Rule2023-11904
National Oil and Hazardous Substances Pollution Contingency Plan; Product Schedule Listing and Authorization of Use Requirements
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Published
June 12, 2023
Effective
December 11, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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 (<a href="/cdn-cgi/l/email-protection#97e0fefbe4f8f9b9f0e5f2f0f8e5eed7f2e7f6b9f0f8e1"><span class="__cf_email__" data-cfemail="c3b4aaafb0acadeda4b1a6a4acb1ba83a6b3a2eda4acb5">[email protected]</span></a>) or Vanessa Principe at 202-564-7913
(<a href="/cdn-cgi/l/email-protection#304042595e535940551e46515e55434351705540511e575f46"><span class="__cf_email__" data-cfemail="9fefedf6f1fcf6effab1e9fef1faececfedffaeffeb1f8f0e9">[email protected]</span></a>). 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 <a href="http://www.epa.gov/oem/">http://www.epa.gov/oem/</a>.
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 <a href="https://www.govinfo.gov/content/pkg/GPO-OILCOMMISSION/pdf/GPO-OILCOMMISSION.pdf">https://www.govinfo.gov/content/pkg/GPO-OILCOMMISSION/pdf/GPO-OILCOMMISSION.pdf</a>.
\2\ See <a href="https://www.epa.gov/office-inspector-general/report-revisions-needed-national-contingency-plan-based-deepwater-horizon">https://www.epa.gov/office-inspector-general/report-revisions-needed-national-contingency-plan-based-deepwater-horizon</a>.
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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
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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
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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
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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
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[…truncated; see source link]Indexed from Federal Register on June 12, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.