Product Schedule (40 CFR
part 300, subpart J).
Estimated number of respondents: 109 responses by 89 existing
product respondents during year one and two of the ICR period; in
addition, 5 new product responses per year, and 10 sorbent submissions
per year. The overall average number of responses during the ICR period
is 51.
Frequency of response: Occasional.
Total estimated burden: 487 to 1,165 hours per year. Burden is
defined at 5 CFR 1320.3(b).
Total estimated cost: $1,040,969 to $1,088,123 per year.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB
approves this ICR, the Agency will announce that approval in the
Federal Register and publish a technical amendment to 40 CFR part 9 to
display the OMB control number for the approved information collection
activities contained in this final rule.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. The
small entities subject to the requirements of this action are 88
potentially small businesses in the following industries: Support
Activities for Mining; Specialty Trade Contractors; Paper
Manufacturing; Petroleum and Coal Products Manufacturing; Chemical
Manufacturing; Plastics and Rubber Products Manufacturing; Durable
Goods Merchant Wholesalers; Nondurable Goods Merchant Wholesalers; Non-
store Retailers; Warehousing and Storage; Professional, Scientific, and
Technical Services; Administrative and Support Services; Waste
Management and Remediation Services; Repair and Maintenance; and
Religious, Grantmaking, Civic, Professional, and Similar Organizations.
The Agency has determined that up to five of the affected small
entities may experience an impact of 1% to 3% of revenues and up to
five of the affected small entities may experience an impact of greater
than 3% of revenues. Details of this analysis are presented in EPA's
Regulatory Impact Analysis, Final Revisions to the National Oil and
Hazardous Substances Pollution Contingency Plan Regulations (40 CFR
part 300 Subpart J), which is available in the docket for this action.
D. Unfunded Mandates Reform Act
This action does not contain any unfunded mandate of $100 million
or more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. This final rule
imposes no new enforceable duty on any state, local, or tribal
governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action has Tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
Tribal governments, nor preempt Tribal law. EPA has concluded that this
action may have Tribal implications because all Tribes can be affected
by oil spills and the subsequent use of oil spill mitigating agents,
such as dispersants and bioremediation agents. Furthermore, CWA section
311(j)(4)(A)(ii) provides for qualified members of federally
[[Page 38331]]
recognized Indian Tribes, where applicable, to be members of Area
Committees. Additionally, E.O. 12777 provides that RRTs may include
representatives from Tribal governments.
EPA consulted with Tribal officials under EPA Policy on
Consultation and Coordination with Indian Tribes early in the process
of developing this regulation to enable them to have meaningful and
timely input into its development. A summary of that consultation is
provided in Regulatory Impact Analysis, Final Revisions to the National
Oil and Hazardous Substances Pollution Contingency Plan Regulations (40
CFR part 300 Subpart J), which is available in the docket for this
action.
As required by section 7(a), EPA's Tribal Consultation Official has
certified that the requirements of the executive order have been met in
a meaningful and timely manner. A copy of the certification is included
in the docket for this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because EPA does not believe the environmental health or safety risks
addressed by this action present a disproportionate risk to children.
The Agency has concluded that the effect of the requirements codified
in this final rule will mitigate the adverse effects of environmental
and socio-economic damage that could otherwise result from major oil
spills. This final action will therefore not have a disproportionate
adverse effect on children.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution or Use
This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy. The requirements specified in the final
rule are intended to encourage the development of safer and more
effective spill mitigating products, and to better target the use of
these products to reduce the risks to human health and the environment;
thus, the rule will result in greater overall environmental protection.
The final rule will not cause reductions in the supply or production of
oil, fuel, coal, or electricity; nor will it result in increased energy
prices, increased cost of energy distribution, or an increased
dependence on foreign supplies of energy.
I. National Technology Transfer and Advancement Act
This rulemaking involves technical standards. Therefore, the Agency
conducted a search to identify potentially applicable voluntary
consensus standards. However, EPA identified no such standards for
efficacy and toxicity testing, and none were brought to the Agency's
attention in comments. Therefore, EPA developed the Baffled Flask
Efficacy Test; the Dispersant Toxicity Test; the Standard Acute
Toxicity Testing for Surface Washing Agents, Bioremediation Agents,
Herding Agents, and Solidifiers; and the Bioremediation Efficacy Test
provided in Appendix C of this final rule.
Additionally, EPA has decided to use voluntary consensus standards
for several product property data points, such as pH, flash point, and
pour point. The product toxicity testing relies on existing protocols
that are universally accepted. The Agency has removed the incorporation
by reference of specific standards to determine physical and chemical
properties and replaced this with a requirement for a citation of the
current applicable standard methodology used to determine these values.
EPA believes that citing the current applicable standard methodology
used to determine the required values is sufficient in lieu of
specifying commonly recognized standard methodologies. Furthermore, EPA
did not incorporate by reference specific test methodologies in the
regulation to avoid the administrative burden of updating the NCP every
time a test methodology is updated to a newer version.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) directs
federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or Indigenous
peoples) and low-income populations.
The EPA believes that the human health or environmental conditions
that exist prior to this action result in or have the potential to
result in disproportionate and adverse human health or environmental
effects on people of color, low-income populations and/or indigenous
peoples. Discharges of oil from facilities regulated by this action
likely pose disproportionate risks to historically marginalized
communities.
The EPA believes that this action is likely to reduce existing
disproportionate and adverse effects on people of color, low-income
populations and/or indigenous peoples. EPA has concluded that the
regulatory requirements will advance fair treatment of those
populations by reducing the disproportionate damages that oil
discharges might otherwise inflict on those populations. EPA has
concluded that the requirements codified in this final rule will
mitigate the adverse effects of environmental and socio-economic damage
that could otherwise result from major oil spills and are likely to
reduce existing disproportionate and adverse effects on people of
color, low-income populations and/or indigenous peoples. EPA has
concluded that the regulatory requirements will advance fair treatment
of those populations by reducing the disproportionate damages that
major oil spills might otherwise inflict on those historically
marginalized populations.
The focus of this action is to modernize and update Subpart J of
the NCP. Nonetheless, the EPA identified environmental justice concerns
associated with the final rule and qualitatively assessed whether the
requirements codified in this final rule will mitigate the adverse
effects of environmental and socioeconomic damage that could otherwise
result from oil spills. EPA has concluded that, while the changes in
this rule were independent of environmental justice considerations, the
regulatory requirements will advance fair treatment of those
populations by reducing the disproportionate damages that discharges
might otherwise inflict on those historically marginalized populations.
Specifically, EPA has concluded that:
The amended requirements to add new listing criteria and
revise efficacy and toxicity testing protocols emphasize development
and listing of ``greener'' oil spill mitigating products and will
increases public transparency on chemical and biological agent
composition.
The amended requirements for authorization of use,
notifications, and data reporting better target agent use to reduce
risks to human health and the environment. The amended requirements
will increase both public awareness on chemical and biological
[[Page 38332]]
agent preparedness planning and response activities, including
potential engagement opportunities, and access to information on the
components for any chemical and biological agent listed on the NCP
Product Schedule. EPA expects the final rule requirements will also
enhance EPA's ability to address area- and regional-specific concerns
and provide greater public awareness of chemical and biological agent
use during a response through public notification.
EPA expects that the final action's emphasis on developing
safer and more effective spill mitigating products, and on better
targeting their use, will reduce the risks to human health and the
environment when chemical and biological agents are used during oil
spill responses in these newly developed areas.
The information supporting Executive Order 12898 review is
contained in the Regulatory Impact Analysis, Final Revisions to the
National Oil and Hazardous Substances Pollution Contingency Plan
Regulations (40 CFR part 300 Subpart J), which includes an
environmental justice analysis and is available in the docket for this
action.
K. Congressional Review Act
This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects
40 CFR Part 110
Environmental protection, Oil pollution, and Reporting and
recordkeeping requirements.
40 CFR Part 300
Air pollution control, Area contingency planning, Bioremediation,
Chemicals, Dispersants, Environmental protection, Hazardous materials,
Hazardous substances, Intergovernmental relations, Natural resources,
Oil spills, Oil spill mitigating devices, Regional response teams,
Sorbents, and Surface washing agents.
Michael S. Regan,
Administrator.
For the reasons set out in the preamble, the Environmental
Protection Agency amends 40 CFR parts 110 and 300 as follows:
PART 110--DISCHARGE OF OIL
0
1. The authority citation for part 110 continues to read as follows:
Authority: 33 U.S.C. 1251 et seq., 33 U.S.C. 1321(b)(3) and
(b)(4) and 1361(a); E.O. 11735, 38 FR 21243, 3 CFR parts 1971-1975
Comp., p. 793.
0
2. Revise Sec. 110.4 to read as follows:
Sec. 110.4 Chemical or biological agents.
The addition of any chemical or biological agent, or any other
substance, to oil to be discharged that would circumvent the provisions
of this part is prohibited.
PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN
0
3. The authority citation for part 300 continues to read as follows:
Authority: 33 U.S.C. 1251 et seq.; 42 U.S.C. 9601-9657; E.O.
13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR
54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR,
1987 Comp., p. 193.
Subpart A--Introduction
0
4. Amend Sec. 300.5 by:
0
a. Adding in alphabetical order definitions of ``Bioaccumulation'',
``Bioconcentration'', ``Biodegradation'', ``Biological agents'', and
``Bioremediation'';
0
b. Revising the definitions of ``Bioremediation agents'', ``Burning
agents'', ``Chemical agents'', ``Dispersants'';
0
c. Adding in alphabetical order the definition of ``Herding agents'';
0
d. Removing the definition of ``Miscellaneous Oil Spill Control Agents
(MOSCA)'';
0
e. Adding in alphabetical order the definition of ``Products'';
0
f. Revising the definition of ``Sinking agents'';
0
g. Adding in alphabetical order the definition of ``Solidifiers'';
0
h. Revising the definition of ``Sorbents'';
0
i. Removing the definitions for ``Surface collecting agents'' and
``Surface washing agent''; and
0
j. Adding in alphabetical order the definition of ``Surface washing
agents''.
Sec. 300.5 Definitions.
* * * * *
Bioaccumulation is the process of accumulation of chemicals in the
tissue of organisms through any route, including respiration,
ingestion, or direct contact with the ambient or contaminated medium.
Bioconcentration is the accumulation of chemicals in the tissues of
organisms from water alone.
Biodegradation is a process by which microorganisms metabolically
decompose contaminants into biomass and smaller molecular compounds
such as carbon dioxide, water, and end products.
Biological agents are microorganisms (typically bacteria, fungi, or
algae) or biological catalysts, such as enzymes, that can enhance the
biodegradation of a contaminated environment.
Bioremediation is the process of enhancing the ability of
microorganisms to convert contaminants into biomass and smaller
molecular end products by the addition of materials into a contaminated
environment to accelerate the natural biodegradation process.
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.
Burning agents are additives that, through physical or chemical
means, improve the combustibility of the materials to which they are
applied.
* * * * *
Chemical agents are elements, compounds, or mixtures designed to
facilitate the removal of oil from a contaminated environment and to
mitigate any deleterious effects. Chemical agent categories include
burning agents, dispersants, herding agents, solidifiers, surface
washing agents, and bioremediation agents that consist of nutrient
additives.
* * * * *
Dispersants are substances that emulsify, disperse, or solubilize
oil by promoting the formation of small droplets or particles of oil in
the water column.
* * * * *
Herding agents are substances that form a film on the water surface
to control the spreading of the oil to allow for oil removal.
* * * * *
Products are chemical or biological agents or other substances
manufactured using a unique composition or formulation.
* * * * *
Sinking agents are substances introduced into an oil discharge for
the purpose of submerging the oil to the bottom of a water body.
* * * * *
Solidifiers are substances that through a chemical reaction cause
oil to become
[[Page 38333]]
a cohesive mass, preventing oil from dissolving or dispersing into the
water column. Solidifiers are generally collected and recovered from
the environment.
Sorbents 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.
Sorbents consist of:
(1) Natural organic substances (e.g., feathers, cork, peat moss,
and cellulose fibers such as bagasse, corncobs, and straw);
(2) Inorganic/mineral compounds (e.g., volcanic ash, perlite,
vermiculite, zeolite, clay); and
(3) Synthetic compounds (e.g., polypropylene, polyethylene,
polyurethane, polyester).
* * * * *
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.
* * * * *
Subpart J--Use of Dispersants, and Other Chemical and Biological
Agents
0
5. Revise the heading of Subpart J as set out above.
0
6. Amend Sec. 300.900 by revising paragraphs (a) and (c), and by
adding paragraph (d) to read as follows:
Sec. 300.900 General.
(a) Section 311(d)(2)(G) of the Clean Water Act (CWA) requires 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. This subpart establishes a schedule that includes the
NCP Product Schedule identifying chemical and biological agents, the
Sorbents Product List, and the 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.
* * * * *
(c) This subpart applies to the use of chemical and biological
agents as defined in Subpart A of this part, or other substances that
may be used to remove, control, or otherwise mitigate oil discharges.
(d) [Reserved]
Sec. 300.905 [Removed]
0
7. Remove Sec. 300.905.
0
8. Revise Sec. 300.910 to read as follows:
Sec. 300.910 Authorization for agent use.
Use of chemical or biological agents in response to oil discharges
must be authorized by the OSC in accordance with the provisions of this
section.
(a) Use of agents identified on the NCP Product Schedule or use of
burning agents on oil discharges addressed by a preauthorization plan.
Area Committees and RRTs shall address, as part of their planning
activities, whether preauthorization of the use of chemical and
biological agents listed on the NCP Product Schedule or the use of
burning agents on certain oil discharges is appropriate. Area
Committees and RRTs shall, as appropriate, include applicable approved
preauthorization plans in ACPs and RCPs. When a preauthorization plan
is approved in advance for the use of certain agents under specified
discharge situations, then the OSC may authorize the use of agents
listed on the NCP Product Schedule, or the use of burning agents, for
the purpose for which they were specifically listed without obtaining
the incident-specific concurrences and without the natural resource
trustees consultations described in paragraph (b) of this section.
(1) Preauthorization plan development. For discharge situations
identified where such agents may be used, the preauthorization plan
must, at a minimum, specify limits for the quantities and the duration
of use, and use parameters for water depth, distance to shoreline, and
proximity to populated areas. In meeting the provisions of this
paragraph, preauthorization plans should document how regional factors
are addressed including likely sources and types of oil that might be
discharged, various potential discharge scenarios, the existence and
location of environmentally sensitive resources or restricted areas
that might be impacted by discharged oil, and logistical factors
including inventory, storage locations and manufacturing capability of
available agents, availability of equipment needed for agent use,
availability of adequately trained operators, and means to monitor
agent use in the environment. Preauthorization plans are to be
developed by the Area Committees or the RRT in consultation with the
Area Committee(s).
(2) Preauthorization plan approval. The EPA representative to the
RRT, the Department of Commerce and the Department of the Interior
natural resource trustees and, as appropriate the RRT representative
from the state(s) with jurisdiction over waters and adjoining
shorelines within the preauthorization plan area shall review and
either approve, approve with modification, or disapprove the
preauthorization plans. The Area Committees and RRTs shall address the
withdrawal of approval from a preauthorization plan, and the RRT shall
notify the NRT of the status of the preauthorization plan within 30
days from any such withdrawal.
(3) Preauthorization plan reviews. The RRT in consultation with the
Area Committee(s) must review, and revise, as needed, approved
preauthorization plans. These reviews must be conducted following a
regular timeframe, established by the RRT and documented in the plan,
to address changes that may impact the conditions under which the use
of chemical and biological agents have been preauthorized. Reviews must
also be conducted in any affected region, at a minimum, after a major
discharge or after a Spill of National Significance (SONS) relevant to
the preauthorization plan area; to address revisions of the NCP Product
Schedule impacting chemical or biological agents that may be
individually listed within a preauthorization plan; and to reflect new
listings of threatened and/or endangered species applicable to the
preauthorization plan area. The EPA RRT representative, the Department
of Commerce and Department of the Interior natural resource trustees,
and the RRT representative from the state(s) with jurisdiction over the
waters of the area to which a preauthorization plan applies shall
review and either approve, approve with modification, or disapprove any
revisions to the preauthorization plans.
(b) Use of agents identified on the NCP Product Schedule or use of
burning agents on oil discharges not addressed by a preauthorization
plan. For discharge situations that are not addressed by a
preauthorization plan developed pursuant to paragraph (a) of this
section, the OSC may authorize the use of chemical or biological agents
identified on the NCP Product Schedule on an oil discharge, or the use
of burning agents, for the specific purpose for which they were listed
with the concurrence of the EPA RRT representative and, as appropriate,
the
[[Page 38334]]
concurrence of the RRT representatives from the state(s) with
jurisdiction over the waters and adjoining shorelines threatened by the
release or discharge, and in consultation with the Department of
Commerce and Department of the Interior natural resource trustees. In
meeting the provisions of this paragraph, the OSC must consider and
document for their authorization request to the RRT, at a minimum, the
parameters for the use of agents including the quantities requested to
be authorized, the duration of use, the depth of water, the distance to
shoreline and proximity to populated areas, and should consider and
document factors such as environmentally sensitive resources or
restricted areas that might be impacted, agent inventory and storage
locations, agent manufacturing capability, availability of equipment
needed for agent use, availability of adequately trained operators and
appropriate means to monitor agent use in the environment.
(c) [Reserved]
(d) Temporary exception. In circumstances to prevent or
substantially reduce an imminent threat to human life that cannot be
immediately addressed by other procedures or provisions of the NCP, the
OSC may authorize the provisional use of any chemical or biological
agent, whether it is identified or not on the NCP Product Schedule,
without obtaining the concurrence of the EPA RRT representative and, as
appropriate, the RRT representatives from the state(s) with
jurisdiction over the waters and adjoining shorelines threatened by the
release or discharge, and without consultation with the Department of
Commerce and the Department of the Interior natural resource trustees.
This exception shall not be used as a substitute for compliance with
Sec. 300.150 of this part, including the use of personal protective
equipment, or when there is sufficient time to seek authorization in
accordance with paragraphs (a) or (b) of this section. If an agent is
authorized for use pursuant to this paragraph, the OSC shall notify as
soon as possible the EPA RRT representative and as appropriate, the RRT
representatives from the affected state(s) and the Department of
Commerce and Department of the Interior natural resource trustees. The
OSC shall document the circumstances and the reasons for use of the
agent authorized pursuant to this paragraph. Agent use for individual
circumstances under this exception shall be in accordance with
paragraphs (a) or (b) of this section no later than 24 hours after
initial application.
(e) Prohibited agents or substances. The OSC may not authorize the
use of the following:
(1) Sinking agents, or any other chemical agent, biological agent,
or any substance that is used to directly sink the oil to the bottom of
a water body.
(2) [Reserved]
(f) Storage and use of agents listed on the NCP Product Schedule.
(1) The OSC may authorize for use only products listed on the NCP
Product Schedule that are documented and certified by the responsible
party or its representative to have been stored under the conditions
provided by the submitter under Sec. 300.915(a)(6), and whose date of
use does not exceed the expiration date listed on the container's label
unless otherwise specified for expired products as provided in Sec.
300.910(f)(2), at the time of the incident.
(2) The OSC may authorize for use products listed on the NCP
Product Schedule that exceed their expiration date after the
responsible party or its representative documents and certifies that
the expired product has been stored under the conditions provided by
the submitter under Sec. 300.915(a)(6) and still meets the applicable
efficacy and toxicity listing provisions under Sec. 300.915, based on
testing of representative samples within the previous 12 months.
(g) Supplemental testing, monitoring, and information. The RRT may
require, for both planning and response, including authorization of
use, supplemental toxicity and efficacy testing, or submission of
available data and information that addresses site, area, and
ecosystem-specific concerns relative to the use of any chemical or
biological agent. The product manufacturer or responsible party shall
provide, upon request of the RRT or OSC, additional monitoring or
testing data and information to inform chemical or biological agent use
decisions specific to a response.
(h) Recovery of chemical agents and other substances from the
environment. The responsible party shall ensure that removal actions
adequately contain, collect, store, and dispose of chemical agents and
other substances that are to be recovered from the environment, unless
otherwise directed by the OSC. Chemical agents and other substances to
be recovered include solidifiers, surface washing agents, and sorbents.
The OSC should, at a minimum, consider factors such as the safety of
response personnel and harm to the environment in making determinations
pursuant to this paragraph.
(i) Reporting of agent use. (1) The authorizing OSC shall provide
the RRT the following information on chemical and biological agents
used in response to an oil discharge: product name, product category,
quantity and concentrations used, duration of use, location(s) of use,
any available data collected, and any available analyses of efficacy
and environmental effects. This information must be provided within 30
days of completion of agent use. This information may be submitted in
accordance with the OSC reporting provisions under Sec. 300.165 of
this part, as applicable, subject to the 30-day timing requirement.
(2) In support of sections 300.135(n) and 300.155(a) and (b) of
this part, the authorizing OSC shall provide for notification to the
public, updated during a response as appropriate, the following
information on chemical and biological agents used in response to an
oil discharge: product name, product category, quantity and
concentrations used, duration of use, and location(s) of use.
0
9. Revise Sec. 300.915 to read as follows:
Sec. 300.915 Data and information requirements for listing on the NCP
Product Schedule or Sorbent Product List.
If you are submitting an application for listing a product to the
NCP Product Schedule or Sorbent Product List, you must provide EPA the
information required under Sec. 300.955. Technical product data
submissions are not required for burning agents. Your submission for
each product must contain:
(a) General information for any product category. (1) Your name,
physical address, email, and telephone number;
(2) Your identity and documentation of that identity, as the
manufacturer of the product, vendor, importer, distributor of the
product, and/or a designated agent acting on behalf of the
manufacturer.
(3) All name(s), brand(s), and/or trademark(s) under which the
product is to be sold;
(4) Names, physical addresses, emails, and telephone numbers of the
primary distributors, vendors, importers and/or designated agent acting
on behalf of the manufacturer;
(5) The Safety Data Sheet (SDS) for the product;
(6) The maximum, minimum, and optimum temperature, humidity, and
other relevant conditions for product storage and a brief description
of the consequences to performance if the product is not stored within
these limits;
[[Page 38335]]
(7) The anticipated shelf life of the product at the storage
conditions noted in paragraph (a)(6) of this section and documentation
for this determination;
(8) A sample product label for all name(s), brand(s), and/or
trademark(s) under which the product is to be sold that includes
manufacture and expiration dates, and conditions for storage. You may
use an existing label provided it already contains the required dates
and storage information;
(9) The chemical or biological agent category under which you want
the product to be considered for listing on the NCP Product Schedule,
including detailed information on the specific process(es) through
which the product affects the oil, and the specific environment(s) on
which it is intended to be used (e.g., waters and/or adjoining
shorelines). If your product meets the definition of more than one
chemical or biological agent category, you must identify all applicable
categories and provide the test data to meet the listing criteria
appropriate to each;
(10) Recommended product use procedures, including product
concentrations, use ratios, types of application equipment, conditions
for use, any application restrictions; and, as applicable, procedures
for product and oil containment, collection, recovery, and disposal.
These procedures must address, as appropriate, variables such as
weather, water salinity, water temperature, types and weathering states
of oils or other pollutants. The procedures must include supporting
documentation and current applicable standard methods used to determine
them;
(11) Available information on environmental fate, including any
known measured data, methodologies, and supporting documentation, on
the persistence, bioconcentration factor, bioaccumulation factor, and
biodegradability of the product and all of its components in the
environment;
(12) The physical and chemical properties of the product, as
appropriate, and a citation for the current applicable standard methods
used to determine them, including:
(i) Physical state and appearance;
(ii) Vapor pressure;
(iii) Flash point;
(iv) Pour point;
(v) Viscosity;
(vi) Specific gravity;
(vii) Particle size for solid components; and
(viii) pH;
(13) The identity and concentration of all components in the
product, including each specific component name; corresponding Chemical
Abstract Service (CAS) Registry Number; the maximum, minimum, and
average weight percent of each component in the product; and the
intended function of each component (e.g., solvent, surfactant);
(14) For products that also contain microorganisms, enzymes, and/or
nutrients, provide the following along with a citation or a description
of the methodology used to determine:
(i) The name of all microorganisms by current genus and species,
including any reclassifications, and any physical, chemical, or
biological manipulation of the genetic composition and the weight
percent of each genus in the product;
(ii) The name of all enzymes and their International Union of
Biochemistry (I.U.B.) number(s); Enzyme Classification (EC) code
numbers; the source of each enzyme; units; and specific oil-degrading
activity;
(iii) The name(s), maximum, minimum, and average weight percent of
the nutrients contained in the product; and
(iv) Data, methodology, and supporting documentation, for the
levels of bacterial, fungal, or viral pathogens or opportunistic
pathogens including, but not limited to: enteric bacteria such as
Salmonella, fecal coliforms, Shigella, coagulase positive
Staphylococci, and beta hemolytic Streptococci and enterococci;
(15) Data, methodology, and supporting documentation for the levels
of the following:
(i) Arsenic, cadmium, chromium, copper, lead, mercury, nickel,
vanadium, zinc, and any other heavy metal reasonably expected to be in
the product;
(ii) Cyanide;
(iii) Chlorinated hydrocarbons;
(iv) Pesticides;
(v) Polychlorinated Biphenyls (PCBs); and
(vi) Polycyclic aromatic hydrocarbons (PAHs).
(16) Certification, including data, methodology, and supporting
documentation, indicating that the product does not contain any of the
prohibited agents or substances identified in Sec. 300.910(e);
(17) Information about the accredited laboratory that conducted the
required tests, including:
(i) Name of the laboratory, address, contact name, email, and phone
number; and
(ii) The national and/or international accreditations held by the
laboratory that are applicable to the test(s) performed;
(18) All test data and calculations, including:
(i) Raw data and replicates, including positive controls;
(ii) Notes and observations collected during tests;
(iii) Calculated mean values and standard deviations;
(iv) Reports, including a summary of stock solution preparation;
(v) Source and preparation of test organisms;
(vi) Test conditions; and
(vii) Chain of custody forms;
(19) An estimate of the annual product production volume, the
average and maximum amount that could be produced per day, and the time
frame needed to reach that maximum production rate in days;
(20) Recognition received from EPA's Design for the Environment
(DfE) or Safer Choice programs, as applicable; and
(21) International product testing or use data or certifications,
if available, informing the performance capabilities or environmental
impacts of the product.
(b) Dispersant testing and listing requirements--(1) Dispersant
efficacy test and listing criteria. Test the dispersant product for
efficacy using the Baffled Flask Test (BFT) method in Appendix C to
part 300. To be listed on the NCP Product Schedule, the dispersant must
demonstrate for each temperature a Dispersant Effectiveness (DE) at the
95% lower confidence level (LCL95) greater than or equal to:
(i) >=70% for Strategic Petroleum Reserve Bryan Mound at 5 [deg]C;
(ii) >=75% for Strategic Petroleum Reserve Bryan Mound at 25
[deg]C;
(2) Dispersant toxicity tests and listing criteria. Use the methods
specified in Appendix C to part 300 to test the dispersant alone, and
the dispersant mixed with Strategic Petroleum Reserve Bryan Mound for
acute toxicity, using Americamysis bahia and Menidia beryllina. Use the
methods specified in Appendix C to part 300 to test the dispersant
alone for developmental toxicity using Strongylocentrotus purpuratus or
Arbacia punctulata and for subchronic effects using Americamysis bahia
and Menidia beryllina. To be listed on the NCP Product Schedule, the
dispersant alone must demonstrate:
(i) A median lethal concentration (LC50) at the lower
95% confidence interval greater than 10 ppm;
(ii) An inhibition concentration for 50% of the test species
(IC50) at the lower 95% confidence interval greater than 1
ppm; and
(iii) A subchronic No Observed Effect Concentration (NOEC) greater
than 1 ppm.
[[Page 38336]]
(3) Limitations. 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.
(c) Surface washing agent testing and listing requirements--(1)
Surface washing agent efficacy test and listing criteria. To be listed
on the NCP Product Schedule, using an applicable standard methodology,
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.
(2) Surface washing agent toxicity test and listing criteria. Using
the toxicity test methodology in Appendix C to part 300, 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. To be listed on the NCP Product Schedule, the
surface washing agent must demonstrate an LC50 at the lower
95% confidence interval greater than 10 ppm in either freshwater or
saltwater for all tested species.
(3) Limitations. Surface washing agent listing would be for use
only in freshwater and/or saltwater environments for which it was
tested and for which it met the efficacy and toxicity listing criteria.
(d) Bioremediation agent testing and listing requirements--(1)
Bioremediation agent efficacy test and listing criteria. 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.
(2) Bioremediation agent toxicity test and listing criteria. 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 greater than 10
ppm in either freshwater or saltwater for all tested species.
(3) Limitations. Bioremediation agent listing would be for use only
in the freshwater and/or saltwater environments for which it was tested
and for which it met the efficacy and toxicity listing criteria.
(4) Generic listing. 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, 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.
(e) Solidifier testing and listing requirements. (1) Solidifiers
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 solidifier must demonstrate an LC50 at the lower 95%
confidence interval greater than 10 ppm in either freshwater or
saltwater for all tested species.
(2) Limitations. Solidifier listing would be for use only in the
freshwater and/or saltwater environments for which it was tested and
for which it met the toxicity listing criteria.
(f) Herding agent testing and listing requirements. (1) Herding
agents 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 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.
(2) Limitations. Herding agent listing would be for use only in
freshwater and/or saltwater environments for which it was tested and
for which it met the toxicity listing criteria.
(g) Sorbent requirements. Known sorbent materials and products will
be identified on a publicly available Sorbent Product List for the use
of such products when responding to an oil discharge as follows:
(1) For sorbent products that consist solely of the following
materials, or any combination thereof, no technical data are required
to be submitted for listing on the Sorbent Product List, and no further
action is necessary for use as a sorbent:
(i) Feathers, cork, peat moss, and cellulose fibers such as
bagasse, corncobs, and straw;
(ii) Volcanic ash, perlite, vermiculite, zeolite, and clay; and
(iii) Polypropylene, polyethylene, polyurethane, and polyester.
(2) If the product consists of one or more natural organic
substances, inorganic/mineral compounds, and/or synthetic compounds not
specifically identified in paragraph (g)(1) of this section but you
believe the product meets the definition of a sorbent then, as
applicable under Sec. 300.955(a) and (b), you must submit the
following information for consideration for listing it as a sorbent on
the Sorbent Product List:
(i) The information required under paragraphs (a)(1) through
(a)(8), and paragraph (a)(13) through (a)(15) of this section;
(ii) The certification required under paragraph (a)(16) of this
section; and
(iii) Information, including data, to support the claim your
product meets the sorbent definition under Sec. 300.5.
Sec. 300.920 [Removed]
0
10. Remove Sec. 300.920.
0
11. Add Sec. 300.950 to read as follows:
Sec. 300.950 Submission of Proprietary Business Information (PBI).
(a) Except as provided in paragraph (b) of this section, all
product information submitted to EPA as required under Sec. 300.915
and Sec. 300.955 will be available for public disclosure upon
submission, without further notice to the submitter.
(b) 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 will
handle such claims in accordance with 40 CFR part 2, subpart B
Confidentiality of Business Information.
(1) You must make your PBI claim at the time you submit your
information to EPA to be listed on the NCP Product Schedule or Sorbent
Product List.
(2) You must separate the PBI from all other submitted information.
Include all PBI separately with your submission package, marking it as
``Proprietary Business Information'' and placing it in a separate inner
envelope labeled with ``PROPRIETARY BUSINESS INFORMATION--TO BE OPENED
BY
[[Page 38337]]
THE PRODUCT SCHEDULE MANAGER ONLY.''
0
12. Add Sec. 300.955 to read as follows:
Sec. 300.955 Addition of a product to the NCP Product Schedule or
Sorbent ProductLlist.
(a) Submission. Submit your complete package to: U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Mail Code: 5104A, Room
1448, William J. Clinton North, Washington, DC 20460, Attention:
Product Schedule Manager.
(b) Package contents. Your package shall include, as applicable, in
this order:
(1) A cover letter on company letterhead signed and dated by you
certifying that:
(i) All testing was conducted on representative product samples;
(ii) Testing was conducted at a nationally or internationally
accredited laboratory in accordance with the methods specified in
Appendix C to part 300, and other applicable methods as appropriate;
and
(iii) All test results and product technical data and information
are true and accurate.
(2) A page numbered Table of Contents showing the information and
data submitted under Sec. 300.915(a) through (g), as applicable;
(3) All required data and information arranged in the same order as
specified in Sec. 300.915(a) through (g); and
(4) A separate envelope containing and labeled Proprietary Business
Information as specified in Sec. 300.950(b), if applicable.
(c) EPA Review. EPA shall, within 90 days of receiving a submission
package:
(1) Review the package for completeness and compliance with all
data and information requirements in Sec. Sec. 300.915, 300.950, and
this section; verify information; and request clarification or
additional information, including testing as necessary;
(2) Make a product listing determination 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; and
(3) Notify you in writing of its decision to list the product on
the NCP Product Schedule or the Sorbent Product List, or of its
decision and supporting rationale to reject the submission. If your
submission is rejected:
(i) You may revise and resubmit a complete package to address test
results, data, or information deficiencies.
(ii) EPA's 90-day review will not start until a complete package is
resubmitted.
(d) Request for review of decision. If your product is rejected for
listing on the NCP Product Schedule or the Sorbent Product List, you
may request that the EPA Administrator or designee review the
determination. Your request must be in writing within 30 days of
receipt of notification of EPA's decision not to list the product on
the NCP Product Schedule or the Sorbent Product List. Your request must
contain a clear and concise statement with supporting facts and
technical analysis demonstrating why the product meets the listing
requirements.
(1) The EPA Administrator or designee may request additional
information from you and may offer an opportunity for you to meet with
EPA.
(2) The EPA Administrator or designee will notify you in writing of
the decision within 60 days of receipt of your request, or within 60
days of receipt of requested additional information.
(e) Changes to a product listing--(1) Administrative change. You
must notify EPA in writing within 30 days of any changes to information
submitted under Sec. 300.915(a)(1) through (8) and Sec.
300.915(a)(19) through (21) for a product on the NCP Product Schedule.
In the notification, you must detail the specific changes, the reasons
for such changes and supporting data and information. EPA may request
additional information and clarification regarding these changes.
(2) Reformulation. If you change the components and/or
concentrations, you must retest the reformulated product according to
the requirements for the product category and submit a new complete
package under a new, distinct name in accordance with Sec. 300.955(b)
for review and consideration for listing on the NCP Product Schedule or
Sorbent Product List by EPA.
(f) Transitioning Listed Products to the New NCP Product Schedule
or Sorbent Product List. All products on the current NCP Product
Schedule as of December 11, 2023 will remain conditionally listed until
December 12, 2025 at which time all products that have not been
submitted and listed in the new NCP Product Schedule based on the
amended test and listing criteria will be removed. Your product will be
transitioned from the current NCP Product Schedule to the new NCP
Product Schedule prior to December 12, 2025 after you submit a new
complete package in accordance with Sec. 300.955(b), and EPA makes a
determination to list the product on the new NCP Product Schedule. All
products previously identified as sorbents by EPA will remain available
for use until December 12, 2025, at which time 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.
0
13. Add Sec. 300.965 to read as follows:
Sec. 300.965 Mandatory Product Disclaimer.
The listing of a product on the NCP Product Schedule does not
constitute approval or recommendation of the product. 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. The disclaimer
must be conspicuous and must be fully reproduced on all product
literatures, labels, and electronic media including website pages.
Disclaimer
[PRODUCT NAME] is listed on the National Contingency Plan (NCP)
Product Schedule. This listing does NOT mean that EPA approves,
recommends, licenses, or certifies the use of [PRODUCT NAME] on an oil
discharge. This listing means only that data have been submitted to EPA
as required by Subpart J of the NCP. 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.
0
14. Add Sec. 300.970 to read as follows:
Sec. 300.970 Removal of a product from the NCP Product Schedule or
Sorbent Product List.
(a) The EPA Administrator or designee may remove your product from
the NCP Product Schedule or the Sorbent Product List for reasons
including, but not limited to:
(1) 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, electronic media, or within the product submission to EPA;
or
(2) Alterations to the components, concentrations, or use
conditions of the product without proper notification to EPA as
required by Sec. 300.955(e); or
(3) Failure to print the disclaimer provided in Sec. 300.965 on
all labels, advertisements, technical literature, or electronic media
for products listed on the NCP Product Schedule; or
[[Page 38338]]
(4) New or relevant information not previously considered
concerning the impacts or potential impacts of the product to human
health or the environment.
(b) EPA will notify you in writing, at your address of record, of
its reasons for deciding to remove the product from the NCP Product
Schedule. If EPA receives no appeal from you in 30 days, the product
will be removed from the NCP Product Schedule without further notice to
you.
(c) You may appeal the decision to remove your product from the NCP
Product Schedule within 30 days of receipt of EPA's notification. Your
appeal must contain a clear and concise statement with supporting facts
and technical analysis demonstrating why the product should not be
removed. The EPA Administrator or designee will notify you in writing
of the decision within 60 days of your appeal, or within 60 days of
receipt of any requested additional information.
0
15. Revise Appendix C to Part 300 to read as follows:
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
Table of Contents
1.0 Applicability and Scope
2.0 Baffled Flask Dispersant Efficacy Test (BFT)
3.0 Dispersant Toxicity Testing
4.0 Standard Acute Toxicity Testing for Surface Washing Agents,
Bioremediation Agents, Herding Agents, and Solidifiers
5.0 Bioremediation Agent Efficacy Test Protocol
Illustrations
Figure Number
1. A Baffled Trypsinizing Flask
Tables
Table Number
1. Constituent Concentrations for GP2 Artificial Seawater
2. Test Oil Characteristics
3. Stock Standard Solution Preparation
4. Dispersant Calibration Example for Test Oil
5. Sample Calculation With ANS
6. Toxicity Testing Requirements for Dispersants
7. Summary of Test Conditions--Dispersant Toxicity
8. Toxicity Testing Requirements for Surface Washing Agents, Herding
Agents, Bioremediation Agents and Solidifiers
9. Summary of Test Conditions--Surface Washing Agents, Herding
Agents, Bioremediation Agents and Solidifiers Toxicity
10. Artificial Seawater Nutrient Concentrations
11. Artificial Seawater Nutrient Concentrations for Bioremediation
Agents Having No Nutrients Included
12. Constituent Concentrations for Artificial Freshwater (Bushnell-
Haas)
13. Freshwater Nutrient Concentrations
14. Artificial Freshwater Nutrient Concentration for Bioremediation
Agents Having No Nutrients Included
15. Bioremediation Efficacy Test--Summary of Experimental Setup
16. Bioremediation Efficacy--Summary of Analytical Procedures
17. QA/QC Checks
Standard Operating Procedures Tables
SOP 3-1 Amount of Stock Solutions Required To Make the Working
Standards
SOP 4-1 Ions Associated With Retention Time Groups
SOP 4-2 Instrumental Conditions for Crude Oil Analysis
SOP 4-3 Ion Abundance Criteria for DFTPP
SOP 4-4 Target Compound List
1.0 Applicability and Scope. This Appendix establishes
laboratory protocols required under Subpart J (Use of Dispersants
and Other Chemical and Biological Agents) of 40 CFR part 300
(National Oil and Hazardous Substances Pollution Contingency Plan)
to make listing determinations for the Product Schedule. The
protocols apply, based on product type, to dispersants,
bioremediation agents, surface washing agents, herding agents, and
solidifiers as defined in Subpart A (Introduction) of 40 CFR part
300.
2.0 Baffled Flask Dispersant Efficacy Test (BFT)
2.1 Summary. This laboratory protocol establishes procedures to
evaluate the degree to which a product effectively disperses oil
spilled on the surface of seawater, using a modified 150-mL screw-
cap trypsinizing flask (an Erlenmeyer flask with baffles) with a
glass and Teflon[supreg] stopcock near the bottom to allow removal
of subsurface water samples without disturbing the surface oil
layer. The efficacy of a dispersant is measured using one reference
oil, Strategic Petroleum Oil Reserve Bryan Mound at two temperatures
(5 [deg]C and 25 [deg]C). Six replicates and one method blank are
required at each temperature. A layer of oil is placed on the
surface of artificial seawater, and the dispersant is added to the
slick at a dispersant:oil ratio (DOR) of 1:25 (4%) by volume. A
standard orbital shaker table provides turbulent mixing at a speed
of 250 revolutions per minute (rpm) for 10 minutes, immediately
after which it is maintained stationary for 10 minutes to allow non-
dispersed oil to rise to the water's surface. An undisturbed water
sample is removed from the bottom of the flask through the stopcock,
extracted with dichloromethane (DCM), and analyzed for oil content
by UV-visible absorption spectrophotometry at wavelengths ranging
between 340 and 400 nm.
2.2 Apparatus. All equipment must be maintained and calibrated
per standard laboratory procedures.
2.2.1 Modified Trypsinizing Flask. A modified 150 mL glass
screw-capped Erlenmeyer flasks with baffles (e.g., Wheaton No.
355394 or equivalent) fitted with a 2 mm bore Teflon[supreg]
stopcock and glass tubing, the center of which is no more than 1.3
cm from the bottom, as shown in Figure 1.
[[Page 38339]]
[GRAPHIC] [TIFF OMITTED] TR12JN23.078
Figure 1. A Baffled Trypsinizing Flask
2.2.2 Orbital Shaker Table. An orbital shaker table with a
variable speed control unit capable of maintaining 250 rpm. The
orbital diameter must be approximately 1.0 inch (2.5 cm) +/-0.1 inch
(0.25 cm).
2.2.3 Spectrophotometer. A UV-visible spectrophotometer capable
of measuring absorbance between 340 and 400 nm (e.g., Shimadzu UV-
1800, Agilent 8453, or equivalent). Use standard transmission-
matched quartz 10-mm path length rectangular cells with PTFE cover
for absorbance measurements.
2.2.4 Glassware. Including: 25-ml graduated mixing cylinders (a
graduated cylinder with a ground glass stopper); 50- and 100-ml
graduated cylinders; 125-mL separatory funnels with Teflon
stopcocks; 10-ml volumetric flasks; 30-ml crimp style glass serum
bottles; 1-, 2-, 5-mL pipettes; other miscellaneous laboratory
items.
2.2.5 Micropipettor. Use a micropipettor capable of dispensing 4
[micro]L of dispersant and 100 [micro]L of oil (e.g., Brinkmann
Eppendorf repeater pipettor with 100 [micro]L and 5 mL syringe tip
attachments or equivalent).
2.2.6 Syringes. 25-, 100-, 250-, 1,000-, 2,500-, 5,000-[micro]l
gas-tight syringes.
2.2.7 Constant temperature rooms or incubators to hold the
shaker at 5 [deg]C and 25 [deg]C.
2.2.8 Analytical Balance.
2.2.9 Chemical fume hood.
2.3 Reagents.
2.3.1 Artificial seawater. Use the artificial seawater GP2
formulation shown in Table 1 of this Appendix.
2.3.2 Test oil. Use the EPA standard reference oil Strategic
Petroleum Reserve Bryan Mound. To obtain this oil at no charge
(except for a minimal shipping fee), see the instructions at http://www.epa.gov/emergencies/content/ncp/index.htm. Selected properties
are summarized in Table 2 of this Appendix.
2.3.3 Dichloromethane (DCM) (also known as methylene chloride),
pesticide quality.
2.4 Container Handling and Storage.
2.4.1 Glassware. If the glassware has been used with oil before,
rinse with DCM to remove as much of the oil adhering to the sides of
the flask as possible; waste DCM may be used. Soak in warm water
with detergent and individually wash with bristled brushes. First
rinse with tap water, then follow with two de-ionized water rinses.
Dry either on a rack or in a 110 [deg]C drying oven. After drying,
rinse with fresh DCM (use sparingly).
2.4.2 Serum bottles and other non-volumetric glassware. Bake for
at least 4 hours in a muffle furnace at 450 [deg]C.
2.5 Calibration Curve for the UV-visible spectrophotometer.
2.5.1 Stock Standard Solution Preparation. Stock standard
solution concentrations are based on the mass measurements after
each addition and density determinations of the oil/dispersant/DCM
solution using a density bottle or a 1-mL gas tight syringe. An
example calculation is given in Table 3 of this Appendix according
to the following equation:
[GRAPHIC] [TIFF OMITTED] TR12JN23.079
Use the reference oil and the specific dispersant being tested
for a particular set of experimental test runs. Prepare the stock
standard solution of dispersant-oil mixture in DCM, starting with 2
ml of the oil, then adding 80 [micro]l of the dispersant followed by
18 ml of DCM.
2.5.2 Six-point Calibration Curve. For the reference oil, add
specific volumes of its stock standard solution (given in Table 4 of
this Appendix) to 30 ml of artificial seawater in a 125 ml
separatory funnel. Extract the oil/dispersant water mixture with
triplicate 5 ml volumes of DCM. Follow each DCM addition by 15
seconds of vigorous shaking, carefully releasing the initial
pressure inside the separatory funnel by partially removing the
[[Page 38340]]
glass stopper inside a fume hood after the first few shakes. Then,
allow a 2-minute stationary period for phase separation for each
extraction. Drain the extracts into a 25-mL graduated mixing
cylinder. Release any entrained bubbles of DCM from the water layer
by sideways shaking of the funnel. Use precaution not to drain water
into the DCM extract as it can affect the absorbance readings.
Adjust the final volume of the collected extracts to 25 mL in the
mixing cylinder using DCM. Determine specific masses for oil
concentrations in the standards as volumes of oil/dispersant
solution multiplied by the concentration of the stock solution. An
example calculation is given in Table 4 of this Appendix. One
calibration curve is needed for the reference oil and dispersant
combination.
2.6 Sample Preparation and Testing. See section 2.7 of this
Appendix for a detailed description of the spectrophotometer's
linear calibration procedure.
2.6.1 Six replicates of the oil and test dispersant are required
at each temperature plus two additional tests of method blanks
(artificial seawater without oil and dispersant), one at each
temperature. A completed test consists of 14 baffled flask tests (a
total of six replicates for the reference oil/test dispersant
combination at two temperatures (5 [deg]C and 25 [deg]C), plus two
method blanks).
2.6.2 Attach a 3-inch length of Teflon tubing to the stopcock of
each of the 150-mL baffled flasks. Add 120 mL of artificial seawater
to each flask. Put screw cap on flasks and place them at the
appropriate temperature (either 5 [deg]C or 25 [deg]C) for
equilibration.
2.6.3 Calibrate and adjust the shaker table to 250
10 rpm.
2.6.4 Prepare and time separately each baffled flask.
Sequentially add 100 [micro]L of oil and 4 [micro]L of dispersant to
the flask layering them onto the center of the seawater to give a
dispersant-to-oil ratio (DOR) of 1:25. Avoid any oil or dispersant
splashing on the flask walls, as it may reduce efficacy or cause
errors in the calculated results. Discard the sample and repeat the
setup if: (1) any oil or dispersant splashing occurs during the
additions, or (2) the dispersant contacts the water first rather
than the oil. This is especially important for 5 [deg]C work because
of increased oil viscosity.
2.6.5 For the oil, fill the tip of the pipettor, using a wipe to
remove any oil from the sides of the tip. Holding the pipettor
vertically, dispense several times back into the reservoir to ensure
that the oil flows smoothly. Insert the syringe tip vertically into
the baffled flask and let the bottom of the pipettor rest on the
neck of the flask. Slowly and carefully dispense the oil one time
onto the center of the water's surface. The remainder of the oil can
either be returned to the oil bottle or set aside for use in the
next test flask.
Note to 2.6.5: If a Brinkmann Eppendorf repeater pipettor is
used for dispensing the oil, attach a 5-mL syringe tip, and set the
dial to 1.
2.6.6 For the dispersant, use the same procedure as for the oil
to dispense onto the center of the oil slick surface. As the
dispersant first contacts the oil, it will usually push the oil to
the sides of the flask. Replace the screw cap onto the flask.
Note to 2.6.6: If a Brinkmann Eppendorf repeater pipettor is
used for dispensing the dispersant, attach a 100-[micro]L syringe
tip, and set the dial to 2.
2.6.7 Carefully place flask securely onto the shaker and agitate
for 10 0.25 minutes at 250 10 rpm.
2.6.8 Remove the flask from the shaker table and allow a
stationary, quiescent period of 10 0.25 minutes to
allow undispersed and/or recoalesced oil droplets to refloat to the
surface.
2.6.9 Carefully open the screw cap, then the stopcock at the
bottom, and discard the first several mL of seawater into a waste
beaker to remove non-mixed water-oil initially trapped in the
stopcock tubing. Collect a volume slightly greater than 30-mL into a
50-mL graduated cylinder. Adjust the collected volume to the 30-mL
mark by removing excess with a disposable glass Pasteur pipette. A
web-like emulsion may form at the solvent/water interface during the
water sample extraction. Avoid pulling any emulsion phase into the
DCM extract as it may cloud the DCM-extract, leading to error.
2.6.10 Transfer the water-oil sample from the graduated cylinder
into a 125-mL glass separatory funnel fitted with a Teflon stopcock.
2.6.11 Add 5 mL DCM to the separatory funnel. Start shaking,
releasing pressure into the fume hood by loosening the glass
stopper. Shake vigorously at least 20 times for 15 seconds.
2.6.12 Allow the funnel to remain in a stationary position for 2
minutes to allow phase separation of the water and DCM.
2.6.13 Drain the DCM layer from the separatory funnel into a 25
mL mixing cylinder. Avoid pulling any emulsion phase into the DCM
extract as it may cloud the DCM extract.
2.6.14 Repeat the DCM-extraction process two or three additional
times until the DCM is clear. Collect each extract in the graduated
cylinder. After the final extraction, lightly shake the separatory
funnel sideways once or twice to dislodge entrained bubbles of DCM
and drain.
2.6.15 Adjust the final volume to a known quantity, 25 mL, in
the mixing cylinder. Using a syringe, dispense 2.5 mL or 5.0 mL of a
reference oil sample into a 10-mL volumetric flask, and fill with
DCM to make either a 1:4 or 1:2 dilution, respectively.
2.6.16 If analysis cannot be conducted immediately, store the
extracted DCM samples at 4 2 [deg]C until time of
analysis. Glass-stoppered mixing cylinders may be used for short-
term storage or prior to bringing the extracts up to volume. After
bringing to volume, transfer the DCM extracts to 25-30 ml crimp-
style serum vials with aluminum/Teflon seals.
2.6.17 Complete all analysis within 10 consecutive days from
when the sample was collected.
2.7 UV-Visible Spectrophotometer Linear Stability Calibration
2.7.1 A six-point calibration of the UV-visible
spectrophotometer is required at least once per day for each oil.
The stability calibration criterion is determined with the six oil
standards identified in Table 4 of this Appendix.
2.7.2 Turn on spectrophotometer and allow it to warm up for at
least 30 minutes before beginning analysis. Blank the instrument for
the wavelengths between 340 and 400 nm with DCM.
2.7.3 If refrigerated, allow all extracts, standards, and
samples to warm to room temperature.
2.7.4 Determine the absorbance of the six standards between the
wavelengths of 340 and 400 nm. This can be done by either one of the
following methods:
2.7.4.1 Trapezoidal Rule. Program the spectrophotometer to take
readings every 5[lambda] or 10[lambda] and calculate the area under
the curve using the Trapezoidal rule:
[GRAPHIC] [TIFF OMITTED] TR12JN23.080
where N + 1 = number of absorbance measurements to delineate N
equally spaced sections of the curve, and H = the distance
([lambda]) between each reading. For H = 5, N + 1 = 13 measurements,
for H = 10, N + 1 = 7. The following formula illustrates readings
taken every 10[lambda].
[GRAPHIC] [TIFF OMITTED] TR12JN23.081
[[Page 38341]]
When using readings taken every 5[lambda], each absorbance sum
is multiplied by 5.
2.7.4.2 Automatic Integration. Program the spectrophotometer to
automatically integrate the area under the curve between 340 nm and
400 nm.
2.7.4.3 If the wavelengths must be manually set on the
spectrophotometer, the older method of only measuring at
340[lambda], 370[lambda], and 400[lambda] may be used. Then
calculate using the trapezoidal rule for N + 1 = 3, H = 30. While
the resulting area count with the older method is less accurate, the
final results are similar since the inaccuracy is systematic.
2.7.5 After determining the area count for each standard,
determine the response factor (RF) for the oil at each concentration
using the following equation:
[GRAPHIC] [TIFF OMITTED] TR12JN23.082
2.7.6 Spectrophotometer stability for the initial calibration is
acceptable when the RFs of the six standard extracts are less than
10% different from the overall mean value for the six standards, as
calculated in Equation 5 of this Appendix and depicted in the
example in Table 4 of this Appendix.
[GRAPHIC] [TIFF OMITTED] TR12JN23.083
2.7.7 If this criterion is satisfied, begin analysis of sample
extracts. Absorbances greater than or equal to 3.5 are not included
because absorbance saturation occurs at and above this value. If any
of the standard oil extracts fails to satisfy the initial-stability
criterion, the source of the problem (e.g., preparation protocol for
the oil standards, spectrophotometer stability, etc.) must be
corrected before analysis of the sample extracts begins.
2.7.8 Determine the slope of the calibration points by using
linear regression forced zero intercept:
[GRAPHIC] [TIFF OMITTED] TR12JN23.084
2.8 Spectrophotometric Analysis and Calculations
2.8.1 Once a successful calibration curve for the reference oil
has been created and verified, measure experimental replicates for
the reference oil at each temperature followed by a standard check
sample.
2.8.2 Determine the area for the absorbance values obtained for
the experimental samples by using Equation 2 of this Appendix and
illustrated by Equation 3 of this Appendix.
2.8.3 Calculate the Total Oil dispersed and the percentage of
oil dispersed (%OD) based on the ratio of oil dispersed in the test
system to the total oil added to the system, as follows:
[GRAPHIC] [TIFF OMITTED] TR12JN23.085
where:
VDCM = final volume of the DCM extract (mL)
Vtw = total seawater in Baffled Flask (120 mL)
Vew = volume seawater extracted (30 mL)
[GRAPHIC] [TIFF OMITTED] TR12JN23.086
where:
rOil = density of the specific test oil, mg/mL and
VOil = Volume (mL of oil added to test flask (100
[micro]L = 0.1 mL))
2.8.4 The %ODs for the six replicates within a particular
treatment are then subjected to an outlier test, the Grubb's Test
[[Page 38342]]
or Maximum Normal Residual test (6). A convenient internet-based
calculator of a Grubbs outlier may be found at: http://www.graphpad.com/quickcalcs/Grubbs1.cfm. If an outlier is detected
(p < 0.05), analyze an additional replicate to obtain the required
six replicates.
2.8.5 Report the Dispersion Efficacy value for each oil and each
temperature, which is the lower 95% confidence level of the 6
independent replicates (DELCL95) for each oil/temperature
combination. Error bars are not needed as reporting the lower
confidence level computationally takes the variability of the
replicates into account as shown in Equation 9 of this Appendix.
[GRAPHIC] [TIFF OMITTED] TR12JN23.087
where %OD%OD = mean percentage oil dispersed for the n = 6
replicates, S = standard deviation, and
t(n-1,1-[alpha]) = 100 * (1-[alpha])th
percentile from the t-distribution with n-1 degrees of freedom. For
6 replicates, tn-1,1-[alpha] = 2.015, where [alpha] =
0.05. An example of the calculations is given in Table 5 of this
Appendix.
2.9 Performance Criterion
The dispersant product tested will remain in consideration for
listing on the NCP Product Schedule if the dispersant efficacy
(DELCL95), as calculated in section 2.8.6 of this
Appendix, is:
------------------------------------------------------------------------
Temp DELCL95 (%)
Oil ([deg]C)
------------------------------------------------------------------------
Bryan Mound...................................... 5 >=70
Bryan Mound...................................... 25 >=75
------------------------------------------------------------------------
2.10 Quality Control (QC) Procedures for Oil Concentration
Measurements
2.10.1 Absorbance readings. Perform at least 5% of all UV-
visible spectrophotometric measurements in duplicate as a QC check
on the analytical measurement method. The absorbance values for the
duplicates must agree within 5% of their mean value.
2.10.2 Method blanks. Analytical method blanks involve an
analysis of artificial seawater blanks (artificial seawater without
oil or dispersant in a baffled flask) through testing and analytical
procedures. Analyze method blanks with a frequency of at least two
per completed test. Oil concentrations in method blanks must be less
than detectable limits.
2.10.3 Accuracy. Determine accuracy by using a mid-point
standard calibration check after each set of replicate samples
analyzed. The acceptance criterion is based on a percent recovery of
90-110% using the following equation:
[GRAPHIC] [TIFF OMITTED] TR12JN23.088
2.10.4 Calibration QC checks. Before analyzing samples, the
spectrophotometer must meet an instrument stability calibration
criterion using the oil standards. The instrument stability for
initial calibration is acceptable when the RFs (Equation 5 of this
Appendix) for each of the six standard concentration levels are less
than 10% different from the overall mean value.
Table 1--Constituent Concentrations for GP2 Artificial Seawater
[Based on Spotte et al., 1984]
------------------------------------------------------------------------
Concentration (g/
Constituent L)
------------------------------------------------------------------------
NaCl................................................. 21.03
Na2SO4............................................... 3.52
KCl.................................................. 0.61
KBr *................................................ 0.088
Na2B4O7 x 10H2O *.................................... 0.034
MgCl2 x 6H2O......................................... 9.50
CaCl2 x 2H2O......................................... 1.32
SrCl2 x 6H2O *....................................... 0.02
NaHCO2 *............................................. 0.17
------------------------------------------------------------------------
* Use Stock Solution, 1 mL/L GP2 for 100X stock solution for Bromide,
Borate, and Strontium. 10 mL/L GP2 for bicarbonate--10X stock solution
as it is not soluble in a 100X solution. Adjust to pH 8.0 prior to
autoclaving.
Table 2--Test Oil Characteristics
[April 2023 oil assay]
----------------------------------------------------------------------------------------------------------------
Density, mg/mL API gravity @15 Viscosity @25
Oil @15 [deg]C [deg]C [deg]C, (cSt) Category by API gravity
----------------------------------------------------------------------------------------------------------------
SPR Bryan Mound................. 0.8320 38.6 4.721 Light Oil.
----------------------------------------------------------------------------------------------------------------
[[Page 38343]]
Table 3--Sample Calculation for Preparation of Oil + Dispersant Stock
Standard Solution
------------------------------------------------------------------------
Item Identifier Amount
------------------------------------------------------------------------
Mass of Bottle, g................... A 29.498
Mass of Bottle + oil, g............. B 31.225
Mass of bottle + disp + oil + DCM, g C 54.380
Mass of oil, g (derived)............ F = B-A 1.727
Mass of disp + oil + DCM, g G = C-A 24.882
(derived)..........................
Mass of 1 mL syringe, g............. D 14.556
Mass of 1 mL syringe + solution, g.. E 15.820
Density of solution, g/mL (derived). H = E-D 1.264
Volume of solution, mL (derived).... I = G/H 19.687
Conc. of stock solution, mg/mL J = F*1000/I 87.704
(derived)..........................
------------------------------------------------------------------------
Table 4--Sample Calculations for Oil + Dispersant Six Point Calibration
----------------------------------------------------------------------------------------------------------------
Oil + Dispersant Stock Standard Solution Concentration = 87.7 mg/mL (Table 3)
-----------------------------------------------------------------------------------------------------------------
Theoretical Area (340-400 Dev. from
Standard--stock vol. (uL) conc., mg/mL nm) RF Avg. RF avg. RF Slope
----------------------------------------------------------------------------------------------------------------
25.............................. 0.088 4.126 0.021 0.021 2.931 48.759
50.............................. 0.175 8.757 0.020 .......... 3.017 ..........
100............................. 0.351 16.559 0.021 .......... 2.577 ..........
150............................. 0.526 25.666 0.021 .......... 0.731 ..........
200............................. 0.702 34.142 0.021 .......... 0.500 ..........
250............................. 0.877 43.006 0.020 .......... 1.260 ..........
----------------------------------------------------------------------------------------------------------------
Table 5--LCL95 Sample Calculation With Test Oil and Example Dispersant `A'
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Area (340- Extract Mass in Total oil
Rep 400 nm) Dilution volume Conc, mg/ 30 mL, dispersed, Efficiency, Average Std. Variance Coef. of LCL95
factor (ml) * mL. mg mg % dev. variation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1.............................................................. 32.197 1 25 0.66 16.51 66.03 79.76 81.30 4.46 19.85 5.48 81.30
2.............................................................. 35.470 1 25 0.73 18.19 72.75 87.87 ........ ........ ......... ......... ........
3.............................................................. 30.260 1 25 0.62 15.52 62.06 74.96 ........ ........ ......... ......... ........
4.............................................................. 31.831 1 25 0.65 16.32 65.28 78.85 ........ ........ ......... ......... ........
5.............................................................. 33.355 1 25 0.68 17.10 68.41 82.63 ........ ........ ......... ......... ........
6.............................................................. 33.791 1 25 0.69 17.33 69.30 83.71 ........ ........ ......... ......... ........
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* = 25 ml of DCM extract captured oil from 30 ml of aqueous DE test.
2.11 References for Section 2.0
(1) U.S. Environmental Protection Agency (1994), ``Swirling Flask
Dispersant Effectiveness Test,'' Title 40 Code of Federal
Regulations, Pt. 300, Appendix C, pp 47458-47461.
(2) Sorial, G.A., A.D. Venosa, K.M, Koran, E. Holder, and D.W. King.
2004. ``Oil spill dispersant effectiveness protocol: I. Impact of
operational variables.'' ASCE J. Env. Eng. 130(10):1073-1084.
(3) Sorial, G.A., A.D. Venosa, K.M, Koran, E. Holder, and D.W. King.
2004. ``Oil spill dispersant effectiveness protocol: II. Performance
of revised protocol.'' ASCE J. Env. Eng. 130(10):1085-1093.
(4) Venosa, A.D., D.W. King, and G.A. Sorial. 2002. ``The baffled
flask test for dispersant effectiveness: a round robin evaluation of
reproducibility and repeatability.'' Spill Sci. & Technol. Bulletin
7(5-6):299-308.
(5) Spotte, S., G. Adams, and P.M. Bubucis. 1984. ``GP2 medium is an
synthetic seawater for culture or maintenance of marine organisms,''
Zoo Biol, 3:229-240.
(6) Grubbs, F. 1969. ``Sample Criteria for Testing Outlying
Observations,'' Annals of Mathematical Statistics, pp. 27-58.
3.0 Dispersant Toxicity Testing
3.1 Summary. This laboratory protocol includes testing for: (1)
dispersant standard static acute toxicity tests for the mysid
shrimp, Americamysis bahia (48-hr duration) and the inland
silverside, Menidia beryllina (96-hr duration); (2) dispersant-oil
mixture static acute toxicity tests for Americamysis bahia and
Menidia beryllina (48-hr and 96-hr duration, respectively); (3)
dispersant developmental assay for Strongylocentrotus purpuratus or
Arbacia punctulata, (72-hr duration); and (4) dispersant 7-day
static subchronic tests with Americamysis bahia and Menidia
beryllina (Table 6 of this Appendix).
Table 6--Toxicity Testing Requirements for Dispersants
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test procedure
---------------------------------------------------------------------------------------------------------------------------------------------------------
96-Hr static acute: Menidia 48-Hr static acute: 72-Hr sea urchin 7-Day subchronic: M.
Test substance beryllina Americamysis Bahia developmental assay beryllina & A. bahia
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dispersant only................. yes.......................... yes.......................... yes........................ yes.
Dispersant--Reference Oil yes.......................... yes.......................... no......................... no.
Mixture.
--------------------------------------------------------------------------------------------------------------------------------------------------------
3.2 Preparation of Stock Solutions
3.2.1 Dispersant. Prepare a 1000 [mu]L/L primary stock solution
prior to test initiation by adding 1.1 mL of dispersant to 1100 mL
of dilution water consisting of salinity
[[Page 38344]]
adjusted uncontaminated natural or artificial seawater, in a glass
vessel. Using a laboratory top stirrer equipped with a stainless-
steel blade, center the stirrer blade in the mixing vessel one inch
off the bottom. Initially mix the resulting stock solution for
approximately five seconds at speeds of <10,000 rpm to avoid
foaming. Thereafter, set the speed to provide a 70% vortex. Using a
glass pipette, remove appropriate aliquots of stock solution from
between the mixing vessel wall and edge of the vortex and place
directly into the dilution water within an exposure vessel. Suspend
mixing of the stock solution after the removal of each aliquot. Base
the preparation of exposure solutions on the nominal concentration
of the stock solution and follow procedures outlined in sections 3.5
and 3.6 of this Appendix.
3.2.2 Dispersant-Reference Oil(s) Mixtures. Use Strategic
Petroleum Reserve Bryan Mound reference oil. To obtain this oil at
no charge (except for a minimal shipping fee) see https://www.epa.gov/emergency-response/national-contingency-plan-subpart-j#howto. Assessment of dispersant-reference oil mixture (DOM)
toxicity is determined for each reference oil using the aqueous
phase of a chemically enhanced-water accommodated fraction (CE-WAF).
Fit a glass aspirator bottle (approximately 23 L) equipped with a
hose bib at the base with a length of silicon tubing containing a
hose clamp. Fill the bottle with 19L of seawater leaving a 20%
headspace above the liquid, place on a magnetic stir plate then add
and center a stir bar. Add the reference oil at 25 g/L using a
silicon tube attached to a glass funnel that reaches just below the
water surface. Using this method reduces the production of air
bubbles on the oil surface slick. Adjust the stir plate to obtain an
oil vortex of 25% of the total volume of the seawater, then add the
dispersant to be tested at a ratio of 1:10 dispersant:oil (2.5 g/L).
Securely seal the bottle to reduce the loss of volatiles using a
silicon stopper and wraps of Parafilm and stir for 18 hours, then
allow the solution to settle for 6 hours. Maintain the temperature
at 25 [deg]C during stirring and settling. Purge the hose at the
base of the bottle of any material followed by removal of the CE-WAF
(aqueous phase) into a clean glass container without disturbing the
surface oil slick. The CE-WAF should be remixed and 1 to 2 L removed
for chemical analysis of total petroleum hydrocarbons (TPH)
following the procedures outlined in section 3.4 of this Appendix.
The remaining volume will be used for the preparation of exposure
solutions following procedures outlined in section 3.3 of this
Appendix. To reduce time and cost, mix sufficient amounts of
dispersant product-reference oil mixture CE-WAF to allow preparation
of exposure solutions for conducting simultaneous acute tests with
both Americamysis bahia and Menidia beryllina.
3.3 Preparation of Exposure Concentrations.
3.3.1 Concentration Selection. Preliminary rangefinder tests may
be necessary using a series of logarithmic concentrations (e.g. 0.1,
1, 10, 100 [micro]l dispersant product/L or mg TPH/L) to determine
the appropriate exposure concentration range necessary to determine
LC50 values and 95% confidence intervals. For definitive
tests, conduct a minimum of five test concentrations using a
geometric ratio between 1.5 and 2.0 (e.g. 2, 4, 8, 16, and 32). Note
that when testing only the dispersant product, the highest test
concentration must not exceed the dispersant's self-dispersibility
limit.
3.3.2 Exposure Concentrations. Exposure solutions are prepared
by adding the appropriate amount of stock solution directly to
dilution water in each test chamber. Mix each exposure solution
using five rotations in one direction followed by five rotations in
the opposite direction using a solid glass stir rod.
3.3.3 Reference Toxicants. Separate toxicity tests must be
performed with a reference toxicant for each species tested. Conduct
additional reference toxicity tests any time a change in the
population or source of a test species occurs. Use sodium dodecyl
sulfate (SDS), also known as dodecyl sodium sulfate (DSS), and
sodium lauryl sulfate (SLS) as the reference toxicant for exposures
conducted with Menidia beryllina and Americamysis bahia. Use copper
chloride as the reference toxicant for exposures conducted with the
sea urchin developmental test. Use reagent grade quality SDS and
copper chloride for tests. Information on procedures for conducting
reference toxicant tests with these species can be found in the
specific EPA methods documents cited in sections 3.5.1, 3.6.1, and
3.7.1 of this Appendix.
3.4 Chemical Analysis of Stock Solutions. Add the 1 L sample of
CE-WAF (Section 3.2.2 of this Appendix) solutions directly to amber
glass bottles with Teflon[supreg]-lined cap. Collect a replicate
sample in the event of accidental loss or if reanalysis of the stock
solution becomes necessary. Adjust sample to a pH=2 using 50%
hydrochloric acid, immediately refrigerate and analyze within 48
hours of collection. Analyze samples for C9-C32 TPH by gas
chromatography-flame ionization detection (GC-FID) following EPA SW-
846, Method 8015B-DRO (4). Report TPH concentration of stock
solutions as milligrams TPH/L and use in the calculation of exposure
concentrations for all toxicity tests conducted with CE-WAF.
3.5 Static Acute Tests with M. beryllina and A. bahia
3.5.1 General. Use EPA's Methods for Measuring the Acute
Toxicity of Effluents and Receiving Waters to Freshwater and Marine
Organisms (EPA-821-R-02-012) (1) for testing each species separately
with dispersant product or a mixture of dispersant product and
reference oil (DOM).
3.5.2 Test Solutions. Modify procedures in EPA-821-R-02-012
specifically dealing with the handling and toxicity testing of
effluents or receiving water samples as follows: Prepare stock
solutions following section 3.2 of this Appendix and exposure
concentrations following section 3.3 of this Appendix.
3.5.3 Number of Treatments, Replicates and Organisms. Conduct a
minimum of three replicates of at least five exposure treatments
plus a minimum of three replicate dilution water controls. Expose
ten organisms per replicate treatment.
3.5.4 Exposure Period. Test duration is 48-hr for Americamysis
bahia and 96-hr for Menidia beryllina. Mortality must be recorded at
each 24-hour period of each test.
3.5.5 Test Acceptability. For each test performed, survival of
control animals must be >90% and test results must allow
determination of statistically valid LC50 and 95%
confidence interval values except in cases where the LC50
is >1000 [mu]l/L or is determined to be greater than the limits of
water solubility of dispersibility.
3.5.6 Static Acute Test Summary. A summary of required test
conditions is provided in Table 7 of this Appendix.
3.6 Sea Urchin Developmental Test with Dispersant Product
3.6.1 General. Use Section 15, ``Purple Urchin,
Strongylocentrotus purpuratus and Sand Dollar, Dendraster
excentricus Larval Development Test Method'' of EPA's Short-Term
Methods for Estimating the Chronic Toxicity of Effluents and
Receiving Waters to West Coast Marine and Estuarine Organisms (EPA/
600/R-95-136) (2). Alternatively, the development of the urchin
Arbacia punctulata may be tested (see Table 7).
3.6.2 Test Organism. Tests of dispersant products are to follow
methods for the purple urchin only. Tests with the sand dollar are
not required.
3.6.3 Test Solutions. Modify procedures in EPA/600/R-95-136,
Section 15 specifically dealing with the handling and toxicity
testing of effluents or receiving water samples as follows: Prepare
stock solutions following section 3.2.1 of this Appendix and
exposure concentrations following section 3.3 of this Appendix.
3.6.4 Number of Treatments and Replicates. Conduct a minimum of
four replicates of five exposure treatments plus a minimum of four
replicate dilution water controls.
3.6.5 Exposure Duration and Test Endpoint. Examine the effects
of the dispersant product on normal development of sea urchin
embryos over a period of 72 hours. An IC50 (the exposure
concentration at which normal development is inhibited in 50% of the
embryos) with 95% confidence intervals are to be determined in place
of an IC25. The concentration of dispersant causing
inhibition of development in 50% of exposed embryos
(IC50) with the lower and upper 95% confidence intervals
(LCI95 and ULCI95) must be calculated at the
end of the exposure period. Mortality determinations are not
required.
3.6.6 Test Acceptability. Requirements of the assay are: (i)
>=80% normal larval development in the control treatment, (ii) the
minimum significant difference (MSD) that can be statically detected
relative to the control is <=25%, iii) test results which support
the determination of a statistically valid IC50 and 95%
confidence interval unless the LC50 is >1000 [mu]l/L or
is greater than the limits of water solubility of dispersibility.
3.6.7 Urchin Developmental Test Summary. A summary of required
test conditions is provided in Table 7 of this Appendix.
3.7 Seven-day Subchronic Tests with M. beryllina and A. bahia
[[Page 38345]]
3.7.1 General. Use Section 13, Method 1006.0, ``Inland
Silverside (Menidia beryllina) Larval Survival and Growth Method,''
and Section 14, Method 1007.0, ``Mysid (Mysidopsis [renamed
Americamysis] bahia) Survival, Growth, and Fecundity Method'' of
EPA's Short-Term Methods for Estimating the Chronic Toxicity of
Effluents and Receiving Waters to Marine and Estuarine Organisms
(EPA-821-R-02-014) (3) for testing of dispersant product.
3.7.2 Test Solutions. Modify procedures in EPA-821-R-02-014,
sections 13 and 14 specifically dealing with the handling and
toxicity testing of effluents or receiving water samples as follows:
Prepare stock solutions following section 3.2.1 of this Appendix and
exposure concentrations following section 3.3 of this Appendix.
Exposure solutions should be renewed every 24 hours for the duration
of the test.
3.7.3 Number of Treatments, Replicates and Organisms. (i)
Menidia beryllina: Conduct a minimum of four replicates of at least
five exposure treatments plus a minimum of four replicate dilution
water controls. Expose ten M. beryllina per replicate treatment.
(ii) Americamysis bahia: Conduct a minimum of eight replicates of at
least five exposure treatments plus a minimum of eight replicate
dilution water controls. Expose five A. bahia per replicate
treatment.
3.7.4 Exposure Duration and Test Endpoint. The test duration is
seven days for both species. Test endpoints for Menidia beryllina
are survival and growth (dry weight) and for Americamysis bahia is
survival, growth (dry weight) and fecundity. Calculate an
LC50 and 95% confidence interval for survival and
IC25 and IC50 with 95% confidence intervals
for growth (and fecundity for A. bahia only). Report the lowest
observed effect concentration (LOEC) and no observed effect
concentration (NOEC) for each endpoint.
3.7.5 Test Acceptability. Requirements of the assay are: (i)
>=80% survival in the control treatment for each species, (ii) dry
weights must meet the specific requirements as stipulated in Method
1006.0 for Menidia beryllina and Method 1007.0 for Americamysis
bahia.
3.7.6 Subchronic Test Summary. A summary of required test
conditions for each species is provided in Table 7 of this Appendix.
3.8 Laboratory Report. The laboratory must include, for each
toxicity test report, all applicable information, data and analyses
as follows:
3.8.1 Test Objective: protocol title and source, endpoint(s);
3.8.2 Product Information: product name, manufacturer contact
information, lot number, production date, date received/chain of
custody;
3.8.3 Contract Facility: contact information;
3.8.4 Dilution Water: source, pretreatment, physical and
chemical characteristics (pH, salinity);
3.8.5 Test Conditions: date and time of test (start and end),
test chambers type and volume, volume of solution per chamber,
number of organisms per chamber, number of replicate chambers per
treatment, feeding frequency, amount and type of food, test
concentrations, test temperature (mean and range), test salinity
(mean and range);
3.8.6 Test Organisms: common and scientific name, source contact
information, age and date purchased, acclimation conditions (e.g.,
temperature, salinity, both mean and range), age at test start;
3.8.7 Reference toxicant: date received, lot number, date of
most recent test, results and current Cumulative Sum Chart, dilution
water used, physical and chemical methods used;
3.8.8 Quality Assurance: verification of laboratory
accreditation, including subcontractor facilities;
3.8.9 Test Results: raw data in tabular and graphical form,
daily records of affected organisms in each concentration replicate
and controls, table of required endpoints (i.e., LC50
with 95% confidence interval (CI), IC25 and
IC50 with 95% CI, LOEC and NOEC), statistical methods
used to calculate endpoints, summary tables of test conditions and
QA data;
3.8.10 Analytical Results: method summary including Limit of
Detection (LOD)/Limit of Quantitation (LOQ), deviations and reasons
if any, sample summary, results including chromatograms and data
qualifiers, QA summary including calibration curves, method blank
and surrogate recovery, analytical results summary; and
3.8.11 Conclusions: Relationship between test endpoints and
threshold limit.
Table 7--Summary of Test Conditions--Dispersant Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development S.
Acute M. beryllina Acute A. bahia Subchronic M. Subchronic A. bahia purpuratus/A.
beryllina punctulata
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test type.......................... Static non-renewal.... Static non-renewal.... Static renewal Static renewal Static non-renewal.
(daily). (daily).
Test duration...................... 96 hours.............. 48 hours.............. 7 days............... 7 days............... 72 2
hours.
Salinity........................... 20 20 20 20 34
2[permil]. 2[permil]. 2[permil]. 2[permil]. 2[permil].
----------------------------------------------------------------------------------------------
Temperature........................ 25 1 [deg]C. Test temperatures must not deviate (maximum minus minimum 15 1
temperature) by for than 3 [deg]C during the test. [deg]C.
--------------------------------------------------------------------------------------------------------------------
Light quality...................... Ambient laboratory illumination.
Light intensity.................... 10-20 [mu]E/m\2\/s.
Photoperiod........................ 16 h light, 8 h darkness, with phase in/out period recommended.
--------------------------------------------------------------------------------------------------------------------
Test chamber size \1\.............. 250 mL................ 250 mL................ 600 mL-1 L........... 400 mL............... 30 mL.
Test solution volume \1\........... 200 mL................ 200 mL................ 500-750 mL........... 150 mL............... 10 mL.
Age of test organism \2\........... 9-14 days............. 1-5 days.............. 7-11 days............ 7 days............... 1 hr old fertilized
eggs.
No. organisms per test chamber..... 10.................... 10.................... 10................... 5.................... 25 embryos per mL.
No. of replicate chambers per 3..................... 3..................... 4.................... 8.................... 4.
concentration.
----------------------------------------------------------------------------------------------
Feeding regime..................... Refer to specific feeding procedures provided in each test method. None.
--------------------------------------------------------------------------------------------------------------------
Aeration........................... None, unless DO falls below 4.0 mg/L, then aerate all chambers. Rate: <100 bubbles/minute.
Test concentrations................ 5 exposure concentrations and a control (minimum required).
--------------------------------------------------------------------------------------------------------------------
Test acceptability (required)...... >=90% survival in >=90% survival in For controls: >=80% For controls: >=80% >=80% normal shell
controls. controls. survival; average survival; average development in
dry weight >=0.5mg dry weight >=0.20 mg. controls.
where test starts
with 7 day old
larvae, or >=0.43 mg
for larvae preserved
for <=7days.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Recommended minimum value.
\2\ Less than or equal to 24-hr range in age.
3.9 References for Section 3.0
(1) U.S. EPA. 2002. Methods for Measuring the Acute Toxicity of
Effluents and Receiving Waters to Freshwater and Marine Organisms.
Fifth Edition. U.S.
[[Page 38346]]
Environmental Protection Agency, Washington, DC (EPA-821-R-02-012).
(2) U.S. EPA. 1995. Short-Term Methods for Estimating the Chronic
Toxicity of Effluents and Receiving Waters to West Coast Marine and
Estuarine Organisms. First Edition. U.S. Environmental Protection
Agency, Washington, DC (EPA/600/R-95-136)
(3) U.S. EPA. 2002. Short-Term Methods for Estimating the Chronic
Toxicity of Effluents and Receiving Waters to Marine and Estuarine
Organisms. Third Edition. U.S. Environmental Protection Agency,
Washington, DC (EPA-821-R-02-014).
(4) U.S. EPA. 2008. Test Methods for Evaluating Solid Waste,
Physical/Chemical Methods U.S. Environmental Protection Agency,
Washington, DC (SW-846) http://www.epa.gov/osw/hazard/testmethods/sw846/online/index.htm.
4.0 Standard Acute Toxicity Testing of Surface Washing Agents,
Bioremediation Agents, Herding Agents, and Solidifiers.
4.1 Summary. This laboratory protocol includes testing for: (1)
saltwater standard static acute toxicity tests for test products
with the mysid shrimp, Americamysis bahia (48-hr duration) and the
inland silverside, Menidia beryllina (96-hr duration); and (2)
freshwater standard static acute toxicity tests for test products
with the daphnid, Ceriodaphnia dubia (48-hr duration) and the
fathead minnow, Pimephales promelas (96-hr duration) (see Table 8 of
this Appendix).
Table 8--Toxicity Testing Requirements for Surface Washing Agents, Herding Agents, Bioremediation Agents and
Solidifiers
----------------------------------------------------------------------------------------------------------------
Test procedure
-------------------------------------------------------------------------------
Application environment 96-hr Static 48-hr Static 96-hr Static 48-hr Static
acute: Menidia acute: acute: Pimephales acute:
beryllina Americamysis bahia promelas Ceriodaphnia dubia
----------------------------------------------------------------------------------------------------------------
Saltwater only.................. yes............... yes............... no................ no.
Freshwater only................. no................ no................ yes............... yes.
Freshwater and saltwater use.... yes............... yes............... yes............... yes.
----------------------------------------------------------------------------------------------------------------
4.2 Dilution Water. Use Section 7 of EPA's Methods for Measuring
the Acute Toxicity of Effluents and Receiving Waters to Freshwater
and Marine Organisms (EPA-821-R-02-012) [1] for preparation of the
appropriate dilution water for each species tested. Use of clean
natural or synthetic seawater for tests conducted with saltwater
species is acceptable.
4.3 Preparation of Stock Solutions.
4.3.1 Liquid Surface Washing Agents and/or Herding Agents.
Prepare a 1000 [micro]L/L stock solution prior to test initiation by
adding 1.1 mL of test product to 1100 mL of dilution water in a
glass vessel. Place on a magnetic stir plate then add and center a
stir bar and adjust the stir plate to obtain a vortex of 25% of the
total volume of the liquid. Mix the resulting stock solution for
approximately five minutes at room temperature. Using a glass
pipette, remove appropriate aliquots of stock solution from between
the mixing vessel wall and edge of the vortex and place directly
into the dilution water within an exposure vessel. Base the
preparation of exposure solutions on the nominal concentration of
the stock solution and follow procedures outlined in sections 4.6
and/or 4.7 of this Appendix, as appropriate.
4.3.2 Bioremediation Agents. For products consisting of two or
more liquid and/or solid components, prepare the product following
the manufacturers recommended procedure and ensure the test product
mixture is completely blended. Prepare a 1000 [micro]L/L stock
solution prior to test initiation by adding 1.1 mL of the test
product mixture to 1100 mL of dilution water in a glass vessel.
Place on a magnetic stir plate then add and center a stir bar and
adjust the stir plate to obtain a vortex of 25% of the total volume
of the liquid. Mix the resulting stock solution for approximately
five minutes at room temperature. Using a glass pipette, remove
appropriate aliquots of stock solution from between the mixing
vessel wall and edge of the vortex and place directly into the
dilution water within an exposure vessel. Base the preparation of
exposure solutions on the nominal concentration of the stock
solution and follow procedures outlined in sections 4.5 and/or 4.6
of this Appendix, as appropriate.
4.3.3 Solid Phase Products. Assessment of the toxicity of
solidifiers and other solid phase products are determined using the
aqueous phase of water-accommodated fractions (WAFs) of the test
product. Fit a glass aspirator bottle (approximately 23L) equipped
with a hose bib at the base with a length of silicon tubing
containing a hose clamp. Fill the bottle with 19L of dilution water
leaving a 20% headspace above the liquid, place on a magnetic stir
plate then add and center a stir bar. Add the test product at 25 g/L
and securely seal the bottle using a silicon stopper and wraps of
parafilm. Adjust the stir plate to obtain a vortex of 25% of the
total fluid volume, stir for 18 hours then settle for 6 hours.
Maintain the temperature at 25 [deg]C during stirring and settling.
Purge the hose at the base of the bottle of any material followed by
removal of the WAF (aqueous phase) into a clean glass container
without disturbing the product on the surface. The WAF should be
remixed and used for the preparation of exposure solutions following
procedures outlined in section 4.4 of this Appendix.
4.4 Preparation of Exposure Concentrations.
4.4.1 Concentration Selection. Preliminary rangefinder tests may
be necessary using a series of logarithmic concentrations (e.g. 0.1,
1, 10, 100 [micro]l test product/L) to determine the appropriate
exposure concentration range necessary to determine LC50
values and 95% confidence intervals. For definitive tests, conduct a
minimum of five test concentrations using a geometric ratio between
1.5 and 2.0 (e.g. 2, 4, 8, 16, and 32). Note that when testing the
product, the highest test concentration should not exceed the test
product's self-dispersibility limit.
4.4.2 Exposure Concentrations. Exposure solutions are prepared
by adding the appropriate amount of stock solution directly to
dilution water in each test chamber. Mix each exposure solution
using five rotations in one direction followed by five rotations in
the opposite direction using a solid glass stir rod.
4.4.3 Reference Toxicants. Separate toxicity tests must be
performed with a reference toxicant for each species tested. Conduct
additional reference toxicity tests any time a change in the culture
population or source of a test species occurs. Use reagent grade
quality sodium dodecyl sulfate (SDS), also known as dodecyl sodium
sulfate (DSS), and sodium lauryl sulfate (SLS) as the reference
toxicant. Information on procedures for conducting reference
toxicant tests with these species can be found in section 4 of EPA's
Methods for Measuring the Acute Toxicity of Effluents and Receiving
Waters to Freshwater and Marine Organisms (EPA-821-R-02-012) (3).
4.5 Saltwater Static Acute Tests with Menidia beryllina and
Americamysis bahia
4.5.1 General. Use EPA's Methods for Measuring the Acute
Toxicity of Effluents and Receiving Waters to Freshwater and Marine
Organisms (EPA-821-R-02-012) (1) for testing each species separately
with the test product.
4.5.2 Test Solutions. Modify procedures in EPA-821-R-02-012
specifically dealing with the handling and toxicity testing of
effluents or receiving water samples as follows: Prepare stock
solutions following the appropriate sections (4.3.1, 4.3.2, or
4.3.3) of this Appendix and exposure concentrations following
section 4.4 of this Appendix.
4.5.3 Number of Treatments, Replicates and Organisms. Conduct a
minimum of three replicates of at least five exposure treatments
plus a minimum of three replicate dilution water controls. Expose
ten organisms per replicate treatment.
4.5.4 Exposure Period. Test duration is 48-hr for A. bahia and
96-hr for M. beryllina.
[[Page 38347]]
Mortality must be recorded at each 24 hour period of each test.
4.5.5 Test Acceptability. For each test performed, survival of
control animals must be >90% and test results must allow
determination of statistically valid LC50 and 95%
confidence interval values except in cases where the LC50
is >1000 [micro]l/L or is determined to be greater than the limits
of water solubility or dispersibility.
4.5.6 Static Acute Test Summary. A summary of required test
conditions is provided in Table 9 of this Appendix.
4.6 Freshwater Static Acute Tests with Pimephales promelas and
Ceriodaphnia dubia
4.6.1 General. Use EPA's Methods for Measuring the Acute
Toxicity of Effluents and Receiving Waters to Freshwater and Marine
Organisms (EPA-821-R-02-012) (1) for testing each species separately
with the test product.
4.6.2 Test Solutions. Modify procedures in EPA-821-R-02-012
specifically dealing with the handling and toxicity testing of
effluents or receiving water samples as follows: Prepare stock
solutions following the appropriate sections (4.3.1, 4.3.2, or
4.3.3) of this Appendix and exposure concentrations following
section 4.4 of this Appendix.
4.6.3 Number of Treatments, Replicates and Organisms. P.
promelas: Conduct a minimum of three replicates of at least five
exposure treatments plus a minimum of three replicate dilution water
controls. Expose ten organisms per replicate treatment. C. dubia:
Conduct a minimum of four replicates of at least five exposure
treatments plus a minimum of four replicate dilution water controls.
Expose five organisms per replicate treatment.
4.6.4 Exposure Period. Test duration is 48-hr for C. dubia and
96-hr for P. promelas. Mortality must be recorded at each 24 hour
period of each test.
4.6.5 Test Acceptability. For each test performed, survival of
control animals must be >90% and test results must allow
determination of statistically valid LC50 and 95%
confidence interval values except in cases where the LC50
is >1000 [micro]l/L or is determined to be greater than the limits
of water solubility of dispersibility.
4.6.6 Static Acute Test Summary. A summary of required test
conditions is provided in Table 9 of this Appendix.
4.7 Laboratory Report. The laboratory must include, for each
toxicity test report, all applicable information, data and analyses
as follows:
4.7.1 Test Objective: protocol title and source, endpoint(s);
4.7.2 Product Information: product name, manufacturer contact
information, lot number, production date, date received/chain of
custody;
4.7.3 Contract Facility: contact information;
4.7.4 Dilution Water: source, pretreatment, physical and
chemical characteristics (pH, salinity);
4.7.5 Test Conditions: date and time of test (start and end),
test chambers type and volume, volume of solution per chamber,
number of organisms per chamber, number of replicate chambers per
treatment, feeding frequency, amount and type of food, test
concentrations, test temperature (mean and range), test salinity
(mean and range);
4.7.6 Test Organisms: common and scientific name, source contact
information, age and date purchased, acclimation conditions (e.g.,
temperature, salinity, both mean and range), age at test start;
4.7.7 Reference toxicant: date received, lot number, date of
most recent test, results and current Cumulative Sum Chart, dilution
water used, physical and chemical methods used;
4.7.8 Quality Assurance: verification of laboratory
accreditation, including subcontractor facilities;
4.7.9 Test Results: raw data in tabular and graphical form,
daily records of affected organisms in each concentration replicate
and controls, table of required endpoints (i.e., LC50,
95% CI, inhibited concentration for 50% of the species
(IC50), lower observed effect concentration (LOEC) and no
observed effect concentration (NOEC)), statistical methods used to
calculate endpoints, summary tables of test conditions and QA data;
and
4.7.10 Conclusions: Relationship between test endpoints and
threshold limit.
Table 9--Summary of Test Conditions--Surface Washing Agents, Herding Agents, Bioremediation Agents and
Solidifiers Toxicity
----------------------------------------------------------------------------------------------------------------
Saltwater acute M. Saltwater acute A. Freshwater acute Freshwater acute
beryllina bahia P. promelas C. dubia
----------------------------------------------------------------------------------------------------------------
Test type....................... Static non-renewal Static non-renewal Static non-renewal Static non-
renewal.
Test duration................... 96 hours.......... 48 hours.......... 96 hours.......... 48 hours.
Salinity........................ 20 20 NA................ NA.
2[permil]. 2[permil].
-------------------------------------------------------------------------------
Temperature..................... 25 1 [deg]C. Test temperatures must not deviate (maximum minus
minimum temperature) by more than 3 [deg]C during the test.
Light quality................... Ambient laboratory illumination.
Light intensity................. 10-20 [micro]E/m\2\/s.
Photoperiod..................... 16 h light, 8 h darkness, with phase in/out period recommended.
-------------------------------------------------------------------------------
Test chamber size \1\........... 250 mL............ 250 mL............ 250 mL............ 30 mL.
Test solution volume \1\........ 200 mL............ 200 mL............ 200 mL............ 15 mL.
Age of test organism \2\........ 9-14 days......... 1-5 days.......... 1-14 days......... <24 hours.
No. organisms per test chamber.. 10................ 10................ 10................ 5.
No. of replicate chambers per 3................. 3................. 3................. 4.
concentration (minimum).
-------------------------------------------------------------------------------
Feeding regime.................. Refer to specific feeding procedures provided in each test method.
Aeration........................ None, unless DO falls below 4.0 mg/L, then aerate all chambers. Rate: <100
bubbles/minute.
Test concentrations............. 5 exposure concentrations and a control (minimum required).
Test acceptability (required)... >=90% survival in controls.
----------------------------------------------------------------------------------------------------------------
\1\ Recommended minimum value.
\2\ Less than or equal to 24-hr range in age.
4.8 References for Section 4
(1) U.S. EPA. 2002. Methods for Measuring the Acute Toxicity of
Effluents and Receiving Waters to Freshwater and Marine Organisms.
Fifth Edition. U.S. Environmental Protection Agency, Washington, DC
(EPA-821-R-02-012).
5.0 Bioremediation Agent Efficacy Test Protocol
5.1 Summary. This protocol quantifies changes in weathered
Alaska North Slope (ANS) crude oil composition of alkanes and
[[Page 38348]]
aromatics resulting from the use of a bioremediation agent in either
artificial seawater or freshwater. The manufacturer may test either
one or both freshwater or saltwater, depending on the product's
intended use. Biodegradation of the alkanes and aromatics is
monitored for 28 days at 20-23 [deg]C. Product flasks at Day 28 are
compared to Day 0 flasks to determine reductions in alkanes and
aromatics. A positive control of a known oil-degrading bacterial
consortium supplied by EPA is tested. A negative, sterile control is
also set up containing exposure water, weathered crude oil, product,
and a sterilant, sodium azide. The purpose of the negative, killed
control is to make sure the disappearance of the oil constituents at
day 28 is due to biodegradation and not some physical loss such as
volatilization. The day 28 GC/MS results from the killed control
must not be less than 90% of the day 0 results. The sample
preparation procedure extracts the oil phase into the solvent
dichloromethane (DCM) (also known as methylene chloride) with a
subsequent solvent exchange into hexane. The hexane extracts are
analyzed by a high-resolution gas chromatograph/mass spectrometer
(GC/MS) operated in the selected ion monitoring mode (SIM) at a scan
rate of >5 scans per second.
Note to 5.1: Alaska North Slope (ANS) crude oil is artificially
weathered by distillation at 521 [deg]F (272 [deg]C) to remove the
low molecular weight hydrocarbons to approximate natural weathering
processes that occur after a spill.
5.2 Apparatus. All equipment must be maintained and calibrated
per standard laboratory procedures.
5.2.1 Assorted flasks and other glassware;
5.2.2 Graduated cylinders (100 mL);
5.2.3 Deionized water;
5.2.4 250 mL borosilicate glass Erlenmeyer flasks;
5.2.5 250 mL separatory funnels with stopcocks
5.2.6 Pasteur pipettes;
5.2.7 Multichannel pipettor (5-50 mL and 50-200 mL);
5.2.8 Autoclave; environmental room or incubator;
5.2.9 Balance accurate to 0.1 mg;
5.2.10 Orbital shaker table with clamps sized to hold flasks
securely;
5.2.11 GC/MS instrument equipped with a DB-5 capillary column
(30 m, 0.25 mm ID, and 0.25 mm film thickness) or equivalent, and a
split/splitless injection port operating in the splitless mode, such
as an Agilent 6890 GC/5973 MS (or equivalent) equipped with an auto-
sampler for testing multiple samples; and
5.2.12 Fixed Rotor Centrifuge.
5.3 Reagents and consortium medium.
5.3.1 Stock Seawater Preparation. Prepare the artificial
seawater GP2 (modified from Spotte et al., 1984) following the
procedures in section 2.3 of this Appendix, to obtain the final
concentration of the salts listed in Table 1 of this Appendix,
except for the sodium bicarbonate (NaHCO3) which is
prepared separately. Autoclave the artificial seawater. Filter
sterilize the concentrated solution of sodium bicarbonate through a
0.45 [mu]m membrane filter and add to the autoclaved and cooled
artificial seawater GP2 to obtain the final concentration listed in
Table 1 of this Appendix.
5.3.2 Seawater for the positive control flasks. Prepare sodium
triphosphate (a.k.a., sodium tripolyphosphate)
(Na5P3O10), potassium nitrate
(KNO3), and ferric chloride hexahydrate (FeCl3
[middot] 6H2O) as a concentrated solution. Filter
sterilize through a 0.45 [mu]m membrane filter and add to autoclaved
artificial seawater to obtain the final nutrient concentrations
listed in Table 10 of this Appendix. Calibrate the pH meter at room
temperature (approximately 20-23 [deg]C) using commercial buffers of
pH 4.0, 7.0, and 10.0, as appropriate, prior to use. Adjust the pH
of the artificial seawater with concentrated hydrochloric acid (HCl)
or 10 normality sodium hydroxide (10 N NaOH), as appropriate.
Table 10--Artificial Seawater Nutrient Concentrations
------------------------------------------------------------------------
Final
Constituent concentration, g/
L
------------------------------------------------------------------------
* FeCl3 [middot] 6H2O................................. 0.050
KNO3.................................................. 2.890
* Na5P3O10............................................ 0.297
------------------------------------------------------------------------
* Added aseptically after the GP2 has been autoclaved to limit
phosphorus and iron precipitation.
5.3.3 Seawater for bioremediation agents that do not include
nutrients. If a bioremediation agent contains living microorganisms
but not nutrients (or limiting concentrations of nutrients), then
nutrients may be added by the manufacturer. However, the total
concentration of the nutrients added to the bioremediation agent
must not exceed the final concentrations listed in Table 11 of this
Appendix.
Table 11--Artificial Seawater Nutrient Concentrations for BioRemediation
Agents Having No Nutrients Included
------------------------------------------------------------------------
Constituent Final concentration, g/L
------------------------------------------------------------------------
as Iron (Fe).............................. 0.010
as Nitrogen (N)........................... 0.400
as Phosphorus (P)......................... 0.075
------------------------------------------------------------------------
If nutrients are supplied by the product manufacturer, the specific
composition and concentration used in the efficacy testing must be
submitted.
5.3.4 Freshwater Preparation. The artificial freshwater, which
is a modification of Bushnell-Haas medium (Haines et al., 2005), is
prepared following the concentrations listed in Table 12 of this
Appendix and then autoclaved. The pH is adjusted to 7.4 before
autoclaving. Constituents removed from the original formulation are
KNO3, K2HPO4 and KH2PO4.
Table 12--Constituent Concentrations for Artificial Freshwater
[Bushnell-Haas]
------------------------------------------------------------------------
Final
Constituent concentration
(mg/L)
------------------------------------------------------------------------
MgSO4 [middot] 7H2O................................... 200
CaCl2 [middot] 2H2O................................... 20
FeCl3 [middot] 6H2O................................... 50
MnSO4 x H2O........................................... 0.0302
H3BO3................................................. 0.0572
ZnSO4 x 7H2O.......................................... 0.0428
(NH4)6Mo7O2........................................... 0.0347
------------------------------------------------------------------------
5.3.5 Freshwater for the positive control. To prepare the
freshwater for the positive controls, prepare the nutrients
potassium phosphate monobasic (KH2PO4), potassium phosphate dibasic
(K2HPO4) and potassium nitrate (KNO3) as a concentrated solution.
Filter sterilize and add to autoclaved artificial freshwater to
obtain the final concentrations given in Table 13 of this Appendix.
Calibrate the pH meter at room temperature (approximately 20-23
[deg]C) using commercial buffers of pH 4.0, 7.0, and 10.0, as
appropriate, prior to use. Adjust the pH of the artificial
freshwater to 7.4 with 1 N HCl or 1 N NaOH, as appropriate.
Table 13--Freshwater Nutrient Concentrations
------------------------------------------------------------------------
Final
Constituent concentration (g/
L) \1\
------------------------------------------------------------------------
KNO3.................................................. 2.89
KH2PO4................................................ 1.00
K2HPO4................................................ 1.00
------------------------------------------------------------------------
\1\ Adjust pH to 7.4 prior to autoclaving.
5.3.6 Freshwater for bioremediation agents that contain living
microorganisms but not nutrients or limiting concentrations of
nutrients. If a bioremediation agent does not include nutrients,
then nutrients may be added. However, the total concentration of the
nutrients added to the bioremediation agent must not exceed the
final concentrations provided in Table 14 of this Appendix.
Table 14--Artificial Freshwater Nutrient Concentrations for
Bioremediation Agents Having No Nutrients Included
------------------------------------------------------------------------
Constituent Final concentration, g/L \1\
------------------------------------------------------------------------
as Iron (Fe).............................. not added since iron is
already in the freshwater
solution.
as Nitrogen (N)........................... 0.400.
as Phosphorus (P)......................... 0.400.
------------------------------------------------------------------------
\1\ Adjust to pH 7.4 prior to autoclaving.
[[Page 38349]]
If nutrients are supplied by the product vendor, the specific
composition and concentration used in the efficacy testing must be
submitted.
5.3.7 Oil Preparation. The test oil, weathered ANS521 crude oil,
can be obtained from EPA at no charge (except for a minimal shipping
fee). See https://www.epa.gov/emergency-response/national-contingency-plan-subpart-j#howto for more information.
5.3.8 Sodium azide sterilant. Prepare a stock solution of
NaN3 for addition to the negative killed control. The
final concentration in the killed controls will be 0.5 g/L.
5.4 Experimental Setup and Procedure
5.4.1 Autoclave clean borosilicate glass Erlenmeyer flasks (250
mL) for 20 minutes at 121 [deg]C at 15 psig.
5.4.2 Label flasks with the appropriate code (negative control,
positive control, or product; day to be sampled (0 or 28); letter
indicating replicate number) to reflect the following treatment
design in Table 15 of this Appendix:
Table 15--Bioremediation Efficacy Test--Summary of Experimental Setup
------------------------------------------------------------------------
Number of
replicates at
Treatment sampling times Analysis
------------------
Day 0 Day 28
------------------------------------------------------------------------
Negative (killed) Control (oil + exposure 0 3 GC/MS
water + product + EPA consortium + NaN3
sterilant)..............................
* Positive control (oil + exposure water 6 6 GC/MS
+ nutrients + EPA consortium)...........
Test Type 1: Product containing living 6 6 GC/MS
microorganisms (oil + exposure water +
living product + supplemented nutrients
(if necessary)).........................
Test Type 2: Product containing 6 6 GC/MS
proprietary nutrients but no live
microorganisms (oil + exposure water +
product + EPA consortium)...............
Test Type 3: Product (such as an enzyme) 6 6 GC/MS
containing no live microorganisms and no
nutrients (oil + exposure water +
product)................................
------------------------------------------------------------------------
* The laboratory must report positive control test results conducted
within the year of any test results for bioremediation products, for
one or both types of water as applicable.
5.4.3 Aseptically dispense 100 mL of pre-sterilized artificial
exposure water (seawater or freshwater) into each sterile flask. For
the positive control flasks, use exposure water containing
nutrients.
5.4.4 Tare the labeled flasks containing exposure water and
other additions, as necessary, on the balance with a minimum
accuracy of 0.01 g. Add drop-wise 0.50 g oil (this results in a
final oil concentration of 5 g/L) using a sterile Pasteur pipette to
the center of the flask taking care to avoid splashing the oil onto
the sides of the flasks. Record the precise weight. ANS521 may be
previously warmed in a hot water bath at 60 [deg]C for 40-60 minutes
to facilitate its flow. Take precautions when handling and charging
the flasks to minimize the likelihood of contamination by exogenous
microbes, including using a new sterile pipette for each series of
flasks.
5.4.5 Preparation of the EPA consortium for both the positive
control flasks and the flasks containing non-living bio-stimulation
products. Use the supplied vials containing approximately 5 mL of
the known EPA consortium frozen in glycerol. Thaw the supplied vials
at room temperature (do not allow cultures preserved in glycerol to
sit at room temperature past thawing), transfer the contents of the
thawed vials to a single sterile centrifuge tube, rinse tubes with
two volumes each of sterile exposure water, centrifuge at between
6,000- and 7,000-times gravity (6,000-7,000 x g) for 15 minutes
using a fixed rotor to fully pellet the cells. Carefully resuspend
the cell pellet in sterile exposure water using the appropriate
volume to achieve the desired seeding density, which will be
provided by EPA upon shipment of the consortium.
5.4.6 Positive control flasks contain exposure water, oil,
nutrients, and the EPA consortium.
5.4.7 Negative killed control flasks for all products shall
contain exposure water, oil, product, the EPA consortium for
products not containing a living culture, and the sodium azide
sterilant at a final concentration of 0.5 g/L. Add the sodium azide
sterilant prior to adding any product or EPA consortium. For the
negative killed control flasks and product flasks, prepare and add
the product to the flasks in a concentration specified by the
manufacturer or vendor.
5.4.8 For non-living products that contain nutrient only, use
the EPA consortium as the inoculum.
5.4.9 For other non-living products (e.g., enzymes), do not add
nutrients or the EPA consortium as the inoculum as they are not
needed.
5.4.10 For products containing living microorganisms, prepare 6
flasks the same way as in Steps a-d, but without the EPA consortium.
A product that contains its own nutrients must not be amended with
nutrients, unless the product contains insufficient nutrients. Since
this is a closed flask test, nutrients could be limiting if they are
at the same concentration as used in the field. This could cause the
product to fail the test. Thus, the manufacturer has the option to
supplement its product with a higher concentration of nutrients than
that contained in the product. Any nutrient supplements to a product
must be reported and must not exceed the concentration limits in
Table 10 (for seawater) and 13 (for freshwater) of this Appendix, as
applicable.
5.4.11 Cap all flasks either with sterile cotton stoppers or
loosely applied aluminum foil to allow gas exchange with the
atmosphere. Set aside the T = 0 flasks for immediate extraction and
analysis. Place the rest of the flasks onto the orbital shaker
table. Do not tip the flasks excessively to avoid stranding oil
above the mixing area of the flask. Set the orbital shaker to 200
rpm and shake the flasks for 28 days at 20-23 [deg]C in the dark.
5.4.12 Submit all information on added microorganisms and
nutrients for testing in the data report.
5.5 Sampling and Chemical Analysis.
5.5.1 Summary. At each sampling event (Days 0 and 28), product
and control flasks are sacrificed for analysis of residual oil
concentrations (SOP 4 of this Appendix). Record all physical
observations for each flask (such as degree of emulsification,
whether the oil has congealed into tar balls, wall growth, color,
etc.) at each sampling. The analytical procedure is summarized in
Table 16 of this Appendix. Dichloromethane (DCM) is the solvent used
for the initial extraction. Solvent-exchange the extract into hexane
prior to injection into the gas chromatograph. The solvent exchange
is done to prevent asphaltenes from contaminating the column.
Table 16--Bioremediation Efficacy--Summary of Analytical Procedures
----------------------------------------------------------------------------------------------------------------
Sampling/ Sample container/ Preservation/ Holding
Matrix Measurement measurement Analysis quantity of storage times
method method sample ([deg]C) (months)
----------------------------------------------------------------------------------------------------------------
DCM........... N/A.............. Solvent Exchange N/A.......... Capped Vial with 4 6
to Hexane. Teflon septa,
30 mL.
[[Page 38350]]
Hexane........ Hydrocarbon SOP 4........... GC/MS........ Capped Vial with 4 6
Concentration. Teflon septa,
10 mL.
----------------------------------------------------------------------------------------------------------------
5.5.2 Hydrocarbon Extraction. To measure extraction efficiency,
200 [micro]L of the 400 mg/L surrogate recovery standard (compounds
and concentrations described in SOP 1 in this Appendix) is added to
each flask. Add 50 mL DCM to each flask. Transfer the contents to a
250 mL separatory funnel and shake for 2 minutes; allow the phases
to separate for 2 minutes. If an emulsion remains after 2 minutes,
centrifuge the emulsion in Teflon[supreg] centrifuge tubes for at
least ten minutes in a low-speed centrifuge at 3,000 times gravity
(3,000 x g) to break the emulsion and recover the DCM phase. Pass
the DCM extract through a funnel plugged with glass wool and
containing approximately 20 g anhydrous, granular sodium sulfate
(Na2SO4) to remove water. Repeat the steps
above two more times with 25 mL DCM each (100 mL DCM used in total).
Add 10 mL DCM on to the sodium sulfate after the third extraction to
rinse off any oil residue. Collect the extract in 125 mL serum
vials, capped with Teflon lined septa and aluminum crimp seals, and
store at 4 [deg]C for up to 6 months.
5.5.3 Solvent Exchange. Perform a solvent exchange (DCM to
hexane) prior to GC/MS analysis to prevent injection of asphaltenes
into the GC/MS column. Transfer the DCM extract to concentration
tubes. Place the tubes in a 29 [deg]C water bath under a stream of
dry nitrogen gas. Reduce the sample to 1 mL and transfer the extract
to a 10 mL volumetric flask. Rinse the concentration tube with
hexane and add it to the volumetric flask 2 times. Adjust the final
volume with hexane to 10 mL.
5.5.4 Hydrocarbon Analysis. Quantify the concentrations of 25
alkanes, 32 aromatics and hopane (SOP 4, Table SOP 4.4 of this
Appendix) using an Agilent 6890 GC/5973 MS or equivalent equipped
with a 30-m x 0.25-mm ID x 0.25-[mu]m film thickness DB-5 or
equivalent fused silica column. To prepare the samples, transfer 1.0
mL of the hexane extract into a 2 mL autosampler vial with Teflon
lined cap. Add 20 [mu]L of internal standard solution to each vial
with a syringe or positive displacement pipettor. SOP 2 of this
Appendix outlines the procedure for preparing the internal standard
solution. Load vials onto the autosampler tray and analyze in
selected ion monitoring mode (SIM). Sum the individual alkane
concentrations for the total alkane concentration and the individual
aromatic concentrations for total aromatic concentrations in each
flask.
5.6 Quality Assurance/Quality Control (QA/QC).
5.6.1 Objectives. The critical variables to be analyzed for each
set of experimental conditions are the individual petroleum
hydrocarbons, i.e., the alkanes ranging in carbon number from nC-14
to nC-35, plus pristane and phytane, and the 2- to 4-ring polycyclic
aromatic hydrocarbons (PAHs) and their alkylated homologs as listed
in SOP 4 of this Appendix. The quality assurance objectives for
precision, accuracy, and detection limits are 20%, 75-
125% recovery, and 22.5 [micro]g/L on average for the 58 compounds,
respectively. For more details, refer to the SOPs of this Appendix.
5.6.2 Precision Objectives. Precision is presented as relative
percent difference (RPD) for duplicate measurements and as relative
standard deviation (RSD, or coefficient of variance) for triplicate
measurements, applicable to replication of treatments as separate
samples.
5.6.3 Accuracy Objectives. These are based on the check
standards and standard oil samples run concurrently with the sample
analyses for GC/MS analysis of critical compounds. Critical
compounds in the check standards and in the oil standards must fall
within 75-125% of expected values for the analysis to be valid. Six
surrogate compounds (SOP 1 of this Appendix) added to each sample
before extraction can also serve as a surrogate for determining
accuracy. The measured surrogate concentrations must fall within 75-
125% of expected values.
5.6.4 Calibration Range. Conduct all measurements within the
linear calibration range of the instrument. The calibrated
concentration range for GC/MS analysis is 0.1 mg/L to 30 mg/L. If
the measured concentration of any critical compound is above the
calibration range, dilute the sample and re-analyze to quantify that
particular compound within the linear calibration range.
5.6.5 Quality Control. Table 17 of this Appendix summarizes the
QC checks for each measurement. See the corresponding SOP in this
Appendix for detailed descriptions of QC checks, frequency,
acceptance criteria, and corrective actions.
Table 17--QA/QC Checks
----------------------------------------------------------------------------------------------------------------
Acceptance
Sample matrix Measurement QA/QC check Frequency criteria Corrective action
----------------------------------------------------------------------------------------------------------------
DCM............ GC/MS hydrocarbon Blanks............ Once per Peak area of Flush with
analysis. calibrated run. interfering solvent, clean
peaks <10% of injection port,
lowest standard and/or bake
peak area. column.
DCM............ GC/MS hydrocarbon DFTPP Check Once per Must pass all If any criteria
analysis. Standard. calibrated run. DFTPP criteria. fail, retune and
rerun DFTPP
check standard.
DCM............ GC/MS hydrocarbon Initial Once per Response Factor If RSD for any
analysis. Calibration calibrated run. RSD <=25% or R2 one compound
Samples. >0.99. >25%,
recalibrate.
DCM............ GC/MS hydrocarbon Calibration Check Every 10-15 25% If >5 compounds
analysis. Standards. samples. of expected are out of
values. range,
recalibrate and
rerun samples.
Hexane......... GC/MS hydrocarbon Surrogates........ Every Sample..... 30% Re-inject.
analysis. of expected
values.
Hexane......... GC/MS hydrocarbon Biomarker Every Sample..... 25% Re-inject.
analysis. Concentration. of average
values.
----------------------------------------------------------------------------------------------------------------
5.7 Pass/Fail Criteria.
5.7.1 Calculate the mean and standard deviation of the hopane-
normalized total aromatics (sum of all resolved aromatics) and
hopane-normalized total alkane concentrations (sum of all resolved
alkanes) from the 6 independent replicates at days 0 and 28. To
normalize, divide the sum of the alkane analytes and the sum of the
aromatic analytes in each replicate by the hopane concentration in
the corresponding replicate.
5.7.2 From those data, calculate the 95% Upper Confidence Level
(UCL95) at days 0 and 28 using the following formula (Equation 11 of
this Appendix):
[[Page 38351]]
[GRAPHIC] [TIFF OMITTED] TR12JN23.089
where:
xt(0and28) = total hopane-normalized alkane or
total hopane-normalized aromatic mean of 6 replicates at days 0 and
28,
t95, 5 df = the 95% one-tailed t-value with 5 degrees of
freedom (2.015),
s = the standard deviation of the 6 replicates at day 0 and 28, and
n = no. of replicates = 6.
5.7.3 Using Equation 12 of this Appendix, calculate the %
reduction of each oil fraction from day 0 to day 28, using the day 0
and 28 UCL95 hopane-normalized values for each fraction:
[GRAPHIC] [TIFF OMITTED] TR12JN23.090
where:
t28(UCL95) = UCL95 of the hopane-
normalized total alkane or total aromatic mean of 6 replicates on
day 28, and
t0(UCL95) = UCL95 of the hopane-normalized
total alkane or total aromatic mean of 6 replicates on day 0.
5.7.4 A product is successful in saltwater or freshwater if the
% reduction of total alkanes (aliphatic fraction) from the GC/MS
analysis is greater than or equal to 85% and the % reduction of
total aromatics (aromatic fraction) is greater than or equal to 35%
at day 28 based on the UCL95 (Equation 12 of this
Appendix). The benchmark reduction ranges in aliphatic and aromatic
fractions for the positive control are the same as for the products
specified above. The average concentration of the biomarker hopane
at day 28 must not differ from the average concentration at day 0 by
more than 12% in the positive control. If the conditions for the
positive control are not met, the entire procedure must be repeated.
5.8 Data Verification and Reporting. GC/MS data files are
generated by MS ChemStation software (the Agilent standard software
for GC/MS) or equivalent for each injection. Data files contain
summed ion chromatograms and selected ion chromatograms. Calibration
curves are generated within MS ChemStation software, and all data
files are calculated against the calibration curve by MS
ChemStation. Data verification would be done by crosschecking
between analysts for 10% of the raw data and its reduction process.
5.9 Laboratory Report. The summary of findings from a product
test must include the data listings for each analyte that was
analyzed (i.e., all individual alkanes and aromatics in the list of
required analytes), along with QA/QC checks (see Table 17) and
instrument detection/reporting limits for each analyte. Express all
concentrations as mg analyte/L exposure water.
5.10 Standard Operating Procedures (SOPs) 1-4
5.10.1 SOP 1. Preparation of Surrogate Recovery Standards
5.10.1.1 Preparation:
5.10.1.1.1 Solvents: Dichloromethane (DCM), Optima grade or
equivalent.
5.10.1.1.2 Reagents:
D36-Heptadecane (C17)
D50-Tetracosane (C24)
D66-Dotriacontane (C32)
D10-1-Methylnaphthalene
D10-Phenanthrene
D10-Pyrene
5-beta-cholestane (coprostane)
Note: Deuterated reagents are available from Cambridge Isotope
Laboratories, Andover, MA.
5.10.1.1.3 Equipment:
Micro-spatula
Small beakers
Glass funnel
Analytical balance (0.0001g)
Vials with Teflon-lined caps
Teflon wash bottle with Optima grade DCM
Volumetric flask (250 mL), class A
Pasteur pipettes
5.10.1.2 Procedure:
5.10.1.2.1 Using a calibrated analytical balance, weigh 100 mg
(0.100 g) of each reagent into separate 10-25 mL beakers.
5.10.1.2.2 Dissolve the reagents in their beakers by adding 10
mL DCM. Use a Pasteur pipette to transfer the solutions to a single
250 mL volumetric flask.
5.10.1.2.3 Wash the beakers 3 or 4 times with DCM. Use a Pasteur
pipette to transfer each of the washings to the 250 mL volumetric
flask.
5.10.1.2.4 Dilute the solution to the 250 mL volume mark on the
volumetric flask with DCM.
5.10.1.2.5 Use a glass stopper to seal the flask and homogenize
the solution by inverting the flask 5 or more times. The final
concentration of this solution is 400 mg/L for each of the reagents.
5.10.1.2.6 Transfer the solution into 40 mL storage vials and
cap with Teflon-lined caps and label each with the date of
preparation, operator, sample names, and concentrations.
5.10.1.2.7 Weigh each vial and record its weight on the label.
This weight is used to monitor possible evaporation during storage.
5.10.1.2.8 Store these vials at 0 [deg]C or lower.
5.10.1.2.9 Before using, allow the solution to come to room
temperature, and then shake it well.
5.10.1.2.10 Weigh the vial before using it and compare the
weight with the last weight recorded on the vial.
5.10.1.2.11 If the weights are consistent, the integrity of the
solution can be assumed. If not, investigate and resolve the cause.
Prepare a new solution if the integrity has been compromised.
5.10.1.3 Quality Control: Inject 20 [mu]L of the surrogate stock
solution into 1 mL DCM. Add 20 [mu]L of the internal standard
solution (SOP 2 of this Appendix). Analyze this solution by GC/MS
using a calibrated method (SOPs 3 and 4 of this Appendix). The
expected concentration of each of the corresponding surrogate
compounds is 8 2 mg/L. If the measured value does not
fall within this range, prepare and measure another independent
surrogate solution. If the measured concentration of the second
surrogate solution is within the allowable tolerance range, the
calibration and instrument conditions are acceptable; properly
discard the first surrogate solution. If the concentration of the
second surrogate solution is also out of range, then clean and
recalibrate the instrument until the problem is resolved.
5.10.2 SOP 2. Preparation of Internal Standard Solution
5.10.2.1 Preparation:
5.10.2.1.1 Solvents: Dichloromethane (DCM), Optima grade or
equivalent
5.10.2.1.2 Reagents:
D34 n-Hexadecane (C16)
D42 n-Eicosane (C20)
D62 n-Triacontane (C30)
D8-Naphthalene
D10-Anthracene
D12-Chrysene
5-alpha-Androstane
Note: Deuterated reagents are available from Cambridge Isotope
Laboratories, Andover, MA.
5.10.2.1.3 Equipment:
Micro-spatula
Small beakers
Glass funnel
Analytical balance (0.0001g), calibrated and checked for accuracy
Amber vials with Teflon-lined caps, labeled
Teflon wash bottle with DCM
Volumetric flask (200 mL), class A
Pasteur pipettes
5.10.2.2 Procedure:
5.10.2.2.1 Using a calibrated analytical balance, weigh 100 mg
(0.100 g) of each of the reagents into separate small beakers.
5.10.2.2.2 Dissolve the reagents in their beakers by adding 10
mL DCM; using a Pasteur pipette, transfer the solutions to a single
200 mL volumetric flask.
[[Page 38352]]
5.10.2.2.3 Wash the beakers 3 or 4 times with DCM; use a Pasteur
pipette to transfer each of the washings to the 200 mL volume mark
on the volumetric flask.
5.10.2.2.4 Dilute the solution with DCM to the 200 mL volume.
5.10.2.2.5 Seal the flask with a glass stopper and homogenize
the solution by inverting the flask a minimum of 5 times. The final
concentration of this solution is 500 mg/L of each reagent.
5.10.2.2.6 Transfer the solution into 40 mL storage vials and
cap with Teflon-lined caps. Label each vial with the date of
preparation, operator, sample names, and concentrations.
5.10.2.2.7 Weigh each vial, and record its weight on the label.
This weight is used to monitor possible evaporation during storage.
5.10.2.2.8 Store this solution at 0 [deg]C or lower.
5.10.2.2.9 Before using, allow the solution to come to room
temperature, and then shake it well.
5.10.2.2.10 Weigh the vial before using it, and compare the
weight with the last weight recorded on the vial.
5.10.2.2.11 If the weights are consistent, the integrity of the
solution can be assumed. If not, investigate and resolve the cause.
Prepare a new solution if the integrity has been compromised.
5.10.2.3 Quality Control: Inject 20 [mu]L of the internal
standard solution into 1 mL DCM. Analyze this solution by GC/MS. The
only peaks corresponding to the internal standards must appear. If
other peaks appear, particularly close to the internal standard
peaks, discard the internal standard solution and prepare a new
solution.
5.10.3 SOP 3. Preparation of Working Standards, Check Standards,
and Oil Standards for GC/MS Consistency.
5.10.3.1 Preparation:
5.10.3.1.1 Solvent: Dichloromethane (DCM), Optima grade or
equivalent
5.10.3.1.2 Stock solutions:
5.10.3.1.2.1 Oil analysis standard: 44 compounds, 100 mg/L in
hexane/DCM (9:1), four, 1-mL vials required. Available from Absolute
Standards, Inc., Hamden, CT, Part #90311.
5.10.3.1.2.2 Nine compound PAH standard: 1,000 mg/L in DCM, one
vial. Available from Absolute Standards, Inc., Hamden, CT, Part
#90822.
5.10.3.1.2.3 1,2-Benzodiphenylene sulfide, (synonym for
naphthobenzothiophene). Prepare a 2 mg/mL stock solution. Available
from Sigma-Aldrich Co., Part # 255122, purity 99%.
5.10.3.1.2.4 Hopane solution (17 [alpha] (H), 21[beta] (H), 0.1
mg/mL in isooctane. Available from Sigma-Aldrich Co. Part #90656.
5.10.3.1.2.5 Surrogate solution: 400 mg/L of each reagent in DCM
(see SOP 1 of this Appendix).
5.10.3.1.2.6 Internal standard solution, 500 mg/L in DCM (see
SOP 2 of this Appendix).
5.10.3.1.3 Alaska North Slope Crude Oil 521 (ANS521).
5.10.3.1.4 Equipment:
5.10.3.1.4.1 Glass storage vials with Teflon-lined caps (2 mL
and 40 mL capacity);
5.10.3.1.4.2 Volumetric flasks, Class A, 5 mL, 10 mL, and 100 mL
5.10.3.1.4.3 Glass syringes capable of dispensing 25-500
[micro]L with an accuracy and precision of 1%, or
equivalent
5.10.3.1.4.4 Wheaton repetitive dispenser, Model 411 STEP-PETTE
or equivalent
5.10.3.1.4.5 Teflon wash bottle filled with Optima grade DCM or
equivalent grade DCM
5.10.3.1.4.6 Pasteur pipettes
The volumes of stock solutions required to make the working
standards are listed in Table SOP 3.1 of this Appendix.
Table SOP 3.1--Amount of Stock Solutions Required To Make the Working Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stock standards A B C D E F
--------------------------------------------------------------------------------------------------------------------------------------------------------
1,2-Benzo-
Oil analysis Aromatics mix diphenylene Surrogate Hopane
Working standards concentration, mg/L mix (44 (9 compounds, sulfide solution solution Volumetric flask volume ISTD (500
compounds, 100 1,000 mg/L) (NBT) (2 mg/ (100 mg/L) (100 mg/L) mL mg/L) [mu]L
mg/L) [mu]L [mu]L mL) [mu]L [mu]L [mu]L
--------------------------------------------------------------------------------------------------------------------------------------------------------
STD 30 (no hopane)..................... 1,500 150 75 375 0 5........................ 100
STD 20 (5 mg/L hopane)................. 1,000 100 50 250 250 5........................ 100
STD 10 (2.5 mg/L hopane)............... 500 50 25 125 125 5........................ 100
STD 5 * (1 mg/L hopane)................ 500 50 25 125 100 10....................... 200
STD 5-Utility (1 mg/L hopane).......... 500 50 25 125 100 10 (used for preparation 0
of STD 2.5 & STD 1).
----------------------------------------------------------------------------------------------------
STD 2.5 (0.5 mg/L hopane).............. Use 5 mL of STD 5-Utility and dilute to 10 mL. 200
STD 1 (0.2 mg/L hopane)................ Use 2 mL of STD 5-Utility and dilute to 10 mL. 200
STD 0.1 (0.2 mg/L hopane).............. Use 0.2 mL of STD 5-Utility and dilute to 10 mL. 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Make extra STD 5 for use as check standard.
5.10.3.2 Procedure for Working Standards and Check Standards:
5.10.3.2.1 Label three 5 mL volumetric flasks as STD30, STD20,
STD10, and two 10 mL volumetric flasks as STD5, and STD5-utility.
5.10.3.2.2 Add 1-2 mL of DCM to each volumetric flask.
5.10.3.2.3 Using glass syringes, add the appropriate volume of
stock solution A (as listed in Table SOP 3.1 of this Appendix) to
the flasks labeled STD30, STD20, STD10, STD5, and STD5-utility.
5.10.3.2.4 Wash the walls of the inner neck of the flasks with
several drops of DCM to rinse off the residue of the stock solution
into the flasks.
5.10.3.2.5 Repeat Step 3 and Step 4 to dispense stock solutions
B-E (do not add stock solution F, internal standard solution, at
this step).
5.10.3.2.6 Dilute to volume with DCM for all the above flasks,
seal with glass stoppers, and invert several times to homogenize the
solutions.
5.10.3.2.7 Label three additional 10 mL volumetric flasks as
STD2.5, STD1, and STD0.1. Wet with 1-2 mL DCM.
5.10.3.2.8 Dispense 5 mL of STD5-utility solution into flask
STD2.5, 2 mL of STD5-utility solution into flask STD1, and 0.2 mL of
STD5-utility solution into flask STD0.1.
5.10.3.2.9 Dilute to volume with DCM, seal with glass stoppers,
and invert several times to homogenize the solutions.
5.10.3.2.10 Using a 100 [mu]L glass syringe, dispense 100 [mu]L
of internal standard solution into flasks STD30, STD20, and STD10.
Dispense 200 [mu]L into flasks STD5, STD2.5, STD1, and STD0.1 to
give a final concentration of 10 mg/L internal standard.
5.10.3.2.11 Seal with glass stoppers, and invert the flasks
several times to homogenize the solutions.
5.10.3.2.12 Transfer the solutions into 2 mL storage vials, and
cap with Teflon-lined caps.
5.10.3.1.13 Label each vial with date of preparation, analyst,
sample names, and concentrations.
5.10.3.2.14 Weigh each storage vial and record its weight on the
label. This weight is used to monitor possible evaporation during
storage.
5.10.3.2.15 Store this solution at 0 [deg]C or below.
5.10.3.2.16 Before using, allow the solution to come to room
temperature, and shake it well.
5.10.3.2.17 Weigh the vial before opening, and compare the
weight with the last weight recorded on the vial. If the weights are
consistent, the integrity of the solution can be assumed. If not,
investigate and resolve the cause. Do not use the solution if the
integrity has been compromised.
5.10.3.3 Procedure for Oil Standard. In a 100 mL volumetric
flask, weigh 0.500 g of the standard ANS521 crude oil, add 2 mL of
surrogate solution (see SOP 1 of this
[[Page 38353]]
Appendix), and bring to volume with DCM. Add 2 mL of internal
standard solution (see SOP 2 of this Appendix). Follow steps
5.10.3.2.11 through 5.10.3.2.17 of this SOP, substituting 40 mL
storage vials for the 2 mL vials.
5.10.3.4 Quality Control/Quality Assurance:
5.10.3.4.1 Run the seven standard solutions using the GC/MS
method (SOP 4) on a tuned GC/MS. Use the EnviroQuant software or
equivalent to calculate the average Relative Response Factor (RRF)
and the relative standard deviation (RSD) of the RRFs for each
analyte over the six concentrations. The RRF is defined as:
[GRAPHIC] [TIFF OMITTED] TR12JN23.091
5.10.3.4.2 The RSD of the RRFs for all analytes must be 25% or
less. Alternatively, the coefficients of determination (R2) for the
calibration curve for each target compounds and surrogate should be
over 0.99.
5.10.4 SOP 4. GC/MS Method for the Analysis of Crude Oil
Samples.
5.10.4.1 Instrument Specifications:
5.10.4.1.1 Use an Agilent 6890 GC coupled with an Agilent 5973
mass selective detector (MSD) and an Agilent 6890 series auto
sampler or equivalent, equipped with a DB-5 capillary column (30 m,
0.25 mm I.D., and 0.25 [mu]m film thickness) or equivalent, and a
split/splitless injection port operating in the splitless mode. Data
acquisition occurs in the SIM (selected ion monitoring) mode for
quantitative analysis. In SIM mode, the dwell time of each ion is
set to be 10 milliseconds and the ions are split up into groups by
retention time. One way to divide the ions is by retention time
grouping as shown in Table SOP 4.1 of this Appendix. The number of
ions in each ion group must be constant, yielding the same scan rate
for each group.
Table SOP 4.1--Ions Associated With Retention Time Groups
------------------------------------------------------------------------
Group Ions
------------------------------------------------------------------------
1............................ 57, 66, 128, 136, 142, 152, 156, 166,
170, 184.
2............................ 57, 66, 166, 170, 178, 180, 184, 188,
192, 194, 198, 208.
3............................ 57, 66, 178, 184, 188, 192, 194, 198,
202, 206, 208, 212, 220, 226.
4............................ 57, 66, 192, 198, 202, 206, 208, 212,
216, 220, 226, 230, 234, 245.
5............................ 57, 66, 191, 217, 228, 240, 242, 248,
256, 262, 264, 270, 276, 284.
------------------------------------------------------------------------
5.10.4.1.2 Table SOP 4.2 of this Appendix summarizes the
instrumental conditions for crude oil analysis. Use only ultra-high
purity helium (99.999% pure) as the carrier gas. In series, connect
a moisture trap, an oxygen trap, and an organic trap to the carrier
gas line before it enters the column.
Table SOP 4.2--Instrumental Conditions for Crude Oil Analysis
------------------------------------------------------------------------
------------------------------------------------------------------------
Instrument........................ Agilent 6890 Series II Gas
Chromatograph (GC) with an Agilent
5973MSD and an Agilent 6890 auto
sampler, or equivalent.
Column............................ DB-5 capillary column (30 m, 0.25 mm
I.D., and 0.25-mm film thickness)
or equivalent.
Carrier Gas....................... Helium, ultra-high purity grade
(99.999%).
Inlet Temperature................. 300 [deg]C.
Transfer Line (detector) 310 [deg]C.
Temperature.
Oven Temperature Program.......... 50 [deg]C for 4 minutes, then 7
[deg]C/min to 310 [deg]C, hold for
18 minutes.
Flow Rate......................... Constant flow at 1mL/min. Linear
velocity: 36.2 cm/sec.
Injection Volume.................. 1 [micro]L.
Split/Splitless Mode.............. Splitless.
Total Run Time.................... 59.18 minutes.
------------------------------------------------------------------------
5.10.4.2 Procedure for preparing the instrument:
5.10.4.2.1 Lower the injection port temperature and the oven
temperature to 50 [deg]C or less to avoid oxidation of the column.
5.10.4.2.2 Replace the liner with a clean, silanized liner. Do
not touch the liner with bare fingers. A small piece of muffled
glass wool may be inserted to protect the column.
5.10.4.2.3 Return the injection port and oven to the appropriate
temperatures.
5.10.4.2.4 Wait five minutes after the temperature equilibrates
before using the instrument.
5.10.4.3 Procedure for tuning the MSD:
5.10.4.3.1 Perform an air/water check. The value reported for
the relative abundance of water (m/z 18), nitrogen (m/z 28), oxygen
(m/z 32), or carbon dioxide (m/z 44) shall be less than 5% of the
base peak for the system to be considered leak free and are expected
to be closed to 1% for a stable system.
5.10.4.3.2 Tune the MSD using the Standard Autotune program and
the decafluorotriphenylphosphine (DFTPP) Tune program to reduce
instrument variability. The Autotune report file is referenced by
the instrument when performing an air/water check and thus must be
run at least once per month. Run standards and samples using DFTPP
Tune parameters, and retune the instrument using DFTPP Tune at least
once per week. The tune programs use three fragment ions of
perfluorotributylamine (PFTBA) as a standard for tuning: m/z 69,
219, and 502. Tune reports must meet the following criteria:
5.10.4.3.2.1 Symmetrical peaks;
5.10.4.3.2.2 Mass assignments within 0.2 amu's from
69, 219, and 502;
5.10.4.3.2.3 Peak widths within 0.5 0.1 amu's;
5.10.4.3.2.4 Relative abundance is 100% for ion 69, at least 35%
for ion 219, and at least 1% for ion 502;
5.10.4.3.2.5 Relative abundances for isotope masses 70, 220, and
503 0.2 amu's are 0.5-1.5%, 2-8%, and 5-15%,
respectively; and
5.10.4.3.2.6 Air and water peaks at m/z = 18, 28, 32, and 44
amu's must be very small and consistent with historical values.
5.10.4.4 Maintaining a log book. Maintain an instrument log
book, and make entries for each use. Include the following
information in the logbook: operator name, helium cylinder tank
pressure and outlet pressure, vacuum gauge reading, any maintenance
performed on the instrument (such as changing the injection port
liner, gold seal, guard column, source cleaning), sequence
[[Page 38354]]
name, data path, samples in order of injection, method information,
GC column number, and the Standard Auto Tune report and DFTPP Tune
report.
5.10.4.5 Running a Solvent Blank: Following a liner change or at
the start of a new run, run an injection of a pure solvent to
confirm that the system is free of excessive or interfering
contamination. Analyze the solvent in SCAN mode using the same
temperature program used for sample analysis. If contamination is
present, analyze additional samples of fresh solvent until the
interfering contamination is removed.
5.10.4.6 Checking the DFTPP Tune: Prior to running the first
calibration standard, verify the instrument tune conditions by
running a 10 ng/[mu]L DFTPP check standard to check the mass
measuring accuracy of the MS, the resolution sensitivity, the
baseline threshold, and the ion abundance ranges. Run the standard
using the DFTPP method provided with the instrument. Each of the
criteria identified in Table SOP 4.2 of this Appendix must be met
before using the instrument for analysis:
Table SOP 4.3--Ion Abundance Criteria for DFTPP
----------------------------------------------------------------------------------------------------------------
Relative to Relative abundance
Mass, M/z mass criteria Purpose of checkpoint
----------------------------------------------------------------------------------------------------------------
51...................................... 442 10-80% of the base peak... Low mass sensitivity.
68...................................... 69 <2% of mass 69............ Low mass resolution.
70...................................... 69 <2% of mass 69............ Low mass resolution.
127..................................... 442 10-80% of the base peak... Low-mid mass sensitivity.
197..................................... 198 <2% of mass 198........... Mid mass resolution.
198..................................... 442 Base peak or >50% of 442.. Mid mass resolution and
sensitivity.
199..................................... 198 5-9% of mass 198.......... Mid mass resolution and
isotope ratio.
275..................................... 442 10-60% of the base peak... Mid-high mass sensitivity.
365..................................... 442 >1% of the base peak...... Baseline threshold.
441..................................... 443 Present and < mass 443.... High mass resolution.
442..................................... 442 Base peak or >50% of 198.. High mass resolution and
sensitivity.
443..................................... 442 15-24% of mass 442........ High mass resolution and
isotopic ratio.
----------------------------------------------------------------------------------------------------------------
5.10.4.7 Calibrating with a Multiple-Point Calibration Curve. A
5- or 6-point calibration curve is obtained by running 5 or 6
working standards (see SOP 3) on the tuned GC/MS instrument.
Calculate the relative response factor (RRF) for each compound
relative to its corresponding deuterated internal standard as
indicated in Table SOP 4.3 of this Appendix. The relative standard
deviation (RSD) of the RRFs for each compound must be less than 25%.
Run an independently prepared check standard immediately after the
calibration standards to validate the accuracy of the calibration
curve.
5.10.4.8 Running Samples. Once the calibration curve has been
validated, samples can be analyzed. Dispense 1,000 [mu]L of sample
extract into labeled auto-sampler vials. Add 20 [mu]L of the
internal standard solution (see SOP 2 of this Appendix) to the
extract using a syringe or a positive displacement pipettor. Run a
check standard every 10 samples to ensure the consistency of the
instrument. The RRF for each compound in the check standard must be
within 25% of the average RRF obtained in the initial calibration.
5.10.4.9 Quantification: Once a calibration table has been
generated, quantify each data file using the ``Calculate and
Generate'' function in the MS ChemStation software, or equivalent
software. Review individual peak integration manually to ensure
proper baseline integration. The quantification of a compound is
based on the peak area of the primary ion (Q Ion) indicated in Table
SOP 4.4 of this Appendix.
Table SOP 4.4--Target Compound List
----------------------------------------------------------------------------------------------------------------
Quantitation Reference compound for Internal standard for
Compound name ion response factor quantitation
----------------------------------------------------------------------------------------------------------------
N D34 C16............................... 66 N D34 C16................. D34 n C16 Q Ion 66.
n-C14................................... 57 n C14.....................
n-C15................................... 57 n C15.....................
n-C16................................... 57 n C16.....................
N D34 C17............................... 66 N D34 C17.................
n-C17................................... 57 n C17.....................
Pristane................................ 57 Pristane..................
n-C18................................... 57 n C18.....................
Phytane................................. 57 Phytane...................
n C19................................... 57 n C19.....................
N D42 C20............................... 66 N D42 C20................. D42 n C20 Q Ion 66.
n C20................................... 57 n C20.....................
n C21................................... 57 n C21.....................
n C22................................... 57 n C22.....................
n C23................................... 57 n C23.....................
N D50 C 24.............................. 66 N D50 C 24................
n C24................................... 57 n C24.....................
n C25................................... 57 n C25.....................
n C26................................... 57 n C26.....................
n C27................................... 57 n C27.....................
n C28................................... 57 n C28.....................
n C29................................... 57 n C29.....................
N D62 C30............................... 66 N D62 C30................. D62 n C30Q Ion 66.
n C30................................... 57 n C30.....................
n C31................................... 57 n C31.....................
N D66 C32............................... 57 N D66 C32.................
n C32................................... 57 n C32.....................
n C33................................... 57 n C33.....................
n C34................................... 57 n C34.....................
[[Page 38355]]
n C35................................... 57 n C35.....................
D8 Naphthalene.......................... 136 D8 Naphthalene............ D8 Naphthalene Q Ion 136.
Naphthalene............................. 128 Naphthalene...............
D10 1-Methylnaphthalene................. 152 D10 1-Methylnaphthalene...
C1 Naphthalene *........................ 142 C1 Naphthalene............
C2 Naphthalene *........................ 156 C2 Naphthalene............
C3 Naphthalene *........................ 170 C3 Naphthalene............
C4 Naphthalene *........................ 184 C3 Naphthalene............
D10 Anthracene.......................... 188 D10 Anthracene............ D10 Anthracene Q Ion 188.
D10 Phenanthrene........................ 188 D10 Phenanthrene..........
Phenanthrene............................ 178 Phenanthrene..............
C1 Phenanthrene *....................... 192 C1 Phenanthrene...........
C2 Phenanthrene *....................... 206 C2 Phenanthrene...........
C3 Phenanthrene *....................... 220 C2 Phenanthrene...........
C4 Phenanthrene *....................... 234 C2 Phenanthrene...........
Fluorene................................ 166 Fluorene..................
C1 Fluorene *........................... 180 Fluorene..................
C2 Fluorene *........................... 194 Fluorene..................
C3 Fluorene *........................... 208 Fluorene..................
Dibenzothiophene........................ 184 Dibenzothiophene..........
C1 Dibenzothiophene *................... 198 Dibenzothiophene..........
C2 Dibenzothiophene *................... 212 Dibenzothiophene..........
C3 Dibenzothiophene *................... 226 Dibenzothiophene..........
Naphthobenzothiophene (NBT)............. 234 Naphthobenzothiophene.....
C1 NBT *................................ 248 Naphthobenzothiophene.....
C2 NBT *................................ 262 Naphthobenzothiophene.....
C3 NBT *................................ 276 Naphthobenzothiophene.....
Fluoranthene............................ 202 Fluoranthene..............
D10 Pyrene.............................. 212 D10 Pyrene................
Pyrene.................................. 202 Pyrene....................
C1 Pyrene *............................. 216 Pyrene....................
C2 Pyrene *............................. 230 Pyrene....................
D12 Chrysene............................ 240 D12 Chrysene.............. D12 Chrysene Q Ion 240.
Benzo(a)anthracene/Chrysene *........... 228 Chrysene..................
C1 Chrysene *........................... 242 Chrysene..................
C2 Chrysene *........................... 256 Chrysene..................
C3 Chrysene *........................... 270 Chrysene..................
C4 Chrysene *........................... 284 Chrysene..................
5[alpha]-androstane..................... 245 5[alpha]-androstane....... 5[alpha]-androstane Q Ion
245.
Coprostane.............................. 219 Coprostane................
Hopane.................................. 191 Hopane....................
----------------------------------------------------------------------------------------------------------------
* Summed compounds; draw an integration line underneath all peaks with selected ion.
5.10.4.10 Equation 14 of this Appendix is used to calculate the
concentration of analytes in units of [mu]g/g oil added:
[GRAPHIC] [TIFF OMITTED] TR12JN23.092
where:
Aanalyte = the peak area of the analyte,
Cistd = the concentration of the internal standard,
Aistd = the area of the internal standard,
RRF = the relative response factor, and
100 is the conversion factor to convert mg/L DCM to [mu]g/g oil
added.
5.10.4.11 If some analytes are not commercially available, the
RRFs of other compounds (usually the parent compound) are used to
quantify those analytes. For example, the RRF of C3-naphthalene may
be used to calculate the concentrations of C3- and C4-naphthalenes.
See Table SOP 4.4 of this Appendix for details. The quantification
of these alkylated PAHs is relative because it is assumed that the
molecular ions of the alkylated PAHs have the same RRFs as the
parent compound ions. Nevertheless, these relative concentrations
are useful for monitoring the fate of these compounds during the
course of any analysis, as long as their concentrations are measured
in a consistent way throughout the analysis.
5.10.4.12 Concentration calculations for all target compounds
are performed using EnviroQuant software or equivalent. Data for
each sample can be printed directly using a customized report
template. Data can also be automatically entered into a spreadsheet
within the EnviroQuant software.
5.10.5 Quality Assurance/Quality Control. The following criteria
must be met before any samples are analyzed:
5.10.5.1 Air/water check to verify the system is leak free.
5.10.5.2 AutoTune and DFTPP Tune pass all criteria.
5.10.5.3 DFTPP check standard passes all criteria.
5.10.5.4 Solvent blank scan indicates the GC/MS system is free
of interfering contamination.
5.10.5.5 Prepare and monitor a control chart of a standard oil
analysis.
[[Page 38356]]
Concentrations of the analytes in the control chart must be no more
than 25% different from their historical averages.
5.10.5.6 Relative response factors for analytes in the check
standards inserted between every 10 samples must be no more than 25
percent different from the average RRF of those same analytes in the
calibration curve. Peak shapes must be symmetrical.
5.11 References for Section 5
(1) Haines, J.R., E.J. Kleiner, K.A. McClellan, K.M. Koran, E.L.
Holder, D.W. King, and A.D. Venosa. 2005. ``Laboratory evaluation of
oil spill bioremediation products in salt and freshwater systems.''
J. Ind. Microbiol. Biotech 32: 171-185.
Appendix E to Part 300 [Removed]
0
16. Remove Appendix E to Part 300.
[FR Doc. 2023-11904 Filed 6-7-23; 11:15 am]
BILLING CODE 6560-50-P