oEPA Environmental Protection
United States Office of Land EPA 550-B-24-002
Agency and June U'2024
Emergency Management
National Oil and Hazardous Substances
Pollution Contingency Plan (NCP)
Subpart J - Use of Dispersants, and Other
Chemical and Biological Agents
Guidance for Listing Products on the
NCP Product Schedule or NCP Sorbent
Product List
Office of Emergency Management
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Disclaimer
This guidance does not create any rightssubstantive or proceduralenforceable by any
party in litigation with the United States of America. It does not substitute for the Clean
Water Act, Oil Pollution Act of 1990, or EPA's regulations; nor is it a regulation itself. Mention
or depiction of products or devices in this guidance does not imply EPA endorsement.
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Preface
Transitioning Listed Products to the New NCP Product Schedule or
Sorbent Product List [§ 300.955(f)]
The regulatory amendments published on June 12, 2023 (88 FR 38280) provide a process to
transition listed products from the current NCP Product Schedule to the new NCP Product
Schedule, as well as for listing sorbent products previously certified by EPA on the new Sorbent
Product List. From December 11, 2023, Subpart J product submitters will have two years to
retest their product and resubmit an application for listing as provided in the NCP. The 24-
month transition period provides time to prepare and submit new packages according to
amended testing and listing requirements and for EPA to review and make listing
determinations. The transition period also allows for the continued availability of listed
products to be accessible for planning and response activities.
NCP Product Schedule Transitioning
All products listed on the | :t 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 on the NCP Product Schedule based on the amended testing and listing
criteria will be removed. Products will be transitioned from the current NCP Product Schedule
to the new NCP Product Schedule prior to December 12, 2025, provided a new complete
package is submitted in accordance with § 300.955(b), and EPA makes a determination to list
the product on the new NCP Product Schedule.
Products listed on the NCP Product Schedule prior to December 11, 2023, for which a new
submission is not received or that do not meet the revised listing criteria, will not be
transitioned to the new NCP Subpart J Product Schedule at the end of the 24-month transition
period on December 12, 2025.
Sorbent Product Transitioning
All products previously identified as sorbents that received written certifications confirming
their status as a sorbent from EPA will remain available for use until December 12, 2025, at
which time all sorbent products must have submitted revised information as applicable under
§ 300.955(a) and (b) and meet any relevant listing requirements to be listed on the new
Sorbent Product List. EPA will no longer issue written certifications for sorbent products after
December 11, 2023. Sorbents products meeting the 2023 Subpart J requirements will be listed
on the publicly available Sorbent Product List. No technical data are required to be submitted
for sorbent products consisting solely of a material, or any combination of the materials,
identified in the definition of sorbent under §300.915(g)(1); these materials are automatically
included on the Sorbent Products List as generic sorbents, and no further action is necessary.
Refer to Chapter 5 Sorbents and the Sorbent Product List of this guidance for more information.
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Table of Contents
Disclaimer i
Preface ii
Table of Contents iii
List of Abbreviations vi
Chapter 1: NCP Subpart J Product Schedule and Sorbent Product List 1
1.1 Introduction 1
1.2 Subpart J Regulatory Background 1
1.3 Data, Information, and Submission Requirements for the NCP Product Schedule or
Sorbent Product List 2
1.4 Using This Guidance 3
1.5 NCP Subpart J Information Line and Website 4
Chapter 2: § 300.5 Definitions Applicable to NCP Product Schedule and Sorbent Product List.... 5
2.1 Introduction 5
2.2 NCP Product Schedule Product Category Definitions 5
2.2.1 Dispersants 5
2.2.2 Surface Washing Agents 5
2.2.3 Bioremediation Agent 5
2.2.4 Solidifiers 5
2.2.5 Herding Agents 5
2.3 Sorbent Product Category Definition 5
Chapter 3: Subpart J Data and Information Requirements for Listing on the NCP Product
Schedule 7
3.1 Introduction 7
3.2 Section 300.915(a) General Information for Any Product Category 7
3.3 Specific Product Category Data Requirements for Products Listed on the NCP Product
Schedule 12
3.3.1 Data Submission Sample Templates for NCP Product Schedule Categories 12
3.3.2 Appendix C to Part 300 Testing Protocols 13
Chapter 4: Subpart J Testing Requirements and Listing Thresholds by Product Category for
Listing on the NCP Product Schedule 15
4.1 Dispersant Testing and Listing Requirements [§ 300.915(b)] 15
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4.1.1 Dispersant Efficacy Test and Listing Criteria [§ 300.915(b)(1)] 15
4.1.2 Dispersant Toxicity Tests and Listing Criteria [§ 300.915(b)(2)] 15
4.1.3 Dispersant Testing and Threshold Summary 16
4.2 Surface Washing Agent Testing and Listing Requirements [§ 300.915(c)] 17
4.2.1 Surface Washing Agent Efficacy Test and Listing Criteria [§ 300.915(c)(1)] 17
4.2.2 Surface Washing Agent Toxicity Test and Listing Criteria [§ 300.915(c)(2)] 17
4.3 Bioremediation Agent Testing and Listing Requirements [§ 300.915(d)] 18
4.3.1 Bioremediation Agent Efficacy Test and Listing Criteria [§ 300.915(d)(1)] 19
4.3.2 Bioremediation Agent Toxicity Test and Listing Criteria [§ 300.915(d)(2)] 19
4.3.3 Generic Listing [§ 300.915(d)(4)] 20
4.4 Solidifier Agent Testing Requirements [§ 300.915(e)] 20
4.5 Herding Agent Testing Requirements [§ 300.915(f)] 21
4.6 Providing a Neat (Undiluted) Sample to Laboratory for Testing 22
4.7 EPA Reference Test Oil Procurement 22
Chapter 5: Sorbents and the Sorbent Product List 24
5.1 Introduction 24
5.2 Sorbent Product List 24
Chapter 6: Proprietary Business Information [§ 300.950] 26
6.1 Introduction 26
6.2 Proprietary Business Information Sample Format for Chemical and Biological Agents
and Sorbents [§ 300.915(a)(13)] 26
6.3 Proprietary Business Information Sample Format for Chemical and Biological Agents
and Sorbent Products Containing Microorganisms, Enzymes, and/or Nutrients [§
300.915(a)(14)] 27
6.4 Submitting Proprietary Business Information 28
Chapter 7: Addition of a Product to the NCP Product Schedule or Sorbent Product List [§
300.955] 29
7.1 Introduction 29
7.2 Package Contents and Cover Letter 29
7.3 Submission Address 29
7.4 EPA Review and Product Listing Determination 30
7.4.1 Review Timeline 30
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7.4.2 Request for Review of Decision 30
Chapter 8. Submitter Responsibilities for Listed Products 31
8.1 Introduction 31
8.2 Notification for Listing 31
8.3 Mandatory Product Disclaimer [§ 300.965] 31
8.4 Making Administrative Changes to a Product Listing [§ 300.955(e)] 31
8.5 Product Reformulation [§ 300.955(e)(2)] 32
Chapter 9: NCP Product Schedule and NCP Product Schedule Technical Notebook 33
9.1 Introduction 33
9.2 NCP Product Schedule 33
9.3 NCP Product Schedule Technical Notebook 33
Chapter 10: Removal of a Product from the NCP Product Schedule or Sorbent Product List [§
300.970] 34
10.1 Introduction 34
10.2 Removal of a Product by EPA 34
10.3 Removal of a Product by a Submitter 35
Attachment A: Product Listing Checklist A-l
Attachment B: Quick Links to the Electronic Code of Federal Regulations (eCFR) B-l
Attachment C: Dispersant Data Submission Sample Template C-l
Attachment D: Surface Washing Agent Data Submission Sample Template D-l
Attachment E: Bioremediation Agent Data Submission Sample Template E-l
Attachment F: Solidifier Product Data Submission Sample Template F-l
Attachment G: Herding Agent Data Submission Sample Template G-l
Attachment H: Sorbent Data Submission Sample Template H-l
Attachment I: Proprietary Business Information (PBI) Submission Sample Template 1-1
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List of Abbreviations
Abs
Accredited Bodies
AKA
Also Known As
BFT
Baffled Flask Test
CFR
Code of Federal Regulations
CWA
Clean Water Act
DE
Dispersant Effectiveness
DfE
Design for the Environment
EPA
Environmental Protection Agency
FR
Federal Register
LC50
Lethal Concentration of 50 percent of the test species
I.U.B.
International Union of Biochemistry
IC50
Inhibition concentration for 50 percent of the test species
ILAP
International Laboratory Accreditation Cooperation
ISO
International Organization for Standardization
NCP
National Oil and Hazardous Substances Pollution Contingency Plan
NELAC
National Environmental Laboratory Accreditation Conference
NELAP
National Environmental Laboratory Accreditation Program
NOEC
No Observed Effect Concentration
OPA
Oil Pollution Act of 1990
PAH
Polycyclic aromatic hydrocarbons
PCB
Polychlorinated biphenyls
SPR
Strategic Petroleum Reserve
TNI
The NELAC Institute
UCL95
Ninety-fifth (95th) percentile Upper Confidence Limit
use
United States Code
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Chapter 1: NCR Subpart J Product Schedule and Sorbent
Product List
1.1 Introduction
The National Oil and Hazardous Substances Pollution Contingency Plan (NCP) is the federal
government's blueprint for responding to both oil spills and hazardous substance releases.
Subpart J of the NCP governs the use of dispersants, other chemicals and other spill mitigating
substances when responding to oil discharges into jurisdictional waters and adjoining shorelines
of the United States.1
The Environmental Protection Agency (EPA or the Agency) proposed revisions to Subpart J of
the NCP in the Federal Register (FR) on January 22, 2015 (80 FR 3383). including amended
testing, listing, and authorization of use provisions, and new monitoring requirements for agent
products. Dispersant monitoring requirements were published in the FR on July 27, 2021 (86 FR
40234) and became effective on January 24, 2022. Final testing, listing, and authorization of use
regulatory amendments were published in the Federal Register on June 12, 2023 (88 FR 38280)
and became effective December 11, 2023.2
The purpose of this document is to provide guidance on the data, information, and submission
requirements for listing chemical and biological agent products on the NCP Product Schedule
and listing sorbent products on the Sorbent Product List.
1.2 Subpart J Regulatory Background
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, direct the President to prepare and publish
the National Oil and Hazardous Substances Pollution Contingency Plan (National Contingency
Plan, or NCP) for removal of oil and hazardous substances. CWA 311(d)(2)(G) provides that the
President establish a schedule that identifies 1) spill mitigating substances that may be used in
carrying out the NCP, if any, 2) the waters in which such substances may be used, and 3) the
quantities of such substances which can be used safely in such waters. Executive Order 12777,
Section 8(b), delegates CWA 311(d)(2)(G) to the EPA Administrator.
Subpart J of the NCP establishes the framework for the use of dispersants and any other spill
mitigating substances in response to oil discharges (40 Code of Federal Regulations (CFR) part
300 series 900). Subpart J implements the statutory schedule required by CWA section
311(d)(2)(G), which 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 spill mitigating substances may be used safely when responding to oil
discharges into waters of the United States and adjoining shorelines.
1 See 33 United States Code (U.S.C.) § 1321(b) for full jurisdictional scope of CWA section 311.
2 Corresponding corrections were published in the Federal Register on June 28, 2023 (88 FR 41834).
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13 Data, Information, and Submission Requirements for the NCR Product
Schedule or Sorbent Product List
This document offers guidance on the requirements established under Subpart J of the NCP for
listing chemical and biological agent products on the NCP Product Schedule or listing sorbent
products on the Sorbent Product List. Product testing protocols, along with additional
requirements for data and information, serve as the basis for a national level screening of these
spill mitigating products. The data, information, and submission requirements, as well as
associated regulatory provisions, include:
§ 300.5 NCP Definitions,
§ 300.915 Data and information requirements for listing on the NCP Product Schedule or
Sorbent Product List,
o § 300.915(a) General Information for any Product Category
o § 300.915(b) Dispersant Testing and Listing Requirements
o § 300.915(c) Surface Washing Agent Testing and Listing Requirements
o § 300.915(d) Bioremediation Agent Testing and Listing Requirements
o § 300.915(e) Solidifier Testing and Listing Requirements
o § 300.915(f) Herding Agent Testing and Listing Requirements
o § 300.915(g) Sorbent Requirements
§300.950 Submission of Proprietary Business Information (PBI),
§ 300.955 Addition of a Product to the NCP Product Schedule or Sorbent Product List,
o § 300.955(a) Submission
o § 300.955(b) Package Contents
o § 300.955(c) EPA Review
o § 300.955(d) Request for Review of Decision
o § 300.955(e) Changes to a Product Listing
o § 300.955(f) Transitioning Listed Products to the New NCP Product Schedule or
Sorbent Product List
§ 300.965 Mandatory Product Disclaimer,
§ 300.970 Removal of a Product from the NCP Product Schedule or Sorbent Product List,
and
Appendix C to Part 300 Requirements for Product Testing Protocols and Summary Test Data
o Dispersant Baffled Flask Efficacy and Toxicity Tests
o Standard Acute Toxicity Test for Bioremediation Agents, Surface Washing Agents,
Herding Agents, and Solidifiers
o Bioremediation Agent Efficacy Test
Subpart J provisions for authorization of use and for atypical dispersant monitoring are not
addressed in this guidance. Additional background information on the atypical dispersant
monitoring requirements can be found in the Federal Register published on July 27, 2021 (86 FR
40234); information on the authorization of use requirements, as well as further information on
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the listing requirements, can be found in the Federal Register published on June 12, 2023 (88 FR
38280).
1.4 Using This Guidance
This guidance is intended to assist those interested in listing an agent product on the NCP
Product Schedule, or a sorbent product on the Sorbent Product List, in understanding the data,
information and submission requirements. A list of acronyms used throughout the guidance is
provided at the beginning of this document.
The guidance is divided into ten chapters and eight attachments as follows:
Chapter 1: NCP Subpart J Product Schedule and Sorbent Product List
Chapter 2: § 300.5 Definitions Applicable to NCP Product Schedule and Sorbent Product List
Chapter 3: Subpart J Data and Information Requirements for Listing on the NCP Product
Schedule
Chapter 4: Subpart J Testing Requirements and Listing Thresholds by Product Category for
Listing on the NCP Product Schedule
Chapter 5: Sorbents and the Sorbent Product List
Chapter 6: Proprietary Business Information (PBI) [§ 300.950]
Chapter 7: Addition of a Product to the NCP Product Schedule or Sorbent Product List
[§ 300.955]
Chapter 8: Submitter Responsibilities for Listed Products
Chapter 9: NCP Product Schedule and NCP Product Schedule Technical Notebook
Chapter 10: Removal of a Product from the NCP Product Schedule or Sorbent Product List
[§ 300.970]
Attachment A: Product Listing Checklist
Attachment B: Quick Links to the Electronic Code of Federal Regulations (eCFR)
Attachment C: Dispersant Data Submission Sample Template
Attachment D: Surface Washing Agent Data Submission Sample Template
Attachment E: Bioremediation Agent Data Submission Sample Template
Attachment F: Solidifier Data Submission Sample Template
Attachment G: Herding Agent Data Submission Sample Template
Attachment H: Sorbent Data Submission Sample Template
Attachment I: Proprietary Business Information (PBI) Submission Sample Template
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1.5 NCP Subpart J Information Line and Website
In addition to this guidance, EPA has
established the NCP Subpart J Information
Line as a resource for answering questions
submitters may have with the submission of
data and information for listing on the NCP
Product Schedule and Sorbent Product List.
The NCP Subpart J Information Line is not a s
maintained by EPA and checked daily by contractor staff. Calls are returned within 24 hours.
Callers should leave their full name, company name, phone number, email address, and reason
for the call (e.g., application materials, clarifications for listing a product).
The NCP Subpart J Information Line and the EPA's OEM NCP Subpart J Website were created to
assist manufacturers with submitting products for listing. The website includes information on
listing a product on the NCP Product Schedule and links to the NCP Product Schedule and the
Technical Notebook. The Technical Notebook includes the relevant data manufacturers
submitted for their product for listing on the NCP Product Schedule. This information provides
useful information to On-Scene Coordinators, Regional Response Teams, and responders on
products listed on the NCP Product Schedule.
NCP Subpart J
Information
Line:
(202) 260-2342
staffed hotline, but a voice messaging service
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Chapter 2: § 300.5 Definitions Applicable to NCP
Product Schedule and Sorbent Product List
2.1 Introduction
Chapter 2 highlights the regulatory definitions of the five NCP Product Schedule agent
categories, as well as of the sorbent category. These definitions clarify and provide information
on the relevant listing categories and allow submitters to identify the listing and testing
requirements applicable to each category. The regulatory definitions are established under Part
300 of the NCP at 40 CFR § 300.5. Additional background information on these definitions can
be found in the Federal Register published on June 12, 2023 (88 FR 38280).
2.2 NCP Product Schedule Product Category Definitions
2.2.1 Dispersants
Substances that emulsify, disperse, or solubilize oil by promoting the formation of small
droplets or particles of oil in the water column.
2.2.2 Surface Washing Agents
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
of oil into the water column.
2.2.3 Bioremediation Agent
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.
2.2.4 Solidifiers
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.
2.2.5 Herding Agents
Substances that form a film on the water surface to control the spreading of the oil to allow for
oil removal.
2.3 Sorbent Product Category Definition
Section 300.5 defines 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,
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biological agent, or sinking agent3. 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).
3 Under § 300.910(e)(1), a sinking agent, or any other chemical agent, biological agent, or any substance that is
used to directly sink oil to the bottom of the water body is considered a prohibited agent or substance.
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Chapter 3: Subpart J Data and Information
Requirements for Listing on the NCR Product Schedule
3.1 Introduction
Chapter 3 will help submitters and testing laboratories to identify and meet the data and
information requirements for all chemical and biological agent product categories covered
under Subpart J for listing on the NCP Products Schedule. Laboratory accreditation
requirements are also discussed in this chapter. Data and information requirements, including
testing protocols, are established under Part 300 of the NCP at 40 CFR § and in
Appendix C to Part 300. Additional data requirements for the following specific chemical and
biological agent product categories are mentioned later in this chapter:
Dispersants (§ 300.915(b));
Surface Washing Agents (§ 300.915(c));
Bioremediation Agents (§ 300.915(d));
Solidifiers (§ 300.915(e)); and
Herding Agents (§ 300.915(f)).
3.2 Section 300.915(a) General Information for Any Product Category
Paragraph (a) of § 300.915 includes the general submission requirements that are applicable to
all types of chemical or biological agents that may be listed on the NCP Product Schedule, as
well as to sorbent products that may be listed on the Sorbent Product List. The sections below
detail the general information and data requirements.
3.2.1 Submitter Information
Under § 300.915(a)(1), submitters are required to provide their name, physical address, email,
and telephone number.
3.2.2 Submitter Identity and Documentation of that Identity
The requirements under § 300.915 are addressed to the submitter of an application for listing a
product to the NCP Product Schedule or Sorbent Product List. Under § 300.915(a)(2), the
submitter must provide its identity, and document 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. The final rule requires there be an entity serving as a single point of
contact responsible for the product submission. This helps avoid any conflicts or claims from
unauthorized entities on products listed or submitted for listing consideration. The phrase
"and/or a designated agent acting on behalf of the manufacturer" in Subpart J provides
flexibility relative to the single, authorized entity that is representing the manufacturer and
submitting a product package for listing consideration. For example, this flexibility may be
applied, as appropriate, to parties that acquire the legal rights to intellectual property for an
existing product such that they would have the legal authority to manufacture the product.
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3.2.3 Product Name(s),. Brand(s), and/or Trademark(s)
Under § 300.915(a)(3), submitters are required to provide all name(s), brand(s), and/or
trademark(s) under which the product is to be sold.
3.2.4 Supplier Information
Under § 300.915(a)(4), submitters are required to provide names, physical addresses, emails,
and telephone numbers of the primary distributors, vendors, importers and/or designated
agents acting on behalf of the manufacturer.
3.2.5 Safety Data Sheet (SDS)
Under § 300.915(a)(5), submitters are required to provide the Safety Data Sheet (SDS) for the
product.
3.2.6 Product Storage Information
Under § 300.915(a)(6), submitters are required 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.
3.2.7 Shelf-life Information
Under § 300.915(a)(7), submitters are required to provide the anticipated shelf life of the
product at the storage conditions noted in paragraph (a)(6) of this section and documentation
for this determination.
3.2.8 Product Label(s)
Under § 300.915(a)(8), submitters are required to provide 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.
3.2.9 Chemical or Biological Agent Category
Under § 300.915(a)(9), submitters are required to provide 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.
3.2.10 Product Use Procedures
Under § 300.915(a)(10), submitters are required to provide 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.
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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 appliable standard methods used to
determine them.
3.2.11 Environmental Fate Information
Under § 300.915(a)(ll), submitters are required to provide 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.
3.2.12 Physical and Chemical Properties
Under § 300.915(a)(12), submitters are required to provide physical and chemical property
information of the product, as appropriate, including a citation of the current applicable
standard methods used to determine these properties. Submitters are required to use an
accredited laboratory to conduct these tests (§ 300.915(a)(17)). The complete list of physical
and chemical data requirements include:
Physical State and Appearance;
Vapor Pressure;
Flash Point;
Pour Point;
Viscosity;
Specific Gravity;
Particle Size for Solid Components; and
. pH.
This information, in combination with the other general product information requirements,
provides added context to the evaluation of product behavior and the process through which it
would affect the oil when used in the intended water and/or shoreline environment.
3.2.13 Product Components Information
Under § 300.915(a)(13), submitters are required to provide the identity and concentration of all
components of 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). For more information on what submitted information will be available for public
disclosure upon submission, see Chapter 6: Proprietary Business Information.
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3.2.14 Microorganism, Enzyme, and/or Nutrient Testing [§ 300.915(a)(14)]
Under § 300.915(a)(14), submitters with products that also contain microorganisms, enzymes,
and/or nutrients, are required to provide the following along with a citation or a description of
the methodology used to determine:
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;
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;
The name(s), maximum, minimum, and average weight percent of the nutrients contained
in the product; and
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.
Reporting may be provided, for example, as the most probable number of the number of
colony-forming units per unit volume. As the regulation does not specify analytical pathogen
testing methods, the submitter may choose from current applicable standard methods for the
purposes of product submission. The methodology for obtaining these values as well as the
supporting documentation must be included with the reported values.
3.2.15 Metals, Cyanide, Chlorinated Hydrocarbons, Pesticides, Polychlorinated Biphenyis and
Polynuclear Aromatic Hydrocarbons Testing [§ 300.91S(a)(lS)]
Under § 300.915(a)(15), submitters are required to provide data, methodology, and supporting
documentation for the levels of the following:
Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and any other
heavy metal reasonably expected to be in the product;
Cyanide;
Chlorinated hydrocarbons;
Pesticides;
Polychlorinated biphenyis (PCBs); and
Polycyclic aromatic hydrocarbons (PAHs).
As the regulation does not specify analytical contaminant testing methods, the submitter may
choose from current applicable standard methods for the purposes of product submission. The
methodology for obtaining these values as well as the supporting documentation must be
included with the reported values.
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3.2.16 Prohibited Agents Certification
Under § 300.915(a)(16), submitters are required to provide certification, including data,
methodology, and supporting documentation, indicating that the product does not contain any
of the prohibited agents or substances identified in § 300.910(e).
3.2.17 Laboratory Accreditation Information
Under § 300.915(a)(17) submitters are required to provide information about the accredited
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 that are applicable to the test(s) performed.
Submitters are required to use accredited laboratories to conduct the testing to support
product submissions for listing consideration on the NCP Product Schedule. Options for
laboratory accreditations include, but are not limited to, the National Environmental Laboratory
Accreditation Program (NELAP); International Organization for Standardization (ISO); and state
accredited bodies.
The National Environmental Laboratory Accreditation Program (NELAP) is an accreditation
system operated by The National Environmental Laboratory Accreditation Conference (NELAC)
Institute (known as The NELAC Institute (TNI). TNI's website is located at: https://www.nelac-
institute.org/index. php.
TNI establishes the standards of NELAP and state governmental agencies recognized by TNI to
serve as Accreditation Bodies (ABs) for labs. Accreditation resources including NELAP
recognized ABs and Non-Governmental ABs can be found under the "Laboratory Accreditation"
tab on the TNI website.
If a state has not adopted NELAP, the state may develop its own accreditation program with its
own requirements, which can be verified through the appropriate state agency website.
U.S. labs can also be accredited by the International Laboratory Accreditation Cooperation
(ILAC) recognized ABs in accordance with ISO/I EC 17025:2005. International laboratories are
assessed against the standard ISO/I EC 17025:2005 "General Requirements for the Competence
of Testing and Calibration Laboratories." In most major countries, ISO/I EC 17025 is the standard
for which most labs must hold accreditation to be deemed technically competent. Accreditation
can be verified via the applicable AB website (e.g., http://search.anab.org/search~accredited~
companies.aspx or https://www.a2la.org/dirsearchnew/newsearch.cfm).
3.2.13 Test Data and Calculations
Under § 300.915(a)(18), submitters are required to provide as part of the submission package
to the agency, all test data and calculations, specifically including the following information:
Raw data and replicates, including positive controls.
Notes and observations collected during tests.
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Calculated mean values and standard deviations.
Reports, including a summary of stock solution preparation.
Source and preparation of test organisms.
Test conditions.
Chain of custody forms.
3.2.19 Production Volume Information
Under § 300.915(a)(19), submitters are required to 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.
3.2.20 Environmental Certifications
Under § 300.915(a)(20), submitters are required to provide any recognition received from EPA's
Design for the Environment (DfE) or Safer Choice programs, as applicable.
3.2.21 International Product Information
Under § 300.915(a)(21), submitters are required to provide international product testing or use
data or certifications, if available, informing the performance capabilities or environmental
impacts of the product.
33 Specific Product Category Data Requirements for Products Listed on the NCP
Product Schedule
As per § 300.915(a)(9), submitters must provide product specific category data and information
requirements for all product categories for which the product meets the category definitions
found in § 300.5. 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. The specific product categories and their rule references
consist of the following:
Dispersants (§ 300.915(b));
Surface Washing Agents (§ 300.915(c)).
Bioremediation Agents (§ 300.915(d));
Solidifiers (§ 300.915(e)); and
Herding Agents (§ 300.915(f)).
More information on these data requirements, which include testing protocols, are found in
Chapter 4: Subpart J Testing Requirements and Listing Thresholds by Product Category for
Listing on the NCP Product Schedule.
3.3.1 Data Submission Sample Templates for NCP Product Schedule Categories
Attachments C through H include sample templates. These sample templates are provided as
examples for compiling data and information in the order of general and product-specific
category requirements for listing a product on the NCP Product Schedule or the Sorbent
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Product List. Sample templates for each product category, with directions and references to the
Subpart J testing and data requirements are included in Attachments C through G of this
guidance. The sorbent product sample template is also included in Attachment H of this
guidance. Subpart J sorbent data and information application requirements are detailed in
Chapter 5 of this guidance. These sample templates may be, but are not required to be, used
when submitting a product for listing. When all the data and information have been compiled,
refer to Chapter 7: Addition of a Product the NCP Product Schedule of Sorbent Product List for
next steps in the listing process.
Table 3-1: Subpart J Data Submission Sample Templates Quick Locator
Attachment C: Dispersant Data Submission Sample Template C-l
Attachment D: Surface Washing Agent Data Submission Sample Template D-l
Attachment E: Bioremediation Agent Data Submission Sample Template E-l
Attachment F: Solidifier Data Submission Sample Template G-l
Attachment G: Herding Agent Data Submission Sample Template F-l
Attachment H Sorbent Data Submission Sample Template H-l
Attachment I: Proprietary Business Information (PBI) Submission Sample Template 1-1
3.3.2 Appendix C to Part 300 Testing Protocols
Appendix C to Part 300 establishes laboratory protocols required under Subpart J to make
determinations for listing a product on the NCP Product Schedule. The protocols apply, based
on product type, to dispersants, bioremediation agents, surface washing agents, herding
agents, and solidifiers as defined in § 300.5 of the NCP. Applicable product testing protocols
include the following:
Appendix C to Part 300, Section 2.0 Baffled Flask Dispersant Efficacy Test (BFT) - This
laboratory protocol establishes procedures to evaluate the degree to which a product
effectively disperses oil spilled on the surface of seawater. The test uses Strategic
Petroleum Reserve Bryan Mound as the reference oil.
Appendix C to Part 300, Section 3.0 Dispersant Toxicity Testing - This laboratory protocol
includes testing for 1) dispersant standard static acute toxicity tests; 2) dispersant-oil
mixture static acute toxicity tests; 3) dispersant developmental assay; and 4) dispersant 7-
day static subchronic tests.
Appendix C to Part 300, Section 4.0 Standard Acute Toxicity Testing for Surface Washing
Agents, Bioremediation Agents, Herding Agents, and Solidifiers - This protocol includes
testing for 1) saltwater standard acute toxicity tests; and 2) freshwater standard acute
toxicity tests.
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Appendix C to Part 300, Section 5.0 Bioremediation Agent Efficacy Test Protocol - This
protocol quantifies changes in Alaska North Slope (ANS) 521 weathered crude oil
composition of alkanes and aromatics resulting from the use of a bioremediation agent in
either artificial seawater or freshwater.
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Chapter 4: Subpart J Testing Requirements and Listing
Thresholds by Product Category for Listing on the NCR
Product Schedule
4.1 Dispersant Testing and Listing Requirements [§ 300.915(b)]
Dispersants are substances that emulsify, disperse, or solubilize oil by promoting the formation
of small droplets or particles of oil in the water column. Manufacturers submitting a product
under the dispersant category are required to test the product for efficacy and toxicity for use
in saltwater environments only. Subpart J requires accredited laboratories to follow the efficacy
and toxicity testing protocols established for dispersant products in Appendix C to Part 300. The
dispersant agent product must meet established thresholds for product listing (See Table 4-1).
4.1.1 Dispersant Efficacy Test and Listing Criteria [§ 300.915(b)(1)]
Efficacy testing of dispersant products using the
Baffled Flask Dispersant Efficacy Test is designed
to be representative of moderately turbulent sea
conditions where dispersants are more likely to be
successful when used. The test is to determine
the product's ability to disperse the SPR Bryan
Mound reference crude oil in saltwater at both
5°C and 25°C. In addition, the test methodology
incorporates baffles in the wall of the testing flask
and adds a stopcock at the bottom (Figure 1),
improving reproducibility and repeatability in the
hands of different laboratory technicians. The
Baffled Flask specifications can be found in
section 2.0 of Appendix C to Part 300.
4.1.2 Dispersant Toxicity Tests and Listing
Criteria [§ 300.915(b)(2)]
Dispersant toxicity testing, only for saltwater
environments, include the following:
Dispersant Standard Static Acute Toxicity Tests - this test is for dispersant alone. It
determines the product's toxicity for saltwater species Americamysis bahia (48-hr duration)
and Menidia beryllina (96-hr duration). The test method uses standardized artificial
saltwater to allow for better reproducibility. Information on specific requirements can be
found in section 3.5 of Appendix C to Part 300.
Dispersant-Oil-Mixture Static Acute Toxicity Tests - The test uses Strategic Petroleum
Reserve Bryan Mound as reference oil for Americamysis bahia (48-hr duration) and Menidia
Figure 1: Modified Baffled Trypsinizing Flask
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beryllina (96-hr duration). Testing the oil and dispersant mixture is intended to provide data
on the relative toxicity of the oil and the potential hazards associated with dispersant use.
Information on specific requirements can be found in section 3.5 of Appendix C to Part 300.
Dispersant Developmental Assay - The test uses dispersant alone and Strongylocentrotus
purpuratus or Arbacia punctulate (72-hour duration). The developmental assay serves as a
sensitive surrogate test for early life stages. Information on specific requirements can be
found in section 3.6 of Appendix C to Part 300.
Dispersant 7-day Static Subchronic Tests - The test uses Americamysis bahia and Menidia
beryllina. The subchronic testing provides additional screening information given
dispersants transfer oil into the water column and are not intended to be recovered from
the environment. Information on specific requirements can be found in section 3.7 of
Appendix C to Part 300.
Separate toxicity tests must be performed with a reference toxicant for each species tested.
Information on acceptable reference toxicants and procedures to conduct reference toxicant
tests with the species can be found in the specific EPA methods cited in sections 3.3.3, 3.5.1,
3.6.1, and 3.7.1 of Appendix C to Part 300.
4.1.3 Dispersant Testing and Threshold Summary
Testing requirements and thresholds are summarized in Table 4-1. To be listed on the NCP
Product Schedule, dispersants must meet the established thresholds. Refer to Chapter 3 and
the data submission sample template in Attachment C of this guidance.
Table 4-1: Dispersants - Subpart J Required Tests and Thresholds
Subpart J Testing Requirements and Thresholds - Dispersants
Required Dispersant Tests
Dispersant Testing Thresholds
Dispersant Baffled Flask Effectiveness Test
(test method found in section 2.0 of Appendix
C to Part 300).
§ 300.915(b)(1): The dispersant must
demonstrate for each temperature a
Dispersant Effectiveness (DE) at the 95%
lower confidence level (LCL95) greater than or
equal to:
> 70% for SPR Bryan Mound Oil at 5°C and
> 75% for SPR at Bryan Mound Oil at 25°C.
Dispersant Alone 48-hr and 96-hr Standard
Static Acute Toxicity Test (test method found
in section 3.5 of Appendix C to Part 300).
§ 300.915(b)(2)(i): The dispersant alone must
demonstrate a lethal concentration of 50
percent of the test species (LC50) at the lower
95% confidence interval of greater than 10
ppm in saltwater for all tested species.
Dispersant Mixed with Oil 48-hr and 96-hr
Static Acute Toxicity Test (test method found
in section 3.5 of Appendix C to Part 300).
§ 300.915(b)(2)(i): The dispersant must
demonstrate an LC50 at the lower 95%
confidence interval of greater than 10 ppm
saltwater only for all tested species.
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Subpart J Testing Requirements and Thresholds - Dispersants
Required Dispersant Tests
Dispersant Testing Thresholds
Dispersant Sea Urchin Developmental
Toxicity Test Assay (test method found in 3.6
of Appendix C to Part 300).
§ 300.915(b)(2)(ii): The inhibition
concentration for 50% of the test species
(IC50) at the lower 95% confidence interval
must be greater than 1 ppm saltwater only for
all tested species.
Dispersant 7-day Sub-chronic Toxicity Test
(test method found in section 3.7 Appendix C
to Part 300).
§ 300.915(b)(2)(iii): The dispersant sub-
chronic No Observed Effect Concentration
(NOEC) must be or greater than 1 ppm
saltwater only for all tested species.
4.2 Surface Washing Agent Testing and Listing Requirements [§ 300.915(c)]
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. The
product and oil are generally to be collected and recovered from the environment with minimal
dissolution, dispersion, or transfer into the water column. Manufacturers submitting a product
under the surface washing agent category are required to test for efficacy and toxicity to
determine listing eligibility on the NCP Product Schedule.
4.2.1 Surface Washing Agent Efficacy Test and Listing Criteria [§ 300.915(c)(1)]
Under § 300.915(c)(1), the Agency has established a surface washing agent efficacy testing
requirement. Accredited laboratories are required to use an applicable standard recognized
efficacy testing methodology for surface washing agents. Using an applicable standard
methodology, surface washing agents must meet an efficacy of greater than or equal to 30% in
either freshwater or saltwater or both. Examples of such methodologies include the American
Society for Testing and Materials (ASTM) Standard Test Method for Evaluating the Effectiveness
of Cleaning Agents4 and the Environment Canada's Test Method5. 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.
4.2.2 Surface Washing Agent Toxicity Test and Listing Criteria [§ 300.915(c)(2)]
Accredited laboratories are required to use the toxicity methodology specified in section 4.0 of
Appendix C to Part 300 depending on the product's intended use:
4 ASTM Standard Test Method for Evaluating the Effectiveness of Cleaning Agents. Designation: G12296
(Reapproved 2008). ASTM International, 100 Barr Harbour Dr., P.O. Box C-700 West Conshohocken, Pennsylvania
19428-2959, United States.
5 Fingas, Merv and Fieldhouse, Ben; "Surface Washing Agents or Beach Cleaners" (2010). Chapter 21 Surface-
Washing Agents or Beach Cleaners. In Oil Spill Science and Technology (p716). London: Gulf Professional
Publishing.
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Freshwater testing for acute toxicity for the product alone using Ceriodaphnia dubia and
Pimephales promelas,
Saltwater testing for acute toxicity for the product alone using Americamysis bahia and
Menidia beryllina, or
Both of the above if product is intended for both freshwater and saltwater applications.
Required data and thresholds are summarized in Table 4-2. To be listed on the NCP Product
Schedule, surface washing agents must meet the established thresholds. Refer to Chapter 3 and
data submission sample template in Attachment D of this guidance.
Table 4-2: Surface Washing Agents: Subpart J Required Tests and Thresholds
Subpart J Testing Requirements and Thresholds Table
Surface Washing Agents
Surface Washing Agents Required Tests
Surface Washing Agents Testing
Thresholds
Surface Washing Agent Effectiveness Test for
Freshwater, Saltwater or Both depending on
product intended use. (Use applicable standard
method and cite method e.g., ASTM Standard Test
Method for Evaluating the Effectiveness of Cleaning
Agents (G12296) and Environment Canada's Test
Method).
§ 300.915(c)(1): Using an applicable
standard methodology, surface washing
agents must meet an efficacy of greater
than or equal to 30% in either
freshwater or saltwater or both.
Surface Washing Agents - Conduct fresh or saltwater toxicity tests or both depending on use
Saltwater 96-hr Static Acute Toxicity Test and
Saltwater 48-hr Static Acute Toxicity Test (test
methods found in section 4.0 of Appendix C to Part
300).
§ 300.915(c)(2): The surface washing
agents must demonstrate an LC50 at the
lower 95% confidence interval of greater
than 10 ppm saltwater for all tested
species.
Freshwater 96-hr Static Acute Freshwater Toxicity
Test and Freshwater 48-hr Static Acute Freshwater
Toxicity Test (test methods found in section 4.0 of
Appendix C to Part 300).
§ 300.915(c)(2): The surface washing
agents must demonstrate an LC50 at the
lower 95% confidence interval of greater
than 10 ppm in freshwater for all tested
species.
4.3 Bioremediation Agent Testing and Listing Requirements
[§ 300.915(d)]
Bioremediation agents include microorganisms, enzymes, and nutrient additives, such as
fertilizers, containing bioavailable forms for nitrogen, phosphorus, and potassium.
Manufacturers submitting a product under the bioremediation agent category are required to
test the product for efficacy and toxicity. Submitters have the option to test products for use in
saltwater environments only, for use in freshwater environments only, or for use in both. The
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bioremediation agent product must meet established thresholds for product listing (See Table
4-3).
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. Section 4.3.3 of this chapter describes the provisions at § 300.915(d)(4) for
generically listed nonproprietary nutrients.
4.3.1 Bioremediation Agent Efficacy Test and Listing Criteria [§ 300.915(d)(1)]
Efficacy testing is to determine the product's ability to biodegrade weathered ANS crude oil in
freshwater or saltwater, or both, depending on the intended product use. The test method,
specified in section 5.0 of Appendix C to Part 300, quantifies changes in the oil composition,
specifically the degradation of both alkanes and aromatics as determined by gas
chromatography/mass spectrophotometry.
4.3.2 Bioremediation Agent Toxicity Test and Listing Criteria [§ 300.915(d)(2)]
Accredited laboratories are required to use the toxicity methodology specified in section 4.0 of
Appendix C to Part 300 depending on the product's intended use:
Freshwater testing for acute toxicity for the product alone using Ceriodaphnia dubia and
Pimephales promelas,
Saltwater testing for acute toxicity for the product alone using Americamysis bahia and
Menidia beryllina, or
Both of the above if product is intended for both freshwater and saltwater applications.
Required data and thresholds are summarized in Table 4-3. To be listed on the NCP Product
Schedule, surface washing agents must meet the established thresholds. Refer to Chapter 3 and
data submission sample template in Attachment E of this guidance.
Table 4-3: Bioremediation Agents - Subpart J Required Tests and Thresholds
Subpart J Testing Requirements and Thresholds
Bioremediation Agents
Required Bioremediation Agent
Tests
Bioremediation Agent Testing Thresholds
Bioremediation 28-Day Effectiveness
Test (test method found in section
5.0 of Appendix C to Part 300) This
test uses weathered ANS test oil.
§ 300.915(d)(1): 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.
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Subpart J Testing Requirements and Thresholds
Bioremediation Agents
Required Bioremediation Agent
Tests
Bioremediation Agent Testing Thresholds
Bioremediation Agents - Conduct fresh or saltwater toxicity tests or both depending on use
Saltwater 96-hr Static Acute Toxicity
Test and Saltwater 48-hr Static Acute
Toxicity Test (test methods found in
section 4.0 of Appendix C to Part
300).
§ 300.915(d)(2): The bioremediation agent must
demonstrate an LC50 at the lower 95% confidence
interval of greater than 10 ppm saltwater for all
tested species.
Freshwater 96-hr Static Acute
Freshwater Toxicity Test and
Freshwater 48-hr Static Acute
Freshwater Toxicity Test (test
methods found in section 4.0 of
Appendix C to Part 300).
§ 300.915(d)(2): The bioremediation agent must
demonstrate an LC50 at the lower 95% confidence
interval of greater than 10 ppm in freshwater for all
tested species.
4.3.3 Generic Listing [§ 300.915(d)(4)],
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. For products that may contain
components not specifically identified in § 300.915(d)(4), the requirements under
§ 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 § 300.915(d).
Please refer to Chapter 3: Subpart J Data and Information Requirements for Listing on the NCP
Product Schedule and the bioremediation data submission sample template in Attachment E of
this guidance for further information.
4.4 Solidifier Agent Testing Requirements [§ 300.915(e)]
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
generally collected and recovered from the environment. Manufacturers submitting a product
under the solidifier agent category are required to test for toxicity to determine listing eligibility
on the NCP Product Schedule. There are no efficacy testing requirements in the NCP Subpart J
for solidifiers.
Accredited laboratories are required to use toxicity testing methods specified in section 4.0 of
Appendix C to Part 300 of Subpart J for the following depending on the product's intended use:
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Freshwater testing for acute toxicity for the product alone using Ceriodaphnia dubia and
Pimephales promelas,
Saltwater testing for acute toxicity for the product alone using Americamysis bahia and
Menidia beryllina, or
Both if product is intended for both freshwater and saltwater applications.
Required data points and thresholds are summarized in Table 4-4. To be listed on the NCP
Product Schedule, solidifier agents must meet the established thresholds. Refer to Chapter 3
Subpart J Data and Information Requirements for Listing on the NCP Product Schedule and data
submission sample template in Attachment F of this guidance.
Table 4-4: Solidifiers - Subpart J Required Tests and Thresholds
Subpart J Testing Requirements and Thresholds - Solidifiers
Solidifier Required Tests
Solidifier Testing Thresholds
Solidifiers - Conduct fresh or saltwater toxicity tests or both depending on use
Saltwater 96-hr Static Acute Toxicity Test
and
Saltwater 48-hr Static Acute Toxicity Test
(test methods found in section 4.0 of
Appendix C to Part 300).
§ 300.915(e)(1): The solidifier must demonstrate
an LC50 at the lower 95% confidence interval of
greater than 10 ppm saltwater for all tested
species.
Freshwater 96-hr Static Acute Freshwater
Toxicity Test and Freshwater 48-hr Static
Acute Freshwater Toxicity Test (test
methods found in section 4.0 of Appendix C
to Part 300).
§ 300.915(e)(1): The solidifier must demonstrate
an LC50 at the lower 95% confidence interval of
greater than 10 ppm in freshwater for all tested
species.
4.5 Herding Agent Testing Requirements [§ 300.915(f)]
Herding agents or herders are substances that form a film on the water surface to control the
spreading of the oil to allow for oil removal. Manufacturers submitting a product under the
herding agent category are required to test for toxicity to determine listing eligibility on the
NCP Product Schedule. There are no efficacy testing requirements in the NCP Subpart J for
herders.
Accredited laboratories are required to use toxicity testing methods specified in section 4.0
Appendix C to Part 300 for the following depending on the product's intended use:
Freshwater testing for acute toxicity for the product alone using Ceriodaphnia dubia and
Pimephales promelas,
Saltwater testing for acute toxicity for the product alone using Americamysis bahia and
Menidia beryllina, or
Both if product is intended for both freshwater and saltwater applications.
Required data and thresholds are summarized in Table 4-5. To be listed on the NCP Product
Schedule, herding agents must meet the established thresholds. Refer to Chapter 3 Subpart J
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Data and Information Requirements for Listing on the NCP Product Schedule and the data
submission sample template in Attachment G of this guidance.
Table 4-5: Herding Agents - Subpart J Required Tests and Thresholds
Subpart J Testing Requirements and Thresholds Table
Herding Agents
Herding Agent Required Tests
Herding Agent Testing Thresholds
Herding Agents - Conduct fresh or saltwater toxicity tests or both depending on use
Saltwater 96-hr Static Acute Toxicity
Test and
Saltwater 48-hr Static Acute Toxicity
Test (test methods found in section 4.0 of
Appendix C to Part 300).
§ 300.915(f)(1): The herding agent must
demonstrate an LC50 at the lower 95% confidence
interval of greater than 10 ppm saltwater for all
tested species.
Freshwater 96-hr Static Acute
Freshwater Toxicity Test and Freshwater
48-hr Static Acute Freshwater Toxicity
Test (test methods found in section 4.0 of
Appendix C to Part 300.
§ 300.915(f)(1): The herding agent must
demonstrate an LC50 at the lower 95% confidence
interval of greater than 10 ppm in freshwater for
all tested species.
4.6 Providing a Neat (Undiluted) Sample to Laboratory for Testing
The neat product sample along with a chain of custody should be provided to the laboratory
conducting testing to aid in product comparison. The test methods described in Appendix C to
Part 300 are intended to provide a basic set of test procedures that will provide baseline data
for comparison of products on a national basis. The testing protocols were not developed with
the intent of replicating possible real-world situations. The dispersant toxicity testing protocol
was developed using conservative estimates. In using the data currently available on the NCP
Product Schedule, On-Scene Coordinators (OSC) and Regional Response Teams (RRT)
understand these data are intended for use for relative comparisons and rankings of products.
4.7 EPA Reference Test Oil Procurement
EPA secured the reference test oils for the
specific purpose of establishing nationally
consistent testing that would serve as a
baseline comparison of products considered for
listing on the NCP Product Schedule. EPA is
providing reference test oils specifically to test
products for listing on the NCP Product
Schedule, as well as to test representative
samples when an expired product is being
considered for authorization for use by an On-
Scene Coordinator to demonstrate the product
Subpart J Reference Test Oils - For
Accredited Laboratories Subpart J
Testing Only
Environmental Data Services,
Ltd (EDS)
5 Brilliant Avenue
Pittsburgh, PA 15215
Phone: (412) 408-3288
Email: dwaldschmidt@eds-us.net
For additional information:
Contact the NCP Subpart J Information Line at
202-260-2342.
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still meets the applicable efficacy and toxicity listing requirements under § 300.915.
EPA, through its contractor Environmental Data Services, Ltd (EDS), will be distributing
reference test oils in volumes limited to those required for testing dispersants and
bioremediation agents for the purposes of listing on the NCP Product Schedule or for
demonstrating whether expired products meet applicable efficacy and toxicity requirements
under § 300.915. EDS is only able to ship reference oils to a laboratory or facility that is
equipped to receive it. There is no charge for the test oils from EDS, but shipping must be paid
for by the recipient laboratory. The two oils available for testing include:
Strategic Petroleum Reserve (SPR) Bryan Mound Test Oil: For Baffled Flask Dispersant
Efficacy Test and Dispersant Toxicity Testing.
Alaska North Slope (ANS) 521 Weathered Test Oil: For Bioremediation Agent Efficacy Test
Protocol.
For surface washing agents, EPA reference test oils are not needed as the applicable standard
efficacy methodology selected by the submitter will specify what test oil to use. Likewise, EPA
reference test oils are not needed for the acute toxicity test of surface washing agents,
solidifiers, or herding agents.
Table 4-6 includes the volume that will be distributed, upon request, to the testing laboratories.
These volumes provide sufficient quantities of EPA reference oil needed to conduct the
required tests for dispersant products or for bioremediation agent products following the
protocols in Appendix C to Part 300.
Table 4-6: Appendix C to Part 300 Reference Test Oil Distribution Quantities for
Subpart J Testing Labs
Distribution Quantities to Meet Appendix C Product Testing Volume Requirements
Product Tests
Oil
Quantity
DISPERSANT -
Strategic Petroleum Reserve
1X500 ml
Efficacy Test
(SPR) Bryan Mound
Product-Oil Mixture Acute Toxicity Test
BIOREMEDIATION AGENT -
Alaska North Slope 521
1 X 2 oz jar
Efficacy Test - Freshwater
Weathered Oil
BIOREMEDIATION AGENT -
Alaska North Slope 521
1 X 2 oz jar
Efficacy Test-Saltwater
Weathered Oil
BIOREMEDIATION AGENT -
Alaska North Slope 521
2 X 2 oz jars
Efficacy Test - Both Freshwater and
Weathered Oil
Saltwater
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Chapter 5: Sorbents and the Sorbent Product List
5.1 Introduction
Sorbents as defined in § 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).
Sorbents are not listed on the NCP Product Schedule. 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. NOTE: Response actions, including the use of sorbents, are
subject to OSC oversight under the NCP.
5.2 Sorbent Product List
Known sorbent materials and products will be identified on a publicly available Sorbent Product
List and will serve as reference for the use of such products when responding to an oil
discharge. The Sorbent Product List is comprised of two parts: 1) sorbents covered by
§ 300.915(g)(1) and 2) sorbents covered by § 300.915(g)(2). Please review the sorbent
provisions under § 300.915(g)(1) and § 300.915(g)(2).
Under § 300.915(g)(1), the Sorbent Product List covers sorbent products that consist solely of
the materials, or any combination thereof, identified in § 300.915(g)(l)(i)-(iii). No technical data
are required to be submitted to EPA. A sorbent product covered by § 300.915(g)(1) is
considered generically listed on the Sorbent Product List whether or not the sorbent product is
also specifically identified on the Sorbent Product List using a name, brand, or trademark. OSCs
should be aware that a sorbent product that consist solely of the materials, or any combination
thereof, listed in § 300.915(g)(l)(i)-(iii), but not specifically identified by a trademark, are
generically listed on the Sorbent Product List. Specific listing of sorbent products with a name,
brand, or trademark under § 300.915(g)(1) are based solely on the sorbent product
representation, and do NOT represent a determination made by EPA. Any sorbent
manufacturer who has determined its sorbent product is covered by § 300.915(g)(1) may ask
EPA to specifically include their name, brand, or trademarked sorbent product by sending EPA
(see address below) the following information:
1) The sorbent product manufacturer's name, physical address, email, and telephone number,
and
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2) The name(s), brand(s), and/or trademark(s) of the sorbent product to EPA's Product
Schedule Manager.
U.S. Environmental Protection Agency
1200 Pennsylvania Ave, NW
Mail Code: 5104A, Room 1448, William J. Clinton North Building
Washington, DC 20460
Attention: Product Schedule Manager
Under § 300.915(g)(2), EPA will consider listing sorbent products on the Sorbent Product List,
consisting of one or more natural organic substances, inorganic/mineral compounds, and/or
synthetic compounds not specifically identified in § 300.915(g)(l)(i)-(iii). EPA will review the
submitted product data and information described in § 300.915(g)(2)(i)-(iii) to determine if the
product meets the regulatory definition of a sorbent. EPA may request clarification or
additional information, as necessary, consistent with the NCP.
Under § 300.955(f), 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 § 300.955(a) and (b) and be listed in the new Sorbent Product
List. The transitions period provides time for products manufacturers to understand the new
provisions.
Section 300.915(g) of Subpart J provides the requirements for sorbent materials and products
to be identified on the publicly available Sorbent Product List for the use of such products when
responding to an oil discharge as follows:
§ 300.915(g)(1), For sorbent products that consist solely of the following materials, or any
combination thereof, no technical data are required, 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.
§ 300.915(g)(2), If the product consists of one or more natural organic substances,
inorganic/mineral compounds, and/or synthetic compounds not specifically identified in
[§ 300.915(g)(1)], but you believe the product meets the definition of a sorbent then, as
applicable under § 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 [§ 300.915];
(ii) The certification required under paragraph (a)(16) of [§ 300.915]; and
(iii) Information, including data, to support the claim your product meets the sorbent
definition under § 300.5.
A sample template for new sorbent data requirements can be found in Attachment H of this
guidance.
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Chapter 6: Proprietary Business Information [§ 300.950]
6.1 Introduction
Subpart J specifies what information submitters are allowed to claim as Proprietary Business
Information or PBI (formerly known as Confidential Business Information or CBI). The aim is to
balance public access to information with proprietary business needs.
When submitting a product for listing on the NCP Product Schedule or the Sorbent Product List,
only certain information may be claimed as PBI in accordance with § 300.950. Specifically,
submitters may only claim as PBI the concentration; the maximum, minimum, and average
weight percent; and the units of each component as identified in § 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. All other information submitted to EPA for listing on
the NCP Product Schedule as required under § 300.915 and § 300.955 cannot be claimed as PBI
and will be available for public disclosure upon submission without further notice to the
submitter. PBI claims must be made at the time the submitter submits the product listing
request to EPA.
Attachment I of this guidance includes a Proprietary Business Information Submission Sample
Template available for use to make PBI claims.
6.2 Proprietary Business Information Sample Format for Chemical and Biological
Agents and Sorbents [§ 300.915(a)(13)]
The submitter may use the following sample format, or similar, when submitting PBI for
chemical and biological agents and sorbents to EPA (refer to Attachment I of this guidance).
Table 6-1 Sample Format for Submitting PBI for Chemical and Biological Agents and Sorbents
Chemical Name
CAS#
Concentration Percentage by
Weight (PBI)
Intended Function
Sodium stearate
822-16-2
MAX/MI N/AVG%
Surfactant
When submitting as PBI the associated concentrations, weight percentages and units for the
components of a chemical or biological agent product, please note the following:
Chemical Name: Use the proper chemical name for each product component and not the
commercial name, chemical families, classes or group names. The chemical name of
product components cannot be claimed PBI.
Chemical Abstract Service (CAS) Registry Number: Include GAS Registry Number for each
chemical. The CAS Registry Number of product components cannot be claimed CBI.
Concentration, Percentage by Weight: Include the concentration, the maximum, minimum,
and average weight percent, and the units as applicable for each component of the total
26
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formulation (This is the only information submitters may claim as PBI). Concentrations are
often expressed in terms of either mass or volume percentages. Generally, the total
average weight percent for chemical components combined should equal or approximate
100% (microorganisms and enzymes are to be reported in their respective units).
Category: Identify the intended function of each component (e.g., surfactant, solvent). The
intended function of product components cannot be claimed PBI.
6.3 Proprietary Business Information Sample Format for Chemical and Biological
Agents and Sorbent Products Containing Microorganisms, Enzymes, and/or
Nutrients [§ 300.915(a)(14)]
The submitter may use the following sample formats, or similar, when submitting PBI for
chemical and biological agents and sorbents that have components containing microorganisms,
enzymes, and/or nutrients to EPA (refer to Attachment I of this guidance).
6-2: Sample Format for Submitting PBI for Products Containing Microorganisms:
Microorganism
Name
Reclassifications
Any Physical,
Chemical, or Biological
Manipulation of
the Genetic Composition
Weight Percent of
Each Genus in the
Product (PBI)
Microorganism
(current genus,
species)
MAX/MI N/AVG%
Microorganisms: Provide the name of all microorganisms by current genus and species.
Reclassification and Manipulation of Genetic Composition: Include any reclassifications
and any physical, chemical, or biological manipulation of the genetic composition.
The genus and species, reclassifications, and the physical, chemical or biological
manipulation of the genetic composition of the product components cannot be claimed as
PBI.
Weight Percent: Include weight percent of each genus in the product. This is the only
information submitters may claim as PBI.
6-3: Sample Format for Submitting PBI for Products Containing Enzymes
Enzyme
Name
International
Union of
Biochemistry
(I.U.B.)
Number(s)
Enzyme
Classification
(EC) Code
Numbers
Source of
Each Enzyme
Units
(PBI)
Specific Oil-
Degrading
Activity
Enzyme
Enzymes: Include 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;
27
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units; and specific oil-degrading activity. The name, I.U.B. and EC, enzyme source and
specific oil-degrading activity of product components cannot be claimed PBI.
Units are expressed in terms of either mass or volume percentages. Enzymes are to be
reported in their respective units; the units may be claimed as PBI.
6-4: Sample Format for Submitting PBI for Products Containing Nutrients
Nutrient Name
CAS#
Weight Percent
Intended Function
Ammonium nitrate
6454-52-2
MAX/MI N/AVG%
Nutrient additive
Nutrient Name: Use the proper nutrient names and not the commercial names, chemical
families, classes or group names. The nutrient names of product components cannot be
claimed PBI.
Chemical Abstract Service (CAS) Registry Number: Include GAS Registry Number for each
nutrient. The CAS Registry Number of product components cannot be claimed CBI.
Concentration, Percentage by Weight: Include the concentration, the maximum, minimum,
and average weight percent, and the units as applicable for each component of the total
formulation. This is the only information that may be claimed as PBI. Concentrations are
often expressed in terms of either mass or volume.
Category: Identify the intended function of each component. The intended function of
nutrient components cannot be claimed as PBI.
6.4 Submitting Proprietary Business Information
REMINDER: PBI information should not be submitted to EPA electronically. Any PBI submitted
electronically to EPA will immediately be deleted in accordance with EPA policy.
When mailing a submission package to EPA for listing a product under the NCP Product
Schedule or the Sorbent Product List, all information claimed as PBI must be enclosed
separately within the submission package and marked "Proprietary Business Information."
Include all PBI separately from the rest of your submission package, mark it as "Proprietary
Business Information" and place it in a separate inner envelope labeled with "PROPRIETARY
BUSINESS INFORMATIONTO BE OPENED BY THE PRODUCT SCHEDULE MANAGER ONLY."
EPA will handle PBI claims in accordance with 40 CFR part 2, subpart B Confidentiality of
Business Information. Shipping Subpart J product submission packages via secure courier (i.e.,
Fed Ex, UPS), as well as sharing the tracking number with EPA, will assist EPA in securing those
packages. When product submission packages arrive at EPA, they are stored in a locked secure
location, with access only to personnel that have been authorized to handle PBI.
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Chapter 7: Addition of a Product to the NCP Product
Schedule or Sorbent Product List [§ 300.955]
7.1 Introduction
To ensure you are submitting a complete package, follow these steps and refer to the product
listing checklist in Attachment A of this guidance when preparing the submission package.
Proper preparation assists EPA in conducting their review. EPA will not review incomplete
packages.
7.2 Package Contents and Cover Letter
Section 300.955(b) specifies that the submitters package shall include, as applicable, in this
order:
(1) A cover letter on company letterhead signed and dated by the submitter 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
§ 300.915(a) through (g), as applicable (Please note: Adding page numbers to each page
will assist EPA in the review of the submission package);
(3) All required data and information arranged in the same order as specified in
§ 300.915(a) through (g); and
(4) A separate envelope containing and labeled Proprietary Business Information as
specified in § 300.950(b), if applicable (see Chapter 6 for detailed information on
submitting PBI).
7.3 Submission Address
Submit your completed package to:
Attn: NCP Product Schedule Manager
U.S. Environmental Protection Agency
1200 Pennsylvania Ave. NW
Mail Code: 5104A, Room 1448
William J. Clinton North Building
Washington, DC 20460
If you have questions on
submitting a product package,
contact the NCP Subpart J
Information Line at:
(202) 260-2342
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7.4 EPA Review and Product Listing Determination
7.4.1 Review Timeline
As provided in § 300.955(c), EPA will within 90 days of receiving a product application package:
(1) Review the package for completeness and compliance with all data and information
requirements in § 300.915, § 300.950, and § 300.955; 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 the submitter 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 the submission is rejected:
(i) The submitter may revise and resubmit a complete package to address test results,
data, or information deficiencies.
(ii) For resubmissions, EPA's 90-day review will not start until a complete package is
resubmitted.
7.4.2 Request for Review of Decision
If your product is rejected for listing on the NCP Product Schedule or the Sorbent Product List,
under § 300.955(d) the submitter may request that the EPA Administrator or designee review
the determination. The 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.
The 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 the
submitter and may offer an opportunity for a meeting with EPA.
(2) The EPA Administrator or designee will notify the submitter in writing of the decision
within 60 days of receipt of the review request, or within 60 days of receipt of requested
additional information.
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Chapter 8. Submitter Responsibilities for Listed
Products
8.1 Introduction
After products are listed on the NCP Product Schedule, there are responsibilities that
submitters must meet. These responsibilities include displaying the mandatory product
disclaimer as provided under § 300.965, notifying EPA of any administrative changes within 30
days, and retesting and submitting new product application packages for product
reformulations. This chapter highlights product listing and submitter responsibilities.
8.2 Notification for Listing
EPA will notify the submitter in writing of its decision to list the product on the NCP Product
Schedule or the Sorbent Product List. In addition to notification in writing of EPA's decision to
list the product on the NCP Product Schedule or Sorbent Product list, products will be posted to
the NCP Product Schedule and Sorbent Product List on EPA's website.
8.3 Mandatory Product Disclaimer [§ 300.965]
The listing of a product on the NCP Product Schedule does not constitute approval or
recommendation of the product for use in response to an oil discharge. To avoid possible
misinterpretation or misrepresentation, any label, advertisement, or technical literature for the
product must display in its entirety the disclaimer shown below. The disclaimer must be
conspicuous and must be fully reproduced on all product literature, labels, and electronic
media including webpages.
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.
8.4 Making Administrative Changes to a Product Listing [§ 300.955(e)]
Submitters must notify EPA in writing within 30 days of any changes to information submitted
under § 300.915(a)(1) through (8) and § 300.915(a)(19) through (21) for a product on the NCP
Product Schedule. Specifically, notifications are required for changes to the following
information:
Submitter's name, physical address, email, and telephone number (§ 300.915(a)(1));
Submitter's 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 (§ 300.915(a)(2));
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All name(s), brand(s), and/or trademark(s) under which the product is to be sold
(§ 300.915(a)(3));
Names, physical addresses, emails, and telephone numbers of the product suppliers, such
as primary distributors, vendors, importers and/or designated agent acting on behalf of the
manufacturer (§ 300.915(a)(4));
The Safety Data Sheet (SDS) for the product (§ 300.915(a)(5));
The maximum, minimum, and optimum temperature, humidity, and other relevant
conditions for product storage and brief description of the consequences to performance if
the product is not stored within these limits (§ 300.915(a)(6));
The anticipated shelf life of the product at the storage conditions noted in (§ 300.915(a)(6))
and documentation for this determination (§ 300.915(a)(7));
A sample product label for all name(s), brand(s), and/or trademark(s) under which the
product is to be sold that includes the manufacture and expiration dates, and conditions for
storage. You may use an existing label provided in already contains the required dates and
storage information ((§ 300.915(a)(8));
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 (§ 300.915(a)(19));
Recognitions received from EPA's Design for the Environment (DfE) or Safer Choice
programs, as applicable (§ 300.915(a)(20)); and
International product testing or use data or certifications, if available, informing the
performance capabilities or environmental impacts of the product ((§ 300.915(a)(21)).
The notification must detail the specific changes, the reasons for such changes, and include
supporting data and information. EPA may request additional information and clarification
regarding these changes.
8.5 Product Reformulation [§ 300.955(e)(2)]
Changes in the components and/or concentrations of a product require that the reformulated
product be retested according to the requirements for the product category and that a new
complete package be submitted under a new, distinct name in accordance with § 300.955(b)
for review and consideration for listing on the NCP Product Schedule or Sorbent Product List by
EPA.
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Chapter 9: NCP Product Schedule and NCP Product
Schedule Technical Notebook
9.1 Introduction
EPA will make a product listing determination based on the technical evaluation of all data and
information submitted in accordance with the requirements for each product category,
relevant information known to the Agency 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. Products listings will be added to the NCP Product Schedule. The product specific data
provided by submitters is made available through the | >duct Schedule Technical
Notebook. The listing of a product on the NCP Product Schedule does not constitute approval
or recommendation of the product, it means only that the regulatory data submission and
testing and listing requirements have been satisfied. Sorbent products are not listed on the NCP
Product Schedule. Instead, sorbents are listed in the Sorbent Product List. For sorbent listing
information, refer to Chapter 5 Sorbents and the Sorbent Product List.
9.2 NCP Product Schedule
The NCP Product Schedule presents products (including all name(s), brand(s), and/or
trademark(s) under which the product is to be sold) in an alphabetical table of contents, with
navigation to the listing information, and by category type (i.e., bioremediation agents,
dispersants, herding agents, solidifiers, and surface washing agents). The NCP Product Schedule
is updated as needed to include, for example, new listings, product removals, and
administrative changes (for more information please refer to Section 8.4: Making
Administrative Changes to a Product Listing, in Chapter 8 of this guidance). The ct
Schedule document is made available for public disclosure on EPA's website. In addition, users
can navigate to the online NCP Product Schedule Technical Notebook Product Data and
Information Summaries by clicking on the product names (and aka's) under the category type.
EPA will assign numbers to the products as they are listed for tracking purposes.
9.3 NCP Product Schedule Technical Notebook
As a companion to the NCP Product Schedule, the | :t Schedule Technical Notebook
contains the Subpart J required data, information, and testing results of listed products as
provided by product submitters. The product data and information in the NCP Product Schedule
Technical Notebook will assist On-Scene Coordinators in further understanding
countermeasures that may be considered in their planning for and responding to oil spills.
The | :t Schedule Technical Notebook is updated as needed to include, for example,
new listings, product removals, and administrative changes (for more information, please refer
to Section 8.4: Making Administrative Changes to a Product Listing, in Chapter 8 of this
guidance); and made available for public disclosure on EPA's website. NCP Product Schedule
Technical Notebook users can navigate to all product data and information summaries,
including all product's name(s), brand(s), and/or trademark(s), by category type, alphabetically,
or categorically by product.
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Chapter 10: Removal of a Product from the NCP Product
Schedule or Sorbent Product List [§ 300.970]
10.1 Introduction
EPA may determine there is a need to remove products from the NCP Product Schedule or the
Sorbent Product List. The Agency will notify the submitter of a determination to remove a listed
product and will provide an opportunity for the submitter to appeal that decision prior to
removal of the listed product from the NCP Product Schedule or the Sorbent Product List.
Additionally, Subpart J does not prohibit submitters from, at any time, requesting their
products be removed from the NCP Product Schedule or Sorbent Product List. The Agency will
make final determinations regarding any such request. The NCP Product Schedule and Sorbent
Product List will identify products that have been removed, including those removed at the
request of the submitter.
10.2 Removal of a Product by EPA
In accordance with § 300.970, the EPA Administrator or designee may remove a listed product
from the NCP Product Schedule or Sorbent Product List for reasons including, but not limited
to:
(1) Misleading, inaccurate, outdated, or incorrect statements and information 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; or
(2) Alterations to the components, concentrations, or use conditions of the product without
proper notification to EPA as required by § 300.955(e); or
(3) Failure to print the disclaimer provided in § 300.965 on all labels, advertisements,
technical literature, or electronic media for products listed on the NCP Product
Schedule; or
(4) New or previously unknown relevant information concerning the impacts or potential
impacts of the product to human health or the environment.
EPA will notify the submitter in writing, at their address of record, of its reasons for deciding to
remove the product. If EPA receives no appeal from the submitter in 30 days, the product will
be removed from the NCP Product Schedule or Sorbent Product List without further notice to
the submitter.
Submitters have the option to appeal the decision to remove their product within 30 days of
receipt of EPA's notification. The 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 the submitter in writing of the decision within 60
days of the appeal, or within 60 days of receipt of any requested additional information.
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103 Removal of a Product by a Submitter
Submitters may request that their listed product be removed from the NCP Product Schedule or
the Sorbent Product List. This may occur, for example, if a product is no longer being
manufactured or if a company is going out of business. Submitters should send a formal letter
to EPA requesting their product be removed from the NCP Product Schedule or the Sorbent
Product List including the reason for removal. EPA will make the final determination on
delisting under any such request.
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Attachment A: Product Listing Checklist
General Checklist for Listing a Product on the NCP Product Schedule
Completed
Activity
1. Read the regulatory requirements under Subpart J of the NCP in their entirety
(including Appendix C to Part 300).
2. Read the product definitions and determine product category (under
§ 300.5 of the NCP. Subpart J Product Categories: Dispersant, Surface Washing
Agent, Bioremediation Agent, Herding Agent, Solidifiers, and Sorbents (see Chapter 2
of this guidance)).
3. Review the specific listing data requirements for your product category (under
§ 300.915 and Appendix C to Part 300, see sample templates in Attachments C - H of
this guidance)
4. Review testing requirements for your product category (under § 300.915 and
including Appendix C to Part 300)
a. Physical and Chemical Properties;
b. Pathogens and Contaminants;
c. Toxicity for all products (choose fresh water, salt water or both as appropriate);
and
d. Efficacy for Dispersants, Surface Washing Agents, and Bioremediation Agents.
5. Select an accredited lab and/or labs to conduct the testing required for your
product category.
a. Send neat (undiluted) product and chain of custody to lab(s) for analysis.
6. Complete application for your product category (see Chapters 3-5 and sample
templates in Attachments C - 1 of this guidance).
7. Follow Proprietary Business Information (PBI) instructions under § 300.950 (see
Chapter 6 and Attachment 1 of this guidance). Note: Submitters may claim as PBI
only the concentrations of components in their product; the maximum, minimum,
and average weight percent of each component; and the units of each component as
identified in § 300.915(a)(13) and (14) and as applicable.
8. Submit your product package to EPA as required under § 300.955:
a. Cover letter;
b. Page numbered Table of Contents;
c. All required data and information arranged in the same order as specified in §
300.915(a) through (g); and
d. A separate envelope containing and labeled Proprietary Business Information as
specified in § 300.950(b), if applicable.
If you have questions, call the NCP Subpart J Information Line at (202) 260-2342.
A-l
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Attachment B: Quick Links to the Electronic Code of
Federal Regulations (eCFR)6
NCP Definitions - § 300.5
Full list of NCP definitions including those applicable to Subpart J:
https://www.ecfr.gov/current/title-40/chapter-
l/subchapter-J/part-300/subpart-A/section-300.5
(eCFR)
Subpart J Regulation
Subpart J Use of Dispersants, and Other Chemical and
Biological Agents:
https://www.ecfr.gov/current/title-40/chapter-
l/subchapter-J/part-300/subpart-J(eCFR)
Appendix C to Part 300
Access to Appendix C to Part 300 Requirements for Product
Testing Protocols and Summary Test Data:
https://www.ecfr.gov/current/title-40/chapter-
l/subchapter-J/part-300#Appendix-C-to-Part-300
(eCFR)
6 The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the
general and permanent rules published in the Federal Register by the departments and agencies of the Federal
Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the
CFR. It is not an official legal edition of the CFR.
B-l
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Attachment C: Dispersant Data Submission Sample
Template
DISPERSANT DATA SUBMISSION SAMPLE TEMPLATE
FOR § 300.915 DATA AND INFORMATION REQUIREMENTS
PRODUCT NAME:
CATEGORY: DISPERSANT
GENERAL PRODUCT INFORMATION [§ 300.915(a)]
(1) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUBMITTER [§ 300.915(a)(1)]
Your name, physical address, email, and telephone number.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(2) SUBMITTER IDENTIFICATION [§ 300.915(a)(2)]
Your identity and documentation of that identity, as the manufacturer of the product; vendor,
importer, or distributor of the product; and/or designated agent acting on behalf of the manufacturer.
(3) PRODUCT NAME, BRAND, OR TRADEMARK [§ 300.915(a)(3)]
All name(s), brand(s), and/or trademark(s) under which the product is to be sold.
(4) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUPPLIERS [§ 300.915(a)(4)]
Names, physical addresses, emails, and telephone numbers of the primary distributors, vendors,
importers, and/or designated agent acting on behalf of the manufacturer.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail:
(Point of Contact)
(5) SAFETY DATA SHEET (SDS) [§ 300.915(a)(5)]
The Safety Data Sheet for the product.
(6) PRODUCT STORAGE [§ 300.915(a)(6)]
1. Maximum storage temperature (e.g., °F and/or °C):
2. Minimum storage temperature (e.g., °F and/or °C):
3. Optimum storage temperature (e.g., °F and/or °C):
4. Humidity (e.g., g/kg):
5. Other relevant conditions for product storage:
6. Description of the consequences to performance if product is not stored within these limits:
C-l
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(7) SHELF LIFE STORAGE CONDITIONS [§ 300.915(a)(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) PRODUCT LABEL [§ 300.915(a)(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) PRODUCT CATEGORY AND PROCESSES [300.915(a)(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, in the specific environment(s) on which it is intended to be used (e.g.,
waters and/or adjoining shoreline). 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 [§ 300.915(a)(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) ENVIRONMENTAL FATE OF COMPONENTS [§ 300.915(a)(ll)]
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) PHYSICAL/CHEMICAL PROPERTIES [§ 300.915(a)(12)]
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:
(viii)pH:
C-2
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(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(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).
See Chapter 6 and the sample template in Attachment I of this guidance.
Note 1: Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter.
Note 2: You must make your PBI claim at the time you submit your information to EPA to be listed on
the NCP Product Schedule and include any PBI information in a separate sealed envelope.
(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
For products that contain microorganisms, enzymes, and/or nutrients, provide the component
information as follows, including a citation and description of the methodology used to determine:
1. Microorganisms [§ 300.915(a)(14)(i)]
a. Name of all microorganisms by current genus and species:
b. Any reclassifications:
c. Any physical, chemical, or biological manipulation of the genetic composition:
d. Weight percent of each genus in the product:
See Chapter 6 and the sample template in Attachment I of this guidance.
2. Enzymes [§ 300.915(a)(14)(ii)]
a. Name of all enzyme(s):
b. International Union of Biochemistry (I.U.B.) Number(s),
c. Enzyme Classification (EC) Code Number:
d. Source of Enzymes:
e. Units:
f. Specific Oil-Degrading Activity:
See Chapter 6 and the sample template in Attachment I of this guidance.
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3. Nutrients [§ 300.915(a)(14)(iii)]
a. Name(s) of all Nutrients:
b. Maximum Weight Percent of Nutrients:
c. Minimum Weight Percent of Nutrients:
d. Average Weight Percent of Nutrients:
See Chapter 6 and the sample template in Attachment I of this guidance.
4. Data, methodology, and supporting documentation for levels of bacterial, fungal, or viral
pathogens, or opportunistic pathogens, including but not limited to [§ 300.915(a)(14)(iv):
Enteric bacteria, suchs as Salmonella, fecal coliforms, Shigella, coagulase postive Staphylococci, and
beta hemolytic Streptococci and enterococci.
NOTE - Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter. You must
make your PBI claim at the time you submit your information to EPA to be listed on the NCP Product
Schedule and include any PBI information in a separate sealed envelope (See Chapter 6 of this
guidance).
(15) DATA, METHODOLOGY AND SUPPORTING DOCUMENTATION FOR LEVELS OF THE FOLLOWING
[§ 300.915(a)(15)]:
Data, methodology, and supporting documentation for the levels of the following:
1. Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and any other heavy
metal reasonably expected to be in the product;
2. Cyanide;
3. Chlorinated hydrocarbons;
4. Pesticides;
5. Polychlorinated biphenyls (PCBs); and
6. Polycyclic aromatic hydrocarbons (PAHs).
(16) PROHIBITED AGENT CERTIFICATION [§ 300.915(a)(16)]
Certification including data, methodology and supporting documentation indicating that product does
not contain any prohibited agents identified in § 300.910(e).
(17) LABORATORY INFORMATION [§ 300.915(a)(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 test(s) performed.
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(18) LABORATORY TEST DATA AND REPORTS [§ 300.915(a)(18)]
All test data and calculations, including:
1. Raw data and replicates, including positive controls;
2. Notes and observations collected during tests;
3. Calculated mean values and standard deviations;
4. Reports, including a summary of stock solution preparation;
5. Source and preparation of test organisms;
6. Test conditions; and
7. Chain of custody forms.
(19) PRODUCTION VOLUMES [§ 300.915(a)(19)]
An estimate of the annual production volume, the average and maximum amount that could be
produced in a day, and the timeframe needed to reach that maximum production rate in days.
(20) DESIGN FOR THE ENVIRONMENT (now Safer Choice) [§ 300.915(a)(20)]
Recognition received from EPA's Design for the Environment (DfE) or Safer Choice programs, as
applicable.
(21) INTERNATIONAL PRODUCT TESTING, DATA, AND/OR CERTIFICATIONS [§ 300.915(a)(21)]
International product testing or use data or certifications, if available, informing the performance
capabilities or environmental impacts of the product.
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PRODUCT CATEGORY TESTING AND LISTING REQUIREMENTS [§ 300.915(b)]
DISPERSANT EFFICACY TEST AND LISTING CRITERIA [§ 300.915(b)(1)]
Efficacy Test: Dispersant must be tested using the Baffled Flask Dispersant Efficacy Test in Appendix C
to Part 300, Section 2.0.
Listing Criteria: Dispersant must demonstrate for each temperature a Dispersant Effectiveness (DE) at
the 95% lower confidence level (LCL95) greater than or equal to:
>70% for Strategic Petroleum Reserve Bryan Mound test oil at 5°C; and
>75% for Strategic Petroleum Reserve Bryan Mound test oil at 25°C.
Test Oil
Dispersant Effectiveness
Temperature at 5°C
Dispersant Effectiveness
Temperature at 25°C
SPR Bryan Mound
[Percent] DElcl95
[Percent] DElcl95
DISPERSANT TOXICITY TESTS AND LISTING CRITERIA [§ 300.915(b)(2)]
Toxicity Tests: Dispersant must be tested, using the methods in Section 3.0 of Appendix C to Part 300,
for:
Dispersant alone and the dispersant mixed with Strategic Petroleum Reserve Bryan Mound for
acute toxicity, using Americamysis bahia and Menidia beryllina;
Dispersant alone for developmental toxicity using Strongylocentrotus purpuratus or Arbacia
punctulata; and
Dispersant alone for subchronic effects using Americamysis bahia and Menidia beryllina.
Listing Criteria: Dispersant tested alone must demonstrate:
For acute toxicity a median lethal concentration for 50% of the test species (LC50) at the lower
95% confidence interval greater than 10 ppm.
For developmental toxicity the inhibition concentration for 50% of the test species (LC50) at
the lower 95% confidence interval greater than 1 ppm; and
For sub-chronic toxicity the No Observed Effect Concentration (NOEC) greater than 1 ppm.
Note: Reference Toxicants. Separate toxicity tests must be performed with a reference toxicant for
each species tested (Section 3.3.3 of Appendix C to part 300). Submitters should provide results in
format shown below.
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PROCE
DURES
96-hr Static
48-hr Static Acute
72-hr Sea Urchin
7-day
Acute Menidia
Americamysis
Developmental
Subchronic
Material Tested
beryllina
bahia
Assay
Strongylocentrotus
purpuratus/Arbacia
punctulata
M. beryllina
& A. bahia
Dispersant Only
Yes
Yes
Yes
Yes
Dispersant/Reference Oil
Yes
Yes
No
No
Mixture
Acute Toxicity Test Data Summary
Material Tested
Saltwater Species
LC50 (ppm)
Dispersant Only
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
Dispersant/Reference Oil
Menidia beryllina
[Cone]
96-hr
Mixture
Americamysis bahia
[Cone]
48-hr
SDS Reference Toxicant
Menidia beryllina
[Cone]
96-hr
(AKA DSS or SLS)
Americamysis bahia
[Cone]
48-hr
Developmental Test Data Summary
Material Tested
Sea Urchin Species
LC50 (ppm)
Dispersant
Strongylocentrotus purpuratus /Arbacia
[Cone]
72-hr
punctulata
Copper Sulfate
Strongylocentrotus purpuratus /Arbacia
[Cone]
72-hr
Reference Toxicant
punctulata
Subchronic Test Data Summary
Material Tested
Saltwater Species
LC50 (ppm)
Dispersant
Menidia beryllina
[Cone]
7-day
Americamysis bahia
[Cone]
7-day
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Attachment D: Surface Washing Agent Data Submission
Sample Template
SURFACE WASHING AGENT DATA SUBMISSION SAMPLE TEMPLATE
FOR § 300.915 DATA AND INFORMATION REQUIREMENTS
PRODUCT NAME:
CATEGORY: SURFACE WASHING AGENT
GENERAL PRODUCT INFORMATION [§ 300.915(a)]
(1) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUBMITTER [§ 300.915(a)(1)]
Your name, physical address, email, and telephone number.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(2) SUBMITTER IDENTIFICATION [§ 300.915(a)(2)]
Your identity and documentation of that identity, as the manufacturer of the product; vendor,
importer, or distributor of the product; and/or designated agent acting on behalf of the
manufacturer.
(3) PRODUCT NAME, BRAND, OR TRADEMARK [§ 300.915(a)(3)]
All name(s), brand(s), and/or trademark(s) under which the product is to be sold.
(4) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUPPLIERS [§ 300.915(a)(4)]
Names, physical addresses, emails, and telephone numbers of the primary distributors, vendors,
importers, and/or designated agent acting on behalf of the manufacturer.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail:
(Point of Contact)
(5) SAFETY DATA SHEET (SDS) [§ 300.915(a)(5)]
The Safety Data Sheet for the product.
(6) PRODUCT STORAGE [§ 300.915(a)(6)]
1. Maximum storage temperature (e.g., °F and/or °C):
2. Minimum storage temperature (e.g., °F and/or °C):
3. Optimum storage temperature (e.g., °F and/or °C):
4. Humidity (e.g., g/kg):
5. Other relevant conditions for product storage:
D-l
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6. Description of the consequences to performance if product is not stored within these limits:
(7) SHELF LIFE STORAGE CONDITIONS [§ 300.915(a)(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) PRODUCT LABEL [§ 300.915(a)(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) PRODUCT CATEGORY AND PROCESSES [300.915(a)(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, in the specific environment(s) on which it is intended to be used
(e.g., waters and/or adjoining shoreline). 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 [§ 300.915(a)(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) ENVIRONMENTAL FATE OF COMPONENTS [§ 300.915(a)(ll)]
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 its components in the environment.
(12) PHYSICAL/CHEMICAL PROPERTIES [§ 300.915(a)(12)]
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:
(viii)pH:
(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(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
D-2
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average weight percent of each component in the product; and the intended function of each
component (e.g., solvent, surfactant).
See Chapter 6 and the sample template in Attachment I of this guidance.
Note 1: Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter.
Note 2: You must make your PBI claim at the time you submit your information to EPA to be listed on
the NCP Product Schedule and include any PBI information in a separate sealed envelope.
(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
For products that contain microorganisms, enzymes, and/or nutrients, provide the component
information as follows, including a citation and description of the methodology used to determine:
1. Microorganisms [§ 300.915(a)(14)(i)]
a. Name of all microorganisms by current genus and species:
b. Any reclassifications:
c. Any physical, chemical, or biological manipulation of the genetic composition:
d. Weight percent of each genus in the product:
See Chapter 6 and the sample template in Attachment I of this guidance.
2. Enzymes [§ 300.915(a)(14)(ii)]
a. Name of all enzyme(s):
b. International Union of Biochemistry (I.U.B.) Number(s):
c. Enzyme Classification (EC) Code Number:
d. Source of Enzymes:
e. Units:
f. Specific Oil-Degrading Activity:
See Chapter 6 and the sample template in Attachment I of this guidance.
D-3
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3. Nutrients [§ 300.915(a)(14)(iii)]
a. Name(s) of all Nutrients:
b. Maximum Weight Percent of Nutrients:
c. Minimum Weight Percent of Nutrients:
d. Average Weight Percent of Nutrients:
See Chapter 6 and the sample template in Attachment I of this guidance.
4. Data, methodology, and supporting documentation for levels of bacterial, fungal, or viral
pathogens, or opportunistic pathogens, including but not limited to [§ 300.915(a)(14)(iv):
Enteric bacteria, suchs as Salmonella, fecal coliforms, Shigella, coagulase postive Staphylococci, and
beta hemolytic Streptococci and enterococci.
NOTE - Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter. You must
make your PBI claim at the time you submit your information to EPA to be listed on the NCP Product
Schedule and include any PBI information in a separate sealed envelope (See Chapter 6 of this
guidance).
(15) DATA, METHODOLOGY AND SUPPORTING DOCUMENTATION FOR LEVELS OF THE FOLLOWING
[§ 300.915(a)(15)]:
Data, methodology, and supporting documentation for the levels of the following:
1. Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and any other heavy
metal reasonably expected to be in the product;
2. Cyanide;
3. Chlorinated hydrocarbons;
4. Pesticides;
5. Polychlorinated biphenyls (PCBs); and
6. Polycyclic aromatic hydrocarbons (PAHs).
(16; PROHIBITED AGENT CERTIFICATION [§ 300.915(a)(16)]
Certification including data, methodology and supporting documentation indicating that product does
not contain prohibited agents identified in § 300.910(e).
(17) LABORATORY INFORMATION [§ 300.915(a)(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 test(s) performed.
D-4
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(18) LABORATORY TEST DATA AND REPORTS [§ 300.915(a)(18)]
All test data and calculations, including:
1. Raw data and replicates, including positive controls;
2. Notes and observations collected during tests;
3. Calculated mean values and standard deviations;
4. Reports, including a summary of stock solution preparation;
5. Source and preparation of test organisms;
6. Test conditions; and
7. Chain of custody forms.
(19) PRODUCTION VOLUMES [§ 300.915(a)(19)]
An estimate of the annual production volume, the average and maximum amount that could be
produced in a day, and the timeframe needed to reach that maximum production rate in days.
20) DESIGN FOR THE ENVIRONMENT (now Safer Choice) [§ 300.915(a)(20)]
Recognition received from EPA's Design for the Environment (DfE) or Safer Choice programs, as
applicable.
(21) INTERNATIONAL PRODUCT TESTING, DATA, AND/OR CERTIFICATIONS [§ 300.915(a)(21)]
International product testing or use data or certifications, if available, informing the performance
capabilities or environmental impacts of the product.
D-5
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PRODUCT CATEGORY TESTING AND LISTING REQUIREMENTS [§ 300.915(c)]
SURFACE WASHING AGENT EFFICACY TEST AND LISTING CRITERIA [§ 300.915(c)(1)]
Efficacy Test: Surface washing agents must be tested using an applicable standard
methodology [e.g., Environment Canada's Test Method or ASTM Standard Test Method for
Evaluating the Effectiveness of Cleaning Agents (ASTM G12296)].
Listing Criteria: Surface washing agent must meet an efficacy of >30% in either freshwater or
saltwater, or both, depending on the intended product use.
Use Environment
Effectiveness (%)
Saltwater use
[Cone] or N/A
Freshwater use
[Cone] or N/A
STANDARD ACUTE TOXICITY TEST AND LISTING CRITERIA [§ 300.915(c)(2)]:
Toxicity Test: Surface washing agents must be tested for acute toxicity in freshwater,
saltwater, or both, depending on the intended product use per the method in Appendix C to
Part 300, section 4.0.
Listing Criteria: 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.
Note: Reference Toxicants. Separate toxicity tests must be performed with a reference toxicant for
each species tested (Section 3.3.3 of Appendix C to part 300). Submitters should provide results in
format shown below.
Use Environment
PROCEDURE
96-hr Static
Acute Menidia
beryllina
48-hr Static
Acute
Americamysis
bahia
96-hr Static
Acute
Pimephales
promelas
48-hr Static
Acute
Ceriodaphnia
dubia
Saltwater use
Yes
Yes
No
No
Freshwater use
No
No
Yes
Yes
Freshwater and saltwater
use
Yes
Yes
Yes
Yes
Saltwater Static Acute Toxicity Test Data Summary:
Material Tested
Saltwater Species
LC50 (ppm)
Surface Washing Agent
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
SDS Reference Toxicant (AKA DSS or SLS)
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
Freshwater Static Acute Toxicity Test Data Summary:
Material Tested
Freshwater Species
LC50 (ppm)
Surface Washing Agent
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
SDS Reference Toxicant (AKA DSS or SLS)
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
D-6
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Attachment E: Bioremediation Agent Data Submission
Sample Template
BIOREMEDIATION AGENT DATA SUBMISSION SAMPLE TEMPLATE
FOR § 300.915 DATA AND INFORMATION REQUIREMENTS
PRODUCT NAME:
CATEGORY: BIOREMEDIATION AGENT
GENERIC LISTING § 300.915(d)(4)
If your 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. These types of products are generically listed as non-proprietary nutrients on the NCP
Product Schedule, and no further action is necessary.
GENERAL PRODUCT INFORMATION [§ 300.915(a)] ~
(1) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUBMITTER [§ 300.915(a)(1)]
Your name, physical address, email, and telephone number.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(2) SUBMITTER IDENTIFICATION [§ 300.915(a)(2)]
Your identity and documentation of that identity, as the manufacturer of the product; vendor, importer,
or distributor of the product; and/or designated agent acting on behalf of the manufacturer.
(3) PRODUCT NAME, BRAND, OR TRADEMARK [§ 300.915(a)(3)]
All name(s), brand(s), and/or trademark(s) under which the product is to be sold.
(4) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUPPLIERS [§ 300.915(a)(4)]
Names, physical addresses, emails, and telephone numbers of the primary distributors, vendors,
importers, and/or designated agent acting on behalf of the manufacturer.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
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(Point of Contact)
(5) SAFETY DATA SHEET (SDS) [§ 300.915(a)(5)]
The Safety Data Sheet for the product.
(6) STORAGE TEMPERATURES [§ 300.915(a)(6)]
1. Maximum storage temperature (e.g., °F and/or °C):
2. Minimum storage temperature (e.g., °F and/or °C):
3. Optimum storage temperature (e.g., °F and/or °C):
4. Humidity (e.g., g/kg):
5. Other relevant conditions for product storage:
6. Description of the consequences to performance if product is not stored within these limits:
(7) SHELF LIFE STORAGE CONDITIONS [§ 300.915(a)(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) PRODUCT LABEL [§ 300.915(a)(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) PRODUCT CATEGORY AND PROCESSES [300.915(a)(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, in the specific environment(s) on which it is intended to be used (e.g., waters
and/or adjoining shoreline). 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 [§ 300.915(a)(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) ENVIRONMENTAL FATE OF COMPONENTS [§ 300.915(a)(ll)]
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) PHYSICAL/CHEMICAL PROPERTIES [§ 300.915(a)(12)]
Physical and chemical properties of the product, as appropriate, and a citation for the current applicable
standard methods used to determine them including:
E-2
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(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:
(viii)pH:
(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(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).
See Chapter 6 and the sample template in Attachment I of this guidance.
Note 1: Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each component
of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All other product
information submitted to EPA as required under § 300.915 and § 300.955 will be available for public
disclosure upon submission, without further notice to the submitter.
Note 2: You must make your PBI claim at the time you submit your information to EPA to be listed on
the NCP Product Schedule and include any PBI information in a separate sealed envelope.
(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
For products that contain microorganisms, enzymes, and/or nutrients, provide the component
information as follows, including a citation and description of the methodology used to determine:
1. Microorganisms [§ 300.915(a)(14)(i)]
a. Name of all microorganisms by current genus and species:
b. Any reclassifications:
c. Any physical, chemical, or biological manipulation of the genetic composition:
d. Weight percent of each genus in the product:
See Chapter 6 and the sample template in Attachment I of this guidance.
2. Enzymes [§ 300.915(a)(14)(ii)]
a. Name of all enzyme(s):
b. International Union of Biochemistry (I.U.B.) Number(s):
c. Enzyme Classification (EC) Code Number:
d. Source of Enzymes:
e. Units:
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f. Specific Oil-Degrading Activity:
See Chapter 6 and the sample template in Attachment I of this guidance.
3. Nutrients [§ 300.915(a)(14)(iii)]
a. Name(s) of all Nutrients:
b. Maximum Weight Percent of Nutrients:
c. Minimum Weight Percent of Nutrients:
d. Average Weight Percent of Nutrients:
See Chapter 6 and the sample template in Attachment I of this guidance.
4. Data, methodology, and supporting documentation for levels of bacterial, fungal, or viral
pathogens, or opportunistic pathogens, including but not limited to [§ 300.915(a)(14)(iv):
Enteric bacteria, suchs as Salmonella, fecal coliforms, Shigella, coagulase postive Staphylococci, and
beta hemolytic Streptococci and enterococci.
NOTE - Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each component
of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All other product
information submitted to EPA as required under § 300.915 and § 300.955 will be available for public
disclosure upon submission, without further notice to the submitter. You must make your PBI claim at
the time you submit your information to EPA to be listed on the NCP Product Schedule and include any
PBI information in a separate sealed envelope (See Chapter 6 of this guidance).
(15) DATA, METHODOLOGY AND SUPPORTING DOCUMENTATION FOR LEVELS OF THE FOLLOWING [§
300.915(a)(15)]:
Data, methodology, and supporting documentation for the levels of the following:
1. Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and any other heavy
metal reasonably expected to be in the product;
2. Cyanide;
3. Chlorinated hydrocarbons;
4. Pesticides;
5. Polychlorinated biphenyls (PCBs); and
6. Polycyclic aromatic hydrocarbons (PAHs).
(16) PROHIBITED AGENT CERTIFICATION [§ 300.915(a)(16)]
Certification including data, methodology and supporting documentation indicating that product does
not contain prohibited agents identified in § 300.910(e).
(17) LABORATORY INFORMATION [§ 300.915(a)(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 test(s) performed.
E-4
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(18) LABORATORY TEST DATA AND REPORTS [§ 300.915(a)(18)]
All test data and calculations, including:
1. Raw data and replicates, including positive controls;
2. Notes and observations collected during tests;
3. Calculated mean values and standard deviations;
4. Reports, including a summary of stock solution preparation;
5. Source and preparation of test organisms;
6. Test conditions; and
7. Chain of custody forms.
(19) PRODUCTION VOLUMES [§ 300.915(a)(19)]
An estimate of the annual production volume, the average and maximum amount that could be
produced in a day, and the timeframe needed to reach that maximum production rate in days.
(20) DESIGN FOR THE ENVIRONMENT (now Safer Choice) [§ 300.915(a)(20)]
Recognition received from EPA's Design for the Environment (DfE) or Safer Choice programs, as
applicable.
(21) INTERNATIONAL PRODUCT TESTING, DATA, AND/OR CERTIFICATIONS [§ 300.915(a)(21)]
International product testing or use data or certifications, if available, informing the performance
capabilities or environmental impacts of the product.
E-5
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PRODUCT CATEGORY TESTING AND LISTING REQUIREMENTS [§ 300.915(d)]
BIOREMEDIATION AGENT EFFICACY TEST AND LISTING CRITERIA [§ 300.915(d)(1)]
Efficacy Test:
o 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, Section 5.0.
o Appendix C specifies three types of tests that are applicable to the type of product: Type 1 for
products containing living microorganisms; Type 2 for products containing proprietary
nutrients but no live microorganism; or Type 3 for products (such as an enzyme) containing no
live microorganisms and no nutrients.
Listing Criteria:
o 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,
o The percentage reduction of total aromatics (aromatic fraction) must be greater than or equal
to 35% at day 28 for saltwater and freshwater based on the UCL95.
o The benchmark reduction ranges in aliphatic and aromatic fractions for the positive control are
the same as for the products specified above,
o The day 28 GC/MS results from the killed control must not be less than 90% of the day 0
results.
Saltwater Data Summary Table:
TOTAL AL
-------
STANDARD ACUTE TOXICITY TEST AND LISTING CRITERIA [§ 300.915(c)(2)]:
Toxicity Test: Bioremdiation agents must be tested for acute toxcitv in freshwater or saltwater, or
both, depending on the intended product use per methods in Appendix C to Part 300, Section 4.0.
Listing Criteria: Bioremediation agents must demonstrate an LC50 at the lower 95% confidence
interval of greater than 10 ppm in either freshwater or saltwater for all tested species.
Note: Reference Toxicants. Separate toxicity tests must be performed with a reference toxicant for each
species tested (Section 3.3.3 of Appendix C to part 300). Submitters should provide results in format
shown below.
Procedure
Material Tested
96-hr Static
Acute
Menidia
beryllina
48-hr Static
Acute
Americamysis
bahia
96-hr Static
Acute
Pimephales
promelas
48-hr Static Acute
Ceriodaphnia dubia
Saltwater only
Yes
Yes
No
No
Freshwater only
No
No
Yes
Yes
Freshwater and saltwater use
Yes
Yes
Yes
Yes
Saltwater Static Acute Toxicity Test Data Summary:
Material Tested
Saltwater Species
LC50 (ppm)
Product
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
SDS Reference Toxicant (AKA DSS or SLS)
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
Freshwater Static Acute Toxicity Test Data Summary:
Material Tested
Freshwater Species
LC50 (ppm)
Product
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
SDS Reference Toxicant (AKA DSS or SLS)
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
E-7
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Attachment F: Solidifier Product Data Submission
Sample Template
SOLIDIFIER DATA SUBMISSION SAMPLE TEMPLATE
FOR § 300.915 DATA AND INFORMATION REQUIREMENTS
PRODUCT NAME:
CATEGORY: SOLIDIFIER
GENERAL PRODUCT INFORMATION [300.915(a)]
(1) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUBMITTER [§ 300.915(a)(1)]
Your name, physical address, email, and telephone number.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(2) SUBMITTER IDENTIFICATION [§ 300.915(a)(2)]
Your identity and documentation of that identity, as the manufacturer of the product; vendor,
importer, or distributor of the product; and/or designated agent acting on behalf of the manufacturer.
(3) PRODUCT NAME, BRAND, OR TRADEMARK [§ 300.915(a)(3)]
All name(s), brand(s), and/or trademark(s) under which the product is to be sold.
(4) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUPPLIERS [§ 300.915(a)(4)]
Names, physical addresses, emails, and telephone numbers of the primary distributors, vendors,
importers, and/or designated agent acting on behalf of the manufacturer.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(5) SAFETY DATA SHEET (SDS) [§ 300.915(a)(5)]
The Safety Data Sheet for the product.
(6) PRODUCT STORAGE [§ 300.915(a)(6)]
1. Maximum storage temperature (e.g., °F and/or °C):
2. Minimum storage temperature (e.g., °F and/or °C):
3. Optimum storage temperature range (e.g., °F and/or °C):
4. Humidity (e.g., g/kg):
F-l
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5. Other relevant conditions for product storage:
6. Description of the consequences to performance if the product is not stored within these limits:
(7) SHELF LIFE STORAGE CONDITIONS [§ 300.915(a)(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) PRODUCT LABEL [§ 300.915(a)(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) PRODUCT CATEGORY AND PROCESSES [300.915(a)(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, in the specific environment(s) on which it is intended to be used (e.g.,
waters and/or adjoining shoreline). 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 [§ 300.915(a)(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) ENVIRONMENTAL FATE OF COMPONENTS [§ 300.915(a)(ll)]
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) PHYSICAL/CHEMICAL PROPERTIES [§ 300.915(a)(12)]
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:
(viii)pH:
(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(13)]
The identity and concentration of all components in the product, including each specific component
F-2
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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).
See Chapter 6 and the sample template in Attachment I of this guidance.
Note 1: Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter.
Note 2: You must make your PBI claim at the time you submit your information to EPA to be listed on
the NCP Product Schedule and include any PBI information in a separate sealed envelope.
(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
For products that contain microorganisms, enzymes, and/or nutrients, provide the component
information as follows, including a citation and description of the methodology used to determine:
1. Microorganisms [§ 300.915(a)(14)(i)]
a. Name of all microorganisms by current genus and species:
b. Any reclassifications:
c. Any physical, chemical, or biological manipulation of the genetic composition:
d. Weight percent of each genus in the product:
See Chapter 6 and the sample template in Attachment I of this guidance.
2. Enzymes [§ 300.915(a)(14)(ii)]
a. Name of all enzyme(s):
b. International Union of Biochemistry (I.U.B.) Number(s):
c. Enzyme Classification (EC) Code Number:
d. Source of Enzymes:
e. Units:
f. Specific Oil-Degrading Activity:
See Chapter 6 and the sample template in Attachment I of this guidance.
-------
3. Nutrients [§ 300.915(a)(14)(iii)]
a. Name(s) of all Nutrients:
b. Maximum Weight Percent of Nutrients:
c. Minimum Weight Percent of Nutrients:
d. Average Weight Percent of Nutrients:
See Chapter 6 and the sample template in Attachment I of this guidance.
4. Data, methodology, and supporting documentation for levels of bacterial, fungal, or viral
pathogens, or opportunistic pathogens, including but not limited to [§ 300.915(a)(14)(iv):
Enteric bacteria, suchs as Salmonella, fecal coliforms, Shigella, coagulase postive Staphylococci, and
beta hemolytic Streptococci and enterococci.
NOTE - Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter. You must
make your PBI claim at the time you submit your information to EPA to be listed on the NCP Product
Schedule and include any PBI information in a separate sealed envelope (See Chapter 6 of this
guidance).
(15) DATA, METHODOLOGY AND SUPPORTING DOCUMENTATION FOR LEVELS OF THE FOLLOWING
[§ 300.915(a)(15)]:
Data, methodology, and supporting documentation for the levels of the following:
1. Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and any other heavy
metal reasonably expected to be in the product;
2. Cyanide;
3. Chlorinated hydrocarbons;
4. Pesticides;
5. Polychlorinated biphenyls (PCBs); and
6. Polycyclic aromatic hydrocarbons (PAHs).
(16) PROHIBITED AGENT CERTIFICATION [§ 300.915(a)(16)]
Certification including data, methodology and supporting documentation indicating that product does
not contain prohibited agents identified in § 300.910(e).
(17) LABORATORY INFORMATION [§ 300.915(a)(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 test(s) performed.
F-4
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(18) LABORATORY TEST DATA AND REPORTS [§ 300.915(a)(18)]
All test data and calculations, including:
1. Raw data and replicates, including positive controls;
2. Notes and observations collected during tests;
3. Calculated mean values and standard deviations;
4. Reports, including a summary of stock solution preparation;
5. Source and preparation of test organisms;
6. Test conditions; and
7. Chain of custody forms.
(19) PRODUCTION VOLUMES [§ 300.915(a)(19)]
An estimate of the annual production volume, the average and maximum amount that could be
produced in a day, and the timeframe needed to reach that maximum production rate in days.
(20) DESIGN FOR THE ENVIRONMENT (now Safer Choice) [§ 300.915(a)(20)]
Recognition received from EPA's Design for the Environment (DfE) or Safer Choice programs, as
applicable.
(21) INTERNATIONAL PRODUCT TESTING, DATA, AND/OR CERTIFICATIONS [§ 300.915(a)(21)]
International product testing or use data or certifications, if available, informing the performance
capabilities or environmental impacts of the product.
F-S
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PRODUCT CATEGORY TESTING AND LISTING REQUIREMENTS [§ 300.915(e)]
STANDARD ACUTE TOXICITY TEST [300.915(e)(1)]:
Toxicity Test: Solidifier must be tested for acute toxicity in saltwater, fresh water, or both
environments, depending on the intended product use per the methods in Appendix C to Part 300,
Section 4.0.
Listing Criteria: Solidifier must demonstrate an LC50 at the lower 95% confidence interval of
greater than 10 ppm in either freshwater, saltwater or both for all tested species.
Note: Reference Toxicants. Separate toxicity tests must be performed with a reference toxicant for
each species tested (Section 3.3.3 of Appendix C to part 300). Submitters should provide results in
format shown below.
Use Environment
Procedure
96-hr Static
Acute Menidia
beryllina
48-hr Static
Acute
Americamysis
bahia
96-hr Static
Acute
Pimephales
promelas
48-hr Static
Acute
Ceriodaphnia
dubia
Saltwater use
Yes
Yes
No
No
Freshwater use
No
No
Yes
Yes
Freshwater and saltwater
use
Yes
Yes
Yes
Yes
Saltwater Static Acute Toxicity Test Data Summary:
Material Tested
Saltwater Species
LC50 (ppm)
Solidifier
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
Reference Toxicant (SDS, DSS, SLS)
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
Freshwater Static Acute Toxicity Test Data Summary:
Material Tested
Species
LC50 (ppm)
Solidifier
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
Reference Toxicant (SDS, DSS, SLS)
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
F-6
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Attachment G: Herding Agent Data Submission Sample
Template
HERDING AGENT DATA SUBMISSION SAMPLE TEMPLATE
FOR § 300.915 DATA AND INFORMATION REQUIREMENTS
PRODUCT NAME:
CATEGORY: HERDING AGENT
GENERAL PRODUCT INFORMATION [300.915(a)]
(1) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUBMITTER [§ 300.915(a)(1)]
Your name, physical address, email, and telephone number.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(2) SUBMITTER IDENTIFICATION [§ 300.915(a)(2)]
Your identity and documentation of that identity, as the manufacturer of the product; vendor,
importer, or distributor of the product; and/or designated agent acting on behalf of the manufacturer.
(3) PRODUCT NAME, BRAND, OR TRADEMARK [§ 300.915(a)(3)]
All name(s), brand(s), and/or trademark(s) under which the product is to be sold.
(4) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUPPLIERS [§ 300.915(a)(4)]
Names, physical addresses, emails, and telephone numbers of the primary distributors, vendors,
importers, and/or designated agent acting on behalf of the manufacturer.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(5) SAFETY DATA SHEET (SDS) [§ 300.915(a)(5)]
The Safety Data Sheet for the product.
(6) PRODUCT STORAGE [§ 300.915(a)(6)]
1. Maximum storage temperature (e.g., °F and/or °C):
2. Minimum storage temperature (e.g., °F and/or °C):
3. Optimum storage temperature range (e.g., °F and/or °C):
4. Humidity (e.g., g/kg):
G-l
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5. Other relevant conditions for product storage:
6. Description of the consequences to performance if the product is not stored within these limits:
(7) SHELF LIFE STORAGE CONDITIONS [§ 300.915(a)(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) PRODUCT LABEL [§ 300.915(a)(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) PRODUCT CATEGORY AND PROCESSES [300.915(a)(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, in the specific environment(s) on which it is intended to be used (e.g.,
waters and/or adjoining shoreline). 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 [§ 300.915(a)(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) ENVIRONMENTAL FATE OF COMPONENTS [§ 300.915(a)(ll)]
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) PHYSICAL/CHEMICAL PROPERTIES [§ 300.915(a)(12)]
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:
(viii)pH:
(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(13)]
The identity and concentration of all components in the product, including each specific component
G-2
-------
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).
See Chapter 6 and the sample template in Attachment I of this guidance.
Note 1: Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter.
Note 2: You must make your PBI claim at the time you submit your information to EPA to be listed on
the NCP Product Schedule and include any PBI information in a separate sealed envelope.
(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
For products that contain microorganisms, enzymes, and/or nutrients, provide the component
information as follows, including a citation and description of the methodology used to determine:
1. Microorganisms [§ 300.915(a)(14)(i)]
a. Name of all microorganisms by current genus and species:
b. Any reclassifications:
c. Any physical, chemical, or biological manipulation of the genetic composition:
d. Weight percent of each genus in the product:
See Chapter 6 and the sample template in Attachment I of this guidance.
2. Enzymes [§ 300.915(a)(14)(ii)]
a. Name of all enzyme(s):
b. International Union of Biochemistry (I.U.B.) Number(s):
c. Enzyme Classification (EC) Code Number:
d. Source of Enzymes:
e. Units:
f. Specific Oil-Degrading Activity:
See Chapter 6 and the sample template in Attachment I of this guidance.
G-3
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3. Nutrients [§ 300.915(a)(14)(iii)]
a. Name(s) of all Nutrients:
b. Maximum Weight Percent of Nutrients:
c. Minimum Weight Percent of Nutrients:
d. Average Weight Percent of Nutrients:
See Chapter 6 and the sample template in Attachment I of this guidance.
4. Data, methodology, and supporting documentation for levels of bacterial, fungal, or viral
pathogens, or opportunistic pathogens, including but not limited to [§ 300.915(a)(14)(iv):
Enteric bacteria, suchs as Salmonella, fecal coliforms, Shigella, coagulase postive Staphylococci, and
beta hemolytic Streptococci and enterococci.
NOTE - Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter. You must
make your PBI claim at the time you submit your information to EPA to be listed on the NCP Product
Schedule and include any PBI information in a separate sealed envelope (See Chapter 6 of this
guidance).
(15) DATA, METHODOLOGY AND SUPPORTING DOCUMENTATION FOR LEVELS OF THE FOLLOWING
[§ 300.915(a)(15)]:
Data, methodology, and supporting documentation for the levels of the following:
1. Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and any other heavy
metal reasonably expected to be in the product;
2. Cyanide;
3. Chlorinated hydrocarbons;
4. Pesticides;
5. Polychlorinated biphenyls (PCBs); and
6. Polycyclic aromatic hydrocarbons (PAHs).
(16) PROHIBITED AGENT CERTIFICATION [§ 300.915(a)(16)]
Certification including data, methodology and supporting documentation indicating that product does
not contain prohibited agents identified in § 300.910(e).
(17) LABORATORY INFORMATION [§ 300.915(a)(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 test(s) performed.
G-4
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(18) LABORATORY TEST DATA AND REPORTS [§ 300.915(a)(18)]
All test data and calculations, including:
1. Raw data and replicates, including positive controls;
2. Notes and observations collected during tests;
3. Calculated mean values and standard deviations;
4. Reports, including a summary of stock solution preparation;
5. Source and preparation of test organisms;
6. Test conditions; and
7. Chain of custody forms.
(19) PRODUCTION VOLUMES [§ 300.915(a)(19)]
An estimate of the annual production volume, the average and maximum amount that could be
produced in a day, and the timeframe needed to reach that maximum production rate in days.
(20) DESIGN FOR THE ENVIRONMENT (now Safer Choice) [§ 300.915(a)(20)]
Recognition received from EPA's Design for the Environment (DfE) or Safer Choice programs, as
applicable.
(21) INTERNATIONAL PRODUCT TESTING, DATA, AND/OR CERTIFICATIONS [§ 300.915(a)(21)]
International product testing or use data or certifications, if available, informing the performance
capabilities or environmental impacts of the product.
G-5
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PRODUCT CATEGORY TESTING AND LISTING REQUIREMENTS [§ 300.915(f)]
STANDARD ACUTE TOXICITY TEST [300.915(f)(1)]:
Toxicity Test: Herding agent must be tested for acute toxicity in saltwater, fresh water, or both,
depending on the intended product use per the methods in Appendix C to Part 300, Section 4.0.
Listing Criteria: Herding 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.
Note: Reference Toxicants. Separate toxicity tests must be performed with a reference toxicant for
each species tested (Section 3.3.3 of Appendix C to part 300). Submitters should provide results in
format shown below.
Procedure
Use Environment
96-hr Static
Acute Menidia
beryllina
48-hr Static
Acute
Americamysis
bahia
96-hr Static
Acute
Pimephales
promelas
48-hr Static
Acute
Ceriodaphnia
dubia
Saltwater use
Yes
Yes
No
No
Freshwater use
No
No
Yes
Yes
Freshwater and saltwater
use
Yes
Yes
Yes
Yes
Saltwater Static Acute Toxicity Test Data Summary:
Material Tested
Saltwater Species
LC50 (ppm)
Herding Agent
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
Reference Toxicant (SDS, DSS, SLS)
Menidia beryllina
[Cone]
96-hr
Americamysis bahia
[Cone]
48-hr
Freshwater Static Acute Toxicity Test Data Summary:
Material Tested
Species
LC50 (ppm)
Herding Agent
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
Reference Toxicant (SDS, DSS, SLS)
Pimephales promelas
[Cone]
96-hr
Ceriodaphnia dubia
[Cone]
48-hr
G-6
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Attachment H: Sorbent Data Submission Sample
Template
SORBENT DATA SUBMISSION SAMPLE TEMPLATE
FOR § 300.915(g)(2) DATA AND INFORMATION REQUIREMENTS
(Sorbents under § 300.915(g)(2) follow § 300.915(a)(1) through (a)(8); (a)(13) through
(a)(15); and certifications under (a)(16))
PRODUCT NAME:
CATEGORY: SORBENT
Under § 300.915(g)(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 § 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 [§ 300.915];
(ii) The certification required under paragraph (a)(16) of [§ 300.915]; and
(iii) Information, including data, to support the claim your product meets the sorbent definition under
§ 300.5.
For more information on listing a sorbent, refer to Chapter 5 Sorbents and the Sorbent Product List of
this guidance.
GENERAL PRODUCT INFORMATION [§ 300.915(a)]
(1) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUBMITTER [§ 300.915(a)(1)]
Your name, physical address, email, and telephone number.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(2) SUBMITTER IDENTIFICATION [§ 300.915(a)(2)]
Your identity and documentation of that identity, as the manufacturer of the product; vendor,
importer, or distributor of the product; and/or designated agent acting on behalf of the manufacturer.
(3) PRODUCT NAME, BRAND, OR TRADEMARK [§ 300.915(a)(3)]
All name(s), brand(s), and/or trademark(s) under which the product is to be sold.
(4) NAME, ADDRESS, EMAIL, AND TELEPHONE NUMBER OF SUPPLIER [§ 300.915(a)(4)]
Names, physical addresses, emails, and telephone numbers of the primary distributors, vendors,
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importers, and/or designated agent acting on behalf of the manufacturer.
Company Name
Physical Address
City, State Zip Code
Phone: (###) ###-####
E-mail
(Point of Contact)
(5) SAFETY DATA SHEET (SDS) [§ 300.915(a)(5)]
The Safety Data Sheet for the product.
(6) PRODUCT STORAGE [§ 300.915(a)(6)]
1. Maximum storage temperature (e.g., °F and/or °C):
2. Minimum storage temperature (e.g., °F and/or °C):
3. Optimum storage temperature range (e.g., °F and/or °C):
4. Humidity (e.g., g/kg):
5. Other relevant conditions for product storage:
6. Description of the consequences to performance if product is not stored within these limits:
(7) SHELF LIFE STORAGE CONDITIONS [§ 300.915(a)(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) PRODUCT LABEL [§ 300.915(a)(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.
Requirements (9) through (12) Not Applicable to Sorbents
(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(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).
See Chapter 6 and the sample template in Attachment I of this guidance.
Note 1: Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter.
Note 2: You must make your PBI claim at the time you submit your information to EPA to be listed on
the NCP Product Schedule and include any PBI information in a separate sealed envelope.
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(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
For products that contain microorganisms, enzymes, and/or nutrients, provide the component
information as follows, including a citation and description of the methodology used to determine:
1. Microorganisms [§ 300.915(a)(14)(i)]
a. Name of all microorganisms by current genus and species:
b. Any reclassifications:
c. Any physical, chemical, or biological manipulation of the genetic composition:
d. Weight percent of each genus in the product:
See Chapter 6 and the sample template in Attachment I of this guidance.
2. Enzymes [§ 300.915(a)(14)(ii)]
a. Name of all enzyme(s):
b. International Union of Biochemistry (I.U.B.) Number(s):
c. Enzyme Classification (EC) Code Number:
d. Source of Enzymes:
e. Units:
f. Specific Oil-Degrading Activity:
See Chapter 6 and the sample template in Attachment I of this guidance.
3. Nutrients [§ 300.915(a)(14)(iii)]
a. Name(s) of all Nutrients:
b. Maximum Weight Percent of Nutrients:
c. Minimum Weight Percent of Nutrients:
d. Average Weight Percent of Nutrients:
See Chapter 6 and the sample template in Attachment I of this guidance.
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4. Data, methodology, and supporting documentation for levels of bacterial, fungal, or viral
pathogens, or opportunistic pathogens, including but not limited to [§ 300.915(a)(14)(iv):
Enteric bacteria, suchs as Salmonella, fecal coliforms, Shigella, coagulase postive Staphylococci, and
beta hemolytic Streptococci and enterococci.
NOTE - Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each
component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All
other product information submitted to EPA as required under § 300.915 and § 300.955 will be
available for public disclosure upon submission, without further notice to the submitter. You must
make your PBI claim at the time you submit your information to EPA to be listed on the NCP Product
Schedule and include any PBI information in a separate sealed envelope (See Chapter 6 of this
guidance).
(15) DATA, METHODOLOGY, AND SUPPORTING DOCUMENTATION FOR LEVELS OF THE FOLLOWING
[§ 300.915(a)(15)]:
Data, methodology, and supporting documentation for the levels of the following:
1. Arsenic, cadmium, chromium, copper, lead, mercury, nickel, vanadium, zinc, and
any other heavy metal reasonably expected to be in the product;
2. Cyanide;
3. Chlorinated hydrocarbons;
4. Pesticides;
5. Polychlorinated biphenyls (PCBs); and
6. Polycyclic aromatic hydrocarbons (PAHs).
(16) PROHIBITED AGENT CERTIFICATION [§ 300.915(a)(16)]
Certification including data, methodology and supporting documentation indicating that product does
not contain prohibited agents identified in § 300.910(e).
Requirements (17)-(21) Not Applicable to Sorbents
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Attachment I: Proprietary Business Information (PBI)
Submission Sample Template
PROPRIETARY BUSINESS INFORMATION (PBI) SUBMISSION SAMPLE TEMPLATE
FOR § 300.915(a)(13) and (14) DATA AND INFORMATION REQUIREMENTS
PRODUCT NAME: [include product name]
CATEGORY: [include product category]
(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(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).
SAMPLE FORMAT:
Chemical Name
CAS#
Concentration Percentage by
Weight (PBI)
Intended Function
Sodium stearate
822-16-2
MAX/MIN/AVG%
Surfactant
Note 1: The total of the average components in the product should equal 100% weight.
Note 2: Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each component
of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All other product
information submitted to EPA as required under § 300.915 and § 300.955 will be available for public
disclosure upon submission, without further notice to the submitter.
Note 3: You must make your PBI claim at the time you submit your information to EPA to be listed on the
NCP Product Schedule and include any PBI information in a separate sealed envelope (See Chapter 6 of
this guidance).
(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
For products that contain microorganisms, enzymes, and/or nutrients, provide the component
information as follows, including a citation and description of the methodology used to determine:
1. Microorganisms [§ 300.915(a)(14)(i)]
a. Name of all microorganisms by current genus and species:
b. Any reclassifications:
c. Any physical, chemical, or biological manipulation of the genetic composition:
d. Weight percent of each genus in the product:
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SAMPLE FORMAT:
Microorganism
Name
Reclassifications
Any Physical, Chemical, or
Biological Manipulation of
the Genetic Composition
Weight Percent of Each
Genus in the Product
(PBI)
Microorganism
(current genus,
species)
MAX/MIN/AVG%
2. Enzymes [§ 300.915(a)(14)(ii)]
a. Name of all enzyme(s):
b. International Union of Biochemistry (I.U.B.) Number(s),
c. Enzyme Classification (EC) Code Number:
d. Source of Enzymes:
e. Units:
f. Specific Oil-Degrading Activity:
SAMPLE FORMAT:
Enzyme Name
International
Union of
Biochemistry
(I.U.B.)
Number(s)
Enzyme
Classification
(EC) Code
Numbers
Source of Each
Enzyme
Units (PBI)
Specific Oil-
Degrading
Activity
Enzyme
3. Nutrients [§ 300.915(a)(14)(iii)]
a. Name(s) of all Nutrients:
b. Maximum Weight Percent of Nutrients:
c. Minimum Weight Percent of Nutrients:
d. Average Weight Percent of Nutrients:
SAMPLE FORMAT:
Nutrient Name
CAS#
Weight Percent
Intended Function
Ammonium nitrate
6454-52-2
MAX/MIN/AVG%
Ammonium nitrate
4. Data, methodology, and supporting documentation for levels of bacterial, fungal, or viral
pathogens, or opportunistic pathogens, including but not limited to [§ 300.915(a)(14)(iv):
Enteric bacteria, such as Salmonella, fecal coliforms, Shigella, coagulase positive Staphylococci, and beta
hemolytic Streptococci and enterococci.
NOTE - Under § 300.950, you may only claim as Proprietary Business Information (PBI) the
concentration, the maximum, minimum, and average weight percent; and the units of each component
of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All other product
information submitted to EPA as required under § 300.915 and § 300.955 will be available for public
disclosure upon submission, without further notice to the submitter. You must make your PBI claim at
the time you submit your information to EPA to be listed on the NCP Product Schedule and include any
PBI information in a separate sealed envelope (See Chapter 6 of this guidance).
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