[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Rules and Regulations]
[Pages 38280-38356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11904]



[[Page 38279]]

Vol. 88

Monday,

No. 112

June 12, 2023

Part III





Environmental Protection Agency





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40 CFR Parts 110 and 300





National Oil and Hazardous Substances Pollution Contingency Plan; 
Product Schedule Listing and Authorization of Use Requirements; Final 
Rule

  Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Rules 
and Regulations  

[[Page 38280]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 110 and 300

[EPA-HQ-OPA-2006-0090; FRL-4526-01-OLEM]
RIN 2050-AE87


National Oil and Hazardous Substances Pollution Contingency Plan; 
Product Schedule Listing and Authorization of Use Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or the Agency) is 
amending the requirements in Subpart J of the National Oil and 
Hazardous Substances Pollution Contingency Plan (NCP) that govern the 
use of dispersants, other chemicals and other spill mitigating 
substances when responding to oil discharges into jurisdictional waters 
of the United States. This action addresses the efficacy and toxicity 
of dispersants and other chemical and biological agents, as well as 
public, state, local, and federal officials' concerns regarding their 
use. Specifically, the Agency is amending the Subpart J regulatory 
requirements for the NCP Product Schedule in two distinct ways. First, 
the Agency is adding new listing criteria, revising the efficacy and 
toxicity testing protocols, and clarifying the evaluation criteria for 
removing products from the NCP Product Schedule. Second, the Agency is 
amending requirements for the authorities, notifications, and data 
reporting when using chemical or biological agents in response to oil 
discharges to Clean Water Act (CWA) section 311 jurisdictional waters 
and adjoining shorelines. These requirements are anticipated to 
encourage the development of safer and more effective spill mitigating 
products and better target the use of these products to reduce the 
risks of oil discharges and response technologies to human health and 
the environment. Further, the amendments are intended to ensure that 
On-Scene Coordinators (OSCs), Regional Response Teams (RRTs), and Area 
Committees (ACs) have sufficient information to support agent 
authorization of use decisions.

DATES:  This final rule is effective on December 11, 2023.

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. EPA-HQ-OPA-2006-0090. All documents in the docket are 
listed on the http://www.regulations.gov website. Although listed in 
the index, some information is not publicly available, e.g., CBI or 
other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available electronically 
through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For general information, contact the 
Superfund, TRI, EPCRA, RMP, and Oil Information Center at 800-424-9346 
or TDD at 800-553-7672 (hearing impaired). In the Washington, DC 
metropolitan area, contact the Superfund, TRI, EPCRA, RMP, and Oil 
Information Center at 703-412-9810 or TDD 703-412-3323. For more 
detailed information on this final rule contact Gregory Wilson at 202-
564-7989 ([email protected]) or Vanessa Principe at 202-564-7913 
([email protected]). The contact address is U.S. Environmental 
Protection Agency, Office of Emergency Management, Regulations 
Implementation Division, 1200 Pennsylvania Avenue NW, Washington, DC 
20460-0002, Mail Code 5104A, or visit the Office of Emergency 
Management website at http://www.epa.gov/oem/.

SUPPLEMENTARY INFORMATION: The contents of this preamble are:

I. General Information
II. Entities Potentially Affected by This Final Rule
III. Statutory Authority and Delegation of Authority
IV. Background
V. This Action
    A. Discharge of Oil
    B. Subpart A--Introduction
    1. Definitions
    C. Subpart J--Use of Dispersants, and Other Chemical and 
Biological Agents
    1. General
    2. Authorization for Agent Use
    3. Data and Information Requirements for Listing on the NCP 
Product Schedule or Sorbent Product List
    4. Submission of Proprietary Business Information (PBI)
    5. Addition of a Product to the NCP Product Schedule or Sorbent 
Product List
    6. Mandatory Product Disclaimer
    7. Removal of a Product From the NCP Product Schedule or the 
Sorbent Product List
    8. Appendix C to Part 300
    9. Appendix E to Part 300
VI. Summary of Final Rule Provisions
VII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review; 
Executive Order 13563: Improving Regulation and Regulatory Review; 
and Executive Order 14094: Modernizing Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations
    K. Congressional Review Act
Part 110--Discharge of Oil
Part 300--National Oil and Hazardous Substances Pollution 
Contingency Plan

I. General Information

    In April 2010, the Deepwater Horizon underwater oil well blowout 
discharged significant quantities of oil into the Gulf of Mexico and 
raised questions about efficacy, toxicity, environmental tradeoffs, and 
the challenges of making dispersant use decisions in response 
operations for certain atypical dispersant use situations.
    In this final action, EPA is establishing new agent testing, 
listing, and authorization of use requirements under Subpart J of the 
NCP to address these challenges. These revisions to Subpart J address 
the use of dispersants and other chemical and biological agents to 
respond to oil discharges into jurisdictional waters and their 
adjoining shorelines as provided under section 311(b)(3) of the CWA. 
Specifically, the Agency is adding, amending, or removing certain 
regulatory definitions and updating requirements associated with the 
authorization of agent use (including preauthorization plan 
development, approval, and review; prohibited agents; storage; agent 
use; recovery; and reporting of use); testing of products (including 
efficacy and toxicity testing protocols); and listing on the NCP 
Product Schedule (including data and information requirements and the 
use of toxicity data to determine listing eligibility; processes for 
listing and delisting, including transitioning products to the new NCP 
Product Schedule; and proprietary business information (PBI)). The 
revisions include improved laboratory protocols for dispersant and 
bioremediation efficacy and toxicity, and will increase the overall 
scientific soundness of the data collected. These amendments to Subpart 
J will help to ensure that only

[[Page 38281]]

products that perform effectively in laboratory testing will be listed 
on the NCP Product Schedule for use in mitigating the effects of oil 
discharges.
    EPA estimates that, to comply with the revised requirements, 
industry may incur a total incremental cost of approximately $283,800 
to $376,500 annually. Note that the range in annualized cost reflects 
differences due to using 3% and 7% discount rates as well as a range 
(low and high) for submitter's paperwork burden. This action does not 
impose significant impacts on a substantial number of small entities. 
The Regulatory Impact Analysis, which can be found in the docket, 
provides more detail on the cost methodology and benefits of this 
action.

II. Entities Potentially Affected by This Final Rule

    Entities affected by the final rule include manufacturers of 
bioremediation agents, dispersants, surface-washing agents, 
solidifiers, herding agents, and sorbents used as countermeasures 
against oil spills, and government entities. The universe of domestic 
product submitters (i.e., product manufacturers) with products listed 
on the NCP Product Schedule provides the basis for identifying affected 
entities. EPA identified 89 affected domestic product manufacturers 
with products currently on the NCP Product Schedule and determined each 
manufacturer's NAICS code using Dun and Bradstreet (D&B) data.

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             NAICS code                                           Industrial category
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213.................................  Support Activities for Mining.
322.................................  Paper Manufacturing.
325.................................  Chemical Manufacturing.
326.................................  Plastics and Rubber Products Manufacturing.
423.................................  Merchant Wholesalers, Durable Goods.
424.................................  Merchant Wholesalers, Nondurable Goods.
454.................................  Nonstore Retailers.
493.................................  Warehousing and Storage.
541.................................  Professional, Scientific, and Technical Services.
561.................................  Administrative and Support Services.
562.................................  Waste Management and Remediation Services.
811.................................  Repair and Maintenance.
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    The Agency's goal is to provide a guide for readers to consider 
regarding entities that potentially could be affected by this action. 
However, this action may affect other entities not listed in this 
table. If you have questions regarding the applicability of this action 
to a particular entity, consult the person(s) listed in the FOR FURTHER 
INFORMATION CONTACT section.

III. Statutory Authority and Delegation of Authority

    Under sections 311(d) and 311(j) of the Clean Water Act (CWA), as 
amended by section 4201 of the Oil Pollution Act of 1990 (OPA), Public 
Law 101-380, the President is directed to prepare and publish the NCP 
for removal of oil and hazardous substances. Specifically, section 
311(d)(2)(G) directs the President to include a schedule identifying 
``(i) dispersants, other chemicals, and other spill mitigating devices 
and substances, if any, that may be used in carrying out the Plan, (ii) 
the waters in which such dispersants, other chemicals, and other spill 
mitigating devices and substances may be used, and (iii) the quantities 
of such dispersant, other chemicals, or other spill mitigating device 
or substance which can be used safely in such waters'' as part of the 
NCP. The Agency has promulgated the NCP, see 40 CFR 300.1 et seq., 
including the schedule of dispersants, other chemicals, and other oil 
spill mitigating devices and substances (see 40 CFR 300.900 et. seq.) 
as required by section 311(d)(2)(G). The President is further 
authorized to revise or otherwise amend the NCP from time to time, as 
the President deems advisable. 33 U.S.C. 1321(d)(3). The authority of 
the President to implement section 311(d)(2)(G) of the CWA is delegated 
to EPA in Executive Order 12777 (56 FR 54757, October 22, 1991). 
Subpart J of the NCP establishes the framework for the use of 
dispersants and any other chemical agents in response to oil discharges 
(40 CFR part 300 series 900). The Agency is further clarifying that the 
statutory schedule as required by CWA section 311(d)(2)(G) includes the 
NCP Product Schedule, the Sorbent Product List, and the Subpart J 
authorization of use procedures that, when taken together, identify the 
waters and quantities in which such dispersants, other chemicals, or 
other spill mitigating devices and substances may be used safely.

IV. Background

    In the United States and around the world, chemical and biological 
agents are among the oil spill mitigation technologies available that 
responders may consider. Subpart J of the NCP sets forth the regulatory 
requirements for the use of chemical and biological agents, which 
includes separate provisions for product testing and listing, and for 
authorization of use procedures. These requirements provide the 
structure for the On-Scene Coordinator (OSC) to determine in each case 
the waters and quantities in which dispersants or other chemical agents 
may be safely used in such waters, if any. This determination is based 
on all relevant circumstances, testing and monitoring data and 
information, and is to be made in accordance with the authorization of 
use procedures, including the appropriate concurrences and 
consultations, found within the regulation. When taken together, the 
Subpart J regulatory requirements address the types of waters and the 
quantities of listed agents that may be authorized for use in response 
to oil discharges. EPA believes that the wide variability in waters, 
weather conditions, organisms living in the waters, and types of oil 
that might be discharged requires this approach.
    The Deepwater Horizon underwater oil well blowout in 2010 raised 
questions about the challenges of making chemical agent use decisions 
in response operations, particularly for certain atypical dispersant 
use situations. To address these and other challenges, the Agency 
proposed to amend Subpart J of the NCP to revise the existing product 
listing criteria, testing protocols, and authorization of use 
procedures, as well as to establish new provisions for dispersant 
monitoring (80 FR 3383, January 22, 2015). In July 2021, EPA published 
a final rule addressing the environmental monitoring of dispersant use 
in response to major discharges and to certain dispersant use 
situations.

[[Page 38282]]

Specifically, the Agency established monitoring requirements for any 
subsurface use of dispersant in response to an oil discharge, surface 
use of dispersant in response to oil discharges of more than 100,000 
U.S. gallons occurring within a 24-hour period, and surface use of 
dispersant for more than 96 hours after initial application in response 
to an oil discharge (86 FR 40234, July 27, 2021). This final action 
addresses the remaining Subpart J revisions proposed in 2015, including 
those associated with the product listing, testing protocols, and 
authorization of use procedures.

V. This Action

    This final action amends two distinct sets of requirements under 
Subpart J: (1) Those related to chemical and biological agent testing 
and listing, and (2) those related to authorization of use. 
Specifically, in this action, the Agency adds, amends, or removes 
certain regulatory definitions associated with Subpart J, and updates 
requirements for the authorization of agent use (including 
preauthorization plan development, approval, and review; case by case 
authorization of prohibited agents; storage; agent use; recovery; and 
reporting of use); testing of products (including efficacy and toxicity 
testing protocols); and listing on the NCP Product Schedule (including 
data and information requirements, processes for adding or removing a 
product to or from the NCP Product Schedule, and proprietary business 
information.) The discussion below explains each of the amendments. It 
also summarizes and provides a response to highlighted public comments 
received on the 2015 proposal. See the Response to Comment Document for 
Listing and Testing of Chemical and Biological Agents, and for the 
Response to Comment Document on the Authorization of Use of Chemical 
and Biological Agents in the rulemaking docket for a complete summary 
and response to public comments. Sections of the NCP not identified to 
be revised in the proposed rule or addressed in this final rule are 
outside the scope of this final action.
    Revisions to Subpart J were under consideration prior to the 
Deepwater Horizon oil spill. The subsequent Deepwater Horizon oil spill 
resulted in recommendations to update Subpart J from the National 
Commission on the BP Deepwater Horizon Oil Spill and Offshore Drilling 
Report \1\ and the EPA Inspector General report titled Revisions Needed 
to the National Contingency Plan Based on Deepwater Horizon Oil Spill 
(Report #11-P-0534),\2\ including that EPA review and update dispersant 
testing protocols for product listing. The Agency's final action 
addresses those recommendations.
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    \1\ See https://www.govinfo.gov/content/pkg/GPO-OILCOMMISSION/pdf/GPO-OILCOMMISSION.pdf.
    \2\ See https://www.epa.gov/office-inspector-general/report-revisions-needed-national-contingency-plan-based-deepwater-horizon.
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    This final action reflects relevant science and research that 
supports the specific provisions and their intent. The Agency 
considered the over 81,000 comments received that offered a wide range 
of perspectives and scientific information. Those comments remain 
relevant to the rulemaking, which will modernize and enhance the 
Subpart J regulatory provisions.
    The Agency is updating the process for listing products on the NCP 
Product Schedule, including expanded testing and listing thresholds. In 
doing so, EPA identified the relevant science to establish a national 
screening process for products to be listed on the NCP Product 
Schedule. Specifically, in amending the NCP Product Schedule listing 
provisions, EPA considered relevant science related to efficacy and 
toxicity testing and has determined it supports both establishing new 
protocols and updating existing protocols under Subpart J for testing 
chemical and biological agent products for listing on the NCP Product 
Schedule. These product testing protocols, along with additional 
requirements for data and information, serve as the basis for a 
national level screening of chemical and biological agent products, and 
include procedures that commercial laboratories are already familiar 
with or can readily adopt. EPA is not aware of changes to the relevant 
science since the proposed rulemaking and is proceeding with taking 
final action on the proposal. Furthermore, the final action builds upon 
the existing NCP framework, providing expanded opportunities for 
decisionmakers to consider any advancements in science beyond efficacy 
and toxicity valuations as part of listing, planning and response 
activities.
    The Agency is also updating the provisions for authorization of use 
by building upon the existing framework, providing further 
opportunities to consider advancements in science as part of the 
planning and authorization of use processes for chemical and biological 
agents. This performance-based approach provides flexibility in 
gathering, and allowing for the consideration of, scientific 
information relevant to a given site or geographic location. This 
allows for better targeting chemical and biological agent use during a 
response and is consistent with the broader NCP framework.

A. Discharge of Oil

    The Agency is revising the text at 40 CFR 110.4 to harmonize it 
with the definitions for chemical and biological agents that are also 
being finalized for Subpart J. The revision replaces the terms 
``dispersants and emulsifiers'' in Sec.  110.4 with the broader term 
``any chemical or biological agent, or any other substance.'' The 
revised definition in Sec.  300.5 for chemical agents, as finalized in 
this action, includes elements, compounds, or mixtures designed to 
facilitate the removal of oil from a contaminated environment and 
mitigate any deleterious effects. The new definition for biological 
agents, also finalized in this action, includes microorganisms 
(typically bacteria, fungi, or algae) or biological catalysts, such as 
enzymes, able to enhance the biodegradation of a contaminated 
environment. By revising the provision at Sec.  110.4, the Agency is 
clarifying that any chemical or biological agent or any other substance 
added to a discharge of oil with the intent to circumvent any provision 
of 40 CFR part 110 is prohibited. The final action replaces the 
specific qualifier ``as defined in Sec.  300.5 of this title'' with the 
broader ``or any other substance'' to emphasize the intent of this 
provision is ultimately to prohibit circumventing part 110 
requirements. The Agency has also amended the section title to 
``Chemical or biological agents.''
    Commenters on the 2015 proposal noted that the rule change would 
ensure no unintended or deliberate circumvention of Sec.  110.4 through 
any inconsistencies with Subpart J definitions. EPA agrees and has 
finalized the rule as described above to refer to the terms ``chemical 
and biological agents'' as opposed to specifically ``emulsifiers'' and 
``dispersants.'' In the finalized provision, EPA also made some 
editorial changes relative to the proposed text for increased clarity.

B. Subpart A--Introduction

1. Definitions
    EPA is finalizing revisions to Sec.  300.5 to amend the definitions 
for bioremediation agents, burning agents, chemical agents, 
dispersants, sinking agents, sorbents, and surface washing agents. 
Additionally, the Agency is finalizing new definitions for 
bioaccumulation, bioconcentration, biodegradation, biological agents, 
bioremediation, herding agents,

[[Page 38283]]

products, and solidifiers. Finally, the Agency is removing the 
definitions for miscellaneous oil spill control agents (MOSCA) and 
surface collecting agents.
(a) Revised Definitions
    Bioremediation agents--The Agency is revising the definition of 
bioremediation agents as proposed, to clarify the previous definition 
and add examples of bioremediation agents. Specifically, the final rule 
defines bioremediation agents as biological agents and/or nutrient 
additives deliberately introduced into a contaminated environment to 
increase the rate of biodegradation and mitigate any deleterious 
effects caused by the contaminant constituents. The definition 
identifies microorganisms and enzymes as bioremediation agents, as well 
as nutrient additives such as fertilizers containing bio-available 
forms of nitrogen, phosphorus, and potassium. This clarification will 
help manufacturers of products to identify the type of product, and 
hence, what testing requirements they will need to comply with to have 
a product listed on the NCP Product Schedule.
    A commenter expressed concerns about grouping all bioremediation 
agents in the revised definition. The commenter stated that the 
definition for bioremediation agent should be broken down for the three 
types of bioremediation because there are significant differences in 
applicability and appropriateness for the application of each type. EPA 
disagrees that the definition of bioremediation agent must explicitly 
include a classification for different types of bioremediation. The 
definition for bioremediation agents in the final action includes 
microorganisms, enzymes, and nutrients, to capture their different 
mechanisms of action (e.g., amending rate limiting nutrients vs. adding 
microbial cultures). The final revisions do not prevent EPA from 
grouping similar bioremediation agents together on the NCP Product 
Schedule, if appropriate.
    A commenter suggested that the definition of bioremediation agents 
should include language prohibiting the use of biological agents that 
could result in non-indigenous species colonization. EPA is not 
prohibiting the use of non-indigenous species, because the addition of 
cultured microorganisms, which may include non-indigenous species, may 
enhance biodegradation of a contaminant in certain situations. EPA 
notes that decisions to use bioremediation agents are subject to Sec.  
300.910, Authorization of Use, and expects the OSC to utilize available 
resources to determine the most appropriate bioremediation agent, if 
any, for use in a response in light of incident and site-specific 
factors.
    Burning agents--The Agency is revising the definition of burning 
agents as proposed, to identify as such those additives that improve 
the combustibility of the materials to which they are applied. This 
could be achieved through either physical or chemical means.
    A commenter interpreted that the proposed definition combines 
burning agents (materials that actually change the combustibility of 
the material they are added to) and ignition agents (ignition devices 
or materials used to start combustion). The commenter recommended that 
the Agency adopt separate definitions for burning and ignition agents 
for clarity. Some commenters suggested that the Agency should either 
include ignition devices within the definition of ``burning agents'' or 
create a separate category for ignition devices. The Agency agrees with 
commenters that ignition devices are distinct from burning agents. The 
final provisions do not include ignition devices in the definition of 
burning agent. The Agency believes that the intent of ignition devices 
is to provide the initial energy to start a burn and typically do not 
enter the water column. While ignition devices provide the initial 
energy to start a burn, these devices are incidental to burning agents, 
which are intended to improve the combustibility of the oil. EPA is 
exercising its discretionary authority and not including ignition 
devices on the NCP Product Schedule given their intended use. 
Furthermore, EPA disagrees with a commenter's statement that burning 
agents are necessarily applied ``prior to ignition;'' EPA believes that 
burning agents could be added after ignition to improve combustibility. 
The definition of burning agents in the final action does not 
specifically state when during an in situ burning cycle a burning agent 
is to be applied. The Agency is finalizing the definition of burning 
agents from the proposed rule without any changes. EPA notes that 
burning agents remain subject to Subpart J authorization of use 
requirements, even though EPA is not requiring specific product 
information and data about burning agents to be submitted to EPA under 
Sec.  300.955.
    Chemical agents--The Agency is revising the definition of chemical 
agents to identify as such those elements, compounds, or mixtures that 
are designed to facilitate the removal of oil from a contaminated 
environment and to mitigate deleterious effects. The chemical agent 
category includes burning agents, dispersants, herding agents, 
solidifiers, surface washing agents, and those bioremediation agents 
that consist of nutrient additives. This revised definition reflects 
the Agency's distinction between chemical and biological agents, 
allowing product manufacturers to better target the testing 
requirements and OSCs to better inform their authorization in specific 
situations. The finalized language also removes from the definition 
certain agent categories that are being eliminated, prohibited, or 
amended, to conform to these changes.
    Several commenters expressed concern with the Agency's proposed 
wording ``designed to facilitate the removal of oil from a contaminated 
environment.'' Commenters indicated that the definition of ``chemical 
agent'' does not make it clear that sinking agents, along with 
dispersants, do not remove or detoxify oil, but rather treat it. 
Commenters also stated that dispersants do not facilitate the removal 
of oil or mitigate deleterious effects. EPA notes that the NCP 
incorporates into Sec.  300.5 the CWA section 311 statutory definition 
of ``remove.'' Under the NCP, ``remove'' or ``removal'' refers to 
containment and removal of oil or hazardous substances from the water 
and shorelines or the taking of such other actions as may be necessary 
to minimize or mitigate damage to the public health or welfare of the 
United States (including, but not limited to, fish, shellfish, 
wildlife, public and private property, and shorelines and beaches) or 
to the environment (40 CFR 300.5). Under the NCP, the term also 
includes monitoring of action to remove a discharge (40 CFR 300.5). 
Dispersants are substances that emulsify, disperse, or solubilize oil 
by promoting the formation of small droplets or particles of oil in the 
water column. The primary purpose of using dispersants is to facilitate 
dispersal of the oil into the water column, where the oil is then 
subject to several fate and transport processes (e.g., dissolution). 
Thus, dispersant use may alter the behavior of oil to which it is 
applied and may result in an action that minimizes or mitigates damage, 
as described in the statutory definition of ``remove.'' In addition, 
depending on the oil composition, certain fractions of the dispersed 
oil may biodegrade over time. Dispersants are appropriately defined as 
chemical agents since they are designed to facilitate the removal of 
oil or mitigate oil's deleterious effects. Furthermore, EPA notes that 
the final provisions maintain the previous approach that

[[Page 38284]]

chemical agents ``. . . facilitate the mitigation of deleterious 
effects or the removal of the pollutant from the water.''
    A commenter stated that the definition of chemical agents should 
clearly delineate between chemical agents that are intended to be 
removed from the environment and those that are not. EPA believes that 
the NCP, as revised under this amendment, sufficiently delineates 
between chemical agents that are intended to be recovered from the 
environment and those that are not. The NCP addresses recovery of 
agents from the environment in multiple chemical agent and substances 
definitions (e.g., surface washing agents, sorbents) and under Sec.  
300.910(h) Recovery of Agents from the Environment.
    Commenters recommended that sinking agents be removed from the 
proposed definition of chemical agents. A commenter suggested that 
including a definition for sinking agents in the context of other 
agents that may be put on the NCP Product Schedule contradicts the 
Agency's stated policy against the use of sinking agents to treat oil 
spills. EPA agrees that sinking agents do not remove oil from the 
environment and that sinking agents should not be included in the 
definition of chemical agents. The finalized definition of chemical 
agents has been modified relative to the proposed version to remove 
sinking agents.
    Dispersants--The Agency is revising the definition of dispersants 
to identify as such those substances that emulsify, disperse, or 
solubilize oil by promoting the formation of small droplets or 
particles of oil in the water column. The Agency acknowledges that the 
primary purpose of dispersants is to facilitate oil transfer from one 
area to another (e.g., oil transferred from the water surface into the 
water column) or to maintain entrainment within the water column (e.g., 
oil maintained in the water column from a subsurface discharge). 
Dispersed oil is then subject to transport by water currents and other 
fate and transport processes (e.g., dissolution, biodegradation), which 
involves many site- and incident-specific factors. Irrespective of 
dispersant use, oil droplets may interact with suspended particulate 
material in the water column. For example, oil naturally dispersed in 
the water column (i.e., untreated dispersed oil) may also interact with 
suspended particulate material.
    A commenter stated that the proposed definition should not identify 
what dispersants are ``typically'' composed of because formula 
components will vary by intended primary use setting. EPA agrees that 
the definition of dispersants should not identify the typical 
composition of dispersants (e.g., solvents, surfactants), not 
necessarily because formula components will vary by intended primary 
use setting, but to avoid the potential misinterpretation that 
dispersants are necessarily comprised of these components. Thus, EPA is 
amending the definition of ``dispersant'' in this final rule by adding 
``. . . substances that emulsify, disperse, or solubilize oil by 
promoting . . .'' and removing ``. . . typically mixtures comprised of 
solvents, surfactants, and additives that promote . . .'' The final 
provision maintains the general approach in the current definition to 
recognize that dispersants are substances ``. . . that emulsify, 
disperse, or solubilize oil . . .'' by promoting the formation of small 
droplets or particles of oil in the water column. Furthermore, based on 
other comments regarding oil-mineral aggregates on the proposed sorbent 
definition, EPA is amending the definition of dispersants to add ``. . 
. or particles . . .'' to indicate that certain particulate materials 
may also act as dispersants. EPA also removed the phrase ``. . . by 
reducing the oil-water interfacial tension'' in order not to identify 
any specific process and to recognize that other processes may also 
result in dispersion of oil.
    Sinking agents--The Agency is revising the definition of sinking 
agents to identify them as those substances introduced into an oil 
discharge to submerge the oil to the bottom of a water body. The former 
definition was ambiguous in distinguishing chemical agents (e.g., 
dispersants) that may submerge oil below the water surface from 
substances that would sink oil to the bottom of the water body. The 
revision clarifies the distinction between sinking agents and other 
agents, such as dispersants, that do not intend to sink oil to the 
bottom of a water body but may have the incidental effect of causing 
some of the discharged oil to settle to the bottom of a water body. The 
Agency believes it is critical to distinguish between sinking agents, 
which are intended to sink oil as the primary mechanism of response, 
and dispersants, which are primarily intended to promote the formation 
of small droplets or particles of oil in the water column. The Agency 
continues to prohibit the use of sinking agents in the remediation of 
oil discharges in water because of their potential for causing adverse 
effects on benthic organisms vital to the food chain of the aquatic 
environment.
    Commenters expressed concerns with the way that the proposed 
definition distinguished between submersion and sinking. The commenters 
stated that both submersion and sinking could cause harm to benthic 
organisms and make oil more difficult to remove; several commenters 
suggested a broader definition of sinking agents to include any agent 
that causes oil to submerge below the water surface in a given 
waterbody, retains oil beneath the water surface, and/or increases 
aggregation of oil-sediment particles beneath the water surface, even 
if the treating agents also qualify for other categories (e.g., 
dispersants, solidifiers, sorbents). The Agency disagrees with the 
recommendations to modify the sinking agent definition as this would 
conflate the definitions of dispersants and sinking agents and would 
effectively work to prohibit the use of dispersants. The final action 
balances the potential for deleterious effects from dispersant use 
against their potential for reducing or mitigating the environmental 
impacts of an oil spill, through the consideration of site-specific 
conditions and within the context of all response options. Adding 
language that characterizes sinking agents as facilitating the transfer 
of oil from the water surface into the water column or retention of oil 
below the water surface would cause confusion with the definition of 
dispersants.
    A commenter provided specific recommended language to edit the 
definition of sinking agents, which included removing the proposed 
phrase ``. . . deliberately for the purpose of submerging . . .''. 
Additionally, another commenter suggested that the Agency's use of the 
term ``deliberately'' in the definition is unworkable because it fails 
to specify whose intent is relevant. EPA agrees that the term 
``deliberately'' presents challenges to interpreting intent. Therefore, 
based on public comment, EPA is removing the term ``deliberately'' from 
the sinking agent definition in this final rule.
    Sorbents--Under the revised definition of sorbents, EPA identifies 
sorbents as inert and insoluble substances that readily absorb and/or 
adsorb oil or hazardous substances and that are not combined with or 
act as a chemical agent, biological agent, or sinking agent. Sorbents 
may be used in their natural bulk form or as manufactured products in 
for example particulate form, sheets, rolls, pillows, or booms. 
Sorbents are generally collected and recovered from the environment. 
The definition also

[[Page 38285]]

includes a list of materials of which sorbents may consist. These 
revisions simplify the definition by removing the definitions of 
absorption and adsorption that were embedded in the former definition 
of sorbents; this is appropriate because absorption and adsorption are 
generally recognized scientific terms and sorbents are not 
distinguished or restricted under Subpart J based on whether they 
absorb or adsorb oil. The revised definition also adds the qualifier 
``natural'' to organic substances, indicating that organic substances 
that have been treated with other substances do not necessarily fall 
under this category of agents and should not be considered a sorbent 
absent being listed on the Sorbent Product List as provided in this 
rule. It also expands on and simplifies the examples by removing the 
references to the type of birds that feathers could come from, by 
adding bagasse to the examples for natural organic substances, and by 
adding clay to the examples for inorganic/mineral compounds. While 
sorbents are not listed on the NCP Product Schedule, a list 
characterizing these materials is included in Sec.  300.915(g) and EPA 
considers the Sorbent Product List in Sec.  300.915(g) to be a part of 
the statutory schedule addressed in 33 U.S.C. 1321(d)(2)(G).
    Commenters replied to the Agency's request for comments on the 
qualifier phrase, ``that are generally collected and recovered from the 
environment.'' Some commenters requested that EPA remove the term 
``generally'' or remove the phrase that sorbents are ``generally 
collected and recovered from the environment.'' Other commenters 
requested that sorbents be used with the intent of collecting and 
removing them from the environment. A commenter requested that the 
Agency clearly require that all sorbent materials must be recovered 
from the environment, and that sorbent use is not authorized in the 
event that the sorbents cannot be removed from the environment. EPA 
disagrees with comments that the phrase ``generally collected and 
recovered from the environment'' should be removed from the definition. 
EPA believes that the phrase recognizes and captures the expectation 
that sorbents are not intended to be left in the environment. EPA 
recognizes that on very limited occasions an OSC may make the 
determination to not recover a sorbent after consideration of factors 
such as the safety of response personnel and potential for greater harm 
to the environment if the sorbent material is recovered rather than 
left in place. Therefore, EPA retained the sentence ``Sorbents are 
generally collected and recovered from the environment'' in the amended 
definition but did move it to later in the provision in order to 
improve editorial flow and clarity. The OSC retains discretion not to 
authorize or direct the use sorbents if the OSC believes that sorbent 
use is inappropriate in light of incident-specific determinations.
    EPA received a range of comments regarding particulate materials 
(e.g., clay) and the definitions of sorbent, sinking agents, and 
dispersants. EPA recognizes that some materials may behave differently 
in the environment based, in part, on the size or configuration of the 
substance. EPA disagrees with comments that clay necessarily behaves 
like a sinking agent in all cases. To address concerns regarding 
particulate materials, EPA is amending the definition of sorbents to 
recognize potentially differing behaviors and to distinguish between 
sorbents and sinking agents. The final revisions to the definition of 
sorbents includes that these substances are ``. . . not combined with 
or act as . . . sinking agents.'' EPA recognizes that substances such 
as clay may be used as a sorbent, but also agrees with commenters that 
they should not act as a sinking agent. EPA believes it is appropriate 
to continue to allow substances such as clay to be listed as sorbents 
and used as a sorbent during a response, provided that they are done so 
in manner that prevents them from acting as a sinking agent (e.g., 
contained in a buoyant boom). The Agency expects that the 
Administrative Record for a response would provide the basis for 
continued sorbent use under OSC oversight or direction, and the 
Administrative Record should address any potential concerns with 
sorbents being used as a sinking agent. EPA also recognizes that 
particulate materials may be manufactured of such configuration (e.g., 
micro- or nanosized) that they are, or are near, neutrally buoyant and 
remain in the water column over an extended time period. EPA recognizes 
comments that particulate materials may promote dispersion by forming 
oil-mineral aggregates (OMAs) and agrees with commenters that such 
substances should be addressed as dispersants rather than sorbents. 
Substances intended for use in a manner similar to a chemical or 
biological agent listed on the NCP Product Schedule (e.g., dispersants) 
should be classified similarly and subject to the same authorization of 
use procedures. The final rule clarifies that dispersants are 
substances that emulsify, disperse, or solubilize oil by promoting the 
formation of small droplets or particles of oil in the water column. 
This revised definition clarifies that substances that emulsify, 
disperse, or solubilize oil include particulate materials because they 
promote the formation of particles of oil (e.g., OMAs). Particulate 
materials that are used in a manner similar to chemical dispersants are 
appropriately categorized as dispersants on the NCP Product Schedule 
and are subject to the same dispersant authorization of use procedures 
under Sec.  300.910.
    Surface washing agents--The Agency is revising the term ``surface 
washing agent'' to ``surface washing agents'' and modifying the 
definition. EPA changed the term from singular to plural to be 
consistent with the other agent definitions. The revised definition 
identifies surface washing agents as those substances that separate oil 
from solid surfaces (e.g., beaches, rocks, metals, or concrete) through 
a detergency mechanism. The revised definition specifies that 
detergency mechanism lifts and floats the oil. The final definition is 
modified slightly from the proposed phrasing to clarify that the 
product and oil are generally to be collected and recovered from the 
environment with minimal dissolution, dispersion, or transfer into the 
water column to be consistent with similar phrases included in the 
sorbents and solidifiers definitions. EPA recognizes that on occasion 
an OSC may make the determination to not recover a surface washing 
agent after consideration of factors such as the safety of response 
personnel and potential for greater harm to the environment if the 
surface washing agent material is recovered rather than left in place 
(see 40 CFR 300.910(h)).
    A commenter suggested that surface washing agents used in fully 
self-contained structures (e.g., tank farms, dry-dock vessels, sand-
cleaning machines) or in a manner that prevents run-off to water (e.g., 
cleaning/wiping of vessel hulls by hand) need not be listed on the NCP 
Product Schedule or require approvals from the OSC or RRT before use. A 
commenter suggested including the phrase ``that are not likely to cause 
additional harm, either alone or in combination with oil, to public 
health or welfare or to the environment'' in the definition. EPA is not 
revising the definition to include this phrase. EPA believes that the 
NCP must retain flexibility to allow for environmental tradeoffs that 
take into consideration incident-specific conditions when determining 
what actions should be taken to immediately and effectively address an 
oil discharge.

[[Page 38286]]

(b) New Definitions
    The Agency is adding several new definitions for terms that are 
used in the amendments to Subpart J. These definitions include basic 
terminology and are consistent with how the terms are generally 
understood by the scientific community.
    Bioaccumulation--The Agency is establishing the definition of 
bioaccumulation, as proposed, to mean the process of accumulation of 
chemicals in the tissue of organisms through any route, including 
respiration, ingestion, or direct contact with the ambient or 
contaminated medium. The Agency is finalizing the definition of 
bioaccumulation from the proposed rule without any changes.
    A commenter expressed support for separate definitions of 
bioaccumulation and bioconcentration. The Agency appreciates and 
recognizes the commenter's perspective that bioaccumulation includes 
multiple routes of exposures to pollutants (e.g., including dietary or 
food chain), whereas bioconcentration only includes water-borne routes 
of exposure (e.g., absorption across the gills).
    Bioconcentration--The Agency is establishing the definition of 
bioconcentration, as proposed, to mean the accumulation of chemicals in 
the tissues of organisms from water alone.
    A commenter expressed support for separate definitions of 
bioaccumulation and bioconcentration, as described above. The Agency is 
finalizing the definition of bioconcentration from the proposed rule 
without any changes.
    Biodegradation--The Agency is establishing the definition of 
biodegradation to mean the process by which microorganisms 
metabolically decompose contaminants into biomass and smaller molecular 
compounds such as carbon dioxide, water, and end products.
    Commenters suggested expanding the definition of biodegradation to 
include the possibility of partial biodegradation, which can result in 
more toxic intermediate products. The commenters stated that partial 
biodegradation is likely to occur in the environment versus controlled 
laboratory conditions. EPA recognizes that partial biodegradation may 
occur in the environment. Therefore, the Agency amended the definition 
of biodegradation in the final rule to replace the phrase ``. . . 
simpler compounds . . .'' with ``. . . smaller molecular compounds . . 
.''. EPA also removed the term ``innocuous'' in the final action to 
recognize that not all end products may be innocuous.
    Biological agents--The Agency is establishing the definition of 
biological agents to mean microorganisms (typically bacteria, fungi, or 
algae) or biological catalysts, such as enzymes, that can enhance the 
biodegradation of a contaminated environment. EPA has slightly amended 
the definition of biological agent in this rulemaking to replace the 
phrase ``. . . able to . . .'' with ``. . . that can . . .'' to better 
reflect the intent of the definition.
    A commenter recommended that the definition of bioremediation 
agents include a ban on agents that may result in the colonization of 
non-indigenous species. While EPA understands that microorganisms 
capable of degrading oil are ubiquitous in nature, the Agency is 
maintaining its prior approach in this rulemaking to recognize the 
addition of microorganisms as a potential bioremediation process. In 
general, the addition of cultured microorganisms, which may include 
non-indigenous species, may enhance biodegradation of a contaminant.
    Bioremediation--The Agency is establishing the definition of 
bioremediation to mean the process of enhancing the ability of 
microorganisms to convert contaminants into biomass and smaller 
molecular end products by the addition of materials into a contaminated 
environment to accelerate the natural biodegradation process.
    Commenters suggested expanding the definition to include the 
possibility of partial bioremediation, which can result in more toxic 
intermediate products. The commenters stated that partial 
bioremediation is likely to occur in the environment versus controlled 
laboratory conditions. EPA recognizes that partial biodegradation may 
lead to the formation of intermediate products. The Agency is amending 
the definition of bioremediation in this final rule to replace the 
phrase ``. . . simpler compounds . . .'' with ``. . . smaller molecular 
compounds . . .''. EPA also removed the term ``innocuous'' to recognize 
that not all end products may be innocuous.
    Herding agents--The Agency is establishing the definition of 
herding agents to mean substances that form a film on the water surface 
to control the spreading of the oil to allow for oil removal. The 
definition for surface collecting agent was removed and replaced with 
the definition for herding agent to better reflect the common 
terminology used in industry for these agents.
    A commenter stated that the Agency should add language to the 
``herding agents'' definition which includes that they are not likely 
to cause harm, either alone or in combination with oil, to public 
health or the environment and that they are intended to be collected 
and recovered from the environment. EPA disagrees with these suggested 
edits to the definition of herding agents. The NCP addresses discharges 
of oil to the environment and response authorities must retain 
flexibility to allow for environmental tradeoffs that consider 
incident-specific conditions when determining what actions should be 
taken to immediately and effectively address the discharge. EPA is 
amending the definition of herding agents in the final rule by 
replacing the proposed phrase ``. . . across the water surface.'' with 
the phrase ``. . . form a film on the water surface . . .'' and adding 
the phrase ``. . . allow for oil removal.'' to better reflect the 
mechanism of action of herding agents.
    Products--The Agency is establishing the definition of products to 
mean chemical or biological agents or other substances manufactured 
using a unique composition or formulation.
    A commenter suggested that the proposed definition of products is 
incomplete because it only includes agents that may be listed on the 
NCP Product Schedule. Other commenters suggested that the definition of 
products should include anything that may be used to mitigate oil 
spills (e.g., burning agents, ignition devices, synthetic sorbents, 
organic or inorganic substances that may be used in bulk form, and 
substances that are manufactured using a unique composition or 
formulation). EPA's definition for products is intended to clarify the 
difference between a specific product and an agent type or category 
under the NCP Product Schedule and the Sorbent Product List. EPA agrees 
that the definition of a product should recognize sorbents by adding 
the term ``other substances.'' The finalized definition clarifies the 
distinction between an agent category (e.g., surface washing agent) or 
substance (e.g., sorbent) from a product for which a manufacturer 
submits an application to the Agency for listing on the NCP Product 
Schedule or the Sorbent Product List. The Agency is not revising the 
definition of ``product'' to specifically include burning agents since 
they are already included in the definition of chemical agents. 
Furthermore, the Agency disagrees to add ``other spill mitigating 
devices'' as it would not accurately reflect the applicability of the 
regulatory provisions for the purposes of the NCP Product Schedule or 
the Sorbent Product List in this final action.

[[Page 38287]]

    Solidifiers--The Agency is establishing the definition of 
solidifiers to mean substances that through a chemical reaction cause 
oil to become a cohesive mass, preventing oil from dissolving or 
dispersing into the water column. Solidifiers are generally collected 
and recovered from the environment. Solidifiers was not previously a 
specific product category on the NCP Product Schedule. The final rule 
amends the definition to recognize that solidifiers are ``generally'' 
to be collected, to recognize that the OSC has flexibility to consider 
factors such as the safety of response personnel and harm to the 
environment in making recovery determinations (see 40 CFR 300.910(h)).
    A commenter requested that the Agency add language to the 
definition to explain that solidifiers have no real advantage over 
sorbents or mechanical recovery and that they have limited 
practicality, may cross-link or react with other substances, and 
require immediate removal from the environment. The commenter mentioned 
that there has been very limited effectiveness testing or recent 
studies on solidifiers. The commenter requested that the definition of 
``solidifiers'' include additional limitations to specify conditions 
under which solidifiers may be used such as proximity to shore and 
quantity of oil. The Agency acknowledges the commenter's concerns; 
however, the Agency disagrees with the suggested edits. The definition 
is intended to convey the mechanism of action and to distinguish 
solidifiers from other chemical or biological agents. Subpart J does 
not state or imply that chemical or biological agents are preferred 
over other response options such as mechanical recovery devices. EPA 
notes that mechanical recovery devices, including skimmers, are outside 
the scope of this action. EPA believes that the circumstances 
surrounding oil discharges and the factors influencing the choice of 
response methods are many. In addition, the final revisions under Sec.  
300.910(g) provide that RRTs may require supplementary toxicity and 
efficacy testing, or to obtain data or information to address site, 
area, or ecosystem-specific concerns relative to the use of any 
chemical or biological agent. The Agency believes that the specific 
conditions under which solidifiers may be used, such as proximity to 
shore and quantity of oil, are better addressed through the 
authorization of use process found at Sec.  300.910 Authorization of 
Use.
(c) Removed Definitions
    Miscellaneous Oil Spill Control Agent (MOSCA)--The Agency is 
removing the definition for miscellaneous oil spill control agent 
(MOSCA). The MOSCA category was used as a catchall for all types of 
products that did not meet other agent definitions; it is being 
replaced with a number of new and/or revised definitions for types of 
agents. As the Agency adds new, more stringent testing requirements for 
listing products on the NCP Product Schedule, there is a need for more 
specific category definitions to assist manufacturers in determining 
which of those testing requirements apply to their products. Commenters 
supported the removal of the definition for MOSCA. A commenter 
specifically expressed support for the removal of the MOSCA category 
provided that a subcategory is included in the ``sorbents'' definition 
to account for the uniqueness of certain products among the other 
sorbents.
    The Agency agrees with comments supporting the removal of the MOSCA 
category and the final action removes the category and definition of 
MOSCAs from the NCP. The Agency has identified product categories to be 
listed on the NCP Product Schedule and revised it accordingly. The 
MOSCA category is no longer necessary or appropriate and is being 
removed from the NCP through this final action. EPA does not believe 
that removing the MOSCA definition results in listed products 
automatically being reassigned to fall under the definition of another 
chemical or biological agent, or substance. The final revisions provide 
for the process to transition listed products from the current NCP 
Product Schedule to the new NCP Product Schedule as described in Sec.  
300.955(f).
    Surface collecting agents--The Agency is removing the definition 
for surface collecting agent and replacing it with a new herding agent 
definition to better reflect the common terminology used in industry 
for these agents.
    EPA did not identify comments on the proposed amendment specific to 
removing the definition for surface collecting agents.

C. Subpart J--Use of Dispersants, and Other Chemical and Biological 
Agents

1. General
    EPA is amending Sec.  300.900 by revising the title and paragraphs 
(a) and (c), and by adding paragraph (d) to reserve for later use. The 
revisions clarify that Subpart J addresses not only chemical agents, 
but also those agents that now fall under the new biological agent 
category. The revisions reaffirm the notion that Subpart J is not only 
comprised of an NCP Product Schedule of chemical and biological agents, 
but also includes testing requirements and authorization of use 
procedures. Consistent with current Subpart J regulatory requirements, 
the Agency is reserving a section for ``Releases of Hazardous 
Substances'' to take place of the current placeholder in Sec.  300.905, 
which is being removed.
    Some commenters on the proposed rule expressed support for the 
update to Sec.  300.900, which clarifies the Agency's duties under the 
CWA, but noted that the Agency should specify waters and quantities 
where products can be used safely, highlighting the importance of the 
word ``safely.'' The Agency recognizes support to clarify that Subpart 
J includes the identification of the waters and quantities in which 
chemical and biological agents may be safely used. In this final 
action, EPA is amending the last sentence of the proposed regulatory 
text under Sec.  300.900 to include the term ``safely'' as provided in 
CWA section 311(d)(2)(G)(iii) based on the comment received.
    In addition, the Agency is clarifying that the statutory schedule 
as required by CWA section 311(d)(2)(G) includes the NCP Product 
Schedule, the Sorbents Product List, and authorization of use 
procedures that, when taken together, identify the waters and 
quantities in which such dispersants, other chemicals, or other spill 
mitigating devices and substances may be used safely. EPA is amending 
the regulation text at Sec.  300.900, and throughout Subpart J, to 
clarify that it is the ``NCP Product Schedule'' which EPA updates 
periodically, in order to avoid confusion with the statutory use of the 
term ``schedule'' referred to in CWA section 311(d)(2)(G).
    Some commenters requested additional clarification related to 
Administrator authority and expressed uncertainty regarding federal 
authority. Specifically, these commenters indicated a need for 
additional clarity regarding the role of the Agency versus that of the 
U.S. Coast Guard or other public or private entities involved in spill 
response. While CWA section 311(c) provides statutory authority for 
certain removal actions and identifies the agencies that are to provide 
the federal OSC (which may include EPA or U.S. Coast Guard), it does 
not provide authority to revise the NCP and does not govern how the NCP 
regulates response actions. The authority to establish, revise, and 
maintain the NCP is addressed in CWA section 311(d), which has been 
delegated to the EPA Administrator in Executive Order 12777 (56 FR 
54757, October 22, 1991). EPA will continue to exercise its authority

[[Page 38288]]

over the NCP, and CWA section 311(c) responses remain subject to NCP 
provisions as per Congressional direction at CWA section 311(c)(1), 
which provides that the President ``shall, in accordance with the 
National Contingency Plan and any appropriate Area Contingency Plan, 
ensure effective and immediate removal of a discharge . . . .'' 
(emphasis added).
2. Authorization for Agent Use
    Section 300.910 sets forth the provisions for the authorization of 
use of products on the NCP Product Schedule in response to oil 
discharges. EPA is adding an introductory paragraph to Sec.  300.910 
that confirms, consistent with the intent of the NCP, that use of 
chemical or biological agents in response to oil discharges must be 
authorized by an OSC in accordance with Subpart J. In the final rule, 
EPA did not include the phrase ``. . . to waters of the U.S. or 
adjoining shorelines . . .'' under the opening clause to Sec.  300.910 
Authorization for agent use since the scope of Subpart J is already 
addressed under Sec.  300.900. Unauthorized use can result in 
violations of sections 301 and 311 of the CWA. Section 301(a) makes 
unlawful ``the discharge of any pollutant by any person,'' except in 
compliance with certain provisions of the CWA. In addition, section 
311(b) establishes penalties for persons who fail or refuse to comply 
with any regulation issued under section 311(j) of the CWA.
    Commenters suggested that the Agency is already required by 
Congress to establish a list of products that may be used for response 
within navigable waters of the United States and EPA is therefore 
required to approve these products for use in response activities. EPA 
disagrees with the characterization that the Agency is required by 
Congress to establish a list of products such that those products are 
automatically authorized for use within the jurisdictional waters of 
the United States by their listing. The CWA provides the President with 
the authority to determine what products, if any, may be used in what 
waters, and in what quantities. The NCP Product Schedule addresses the 
chemical and biological agents that may be authorized for use upon 
consideration of both the appropriateness of their use in the impacted 
waters and the amount of product that may be used safely in response to 
the unique nature of each oil discharge. EPA does not believe a ``one 
size fits all'' approach to emergency response is appropriate or 
prudent. A ``one size fits all'' approach could lead to significant 
under- and over-use of products that could exacerbate oil discharges 
absent consideration of all the specific conditions of each individual 
discharge. The final action provides for flexibility to evaluate the 
specific nature of an oil discharge when considering the authorization 
of a chemical or biological agents.
(a) Use of Agents Identified on the NCP Product Schedule or Use of 
Burning Agents on Oil Discharges Addressed by a Preauthorization Plan
    The Agency is revising Sec.  300.910(a) to address the 
preauthorized use of chemical and biological agents identified on the 
NCP Product Schedule. The Agency reorganized paragraph (a) to provide 
greater clarity about RRT and Area Committee responsibilities. The 
revisions to Sec.  300.910(a) clarify the process for preauthorization, 
the responsibilities of all involved parties, and the factors to 
consider during the preauthorization process, including the 
authorization for the use of agents by the OSC at the time of a 
discharge. The reorganized paragraph (a) also makes the regulatory text 
easier to read and follow. The Agency added procedure and review 
requirements at Sec.  300.910(a)(3) intended to ensure preauthorization 
plans are maintained so they are up to date. The finalized provisions 
also address recommendations from the National Commission on the BP 
Deepwater Horizon Oil Spill and Offshore Drilling report and EPA's 
Inspector General report titled Revisions Needed to National 
Contingency Plan Based on Deepwater Horizon Oil Spill (Report #11-P-
0534). The final revisions do not change the NCP's fundamental policies 
regarding roles of Federal, state, and local representatives involved 
in planning for and responding to an oil discharge, but rather clarify 
the regulatory requirements and further explain the responsibilities 
for each party.
    Some commenters expressed concerns that the proposed rule focused 
on preauthorization and suggested that the focus should instead be on 
consultation and concurrence. The Agency recognizes that the RRTs and/
or Area Committees must consider whether preauthorization of chemical 
and biological agents is appropriate, while maintaining the existing 
concurrence and consultation roles on authorization of use. The revised 
preauthorization provisions provide greater clarity on the factors the 
RRT must address and those factors they should consider in developing a 
preauthorization plan. Department of the Interior (DOI) and Department 
of Commerce (DOC) natural resource trustees retain their concurrence 
role when approving preauthorization plans. DOI and DOC natural 
resource trustee concurrence is appropriate as preauthorization plans 
are developed during the contingency planning phase, when there is 
sufficient time to identify and resolve natural resource concerns.
    A commenter advocated for clarification of ``mixed use'' products, 
indicating that some of the products on the NCP Product Schedule have 
multiple uses and that during preauthorization planning all potential 
uses of an agent or product should be factored into the planning 
decisions. EPA recognizes that a ``mixed use'' product that meets the 
definition of more than one chemical or biological agent category may 
raise authorization of use issues when (1) listed under more than one 
chemical or biological agent category or (2) listed under one chemical 
or biological agent category but still meets the definition of another 
product category because of an alternate mechanism of action. The 
listing of a product on the NCP Product Schedule should not cause 
confusion on how that product is authorized at the time of an incident. 
Noting these concerns, the final action allows for the evaluation of 
products on an individual basis and informs the decision on whether and 
under which category to list a product on the NCP Product Schedule.
    Some commenters expressed concern or requested clarification on the 
roles and authorities of RRTs and Area Committees in preauthorization 
planning. Area Committees' roles and authorities under CWA section 
311(j)(4) are outside the scope of this rulemaking. Nonetheless, CWA 
section 311(j)(4) provides the roles of the Area Committees in planning 
for the use of dispersants, including for Area Contingency Plans to 
list the equipment (including firefighting equipment), dispersants or 
other mitigating substances and devices, and personnel available to an 
owner or operator, Federal, State, and local agencies, and tribal 
governments, to ensure an effective and immediate removal of a 
discharge, and to ensure mitigation or prevention of a substantial 
threat of a discharge. EPA notes that not all spill mitigating 
equipment, substances or devices may be available or appropriate in 
certain planning areas. EPA believes that to create the best possible 
response system, it is important that the regional-level and area-level 
contingency planning efforts of the RRTs and Area Committees, 
respectively, are closely coordinated. RRTs and Area Committees

[[Page 38289]]

should work together to develop mutually acceptable preauthorization 
plans, as appropriate. The standing RRTs also have responsibilities for 
oil spill contingency planning on a regional basis and can facilitate 
consistency among Area Committees. In instances where the RRT and Area 
Committees exist as separate entities, several RRT representatives 
likely also serve on the Area Committees for that region, allowing for 
familiarity with the roles and responsibilities of each entity. In 
instances (e.g., in the inland zone) where RRTs fulfill the role of the 
Area Committees, they are thus responsible for both regional and area-
level contingency planning (see 57 FR 15197, April 24, 1992). EPA 
agrees that in the development of preauthorization plans, RRTs should 
either provide Area Committees with an opportunity to provide input or 
should consider relevant information in Area Contingency Plans (ACPs) 
(e.g., Fish and Wildlife and Sensitive Environments Annex). The RRTs 
and Area Committees should identify all potentially affected biological 
resources and their habitats likely to be negatively impacted, and not 
only those that are expected to benefit.
    Another commenter noted that not all regions have a use for 
preauthorization planning, suggesting that only regions with use for 
these plans should be required to develop planning materials. While 
RRTs and ACs must consider whether having a preauthorization plan is 
appropriate, the final action does not mandate preauthorization plans 
to be developed or preauthorization of any chemical or biological 
agents. EPA modified the proposed text to remove the phrase ``in a 
preauthorization plan'' to avoid a misinterpretation that Sec.  
300.910(a) requires that RRTs develop preauthorization plans. EPA also 
amended the final action under Sec.  300.910(a) to further clarify the 
provision is to consider whether ``preauthorization of'' the use of 
chemical and biological agents is appropriate.
    The final action provides that an OSC may authorize the use of 
agents listed on the NCP Product Schedule, or the use of burning 
agents, for the purpose for which they were specifically listed without 
obtaining the incident-specific concurrences and without the natural 
resource trustees consultations described in Sec.  300.910(b). Some 
commenters supported approval of preauthorization plans by natural 
resource trustees. EPA amended the final provision to clarify that the 
OSC does not need to obtain the incident-specific natural resource 
trustees consultations described in paragraph (b) of this section when 
authorizing the use of certain agents under Sec.  300.910(a) by adding 
the phrase ``. . . and without the natural resource trustees' 
consultations . . .'' described in paragraph (b) of this section. The 
final provisions provide for DOI and DOC natural resource trustees 
concurrence on preauthorization plans rather than consultations. EPA 
continues to believe that DOI and DOC natural resource trustee 
concurrence is more appropriate than consultation during the 
contingency planning phase, when there is sufficient time to identify 
and resolve natural resource concerns while considering whether 
preauthorization is appropriate. Consistent with previous 
preauthorization approval requirements, the final revisions provide for 
DOI and DOC natural resource trustee approval, approval with 
modification, or disapproval of preauthorization plans.
    The final action provides that chemical or biological agents on the 
NCP Product Schedule may only be authorized for the purpose for which 
they were specifically listed. EPA amended the final provision to 
replace the phrase ``. . . intended purpose . . .'' with ``. . . for 
the purpose for which they were specifically listed . . .'' for greater 
clarity. This revision was made in response to a commenter's concern 
that chemical or biological agents may only be used for their intended 
use within a specific category (e.g., an agent that is listed as a 
surface washing agent cannot be authorized for use as a dispersant).
    In the finalized provision, EPA also made some editorial changes to 
the proposed text for increased clarity.
    Preauthorization Plan Development. At Sec.  300.910(a)(1), EPA is 
finalizing requirements for the preauthorization plan's site-specific 
factors. While the revisions simplify the language and clarify the 
requirements, the Agency kept in place the fundamental elements that 
were contained in the former Sec.  300.910(a) text. The provision 
states that preauthorization plans must, at a minimum, specify limits 
for the quantities and duration of use, and use parameters for water 
depth, distance to shoreline, and proximity to populated areas for 
discharge situations identified in which agents may be used. The Agency 
believes that clearly stating the use parameters in a preauthorization 
plan will make it easier for planners to address concerns of 
preauthorizing agent use and in turn for responders to authorize their 
use. In meeting these provisions, the preauthorization plans should 
document how both regional and logistical factors were addressed when 
establishing use limits and parameters for chemical and biological 
agents. Regional factors include the likely sources and types of oil 
that might be discharged, various potential discharge scenarios, and 
the existence and location of environmentally sensitive resources or 
restricted areas that might be impacted by discharged oil. Logistical 
factors include inventory, storage locations and manufacturing 
capability of available agents, availability of equipment needed for 
agent use, availability of adequately trained operators, and the 
availability of appropriate means to monitor agent use in the 
environment.
    Several commenters requested clarification on the need to specify 
limits to the quantities and duration of agent use and the proposed use 
parameters for water depth, distance from shoreline, and proximity to 
populated areas; commenters noted that it is not realistic to predict 
all scenarios. EPA recognizes that oil discharges may occur under 
various scenarios. EPA does not envision that preauthorization plans 
would address every scenario imaginable, but instead will only address 
those specific circumstances under which RRT member agencies with roles 
and responsibilities under the NCP agree that an OSC does not need to 
obtain specific concurrence and consultations under Sec.  300.910(b) in 
effectuating a preauthorized action. For example, a potential oil 
discharge scenario may involve a response that occurs over several 
days. The use of a chemical or biological agent (e.g., surface 
dispersant use) during the initial response phase may be preauthorized 
in a manner such that any use beyond that initial response phase would 
be subject to Sec.  300.910(b) and in limited circumstances subject to 
Sec.  300.910(b). While the preauthorization plan must specify limits 
for the quantities and the duration of use, and use parameters for 
water depth, distance to shoreline, and proximity to populated areas, 
RRTs may wish to include other criteria in defining the scope of the 
preauthorization plan. Based on public comments, EPA is amending the 
final provisions to reflect that the limits for the quantities and the 
duration of use, and use parameters for water depth, distance to 
shoreline, and proximity to populated areas are the minimum criteria 
that RRTs must specify by inserting the phrase ``at a minimum'' before 
the specific criteria in the regulatory text.
    Commenters supported considering environmental tradeoffs in 
determining response options that provide the greatest environmental 
protection by

[[Page 38290]]

identifying the affected biological resources and their habitats likely 
to be negatively impacted, as well as those that are expected to 
benefit. For example, a commenter suggested that the Agency rely upon 
the Net Environmental Benefit Analysis (NEBA) framework as a foundation 
for preauthorization planning, as opposed to artificially setting 
limits on dispersant use. EPA's understanding is that ``NEBA'' is a 
term used by some stakeholders in the response community to engage with 
various interested parties to consider available response options, 
including mechanical recovery. EPA also acknowledges that different 
stakeholders have varying perspectives on what factors beyond 
environmental considerations (e.g., economic, health, and safety) are 
included in a NEBA, or what response options may provide the ``greatest 
environmental protection.'' While there is no prohibition on the use of 
environmental tradeoff methodologies, the use of such methodologies 
must conform with all applicable statutory and regulatory authorities.
    A commenter disagreed with the use of the word ``likely'' in 
reference to the sources and types of oil that may be spilled and 
suggested keeping ``potential'' instead, as a more conservative term 
that is more appropriate for preauthorization planning. EPA believes 
the phrase ``likely sources and types of oil'' better focuses on the 
sources and types of oil specific to the preauthorization plan for 
which agents may be used. While RRTs and Area Committees should 
consider ``likely sources and types of oil'' in developing 
preauthorization plans, the Agency believes they should also have the 
flexibility to consider other potential sources and types of oil, as 
appropriate, and the final revisions do not preclude RRTs and Area 
Committees from considering them. In considering the use of the term 
``potential'' as offered by the commenter, EPA decided to clarify the 
phrase ``various discharge scenarios'' as used in the proposed rule. 
EPA recognizes that when developing a preauthorization plan, Area 
Committees and RRTs should not misinterpret ``various discharge 
scenarios'' to only mean past incidences but should also consider 
potential discharges scenarios. While RRTs and Area Committees should 
consider past discharge scenarios, the Agency believes they should also 
have the flexibility to consider potential discharge scenarios. In this 
respect, EPA agrees with the commenter that the term ``potential'' is 
more appropriate and is amending the phrase in the regulatory text to 
include ``potential''. EPA believes the revised phrase ``various 
potential discharge scenarios'' more accurately reflects EPA's intent.
    Some commenters expressed concern or requested clarification on the 
roles and authorities of RRTs and Area Committees in preauthorization 
planning. EPA agrees that in the development of preauthorization plans, 
RRTs should either provide Area Committees with an opportunity to 
provide input or should consider relevant information in ACPs (e.g., 
Fish and Wildlife and Sensitive Environments Annex). The RRTs and Area 
Committees should identify all potentially affected biological 
resources and their habitats likely to be negatively impacted, and not 
only those that are expected to benefit. EPA amended the final 
provision to ensure that Area Committees are involved in 
preauthorization plan development. EPA notes that the broader area 
contingency planning provisions are established under Sec.  300.210(c) 
and are outside the scope of this action.
    Preauthorization Plan Approval. At Sec.  300.910(a)(2), EPA is 
finalizing requirements related to the roles and responsibilities 
involved in reviewing and approving preauthorization plans, and 
procedures if preauthorization plan approval is withdrawn. The final 
action retains the concurrence requirement for preauthorization plans 
from the former version of the rule; given that preauthorization plans 
are developed during the contingency planning phase, DOC and DOI 
natural resource trustee concurrence is preferred over just 
consultation because it provides for sufficient time to identify and 
resolve natural resource concerns.
    Commenters suggested that the preauthorization planning process be 
completed under mandatory timelines, including a suggestion that plans 
must be reviewed within a 90-day time frame, or that the Agency 
otherwise stipulate that the plan cannot be blocked from being used by 
an Area or Region. EPA does not believe that it is appropriate to 
establish specific deadlines for the review and approval of 
preauthorization plans because both the Area Committees and RRTs 
coordinate their approach to reviewing and revising existing 
preauthorization plans and determine what information they may need to 
amend their preauthorization plan, as appropriate. EPA believes RRTs 
and ACs should begin their reviews as expeditiously as possible where 
preauthorization plans exist, but they also must be afforded 
flexibility in implementing the final revisions to ensure 
preauthorization plans are up-to-date when implemented in the event of 
a discharge.
    To be consistent with terminology for preauthorization plan 
approvals, EPA is revising the provision in the final action to 
substitute the phrase ``withdrawal of approval from a preauthorization 
plan . . .'' for ``withdrawal of concurrence . . .'' The amended rule 
offers specific procedures to follow should an authorizing agency 
decide to withdraw their approval from a preauthorization plan: the 
Area Committees and RRTs must address the withdrawal of approval from 
the preauthorization plan within 30 days of the withdrawal, allowing an 
opportunity to address the concerns. Additionally, the RRT must notify 
the National Response Team (NRT) of the final status of the 
preauthorization plan within 30 days from withdrawal. The absence of an 
approved preauthorization plan means authorizations for agent use are 
to be conducted in accordance with paragraph Sec.  300.910(b) or in 
limited circumstances under Sec.  300.910(d). Therefore, the Agency 
believes that the phrase ``the preauthorization plan becomes invalid 
and the authorization of use for chemical or biological agents must be 
performed according to paragraph (b)'' is unnecessary and redundant and 
is striking it from the final provision. The Agency continues to 
believe that preauthorization plans serve as a valuable advanced 
planning tool that supports decision making, and strongly encourages 
the resolution of any withdrawal of approval in a manner that addresses 
concerns raised.
    Commenters expressed concerns over the potential impact of allowing 
for withdrawal of preauthorization plan approval. EPA disagrees that 
the ability to withdraw may incentivize the development of 
preauthorization plans with no intent of maintaining concurrence during 
a response. EPA also disagrees that the withdrawal of approval from a 
preauthorization plan subverts the OSC's authority to use dispersants 
and that this provision should be removed. RRT member agencies who have 
responsibilities in approving preauthorization plans have always had 
the discretion to withdraw their approval at any time. An OSC may still 
authorize the use of dispersants and other agents outside of an 
approved preauthorization plan in accordance with Sec.  300.910(b) or 
in limited circumstances under Sec.  300.910(d). Case-by-case 
authorization of use under Sec.  300.910(b) is an appropriate and 
timely process to authorize the use of dispersants and other agents and 
should not delay response operations such as

[[Page 38291]]

the deployment of mechanical recovery. In contrast, restricting the 
flexibility to withdraw approval from a preauthorization plan could 
serve as a disincentive to approve a preauthorization plan or result in 
limiting the plan's scope and lead to more frequent requests for 
authorization by OSCs under Sec.  300.910(b). EPA disagrees that the 
preauthorization plan should stay in effect for 30 days after 
withdrawal of approval while allowing RRTs and Area Committees to 
address the withdrawal. A withdrawal likely signals concerns amongst at 
least one of the approving bodies with actions or activities that had 
been preauthorized. The final provisions provide a 30-day timeframe for 
the RRT to notify the NRT of the status of the preauthorization plan 
after any such withdrawal. EPA believes that RRTs and Area Committees 
are likely to be aware of concerns prior to withdrawal of approval from 
a preauthorization plan, can work to resolve any perceived differences 
prior to any withdrawal, and are not prohibited from entering into new 
preauthorization plans addressing the same or similar areas in the 
future. For an active incident where chemical and biological agents 
have been authorized for use under a preauthorization plan, EPA 
encourages RRT member agencies with approval roles to work with the RRT 
to promptly resolve concerns and avoid potential withdrawal of plan 
approval during a response.
    Several commenters suggested a need for public input and 
notification during the preauthorization plan approval process, 
including a requirement for public notification following the 
withdrawal of concurrence. Another commenter recommended a formal 
public review and comment period on each preauthorization decision, 
recommending that the RRTs and Area Committees should be required to 
provide a written peer-reviewed scientific and technical study to 
support any preauthorization plan, and provide a 60-day public review 
and comment period. EPA disagrees that the RRTs and Area Committees 
should be required to provide a written peer-reviewed scientific and 
technical study to support any preauthorization plan, or that they 
should provide a 60-day public review and comment period or formal 
public review and comment period on each preauthorization decision. The 
Agency believes that the RRTs and Area Committees should have the 
flexibility to tailor preauthorization plans to their regional needs. 
While EPA recognizes the benefits of public feedback on 
preauthorization plans including independent scientific input, the 
Agency does not believe it should be a mandatory requirement. 
Subjecting preauthorization plans to an external peer-review process 
may limit RRTs' and Area Committees' ability to utilize 
preauthorization plans. Nonetheless, public and private stakeholders 
may provide input, such as relevant scientific data and information, in 
area and regional contingency planning activities that are open to 
public participation, and RRTs and Area Committees retain flexibility 
to seek public comment or input on any preauthorization plan in 
accordance with applicable statutes and regulations if they believe 
such participation is warranted. EPA notes that the amendments to 
Subpart J include a public notification provision under Sec.  
300.910(i) Reporting of Agent Use to notify the public on chemical and 
biological agents used during a response and to provide certain 
required information.
    In the finalized provision, EPA also made some editorial changes to 
the proposed text for increased clarity in addition to the specific 
changes described above.
    Preauthorization Plan Reviews. At Sec.  300.910(a)(3), EPA is 
finalizing new requirements related to the review and revision, if 
needed, of preauthorization plans. The review requirement is intended 
to ensure that preauthorization plans are actively maintained and 
updated to reflect revisions to the NCP Product Schedule. A periodic 
review, following a regular timeframe, is expected to ensure that the 
preauthorization plan is consistent with any revisions to the NCP 
Product Schedule, and also with revisions to ACPs, facility, and vessel 
response plans. The provision specifically requires reviews to be 
conducted at a minimum, after a major discharge (a ``major discharge'' 
means a discharge of more than 10,000 gallons of oil to the inland 
waters or more than 100,000 gallons of oil to the coastal waters) \3\ 
or after a Spill of National Significance (SONS) relevant to the 
preauthorization plan area; to address revisions of the NCP Product 
Schedule impacting chemical or biological agents that may be 
individually listed within a preauthorization plan; and to reflect new 
listings of threatened and/or endangered species applicable to the 
preauthorization plan area. Review is to be done by the EPA RRT 
representative, the DOC and DOI natural resource trustees, and the RRT 
representative from the state(s) with jurisdiction over the waters of 
the area to which a preauthorization plan applies.
---------------------------------------------------------------------------

    \3\ See 40 CFR 300.5 ``Size classes''.
---------------------------------------------------------------------------

    Several commenters recommended that additional entities should be 
able to participate in the review or comment process during the 
preauthorization plan review cycle (e.g., local and tribal governments, 
the Occupational Safety and Health Administration (OSHA), Department of 
Health and Human Services (DHHS), and the public). EPA reiterates that 
all members of the ACs and RRTs will be afforded an opportunity to 
provide input during a review of a preauthorization plan. However, only 
the RRT representatives from EPA, the state(s) with jurisdiction over 
the waters of the area to which the plan applies, and the DOC and DOI 
natural resource trustees will have the authority to approve, 
disapprove, or approve with modification any revisions to an existing 
preauthorization plan. This approval process is consistent with the 
authorization procedures contained in the former Sec.  300.910(a) and 
should minimize the time necessary for RRT approval of any amendments 
to an existing preauthorization plan. EPA amended the final provision 
by adding the phrase ``The RRT in consultation with the Area 
Committee(s) . . .'' to provide that review of preauthorization plans 
are coordinated with the applicable ACs so that ACs may amend relevant 
ACPs, as appropriate.
    The proposal would have required plans to be reviewed at least 
every five years. Commenters provided a range of feedback on this 
proposed timeframe. EPA recognizes that some commenters supported a 
five-year review cycle, while others suggested shorter, longer, or no 
timeframes. As stated in the preamble to the proposed rule, a five-year 
review cycle is consistent with facility response planning 
requirements. EPA believes the five-year review process has worked well 
for facility response planning and believes preauthorization plans 
should be reviewed and revised in a similar fashion. While EPA still 
believes that a five-year review cycle is a reasonable time frame, the 
Agency also agrees with commenters that an alternative timeframe may be 
appropriate based on regional circumstances. Based on comments, EPA is 
amending the timeframe for preauthorization plan from five years to a 
regular timeframe established by the RRT and documented in the plan. 
Under the revised provision, the Area Committees and RRTs must still 
periodically review, and revise as needed, preauthorization plans. 
However, the Area Committees and RRTs are to establish the timeframe 
and document that timeframe in the

[[Page 38292]]

plan. The Area Committees and RRTs should also provide to the public 
the rationale for establishing said timeframe. EPA believes the revised 
provision is consistent with recommendations in the National Commission 
on the BP Deepwater Horizon Oil Spill and Offshore Drilling report and 
EPA Inspector General report: Revisions Needed to National Contingency 
Plan Based on Deepwater Horizon Oil Spill (Report No. 11-P-0534) for 
periodic reviews of contingency plans. The Agency recognizes that 
development of preauthorization plans can be resource intensive; 
however, once developed, a periodic review, and revision as needed, 
should require much less effort. EPA disagrees that it is overly 
burdensome for RRTs to periodically review, especially with the revised 
provision to provide additional flexibility to the RRTs to establish 
and document their own review schedule.
    EPA also made other changes to the proposed text based on comments 
received. Several commenters suggested additional triggering events for 
preauthorization plan review. The Agency agrees that changes other than 
the trigger events specifically listed in the revised rule may impact 
the conditions under which the use of chemical and biological agents is 
preauthorized. EPA amended the final provision to clarify that the 
triggering events are minimum criteria by including the phrase 
``Reviews must also be conducted in any affected region, at a minimum . 
. .''. Some other commenters stated that reviews should be required 
only after major NCP Product Schedule listing changes to agents that 
may be used in the preauthorization plan area, as opposed to smaller 
less significant administrative changes in the NCP Product Schedule. 
The final provisions provide for preauthorization plans to be reviewed 
to address revisions to the NCP Product Schedule ``impacting chemical 
or biological agents that may be individually listed within a 
preauthorization plan.'' The revision is intended to avoid confusion 
with other, non-substantive changes to the NCP Product Schedule. EPA 
also amended the final provision to add the phrase ``. . . relevant to 
the preauthorization plan area; . . .'' to clarify the provision 
applies to the relevant RRT. The amendment also avoids 
misinterpretation that an RRT not impacted by a major discharge or by a 
Spill of National Significance (SONS) would be required to review their 
preauthorization plan as a result of events outside their region. 
Similarly, EPA amended the final provision by adding the phrase ``. . . 
applicable to the preauthorization plan area'' to clarify the 
applicability of the provision to the relevant RRT and to avoid 
confusion that new listings of threatened and/or endangered species in 
one or more regions requires all RRTs to review their preauthorization 
plans.
(b) Use of Agents Identified on the NCP Product Schedule or Use of 
Burning Agents on Oil Discharges Not Addressed by a Preauthorization 
Plan
    The Agency is revising Sec.  300.910(b) to address the use of 
chemical or biological agents identified on the NCP Product Schedule or 
the use of burning agents in spill situations that have not been 
addressed in preauthorization plans. The revisions clarify the 
authorities and responsibilities of relevant parties and the factors to 
consider when authorizing the use of agents in these situations. The 
revisions also clarify that the provision applies to burning agents as 
well as products that are listed on the NCP Product Schedule. The 
revisions to Subpart J do not change, from the former rule provisions, 
the Agency's fundamental policies regarding the roles of Federal, 
state, Tribal, and local representatives involved in an oil discharge 
response. The revisions maintain from the former rule the OSC's 
authority to authorize the use of chemical or biological agents on the 
oil discharge; the concurrence of the EPA representative to the RRT 
and, as appropriate, the concurrence of the RRT representatives from 
jurisdictional states; and the requirement for consultation with the 
DOC and DOI natural resource trustees.
    As with paragraph (a), the final provisions under paragraph (b) 
specify the parameters that must be considered by the OSC for 
authorizing agent use on a case-by-case basis. Similar to 
preauthorization plans, the scope of the case-by-case authorization may 
include other criteria. EPA is amending the final provisions, relative 
to the proposal, to reflect that the parameters for the use of agents, 
including the quantities requested to be authorized, the duration of 
use, the depth of water, the distance to shoreline and proximity to 
populated areas, are the minimum criteria OSCs must specify by 
inserting the phrase ``for their authorization request to the RRT, at a 
minimum'' in the final regulatory text. The Agency is also replacing 
the phrase ``. . . to be used . . .'' with ``. . . requested to be 
authorized . . .'' to avoid confusion that the OSC must use the 
entirety of the requested quantities, rather than not exceeding the 
quantities authorized by the RRT. The Agency also specifies that OSCs 
should address factors such as environmentally sensitive resources or 
restricted areas that might be impacted, agent inventory and storage 
locations, agent manufacturing capability, availability of equipment 
needed for agent use, availability of adequately trained operators and 
appropriate means to monitor agent use in the environment.
    Some commenters, for various reasons, opposed the use of any agents 
if the agents were not approved in a preauthorization process, even if 
they are listed on the NCP Product Schedule. EPA disagrees with 
commenters that agents should not be authorized for use if they are not 
covered under an approved preauthorization plan. EPA also disagrees 
that case-by-case authorization under Sec.  300.910(b) provides a 
lesser standard for authorization. EPA notes the time critical nature 
of oil discharge responses and that the circumstances surrounding every 
potential discharge situation are not foreseeable or lend themselves to 
pre-planning. Not having a preauthorization plan approved by relevant 
RRT Agencies does not preclude the RRT or OSC from considering chemical 
or biological agent use for response during planning discussions. 
However, neither an approved preauthorization plan under Sec.  
300.910(a) nor case-by-case authorization under Sec.  300.910(b) 
provide for a specific authorization outcome. Authorization of use 
determinations regarding chemical or biological agents are made for 
each individual discharge with consideration of the incident specific 
conditions and must be consistent with CWA section 311(d)(2)(G) and the 
Subpart J regulations. EPA believes there are multiple opportunities 
through regional and area contingency planning and from provisions 
included in the final action that RRTs may use to support case-by-case 
decision making. Contingency planning processes (e.g., RCPs, ACPs, and 
vessel and facility response plans) may inform whether the use of 
chemical or biological agents is appropriate, including during case-by-
case authorization under Sec.  300.910(b). Separate from the regional 
and area contingency planning requirements described in the NCP, EPA 
acknowledges the benefits from advanced planning to support expedited 
decision making. The Agency recognizes that incident-specific 
authorization (i.e., case-by-case authorization) for discharge 
situations

[[Page 38293]]

not covered by preauthorization plans may benefit from planning in 
advance to support expedited decision making. The final action supports 
contingency planning efforts by establishing provisions for RRTs to 
gather supplementary toxicity and efficacy testing, monitoring, or to 
obtain available data or information relative to the use of a chemical 
or biological agent (see Sec.  300.910(g)). RRTs may need additional 
testing or information for situations that fall under Sec.  300.910(b).
    Some commenters advocated for EPA to require concurrence from 
natural resource trustees rather than consultation under Sec.  
300.910(b). Section 1011 of the Oil Pollution Act (OPA) states that 
``The President shall consult with the affected trustees designated 
under section 1006 on the appropriate removal action to be taken in 
connection with any discharge of oil.'' Executive Order 12777 delegates 
this responsibility to the OSC. EPA believes the consultation 
requirement under Sec.  300.910(b) is consistent with statutory 
requirements under OPA and maintains the approach of consultations with 
DOI and DOC natural resource trustees in the final provisions. It is 
important to note that consultation with the trustees does not mean 
that the OSC must obtain the concurrence of the trustees. EPA 
recognizes the decision to use a chemical or biological agent is highly 
dependent upon specific circumstances, locations, and conditions which 
must be assessed by the OSC and relevant RRT member agencies. The EPA 
and the state RRT representative(s), and DOC and DOI natural resource 
trustees, are in a unique position to understand local conditions and 
to collect and coordinate quickly the necessary local information.
    Several commenters addressed the proposed removal of the term 
``when practicable'' from the former rule text regarding consultation 
with the DOC and DOI. Some supported the removal of this language, 
stating that consultation and concurrence should always be pursued 
during case-by-case response decision making, since the situations may 
present unique challenges. Other commenters opposed the removal of the 
term ``when practicable'' and recommended leaving the language as is, 
asserting that it has worked well for years and that continued 
flexibility in the approval process is warranted. Commenters suggested 
that delays in discharge mitigation may occur when waiting for 
consultations, and that EPA should establish a consultation time limit. 
The Agency believes that the case-by-case decision making should 
include consultations with natural resource trustees since these 
discharge situations may present unique challenges when selecting a 
response option that involves chemical or biological agents. EPA also 
notes that OPA 1011 (33 U.S.C. 2711) provides for consultations with 
the affected trustees on the appropriate removal action to be taken in 
connection with an oil discharge. Furthermore, Sec.  300.305(e) 
provides that the OSC shall consult with the affected trustees on the 
appropriate removal action to be taken. EPA disagrees with concerns 
that seeking natural resource trustee input could result in delays in 
the use of a chemical or biological agent. While EPA supports timely 
decision making, it does not interpret timely decision making to 
necessarily mean concurring with an OSC request to authorize the use of 
a chemical or biological agent; consultation can allow for a more 
immediate exchange of information and ideas when addressing a time-
critical response. EPA disagrees with establishing a consultation 
timeframe (e.g., 36 or 48 hours) for natural resource trustees and 
notes that it is contrary to the intent of seeking input on a removal 
action (e.g., chemical agent use) prior to its use. While the Agency 
recognizes the time-critical nature of decision making during a 
response, advances in communication technology (e.g., smart phones, 
email) provide OSCs with increased capabilities to communicate quickly. 
The Agency believes it is reasonable to expect an OSC to be able to 
notify and explain the circumstances requiring use of the certain 
agents to natural resource trustees in a timely manner. The final 
revisions to Sec.  300.910(b) include removing the phrase ``when 
practicable'' with respect to consultation with the DOC and DOI natural 
resource trustees. EPA believes that the final revisions to Subpart J 
better align with the statutory and regulatory provisions.
    A commenter supported the provision to authorize only products that 
are appropriate and used for their intended purpose under Sec.  
300.910(b). To provide additional editorial clarity, the revised 
provision replaces ``. . . chemical or biological agents identified on 
the Schedule for their intended purpose . . .'' with ``. . . for the 
specific purpose for which they were listed . . .''
    A commenter expressed opposition to the requirement in Sec.  
300.910(b) to document the parameters for use of agents when there is 
not a preauthorization plan, emphasizing the need for quick decision 
making, noting that the information is already required elsewhere (33 
CFR parts 154 and 155) or unnecessary at the time when action is 
required. Another commenter recommended revisions to the rule text 
which would increase the specificity of these parameters. While EPA 
supports timely decision making, EPA does not interpret timely decision 
making to be inhibited by documentation requirements that both inform 
RRT Agencies with roles and responsibilities under the NRT for chemical 
and biological agent use and support the OSC's decision making. 
Furthermore, EPA recognizes the request that Sec.  300.910(b) increase 
the specificity of the parameters for the use of products. EPA agrees 
that site-specific factors are an important consideration when 
authorizing the use of a chemical or biological agent. For example, 
environmental characteristics such as local ocean water circulation 
patterns may affect oil transport and therefore influence whether 
dispersants are authorized for use, and if so, to what extent. Even 
within a chemical agent category (e.g., dispersants), environmental 
conditions may vary locally, if not seasonally. EPA agrees that such 
information, if available, should be documented during case-by-case 
authorization of use. However, there may be several site-specific 
factors to consider where such information may be unavailable; the fact 
that information is unavailable, including assumptions used in lieu of 
unavailable information, should also be documented. EPA believes the 
relevant Agencies should be afforded flexibility in considering 
relevant factors when authorizing chemical and biological agents and to 
tailor the scope of the authorization with consideration of site-
specific conditions. EPA does not believe that it is appropriate or 
feasible to include all potential site-specific information within the 
regulation. Rather, relevant site-specific factors to consider during 
case-by-case authorization are more appropriately addressed through 
development of guidance materials as appropriate, as well as through 
informed decision making.
    A commenter requested that EPA provide notification within 24 hours 
of spills and product use to health care providers and the public, in 
the language(s) spoken in the impacted region. The final action 
includes new provision under Sec.  300.910(i)(2) that requires the OSC 
to provide notification to the public in support of Sec. Sec.  
300.135(n) and 300.155(a) and (b). Under Sec. Sec.  300.135(n) and 
300.155(a) of the NCP, the OSC should ensure all appropriate public and 
private interests are kept informed and that their

[[Page 38294]]

concerns are considered throughout a response, to the extent 
practicable. However, EPA did not include a specific requirement to 
provide the notification in the language(s) spoken in the impacted 
region. The reporting provision does not preclude including public 
notification in different languages and EPA encourages consideration of 
impacted communities when communicating response actions, including 
developing materials in languages understood by local communities. 
However, it is impractical to require an OSC to provide notification in 
all language(s) spoken in the impacted region during an emergency 
response where chemical or biological agents may be authorized as the 
Agency cannot predict where and when an oil discharge occurs. The OSC 
retains discretion to provide public notification in additional 
languages if the OSC determines it to be appropriate.
    A commenter stated that changing the language in this section, from 
``navigable waters threatened'' to ``waters and adjoining shorelines 
threatened'' creates additional barriers to use dispersants and limits 
OSC actions. Another commenter stated that the proposed updates 
conflict with E.O. 12777 and the CWA because they do not distinguish 
between coastal and inland zones for planning and operational decision 
making reserved for the area where the OSC is directing the response. 
EPA believes that the amended provision provides consistency with the 
provisions in Sec.  300.910(a); the Agency is not limiting the 
jurisdictional scope of the NCP as provided under section 311(b)(3) of 
the CWA.
    In the final rule provision, EPA also made some editorial changes 
to the proposed text for increased clarity in addition to the changes 
described above.
(c) Burning Agents
    EPA proposed to replace the current authorization of use for 
burning agents in Sec.  300.910(c) to provide greater flexibility to 
OSCs for authorizing the use of burning agents. Specifically, the 
Agency proposed that OSCs may authorize the use of burning agents for 
authorized in-situ burns. EPA received comments that supported the 
proposed amendments, that requested clarification of the proposed 
changes, and that raised concerns regarding the consultation and 
concurrence role of the RRT. Based on public comments received, EPA is 
not revising Sec.  300.910(c) as proposed, but is instead reserving 
Sec.  300.910(c) and is amending the regulatory text in Sec.  
300.910(a) and (b) to specifically clarify that Sec.  300.910(a) and 
(b) apply to the authorization of use of burning agents. For 
preauthorization requirements under the Sec.  300.910(a), the final 
provisions maintain the previous approach to address burning agents. 
Under Sec.  300.910(b), the final revisions incorporate burning agents 
in the case-by-case authorization, along with chemical and biological 
agents listed on the NCP Product Schedule. This approach eliminates the 
need to have a separate regulatory requirement for burning agents for 
case-by-case authorizations. To maintain consistency with the 
regulation's previous structural organization familiar within the 
response community, EPA is reserving Sec.  300.910(c).
    Several commenters expressed general concern about or opposition to 
the use of burning agents and the use of in-situ burning as a spill 
response method. Additionally, several commenters expressed concern 
regarding various environmental impacts, particularly the impacts to 
aquatic and benthic environments and to air quality, from the use of 
burning agents and in-situ burns. While burning agents are used in de 
minimis quantities relative to the discharged oil they would be applied 
to, and when considering the response as a whole, EPA recognizes that 
the use of burning agents and in-situ burning may have environmental 
impacts. However, Subpart J does not state or imply that chemical or 
biological agents are preferred over other response options. Neither 
the current nor final rule mandates the use of chemical or biological 
agents, nor removes them from consideration as a response option. 
Rather, the Subpart J regulations provide a framework for authorizing 
their use, as appropriate. EPA believes that the circumstances 
surrounding oil discharges may vary and therefore there are many 
factors influencing the choice of response methods. During a response, 
in-situ burning may be considered along with other response options. 
Burning agents may be used as part of the in-situ burning process. 
Depending on incident-specific conditions, timely deployment of several 
response options may occur while tradeoffs are evaluated to determine 
which response option (or combination thereof) addresses response 
objectives. In-situ burning may reduce the need for collection, 
storage, transport, and disposal of recovered material by converting a 
fraction of the oil to gaseous combustion products. However, the Agency 
also recognizes that combustion products may include smoke or soot in 
addition to carbon dioxide and water. Monitoring of in-situ burns 
through information collection can inform decision making during a 
response. EPA recognizes comments regarding air quality concerns, 
including generation of particulates and toxic gases (specifically VOCs 
and PAHs) and potential impacts on communities. Beyond Subpart J, the 
NCP includes provisions for OSCs to address health and safety concerns 
of workers under Sec.  300.150. The NCP recognizes that the OSC may 
call upon DHHS to assist in determining public health threats 
throughout any response action (see Sec.  300.135(h)). In addition, the 
OSC may monitor air quality to identify potential public health 
concerns from air residues from in-situ burning. EPA also recognizes 
that in-situ burning of crude petroleum oil may result in residues that 
are not only emitted to the air, but are also entrained in the water 
column. In-situ burning that is initiated using burning agents may lead 
to the possibility for organisms dwelling in the water column to come 
in physical contact with residues from the combusted oil. While the 
burning agent itself is expected to be consumed through combustion, the 
Agency believes that the harmful impact to an organism caused by 
physical contact (e.g., ingestion by fish) with the residue from 
combusted oil from an in-situ burn initiated by a burning agent is just 
as concerning as the effects of any residual burning agent. Subpart J 
does not mandate the use of burning agents. Rather, it provides a 
framework to consider their authorization by RRTs and OSCs. EPA 
recognizes the commenters' concerns regarding potential environmental 
impacts from in-situ burning initiated by burning agents. The final 
provisions under Sec.  300.910(a) and (b) maintain the current approach 
that keeps RRTs, including state(s) and natural resource trustees, 
actively involved in the authorization of burning agents for in-situ 
burns. EPA believes that the fact that an in-situ burn initiated by a 
burning agent may cause oil to enter the water column is sufficient 
reason for RRTs or OSCs to consider whether supplemental monitoring of 
in-situ burn residue is appropriate. In-situ burning operations are 
subject to OSC oversight, with OSC authorization required for burning 
agent use.
    Some commenters supported not listing burning agents on the NCP 
Product Schedule, and several other commenters disagreed, stating that 
burning agents, like other spill response agents, should be listed on 
the schedule and be regulated with the same efficacy, toxicity, and 
public ingredient

[[Page 38295]]

disclosure standards as other listed agents. EPA recognizes comments 
supporting and opposing the listing of burning agent products on the 
NCP Product Schedule. EPA recognizes burning agents as a type of 
chemical agent that must be authorized for use in accordance with the 
provision under Sec.  300.910. EPA disagrees with the comment that the 
increasing frequency of burning agent use contradicts the argument that 
the small quantities make listing considerations unnecessary. The 
Agency believes that burning agents are used in de minimis quantities 
relative to the discharged oil they would be applied to, and when 
considering the response as a whole, and are expected to rapidly burn 
off during use, which serves to remove them from the water. Burning 
agents are generally added to an oil slick to initiate an in-situ burn 
after which the oil slick itself is expected to maintain the burn. 
Although EPA is maintaining the current approach of not specifically 
listing burning agent products on the NCP Product Schedule, RRTs may 
still gather additional information on burning agents and monitor their 
use under Sec.  300.910(g) Supplemental Testing, Monitoring, and 
Information. EPA agrees with comments that an in-situ burn may raise 
concerns regarding environmental impacts and believes that maintaining 
the current approach keeps RRTs appropriately and actively involved in 
the decision making to authorize the use of burning agents used in in-
situ burning. Furthermore, provisions within the NCP but outside the 
scope of this rulemaking include requirements for OSCs to address 
health and safety concerns of workers and the public. For example, 
Sec.  300.150 provides requirements to address worker health and 
safety.
(d) Temporary Exception
    EPA is revising Sec.  300.910(d) to clarify the intent of the 
existing exception to the preauthorization and case-by-case 
authorization of use regulations. The Agency is including the term 
``temporary'' as a qualifier to the final provision's title, to reflect 
that there is a time limitation for operating under this provision 
during a response. The temporary exception provision provides that the 
OSC may authorize the use of any chemical or biological agent, whether 
it is identified or not on the NCP Product Schedule, without obtaining 
the concurrence of the EPA RRT representative and, as appropriate, the 
RRT representatives from the state(s) with jurisdiction over the waters 
and adjoining shorelines threatened by the release or discharge, and 
without consultation with the Department of Commerce and the Department 
of the Interior natural resource trustees. That is, it allows OSCs to 
authorize the use of any agent when it is determined that the use of 
the agent is necessary to prevent or substantially reduce an imminent 
threat to human life that cannot be immediately addressed by other 
procedures or provisions of the NCP. The Agency believes that the 
protection of human life is the primary consideration in responding to 
an oil discharge. Accordingly, the OSC must have the ability to use any 
agents that would effectively and expeditiously mitigate the threat to 
human life, particularly in situations where chemical agents on the NCP 
Product Schedule are not immediately available. The final provision 
includes the phrase ``and without consultation with the Department of 
Commerce and the Department of the Interior natural resource trustees'' 
to further clarify the OSC authority under this provision relative to 
concurrences and consultations otherwise required for the authorization 
of chemical and biological agent use under Sec.  300.910(a) or (b). 
However, this exception cannot be used as a substitute for compliance 
with Sec.  300.150, including the use of personal protective equipment, 
or when there is sufficient time to seek authorization in accordance 
with Sec.  300.910(a) or (b). EPA notes that the temporary exception 
does not affect other authorities available to an OSC under the NCP, 
separate from Subpart J, to take actions to address a threat to human 
life, such as ordering evacuations or repositioning equipment and 
personnel.
    The exception provides for authorization of agent use to occur, 
within a limited timeframe and for the specific purpose of preventing 
or substantially reducing an imminent threat to human life, if there is 
insufficient time to obtain the required concurrences for 
preauthorization or authorization of use for products on the NCP 
Product Schedule under paragraphs (a) and (b) respectively. To more 
clearly describe when the exception must not be used, EPA amended the 
final provision to add the phrase ``. . . or when there is sufficient 
time to seek authorization in accordance with paragraphs (a) or (b) of 
this section.'' The provision is not intended for the OSC to override 
an authorization decision of an RRT on chemical and biological agent 
use for the specific incident conditions. The revision in the final 
action is consistent with the intent of the provision as described in 
previous NCP final rulemakings (see 55 FR 8808, March 8, 1990).
    The Agency recognizes oil discharges generally will not pose 
threats to human life of an immediacy or magnitude that would warrant 
invoking the temporary exception provision. However, EPA believes that 
there may be unforeseen circumstances where an oil discharge poses an 
immediate life-threatening situation, and for which an OSC must have 
the ability to use agents that could effectively and expeditiously 
mitigate the imminent threat to human life. The Agency interprets a 
situation that poses an imminent threat to human life to be one which 
could reasonably be expected to cause death or serious physical harm 
such that a part of the body would be severely damaged. Further, the 
Agency also interprets that this imminent threat to human life must be 
immediate for this exception provision to be applicable, meaning that 
it is expected that death or serious physical harm could occur 
immediately or before any other action can be otherwise implemented. 
The former language in Sec.  300.910(d) used the terms ``hazard'' and 
``threat'' interchangeably. The amended regulatory language replaces 
``hazard'' with ``threat'' for consistency and to establish the intent 
and expectation of the use of the exception more clearly.
    Several commenters recommended that the Agency remove the exception 
provision. These commenters claimed that it is unclear what 
circumstances would occur requiring the OSC to decide to apply 
dispersants to protect human health; the exceptions are not necessary; 
and that the rarity of use of this exemption is evidence that most oil 
discharges do not pose threats to human life of an immediacy and 
magnitude that warrant the exception provision. Some commenters 
suggested that without more direction, strict guidelines, or guidance 
from the Agency regarding when this provision could be invoked, the 
proposed rule allows for potential overreach in the use of the 
exception authority. The Agency recognizes the comments opposing the 
exception provision and the selection of spill response agents to focus 
on human health risks. Nonetheless, the Agency reiterates that 
protection of human life is the primary consideration in responding to 
an oil discharge. EPA notes that the other authorities available to an 
OSC under the NCP to take actions to address a threat to human life, 
such as ordering evacuations or repositioning equipment and personnel, 
are not affected by the revisions to the temporary exception provision 
in this final action. The Agency is maintaining

[[Page 38296]]

the exception provision and is finalizing the proposed amendments with 
modifications to further clarify the provision's intent and address the 
concerns regarding potential overreach. The finalized exception 
provision provides the OSC this authority only in circumstances to 
prevent or substantially reduce an unforeseeable threat to human life 
that cannot be immediately addressed by other procedures or provisions 
of the NCP. Additionally, the Agency added the term ``individual 
circumstances'' to provide the OSC flexibility to address one or more 
separate unforeseen threats to human life at any time during a 
response. The intent behind this temporary exception provision is to 
eliminate potential delays in responding to life-threatening 
situations. The modifications finalized in this action do not change 
previous policy but rather clarify the intent and scope of the 
exception. While the Agency expects this temporary exception to be 
rarely needed, it continues to believe it is appropriate that the NCP 
include a temporary exception provision to capture unforeseen and 
immediate life-threatening situations. However, it is important to note 
that, while all threats to human life are health and safety issues, not 
all health and safety issues in turn pose an immediate threat to human 
life. The Agency stresses the intent is for this temporary exception to 
be applicable only to those imminent life-threatening situations which 
cannot be addressed through the implementation of other procedures or 
provisions in the NCP and has amended the final provision accordingly. 
The final provision also clarifies that the exception must not be used 
as a substitute for compliance with Sec.  300.150 of this part, 
including the use of personal protective equipment.
    Some commenters suggested that the OSC should only be allowed to 
use products that are listed on the NCP Product Schedule under the 
exception; a commenter stated that use of products not on the NCP 
Product Schedule negates the purpose of contingency planning, and that 
the OSC should only be able to authorize the use of agents listed on 
the NCP Product Schedule when the agent is necessary to protect human 
life. Some commenters expressed concerns regarding use of agents 
without peer-reviewed scientific or technical evidence to show that the 
dispersant chemical is safe for humans, wildlife, or the ecosystem. A 
commenter noted that if the work required to add a product to the NCP 
Product Schedule was not complete prior to a spill then responders 
should not have the option of bypassing the process by using the 
exception clause. The Agency shares the concern for any use of chemical 
or biological agent products not listed on the NCP Product Schedule. 
The fact that the exception applies broadly to include chemical or 
biological agents not identified on the NCP Product Schedule 
necessitates the temporary nature of the exception. The Agency 
reiterates that the OSC authorities provided under this temporary 
exception are not intended to allow bypassing or circumventing the 
processes established under Subpart J. Specifically, the temporary 
exception is not intended to bypass those provisions for testing and 
listing chemical and biological agent products established under Sec.  
300.915. The provisions for testing and listing chemical and biological 
agent products on the NCP Product Schedule are intended to ensure that 
these products have met baseline efficacy and toxicity requirements, 
promoting the use of safer and more effective spill mitigating 
products. The limited timeframe addresses concerns regarding the extent 
of the temporary exception applicability, and promptly brings back into 
the decision making process the required environmental considerations 
that are built into the authorization of use provisions under Sec.  
300.910(a) and (b), including the use of chemical and biological agent 
products only when they are listed in the NCP Product Schedule.
    Several commenters requested a 24-hour (or shorter) timeframe 
instead of 48 hours for OSC product use notification and concurrence. 
These commenters indicated that a 48-hour window for the OSC to operate 
without concurrence seemed excessive, and that members of the RRT and 
natural resource trustees should be engaged in this type of decision 
making as soon as is feasible, as well as OSHA and the DHHS for human 
health impacts. They noted that with advances in communication 
technology, a 24-hour timeframe for OSC notification should be 
attainable. The Agency acknowledges the support for specifying a 
timeframe for the temporary exception to best clarify the intent that 
this provision is to be a temporary and limited measure. Based upon 
comments, the Agency is finalizing the provision's language to modify 
the proposed 48-hour timeframe for which the temporary exception would 
be applicable. The Agency is finalizing a further limited timeframe of 
24 hours, recognizing that those entities with concurrence and 
consultation roles under Subpart J, and who bring relevant 
environmental expertise to these types of decision making, should 
indeed be engaged as soon as possible. Additionally, this change 
acknowledges the advances in communications since the exception 
provision was last revisited under the NCP in 1994. Technologies are 
now available that allow the OSC to notify the EPA RRT representative, 
the state(s), and natural resource trustees of this decision within the 
24-hour timeframe, if not sooner. This 24-hour timeframe further 
addresses concerns regarding the extent of the temporary exception's 
applicability, and promptly brings back into the decision making 
process the required environmental considerations that are built into 
the authorization of use provisions under Sec.  300.910(a) and (b). The 
final amendments also include the phrase ``after initial application'' 
to further clarify when the 24-hour timeframe begins. The timeframe in 
the final rule balances the need to address an unforeseen imminent 
threat to human life during a response with the roles and 
responsibilities of EPA, the state(s), and DOI and DOC natural resource 
trustees regarding chemical or biological agent use under Sec.  
300.910(a) or (b). EPA notes that the temporary exception provision 
does not affect other authorities available to an OSC under the NCP, 
separate from Subpart J, to take actions to address a threat to human 
life, such as ordering evacuations or repositioning equipment and 
personnel.
    Many commenters expressed support for the notification requirements 
in Sec.  300.910(d). A commenter stated that the notifications should 
be made available to the public for awareness of the imminent threat to 
human life and the use of products to address the threat. Some other 
commenters cited concern regarding the notification requirement and 
recommended that there should not be any limits on the OSC's ability to 
make decisions protecting human life. A commenter asserted that the 
requirements are inappropriate, and that the Agency has not adequately 
justified the proposed notification requirements in terms of additional 
benefits compared with the existing requirements. The Agency recognizes 
the concerns regarding the notification requirements within the 
temporary exception. The final regulatory language includes the 
requirement for the OSC to notify as soon as possible, and to document 
the circumstances and the reasons for use of the agent, to the EPA RRT 
representative and, as appropriate, the RRT representatives from the 
affected state(s) and the DOC and DOI natural resource

[[Page 38297]]

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

[[Page 38298]]

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

[[Page 38299]]

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

[[Page 38300]]

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

[[Page 38301]]

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

[[Page 38302]]

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

[[Page 38303]]

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

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

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

[[Page 38304]]

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

[[Page 38305]]

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

[[Page 38306]]

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

[[Page 38307]]

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

[[Page 38308]]

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

[[Page 38309]]

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

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

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

[[Page 38310]]

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

[[Page 38311]]

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

[[Page 38312]]

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

[[Page 38313]]

dispersed oil under the same test conditions. This final action 
provides for consideration of regional conditions under the 
authorization of use provisions under Sec.  300.910. For example, Sec.  
300.910(a)(1) provides for consideration of the existence and location 
of environmentally sensitive resources when developing a 
preauthorization plan. In addition, Sec.  300.910(g) provides for 
supplemental testing and information to address site, area, and 
ecosystem-specific concerns.
    A few commenters expressed concerns about the proposed updates to 
Sec.  300.915(b)(2) regarding developmental toxicity testing, stating 
that the use of the purple urchin assay is arbitrary and capricious 
given that this species' habitat is the shallow nearshore, tidal 
environment, which is unlikely to be exposed to dispersants during a 
response effort. Commenters also expressed concerns related to the lack 
of experience in conducting this type of assay and the potential 
difficulty in interpreting results between multiple laboratories. EPA 
disagrees that the use of the purple urchin assay is arbitrary and 
capricious. EPA notes that, along with the other toxicity test, the sea 
urchin developmental assay and listing threshold requirements screen 
dispersant products for hazard. The sea urchin developmental assay 
established as part of the final rule serve as a sensitive surrogate 
test for echinoderm early life stages. This test organism is intended 
to expand the taxonomic diversity of species used in product hazard 
assessment and is not intended to represent any particular species or 
habitat in affected environments. EPA adapted an existing toxicity 
testing approach to allow inclusion of this species in product hazard 
assessment. To facilitate further flexibility to laboratories 
conducting the developmental assay, the Agency amended the final 
provisions to include the option to use the purple sea urchin A. 
punctulata in lieu of S. purpuratus for the developmental assay. In 
addition, EPA amended the final provision under Sec.  300.915(b)(2) to 
replace the phrase ``. . . using a sea urchin assay . . .'' with the 
phrase ``. . . using Strongylocentrotus purpuratus or Arbacia 
punctulata . . .'' to recognize the additional species flexibility for 
laboratories conducting the developmental assay based on guidance and 
organism availability, and to be consistent with regulatory text for 
the other toxicity tests where the organisms are identified.
    Toxicity Thresholds. In the finalized provisions at Sec.  
300.915(b)(2)(i)-(iii), EPA is providing thresholds to determine 
eligibility for listing on the NCP Product Schedule. Specifically, to 
be listed on the NCP Product Schedule, the dispersant tested alone must 
demonstrate: (i) A median lethal concentration (LC50) at the 
lower 95% confidence interval greater than 10 ppm; (ii) an inhibition 
concentration for 50% of the test species (IC50) at the 
lower 95% confidence interval greater than 1 ppm; and (iii) a 
subchronic No Observed Effect Concentration (NOEC) greater than 1 ppm. 
The finalized regulatory text has been modified from that proposed to 
list these requirements in subsections (i) through (iii), to provide 
greater clarity.
    Commenters expressed concern that the proposed dispersed oil 
toxicity test and its threshold could result in the elimination of many 
dispersants (and potential future dispersants) from the NCP Product 
Schedule. A commenter stated that it might be difficult for any 
effective dispersant, mixed with crude oil, to meet the Agency's 10 ppm 
LC50 concentration requirement. The commenter noted that a 
significant fraction of the toxicity reported from these tests can be 
attributed to the crude oil alone, masking the dispersant toxicity. 
Another commenter explained that, based on a toxicity study, a specific 
product would not pass the proposed toxicity limit, and that given the 
reported LC50 of ANS oil alone, it is unlikely that any of 
the current dispersants on the NCP Product Schedule would meet the 
proposed toxicity limit. The commenter notes that this is consistent 
with the results of a study using Louisiana sweet crude oil in which 
all of the nine investigated dispersants currently included on the NCP 
Product Schedule failed a toxicity threshold requirement of 10 ppm. 
Furthermore, commenters suggested it is not clear whether any 
dispersant will be approved for the NCP Product Schedule when both 
toxicity and effectiveness tests are required, and that the standard 
static acute toxicity testing of dispersant-oil mixtures do not 
represent real world exposures. The Agency recognizes comments 
regarding establishing a listing threshold for the dispersant-oil 
mixture toxicity test for the purposes of being listed on the NCP 
Product Schedule. The final provisions establish that the listing 
threshold for acute toxicity testing applies to the results from the 
dispersant-only toxicity test and not the results from the dispersant-
oil mixture toxicity test. Nonetheless, the results from toxicity 
testing for dispersant alone and dispersant-oil mixture as required 
under Sec.  300.915 are to be made available in the NCP Product 
Schedule Technical Notebook for OSCs, ACs, and RRTs to consider in 
planning for and responding to an oil discharge.
(3) Limitations
    In the finalized provision at Sec.  300.915(b)(3), EPA specifies 
that a dispersant may only be listed on the NCP Product Schedule for 
use in saltwater environments for which it meets the efficacy and 
toxicity listing criteria. Dispersants are typically designed and 
traditionally used for responding to oil discharges in saltwater in the 
United States. In general, the effectiveness of dispersants decreases 
as the salinity of the water decreases. In waters with no salinity, 
many dispersants have shown a very low effectiveness or are sometimes 
completely ineffective.\6\ The Agency is also concerned with using 
dispersants in freshwater environments because of the limited dilution 
typically available as compared with the open sea and because of the 
existence of water intakes in rivers, streams, and lakes for use in 
drinking water supplies. Using dispersants in freshwater has the 
potential for compounding the impacts caused by already discharged 
petroleum products, particularly near potable and non-potable 
subsurface water intakes.
---------------------------------------------------------------------------

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

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

[[Page 38314]]

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

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

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

[[Page 38315]]

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

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

    In addition to testing the surface washing agent alone, some 
commenters suggested that the Agency require toxicity testing with 
surface washing agent-oil mixtures, to determine whether the addition 
of the surface washing agent may enhance or alter toxicity of the oil. 
Commenters asserted that this would better approximate conditions that 
organisms may encounter in the natural environment. EPA believes the 
final rule provisions for acute toxicity testing for surface washing 
agents is adequate given these products are not likely to be used in 
the same quantities or durations as dispersants. EPA notes surface 
washing agents are intended to be recovered from the environment, 
unlike dispersants. In addition, while the Agency requested comment on 
a protocol for preparation of product/oil mixtures for toxicity 
testing, the Agency did not identify comments or sufficient information 
to tailor the exposure solutions for oil-SWA mixtures. Nonetheless, EPA 
believes the final provisions will help the Agency gather additional 
technical information specific to the product category. In addition, 
EPA may request clarification or additional information as necessary 
under Sec.  300.955(c)(1) to inform the Agency's evaluation of a 
product.
    In the finalized provisions, EPA made only editorial changes to the 
proposed text for increased clarity.
(3) Limitations
    At Sec.  300.915(c)(3), the Agency specifies that surface washing 
agents may only be used in those water environments (freshwater and/or 
saltwater) for which the product was tested and for which it met the 
efficacy and toxicity listing threshold criteria. The Agency recognizes 
that products may yield effective results in certain environments and 
not in others. Products that may be effective in freshwater 
environments may not necessarily be so in saltwater environments, and 
vice versa. Product manufacturers maintain flexibility to select which 
environment the product is to be tested and authorized for use within 
these limitations.
    No comments on this provision were identified. EPA made editorial 
changes to the final provisions to provide greater clarity.
(d) Bioremediation Agent Testing and Listing Requirements
    The Agency is establishing toxicity testing protocols, revising the 
efficacy testing protocols, and establishing both efficacy and toxicity 
listing thresholds for bioremediation agents in Sec.  300.915(d). As 
now defined in Sec.  300.5, bioremediation agents are biological agents 
and/or nutrient additives deliberately introduced into a contaminated 
environment to increase the rate of biodegradation and mitigate any 
deleterious effects caused by the contaminant constituents. 
Bioremediation agents include microorganisms, enzymes, and nutrient 
additives such as fertilizers containing bioavailable forms of 
nitrogen, phosphorus, and potassium.
    A commenter suggested that bioremediation agent formulas should be 
restricted to only those components necessary for the proposed primary 
use of any listed product, noting, for example, that bioremediation 
agents formulated for land-based settings may not need components such 
as surfactants to be effective, whereas the product may not need other 
components such as sugars and nutrients to be effective for use in or 
near water. This final rule requires product listing submissions to 
provide information on the intended function of each component (e.g., 
solvent, surfactant) under Sec.  300.915(a)(13). EPA notes that some 
components other than those components necessary for the primary use 
may still serve to support the product's function. However, EPA also 
recognizes concerns that a product (e.g., bioremediation agents) may 
contain components that may support an alternate mechanism of action 
(e.g., surfactants) and could potentially meet the definition of 
another product category (e.g., dispersants). EPA amended the final 
provision under Sec.  300.915(a)(9) to remove the phrase ``. . . and 
you want it considered for listing on the NCP Product Schedule in more 
than one category . . .'' to ensure that product manufacturers identify 
all applicable chemical or biological agent categories. If a product 
meets the definition of more than one chemical or biological agent 
category, the product manufacturer must provide the test data 
appropriate to each category. The final provision ensures that the 
Agency has the information necessary to evaluate the product for 
listing on the NCP Product Schedule regardless of whether the submitter 
requests it to be listed in a specific product category.
    A commenter expressed concern related to the use of nonindigenous 
or genetically modified bioremediation agents, stating that they may 
colonize areas where they are being applied. The commenter suggested 
that the Agency should not allow use of genetically modified agents in 
response activities. The Agency disagrees that the NCP should 
completely prohibit the use of nonindigenous or genetically modified 
agents in response activities. The final action establishes 
requirements for submitters to disclose bioremediation agent product 
information under Sec.  300.915(a)(13) and (14), including components 
and any physical, chemical, or biological manipulation of the genetic 
composition. In addition, Sec.  300.950, Submission of Proprietary 
Business Information (PBI), specifies that only certain information as 
identified in Sec.  300.915(a)(13) and (14) may be claimed as PBI. All 
other information submitted to EPA for listing on the NCP Product 
Schedule as required under Sec.  300.915 and Sec.  300.955 cannot be 
claimed as PBI and will be available for public disclosure upon 
submission without further notice to the submitter. The Agency believes 
that the final provisions afford OSCs, Area Committees, and RRTs with 
the flexibility to establish the appropriate agent to use during 
response and response planning activities.
(1) Bioremediation Agent Efficacy
    The final provisions reflect a series of changes from the previous 
requirements for the efficacy testing protocol for bioremediation 
agents. The new protocol includes freshwater testing in addition to the 
updated saltwater-based test and uses artificial water for both 
freshwater and saltwater testing, replacing the natural seawater

[[Page 38316]]

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

[[Page 38317]]

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

[[Page 38318]]

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

[[Page 38319]]

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

[[Page 38320]]

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

[[Page 38321]]

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

[[Page 38322]]

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

[[Page 38323]]

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

[[Page 38324]]

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

[[Page 38325]]

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

[[Page 38326]]

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

[[Page 38327]]

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

[[Page 38328]]

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

VI. Summary of Final Rule Provisions

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

[[Page 38329]]

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

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


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

[[Page 38330]]

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

VII. Statutory and Executive Order Reviews

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

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

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

B. Paperwork Reduction Act

    The information collection activities in this final action will be 
submitted for approval to the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (PRA). The Information Collection 
Request (ICR) document prepared by EPA has been assigned EPA ICR No. 
1664.14. You can find a copy of the ICR in the docket for this rule, 
and it is briefly summarized here. The information collection 
requirements are not enforceable until OMB approves them.
    The NCP Product Schedule listing and authorization of use 
provisions of the final rule include requirements for submission of 
general product information and documentation of information related to 
product testing. For this ICR, EPA has estimated an average annual 
total burden for respondents of 487 to 1,165 hours per year in the 
first three years, and average annual labor and O&M costs of $1,040,969 
to $1,088,123. EPA has carefully considered the burden imposed upon the 
regulated community by the regulations. EPA believes that the 
activities required are necessary and, to the extent possible, has 
attempted to minimize the burden imposed. The minimum requirements 
specified in the final rule are intended to encourage the development 
of safer and more effective spill mitigating products, and to better 
target the use of these products to reduce the risks to human health 
and the environment.
    Respondents/affected entities: Manufacturers of dispersants, other 
chemical and biological agents, other spill mitigating devices and 
substances.
    Respondent's obligation to respond: Mandatory if manufacturer 
wishes to have a product listed on the NCP Product Schedule (40 CFR 
part 300, subpart J).
    Estimated number of respondents: 109 responses by 89 existing 
product respondents during year one and two of the ICR period; in 
addition, 5 new product responses per year, and 10 sorbent submissions 
per year. The overall average number of responses during the ICR period 
is 51.
    Frequency of response: Occasional.
    Total estimated burden: 487 to 1,165 hours per year. Burden is 
defined at 5 CFR 1320.3(b).
    Total estimated cost: $1,040,969 to $1,088,123 per year.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for the 
EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB 
approves this ICR, the Agency will announce that approval in the 
Federal Register and publish a technical amendment to 40 CFR part 9 to 
display the OMB control number for the approved information collection 
activities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA. The 
small entities subject to the requirements of this action are 88 
potentially small businesses in the following industries: Support 
Activities for Mining; Specialty Trade Contractors; Paper 
Manufacturing; Petroleum and Coal Products Manufacturing; Chemical 
Manufacturing; Plastics and Rubber Products Manufacturing; Durable 
Goods Merchant Wholesalers; Nondurable Goods Merchant Wholesalers; Non-
store Retailers; Warehousing and Storage; Professional, Scientific, and 
Technical Services; Administrative and Support Services; Waste 
Management and Remediation Services; Repair and Maintenance; and 
Religious, Grantmaking, Civic, Professional, and Similar Organizations. 
The Agency has determined that up to five of the affected small 
entities may experience an impact of 1% to 3% of revenues and up to 
five of the affected small entities may experience an impact of greater 
than 3% of revenues. Details of this analysis are presented in EPA's 
Regulatory Impact Analysis, Final Revisions to the National Oil and 
Hazardous Substances Pollution Contingency Plan Regulations (40 CFR 
part 300 Subpart J), which is available in the docket for this action.

D. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandate of $100 million 
or more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. This final rule 
imposes no new enforceable duty on any state, local, or tribal 
governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action has Tribal implications. However, it will neither 
impose substantial direct compliance costs on federally recognized 
Tribal governments, nor preempt Tribal law. EPA has concluded that this 
action may have Tribal implications because all Tribes can be affected 
by oil spills and the subsequent use of oil spill mitigating agents, 
such as dispersants and bioremediation agents. Furthermore, CWA section 
311(j)(4)(A)(ii) provides for qualified members of federally

[[Page 38331]]

recognized Indian Tribes, where applicable, to be members of Area 
Committees. Additionally, E.O. 12777 provides that RRTs may include 
representatives from Tribal governments.
    EPA consulted with Tribal officials under EPA Policy on 
Consultation and Coordination with Indian Tribes early in the process 
of developing this regulation to enable them to have meaningful and 
timely input into its development. A summary of that consultation is 
provided in Regulatory Impact Analysis, Final Revisions to the National 
Oil and Hazardous Substances Pollution Contingency Plan Regulations (40 
CFR part 300 Subpart J), which is available in the docket for this 
action.
    As required by section 7(a), EPA's Tribal Consultation Official has 
certified that the requirements of the executive order have been met in 
a meaningful and timely manner. A copy of the certification is included 
in the docket for this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is 
not economically significant as defined in Executive Order 12866, and 
because EPA does not believe the environmental health or safety risks 
addressed by this action present a disproportionate risk to children. 
The Agency has concluded that the effect of the requirements codified 
in this final rule will mitigate the adverse effects of environmental 
and socio-economic damage that could otherwise result from major oil 
spills. This final action will therefore not have a disproportionate 
adverse effect on children.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution or Use

    This action is not a ``significant energy action'' because it is 
not likely to have a significant adverse effect on the supply, 
distribution, or use of energy. The requirements specified in the final 
rule are intended to encourage the development of safer and more 
effective spill mitigating products, and to better target the use of 
these products to reduce the risks to human health and the environment; 
thus, the rule will result in greater overall environmental protection. 
The final rule will not cause reductions in the supply or production of 
oil, fuel, coal, or electricity; nor will it result in increased energy 
prices, increased cost of energy distribution, or an increased 
dependence on foreign supplies of energy.

I. National Technology Transfer and Advancement Act

    This rulemaking involves technical standards. Therefore, the Agency 
conducted a search to identify potentially applicable voluntary 
consensus standards. However, EPA identified no such standards for 
efficacy and toxicity testing, and none were brought to the Agency's 
attention in comments. Therefore, EPA developed the Baffled Flask 
Efficacy Test; the Dispersant Toxicity Test; the Standard Acute 
Toxicity Testing for Surface Washing Agents, Bioremediation Agents, 
Herding Agents, and Solidifiers; and the Bioremediation Efficacy Test 
provided in Appendix C of this final rule.
    Additionally, EPA has decided to use voluntary consensus standards 
for several product property data points, such as pH, flash point, and 
pour point. The product toxicity testing relies on existing protocols 
that are universally accepted. The Agency has removed the incorporation 
by reference of specific standards to determine physical and chemical 
properties and replaced this with a requirement for a citation of the 
current applicable standard methodology used to determine these values. 
EPA believes that citing the current applicable standard methodology 
used to determine the required values is sufficient in lieu of 
specifying commonly recognized standard methodologies. Furthermore, EPA 
did not incorporate by reference specific test methodologies in the 
regulation to avoid the administrative burden of updating the NCP every 
time a test methodology is updated to a newer version.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
federal agencies, to the greatest extent practicable and permitted by 
law, to make environmental justice part of their mission by identifying 
and addressing, as appropriate, disproportionately high and adverse 
human health or environmental effects of their programs, policies, and 
activities on minority populations (people of color and/or Indigenous 
peoples) and low-income populations.
    The EPA believes that the human health or environmental conditions 
that exist prior to this action result in or have the potential to 
result in disproportionate and adverse human health or environmental 
effects on people of color, low-income populations and/or indigenous 
peoples. Discharges of oil from facilities regulated by this action 
likely pose disproportionate risks to historically marginalized 
communities.
    The EPA believes that this action is likely to reduce existing 
disproportionate and adverse effects on people of color, low-income 
populations and/or indigenous peoples. EPA has concluded that the 
regulatory requirements will advance fair treatment of those 
populations by reducing the disproportionate damages that oil 
discharges might otherwise inflict on those populations. EPA has 
concluded that the requirements codified in this final rule will 
mitigate the adverse effects of environmental and socio-economic damage 
that could otherwise result from major oil spills and are likely to 
reduce existing disproportionate and adverse effects on people of 
color, low-income populations and/or indigenous peoples. EPA has 
concluded that the regulatory requirements will advance fair treatment 
of those populations by reducing the disproportionate damages that 
major oil spills might otherwise inflict on those historically 
marginalized populations.
    The focus of this action is to modernize and update Subpart J of 
the NCP. Nonetheless, the EPA identified environmental justice concerns 
associated with the final rule and qualitatively assessed whether the 
requirements codified in this final rule will mitigate the adverse 
effects of environmental and socioeconomic damage that could otherwise 
result from oil spills. EPA has concluded that, while the changes in 
this rule were independent of environmental justice considerations, the 
regulatory requirements will advance fair treatment of those 
populations by reducing the disproportionate damages that discharges 
might otherwise inflict on those historically marginalized populations. 
Specifically, EPA has concluded that:
     The amended requirements to add new listing criteria and 
revise efficacy and toxicity testing protocols emphasize development 
and listing of ``greener'' oil spill mitigating products and will 
increases public transparency on chemical and biological agent 
composition.
     The amended requirements for authorization of use, 
notifications, and data reporting better target agent use to reduce 
risks to human health and the environment. The amended requirements 
will increase both public awareness on chemical and biological

[[Page 38332]]

agent preparedness planning and response activities, including 
potential engagement opportunities, and access to information on the 
components for any chemical and biological agent listed on the NCP 
Product Schedule. EPA expects the final rule requirements will also 
enhance EPA's ability to address area- and regional-specific concerns 
and provide greater public awareness of chemical and biological agent 
use during a response through public notification.
     EPA expects that the final action's emphasis on developing 
safer and more effective spill mitigating products, and on better 
targeting their use, will reduce the risks to human health and the 
environment when chemical and biological agents are used during oil 
spill responses in these newly developed areas.
    The information supporting Executive Order 12898 review is 
contained in the Regulatory Impact Analysis, Final Revisions to the 
National Oil and Hazardous Substances Pollution Contingency Plan 
Regulations (40 CFR part 300 Subpart J), which includes an 
environmental justice analysis and is available in the docket for this 
action.

K. Congressional Review Act

    This action is subject to the CRA, and the EPA will submit a rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects

40 CFR Part 110

    Environmental protection, Oil pollution, and Reporting and 
recordkeeping requirements.

40 CFR Part 300

    Air pollution control, Area contingency planning, Bioremediation, 
Chemicals, Dispersants, Environmental protection, Hazardous materials, 
Hazardous substances, Intergovernmental relations, Natural resources, 
Oil spills, Oil spill mitigating devices, Regional response teams, 
Sorbents, and Surface washing agents.

Michael S. Regan,
Administrator.

    For the reasons set out in the preamble, the Environmental 
Protection Agency amends 40 CFR parts 110 and 300 as follows:

PART 110--DISCHARGE OF OIL

0
1. The authority citation for part 110 continues to read as follows:

    Authority:  33 U.S.C. 1251 et seq., 33 U.S.C. 1321(b)(3) and 
(b)(4) and 1361(a); E.O. 11735, 38 FR 21243, 3 CFR parts 1971-1975 
Comp., p. 793.


0
2. Revise Sec.  110.4 to read as follows:


Sec.  110.4  Chemical or biological agents.

    The addition of any chemical or biological agent, or any other 
substance, to oil to be discharged that would circumvent the provisions 
of this part is prohibited.

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION 
CONTINGENCY PLAN

0
3. The authority citation for part 300 continues to read as follows:

    Authority:  33 U.S.C. 1251 et seq.; 42 U.S.C. 9601-9657; E.O. 
13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 
54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 
1987 Comp., p. 193.

Subpart A--Introduction

0
4. Amend Sec.  300.5 by:
0
a. Adding in alphabetical order definitions of ``Bioaccumulation'', 
``Bioconcentration'', ``Biodegradation'', ``Biological agents'', and 
``Bioremediation'';
0
b. Revising the definitions of ``Bioremediation agents'', ``Burning 
agents'', ``Chemical agents'', ``Dispersants'';
0
c. Adding in alphabetical order the definition of ``Herding agents'';
0
d. Removing the definition of ``Miscellaneous Oil Spill Control Agents 
(MOSCA)'';
0
e. Adding in alphabetical order the definition of ``Products'';
0
f. Revising the definition of ``Sinking agents'';
0
g. Adding in alphabetical order the definition of ``Solidifiers'';
0
h. Revising the definition of ``Sorbents'';
0
i. Removing the definitions for ``Surface collecting agents'' and 
``Surface washing agent''; and
0
j. Adding in alphabetical order the definition of ``Surface washing 
agents''.


Sec.  300.5  Definitions.

* * * * *
    Bioaccumulation is the process of accumulation of chemicals in the 
tissue of organisms through any route, including respiration, 
ingestion, or direct contact with the ambient or contaminated medium.
    Bioconcentration is the accumulation of chemicals in the tissues of 
organisms from water alone.
    Biodegradation is a process by which microorganisms metabolically 
decompose contaminants into biomass and smaller molecular compounds 
such as carbon dioxide, water, and end products.
    Biological agents are microorganisms (typically bacteria, fungi, or 
algae) or biological catalysts, such as enzymes, that can enhance the 
biodegradation of a contaminated environment.
    Bioremediation is the process of enhancing the ability of 
microorganisms to convert contaminants into biomass and smaller 
molecular end products by the addition of materials into a contaminated 
environment to accelerate the natural biodegradation process.
    Bioremediation agents are biological agents and/or nutrient 
additives deliberately introduced into a contaminated environment to 
increase the rate of biodegradation and mitigate any deleterious 
effects caused by the contaminant constituents. Bioremediation agents 
include microorganisms, enzymes, and nutrient additives such as 
fertilizers containing bioavailable forms of nitrogen, phosphorus, and 
potassium.
    Burning agents are additives that, through physical or chemical 
means, improve the combustibility of the materials to which they are 
applied.
* * * * *
    Chemical agents are elements, compounds, or mixtures designed to 
facilitate the removal of oil from a contaminated environment and to 
mitigate any deleterious effects. Chemical agent categories include 
burning agents, dispersants, herding agents, solidifiers, surface 
washing agents, and bioremediation agents that consist of nutrient 
additives.
* * * * *
    Dispersants are substances that emulsify, disperse, or solubilize 
oil by promoting the formation of small droplets or particles of oil in 
the water column.
* * * * *
    Herding agents are substances that form a film on the water surface 
to control the spreading of the oil to allow for oil removal.
* * * * *
    Products are chemical or biological agents or other substances 
manufactured using a unique composition or formulation.
* * * * *
    Sinking agents are substances introduced into an oil discharge for 
the purpose of submerging the oil to the bottom of a water body.
* * * * *
    Solidifiers are substances that through a chemical reaction cause 
oil to become

[[Page 38333]]

a cohesive mass, preventing oil from dissolving or dispersing into the 
water column. Solidifiers are generally collected and recovered from 
the environment.
    Sorbents are inert and insoluble substances that readily absorb 
and/or adsorb oil or hazardous substances, and that are not combined 
with or act as a chemical agent, biological agent, or sinking agent. 
Sorbents may be used in their natural bulk form or as manufactured 
products in particulate form, sheets, rolls, pillows, or booms. 
Sorbents are generally collected and recovered from the environment. 
Sorbents consist of:
    (1) Natural organic substances (e.g., feathers, cork, peat moss, 
and cellulose fibers such as bagasse, corncobs, and straw);
    (2) Inorganic/mineral compounds (e.g., volcanic ash, perlite, 
vermiculite, zeolite, clay); and
    (3) Synthetic compounds (e.g., polypropylene, polyethylene, 
polyurethane, polyester).
* * * * *
    Surface washing agents are substances that separate oil from solid 
surfaces, such as beaches, rocks, metals, or concrete, through a 
detergency mechanism that lifts and floats oil. Product and oil are 
generally to be collected and recovered from the environment with 
minimal dissolution, dispersion, or transfer into the water column.
* * * * *

Subpart J--Use of Dispersants, and Other Chemical and Biological 
Agents

0
5. Revise the heading of Subpart J as set out above.

0
6. Amend Sec.  300.900 by revising paragraphs (a) and (c), and by 
adding paragraph (d) to read as follows:


Sec.  300.900  General.

    (a) Section 311(d)(2)(G) of the Clean Water Act (CWA) requires EPA 
to prepare a schedule identifying dispersants, other chemicals, other 
spill mitigating devices and substances, if any, that may be used in 
carrying out the NCP; and the waters and quantities in which they may 
be used safely. This subpart establishes a schedule that includes the 
NCP Product Schedule identifying chemical and biological agents, the 
Sorbents Product List, and the authorization of use procedures that, 
when taken together, identify the waters and quantities in which such 
dispersants, other chemicals, or other spill mitigating devices and 
substances may be used safely.
* * * * *
    (c) This subpart applies to the use of chemical and biological 
agents as defined in Subpart A of this part, or other substances that 
may be used to remove, control, or otherwise mitigate oil discharges.
    (d) [Reserved]


Sec.  300.905  [Removed]

0
7. Remove Sec.  300.905.

0
8. Revise Sec.  300.910 to read as follows:


Sec.  300.910  Authorization for agent use.

    Use of chemical or biological agents in response to oil discharges 
must be authorized by the OSC in accordance with the provisions of this 
section.
    (a) Use of agents identified on the NCP Product Schedule or use of 
burning agents on oil discharges addressed by a preauthorization plan. 
Area Committees and RRTs shall address, as part of their planning 
activities, whether preauthorization of the use of chemical and 
biological agents listed on the NCP Product Schedule or the use of 
burning agents on certain oil discharges is appropriate. Area 
Committees and RRTs shall, as appropriate, include applicable approved 
preauthorization plans in ACPs and RCPs. When a preauthorization plan 
is approved in advance for the use of certain agents under specified 
discharge situations, then the OSC may authorize the use of agents 
listed on the NCP Product Schedule, or the use of burning agents, for 
the purpose for which they were specifically listed without obtaining 
the incident-specific concurrences and without the natural resource 
trustees consultations described in paragraph (b) of this section.
    (1) Preauthorization plan development. For discharge situations 
identified where such agents may be used, the preauthorization plan 
must, at a minimum, specify limits for the quantities and the duration 
of use, and use parameters for water depth, distance to shoreline, and 
proximity to populated areas. In meeting the provisions of this 
paragraph, preauthorization plans should document how regional factors 
are addressed including likely sources and types of oil that might be 
discharged, various potential discharge scenarios, the existence and 
location of environmentally sensitive resources or restricted areas 
that might be impacted by discharged oil, and logistical factors 
including inventory, storage locations and manufacturing capability of 
available agents, availability of equipment needed for agent use, 
availability of adequately trained operators, and means to monitor 
agent use in the environment. Preauthorization plans are to be 
developed by the Area Committees or the RRT in consultation with the 
Area Committee(s).
    (2) Preauthorization plan approval. The EPA representative to the 
RRT, the Department of Commerce and the Department of the Interior 
natural resource trustees and, as appropriate the RRT representative 
from the state(s) with jurisdiction over waters and adjoining 
shorelines within the preauthorization plan area shall review and 
either approve, approve with modification, or disapprove the 
preauthorization plans. The Area Committees and RRTs shall address the 
withdrawal of approval from a preauthorization plan, and the RRT shall 
notify the NRT of the status of the preauthorization plan within 30 
days from any such withdrawal.
    (3) Preauthorization plan reviews. The RRT in consultation with the 
Area Committee(s) must review, and revise, as needed, approved 
preauthorization plans. These reviews must be conducted following a 
regular timeframe, established by the RRT and documented in the plan, 
to address changes that may impact the conditions under which the use 
of chemical and biological agents have been preauthorized. Reviews must 
also be conducted in any affected region, at a minimum, after a major 
discharge or after a Spill of National Significance (SONS) relevant to 
the preauthorization plan area; to address revisions of the NCP Product 
Schedule impacting chemical or biological agents that may be 
individually listed within a preauthorization plan; and to reflect new 
listings of threatened and/or endangered species applicable to the 
preauthorization plan area. The EPA RRT representative, the Department 
of Commerce and Department of the Interior natural resource trustees, 
and the RRT representative from the state(s) with jurisdiction over the 
waters of the area to which a preauthorization plan applies shall 
review and either approve, approve with modification, or disapprove any 
revisions to the preauthorization plans.
    (b) Use of agents identified on the NCP Product Schedule or use of 
burning agents on oil discharges not addressed by a preauthorization 
plan. For discharge situations that are not addressed by a 
preauthorization plan developed pursuant to paragraph (a) of this 
section, the OSC may authorize the use of chemical or biological agents 
identified on the NCP Product Schedule on an oil discharge, or the use 
of burning agents, for the specific purpose for which they were listed 
with the concurrence of the EPA RRT representative and, as appropriate, 
the

[[Page 38334]]

concurrence of the RRT representatives from the state(s) with 
jurisdiction over the waters and adjoining shorelines threatened by the 
release or discharge, and in consultation with the Department of 
Commerce and Department of the Interior natural resource trustees. In 
meeting the provisions of this paragraph, the OSC must consider and 
document for their authorization request to the RRT, at a minimum, the 
parameters for the use of agents including the quantities requested to 
be authorized, the duration of use, the depth of water, the distance to 
shoreline and proximity to populated areas, and should consider and 
document factors such as environmentally sensitive resources or 
restricted areas that might be impacted, agent inventory and storage 
locations, agent manufacturing capability, availability of equipment 
needed for agent use, availability of adequately trained operators and 
appropriate means to monitor agent use in the environment.
    (c) [Reserved]
    (d) Temporary exception. In circumstances to prevent or 
substantially reduce an imminent threat to human life that cannot be 
immediately addressed by other procedures or provisions of the NCP, the 
OSC may authorize the provisional use of any chemical or biological 
agent, whether it is identified or not on the NCP Product Schedule, 
without obtaining the concurrence of the EPA RRT representative and, as 
appropriate, the RRT representatives from the state(s) with 
jurisdiction over the waters and adjoining shorelines threatened by the 
release or discharge, and without consultation with the Department of 
Commerce and the Department of the Interior natural resource trustees. 
This exception shall not be used as a substitute for compliance with 
Sec.  300.150 of this part, including the use of personal protective 
equipment, or when there is sufficient time to seek authorization in 
accordance with paragraphs (a) or (b) of this section. If an agent is 
authorized for use pursuant to this paragraph, the OSC shall notify as 
soon as possible the EPA RRT representative and as appropriate, the RRT 
representatives from the affected state(s) and the Department of 
Commerce and Department of the Interior natural resource trustees. The 
OSC shall document the circumstances and the reasons for use of the 
agent authorized pursuant to this paragraph. Agent use for individual 
circumstances under this exception shall be in accordance with 
paragraphs (a) or (b) of this section no later than 24 hours after 
initial application.
    (e) Prohibited agents or substances. The OSC may not authorize the 
use of the following:
    (1) Sinking agents, or any other chemical agent, biological agent, 
or any substance that is used to directly sink the oil to the bottom of 
a water body.
    (2) [Reserved]
    (f) Storage and use of agents listed on the NCP Product Schedule. 
(1) The OSC may authorize for use only products listed on the NCP 
Product Schedule that are documented and certified by the responsible 
party or its representative to have been stored under the conditions 
provided by the submitter under Sec.  300.915(a)(6), and whose date of 
use does not exceed the expiration date listed on the container's label 
unless otherwise specified for expired products as provided in Sec.  
300.910(f)(2), at the time of the incident.
    (2) The OSC may authorize for use products listed on the NCP 
Product Schedule that exceed their expiration date after the 
responsible party or its representative documents and certifies that 
the expired product has been stored under the conditions provided by 
the submitter under Sec.  300.915(a)(6) and still meets the applicable 
efficacy and toxicity listing provisions under Sec.  300.915, based on 
testing of representative samples within the previous 12 months.
    (g) Supplemental testing, monitoring, and information. The RRT may 
require, for both planning and response, including authorization of 
use, supplemental toxicity and efficacy testing, or submission of 
available data and information that addresses site, area, and 
ecosystem-specific concerns relative to the use of any chemical or 
biological agent. The product manufacturer or responsible party shall 
provide, upon request of the RRT or OSC, additional monitoring or 
testing data and information to inform chemical or biological agent use 
decisions specific to a response.
    (h) Recovery of chemical agents and other substances from the 
environment. The responsible party shall ensure that removal actions 
adequately contain, collect, store, and dispose of chemical agents and 
other substances that are to be recovered from the environment, unless 
otherwise directed by the OSC. Chemical agents and other substances to 
be recovered include solidifiers, surface washing agents, and sorbents. 
The OSC should, at a minimum, consider factors such as the safety of 
response personnel and harm to the environment in making determinations 
pursuant to this paragraph.
    (i) Reporting of agent use. (1) The authorizing OSC shall provide 
the RRT the following information on chemical and biological agents 
used in response to an oil discharge: product name, product category, 
quantity and concentrations used, duration of use, location(s) of use, 
any available data collected, and any available analyses of efficacy 
and environmental effects. This information must be provided within 30 
days of completion of agent use. This information may be submitted in 
accordance with the OSC reporting provisions under Sec.  300.165 of 
this part, as applicable, subject to the 30-day timing requirement.
    (2) In support of sections 300.135(n) and 300.155(a) and (b) of 
this part, the authorizing OSC shall provide for notification to the 
public, updated during a response as appropriate, the following 
information on chemical and biological agents used in response to an 
oil discharge: product name, product category, quantity and 
concentrations used, duration of use, and location(s) of use.

0
9. Revise Sec.  300.915 to read as follows:


Sec.  300.915  Data and information requirements for listing on the NCP 
Product Schedule or Sorbent Product List.

    If you are submitting an application for listing a product to the 
NCP Product Schedule or Sorbent Product List, you must provide EPA the 
information required under Sec.  300.955. Technical product data 
submissions are not required for burning agents. Your submission for 
each product must contain:
    (a) General information for any product category. (1) Your name, 
physical address, email, and telephone number;
    (2) Your identity and documentation of that identity, as the 
manufacturer of the product, vendor, importer, distributor of the 
product, and/or a designated agent acting on behalf of the 
manufacturer.
    (3) All name(s), brand(s), and/or trademark(s) under which the 
product is to be sold;
    (4) Names, physical addresses, emails, and telephone numbers of the 
primary distributors, vendors, importers and/or designated agent acting 
on behalf of the manufacturer;
    (5) The Safety Data Sheet (SDS) for the product;
    (6) The maximum, minimum, and optimum temperature, humidity, and 
other relevant conditions for product storage and a brief description 
of the consequences to performance if the product is not stored within 
these limits;

[[Page 38335]]

    (7) The anticipated shelf life of the product at the storage 
conditions noted in paragraph (a)(6) of this section and documentation 
for this determination;
    (8) A sample product label for all name(s), brand(s), and/or 
trademark(s) under which the product is to be sold that includes 
manufacture and expiration dates, and conditions for storage. You may 
use an existing label provided it already contains the required dates 
and storage information;
    (9) The chemical or biological agent category under which you want 
the product to be considered for listing on the NCP Product Schedule, 
including detailed information on the specific process(es) through 
which the product affects the oil, and the specific environment(s) on 
which it is intended to be used (e.g., waters and/or adjoining 
shorelines). If your product meets the definition of more than one 
chemical or biological agent category, you must identify all applicable 
categories and provide the test data to meet the listing criteria 
appropriate to each;
    (10) Recommended product use procedures, including product 
concentrations, use ratios, types of application equipment, conditions 
for use, any application restrictions; and, as applicable, procedures 
for product and oil containment, collection, recovery, and disposal. 
These procedures must address, as appropriate, variables such as 
weather, water salinity, water temperature, types and weathering states 
of oils or other pollutants. The procedures must include supporting 
documentation and current applicable standard methods used to determine 
them;
    (11) Available information on environmental fate, including any 
known measured data, methodologies, and supporting documentation, on 
the persistence, bioconcentration factor, bioaccumulation factor, and 
biodegradability of the product and all of its components in the 
environment;
    (12) The physical and chemical properties of the product, as 
appropriate, and a citation for the current applicable standard methods 
used to determine them, including:
    (i) Physical state and appearance;
    (ii) Vapor pressure;
    (iii) Flash point;
    (iv) Pour point;
    (v) Viscosity;
    (vi) Specific gravity;
    (vii) Particle size for solid components; and
    (viii) pH;
    (13) The identity and concentration of all components in the 
product, including each specific component name; corresponding Chemical 
Abstract Service (CAS) Registry Number; the maximum, minimum, and 
average weight percent of each component in the product; and the 
intended function of each component (e.g., solvent, surfactant);
    (14) For products that also contain microorganisms, enzymes, and/or 
nutrients, provide the following along with a citation or a description 
of the methodology used to determine:
    (i) The name of all microorganisms by current genus and species, 
including any reclassifications, and any physical, chemical, or 
biological manipulation of the genetic composition and the weight 
percent of each genus in the product;
    (ii) The name of all enzymes and their International Union of 
Biochemistry (I.U.B.) number(s); Enzyme Classification (EC) code 
numbers; the source of each enzyme; units; and specific oil-degrading 
activity;
    (iii) The name(s), maximum, minimum, and average weight percent of 
the nutrients contained in the product; and
    (iv) Data, methodology, and supporting documentation, for the 
levels of bacterial, fungal, or viral pathogens or opportunistic 
pathogens including, but not limited to: enteric bacteria such as 
Salmonella, fecal coliforms, Shigella, coagulase positive 
Staphylococci, and beta hemolytic Streptococci and enterococci;
    (15) Data, methodology, and supporting documentation for the levels 
of the following:
    (i) Arsenic, cadmium, chromium, copper, lead, mercury, nickel, 
vanadium, zinc, and any other heavy metal reasonably expected to be in 
the product;
    (ii) Cyanide;
    (iii) Chlorinated hydrocarbons;
    (iv) Pesticides;
    (v) Polychlorinated Biphenyls (PCBs); and
    (vi) Polycyclic aromatic hydrocarbons (PAHs).
    (16) Certification, including data, methodology, and supporting 
documentation, indicating that the product does not contain any of the 
prohibited agents or substances identified in Sec.  300.910(e);
    (17) Information about the accredited laboratory that conducted the 
required tests, including:
    (i) Name of the laboratory, address, contact name, email, and phone 
number; and
    (ii) The national and/or international accreditations held by the 
laboratory that are applicable to the test(s) performed;
    (18) All test data and calculations, including:
    (i) Raw data and replicates, including positive controls;
    (ii) Notes and observations collected during tests;
    (iii) Calculated mean values and standard deviations;
    (iv) Reports, including a summary of stock solution preparation;
    (v) Source and preparation of test organisms;
    (vi) Test conditions; and
    (vii) Chain of custody forms;
    (19) An estimate of the annual product production volume, the 
average and maximum amount that could be produced per day, and the time 
frame needed to reach that maximum production rate in days;
    (20) Recognition received from EPA's Design for the Environment 
(DfE) or Safer Choice programs, as applicable; and
    (21) International product testing or use data or certifications, 
if available, informing the performance capabilities or environmental 
impacts of the product.
    (b) Dispersant testing and listing requirements--(1) Dispersant 
efficacy test and listing criteria. Test the dispersant product for 
efficacy using the Baffled Flask Test (BFT) method in Appendix C to 
part 300. To be listed on the NCP Product Schedule, the dispersant must 
demonstrate for each temperature a Dispersant Effectiveness (DE) at the 
95% lower confidence level (LCL95) greater than or equal to:
    (i) >=70% for Strategic Petroleum Reserve Bryan Mound at 5 [deg]C;
    (ii) >=75% for Strategic Petroleum Reserve Bryan Mound at 25 
[deg]C;
    (2) Dispersant toxicity tests and listing criteria. Use the methods 
specified in Appendix C to part 300 to test the dispersant alone, and 
the dispersant mixed with Strategic Petroleum Reserve Bryan Mound for 
acute toxicity, using Americamysis bahia and Menidia beryllina. Use the 
methods specified in Appendix C to part 300 to test the dispersant 
alone for developmental toxicity using Strongylocentrotus purpuratus or 
Arbacia punctulata and for subchronic effects using Americamysis bahia 
and Menidia beryllina. To be listed on the NCP Product Schedule, the 
dispersant alone must demonstrate:
    (i) A median lethal concentration (LC50) at the lower 
95% confidence interval greater than 10 ppm;
    (ii) An inhibition concentration for 50% of the test species 
(IC50) at the lower 95% confidence interval greater than 1 
ppm; and
    (iii) A subchronic No Observed Effect Concentration (NOEC) greater 
than 1 ppm.

[[Page 38336]]

    (3) Limitations. A dispersant may only be listed on the NCP Product 
Schedule for use in saltwater environments for which it meets the 
efficacy and toxicity listing criteria.
    (c) Surface washing agent testing and listing requirements--(1) 
Surface washing agent efficacy test and listing criteria. To be listed 
on the NCP Product Schedule, using an applicable standard methodology, 
the surface washing agent must meet an efficacy of greater than or 
equal to 30% in either freshwater or saltwater, or both, depending on 
the intended product use.
    (2) Surface washing agent toxicity test and listing criteria. Using 
the toxicity test methodology in Appendix C to part 300, test the 
surface washing agent for acute toxicity against freshwater species 
Ceriodaphnia dubia and Pimephales promelas, or saltwater species 
Americamysis bahia and Menidia beryllina, or both, depending on the 
intended product use. To be listed on the NCP Product Schedule, the 
surface washing agent must demonstrate an LC50 at the lower 
95% confidence interval greater than 10 ppm in either freshwater or 
saltwater for all tested species.
    (3) Limitations. Surface washing agent listing would be for use 
only in freshwater and/or saltwater environments for which it was 
tested and for which it met the efficacy and toxicity listing criteria.
    (d) Bioremediation agent testing and listing requirements--(1) 
Bioremediation agent efficacy test and listing criteria. To be listed 
on the NCP Product Schedule, a bioremediation agent must successfully 
degrade both alkanes and aromatics as determined by gas chromatography/
mass spectrometry (GC/MS) in freshwater or saltwater, or both, 
depending on the intended product use, following the test method 
specified in Appendix C to part 300. The percentage reduction of total 
alkanes (aliphatic fraction) from the GC/MS analysis must be greater 
than or equal to 85% at day 28, based on the ninety-fifth (95th) 
percentile Upper Confidence Limit (UCL95) for both 
freshwater and saltwater. The percentage reduction of total aromatics 
(aromatic fraction) must be greater than or equal to 35% at day 28 for 
both saltwater and freshwater based on the UCL95.
    (2) Bioremediation agent toxicity test and listing criteria. The 
bioremediation agent must be tested for acute toxicity in freshwater or 
saltwater, or both, depending on the intended product use, following 
the method specified in Appendix C to part 300. To be listed on the NCP 
Product Schedule, the bioremediation agent must demonstrate an 
LC50 at the lower 95% confidence interval greater than 10 
ppm in either freshwater or saltwater for all tested species.
    (3) Limitations. Bioremediation agent listing would be for use only 
in the freshwater and/or saltwater environments for which it was tested 
and for which it met the efficacy and toxicity listing criteria.
    (4) Generic listing. If the product consists solely of: ammonium 
nitrate, ammonium phosphate, ammonium sulfate, calcium ammonium 
nitrate, sodium nitrate, potassium nitrate, synthetically-derived urea, 
sodium triphosphate (or tripolyphosphate), sodium phosphate, potassium 
phosphate (mono- or dibasic), triple super phosphate, potassium 
sulphate, or any combination thereof, no technical product data are 
required. The product will be generically listed as non-proprietary 
nutrients on the NCP Product Schedule, and no further action is 
necessary.
    (e) Solidifier testing and listing requirements. (1) Solidifiers 
must be tested for acute toxicity in freshwater or saltwater, or both, 
depending on the intended product use, following the method specified 
in Appendix C to part 300. To be listed on the NCP Product Schedule, 
the solidifier must demonstrate an LC50 at the lower 95% 
confidence interval greater than 10 ppm in either freshwater or 
saltwater for all tested species.
    (2) Limitations. Solidifier listing would be for use only in the 
freshwater and/or saltwater environments for which it was tested and 
for which it met the toxicity listing criteria.
    (f) Herding agent testing and listing requirements. (1) Herding 
agents must be tested for acute toxicity in freshwater or saltwater, or 
both, depending on the intended product use, following the method 
specified in Appendix C to part 300. To be listed on the NCP Product 
Schedule, the herding agent must demonstrate an LC50 at the 
lower 95% confidence interval greater than 10 ppm in either freshwater 
or saltwater for all tested species.
    (2) Limitations. Herding agent listing would be for use only in 
freshwater and/or saltwater environments for which it was tested and 
for which it met the toxicity listing criteria.
    (g) Sorbent requirements. Known sorbent materials and products will 
be identified on a publicly available Sorbent Product List for the use 
of such products when responding to an oil discharge as follows:
    (1) For sorbent products that consist solely of the following 
materials, or any combination thereof, no technical data are required 
to be submitted for listing on the Sorbent Product List, and no further 
action is necessary for use as a sorbent:
    (i) Feathers, cork, peat moss, and cellulose fibers such as 
bagasse, corncobs, and straw;
    (ii) Volcanic ash, perlite, vermiculite, zeolite, and clay; and
    (iii) Polypropylene, polyethylene, polyurethane, and polyester.
    (2) If the product consists of one or more natural organic 
substances, inorganic/mineral compounds, and/or synthetic compounds not 
specifically identified in paragraph (g)(1) of this section but you 
believe the product meets the definition of a sorbent then, as 
applicable under Sec.  300.955(a) and (b), you must submit the 
following information for consideration for listing it as a sorbent on 
the Sorbent Product List:
    (i) The information required under paragraphs (a)(1) through 
(a)(8), and paragraph (a)(13) through (a)(15) of this section;
    (ii) The certification required under paragraph (a)(16) of this 
section; and
    (iii) Information, including data, to support the claim your 
product meets the sorbent definition under Sec.  300.5.


Sec.  300.920  [Removed]

0
10. Remove Sec.  300.920.

0
11. Add Sec.  300.950 to read as follows:


Sec.  300.950  Submission of Proprietary Business Information (PBI).

    (a) Except as provided in paragraph (b) of this section, all 
product information submitted to EPA as required under Sec.  300.915 
and Sec.  300.955 will be available for public disclosure upon 
submission, without further notice to the submitter.
    (b) You may only claim as PBI the concentration; the maximum, 
minimum, and average weight percent; and the units of each component as 
identified in Sec.  300.915(a)(13) and (14) and as applicable. EPA will 
handle such claims in accordance with 40 CFR part 2, subpart B 
Confidentiality of Business Information.
    (1) You must make your PBI claim at the time you submit your 
information to EPA to be listed on the NCP Product Schedule or Sorbent 
Product List.
    (2) You must separate the PBI from all other submitted information. 
Include all PBI separately with your submission package, marking it as 
``Proprietary Business Information'' and placing it in a separate inner 
envelope labeled with ``PROPRIETARY BUSINESS INFORMATION--TO BE OPENED 
BY

[[Page 38337]]

THE PRODUCT SCHEDULE MANAGER ONLY.''

0
12. Add Sec.  300.955 to read as follows:


Sec.  300.955  Addition of a product to the NCP Product Schedule or 
Sorbent ProductLlist.

    (a) Submission. Submit your complete package to: U.S. Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Mail Code: 5104A, Room 
1448, William J. Clinton North, Washington, DC 20460, Attention: 
Product Schedule Manager.
    (b) Package contents. Your package shall include, as applicable, in 
this order:
    (1) A cover letter on company letterhead signed and dated by you 
certifying that:
    (i) All testing was conducted on representative product samples;
    (ii) Testing was conducted at a nationally or internationally 
accredited laboratory in accordance with the methods specified in 
Appendix C to part 300, and other applicable methods as appropriate; 
and
    (iii) All test results and product technical data and information 
are true and accurate.
    (2) A page numbered Table of Contents showing the information and 
data submitted under Sec.  300.915(a) through (g), as applicable;
    (3) All required data and information arranged in the same order as 
specified in Sec.  300.915(a) through (g); and
    (4) A separate envelope containing and labeled Proprietary Business 
Information as specified in Sec.  300.950(b), if applicable.
    (c) EPA Review. EPA shall, within 90 days of receiving a submission 
package:
    (1) Review the package for completeness and compliance with all 
data and information requirements in Sec. Sec.  300.915, 300.950, and 
this section; verify information; and request clarification or 
additional information, including testing as necessary;
    (2) Make a product listing determination based on a technical 
evaluation of all data and information submitted in accordance with the 
requirements for each product category, relevant information on impacts 
or potential impacts of the product or any of its components on human 
health or the environment, and the intended use of the product; and
    (3) Notify you in writing of its decision to list the product on 
the NCP Product Schedule or the Sorbent Product List, or of its 
decision and supporting rationale to reject the submission. If your 
submission is rejected:
    (i) You may revise and resubmit a complete package to address test 
results, data, or information deficiencies.
    (ii) EPA's 90-day review will not start until a complete package is 
resubmitted.
    (d) Request for review of decision. If your product is rejected for 
listing on the NCP Product Schedule or the Sorbent Product List, you 
may request that the EPA Administrator or designee review the 
determination. Your request must be in writing within 30 days of 
receipt of notification of EPA's decision not to list the product on 
the NCP Product Schedule or the Sorbent Product List. Your request must 
contain a clear and concise statement with supporting facts and 
technical analysis demonstrating why the product meets the listing 
requirements.
    (1) The EPA Administrator or designee may request additional 
information from you and may offer an opportunity for you to meet with 
EPA.
    (2) The EPA Administrator or designee will notify you in writing of 
the decision within 60 days of receipt of your request, or within 60 
days of receipt of requested additional information.
    (e) Changes to a product listing--(1) Administrative change. You 
must notify EPA in writing within 30 days of any changes to information 
submitted under Sec.  300.915(a)(1) through (8) and Sec.  
300.915(a)(19) through (21) for a product on the NCP Product Schedule. 
In the notification, you must detail the specific changes, the reasons 
for such changes and supporting data and information. EPA may request 
additional information and clarification regarding these changes.
    (2) Reformulation. If you change the components and/or 
concentrations, you must retest the reformulated product according to 
the requirements for the product category and submit a new complete 
package under a new, distinct name in accordance with Sec.  300.955(b) 
for review and consideration for listing on the NCP Product Schedule or 
Sorbent Product List by EPA.
    (f) Transitioning Listed Products to the New NCP Product Schedule 
or Sorbent Product List. All products on the current NCP Product 
Schedule as of December 11, 2023 will remain conditionally listed until 
December 12, 2025 at which time all products that have not been 
submitted and listed in the new NCP Product Schedule based on the 
amended test and listing criteria will be removed. Your product will be 
transitioned from the current NCP Product Schedule to the new NCP 
Product Schedule prior to December 12, 2025 after you submit a new 
complete package in accordance with Sec.  300.955(b), and EPA makes a 
determination to list the product on the new NCP Product Schedule. All 
products previously identified as sorbents by EPA will remain available 
for use until December 12, 2025, at which time all sorbent products 
must have submitted information as applicable under Sec.  300.955(a) 
and (b) and be listed in the new Sorbent Product List.

0
13. Add Sec.  300.965 to read as follows:


Sec.  300.965  Mandatory Product Disclaimer.

    The listing of a product on the NCP Product Schedule does not 
constitute approval or recommendation of the product. To avoid possible 
misinterpretation or misrepresentation, any label, advertisement, or 
technical literature for products listed on the NCP Product Schedule 
must display in its entirety the disclaimer shown below. The disclaimer 
must be conspicuous and must be fully reproduced on all product 
literatures, labels, and electronic media including website pages.
Disclaimer
    [PRODUCT NAME] is listed on the National Contingency Plan (NCP) 
Product Schedule. This listing does NOT mean that EPA approves, 
recommends, licenses, or certifies the use of [PRODUCT NAME] on an oil 
discharge. This listing means only that data have been submitted to EPA 
as required by Subpart J of the NCP. Only a Federal On-Scene 
Coordinator (OSC) may authorize use of this product in accordance with 
Subpart J of the NCP in response to an oil discharge.


0
14. Add Sec.  300.970 to read as follows:


Sec.  300.970  Removal of a product from the NCP Product Schedule or 
Sorbent Product List.

    (a) The EPA Administrator or designee may remove your product from 
the NCP Product Schedule or the Sorbent Product List for reasons 
including, but not limited to:
    (1) Statements or information that are misleading, inaccurate, 
outdated, or incorrect regarding the composition or use of the product 
to remove or control oil discharges made to any person, or private or 
public entity, including on labels, advertisements, technical 
literature, electronic media, or within the product submission to EPA; 
or
    (2) Alterations to the components, concentrations, or use 
conditions of the product without proper notification to EPA as 
required by Sec.  300.955(e); or
    (3) Failure to print the disclaimer provided in Sec.  300.965 on 
all labels, advertisements, technical literature, or electronic media 
for products listed on the NCP Product Schedule; or

[[Page 38338]]

    (4) New or relevant information not previously considered 
concerning the impacts or potential impacts of the product to human 
health or the environment.
    (b) EPA will notify you in writing, at your address of record, of 
its reasons for deciding to remove the product from the NCP Product 
Schedule. If EPA receives no appeal from you in 30 days, the product 
will be removed from the NCP Product Schedule without further notice to 
you.
    (c) You may appeal the decision to remove your product from the NCP 
Product Schedule within 30 days of receipt of EPA's notification. Your 
appeal must contain a clear and concise statement with supporting facts 
and technical analysis demonstrating why the product should not be 
removed. The EPA Administrator or designee will notify you in writing 
of the decision within 60 days of your appeal, or within 60 days of 
receipt of any requested additional information.


0
15. Revise Appendix C to Part 300 to read as follows:

Appendix C to Part 300--Requirements for Product Testing Protocols and 
Summary Test Data: Dispersant Baffled Flask Efficacy and Toxicity 
Tests; Standard Acute Toxicity Test for Bioremediation Agents, Surface 
Washing Agents, Herding Agents, and Solidifiers; and Bioremediation 
Agent Efficacy Test

Table of Contents

1.0 Applicability and Scope
2.0 Baffled Flask Dispersant Efficacy Test (BFT)
3.0 Dispersant Toxicity Testing
4.0 Standard Acute Toxicity Testing for Surface Washing Agents, 
Bioremediation Agents, Herding Agents, and Solidifiers
5.0 Bioremediation Agent Efficacy Test Protocol

Illustrations

Figure Number

1. A Baffled Trypsinizing Flask

Tables

Table Number

1. Constituent Concentrations for GP2 Artificial Seawater
2. Test Oil Characteristics
3. Stock Standard Solution Preparation
4. Dispersant Calibration Example for Test Oil
5. Sample Calculation With ANS
6. Toxicity Testing Requirements for Dispersants
7. Summary of Test Conditions--Dispersant Toxicity
8. Toxicity Testing Requirements for Surface Washing Agents, Herding 
Agents, Bioremediation Agents and Solidifiers
9. Summary of Test Conditions--Surface Washing Agents, Herding 
Agents, Bioremediation Agents and Solidifiers Toxicity
10. Artificial Seawater Nutrient Concentrations
11. Artificial Seawater Nutrient Concentrations for Bioremediation 
Agents Having No Nutrients Included
12. Constituent Concentrations for Artificial Freshwater (Bushnell-
Haas)
13. Freshwater Nutrient Concentrations
14. Artificial Freshwater Nutrient Concentration for Bioremediation 
Agents Having No Nutrients Included
15. Bioremediation Efficacy Test--Summary of Experimental Setup
16. Bioremediation Efficacy--Summary of Analytical Procedures
17. QA/QC Checks

Standard Operating Procedures Tables

SOP 3-1 Amount of Stock Solutions Required To Make the Working 
Standards
SOP 4-1 Ions Associated With Retention Time Groups
SOP 4-2 Instrumental Conditions for Crude Oil Analysis
SOP 4-3 Ion Abundance Criteria for DFTPP
SOP 4-4 Target Compound List

    1.0 Applicability and Scope. This Appendix establishes 
laboratory protocols required under Subpart J (Use of Dispersants 
and Other Chemical and Biological Agents) of 40 CFR part 300 
(National Oil and Hazardous Substances Pollution Contingency Plan) 
to make listing determinations for the Product Schedule. The 
protocols apply, based on product type, to dispersants, 
bioremediation agents, surface washing agents, herding agents, and 
solidifiers as defined in Subpart A (Introduction) of 40 CFR part 
300.
    2.0 Baffled Flask Dispersant Efficacy Test (BFT)
    2.1 Summary. This laboratory protocol establishes procedures to 
evaluate the degree to which a product effectively disperses oil 
spilled on the surface of seawater, using a modified 150-mL screw-
cap trypsinizing flask (an Erlenmeyer flask with baffles) with a 
glass and Teflon[supreg] stopcock near the bottom to allow removal 
of subsurface water samples without disturbing the surface oil 
layer. The efficacy of a dispersant is measured using one reference 
oil, Strategic Petroleum Oil Reserve Bryan Mound at two temperatures 
(5 [deg]C and 25 [deg]C). Six replicates and one method blank are 
required at each temperature. A layer of oil is placed on the 
surface of artificial seawater, and the dispersant is added to the 
slick at a dispersant:oil ratio (DOR) of 1:25 (4%) by volume. A 
standard orbital shaker table provides turbulent mixing at a speed 
of 250 revolutions per minute (rpm) for 10 minutes, immediately 
after which it is maintained stationary for 10 minutes to allow non-
dispersed oil to rise to the water's surface. An undisturbed water 
sample is removed from the bottom of the flask through the stopcock, 
extracted with dichloromethane (DCM), and analyzed for oil content 
by UV-visible absorption spectrophotometry at wavelengths ranging 
between 340 and 400 nm.
    2.2 Apparatus. All equipment must be maintained and calibrated 
per standard laboratory procedures.
    2.2.1 Modified Trypsinizing Flask. A modified 150 mL glass 
screw-capped Erlenmeyer flasks with baffles (e.g., Wheaton No. 
355394 or equivalent) fitted with a 2 mm bore Teflon[supreg] 
stopcock and glass tubing, the center of which is no more than 1.3 
cm from the bottom, as shown in Figure 1.

[[Page 38339]]

[GRAPHIC] [TIFF OMITTED] TR12JN23.078

Figure 1. A Baffled Trypsinizing Flask

    2.2.2 Orbital Shaker Table. An orbital shaker table with a 
variable speed control unit capable of maintaining 250 rpm. The 
orbital diameter must be approximately 1.0 inch (2.5 cm) +/-0.1 inch 
(0.25 cm).
    2.2.3 Spectrophotometer. A UV-visible spectrophotometer capable 
of measuring absorbance between 340 and 400 nm (e.g., Shimadzu UV-
1800, Agilent 8453, or equivalent). Use standard transmission-
matched quartz 10-mm path length rectangular cells with PTFE cover 
for absorbance measurements.
    2.2.4 Glassware. Including: 25-ml graduated mixing cylinders (a 
graduated cylinder with a ground glass stopper); 50- and 100-ml 
graduated cylinders; 125-mL separatory funnels with Teflon 
stopcocks; 10-ml volumetric flasks; 30-ml crimp style glass serum 
bottles; 1-, 2-, 5-mL pipettes; other miscellaneous laboratory 
items.
    2.2.5 Micropipettor. Use a micropipettor capable of dispensing 4 
[micro]L of dispersant and 100 [micro]L of oil (e.g., Brinkmann 
Eppendorf repeater pipettor with 100 [micro]L and 5 mL syringe tip 
attachments or equivalent).
    2.2.6 Syringes. 25-, 100-, 250-, 1,000-, 2,500-, 5,000-[micro]l 
gas-tight syringes.
    2.2.7 Constant temperature rooms or incubators to hold the 
shaker at 5 [deg]C and 25 [deg]C.
    2.2.8 Analytical Balance.
    2.2.9 Chemical fume hood.
    2.3 Reagents.
    2.3.1 Artificial seawater. Use the artificial seawater GP2 
formulation shown in Table 1 of this Appendix.
    2.3.2 Test oil. Use the EPA standard reference oil Strategic 
Petroleum Reserve Bryan Mound. To obtain this oil at no charge 
(except for a minimal shipping fee), see the instructions at http://www.epa.gov/emergencies/content/ncp/index.htm. Selected properties 
are summarized in Table 2 of this Appendix.
    2.3.3 Dichloromethane (DCM) (also known as methylene chloride), 
pesticide quality.
    2.4 Container Handling and Storage.
    2.4.1 Glassware. If the glassware has been used with oil before, 
rinse with DCM to remove as much of the oil adhering to the sides of 
the flask as possible; waste DCM may be used. Soak in warm water 
with detergent and individually wash with bristled brushes. First 
rinse with tap water, then follow with two de-ionized water rinses. 
Dry either on a rack or in a 110 [deg]C drying oven. After drying, 
rinse with fresh DCM (use sparingly).
    2.4.2 Serum bottles and other non-volumetric glassware. Bake for 
at least 4 hours in a muffle furnace at 450 [deg]C.
    2.5 Calibration Curve for the UV-visible spectrophotometer.
    2.5.1 Stock Standard Solution Preparation. Stock standard 
solution concentrations are based on the mass measurements after 
each addition and density determinations of the oil/dispersant/DCM 
solution using a density bottle or a 1-mL gas tight syringe. An 
example calculation is given in Table 3 of this Appendix according 
to the following equation:
[GRAPHIC] [TIFF OMITTED] TR12JN23.079

    Use the reference oil and the specific dispersant being tested 
for a particular set of experimental test runs. Prepare the stock 
standard solution of dispersant-oil mixture in DCM, starting with 2 
ml of the oil, then adding 80 [micro]l of the dispersant followed by 
18 ml of DCM.
    2.5.2 Six-point Calibration Curve. For the reference oil, add 
specific volumes of its stock standard solution (given in Table 4 of 
this Appendix) to 30 ml of artificial seawater in a 125 ml 
separatory funnel. Extract the oil/dispersant water mixture with 
triplicate 5 ml volumes of DCM. Follow each DCM addition by 15 
seconds of vigorous shaking, carefully releasing the initial 
pressure inside the separatory funnel by partially removing the

[[Page 38340]]

glass stopper inside a fume hood after the first few shakes. Then, 
allow a 2-minute stationary period for phase separation for each 
extraction. Drain the extracts into a 25-mL graduated mixing 
cylinder. Release any entrained bubbles of DCM from the water layer 
by sideways shaking of the funnel. Use precaution not to drain water 
into the DCM extract as it can affect the absorbance readings. 
Adjust the final volume of the collected extracts to 25 mL in the 
mixing cylinder using DCM. Determine specific masses for oil 
concentrations in the standards as volumes of oil/dispersant 
solution multiplied by the concentration of the stock solution. An 
example calculation is given in Table 4 of this Appendix. One 
calibration curve is needed for the reference oil and dispersant 
combination.
    2.6 Sample Preparation and Testing. See section 2.7 of this 
Appendix for a detailed description of the spectrophotometer's 
linear calibration procedure.
    2.6.1 Six replicates of the oil and test dispersant are required 
at each temperature plus two additional tests of method blanks 
(artificial seawater without oil and dispersant), one at each 
temperature. A completed test consists of 14 baffled flask tests (a 
total of six replicates for the reference oil/test dispersant 
combination at two temperatures (5 [deg]C and 25 [deg]C), plus two 
method blanks).
    2.6.2 Attach a 3-inch length of Teflon tubing to the stopcock of 
each of the 150-mL baffled flasks. Add 120 mL of artificial seawater 
to each flask. Put screw cap on flasks and place them at the 
appropriate temperature (either 5 [deg]C or 25 [deg]C) for 
equilibration.
    2.6.3 Calibrate and adjust the shaker table to 250  
10 rpm.
    2.6.4 Prepare and time separately each baffled flask. 
Sequentially add 100 [micro]L of oil and 4 [micro]L of dispersant to 
the flask layering them onto the center of the seawater to give a 
dispersant-to-oil ratio (DOR) of 1:25. Avoid any oil or dispersant 
splashing on the flask walls, as it may reduce efficacy or cause 
errors in the calculated results. Discard the sample and repeat the 
setup if: (1) any oil or dispersant splashing occurs during the 
additions, or (2) the dispersant contacts the water first rather 
than the oil. This is especially important for 5 [deg]C work because 
of increased oil viscosity.
    2.6.5 For the oil, fill the tip of the pipettor, using a wipe to 
remove any oil from the sides of the tip. Holding the pipettor 
vertically, dispense several times back into the reservoir to ensure 
that the oil flows smoothly. Insert the syringe tip vertically into 
the baffled flask and let the bottom of the pipettor rest on the 
neck of the flask. Slowly and carefully dispense the oil one time 
onto the center of the water's surface. The remainder of the oil can 
either be returned to the oil bottle or set aside for use in the 
next test flask.
    Note to 2.6.5: If a Brinkmann Eppendorf repeater pipettor is 
used for dispensing the oil, attach a 5-mL syringe tip, and set the 
dial to 1.
    2.6.6 For the dispersant, use the same procedure as for the oil 
to dispense onto the center of the oil slick surface. As the 
dispersant first contacts the oil, it will usually push the oil to 
the sides of the flask. Replace the screw cap onto the flask.
    Note to 2.6.6: If a Brinkmann Eppendorf repeater pipettor is 
used for dispensing the dispersant, attach a 100-[micro]L syringe 
tip, and set the dial to 2.
    2.6.7 Carefully place flask securely onto the shaker and agitate 
for 10  0.25 minutes at 250  10 rpm.
    2.6.8 Remove the flask from the shaker table and allow a 
stationary, quiescent period of 10  0.25 minutes to 
allow undispersed and/or recoalesced oil droplets to refloat to the 
surface.
    2.6.9 Carefully open the screw cap, then the stopcock at the 
bottom, and discard the first several mL of seawater into a waste 
beaker to remove non-mixed water-oil initially trapped in the 
stopcock tubing. Collect a volume slightly greater than 30-mL into a 
50-mL graduated cylinder. Adjust the collected volume to the 30-mL 
mark by removing excess with a disposable glass Pasteur pipette. A 
web-like emulsion may form at the solvent/water interface during the 
water sample extraction. Avoid pulling any emulsion phase into the 
DCM extract as it may cloud the DCM-extract, leading to error.
    2.6.10 Transfer the water-oil sample from the graduated cylinder 
into a 125-mL glass separatory funnel fitted with a Teflon stopcock.
    2.6.11 Add 5 mL DCM to the separatory funnel. Start shaking, 
releasing pressure into the fume hood by loosening the glass 
stopper. Shake vigorously at least 20 times for 15 seconds.
    2.6.12 Allow the funnel to remain in a stationary position for 2 
minutes to allow phase separation of the water and DCM.
    2.6.13 Drain the DCM layer from the separatory funnel into a 25 
mL mixing cylinder. Avoid pulling any emulsion phase into the DCM 
extract as it may cloud the DCM extract.
    2.6.14 Repeat the DCM-extraction process two or three additional 
times until the DCM is clear. Collect each extract in the graduated 
cylinder. After the final extraction, lightly shake the separatory 
funnel sideways once or twice to dislodge entrained bubbles of DCM 
and drain.
    2.6.15 Adjust the final volume to a known quantity, 25 mL, in 
the mixing cylinder. Using a syringe, dispense 2.5 mL or 5.0 mL of a 
reference oil sample into a 10-mL volumetric flask, and fill with 
DCM to make either a 1:4 or 1:2 dilution, respectively.
    2.6.16 If analysis cannot be conducted immediately, store the 
extracted DCM samples at 4  2 [deg]C until time of 
analysis. Glass-stoppered mixing cylinders may be used for short-
term storage or prior to bringing the extracts up to volume. After 
bringing to volume, transfer the DCM extracts to 25-30 ml crimp-
style serum vials with aluminum/Teflon seals.
    2.6.17 Complete all analysis within 10 consecutive days from 
when the sample was collected.
    2.7 UV-Visible Spectrophotometer Linear Stability Calibration
    2.7.1 A six-point calibration of the UV-visible 
spectrophotometer is required at least once per day for each oil. 
The stability calibration criterion is determined with the six oil 
standards identified in Table 4 of this Appendix.
    2.7.2 Turn on spectrophotometer and allow it to warm up for at 
least 30 minutes before beginning analysis. Blank the instrument for 
the wavelengths between 340 and 400 nm with DCM.
    2.7.3 If refrigerated, allow all extracts, standards, and 
samples to warm to room temperature.
    2.7.4 Determine the absorbance of the six standards between the 
wavelengths of 340 and 400 nm. This can be done by either one of the 
following methods:
    2.7.4.1 Trapezoidal Rule. Program the spectrophotometer to take 
readings every 5[lambda] or 10[lambda] and calculate the area under 
the curve using the Trapezoidal rule:
[GRAPHIC] [TIFF OMITTED] TR12JN23.080

where N + 1 = number of absorbance measurements to delineate N 
equally spaced sections of the curve, and H = the distance 
([lambda]) between each reading. For H = 5, N + 1 = 13 measurements, 
for H = 10, N + 1 = 7. The following formula illustrates readings 
taken every 10[lambda].
[GRAPHIC] [TIFF OMITTED] TR12JN23.081


[[Page 38341]]


    When using readings taken every 5[lambda], each absorbance sum 
is multiplied by 5.
    2.7.4.2 Automatic Integration. Program the spectrophotometer to 
automatically integrate the area under the curve between 340 nm and 
400 nm.
    2.7.4.3 If the wavelengths must be manually set on the 
spectrophotometer, the older method of only measuring at 
340[lambda], 370[lambda], and 400[lambda] may be used. Then 
calculate using the trapezoidal rule for N + 1 = 3, H = 30. While 
the resulting area count with the older method is less accurate, the 
final results are similar since the inaccuracy is systematic.
    2.7.5 After determining the area count for each standard, 
determine the response factor (RF) for the oil at each concentration 
using the following equation:
[GRAPHIC] [TIFF OMITTED] TR12JN23.082

    2.7.6 Spectrophotometer stability for the initial calibration is 
acceptable when the RFs of the six standard extracts are less than 
10% different from the overall mean value for the six standards, as 
calculated in Equation 5 of this Appendix and depicted in the 
example in Table 4 of this Appendix.
[GRAPHIC] [TIFF OMITTED] TR12JN23.083

    2.7.7 If this criterion is satisfied, begin analysis of sample 
extracts. Absorbances greater than or equal to 3.5 are not included 
because absorbance saturation occurs at and above this value. If any 
of the standard oil extracts fails to satisfy the initial-stability 
criterion, the source of the problem (e.g., preparation protocol for 
the oil standards, spectrophotometer stability, etc.) must be 
corrected before analysis of the sample extracts begins.
    2.7.8 Determine the slope of the calibration points by using 
linear regression forced zero intercept:
[GRAPHIC] [TIFF OMITTED] TR12JN23.084

    2.8 Spectrophotometric Analysis and Calculations
    2.8.1 Once a successful calibration curve for the reference oil 
has been created and verified, measure experimental replicates for 
the reference oil at each temperature followed by a standard check 
sample.
    2.8.2 Determine the area for the absorbance values obtained for 
the experimental samples by using Equation 2 of this Appendix and 
illustrated by Equation 3 of this Appendix.
    2.8.3 Calculate the Total Oil dispersed and the percentage of 
oil dispersed (%OD) based on the ratio of oil dispersed in the test 
system to the total oil added to the system, as follows:
[GRAPHIC] [TIFF OMITTED] TR12JN23.085

where:

VDCM = final volume of the DCM extract (mL)
Vtw = total seawater in Baffled Flask (120 mL)
Vew = volume seawater extracted (30 mL)
[GRAPHIC] [TIFF OMITTED] TR12JN23.086

where:

rOil = density of the specific test oil, mg/mL and
VOil = Volume (mL of oil added to test flask (100 
[micro]L = 0.1 mL))

    2.8.4 The %ODs for the six replicates within a particular 
treatment are then subjected to an outlier test, the Grubb's Test

[[Page 38342]]

or Maximum Normal Residual test (6). A convenient internet-based 
calculator of a Grubbs outlier may be found at: http://www.graphpad.com/quickcalcs/Grubbs1.cfm. If an outlier is detected 
(p < 0.05), analyze an additional replicate to obtain the required 
six replicates.
    2.8.5 Report the Dispersion Efficacy value for each oil and each 
temperature, which is the lower 95% confidence level of the 6 
independent replicates (DELCL95) for each oil/temperature 
combination. Error bars are not needed as reporting the lower 
confidence level computationally takes the variability of the 
replicates into account as shown in Equation 9 of this Appendix.
[GRAPHIC] [TIFF OMITTED] TR12JN23.087

where %OD%OD = mean percentage oil dispersed for the n = 6 
replicates, S = standard deviation, and 
t(n-1,1-[alpha]) = 100 * (1-[alpha])th 
percentile from the t-distribution with n-1 degrees of freedom. For 
6 replicates, tn-1,1-[alpha] = 2.015, where [alpha] = 
0.05. An example of the calculations is given in Table 5 of this 
Appendix.

    2.9 Performance Criterion
    The dispersant product tested will remain in consideration for 
listing on the NCP Product Schedule if the dispersant efficacy 
(DELCL95), as calculated in section 2.8.6 of this 
Appendix, is:

------------------------------------------------------------------------
                                                     Temp    DELCL95 (%)
                       Oil                         ([deg]C)
------------------------------------------------------------------------
Bryan Mound......................................        5         >=70
Bryan Mound......................................       25         >=75
------------------------------------------------------------------------

    2.10 Quality Control (QC) Procedures for Oil Concentration 
Measurements
    2.10.1 Absorbance readings. Perform at least 5% of all UV-
visible spectrophotometric measurements in duplicate as a QC check 
on the analytical measurement method. The absorbance values for the 
duplicates must agree within 5% of their mean value.
    2.10.2 Method blanks. Analytical method blanks involve an 
analysis of artificial seawater blanks (artificial seawater without 
oil or dispersant in a baffled flask) through testing and analytical 
procedures. Analyze method blanks with a frequency of at least two 
per completed test. Oil concentrations in method blanks must be less 
than detectable limits.
    2.10.3 Accuracy. Determine accuracy by using a mid-point 
standard calibration check after each set of replicate samples 
analyzed. The acceptance criterion is based on a percent recovery of 
90-110% using the following equation:
[GRAPHIC] [TIFF OMITTED] TR12JN23.088

    2.10.4 Calibration QC checks. Before analyzing samples, the 
spectrophotometer must meet an instrument stability calibration 
criterion using the oil standards. The instrument stability for 
initial calibration is acceptable when the RFs (Equation 5 of this 
Appendix) for each of the six standard concentration levels are less 
than 10% different from the overall mean value.

     Table 1--Constituent Concentrations for GP2 Artificial Seawater
                     [Based on Spotte et al., 1984]
------------------------------------------------------------------------
                                                       Concentration (g/
                     Constituent                               L)
------------------------------------------------------------------------
NaCl.................................................              21.03
Na2SO4...............................................               3.52
KCl..................................................               0.61
KBr *................................................              0.088
Na2B4O7 x 10H2O *....................................              0.034
MgCl2 x 6H2O.........................................               9.50
CaCl2 x 2H2O.........................................               1.32
SrCl2 x 6H2O *.......................................               0.02
NaHCO2 *.............................................               0.17
------------------------------------------------------------------------
* Use Stock Solution, 1 mL/L GP2 for 100X stock solution for Bromide,
  Borate, and Strontium. 10 mL/L GP2 for bicarbonate--10X stock solution
  as it is not soluble in a 100X solution. Adjust to pH 8.0 prior to
  autoclaving.


                                        Table 2--Test Oil Characteristics
                                             [April 2023 oil assay]
----------------------------------------------------------------------------------------------------------------
                                   Density, mg/mL    API gravity @15    Viscosity @25
               Oil                   @15 [deg]C          [deg]C         [deg]C, (cSt)    Category by API gravity
----------------------------------------------------------------------------------------------------------------
SPR Bryan Mound.................            0.8320              38.6             4.721  Light Oil.
----------------------------------------------------------------------------------------------------------------


[[Page 38343]]


  Table 3--Sample Calculation for Preparation of Oil + Dispersant Stock
                            Standard Solution
------------------------------------------------------------------------
                Item                      Identifier          Amount
------------------------------------------------------------------------
Mass of Bottle, g...................                  A           29.498
Mass of Bottle + oil, g.............                  B           31.225
Mass of bottle + disp + oil + DCM, g                   C          54.380
Mass of oil, g (derived)............            F = B-A            1.727
Mass of disp + oil + DCM, g                        G = C-A        24.882
 (derived)..........................
Mass of 1 mL syringe, g.............                  D           14.556
Mass of 1 mL syringe + solution, g..                  E           15.820
Density of solution, g/mL (derived).            H = E-D            1.264
Volume of solution, mL (derived)....            I = G/H           19.687
Conc. of stock solution, mg/mL             J = F*1000/I           87.704
 (derived)..........................
------------------------------------------------------------------------


                     Table 4--Sample Calculations for Oil + Dispersant Six Point Calibration
----------------------------------------------------------------------------------------------------------------
                  Oil + Dispersant Stock Standard Solution Concentration = 87.7 mg/mL (Table 3)
-----------------------------------------------------------------------------------------------------------------
                                    Theoretical    Area (340-400                           Dev. from
    Standard--stock vol. (uL)      conc., mg/mL         nm)           RF        Avg. RF     avg. RF      Slope
----------------------------------------------------------------------------------------------------------------
25..............................           0.088           4.126       0.021       0.021       2.931      48.759
50..............................           0.175           8.757       0.020  ..........       3.017  ..........
100.............................           0.351          16.559       0.021  ..........       2.577  ..........
150.............................           0.526          25.666       0.021  ..........       0.731  ..........
200.............................           0.702          34.142       0.021  ..........       0.500  ..........
250.............................           0.877          43.006       0.020  ..........       1.260  ..........
----------------------------------------------------------------------------------------------------------------


                                                           Table 5--LCL95 Sample Calculation With Test Oil and Example Dispersant `A'
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Area (340-             Extract             Mass in   Total oil
                              Rep                                 400 nm)    Dilution   volume   Conc, mg/  30 mL,   dispersed,  Efficiency,   Average    Std.     Variance   Coef. of    LCL95
                                                                              factor    (ml) *      mL.       mg         mg           %                   dev.               variation
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1..............................................................     32.197          1        25      0.66     16.51       66.03        79.76     81.30      4.46      19.85       5.48     81.30
2..............................................................     35.470          1        25      0.73     18.19       72.75        87.87  ........  ........  .........  .........  ........
3..............................................................     30.260          1        25      0.62     15.52       62.06        74.96  ........  ........  .........  .........  ........
4..............................................................     31.831          1        25      0.65     16.32       65.28        78.85  ........  ........  .........  .........  ........
5..............................................................     33.355          1        25      0.68     17.10       68.41        82.63  ........  ........  .........  .........  ........
6..............................................................     33.791          1        25      0.69     17.33       69.30        83.71  ........  ........  .........  .........  ........
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* = 25 ml of DCM extract captured oil from 30 ml of aqueous DE test.

    2.11 References for Section 2.0

(1) U.S. Environmental Protection Agency (1994), ``Swirling Flask 
Dispersant Effectiveness Test,'' Title 40 Code of Federal 
Regulations, Pt. 300, Appendix C, pp 47458-47461.
(2) Sorial, G.A., A.D. Venosa, K.M, Koran, E. Holder, and D.W. King. 
2004. ``Oil spill dispersant effectiveness protocol: I. Impact of 
operational variables.'' ASCE J. Env. Eng. 130(10):1073-1084.
(3) Sorial, G.A., A.D. Venosa, K.M, Koran, E. Holder, and D.W. King. 
2004. ``Oil spill dispersant effectiveness protocol: II. Performance 
of revised protocol.'' ASCE J. Env. Eng. 130(10):1085-1093.
(4) Venosa, A.D., D.W. King, and G.A. Sorial. 2002. ``The baffled 
flask test for dispersant effectiveness: a round robin evaluation of 
reproducibility and repeatability.'' Spill Sci. & Technol. Bulletin 
7(5-6):299-308.
(5) Spotte, S., G. Adams, and P.M. Bubucis. 1984. ``GP2 medium is an 
synthetic seawater for culture or maintenance of marine organisms,'' 
Zoo Biol, 3:229-240.
(6) Grubbs, F. 1969. ``Sample Criteria for Testing Outlying 
Observations,'' Annals of Mathematical Statistics, pp. 27-58.
    3.0 Dispersant Toxicity Testing
    3.1 Summary. This laboratory protocol includes testing for: (1) 
dispersant standard static acute toxicity tests for the mysid 
shrimp, Americamysis bahia (48-hr duration) and the inland 
silverside, Menidia beryllina (96-hr duration); (2) dispersant-oil 
mixture static acute toxicity tests for Americamysis bahia and 
Menidia beryllina (48-hr and 96-hr duration, respectively); (3) 
dispersant developmental assay for Strongylocentrotus purpuratus or 
Arbacia punctulata, (72-hr duration); and (4) dispersant 7-day 
static subchronic tests with Americamysis bahia and Menidia 
beryllina (Table 6 of this Appendix).

                                                 Table 6--Toxicity Testing Requirements for Dispersants
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Test procedure
---------------------------------------------------------------------------------------------------------------------------------------------------------
                                   96-Hr static acute: Menidia        48-Hr static acute:             72-Hr sea urchin           7-Day subchronic: M.
         Test substance                     beryllina                  Americamysis Bahia           developmental assay          beryllina & A. bahia
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dispersant only.................  yes..........................  yes..........................  yes........................  yes.
Dispersant--Reference Oil         yes..........................  yes..........................  no.........................  no.
 Mixture.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3.2 Preparation of Stock Solutions
    3.2.1 Dispersant. Prepare a 1000 [mu]L/L primary stock solution 
prior to test initiation by adding 1.1 mL of dispersant to 1100 mL 
of dilution water consisting of salinity

[[Page 38344]]

adjusted uncontaminated natural or artificial seawater, in a glass 
vessel. Using a laboratory top stirrer equipped with a stainless-
steel blade, center the stirrer blade in the mixing vessel one inch 
off the bottom. Initially mix the resulting stock solution for 
approximately five seconds at speeds of <10,000 rpm to avoid 
foaming. Thereafter, set the speed to provide a 70% vortex. Using a 
glass pipette, remove appropriate aliquots of stock solution from 
between the mixing vessel wall and edge of the vortex and place 
directly into the dilution water within an exposure vessel. Suspend 
mixing of the stock solution after the removal of each aliquot. Base 
the preparation of exposure solutions on the nominal concentration 
of the stock solution and follow procedures outlined in sections 3.5 
and 3.6 of this Appendix.
    3.2.2 Dispersant-Reference Oil(s) Mixtures. Use Strategic 
Petroleum Reserve Bryan Mound reference oil. To obtain this oil at 
no charge (except for a minimal shipping fee) see https://www.epa.gov/emergency-response/national-contingency-plan-subpart-j#howto. Assessment of dispersant-reference oil mixture (DOM) 
toxicity is determined for each reference oil using the aqueous 
phase of a chemically enhanced-water accommodated fraction (CE-WAF). 
Fit a glass aspirator bottle (approximately 23 L) equipped with a 
hose bib at the base with a length of silicon tubing containing a 
hose clamp. Fill the bottle with 19L of seawater leaving a 20% 
headspace above the liquid, place on a magnetic stir plate then add 
and center a stir bar. Add the reference oil at 25 g/L using a 
silicon tube attached to a glass funnel that reaches just below the 
water surface. Using this method reduces the production of air 
bubbles on the oil surface slick. Adjust the stir plate to obtain an 
oil vortex of 25% of the total volume of the seawater, then add the 
dispersant to be tested at a ratio of 1:10 dispersant:oil (2.5 g/L). 
Securely seal the bottle to reduce the loss of volatiles using a 
silicon stopper and wraps of Parafilm and stir for 18 hours, then 
allow the solution to settle for 6 hours. Maintain the temperature 
at 25 [deg]C during stirring and settling. Purge the hose at the 
base of the bottle of any material followed by removal of the CE-WAF 
(aqueous phase) into a clean glass container without disturbing the 
surface oil slick. The CE-WAF should be remixed and 1 to 2 L removed 
for chemical analysis of total petroleum hydrocarbons (TPH) 
following the procedures outlined in section 3.4 of this Appendix. 
The remaining volume will be used for the preparation of exposure 
solutions following procedures outlined in section 3.3 of this 
Appendix. To reduce time and cost, mix sufficient amounts of 
dispersant product-reference oil mixture CE-WAF to allow preparation 
of exposure solutions for conducting simultaneous acute tests with 
both Americamysis bahia and Menidia beryllina.
    3.3 Preparation of Exposure Concentrations.
    3.3.1 Concentration Selection. Preliminary rangefinder tests may 
be necessary using a series of logarithmic concentrations (e.g. 0.1, 
1, 10, 100 [micro]l dispersant product/L or mg TPH/L) to determine 
the appropriate exposure concentration range necessary to determine 
LC50 values and 95% confidence intervals. For definitive 
tests, conduct a minimum of five test concentrations using a 
geometric ratio between 1.5 and 2.0 (e.g. 2, 4, 8, 16, and 32). Note 
that when testing only the dispersant product, the highest test 
concentration must not exceed the dispersant's self-dispersibility 
limit.
    3.3.2 Exposure Concentrations. Exposure solutions are prepared 
by adding the appropriate amount of stock solution directly to 
dilution water in each test chamber. Mix each exposure solution 
using five rotations in one direction followed by five rotations in 
the opposite direction using a solid glass stir rod.
    3.3.3 Reference Toxicants. Separate toxicity tests must be 
performed with a reference toxicant for each species tested. Conduct 
additional reference toxicity tests any time a change in the 
population or source of a test species occurs. Use sodium dodecyl 
sulfate (SDS), also known as dodecyl sodium sulfate (DSS), and 
sodium lauryl sulfate (SLS) as the reference toxicant for exposures 
conducted with Menidia beryllina and Americamysis bahia. Use copper 
chloride as the reference toxicant for exposures conducted with the 
sea urchin developmental test. Use reagent grade quality SDS and 
copper chloride for tests. Information on procedures for conducting 
reference toxicant tests with these species can be found in the 
specific EPA methods documents cited in sections 3.5.1, 3.6.1, and 
3.7.1 of this Appendix.
    3.4 Chemical Analysis of Stock Solutions. Add the 1 L sample of 
CE-WAF (Section 3.2.2 of this Appendix) solutions directly to amber 
glass bottles with Teflon[supreg]-lined cap. Collect a replicate 
sample in the event of accidental loss or if reanalysis of the stock 
solution becomes necessary. Adjust sample to a pH=2 using 50% 
hydrochloric acid, immediately refrigerate and analyze within 48 
hours of collection. Analyze samples for C9-C32 TPH by gas 
chromatography-flame ionization detection (GC-FID) following EPA SW-
846, Method 8015B-DRO (4). Report TPH concentration of stock 
solutions as milligrams TPH/L and use in the calculation of exposure 
concentrations for all toxicity tests conducted with CE-WAF.
    3.5 Static Acute Tests with M. beryllina and A. bahia
    3.5.1 General. Use EPA's Methods for Measuring the Acute 
Toxicity of Effluents and Receiving Waters to Freshwater and Marine 
Organisms (EPA-821-R-02-012) (1) for testing each species separately 
with dispersant product or a mixture of dispersant product and 
reference oil (DOM).
    3.5.2 Test Solutions. Modify procedures in EPA-821-R-02-012 
specifically dealing with the handling and toxicity testing of 
effluents or receiving water samples as follows: Prepare stock 
solutions following section 3.2 of this Appendix and exposure 
concentrations following section 3.3 of this Appendix.
    3.5.3 Number of Treatments, Replicates and Organisms. Conduct a 
minimum of three replicates of at least five exposure treatments 
plus a minimum of three replicate dilution water controls. Expose 
ten organisms per replicate treatment.
    3.5.4 Exposure Period. Test duration is 48-hr for Americamysis 
bahia and 96-hr for Menidia beryllina. Mortality must be recorded at 
each 24-hour period of each test.
    3.5.5 Test Acceptability. For each test performed, survival of 
control animals must be >90% and test results must allow 
determination of statistically valid LC50 and 95% 
confidence interval values except in cases where the LC50 
is >1000 [mu]l/L or is determined to be greater than the limits of 
water solubility of dispersibility.
    3.5.6 Static Acute Test Summary. A summary of required test 
conditions is provided in Table 7 of this Appendix.
    3.6 Sea Urchin Developmental Test with Dispersant Product
    3.6.1 General. Use Section 15, ``Purple Urchin, 
Strongylocentrotus purpuratus and Sand Dollar, Dendraster 
excentricus Larval Development Test Method'' of EPA's Short-Term 
Methods for Estimating the Chronic Toxicity of Effluents and 
Receiving Waters to West Coast Marine and Estuarine Organisms (EPA/
600/R-95-136) (2). Alternatively, the development of the urchin 
Arbacia punctulata may be tested (see Table 7).
    3.6.2 Test Organism. Tests of dispersant products are to follow 
methods for the purple urchin only. Tests with the sand dollar are 
not required.
    3.6.3 Test Solutions. Modify procedures in EPA/600/R-95-136, 
Section 15 specifically dealing with the handling and toxicity 
testing of effluents or receiving water samples as follows: Prepare 
stock solutions following section 3.2.1 of this Appendix and 
exposure concentrations following section 3.3 of this Appendix.
    3.6.4 Number of Treatments and Replicates. Conduct a minimum of 
four replicates of five exposure treatments plus a minimum of four 
replicate dilution water controls.
    3.6.5 Exposure Duration and Test Endpoint. Examine the effects 
of the dispersant product on normal development of sea urchin 
embryos over a period of 72 hours. An IC50 (the exposure 
concentration at which normal development is inhibited in 50% of the 
embryos) with 95% confidence intervals are to be determined in place 
of an IC25. The concentration of dispersant causing 
inhibition of development in 50% of exposed embryos 
(IC50) with the lower and upper 95% confidence intervals 
(LCI95 and ULCI95) must be calculated at the 
end of the exposure period. Mortality determinations are not 
required.
    3.6.6 Test Acceptability. Requirements of the assay are: (i) 
>=80% normal larval development in the control treatment, (ii) the 
minimum significant difference (MSD) that can be statically detected 
relative to the control is <=25%, iii) test results which support 
the determination of a statistically valid IC50 and 95% 
confidence interval unless the LC50 is >1000 [mu]l/L or 
is greater than the limits of water solubility of dispersibility.
    3.6.7 Urchin Developmental Test Summary. A summary of required 
test conditions is provided in Table 7 of this Appendix.
    3.7 Seven-day Subchronic Tests with M. beryllina and A. bahia

[[Page 38345]]

    3.7.1 General. Use Section 13, Method 1006.0, ``Inland 
Silverside (Menidia beryllina) Larval Survival and Growth Method,'' 
and Section 14, Method 1007.0, ``Mysid (Mysidopsis [renamed 
Americamysis] bahia) Survival, Growth, and Fecundity Method'' of 
EPA's Short-Term Methods for Estimating the Chronic Toxicity of 
Effluents and Receiving Waters to Marine and Estuarine Organisms 
(EPA-821-R-02-014) (3) for testing of dispersant product.
    3.7.2 Test Solutions. Modify procedures in EPA-821-R-02-014, 
sections 13 and 14 specifically dealing with the handling and 
toxicity testing of effluents or receiving water samples as follows: 
Prepare stock solutions following section 3.2.1 of this Appendix and 
exposure concentrations following section 3.3 of this Appendix. 
Exposure solutions should be renewed every 24 hours for the duration 
of the test.
    3.7.3 Number of Treatments, Replicates and Organisms. (i) 
Menidia beryllina: Conduct a minimum of four replicates of at least 
five exposure treatments plus a minimum of four replicate dilution 
water controls. Expose ten M. beryllina per replicate treatment. 
(ii) Americamysis bahia: Conduct a minimum of eight replicates of at 
least five exposure treatments plus a minimum of eight replicate 
dilution water controls. Expose five A. bahia per replicate 
treatment.
    3.7.4 Exposure Duration and Test Endpoint. The test duration is 
seven days for both species. Test endpoints for Menidia beryllina 
are survival and growth (dry weight) and for Americamysis bahia is 
survival, growth (dry weight) and fecundity. Calculate an 
LC50 and 95% confidence interval for survival and 
IC25 and IC50 with 95% confidence intervals 
for growth (and fecundity for A. bahia only). Report the lowest 
observed effect concentration (LOEC) and no observed effect 
concentration (NOEC) for each endpoint.
    3.7.5 Test Acceptability. Requirements of the assay are: (i) 
>=80% survival in the control treatment for each species, (ii) dry 
weights must meet the specific requirements as stipulated in Method 
1006.0 for Menidia beryllina and Method 1007.0 for Americamysis 
bahia.
    3.7.6 Subchronic Test Summary. A summary of required test 
conditions for each species is provided in Table 7 of this Appendix.
    3.8 Laboratory Report. The laboratory must include, for each 
toxicity test report, all applicable information, data and analyses 
as follows:
    3.8.1 Test Objective: protocol title and source, endpoint(s);
    3.8.2 Product Information: product name, manufacturer contact 
information, lot number, production date, date received/chain of 
custody;
    3.8.3 Contract Facility: contact information;
    3.8.4 Dilution Water: source, pretreatment, physical and 
chemical characteristics (pH, salinity);
    3.8.5 Test Conditions: date and time of test (start and end), 
test chambers type and volume, volume of solution per chamber, 
number of organisms per chamber, number of replicate chambers per 
treatment, feeding frequency, amount and type of food, test 
concentrations, test temperature (mean and range), test salinity 
(mean and range);
    3.8.6 Test Organisms: common and scientific name, source contact 
information, age and date purchased, acclimation conditions (e.g., 
temperature, salinity, both mean and range), age at test start;
    3.8.7 Reference toxicant: date received, lot number, date of 
most recent test, results and current Cumulative Sum Chart, dilution 
water used, physical and chemical methods used;
    3.8.8 Quality Assurance: verification of laboratory 
accreditation, including subcontractor facilities;
    3.8.9 Test Results: raw data in tabular and graphical form, 
daily records of affected organisms in each concentration replicate 
and controls, table of required endpoints (i.e., LC50 
with 95% confidence interval (CI), IC25 and 
IC50 with 95% CI, LOEC and NOEC), statistical methods 
used to calculate endpoints, summary tables of test conditions and 
QA data;
    3.8.10 Analytical Results: method summary including Limit of 
Detection (LOD)/Limit of Quantitation (LOQ), deviations and reasons 
if any, sample summary, results including chromatograms and data 
qualifiers, QA summary including calibration curves, method blank 
and surrogate recovery, analytical results summary; and
    3.8.11 Conclusions: Relationship between test endpoints and 
threshold limit.

                                                Table 7--Summary of Test Conditions--Dispersant Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                       Development S.
                                       Acute M. beryllina        Acute A. bahia          Subchronic M.       Subchronic A. bahia       purpuratus/A.
                                                                                           beryllina                                     punctulata
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test type..........................  Static non-renewal....  Static non-renewal....  Static renewal         Static renewal         Static non-renewal.
                                                                                      (daily).               (daily).
Test duration......................  96 hours..............  48 hours..............  7 days...............  7 days...............  72  2
                                                                                                                                    hours.
Salinity...........................  20          20          20         20         34 
                                      2[permil].              2[permil].              2[permil].             2[permil].             2[permil].
                                    ----------------------------------------------------------------------------------------------
Temperature........................       25  1 [deg]C. Test temperatures must not deviate (maximum minus minimum      15  1
                                                           temperature) by for than 3 [deg]C during the test.                       [deg]C.
                                    --------------------------------------------------------------------------------------------------------------------
Light quality......................                                            Ambient laboratory illumination.
Light intensity....................                                                  10-20 [mu]E/m\2\/s.
Photoperiod........................                            16 h light, 8 h darkness, with phase in/out period recommended.
                                    --------------------------------------------------------------------------------------------------------------------
Test chamber size \1\..............  250 mL................  250 mL................  600 mL-1 L...........  400 mL...............  30 mL.
Test solution volume \1\...........  200 mL................  200 mL................  500-750 mL...........  150 mL...............  10 mL.
Age of test organism \2\...........  9-14 days.............  1-5 days..............  7-11 days............  7 days...............  1 hr old fertilized
                                                                                                                                    eggs.
No. organisms per test chamber.....  10....................  10....................  10...................  5....................  25 embryos per mL.
No. of replicate chambers per        3.....................  3.....................  4....................  8....................  4.
 concentration.
                                    ----------------------------------------------------------------------------------------------
Feeding regime.....................               Refer to specific feeding procedures provided in each test method.               None.
                                    --------------------------------------------------------------------------------------------------------------------
Aeration...........................               None, unless DO falls below 4.0 mg/L, then aerate all chambers. Rate: <100 bubbles/minute.
Test concentrations................                              5 exposure concentrations and a control (minimum required).
                                    --------------------------------------------------------------------------------------------------------------------
Test acceptability (required)......  >=90% survival in       >=90% survival in       For controls: >=80%    For controls: >=80%    >=80% normal shell
                                      controls.               controls.               survival; average      survival; average      development in
                                                                                      dry weight >=0.5mg     dry weight >=0.20 mg.  controls.
                                                                                      where test starts
                                                                                      with 7 day old
                                                                                      larvae, or >=0.43 mg
                                                                                      for larvae preserved
                                                                                      for <=7days.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Recommended minimum value.
\2\ Less than or equal to 24-hr range in age.

    3.9 References for Section 3.0

(1) U.S. EPA. 2002. Methods for Measuring the Acute Toxicity of 
Effluents and Receiving Waters to Freshwater and Marine Organisms. 
Fifth Edition. U.S.

[[Page 38346]]

Environmental Protection Agency, Washington, DC (EPA-821-R-02-012).
(2) U.S. EPA. 1995. Short-Term Methods for Estimating the Chronic 
Toxicity of Effluents and Receiving Waters to West Coast Marine and 
Estuarine Organisms. First Edition. U.S. Environmental Protection 
Agency, Washington, DC (EPA/600/R-95-136)
(3) U.S. EPA. 2002. Short-Term Methods for Estimating the Chronic 
Toxicity of Effluents and Receiving Waters to Marine and Estuarine 
Organisms. Third Edition. U.S. Environmental Protection Agency, 
Washington, DC (EPA-821-R-02-014).
(4) U.S. EPA. 2008. Test Methods for Evaluating Solid Waste, 
Physical/Chemical Methods U.S. Environmental Protection Agency, 
Washington, DC (SW-846) http://www.epa.gov/osw/hazard/testmethods/sw846/online/index.htm.

    4.0 Standard Acute Toxicity Testing of Surface Washing Agents, 
Bioremediation Agents, Herding Agents, and Solidifiers.
    4.1 Summary. This laboratory protocol includes testing for: (1) 
saltwater standard static acute toxicity tests for test products 
with the mysid shrimp, Americamysis bahia (48-hr duration) and the 
inland silverside, Menidia beryllina (96-hr duration); and (2) 
freshwater standard static acute toxicity tests for test products 
with the daphnid, Ceriodaphnia dubia (48-hr duration) and the 
fathead minnow, Pimephales promelas (96-hr duration) (see Table 8 of 
this Appendix).

  Table 8--Toxicity Testing Requirements for Surface Washing Agents, Herding Agents, Bioremediation Agents and
                                                   Solidifiers
----------------------------------------------------------------------------------------------------------------
                                                                  Test procedure
                                 -------------------------------------------------------------------------------
     Application environment         96-hr Static        48-hr Static        96-hr Static        48-hr Static
                                    acute: Menidia          acute:         acute: Pimephales        acute:
                                       beryllina      Americamysis bahia       promelas       Ceriodaphnia dubia
----------------------------------------------------------------------------------------------------------------
Saltwater only..................  yes...............  yes...............  no................  no.
Freshwater only.................  no................  no................  yes...............  yes.
Freshwater and saltwater use....  yes...............  yes...............  yes...............  yes.
----------------------------------------------------------------------------------------------------------------

    4.2 Dilution Water. Use Section 7 of EPA's Methods for Measuring 
the Acute Toxicity of Effluents and Receiving Waters to Freshwater 
and Marine Organisms (EPA-821-R-02-012) [1] for preparation of the 
appropriate dilution water for each species tested. Use of clean 
natural or synthetic seawater for tests conducted with saltwater 
species is acceptable.
    4.3 Preparation of Stock Solutions.
    4.3.1 Liquid Surface Washing Agents and/or Herding Agents. 
Prepare a 1000 [micro]L/L stock solution prior to test initiation by 
adding 1.1 mL of test product to 1100 mL of dilution water in a 
glass vessel. Place on a magnetic stir plate then add and center a 
stir bar and adjust the stir plate to obtain a vortex of 25% of the 
total volume of the liquid. Mix the resulting stock solution for 
approximately five minutes at room temperature. Using a glass 
pipette, remove appropriate aliquots of stock solution from between 
the mixing vessel wall and edge of the vortex and place directly 
into the dilution water within an exposure vessel. Base the 
preparation of exposure solutions on the nominal concentration of 
the stock solution and follow procedures outlined in sections 4.6 
and/or 4.7 of this Appendix, as appropriate.
    4.3.2 Bioremediation Agents. For products consisting of two or 
more liquid and/or solid components, prepare the product following 
the manufacturers recommended procedure and ensure the test product 
mixture is completely blended. Prepare a 1000 [micro]L/L stock 
solution prior to test initiation by adding 1.1 mL of the test 
product mixture to 1100 mL of dilution water in a glass vessel. 
Place on a magnetic stir plate then add and center a stir bar and 
adjust the stir plate to obtain a vortex of 25% of the total volume 
of the liquid. Mix the resulting stock solution for approximately 
five minutes at room temperature. Using a glass pipette, remove 
appropriate aliquots of stock solution from between the mixing 
vessel wall and edge of the vortex and place directly into the 
dilution water within an exposure vessel. Base the preparation of 
exposure solutions on the nominal concentration of the stock 
solution and follow procedures outlined in sections 4.5 and/or 4.6 
of this Appendix, as appropriate.
    4.3.3 Solid Phase Products. Assessment of the toxicity of 
solidifiers and other solid phase products are determined using the 
aqueous phase of water-accommodated fractions (WAFs) of the test 
product. Fit a glass aspirator bottle (approximately 23L) equipped 
with a hose bib at the base with a length of silicon tubing 
containing a hose clamp. Fill the bottle with 19L of dilution water 
leaving a 20% headspace above the liquid, place on a magnetic stir 
plate then add and center a stir bar. Add the test product at 25 g/L 
and securely seal the bottle using a silicon stopper and wraps of 
parafilm. Adjust the stir plate to obtain a vortex of 25% of the 
total fluid volume, stir for 18 hours then settle for 6 hours. 
Maintain the temperature at 25 [deg]C during stirring and settling. 
Purge the hose at the base of the bottle of any material followed by 
removal of the WAF (aqueous phase) into a clean glass container 
without disturbing the product on the surface. The WAF should be 
remixed and used for the preparation of exposure solutions following 
procedures outlined in section 4.4 of this Appendix.
    4.4 Preparation of Exposure Concentrations.
    4.4.1 Concentration Selection. Preliminary rangefinder tests may 
be necessary using a series of logarithmic concentrations (e.g. 0.1, 
1, 10, 100 [micro]l test product/L) to determine the appropriate 
exposure concentration range necessary to determine LC50 
values and 95% confidence intervals. For definitive tests, conduct a 
minimum of five test concentrations using a geometric ratio between 
1.5 and 2.0 (e.g. 2, 4, 8, 16, and 32). Note that when testing the 
product, the highest test concentration should not exceed the test 
product's self-dispersibility limit.
    4.4.2 Exposure Concentrations. Exposure solutions are prepared 
by adding the appropriate amount of stock solution directly to 
dilution water in each test chamber. Mix each exposure solution 
using five rotations in one direction followed by five rotations in 
the opposite direction using a solid glass stir rod.
    4.4.3 Reference Toxicants. Separate toxicity tests must be 
performed with a reference toxicant for each species tested. Conduct 
additional reference toxicity tests any time a change in the culture 
population or source of a test species occurs. Use reagent grade 
quality sodium dodecyl sulfate (SDS), also known as dodecyl sodium 
sulfate (DSS), and sodium lauryl sulfate (SLS) as the reference 
toxicant. Information on procedures for conducting reference 
toxicant tests with these species can be found in section 4 of EPA's 
Methods for Measuring the Acute Toxicity of Effluents and Receiving 
Waters to Freshwater and Marine Organisms (EPA-821-R-02-012) (3).
    4.5 Saltwater Static Acute Tests with Menidia beryllina and 
Americamysis bahia
    4.5.1 General. Use EPA's Methods for Measuring the Acute 
Toxicity of Effluents and Receiving Waters to Freshwater and Marine 
Organisms (EPA-821-R-02-012) (1) for testing each species separately 
with the test product.
    4.5.2 Test Solutions. Modify procedures in EPA-821-R-02-012 
specifically dealing with the handling and toxicity testing of 
effluents or receiving water samples as follows: Prepare stock 
solutions following the appropriate sections (4.3.1, 4.3.2, or 
4.3.3) of this Appendix and exposure concentrations following 
section 4.4 of this Appendix.
    4.5.3 Number of Treatments, Replicates and Organisms. Conduct a 
minimum of three replicates of at least five exposure treatments 
plus a minimum of three replicate dilution water controls. Expose 
ten organisms per replicate treatment.
    4.5.4 Exposure Period. Test duration is 48-hr for A. bahia and 
96-hr for M. beryllina.

[[Page 38347]]

Mortality must be recorded at each 24 hour period of each test.
    4.5.5 Test Acceptability. For each test performed, survival of 
control animals must be >90% and test results must allow 
determination of statistically valid LC50 and 95% 
confidence interval values except in cases where the LC50 
is >1000 [micro]l/L or is determined to be greater than the limits 
of water solubility or dispersibility.
    4.5.6 Static Acute Test Summary. A summary of required test 
conditions is provided in Table 9 of this Appendix.
    4.6 Freshwater Static Acute Tests with Pimephales promelas and 
Ceriodaphnia dubia
    4.6.1 General. Use EPA's Methods for Measuring the Acute 
Toxicity of Effluents and Receiving Waters to Freshwater and Marine 
Organisms (EPA-821-R-02-012) (1) for testing each species separately 
with the test product.
    4.6.2 Test Solutions. Modify procedures in EPA-821-R-02-012 
specifically dealing with the handling and toxicity testing of 
effluents or receiving water samples as follows: Prepare stock 
solutions following the appropriate sections (4.3.1, 4.3.2, or 
4.3.3) of this Appendix and exposure concentrations following 
section 4.4 of this Appendix.
    4.6.3 Number of Treatments, Replicates and Organisms. P. 
promelas: Conduct a minimum of three replicates of at least five 
exposure treatments plus a minimum of three replicate dilution water 
controls. Expose ten organisms per replicate treatment. C. dubia: 
Conduct a minimum of four replicates of at least five exposure 
treatments plus a minimum of four replicate dilution water controls. 
Expose five organisms per replicate treatment.
    4.6.4 Exposure Period. Test duration is 48-hr for C. dubia and 
96-hr for P. promelas. Mortality must be recorded at each 24 hour 
period of each test.
    4.6.5 Test Acceptability. For each test performed, survival of 
control animals must be >90% and test results must allow 
determination of statistically valid LC50 and 95% 
confidence interval values except in cases where the LC50 
is >1000 [micro]l/L or is determined to be greater than the limits 
of water solubility of dispersibility.
    4.6.6 Static Acute Test Summary. A summary of required test 
conditions is provided in Table 9 of this Appendix.
    4.7 Laboratory Report. The laboratory must include, for each 
toxicity test report, all applicable information, data and analyses 
as follows:
    4.7.1 Test Objective: protocol title and source, endpoint(s);
    4.7.2 Product Information: product name, manufacturer contact 
information, lot number, production date, date received/chain of 
custody;
    4.7.3 Contract Facility: contact information;
    4.7.4 Dilution Water: source, pretreatment, physical and 
chemical characteristics (pH, salinity);
    4.7.5 Test Conditions: date and time of test (start and end), 
test chambers type and volume, volume of solution per chamber, 
number of organisms per chamber, number of replicate chambers per 
treatment, feeding frequency, amount and type of food, test 
concentrations, test temperature (mean and range), test salinity 
(mean and range);
    4.7.6 Test Organisms: common and scientific name, source contact 
information, age and date purchased, acclimation conditions (e.g., 
temperature, salinity, both mean and range), age at test start;
    4.7.7 Reference toxicant: date received, lot number, date of 
most recent test, results and current Cumulative Sum Chart, dilution 
water used, physical and chemical methods used;
    4.7.8 Quality Assurance: verification of laboratory 
accreditation, including subcontractor facilities;
    4.7.9 Test Results: raw data in tabular and graphical form, 
daily records of affected organisms in each concentration replicate 
and controls, table of required endpoints (i.e., LC50, 
95% CI, inhibited concentration for 50% of the species 
(IC50), lower observed effect concentration (LOEC) and no 
observed effect concentration (NOEC)), statistical methods used to 
calculate endpoints, summary tables of test conditions and QA data; 
and
    4.7.10 Conclusions: Relationship between test endpoints and 
threshold limit.

     Table 9--Summary of Test Conditions--Surface Washing Agents, Herding Agents, Bioremediation Agents and
                                              Solidifiers Toxicity
----------------------------------------------------------------------------------------------------------------
                                  Saltwater acute M.  Saltwater acute A.   Freshwater acute    Freshwater acute
                                       beryllina             bahia            P. promelas          C. dubia
----------------------------------------------------------------------------------------------------------------
Test type.......................  Static non-renewal  Static non-renewal  Static non-renewal  Static non-
                                                                                               renewal.
Test duration...................  96 hours..........  48 hours..........  96 hours..........  48 hours.
Salinity........................  20      20      NA................  NA.
                                   2[permil].          2[permil].
                                 -------------------------------------------------------------------------------
Temperature.....................    25  1 [deg]C. Test temperatures must not deviate (maximum minus
                                            minimum temperature) by more than 3 [deg]C during the test.
Light quality...................                         Ambient laboratory illumination.
Light intensity.................                              10-20 [micro]E/m\2\/s.
Photoperiod.....................          16 h light, 8 h darkness, with phase in/out period recommended.
                                 -------------------------------------------------------------------------------
Test chamber size \1\...........  250 mL............  250 mL............  250 mL............  30 mL.
Test solution volume \1\........  200 mL............  200 mL............  200 mL............  15 mL.
Age of test organism \2\........  9-14 days.........  1-5 days..........  1-14 days.........  <24 hours.
No. organisms per test chamber..  10................  10................  10................  5.
No. of replicate chambers per     3.................  3.................  3.................  4.
 concentration (minimum).
                                 -------------------------------------------------------------------------------
Feeding regime..................        Refer to specific feeding procedures provided in each test method.
Aeration........................    None, unless DO falls below 4.0 mg/L, then aerate all chambers. Rate: <100
                                                                  bubbles/minute.
Test concentrations.............            5 exposure concentrations and a control (minimum required).
Test acceptability (required)...                            >=90% survival in controls.
----------------------------------------------------------------------------------------------------------------
\1\ Recommended minimum value.
\2\ Less than or equal to 24-hr range in age.

    4.8 References for Section 4

(1) U.S. EPA. 2002. Methods for Measuring the Acute Toxicity of 
Effluents and Receiving Waters to Freshwater and Marine Organisms. 
Fifth Edition. U.S. Environmental Protection Agency, Washington, DC 
(EPA-821-R-02-012).

    5.0 Bioremediation Agent Efficacy Test Protocol
    5.1 Summary. This protocol quantifies changes in weathered 
Alaska North Slope (ANS) crude oil composition of alkanes and

[[Page 38348]]

aromatics resulting from the use of a bioremediation agent in either 
artificial seawater or freshwater. The manufacturer may test either 
one or both freshwater or saltwater, depending on the product's 
intended use. Biodegradation of the alkanes and aromatics is 
monitored for 28 days at 20-23 [deg]C. Product flasks at Day 28 are 
compared to Day 0 flasks to determine reductions in alkanes and 
aromatics. A positive control of a known oil-degrading bacterial 
consortium supplied by EPA is tested. A negative, sterile control is 
also set up containing exposure water, weathered crude oil, product, 
and a sterilant, sodium azide. The purpose of the negative, killed 
control is to make sure the disappearance of the oil constituents at 
day 28 is due to biodegradation and not some physical loss such as 
volatilization. The day 28 GC/MS results from the killed control 
must not be less than 90% of the day 0 results. The sample 
preparation procedure extracts the oil phase into the solvent 
dichloromethane (DCM) (also known as methylene chloride) with a 
subsequent solvent exchange into hexane. The hexane extracts are 
analyzed by a high-resolution gas chromatograph/mass spectrometer 
(GC/MS) operated in the selected ion monitoring mode (SIM) at a scan 
rate of >5 scans per second.
    Note to 5.1: Alaska North Slope (ANS) crude oil is artificially 
weathered by distillation at 521 [deg]F (272 [deg]C) to remove the 
low molecular weight hydrocarbons to approximate natural weathering 
processes that occur after a spill.
    5.2 Apparatus. All equipment must be maintained and calibrated 
per standard laboratory procedures.
    5.2.1 Assorted flasks and other glassware;
    5.2.2 Graduated cylinders (100 mL);
    5.2.3 Deionized water;
    5.2.4 250 mL borosilicate glass Erlenmeyer flasks;
    5.2.5 250 mL separatory funnels with stopcocks
    5.2.6 Pasteur pipettes;
    5.2.7 Multichannel pipettor (5-50 mL and 50-200 mL);
    5.2.8 Autoclave; environmental room or incubator;
    5.2.9 Balance accurate to 0.1 mg;
    5.2.10 Orbital shaker table with clamps sized to hold flasks 
securely;
    5.2.11 GC/MS instrument equipped with a DB-5 capillary column 
(30 m, 0.25 mm ID, and 0.25 mm film thickness) or equivalent, and a 
split/splitless injection port operating in the splitless mode, such 
as an Agilent 6890 GC/5973 MS (or equivalent) equipped with an auto-
sampler for testing multiple samples; and
    5.2.12 Fixed Rotor Centrifuge.
    5.3 Reagents and consortium medium.
    5.3.1 Stock Seawater Preparation. Prepare the artificial 
seawater GP2 (modified from Spotte et al., 1984) following the 
procedures in section 2.3 of this Appendix, to obtain the final 
concentration of the salts listed in Table 1 of this Appendix, 
except for the sodium bicarbonate (NaHCO3) which is 
prepared separately. Autoclave the artificial seawater. Filter 
sterilize the concentrated solution of sodium bicarbonate through a 
0.45 [mu]m membrane filter and add to the autoclaved and cooled 
artificial seawater GP2 to obtain the final concentration listed in 
Table 1 of this Appendix.
    5.3.2 Seawater for the positive control flasks. Prepare sodium 
triphosphate (a.k.a., sodium tripolyphosphate) 
(Na5P3O10), potassium nitrate 
(KNO3), and ferric chloride hexahydrate (FeCl3 
[middot] 6H2O) as a concentrated solution. Filter 
sterilize through a 0.45 [mu]m membrane filter and add to autoclaved 
artificial seawater to obtain the final nutrient concentrations 
listed in Table 10 of this Appendix. Calibrate the pH meter at room 
temperature (approximately 20-23 [deg]C) using commercial buffers of 
pH 4.0, 7.0, and 10.0, as appropriate, prior to use. Adjust the pH 
of the artificial seawater with concentrated hydrochloric acid (HCl) 
or 10 normality sodium hydroxide (10 N NaOH), as appropriate.

          Table 10--Artificial Seawater Nutrient Concentrations
------------------------------------------------------------------------
                                                              Final
                      Constituent                       concentration, g/
                                                                L
------------------------------------------------------------------------
* FeCl3 [middot] 6H2O.................................             0.050
KNO3..................................................             2.890
* Na5P3O10............................................             0.297
------------------------------------------------------------------------
* Added aseptically after the GP2 has been autoclaved to limit
  phosphorus and iron precipitation.

    5.3.3 Seawater for bioremediation agents that do not include 
nutrients. If a bioremediation agent contains living microorganisms 
but not nutrients (or limiting concentrations of nutrients), then 
nutrients may be added by the manufacturer. However, the total 
concentration of the nutrients added to the bioremediation agent 
must not exceed the final concentrations listed in Table 11 of this 
Appendix.

Table 11--Artificial Seawater Nutrient Concentrations for BioRemediation
                   Agents Having No Nutrients Included
------------------------------------------------------------------------
                Constituent                   Final concentration, g/L
------------------------------------------------------------------------
as Iron (Fe)..............................  0.010
as Nitrogen (N)...........................  0.400
as Phosphorus (P).........................  0.075
------------------------------------------------------------------------

If nutrients are supplied by the product manufacturer, the specific 
composition and concentration used in the efficacy testing must be 
submitted.
    5.3.4 Freshwater Preparation. The artificial freshwater, which 
is a modification of Bushnell-Haas medium (Haines et al., 2005), is 
prepared following the concentrations listed in Table 12 of this 
Appendix and then autoclaved. The pH is adjusted to 7.4 before 
autoclaving. Constituents removed from the original formulation are 
KNO3, K2HPO4 and KH2PO4.

     Table 12--Constituent Concentrations for Artificial Freshwater
                             [Bushnell-Haas]
------------------------------------------------------------------------
                                                              Final
                      Constituent                         concentration
                                                             (mg/L)
------------------------------------------------------------------------
MgSO4 [middot] 7H2O...................................               200
CaCl2 [middot] 2H2O...................................                20
FeCl3 [middot] 6H2O...................................                50
MnSO4 x H2O...........................................            0.0302
H3BO3.................................................            0.0572
ZnSO4 x 7H2O..........................................            0.0428
(NH4)6Mo7O2...........................................            0.0347
------------------------------------------------------------------------

    5.3.5 Freshwater for the positive control. To prepare the 
freshwater for the positive controls, prepare the nutrients 
potassium phosphate monobasic (KH2PO4), potassium phosphate dibasic 
(K2HPO4) and potassium nitrate (KNO3) as a concentrated solution. 
Filter sterilize and add to autoclaved artificial freshwater to 
obtain the final concentrations given in Table 13 of this Appendix. 
Calibrate the pH meter at room temperature (approximately 20-23 
[deg]C) using commercial buffers of pH 4.0, 7.0, and 10.0, as 
appropriate, prior to use. Adjust the pH of the artificial 
freshwater to 7.4 with 1 N HCl or 1 N NaOH, as appropriate.

              Table 13--Freshwater Nutrient Concentrations
------------------------------------------------------------------------
                                                              Final
                      Constituent                       concentration (g/
                                                             L) \1\
------------------------------------------------------------------------
KNO3..................................................              2.89
KH2PO4................................................              1.00
K2HPO4................................................              1.00
------------------------------------------------------------------------
\1\ Adjust pH to 7.4 prior to autoclaving.

    5.3.6 Freshwater for bioremediation agents that contain living 
microorganisms but not nutrients or limiting concentrations of 
nutrients. If a bioremediation agent does not include nutrients, 
then nutrients may be added. However, the total concentration of the 
nutrients added to the bioremediation agent must not exceed the 
final concentrations provided in Table 14 of this Appendix.

       Table 14--Artificial Freshwater Nutrient Concentrations for
           Bioremediation Agents Having No Nutrients Included
------------------------------------------------------------------------
                Constituent                 Final concentration, g/L \1\
------------------------------------------------------------------------
as Iron (Fe)..............................  not added since iron is
                                             already in the freshwater
                                             solution.
as Nitrogen (N)...........................  0.400.
as Phosphorus (P).........................  0.400.
------------------------------------------------------------------------
\1\ Adjust to pH 7.4 prior to autoclaving.


[[Page 38349]]

If nutrients are supplied by the product vendor, the specific 
composition and concentration used in the efficacy testing must be 
submitted.
    5.3.7 Oil Preparation. The test oil, weathered ANS521 crude oil, 
can be obtained from EPA at no charge (except for a minimal shipping 
fee). See https://www.epa.gov/emergency-response/national-contingency-plan-subpart-j#howto for more information.
    5.3.8 Sodium azide sterilant. Prepare a stock solution of 
NaN3 for addition to the negative killed control. The 
final concentration in the killed controls will be 0.5 g/L.
    5.4 Experimental Setup and Procedure
    5.4.1 Autoclave clean borosilicate glass Erlenmeyer flasks (250 
mL) for 20 minutes at 121 [deg]C at 15 psig.
    5.4.2 Label flasks with the appropriate code (negative control, 
positive control, or product; day to be sampled (0 or 28); letter 
indicating replicate number) to reflect the following treatment 
design in Table 15 of this Appendix:

  Table 15--Bioremediation Efficacy Test--Summary of Experimental Setup
------------------------------------------------------------------------
                                               Number of
                                             replicates at
                Treatment                   sampling times     Analysis
                                          ------------------
                                            Day 0    Day 28
------------------------------------------------------------------------
Negative (killed) Control (oil + exposure        0        3        GC/MS
 water + product + EPA consortium + NaN3
 sterilant)..............................
* Positive control (oil + exposure water         6        6        GC/MS
 + nutrients + EPA consortium)...........
Test Type 1: Product containing living           6        6        GC/MS
 microorganisms (oil + exposure water +
 living product + supplemented nutrients
 (if necessary)).........................
Test Type 2: Product containing                  6        6        GC/MS
 proprietary nutrients but no live
 microorganisms (oil + exposure water +
 product + EPA consortium)...............
Test Type 3: Product (such as an enzyme)         6        6        GC/MS
 containing no live microorganisms and no
 nutrients (oil + exposure water +
 product)................................
------------------------------------------------------------------------
* The laboratory must report positive control test results conducted
  within the year of any test results for bioremediation products, for
  one or both types of water as applicable.

    5.4.3 Aseptically dispense 100 mL of pre-sterilized artificial 
exposure water (seawater or freshwater) into each sterile flask. For 
the positive control flasks, use exposure water containing 
nutrients.
    5.4.4 Tare the labeled flasks containing exposure water and 
other additions, as necessary, on the balance with a minimum 
accuracy of 0.01 g. Add drop-wise 0.50 g oil (this results in a 
final oil concentration of 5 g/L) using a sterile Pasteur pipette to 
the center of the flask taking care to avoid splashing the oil onto 
the sides of the flasks. Record the precise weight. ANS521 may be 
previously warmed in a hot water bath at 60 [deg]C for 40-60 minutes 
to facilitate its flow. Take precautions when handling and charging 
the flasks to minimize the likelihood of contamination by exogenous 
microbes, including using a new sterile pipette for each series of 
flasks.
    5.4.5 Preparation of the EPA consortium for both the positive 
control flasks and the flasks containing non-living bio-stimulation 
products. Use the supplied vials containing approximately 5 mL of 
the known EPA consortium frozen in glycerol. Thaw the supplied vials 
at room temperature (do not allow cultures preserved in glycerol to 
sit at room temperature past thawing), transfer the contents of the 
thawed vials to a single sterile centrifuge tube, rinse tubes with 
two volumes each of sterile exposure water, centrifuge at between 
6,000- and 7,000-times gravity (6,000-7,000 x g) for 15 minutes 
using a fixed rotor to fully pellet the cells. Carefully resuspend 
the cell pellet in sterile exposure water using the appropriate 
volume to achieve the desired seeding density, which will be 
provided by EPA upon shipment of the consortium.
    5.4.6 Positive control flasks contain exposure water, oil, 
nutrients, and the EPA consortium.
    5.4.7 Negative killed control flasks for all products shall 
contain exposure water, oil, product, the EPA consortium for 
products not containing a living culture, and the sodium azide 
sterilant at a final concentration of 0.5 g/L. Add the sodium azide 
sterilant prior to adding any product or EPA consortium. For the 
negative killed control flasks and product flasks, prepare and add 
the product to the flasks in a concentration specified by the 
manufacturer or vendor.
    5.4.8 For non-living products that contain nutrient only, use 
the EPA consortium as the inoculum.
    5.4.9 For other non-living products (e.g., enzymes), do not add 
nutrients or the EPA consortium as the inoculum as they are not 
needed.
    5.4.10 For products containing living microorganisms, prepare 6 
flasks the same way as in Steps a-d, but without the EPA consortium. 
A product that contains its own nutrients must not be amended with 
nutrients, unless the product contains insufficient nutrients. Since 
this is a closed flask test, nutrients could be limiting if they are 
at the same concentration as used in the field. This could cause the 
product to fail the test. Thus, the manufacturer has the option to 
supplement its product with a higher concentration of nutrients than 
that contained in the product. Any nutrient supplements to a product 
must be reported and must not exceed the concentration limits in 
Table 10 (for seawater) and 13 (for freshwater) of this Appendix, as 
applicable.
    5.4.11 Cap all flasks either with sterile cotton stoppers or 
loosely applied aluminum foil to allow gas exchange with the 
atmosphere. Set aside the T = 0 flasks for immediate extraction and 
analysis. Place the rest of the flasks onto the orbital shaker 
table. Do not tip the flasks excessively to avoid stranding oil 
above the mixing area of the flask. Set the orbital shaker to 200 
rpm and shake the flasks for 28 days at 20-23 [deg]C in the dark.
    5.4.12 Submit all information on added microorganisms and 
nutrients for testing in the data report.
    5.5 Sampling and Chemical Analysis.
    5.5.1 Summary. At each sampling event (Days 0 and 28), product 
and control flasks are sacrificed for analysis of residual oil 
concentrations (SOP 4 of this Appendix). Record all physical 
observations for each flask (such as degree of emulsification, 
whether the oil has congealed into tar balls, wall growth, color, 
etc.) at each sampling. The analytical procedure is summarized in 
Table 16 of this Appendix. Dichloromethane (DCM) is the solvent used 
for the initial extraction. Solvent-exchange the extract into hexane 
prior to injection into the gas chromatograph. The solvent exchange 
is done to prevent asphaltenes from contaminating the column.

                       Table 16--Bioremediation Efficacy--Summary of Analytical Procedures
----------------------------------------------------------------------------------------------------------------
                                       Sampling/                    Sample container/  Preservation/    Holding
    Matrix         Measurement        measurement       Analysis       quantity of        storage        times
                                        method           method          sample          ([deg]C)      (months)
----------------------------------------------------------------------------------------------------------------
DCM...........  N/A..............  Solvent Exchange  N/A..........  Capped Vial with               4           6
                                    to Hexane.                       Teflon septa,
                                                                     30 mL.

[[Page 38350]]

 
Hexane........  Hydrocarbon        SOP 4...........  GC/MS........  Capped Vial with               4           6
                 Concentration.                                      Teflon septa,
                                                                     10 mL.
----------------------------------------------------------------------------------------------------------------

    5.5.2 Hydrocarbon Extraction. To measure extraction efficiency, 
200 [micro]L of the 400 mg/L surrogate recovery standard (compounds 
and concentrations described in SOP 1 in this Appendix) is added to 
each flask. Add 50 mL DCM to each flask. Transfer the contents to a 
250 mL separatory funnel and shake for 2 minutes; allow the phases 
to separate for 2 minutes. If an emulsion remains after 2 minutes, 
centrifuge the emulsion in Teflon[supreg] centrifuge tubes for at 
least ten minutes in a low-speed centrifuge at 3,000 times gravity 
(3,000 x g) to break the emulsion and recover the DCM phase. Pass 
the DCM extract through a funnel plugged with glass wool and 
containing approximately 20 g anhydrous, granular sodium sulfate 
(Na2SO4) to remove water. Repeat the steps 
above two more times with 25 mL DCM each (100 mL DCM used in total). 
Add 10 mL DCM on to the sodium sulfate after the third extraction to 
rinse off any oil residue. Collect the extract in 125 mL serum 
vials, capped with Teflon lined septa and aluminum crimp seals, and 
store at 4 [deg]C for up to 6 months.
    5.5.3 Solvent Exchange. Perform a solvent exchange (DCM to 
hexane) prior to GC/MS analysis to prevent injection of asphaltenes 
into the GC/MS column. Transfer the DCM extract to concentration 
tubes. Place the tubes in a 29 [deg]C water bath under a stream of 
dry nitrogen gas. Reduce the sample to 1 mL and transfer the extract 
to a 10 mL volumetric flask. Rinse the concentration tube with 
hexane and add it to the volumetric flask 2 times. Adjust the final 
volume with hexane to 10 mL.
    5.5.4 Hydrocarbon Analysis. Quantify the concentrations of 25 
alkanes, 32 aromatics and hopane (SOP 4, Table SOP 4.4 of this 
Appendix) using an Agilent 6890 GC/5973 MS or equivalent equipped 
with a 30-m x 0.25-mm ID x 0.25-[mu]m film thickness DB-5 or 
equivalent fused silica column. To prepare the samples, transfer 1.0 
mL of the hexane extract into a 2 mL autosampler vial with Teflon 
lined cap. Add 20 [mu]L of internal standard solution to each vial 
with a syringe or positive displacement pipettor. SOP 2 of this 
Appendix outlines the procedure for preparing the internal standard 
solution. Load vials onto the autosampler tray and analyze in 
selected ion monitoring mode (SIM). Sum the individual alkane 
concentrations for the total alkane concentration and the individual 
aromatic concentrations for total aromatic concentrations in each 
flask.
    5.6 Quality Assurance/Quality Control (QA/QC).
    5.6.1 Objectives. The critical variables to be analyzed for each 
set of experimental conditions are the individual petroleum 
hydrocarbons, i.e., the alkanes ranging in carbon number from nC-14 
to nC-35, plus pristane and phytane, and the 2- to 4-ring polycyclic 
aromatic hydrocarbons (PAHs) and their alkylated homologs as listed 
in SOP 4 of this Appendix. The quality assurance objectives for 
precision, accuracy, and detection limits are 20%, 75-
125% recovery, and 22.5 [micro]g/L on average for the 58 compounds, 
respectively. For more details, refer to the SOPs of this Appendix.
    5.6.2 Precision Objectives. Precision is presented as relative 
percent difference (RPD) for duplicate measurements and as relative 
standard deviation (RSD, or coefficient of variance) for triplicate 
measurements, applicable to replication of treatments as separate 
samples.
    5.6.3 Accuracy Objectives. These are based on the check 
standards and standard oil samples run concurrently with the sample 
analyses for GC/MS analysis of critical compounds. Critical 
compounds in the check standards and in the oil standards must fall 
within 75-125% of expected values for the analysis to be valid. Six 
surrogate compounds (SOP 1 of this Appendix) added to each sample 
before extraction can also serve as a surrogate for determining 
accuracy. The measured surrogate concentrations must fall within 75-
125% of expected values.
    5.6.4 Calibration Range. Conduct all measurements within the 
linear calibration range of the instrument. The calibrated 
concentration range for GC/MS analysis is 0.1 mg/L to 30 mg/L. If 
the measured concentration of any critical compound is above the 
calibration range, dilute the sample and re-analyze to quantify that 
particular compound within the linear calibration range.
    5.6.5 Quality Control. Table 17 of this Appendix summarizes the 
QC checks for each measurement. See the corresponding SOP in this 
Appendix for detailed descriptions of QC checks, frequency, 
acceptance criteria, and corrective actions.

                                             Table 17--QA/QC Checks
----------------------------------------------------------------------------------------------------------------
                                                                                Acceptance
 Sample matrix       Measurement         QA/QC check         Frequency           criteria      Corrective action
----------------------------------------------------------------------------------------------------------------
DCM............  GC/MS hydrocarbon   Blanks............  Once per           Peak area of       Flush with
                  analysis.                               calibrated run.    interfering        solvent, clean
                                                                             peaks <10% of      injection port,
                                                                             lowest standard    and/or bake
                                                                             peak area.         column.
DCM............  GC/MS hydrocarbon   DFTPP Check         Once per           Must pass all      If any criteria
                  analysis.           Standard.           calibrated run.    DFTPP criteria.    fail, retune and
                                                                                                rerun DFTPP
                                                                                                check standard.
DCM............  GC/MS hydrocarbon   Initial             Once per           Response Factor    If RSD for any
                  analysis.           Calibration         calibrated run.    RSD <=25% or R2    one compound
                                      Samples.                               >0.99.             >25%,
                                                                                                recalibrate.
DCM............  GC/MS hydrocarbon   Calibration Check   Every 10-15        25%    If >5 compounds
                  analysis.           Standards.          samples.           of expected        are out of
                                                                             values.            range,
                                                                                                recalibrate and
                                                                                                rerun samples.
Hexane.........  GC/MS hydrocarbon   Surrogates........  Every Sample.....  30%    Re-inject.
                  analysis.                                                  of expected
                                                                             values.
Hexane.........  GC/MS hydrocarbon   Biomarker           Every Sample.....  25%    Re-inject.
                  analysis.           Concentration.                         of average
                                                                             values.
----------------------------------------------------------------------------------------------------------------

    5.7 Pass/Fail Criteria.
    5.7.1 Calculate the mean and standard deviation of the hopane-
normalized total aromatics (sum of all resolved aromatics) and 
hopane-normalized total alkane concentrations (sum of all resolved 
alkanes) from the 6 independent replicates at days 0 and 28. To 
normalize, divide the sum of the alkane analytes and the sum of the 
aromatic analytes in each replicate by the hopane concentration in 
the corresponding replicate.
    5.7.2 From those data, calculate the 95% Upper Confidence Level 
(UCL95) at days 0 and 28 using the following formula (Equation 11 of 
this Appendix):

[[Page 38351]]

[GRAPHIC] [TIFF OMITTED] TR12JN23.089

where:

xt(0and28) = total hopane-normalized alkane or 
total hopane-normalized aromatic mean of 6 replicates at days 0 and 
28,
t95, 5 df = the 95% one-tailed t-value with 5 degrees of 
freedom (2.015),
s = the standard deviation of the 6 replicates at day 0 and 28, and
n = no. of replicates = 6.

    5.7.3 Using Equation 12 of this Appendix, calculate the % 
reduction of each oil fraction from day 0 to day 28, using the day 0 
and 28 UCL95 hopane-normalized values for each fraction:
[GRAPHIC] [TIFF OMITTED] TR12JN23.090

where:

t28(UCL95) = UCL95 of the hopane-
normalized total alkane or total aromatic mean of 6 replicates on 
day 28, and
t0(UCL95) = UCL95 of the hopane-normalized 
total alkane or total aromatic mean of 6 replicates on day 0.

    5.7.4 A product is successful in saltwater or freshwater if the 
% reduction of total alkanes (aliphatic fraction) from the GC/MS 
analysis is greater than or equal to 85% and the % reduction of 
total aromatics (aromatic fraction) is greater than or equal to 35% 
at day 28 based on the UCL95 (Equation 12 of this 
Appendix). The benchmark reduction ranges in aliphatic and aromatic 
fractions for the positive control are the same as for the products 
specified above. The average concentration of the biomarker hopane 
at day 28 must not differ from the average concentration at day 0 by 
more than 12% in the positive control. If the conditions for the 
positive control are not met, the entire procedure must be repeated.
    5.8 Data Verification and Reporting. GC/MS data files are 
generated by MS ChemStation software (the Agilent standard software 
for GC/MS) or equivalent for each injection. Data files contain 
summed ion chromatograms and selected ion chromatograms. Calibration 
curves are generated within MS ChemStation software, and all data 
files are calculated against the calibration curve by MS 
ChemStation. Data verification would be done by crosschecking 
between analysts for 10% of the raw data and its reduction process.
    5.9 Laboratory Report. The summary of findings from a product 
test must include the data listings for each analyte that was 
analyzed (i.e., all individual alkanes and aromatics in the list of 
required analytes), along with QA/QC checks (see Table 17) and 
instrument detection/reporting limits for each analyte. Express all 
concentrations as mg analyte/L exposure water.
    5.10 Standard Operating Procedures (SOPs) 1-4
    5.10.1 SOP 1. Preparation of Surrogate Recovery Standards
    5.10.1.1 Preparation:
    5.10.1.1.1 Solvents: Dichloromethane (DCM), Optima grade or 
equivalent.
    5.10.1.1.2 Reagents:

D36-Heptadecane (C17)
D50-Tetracosane (C24)
D66-Dotriacontane (C32)
D10-1-Methylnaphthalene
D10-Phenanthrene
D10-Pyrene
5-beta-cholestane (coprostane)

Note: Deuterated reagents are available from Cambridge Isotope 
Laboratories, Andover, MA.
    5.10.1.1.3 Equipment:

Micro-spatula
Small beakers
Glass funnel
Analytical balance (0.0001g)
Vials with Teflon-lined caps
Teflon wash bottle with Optima grade DCM
Volumetric flask (250 mL), class A
Pasteur pipettes

    5.10.1.2 Procedure:
    5.10.1.2.1 Using a calibrated analytical balance, weigh 100 mg 
(0.100 g) of each reagent into separate 10-25 mL beakers.
    5.10.1.2.2 Dissolve the reagents in their beakers by adding 10 
mL DCM. Use a Pasteur pipette to transfer the solutions to a single 
250 mL volumetric flask.
    5.10.1.2.3 Wash the beakers 3 or 4 times with DCM. Use a Pasteur 
pipette to transfer each of the washings to the 250 mL volumetric 
flask.
    5.10.1.2.4 Dilute the solution to the 250 mL volume mark on the 
volumetric flask with DCM.
    5.10.1.2.5 Use a glass stopper to seal the flask and homogenize 
the solution by inverting the flask 5 or more times. The final 
concentration of this solution is 400 mg/L for each of the reagents.
    5.10.1.2.6 Transfer the solution into 40 mL storage vials and 
cap with Teflon-lined caps and label each with the date of 
preparation, operator, sample names, and concentrations.
    5.10.1.2.7 Weigh each vial and record its weight on the label. 
This weight is used to monitor possible evaporation during storage.
    5.10.1.2.8 Store these vials at 0 [deg]C or lower.
    5.10.1.2.9 Before using, allow the solution to come to room 
temperature, and then shake it well.
    5.10.1.2.10 Weigh the vial before using it and compare the 
weight with the last weight recorded on the vial.
    5.10.1.2.11 If the weights are consistent, the integrity of the 
solution can be assumed. If not, investigate and resolve the cause. 
Prepare a new solution if the integrity has been compromised.
    5.10.1.3 Quality Control: Inject 20 [mu]L of the surrogate stock 
solution into 1 mL DCM. Add 20 [mu]L of the internal standard 
solution (SOP 2 of this Appendix). Analyze this solution by GC/MS 
using a calibrated method (SOPs 3 and 4 of this Appendix). The 
expected concentration of each of the corresponding surrogate 
compounds is 8  2 mg/L. If the measured value does not 
fall within this range, prepare and measure another independent 
surrogate solution. If the measured concentration of the second 
surrogate solution is within the allowable tolerance range, the 
calibration and instrument conditions are acceptable; properly 
discard the first surrogate solution. If the concentration of the 
second surrogate solution is also out of range, then clean and 
recalibrate the instrument until the problem is resolved.
    5.10.2 SOP 2. Preparation of Internal Standard Solution
    5.10.2.1 Preparation:
    5.10.2.1.1 Solvents: Dichloromethane (DCM), Optima grade or 
equivalent
    5.10.2.1.2 Reagents:

D34 n-Hexadecane (C16)
D42 n-Eicosane (C20)
D62 n-Triacontane (C30)
D8-Naphthalene
D10-Anthracene
D12-Chrysene
5-alpha-Androstane

    Note: Deuterated reagents are available from Cambridge Isotope 
Laboratories, Andover, MA.
    5.10.2.1.3 Equipment:

 Micro-spatula
Small beakers
Glass funnel
Analytical balance (0.0001g), calibrated and checked for accuracy
Amber vials with Teflon-lined caps, labeled
Teflon wash bottle with DCM
Volumetric flask (200 mL), class A
Pasteur pipettes

    5.10.2.2 Procedure:
    5.10.2.2.1 Using a calibrated analytical balance, weigh 100 mg 
(0.100 g) of each of the reagents into separate small beakers.
    5.10.2.2.2 Dissolve the reagents in their beakers by adding 10 
mL DCM; using a Pasteur pipette, transfer the solutions to a single 
200 mL volumetric flask.

[[Page 38352]]

    5.10.2.2.3 Wash the beakers 3 or 4 times with DCM; use a Pasteur 
pipette to transfer each of the washings to the 200 mL volume mark 
on the volumetric flask.
    5.10.2.2.4 Dilute the solution with DCM to the 200 mL volume.
    5.10.2.2.5 Seal the flask with a glass stopper and homogenize 
the solution by inverting the flask a minimum of 5 times. The final 
concentration of this solution is 500 mg/L of each reagent.
    5.10.2.2.6 Transfer the solution into 40 mL storage vials and 
cap with Teflon-lined caps. Label each vial with the date of 
preparation, operator, sample names, and concentrations.
    5.10.2.2.7 Weigh each vial, and record its weight on the label. 
This weight is used to monitor possible evaporation during storage.
    5.10.2.2.8 Store this solution at 0 [deg]C or lower.
    5.10.2.2.9 Before using, allow the solution to come to room 
temperature, and then shake it well.
    5.10.2.2.10 Weigh the vial before using it, and compare the 
weight with the last weight recorded on the vial.
    5.10.2.2.11 If the weights are consistent, the integrity of the 
solution can be assumed. If not, investigate and resolve the cause. 
Prepare a new solution if the integrity has been compromised.
    5.10.2.3 Quality Control: Inject 20 [mu]L of the internal 
standard solution into 1 mL DCM. Analyze this solution by GC/MS. The 
only peaks corresponding to the internal standards must appear. If 
other peaks appear, particularly close to the internal standard 
peaks, discard the internal standard solution and prepare a new 
solution.
    5.10.3 SOP 3. Preparation of Working Standards, Check Standards, 
and Oil Standards for GC/MS Consistency.
    5.10.3.1 Preparation:
    5.10.3.1.1 Solvent: Dichloromethane (DCM), Optima grade or 
equivalent
    5.10.3.1.2 Stock solutions:
    5.10.3.1.2.1 Oil analysis standard: 44 compounds, 100 mg/L in 
hexane/DCM (9:1), four, 1-mL vials required. Available from Absolute 
Standards, Inc., Hamden, CT, Part #90311.
    5.10.3.1.2.2 Nine compound PAH standard: 1,000 mg/L in DCM, one 
vial. Available from Absolute Standards, Inc., Hamden, CT, Part 
#90822.
    5.10.3.1.2.3 1,2-Benzodiphenylene sulfide, (synonym for 
naphthobenzothiophene). Prepare a 2 mg/mL stock solution. Available 
from Sigma-Aldrich Co., Part # 255122, purity 99%.
    5.10.3.1.2.4 Hopane solution (17 [alpha] (H), 21[beta] (H), 0.1 
mg/mL in isooctane. Available from Sigma-Aldrich Co. Part #90656.
    5.10.3.1.2.5 Surrogate solution: 400 mg/L of each reagent in DCM 
(see SOP 1 of this Appendix).
    5.10.3.1.2.6 Internal standard solution, 500 mg/L in DCM (see 
SOP 2 of this Appendix).
    5.10.3.1.3 Alaska North Slope Crude Oil 521 (ANS521).
    5.10.3.1.4 Equipment:
    5.10.3.1.4.1 Glass storage vials with Teflon-lined caps (2 mL 
and 40 mL capacity);
    5.10.3.1.4.2 Volumetric flasks, Class A, 5 mL, 10 mL, and 100 mL
    5.10.3.1.4.3 Glass syringes capable of dispensing 25-500 
[micro]L with an accuracy and precision of  1%, or 
equivalent
    5.10.3.1.4.4 Wheaton repetitive dispenser, Model 411 STEP-PETTE 
or equivalent
    5.10.3.1.4.5 Teflon wash bottle filled with Optima grade DCM or 
equivalent grade DCM
    5.10.3.1.4.6 Pasteur pipettes
    The volumes of stock solutions required to make the working 
standards are listed in Table SOP 3.1 of this Appendix.

                                     Table SOP 3.1--Amount of Stock Solutions Required To Make the Working Standards
--------------------------------------------------------------------------------------------------------------------------------------------------------
            Stock standards                     A                B              C            D            E                                       F
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            1,2-Benzo-
                                           Oil analysis    Aromatics mix   diphenylene   Surrogate      Hopane
 Working standards concentration, mg/L       mix (44       (9 compounds,     sulfide      solution     solution    Volumetric flask volume    ISTD (500
                                          compounds, 100    1,000 mg/L)    (NBT) (2 mg/  (100 mg/L)   (100 mg/L)              mL             mg/L) [mu]L
                                           mg/L) [mu]L         [mu]L        mL) [mu]L      [mu]L        [mu]L
--------------------------------------------------------------------------------------------------------------------------------------------------------
STD 30 (no hopane).....................            1,500              150           75          375            0  5........................          100
STD 20 (5 mg/L hopane).................            1,000              100           50          250          250  5........................          100
STD 10 (2.5 mg/L hopane)...............              500               50           25          125          125  5........................          100
STD 5 * (1 mg/L hopane)................              500               50           25          125          100  10.......................          200
STD 5-Utility (1 mg/L hopane)..........              500               50           25          125          100  10 (used for preparation             0
                                                                                                                   of STD 2.5 & STD 1).
                                        ----------------------------------------------------------------------------------------------------
STD 2.5 (0.5 mg/L hopane)..............                            Use 5 mL of STD 5-Utility and dilute to 10 mL.                                    200
STD 1 (0.2 mg/L hopane)................                            Use 2 mL of STD 5-Utility and dilute to 10 mL.                                    200
STD 0.1 (0.2 mg/L hopane)..............                           Use 0.2 mL of STD 5-Utility and dilute to 10 mL.                                   200
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Make extra STD 5 for use as check standard.

    5.10.3.2 Procedure for Working Standards and Check Standards:
    5.10.3.2.1 Label three 5 mL volumetric flasks as STD30, STD20, 
STD10, and two 10 mL volumetric flasks as STD5, and STD5-utility.
    5.10.3.2.2 Add 1-2 mL of DCM to each volumetric flask.
    5.10.3.2.3 Using glass syringes, add the appropriate volume of 
stock solution A (as listed in Table SOP 3.1 of this Appendix) to 
the flasks labeled STD30, STD20, STD10, STD5, and STD5-utility.
    5.10.3.2.4 Wash the walls of the inner neck of the flasks with 
several drops of DCM to rinse off the residue of the stock solution 
into the flasks.
    5.10.3.2.5 Repeat Step 3 and Step 4 to dispense stock solutions 
B-E (do not add stock solution F, internal standard solution, at 
this step).
    5.10.3.2.6 Dilute to volume with DCM for all the above flasks, 
seal with glass stoppers, and invert several times to homogenize the 
solutions.
    5.10.3.2.7 Label three additional 10 mL volumetric flasks as 
STD2.5, STD1, and STD0.1. Wet with 1-2 mL DCM.
    5.10.3.2.8 Dispense 5 mL of STD5-utility solution into flask 
STD2.5, 2 mL of STD5-utility solution into flask STD1, and 0.2 mL of 
STD5-utility solution into flask STD0.1.
    5.10.3.2.9 Dilute to volume with DCM, seal with glass stoppers, 
and invert several times to homogenize the solutions.
    5.10.3.2.10 Using a 100 [mu]L glass syringe, dispense 100 [mu]L 
of internal standard solution into flasks STD30, STD20, and STD10. 
Dispense 200 [mu]L into flasks STD5, STD2.5, STD1, and STD0.1 to 
give a final concentration of 10 mg/L internal standard.
    5.10.3.2.11 Seal with glass stoppers, and invert the flasks 
several times to homogenize the solutions.
    5.10.3.2.12 Transfer the solutions into 2 mL storage vials, and 
cap with Teflon-lined caps.
    5.10.3.1.13 Label each vial with date of preparation, analyst, 
sample names, and concentrations.
    5.10.3.2.14 Weigh each storage vial and record its weight on the 
label. This weight is used to monitor possible evaporation during 
storage.
    5.10.3.2.15 Store this solution at 0 [deg]C or below.
    5.10.3.2.16 Before using, allow the solution to come to room 
temperature, and shake it well.
    5.10.3.2.17 Weigh the vial before opening, and compare the 
weight with the last weight recorded on the vial. If the weights are 
consistent, the integrity of the solution can be assumed. If not, 
investigate and resolve the cause. Do not use the solution if the 
integrity has been compromised.
    5.10.3.3 Procedure for Oil Standard. In a 100 mL volumetric 
flask, weigh 0.500 g of the standard ANS521 crude oil, add 2 mL of 
surrogate solution (see SOP 1 of this

[[Page 38353]]

Appendix), and bring to volume with DCM. Add 2 mL of internal 
standard solution (see SOP 2 of this Appendix). Follow steps 
5.10.3.2.11 through 5.10.3.2.17 of this SOP, substituting 40 mL 
storage vials for the 2 mL vials.
    5.10.3.4 Quality Control/Quality Assurance:
    5.10.3.4.1 Run the seven standard solutions using the GC/MS 
method (SOP 4) on a tuned GC/MS. Use the EnviroQuant software or 
equivalent to calculate the average Relative Response Factor (RRF) 
and the relative standard deviation (RSD) of the RRFs for each 
analyte over the six concentrations. The RRF is defined as:
[GRAPHIC] [TIFF OMITTED] TR12JN23.091

    5.10.3.4.2 The RSD of the RRFs for all analytes must be 25% or 
less. Alternatively, the coefficients of determination (R2) for the 
calibration curve for each target compounds and surrogate should be 
over 0.99.
    5.10.4 SOP 4. GC/MS Method for the Analysis of Crude Oil 
Samples.
    5.10.4.1 Instrument Specifications:
    5.10.4.1.1 Use an Agilent 6890 GC coupled with an Agilent 5973 
mass selective detector (MSD) and an Agilent 6890 series auto 
sampler or equivalent, equipped with a DB-5 capillary column (30 m, 
0.25 mm I.D., and 0.25 [mu]m film thickness) or equivalent, and a 
split/splitless injection port operating in the splitless mode. Data 
acquisition occurs in the SIM (selected ion monitoring) mode for 
quantitative analysis. In SIM mode, the dwell time of each ion is 
set to be 10 milliseconds and the ions are split up into groups by 
retention time. One way to divide the ions is by retention time 
grouping as shown in Table SOP 4.1 of this Appendix. The number of 
ions in each ion group must be constant, yielding the same scan rate 
for each group.

        Table SOP 4.1--Ions Associated With Retention Time Groups
------------------------------------------------------------------------
            Group                                 Ions
------------------------------------------------------------------------
1............................  57, 66, 128, 136, 142, 152, 156, 166,
                                170, 184.
2............................  57, 66, 166, 170, 178, 180, 184, 188,
                                192, 194, 198, 208.
3............................  57, 66, 178, 184, 188, 192, 194, 198,
                                202, 206, 208, 212, 220, 226.
4............................  57, 66, 192, 198, 202, 206, 208, 212,
                                216, 220, 226, 230, 234, 245.
5............................  57, 66, 191, 217, 228, 240, 242, 248,
                                256, 262, 264, 270, 276, 284.
------------------------------------------------------------------------

    5.10.4.1.2 Table SOP 4.2 of this Appendix summarizes the 
instrumental conditions for crude oil analysis. Use only ultra-high 
purity helium (99.999% pure) as the carrier gas. In series, connect 
a moisture trap, an oxygen trap, and an organic trap to the carrier 
gas line before it enters the column.

      Table SOP 4.2--Instrumental Conditions for Crude Oil Analysis
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Instrument........................  Agilent 6890 Series II Gas
                                     Chromatograph (GC) with an Agilent
                                     5973MSD and an Agilent 6890 auto
                                     sampler, or equivalent.
Column............................  DB-5 capillary column (30 m, 0.25 mm
                                     I.D., and 0.25-mm film thickness)
                                     or equivalent.
Carrier Gas.......................  Helium, ultra-high purity grade
                                     (99.999%).
Inlet Temperature.................  300 [deg]C.
Transfer Line (detector)            310 [deg]C.
 Temperature.
Oven Temperature Program..........  50 [deg]C for 4 minutes, then 7
                                     [deg]C/min to 310 [deg]C, hold for
                                     18 minutes.
Flow Rate.........................  Constant flow at 1mL/min. Linear
                                     velocity: 36.2 cm/sec.
Injection Volume..................  1 [micro]L.
Split/Splitless Mode..............  Splitless.
Total Run Time....................  59.18 minutes.
------------------------------------------------------------------------

    5.10.4.2 Procedure for preparing the instrument:
    5.10.4.2.1 Lower the injection port temperature and the oven 
temperature to 50 [deg]C or less to avoid oxidation of the column.
    5.10.4.2.2 Replace the liner with a clean, silanized liner. Do 
not touch the liner with bare fingers. A small piece of muffled 
glass wool may be inserted to protect the column.
    5.10.4.2.3 Return the injection port and oven to the appropriate 
temperatures.
    5.10.4.2.4 Wait five minutes after the temperature equilibrates 
before using the instrument.
    5.10.4.3 Procedure for tuning the MSD:
    5.10.4.3.1 Perform an air/water check. The value reported for 
the relative abundance of water (m/z 18), nitrogen (m/z 28), oxygen 
(m/z 32), or carbon dioxide (m/z 44) shall be less than 5% of the 
base peak for the system to be considered leak free and are expected 
to be closed to 1% for a stable system.
    5.10.4.3.2 Tune the MSD using the Standard Autotune program and 
the decafluorotriphenylphosphine (DFTPP) Tune program to reduce 
instrument variability. The Autotune report file is referenced by 
the instrument when performing an air/water check and thus must be 
run at least once per month. Run standards and samples using DFTPP 
Tune parameters, and retune the instrument using DFTPP Tune at least 
once per week. The tune programs use three fragment ions of 
perfluorotributylamine (PFTBA) as a standard for tuning: m/z 69, 
219, and 502. Tune reports must meet the following criteria:
    5.10.4.3.2.1 Symmetrical peaks;
    5.10.4.3.2.2 Mass assignments within 0.2 amu's from 
69, 219, and 502;
    5.10.4.3.2.3 Peak widths within 0.5  0.1 amu's;
    5.10.4.3.2.4 Relative abundance is 100% for ion 69, at least 35% 
for ion 219, and at least 1% for ion 502;
    5.10.4.3.2.5 Relative abundances for isotope masses 70, 220, and 
503  0.2 amu's are 0.5-1.5%, 2-8%, and 5-15%, 
respectively; and
    5.10.4.3.2.6 Air and water peaks at m/z = 18, 28, 32, and 44 
amu's must be very small and consistent with historical values.
    5.10.4.4 Maintaining a log book. Maintain an instrument log 
book, and make entries for each use. Include the following 
information in the logbook: operator name, helium cylinder tank 
pressure and outlet pressure, vacuum gauge reading, any maintenance 
performed on the instrument (such as changing the injection port 
liner, gold seal, guard column, source cleaning), sequence

[[Page 38354]]

name, data path, samples in order of injection, method information, 
GC column number, and the Standard Auto Tune report and DFTPP Tune 
report.
    5.10.4.5 Running a Solvent Blank: Following a liner change or at 
the start of a new run, run an injection of a pure solvent to 
confirm that the system is free of excessive or interfering 
contamination. Analyze the solvent in SCAN mode using the same 
temperature program used for sample analysis. If contamination is 
present, analyze additional samples of fresh solvent until the 
interfering contamination is removed.
    5.10.4.6 Checking the DFTPP Tune: Prior to running the first 
calibration standard, verify the instrument tune conditions by 
running a 10 ng/[mu]L DFTPP check standard to check the mass 
measuring accuracy of the MS, the resolution sensitivity, the 
baseline threshold, and the ion abundance ranges. Run the standard 
using the DFTPP method provided with the instrument. Each of the 
criteria identified in Table SOP 4.2 of this Appendix must be met 
before using the instrument for analysis:

                                 Table SOP 4.3--Ion Abundance Criteria for DFTPP
----------------------------------------------------------------------------------------------------------------
                                            Relative to       Relative abundance
                Mass, M/z                      mass                criteria              Purpose of checkpoint
----------------------------------------------------------------------------------------------------------------
51......................................             442  10-80% of the base peak...  Low mass sensitivity.
68......................................              69  <2% of mass 69............  Low mass resolution.
70......................................              69  <2% of mass 69............  Low mass resolution.
127.....................................             442  10-80% of the base peak...  Low-mid mass sensitivity.
197.....................................             198  <2% of mass 198...........  Mid mass resolution.
198.....................................             442  Base peak or >50% of 442..  Mid mass resolution and
                                                                                       sensitivity.
199.....................................             198  5-9% of mass 198..........  Mid mass resolution and
                                                                                       isotope ratio.
275.....................................             442  10-60% of the base peak...  Mid-high mass sensitivity.
365.....................................             442  >1% of the base peak......  Baseline threshold.
441.....................................             443  Present and < mass 443....  High mass resolution.
442.....................................             442  Base peak or >50% of 198..  High mass resolution and
                                                                                       sensitivity.
443.....................................             442  15-24% of mass 442........  High mass resolution and
                                                                                       isotopic ratio.
----------------------------------------------------------------------------------------------------------------

    5.10.4.7 Calibrating with a Multiple-Point Calibration Curve. A 
5- or 6-point calibration curve is obtained by running 5 or 6 
working standards (see SOP 3) on the tuned GC/MS instrument. 
Calculate the relative response factor (RRF) for each compound 
relative to its corresponding deuterated internal standard as 
indicated in Table SOP 4.3 of this Appendix. The relative standard 
deviation (RSD) of the RRFs for each compound must be less than 25%. 
Run an independently prepared check standard immediately after the 
calibration standards to validate the accuracy of the calibration 
curve.
    5.10.4.8 Running Samples. Once the calibration curve has been 
validated, samples can be analyzed. Dispense 1,000 [mu]L of sample 
extract into labeled auto-sampler vials. Add 20 [mu]L of the 
internal standard solution (see SOP 2 of this Appendix) to the 
extract using a syringe or a positive displacement pipettor. Run a 
check standard every 10 samples to ensure the consistency of the 
instrument. The RRF for each compound in the check standard must be 
within 25% of the average RRF obtained in the initial calibration.
    5.10.4.9 Quantification: Once a calibration table has been 
generated, quantify each data file using the ``Calculate and 
Generate'' function in the MS ChemStation software, or equivalent 
software. Review individual peak integration manually to ensure 
proper baseline integration. The quantification of a compound is 
based on the peak area of the primary ion (Q Ion) indicated in Table 
SOP 4.4 of this Appendix.

                                       Table SOP 4.4--Target Compound List
----------------------------------------------------------------------------------------------------------------
                                           Quantitation     Reference compound for       Internal standard for
              Compound name                     ion             response factor              quantitation
----------------------------------------------------------------------------------------------------------------
N D34 C16...............................              66  N D34 C16.................  D34 n C16 Q Ion 66.
n-C14...................................              57  n C14.....................
n-C15...................................              57  n C15.....................
n-C16...................................              57  n C16.....................
N D34 C17...............................              66  N D34 C17.................
n-C17...................................              57  n C17.....................
Pristane................................              57  Pristane..................
n-C18...................................              57  n C18.....................
Phytane.................................              57  Phytane...................
n C19...................................              57  n C19.....................
N D42 C20...............................              66  N D42 C20.................  D42 n C20 Q Ion 66.
n C20...................................              57  n C20.....................
n C21...................................              57  n C21.....................
n C22...................................              57  n C22.....................
n C23...................................              57  n C23.....................
N D50 C 24..............................              66  N D50 C 24................
n C24...................................              57  n C24.....................
n C25...................................              57  n C25.....................
n C26...................................              57  n C26.....................
n C27...................................              57  n C27.....................
n C28...................................              57  n C28.....................
n C29...................................              57  n C29.....................
N D62 C30...............................              66  N D62 C30.................  D62 n C30Q Ion 66.
n C30...................................              57  n C30.....................
n C31...................................              57  n C31.....................
N D66 C32...............................              57  N D66 C32.................
n C32...................................              57  n C32.....................
n C33...................................              57  n C33.....................
n C34...................................              57  n C34.....................

[[Page 38355]]

 
n C35...................................              57  n C35.....................
D8 Naphthalene..........................             136  D8 Naphthalene............  D8 Naphthalene Q Ion 136.
Naphthalene.............................             128  Naphthalene...............
D10 1-Methylnaphthalene.................             152  D10 1-Methylnaphthalene...
C1 Naphthalene *........................             142  C1 Naphthalene............
C2 Naphthalene *........................             156  C2 Naphthalene............
C3 Naphthalene *........................             170  C3 Naphthalene............
C4 Naphthalene *........................             184  C3 Naphthalene............
D10 Anthracene..........................             188  D10 Anthracene............  D10 Anthracene Q Ion 188.
D10 Phenanthrene........................             188  D10 Phenanthrene..........
Phenanthrene............................             178  Phenanthrene..............
C1 Phenanthrene *.......................             192  C1 Phenanthrene...........
C2 Phenanthrene *.......................             206  C2 Phenanthrene...........
C3 Phenanthrene *.......................             220  C2 Phenanthrene...........
C4 Phenanthrene *.......................             234  C2 Phenanthrene...........
Fluorene................................             166  Fluorene..................
C1 Fluorene *...........................             180  Fluorene..................
C2 Fluorene *...........................             194  Fluorene..................
C3 Fluorene *...........................             208  Fluorene..................
Dibenzothiophene........................             184  Dibenzothiophene..........
C1 Dibenzothiophene *...................             198  Dibenzothiophene..........
C2 Dibenzothiophene *...................             212  Dibenzothiophene..........
C3 Dibenzothiophene *...................             226  Dibenzothiophene..........
Naphthobenzothiophene (NBT).............             234  Naphthobenzothiophene.....
C1 NBT *................................             248  Naphthobenzothiophene.....
C2 NBT *................................             262  Naphthobenzothiophene.....
C3 NBT *................................             276  Naphthobenzothiophene.....
Fluoranthene............................             202  Fluoranthene..............
D10 Pyrene..............................             212  D10 Pyrene................
Pyrene..................................             202  Pyrene....................
C1 Pyrene *.............................             216  Pyrene....................
C2 Pyrene *.............................             230  Pyrene....................
D12 Chrysene............................             240  D12 Chrysene..............  D12 Chrysene Q Ion 240.
Benzo(a)anthracene/Chrysene *...........             228  Chrysene..................
C1 Chrysene *...........................             242  Chrysene..................
C2 Chrysene *...........................             256  Chrysene..................
C3 Chrysene *...........................             270  Chrysene..................
C4 Chrysene *...........................             284  Chrysene..................
5[alpha]-androstane.....................             245  5[alpha]-androstane.......  5[alpha]-androstane Q Ion
                                                                                       245.
Coprostane..............................             219  Coprostane................
Hopane..................................             191  Hopane....................
----------------------------------------------------------------------------------------------------------------
* Summed compounds; draw an integration line underneath all peaks with selected ion.

    5.10.4.10 Equation 14 of this Appendix is used to calculate the 
concentration of analytes in units of [mu]g/g oil added:
[GRAPHIC] [TIFF OMITTED] TR12JN23.092

where:

Aanalyte = the peak area of the analyte,
Cistd = the concentration of the internal standard,
Aistd = the area of the internal standard,
RRF = the relative response factor, and
100 is the conversion factor to convert mg/L DCM to [mu]g/g oil 
added.

    5.10.4.11 If some analytes are not commercially available, the 
RRFs of other compounds (usually the parent compound) are used to 
quantify those analytes. For example, the RRF of C3-naphthalene may 
be used to calculate the concentrations of C3- and C4-naphthalenes. 
See Table SOP 4.4 of this Appendix for details. The quantification 
of these alkylated PAHs is relative because it is assumed that the 
molecular ions of the alkylated PAHs have the same RRFs as the 
parent compound ions. Nevertheless, these relative concentrations 
are useful for monitoring the fate of these compounds during the 
course of any analysis, as long as their concentrations are measured 
in a consistent way throughout the analysis.
    5.10.4.12 Concentration calculations for all target compounds 
are performed using EnviroQuant software or equivalent. Data for 
each sample can be printed directly using a customized report 
template. Data can also be automatically entered into a spreadsheet 
within the EnviroQuant software.
    5.10.5 Quality Assurance/Quality Control. The following criteria 
must be met before any samples are analyzed:
    5.10.5.1 Air/water check to verify the system is leak free.
    5.10.5.2 AutoTune and DFTPP Tune pass all criteria.
    5.10.5.3 DFTPP check standard passes all criteria.
    5.10.5.4 Solvent blank scan indicates the GC/MS system is free 
of interfering contamination.
    5.10.5.5 Prepare and monitor a control chart of a standard oil 
analysis.

[[Page 38356]]

Concentrations of the analytes in the control chart must be no more 
than 25% different from their historical averages.
    5.10.5.6 Relative response factors for analytes in the check 
standards inserted between every 10 samples must be no more than 25 
percent different from the average RRF of those same analytes in the 
calibration curve. Peak shapes must be symmetrical.
    5.11 References for Section 5

(1) Haines, J.R., E.J. Kleiner, K.A. McClellan, K.M. Koran, E.L. 
Holder, D.W. King, and A.D. Venosa. 2005. ``Laboratory evaluation of 
oil spill bioremediation products in salt and freshwater systems.'' 
J. Ind. Microbiol. Biotech 32: 171-185.

Appendix E to Part 300 [Removed]

0
16. Remove Appendix E to Part 300.

[FR Doc. 2023-11904 Filed 6-7-23; 11:15 am]
BILLING CODE 6560-50-P