[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2024 Edition]
[From the U.S. Government Publishing Office]
[[Page 1]]
Title 40
Protection of Environment
________________________
Parts 700 to 722
Revised as of July 1, 2024
Containing a codification of documents of general
applicability and future effect
As of July 1, 2024
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 40:
Chapter I--Environmental Protection Agency
(Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 1277
Alphabetical List of Agencies Appearing in the CFR...... 1297
List of CFR Sections Affected........................... 1307
[[Page iv]]
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 40 CFR 700.17 refers
to title 40, part 700,
section 17.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
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To determine whether a Code volume has been amended since its
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Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative
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Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
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OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
amendments to existing regulations in the CFR. These OMB numbers are
placed as close as possible to the applicable recordkeeping or reporting
requirements.
PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of
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Code users may find the text of provisions in effect on any given date
in the past by using the appropriate List of CFR Sections Affected
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Affected'' is published at the end of each CFR volume. For changes to
the Code prior to the LSA listings at the end of the volume, consult
previous annual editions of the LSA. For changes to the Code prior to
2001, consult the List of CFR Sections Affected compilations, published
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.
``[RESERVED]'' TERMINOLOGY
The term ``[Reserved]'' is used as a place holder within the Code of
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INCORPORATION BY REFERENCE
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This material, like any other properly issued regulation, has the force
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What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
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CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Authorities
and Rules. A list of CFR titles, chapters, subchapters, and parts and an
alphabetical list of agencies publishing in the CFR are also included in
this volume.
An index to the text of ``Title 3--The President'' is carried within
that volume.
[[Page vii]]
The Federal Register Index is issued monthly in cumulative form.
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the daily Federal Register.
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the revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
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INQUIRIES
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Oliver A. Potts,
Director,
Office of the Federal Register
July 1, 2024
[[Page ix]]
THIS TITLE
Title 40--Protection of Environment is composed of thirty-seven
volumes. The parts in these volumes are arranged in the following order:
Parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-
52.2019), part 52 (52.2020-end of part 52), parts 53-59, part 60 (60.1-
60.499), part 60 (60.500-end of part 60, sections), part 60
(Appendices), parts 61-62, part 63 (63.1-63.599), part 63 (63.600-
63.1199), part 63 (63.1200-63.1439), part 63 (63.1440-63.6175), part 63
(63.6580-63.8830), part 63 (63.8980-end of part 63), parts 64-71, parts
72-78, parts 79-80, part 81, parts 82-84, parts 85-96, parts 97-99,
parts 100-135, parts 136-149, parts 150-189, parts 190-259, parts 260-
265, parts 266-299, parts 300-399, parts 400-424, parts 425-699, parts
700-722, parts 723-789, parts 790-999, parts 1000-1059, and part 1060 to
end. The contents of these volumes represent all current regulations
codified under this title of the CFR as of July 1, 2024.
Chapter I--Environmental Protection Agency appears in all thirty-
seven volumes. OMB control numbers for title 40 appear in Sec. 9.1 of
this chapter.
Chapters IV-IX--Regulations issued by the Environmental Protection
Agency and Department of Justice, Council on Environmental Quality,
Chemical Safety and Hazard Investigation Board, Environmental Protection
Agency and Department of Defense; Uniform National Discharge Standards
for Vessels of the Armed Forces, Gulf Coast Ecosystem Restoration
Council, and the Federal Permitting Improvement Steering Council appear
in volume thirty-seven.
For this volume, Christine Colaninno was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 40--PROTECTION OF ENVIRONMENT
(This book contains parts 700 to 722)
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Part
chapter i--Environmental Protection Agency (Continued)...... 700
[[Page 3]]
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
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Editorial Note: Nomenclature changes to chapter I appear at 65 FR
47324, 47325, Aug. 2, 2000; 66 FR 34375, 34376, June 28, 2001.
SUBCHAPTER R--TOXIC SUBSTANCES CONTROL ACT
Part Page
700 General..................................... 5
702 General practices and procedures............ 20
703 Confidentiality claims...................... 42
704 Reporting and recordkeeping requirements.... 51
705 Reporting and recordkeeping requirements for
certain per- and polyfluoroalkyl
substances.............................. 80
707 Chemical imports and exports................ 100
710 Compilation of the TSCA chemical substance
inventory............................... 105
711 TSCA chemical data reporting requirements... 119
712 Chemical information rules.................. 151
713 Reporting requirements for the TSCA
inventory of mercury supply, use, and
trade................................... 173
716 Health and safety data reporting............ 179
717 Records and reports of allegations that
chemical substances cause significant
adverse reactions to health or the
environment............................. 218
720 Premanufacture notification................. 223
721 Significant new uses of chemical substances. 245
722
[Reserved]
[[Page 5]]
SUBCHAPTER R_TOXIC SUBSTANCES CONTROL ACT
PART 700_GENERAL--Table of Contents
Subpart A_Addresses
Sec.
700.17 Addresses for the Office of Pollution Prevention and Toxics.
Subpart B [Reserved]
Subpart C_Fees
700.40 Purpose and applicability.
700.41 Radon user fees.
700.43 Definitions applicable to this subpart.
700.45 Fee payments.
700.49 Failure to remit fees.
Authority: 15 U.S.C. 2625 and 2665, 44 U.S.C. 3504.
Source: 53 FR 31252, Aug. 17, 1988, unless otherwise noted.
Subpart A_Addresses
Source: 77 FR 46292, Aug. 3, 2012, unless otherwise noted.
Sec. 700.17 Addresses for the Office of Pollution Prevention and Toxics.
The official addresses, unless otherwise noted, are as follows:
(a) Correspondence and non-docket materials--(1) United States
Postal Service mailing address. Office of Pollution Prevention and
Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
(2) Hand/courier delivery address. Office of Pollution Prevention
and Toxics, Environmental Protection Agency, EPA East Bldg., 1201
Constitution Ave. NW., Washington, DC 20004. This is not a mailing
address. You must make arrangements with the person receiving your
delivery.
(b) Office of Pollution Prevention and Toxics Docket (OPPT Docket)--
(1) Electronic docket address. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov.
Although listed in the docket index at regulations.gov, some information
is not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, will be publicly available
only at the OPPT Docket.
(2) Physical location. Environmental Protection Agency Docket Center
(EPA/DC), Environmental Protection Agency, EPA West Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The telephone
number for the OPPT Docket is (202) 566-0280. This is not a mailing
address. For instructions on visiting the docket, go to http://
www.epa.gov/dockets/contacts.htm.
(3) United States Postal Service mailing address. Document Control
Office (7407M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001.
(4) Hand/courier delivery address. Document Control Office, Office
of Pollution Prevention and Toxics, Environmental Protection Agency, EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC.
Deliveries are only accepted between 8:30 a.m. and 4 p.m., and special
arrangements should be made for deliveries of boxed information. The
telephone number for the Document Control Office is (202) 564-8930.
Subpart B [Reserved]
Subpart C_Fees
Sec. 700.40 Purpose and applicability.
(a) Purpose. The purpose of this subpart is to establish and collect
fees from manufacturers and processors to defray part of EPA's cost of
administering the Toxic Substances Control Act (15 U.S.C. 2601-2692), as
amended by the Frank R. Lautenberg Chemical Safety for the 21st Century
Act (Pub. L. 114-182).
(b) Applicability. This subpart applies to all manufacturers who are
required to submit information under section 4 of the Act, who submit
certain notices and exemption requests to EPA under section 5 of the
Act, who manufacture a chemical substance that is subject to a risk
evaluation under TSCA section 6(b)(4) of the Act, and who process a
[[Page 6]]
chemical substance that is the subject of a Significant New Use Notice
(SNUN) or Test Market Exemption (TME) under section 5 of the Act and who
are required to submit information under section 4 of the Act related to
a SNUN submission.
(c) Effective date. After October 18, 2018, all persons specified in
Sec. 700.45 and paragraph (a) of this section must comply with this
subpart.
[83 FR 52713, Oct. 17, 2018]
Sec. 700.41 Radon user fees.
User fees relating to radon proficiency programs authorized under
the Toxic Substances Control Act appear at 40 CFR part 195.
[59 FR 13177, Mar. 18, 1994]
Sec. 700.43 Definitions applicable to this subpart.
Definitions in section 3 of the Act (15 U.S.C. 2602), as well as
definitions contained in Sec. Sec. 704.3, 720.3, 723.175(b), 725.3, and
790.3 of this chapter, apply to this subpart unless otherwise specified
in this section. In addition, the following definitions apply:
Consolidated microbial commercial activity notice or consolidated
MCAN means any MCAN submitted to EPA that covers more than one
microorganism (each being assigned a separate MCAN number by EPA) as a
result of a prenotice agreement with EPA.
Consolidated premanufacture notice or consolidated PMN means any PMN
submitted to EPA that covers more than one chemical substance (each
being assigned a separate PMN number by EPA) as a result of a prenotice
agreement with EPA (See 48 FR 21734).
Consortium means an association of manufacturers and/or processors
who have made an agreement to jointly split the cost of applicable fees.
Enforceable consent agreement means a consent agreement used by EPA
to accomplish testing where a consensus exists among EPA and interested
parties (as identified in Sec. 790.22(b)(2)) concerning the need for
and scope of testing under section 4 of the Act.
EPA-initiated risk evaluation means any risk evaluation conducted
pursuant to section 6(b)(4)(C)(i) of the Act.
Exemption notice means any notice submitted to EPA under Sec.
723.175 of this chapter.
Final product means a new chemical substance (as ``new chemical
substance'' is defined in Sec. 720.3 of this chapter) that is
manufactured by a person for distribution in commerce, or for use by the
person other than as an intermediate.
Joint submitters mean two or more persons who submit a TSCA section
5 notice together.
Manufacturer-requested risk evaluation means any chemical substance
risk evaluation conducted at the request of one or more manufacturers of
that chemical substance pursuant to section 6(b)(4)(C)(ii) of the Act.
Microbial commercial activity notice or MCAN means any notice for
microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act
in accordance with subpart D of part 725 of this chapter.
Person means a manufacturer or processor.
Premanufacture notice or PMN means any notice submitted to EPA
pursuant to section 5(a)(1)(A) of the Act in accordance with part 720 of
this chapter or Sec. 723.250 of this chapter.
Principal sponsor means a person who assumes primary responsibility
for the direction of study, the payment of fees to EPA, and for oral and
written communication with EPA.
Production volume means manufactured (including imported) amount in
pounds.
Risk evaluation means any risk evaluation conducted pursuant to
section 6(b) of the Act.
Section 5 notice means any PMN, consolidated PMN, intermediate PMN,
significant new use notice, exemption notice, exemption application, any
MCAN or consolidated MCAN submitted under section 5 of the Act.
Significant new use notice or SNUN means any notice submitted to EPA
pursuant to section 5(a)(1)(B) of the Act in accordance with part 721 of
this chapter.
Small business concern means a manufacturer or processor who meets
the size standards identified in the following table. The number of
employees indicates the maximum allowed for a
[[Page 7]]
manufacturer or processor to be considered small. If the North American
Industry Classification System (NAICS) code of a manufacturer or
processor is not represented in the table, it will be considered small
if it has 500 or fewer employees. When calculating the number of
employees, a manufacturer or processor must include the employees of all
of its ``parent companies'' (if any) and all companies it ``owns or
controls,'' as defined by 40 CFR 704.3. The number of employees are
calculated as the average number of people employed for each pay period
of the business' latest 12 calendar months, regardless of hours worked
or temporary status.
----------------------------------------------------------------------------------------------------------------
Small business concern size standards
Potentially affected NAICS NAICS description (number of employees)
----------------------------------------------------------------------------------------------------------------
324110.............................. Petroleum Refineries........... 1,500 or fewer.
325110.............................. Petrochemical Manufacturing.... 1,000 or fewer.
325120.............................. Industrial Gas Manufacturing... 1,000 or fewer.
325130.............................. Synthetic Dye and Pigment 1,000 or fewer.
Manufacturing.
325180.............................. Other Basic Inorganic Chemical 1,000 or fewer.
Manufacturing.
325193.............................. Ethyl Alcohol Manufacturing.... 1,000 or fewer.
325194.............................. Cyclic Crude, Intermediate, and 1,250 or fewer.
Gum and Wood Chemical
Manufacturing.
325199.............................. All Other Basic Organic 1,250 or fewer.
Chemical Manufacturing.
325211.............................. Plastics Material and Resin 1,250 or fewer.
Manufacturing.
325212.............................. Synthetic Rubber Manufacturing. 1,000 or fewer.
325220.............................. Artificial and Synthetic Fibers 1,000 or fewer.
and Filaments Manufacturing.
325311.............................. Nitrogenous Fertilizer 1,000 or fewer.
Manufacturing.
325312.............................. Phosphatic Fertilizer 750 or fewer.
Manufacturing.
325314.............................. Fertilizer (Mixing Only) 500 or fewer.
Manufacturing.
325320.............................. Pesticide and Other 1,000 or fewer.
Agricultural Chemical
Manufacturing.
325411.............................. Medicinal and Botanical 1,000 or fewer.
Manufacturing.
325412.............................. Pharmaceutical Preparation 1,250 or fewer.
Manufacturing.
325413.............................. InVitro Diagnostic Substance 1,250 or fewer.
Manufacturing.
325414.............................. Biological Product (except 1,250 or fewer.
Diagnostic) Manufacturing.
325510.............................. Paint and Coating Manufacturing 1,000 or fewer.
325520.............................. Adhesive Manufacturing......... 500 or fewer.
325611.............................. Soap and Other Detergent 1,000 or fewer.
Manufacturing.
325612.............................. Polish and Other Sanitation 750 or fewer.
Good Manufacturing.
325613.............................. Surface Active Agent 750 or fewer.
Manufacturing.
325620.............................. Toilet Preparation 1,250 or fewer.
Manufacturing.
325910.............................. Printing Ink Manufacturing..... 500 or fewer.
325920.............................. Explosives Manufacturing....... 750 or fewer.
325991.............................. Custom Compounding of Purchased 500 or fewer.
Resins.
325992.............................. Photographic Film, Paper, Plate 1,500 or fewer.
and Chemical Manufacturing.
325998.............................. All Other Miscellaneous 500 or fewer.
Chemical Product and
Preparation Manufacturing.
424690.............................. Other Chemical and Allied 150 or fewer.
Products Merchant Wholesalers.
424710.............................. Petroleum Bulk Stations and 200 or fewer.
Terminals.
424720.............................. Petroleum and Petroleum 200 or fewer.
Products Merchant Wholesalers
(except Bulk Stations and
Terminals).
----------------------------------------------------------------------------------------------------------------
Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or analysis
or chemical research on, or analysis of, such substance or another
substance, including such research or analysis for the development of a
product'') means quantities of a chemical substance manufactured
(including imported), or processed or proposed to be manufactured
(including imported), or processed solely for research and development
that are not greater than reasonably necessary for such purposes.
Test order means an order to develop information pursuant to section
4(a) of the Act.
Test rule refers to a regulation requiring the development of
information pursuant to section 4(a) of the Act.
[53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, Apr. 11, 1997;
83 FR 52713, Oct. 17, 2018; 89 FR 12974, Feb. 21, 2024]
Sec. 700.45 Fee payments.
(a) Persons who must pay fees. (1) Manufacturers submitting a TSCA
section 5 notice to EPA shall remit for each such notice the applicable
fee identified in
[[Page 8]]
paragraph (c) of this section in accordance with the procedures in
paragraphs (f) and (g) of this section.
(2) Manufacturers and processors of chemical substances and mixtures
required to submit information for these chemical substances and
mixtures under a TSCA section 4(a) test order or enforceable consent
agreement, or manufacturers of chemical substances and mixtures required
to submit information for these chemical substance and mixtures under a
TSCA section 4(a) test rule, shall remit for each such test rule, order,
or enforceable consent agreement the applicable fee identified in
paragraph (c) of this section in accordance with the procedures in
paragraphs (f) and (g) of this section. Manufacturers of a chemical
substance subject to a test rule under TSCA section 4(a) are exempted
from fee payment requirements in this section, if they meet one or more
of the exemptions under this paragraphs (a)(2)(i) through (v) of this
section on or after the certification cutoff date identified in
paragraph (b)(6) of this section and do not conduct manufacturing
outside of those exemptions after the certification cutoff dates or if
they meet the exemptions under paragraph (a)(2)(vi) of this section for
the five-year period preceding publication of the preliminary list and
do not conduct manufacturing outside of that exemption during the five-
year period preceding publication of the preliminary list; and the
exemptions are only available if the manufacturer will meet one or more
of the exemptions in this paragraph (a)(2)(i) through (vi) in the
successive five years; and will not conduct manufacturing outside of the
exemptions in paragraphs (a)(2)(i) through (v) of this section in the
successive five years or will meet the exemption in paragraph (a)(2)(vi)
of this section in the successive five years:
(i) Import articles containing that chemical substance;
(ii) Produce that chemical substance as a byproduct that is not
later used for commercial purposes or distributed for commercial use;
(iii) Manufacture that chemical substance as an impurity as defined
in 40 CFR 704.3;
(iv) Manufacture that chemical substance as a non-isolated
intermediate as defined in 40 CFR 704.3;
(v) Manufacture small quantities of that chemical substance solely
for research and development, as defined in 40 CFR 700.43; or
(vi) Manufacture that chemical substance in quantities below a 1,100
lbs annual production volume as described in Sec. 700.43, unless all
manufacturers of that chemical substance manufacture that chemical in
quantities below a 1,100 lbs annual production volume as defined in
Sec. 700.43, in which case this exemption is not applicable.
(3) Manufacturers of a chemical substance that is subject to a risk
evaluation under section 6(b) of the Act, shall remit for each such
chemical risk evaluation the applicable fee identified in paragraph (c)
of this section in accordance with the procedures in paragraphs (f) and
(g) of this section. Manufacturers of a chemical substance subject to
risk evaluation under section 6(b) of the Act are exempted from fee
payment requirements in this section, if they meet one or more of the
exemptions under paragraphs (a)(3)(i) through (v) of this section on or
after the certification cutoff date identified in paragraph (b)(6)(i) of
this section and do not conduct manufacturing outside of those
exemptions after the certification cutoff dates or if they meet the
exemptions under paragraph (a)(3)(vi) of this section for the five-year
period preceding publication of the preliminary list and do not conduct
manufacturing outside of that exemption during the five-year period
preceding publication of the preliminary list; and the exemptions are
only available if the manufacturer will meet one or more of the
exemptions in paragraphs (a)(3)(i) through (vi) of this section in the
successive five years and will not conduct manufacturing outside of the
exemptions in paragraphs (a)(3)(i) through (v) of this section in the
successive five years or will meet the exemption in paragraph (a)(3)(vi)
of this section in the successive five years:
(i) Import articles containing that chemical substance;
(ii) Produce that chemical substance as a byproduct that is not
later used
[[Page 9]]
for commercial purposes or distributed for commercial use;
(iii) Manufacture that chemical substance as an impurity as defined
in 40 CFR 704.3;
(iv) Manufacture that chemical substance as a non-isolated
intermediate as defined in 40 CFR 704.3;
(v) Manufacture small quantities of that chemical substance solely
for research and development, as defined in Sec. 700.43; or
(vi) manufacture that chemical substance in quantities below a 2,500
lbs annual production volume as described in Sec. 700.43, unless all
manufacturers of that chemical substance manufacture that chemical in
quantities below a 2,500 lbs annual production volume as defined in
Sec. 700.43, in which case this exemption is not applicable.
(4) Processors submitting a SNUN or TME under TSCA section 5 to EPA
shall remit for each such notice the applicable fee identified in
paragraph (c) of this section in accordance with the procedures in
paragraphs (f) and (g) of this section.
(5) Processors of chemical substances and mixtures subject to a TSCA
section 4(a) test rule, test order, or enforceable consent agreement in
association with a SNUN submission referenced in paragraph (a)(4) of
this section shall remit for each such test rule, order, or enforceable
consent agreement the applicable fee identified in paragraph (c) of this
section in accordance with the procedures in paragraphs (f) and (g) of
this section.
(b) Identifying manufacturers subject to fees--(1) In general. For
purposes of identifying manufacturers subject to fees for section 4 test
rules and section 6 EPA-initiated risk evaluations, EPA will publish a
preliminary list of manufacturers identified through a review of data
sources described in paragraph (b)(2) of this subsection; provide an
opportunity for public comment; and publish a final list specifying the
manufacturers responsible for payment.
(2) Data sources. To compile the preliminary list, EPA will rely on
information submitted to the Agency (such as the information submitted
under sections 5(a), 8(a), 8(b), and to the Toxics Release Inventory) as
well as other information available to the Agency, including publicly
available information or information submitted to other agencies to
which EPA has access. To be able to include the most recent CDR data and
to account for annual or other typical fluctuations in manufacturing,
EPA will use the five most recent years of data submitted or available
to the Agency to develop the preliminary list.
(3) Publication of preliminary list. (i) For risk evaluations
initiated by EPA under section 6, the preliminary list will be published
at the time of final designation of the chemical substance as a High-
Priority Substance.
(ii) For test rules under section 4, the preliminary list will be
published with the proposed test rule.
(4) Public comment period. Following publication of the preliminary
list, EPA will provide a period of public comment that is no less than
30 days.
(5) Self-identification. All manufacturers other than those listed
in paragraphs (a)(2)(i) through (iii) and (a)(3)(i) through (iii) of
this section who have manufactured (including imported) the chemical
substance in the previous five years must submit notice to EPA,
irrespective of whether they are included in the preliminary list
specified in paragraph (b)(3) of this section. The notice must be
submitted electronically via EPA's Central Data Exchange (CDX), the
Agency's electronic reporting portal, using the Chemical Information
Submission System (CISS) reporting tool, and must contain the following
information:
(i) Contact information. The name and address of the submitting
company, the name and address of the authorized official for the
submitting company, and the name and telephone number of a person who
will serve as technical contact for the submitting company and who will
be able to answer questions about the information submitted by the
company to EPA.
(ii) Certification of cessation. If a manufacturer has manufactured
in the five-year period preceding publication of the preliminary list
but has ceased manufacture prior to the certification cutoff dates
identified in paragraph (b)(6) of this section and will not manufacture
the substance again in the successive five years, the manufacturer
[[Page 10]]
may submit a certification statement attesting to these facts. If EPA
receives such a certification statement from a manufacturer, the
manufacturer will not be included in the final list of manufacturers
described in paragraph (b)(7) of this section and will not be obligated
to pay the fee under this section.
(iii) Certification of no manufacture. If a manufacturer is
identified on the preliminary list but has not manufactured the chemical
in the five-year period preceding publication of the preliminary list,
the manufacturer may submit a certification statement attesting to these
facts. If EPA receives such a certification statement from a
manufacturer, the manufacturer will not be included in the final list of
manufacturers described in paragraph (b)(7) of this section and will not
be obligated to pay the fee under this section.
(iv) Certification of meeting exemption. If a manufacturer is
identified on the preliminary list and exclusively meets one or more of
the exemptions as described in paragraph (a)(2) or (a)(3) of this
section, the manufacturer must submit a certification statement
attesting to these facts in order to not be included in the final list
of manufacturers described in paragraph (b)(7) of this section. If a
manufacturer is not on a preliminary list and exclusively meets one or
more of the exemptions as described in paragraph (a)(2) or (a)(3) of
this section, the manufacturer may submit a certification statement
attesting to these facts. If EPA receives such a certification statement
from a manufacturer, the manufacturer will not be included in the final
list of manufacturers described in paragraph (b)(7) of this section and
will not be obligated to pay the fee under this section, unless all
manufacturers of that chemical substance meet the exemption as described
in (a)(2)(vi) or (a)(3)(vi) of this section.
(v) Production volume. If a manufacturer has not submitted
certification of cessation, as described in paragraph (b)(5)(ii) of this
section, or certification of no manufacture, as described in paragraph
(b)(5)(iii) of this section, for purposes of identifying manufacturers
subject to fees for TSCA section 6 EPA-initiated risk evaluations and
does not meet one or more of the exemptions in paragraph (a)(3)(i)
through (v) of this section, the manufacturer must submit their
production volume as defined in 40 CFR 700.43 for the applicable
substance for the three calendar years prior to publication of the
preliminary list. Only production volume reported to EPA prior to the
final list being published will be used in determining fees described in
Sec. 700.45(f).
(6) Certification cutoff date. (i) For a section 6 EPA-initiated
risk evaluation, the cutoff date for purposes of paragraph (b)(5)(ii) of
this section is the day prior to initiation of the prioritization
process for the applicable chemical substance.
(ii) For a section 4 test rule, the cutoff date for purposes of
paragraph (b)(5)(ii) of this section is the day prior to publication of
the proposed test rule for the applicable chemical substance.
(7) Publication of final list. EPA expects to publish a final list
of manufacturers to identify the specific manufacturers subject to the
applicable fee. This list will indicate if additional manufacturers
self-identified pursuant to paragraph (b)(5) of this section, if other
manufacturers were identified through credible public comment, and if
manufacturers submitted certification of cessation, no manufacture, or
meeting exemption pursuant to paragraph (b)(5)(ii), (iii), or (iv) of
this section. The final list will be published no later than
concurrently with the final scope document for risk evaluations
initiated by EPA under TSCA section 6, and with the final test rule for
test rules under TSCA section 4. EPA may modify the list after the
publication of the final list.
(8) Effect of final list. Manufacturers who are listed on the final
list are subject to the applicable fee identified in paragraph (c) of
this section.
(9) Identifying manufacturers for other fee categories. For Section
4 Test Orders and enforceable consent agreements, and Section 6
Manufacturer-Requested Risk Evaluations, EPA will not conduct the
identification process described in paragraphs (b)(1) through (8) of
this section, as manufacturers self-identify through a submission or are
already otherwise known to Agency.
[[Page 11]]
However, those manufacturers are required to provide an information
submission to EPA for the purposes of fee administration. The notice
must be submitted electronically via the Agency's electronic reporting
software (e.g., Central Data Exchange (CDX)) and must contain the
manufacturers: Full name, address, telephone number and email address.
Timing of this submission must be as follows:
(i) For section 4 test orders and enforceable consent agreements,
the informational submission in this paragraph (b)(9) must be provided
within 30 days following notification from EPA.
(ii) For section 6 manufacturer-requested risk evaluations, the
informational submission in this paragraph (b)(9) is required as part of
the procedural process for making such requests, and must be completed
at the time of making the request.
(10) Recordkeeping. After April 22, 2024:
(i) All manufacturers other than those listed in paragraph (a)(2)(i)
through (v) or (a)(3)(i) through (v) of this section must maintain
production volume records related to compliance with paragraph (b)(5)(v)
of this section. These records must be maintained for a period of five
years from the date notice is submitted pursuant to paragraph (b)(5) of
this section.
(ii) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(iv) or (a)(3)(iv) of this
section must maintain manufacturing and other business records related
to compliance with the exemption criteria described in paragraph
(a)(2)(iv) or (a)(3)(iv) of this section, respectively. These records
must be maintained for a period of five years from the date the notice
is submitted pursuant to paragraph (b)(5) of this section.
(iii) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(v) or (a)(3)(v) of this
section must maintain manufacturing and other business records related
to compliance with the exemption criteria described in paragraph
(a)(2)(v) or (a)(3)(v) of this section, respectively, such as production
volume, plans of study, information from research and development
notebooks, study reports, or notice solely for research and development
use. These records must be maintained for a period of five years from
the date the notice is submitted pursuant to paragraph (b)(5) of this
section.
(iv) Those manufacturers that are exempt from fee payment
requirements pursuant to paragraph (a)(2)(vi) or (a)(3)(vi) of this
section must maintain production volume records related to compliance
with the exemption criteria described in paragraph (a)(2)(vi) or
(a)(3)(vi) of this section, respectively. These records must be
maintained for a period of five years from the date the notice is
submitted pursuant to paragraph (b)(5) of this section.
(c) Fees for the 2024, 2025, and 2026 fiscal years. Persons shall
remit fee payments to EPA as follows:
(1) Small business concerns. Small business concerns shall remit
fees as follows:
(i) Premanufacture notice and consolidated premanufacture notice.
Persons shall remit a fee totaling $6,480 for each premanufacture notice
(PMN) or consolidated PMN submitted in accordance with part 720 of this
chapter.
(ii) Significant new use notice. Persons shall remit a fee totaling
$6,480 for each significant new use notice (SNUN) submitted in
accordance with part 721 of this chapter.
(iii) Exemption application. Persons shall remit a fee totaling
$2,180 for each of the following exemption requests submitted under TSCA
section 5:
(A) Low releases and low exposures exemption or LoREX request
submitted to EPA pursuant to section 5(a)(1) of the Act in accordance
with Sec. 723.50(a)(1)(ii) of this chapter.
(B) Low volume exemption or LVE request submitted to EPA pursuant to
section 5(a)(1) of the Act in accordance with Sec. 723.50(a)(1)(i) of
this chapter.
(C) Test marketing exemption or TME application submitted to EPA
pursuant to section 5 of the Act in accordance with Sec. Sec. 725.300
through 725.355 of this chapter.
(D) TSCA experimental release application or TERA application
submitted to EPA pursuant to section 5 of the Act for research and
development activities
[[Page 12]]
involving microorganisms in accordance with Sec. Sec. 725.200 through
725.260 of this chapter.
(E) Tier II exemption application submitted to EPA pursuant to
section 5 of the Act in accordance with Sec. Sec. 725.428 through
725.455 of this chapter.
(iv) Instant photographic film article exemption notice. Persons
shall remit a fee totaling $2,180 for each instant photographic film
article exemption notice submitted in accordance with Sec. 723.175 of
this chapter.
(v) Microbial commercial activity notice and consolidated microbial
commercial activity notice. Persons shall remit a fee totaling $6,480
for each microbial commercial activity notice (MCAN) or consolidated
MCAN submitted in accordance with Sec. Sec. 725.25 through 725.36 of
this chapter.
(vi) Persons shall remit a total of twenty percent of the applicable
fee under paragraph (c)(2)(vi), (vii) or (viii) of this section for a
test rule, test order, or enforceable consent agreement.
(vii) Persons shall remit a total fee of twenty percent of the
applicable fee under paragraphs (c)(2)(ix) of this section for an EPA-
initiated risk evaluation.
(viii) Persons shall remit the total fee under paragraph (c)(2)(x)
or (xi) of this section, as applicable, for a manufacturer-requested
risk evaluation.
(2) Others. Persons other than small business concerns shall remit
fees as follows:
(i) PMN and consolidated PMN. Persons shall remit a fee totaling
$37,000 for each PMN or consolidated PMN submitted in accordance with
part 720 of this chapter.
(ii) SNUN. Persons shall remit a fee totaling $37,000 for each
significant new use notice submitted in accordance with part 721 of this
chapter.
(iii) Exemption applications. Persons shall remit a fee totaling
$10,870 for each of the following exemption requests, and modifications
to previous exemption requests, submitted under section 5 of the Act:
(A) Low releases and low exposures exemption or LoREX request
submitted to EPA pursuant to section 5(a)(1) of the Act in accordance
with Sec. 723.50(a)(1)(ii) of this chapter.
(B) Low volume exemption or LVE request submitted to EPA pursuant to
section 5(a)(1) of the Act in accordance with Sec. 723.50(a)(1)(i) of
this chapter.
(C) Test marketing exemption or TME application submitted to EPA
pursuant to section 5 of the Act in accordance with Sec. Sec. 725.300
through 725.355 of this chapter, unless the submitting company has
graduated from EPA's Sustainable Futures program, in which case this
exemption fee is waived.
(D) TSCA experimental release application or TERA application
submitted to EPA pursuant to section 5 of the Act for research and
development activities involving microorganisms in accordance with
Sec. Sec. 725.200 through 725.260 of this chapter.
(E) Tier II exemption application submitted to EPA pursuant to
section 5 of the Act in accordance with Sec. Sec. 725.428 through
725.455 of this chapter.
(iv) Instant photographic film article exemption notice. Persons
shall remit a fee totaling $10,870 for each exemption notice submitted
in accordance with Sec. 723.175 of this chapter.
(v) MCAN and consolidated MCAN. Persons shall remit a fee totaling
$37,000 for each MCAN or consolidated MCAN submitted in accordance with
Sec. Sec. 725.25 through 725.36 of this chapter.
(vi) Test rule. Persons shall remit a fee totaling $50,000 for each
test rule.
(vii) Test order. Persons shall remit a fee totaling $25,000 for
each test order.
(viii) Enforceable consent agreement. Persons shall remit a fee
totaling $50,000 for each enforceable consent agreement.
(ix) EPA-initiated chemical risk evaluation. Persons shall remit a
fee totaling $4,287,000.
(x) Manufacturer-requested risk evaluation of a Work Plan Chemical.
Persons shall remit an initial fee of $1,414,924, a second payment of
$1,414,924, and final payment to total 50% of the actual costs of this
activity, in accordance with the procedures in paragraph (g) of this
section. The final payment amount will be determined by EPA, and invoice
issued to the requesting manufacturer.
(xi) Manufacturer-requested risk evaluation of a non-work plan
chemical. Persons shall remit an initial fee of $2,829,847, a second
payment of
[[Page 13]]
$2,829,847, and final payment to total 100% of the actual costs of the
activity, in accordance with the procedures in paragraph (g) of this
section. The final payment amount will be determined by EPA, and invoice
issued to the requesting manufacturer.
(d) Fees for 2026 fiscal year and beyond. (1) Fees for the 2026 and
later fiscal years will be adjusted on a three-year cycle by multiplying
the fees in paragraph (c) of this section by the current PPI index value
with a base year of 2024 using the following formula:
FA = F x I
Where:
FA = the inflation-adjusted future year fee amount.
F = the fee specified in paragraph (c) of this section.
I = Producer Price Index for Chemicals and Allied Products inflation
value with 2024 as a base year.
(2) Updated fee amounts for PMNs, SNUNs, MCANs, exemption notices,
exemption applications, and manufacturer-requested risk evaluation
requests apply to submissions received by the Agency on or after October
1 of every three-year fee adjustment cycle beginning in fiscal year 2024
(October 1, 2023). Updated fee amounts also apply to test rules, test
orders, enforceable consent agreements and EPA-initiated risk
evaluations that are ``noticed'' on or after October 1 of every three-
year fee adjustment cycle, beginning in fiscal year 2026.
(3) The Agency will initiate public consultation through notice-and-
comment rulemaking prior to making fee adjustments beyond inflation. If
it is determined that no additional adjustment is necessary beyond for
inflation, EPA will provide public notice of the inflation-adjusted fee
amounts through posting to the Agency's web page by the beginning of
each three-year fee adjustment cycle (October 1, 2026, October 1, 2029,
etc.). If the Agency determines that adjustments beyond inflation are
necessary, EPA will provide public notice of that determination and the
process to be followed to make those adjustments.
(e) No fee required. Persons are exempt from remitting any fee for
Tier I exemption submissions under Sec. 725.424 and polymer exemption
reports submitted under Sec. 723.250 of this chapter.
(f) Multiple parties, including joint submitters and consortia. (1)
Joint submitters of a TSCA section 5 notice are required to remit the
applicable fee identified in paragraph (c) of this section for each
section 5 notice submitted. Only one fee is required for each
submission, regardless of the number of joint submitters for that
notice. To qualify for the fee identified in paragraph (c)(1) of this
section, each joint submitter of a TSCA section 5 notice must qualify as
a small business concern under Sec. 700.43 of this chapter.
(2) Any consortium formed to split the cost of the applicable fee
under section 4 of the Act is required to remit the appropriate fee
identified in paragraph (c) of this section for each test rule, test
order, or enforceable consent agreement regardless of the number of
manufacturers and/or processors in that consortium. For the consortium
to qualify for the fee identified in paragraph (c)(1) of this section,
each person in the consortium must qualify as a small business concern
under Sec. 700.43 of this chapter. Failure to submit fee payment
pursuant to this paragraph, or to provide notice of failure to reach
agreement pursuant to paragraph (f)(2)(v) of this section constitutes a
violation by each consortium member.
(i) The consortium must identify a principal sponsor and provide
notification to EPA that a consortium has formed. The notification must
be accomplished within 90 days of the publication date of a test rule
under section 4 of the Act, or within 90 days of the effective date of a
test order under section 4 of the Act, or within 90 days of the signing
of an enforceable consent agreement under section 4 of the Act. EPA may
permit additional entities to join an existing consortium after the
expiration of the notification period if the principal sponsor provides
updated notification.
(ii) Notification must be submitted electronically via the Agency's
electronic reporting software--Central Data Exchange (CDX)--and include
the following information:
(A) Full name, address, telephone number and signature of principal
sponsor;
[[Page 14]]
(B) Name(s) and contact information for each manufacturer and/or
processor associating with the consortium.
(iii) It is up to the consortium to determine how fees will be split
among the persons in the consortium.
(iv) Consortia are strongly encouraged to set lower fees for small
business concerns participating in the consortium.
(v) If a consortium is unable to come to terms on how fees will be
split among the persons in the consortium, the principal sponsor must
notify EPA in writing before the end of the notification period in
paragraph (f)(2)(i) of this section.
(vi) If a consortium provides notice to EPA under paragraph
(f)(2)(v) of this section that they failed to reach agreement on
payment, EPA will assess fees to all persons as individuals described
under paragraph (f)(4) of this section.
(3) Any consortium formed to split the cost of the applicable fee
supporting a risk evaluation under section 6(b) of the Act is required
to remit the appropriate fee identified in paragraph (c) of this section
for each risk evaluation, regardless of the number of manufacturers in
that consortium. For the consortium to qualify for the fee identified in
paragraph (c)(1)(vii) of this section, each person in the consortium
must qualify as a small business concern under Sec. 700.43 of this
chapter. Failure to provide notice or submit fee payment pursuant to
this paragraph (f)(3) constitutes a violation by each consortium member.
(i) Notification must be provided to EPA that a consortium has
formed. The notification must be accomplished within 90 days of the
publication of the final scope of a chemical risk evaluation under
section 6(b)(4)(D) of the Act or within 90 days of EPA providing
notification to a manufacturer that a manufacturer-requested risk
evaluation has been granted. EPA may permit additional entities to join
an existing consortium after the expiration of the notification period
if the principal sponsor provides updated notification.
(ii) Notification must be submitted electronically via the Agency's
electronic reporting software--Central Data Exchange (CDX)--and include
the following information:
(A) Full name, address, telephone number and signature of principal
sponsor;
(B) Name(s) and contact information for each manufacturer and/or
processor associating with the consortium.
(iii) It is up to the consortium to determine how fees will be split
among the persons in the consortium.
(iv) Consortia are strongly encouraged to set lower fees for small
business concerns participating in the consortium.
(v) If a consortium is unable to come to terms on how fees will be
split among the persons in the consortium, the principal sponsor must
notify EPA in writing before the end of the notification period in
paragraph (f)(3)(i) of this section.
(vi) If a consortium provides notice to EPA under paragraph
(f)(3)(v) of this section that they failed to reach agreement on
payment, EPA will assess fees to all persons as individuals as described
under paragraph (f)(4) of this section.
(4) If multiple persons are subject to fees triggered by section 4
or 6(b) of the Act and no consortium is formed, EPA will determine the
portion of the total applicable fee to be remitted by each person
subject to the requirement.
(i) Each person's share of the applicable fees triggered by section
4 of the Act specified in paragraph (c) of this section shall be in
proportion to the total number of manufacturers and/or processors of the
chemical substance, with lower fees for small businesses:
[[Page 15]]
[GRAPHIC] [TIFF OMITTED] TR21FE24.000
Where:
Ps = the portion of the fee under paragraph (c) of this
section that is owed by a person who qualifies as a small
business concern under Sec. 700.43 of this chapter.
Po = the portion of the fee owed by a person other than a
small business concern.
F = the total fee required under paragraph (c) of this section.
Mt = the total number of persons subject to the fee
requirement.
Ms = the number of persons subject to the fee requirement who
qualify as a small business concern.
(ii) Each person's share of the applicable fees triggered by section
6(b) of the Act specified in paragraph (c) of this section shall be in
proportion to the total number of manufacturers and their reported
production volume as described in Sec. 700.45(b)(v) of the chemical
substance, with lower fees for small businesses:
[GRAPHIC] [TIFF OMITTED] TR21FE24.001
(iii) Remaining manufacturers (i.e., those that do not qualify as a
small business concern) are then ranked in ascending order (from lowest
to highest) based on reported production volume as described in Sec.
700.45(b)(v). Each remaining manufacturer is assigned a number with 1
for lowest production volume, 2 for second lowest production volume,
etc.
Table 1 to Paragraph (f)(4)(iii)--Example of Placing Manufacturers That
Do Not Qualify as a Small Business Concern in Ascending Order
------------------------------------------------------------------------
Assigned
Manufacturer(s) No. (N)
------------------------------------------------------------------------
Manufacturer with lowest production volume................... 1
Manufacturer with 2nd lowest production volume............... 2
Manufacturer with 3rd lowest production volume............... 3
. . . etc.
[GRAPHIC] [TIFF OMITTED] TR21FE24.002
[[Page 16]]
Where:
Ps = the portion of the fee under paragraph (c) of this
section that is owed by a person who qualifies as a small
business concern under Sec. 700.43 of this chapter.
P=20th = the portion of the fee owed by a person
other than a small business concern in the top 20th
percentile.
P<20th = the portion of the fee owed by a person other than a
small business concern not in the top 20th percentile.
F = the total fee required under paragraph (c) of this section.
Mt = the total number of persons subject to the fee
requirement.
Ms = the number of persons subject to the fee requirement who
qualify as a small business concern.
N20th = The assigned number as illustrated in Table 1 to the
manufacturer(s) with a production volume as described in
700.45(b)(v) at which the manufacturers with production volume
greater than or equal to are in the top 20th percentile.
M=20th = the total number of persons with
production volume as described in 700.45(b)(v) greater than or
equal to the manufacturer(s) with a production volume as
N20th.
M<20th = the total number of persons with production volume
as described in 700.45(b)(v) less than the manufacturer(s)
with a production volume as N20th.
Fo = the total fee required under paragraph (c) of this
section by all person(s) other than a small business concern.
(iv) In the event there are three or less manufacturers identified
for a chemical substance, EPA will distribute the fee evenly among those
three or less fee payers, regardless of production volume.
(v) In the event the number assigned to the top 20th percentile is
not an integer, EPA will round to the nearest integer to determine the
manufacturer(s) with the reported production volume as described in
Sec. 700.45(b)(v) greater than or equal to the top 20th percentile.
(vi) In the event multiple manufacturers report the same production
volume as described in Sec. 700.45(b)(v) and are greater than or equal
to the top 20th percentile, EPA will include all manufacturers with that
same production volume in the fee calculation for the top 20th
percentile group.
(5) If multiple persons are subject to fees triggered by section 4
of the Act and some inform EPA of their intent to form a consortium
while others choose not to associate with the consortium, EPA will take
the following steps to allocate fee amounts:
(i) Count the total number of manufacturers, including the number of
manufacturers within any consortia; divide the total fee amount by the
total number of manufacturers; and allocate equally on a per capita
basis to generate a base fee;
(ii) Provide all small businesses who are either not associated with
a consortium, or associated with an all- small business consortium, with
an 80% discount from the base fee referenced previously;
(iii) Calculate the total remaining fee and total number of
remaining manufacturers by subtracting out the discounted fees and the
number of small businesses identified;
(iv) Reallocate the remaining fee across those remaining individuals
and groups in equal amounts, counting each manufacturer in a consortium
as one person; and
(v) Inform consortia and individuals of their requisite fee amount.
Small businesses in a successfully-formed consortium, other than a
consortium of all small businesses, will not be afforded the 80%
discount by EPA, but consortia managers are strongly encouraged to
provide a discount for small business concerns.
(6) If multiple persons are subject to fees triggered by section
6(b) of the Act and some inform EPA of their intent to form a consortium
while others choose not to associate with the consortium, EPA will take
the following steps to allocate fee amounts:
(i) Count the total number of manufacturers, including the number of
manufacturers within any consortia; divide the total fee amount by the
total number of manufacturers; and allocate equally on a per capita
basis to generate a base fee;
(ii) Provide all small businesses who are either not associated with
a consortium, or associated with an all-small business consortium, with
an 80% discount from the base fee referenced previously;
(iii) Calculate the total remaining fee and total number of
remaining manufacturers by subtracting out the discounted fees and the
number of small businesses identified;
[[Page 17]]
(iv) Place remaining manufacturers in ascending order (from lowest
to highest) based on reported production volume as described in Sec.
700.45(b)(v). Assign each remaining manufacturer a number with 1 for
lowest production volume, 2 for second lowest production volume, etc.;
(v) Determine the manufacturer(s) in the top 20th percentile by
multiplying the total number of remaining manufacturers by 0.8. then
comparing that number to the manufacturer(s) with that assigned number
as described in paragraph (f)(6)(iv) of this section;
(vi) Reallocate 80% of the total remaining fee evenly across that
manufacturer(s) with a production volume amount equal to or larger than
that manufacturer(s) (the top 20th percentile), counting each
manufacturer in a consortium as one person;
(vii) Reallocate the remaining fee evenly across the remaining
manufacturers, counting each manufacturer in a consortium as one person;
and
(viii) Inform consortia and individuals of their requisite fee
amount. Small businesses in a successfully formed consortium, other than
a consortium of all small businesses, will not be afforded the 80%
discount by EPA, but consortia managers are strongly encouraged to
provide a discount for small business concerns.
(g) Remittance procedure--(1) Electronic payment. Each remittance
under this section shall be paid electronically in U.S. dollars, using
one of the electronic payment methods supported by the Department of the
Treasury's Pay.gov online electronic payment service, or any applicable
additional or successor online electronic payment service offered by the
Department of Treasury.
(2) Fees incurred prior to October 18, 2018. Timing of payment for
fees incurred between October 1, 2018 and October 18, 2018. Fees
required by paragraph (c) of this section for which the fee-triggering
action or event occurred between October 1, 2018, and October 18, 2018
shall be paid in response to invoices EPA will send within 30 days of
October 18, 2018.
(3) Fees incurred after October 18, 2018. Timing of payment for fees
incurred after October 18, 2018. Fees required by paragraph (c) of this
section for which the fee-triggering action or event occurred after
October 18, 2018 shall be paid at the following time:
(i) Test orders and test rules. The applicable fee specified in
paragraph (c) of this section shall be paid in full not later than 180
days after the effective date of a test rule or test order under section
4 of the Act.
(ii) Enforceable consent agreements. The applicable fee specified in
paragraph (c) of this section shall be paid in full not later than 120
days after the signing of an enforceable consent agreement under section
4 of the Act.
(iii) Section 5 notice. The applicable fee specified in paragraph
(c) of this section shall be paid in full immediately upon submission of
a TSCA section 5 notice.
(iv) Risk evaluations. (A) For EPA-initiated risk evaluations, the
applicable fee specified in paragraph (c) of this section shall be paid
in two installments, with the first payment of 50% due 180 days after
publishing the final scope of a risk evaluation and the second payment
for the remainder of the fee due 545 days after publishing the final
scope of a risk evaluation under section 6(b)(4)(D) of the Act.
(B) For manufacturer-requested risk evaluations under section
6(b)(4)(C)(ii) of the Act, the applicable fees specified in paragraph
(c) of this section shall be paid as follows:
(1) The applicable fee specified in paragraph (c) of this section
shall be paid in three installments. The first payment shall be due no
later than 180 days after EPA provides the submitting manufacture(s)
notice that it has granted the request.
(2) The second payment shall be due no later than 545 days after EPA
provides the submitting manufacturer(s) notice that it has granted the
request.
(3) The final payment shall be due no later than 30 days after EPA
publishes the final risk evaluation.
(4) Payment identity. (i) Persons who submit a TSCA section 5 notice
shall place an identifying number and a payment identity number on the
front page of each TSCA section 5 notice submitted. The identifying
number must include the letters ``TS'' followed by a combination of 6
numbers (letters may
[[Page 18]]
be substituted for some numbers). The payment identity number may be a
``Pay.gov'' transaction number used to transmit the fee. The same TS
number and the submitter's name must appear on the corresponding fee
remittance under this section. If a remittance applies to more than one
TSCA section 5 notice, the person shall include the name of the
submitter and a new TS number for each TSCA section 5 notice to which
the remittance applies, and the amount of the remittance that applies to
each notice.
(ii) Persons who are required to submit a letter of intent to
conduct testing per Sec. 790.45 of this chapter shall place a payment
identity number on the front page of each letter submitted. The
identifying number must include the letters ``TS'' followed by a
combination of 6 numbers (letters may be substituted for some numbers).
The payment identity number may be a ``Pay.gov'' transaction number used
to transmit the fee. The same TS number and the submitter's name must
appear on the corresponding fee remittance under this section. If a
remittance applies to more than one letter of intent to conduct testing,
the person shall include the name of the submitter and a new TS number
for each letter of intent to conduct testing to which the remittance
applies, and the amount of the remittance that applies to each letter of
intent.
(iii) Persons who sign an enforceable consent agreement per Sec.
790.60 of this chapter shall place a payment identity number within the
contents of the signed agreement. The identifying number must include
the letters ``TS'' followed by a combination of 6 numbers (letters may
be substituted for some numbers). The payment identity number may be a
``Pay.gov'' transaction number used to transmit the fee. The same TS
number and the submitter's name must appear on the corresponding fee
remittance under this section. If a remittance applies to more than one
enforceable consent agreement, the party or parties shall include the
name of the submitter(s) and a new TS number for each enforceable
consent agreement to which the remittance applies, and the amount of the
remittance that applies to each enforceable consent agreement.
(5) Small business certification. (i) Each person who remits the fee
identified in paragraph (c)(1) of this section for a PMN, consolidated
PMN, or SNUN shall insert a check mark for the statement, ``The company
named in part 1, section A is a small business concern under 40 CFR
700.43 and has remitted a fee of $6,480 in accordance with 40 CFR
700.45(c).'' under ``CERTIFICATION'' on page 2 of the Premanufacture
Notice for New Chemical Substances (EPA Form 7710-25).
(ii) Each person who remits the fee identified in paragraph (c)(1)
of this section for a LVE, LoREX, TERA, TME, or Tier II exemption
request under TSCA section 5 shall insert a check mark for the
statement, ``The company named in part 1, section A is a small business
concern under 40 CFR 700.43 and has remitted a fee of $2,180 in
accordance with 40 CFR 700.45(c).'' in the exemption application.
(iii) Each person who remits the fee identified in paragraph (c)(1)
of this section for an exemption notice under Sec. 723.175 of this
chapter shall include the words, ``The company or companies identified
in this notice is/are a small business concern under 40 CFR 700.43 and
has/have remitted a fee of $2,180 in accordance with 40 CFR 700.45(c).''
in the certification required in Sec. 723.175(i)(1)(x) of this chapter.
(iv) Each person who remits the fee identified in paragraph (c)(1)
of this section for a MCAN or consolidated MCAN for a microorganism
shall insert a check mark for the statement, ``The company named in part
1, section A is a small business concern under 40 CFR 700.43 and has
remitted a fee of $6,480 in accordance with 40 CFR 700.45(c).'' in the
certification required in Sec. 725.25(b) of this chapter.
(6) Payment certification statement. (i) Each person who remits a
fee identified in paragraph (c)(2) of this section for a PMN,
consolidated PMN, or SNUN shall insert a check mark for the statement,
``The company named in part 1, section A has remitted the fee of $37,000
specified in 40 CFR 700.45(c).'' under ``CERTIFICATION'' on page 2 of
the Premanufacture Notice for New Chemical Substances (EPA Form 7710-
25).
[[Page 19]]
(ii) Each person who remits a fee identified in paragraph (c)(2) of
this section for a LVE, LoREX, TERA, TME, or Tier II exemption request
under TSCA section 5 shall insert a check mark for the statement, ``The
company named in part 1, section A has remitted the fee of $10,870
specified in 40 CFR 700.45(c).'' in the exemption application.
(iii) Each person who remits the fee identified in paragraph (c)(2)
of this section for an exemption notice under Sec. 723.175 of this
chapter shall include the words, ``The company or companies identified
in this notice has/have remitted a fee of $10,870 in accordance with 40
CFR 700.45(c).'' in the certification required in Sec. 723.175(i)(1)(x)
of this chapter.
(iv) Each person who remits the fee identified in paragraph (c)(2)
of this section for a MCAN for a microorganism shall insert a check mark
for the statement, ``The company named in part 1, section A has remitted
the fee of $37,000 in accordance with 40 CFR 700.45(c).'' in the
certification required in Sec. 725.25(b) of this chapter.
(h) Full fee refunds. EPA will refund, in totality, any fee paid for
a section 5 notice whenever the Agency determines:
(1) That the chemical substance that is the subject of a PMN,
consolidated PMN, exemption request, or exemption notice, is not a new
chemical substance as of the date of submission of the notice,
(2) In the case of a SNUN, that the notice was not required,
(3) That as of the date of submission of the notice: The
microorganism that is the subject of a MCAN or consolidated MCAN is not
a new microorganism; nor is the use involving the microorganism a
significant new use; or
(4) When the Agency fails to make a determination on a notice by the
end of the applicable notice review period under Sec. 720.75 or Sec.
725.50 of this chapter, unless the Agency determines that the submitter
unduly delayed the process, or
(5) When the Agency fails to approve, or deny an exemption request
within the applicable period under Sec. 720.38(d), Sec. 723.50(g), or
Sec. 725.50(b) of this chapter, unless the Agency determines that the
submitter unduly delayed the process.
(i) Partial fee refunds. (1) If a TSCA section 5 notice is withdrawn
during the first 10 business days after the beginning of the applicable
review period under Sec. 720.75(a) of this chapter, the Agency will
refund all but 25% of the fee as soon as practicable.
(2) Once withdrawn, any future submission related to the TSCA
section 5 notice must be submitted as a new notice.
(3) If EPA determines that the initial payment for a manufacturer-
requested risk evaluation exceed the applicable fee in paragraph (c) of
this section, EPA will refund the difference.
[83 FR 52714, Oct. 17, 2018, as amended at 89 FR 12974, Feb. 21, 2024]
Sec. 700.49 Failure to remit fees.
(a) EPA will not consider a TSCA section 5 notice to be complete
unless the appropriate certification under Sec. 700.45(g) is included
and until the appropriate remittance under Sec. 700.45(c) has been
submitted as provided in Sec. 700.45(g). EPA will notify the submitter
of a section 5 notice that it is incomplete in accordance with
Sec. Sec. 720.65(c) and 725.33(b)(1) of this chapter.
(b) Failure to submit the appropriate remittance specified under
Sec. 700.45(c) for a test order, test rule, enforceable consent
agreement, or EPA-initiated risk evaluation as provided in Sec.
700.45(g) is a violation of TSCA and enforceable under section 15 of the
Act.
(c) EPA will not initiate a manufacturer-requested risk evaluation
the request for which the Agency has otherwise determined to be complete
unless EPA has determined to grant the request and the appropriate
initial remittance under Sec. 700.45(c) has been submitted as provided
in Sec. 700.45(g).
(d) Failure to submit the appropriate final remittance specified
under Sec. 700.45(c) for a manufacturer-requested risk evaluation as
provided in Sec. 700.45(g) is a violation of TSCA and enforceable under
section 15 of the Act.
[83 FR 52719, Oct. 17, 2018]
[[Page 20]]
PART 702_GENERAL PRACTICES AND PROCEDURES--Table of Contents
Subpart A_Procedures for Prioritization of Chemical Substances for Risk
Evaluation
Sec.
702.1 General provisions.
702.3 Definitions.
702.4 [Reserved]
702.5 Candidate selection.
702.7 Initiation of prioritization process.
702.9 Screening review and proposed priority designation.
702.11 Final priority designation.
702.13 Revision of designation.
702.15 Effect of designation as a low-priority substance.
702.17 Effect of designation as a high-priority substance.
Subpart B_Procedures for Chemical Substance Risk Evaluations
702.31 General provisions.
702.33 Definitions.
702.35 Chemical substances designated for risk evaluation.
702.37 Submission of manufacturer requests for risk evaluations.
702.39 Interagency collaboration.
702.41 Evaluation requirements.
702.43 Risk Characterization.
702.45 Peer review.
702.47 Unreasonable risk determination.
702.49 Risk evaluation timeframes and actions.
702.51 Publically available information.
Subpart C_Citizen Suit
702.60 Purpose.
702.61 Service of notice.
702.62 Contents of notice.
Authority: 15 U.S.C. 2605 and 2619.
Source: 47 FR 2773, Jan. 19, 1982, unless otherwise noted.
Subpart A_Procedures for Prioritization of Chemical Substances for Risk
Evaluation
Source: 82 FR 33762, July 20, 2017, unless otherwise noted.
Sec. 702.1 General provisions.
(a) Purpose. This regulation establishes the risk-based screening
process for designating chemical substances as a High-Priority Substance
or a Low-Priority Substance for risk evaluation as required under
section 6(b) of the Toxic Substances Control Act, as amended (15 U.S.C.
2605(b)).
(b) Scope of designations. EPA will make priority designations
pursuant to these procedures for a chemical substance, not for a
specific condition or conditions of uses of a chemical substance.
(c) Categories of chemical substances. Nothing in this subpart shall
be interpreted as a limitation on EPA's authority under 15 U.S.C.
2625(c) to take action, including the actions contemplated in this
subpart, on a category of chemical substances.
(d) Prioritization timeframe. The Agency will publish a final
priority designation for a chemical substance in no fewer than 9 months
and no longer than 1 year following initiation of prioritization
pursuant to Sec. 702.7.
(e) Metals or metal compounds. EPA will identify priorities for
chemical substances that are metals or metal compounds in accordance
with 15 U.S.C. 2605(b)(2)(E).
(f) Applicability. These regulations do not apply to any chemical
substance for which a manufacturer requests a risk evaluation under 15
U.S.C. 2605(b)(4)(C).
(g) Scientific standards and weight of the scientific evidence.
EPA's proposed priority designations under Sec. 702.9 and final
priority designations under Sec. 702.11 will be consistent with the
scientific standards provision in 15 U.S.C. 2625(h) and the weight of
the scientific evidence provision in 15 U.S.C. 2625(i).
(h) Interagency collaboration. EPA will consult with other relevant
Federal Agencies during the administration of this subpart.
Sec. 702.3 Definitions.
For purposes of this subpart, the following definitions apply:
Act means the Toxic Substances Control Act, as amended (15 U.S.C.
2601 et seq.).
Conditions of use means the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.
EPA means the U.S. Environmental Protection Agency.
[[Page 21]]
High-priority substance means a chemical substance that EPA
determines, without consideration of costs or other non-risk factors,
may present an unreasonable risk of injury to health or the environment
because of a potential hazard and a potential route of exposure under
the conditions of use, including an unreasonable risk to potentially
exposed or susceptible subpopulations identified as relevant by EPA.
Low-priority substance means a chemical substance that EPA
concludes, based on information sufficient to establish, without
consideration of costs or other non-risk factors, does not meet the
standard for a High-Priority Substance.
Potentially exposed or susceptible subpopulation means a group of
individuals within the general population identified by the
Administrator who, due to either greater susceptibility or greater
exposure, may be at greater risk than the general population of adverse
health effects from exposure to a chemical substance or mixture, such as
infants, children, pregnant women, workers, or the elderly.
Reasonably available information means information that EPA
possesses or can reasonably generate, obtain and synthesize for use,
considering the deadlines specified in 15 U.S.C. 2605(b) for
prioritization and risk evaluation. Information that meets such terms is
reasonably available information whether or not the information is
confidential business information that is protected from public
disclosure under 15 U.S.C. 2613.
Sec. 702.4 [Reserved]
Sec. 702.5 Candidate selection.
(a) General objective. In selecting candidates for a High-Priority
Substance designation, it is EPA's general objective to select those
chemical substances with the greatest hazard and exposure potential
first, considering reasonably available information on the relative
hazard and exposure of potential candidates. In selecting candidates for
Low-Priority Substance designation, it is EPA's general objective to
select those chemical substances with hazard and/or exposure
characteristics under the conditions of use such that a risk evaluation
is not warranted at the time to determine whether the chemical substance
presents an unreasonable risk of injury to health or the environment,
including an unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant by EPA.
(b) Available information. EPA expects to ensure that there is
reasonably available information to meet the deadlines for
prioritization under the Act.
(c) Preferences and TSCA work plan. In selecting a candidate for
prioritization as a High-Priority Substance, EPA will:
(1) Give preference to:
(i) Chemical substances that are listed in the 2014 update of the
TSCA Work Plan for Chemical Assessments as having a persistence and
bioaccumulation score of 3; and
(ii) Chemical substances that are listed in the 2014 update of the
TSCA Work Plan for Chemical Assessments that are known human carcinogens
and have high acute and chronic toxicity; and
(2) Identify a sufficient number of candidates from the 2014 update
of the TSCA Work Plan for Chemical Assessments to ensure that, at any
given time, at least 50 percent of risk evaluations being conducted by
EPA are drawn from that list until all substances on the list have been
designated as either a High-Priority Substance or Low-Priority Substance
pursuant to Sec. 702.11.
(d) Purpose. The purpose of the preferences and criteria in
paragraphs (a) through (c) of this section is to inform EPA's decision
whether or not to initiate the prioritization process pursuant to Sec.
702.7, and the proposed designation of the chemical substance as either
a High-Priority Substance or a Low-Priority Substance pursuant to Sec.
702.9.
(e) Insufficient information. If EPA believes it would not have
sufficient information for purposes of prioritization, EPA generally
expects to obtain the information necessary to inform prioritization
prior to initiating the process pursuant to Sec. 702.9, using
[[Page 22]]
voluntary means of information gathering and, as necessary, exercising
its authorities under the Act in accordance with the requirements of 15
U.S.C. 2603, 15 U.S.C. 2607, and 15 U.S.C. 2610. In exercising its
authority under 15 U.S.C. 2603(a)(2), EPA will identify the need for the
information in accordance with 15 U.S.C. 2603(a)(3).
Sec. 702.7 Initiation of prioritization process.
(a) EPA generally expects to initiate the prioritization process for
a chemical substance only when it believes that the information
necessary to prioritize the substance is reasonably available.
(b) EPA will initiate prioritization by publishing a notice in the
Federal Register identifying a chemical substance for prioritization.
EPA will include a general explanation in this notice for why it chose
to initiate the process on the chemical substance.
(c) The prioritization timeframe in Sec. 702.1(d) begins upon EPA's
publication of the notice described in paragraph (b) of this section.
(d) Publication of the notice in the Federal Register pursuant to
paragraph (b) of this section will initiate a period of 90 days during
which interested persons may submit relevant information on that
chemical substance. Relevant information might include, but is not
limited to, any information that may inform the screening review
conducted pursuant to Sec. 702.9(a). EPA will open a separate docket
for each chemical substance to facilitate receipt of information.
(e) EPA may, in its discretion, extend the public comment period in
paragraph (d) of this section for up to three months in order to receive
or evaluate information submitted under 15 U.S.C. 2603(a)(2)(B). The
length of the extension will be based upon EPA's assessment of the time
necessary for EPA to receive and/or evaluate information submitted under
15 U.S.C. 2603(a)(2)(B).
Sec. 702.9 Screening review and proposed priority designation.
(a) Screening review. Following the close of the comment period
described in Sec. 702.7(d), including any extension pursuant to
paragraph (e) of that section, EPA will generally use reasonably
available information to screen the candidate chemical substance against
the following criteria and considerations:
(1) The chemical substance's hazard and exposure potential;
(2) The chemical substance's persistence and bioaccumulation;
(3) Potentially exposed or susceptible subpopulations;
(4) Storage of the chemical substance near significant sources of
drinking water;
(5) The chemical substance's conditions of use or significant
changes in conditions of use;
(6) The chemical substance's production volume or significant
changes in production volume; and
(7) Other risk-based criteria that EPA determines to be relevant to
the designation of the chemical substance's priority.
(b) Information sources. In conducting the screening review in
paragraph (a) of this section, EPA expects to consider sources of
information relevant to the listed criteria and consistent with the
scientific standards provision in 15 U.S.C. 2625(h), including, as
appropriate, sources for hazard and exposure data listed in Appendices A
and B of the TSCA Work Plan Chemicals: Methods Document (February 2012).
(c) Proposed designation. Based on the results of the screening
review in paragraph (a) of this section, relevant information received
from the public as described in Sec. 702.7(d), and other information as
appropriate and consistent with 15 U.S.C. 2625(h) and (i), EPA will
propose to designate the chemical substance as either a High-Priority
Substance or Low-Priority Substance, along with an identification of the
information, analysis, and basis used to support the proposed
designation.
(d) Costs and non-risk factors. EPA will not consider costs or other
non-risk factors in making a proposed priority designation.
(e) Insufficient information. If information remains insufficient to
enable the proposed designation of the chemical substance as a Low-
Priority Substance after any extension of the initial public comment
period pursuant to Sec. 702.7(e), EPA will propose to designate
[[Page 23]]
the chemical substance as a High-Priority Substance.
(f) Conditions of use. EPA will propose to designate a chemical
substance as a High-Priority Substance based on the proposed conclusion
that the chemical substance satisfies the definition of High-Priority
Substance in Sec. 702.3 under one or more activities that the Agency
determines constitute conditions of use. EPA will propose to designate a
chemical substance as a Low-Priority Substance based on the proposed
conclusion that the chemical substance meets the definition of Low-
Priority Substance in Sec. 702.3 under the activities that the Agency
determines constitute conditions of use.
(g) Publication. EPA will publish the proposed designation in the
Federal Register, along with an identification of the information,
analysis and basis used to support a proposed designation, in a form and
manner that EPA deems appropriate, and provide a comment period of 90
days, during which time the public may submit comment on EPA's proposed
designation. EPA will open a docket to facilitate receipt of public
comment.
Sec. 702.11 Final priority designation.
(a) After considering any additional information collected from the
proposed designation process in Sec. 702.9, as appropriate, EPA will
finalize its designation of a chemical substance as either a High-
Priority Substance or a Low-Priority Substance consistent with 15 U.S.C.
2625(h) and (i).
(b) EPA will not consider costs or other non-risk factors in making
a final priority designation.
(c) EPA will publish each final priority designation in the Federal
Register, along with an identification of the information, analysis, and
basis used to support a final designation consistent with 15 U.S.C.
2625(h), (i) and (j). For High-Priority Substance designations, EPA
generally expects to indicate which condition(s) of use were the primary
basis for such designations.
(d) As required in 15 U.S.C. 2605(b)(3)(C), EPA will finalize a
designation for at least one High-Priority Substance for each risk
evaluation it completes, other than a risk evaluation that was requested
by a manufacturer pursuant to subpart B of this part. The obligation in
15 U.S.C. 2605(b)(3)(C) will be satisfied by the designation of at least
one High-Priority Substance where such designation specifies the risk
evaluation that the designation corresponds to, and where the
designation occurs within a reasonable time before or after the
completion of the risk evaluation.
Sec. 702.13 Revision of designation.
EPA may revise a final designation of a chemical substance from Low-
Priority to High-Priority Substance at any time based on reasonably
available information. To revise such a designation, EPA will re-
initiate the prioritization process on that chemical substance in
accordance with Sec. 702.7, re-screen the chemical substance and
propose a priority designation pursuant to Sec. 702.9, and finalize the
priority designation pursuant to Sec. 702.11.
Sec. 702.15 Effect of designation as a low-priority substance.
Designation of a chemical substance as a Low-Priority Substance
under Sec. 702.11 means that a risk evaluation of the chemical
substance is not warranted at the time, but does not preclude EPA from
later revising the designation pursuant to Sec. 702.13, if warranted.
Designation as a Low-Priority Substance is not a finding that the
chemical substance does not present an unreasonable risk, but rather
that it does not meet the High-Priority Substance definition.
Sec. 702.17 Effect of designation as a high-priority substance.
Final designation of a chemical substance as a High-Priority
Substance under Sec. 702.11 initiates a risk evaluation pursuant to
subpart B of this part. Designation as a High-Priority Substance is not
a final agency action and is not subject to judicial review until the
date of promulgation of the associated final rule under section 6(a).
Designation as a High-Priority Substance is not a finding that the
chemical substance presents an unreasonable risk.
[[Page 24]]
Subpart B_Procedures for Chemical Substance Risk Evaluations
Source: 82 FR 33747, July 20, 2017, unless otherwise noted.
Effective Date Note: At 89 FR 37052, May 3, 2024, subpart B was
revised and republished, effective July 2, 2024. For the convenience of
the user, the new subpart 702 follows the text of this subpart.
Sec. 702.31 General provisions.
(a) Purpose. This subpart establishes the EPA process for conducting
a risk evaluation to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment as required
under TSCA section 6(b)(4)(B) (15 U.S.C. 2605(b)(4)(B)).
(b) Scope. These regulations establish the general procedures, key
definitions, and timelines EPA will use in a risk evaluation conducted
pursuant to TSCA section 6(b) (15 U.S.C. 2605(b)).
(c) Applicability. The requirements of this part apply to all
chemical substance risk evaluations initiated pursuant to TSCA section
6(b) (15 U.S.C. 2605(b)).
(d) Enforcement. Submission to EPA of inaccurate, incomplete, or
misleading information pursuant to a risk evaluation conducted pursuant
to 15 U.S.C. 2605(b)(4)(B) is a prohibited act under 15 U.S.C. 2614,
subject to penalties under 15 U.S.C. 2615 and Title 18 of the U.S. Code.
Sec. 702.33 Definitions.
All definitions in TSCA apply to this subpart. In addition, the
following definitions apply:
Act means the Toxic Substances Control Act, as amended (15 U.S.C.
2601 et seq.).
Aggregate exposure means the combined exposures to an individual
from a single chemical substance across multiple routes and across
multiple pathways.
Best available science means science that is reliable and unbiased.
Use of best available science involves the use of supporting studies
conducted in accordance with sound and objective science practices,
including, when available, peer reviewed science and supporting studies
and data collected by accepted methods or best available methods (if the
reliability of the method and the nature of the decision justifies use
of the data). Additionally, EPA will consider as applicable:
(1) The extent to which the scientific information, technical
procedures, measures, methods, protocols, methodologies, or models
employed to generate the information are reasonable for and consistent
with the intended use of the information;
(2) The extent to which the information is relevant for the
Administrator's use in making a decision about a chemical substance or
mixture;
(3) The degree of clarity and completeness with which the data,
assumptions, methods, quality assurance, and analyses employed to
generate the information are documented;
(4) The extent to which the variability and uncertainty in the
information, or in the procedures, measures, methods, protocols,
methodologies, or models, are evaluated and characterized; and
(5) The extent of independent verification or peer review of the
information or of the procedures, measures, methods, protocols,
methodologies or models.
Conditions of use means the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.
EPA means the U.S. Environmental Protection Agency.
Pathways means the mode through which one is exposed to a chemical
substance, including but not limited to: Food, water, soil, and air.
Potentially exposed or susceptible subpopulation means a group of
individuals within the general population identified by the Agency who,
due to either greater susceptibility or greater exposure, may be at
greater risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, or the elderly.
Reasonably available information means information that EPA
possesses
[[Page 25]]
or can reasonably generate, obtain, and synthesize for use in risk
evaluations, considering the deadlines specified in TSCA section
6(b)(4)(G) for completing such evaluation. Information that meets the
terms of the preceding sentence is reasonably available information
whether or not the information is confidential business information,
that is protected from public disclosure under TSCA section 14.
Routes means the particular manner by which a chemical substance may
contact the body, including absorption via ingestion, inhalation, or
dermally (integument).
Sentinel exposure means the exposure from a single chemical
substance that represents the plausible upper bound of exposure relative
to all other exposures within a broad category of similar or related
exposures.
Uncertainty means the imperfect knowledge or lack of precise
knowledge of the real world either for specific values of interest or in
the description of the system.
Variability means the inherent natural variation, diversity, and
heterogeneity across time and/or space or among individuals within a
population.
Weight of scientific evidence means a systematic review method,
applied in a manner suited to the nature of the evidence or decision,
that uses a pre-established protocol to comprehensively, objectively,
transparently, and consistently, identify and evaluate each stream of
evidence, including strengths, limitations, and relevance of each study
and to integrate evidence as necessary and appropriate based upon
strengths, limitations, and relevance.
Sec. 702.35 Chemical substances designated for risk evaluation.
(a) Chemical substances undergoing risk evaluation. A risk
evaluation for a chemical substance designated by the Agency as a High-
Priority Substance pursuant to the prioritization process described in
subpart A, identified under 15 U.S.C. 2605(b)(2)(A), or initiated at the
request of a manufacturer or manufacturers under Sec. 702.37, will be
conducted in accordance with this part, except that risk evaluations
that are initiated prior to the effective date of this rule will be
conducted in accordance with this part to the maximum extent
practicable.
(b) Percentage requirements. The Agency will ensure that, of the
number of chemical substances that undergo risk evaluation under 15
U.S.C. 2605(b)(4)(C)(i), the number of chemical substances undergoing
risk evaluation under 15 U.S.C. 2605(b)(4)(C)(ii) is not less than 25%,
if sufficient requests that comply with 702.37, and not more than 50%.
(c) Manufacturer requests for work plan chemical substances.
Manufacturer requests for risk evaluations, described in paragraph (a)
of this section, for chemical substances that are drawn from the 2014
update of the TSCA Work Plan for Chemical Assessments will be granted at
the discretion of the Agency. Such evaluations are not subject to the
percentage requirements in paragraph (b) of this section.
Sec. 702.37 Submission of manufacturer requests for risk evaluations.
(a) General provision. Any request that EPA conduct a risk
evaluation pursuant to this part must comply with all the procedures and
criteria in this section to be eligible to be granted by EPA.
(b) Method for submission. One or more manufacturers of a chemical
substance may request that EPA conduct a risk evaluation. All requests
submitted to EPA under this subpart must be submitted via the EPA
Central Data Exchange (CDX) found at http://cdx.epa.gov. Requests must
include all of the following information:
(1) Name, mailing address, and contact information of the entity (or
entities) submitting the request. If more than one manufacturer submits
the request, all individual manufacturers must provide their contact
information.
(2) The chemical identity of the chemical substance that is the
subject of the request. At a minimum, this includes, all known names of
the chemical substance, including common or trades names, CAS number,
and molecular structure of the chemical substance A request for risk
evaluations of a category of chemical substances must include an
explanation of why the category is appropriate under 15 U.S.C.
[[Page 26]]
2625(c), and EPA will grant such request only upon determining that the
requested category is appropriate for risk evaluation.
(3) The manufacturer must identify the circumstances on which they
are requesting that EPA conduct a risk evaluation and include a
rationale for why these circumstances constitute conditions of use under
Sec. 702.33.
(4) The request must also include a list of all the existing
information that is relevant to whether the chemical substance, under
the circumstances identified by the manufacturer(s), presents an
unreasonable risk of injury to health or the environment. The list must
be accompanied by an explanation as to why such information is adequate
to permit EPA to complete a risk evaluation addressing the circumstances
identified by the manufacturer(s), The request need not include copies
of the information; citations are sufficient, if the information is
publically available. The request must include or reference all
available information on the health and environmental hazard(s) of the
chemical substance, human and environmental exposure(s), and exposed
population(s), as relevant to the circumstances identified in the
request. At a minimum, this must include all the following, as relevant
to the circumstances identified:
(i) The chemical substance's hazard and exposure potential;
(ii) The chemical substance's persistence and bioaccumulation;
(iii) Potentially exposed or susceptible subpopulations which the
manufacturer(s) believes to be relevant to the EPA risk evaluation;
(iv) Whether there is any storage of the chemical substance near
significant sources of drinking water, including the storage facility
location and the nearby drinking water source(s);
(v) The chemical substance's production volume or significant
changes in production volume; and
(vi) Any other information relevant to the potential risks of the
chemical substance under the circumstances identified in the request.
(5) The request must include a commitment to provide to EPA any
referenced information upon request.
(6) Scientific information submitted must be consistent with the
scientific standards in 15 U.S.C. 2625(h).
(7) A signed certification that all information contained in the
request is accurate and complete, as follows:
(i) I certify that to the best of my knowledge and belief:
(A) The company named in this request manufacturers the chemical
substance identified for risk evaluation.
(B) All information provided in the notice is complete and accurate
as of the date of the request.
(C) I have either identified or am submitting all information in my
possession, control, and a description of all other data known to or
reasonably ascertainable by me as required for this request under this
part. I am aware it is unlawful to knowingly submit incomplete, false
and/or misleading information in this request and there are significant
criminal penalties for such unlawful conduct, including the possibility
of fine and imprisonment.
(ii) [Reserved]
(c) Optional elements. A manufacturer may provide information that
will inform EPA's determination as to whether restrictions imposed by
one or more States have the potential to have a significant impact on
interstate commerce or health or the environment, and that as a
consequence the request is entitled to preference pursuant to 15 U.S.C.
2605(b)(4)(E)(iii).
(d) Confidential business information. Claims of confidentiality
must be made in accordance with the procedures described in 40 CFR part
703.
(e) EPA process for evaluating manufacturer requests--(1) Review for
completeness. Upon receipt of the request, EPA will verify that the
request is facially complete, i.e., that information has been submitted
that appears to be consistent with the requirements in paragraphs (b)
through (d) of this section. EPA will inform the submitting
manufacturer(s) if EPA has determined that the request is incomplete,
and cannot be processed. Facially complete requests will be processed as
described in this subpart.
(2) Public notification of receipt of request. Within 15 business
days of receipt of a facially complete submission, EPA will notify the
public of receipt of
[[Page 27]]
the manufacturer request. This notification will include any information
submitted by the manufacturer that is not CBI, including the
condition(s) of use for which the evaluation is requested.
(3) Conditions of use to be evaluated. EPA will assess whether the
circumstances identified in the request constitute condition of use
under Sec. 702.33, and whether those conditions of use warrant
inclusion within the scope of a risk evaluation for the chemical
substance. EPA will also assess what, if any, additional conditions of
use that warrant inclusion within the scope of a risk evaluation for the
chemical substance. EPA will conduct these assessments and make proposed
determinations based on the same considerations applied in the same
manner as it would for a risk evaluation for a high-priority substance.
(4) Public notice and comment. No later than 60 business days of
receiving a request that EPA has determined to be complete under
paragraph (e)(1) of this section, EPA will submit for publication the
receipt of the request in the Federal Register, open a docket for that
request and provide no less than a 45 calendar day public comment
period. The docket will contain the manufacturer request (excluding
information claimed as CBI) and EPA' proposed additions of conditions of
use as described in paragraph (e)(3) of this section, and the basis for
these proposed additions. During the comment period the public may
submit comments and information relevant to the requested risk
evaluation, in particular, commenters are encouraged to identify any
information not included in the request or the proposed determinations
that the commenters believe would be needed to conduct a risk
evaluation, and to provide any other information relevant to EPA's
proposed determinations of the conditions of use, such as information on
other conditions of use of the chemical than those included in the
request or in EPA's proposed determinations
(5) Supplementation of original request. (i) At any time prior to
the end of the comment period, the requesting manufacturer(s) may
supplement the original request with any new information it receives.
(ii) At any point prior to the completion of a risk evaluation
pursuant to this section, manufacturer(s) must supplement the original
request with any information that meets the criteria in 15 U.S.C.
2607(e) and this section, or with any other information that has the
potential to change EPA's risk evaluation with respect to the conditions
of use as requested by the manufacturer. Such information must be
submitted consistent with section 8(e) if the information is subject to
that section or otherwise within 30 calendar days of the manufacturer's
obtaining the information.
(6) EPA's decision. (i) Within 60 days of the end of the comment
period provided in paragraph (e)(4) of this section, EPA will review the
request along with any additional information received during the
comment period to determine whether the request meets the criteria and
requirements of this section.
(ii) EPA will grant the request if it determines that all of the
following have been met:
(A) That the circumstances identified in the request constitute
conditions of use that warrant inclusion in a risk evaluation for the
chemical substance;
(B) That EPA has all of the information needed to conduct such risk
evaluation on the conditions of use that were the subject of the
request; and
(C) All other criteria and requirements of this section have been
met.
(iii) At the end of this 60-day period, EPA will notify the
submitting manufacturer(s) of its decision and include the basis for
granting or denying the request. Bases for a denial, include the
manufacturer has not provided sufficient information to complete the
risk evaluation on the condition(s) of use requested, or that the
circumstances identified in the request either do not constitute
conditions of use, or the conditions of use do not warrant inclusion in
a risk evaluation for the chemical substance. This notification will
also identify any additional conditions of use, as determined by the
Administrator, that will be included in this risk evaluation.
(iv) Within 30 days of receipt of EPA's notification the
requester(s) may withdraw the request.
[[Page 28]]
(7) Public notice of decision. EPA will make public EPA's decision
to grant or deny the request at the time that EPA notifies the
manufacturer.
(8) Compliant request. EPA will initiate a risk evaluation for all
requests for non-TSCA Work Plan Chemicals that meet the criteria in this
subpart, until EPA determines that the number of manufacturer-requested
chemical substances undergoing risk evaluation is equal to 25% of the
High-Priority Substances identified in subpart A as undergoing risk
evaluation. Once that level has been reached, EPA will initiate at least
one new manufacturer-requested risk evaluation for each manufacturer-
requested risk evaluation completed so long as there are sufficient
requests that meet the criteria of this subpart, as needed to ensure
that the number of manufacturer-requested risk evaluations is equal to
at least 25% of the High-Priority substances risk evaluation and not
more than 50%.
(9) Preferences. In conformance with Sec. 702.35(c), in evaluating
requests for TSCA Work Plan Chemicals and requests for non-TSCA Work
Plan chemicals in excess of the 25% threshold in Sec. 702.35(b), EPA
will first give preference to requests for risk evaluations on chemical
substances:
(i) First, for which the Agency determines that restrictions imposed
by one or more States have the potential to have a significant impact on
interstate commerce, health or the environment; and then
(ii) Second, based on the order in which the requests are received.
(10) No preferential treatment. Once granted, EPA will initiate the
risk evaluation and thereafter will conduct the risk evaluation
following the procedures in Sec. Sec. 702.39 through 702.51. EPA will
not expedite or otherwise provide special treatment to a risk evaluation
conducted as a result of a manufacturer's request.
(11) Fees. Manufacturers must pay fees to support risk evaluations
as specified under 15 U.S.C. 2605(b)(4)(E)(ii).
[82 FR 33747, July 20, 2017, as amended at 88 FR 37166, June 7, 2023]
Sec. 702.39 Interagency collaboration.
During the risk evaluation process, not to preclude any additional,
prior, or subsequent collaboration, EPA will consult with other relevant
Federal agencies.
Sec. 702.41 Evaluation requirements.
(a) Considerations. (1) Each risk evaluation will include all of the
following components:
(i) A Scope, including a Conceptual Model and an Analysis Plan;
(ii) A Hazard Assessment;
(iii) An Exposure Assessment;
(iv) A Risk Characterization; and
(v) A Risk Determination.
(2) EPA guidance will be used, as applicable where it represents the
best available science appropriate for the particular risk evaluation.
(3) Where appropriate, a risk evaluation will be conducted on a
category of chemical substances. EPA will determine whether to conduct
an evaluation on a category of chemical substances, and the composition
of the category based on the considerations listed in 15 U.S.C. 2625(c).
(4) EPA will document that it has used the best available science
and weight of scientific evidence approaches in the risk evaluation
process.
(5) EPA will ensure that all supporting analyses and components of
the risk evaluation are suitable for their intended purpose, and well-
tailored to the problems and decision at hand, in order to inform the
development of a technically sound determination as to whether a
chemical substance presents an unreasonable risk of injury to health or
the environment under the conditions of use within the scope of the risk
evaluation, based on the weight of the scientific evidence.
(6) The extent to which EPA will refine its evaluations for one or
more condition of use in any risk evaluation will vary as necessary to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment.
(7) To the extent a determination as to the level of risk presented
by a condition of use can be made, for example,
[[Page 29]]
using assumptions, uncertainty factors, and models or screening
methodologies, EPA may determine that no further information or analysis
is needed to complete its risk evaluation of the condition(s) of use.
(8) In general, EPA intends to determine whether a chemical
substance does or does not present an unreasonable risk under all of the
conditions of use within the scope of the risk evaluations, and intends
to identify the individual conditions of use or categories of conditions
of use that are responsible for such determinations.
(9) Within the time frame in Sec. 702.43(d), EPA will complete the
risk evaluation of the chemical substance addressing all of the
conditions of use within the scope of the evaluation. However, EPA may
complete its evaluation of the chemical substance under specific
conditions of use or categories of conditions of use at any point
following the issuance of the final scope document, and issue its
determination as to whether the chemical substance under those
conditions of use does or does not present an unreasonable risk to
health or the environment under those conditions of use. EPA will follow
all of the requirements and procedures in this Subpart when it conducts
its evaluation of the chemical substance under any individual or
specific conditions of use.
(10) EPA will evaluate chemical substances that are metals or metal
compounds in accordance with 15 U.S.C. 2605(b)(2)(E).
(b) Information and information sources. (1) EPA will base each risk
evaluation on reasonably available information.
(2) EPA generally expects to initiate a risk evaluation for a
chemical substance when EPA believes that all or most of the information
necessary to perform the risk evaluation is reasonably available. EPA
expects to use its authorities under the Act, and other information
gathering authorities, when necessary to obtain the information needed
to perform a risk evaluation for a chemical substance before initiating
the risk evaluation for such substance. EPA will use such authorities on
a case-by-case basis during the performance of a risk evaluation to
obtain information as needed to ensure that EPA has adequate, reasonably
available information to perform the evaluation.
(3) Among other sources of information, the Agency will consider
information and advice provided by the Science Advisory Committee on
Chemicals established pursuant to 15 U.S.C. 2625.
(4) In conducting risk evaluations, EPA will utilize reasonably
available information including information, models, and screening
methodologies, as appropriate. The approaches used will be determined by
the quality of the information, the deadlines specified in TSCA section
6(b)(4)(G) for completing the risk evaluation, and the extent to which
the information reduces uncertainty.
(5) Where appropriate, to the extent practicable, and scientifically
justified, EPA will require the development of information generated
without the use of new testing on vertebrates in performing risk
evaluation.
(c) Scope of the risk evaluation. The scope of the risk evaluation
will include all the following:
(1) The condition(s) of use, as determined by the Administrator,
that the EPA plans to consider in the risk evaluation.
(2) The potentially exposed populations, including any potentially
exposed or susceptible subpopulations as identified as relevant to the
risk evaluation by the Agency under the conditions of use, that EPA
plans to evaluate; the ecological receptors that EPA plans to evaluate;
and the hazards to health and the environment that EPA plans to
evaluate.
(3) A description of the reasonably available information and
science approaches EPA plans to use in the risk evaluation.
(4) A conceptual model:
(i) The scope documents will include a Conceptual Model that
describes actual or predicted relationships between the chemical
substance, the conditions of use within the scope of the evaluation and
human and environmental receptors.
(ii) The conceptual model will identify human and ecological health
hazards the EPA plans to evaluate for the
[[Page 30]]
exposure scenarios EPA plans to evaluate.
(iii) Conceptual model development will consider the life cycle of
the chemical substance, including manufacture, processing, distribution
in commerce, storage, use, and disposal, relevant to the conditions of
use within the scope of the evaluation
(5) An analysis plan:
(i) The scope documents will include an analysis plan that
identifies the approaches, methods, and/or metrics that EPA plans to use
to assess exposures, effects, and risk, including associated uncertainty
and variability for each risk evaluation. The analysis plan will also
identify the strategy for using information, accepted science policies,
models, and screening methodologies.
(ii) Hypotheses about the relationships identified in the conceptual
model will be described. The relative strengths of alternative
hypotheses if any will be evaluated to determine the appropriate risk
assessment approaches.
(6) The Agency's plan for peer review.
(7) Developing the scope.
(i) Draft scope. For each risk evaluation to be conducted EPA will
publish a document in the Federal Register that specifies the draft
scope of the risk evaluation the Agency plans to conduct. The document
will address the elements in paragraphs (c)(1) through (6) of this
section.
(ii) Timeframes. EPA generally expects to publish the draft scope no
later than 3 months from the initiation of the risk evaluation process
for the chemical substance.
(iii) Public comments. EPA will allow a public comment period of no
less than 45 calendar days during which interested persons may submit
comment on EPA's draft risk evaluation scope. EPA will open a docket to
facilitate receipt of public comments.
(8) Final scope:
(i) The Agency will, no later than 6 months after the initiation of
a risk evaluation, publish a document in the Federal Register that
specifies the final scope of the risk evaluation the Agency plans to
conduct. The document shall address the elements in paragraphs (c)(1)
through (6) of this section.
(ii) For a chemical substance designated as a High-Priority
Substance under subpart A of this part, EPA will not publish the final
scope of the risk evaluation until at least 12 months have elapsed from
the initiation of the prioritization process for the chemical substance.
(d) Hazard assessment. (1) The hazard information relevant to the
chemical substance will be evaluated using hazards identified in the
final scope document published pursuant to paragraph (c)(8) of this
section, for the identified exposure scenarios, including any identified
potentially exposed or susceptible subpopulation(s).
(2) The hazard assessment process will identify the types of hazards
to health or the environment posed by the chemical substance under the
condition(s) of use within the scope of the risk evaluation. Hazard
information related to potential health and environmental hazards of the
chemical substance will be reviewed in a manner consistent with best
available science and weight of scientific evidence as defined in Sec.
702.33 and all assessment methods will be documented. This process
includes the identification, evaluation, and synthesis of information to
describe the potential health and environmental hazards of the chemical
substance.
(3) Relevant potential human and environmental hazards will be
evaluated.
(4) The relationship between the dose of the chemical substance and
the occurrence of health and environmental effects or outcomes will be
evaluated.
(5) Studies evaluated may include, but would not be limited to:
Human epidemiological studies, in vivo and/or in vitro laboratory
studies, biomonitoring studies, mechanistic and/or kinetic studies in a
variety of test systems, including but not limited to toxicokinetics and
toxicodynamics, computational toxicology such as high-throughput assays,
genomic response assays, data from structure-activity relationships, and
ecological field data.
(6) Hazard identification will include an evaluation of the
strengths, limitations, and uncertainties associated with the reasonably
available information.
[[Page 31]]
(7) The human health hazard assessment will consider all potentially
exposed and susceptible subpopulation(s) determined to be relevant, as
identified in the final scope document published pursuant to paragraph
(c)(8) of this section.
(8) The environmental health hazard assessment will consider the
relationship between the chemical substance and the occurrence of an
ecological hazard elicited.
(e) Exposure assessment. (1) Where relevant, the likely duration,
intensity, frequency, and number of exposures under the conditions of
use will be considered.
(2) Chemical-specific factors including, but not limited to:
Physical- chemical properties and environmental fate and transport
parameters will be examined.
(3) Exposure information related to potential human health or
ecological hazards of the chemical substance will be reviewed in a
manner consistent with the description of best available science and
weight of scientific evidence in Sec. 702.33 and all methods will be
documented.
(4) The human health exposure assessment will consider all
potentially exposed and susceptible subpopulation(s) determined to be
relevant, as identified in the final scope document published pursuant
to paragraph (c)(8) of this section.
(5) Environmental health exposure assessment:
(i) The environmental health exposure assessment will characterize
and evaluate the interaction of the chemical substance with the
ecological receptors identified in the final scope document published
pursuant to paragraph (c)(8) of this section.
(ii) Exposures considered will include populations and communities,
depending on the chemical substance and the ecological characteristic
involved.
Sec. 702.43 Risk Characterization.
(a) Risk Characterization considerations. EPA will:
(1) Integrate the hazard and exposure assessments into quantitative
and/or qualitative estimates of risk for the identified populations
(including any potentially exposed or susceptible subpopulation(s))
identified in the final scope document published pursuant to Sec.
702.41(c)(8) and ecological characteristics for the conditions of use
within the scope of the risk evaluation;
(2) Describe whether aggregate or sentinel exposures under the
conditions of use were considered and the basis for their consideration;
(3) Not consider costs or other nonrisk factors;
(4) Take into account, where relevant, the likely duration,
intensity, frequency, and number of exposures under the condition(s) of
use of the chemical substance; and
(5) Describe the weight of the scientific evidence for the
identified hazards and exposures.
(b) Risk Characterization summary. The Risk Characterization will
summarize, as applicable, the considerations addressed throughout the
evaluation components, in carrying out the obligations under 15 U.S.C.
2625(h). This summary will include, as appropriate, a discussion of:
(1) Considerations regarding uncertainty and variability.
Information about uncertainty and variability in each step of the risk
evaluation (e.g., use of default assumptions, scenarios, choice of
models, and information used for quantitative analysis) will be
integrated into an overall characterization and/or analysis of the
impact of the uncertainty and variability on estimated risks. EPA may
describe the uncertainty using a qualitative assessment of the overall
strength and limitations of the data used in the assessment.
(2) Considerations of data quality. A discussion of data quality
(e.g., reliability, relevance, and whether methods employed to generate
the information are reasonable for and consistent with the intended use
of the information), as well as assumptions used, will be included to
the extent necessary. EPA also expects to include a discussion of the
extent of independent verification or peer review of the information or
of the procedures, measures, methods, protocols, methodologies, or
models used in the risk evaluation.
(3) Considerations of alternative interpretations. If appropriate
and relevant, where alternative interpretations are plausible, a
discussion of alternative
[[Page 32]]
interpretations of the data and analyses will be included.
(4) Considerations for environmental risk evaluations. For
environmental risk evaluations, it may be necessary to discuss the
nature and magnitude of the effects, the spatial and temporal patterns
of the effects, implications at the individual, species, population, and
community level, and the likelihood of recovery subsequent to exposure
to the chemical substance.
Sec. 702.45 Peer review.
The EPA Peer Review Handbook (2015), the Office of Management and
Budget Final Information Quality Bulletin for Peer Review (OMB
Bulletin), and other available, relevant and applicable methods
consistent with 15 U.S.C. 2625, will serve as the guidance for peer
review activities. Peer review will be conducted on the risk evaluations
for the chemical substances identified pursuant to 15 U.S.C.
2605(b)(4)(A).
Sec. 702.47 Unreasonable risk determination.
As part of the risk evaluation, EPA will determine whether the
chemical substance presents an unreasonable risk of injury to health or
the environment under each condition of uses within the scope of the
risk evaluation, either in a single decision document or in multiple
decision documents.
Sec. 702.49 Risk evaluation timeframes and actions.
(a) Draft risk evaluation timeframe. EPA will publish a draft risk
evaluation in the Federal Register, open a docket to facilitate receipt
of public comment, and provide no less than a 60-day comment period,
during which time the public may submit comment on EPA's draft risk
evaluation.
(b) Final risk evaluation. (1) EPA will complete a risk evaluation
for the chemical substance under the conditions of use within the scope
of the risk evaluation as soon as practicable, but not later than 3
years after the date on which the Agency initiates the risk evaluation.
(2) The Agency may extend the deadline for a risk evaluation for not
more than 6 months. The total time elapsed between initiation of the
risk evaluation and completion of the risk evaluation may not exceed 3
and one half years.
(3) EPA will publish the final risk evaluation in the Federal
Register.
(c) Final determination of unreasonable risk. Upon determination by
the EPA that a chemical substance under one or more of the conditions of
use within the scope of the risk evaluation presents an unreasonable
risk of injury to health or the environment as described in Sec.
702.47, the Agency will initiate action as required pursuant to 15
U.S.C. 2605(a).
(d) Final determination of no unreasonable risk. A determination by
EPA that the chemical substance, under one or more of the conditions of
use within the scope of the risk evaluation, does not present an
unreasonable risk of injury to health or the environment will be issued
by order and considered to be a final Agency action, effective on the
date of issuance of the order.
Sec. 702.51 Publically available information.
For each risk evaluation, EPA will maintain a public docket at
http://www.regulations.gov to provide public access to the following
information, as applicable for that risk evaluation:
(a) The draft scope, final scope, draft risk evaluation, and final
risk evaluation;
(b) All notices, determinations, findings, consent agreements, and
orders;
(c) Any information required to be provided to the Agency under 15
U.S.C. 2603;
(d) A nontechnical summary of the risk evaluation;
(e) A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation;
(f) The final peer review report, including the response to peer
review and public comments received during peer review; and
(g) Response to public comments received on the draft scope and the
draft risk evaluation.
Effective Date Note: At 89 FR 37052, May 3, 2024, subpart B was
revised and republished, effective July 2, 2024. For the convenience of
the user, the revised text is set forth as follows:
[[Page 33]]
Subpart B_Procedures for Chemical Substance Risk Evaluations
Sec. 702.31 General provisions.
(a) Purpose. This subpart establishes the EPA process for conducting
a risk evaluation to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment as required
under TSCA section 6(b)(4)(B) (15 U.S.C. 2605(b)(4)(B)).
(b) Scope. These regulations establish the general procedures, key
definitions, and timelines EPA will use in a risk evaluation conducted
pursuant to TSCA section 6(b) (15 U.S.C. 2605(b)).
(c) Applicability. The requirements of this part apply to all
chemical substance risk evaluations initiated pursuant to TSCA section
6(b) (15 U.S.C. 2605(b)) beginning June 3, 2024. For risk evaluations
initiated prior to this date, but not yet finalized, EPA will seek to
apply the requirements in this subpart to the extent practicable. These
requirements shall not apply retroactively to risk evaluations already
finalized.
(d) Categories of chemical substances. Consistent with EPA's
authority to take action with respect to categories of chemicals under
15 U.S.C. 2625(c), all references in this part to ``chemical'' or
``chemical substance'' shall also apply to ``a category of chemical
substances.''
Sec. 702.33 Definitions.
All definitions in TSCA apply to this subpart. In addition, the
following definitions apply:
Act means the Toxic Substances Control Act (TSCA), as amended (15
U.S.C. 2601 et seq.).
Aggregate exposure means the combined exposures from a chemical
substance across multiple routes and across multiple pathways.
Conditions of use means the circumstances, as determined by the
Administrator, under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of.
EPA means the U.S. Environmental Protection Agency.
Pathways means the physical course a chemical substance takes from
the source to the organism exposed.
Potentially exposed or susceptible subpopulation means a group of
individuals within the general population identified by EPA who, due to
either greater susceptibility or greater exposure, may be at greater
risk than the general population of adverse health effects from exposure
to a chemical substance or mixture, such as infants, children, pregnant
women, workers, the elderly, or overburdened communities.
Reasonably available information means information that EPA
possesses or can reasonably generate, obtain, and synthesize for use in
risk evaluations, considering the deadlines specified in TSCA section
6(b)(4)(G) for completing such evaluation. Information that meets the
terms of the preceding sentence is reasonably available information
whether or not the information is confidential business information,
that is protected from public disclosure under TSCA section 14.
Routes means the ways a chemical substance enters an organism after
contact, e.g., by ingestion, inhalation, or dermal absorption.
Sentinel exposure means the exposure from a chemical substance that
represents the plausible upper bound of exposure relative to all other
exposures within a broad category of similar or related exposures.
Uncertainty means the imperfect knowledge or lack of precise
knowledge of the real world either for specific values of interest or in
the description of the system.
Variability means the inherent natural variation, diversity, and
heterogeneity across time and/or space or among individuals within a
population.
Sec. 702.35 Chemical substances subject to risk evaluation.
(a) Chemical substances undergoing risk evaluation. A risk
evaluation for a chemical substance designated by EPA as a High-Priority
Substance pursuant to the prioritization process described in subpart A
or initiated at the request of a manufacturer or manufacturers under
Sec. 702.45, will be conducted in accordance with this part, subject to
Sec. 702.31(c).
(b) Percentage requirements. Pursuant to 15 U.S.C. 2605(b)(4)(E)(i)
and in accordance with Sec. 702.45(j)(1), EPA will ensure that the
number of chemical substances for which a manufacturer-requested risk
evaluation is initiated pursuant to Sec. 702.45(e)(9) is not less than
25%and not more than 50% of the number of chemical substances for which
a risk evaluation was initiated upon designation as a High-Priority
Substance under subpart A.
(c) Manufacturer-requested risk evaluations for work plan chemical
substances. Manufacturer requests for risk evaluations, described in
paragraph (a) of this section, for chemical substances that are drawn
from the 2014 update of the TSCA Work Plan for Chemical Assessments will
be granted at the discretion of EPA. Such evaluations are not subject to
the percentage requirements in paragraph (b) of this section.
Sec. 702.37 Evaluation requirements.
(a) Considerations. (1) EPA will use applicable EPA guidance when
conducting risk evaluations, as appropriate and where it represents the
best available science.
[[Page 34]]
(2) EPA will document that the risk evaluation is consistent with
the best available science and based on the weight of the scientific
evidence. In determining best available science, EPA shall consider as
applicable:
(i) The extent to which the scientific information, technical
procedures, measures, methods, protocols, methodologies, or models
employed to generate the information are reasonable for and consistent
with the intended use of the information;
(ii) The extent to which the information is relevant for the
Administrator's use in making a decision about a chemical substance or
mixture;
(iii) The degree of clarity and completeness with which the data,
assumptions, methods, quality assurance, and analyses employed to
generate the information are documented;
(iv) The extent to which the variability and uncertainty in the
information, or in the procedures, measures, methods, protocols,
methodologies, or models, are evaluated and characterized; and
(v) The extent of independent verification or peer review of the
information or of the procedures, measures, methods, protocols,
methodologies or models.
(3) EPA will ensure that all supporting analyses and components of
the risk evaluation are suitable for their intended purpose, and
tailored to the problems and decision at hand, in order to inform the
development of a technically sound determination as to whether a
chemical substance presents an unreasonable risk of injury to health or
the environment under the conditions of use, based on the weight of the
scientific evidence.
(4) EPA will not exclude conditions of use from the scope of the
risk evaluation, but a fit-for-purpose approach may result in varying
types and levels of analysis and supporting information for certain
conditions of use, consistent with paragraph (b) of this section. The
extent to which EPA will refine its evaluations for one or more
condition of use in any risk evaluation will vary as necessary to
determine whether a chemical substance presents an unreasonable risk of
injury to health or the environment.
(5) EPA will evaluate chemical substances that are metals or metal
compounds in accordance with 15 U.S.C. 2605(b)(2)(E).
(b) Information and information sources. (1) EPA will base each risk
evaluation on reasonably available information.
(2) EPA will apply systematic review methods to assess reasonably
available information, as needed to carry out risk evaluations that meet
the requirements in TSCA section 26(h) and (i), in a manner that is
objective, unbiased, and transparent.
(3) EPA may determine that certain information gaps can be addressed
through application of assumptions, uncertainty factors, models, and/or
screening to conduct its analysis with respect to the chemical
substance, consistent with 15 U.S.C. 2625. The approaches used will be
determined by the quality of reasonably available information, the
deadlines specified in TSCA section 6(b)(4)(G) for completing the risk
evaluation, and the extent to which the information reduces uncertainty.
(4) EPA expects to use its authorities under the Act, and other
information gathering authorities, when necessary to obtain the
information needed to perform a risk evaluation for a chemical substance
before initiating the risk evaluation for such substance. EPA will also
use such authorities during the performance of a risk evaluation to
obtain information as needed and on a case-by-case basis to ensure that
EPA has adequate, reasonably available information to perform the
evaluation. Where appropriate, to the extent practicable, and
scientifically justified, EPA will require the development of
information generated without the use of new testing on vertebrates.
(5) Among other sources of information, EPA will also consider
information and advice provided by the Science Advisory Committee on
Chemicals established pursuant to 15 U.S.C. 2625(o).
Sec. 702.39 Components of risk evaluation.
(a) In general. Each risk evaluation will include all of the
following components:
(1) A Scope;
(2) A Hazard Assessment;
(3) An Exposure Assessment;
(4) A Risk Characterization; and
(5) A Risk Determination.
(b) Scope of the risk evaluation. The scope of the risk evaluation
will include all the following:
(1) The condition(s) of use the EPA expects to consider in the risk
evaluation.
(2) The potentially exposed populations, including any potentially
exposed or susceptible subpopulations as identified as relevant to the
risk evaluation by EPA under the conditions of use that EPA plans to
evaluate.
(3) The ecological receptors that EPA plans to evaluate.
(4) The hazards to health and the environment that EPA plans to
evaluate.
(5) A description of the reasonably available information and
scientific approaches EPA plans to use in the risk evaluation.
(6) A conceptual model that describes the actual or predicted
relationships between the chemical substance, its associated conditions
of use through predicted exposure scenarios, and the identified human
and environmental receptors and human and ecological health hazards.
(7) An analysis plan that includes hypotheses and descriptions about
the relationships identified in the conceptual model
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and the approaches and strategies EPA intends to use to assess exposure
and hazard effects, and to characterize risk; and a description,
including quality, of the data, information, methods, and models, that
EPA intends to use in the analysis and how uncertainty and variability
will be characterized.
(8) EPA's plan for peer review consistent with Sec. 702.41.
(c) Hazard assessment. (1) The hazard assessment process includes
the identification, evaluation, and synthesis of information to describe
the potential health and environmental hazards of the chemical substance
under the conditions of use.
(2) Hazard information related to potential health and environmental
hazards of the chemical substance will be reviewed in a manner
consistent with best available science based on the weight of scientific
evidence and all assessment methods will be documented.
(3) Consistent with Sec. 702.37(b), information evaluated may
include, but would not be limited to: Human epidemiological studies, in
vivo and/or in vitro laboratory studies, biomonitoring and/or human
clinical studies, ecological field data, read across, mechanistic and/or
kinetic studies in a variety of test systems. These may include but are
not limited to: toxicokinetics and toxicodynamics (e.g., physiological-
based pharmacokinetic modeling), and computational toxicology (e.g.,
high-throughput assays, genomic response assays, data from structure-
activity relationships, in silico approaches, and other health effects
modeling).
(4) The hazard information relevant to the chemical substance will
be evaluated for identified human and environmental receptors, including
all identified potentially exposed or susceptible subpopulation(s)
determined to be relevant, for the exposure scenarios relating to the
conditions of use.
(5) The relationship between the dose of the chemical substance and
the occurrence of health and environmental effects or outcomes will be
evaluated.
(6) Hazard identification will include an evaluation of the
strengths, limitations, and uncertainties associated with the reasonably
available information.
(d) Exposure assessment. (1) Where relevant, the likely duration,
intensity, frequency, and number of exposures under the conditions of
use will be considered.
(2) Exposure information related to potential human health or
ecological hazards of the chemical substance will be reviewed in a
manner consistent with best available science based on the weight of
scientific evidence and all assessment methods will be documented.
(3) Consistent with Sec. 702.37(b), information evaluated may
include, but would not be limited to: chemical release reports, release
or emission scenarios, data and information collected from monitoring or
reporting, release estimation approaches and assumptions, biological
monitoring data, workplace monitoring data, chemical exposure health
data, industry practices with respect to occupational exposure control
measures, and exposure modeling.
(4) Chemical-specific factors, including, but not limited to
physical-chemical properties and environmental fate and transport
parameters, will be examined.
(5) The human health exposure assessment will consider all
potentially exposed or susceptible subpopulation(s) determined to be
relevant.
(6) Environmental health exposure assessment will characterize and
evaluate the interaction of the chemical substance with the ecological
receptors and the exposures considered, including populations and
communities, depending on the chemical substance and the ecological
characteristic involved.
(7) EPA will describe whether sentinel exposures under the
conditions of use were considered and the basis for their consideration.
(8) EPA will consider aggregate exposures to the chemical substance,
and, when supported by reasonably available information, consistent with
the best available science and based on the weight of scientific
evidence, include an aggregate exposure assessment in the risk
evaluation, or will otherwise explain in the risk evaluation the basis
for not including such an assessment.
(9) EPA will assess all exposure routes and pathways relevant to the
chemical substance under the conditions of use, including those that are
regulated under other federal statutes.
(e) Risk characterization. (1) Requirements. To characterize the
risks from the chemical substance, EPA will:
(i) Integrate the hazard and exposure assessments into quantitative
and/or qualitative estimates relevant to specific risks of injury to
health or the environment, including any potentially exposed or
susceptible subpopulations identified, under the conditions of use;
(ii) Not consider costs or other non-risk factors; and
(iii) Describe the weight of the scientific evidence for the
identified hazards and exposures.
(2) Summary of considerations. EPA will summarize, as applicable,
the considerations addressed throughout the evaluation components, in
carrying out the obligations under 15 U.S.C. 2625(h). This summary will
include, as appropriate, a discussion of:
(i) Considerations regarding uncertainty and variability.
Information about uncertainty and variability in each step of the risk
evaluation (e.g., use of default assumptions, scenarios, choice of
models, and information
[[Page 36]]
used for quantitative analysis) will be integrated into an overall
characterization and/or analysis of the impact of the uncertainty and
variability on estimated risks. EPA may describe the uncertainty using a
qualitative assessment of the overall strength and limitations of the
data and approaches used in the assessment.
(ii) Considerations of data quality. A discussion of data quality
(e.g., reliability, relevance, and whether methods employed to generate
the information are reasonable for and consistent with the intended use
of the information), as well as assumptions used, will be included to
the extent necessary. EPA also expects to include a discussion of the
extent of independent verification or peer review of the information or
of the procedures, measures, methods, protocols, methodologies, or
models used in the risk evaluation.
(iii) Considerations of alternative interpretations. If appropriate
and relevant, where alternative interpretations are plausible, a
discussion of alternative interpretations of the data and analyses will
be included.
(iv) Additional considerations for environmental risk. For
evaluation of environmental risk, it may be necessary to discuss the
nature and magnitude of the effects, the spatial and temporal patterns
of the effects, implications at the individual, species, population, and
community level, and the likelihood of recovery subsequent to exposure
to the chemical substance.
(f) Risk determination. (1) As part of the risk evaluation, EPA will
make a single determination as to whether the chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation,
under the conditions of use.
(2) In determining whether unreasonable risk is presented, EPA's
consideration of occupational exposure scenarios will take into account
reasonably available information, including known and reasonably
foreseen circumstances where subpopulations of workers are exposed due
to the absence or ineffective use of personal protective equipment. EPA
will not consider exposure reduction based on assumed use of personal
protective equipment as part of the risk determination.
(3) EPA will determine whether a chemical substance does or does not
present an unreasonable risk after considering the risks posed under the
conditions of use and, where EPA makes a determination of unreasonable
risk, EPA will identify the conditions of use that significantly
contribute to such determination.
Sec. 702.41 Peer review.
EPA will conduct peer review activities on risk evaluations
conducted pursuant to 15 U.S.C. 2605(b)(4)(A). EPA expects such
activities, including decisions regarding the appropriate scope and type
of peer review, to be consistent with the applicable peer review
policies, procedures, and methods in guidance promulgated by the Office
of Management and Budget and EPA, and in accordance with 15 U.S.C.
2625(h) and (i).
Sec. 702.43 Risk evaluation actions and timeframes.
(a) Draft scope. (1) For each risk evaluation to be conducted, EPA
will publish a document that specifies the draft scope of the risk
evaluation EPA plans to conduct and publish a notice of availability in
the Federal Register. The document will address the elements in Sec.
702.39(b).
(2) EPA generally expects to publish the draft scope during the
prioritization process concurrent with publication of a proposed
designation as a High-Priority Substance pursuant to Sec. 702.9(g), but
no later than 3 months after the initiation of the risk evaluation
process for the chemical substance.
(3) EPA will allow a public comment period of no less than 45
calendar days during which interested persons may submit comment on
EPA's draft scope. EPA will open a docket to facilitate receipt of
public comments.
(b) Final scope. (1) EPA will, no later than 6 months after the
initiation of a risk evaluation, publish a document that specifies the
final scope of the risk evaluation EPA plans to conduct, and publish a
notice of availability in the Federal Register. The document shall
address the elements in Sec. 702.39(b).
(2) For a chemical substance designated as a High-Priority Substance
under subpart A of this part, EPA will not publish the final scope of
the risk evaluation until at least 12 months have elapsed from the
initiation of the prioritization process for the chemical substance.
(c) Draft risk evaluation. EPA will publish a draft risk evaluation,
publish a notice of availability in the Federal Register, open a docket
to facilitate receipt of public comment, and provide no less than a 60-
day comment period, during which time the public may submit comment on
EPA's draft risk evaluation. The document shall include the elements in
Sec. 702.39(c) through (f).
(d) Final risk evaluation. (1) EPA will complete and publish a final
risk evaluation for the chemical substance under the conditions of use
as soon as practicable, but not later than 3 years after the date on
which EPA initiates the risk evaluation. The document shall include the
elements in Sec. 702.39(c) through (f) and EPA will publish a notice of
availability in the Federal Register.
(2) EPA may extend the deadline for a risk evaluation for not more
than 6 months. The total time elapsed between initiation of the risk
evaluation and completion of the risk
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evaluation may not exceed 3- and one-half years.
(e) Final determination of unreasonable risk. Upon determination by
the EPA pursuant to Sec. 702.39(f) that a chemical substance presents
an unreasonable risk of injury to health or the environment, EPA will
initiate action as required pursuant to 15 U.S.C. 2605(a).
(f) Final determination of no unreasonable risk. A determination by
the EPA pursuant to Sec. 702.39(f) that the chemical substance does not
present an unreasonable risk of injury to health or the environment will
be issued by order and considered to be a final Agency action, effective
on the date of issuance of the order.
(g) Substantive revisions to scope documents and risk evaluations.
The circumstances under which EPA will undertake substantive revisions
to scope and risk evaluation documents are as follows:
(1) Draft documents. To the extent there are changes to a draft
scope or draft risk evaluation, EPA will describe such changes in the
final document.
(2) Final scope. To the extent there are changes to the scope of the
risk evaluation after publication of the final scope document, EPA will
describe such changes in the draft risk evaluation, or, where
appropriate and prior to the issuance of a draft risk evaluation, may
make relevant information publicly available in the docket and publish a
notice of availability of that information in the Federal Register.
(3) Final risk evaluation. For any chemical substance for which EPA
has already finalized a risk evaluation, EPA will generally not revise,
supplement, or reissue a final risk evaluation without first undergoing
the procedures at Sec. 702.7 to re-initiate the prioritization process
for that chemical substance, except where EPA has determined it to be in
the interest of protecting human health or the environment to do so,
considering the statutory responsibilities and deadlines under 15 U.S.C.
2605.
(4) Process for revisions to final risk evaluations. Where EPA
determines to revise or supplement a final risk evaluation pursuant to
paragraph (g)(3) of this section, EPA will follow the same procedures in
this section including publication of a new draft and final risk
evaluation and solicitation of public comment in accordance with
Sec. Sec. 702.43(c) and (d), and peer review, as appropriate, in
accordance with Sec. 702.41.
Sec. 702.45 Submission of manufacturer requests for risk evaluations.
(a) General provisions. (1) One or more manufacturers of a chemical
substance may request that EPA conduct a risk evaluation on a chemical
substance.
(2) Such requests must comply with all the requirements, procedures,
and criteria in this section.
(3) Subject to limited exceptions in paragraph (e)(7)(iii) of this
section, it is the burden of the requesting manufacturer(s) to provide
EPA with the information necessary to carry out the risk evaluation.
(4) In determining whether there is sufficient information to
support a manufacturer-requested risk evaluation, EPA expects to apply
the same standard as it would for EPA-initiated risk evaluations,
including but not limited to the considerations and requirements in
Sec. 702.37.
(5) EPA may identify data needs at any time during the process
described in this section, and, by submitting a request for risk
evaluation under this section, the requesting manufacturer(s) agrees to
provide, or develop and provide, EPA with information EPA deems
necessary to carry out the risk evaluation, consistent with the
provisions described in this subpart.
(6) EPA will not expedite or otherwise provide special treatment to
a manufacturer-requested risk evaluation pursuant to 15 U.S.C.
2605(b)(4)(E)(ii).
(7) Once initiated in accordance with paragraph (e)(9) of this
section, EPA will conduct manufacturer-requested risk evaluations
following the procedures in Sec. Sec. 702.37 through 702.43 and
Sec. Sec. 702.47 through 702.49 of this subpart.
(8) For purposes of this section, information that is ``known to or
reasonably ascertainable by'' the requesting manufacturer(s) would
include all information in the requesting manufacturer's possession or
control, plus all information that a reasonable person similarly
situated might be expected to possess, control, or know. Meeting this
standard requires an exercise and documentation of due diligence that
may vary depending on the circumstances and parties involved. At a
minimum, due diligence requires:
(i) A thorough search and collection of publicly available
information;
(ii) A reasonable inquiry within the requesting manufacturer's
entire organization; and
(iii) A reasonably inquiry outside of the requesting manufacturer's
organization, including inquiries to upstream suppliers; downstream
users; and employees or other agents of the manufacturer, including
persons involved in research and development, import or production, or
marketing.
(9) In the event that a group of manufacturers of a chemical
substance submit a request for risk evaluation under this section, the
term ``requesting manufacturer'' in paragraphs (a), (c), and (i) of this
section shall apply to all manufacturers in the group. EPA will
otherwise coordinate with the primary contact named in the request for
purposes of communication, payment of fees, and other actions as needed.
(b) Method for submission. All manufacturer-requested risk
evaluations under this
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subpart must be submitted via the EPA Central Data Exchange (CDX) found
at https://cdx.epa.gov.
(c) Content of request. Requests must include all of the following
information:
(1) Name, mailing address, and contact information of the entity (or
entities) submitting the request. If more than one manufacturer submits
the request, all individual manufacturers must provide their contact
information.
(2) The chemical identity of the chemical substance that is the
subject of the request. At a minimum, this includes: all known names of
the chemical substance, including common or trades names, CAS number,
and molecular structure of the chemical substance.
(3) For requests pertaining to a category of chemical substances, an
explanation of why the category is appropriate under 15 U.S.C. 2625(c).
EPA will determine whether the category is appropriate for risk
evaluation as part of reviewing the request in paragraph (e) of this
section.
(4) A description of the circumstances under which the chemical
substance is intended, known, or reasonably foreseen to be manufactured,
processed, distributed in commerce, used, or disposed of, and all
information known to or reasonably ascertainable by the requesting
manufacturer that supports the identification of the circumstances
described in this paragraph (c)(4).
(5) All information known to or reasonably ascertainable by the
requesting manufacturer(s) on the health and environmental hazard(s) of
the chemical substance, human and environmental exposure(s), and exposed
population(s), including but not limited to:
(i) The chemical substance's exposure potential, including
occupational, general population and consumer exposures, and facility
release information;
(ii) The chemical substance's hazard potential, including all
potential environmental and human health hazards;
(iii) The chemical substance's physical and chemical properties;
(iv) The chemical substance's fate and transport properties
including persistence and bioaccumulation;
(v) Industrial and commercial locations where the chemical is used
or stored;
(vi) Whether there is any storage of the chemical substance near
significant sources of drinking water, including the storage facility
location and the nearby drinking water source(s);
(vii) Consumer products containing the chemical;
(viii) The chemical substance's production volume or significant
changes in production volume; and
(ix) Any other information relevant to the hazards, exposures and/or
risks of the chemical substance.
(6) Where information described in paragraph (c)(4) or (5) of this
section is unavailable, an explanation as to why, and the rationale for
why, in the requester's view, the provided information is nonetheless
sufficient to allow EPA to complete a risk evaluation on the chemical
substance.
(7) Copies of all information referenced in paragraph (c)(5) of this
section, or citations if the information is readily available from
public sources.
(8) A signed certification from the requesting manufacturer(s) that
all information contained in the request is accurate and complete, as
follows:
I certify that to the best of my knowledge and belief:
(A) The company named in this request manufactures the chemical
substance identified for risk evaluation.
(B) All information provided in the request is complete and accurate
as of the date of the request.
(C) I have either identified or am submitting all information in my
possession and control, and a description of all other data known to or
reasonably ascertainable by me as required under this part. I am aware
it is unlawful to knowingly submit incomplete, false and/or misleading
information in this request and there are significant criminal penalties
for such unlawful conduct, including the possibility of fine and
imprisonment.
(9) Where appropriate, information that will inform EPA's
determination as to whether restrictions imposed by one or more States
have the potential to have a significant impact on interstate commerce
or health or the environment, and that as a consequence the request is
entitled to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii).
(d) Confidential business information. Persons submitting a request
under this subpart are subject to EPA confidentiality regulations at 40
CFR part 2, subpart B, and 40 CFR part 703.
(e) EPA process for reviewing requests. (1) Public notification of
receipt of request. Within 15 days of receipt of a manufacturer-
requested risk evaluation, EPA will notify the public that such request
has been received.
(2) Initial review for completeness. EPA will determine whether the
request appears to meet the requirements specified in this section
(i.e., complete), or whether the request appears to not have met the
requirements specified in this section (i.e., incomplete). EPA will
notify the requesting manufacturer of the outcome of this initial
review. For requests initially determined to be incomplete, EPA will
cease review, pending actions taken by the requesting manufacturer
pursuant to paragraph (f) of this section. For requests initially
determined to be complete, EPA will proceed to the public notice and
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comment process described in paragraph (e)(3) of this section.
(3) Public notice and comment. No later than 90 days after initially
determining a request to be complete pursuant to paragraph (e)(2) of
this section, EPA will submit for publication the receipt of the request
in the Federal Register, open a docket for that request and provide no
less than a 60-day public comment period. The docket will contain the
CBI sanitized copies of the request and all supporting information. The
notice will encourage the public to submit comments and information
relevant to the manufacturer-requested risk evaluation, including, but
not limited to, identifying information not provided in the request,
information the commenter believes necessary to conduct a risk
evaluation, and any other information relevant to the conditions of use.
(4) Secondary review for sufficiency. Within 90 days following the
end of the comment period in paragraph (e)(3) of this section, EPA will
further consider whether public comments highlight deficiencies in the
request not identified during EPA's initial review, and/or that the
available information is not sufficient to support a reasoned
evaluation. EPA will notify the requesting manufacturer of the outcome
of this review. For requests determined to not be supported by
sufficient information, EPA will cease review, pending actions taken
pursuant to paragraph (f) of this section. For requests determined to be
supported by sufficient information, EPA will proceed with request
review process in accordance with paragraph (e)(5) of this section.
(5) Grant. Where EPA determines a request to be complete and
sufficiently supported in accordance with paragraphs (e)(2) and (4) of
this section, and subject to the percentage limitations in TSCA section
6(b)(4)(E)(i)(II), EPA will grant the request. A grant does not mean
that EPA has all information necessary to complete the risk evaluation.
(6) Publication of draft conditions of use and request for
information. EPA will publish a notice in the Federal Register that
identifies draft conditions of use, requests relevant information from
the public, and provides no less than a 60-day public comment period.
Within 90 days following the close of the public comment period in this
paragraph, EPA will determine whether further information is needed to
carry out the risk evaluation and notify the requesting manufacturer of
its determination, pursuant to paragraph (e)(7) of this section. If EPA
determines at this time that no further information is necessary, EPA
will initiate the risk evaluation, pursuant to paragraph (e)(9) of this
section.
(7) Identification of information needs. Where additional
information needs are identified, EPA will notify the requesting
manufacturer and set a reasonable amount of time, as determined by EPA,
for response. In response to EPA's notice, and subject to the
limitations in paragraph (g) of this section, the requesting
manufacturer may:
(i) Provide the necessary information. EPA will set a reasonable
amount of time, as determined by EPA, for the requesting manufacturer to
produce or develop and produce the information. Upon receipt of the new
information, EPA will review for sufficiency and make publicly available
to the extent possible, including CBI-sanitized copies of that
information; or
(ii) Withdraw the risk evaluation request. Fees to be collected or
refunded shall be determined pursuant to paragraph (k) of this section
and 40 CFR 700.45; or
(iii) Request that EPA obtain the information using authorities
under TSCA sections 4, 8 or 11. The requesting manufacturer must provide
a rationale as to why the information is not reasonably ascertainable to
them. EPA will review and provide notice of its determination to the
requesting manufacturer. Upon receipt of the information, EPA will
review the additional information for sufficiency and provide additional
public notice.
(8) Unfulfilled information needs. In circumstances where there have
been additional data needs identified pursuant to paragraph (e)(7) of
this section that are not fulfilled, because the requesting manufacturer
is unable or unwilling to fulfill those needs in a timely manner, the
requesting manufacture has produced information that is insufficient as
determined by EPA, or EPA determines that a request to use TSCA
authorities under section 4, 8 or 11 is not warranted, EPA may deem the
request to be constructively withdrawn under paragraph (e)(7)(ii) of
this section.
(9) Initiation of the risk evaluation. Within 90 days of the end of
the comment period provided in paragraph (e)(6) of this section, or
within 90 days of EPA determining that information identified and
received pursuant to paragraph (e)(7) of this section is sufficient, EPA
will initiate the requested risk evaluation and follow all requirements
in this subpart, including but not limited to Sec. Sec. 702.37 through
702.43 and Sec. Sec. 702.47 through 702.49 of this subpart, and notify
the requesting manufacturer and the public. Initiation of the risk
evaluation does not limit or prohibit the Agency from identifying
additional data needs during the risk evaluation process.
(f) Incomplete or insufficient request. Where EPA has determined
that a request is incomplete or insufficient pursuant to paragraph
(e)(2) or (4) of this section, the requesting manufacturer may
supplement and resubmit the request. EPA will follow the process
described in paragraph (e) of this section as it would for a new
request.
(g) Withdrawal of request. The requesting manufacturer may withdraw
a request at
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any time prior to EPA's grant of such request pursuant to paragraph
(e)(5) of this section, or in accordance with paragraph (e)(7) of this
section and subject to payment of applicable fees. The requesting
manufacturer may not withdraw a request once EPA has initiated the risk
evaluation. EPA may deem a request constructively withdrawn in the event
of unfulfilled information needs pursuant to paragraph (e)(8) of this
section or non-payment of fees as required in 40 CFR 700.45. EPA will
notify the requesting manufacturer and the public of the withdrawn
request.
(h) Data needs identified post-initiation. Where EPA identifies
additional data needs after the risk evaluation has been initiated, the
requesting manufacturer may remedy the deficiency pursuant to paragraph
(e)(7)(i) or (iii) of this section.
(i) Supplementation of original request. At any time prior to the
end of the comment period described in paragraph (e)(6) of this section,
the requesting manufacturer(s) may supplement the original request with
any new information that becomes available to the requesting
manufacturer(s). At any point prior to the completion of a manufacturer-
requested risk evaluation pursuant to this section, the requesting
manufacturer(s) must supplement the original request with any
information that meets the criteria in 15 U.S.C. 2607(e) and this
section, or with any other reasonably ascertainable information that has
the potential to change EPA's risk evaluation. Such information must be
submitted consistent with 15 U.S.C. 2607(e) if the information is
subject to that section or otherwise within 30 days of when the
requesting manufacturer(s) obtain the information.
(j) Limitations on manufacturer-requested risk evaluations. (1) In
general. EPA will initiate a risk evaluation for all requests from
manufacturers for non-TSCA Work Plan Chemicals that meet the criteria in
this subpart, until EPA determines that the number of manufacturer-
requested chemical substances undergoing risk evaluation is equal to 25%
of the High-Priority Substances identified in subpart A as undergoing
risk evaluation. Once that level has been reached, EPA will initiate at
least one new manufacturer-requested risk evaluation for each
manufacturer-requested risk evaluation completed so long as there are
sufficient requests that meet the criteria of this subpart, as needed to
ensure that the number of manufacturer-requested risk evaluations is
equal to at least 25% of the High-Priority substances risk evaluations
and not more than 50%.
(2) Preferences. In conformance with Sec. 702.35(c), in evaluating
requests for TSCA Work Plan Chemicals and requests for non-TSCA Work
Plan chemicals, EPA will give preference to requests for risk
evaluations on chemical substances:
(i) First, for which EPA determines that restrictions imposed by one
or more States have the potential to have a significant impact on
interstate commerce, health or the environment; and then
(ii) Second, based on the order in which the requests are received.
(k) Fees. Manufacturers must pay fees to support risk evaluations as
specified under 15 U.S.C. 2605(b)(4)(E)(ii), and in accordance with 15
U.S.C. 2625(b) and 40 CFR 700.45. In the event that a request for a risk
evaluation is withdrawn by the requesting manufacturer pursuant to
paragraph (g) of this section, the total fee amount due will be either,
in accordance with 40 CFR 700.45(c)(2)(x) or (xi) (as adjusted by 40 CFR
700.45(d) when applicable), 50% or 100% of the actual costs expended in
carrying out the risk evaluation as of the date of receipt of the
withdrawal notice. The payment amount will be determined by EPA, and
invoice or refund issued to the requesting manufacturer as appropriate.
Sec. 702.47 Interagency collaboration.
During the risk evaluation process, not to preclude any additional,
prior, or subsequent collaboration, EPA will consult with other relevant
Federal agencies.
Sec. 702.49 Publicly available information.
For each risk evaluation, EPA will maintain a public docket at
https://www.regulations.gov to provide public access to the following
information, as applicable for that risk evaluation:
(a) The draft scope, final scope, draft risk evaluation, and final
risk evaluation;
(b) All notices, determinations, findings, consent agreements, and
orders;
(c) Any information required to be provided to EPA under 15 U.S.C.
2603;
(d) A nontechnical summary of the risk evaluation;
(e) A list of the studies, with the results of the studies,
considered in carrying out each risk evaluation;
(f) Any final peer review report, including the response to peer
review and public comments received during peer review;
(g) Response to public comments received on the draft scope and the
draft risk evaluation; and
(h) Where unreasonable risk to workers is identified via inhalation,
EPA's calculation of a risk-based occupational exposure value.
Subpart C_Citizen Suit
Sec. 702.60 Purpose.
Section 20 of the Toxic Substances Control Act (TSCA) authorizes any
person to begin a civil action to compel performance by the
Environmental
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Protection Agency (EPA) of TSCA non-discretionary acts or duties
(section 20(a)(2)) or to restrain any violation of TSCA, or of any rule
promulgated under sections 4, 5, or 6, or of any order issued under
section 5 of TSCA (section 20(a)(1)). The purpose of this regulation is
to prescribe procedures governing the giving of a notice of intent to
file suit required by section 20(b) of TSCA as a prerequisite to
beginning such civil actions.
Sec. 702.61 Service of notice.
(a) Notice as a prerequisite to suit. Under section 20 of TSCA, no
civil action may be commenced by a citizen to restrain a violation of
TSCA, or a rule or order thereunder, unless at least 60 days in advance
the citizen has given notice of the intent to file suit to the
Administrator and to the person who is alleged to have committed the
violation. No civil action may be commenced by a citizen to compel the
Administrator to perform any non-discretionary act or duty under TSCA,
unless at least 60 days in advance the citizen has given notice of the
intent to file suit to the Administrator. However, in the case of an
alleged failure by the Administrator to file an action under section 7
of TSCA, the citizen must give notice to the Administrator only 10 days
in advance of filing the civil action.
(b) Method of service. Notice of intent to file suit can be either
personally served or served by certified mail--return receipt
requested--to persons identified in paragraph (d) of this section.
(c) Date of service. The effective date of service of a notice given
in accordance with this rule shall be the date of the return receipt, if
served by mail, or the date of receipt if personally served.
(d) Persons to be served--(1) Violations of TSCA rules or TSCA
order. (i) If the alleged violator is a private individual or a
corporation, notice of intent to file suit shall be served on the
individual or the owner or managing agent of the plant, facility, or
activity alleged to be in violation. If the alleged violator is a
corporation, a copy of the notice shall also be sent to the registered
agent, if any, of such corporation in the State in which such violation
is alleged to have occurred. Notice shall also be served on the
Administrator of the EPA.
(ii) If the alleged violator is a State or local government entity,
notice of intent to file suit shall be served on the head of the agency.
Notice shall also be served on the Administrator of the EPA, and a copy
shall be sent to the Attorney General of the United States.
(iii) If the alleged violator is a Federal agency, notice of intent
to file suit shall be served on the head of the agency. Notice shall
also be served on the Administrator of the EPA, and a copy shall be sent
to the Attorney General of the United States.
(2) Performance of non-discretionary TSCA acts or duties. Notice of
intent to file suit shall be served on the Administrator of the EPA and
a copy shall be sent to the Attorney General of the United States.
(3) Address of persons to be served. (i) EPA Administrator: 1200
Pennsylvania Ave., NW., Washington, DC 20460. (ii) Attorney General of
the United States: 10th and Constitution Avenue, NW., Washington, DC
20530.
Sec. 702.62 Contents of notice.
(a) Violation of TSCA rule or TSCA order. Notice of intent to file
suit regarding an alleged violation of TSCA or any rule promulgated
under sections 4, 5, or 6, or an order issued under section 5, shall
include sufficient information to permit the recipient to identify:
(1) The specific provision of TSCA or of the rule or order under
TSCA alleged to have been violated.
(2) The activity alleged to constitute a violation.
(3) The person or persons responsible for the alleged violation.
(4) The location of the alleged violation.
(5) The date or dates of the alleged violation as closely as the
citizen is able to specify them.
(6) The full name, address, and telephone number of the citizen
giving notice.
(b) Failure to act. Notice regarding an alleged failure of the
Administrator to perform any act or duty which is not discretionary
shall:
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(1) Identify the specific provision of TSCA which requires an act or
creates a duty.
(2) Describe with reasonable specificity the action taken or not
taken by the Administrator which is alleged to constitute a failure to
perform the act or duty.
(3) State the full name, address, and telephone number of the
citizen giving the notice.
(c) Identification of Counsel. The notice shall state the name,
address, and telephone number of the Legal Counsel, if any, representing
the citizen giving the notice.
PART 703_CONFIDENTIALITY CLAIMS--Table of Contents
Sec.
703.1 Purpose and applicability.
703.3 Definitions.
703.5 Requirements for asserting and maintaining confidentiality claims.
703.7 EPA review of confidentiality claims under TSCA section 14(g).
703.8 EPA review of confidentiality claims under TSCA section 14(f).
Authority: 15 U.S.C. 2613.
Source: 88 FR 37166, June 7, 2023, unless otherwise noted.
Sec. 703.1 Purpose and applicability.
(a) The purpose of this part is to describe procedures for asserting
and maintaining confidentiality claims in accordance with TSCA section
14, and for EPA review of such claims. The procedures described in this
part are generally applicable to the submission and EPA review of any
TSCA submission, except to the extent that application of the
requirements would be inconsistent with TSCA section 14(i). The
procedures include requirements concerning the form and manner in which
TSCA submissions must be made to meet requirements in TSCA sections
14(b) and (c), to facilitate EPA review of such claims in accordance
with TSCA sections 14(f) and (g), and to facilitate disclosure of non-
confidential information to the public in accordance with TSCA, FOIA,
and their implementing regulations.
(b) This part applies to all information that is reported to or
otherwise obtained by EPA pursuant to TSCA or its implementing
regulations. This includes information that was first obtained by EPA
other than pursuant to the authority of TSCA or its implementing
regulations, provided that the following two criteria have been met:
(1) EPA has authority to collect the information under TSCA; and
(2) Either:
(i) Subsequent to its submission the information is being used to
satisfy the obligation of a person under TSCA or its implementing
regulations; or
(ii) EPA makes use of the information in the course of carrying out
its responsibilities under TSCA (e.g., EPA considered such information
in its actions under TSCA sections 4, 5, or 6).
(c)(1) This part applies regardless of the following:
(i) Whether the information is intended by its submitter to be used
by EPA in implementing TSCA;
(ii) Whether TSCA or an implementing regulation was cited as
authority for the request or submission of the information; or
(iii) Whether the information was provided directly to EPA or
through some third person.
(2) However, where such information is not protected from disclosure
under TSCA Section 14, but the statute under which the information was
originally provided to EPA limits disclosure for reasons other than
business confidentiality (for example, limited disclosure of pesticide
data to multinational pesticide producers under 7 U.S.C. 136h(g)), the
disclosure limitation in the statute under which the information was
obtained by EPA continues to apply, except where TSCA expressly requires
disclosure of that information.
(d) The provisions of 40 CFR part 2, subpart B, apply to this
section, as modified by 40 CFR 2.306.
Sec. 703.3 Definitions.
The definitions in this section and the definitions in TSCA section
3 apply to this part. In addition, the definition in Sec. 720.3(ff) of
this subchapter for test data also applies in this part.
Accept in the context of asserting a TSCA CBI claim means EPA's
first approval of the submission containing the CBI claim in CISS, or
its successor system.
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Act, or TSCA, means the Toxic Substances Control Act, 15 U.S.C. 2601
et seq.
CDX or Central Data Exchange means EPA's centralized electronic
document receiving system, or its successor system.
CISS or Chemical Information Submission System means EPA's web-based
reporting tool for preparing and submitting TSCA submissions, or its
successor system.
Confidentiality claim means a claim or allegation that business
information is entitled to confidential treatment.
FOIA means the Freedom of Information Act, 5 U.S.C. 552, et seq.
Health and safety study has the same meaning as that provided in
Sec. 720.3(k) of this subchapter, except that for purposes of this part
703 the following information is not part of a health and safety study:
(1) The name, address, or other identifying information for the
submitting company, including identification of the laboratory that
conducted the study in cases where the laboratory is part of or closely
affiliated with the submitting company.
(2) Internal product codes (i.e., code names for the test substance
used internally by the submitting company or to identify the test
substance to the test laboratory).
(3) Names and contact details for testing laboratory personnel and
names and other private information for health and safety study
participants or persons involved in chemical incidents such as would
typically be withheld under 5 U.S.C. 552(b)(6) or under other privacy
laws.
(4) Information pertaining to test substance product development,
advertising, or marketing plans, or to cost and other financial data.
Sec. 703.5 Requirements for asserting and maintaining confidentiality claims.
Any person who submits information under TSCA or these implementing
regulations may assert a business confidentiality claim to information
included in such submission except where such a claim is disallowed by
applicable regulation under this subchapter. Such claim must be made
concurrent with submission of the information. If no such claim
accompanies the submission, EPA will not recognize a confidentiality
claim, and the information in or referred to in that submission may be
made available to the public (e.g., by publication of specific chemical
name and CASRN on the public portion of the TSCA Inventory) without
further notice.
(a) Supporting statement and certification. (1) A person asserting a
confidentiality claim must submit a statement that the person has:
(i) Taken reasonable measures to protect the confidentiality of the
information;
(ii) Determined that the information is not required to be disclosed
or otherwise made available to the public under any other Federal law;
(iii) A reasonable basis to conclude that disclosure of the
information is likely to cause substantial harm to the competitive
position of the person; and
(iv) A reasonable basis to believe that the information is not
readily discoverable through reverse engineering.
(2) The person must also certify that these four statements and any
information required to substantiate the confidentiality claim in
accordance with paragraph (b) of this section are true and correct.
(b) Substantiation. (1) Confidentiality claims must be substantiated
at the time of submission to EPA, unless exempt under paragraph (b)(5)
of this section. In the case of information collected by EPA or on
behalf of EPA in person at the site of a TSCA inspection under section
11 of the Act, the affected company must assert its confidentiality
claim(s) in writing at the time the information is collected, and then
must provide substantiation of its confidentiality claims and the
supporting statement and certification described in paragraph (a) of
this section within ten business days after the inspection ends.
Confidentiality claims lacking required substantiation after ten
business days will be treated as deficient under paragraph (e) of this
section. Unless otherwise directed by EPA, such information or materials
must be submitted via CDX. In the case of an unusually voluminous
document collection under section 11 of the Act,
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the affected company may request additional time to assert claims and
provide substantiation, which EPA may grant at its discretion. The
inspection is considered to have ended when the inspector physically
exits the regulated facility on the last day of the inspection.
(2) Information in substantiations may be claimed as confidential.
Such claims must be accompanied by the certification described in
paragraph (a) of this section but need not be themselves separately
substantiated.
(3) Substantiation questions for all claims. Unless otherwise
specified elsewhere in this subchapter (e.g., 40 CFR part 711), answers
to the following questions must be provided for each confidentiality
claim in a TSCA submission:
(i) Please specifically explain what harm to the competitive
position of your business would be likely to result from the release of
the information claimed as confidential. How would that harm be
substantial? Why is the substantial harm to your competitive position
likely (i.e., probable) to be caused by release of the information
rather than just possible? If you claimed multiple types of information
to be confidential (e.g., site information, exposure information,
environmental release information, etc.), explain how disclosure of each
type of information would be likely to cause substantial harm to the
competitive position of your business.
(ii) Has your business taken precautions to protect the
confidentiality of the disclosed information? If yes, please explain and
identify the specific measures, including but not limited to internal
controls, that your business has taken to protect the information
claimed as confidential. If the same or similar information was
previously reported to EPA as non-confidential (such as in an earlier
version of this submission), please explain the circumstances of that
prior submission and reasons for believing the information is
nonetheless still confidential.
(iii)(A) Is any of the information claimed as confidential required
to be publicly disclosed under any other Federal law? If yes, please
explain.
(B) Does any of the information claimed as confidential otherwise
appear in any public documents, including (but not limited to) safety
data sheets; advertising or promotional material; professional or trade
publications; State, local, or Federal agency files; or any other media
or publications available to the general public? If yes, please explain
why the information should be treated as confidential. If this chemical
is patented and the patent reveals the information you are claiming
confidential, please explain your reasons for believing the information
is nonetheless still confidential.
(iv) Is the claim of confidentiality intended to last less than 10
years (see TSCA section 14(e)(1)(B))? If yes, please indicate the number
of years (between 1 and 10 years) or the specific date after which the
claim is withdrawn.
(v) Has EPA, another Federal agency, or court made any
confidentiality determination regarding information associated with this
chemical substance? If yes, please provide the circumstances associated
with the prior determination, whether or not the information was found
to be entitled to confidential treatment, the entity that made the
decision, and the date of the determination.
(4) Additional substantiation questions for chemical identity-
related claims only. Unless otherwise specified in the relevant
electronic reporting form, answers to the following questions must be
provided for each chemical identity-related confidentiality claim in a
TSCA submission:
(i) Is this chemical substance publicly known (including by your
competitors) to be in U.S. commerce? If yes, please explain why the
specific chemical identity should still be afforded confidential status
(e.g., the chemical substance is publicly known only as being
distributed in commerce for research and development purposes, but no
other information about the current commercial distribution of the
chemical substance in the United States is publicly available). If no,
please complete the certification statement:
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I certify that on the date referenced I searched the internet for
the chemical substance identity (i.e., by both chemical substance name
and CASRN). I did not find a reference to this chemical substance and
have no knowledge of public information that would indicate that the
chemical is being manufactured or imported by anyone for a commercial
purpose in the United States. [provide date].
(ii) Does this specific chemical substance leave the site of
manufacture (including import) in any form, e.g., as a product,
effluent, emission? If yes, please explain what measures have been taken
to guard against the discovery of its identity.
(iii) If the chemical substance leaves the site in a form that is
available to the public or your competitors, can the chemical identity
be readily discovered by analysis of the substance (e.g., product,
effluent, emission), in light of existing technologies and any costs,
difficulties, or limitations associated with such technologies? Please
explain why or why not.
(iv) Would disclosure of the specific chemical identity release
confidential process information? If yes, please explain.
(5) Information described in paragraphs (b)(5)(i) and (ii) of this
section is exempt from the requirement to substantiate the claim at the
time of submission. EPA may identify on a reporting form certain
information as exempt from substantiation. Additional assertions of
exemption from substantiation may be asserted by the submitter. Each
such assertion must include a detailed explanation for why the
information falls within the claimed exemption. If the explanation is
missing or inadequate, and the claim is not otherwise substantiated, EPA
will place a hold on the submission, as described in paragraph (e) of
this section.
(i) The following information types are exempt from the
substantiation requirement at the time of information submission:
(A) Specific information describing the processes used in
manufacture or processing of a chemical substance, mixture, or article;
(B) Marketing and sales information;
(C) Information identifying a supplier or customer;
(D) Details of the full composition of a mixture and the respective
percentages of constituents;
(E) Specific information regarding the use, function, or application
of a chemical substance or mixture in a process, mixture, or article;
and
(F) Specific production or import volumes.
(ii) Exemption for chemical substances not yet offered for
commercial distribution.
(A) A confidentiality claim for specific identity of a chemical
substance, where the submission is made prior to the date on which the
chemical substance whose identity is claimed as confidential is first
offered for commercial distribution, is exempt from the requirement to
substantiate confidentiality claims at the time of submission.
(B) A specific chemical identity claim includes specific chemical
names, CAS numbers, molecular formulas, reactants (if required to be
reported as part of the identification of the chemical, such as for
Class 2 substances in Sec. 720.45(a) of this subchapter), and
structural diagrams; or in the case of microorganisms, genus and species
name and genetic construct.
(C) This exemption applies where the submitter lacks information to
reasonably conclude that the chemical substance has been offered for
commercial distribution, where both:
(1) The chemical substance is not on the TSCA Inventory; and
(2) The substance is otherwise not publicly known to have been
offered for commercial distribution.
(c) Public copies. All TSCA submissions and their accompanying
attachments that include a confidentiality claim must be accompanied, at
the time of submission, by a public version of the submission and any
attachments, with all information that is claimed as confidential
removed. In the case of documents collected by EPA or on behalf of EPA
in person at the site of a TSCA inspection under section 11 of the Act,
the affected company must provide such public copies at the same
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time and in the same manner as it provides substantiation of its
confidentiality claims in accordance with paragraph (b)(1) of this
section, within ten working days after the inspection ends. Only
information that is claimed as confidential may be redacted or removed.
Generally, a public copy that removes all or substantially all of the
information would not meet the requirements of this paragraph (c) so
will likely be treated as deficient under paragraph (e) of this section.
(1) Where the applicable reporting form or electronic reporting tool
contains a checkbox or other means of designating with specificity what
information is claimed as confidential, no further action by the
submitter is required to satisfy this requirement.
(2) For all other information claimed as confidential, including but
not limited to information in attachments and in substantiations
required under paragraph (b) of this section, the submitter must prepare
and attach a public copy. EPA may treat as deficient submissions with
public copies that are entirely blank or that are substantially reduced
in length as compared to the CBI version (see paragraph (e) of this
section).
(d) Generic name. Each confidentiality claim for specific chemical
identity must be accompanied by a structurally descriptive generic name
for that substance. This generic name must be consistent with guidance
on the determination of structurally descriptive generic names developed
in accordance with, and made binding by, section 14(c)(4)(A) of the Act
(e.g., Guidance for Creating Generic Names for Confidential Chemical
Substance Identity Reporting under TSCA; available at https://
www.epa.gov/ tsca-inventory/guidance-creating- generic-names-
confidential- chemical-substance-identity-reporting), and 15 U.S.C.
2613(c)(1)(C)(ii).
(1) At a minimum, the generic name must either:
(i) Be identical to the generic name for the same substance included
on the non-confidential portion of the TSCA Inventory (if the substance
is listed on the TSCA Inventory), or
(ii) For substances that are not listed on the TSCA Inventory, mask
only the confidential portions of the specific chemical name. In most
cases, only one structural element of a specific chemical name may be
masked to protect a confidential chemical identity--if the submitter of
a proposed generic name wishes to mask more than one such element, the
submission must include an explanation of why masking only one element
is insufficient to protect the confidential identity.
(2) Notwithstanding paragraph (d)(1) of this section, EPA may
conclude that a generic name provided with the submission and listed on
the current non-confidential version of the TSCA Inventory does not
comply with 15 U.S.C. 2613(c)(1)(C). In such cases, EPA will notify the
submitting company and proceed as described in paragraph (c)(4) of this
section.
(3) A generic name that meets the requirements of section
14(c)(1)(C) of the Act prior to the date on which the chemical substance
is first offered for commercial distribution for the purposes of a pre-
market submission (e.g., a PMN) may not be sufficient for the purposes
of subsequent listing on the TSCA Inventory, as identified upon review
under section 14(g)(1)(C)(i) of the Act of a confidentiality claim for
specific chemical identity made in a Notice of Commencement required
under Sec. 720.102 or Sec. 725.190(f) of this subchapter. In such
cases, EPA will notify the submitting company and proceed as described
in Sec. 720.102(f) or Sec. 725.190(f) of this subchapter.
(4) If EPA concludes that the proposed generic name does not comply
with 15 U.S.C. 2613(c)(1)(C), EPA will notify the submitter, and provide
10 business days for the submitter to provide a revised generic name. If
EPA concludes that the revised generic name is still not acceptable, EPA
will hold the submission for an additional period of up to 10 business
days, proceeding as set out in paragraph (e) of this section.
(e) Deficient confidentiality claims. (1) A confidentiality claim
under TSCA is deficient if it meets one or more of the following
criteria:
(i) The confidentiality claim is not accompanied by the supporting
statement and certification required by paragraph (a) of this section.
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(ii) The confidentiality claim is not accompanied by the
substantiation required by paragraph (b) of this section. If the
submitter claims an exemption from substantiation under paragraph (b)(5)
of this section and the exemption does not apply or an explanation is
not provided for the exemption pursuant to paragraph (b)(5) of this
section, the confidentiality claim is deficient.
(iii) The confidentiality claim is not accompanied by a public copy
that meets the requirements of paragraph (c) of this section.
(iv) The confidentiality claim is for a specific chemical identity
and is not accompanied by a generic name that meets the requirements of
paragraph (d) of this section.
(2) A submission that is identified as deficient under paragraph
(e)(1) of this section will be held for a period of up to 10 business
days, and the submitter will be notified via CDX as described in
paragraph (h) of this section. During the hold, which commences on the
day the CDX notice is sent, any applicable review period for the
underlying submission will be suspended until either the deficiency is
corrected or the 10 business days elapse without such correction. Upon
the occurrence of the first of either of these events, the applicable
review period for the underlying submission commences or comes out of
suspension. If the deficiency is not remedied during the suspension, EPA
will proceed with review of the submission and may deny the CBI
claim(s).
(f) Electronic reporting required. (1) TSCA submissions bearing
confidentiality claims must be submitted via CDX, except where EPA
directs that information subpoenaed under section 11(c) of the Act or
materials collected or requested by EPA as part of an inspection under
section 11(a) of the Act, not be submitted via CDX. Any required TSCA
submission asserting a CBI claim that does not meet the requirements of
this paragraph will be deemed incomplete. EPA reserves the ability to
waive the requirements of this paragraph, at its discretion, where
compliance is infeasible.
(2) You must use CISS to complete and submit TSCA submissions via
CDX. To access CISS go to https://cdx.epa.gov/ and follow the
appropriate links.
(3) On receipt by EPA, each electronic TSCA submission will be
assigned a case number or document identifier, which will be available
to the submitter in their CDX account. This identifier may be used as a
reference in future communications that concern the substance and may be
used by EPA in public communications (e.g., Federal Register notices)
that concern the submission, such as notices of receipt, final
confidentiality determination, pending confidentiality claim expiration,
or in other regulatory actions that concern the TSCA submission.
(g) Requirement to report health and safety studies using templates.
Submitters of health and safety studies or information from such studies
must provide such data in templated form, using an appropriate OECD
harmonized template, if such template is available for the data type
(https://www.oecd.org/ehs/templates/). Individual test or data
submission rules or orders may specify an appropriate template or
templates. Submission of templated data is not a substitute for
submitting a full study report where a specific TSCA rule or order
requires submission of the full study report (e.g., Sec. 720.50(a) of
this subchapter, or according to the terms of a specific order under
section 5(e) of the Act).
(h) Requirement to maintain company contact information; electronic
notices concerning confidentiality claims. (1) To facilitate ongoing or
future communication concerning TSCA submissions, current contact
information for all of the individuals associated with a particular TSCA
submission must be maintained. Contact information for all the
individuals associated with a particular TSCA submission must be updated
by amending the submission via CDX, except that submissions that are
either no longer accessible to the submitting company or that were not
submitted via CDX (e.g., submissions that were originally provided on
paper or other physical media), updated company contact must be provided
via CDX using the appropriate EPA-provided electronic reporting
application in
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CISS. In circumstances where ownership of the company or unit of a
company has changed, such that contact information for one or more prior
TSCA submissions that include confidentiality claims is affected, a
notice of transfer of ownership must be directed to EPA via CDX.
Instructions for providing this notice and for requesting access to
copies of a prior TSCA submission are available at https://cdx.epa.gov/.
(2) When EPA contacts a TSCA submitter concerning confidentiality
claims (e.g., related to a pending or concluded confidentiality claim
review, a deficient submission, or in relation to the 10-year expiration
of a confidentiality claim (described in section 14(e) of the Act)), EPA
may provide notices and other correspondence to the submitter via CDX,
using the contact information provided in the most recent version of the
submission, or using the contact information provided in a more recent
notice of transfer of ownership relating to that submission. The fact
and date of delivery of such notice is verified automatically by CDX.
(3) In addition to individual notice described in paragraph (h)(2)
of this section, EPA will publish on its website, or other appropriate
platform, a list of TSCA submissions with confidentiality claims that
are approaching the end of the ten-year period of protection described
in section 14(e) of the Act. Such TSCA submissions will be referred to
by the TSCA case or document identifier (as described in paragraph
(f)(3) of this section) that was assigned to the submission by EPA when
it was originally submitted. TSCA submissions will be added to this list
at least 60 days prior to the end of the ten-year period of protection,
along with instructions for reasserting and substantiating expiring
claims.
(4) When a confidentiality claim is being reviewed pursuant to
section 14(f) of the Act, EPA will provide, when necessary, notice of
such review and an opportunity to substantiate or resubstantiate the
affected confidentiality claim to the submitter using the contact
information for the authorized official or technical contact provided in
the most recent version of the submission or in a more recent notice of
transfer of ownership relating to that submission.
(5) Where the submission with the relevant CBI claim was not
originally made via CDX, EPA will send the notice via courier or US Mail
to the company address provided in the most recent TSCA submission made
by that company, or via other means that allows verification of the fact
and date of receipt. The notice will provide instructions for
substantiating claims that were exempt from substantiation when the
confidentiality claim was asserted or for which the submitter was
otherwise not required to provide substantiation at the time of initial
submission, and for updating or re-substantiating as necessary any
claims that were previously substantiated.
(i) Withdrawing confidentiality claims. TSCA confidentiality claims
may be voluntarily withdrawn by the submitter at any time.
(1) Confidentiality claims in TSCA submissions that were originally
made via electronic submission may be withdrawn. To withdraw a claim, a
person must reopen the submission in CDX, remove confidentiality
markings (e.g., confidential checkmarks or bracketing), revise public
copies including any attachments to unredact the information no longer
claimed confidential, and then resubmit the submission.
(2) For submissions that were not originally made via CDX, or that
are no longer accessible to the submitting company via CDX,
confidentiality claims may also be withdrawn via CDX using the ``TSCA
Communications'' application or successor system. The withdrawal
correspondence must indicate the case or document number (or other
applicable document identifier or document identifying details) from
which CBI claims are being withdrawn, identify the submitting company,
and include a list or description of the information for which CBI
claims are being withdrawn, including page numbers where relevant.
Current contact information for the person withdrawing the claim must
also be provided, in the event EPA needs clarification concerning which
claim or claims are being withdrawn.
(j) Amending public copy following confidentiality claim denial or
expiration. (1)
[[Page 49]]
Following the expiration or EPA's denial of a TSCA confidentiality
claim, the person who asserted the denied or expired claim should
prepare and submit a revised public copy of the submission to EPA,
following the procedures for voluntarily withdrawing claims described in
paragraph (i) of this section.
(2) If the person who asserted the denied or expired claim declines
or fails to provide within 30 days a revised public copy of the
submission that includes the information for which the confidentiality
claim(s) were denied or expired, EPA may prepare an addendum to the
original public copy, as needed, disclosing the information to the
public.
Sec. 703.7 EPA review of confidentiality claims under TSCA section 14(g).
(a) Representative subset and selection of submissions for review.
(1) A representative subset consists of at least 25 percent of
confidentiality claims asserted under TSCA, not including claims for
specific chemical identity or for the categories of information listed
in section 14(c)(2) of the Act. Excluded from the representative subset
are:
(i) Inquiries with respect to potential submission to EPA of a
notification under 40 CFR part 720, 721, 723, or 725 by a person who has
not submitted the notification at the time of the inquiry, including
inquiries under Sec. 720.25(b) or Sec. 721.11 of this subchapter;
(ii) Submissions or other communication not submitted to EPA via
CDX; and
(iii) Amendments to previous TSCA submissions.
(2) To satisfy its confidentiality claim review obligations under
section 14(g)(1)(C)(ii) of the Act, EPA will generally review all claims
(except those exempt from substantiation under section 14(c)(2) of the
Act) in every fourth TSCA submission submitted via CDX that is part of
the representative subset, in chronological order of receipt by EPA. For
each submission selected for review as part of the representative
subset, EPA reviews and approves or denies every individual
confidentiality claim in that submission (except claims that are exempt
under sections 14(c)(2) and 14(g) of the Act), including claims made in
attachments and amendments available to EPA at the time of the review.
(b) Review of new and expiring confidentiality claims under TSCA
Section 14(g). (1)(i) Under section 14(g) of the Act, EPA will review:
(A) All chemical identity claims asserted in TSCA submissions except
those that are exempt from substantiation according to section
14(c)(2)(G) of the Act; and
(B) a representative subset of other confidentiality claims as
provided in paragraph (a) of this section.
(ii) Final determinations will be issued by the General Counsel or
their designee, which may include personnel outside of the Office of
General Counsel.
(2) EPA will review all timely requests for extension of claims
under section 14(e) of the Act within 30 days of receipt.
(3) EPA will also review or re-review confidentiality claims under
certain other circumstances, as set out in section 14(f) of the Act.
Review under section 14(f) of the Act are conducted in accordance with
procedures set out in Sec. 703.8.
(c) Commencement of the review period and effect of amendments.
Subject to Sec. 703.5(e), the 90-day review period described in section
14(g) of the Act begins on the day that EPA accepts a new TSCA
submission that includes confidentiality claims. For new information,
other than specific chemical identity, added to a submission after EPA
first accepts the submission, the review will take into account such
amendments to that submission that are made either up to 60 days from
the original submission date, or until the Agency issues a final
confidentiality determination for the submission, whichever comes first.
If a submission is amended to report an additional or different chemical
substance that includes a new specific chemical identity claim, the TSCA
section 14(g) review period for the added chemical identity begins on
the day EPA accepts the amendment including the new claim.
(d) Publication of final determinations. Final confidentiality
determinations will be published on EPA's website, or
[[Page 50]]
other platform, periodically, in accordance with the requirements of
section 26(j) of the Act.
(e) Claim denials and notice period. In the case that EPA determines
that a claim or part of a claim is not entitled to confidential
treatment, EPA will provide notice of the denial to the person who made
the claim and provide reasons for the denial or denial in part. The
notice will be provided, as described in Sec. 703.5(h). The 30-day
notice period described in section 14(g)(2)(B) of the Act begins on the
next business day following the date the notice is made available to the
submitter in their CDX account.
(f) Substantive criteria for use in confidentiality determinations.
Information claimed as confidential under section 14 of the Act will be
approved if all of the following apply:
(1) The business has asserted a business confidentiality claim which
has not expired by its terms, nor been waived nor withdrawn;
(2) The business has satisfactorily shown that it has taken
reasonable measures to protect the confidentiality of the information,
and that it intends to continue to take such measures for as long as the
claim is maintained;
(3) The information is not, and has not been, reasonably obtainable
without the business's consent by other persons (other than governmental
bodies) by use of legitimate means (other than discovery based on a
showing of special need in a judicial or quasi-judicial proceeding;
e.g., the business has demonstrated a reasonable basis to believe the
information is not readily discoverable through reverse engineering);
(4) The business has demonstrated a reasonable basis to conclude
that disclosure of the information is likely to cause substantial harm
to the competitive position of the business; and
(5) No statute denies confidential protection to the information.
Information from health and safety studies respecting any chemical that
has been offered for commercial distribution or for which testing is
required under section 4 of the Act or notice is required under section
5 of the Act is not entitled to confidential treatment, except that the
following information may be entitled to confidential treatment if it
otherwise meets the remainder of criteria in this paragraph (f):
(i) Any information, including formulas (including molecular
structures) of a chemical substance or mixture, that discloses processes
used in the manufacturing or processing of a chemical substance or
mixture; or
(ii) In the case of a mixture, the portion of the mixture comprised
by any of the chemical substances in the mixture.
(6) The business adequately demonstrates that the information is
commercial or financial information obtained from a person and is
confidential within the meaning of FOIA Exemption 4 (5 U.S.C.
552(b)(4)).
(g) Criteria to use in consideration of requests for extension under
TSCA section 14(e). Requests to extend the period of confidentiality
protection under TSCA section 14(e) will be evaluated using the same
criteria as described in paragraph (f) of this section. Requests for
extension may rely on a substantiation previously provided to EPA, but
the submitter must recertify that the substantiation is still true and
correct.
Sec. 703.8 EPA review of confidentiality claims under TSCA section
14(f).
(a) Review of confidentiality claims initiated under TSCA Section
14(f). In accordance with the procedures described in this section, EPA
may review confidentiality claims where authorized by TSCA section
14(f)(1), and will review confidentiality claims subject to TSCA section
14(f)(2) in the following situations:
(1) In response to a request under the Freedom of Information Act (5
U.S.C. 552) for TSCA information claimed confidential;
(2) If EPA has reason to believe that information claimed
confidential does not qualify for protection from disclosure; or
(3) For any chemical substance which EPA determines under TSCA
section 6(b)(4)(A) presents an unreasonable risk of injury to health or
the environment.
(b) Substantiation exemptions not applicable. The exemptions from
substantiation requirements contained in section 14(c)(2) of TSCA do not
apply to confidentiality claims reviewed under
[[Page 51]]
this section 703.8, even if such exemptions applied when the information
was originally submitted to EPA.
(c) Additional substantiation. If necessary, such as where
substantiation has not previously been provided for confidentiality
claims under review, or where EPA has reason to believe the
substantiation is incomplete or out of date, EPA will request additional
substantiation from the person(s) that claimed the information as
confidential.
(d) Additional substantiation notice. If additional substantiation
is necessary, EPA will provide notice to the person that claimed the
information as confidential in the manner specified in Sec.
703.5(h)(4). The notice will provide the time allowed for additional
substantiation from the business and the method for requesting a time
extension if necessary. If the person does not make a timely response or
extension request, EPA will consider any existing substantiations in its
review of the claims or, in the case of any unsubstantiated claim, EPA
will construe this as a waiver of the claim and may make the information
public without any further notice to the submitter.
(e) Substantive criteria for use in confidentiality determinations.
The criteria in Sec. 703.7(f) apply to confidentiality determinations
initiated under TSCA section 14(f).
(f) Adverse determinations and notice period. Final determinations
will be issued by the General Counsel or their designee, including
personnel outside of the Office of General Counsel. Except for instances
where claims were waived, if EPA determines that information claimed
confidential does not qualify for protection from disclosure, EPA will
provide written notice to the person who asserted the claim. The notice
will be provided electronically, as described in Sec. 703.5(h)(2). The
30-day notice period described in TSCA section 14(g)(2)(B) begins on the
next business day following the date the notice is made available to the
submitter in their CDX account.
(g) Disclosure of Information. After a final determination has been
made by EPA to release some or all of the information claimed as
confidential, the Agency shall make the information available to the
public (in the absence of a court order prohibiting disclosure)
whenever:
(1) The period provided for commencement by a business of an action
to obtain judicial review of the determination has expired without
notice to EPA of commencement of such an action; or
(2) The court, in a timely-commenced action, has denied the person's
motion for a preliminary injunction, or has otherwise upheld the EPA
determination.
(h) Notice relating to public requests for records. Any person whose
request for release of the information under 5 U.S.C. 552 is pending at
the time notice is given under paragraph (f) of this section shall be
furnished notice under 5 U.S.C. 552 either stating the circumstances
under which the some or all of the information will be released or
denying the request if all requested information was found to be
entitled to confidential treatment.
PART 704_REPORTING AND RECORDKEEPING REQUIREMENTS--Table of Contents
Subpart A_General Reporting and Recordkeeping Provisions for Section
8(a) Information-Gathering Rules
Sec.
704.1 Scope.
704.3 Definitions.
704.5 Exemptions.
704.7 Confidential business information claims.
704.9 Where to send reports.
704.11 Recordkeeping.
704.13 Compliance and enforcement.
Subpart B_Chemical-Specific Reporting and Recordkeeping Rules
704.20 Chemical substances manufactured or processed at the nanoscale.
704.25 11-Aminoundecanoic acid.
704.33 P-tert-butylbenzoic acid (P-TBBA), p-tert-butyltoluene (P-TBT)
and p-tert-butylbenzaldehyde (P-TBB).
704.43 Chlorinated naphthalenes.
704.45 Chlorinated terphenyl.
704.95 Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis-
(methylene)]]tetrakis-(EDTMPA) and its salts.
704.102 Hexachloronorbornadiene.
704.104 Hexafluoropropylene oxide.
704.175 4,4'-methylenebis(2-chloroaniline) (MBOCA).
704.180 Asbestos.
[[Page 52]]
Authority: 15 U.S.C. 2607(a).
Subpart A_General Reporting and Recordkeeping Provisions for Section
8(a) Information-Gathering Rules
Sec. 704.1 Scope.
(a) This part specifies reporting and recordkeeping procedures under
section 8(a) of the Toxic Substances Control Act (TSCA) for
manufacturers, importers, and processors of chemical substances and
mixtures (hereafter collectively referred to as substances) that are
identified in subpart B of this part. The reporting and recordkeeping
provisions in subpart A of this part apply throughout this part unless
revised in any other subpart.
(b) Subpart B of this part sets out chemical-specific reporting and
recordkeeping requirements under section 8(a) of TSCA.
[53 FR 51715, Dec. 22, 1988, as amended at 60 FR 31920, June 19, 1995]
Sec. 704.3 Definitions.
All definitions as set forth in section 3 of TSCA apply in this
part. In addition, the following definitions are provided for the
purposes of this part.
Annual means the corporate fiscal year.
Article means a manufactured item (1) which is formed to a specific
shape or design during manufacture, (2) which has end use function(s)
dependent in whole or in part upon its shape or design during end use,
and (3) which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design.
Byproduct means a chemical substance produced without a separate
commercial intent during the manufacture, processing, use, or disposal
of another chemical substance(s) or mixture(s).
CAS Number means Chemical Abstracts Service Registry Number.
Coproduct means a chemical substance produced for a commercial
purpose during the manufacture, processing, use, or disposal of another
chemical substance or mixture.
Customer means any person to whom a manufacturer, importer, or
processor directly distributes any quantity of a chemical substance,
mixture, mixture containing the substance or mixture, or article
containing the substance or mixture, whether or not a sale is involved.
Domestic means within the geographical boundaries of the 50 United
States, including the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana
Islands, and any other territory or possession of the United States.
Enclosed process means a manufacturing or processing operation that
is designed and operated so that there is no intentional release into
the environment of any substance present in the operation. An operation
with fugitive, inadvertent, or emergency pressure relief releases
remains an enclosed process so long as measures are taken to prevent
worker exposure to and environmental contamination from the releases.
EPA means the United States Environmental Protection Agency.
Import means to import for commercial purposes.
Import for commercial purposes means to import with the purpose of
obtaining an immediate or eventual commercial advantage for the
importer, and includes the importation of any amount of a chemical
substance or mixture. If a chemical substance or mixture containing
impurities is imported for commercial purposes, then those impurities
also are imported for commercial purposes.
Import in bulk form means to import a chemical substance (other than
as part of a mixture or article) in any quantity, in cans, bottles,
drums, barrels, packages, tanks, bags, or other containers, if the
chemical substance is intended to be removed from the container and the
substance has an end use
[[Page 53]]
or commercial purpose separate from the container.
Importer means (1) any person who imports any chemical substance or
any chemical substance as part of a mixture or article into the customs
territory of the United States, and includes:
(i) The person primarily liable for the payment of any duties on the
merchandise, or
(ii) An authorized agent acting on his behalf.
(2) Importer also includes, as appropriate:
(i) The consignee.
(ii) The importer of record.
(iii) The actual owner if an actual owner's declaration and
superseding bond have been filed in accordance with 19 CFR 141.20.
(iv) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred in accordance with subpart C of 19 CFR
part 144.
(3) For the purposes of this definition, the customs territory of
the United States consists of the 50 States, Puerto Rico, and the
District of Columbia.
Impurity means a chemical substance which is unintentionally present
with another chemical substance.
Intermediate means any chemical substance that is consumed, in whole
or in part, in chemical reactions used for the intentional manufacture
of other chemical substances or mixtures, or that is intentionally
present for the purpose of altering the rates of such chemical
reactions.
Known to or reasonably ascertainable by means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know.
Manufacture means to manufacture for commercial purposes.
Manufacture for commercial purposes means: (1) To import, produce,
or manufacture with the purpose of obtaining an immediate or eventual
commercial advantage for the manufacturer, and includes among other
things, such ``manufacture'' of any amount of a chemical substance or
mixture:
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research
and development, or as an intermediate.
(2) Manufacture for commercial purposes also applies to substances
that are produced coincidentally during the manufacture, processing,
use, or disposal of another substance or mixture, including both
byproducts that are separated from that other substance or mixture and
impurities that remain in that substance or mixture. Such byproducts and
impurities may, or may not, in themselves have commercial value. They
are nonetheless produced for the purpose of obtaining a commercial
advantage since they are part of the manufacture of a chemical product
for a commercial purpose.
Manufacturer means a person who imports, produces, or manufactures a
chemical substance. A person who extracts a component chemical substance
from a previously existing chemical substance or a complex combination
of substances is a manufacturer of that component chemical substance.
Non-isolated intermediate means any intermediate that is not
intentionally removed from the equipment in which it is manufactured,
including the reaction vessel in which it is manufactured, equipment
which is ancillary to the reaction vessel, and any equipment through
which the substance passes during a continuous flow process, but not
including tanks or other vessels in which the substance is stored after
its manufacture. Mechanical or gravity transfer through a closed system
is not considered to be intentional removal, but storage or transfer to
shipping containers ``isolates'' the substance by removing it from
process equipment in which it is manufactured.
Own or control means ownership of 50 percent or more of a company's
voting stock or other equity rights, or the power to control the
management and policies of that company. A company may own or control
one or more sites. A company may be owned or controlled by a foreign or
domestic parent company.
Parent company is a company that owns or controls another company.
Person includes any individual, firm, company, corporation, joint
venture,
[[Page 54]]
partnership, sole proprietorship, association, or any other business
entity; any State or political subdivision thereof; any municipality;
any interstate body; and any department, agency, or instrumentality of
the Federal Government.
Possession or control means in the possession or control of any
person, or of any subsidiary, partnership in which the person is a
general partner, parent company, or any company or partnership which the
parent company owns or controls, if the subsidiary, parent company, or
other company or partnership is associated with the person in the
research, development, test marketing, or commercial marketing of the
substance in question. Information is in the possession or control of a
person if it is:
(1) In the person's own files including files maintained by
employees of the person in the course of their employment.
(2) In commercially available data bases to which the person has
purchased access.
(3) Maintained in the files in the course of employment by other
agents of the person who are associated with research, development, test
marketing, or commercial marketing of the chemical substance in
question.
Process means to process for commercial purposes.
Process for commercial purposes means the preparation of a chemical
substance or mixture after its manufacture for distribution in commerce
with the purpose of obtaining an immediate or eventual commercial
advantage for the processor. Processing of any amount of a chemical
substance or mixture is included in this definition. If a chemical
substance or mixture containing impurities is processed for commercial
purposes, then the impurities also are processed for commercial
purposes.
Processor means any person who processes a chemical substance or
mixture.
Production volume means the quantity of a substance which is
produced by a manufacturer, as measured in kilograms or pounds.
Propose to manufacture, import, or process means that a person has
made a firm management decision to commit financial resources for the
manufacture, import, or processing of a specified chemical substance or
mixture.
Site means a contiguous property unit. Property divided only by a
public right-of-way shall be considered one site. There may be more than
one plant on a single site. The site for a person who imports a
substance is the site of the operating unit within the person's
organization which is directly responsible for importing the substance
and which controls the import transaction and may in some cases be the
organization's headquarters office in the United States.
Small government means the government of a city, county, town,
township, village, school district, or special district with a
population of less than 50,000.
Small manufacturer means a manufacturer (including importer) that
meets either of the following standards:
(1) First standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $120 million. However, if
the annual production or importation volume of a particular substance at
any individual site owned or controlled by the manufacturer or importer
is greater than 45,400 kilograms (100,000 lbs), the manufacturer
(including importer) will not qualify as small for purposes of reporting
on the production or importation of that substance at that site, unless
the manufacturer (including importer) qualifies as small under paragraph
(2) of this definition.
(2) Second standard. A manufacturer (including importer) of a
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $12 million, regardless of
the quantity of substances produced or imported by that manufacturer
(including importer).
(3) Inflation index. EPA shall make use of the Producer Price Index
for Chemicals and Allied Products, as compiled by the U.S. Bureau of
Labor Statistics, for purposes of determining the need to adjust the
total annual sales values and for determining new sales values when
adjustments are made. EPA may adjust the total annual sales
[[Page 55]]
values whenever the Agency deems it necessary to do so, provided that
the five-year average of the Producer Price Index for Chemicals and
Allied Products has changed more than 20 percent since either the most
recent previous change in sales values or May 28, 2020, whichever is
later. EPA shall provide Federal Register notification when changing the
total annual sales values.
Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or analysis
or chemical research on, or analysis of, such substance or another
substance, including such research or analysis for the development of a
product'') means quantities of a chemical substance manufactured,
imported, or processed or proposed to be manufactured, imported, or
processed solely for research and development that are not greater than
reasonably necessary for such purposes.
Substance means either a chemical substance or mixture unless
otherwise indicated.
Test marketing means the distribution in commerce of no more than a
predetermined amount of a chemical substance, mixture, article
containing that chemical substance or mixture, or a mixture containing
that substance, by a manufacturer or processor, to no more than a
defined number of potential customers to explore market capability in a
competitive situation during a predetermined testing period prior to the
broader distribution of that chemical substance, mixture, or article in
commerce.
Total annual sales means the total annual revenue (in dollars)
generated by the sale of all products of a company. Total annual sales
must include the total annual sales revenue of all sites owned or
controlled by that company and the total annual sales revenue of that
company's subsidiaries and foreign or domestic parent company, if any.
TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
[53 FR 51715, Dec. 22, 1988, as amended at 76 FR 50858, Aug. 16, 2011;
76 FR 54933, Sept. 6, 2011; 85 FR 31995, May 28, 2020]
Sec. 704.5 Exemptions.
A person who is subject to reporting requirements for a substance
identified in this part is exempt from those requirements to the extent
that the person and that person's use of the substance is described in
this section. This section is superseded by any TSCA section 8(a) rule
that adds to, removes, or revises the exemptions described in this
section.
(a) Articles. A person who imports, processes, or proposes to import
or process a substance identified in this part solely as part of an
article is exempt from the reporting requirements of this part with
regard to that substance.
(b) Byproducts. A person who manufactures, imports, or proposes to
manufacture or import a substance identified in this part solely as a
byproduct is exempt from the reporting requirements of this part.
(c) Impurities. A person who manufactures, imports, processes, or
proposes to manufacture, import, or process a substance identified in
this part solely as an impurity is exempt from the reporting
requirements of this part.
(d) Non-isolated intermediate. A person who manufactures or proposes
to manufacture a substance identified in this part solely as a non-
isolated intermediate is exempt from the reporting requirements of this
part.
(e) Research and development. A person who manufactures, imports,
processes, or proposes to manufacture, import, or process a substance
identified in this part only in small quantities solely for research and
development is exempt from the reporting requirements of this part.
(f) Small manufacturers and importers. Small manufacturers and
importers are exempt from the reporting requirements of this part.
[53 FR 51717, Dec. 22, 1988]
Sec. 704.7 Confidential business information claims.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
[88 FR 37171, June 7, 2023]
[[Page 56]]
Sec. 704.9 Where to send reports.
Reports must be submitted by certified mail to the Document Control
Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, ATTN: 8(a) Reporting.
[60 FR 34463, July 3, 1995, as amended at 71 FR 33641, June 12, 2006]
Sec. 704.11 Recordkeeping.
Each person who is subject to the reporting requirements of this
part must retain the following records for 3 years following the
creation or compilation of the record.
(a) A copy of each report submitted by the person in response to the
requirements of this part.
(b) Materials and documentation sufficient to verify or reconstruct
the values submitted in the report.
(c) A copy of each notice sent by the person, return receipt
requested, to that person's customers for the purpose of notifying their
customers of the customer's reporting obligations under this part.
(d) All return receipts signed by the person's customers who
received the notice described in paragraph (c) of this section.
[53 FR 51717, Dec. 22, 1988, as amended at 58 FR 34204, June 23, 1993]
Sec. 704.13 Compliance and enforcement.
Violators of the requirements of this part may be subject to civil
administrative penalties up to $25,000 per day of violation or criminal
prosecution, as provided in sections 15 and 16 of TSCA. In addition,
under section 17, EPA may seek judicial relief to compel submission of
required information.
[53 FR 51717, Dec. 22, 1989]
Subpart B_Chemical-Specific Reporting and Recordkeeping Rules
Sec. 704.20 Chemical substances manufactured or processed at
the nanoscale.
(a) Definitions. For purposes of this section the terms below are
defined as follows:
An agglomerate is a collection of weakly bound particles or
aggregates or mixtures of the two where the resulting external surface
area is similar to the sum of the surface areas of the individual
components.
An aggregate is a particle comprising strongly bonded or fused
particles where the resulting external surface area may be significantly
smaller than the sum of calculated surface areas of the individual
components.
Central Data Exchange or CDX means EPA's centralized electronic
submission receiving system.
CISS tool means the Chemical Information Submission System, EPA's
electronic, web-based reporting tool for the completion and submission
of data, reports, and other information, or its successors.
Discrete form of a reportable chemical substance differs from
another form of the same reportable chemical substance in one or more of
the following 3 characteristics:
(i) The change in the reportable chemical substance is due to all of
the following:
(A) There is a change in process to effect a change in size, a
change in one or more of the properties of the reportable chemical
substances identified in paragraph (i)(C) of this definition, or both;
(B) There is a size variation in the mean particle size that is
greater than 7 times the standard deviation of the mean particle size
( 7 times the standard deviation); and
(C) There is a change in at least one of the following properties:
Zeta potential, specific surface area, dispersion stability, or surface
reactivity, that is greater than 7 times the standard deviation of the
measured value ( 7 times the standard deviation).
(ii) The reportable chemical substance has a different morphology.
Examples of morphologies include but are not limited to sphere, rod,
ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree,
flower, ring, torus, cone, and sheet.
(iii) A reportable chemical substance that is coated with another
chemical substance or mixture at the end of manufacturing or processing
has a coating that consists of a different chemical substance or
mixture.
[[Page 57]]
Nanoscale Materials Stewardship Program was a program conducted by
EPA from January 2008 to December 2009 under which some nanoscale
material manufacturers and processors voluntarily provided EPA available
information on engineered nanoscale materials that were manufactured,
processed or used.
Particle is a minute piece of matter with defined physical
boundaries.
Primary particles are particles or droplets that form during
manufacture of a chemical substance before aggregation or
agglomerization occurs.
Reportable chemical substance is a chemical substance as defined in
section 3 of TSCA that is solid at 25 [deg]C and standard atmospheric
pressure, that is manufactured or processed in a form where any
particles, including aggregates and agglomerates, are in the size range
of 1-100 nm in at least one dimension, and that is manufactured or
processed to exhibit unique and novel properties because of its size. A
reportable chemical substance does not include a chemical substance that
is manufactured or processed in a form where less than 1% of any
particles, including aggregates, and agglomerates, measured by weight
are in the size range of 1-100 nm.
Small manufacturer or processor means any manufacturer or processor
whose total annual sales, when combined with those of its parent company
(if any), are less than $11 million. The definition of small
manufacturer in section 704.3 of this title does not apply to reporting
under this section (40 CFR 704.20).
Specific surface area means the ratio of the area of the surface of
the reportable chemical substance to its mass or volume. Specific
surface area by mass is the ratio of the area of the surface of a
nanoscale material divided by the mass (m\2\/kg) and the specific
surface area by volume is the area of the surface of the reportable
chemical substance divided by its volume m\2\/m\3\.
Surface reactivity means the reactivity at the surface of a
reportable chemical substance. It is dependent upon factors such as
redox potential, which is a measure of the tendency of a substance to
lose or acquire electrons, photocatalytic activity, including the
potential to generate free radicals.
Unique and novel properties means any size-dependent properties that
vary from those associated with other forms or sizes of the same
chemical substance, and such properties are a reason that the chemical
substance is manufactured or processed in that form or size.
Zeta potential is the electrostatic potential near the particle
surface.
(b) Persons who must report. (1) Persons who can reasonably
ascertain that they are manufacturers and processors of a discrete form
of a reportable chemical substance during the three years prior to the
final effective date of the rule must report except as provided in
paragraph (c) of this section.
(2) Persons who can reasonably ascertain that they propose to
manufacture or process a discrete form of a reportable chemical
substance after the final effective date of the rule which was not
reported under paragraph (b)(1) of this section must report except as
provided in paragraph (c) of this section.
(c) When reporting is not required. (1) The following chemical
substances are not subject to reporting under this section:
(i) Chemical substances formed at the nanoscale as part of a film on
a surface.
(ii) DNA.
(iii) RNA.
(iv) Proteins.
(v) Enzymes.
(vi) Lipids.
(vii) Carbohydrates.
(viii) Peptides.
(ix) Liposomes.
(x) Antibodies.
(xi) Viruses.
(xii) Microorganisms.
(xiii) Chemical substances which dissociate completely in water to
form ions that are smaller than 1 nanometer.
(xiv) Chemical substances that are not on the TSCA Chemical
Substance Inventory at the time reporting would otherwise be required
under this section.
(2) Persons who submitted a notice under 40 CFR parts 720, 721, or
723 for a reportable chemical substance on or after January 1, 2005 are
not required
[[Page 58]]
to submit a report for the reportable chemical substance submitted
except where the person manufactures or processes a discrete form of the
reportable chemical substance.
(3) Section 704.5(a) through (e) apply to reporting under this
section. Small manufacturers and processors as defined in paragraph (a)
of this section are exempt from reporting under this section.
(4) Persons who submitted some or all of the required information
for a reportable chemical substance as part of the Nanoscale Materials
Stewardship Program are not required to report the information
previously submitted except where the person manufactures or processes a
discrete form of the reportable chemical substance.
(d) What information to report. The following information must be
reported for each discrete form of a reportable chemical substance to
the extent that it is known to or reasonably ascertainable by the person
reporting:
(1) The common or trade name, the specific chemical identity
including the correct Chemical Abstracts (CA) Index Name and available
Chemical Abstracts Service (CAS) Registry Number, and the molecular
structure of each chemical substance or mixture. Information must be
reported as specified in Sec. 720.45.
(2) Material characteristics including particle size, morphology,
and surface modifications.
(3) Physical/chemical properties.
(4) The maximum weight percentage of impurities and byproducts
resulting from the manufacture, processing, use, or disposal of each
chemical substance.
(5)(i) Persons described in paragraph (b)(1) of this section must
report the annual production volume for the previous three years before
the effective date of the final rule and an estimate of the maximum
production volume for any consecutive 12-month period during the next
two years of production after the final effective date of this rule.
(ii) Persons described in paragraph (b)(2) of this section must
report the estimated maximum 12 month production volume and the
estimated maximum production volume for any consecutive 12 month period
during the first three years of production.
(iii) Estimates for paragraphs (d)(5)(i) and (ii) of this section
must be on 100% chemical basis of the discrete form of the solid
nanoscale material.
(6) Use information describing the category of each use by function
and application, estimates of the amount manufactured or processed for
each category of use, and estimates of the percentage in the formulation
for each use.
(7) Detailed information on methods of manufacturing or processing.
(8) Exposure information with estimates of the number of individuals
exposed in their places of employment, descriptions and duration of the
occupational tasks that cause such exposure, descriptions and estimates
of any general population or consumer exposures.
(9) Release information with estimates of the amounts released,
descriptions and duration of the activities that cause such releases,
and whether releases are directly to the environment or to control
technology.
(10) Risk management practices describing protective equipment for
individuals, engineering controls, control technologies used, any hazard
warning statement, label, safety data sheet, customer training, or other
information which is provided to any person who is reasonably likely to
be exposed to this substance regarding protective equipment or practices
for the safe handing, transport, use, or disposal of the substance.
(11) Existing information concerning the environmental and health
effects.
(e) How to report. You must use CDX and the CISS tool to complete
and submit the information required under this part to EPA
electronically.
(1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA
Sec. 8(a) Reporting for Nanoscale Materials: Information Submission
Form.
(2) Electronic submission. You must submit the required information
to EPA electronically via CDX and using the CISS tool.
(i) To access the CDX portal, go to https://cdx.epa.gov.
(ii) The CISS tool is accessible in CDX.
[[Page 59]]
(f) When to report. (1) Persons specified in paragraph (b)(1) of
this section must report the information specified in paragraph (d) of
this section within one year after the final effective date of the rule.
(2) Persons specified in paragraph (b)(2) of this section must
report the information specified in paragraph (d) of this section at
least 135 days before commencing manufacture or processing of a discrete
form of the reportable chemical substance, except where the person has
not formed an intent to manufacture or process that discrete form at
least 135 days before commencing such manufacture or processing, in
which case the information must be filed within 30 days of the formation
of such an intent.
(g) Recordkeeping. Any person subject to the reporting requirements
of this section is subject to the recordkeeping requirements in Sec.
704.11(a) and (b).
(h) Confidential business information. (1) Persons submitting a
notice under this rule are subject to the requirements for confidential
business information claims in Sec. 704.7(a) through (c).
(2) In submitting a claim of confidentiality, a person attests to
the truth of the following four statements concerning all information
which is claimed confidential:
(i) My company has taken measures to protect the confidentiality of
the information,
(ii) I have determined that the information is not required to be
disclosed or otherwise made available to the public under any other
Federal law.
(iii) I have a reasonable basis to conclude that disclosure of the
information is likely to cause substantial harm to the competitive
position of the person.
(iv) I have a reasonable basis to believe that the information is
not readily discoverable through reverse engineering.
[82 FR 3653, Jan. 12, 2017]
Sec. 704.25 11-Aminoundecanoic acid.
(a) Definitions--(1) 11-AA means the chemical substance 11-
aminoundecanoic acid, CAS Number 2432-99-7.
(2) Enclosed process means a process that is designed and operated
so that there is no intentional release of any substance present in the
process. A process with fugitive, inadvertent, or emergency pressure
relief releases remains an enclosed process so long as measures are
taken to prevent worker exposure to an environmental contamination from
the releases.
(3) Internal subunit means a subunit that is covalently linked to at
least two other subunits. Internal subunits of polymer molecules are
chemically derived from monomer molecules that have formed covalent
links between two or more other molecules.
(4) Monomer means a chemical substance that has the capacity to form
links between two or more other molecules.
(5) Polymer means a chemical substance that consists of at least a
simple weight majority of polymer molecules but consists of less than a
simple weight majority of molecules with the same molecular weight.
Collectively, such polymer molecules must be distributed over a range of
molecular weights wherein differences in molecular weight are primarily
attributable to differences in the number of internal subunits.
(6) Polymer molecule means a molecule which includes at least four
covalently linked subunits, at least two of which are internal subunits.
(7) Small processor means a processor that meets either the standard
in paragraph (a)(7)(i) of this section or the standard in paragraph
(a)(7)(ii) of this section.
(i) First standard. A processor of a chemical substance is small if
its total annual sales, when combined with those of its parent company,
if any, are less than $40 million. However, if the annual processing
volume of a particular chemical substance at any individual site owned
or controlled by the processor is greater than 45,400 kilograms (100,000
pounds), the processor shall not qualify as small for purposes of
reporting on the processing of that chemical substance at that site,
unless the processor qualifies as small under paragraph (a)(7)(ii) of
this section.
(ii) Second standard. A processor of a chemical substance is small
if its total annual sales, when combined with those of its parent
company (if any),
[[Page 60]]
are less than $4 million, regardless of the quantity of the particular
chemical substance processed by that company.
(iii) Inflation index. EPA will use the Inflation Index described in
the definition of small manufacturer set forth in Sec. 704.3, for
purposes of adjusting the total annual sales values of this small
processor definition. EPA will provide notice in the Federal Register
when changing the total annual sales values of this definition.
(8) Subunit means an atom or group of associated atoms chemically
derived from corresponding reactants.
(b) Persons who must report. Except as provided in paragraph (c) of
this section, the following persons are subject to this section:
(1) Persons who manufacture or propose to manufacture 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(2) Persons who import or propose to import 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(3) Persons who process or propose to process 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(c) Persons not subject to this section. The following persons are
not subject to this section:
(1) Small manufacturers (includes importers) as described in Sec.
704.3.
(2) Small processors.
(3) Persons described in Sec. 704.5.
(4) Persons who, at any time during the 3-year period ending July
22, 1986, manufactured, imported, or processed 11-AA:
(i) For use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or
(ii) For use as a component in photoprocessing solutions.
(d) What information to report. Persons identified in paragraph (b)
of this section must submit a Premanufacture Notice Form (EPA Form 7710-
25).
(e) When to report. (1) Persons who intend to manufacture, import,
or process 11-AA for use as an intermediate in the manufacture of
polymers in an enclosed process when it is expected that the 11-AA will
be fully polymerized during the manufacturing process or for use as a
component in photoprocessing solutions must notify EPA within 30 days
after making a firm management decision to commit financial resources
for the manufacturing, importing, or processing of 11-AA.
(2) Persons who initiated manufacturing, importing, or processing of
11-AA for use as an intermediate in the manufacture of polymers in an
enclosed process when it is expected that the 11-AA will be fully
polymerized during the manufacturing process, or for use as a component
in photoprocessing solutions during the time period between July 22,
1986 and July 13, 1987 must notify EPA by August 10, 1987.
(f) Recordkeeping. Persons subject to the reporting requirements of
this section must retain documentation of information contained in their
reports for a period of 5 years from the date of submission of the
report.
(g) Where to send reports. Reports must be submitted by certified
mail to the Document Control Office (DCO) (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: 11-AA
Notification.
[52 FR 19864, May 28, 1987, as amended at 60 FR 16308, Mar. 29, 1995; 60
FR 34463, July 3, 1995; 71 FR 33641, June 12, 2006]
Sec. 704.33 P-tert-butylbenzoic acid (P-TBBA), p-tert-butyltoluene
(P-TBT) and p-tert-butylbenzaldehyde (P-TBB).
(a) Definitions--(1) P-TBBA means the substance p-tert-butylbenzoic
acid,
[[Page 61]]
also identified as 4-(1,1-dimethylethyl)benzoic acid, CAS No. 98-73-7.
(2) P-TBT means the substance p-tert-butyltoluene, also identified
as 1-(1,1-dimethylethyl)-4-methylbenzene, CAS No. 98-51-1.
(3) P-TBB means the substance p-tert-butylbenzaldehyde, also
identified as 4-(1,1-dimethylethyl)benzaldehyde, CAS No. 939-97-9.
(4) Small processor means a processor that meets either the standard
in paragraph (a)(4)(i) of this section or the standard in paragraph
(a)(4)(ii) of this section.
(i) First standard. A processor of a chemical substance is small if
its total annual sales, when combined with those of its parent company,
if any, are less than $40 million. However, if the annual processing
volume of a particular chemical substance at any individual site owned
or controlled by the processor is greater than 45,400 kilograms (100,000
pounds), the processor shall not qualify as small for purposes of
reporting on the processing of that chemical substance at that site,
unless the processor qualifies as small under paragraph (a)(1)(ii) of
this section.
(ii) Second standard. A processor of a chemical substance is small
if its total annual sales, when combined with those of its parent
company (if any), are less than $4 million, regardless of the quantity
of the particular chemical substance processed by that company.
(iii) Inflation index. EPA shall use the Inflation Index described
in the definition of small manufacturer that is set forth in Sec.
704.3, for purposes of adjusting the total annual sales values of this
small processor definition. EPA shall provide Federal Register
notification when changing the total annual sales values of this
definition.
(b) Persons who must report. Except as provided in paragraph (c) of
this section, the following persons are subject to the reporting
requirements of this rule; a person may become subject to this rule more
than once, for more than one substance or under more than one of the
criteria listed in this paragraph (b).
(1) Persons who manufactured, imported, or processed P-TBBA, P-TBT,
and/or P-TBB for commercial purposes during the person's latest complete
corporate fiscal year prior to June 25, 1986. For purposes of this
provision, processors of P-TBBA, P-TBT, and/or P-TBB shall include only
those persons who processed the substances other than as non-isolated
intermediates.
(2) Persons who commence manufacture or importation of P-TBBA, P-
TBT, and/or P-TBB for commercial purposes after June 25, 1986. This
provision is applicable to persons who cease manufacture or importation
of P-TBBA, P-TBT, and/or P-TBB after June 25, 1986 and then subsequently
resume manufacture or importation of the substance(s).
(3) Persons who process P-TBBA, P-TBT, and/or P-TBB for commercial
purposes in any way other than as a non-isolated intermediate after June
25, 1986.
(c) Persons not subject to this rule. In addition to the persons
described in Sec. 704.5, small processors, as defined in paragraph
(a)(4) of this section, are not subject to this rule.
(d) Information to report. Persons subject to this rule as described
in paragraph (b) of this section shall report information to EPA as
specified in this paragraph (d). Respondents to this rule shall report
all information that is known to or reasonably ascertainable by the
person reporting. For purposes of importer reporting under this
paragraph, a site is the operating unit within the person's organization
which is directly responsible for importing the substance and which
controls the import transaction. The import site may in some cases be
the organization's headquarters office in the United States.
(1) All manufacturers, importers, and processors specified in
paragraph (b) of this section shall report their name and headquarters
address.
(2) All manufacturers, importers, and processors specified in
paragraph (b) of this section shall report the name, address, and office
telephone number (including area code) of their principal technical
contact.
(3) All manufacturers, importers, and processors specified in
paragraph (b) of this section shall report the name and address of each
site where P-TBBA, P-TBT, and/or P-TBB is manufactured, imported, or
processed.
[[Page 62]]
(4) All manufacturers, importers, and processors specified in
paragraph (b)(1) of this section only shall report the information
described in this paragraph (d)(4). Respondents to this paragraph (d)(4)
shall report separately for each substance that they manufacture,
import, or process, and for each site at which they do so. However, if
the information to be reported in response to this paragraph (d)(4) is
the same for different sites, the respondent need not report separately
for each site but need only notify EPA that the information is the same
for each site. The information to be reported under this paragraph
(d)(4) shall cover the respondent's latest complete corporate fiscal
year prior to June 25, 1986. Respondents to this paragraph (d)(4) shall
report the following information:
(i) The total quantity (by weight) of P-TBBA, P-TBT, or P-TBB
manufactured, imported, or processed for commercial purposes per site.
(ii) A narrative description of the manufacturing, importing, or
processing operation(s) involving P-TBBA, P-TBT, or P-TBB at each site.
(iii) A narrative description of worker activities involving P-TBBA,
P-TBT, or P-TBB at each site, including the number of workers
potentially exposed to each substance and, if applicable, the number of
workers potentially exposed to more than one substance.
(iv) The potential routes of worker exposure to P-TBBA, P-TBT, or P-
TBB at each site (e.g., inhalation, ingestion, dermal absorption).
(v) Available monitoring data from employee breathing zones with
potential exposure to P-TBBA, P-TBT, or P-TBB at each site, including a
description of the method of monitoring, the number of samples taken,
and the potential number of workers similarly exposed for each worker
job category. Respondents to this paragraph (d)(4)(v) shall submit data
showing a range of 8-hour time weighted averages (TWAs), provided that
the data are available in that form. Respondents also shall submit a
calculated geometric mean of these data, with an explanation of the
method by which the mean was derived. However, if the monitoring data
are not available in the form of 8-hour TWAs, respondents shall submit
raw sample data results and the duration time of sampling for each job
category.
(vi) A narrative description of any personal protective equipment
and/or engineering controls used to prevent exposure to P-TBBA, P-TBT,
or P-TBB at each site.
(vii) A listing of the estimated quantities of P-TBBA, P-TBT, or P-
TBB released directly into air, water, or land from each site.
(viii) A narrative description of the times during the
manufacturing, importing, or processing operations involving P-TBBA, P-
TBT, or P-TBB when environmental release occurs at each site.
(ix) A narrative description of any engineering controls used to
prevent environmental release of P-TBBA, P-TBT, or P-TBB at each site.
(x) A narrative description of all known end uses of any P-TBBA, P-
TBT, or P-TBB that is manufactured, imported, or processed by the
respondent. The narrative need not include customer identity.
(xi) A narrative description of the methods used at each site for
disposing of wastes generated during the manufacture, importation, or
processing of P-TBBA, P-TBT, or P-TBB, including the quantity and
content of such wastes (per site), the method of disposal, and an
identification of the disposal site(s).
(5) All manufactureres, importers, and processors specified in
paragraph (b) of this section shall report the information described in
this paragraph (d)(5). Respondents to this paragraph (d)(5) shall report
separately for each substance that they intend to manufacture, import,
or process during the first 2 years following the date on which they
become subject to this rule. The data reported under this paragraph
(d)(5) shall cover that 2-year period. Respondents to this paragraph
(d)(5) shall report separately for each site at which they intend to
manufacture, import, or process each substance. Respondents need not
comply with this paragraph (d)(5) if the information to be reported is
identical to that reported by the respondent under paragraph (d)(4) of
this section, provided that the respondent makes note of that
[[Page 63]]
fact to EPA. Respondents to this paragraph (d)(5) shall report the
following information:
(i) An estimate of the total quantity (by weight) of P-TBBA, P-TBT,
or P-TBB that the respondent intends to manufacture, import, or process
for commercial purposes per site during each of the first 2 years
following the date on which the respondent becomes subject to this rule.
(ii) A narrative description of the intended manufacturing,
importing, or processing activities involving P-TBBA, P-TBT, or P-TBB at
each site during the first 2 years following the date on which the
respondent becomes subject to this rule. The description shall include a
summary of the intended manufacturing, importing, or processing
operation(s); a summary of intended worker activities involving the
substances, including an estimate of the number of persons anticipated
to be exposed annually to P-TBBA, P-TBT, or P-TBB (per site) during the
2-year period, the anticipated routes of worker exposure to the
substances (e.g., inhalation, ingestion, dermal absorption); and a
summary of any personal protective equipment and/or engineering controls
that the respondent intends to use to prevent exposure to the
substances.
(iii) A narrative description of anticipated environmental releases
of P-TBBA, P-TBT, or P-TBB at each site from the manufacture,
importation, or processing of these substances during the first 2 years
following the date on which the respondent becomes subject to this rule.
The narrative shall include the anticipated quantities of each substance
released directly into air, water, or land, the anticipated routes of
environmental release, and any intended engineering controls to be used
to prevent environmental release of the substances.
(iv) A narrative description of all anticipated end uses or P-TBBA,
P-TBT, or P-TBB resulting from the respondent's manufacture,
importation, or processing of the substances during the first 2 years
following the date on which the respondent becomes subject to this rule.
The summary need not include customer identity.
(v) A narrative summary of the anticipated disposal of wastes
generated from the manufacture, importation, or processing of P-TBBA, P-
TBT, or P-TBB during the first 2 years following the date on which the
respondent becomes subject to this rule. The summary shall include the
anticipated quantity and content of such wastes (per site), the intended
method of disposal, and an identification of intended disposal site(s).
(e) When to report. Persons subject to this rule must submit the
requisite information to EPA within 60 days of becoming subject to the
rule under the standards set forth in paragraph (b) of this section.
(f) Certification. Persons subject to this rule must attach the
following statement to any information submitted to EPA in response to
this rule: ``I hereby certify that, to the best of my knowledge and
belief, all of the attached information is complete and accurate.'' This
statement shall be signed and dated by the company's principal technical
contact.
(g) Recordkeeping. Persons subject to the reporting requirements of
this section must retain documentation of information contained in their
reports for a period of 5 years from the date of the submission of the
report.
[51 FR 17339, May 12, 1986; 51 FR 18323, May 19, 1986, as amended at 52
FR 20083, May 29, 1987; 58 FR 34204, June 23, 1993]
Sec. 704.43 Chlorinated naphthalenes.
(a) Definitions--(1) Extent of chlorination means the percent by
weight of chlorine.
(2) Import means to import in bulk form or as part of a mixture.
(3) Isomeric ratio means the relative amounts of each isomeric
chlorinated naphthalene that composes the chemical substance; and for
each isomer the relative amounts of each chlorinated naphthalene
designated by the position of the chlorine atom(s) on the naphthalene.
(4) Polychlorinated biphenyl means any chemical substance that is
limited to the biphenyl molecule and that has been chlorinated to
varying degrees.
(5) Small manufacturer means a manufacturer (including importers)
who
[[Page 64]]
meets either paragraph (a)(5) (i) or (ii) of this section:
(i) A manufacturer of a chemical substance is small if its total
annual sales, when combined with those of its parent company (if any),
are less than $40 million. However, if the annual production volume of a
particular chemical substance at any individual site owned or controlled
by the manufacturer is greater than 45,400 kilograms (100,000 pounds),
the manufacturer shall not qualify as small for purposes of reporting on
the production of that chemical substance at that site, unless the
manufacturer qualifies as small under paragraph (a)(5)(ii) of this
section.
(ii) A manufacturer of a chemical substance is small if its total
annual sales, when combined with those of its parent company (if any),
are less than $4 million, regardless of the quantity of the particular
chemical substance produced by that manufacturer.
(iii) For imported mixtures containing a chemical substance
identified in paragraph (b) of this section, the 45,400 kilograms
(100,000 pounds) standard in paragraph (a)(5)(i) of this section applies
only to the amount of the chemical substance in a mixture and not the
other components of the mixture.
(6) Waste means any solid liquid, semisolid, or contained gaseous
material that results from the production of a chemical substance
identified in paragraph (b) of this section and which is to be disposed.
(b) Substances for which reports must be submitted.
------------------------------------------------------------------------
CAS registry number Chemical substance
------------------------------------------------------------------------
90-13-1.......................... Naphthalene, 1-chloro-
91-58-7.......................... Naphthalene, 2-chloro-
1321-64-8........................ Naphthalene, pentachloro-
1321-65-9........................ Naphthalene, trichloro-
1335-87-1........................ Naphthalene, hexachloro-
1335-88-2........................ Naphthalene, tetrachloro-
1825-30-5........................ Naphthalene, 1,5-dichloro-
1825-31-6........................ Naphthalene, 1,4-dichloro-
2050-69-3........................ Naphthalene, 1,2-dichloro-
2050-72-8........................ Naphthalene, 1,6-dichloro-
2050-73-9........................ Naphthalene, 1,7-dichloro-
2050-74-0........................ Naphthalene, 1,8-dichloro-
2050-75-1........................ Naphthalene, 2,3-dichloro-
2065-70-5........................ Naphthalene, 2,6-dichloro-
2198-75-6........................ Naphthalene, 1,3-dichloro-
2198-77-8........................ Naphthalene, 2,7-dichloro-
2234-13-1........................ Naphthalene, octachloro-
25586-43-0........................ Naphthalene, chloro-
32241-08-0........................ Naphthalene, heptachloro-
70776-03-3........................ Naphthalene, chloro derivatives.
------------------------------------------------------------------------
(c) Persons who must report. (1) Persons who are manufacturing or
importing a chemical substance identified in paragraph (b) of this
section on October 8, 1984.
(2) Persons who propose to import a chemical substance identified in
paragraph (b) of this section on or after October 8, 1984.
(3) Persons who manufacture a chemical substance identified in
paragraph (b) of this section after October 8, 1984.
(4) A person is required to report only once for each chemical
substance identified in paragraph (b) of this section.
(d) Persons exempt from reporting. (1) Small manufacturers.
(2) Persons described in Sec. 704.5.
(e) What information to report. Persons described in paragraph (c)
of this section must notify EPA of current or prospective manufacture or
import. The notice must include, to the extent that it is known to or
reasonably ascertainable by the person making the report, the following
information:
(1) Company name and address.
(2) Name, address, and telephone number of the principal technical
contact.
(3) For chemical substances proposed to be imported, the proposed
date of import.
(4) A description of the use(s) or intended use(s) for the chemical
substance.
(5) A description of the isomeric ratio and extent of chlorination
of the chemical substance and the impurity level of polychlorinated
biphenyls.
(6) The quantity (by weight) manufactured or imported within 12
months prior to October 8, 1984, if any, and the estimated quantity (by
weight) to be manufactured or imported for the first 3 years following
the date of the report or the date of the intended start of import
whichever occurs later.
(7) The number of persons exposed to the chemical substance during
manufacture, import, processing, distribution in commerce, use, and
disposal.
(8) If a manufacturer's waste contains one or more of the chemical
substances identified in paragraph (b) of this section, the manufacturer
must:
(i) Provide the quantity (by weight) of the chemical substances
identified
[[Page 65]]
in paragraph (b) of this section present in the waste.
(ii) Identify the constituents of the waste and their
concentrations,
(iii) State the rate of waste generation as a percentage of
production volume,
(iv) Describe where in the manufacturing process the waste is
generated, and
(v) Describe the method for disposal of the waste.
(f) When to report. (1) Persons who are manufacturing or importing a
chemical substance identified in paragraph (b) of this section on
October 8, 1984 must notify EPA by November 6, 1984.
(2) Persons who propose to import a chemical substance identified in
paragraph (b) of this section on or after October 8, 1984 must notify
EPA by November 6, 1984, or 15 days after making the management decision
described in Sec. 704.3, whichever is later in time.
(3) Persons who manufacture a chemical substance identified in
paragraph (b) of this section after October 8, 1984 must notify EPA
within 30 days after the initial date of manufacture.
[49 FR 33653, Aug. 24, 1984; 49 FR 45133, Nov. 15, 1984; 50 FR 1215,
Jan. 10, 1985; 51 FR 19839, June 3, 1986; 52 FR 20083, May 29, 1987.
Redesignated at 53 FR 51717, Dec. 22, 1988]
Sec. 704.45 Chlorinated terphenyl.
(a) Definitions--(1) Chlorinated terphenyl means a chemical
substance, CAS No. 61788-33-6, comprised of chlorinated ortho-, meta-,
and paraterphenyl.
(2) Extent of chlorination means the percent by weight of chlorine
for each isomer (ortho, meta, and para).
(3) Isomeric ratio means the ratios of ortho-, meta-, and
parachlorinated terphenyls.
(4) Polychlorinated biphenyl means any chemical substance that is
limited to the biphenyl molecule that has been chlorinated to varying
degrees.
(5) Small manufacturer means a manufacturer (importers are defined
as manufacturers under TSCA) who meets either of the following standards
under this rule:
(i) First standard. A manufacturer of an existing chemical substance
is small if its total annual sales, when combined with those of its
parent company (if any), are less than $40 million. However, if the
annual production volume of a particular chemical substance at any
individual site owned or controlled by the manufacturer is greater than
45,400 kilograms (100,000 pounds), the manufacturer shall not qualify as
small for purposes of reporting on the production of that chemical
substance at the site, unless the manufacturer qualified as small under
paragraph (a)(5)(ii) of this section.
(ii) Second standard. A manufacturer of an existing chemical
substance is small if its total annual sales, when combined with those
of its parent company (if any), are less than $4 million, regardless of
the quantity of chemicals produced by that manufacturer.
(b) Persons who must report. Except for small manufacturers and as
provided in Sec. 704.5, the following persons are subject to the rule:
(1) Persons who manufacture or propose to manufacture chlorinated
terphenyl.
(2) Persons who import (importers) or propose to import chlorinated
terphenyl as a chemical substance in bulk or as part of a mixture.
(c) What information to report. Persons subject to this rule as
described in paragraph (b) of this section must notify EPA of current or
proposed manufacture or import of chlorinated terphenyl. The notice must
include, to the extent that it is known to the person making the report
or is reasonably ascertainable, the following information:
(1) Company name and address.
(2) Name, address, and telephone number of principal technical
contact.
(3) A description of the use(s) or intended use(s) for chlorinated
terphenyl.
(4) A description of the isomeric ratio and extent of chlorination
of the chlorinated terphenyl and the impurity level of polychlorinated
biphenyls.
(5) The quantity (by weight) manufactured or imported within 12
months prior to the effective date of the rule, if any, and the
estimated quantity (by weight) to be manufactured or imported for the
first three years following the date of the report or the date of the
intended start of production, whichever occurs later.
[[Page 66]]
(6) The proposed date for the initiation of manufacturing or
importation of chlorinated terphenyl, if appropriate.
(d) When to report. Persons who are manufacturing or importing
chlorinated terphenyl on the effective date of the rule must notify EPA
within 30 days of the effective date of the rule. Persons who propose to
manufacture or import chlorinated terphenyl must notify EPA within 15
days after making the management decision described in Sec. 704.3
``Proposed to manufacture or import''.
[49 FR 11184, Mar. 26, 1984, as amended at 49 FR 32068, Aug. 10, 1984;
50 FR 2048, Jan. 15, 1985; 52 FR 20083, May 29, 1987. Redesignated at 53
FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]
Sec. 704.95 Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis-
(methylene)]]tetrakis- (EDTMPA) and its salts.
(a) Substances for which reporting is required. The chemical
substances for which reporting is required under this section are:
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
1429-50-1 Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis
(methylene)]] tetrakis- (EDTMPA)
15142-96-8 Phosphonic acid, [1,2-ethanediyl-
bis[nitrilobis(methylene)]] tetrakis-, hexasodium salt
34274-30-1 Phosphonic acid, [1,2-ethanediyl-
bis[nitrilobis(methylene)]] tetrakis-, potassium salt
57011-27-5 Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis
(methylene)]] tetrakis-, ammonium salt
67924-23-6 Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis-[phosphonato]] (8-)]-,
pentapotassium hydrogen, (OC-6-21)-
67969-67-9 Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis- [phosphonato]] (8-)-
N,N',O,O'',O'''',O'''''']-, pentasodium hydrogen, (OC-6-
21)-
67989-89-3 Cuprate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis- [phosphonato]] (8-)]-,
pentapotassium hydrogen, (OC-6-21)-
68025-39-8 Cobaltate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis- [phosphonato]] (6-)-
N,N',O,O'',O'''',O'''''']-, pentaammonium hydrogen, (OC-6-
21)-
68188-96-5 Phosphonic acid, [1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis-, tetrapotassium salt
68309-98-8 Cadmate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis- [phosphonato]] (8-)]-,
pentapotassium hydrogen, (OC-6-21)-
68901-17-7 Phosphonic acid, [1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis-, octaammonium salt
68958-86-1 Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis- [phosphonato]] (8-)]-,
pentaammonium hydrogen, (OC-6-21)-
68958-87-2 Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis- [phosphonato]] (8-)]-,
pentapotassium hydrogen, (OC-6-21)-
68958-88-3 Nickelate (6-), [[[1,2-ethanediylbis [nitrilobis
(methylene)]] tetrakis [phosphonato]] (8-)]-, pentasodium
hydrogen, (OC-6-21)-
------------------------------------------------------------------------
(b) Persons who must report. Unless exempt as provided in Sec.
704.5, reports must be submitted by:
(1) Persons who manufacture or import any of the substances
identified in paragraph (a) of this section.
(2) Persons who propose to manufacture or propose to import any of
the substances identified in paragraph (a) of this section. For the
purposes of importer reporting under this section, an import site is the
operating unit within the person's organization which is directly
responsible for importing the substance and which controls the import
transaction; the import site may in some cases be the organization's
headquarters office in the United States.
(c) What information to report. Persons identified in paragraph (b)
of this section must report to EPA, for each of the substances
identified in paragraph (a) of this section, the following information
to the extent known to or reasonably ascertainable by them.
(1) Initial Report:
(i) Name and Chemical Abstracts Service Registry Number of the
substance for which the report is submitted.
(ii) Company name and headquarters address.
(iii) Name, address, and telephone number of the principal technical
contact.
(iv) The total quantity (by weight in pounds) of the substance
manufactured or imported for the person's most recently completed
corporate fiscal year.
(v) A description of the commercial uses of the substance during the
person's most recently completed corporate fiscal year, including the
production volume for each use.
(vi) The estimated quantity (by weight in pounds) of the substance
proposed to be manufactured or imported in the person's current
corporate fiscal year.
[[Page 67]]
(vii) A description of the intended commercial uses of the substance
during the person's current corporate fiscal year, including the
estimated production volume for each use.
(2) Follow-up Report:
(i) Name and Chemical Abstracts Service Registry Number of the
substance for which the report is submitted.
(ii) Company name and headquarters address.
(iii) Name, address, and telephone number of the principal technical
contact.
(iv) The estimated quantity (by weight in pounds) of the substance
proposed to be manufactured or imported in the person's current
corporate fiscal year.
(v) A description of the intended commercial uses of the substance
during the person's current corporate fiscal year, including the
estimated production volume for each use.
(d) When to report. (1) Persons specified in paragraph (b)(1) of
this section who are manufacturing or importing the substance as of
December 5, 1988 must submit an initial report described in paragraph
(c)(1) of this section by January 3, 1989.
(2) Persons specified in paragraph (b)(2) of this section must
submit an initial report within 30 days after making the management
decision described in Sec. 704.3 or by January 3, 1989, whichever is
later.
(3) Persons specified in paragraph (b) of this section, who
submitted a report described in paragraph (c)(1) of this section, must
submit a follow-up report described in paragraph (c)(2) of this section
within 30 days of making the management decision, described at Sec.
704.3, to do either of the following events:
(i) Manufacture or import the substance in a quantity 50 percent
greater than the quantity reported in the most recently submitted
report.
(ii) Manufacture or import the substance for a use not reported for
that substance in any previous report.
(e) Certification. Persons subject to this section must attach the
following statement to any information submitted to EPA in response to
this section: ``I hereby certify that, to the best of my knowledge and
belief, all of the attached information is complete and accurate.'' This
statement must be signed and dated by the company's principal technical
contact.
(f) Recordkeeping. Persons subject to the reporting requirements of
this section must retain documentation of information contained in their
reports for a period of 5 years from the date of the submission of the
report.
[53 FR 41337, Oct. 21, 1988, as amended at 58 FR 34204, June 23, 1993]
Sec. 704.102 Hexachloronorbornadiene.
(a) Definitions--(1) Endrin means the pesticide 2,7:3,6-
Dimethanonaphth[2,3-b]oxirene,3,4,5,6,9,9-hexachloro-
1a,2,2a,3,6,6a,7,7a-octahydro-, (1aalpha, 2beta, 2abeta, 3alpha, 6alpha,
6abeta, 7beta, 7aalpha)-, CAS Number 72-20-8.
(2) HEX-BCH means the chemical substance 1,2,3,4,7,7-
hexachloronorbornadiene, CAS Number 3389-71-7.
(3) Isodrin means the pesticide 1,4:5,8-
Dimethanonaphthalene,1,2,3,4,10,10-hexacholoro-1,4,4a,5,8,8a-hexahydro-,
(1alpha, 4alpha, 4abeta, 5beta, 8beta, 8abeta)-, CAS Number 465-73-6.
(4) Small business means any manufacturer, importer, or processor
who meets either paragraph (a)(4)(i) or (ii) of this section:
(i) A business is small if its total annual sales, when combined
with those of its parent (if any), are less than $40 million. However,
if the annual manufacture, importation, or processing volume of a
particular chemical substance at any individual site owned or controlled
by the business is greater than 45,400 kilograms (100,000 pounds), the
business shall not qualify as small for purposes of reporting on the
manufacture, importation, or processing of that chemical substance at
that site, unless the business qualifies as small under paragraph
(a)(4)(ii) of this section.
(ii) A business is small if its total annual sales, when combined
with those of its parent company (if any), are less than $4 million,
regardless of the quantity of the particular chemical substance
manufactured, imported, or processed by that business.
(iii) For imported and processed mixtures containing HEX-BCH, the
45,400 kilograms (100,000 pounds) standard in
[[Page 68]]
paragraph (a)(4)(i) of this section applies only to the amount of HEX-
BCH in a mixture and not the other components of the mixture.
(5) 8-hour time weighted average means the cumulative exposure for
an 8-hour work shift computed as follows:
[GRAPHIC] [TIFF OMITTED] TR25SE06.003
Where:
E is the equivalent exposure for the working shift.
Ci is the concentration (i.e., parts per million) during any
period of time (Ti) where the concentration remains
constant.
Ti is the duration in hours of the exposure at the
concentration Ci.
(6) Year means corporate fiscal year.
(b) Persons who must report. (1) Reports must be submitted by:
(i) Persons who are manufacturing, importing, or processing HEX-BCH
for use as an intermediate in the production or isodrin or endrin on or
after January 2, 1986; and
(ii) Persons who propose to manufacture, import, or process HEX-BCH
for use as an intermediate in the production of isodrin or endrin, on or
after January 2, 1986.
(2) Persons described in paragraph (b)(1) of this section who engage
or propose to engage in more than one activity (i.e., manufacture and
processing) must report the information required in paragraph (d)
separately for each activity.
(c) Persons exempt from reporting. (1) Small businesses.
(2) Persons described in Sec. 704.5(a) and (c).
(d) Information to report. (1) Initial reports must include, to the
extent that it is known to or reasonably ascertainable by the person
reporting, the following information:
(i) Company name and address.
(ii) Name, address, and telephone number of the principal contact.
(iii) Name and address of plant sites where HEX-BCH is or is
proposed to be manufactured, imported, or processed, noting for each
plant site which activity takes or would take place at each site.
(iv) If applicable, the intended date for initiating the
manufacture, import, or processing of HEX-BCH.
(v) If applicable, the actual quantity (by weight) of HEX-BCH
manufactured, imported, or processed during the most recently concluded
year.
(vi) The estimated quantity (by weight) of HEX-BCH to be
manufactured, imported, or processed each year during the first 3 years
following the date of the report or the date of the intended start of
manufacture, import, or processing, whichever occurs later.
(vii) For each year described in paragraphs (d)(1) (v) and (vi) of
this section: the number or expected number of employees exposed to HEX-
BCH during the manufacture, import, processing, distribution in
commerce, use, and disposal; the routes of exposure; and the 8-hour time
weighted average of exposure.
(viii) If employees are exposed or expected to be exposed to HEX-
BCH, state for each reported route of exposure, whether personal
protective equipment is used or expected to be used, and a description
of the personal protective equipment.
(ix) The actual or anticipated quantity, content, method of
disposal, and disposal site of any wastes generated or expected to be
generated during the manufacture, importation, or processing of HEX-BCH.
(2) Subsequent reports must provide, to the extent known to or
reasonably ascertainable by the person reporting, the information in
paragraph (d)(1) of this section and a statement explaining why the
subsequent report is required.
(e) When to report. (1) Persons who are manufacturing, importing, or
processing HEX-BCH on January 2, 1986, must submit an initial report to
EPA by February 3, 1986.
(2) Persons who propose to manufacture, import, or process HEX-BCH
on or after January 2, 1986, must submit an initial report to EPA by
February 3, 1986, or 30 days after making the management decision
described in Sec. 704.3 ``Propose to manufacture, import, or process,''
whichever is later in time.
(3) Persons described in paragraph (b) of this section, who have
submitted a report described in paragraph (d) of this section, must
submit a subsequent
[[Page 69]]
report within 30 days of any of the following events. Based on the most
recently submitted report:
(i) The manufacture, importation, or processing of HEX-BCH begins at
a plant site different than that reported pursuant to paragraph
(d)(1)(iii) of this section.
(ii) The actual quantity (by weight) of HEX-BCH manufactured,
imported, or processed in a given year is greater than or equal to 200
percent of the estimated value for that year reported pursuant to
paragraph (d)(1)(vi) of this section.
(iii) The total number of employees exposed to HEX-BCH is greater
than 130 percent of the projected value reported pursuant to paragraph
(d)(1)(vii) of this section.
(iv) The route of exposures to HEX-BCH differs from that reported
pursuant to paragraph (d)(1)(vii) of this section.
(v) The actual 8-hour time weighted average exposure for any
activity exceeds the projection reported pursuant to paragraph
(d)(1)(vii) of this section by more than 100 percent.
(vi) The method of disposal or disposal site reported pursuant to
paragraph (d)(1)(ix) of this section has changed.
(vii) Three years have passed since the most recent submission of a
report and the person is still engaged in the manufacture, importation,
or processing of HEX-BCH.
(f) Certification of review. Each person who submits a report under
this section must for 3 years following the submission date of the most
recent submission, review their activities at the end of each year to
determine whether any reportable event specified in paragraph (e)(3) of
this section has occurred. If a review shows that none of these events
has occurred, the person is required to certify this fact in writing.
(g) Recordkeeping. Any person subject to the reporting requirements
of this section must:
(1) Retain documentation of information contained in their reports.
This documentation must be maintained for a period of 3 years from the
date of the submission of the report; and
(2) Retain the certification required by paragraph (f) of this
section for 3 years from the date of its creation.
[50 FR 47536, Nov. 19, 1985, as amended at 52 FR 20083, May 29, 1987.
Redesignated at 53 FR 51717, Dec. 22, 1988; 58 FR 34204, June 23, 1993]
Sec. 704.104 Hexafluoropropylene oxide.
(a) Definitions. (1) ``HFPO'' means the chemical substance
hexafluoropropylene oxide, CAS Number 428-59-1. [Listed in TSCA
Inventory as oxirane, trifluoro(trifluoromethyl)-]
(2) ``Enclosed process'' means a process that is designed and
operated so that there is no intentional release of any substance
present in the process. A process with fugitive, inadvertent, or
emergency pressure relief releases remains an enclosed process so long
as measures are taken to prevent worker exposure to and environmental
contamination from the releases.
(3) ``Small processor'' means a processor that meets either the
standard in paragraph (a)(3)(i) of this section or the standard in
paragraph (a)(3)(ii) of this section.
(i) First standard. A processor of a chemical substance is small if
its total annual sales, when combined with those of its parent company,
if any, are less than $40 million. However, if the annual processing
volume of a particular chemical substance at any individual site owned
or controlled by the processor is greater than 45,400 kilograms (100,000
pounds), the processor shall not qualify as small for purposes of
reporting on the processing of that chemical substance at that site,
unless the processor qualifies as small under paragraph (a)(3)(ii) of
this section.
(ii) Second standard. A processor of a chemical substance is small
if its total annual sales, when combined with those of its parent
company (if any), are less than $4 million, regardless of the quantity
of the particular chemical substance processed by that company.
(iii) Inflation index. EPA will use the Inflation Index described in
the definition of ``small manufacturer'' that is set forth in Sec.
704.3 for purposes of adjusting the total annual sales values of this
small processor definition. EPA will provide Federal Register
notification when changing the total annual sales values of this
definition.
[[Page 70]]
(b) Persons who must report. Except as provided in paragraph (c) of
this section, the following persons are subject to this section:
(1) Persons who manufacture or propose to manufacture HFPO for use
as an intermediate in the manufacture of fluorinated substances in an
enclosed process.
(2) Persons who import or propose to import HFPO for use as an
intermediate in the manufacture of fluorinated substances in an enclosed
process.
(3) Persons who process or propose to process HFPO as an
intermediate in the manufacture of fluorinated substances in an enclosed
process.
(c) Persons not subject to this rule. The following persons are not
subject to this rule:
(1) Small processors.
(2) Persons described in Sec. 704.5(a) through (f).
(3) Persons who have already submitted to EPA a completed copy of
the Preliminary Assessment Information Manufacturer's Report (EPA Form
7710-35, as described at Sec. 712.28 of this chapter) for HFPO are not
required to report under this section with respect to activities
previously reported on.
(d) What information to report. Persons identified in paragraph (b)
of this section must submit a Premanufacture Notice Form (EPA Form 7710-
25).
(e) When to report. (1) Persons who are manufacturing, importing, or
processing, or who propose to manufacture, import, or process HFPO for
use as an intermediate in the manufacture of fluorinated substances in
an enclosed process as of December 10, 1987, must report by February 8,
1988.
(2) Persons who propose to manufacture, import, or process HFPO for
use as an intermediate in the manufacture of fluorinated substances in
an enclosed process after December 10, 1987, must report within 30 days
after making a firm management decision to commit financial resources
for the manufacturing, importing, or processing of HFPO.
(f) Recordkeeping. Persons subject to the reporting requirements of
this section must retain documentation of information contained in their
reports for a period of 5 years from the date of submission of the
reports.
(g) Where to send reports. Reports must be submitted by certified
mail to the Document Control Office (DCO) (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: HFPO Reporting.
[52 FR 41299, Oct. 27, 1987, as amended at 58 FR 34204, June 23, 1993;
60 FR 16308, Mar. 29, 1995; 60 FR 31920, June 19, 1995; 60 FR 34463,
July 3, 1995; 71 FR 33641, June 12, 2006; 85 FR 31995, May 28, 2020]
Sec. 704.175 4,4'-methylenebis(2-chloroaniline) (MBOCA).
(a) Substance subject to reporting. The chemical substance 4,4'-
methylenebis(2-chloroaniline) (CAS No. 101-14-4) is subject to reporting
under this section. The substance also is identified as 4,4'-
methylenebis(2-chlorobenzenamine) and MBOCA.
(b) Persons who must report. Except as provided in paragraph (c) of
this section, the following persons are subject to this rule.
(1) Persons who propose to manufacture MBOCA in the United States on
or after June 2, 1986.
(2) Persons who are manufacturing MBOCA in the United States as of
June 2, 1986.
(3) Persons manufacturing MBOCA in the United States on or after
June 2, 1986 who propose to change their manner or method of
manufacturing the substance from a manner or method of manufacturing
that previously was reported under this section.
(c) Persons not subject to this rule. The following persons are
exempt from the reporting requirements of this section:
(1) Persons who import MBOCA into the customs territory of the
United States and do not otherwise manufacture the substance in the
United States.
(2) Persons who complied with the requirements of this section prior
to June 2, 1986 and received written notification of compliance from
EPA.
(d) What information to report. Persons who are subject to this rule
as described in paragraph (b) of this section must report information to
EPA by completing the following parts of the
[[Page 71]]
notice form contained in appendix A to part 720 of this chapter: Parts
I.A., I.B., I.C.1., I.C.3., and II.A.; also, part III as appropriate.
Persons subject to the requirements of this section also must submit a
narrative description of any processing and packaging of MBOCA that
occurs at the manufacturing plant site, including the number of workers
potentially exposed to MBOCA during on-site processing and packaging of
MBOCA and a description of any personal protective equipment and/or
engineering controls that would be used to prevent release of and
exposure to MBOCA during on-site processing and packaging. Persons
subject to the requirements of this section are not required to submit
information on processing or use of MBOCA away from the manufacturing
plant site. Respondents to this rule shall report all information that
is known to or reasonably ascertainable by the person reporting.
(e) When to report. (1) Persons specified in paragraph (b)(1) of
this section must report by July 2, 1986 or within 30 days after making
a firm management decision to commit financial resources for the
manufacture of MBOCA, whichever is later in time.
(2) Persons specified in paragraph (b)(2) of this section must
report by July 2, 1986.
(3) Persons specified in paragraph (b)(3) of this section must
report within 30 days of making a firm management decision to commit
financial resources to change their manner or method of manufacturing
the substance from a manner or method of manufacturing that previously
was reported under this section.
[51 FR 13223, Apr. 18, 1986, as amended at 52 FR 20083, May 29, 1987; 58
FR 34204, June 23, 1993]
Sec. 704.180 Asbestos.
(a) Definitions. The definitions in subpart A of this part apply to
Sec. 704.180 unless otherwise specified in this section.
Asbestos is a collective term meaning any of the substances listed
in Table 1 of this paragraph (a).
Table 1 to Paragraph (a)--CASRN of Asbestos Types
------------------------------------------------------------------------
CASRN Asbestos type
------------------------------------------------------------------------
1332-21-4............................. Asbestos.
12001-29-5............................ Chrysotile.
12001-28-4............................ Crocidolite.
12172-73-5............................ Amosite.
77536-67-5............................ Anthophyllite.
77536-68-6............................ Tremolite.
77536-66-4............................ Actinolite.
NA.................................... Libby amphibole asbestos (mainly
consisting of tremolite [CASRN
77536-68-6], winchite [CASRN
12425-92-2], and richterite
[CASRN 17068-76-7]).
------------------------------------------------------------------------
Bulk asbestos means any quantity of asbestos fiber of any type or
grade, or combination of types or grades, that is mined or milled with
the purpose of obtaining asbestos. This term does not include asbestos
that is produced or processed as a contaminant or an impurity.
Bulk materials containing asbestos means bulk materials in which
asbestos is being mined or milled as an impurity.
Chemical Information Submission System or CISS means EPA's
electronic, web-based reporting tool for the completion and submission
of CDR data, reports, and other information, or its successors.
Form A means an abbreviated form for persons who know or can
reasonably ascertain that they manufactured (including imported) or
processed asbestos, including as an impurity, during the reporting
period described in paragraph (f) of this section but do not know and
cannot reasonably ascertain the amount of asbestos manufactured
(including imported) or processed by them.
Form B means the standard form to be used by persons who know or can
reasonably ascertain that they manufactured (including imported) or
processed asbestos, including as an impurity, during the reporting
period described in paragraph (f) of this section and know or can
reasonably ascertain how much asbestos they manufactured (including
imported) or produced.
Primary processor means a person who starts with bulk asbestos or
bulk materials containing asbestos, and makes a mixture that contains
asbestos as a component.
[[Page 72]]
Secondary processor means a person who further processes asbestos,
after primary processing of asbestos is completed, including as a
component of a mixture, or an article containing asbestos.
Small processor means any processor whose total annual sales, when
combined with those of its parent company (if any), are less than $12
million.
(b) Substance for which reports must be submitted. The requirements
of this section apply to asbestos, including asbestos in bulk form, in
an article and/or product, as an impurity, or as a component of a
mixture.
(c) Persons who must report. Persons (i.e., plant sites) who have
manufactured (including imported), or processed asbestos, including
asbestos as a component of a mixture, asbestos in articles, or asbestos
as an impurity in the four full calendar years prior to the effective
date of this rule, and with annual sales greater than or equal to
$500,000, in any calendar year from 2019 to 2022, when combined with
those of their ultimate parent company (if any), must report under this
subpart.
(d) Persons exempt from reporting. A person who is subject to
reporting requirements pursuant to paragraph (c) of this section is
exempt from the requirements in this subpart to the extent that the
person and that person's use of asbestos is described in this paragraph
(d).
(1) Non-isolated intermediate. A person who manufactures or proposes
to manufacture asbestos, as described in paragraph (c) of this section,
solely as a non-isolated intermediate is exempt from the reporting
requirements of this subpart.
(2) Research and development. A person who manufactures (including
imports), processes, or proposes to manufacture (including import), or
process asbestos, as described in paragraph (c) of this section, only in
small quantities solely for research and development is exempt from the
reporting requirements of this subpart.
(3) Small manufacturers (including importers) and processors. Small
manufacturers (including importers) and processors are exempt from the
reporting requirements of this subpart for Libby amphibole asbestos
only.
(4) Byproducts. A person who manufactures (including imports) or
proposes to manufacture (including import) asbestos solely as a
byproduct is exempt from the reporting requirements of this subpart.
(e) Reporting information to EPA. Persons described in paragraph (c)
of this section and not described and exempted in paragraph (d) of this
section must report to EPA the following information, to the extent
known to or reasonably ascertainable by them. In the event that specific
numeric data are not known or are not reasonably ascertainable by the
submitter, then reasonable estimates may be submitted.
(1) Required forms. Report using the appropriate Form, based on
whether you know or can reasonably ascertain a quantity for asbestos.
(i) Form A. Report using Form A if you know or can reasonably
ascertain that asbestos, including as a component of a mixture or
article, or as an impurity, but are unable to determine the asbestos
quantity by weight.
(ii) Form B. Report using Form B if you know or can reasonably
ascertain a quantity for asbestos, including as a component of a mixture
or article, or as an impurity.
(2) A certification statement signed and dated by an authorized
official of the submitter company. The authorized official must certify
that the submitted information has been completed in compliance with the
requirements of this part and that the confidentiality claims made on
Form A or Form B are true and correct. The certification must be signed
and dated by the authorized official for the submitter company, and
provide that person's name, official title, and email address.
(3) Company and plant site information. The following currently
correct company and plant site information must be reported for each
site at which a reportable chemical substance is manufactured (including
imported) or processed (see Sec. 704.3 for the definition of ``site,''
which includes what ``site'' means for importers):
(i) Company name. The highest-level U.S. parent company name,
address, and Dun and Bradstreet D-U-N-S[supreg] (D&B) number. A
submitter under this
[[Page 73]]
part must obtain a D&B number for the U.S. parent company if none
exists.
(ii) Authorized official. The name of a person who will serve as
Authorized Official for the submitter company, and who will be able to
sign the certification statement as described in paragraph (e)(2) of
this section, the Authorized Official's full mailing address, telephone
number, and email address.
(iii) Point of contact. The name of a person who will serve as
technical contact for the submitter company, and who will be able to
answer questions about the information submitted by the company to EPA,
the contact person's full mailing address, telephone number, and email
address.
(iv) Site information. The site name, full street address, including
the county or parish (or other jurisdictional indicator) in which the
plant site is located. Also report the following:
(A) The appropriate D&B number for the plant site. If none exists,
you must obtain a D&B number for the reported site.
(B) Other site identification numbers, including the Facility
Registry Service (FRS) identification number, if they exist.
(v) Applicable NAICS code. The six-digit North American Industry
Classification System (NAICS) code(s) of the site.
(vi) Number of employees. The total number of employees at the site.
Select from among the ranges of employees listed in Table 2 of this
paragraph (e) and report the corresponding code (i.e., W1 through W8):
Table 2 to Paragraph (e)--Codes for Reporting Number of Employees
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
W1................................ Fewer than 10 employees.
W2................................ At least 10 but fewer than 25
employees.
W3................................ At least 25 but fewer than 50
employees.
W4................................ At least 50 but fewer than 100
employees.
W5................................ At least 100 but fewer than 500
employees.
W6................................ At least 500 but fewer than 1,000
employees.
W7................................ At least 1,000 but fewer than 10,000
employees.
W8................................ At least 10,000 employees.
------------------------------------------------------------------------
(4) Activity information. The following activity information must be
reported.
(i) Type of activity at reporting site. Report all that apply.
(A) Mining of bulk asbestos or bulk materials containing asbestos,
including as an impurity.
(B) Milling of bulk asbestos or bulk materials containing asbestos,
including as an impurity.
(C) Importing of bulk asbestos or bulk materials containing
asbestos, including as an impurity.
(1) For importing only. For importing only, if the imported bulk
material was never physically present at the reporting site.
(2) [Reserved]
(D) Primary processing of bulk asbestos or bulk materials containing
asbestos, including as an impurity.
(E) Secondary processing of asbestos, including as a component of a
mixture, or an article containing asbestos.
(F) Importing of asbestos, including as a component of a mixture, or
an article containing asbestos.
(ii) For importing only. For importing only, if the imported bulk
material was never physically present at the reporting site.
(iii) Form B only. For mining, milling, or importing of bulk
asbestos reported under activity in paragraphs (e)(4)(i)(A) through (C)
of this section, report by year:
(A) The most specific asbestos type that applies. Select from among
the asbestos types listed in Table 1 of paragraph (a) in this section.
If the specific asbestos type is not known or reasonably ascertainable,
report the general listing, ``asbestos CASRN 1332-21-4''.
(B) Report. For each asbestos type, report the following:
(1) Quantity of asbestos, in pounds.
(2) Disposition of asbestos (see Table 3 to this paragraph (e)).
Table 3 to Paragraph (e)--Disposition
------------------------------------------------------------------------
Code Disposition description
------------------------------------------------------------------------
1................................. Used on-site, including further
processed.
2................................. Stored on-site.
3................................. Sent to another U.S. site (including
intra-company transfer) for use or
processing.
4................................. Stored at another U.S. site
(including intra-company transfer).
5................................. Exported outside of the U.S. without
further processing.
6................................. Disposed of within the U.S.
(explain).
7................................. Other (explain).
------------------------------------------------------------------------
(iv) Reporting information for mining, milling, or importing of bulk
materials
[[Page 74]]
containing asbestos, including as an impurity. For mining, milling, or
importing of bulk materials containing asbestos reported under the
activity identified in paragraphs (e)(4)(i)(A) through (C) of this
section, report by year:
(A) Bulk material type manufactured or processed.
(B) For Form B only, for each bulk material type:
(1) Quantity of bulk material manufactured or processed.
(2) Percent asbestos impurity by weight in bulk material.
(3) The most specific asbestos type that applies. Select from among
the asbestos types listed in Table 1 to paragraph (a) of this section.
If the specific asbestos type is not known or reasonably ascertainable,
report the general listing, asbestos CASRN 1332-21-4.
(4) Any testing of or test results assessing the asbestos content of
your bulk material in the applicable reporting years.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your bulk material and what
method and type of test was used for determining asbestos content, and
provide the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertained the presence and amount of asbestos in the bulk
materials.
(C) For each bulk material type, the disposition of bulk material
(see Table 3 of this paragraph (e)).
(D) For importing only, if the imported bulk material was never
physically present at the reporting site.
(v) Reporting information for primary processors. For primary
processing reported under activity identified in paragraph (e)(4)(i)(D)
of this section, report by year:
(A) For Form B only, the total quantity of asbestos processed.
(B) End product type, selecting from products listed in Table 4 of
this paragraph (e). If your end product is not listed, report ``other''
and provide a brief description. For each end product type, report:
(1) For Form B only, the most specific asbestos types that apply.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If the specific asbestos types are not known or
reasonably ascertainable, report the general listing, ``asbestos CASRN
1332-21-4''. Report also the total annual quantity of each of the
asbestos types processed.
(2) The total annual production quantity of end products produced,
using the associated unit of measure listed in Table 4 of this paragraph
(e). If a unit of measure is not listed, provide the unit of measure
associated with the quantity reported.
(3) For Form B only, the percentage of asbestos in the end product.
(4) For Form B only, the disposition of the end product (see Table 3
of this paragraph (e)).
(5) For Form B only, explain if you tested or received test results
assessing the asbestos content of your end product in the applicable
reporting years.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your end product and what
method and type of test was used for determining asbestos content, and
provide the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertain the presence and amount of asbestos in the end
product.
Table 4 to Paragraph (e)--End Product Types
------------------------------------------------------------------------
End product unit of
Code Name measure
------------------------------------------------------------------------
Papers, Felts, and Related Products
------------------------------------------------------------------------
01.......................... Commercial paper.... Short Tons.
02.......................... Rollerboard......... Short Tons.
03.......................... Millboard........... Short Tons.
04.......................... Pipeline wrap....... Short Tons.
05.......................... Beater-add gasketing Short Tons.
paper.
06.......................... High-grade Short Tons.
electrical paper.
07.......................... Unsaturated roofing Short Tons.
felt.
08.......................... Saturated roofing Short Tons.
felt.
09.......................... Flooring felt....... Short Tons.
[[Page 75]]
10.......................... Corrugated paper.... Short Tons.
11.......................... Specialty paper Short Tons.
(specify generic
name).
12.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Floor Coverings
------------------------------------------------------------------------
13.......................... Vinyl asbestos floor Square yards.
tile.
14.......................... Asbestos felt backed Square yards.
vinyl flooring.
15.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Asbestos Cement Products
------------------------------------------------------------------------
16.......................... A/C pipe and Short Tons.
fittings.
17.......................... A/C sheet, flat..... 100 sq. ft.
18.......................... A/C sheet corrugated 100 sq. ft.
19.......................... A/C shingle......... Squares.
20.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Transportation Friction Materials (including aircrafts, marine vessels,
railroad engine and railcars, and other vehicles)
------------------------------------------------------------------------
21.......................... Drum brake lining Pieces.
(light-medium
vehicle).
22.......................... Disc brake pads Pieces.
(light-medium
vehicle).
23.......................... Disc brake pads Pieces.
(heavy vehicle).
24.......................... Brake block (heavy Pieces.
equipment).
25.......................... Clutch facings (all) Pieces.
26.......................... Automatic Pieces.
transmission
friction components.
27.......................... Friction materials Pieces.
(industrial and
commercial).
28.......................... Custom automotive Pieces.
body filler.
29.......................... Transmissions....... Pieces.
30.......................... Mufflers............ Pieces.
31.......................... Radiator top Pieces.
insulation.
32.......................... Radiator sealant.... Pieces.
33.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Appliances
------------------------------------------------------------------------
34.......................... Appliance Industrial Pieces.
and consumer
(specify generic
name).
35.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Construction Products
------------------------------------------------------------------------
36.......................... Boiler and furnace Pieces.
baffles.
37.......................... Decorated building Pieces.
panels.
38.......................... Asbestos cement Pieces.
sheet.
39.......................... Flexible Air Pieces.
Conductor.
40.......................... Hoods and Vents..... Pieces.
41.......................... Portable Pieces.
construction
building.
42.......................... Roofing, saturated.. Pieces.
43.......................... Roof shingles....... Pieces.
44.......................... Wallboard........... Pieces.
45.......................... Wall/roofing panels. Pieces.
46.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Electrical Products and Components
------------------------------------------------------------------------
47.......................... Cable insulation.... Pieces.
48.......................... Electronic motor Pieces.
components.
49.......................... Electrical Pieces.
resistance supports.
50.......................... Electrical Pieces.
switchboard.
51.......................... Electrical switch Pieces.
supports.
52.......................... Electrical wire Pieces.
insulation.
53.......................... Motor armature...... Pieces.
54.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Fire and Heat Shielding Equipment and Components
------------------------------------------------------------------------
55.......................... Arc deflectors...... Pieces.
56.......................... Fire doors.......... Pieces.
57.......................... Fireproof absorbent Short Tons.
paper.
58.......................... Heat shields........ Pieces.
59.......................... Molten metal Pieces.
handling equipment.
60.......................... Oven and stove Short Tons.
insulation.
[[Page 76]]
61.......................... Pipe wrap........... Pieces.
62.......................... Stove lining, wood Pieces.
and coal.
63.......................... Stove pipe rings.... Pieces.
64.......................... Sleeves............. Pieces.
65.......................... Thermal Insulation.. Short Tons.
66.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Textiles and Clothing
------------------------------------------------------------------------
67.......................... Cloth............... Pounds.
68.......................... Thread, yarn, lap, Pounds.
roving, cord, rope,
or wick.
69.......................... Aprons.............. Pieces.
70.......................... Boots............... Pieces.
71.......................... Gloves and mittens.. Pieces.
72.......................... Hats and helmets.... Pieces.
73.......................... Overgaiters......... Pieces.
74.......................... Suits............... Pieces.
75.......................... Aluminized cloth.... Short Tons.
76.......................... Rope or braiding.... Short Tons.
77.......................... Yarn, lap or roving. Short Tons.
78.......................... Wicks............... Short Tons.
79.......................... Bags................ Pieces.
80.......................... Belting............. Short Tons.
81.......................... Blankets............ Pieces.
82.......................... Carpet padding...... Short Tons.
83.......................... Commercial/ Short Tons.
industrial dryer
felts.
84.......................... Draperies........... Pieces.
85.......................... Drip cloths......... Pieces.
86.......................... Fire hoses.......... Pieces.
87.......................... Ironing board pads Pieces.
and insulation.
88.......................... Mantles, lamp or Pieces.
catalytic heater.
89.......................... Packing and Pieces.
packaging
components.
90.......................... Piano and organ Pieces.
felts.
91.......................... Rugs................ Pieces.
92.......................... Tape................ Pieces.
93.......................... Theater curtains.... Pieces.
94.......................... Umbrellas........... Pieces.
95.......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Gaskets
------------------------------------------------------------------------
96.......................... Sheet gasketing, Pieces.
rubber encapsulated
beater addition.
97.......................... Sheet gasketing, Pieces.
rubber encapsulated
compressed.
98.......................... Compressed sheet Pieces.
gasketing (other).
99.......................... Metal reinforced Pieces.
gaskets.
100......................... Automotive gaskets.. Pieces.
101......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Marine Equipment and Supplies
------------------------------------------------------------------------
102......................... Caulks, marine...... Pounds.
103......................... Liners, pond or Pieces.
canal.
104......................... Marine bulkheads.... Pieces.
105......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
Paints, Coatings, Sealants and Compounds
------------------------------------------------------------------------
106......................... Asphaltic compounds. Pounds.
107......................... Automotive/truck Gallons.
body coatings.
108......................... Buffing and Pounds.
polishing compounds.
109......................... Caulking and Pounds.
patching compounds.
110......................... Drilling fluid...... Gallons.
111......................... Flashing compounds.. Pounds.
112......................... Furnace cement...... Pounds.
113......................... Glazing compounds... Pounds.
114......................... Plaster and stucco.. Pounds.
115......................... Pump valve, flange Pieces.
and tank sealing
components.
116......................... Roof coatings....... Gallons.
117......................... Textured paints..... Gallons.
118......................... Tile cement......... Pounds.
119......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
[[Page 77]]
Other Products
------------------------------------------------------------------------
120......................... Sheet gasketing Square yards.
(other than beater-
add).
122......................... Packing............. Pounds.
123......................... Paints and surface Gallons.
coatings.
124......................... Adhesives and Gallons.
sealants.
125......................... Asbestos-reinforced Pounds.
plastics.
126......................... Insulation materials (Specify).
not elsewhere
classified (specify
generic name).
127......................... Mixed or repackaged Short Tons.
asbestos.
128......................... Aerial distress Pieces.
flares.
129......................... Acoustical product.. Pieces.
130......................... Ammunition wadding.. Pieces.
131......................... Ash trays........... Pieces.
132......................... Baking sheets....... Pieces.
133......................... Blackboards......... Pieces.
134......................... Candlesticks........ Pieces.
135......................... Chemical tanks and Pieces.
vessels.
136......................... Filters............. Pieces.
137......................... Grommets............ Pieces.
138......................... Gun grips........... Pieces.
139......................... Jewelry making Pieces.
equipment.
140......................... Kilns............... Pieces.
141......................... Lamp sockets........ Pieces.
142......................... Light bulbs (all Pieces.
types).
143......................... Linings for vaults, Pieces.
safes, humidifiers
and filing cabinets.
144......................... Phonograph records.. Pieces.
145......................... Pottery clay........ Pounds.
146......................... Welding rod coatings Pieces.
147......................... Other (specify (Specify).
generic name).
------------------------------------------------------------------------
(vi) Reporting information for secondary processors. For secondary
processing reported under the activity identified in paragraph
(e)(4)(i)(E) of this section, report by year:
(A) For Form B only, the estimated total quantity of asbestos
processed.
(B) End product type listed in Table 4 of this paragraph (e). For
each product type, report:
(1) For Form B only, the most specific asbestos types that apply.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If the specific asbestos type is not known or
reasonably ascertainable, report the general listing, asbestos CASRN
1332-21-4. Also report the quantity of each type of asbestos.
(2) The total annual production quantity of the end products
produced, using the associated unit of measure listed in Table 4 of this
paragraph (e).
(3) For Form B only, the percentage of asbestos in the end product.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your products and what method
and type of test was used for determining asbestos content, and provide
the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertained the presence and amount of asbestos in the end
product.
(4) For Form B only, the disposition of the end product (see Table 3
of this paragraph (e)).
(vii) Reporting information for importers. For importing reported
under an activity identified in paragraph (e)(4)(i)(F) of this section,
report by year:
(A) For Form B only, the estimated total quantity of asbestos
imported.
(B) Imported product type (Table 4 of this paragraph (e)). For each
imported product type, report:
(1) Whether the imported product is a mixture or an article.
(2) For Form B only, the most specific asbestos types that apply.
Select from among the asbestos types listed in Table 1 in paragraph (a)
of this section. If a specific asbestos type is not known or reasonably
ascertainable, report the general listing, ``asbestos CASRN 1332-21-4''.
Also report the quantity of each asbestos type.
[[Page 78]]
(3) The total annual import quantity of the imported product, using
the associated unit of measure listed in Table 4 of this paragraph (e).
(4) Whether the imported asbestos was never physically present at
the reporting site.
(5) For Form B only, the percentage of asbestos in the product.
(6) For Form B only, explain if you tested or received test results
assessing the asbestos content of your imported product in the
applicable reporting years.
(i) If testing was conducted, specify how often testing was
conducted on the presence of asbestos in your imported product and what
method and type of test was used for determining asbestos content, and
provide the test results.
(ii) If testing was not conducted, explain how you knew or
reasonably ascertained the presence and amount of asbestos in the
imported product.
(7) For Form B only, the disposition of the imported product (see
Table 3 of this paragraph (e)).
(5) Employee information. For each activity reported, report the
following information about employees at the associated site:
(i) Number of employees involved with activity. Select from among
the ranges of employees listed in Table 2 of this paragraph (e) and
report the corresponding code (i.e., W1 through W8).
(ii) Is personal protective equipment used? If yes, identify the
type(s) of personal protective equipment used.
(iii) For Form B only, submit any workplace exposure measurement
assessments and data (e.g., monitoring).
(f) When to report. All information reported to EPA under this
section must be submitted during the applicable submission period. The
submission period shall begin six months following the effective date of
this rule and last for three months.
(g) Recordkeeping requirements. Each person who reports under this
part must maintain records that document information reported under this
part and in accordance with TSCA, permit access to, and the copying of
such records by EPA officials. Relevant records must be retained for a
period of five years beginning on the last day of the submission period.
(h) Confidentiality claims--(1) Assertion of confidentiality
claims--(i) Generally. Any person submitting information under this part
may assert a confidentiality claim for that information, except for
information described in paragraph (h)(1)(ii) of this section. Any such
confidentiality claims must be asserted electronically, pursuant to
Sec. 704.180(i), at the time the information is submitted. Information
claimed as confidential in accordance with this section will be treated
and disclosed in accordance with the procedures in 40 CFR part 2 and
section 14 of TSCA.
(ii) Exceptions. Confidentiality claims may not be asserted with
respect to the following:
(A) Site NAICS code required by Sec. 704.180(e)(3)(v);
(B) For chemical identities and bulk material forms required by
Sec. Sec. 704.180(e)(4)(iii)(A), (iv)(A), (iv)(B)(3), (v)(B)(1),
(vi)(B)(1), and (vii)(B)(2);
(C) Any data element that is left blank or designated as ``not known
or reasonably ascertainable;'' or
(D) Health and safety data required by Sec. 704.180(e)(5)(iii),
except that the following information may be claimed as confidential:
(1) Information that would reveal processes used in the
manufacturing, importing, or processing of the substance or mixture, or
the portion of a mixture comprised by any of the substances in the
mixture, provided that the information is expressly identified as
revealing processing information or portion of a mixture;
(2) Company name or address, financial statistics, and product codes
used by a company and contained in a study; and
(3) Information other than company name or address, financial
statistics, and product codes used by a company, which is contained in a
study, the disclosure of which would clearly be an unwarranted invasion
of personal privacy (such as individual medical records).
(iii) Certification statement for claims. An authorized official
representing a person asserting a claim of confidentiality must certify
that the submission complies with the requirements of this part by
signing and dating the following certification statement:
[[Page 79]]
``I certify that all claims for confidentiality asserted with this
submission are true and correct, and all information submitted herein to
substantiate such claims is true and correct. Any knowing and willful
misrepresentation is subject to criminal penalty pursuant to 18 U.S.C.
1001. I further certify that: I have taken reasonable measures to
protect the confidentiality of the information; I have determined that
the information is not required to be disclosed or otherwise made
available to the public under any other Federal law; I have a reasonable
basis to conclude that disclosure of the information is likely to cause
substantial harm to the competitive position of my company; and I have a
reasonable basis to believe that the information is not readily
discoverable through reverse engineering.''
(2) Substantiation--(i) Requirement to substantiate. Confidentiality
claims must be substantiated at the time of submission to EPA, unless
exempt under paragraph (h)(2)(iv) of this section.
(ii) Information in substantiations may be claimed as confidential.
Such claims must be accompanied by the certification described in
paragraph (h)(1)(iii) of this section, but need not be themselves
substantiated.
(iii) Substantiation questions for all claims. Answers to the
following questions must be provided for each confidentiality claim in a
TSCA submission:
(A) Please specifically explain what harm to the competitive
position of your business would be likely to result from the release of
the information claimed as confidential. How would that harm be
substantial? Why is the substantial harm to your competitive position
likely (i.e., probable) to be caused by release of the information
rather than just possible? If you claimed multiple types of information
to be confidential (e.g., site information, exposure information,
environmental release information), explain how disclosure of each type
of information would be likely to cause substantial harm to the
competitive position of your business.
(B) Has your business taken precautions to protect the
confidentiality of the disclosed information? If yes, please explain and
identify the specific measures, including but not limited to internal
controls, that your business has taken to protect the information
claimed as confidential. If the same or similar information was
previously reported to EPA as non-confidential (such as in an earlier
version of this submission), please explain the circumstances of that
prior submission and reasons for believing the information is
nonetheless still confidential.
(C)(1) Is any of the information claimed as confidential required to
be publicly disclosed under any other Federal law? If yes, please
explain.
(2) Does any of the information claimed as confidential otherwise
appear in any public documents, including (but not limited to) safety
data sheets; advertising or promotional material; professional or trade
publications; state, local, or Federal agency files; or any other media
or publications available to the general public? If yes, please explain
why the information should be treated as confidential.
(3) Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
(D) Is the claim of confidentiality intended to last less than 10
(ten) years (see TSCA section 14(e)(1)(B))? If yes, please indicate the
number of years (between 1 (one) and 10 (ten) years) or the specific
date after which the claim is withdrawn.
(E) Has EPA, another federal agency, or court made any
confidentiality determination regarding information associated with this
chemical substance? If yes, please provide the circumstances associated
with the prior determination, whether the information was found to be
entitled to confidential treatment, the entity that made the decision,
and the date of the determination.
(iv) Exemptions from the substantiation requirement. Confidentiality
claims are exempt from the requirement to substantiate the claim at the
time of submission for the data elements required pursuant to paragraphs
(e)(4)(iii)(B)(1), (iv)(B)(1), (v)(A), (v)(B)(2), (vi)(A), (vi)(B)(2),
(vii)(A), and (vii)(B)(3) of this section.
[[Page 80]]
(v) No claim of confidentiality. Information not claimed as
confidential in accordance with the requirements of this section may be
made public without further notice.
(vi) Public copies. Submissions and their accompanying attachments
that include a confidentiality claim must be accompanied, at the time of
submission, by a public version of the submission and any attachments,
with all information that is claimed as confidential removed. Only
information that is claimed as confidential may be redacted or removed.
Generally, a public copy that removes all or substantially all of the
information would not meet the requirements of this paragraph.
(A) Where the electronic reporting tool contains a checkbox or other
means of designating with specificity what information is claimed as
confidential, no further action by the submitter is required to satisfy
this requirement.
(B) For all other information claimed as confidential, including but
not limited to information in attachments and in substantiations
required under paragraph (h) of this section, the submitter must prepare
and attach a public copy. Submissions with public or sanitized copies
that are entirely blank or that are substantially reduced in length as
compared to the CBI version will not meet the requirements of this
paragraph (h)(2)(vi) of this section.
(i) Electronic reporting. You must use the EPA Central Data Exchange
(CDX) to complete and submit the information required under this
section. Submissions may only be made as set forth in this paragraph.
Submissions must be sent electronically to EPA using the asbestos
reporting tool in CDX. The information submitted and all attachments
(unless the attachment appears in scientific literature) must be in
English. All information must be true and correct. Access the asbestos
reporting tool and instructions, as follows:
(1) By website. Access the asbestos reporting tool via the CDX
homepage at https://cdx.epa.gov/ and follow the applicable instructions.
(2) By phone or email. Contact the EPA TSCA Hotline at (202) 554-
1404 or [email protected].
[88 FR 47800, July 25, 2023; 88 FR 84242, Dec. 5, 2023]
PART 705_REPORTING AND RECORDKEEPING REQUIREMENTS FOR CERTAIN PER-
AND POLYFLUOROALKYL SUBSTANCES--Table of Contents
Sec.
705.1 Scope, compliance, and enforcement.
705.3 Definitions.
705.5 Substances for which reports must be submitted.
705.10 Persons who must report.
705.12 Activities for which reporting is not required.
705.15 What information to report.
705.18 Article importer and R&D substance reporting options.
705.20 When to report.
705.22 Duplicative reporting.
705.25 Recordkeeping requirements.
705.30 Confidentiality claims.
705.35 Electronic reporting.
Authority: 15 U.S.C. 2607(a)(7).
Source: 88 FR 70548, Oct. 11, 2023, unless otherwise noted.
Sec. 705.1 Scope, compliance, and enforcement.
(a) This part specifies reporting and recordkeeping procedures for
manufacturers (including importers) of per- and polyfluoroalkyl
substances (hereafter referred to as PFAS) under section 8(a)(7) of the
Toxic Substances Control Act (TSCA).
(b) TSCA section 15(3) makes it unlawful for any person to fail or
refuse to submit information required under this part. In addition, TSCA
section 15(3) makes it unlawful for any person to fail to keep, and
permit access to, records required by this part. TSCA section 16
provides that any person who violates a provision of TSCA section 15 is
liable to the United States for a civil penalty and may be criminally
prosecuted. Pursuant to TSCA section 17, the Federal Government may seek
judicial relief to compel submission of TSCA section 8(a) information
and to otherwise restrain any violation of TSCA section 15. TSCA section
11 allows for inspections to assure compliance, and the Environmental
Protection Agency's (EPA) Administrator
[[Page 81]]
may by subpoena require the attendance and testimony of witnesses and
the production of reports, papers, documents, answers to questions, and
other information that the Administrator deems necessary.
(c) Each person who reports under this part must maintain records
that document information reported under this part and, in accordance
with TSCA, permit access to, and the copying of, such records by EPA
officials.
Sec. 705.3 Definitions.
The definitions in this section and the definitions in TSCA section
3 apply to this part. In addition, the definitions in 40 CFR 704.3 also
apply to this part, except the definition for small quantities solely
for research and development.
Article means a manufactured item which:
(1) Is formed to a specific shape or design during manufacture;
(2) Has end use function(s) depending in whole or in part upon its
shape or design during end use; and
(3) Has either no change of chemical composition during its end use
or only those changes of composition which have no commercial purpose
separate from that of the article, and that result from a chemical
reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design.
Central Data Exchange or CDX means EPA's centralized electronic
submission receiving system.
Chemical Information Submission System or CISS means EPA's
electronic, web-based reporting tool for the completion and submission
of data, reports, and other information, or its successors.
Commercial use means the use of a chemical substance or a mixture
containing a chemical substance (including as part of an article) in a
commercial enterprise providing saleable goods or services.
Consumer use means the use of a chemical substance or a mixture
containing a chemical substance (including as part of an article) when
sold to or made available to consumers for their use.
Environmental or health effects information means any information of
any effect of a chemical substance or mixture containing a chemical
substance on health or the environment or on both. This includes all
health and safety studies.
(1) Not only is information that arises as a result of a formal,
disciplined study included, but other information relating to the
effects of a chemical substance or mixture containing a chemical
substance on health or the environment is also included. Any information
that bears on the effects of a chemical substance on health or the
environment would be included.
(2) Examples are:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological effects; mammalian absorption, distribution, metabolism,
and excretion; cumulative, additive, and synergistic effects; and acute,
subchronic, and chronic effects.
(ii) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including acute
toxicity tests, chronic toxicity tests, critical life-stage tests,
behavioral tests, algal growth tests, seed germination tests, plant
growth or damage tests, microbial function tests, bioconcentration or
bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular chemical substance or
mixture containing a chemical substance on the environment, including
surveys, tests, and studies of: Biological, photochemical, and chemical
degradation; structure/activity relationships; air, water, and soil
transport; biomagnification and bioconcentration; and chemical and
physical properties, e.g., boiling point, vapor pressure, evaporation
rates from soil and water, octanol/water partition coefficient, and
water solubility.
(iv) Monitoring data, including but not limited to when they have
been aggregated and analyzed to measure the
[[Page 82]]
exposure of humans or the environment to a chemical substance or mixture
containing a chemical substance.
Health and safety studies means any study of any effect of a
chemical substance or mixture on health or the environment or on both,
including underlying information and epidemiological studies, studies of
occupational exposure to a chemical substance or mixture, toxicological,
clinical, and ecological studies of a chemicals substance or mixture
containing a chemical substance, and any test performed under TSCA. The
following information is not part of a health and safety study:
(1) The name, address, or other identifying information for the
submitting company, including identification of the laboratory that
conducted the study in cases where the laboratory is part of or closely
affiliated with the submitting company;
(2) Internal product codes (i.e., code names for the test substance
used internally by the submitting company or to identify the test
substance to the test laboratory);
(3) Names and contact details for testing laboratory personnel and
names and other private information for health and safety study
participants or persons involved in chemical incidents such as would
typically be withheld under 5 U.S.C. 552(b)(6) or under other privacy
laws; and
(4) Information pertaining to test substance product development,
advertising, or marketing plans, or to cost and other financial data.
Highest-level U.S. parent company means the highest-level company of
the site's ownership hierarchy as of the start of the submission period
during which data are being reported according to the following
instructions. The highest-level U.S. parent company is located within
the United States. The following rules govern how to identify the
highest-level U.S. parent company:
(1) If the site is entirely owned by a single U.S. company that is
not owned by another company, that single company is the U.S. parent
company.
(2) If the site is entirely owned by a single U.S. company that is,
itself, owned by another U.S.-based company (e.g., it is a division or
subsidiary of a higher-level company), the highest-level domestic
company in the ownership hierarchy is the U.S. parent company.
(3) If the site is owned by more than one company (e.g., company A
owns 40 percent, company B owns 35 percent, and company C owns 25
percent), the company with the largest ownership interest in the site is
the U.S. parent company. If a higher-level company in the ownership
hierarchy owns more than one ownership company, then determine the
entity with the largest ownership by considering the lower-level
ownerships in combination (e.g., corporation X owns companies B and C,
for a total ownership of 60 percent for the site).
(4) If the site is owned by a 50:50 joint venture or a cooperative,
the joint venture or cooperative is its own parent company. If the site
is owned by a U.S. joint venture or cooperative, the highest level of
the joint venture or cooperative is the U.S. parent company.
(5) If the site is federally owned, the highest-level Federal agency
or department is the U.S. parent company.
(6) If the site is owned by a non-Federal public entity, that entity
(such as a municipality, State, or tribe) is the U.S. parent company.
Industrial function means the intended physical or chemical
characteristic for which a chemical substance or mixture is consumed as
a reactant; incorporated into a formulation, mixture, reaction product
or article; repackaged; or used.
Industrial use means use at a site at which one or more chemical
substances or mixtures are manufactured (including imported) or
processed.
Intended for use by children means the chemical substance or mixture
is used in or on a product that is specifically intended for use by
children aged 14 or younger. A chemical substance or mixture containing
a chemical substance is intended for use by children when the submitter
answers ``yes'' to at least one of the following questions for the
product into which the submitter's chemical substance or mixture
containing a chemical substance is incorporated:
(1) Is the product commonly recognized (i.e., by a reasonable
person) as
[[Page 83]]
being intended for children aged 14 or younger?
(2) Does the manufacturer of the product state through product
labeling or other written materials that the product is intended for or
will be used by children aged 14 or younger?
(3) Is the advertising, promotion, or marketing of the product aimed
at children aged 14 or younger?
Known to or reasonably ascertainable by means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know.
Manufacture means to import into the customs territory of the United
States (as defined in general note 2 of the Harmonized Tariff Schedule
of the United States (19 U.S.C. 1202)), produce, or manufacture for
commercial purposes.
Manufacture for commercial purposes means:
(1) To import, produce, or manufacture with the purpose of obtaining
an immediate or eventual commercial advantage for the manufacturer, and
includes among other things, such ``manufacture'' of any amount of a
chemical substance or mixture containing a chemical substance:
(i) For commercial distribution, including for test marketing; and/
or
(ii) For use by the manufacturer, including use for product research
and development, or as an intermediate.
(2) Manufacture for commercial purposes also applies to substances
that are produced coincidentally during the manufacture, processing,
use, or disposal of another substance or mixture containing a chemical
substance, including both byproducts that are separated from that other
substance or mixture containing a chemical substance and impurities that
remain in that substance or mixture containing a chemical substance.
Such byproducts and impurities may, or may not, in themselves have
commercial value. They are nonetheless produced for the purpose of
obtaining a commercial advantage since they are part of the manufacture
of a chemical product for a commercial purpose.
Per- and polyfluoroalkyl substances or PFAS means, for the purpose
of this part, any chemical substance or mixture containing a chemical
substance that structurally contains at least one of the following three
sub-structures:
(1) R-(CF2)-CF(R[min])R[sec], where both the
CF2 and CF moieties are saturated carbons.
(2) R-CF2OCF2-R[min], where R and R[min] can
either be F, O, or saturated carbons.
(3) CF3C(CF3)R[min]R[sec], where R[min] and
R[sec] can either be F or saturated carbons.
Possession or control means in possession or control of the
submitter, or of any subsidiary, partnership in which the submitter is a
general partner, parent company, or any company or partnership which the
parent company owns or controls, if the subsidiary, parent company, or
other company or partnership is associated with the submitter in the
research, development, test marketing, or commercial marketing of the
chemical substance in question. (A parent company owns or controls
another company if the parent owns or controls 50 percent or more of the
other company's voting stock. A parent company owns or controls any
partnership in which it is a general partner.) Information is included
within this definition if it is:
(1) In files maintained by submitter's employees who are:
(i) Associated with research, development, test marketing, or
commercial marketing of the chemical substance in question; and/or
(ii) Reasonably likely to have such data.
(2) Maintained in the files of other agents of the submitter who are
associated with research, development, test marketing, or commercial
marketing of the chemical substance in question in the course of their
employment as such agents.
Research and development (R&D) means activities intended solely as
scientific experimentation, research, or analysis. R&D focuses on the
analysis of the chemical or physical characteristics, the performance,
or the production characteristics of a chemical substance, a mixture
containing the substance, or an article. R&D encompasses a wide range of
activities which may occur in a laboratory, pilot plant, commercial
plant outside the research facility, or at other sites appropriate for
[[Page 84]]
R&D. General distribution of chemical substances to consumers does not
constitute R&D.
Site-limited means a chemical substance is manufactured and
processed only within a site and is not distributed as a chemical
substance or as part of a mixture or article containing a chemical
substance outside the site. Imported chemical substances are never site-
limited.
Worker means someone at a site of manufacture, import, or processing
who performs work activities near sources of a chemical substance or
mixture or directly handles the chemical substance or mixture during the
performance of work activities.
Sec. 705.5 Substances for which reports must be submitted.
The requirements of this part apply to all chemical substances and
mixtures containing a chemical substance (including articles) that are a
PFAS, consistent with the definition of PFAS at Sec. 705.3.
Sec. 705.10 Persons who must report.
Persons who have manufactured for commercial purposes a chemical
substance identified in Sec. 705.5 at any period from January 1, 2011,
through the end of the last calendar year prior to November 13, 2023,
except as described in Sec. 705.12, is subject to the requirements of
this part.
Sec. 705.12 Activities for which reporting is not required.
Reporting under this part is not required for the import of
municipal solid waste streams for the purpose of disposal or destruction
of the waste. Additionally, reporting is not required for a Federal
agency which imports PFAS when it is not for any immediate or eventual
commercial advantage.
Sec. 705.15 What information to report.
For the one-time submission, persons identified in Sec. 705.10 must
report to EPA, for each site of each of the chemical substances
identified in Sec. 705.5, the following information to the extent known
to or reasonably ascertainable by them, except as allowed under Sec.
705.18. In the event that actual data is not known to or reasonably
ascertainable by the submitter, then reasonable estimates may be
submitted:
(a) Company and plant site information. The following currently
correct company and plant site information must be reported for each
site at which a reportable chemical substance is manufactured (see 40
CFR 711.3 for the ``site'' for importers):
(1) The highest-level U.S. parent company name, address, and Dun and
Bradstreet D-U-N-S[supreg] (D&B) number, if one exists.
(2) The name of a person who will serve as Authorized Official for
the submitter company, and who will be able to sign the certification
statement as described in Sec. 705.30(d), the Authorized Official's
full mailing address, telephone number, and email address.
(3) The name of a person who will serve as technical contact for the
submitter company, and who will be able to answer questions about the
information submitted by the company to EPA, the contact person's full
mailing address, telephone number, and email address.
(4) The name, full street address, and six-digit North American
Industry Classification System (NAICS) code(s) of the site. A submitter
under this part must include the appropriate D&B number for each plant
site reported, and the county or parish (or other jurisdictional
indicator) in which the plant site is located. A submitter under this
part must obtain a D&B number for the site reported if none exists. A
submitter under this part must also provide other site identification
numbers, including the Facility Registry Service (FRS) identification
number, if they exist.
(b) Chemical-specific information. The following chemical-specific
information must be reported for each chemical substance that is a PFAS
manufactured for each year since January 1, 2011, except as allowed
under Sec. 705.18. This includes each chemical substance that is a PFAS
and incorporated into mixtures:
(1) The common or trade name, the chemical identity, and, except for
chemical substances that are Class 1 substances on the TSCA Inventory,
the representative molecular structure of
[[Page 85]]
each PFAS for which such a report is required.
(i) The specific, currently correct Chemical Abstracts (CA) Index
name as used to list the chemical substance on the TSCA Inventory and
the correct corresponding Chemical Abstracts Service Registry Number
(CASRN) for each reportable PFAS at each site. Submitters who wish to
report chemical substances listed on the confidential portion of the
TSCA Inventory will need to report the chemical substance using a TSCA
Accession Number. If a submitter has a low-volume exemption (LVE) case
number for the chemical substance, that number may also be used if a
CASRN is not known to or reasonably ascertainable by the submitter.
(ii) In addition to reporting the number itself, submitters must
specify the type of number they are reporting by selecting from among
the codes in table 1 to this paragraph (b)(1)(ii).
Table 1 to Paragraph (b)(1)(ii)--Codes To Specify Type of Chemical
Identifying Number
------------------------------------------------------------------------
Code Number type
------------------------------------------------------------------------
A............................... TSCA Accession Number.
C............................... Chemical Abstracts Service Registry
Number (CASRN).
L............................... Low-volume exemption (LVE) case
number.
------------------------------------------------------------------------
(iii) If the CASRN or specific identifier (i.e., Accession Number or
LVE number) of the PFAS is not known to or reasonably ascertainable
(NKRA) to the submitter (e.g., if the chemical identity is claimed as
confidential business information by the submitter's supplier, or if the
submitter knows they have a PFAS but are unable to ascertain its
specific identifier and/or specific chemical identity), the submitter
may provide a generic name or description of the PFAS and also initiate
a joint submission if the secondary submitter is known. The submitter
may only initiate a joint submission if the CASRN or the specific
identifier (i.e., Accession Number or LVE number) is not known or
reasonably ascertainable, and a secondary submitter (who would provide
such information) is known. The manufacturer (including importer) must
use the reporting tool described under Sec. 705.35 to ask the supplier
or other entity to provide the chemical identity directly to EPA in a
joint submission. Such request must include instructions for submitting
chemical identity information electronically, using e-CDRweb and CDX
(see 40 CFR 711.35), and for clearly referencing the manufacturer's
(including importer) submission. Contact information for the supplier or
other entity, a trade name or other designation for the chemical
substance, and a copy of the request to the supplier or other entity
must be included with the manufacturer's (including importer)
submission. If, after conducting due diligence and reviewing known or
reasonably ascertainable information, a secondary submitter to complete
the joint submission is not known, the reporter may indicate that the
secondary submitter is NKRA. However, the PFAS manufacturer would be
required to provide as much identifying detail as they have regarding
the PFAS identity, and would be able to report to EPA without initiating
a joint submission even if they do not know the underlying identity of
the chemical substance.
(2) The physical form(s) of the PFAS as it is sent off-site from
each site. If the PFAS is site-limited, you must report the physical
form(s) of the PFAS at the time it is reacted on-site to produce a
different chemical substance. For each PFAS at each site, the submitter
must report as many physical forms as applicable from among the physical
forms listed in this unit:
(i) Dry powder.
(ii) Pellets or large crystals.
(iii) Water- or solvent-wet solid.
(iv) Other solid.
(v) Gas or vapor.
(vi) Liquid.
(c) Categories of use. For each year since January 1, 2011, report
the following information on categories of use of each chemical
substance that is a PFAS manufactured for commercial purposes.
(1) Industrial processing and use information. A designation
indicating the type of industrial processing or use operation(s) at each
site that receives a PFAS from the submitter site directly or indirectly
(whether the recipient site(s) are controlled by the submitter
[[Page 86]]
site or not). For each PFAS, report the letters which correspond to the
appropriate processing or use operation(s) listed in table 2 to this
paragraph (c)(1). A particular designation may need to be reported more
than once, to the extent that a submitter reports more than one sector
that applies to a given designation under this paragraph (c)(1).
Table 2 to Paragraph (c)(1)--Codes for Reporting Type of Industrial
Processing or Use Operation
------------------------------------------------------------------------
Designation Operation
------------------------------------------------------------------------
PC.................................. Processing as a reactant.
PF.................................. Processing--incorporation into
formulation, mixture, or reaction
product.
PA.................................. Processing--incorporation into
article.
PK.................................. Processing--repackaging.
U................................... Use--non-incorporative activities.
------------------------------------------------------------------------
(2) Corresponding sector code. A code indicating the sector(s) that
best describes the industrial activities associated with each industrial
processing or use operation reported under this section. For each
chemical substance, report the code that corresponds to the appropriate
sector(s) listed in table 3 to this paragraph (c)(2). A particular
sector code may need to be reported more than once, to the extent that a
submitter reports more than one function code that applies to a given
sector code under this paragraph (c)(2).
Table 3 to Paragraph (c)(2)--Codes for Reporting Industrial Sectors
------------------------------------------------------------------------
Code Sector description
------------------------------------------------------------------------
IS1............................. Agriculture, forestry, fishing, and
hunting.
IS2............................. Oil and gas drilling, extraction, and
support activities.
IS3............................. Mining (except oil and gas) and
support activities.
IS4............................. Utilities.
IS5............................. Construction.
IS6............................. Food, beverage, and tobacco product
manufacturing.
IS7............................. Textiles, apparel, and leather
manufacturing.
IS8............................. Wood product manufacturing.
IS9............................. Paper manufacturing.
IS10............................ Printing and related support
activities.
IS11............................ Petroleum refineries.
IS12............................ Asphalt paving, roofing, and coating
materials manufacturing.
IS13............................ Petroleum lubricating oil and grease
manufacturing.
IS14............................ All other petroleum and coal products
manufacturing.
IS15............................ Petrochemical manufacturing.
IS16............................ Industrial gas manufacturing.
IS17............................ Synthetic dye and pigment
manufacturing.
IS18............................ Carbon black manufacturing.
IS19............................ All other basic inorganic chemical
manufacturing.
IS20............................ Cyclic crude and intermediate
manufacturing.
IS21............................ All other basic organic chemical
manufacturing.
IS22............................ Plastics material and resin
manufacturing.
IS23............................ Synthetic rubber manufacturing.
IS24............................ Organic fiber manufacturing.
IS25............................ Pesticide, fertilizer, and other
agricultural chemical manufacturing.
IS26............................ Pharmaceutical and medicine
manufacturing.
IS27............................ Paint and coating manufacturing.
IS28............................ Adhesive manufacturing.
IS29............................ Soap, cleaning compound, and toilet
preparation manufacturing.
IS30............................ Printing ink manufacturing.
IS31............................ Explosives manufacturing.
IS32............................ Custom compounding of purchased
resins.
IS33............................ Photographic film, paper, plate, and
chemical manufacturing.
IS34............................ All other chemical product and
preparation manufacturing.
IS35............................ Plastics product manufacturing.
IS36............................ Rubber product manufacturing.
IS37............................ Non-metallic mineral product
manufacturing (includes cement, clay,
concrete, glass, gypsum, lime, and
other non-metallic mineral product
manufacturing).
IS38............................ Primary metal manufacturing.
IS39............................ Fabricated metal product
manufacturing.
IS40............................ Machinery manufacturing.
IS41............................ Computer and electronic product
manufacturing.
IS42............................ Electrical equipment, appliance, and
component manufacturing.
IS43............................ Transportation equipment
manufacturing.
IS44............................ Furniture and related product
manufacturing.
IS45............................ Miscellaneous manufacturing.
IS46............................ Wholesale and retail trade.
IS47............................ Services.
IS48............................ Other (requires additional
information).
------------------------------------------------------------------------
(3) Corresponding function category. For each sector reported under
paragraph (c)(2) of this section, the applicable code(s) from table 4 to
this paragraph (c)(3) must be selected to designate the function
category(ies) that best represents the specific manner in which the PFAS
is used.
Table 4 to Paragraph (c)(3)--Codes for Reporting Function Categories
------------------------------------------------------------------------
Code Category
------------------------------------------------------------------------
F001............................ Abrasives.
F002............................ Etching agent.
F003............................ Adhesion/cohesion promoter.
F004............................ Binder.
F005............................ Flux agent.
F006............................ Sealant (barrier).
F007............................ Absorbent.
F008............................ Adsorbent.
F009............................ Dehydrating agent (desiccant).
F010............................ Drier.
F011............................ Humectant.
F012............................ Soil amendments (fertilizers).
F013............................ Anti-adhesive/cohesive.
F014............................ Dusting agent.
F015............................ Bleaching agent.
F016............................ Brightener.
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F017............................ Anti-scaling agent.
F018............................ Corrosion inhibitor.
F019............................ Dye.
F020............................ Fixing agent (mordant).
F021............................ Hardener.
F022............................ Filler.
F023............................ Anti-static agent.
F024............................ Softener and conditioner.
F025............................ Swelling agent.
F026............................ Tanning agents not otherwise
specified.
F027............................ Waterproofing agent.
F028............................ Wrinkle resisting agent.
F029............................ Flame retardant.
F030............................ Fuel agents.
F031............................ Fuel.
F032............................ Heat transferring agent.
F033............................ Hydraulic fluids.
F034............................ Insulators.
F035............................ Refrigerants.
F036............................ Anti-freeze agent.
F037............................ Intermediate.
F038............................ Monomers.
F039............................ Ion exchange agent.
F040............................ Anti-slip agent.
F041............................ Lubricating agent.
F042............................ Deodorizer.
F043............................ Fragrance.
F044............................ Oxidizing agent.
F045............................ Reducing agent.
F046............................ Photosensitive agent.
F047............................ Photosensitizers.
F048............................ Semiconductor and photovoltaic agent.
F049............................ UV stabilizer.
F050............................ Opacifer.
F051............................ Pigment.
F052............................ Plasticizer.
F053............................ Plating agent.
F054............................ Catalyst.
F055............................ Chain transfer agent.
F056............................ Chemical reaction regulator.
F057............................ Crystal growth modifiers (nucleating
agents).
F058............................ Polymerization promoter.
F059............................ Terminator/Blocker.
F060............................ Processing aids, specific to petroleum
production.
F061............................ Antioxidant.
F062............................ Chelating agent.
F063............................ Defoamer.
F064............................ pH regulating agent.
F065............................ Processing aids not otherwise
specified.
F066............................ Energy Releasers (explosives, motive
propellant).
F067............................ Foamant.
F068............................ Propellants, non-motive (blowing
agents).
F069............................ Cloud-point depressant.
F070............................ Flocculating agent.
F071............................ Flotation agent.
F072............................ Solids separation (precipitating)
agent, not otherwise specified.
F073............................ Cleaning agent.
F074............................ Diluent.
F075............................ Solvent.
F076............................ Surfactant (surface active agent).
F077............................ Emulsifier.
F078............................ Thickening agent.
F079............................ Viscosity modifiers.
F080............................ Laboratory chemicals.
F081............................ Dispersing agent.
F082............................ Freeze-thaw additive.
F083............................ Surface modifier.
F084............................ Wetting agent (non-aqueous).
F085............................ Aerating and deaerating agents.
F086............................ Explosion inhibitor.
F087............................ Fire extinguishing agent.
F088............................ Flavoring and nutrient.
F089............................ Anti-redeposition agent.
F090............................ Anti-stain agent.
F091............................ Anti-streaking agent.
F092............................ Conductive agent.
F093............................ Incandescent agent.
F094............................ Magnetic element.
F095............................ Anti-condensation agent.
F096............................ Coalescing agent.
F097............................ Film former.
F098............................ Demulsifier.
F099............................ Stabilizing agent.
F100............................ Alloys.
F101............................ Density modifier.
F102............................ Elasticizer.
F103............................ Flow promoter.
F104............................ Sizing agent.
F105............................ Solubility enhancer.
F106............................ Vapor pressure modifiers.
F107............................ Embalming agent.
F108............................ Heat stabilizer.
F109............................ Preservative.
F110............................ Anti-caking agent.
F111............................ Deflocculant.
F112............................ Dust suppressant.
F113............................ Impregnation agent.
F114............................ Leaching agent.
F115............................ Tracer.
F116............................ X-ray absorber.
F999............................ Other.
------------------------------------------------------------------------
(4) Consumer and commercial use information. Using the applicable
codes listed in table 5 to this paragraph (c)(4), submitters must
designate the consumer and commercial product category(ies) that best
describe the consumer and commercial products in which each PFAS is used
(whether the recipient site(s) are controlled by the submitter site or
not). If more than 10 codes apply to a PFAS, submitters need only report
the 10 codes for PFAS that cumulatively represent the largest percentage
of the submitter's production volume for that chemical, measured by
weight. If none of the listed consumer and commercial product categories
accurately describes the consumer and commercial products in which each
PFAS is used, the category ``Other'' may be used, and must include a
description of the use.
[[Page 88]]
Table 5 to Paragraph (c)(4)--Codes for Reporting Consumer and Commercial
Product Categories
------------------------------------------------------------------------
Code Category
------------------------------------------------------------------------
Chemical Substances in Furnishing, Cleaning, Treatment Care Products
------------------------------------------------------------------------
CC101........................... Construction and building materials
covering large surface areas
including stone, plaster, cement,
glass and ceramic articles; fabrics,
textiles, and apparel.
CC102........................... Furniture & furnishings including
plastic articles (soft); leather
articles.
CC103........................... Furniture & furnishings including
stone, plaster, cement, glass and
ceramic articles; metal articles; or
rubber articles.
CC104........................... Leather conditioner.
CC105........................... Leather tanning, dye, finishing,
impregnation and care products.
CC106........................... Textile (fabric) dyes.
CC107........................... Textile finishing and impregnating/
surface treatment products.
CC108........................... All-purpose foam spray cleaner.
CC109........................... All-purpose liquid cleaner/polish.
CC110........................... All-purpose liquid spray cleaner.
CC111........................... All-purpose waxes and polishes.
CC112........................... Appliance cleaners.
CC113........................... Drain and toilet cleaners (liquid).
CC114........................... Powder cleaners (floors).
CC115........................... Powder cleaners (porcelain).
CC116........................... Dishwashing detergent (liquid/gel).
CC117........................... Dishwashing detergent (unit dose/
granule).
CC118........................... Dishwashing detergent liquid (hand-
wash).
CC119........................... Dry cleaning and associated products.
CC120........................... Fabric enhancers.
CC121........................... Laundry detergent (unit-dose/granule).
CC122........................... Laundry detergent (liquid).
CC123........................... Stain removers.
CC124........................... Ion exchangers.
CC125........................... Liquid water treatment products.
CC126........................... Solid/Powder water treatment products.
CC127........................... Liquid body soap.
CC128........................... Liquid hand soap.
CC129........................... Solid bar soap.
CC130........................... Air fresheners for motor vehicles.
CC131........................... Continuous action air fresheners.
CC132........................... Instant action air fresheners.
CC133........................... Anti-static spray.
CC134........................... Apparel finishing, and impregnating/
surface treatment products.
CC135........................... Insect repellent treatment.
CC136........................... Pre-market waxes, stains, and polishes
applied to footwear.
CC137........................... Post-market waxes, and polishes
applied to footwear (shoe polish).
CC138........................... Waterproofing and water-resistant
sprays.
------------------------------------------------------------------------
Chemical Substances in Construction, Paint, Electrical, and Metal
Products
------------------------------------------------------------------------
CC201........................... Fillers and putties.
CC202........................... Hot-melt adhesives.
CC203........................... One-component caulks.
CC204........................... Solder.
CC205........................... Single-component glues and adhesives.
CC206........................... Two-component caulks.
CC207........................... Two-component glues and adhesives.
CC208........................... Adhesive/Caulk removers.
CC209........................... Aerosol spray paints.
CC210........................... Lacquers, stains, varnishes and floor
finishes.
CC211........................... Paint strippers/removers.
CC212........................... Powder coatings.
CC213........................... Radiation curable coatings.
CC214........................... Solvent-based paint.
CC215........................... Thinners.
CC216........................... Water-based paint.
CC217........................... Construction and building materials
covering large surface areas,
including wood articles.
CC218........................... Construction and building materials
covering large surface areas,
including paper articles; metal
articles; stone, plaster, cement,
glass and ceramic articles.
CC219........................... Machinery, mechanical appliances,
electrical/electronic articles.
CC220........................... Other machinery, mechanical
appliances, electronic/electronic
articles.
CC221........................... Construction and building materials
covering large surface areas,
including metal articles.
CC222........................... Electrical batteries and accumulators.
------------------------------------------------------------------------
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
CC990........................... Non-TSCA use.
CC301........................... Packaging (excluding food packaging),
including paper articles.
CC302........................... Other articles with routine direct
contact during normal use, including
paper articles.
CC303........................... Packaging (excluding food packaging),
including rubber articles; plastic
articles (hard); plastic articles
(soft).
CC304........................... Other articles with routine direct
contact during normal use including
rubber articles; plastic articles
(hard).
CC305........................... Toys intended for children's use (and
child dedicated articles), including
fabrics, textiles, and apparel; or
plastic articles (hard).
CC306........................... Adhesives applied at elevated
temperatures.
CC307........................... Cement/concrete.
CC308........................... Crafting glue.
CC309........................... Crafting paint (applied to body).
CC310........................... Crafting paint (applied to craft).
CC311........................... Fixatives and finishing spray
coatings.
CC312........................... Modelling clay.
CC313........................... Correction fluid/tape.
CC314........................... Inks in writing equipment (liquid).
CC315........................... Inks used for stamps.
CC316........................... Toner/Printer cartridge.
CC317........................... Liquid photographic processing
solutions.
------------------------------------------------------------------------
Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
Products
------------------------------------------------------------------------
CC401........................... Exterior car washes and soaps.
CC402........................... Exterior car waxes, polishes, and
coatings.
CC403........................... Interior car care.
CC404........................... Touch up auto paint.
CC405........................... Degreasers.
CC406........................... Liquid lubricants and greases.
CC407........................... Paste lubricants and greases.
CC408........................... Spray lubricants and greases.
CC409........................... Anti-freeze liquids.
CC410........................... De-icing liquids.
CC411........................... De-icing solids.
CC412........................... Lock de-icers/releasers.
CC413........................... Cooking and heating fuels.
CC414........................... Fuel additives.
CC415........................... Vehicular or appliance fuels.
CC416........................... Explosive materials.
CC417........................... Agricultural non-pesticidal products.
CC418........................... Lawn and garden care products.
------------------------------------------------------------------------
[[Page 89]]
Chemical Substances in Products Not Described by Other Codes
------------------------------------------------------------------------
CC980........................... Other (specify).
CC990........................... Non-TSCA use.
------------------------------------------------------------------------
(5) Applicable codes for each commercial and consumer products. For
each consumer and commercial product category reported under paragraph
(c)(4) of this section, the applicable code(s) described in table 4 to
paragraph (c)(3) of this section must be selected to designate the
function category(ies) that best represents the specific manner in which
the PFAS is used.
(6) Commercial and consumer products. Submitters must indicate, for
each consumer and commercial product category reported under paragraph
(c)(4) of this section, whether the use is a consumer or a commercial
use, or both.
(7) Consumer product category. Submitters must determine, within
each consumer and commercial product category reported under paragraph
(c)(4) of this section, whether any amount of each reportable chemical
substance manufactured (including imported) by the submitter is present
in (for example, a plasticizer chemical substance used to make
pacifiers) or on (for example, as a component in the paint on a toy) any
consumer products intended for use by children age 14 or younger,
regardless of the concentration of the chemical substance remaining in
or on the product. Submitters must select from the following options:
The chemical substance is used in or on any consumer products intended
for use by children; the chemical substance is not used in or on any
consumer products intended for use by children; or information as to
whether the chemical substance is used in or on any consumer products
intended for use by children is not known to or reasonably ascertainable
by the submitter.
(8) Concentrations of PFAS. For each year where the PFAS is used in
consumer or commercial products, the estimated typical maximum
concentration, measured by weight, of the chemical substance in each
consumer and commercial product category reported under paragraph (c)(4)
of this section. For each PFAS in each commercial and consumer product
category reported under paragraph (c)(4) of this section, submitters
must select from among the ranges of concentrations listed in table 6 to
this paragraph (c)(8) and report the corresponding code (i.e., M1
through M5):
Table 6 to Paragraph (c)(8)--Codes for Reporting Maximum Concentration
of Chemical Substance
------------------------------------------------------------------------
Code Concentration range (% weight)
------------------------------------------------------------------------
M1.............................. Less than 1% by weight.
M2.............................. At least 1 but less than 30% by
weight.
M3.............................. At least 30 but less than 60% by
weight.
M4.............................. At least 60 but less than 90% by
weight.
M5.............................. At least 90% by weight.
------------------------------------------------------------------------
(d) Manufactured amounts. For each year since January 1, 2011, the
total amounts manufactured of each PFAS, including the amounts
manufactured in each calendar year for each category of use as described
in paragraph (c) of this section.
(1) Total volume. For each year the PFAS was manufactured, the total
annual volume (in pounds) of each PFAS domestically manufactured or
imported at each site. The total annual domestically manufactured volume
(not including imported volume) and the total annual imported volume
must be separately reported. These amounts must be reported to two
significant figures of accuracy.
(2) Site designation. A designation indicating, for each PFAS at
each site, whether the imported PFAS is physically present at the
reporting site.
(3) Volume imported. The volume directly exported of each PFAS
domestically manufactured or imported at each site. These amounts must
be reported to two significant figures of accuracy.
(4) Production volume. The estimated percentage, rounded off to the
closest 10 percent, of total production volume of the reportable
chemical substance associated with each combination of industrial
processing or use operation, sector, and function category as reported
in paragraph (c) of this section. Where a particular combination of
industrial processing or use operation,
[[Page 90]]
sector, and function category accounts for less than 5 percent of the
submitter's site's total production volume of a reportable chemical
substance, the percentage must not be rounded off to 0 percent. Instead,
in such a case, submitters must report the percentage, rounded off to
the closest 1 percent, of the submitter's site's total production volume
of the reportable chemical substance associated with the particular
combination of industrial processing or use operation, sector, and
function category.
(5) Site production volume. The estimated percentage, rounded off to
the closest 10 percent, of the submitter's site's total production
volume of the PFAS associated with each consumer and commercial product
category as reported in paragraph (c)(4) of this section. Where a
particular consumer and commercial product category accounts for less
than 5 percent of the total production volume of a reportable chemical
substance, the percentage must not be rounded off to 0 percent. Instead,
in such a case, submitters must report the percentage, rounded off to
the closest 1 percent, of the submitter's site's total production volume
of the reportable chemical substance associated with the particular
consumer and commercial product category.
(6) Site-limited. An indication of whether the PFAS was site-
limited.
(7) Volume recycled. The total volume (in pounds) of each PFAS
recycled on-site.
(e) Byproduct reporting. A description of the byproducts resulting
from the manufacture, processing, use, or disposal of each PFAS.
(1) Byproduct identification. For each byproduct produced from the
manufacture, processing, use, or disposal of a PFAS, the submitter will
identify the byproduct by its specific, currently correct CA Index name
as used to list the chemical substance on the TSCA Inventory and the
correct corresponding CASRN. A submitter under this part may use a known
EPA-designated TSCA Accession Number for a chemical substance in lieu of
a CASRN when a CASRN is not known to or reasonably ascertainable by the
submitter. Submitters who wish to report chemical substances listed on
the confidential portion of the TSCA Inventory will need to report the
chemical substance using a TSCA Accession Number.
(i) In addition to reporting the number itself, submitters must
specify the type of number they are reporting by selecting from among
the codes in table 1 to paragraph (b)(1)(ii) of this section.
(ii) If the specific chemical identity of the byproduct is unknown
to the submitter, the submitter may provide a description of the
chemical substance.
(iii) An indication of which specific PFAS activity(ies) (i.e.,
manufacture, process, use, or disposal) manufactured the byproduct.
(2) Releases. An indication of whether the byproduct is released to
the environment, and if so, the environmental medium to which it is
released (i.e., air, water, land).
(3) Volume. For each year, the byproduct volume (in pounds) released
to the environment.
(f) Environmental and health effects. All existing information
concerning the environmental and health effects of such substance or
mixture containing a chemical substance in the manufacturer's possession
or control. The scope of this information shall not be limited to
studies conducted or published since 2011.
(1) Organization for Economic Cooperation and Development (OECD)
Harmonized Templates. For each published study report, the submitter
shall complete an OECD Harmonized Templates for Reporting Chemical Test
Summaries and submit the accompanying study reports and supporting
information. This can be accomplished by using the freely available
IUCLID software.
(2) Human health data--preliminary studies. Submitters shall also
provide any additional human health data not in study reports, including
but not limited to any preliminary studies, informal test results in
workers, or inhalation studies.
(3) Analytical tests. Submitters shall also provide the names of any
analytical or test methods used to detect or otherwise test for the
PFAS.
[[Page 91]]
(g) Worker exposure data. The number of individuals exposed to PFAS
in their places of employment and the duration of such exposure.
(1) Employment activities. A narrative description of worker
activities involving the PFAS at the manufacturing site, such as bag
dumping, sampling, cleaning, or unloading drums.
(2) Number of workers. For each worker activity in this paragraph,
indicate the number of workers reasonably likely to be exposed. The
submitter must select from among the worker ranges listed in table 7 to
this paragraph (g)(2) and report the corresponding code (i.e., W1 though
W8).
Table 7 to Paragraph (g)(2)--Codes for Reporting Number of Workers
Reasonably Likely To Be Exposed
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
W1.............................. Fewer than 10 workers.
W2.............................. At least 10 but fewer than 25 workers.
W3.............................. At least 25 but fewer than 50 workers.
W4.............................. At least 50 but fewer than 100
workers.
W5.............................. At least 100 but fewer than 500
workers.
W6.............................. At least 500 but fewer than 1,000
workers.
W7.............................. At least 1,000 but fewer than 10,000
workers.
W8.............................. At least 10,000 workers.
------------------------------------------------------------------------
(3) Exposure scenarios. For each worker activity in this paragraph
(g), the maximum duration of exposure for any worker at the
manufacturing site, for each of the following scenarios:
(i) The daily exposure duration (in hours per day) in the case of
the worker with greatest annual exposure frequency (i.e., the worker
exposed the most days per year); and
(ii) The annual exposure frequency (in days per year) in the case of
the worker with greatest daily exposure duration (i.e., the worker
exposed for the most hours per day during the year).
(4) Exposure by category. For each combination of industrial
processing or use operation, sector, and function category identified in
paragraph (c) of this section, the submitter must estimate the number of
workers reasonably likely to be exposed to each PFAS. For each
combination associated with each chemical substance, the submitter must
select from among the worker ranges listed in table 7 to paragraph
(g)(2) of this section and report the corresponding code (i.e., W1
though W8).
(5) Duration of exposure industrial use. For each PFAS, the maximum
duration of exposure for any worker for each combination of industrial
processing or use operation, sector, and function category, for each of
the following scenarios:
(i) The daily exposure duration (in hours per day) in the case of
the worker with the greatest annual exposure frequency (i.e., the worker
exposed the most days per year); and
(ii) The annual exposure frequency (in days per year) in the case of
the worker with the greatest daily exposure duration (i.e., the worker
exposed for the most hours per day during the year).
(6) Commercial workers. Where the PFAS is used in a commercial
product, the submitter must estimate the number of commercial workers
reasonably likely to be exposed to each reportable chemical substance.
For each commercial use associated with each substance, the submitter
must select from among the worker ranges listed in table 7 to paragraph
(g)(2) of this section and report the corresponding code (i.e., W1
though W8).
(7) Duration of exposure commercial use. For each PFAS, the maximum
duration of exposure for any worker for each commercial use, for each of
the following scenarios:
(i) The daily exposure duration (in hours per day) in the case of
the worker with greatest annual exposure frequency (i.e., the worker
exposed the most days per year); and
(ii) The annual exposure frequency (in days per year) in the case of
the worker with greatest daily exposure duration (i.e., the worker
exposed for the most hours per day during the year).
(h) Disposal data. During the years in which the PFAS was
manufactured, the manners or methods of its disposal, and any changes to
the disposal methods or processes.
(1) Categories of disposal methods. Description of disposal
processes or methods, using the appropriate codes in table 8 to this
paragraph (h)(1), and additional descriptions as needed.
[[Page 92]]
Table 8 to Paragraph (h)(1)--Codes for Reporting Disposal Methods
------------------------------------------------------------------------
Code Disposal method
------------------------------------------------------------------------
D1.............................. On-site land disposal: Resource
Conservation and Recovery Act (RCRA)
Class C landfill (hazardous).
D2.............................. On-site land disposal: other landfill.
D3.............................. Other on-site land disposal.
D4.............................. On-site underground injection (UIC).
D5.............................. Off-site land disposal: RCRA Class C
landfill (hazardous).
D6.............................. Off-site land disposal: other
landfill.
D7.............................. On-site incineration.
D8.............................. Off-site incineration.
D9.............................. Publicly owned treatment works (POTW).
D10............................. Other off-site waste transfer.
D11............................. Release to surface water.
D12............................. Release to air (stack emissions).
D13............................. Release to air (fugitive emissions).
D99............................. Other.
------------------------------------------------------------------------
(2) Disposal processes. Describe any changes to the disposal
process(es) or method(s) indicated in paragraph (h)(1) of this section
for any PFAS manufactured since 2011.
(3) Disposal volume. Indicate total volume of the PFAS that was
released to each environmental medium in each year since 2011: land,
water, and air.
(4) Incineration volume. Indicate total volume of the PFAS that was
incinerated on-site in each year since 2011. If incineration occurred,
indicate the temperature (in degrees Celsius) at which the PFAS was
incinerated. If incineration occurred at multiple temperatures, indicate
the minimum temperature (in degrees Celsius) at which the PFAS was
incinerated.
Sec. 705.18 Article importer and R&D substance reporting options.
For the one-time submission, certain manufacturers have the option
to use a streamlined reporting form if they do not know nor can
reasonably ascertain information requested under Sec. 705.15, beyond
what is listed in this part. Paragraph (a) of this section lists the
information which a manufacturer who has imported a PFAS within an
article must report to the extent they know or can reasonably ascertain.
Paragraph (b) of this section lists the information that manufacturers
of PFAS that are solely R&D substances manufactured in volumes no
greater than 10 kilograms per year must report to the extent they know
or can reasonably ascertain.
(a) Article reporting. Any importer of an article which contains a
chemical substance that is a PFAS and who meets the reporting
requirements described in Sec. 705.10 has the option to submit
information to EPA using a streamlined reporting form for that PFAS in
the imported article, for each year since January 1, 2011, in which the
PFAS was imported in an article. Information must be submitted to the
extent the submitter knows or can reasonably ascertain. In the event
that actual data is not known to or reasonably ascertainable by the
submitter, then reasonable estimates may be submitted. The information
requested on the streamlined reporting form for article importers
includes:
(1) Company and plant site information. All company and plant site
information requested under Sec. 705.15(a) shall be reported.
(2) Chemical-specific information. The following chemical-specific
information must be reported for each chemical substance that is a PFAS
imported in an article, for each year since January 1, 2011, in which
that PFAS was imported within an article.
(i) The common or trade name, the chemical identity, and, except for
chemical substances that are Class 1 substances on the TSCA Inventory
(Inventory), the representative molecular structure of each PFAS for
which such a report is required. Submitters who wish to report chemical
substances listed on the confidential portion of the Inventory will need
to report the chemical substance using a TSCA Accession Number. If a
submitter has a low-volume exemption (LVE) case number for the chemical
substance, that number may also be used if a CASRN is not known to or
reasonably ascertainable by the submitter. In addition to reporting the
number itself, submitters must specify the type of number they are
reporting by selecting from among the codes in table 1 to Sec.
705.15(b)(1)(ii).
(ii) If the specific chemical identity of the PFAS imported in an
article is not known to or reasonably ascertainable to the submitter
(e.g., if the chemical identity is claimed as confidential business
information by the submitter's supplier, or if the submitter knows they
have a PFAS but is unable
[[Page 93]]
to ascertain its specific chemical identity), the submitter may provide
a generic name or description of the PFAS.
(3) Categories of use. For each year since January 1, 2011, report
the following information on categories of use of each PFAS imported in
an article.
(i) Industrial processing and use information. A designation
indicating the type of industrial processing or use operation(s) at each
site that receives a PFAS from the submitter site directly or indirectly
(whether the recipient site(s) are controlled by the submitter site or
not). For each PFAS that was imported in an article, report the letters
which correspond to the appropriate processing or use operation(s)
listed in table 2 to Sec. 705.15(c)(1). A particular designation may
need to be reported more than once, to the extent that a submitter
reports more than one sector that applies to a given designation under
this paragraph (a)(3)(i).
(ii) Industrial activities sector. A code indicating the sector(s)
that best describe the industrial activities associated with each
industrial processing or use operation reported under this section. For
each PFAS that was imported in an article, report the code that
corresponds to the appropriate sector(s) listed in table 3 to Sec.
705.15(c)(2). A particular sector code may need to be reported more than
once, to the extent that a submitter reports more than one function code
that applies to a given sector code under this paragraph (a)(3)(ii).
(iii) Sector specific function categories. For each sector reported
under paragraph (a)(3)(ii) of this section, the applicable code(s) from
table 4 to Sec. 705.15(c)(3) must be selected to designate the function
category(ies) that best represents the specific manner in which the PFAS
in the imported article is used.
(iv) Consumer and commercial use information. Using the applicable
codes listed in table 5 to Sec. 705.15(c)(4), submitters must designate
the consumer and commercial product category(ies) that best describe the
consumer and commercial products in which each PFAS that is in an
imported article is used (whether the recipient site(s) are controlled
by the submitter site or not). If more than 10 codes apply to a PFAS in
an imported article, submitters need only report the 10 codes for PFAS
that cumulatively represent the largest percentage of the submitter's
production volume for that chemical, measured by weight. If none of the
listed consumer and commercial product categories accurately describe
the consumer and commercial products in which each PFAS is used, the
category ``Other'' may be used, and must include a description of the
use.
(v) Product specific function categories. For each consumer and
commercial product category reported under paragraph (a)(3)(iv) of this
section, the applicable code(s) described in table 4 to Sec.
705.15(c)(3) must be selected to designate the function category(ies)
that best represents the specific manner in which the PFAS in an
imported article is used.
(vi) Consumer or commercial use designation. Submitters must
indicate, for each consumer and commercial product category reported
under paragraph (a)(3)(v) of this section, whether the use is a consumer
or a commercial use, or both.
(vii) In or on consumer products intended for children. Submitters
must determine, within each consumer and commercial product category
reported under paragraph (a)(3)(v) of this section, whether any amount
of each reportable chemical substance manufactured (including imported)
by the submitter is present in (for example, a plasticizer chemical
substance used to make pacifiers) or on (for example, as a component in
the paint on a toy) any consumer products intended for use by children
age 14 or younger, regardless of the concentration of the chemical
substance remaining in or on the product. Submitters must select from
the following options: The chemical substance is used in or on any
consumer products intended for use by children; the chemical substance
is not used in or on any consumer products intended for use by children;
or information as to whether the chemical substance is used in or on any
consumer products intended for use by children is not known to or
reasonably ascertainable by the submitter.
(viii) Estimated maximum concentration. For each year where the PFAS
in
[[Page 94]]
an imported article is used in consumer or commercial products, the
submitter must report the estimated typical maximum concentration,
measured by weight, of the chemical substance in each consumer and
commercial product category reported under paragraph (a)(3)(v) of this
section. For each PFAS in an imported article in each commercial and
consumer product category reported under paragraph (a)(3)(v) of this
section, submitters must select from among the ranges of concentrations
listed in table 1 to this paragraph (a)(3)(viii) and report the
corresponding code (i.e., AM1 through AM5):
Table 1 to Paragraph (a)(3)(viii)--Codes for Reporting Maximum
Concentration of PFAS in an Imported Article
------------------------------------------------------------------------
Code Concentration range (% weight)
------------------------------------------------------------------------
AM1............................. Less than 0.1% by weight.
AM2............................. At least 0.1% but less than 1% by
weight.
AM3............................. At least 1% but less than 10% by
weight.
AM4............................. At least 10% but less than 30% by
weight.
AM5............................. At least 30% by weight.
------------------------------------------------------------------------
(4) Imported article production volume. For each calendar year since
January 1, 2011, in which the PFAS was imported in an article, the
production volume of the imported article. The imported production
volume must be reported to two significant figures of accuracy. The
submitter must also provide the unit of measurement of the imported
production volume by selecting among the table 2 to this paragraph
(a)(4). The submitter must also designate, for each PFAS imported in an
article, whether the imported PFAS was ever physically present at the
reporting site.
Table 2 to Paragraph (a)(4)--Codes To Specify Unit of Measurement for
the Imported Article Production Volume
------------------------------------------------------------------------
Code Unit of measurement
------------------------------------------------------------------------
LB.............................. Pounds.
TN.............................. Tons.
QT.............................. Quantity of imported article.
O............................... Other (must specify).
------------------------------------------------------------------------
(5) Additional article data. The submitter has the option to provide
any additional information to EPA that is requested under Sec. 705.15
on the PFAS imported in an article, including supplemental attachments.
(b) Research and development (R&D). Any manufacturer of a PFAS R&D
substance that was manufactured in volumes no greater than 10 kilograms
per year and who meets the reporting requirements described in Sec.
705.10 has the option to submit information to EPA using a streamlined
reporting form for each such PFAS, for each year since January 1, 2011,
in which the PFAS was manufactured for R&D purposes in volumes no
greater than 10 kilograms per year. Information must be submitted to the
extent the submitter knows or can reasonably ascertain. In the event
that actual data is not known to or reasonably ascertainable by the
submitter, then reasonable estimates may be submitted. The information
requested on the streamlined reporting form for R&D manufacturers
includes:
(1) Company and plant site information. All company and plant site
information requested under Sec. 705.15(a) shall be reported.
(2) Chemical-specific information. The following chemical-specific
information must be reported for each R&D chemical substance that is a
PFAS and each mixture containing a chemical substance that is a PFAS and
meets the requirements for the reporting option under this paragraph
(b)(2). The information must be reported for each year since January 1,
2011, in which that PFAS was manufactured for R&D purposes in quantities
no greater than 10 kilograms per year.
(i) The common or trade name, the chemical identity, and, except for
chemical substances that are Class 1 substances on the TSCA Inventory,
the representative molecular structure of each PFAS for which such a
report is required. Submitters who wish to report chemical substances
listed on the confidential portion of the TSCA Inventory will need to
report the chemical substance using a TSCA Accession Number. If a
submitter has a low-volume exemption (LVE) case number for the chemical
substance, that number may also be used if a CASRN is not known to or
reasonably ascertainable by the submitter. In addition to reporting the
number itself, submitters must specify the type of number they are
reporting by selecting from among the codes in table 1 to Sec.
705.15(b)(1)(ii).
[[Page 95]]
(ii) If the specific chemical identity of the PFAS is not known to
or reasonably ascertainable to the submitter (e.g., if the chemical
identity is claimed as confidential business information by the
submitter's supplier, or if the submitter knows they have a PFAS but are
unable to ascertain its specific chemical identity), the submitter may
provide a generic name or description of the PFAS.
(3) Production volume. The submitter must report for each year since
January 1, 2011, in which the PFAS was manufactured, the total annual
volume (in pounds) of each PFAS domestically manufactured or imported at
each site. The total annual domestically manufactured volume (not
including imported volume) and the total annual imported volume must be
separately reported. These amounts must be reported to two significant
figures of accuracy.
(i) A designation indicating, for each PFAS at each site, whether
any imported PFAS is ever physically present at the reporting site.
(ii) [Reserved]
(4) Additional R&D data. The submitter has the option to provide any
additional information to EPA that is requested under Sec. 705.15 on
the PFAS, including supplemental attachments.
Sec. 705.20 When to report.
All information reported to EPA in response to the requirements of
this part must be submitted during the applicable submission period. For
all reporters submitting information pursuant to Sec. Sec. 705.15 and
705.18(b) (research and development), the submission period shall begin
one year following November 13, 2023, and last for six months: November
12, 2024, through May 8, 2025. For any reporter who is reporting under
this part exclusively pursuant to Sec. 705.18(a) (article importers),
and is also considered a small manufacturer under the definition at 40
CFR 704.3, the submission period shall begin one year following November
13, 2023, and last for 12 months: November 12, 2024, through November
10, 2025.
Sec. 705.22 Duplicative reporting.
Any person covered in this part may notify EPA through the
electronic reporting system in Sec. 705.35 that certain information has
already been submitted to EPA, and any such person does not need to re-
submit the information. The notification must include the statutory and
regulatory provision under which the information was submitted and in
which year it was submitted. This ability is limited to the type of
information listed in this section. If the previous submission did not
account for all information required to be submitted pursuant to this
part (e.g., due to exemptions inapplicable to this part), then the
person may not rely on that prior submission to satisfy the reporting
requirements of this part.
(a) Chemical Data Reporting rule. If a person identified in Sec.
705.10 has already reported certain information in Sec. 705.15 to EPA
pursuant to the Chemical Data Reporting rule at 40 CFR part 711, then
duplicative reporting of that information is not required of the years
for which the information has already been reported. Such information
that may potentially be duplicative under this part is limited to:
(1) Chemical description. Physical state of the chemical or mixture
containing a chemical substance, pursuant to 40 CFR 711.15(b)(3)(C)(ix).
(2) Sector description. Industrial processing and use type,
sector(s), functional category(ies), and percent of production volume
for each use, pursuant to 40 CFR 711.15(b)(4)(i)(A) through (D).
(3) Product category. Consumer and/or commercial indicator, product
category(ies), functional category(ies), percent of production volume
for each use, indicator for use in products intended for children, and
maximum concentration in the product, pursuant to 40 CFR
711.15(b)(4)(ii)(A) through (F).
(4) Workers. Number of workers reasonably likely to be exposed for
each combination of industrial processing or use operation, sector, and
function, pursuant to 40 CFR 711.15(b)(4)(i)(F), and the number of
commercial workers reasonably likely to be exposed when the substance is
used in a commercial product, pursuant to 40 CFR 711.15(b)(4)(ii)(G).
[[Page 96]]
(5) Volume. Production volume, both domestically manufactured and
imported, an indicator for the imported chemical never physically at
site, and the volume directly exported, pursuant to 40 CFR
711.15(b)(3)(iii) through (v).
(b) Greenhouse Gas Reporting rule. If a person identified in Sec.
705.10 has already reported certain information in Sec. 705.15 to EPA
pursuant to the Greenhouse Gas Reporting rule at 40 CFR part 98, then
duplicative reporting of that information is not required of the years
for which the information has already been reported. Such information
that may potentially be duplicative under this part is limited to:
(1) Imported. Production volume (imported), pursuant to 40 CFR
98.416(c)(1) and (2).
(2) Exported. Volume directly exported, pursuant to 40 CFR
98.416(d)(1).
(3) Incinerated. Total volume incinerated on-site, pursuant to 40
CFR part 98.
(c) Toxics Release Inventory reporting rule. If a person identified
in Sec. 705.10 has already reported certain information in Sec. 705.15
to EPA pursuant to the Toxics Release Inventory reporting rule at 40 CFR
part 372, then duplicative reporting of that information is not required
of the years for which the information has already been reported. Such
information that may potentially be duplicative under this part is
limited to:
(1) Recycled. Total volume recycled on-site, pursuant to 40 CFR
372.85(b)(16).
(2) Disposal. Description of disposal process(es), pursuant to 40
CFR 372.85(b)(14) and (15).
(3) Release to land. Total volume released to land, pursuant to 40
CFR 372.85(b)(14)(i)(D) and (E).
(4) Release to water. Total volume released to water, pursuant to 40
CFR 372.85(b)(14)(i)(C).
(5) Release to air. Total volume released to air, pursuant to 40 CFR
372.85(b)(14)(i)(A) and (B).
(6) Incinerated. Total volume incinerated on-site, pursuant to 40
CFR 372.85(b)(16).
(d) TSCA sections 8(d) and 8(e) reporting. If a person identified in
Sec. 705.10 has already reported certain information in Sec. 705.15(f)
to EPA, then duplicative reporting of that information is not required
of the years for which the information has already been reported. Such
information that may potentially be duplicative under this part is
limited to health and safety studies submitted pursuant to TSCA section
8(d), notification of substantial risks pursuant to TSCA section 8(e),
or other information concerning environmental and health effects of the
PFAS.
(e) Byproduct reporting. If a person identified in Sec. 705.10 must
report byproducts information pursuant to Sec. 705.15(e), and those
byproducts are also PFAS that are reported independently pursuant to
this part, then duplicative reporting of the environmental releases as
byproducts is not required. Such information that may potentially be
duplicative is limited to:
(1) Incineration. An indication of whether the byproduct is released
to the environment, and if so, the environmental medium to which it is
released (i.e., air, water, land), pursuant to Sec. 705.15(e)(2).
(2) Byproduct volume. For each year, the byproduct volume (in
pounds) released to the environment, pursuant to Sec. 705.15(e)(3).
(f) Environmental and health effects information. If a person
identified in Sec. 705.10 has already reported the information in Sec.
705.15(f) to EPA, then duplicative reporting of that information is not
required, except to the extent required by to Sec. 705.30. The
notification required by this paragraph (f) must also include the EPA
office (e.g., EPA region or Headquarters Office) and case number or
other identifier for the prior submission.
(g) Reporting timeframe. Any person covered in this part must report
all information to EPA in Sec. 705.15 for each year since January 1,
2011, in which that person manufactured a chemical substance that is a
PFAS or a mixture containing a PFAS. If a person has already reported
any of the data elements identified in paragraph (a) of this section,
but not for all years since 2011, then that person must submit the
required information for the intervening years. If a person has already
reported any of the data elements identified in paragraph (a), (b), or
(c) of this section, and the previous submissions did not account for
all activities that
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are reportable under this part due to exemptions or thresholds that do
not apply to this part, then that information is not considered
duplicative reporting, and the person must submit information for that
data element responsive to this part.
Sec. 705.25 Recordkeeping requirements.
Each person who is subject to the reporting requirements of this
part must retain records that document any information reported to EPA.
Relevant records must be retained for a period of 5 years beginning on
the last day of the submission period.
Sec. 705.30 Confidentiality claims.
(a) Making confidentiality claims--(1) Generally. Any person
submitting information under this part may assert a confidentiality
claim for that information, except for information described in
paragraph (a)(2) of this section. All such confidentiality claims must
be asserted at the time the information is submitted. Instructions for
asserting confidentiality claims are provided in the document identified
in Sec. 705.35. Information claimed as confidential business
information in accordance with this section will be treated and
disclosed in accordance with the procedures in 40 CFR part 703 and TSCA
section 14.
(2) Exceptions. Confidentiality claims cannot be asserted for the
following:
(i) Specific chemical identity if the chemical is on the public
(non-confidential) TSCA Inventory or reported as non-confidential in an
LVE;
(ii) For processing and use data elements required by Sec. Sec.
705.15(c)(1) through (7) and 705.18(a)(3)(i) through (vii);
(iii) When a response is left blank or designated as ``not known or
reasonably ascertainable;''
(iv) For specific chemical identity by submitters of article
importer forms described in Sec. 705.18(a);
(v) For all generic chemical names;
(vi) For any PFAS that are on the public (non-confidential) TSCA
Inventory, the chemical's CASRN;
(vii) For the Inventory Accession Numbers for PFAS that are on the
confidential TSCA Inventory; or,
(viii) For LVE numbers.
(3) All existing information concerning environmental and health
effects. (i) Any person submitting a health and safety study, or
information from a healthy and safety study, under this part may only
assert a confidentiality claim for information that discloses processes
used in the manufacturing or processing of a chemical substance or
mixture or, in the case of a mixture, the release of data disclosing the
portion of the mixture comprised by any of the chemical substances in
the mixture.
(ii) If any information submitted under Sec. 705.15(f) is claimed
as confidential business information, a person who submits the
information must provide EPA, at the time of submission, a sanitized
copy for public release, removing only that information that is claimed
as confidential business information.
(iii) Any person who has previously submitted information under
Sec. 705.15(f) and claimed it as confidential business information is
required to reassert and re-substantiate the confidential business
information claim if they seek to maintain the claim of confidential
business information. Such persons are required to submit s a revised
sanitized copy.
(b) Substantiation of confidentiality claims. (1) Unless exempted,
all confidentiality claims require substantiation at the time of
submission and must be signed and dated by an authorized official.
(2) Confidentiality claims for the following data elements are
exempt from the substantiation requirement in paragraph (b)(1) of this
section:
(i) Volume. Production volume information required pursuant to
Sec. Sec. 705.15(d)(1), (5), and (6) and 705.18(a)(4) and (b)(3)(i).
(ii) Primary submitter. Joint submission information from the
primary submitter, consisting of trade name and supplier identification
required pursuant to Sec. 705.15(b)(1)(i) and (ii).
(iii) Secondary submitter. Joint submission information from the
secondary submitter, consisting of the percentage of formulation
required pursuant to Sec. 705.15(b)(1)(i) and (ii).
(c) Marking information claimed as confidential business information
in confidentiality substantiation documentation. If any of the
information contained in
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the answers to the questions listed in paragraph (e) of this section is
asserted to contain information that itself is considered to be
confidential, you must clearly identify the information that is claimed
confidential.
(d) Certification statement for claims. An authorized official
representing a person asserting a claim of confidentiality must certify
that the submission complies with the requirements of this part by
signing and dating the following certification statement:
``I certify that all claims for confidentiality asserted with this
submission are true and correct, and all information submitted herein to
substantiate such claims is true and correct. Any knowing and willful
misrepresentation is subject to criminal penalty pursuant to 18 U.S.C.
1001. I further certify that: (1) I have taken reasonable measures to
protect the confidentiality of the information; (2) I have determined
that the information is not required to be disclosed or otherwise made
available to the public under any other Federal law; (3) I have a
reasonable basis to conclude that disclosure of the information is
likely to cause substantial harm to the competitive position of my
company; and (4) I have a reasonable basis to believe that the
information is not readily discoverable through reverse engineering.''
(e) Substantiation requirements for all types of confidentiality
claims. For each data element that is claimed as confidential business
information, you must submit with your report detailed written answers
to the following questions:
(1) Substantial harm due to release. Please specifically explain
what harm to the competitive position of your business would be likely
to result from the release of the information claimed as confidential
business information. How would that harm be substantial? Why is the
substantial harm to your competitive position likely (i.e., probable) to
be caused by release of the information rather than just possible? If
you claimed multiple types of information to be confidential (e.g., site
information, exposure information, environmental release information,
etc.), explain how disclosure of each type of information would be
likely to cause substantial harm to the competitive position of your
business. (40 CFR 703.5(b)(3))
(2) Precautions to protect confidentiality. Has your business taken
precautions to protect the confidentiality of the disclosed information?
If yes, please explain and identify the specific measures, including but
not limited to internal controls, that your business has taken to
protect the information claimed as confidential business information. If
the same or similar information was previously reported to EPA as non-
confidential (such as in an earlier version of this submission), please
explain the circumstances of that prior submission and reasons for
believing the information is nonetheless still confidential.
(3) Disclosure under Federal law or publicly available information.
(i) Is any of the information claimed as confidential business
information required to be publicly disclosed under any other Federal
law? If yes, please explain.
(ii) Does any of the information claimed as confidential business
information otherwise appear in any public documents, including (but not
limited to) safety data sheets; advertising or promotional material;
professional or trade publications; state, local, or Federal agency
files; or any other media or publications available to the general
public? If yes, please explain why the information should be treated as
confidential. If this chemical is patented and the patent reveals the
information you are claiming to be confidential business information,
please explain your reasons for believing the information is nonetheless
still confidential.
(4) Duration of claims. Is the claim of confidentiality intended to
last less than 10 years (see TSCA section 14(e)(1)(B))? If yes, please
indicate the number of years (between 1-10 years) or the specific date
after which the claim is withdrawn.
(5) Previously disclosed information. Has EPA, another Federal
agency, or court made any confidentiality determination regarding
information associated with this chemical substance? If yes, please
provide the circumstances associated with the prior determination,
whether the information was found to be entitled to confidential
treatment, the entity that made the decision, and the date of the
determination.
[[Page 99]]
(f) Additional requirements for specific chemical identity. A person
may assert a claim of confidentiality for the specific chemical identity
of a chemical substance as described in Sec. Sec. 705.15(b)(1)(i) and
705.18(b)(2)(i) only if the identity of that chemical substance is
treated as confidential in the Master Inventory File (or as a
confidential LVE) as of the time the report is submitted for that
chemical substance, if that substance is currently on the Inventory or
is an LVE. Any person who asserts a claim of confidentiality for the
specific chemical identity under this paragraph must provide a generic
chemical name. To assert a claim of confidentiality for the identity of
a reportable chemical substance, you must submit with the report
detailed written answers to the questions from paragraph (b) of this
section and to the following questions.
(1) Chemical substance in U.S. commerce. Is this chemical substance
publicly known (including by your competitors) to be in U.S. commerce?
If yes, please explain why the specific chemical identity should still
be afforded confidential status (e.g., the chemical substance is
publicly known only as being distributed in commerce for research and
development purposes, but no other information about the current
commercial distribution of the chemical substance in the United States
is publicly available) (40 CFR 703.5(b)(4)). If no, please complete the
certification statement:
``I certify that on the date referenced, I searched the internet for
the chemical substance identity (i.e., by both chemical substance name
and CASRN). I did not find a reference to this chemical substance and
have no knowledge of public information that would indicate that the
chemical is being manufactured or imported by anyone for a commercial
purpose in the United States. [provide date].''
(2) Leave manufacturing site. Does this particular chemical
substance leave the site of manufacture (including import) in any form,
e.g., as a product, effluent, emission? If yes, please explain what
measures have been taken to guard against the discovery of its identity.
(3) Chemical identity. If the chemical substance leaves the site in
a form that is available to the public or your competitors, can the
chemical identity be readily discovered by analysis of the substance
(e.g., product, effluent, emission), in light of existing technologies
and any costs, difficulties, or limitations associated with such
technologies? Please explain why or why not.
(4) Chemical name. Would disclosure of the specific chemical name
release confidential process information? If yes, please explain.
(g) Joint submissions. If a primary submitter asks a secondary
submitter to provide information directly to EPA in a joint submission
under Sec. Sec. 705.15(b)(1)(i) and 705.18(b)(2)(i), only the primary
submitter may assert a confidentiality claim for the data elements that
it directly submits to EPA. The primary submitter must substantiate
those claims that are not exempt under paragraph (b)(2) of this section.
The secondary submitter is responsible for asserting all confidentiality
claims for the data elements that it submits directly to EPA and for
substantiating those claims that are not exempt under paragraph (b)(3)
of this section.
(h) No claim of confidentiality. Except for the chemical identity on
article importer forms submitted under Sec. 705.18(a), information not
claimed as confidential business information in accordance with the
requirements of this section may be made public (e.g., by publication of
specific chemical name and CASRN on the public portion of the TSCA
Inventory). EPA will provide advance public notice of specific chemical
identities to be added to the public portion of the TSCA Inventory.
Sec. 705.35 Electronic reporting.
You must use CDX to complete and submit the reporting form required
under this part. Submissions may only be made as set forth in this
section. Submissions must be sent electronically to EPA via CDX. The
information submitted and all attachments (unless the attachment appears
in scientific literature) must be in English. All information must be
true and correct. Access the PFAS 8(a)(7) reporting tool and
instructions, as follows:
(a) By website. Access the PFAS 8(a)(7) reporting tool via the CDX
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homepage at https://cdx.epa.gov/ and follow the appropriate links.
(b) By phone or email. Contact the EPA TSCA Hotline at (202) 554-
1404 or [email protected].
PART 707_CHEMICAL IMPORTS AND EXPORTS--Table of Contents
Subpart A [Reserved]
Subpart B_General Import Requirements and Restrictions
Sec.
707.20 Chemical substances import policy.
Subpart C [Reserved]
Subpart D_Notices of Export Under Section 12(b)
707.60 Applicability and compliance.
707.63 Definitions.
707.65 Submission to the agency.
707.67 Contents of notice.
707.70 EPA notice to foreign governments.
707.72 Termination of reporting requirements.
707.75 Confidentiality.
Authority: 15 U.S.C. 2611(b) and 2612.
Source: 45 FR 82850, Dec. 16, 1980, unless otherwise noted.
Subpart A [Reserved]
Subpart B_General Import Requirements and Restrictions
Sec. 707.20 Chemical substances import policy.
(a) Scope. (1) This statement addresses the policy of the
Environmental Protection Agency (EPA) on importation of chemical
substances, mixtures, and articles under section 13 of the Toxic
Substances Control Act (TSCA; 15 U.S.C. 2601 et seq.). In particular, it
addresses aspects of the regulation promulgated by the United States
Customs Service (Customs), Department of the Treasury (19 CFR 12.118
through 12.127, and 127.28 [amended]) to implement section 13 of TSCA,
15 U.S.C. 2612. Section 13 requires the Secretary of the Treasury to
refuse entry into the Customs territory of the United States of a
chemical substance, mixture, or article if it does not comply with rules
in effect under TSCA, or if it is offered for entry in violation of TSCA
or rules or orders under TSCA.
(2) In addition to this statement of policy, EPA will continue, as
necessary, to address problems associated with imports in rulemaking and
other actions under individual sections of TSCA, i.e., sections 4, 5, 6,
7, 8, and 12. Sections 5, 6, and 7 apply directly to imports subject to
the section 13 requirements. Section 12 may apply to export of a
shipment that is refused entry under section 13. Importers may have
obligations under sections 4 and 8; section 4 and 8 requirements for
importers would not apply to individual chemical shipments and thus are
not included under section 13 requirements. Interested persons should
refer to the records of these individual rulemaking actions for specific
information and guidance.
(b) Objectives. (1) TSCA is intended to be comprehensive, and assure
protection of health and the environment from unreasonable risks
associated with chemicals whether the chemicals are imported or produced
domestically. This intent is manifested by the inclusion of importation
in the Act's definition of the term ``manufacture'': ``[M]anufacture
means to import * * *, produce, or manufacture'' (15 U.S.C. 2602(7)).
Thus, importers are responsible for insuring that chemical importation
complies with TSCA just as domestic manufacturers are responsible for
insuring that chemical manufacture complies with TSCA.
(2)(i) The section 13 rule requires importers to sign the following
statement for each import of chemical substances subject to TSCA: ``I
certify that all chemical substances in this shipment comply with all
applicable rules or orders under TSCA and that I am not offering a
chemical substance for entry in violation of TSCA or any applicable rule
or order under TSCA.'' The certification will document that, in
accordance with TSCA, the importer has taken the necessary steps to
insure compliance.
(ii) The section 13 rule requires importers of chemicals not subject
to TSCA (e.g., pesticides) to certify that compliance with TSCA is not
required. Importers must certify this by signing the statement: ``I
certify that all
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chemicals in this shipment are not subject to TSCA.'' This is
appropriate when a chemical import is not clearly identified as a
pesticide or other chemical not subject to TSCA.
(3) The United States is involved in a major effort toward
international harmonization in the control of chemicals. At such time as
international agreement is reached on this issue, EPA would be prepared
to modify its policy if necessary. EPA believes that its international
harmonization efforts in the control of chemicals will protect health
and the environment while fulfilling its obligations under the Trade
Agreements Act of 1979.
(c) The section 13 rule--(1) General certification. (i) The rule
promulgated under section 13 of TSCA by Customs, in consultation with
EPA, implements the requirement of section 13 that chemical substances,
mixtures, or articles not in compliance with TSCA, or whose importation
is not in compliance with TSCA, shall be denied entry into the customs
territory of the United States. The rule requires that importers certify
by a statement, on the entry document or invoice, that any shipment of a
chemical substance subject to TSCA, imported in bulk or as part of a
mixture, complies with TSCA, and that it is not offered for entry in
violation of TSCA or any rule or order under TSCA, or that the chemicals
imported are not subject to TSCA.
(ii) The certification applies to TSCA sections 5, 6, and 7.
(iii) EPA expects that this certification will be based upon actual
knowledge of the importer in most cases. However, EPA realizes that
sometimes importers may not have actual knowledge of the chemical
composition of imported mixtures. In these cases, the importer should
attempt to discover the chemical constituents of the shipment by
contacting another party to the transaction (e.g., his principal or the
foreign manufacturer). This person may be able to identify the
components of the mixture, or at least state that the substances comply
with TSCA. The greater the effort an importer makes to learn the
identities of the imported substances and their compliance with TSCA,
the smaller his chance of committing a violation by importing a
noncomplying shipment. If a shipment is ultimately determined to have
violated TSCA, the good faith efforts of the importer to verify
compliance, as evidenced by documents contained in his files, may
obviate or mitigate the assessment of a civil penalty under section 16
of TSCA.
(2) EPA enforcement. (i) EPA and Customs will monitor chemical
imports to determine if shipments and their import comply with the
certification requirements and the substantive mandates of TSCA. Customs
will refuse entry to any shipment until such time as the certification
is properly submitted. Customs will also detain a shipment if there are
reasonable grounds to believe that such shipment or its import violates
TSCA or regulations or orders thereunder. A violative shipment must
either be brought into compliance, exported, destroyed, or voluntarily
abandoned within the time periods prescribed in 19 CFR 12.124 of the
section 13 rule.
(ii) When EPA determines that a shipment should be detained, EPA
will identify the reasons for the detention and the necessary actions
for an importer to bring the shipment into compliance with TSCA. If EPA
has given this information to Customs before the district director
issues the detention notice, the information will become part of the
detention notice. The importer should contact one of the following EPA
regional offices for guidance as to the proper procedures to correct any
deficiencies in the shipment.
Region I
5 Post Office Square--Suite 100, Boston, MA 02109-3912 (617-918-
1700).
Region II
26 Federal Plaza, New York, NY 10278 (201-321-6669)
Region III
Curtis Building, 6th and Walnut Streets, Philadelphia, PA 19106 (215-
597-7668)
Region IV
345 Courtland Street, NE., Atlanta, GA 30365 (404-881-3864)
Region V
77 West Jackson Boulevard, Chicago, IL 60604 (312-353-2291)
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Region VI
1201 Elm Street, Suite 500, Dallas, Texas 75270-2102 (214-665-2760)
Region VII
11201 Renner Boulevard, AWMD/WEMM, Lenexa, Kansas 66219
Region VIII
1860 Lincoln Street, Denver, CO 80295 (303-837-3926)
Region IX
75 Hawthorne Street, San Francisco, CA 94105 (415) 947-4402.
Region X
1200 Sixth Avenue, Seattle, WA 98101 (206-442-2871)
(iii) If Customs detains or refuses entry of a shipment (other than
for failure to make the general certification) and the importer takes
measures necessary to bring the shipment into conformity with the
requirements of TSCA, EPA officials will reassess the shipment to
determine its current compliance status. When a shipment is no longer in
violation, EPA will notify the district director and the importer. The
district director will then release the shipment. This notice will also
serve as a determination to permit entry under 19 CFR 12.123(c) if a
shipment is brought into compliance before the 19 CFR 12.123(c)
decisionmaking process has been completed. If compliance is achieved
after a 19 CFR 12.123(c) determination (adverse to the importer) has
been made, the EPA notice to the district director will serve as a
reversal of the decision to refuse entry.
(3) EPA assistance. Assistance in determining whether a chemical
shipment is in compliance with TSCA can be obtained from the Director,
Environmental Assistance Division (7408), Office of Pollution Prevention
and Toxics, U.S. Environmental Protection Agency, Room E-543B, 1200
Pennsylvania Ave., NW., Washington, DC 20460, Telephone: (202) 554-1404,
TDD: (202) 544-0551.
[48 FR 55464, Dec. 13, 1983, as amended at 60 FR 34463, July 3, 1995; 62
FR 1834, Jan. 14, 1997; 75 FR 69353, Nov. 12, 2010; 76 FR 49674, Aug.
11, 2011; 78 FR 37978, June 25, 2013; 84 FR 44232, Aug. 23, 2019]
Subpart C [Reserved]
Subpart D_Notices of Export Under Section 12(b)
Sec. 707.60 Applicability and compliance.
(a) Section 12(b) of the Toxic Substances Control Act requires any
person who exports or intends to export a chemical substance or mixture
to notify the Environmental Protection Agency of such exportation to a
particular country if any of the following actions have been taken under
the Act with respect to that chemical substance or mixture:
(1) Data are required under section 4 or 5(b),
(2) An order has been issued under section 5,
(3) A rule has been proposed or promulgated under section 5 or 6, or
(4) An action is pending, or relief has been granted under section 5
or 7.
(b) No notice of export will be required for articles, except PCB
articles, unless the Agency so requires in the context of individual
section 5, 6, or 7 actions.
(c)(1) Except as provided in paragraphs (c)(2) and (3) of this
section no notice of export is required for the export of a chemical
substance or mixture for which export notification is otherwise
required, where such chemical substance or mixture is present in a
concentration of less than 1% (by weight or volume).
(2) No notice of export is required for the export of a chemical
substance or mixture that is a known or potential human carcinogen where
such chemical substance or mixture is present in a concentration of less
than 0.1% (by weight or volume). A chemical is considered to be a known
or potential human carcinogen, for purposes of TSCA section 12(b) export
notification, if that chemical is:
(i) A chemical substance or mixture listed as a ``known to be human
carcinogen'' or ``reasonably anticipated to be human carcinogen'' in the
Report on Carcinogens (latest edition) issued by the U.S. Department of
Health and Human Services, Public Heath Service, National Toxicology
Program,
[[Page 103]]
(ii) A chemical substance or mixture is classified as ``carcinogenic
to humans'' (Group 1), ``probably carcinogenic to humans'' (Group 2A),
or ``probably carcinogenic to humans'' (Group 2B) in the Monographs and
Supplements on the Evaluation of Carcinogenic Risks to Humans issued by
the World Health Organization International Agency for Research on
Cancer (IARC), Lyons, France (latest editions), or
(iii) Alpha-naphthylamine (Chemical Abstract Service Registry Number
(CAS No.) 134-32-7) or 4-nitrobiphenyl (CAS No. 92-93-3).
(3) No notice of export is required for the export of
polychlorinated biphenyl chemicals (PCBs) (see definition in 40 CFR
761.3), where such chemical substances are present in a concentration of
less than or equal to 50 ppm (by weight or volume).
(d) Any person who exports or intends to export PCBs or PCB articles
(see definition in 40 CFR 761.3), for any purpose other than disposal,
shall notify EPA of such intent or exportation under TSCA section 12(b),
except as specified in Sec. 707.60(c)(3). PCBs and PCB articles have
the definitions published in 40 CFR 761.3.
(e) Any person who would be prohibited by a TSCA section 5 or 6
regulation from exporting a chemical substance or mixture, but who is
granted an exemption by EPA to export that chemical substance or
mixture, shall notify EPA under TSCA section 12(b) of such intent to
export or exportation.
(f) Failure to comply with TSCA section 12(b) as set forth in this
part will be considered a violation of TSCA section 15(3), and will
subject the exporter to the penalty, enforcement, and seizure provisions
of TSCA sections 16 and 17.
[45 FR 82850, Dec. 16, 1980, as amended at 71 FR 66244, Nov. 14, 2006;
71 FR 68751, Nov. 28, 2006]
Sec. 707.63 Definitions.
The definitions set forth in the Toxic Substances Control Act,
section 3, apply for this part. In addition, the following abbreviations
and definitions are provided for purposes of this rule:
CDX or Central Data Exchange means EPA's centralized electronic
document receiving system, or its successor system.
EPA means the Environmental Protection Agency.
Exporter means the person who, as the principal party in interest in
the export transaction, has the power and responsibility for determining
and controlling the sending of the chemical substance or mixture to a
destination out of the customs territory of the United States.
Regulated chemical means any chemical substance or mixture for which
export notice is required under Sec. 707.60.
TSCA means the Toxic Substances Control Act.
[45 FR 82850, Dec. 16, 1980, as amended at 88 FR 37171, June 7, 2023]
Sec. 707.65 Submission to the agency.
(a) For each action under TSCA triggering export notification,
exporters must notify EPA of their export or intended export of each
subject chemical substance or mixture for which export notice is
required under Sec. 707.60 in accordance with the following:
(1)(i) The export notice must be for the first export or intended
export by an exporter to a particular country in a calendar year when
the chemical substance or mixture is the subject of an order issued, an
action that is pending, or relief that has been granted under TSCA
section 5(f), a rule that has been proposed or promulgated under TSCA
section 6, or an action that is pending or relief that has been granted
under TSCA section 7.
(ii) The export notice must only be for the first export or intended
export by an exporter to a particular country when the chemical
substance or mixture is the subject of an order issued, an action that
is pending, or relief that has been granted under TSCA section 5(e), a
rule that has been proposed or promulgated under TSCA section 5(a)(2),
or when the submission of data is required under TSCA section 4 or 5(b).
Under this paragraph, notice of export to a particular country is not
required if an exporter previously submitted to EPA a notice of export
to that country prior to January 16, 2007.
(2) The export notice must be submitted to EPA within seven days of
forming the intent to export or on the
[[Page 104]]
date of export, whichever is earlier. A notice of intent to export must
be based on a definite contractual obligation, or an equivalent intra-
company agreement, to export the regulated chemical.
(b) If the EPA action that prompts the notice is a proposed rule,
the requirement to submit export notices to EPA shall begin thirty days
after publication of the action in the Federal Register.
(c) Export notices must be submitted via CDX, using the TSCA section
12(b) Export Notification Application or its successor.
[88 FR 37171, June 7, 2023]
Sec. 707.67 Contents of notice.
The notice to EPA shall include:
(a) The name of the regulated chemical as it appears in the TSCA
section 4, 5, 6, and/or 7 action. For substances on the confidential
portion of the TSCA Inventory, the substance must be identified by
generic name and accession number, or by any other non-confidential
identifier under which it is listed on the TSCA section 12(b) reporting
list maintained by EPA and available in the TSCA section 12(b) Export
Notification Application described in Sec. 707.65(c). If a category is
regulated, the name of the individual regulated chemical within that
category, as well as the category, must be given. The name must be that
which appears in the TSCA Inventory if the chemical appears there.
(b) The name and address of the exporter.
(c) The country (countries) of import.
(d) The date(s) of export or intended export.
(e) The section (4, 5, 6, and/or 7) of TSCA under which EPA has
taken action.
[45 FR 82850, Dec. 16, 1980, as amended at 71 FR 66245, Nov. 14, 2006;
88 FR 37172, June 7, 2023]
Sec. 707.70 EPA notice to foreign governments.
(a)(1) Notice by EPA to the importing country shall be sent no later
than 5 working days after receipt by the TSCA Document Processing Center
of the first annual notification from any exporter for each chemical
substance or mixture that is the subject of an order issued, an action
that is pending, or relief that has been granted under TSCA section
5(f), a rule that has been proposed or promulgated under TSCA section 6,
or an action that is pending or relief that has been granted under TSCA
section 7.
(2) Notice by EPA to the importing country shall be sent no later
than 5 working days after receipt by the TSCA Document Processing Center
of the first notification from any exporter for each chemical substance
or mixture that is the subject of an order issued, an action that is
pending, or relief that has been granted under TSCA section 5(e), a rule
that has been proposed or promulgated under TSCA section 5(a)(2), or for
which the submission of data is required under TSCA section 4 or 5(b).
(b) Notices shall:
(1) Identify the regulated chemical.
(2) Summarize the regulatory action taken, or indicate the
availability of data under section 4 or 5(b) of TSCA.
(3) Identify an EPA official to contact for further information.
(4) Include a copy of the pertinent Federal Register notice.
(c) Notices shall be sent to the country's ambassador in Washington,
DC, or other official designated by the foreign government, and to the
United States Department of State.
[45 FR 82850, Dec. 16, 1980, as amended at 58 FR 40242, July 27, 1993;
71 FR 66245, Nov. 14, 2006]
Sec. 707.72 Termination of reporting requirements.
(a) The reporting requirements of subpart D of this part are
terminated for certain specific chemical substances and mixtures as set
forth in this paragraph.
(1) When data required under part 766 of this chapter have been
submitted to EPA for a specific chemical substance produced by a
specific process, and the data show no positive test result as defined
in Sec. 766.3 of this chapter, reporting is no longer required by
persons who export or intend to export that substance produced by that
process.
(2) [Reserved]
[[Page 105]]
(b) [Reserved]
[52 FR 21437, June 5, 1987]
Sec. 707.75 Confidentiality.
(a) A person may assert a claim of confidentiality for any
information which is submitted to EPA in a notice.
(b) Any claim of confidentiality must accompany the information at
the time it is submitted to EPA. In the notice, the submitter must
clearly identify the information that is claimed confidential by marking
the specific information on each page with a label such as
``confidential business information'', ``proprietary'', or ``trade
secret''.
(c) Notwithstanding any claim of confidentiality, information
outlined in Sec. 707.70 will be included in the EPA notice to the
foreign government. With this exception, EPA will disclose information
that is covered by a claim of confidentiality asserted in accordance
with this section only to the extent permitted by, and in accordance
with, the procedures set forth in TSCA and part 2 of this chapter.
(d) Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
[45 FR 82850, Dec. 16, 1980, as amended at 88 FR 37172, June 7, 2023]
PART 710_COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY--Table of Contents
Subpart A_General Provisions
Sec.
710.1 Scope and compliance.
710.3 Definitions.
710.4 Scope of the inventory.
Subpart B_Commercial Activity Notification
710.23 Definitions.
710.25 Persons subject to the notification requirement.
710.27 Activities for which notification is not required.
710.29 Information required in the notification.
710.30 When to submit notifications.
710.33 Co-manufacturers and co-processors.
710.35 Recordkeeping requirements.
710.37 Confidentiality claims.
710.39 Electronic filing.
Subpart C_Review Plan
710.41 Scope.
710.43 Persons subject to substantiation requirement.
710.45 Contents of substantiation.
710.47 When to submit substantiation or information on previous
substantiation.
710.49 Failure to report.
710.51 Electronic filing.
710.53 Recordkeeping requirements.
710.55 Claim review, duration of protection, TSCA Inventory maintenance,
posting results, and extension.
Authority: 15 U.S.C. 2607(a) and (b).
Subpart A_General Provisions
Sec. 710.1 Scope and compliance.
(a) This part establishes regulations governing reporting and
recordkeeping by certain persons who manufacture, import, or process
chemical substances for commercial purposes under section 8(a) of the
Toxic Substances Control Act (15 U.S.C. 2607(a)) (TSCA). Section 8(a)
authorizes the Administrator to require reporting of information
necessary for administration of the Act and requires EPA to issue
regulations for the purpose of compiling and keeping current an
inventory of chemical substances manufactured or processed for a
commercial purpose, as required by section 8(b) of the Act. Following an
initial reporting period, EPA published an initial inventory of chemical
substances manufactured, processed, or imported for commercial purposes.
In accordance with section 8(b), EPA periodically amends the inventory
to include new chemical substances which are manufactured or imported
for a commercial purpose and reported under section 5(a)(1) of the Act.
EPA also revises the categories of chemical substances and makes other
amendments as appropriate.
(b) This part applies to the activities associated with the
compilation of the TSCA Chemical Substance Inventory (Inventory) and the
designation of chemical substances on the TSCA Inventory as active or
inactive in U.S. commerce.
(c) Section 15(3) of TSCA makes it unlawful for any person to fail
or refuse to submit information required under these reporting
regulations. In
[[Page 106]]
addition, section 15(3) makes it unlawful for any person to fail to
keep, and permit access to, records required by these regulations.
Section 16 provides that any person who violates a provision of section
15 is liable to the United States for a civil penalty and may be
criminally prosecuted. Pursuant to section 17, the Government may seek
judicial relief to compel submission of section 8(a) information and to
otherwise restrain any violation of section 15. (EPA does not intend to
concentrate its enforcement efforts on insignificant clerical errors in
reporting.)
(d) Each person who reports under these regulations must maintain
records that document information reported under these regulations and,
in accordance with the Act, permit access to, and the copying of, such
records by EPA officials.
[68 FR 887, Jan. 7, 2003, as amended at 76 FR 50859, Aug. 16, 2011; 76
FR 54933, Sept. 6, 2011; 82 FR 37539, Aug. 11, 2017]
Sec. 710.3 Definitions.
For purposes of this part:
(a) The following terms will have the meaning contained in the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the
regulations issued under such Act: Cosmetic, device, drug, food, and
food additive. In addition, the term food includes poultry and poultry
products, as defined in the Poultry Products Inspection Act, 21 U.S.C.
453 et seq.; meats and meat food products, as defined in the Federal
Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as
defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
(b) The term pesticide will have the meaning contained in the
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et
seq., and the regulations issued thereunder.
(c) The following terms will have the meaning contained in the
Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq., and the regulations
issued thereunder: Byproduct material, source material, and special
nuclear material.
(d) The following definitions also apply to this part:
Act means the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et
seq.
Administrator means the Administrator of the U.S. Environmental
Protection Agency, any employee or authorized representative of the
Agency to whom the Administrator may either herein or by order delegate
his/her authority to carry out his/her functions, or any other person
who will by operation of law be authorized to carry out such functions.
Article means a manufactured item:
(1) Which is formed to a specific shape or design during
manufacture,
(2) Which has end use function(s) dependent in whole or in part upon
its shape or design during end use, and
(3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article and that may occur as
described in Sec. 710.4(d)(5); except that fluids and particles are not
considered articles regardless of shape or design.
Byproduct means a chemical substance produced without a separate
commercial intent during the manufacture, processing, use, or disposal
of another chemical substance(s) or mixture(s).
CASRN means Chemical Abstracts Service Registry Number.
Chemical substance means any organic or inorganic substance of a
particular molecular identity, including any combination of such
substances occurring in whole or in part as a result of a chemical
reaction or occurring in nature, and any chemical element or uncombined
radical; except that ``chemical substance'' does not include:
(1) Any mixture;
(2) Any pesticide when manufactured, processed, or distributed in
commerce for use as a pesticide;
(3) Tobacco or any tobacco product, but not including any derivative
products;
(4) Any source material, special nuclear material, or byproduct
material;
(5) Any pistol, firearm, revolver, shells, and cartridges; and
(6) Any food, food additive, drug, cosmetic, or device, when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device.
[[Page 107]]
Commerce means trade, traffic, transportation, or other commerce:
(1) Between a place in a State and any place outside of such State
or
(2) Which affects trade, traffic, transportation, or commerce
between a place in a State and any place outside of such State.
Customs territory of the United States means the 50 States, Puerto
Rico, and the District of Columbia.
Distribute in commerce and distribution in commerce means to sell in
commerce, to introduce or deliver for introduction into commerce, or to
hold after its introduction into commerce.
Domestic means within the geographical boundaries of the 50 United
States, the District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and
any other territory or possession of the United States.
EPA means the U.S. Environmental Protection Agency.
Importer means any person who imports any chemical substance,
including a chemical substance as part of a mixture or article, into the
customs territory of the United States. ``Importer'' includes the person
primarily liable for the payment of any duties on the merchandise or an
authorized agent acting on his or her behalf. The term also includes, as
appropriate,
(1) The consignee,
(2) The importer of record,
(3) the actual owner if an actual owner's declaration and
superseding bond has been filed in accordance with 19 CFR 141.20, or
(4) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred in accordance with subpart C of 19 CFR
144.
Impurity means a chemical substance which is unintentionally present
with another chemical substance.
Intermediate means any chemical substance that is consumed, in whole
or in part, in chemical reaction(s) used for the intentional manufacture
of other chemical substance(s) or mixture(s), or that is intentionally
present for the purpose of altering the rate(s) of such chemical
reaction(s).
Inventory means the TSCA Chemical Substance Inventory, which is
EPA's comprehensive list of confidential and non-confidential chemical
substances manufactured or processed in the United States for nonexempt
commercial purpose that EPA compiled and keeps current under section
8(b) of the Act.
Manufacture means to manufacture, produce, or import, for commercial
purposes. Manufacture includes the extraction, for commercial purposes,
of a component chemical substance from a previously existing chemical
substance or complex combination of chemical substances. When a chemical
substance, manufactured other than by import, is: (1) Produced
exclusively for another person who contracts for such production, and
(2) that other person specifies the identity of the chemical substance
and controls the total amount produced and the basic technology for the
plant process, then that chemical substance is co-manufactured by the
producing manufacturer and the person contracting for such production.
Manufacture for commercial purposes means: (1) To manufacture,
produce, or import with the purpose of obtaining an immediate or
eventual commercial advantage, and includes, among other things, the
``manufacture'' of any amount of a chemical substance or mixture (i) for
commercial distribution, including for test marketing, or (ii) for use
by the manufacturer, including use for product research and development
or as an intermediate. (2) The term also applies to substances that are
produced coincidentally during the manufacture, processing, use, or
disposal of another substance or mixture, including byproducts that are
separated from that other substance or mixture and impurities that
remain in that substance or mixture. Byproducts and impurities without
separate commercial value are nonetheless produced for the purpose of
obtaining a commercial advantage, since they are part of the manufacture
of a chemical substance for commercial purposes.
Manufacturer means a person who manufactures a chemical substance.
Mixture means any combination of two or more chemical substances if
the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except that
[[Page 108]]
``mixture'' does include (1) any combination which occurs, in whole or
in part, as a result of a chemical reaction if the combination could
have been manufactured for commercial purposes without a chemical
reaction at the time the chemical substances comprising the combination
were combined, and if all of the chemical substances comprising the
combination are not new chemical substances, and (2) hydrates of a
chemical substance or hydrated ions formed by association of a chemical
substance with water, so long as the nonhydrated form is itself not a
new chemical substance.
New chemical substance means any chemical substance which is not
included on the Inventory.
Person includes any individual, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other
business entity; any State or political subdivision thereof; any
municipality; any interstate body; and any department, agency, or
instrumentality of the Federal Government.
Process means to process for commercial purposes. Process includes
the preparation of a chemical substance or mixture, after its
manufacture, (1) in the same form or physical state as, or in a
different form or physical state from, that in which it was received by
the person so preparing such substance or mixture, or (2) as part of a
mixture or article containing the chemical substance or mixture.
Process for commercial purposes means the preparation of a chemical
substance or mixture after its manufacture for distribution in commerce
with the purpose of obtaining an immediate or eventual commercial
advantage for the processor. Processing of any amount of a chemical
substance or mixture is included in this definition. If a chemical
substance or mixture containing impurities is processed for commercial
purposes, then the impurities also are processed for commercial
purposes.
Processor means any person who processes a chemical substance or
mixture.
Site means a contiguous property unit. Property divided only by a
public right-of-way will be considered one site. More than one
manufacturing plant may be located on a single site.
(1) For chemical substances manufactured under contract, i.e., by a
toll manufacturer, the site is the location where the chemical substance
is physically manufactured.
(2) The site for an importer who imports a chemical substance
described in Sec. 710.25 is the U.S. site of the operating unit within
the person's organization that is directly responsible for importing the
chemical substance. The import site, in some cases, may be the
organization's headquarters in the United States. If there is no such
operating unit or headquarters in the United States, the site address
for the importer is the U.S. address of an agent acting on behalf of the
importer who is authorized to accept service of process for the
importer.
Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or analysis
or chemical research on, or analysis of, such substance or another
substance, including such research or analysis for the development of a
product'') means quantities of a chemical substance manufactured,
imported, or processed or proposed to be manufactured, imported, or
processed solely for research and development that are not greater than
reasonably necessary for such purposes.
State means any State of the United States, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam,
American Samoa, the Northern Mariana Islands, or any other territory or
possession of the United States.
Technically qualified individual means a person:
(1) Who because of his/her education, training, or experience, or a
combination of these factors, is capable of appreciating the health and
environmental risks associated with the chemical substance which is used
under his/her supervision,
(2) Who is responsible for enforcing appropriate methods of
conducting scientific experimentation, analysis, or chemical research in
order to minimize such risks, and
(3) Who is responsible for the safety assessments and clearances
related to
[[Page 109]]
the procurement, storage, use, and disposal of the chemical substance as
may be appropriate or required within the scope of conducting the
research and development activity. The responsibilities in this
paragraph may be delegated to another individual, or other individuals,
as long as each meets the criteria in paragraph (1) of this definition.
Test marketing means the distribution in commerce of no more than a
predetermined amount of a chemical substance, mixture, or article
containing that chemical substance or mixture, by a manufacturer or
processor to no more than a defined number of potential customers to
explore market capability in a competitive situation during a
predetermined testing period prior to the broader distribution of that
chemical substance, mixture, or article in commerce.
United States, when used in the geographic sense, means all of the
States, territories, and possessions of the United States.
[68 FR 888, Jan. 7, 2003, as amended at 69 FR 40791, July 7, 2004; 76 FR
50859, Aug. 16, 2011; 76 FR 54933, Sept. 6, 2011; 82 FR 37539, Aug. 11,
2017]
Sec. 710.4 Scope of the inventory.
(a) Chemical substances subject to these regulations. Only chemical
substances which are manufactured, imported, or processed ``for a
commercial purpose,'' as defined in Sec. 710.3(d), are subject to these
regulations.
(b) Naturally occurring chemical substances automatically included.
Any chemical substance which is naturally occurring and:
(1) Which is (i) unprocessed or (ii) processed only by manual,
mechanical, or gravitational means; by dissolution in water; by
flotation; or by heating solely to remove water; or
(2) Which is extracted from air by any means, will automatically be
included in the inventory under the category ``Naturally Occurring
Chemical Substances.'' Examples of such substances are: raw agricultural
commodities; water, air, natural gas, and crude oil; and rocks, ores,
and minerals.
(c) Substances excluded by definition or section 8(b) of TSCA. The
following substances are excluded from the inventory:
(1) Any substance which is not considered a ``chemical substance''
as provided in subsection 3(2)(B) of the Act and in the definition of
``chemical substance'' in Sec. 710.3(d);
(2) Any mixture as defined in Sec. 710.3(d);
Note: A chemical substance that is manufactured as part of a mixture
is subject to these reporting regulations. This exclusion applies only
to the mixture and not to the chemical substances of which the mixture
is comprised. The term ``mixture'' includes alloys, inorganic glasses,
ceramics, frits, and cements, including Portland cement.
(3) Any chemical substance which is manufactured, imported, or
processed solely in small quantities for research and development, as
defined in Sec. 710.3(d); and
(4) Any chemical substance not manufactured, processed or imported
for a commercial purpose since January 1, 1975.
(d) Chemical substances excluded from the inventory. The following
chemical substances are excluded from the inventory. Although they are
considered to be manufactured or processed for a commercial purpose for
the purpose of section 8 of the Act, they are not manufactured or
processed for distribution in commerce as chemical substances per se and
have no commercial purpose separate from the substance, mixture, or
article of which they may be a part.
Note: In addition, chemical substances excluded here will not be
subject to premanufacture notification under section 5 of the Act.
(1) Any impurity.
(2) Any byproduct which has no commercial purpose.
Note: A byproduct which has commercial value only to municipal or
private organizations who (i) burn it as a fuel, (ii) dispose of it as a
waste, including in a landfill or for enriching soil, or (iii) extract
component chemical substances which have commercial value, may be
reported for the inventory, but will not be subject to premanufacture
notification under section 5 of the Act if not included.
(3) Any chemical substance which results from a chemical reaction
that occurs incidental to exposure of another chemical substance,
mixture, or article to environmental factors such as air,
[[Page 110]]
moisture, microbial organisms, or sunlight.
(4) Any chemical substance which results from a chemical reaction
that occurs incidental to storage of another chemical substance,
mixture, or article.
(5) Any chemical substance which results from a chemical reaction
that occurs upon end use of other chemical substances, mixtures, or
articles such as adhesives, paints, miscellaneous cleansers or other
housekeeping products, fuels and fuel additives, water softening and
treatment agents, photographic films, batteries, matches, and safety
flares, and which is not itself manufactured for distribution in
commerce or for use as an intermediate.
(6) Any chemical substance which results from a chemical reaction
that occurs upon use of curable plastic or rubber molding compounds,
inks, drying oils, metal finishing compounds, adhesives, or paints; or
other chemical substances formed during manufacture of an article
destined for the marketplace without further chemical change of the
chemical substance except for those chemical changes that may occur as
described elsewhere in this Sec. 710.4(d).
(7) Any chemical substance which results from a chemical reaction
that occurs when (i) a stabilizer, colorant, odorant, antioxidant,
filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor,
antifoamer or de-foamer, dispersant, precipitation inhibitor, binder,
emulsifier, de-emulsifier, dewatering agent, agglomerating agent,
adhesion promoter, flow modifier, pH neutralizer, sequesterant,
coagulant, flocculant, fire retardant, lubricant, chelating agent, or
quality control reagent functions as intended or (ii) a chemical
substance, solely intended to impart a specific physicochemical
characteristic, functions as intended.
(8) Chemical substances which are not intentionally removed from the
equipment in which they were manufactured.
Note: See note to definition of ``intermediate'' at Sec. 710.3(d)
for explanation of ``equipment in which it was manufactured.''
[42 FR 64572, Dec. 23, 1977, as amended at 68 FR 889, Jan. 7, 2003]
Subpart B_Commercial Activity Notification
Source: 82 FR 37540, Aug. 11, 2017, unless otherwise noted.
Sec. 710.23 Definitions.
The following definitions also apply to subpart B of this part.
Active substance means any interim active substance, any naturally
occurring chemical substance as defined by Sec. 710.27(b), any chemical
substance that was added to the Inventory on or after June 21, 2006
pursuant to a Notice of Commencement under Sec. 720.102 received by the
Agency on or after June 21, 2006, and any chemical substance subject to
commercial activity designation that the Administrator designates as
active based on the receipt of a notice under this subpart.
Central Data Exchange or CDX means EPA's centralized electronic
document reporting portal, or its successors.
Chemical Information Submission System or CISS means EPA's web-based
reporting tool for preparing and submitting a Notice of Activity.
Chemical substance subject to commercial activity designation means
a chemical substance that requires a designation as either an active or
an inactive substance. A chemical substance is subject to commercial
activity designation if it is not an interim active substance, it was
added to the Inventory before June 21, 2006, it is not a naturally
occurring chemical substance as defined by Sec. 710.27(b), and it has
not yet been designated by the Administrator as either an active or an
inactive substance.
e-NOA means EPA's software module within CISS for generating and
completing Notice of Activity Forms A and B.
Existing claim for protection of specific chemical identity against
disclosure is a claim for protection of the specific chemical identity
of a chemical substance that is listed on the confidential portion of
the Inventory, asserted prior to June 22, 2016.
Inactive substance means any chemical substance subject to
commercial activity designation, that the Administrator designates as
inactive based on the lack of receipt of a notice under
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this subpart, effective 90 days after the Administrator identifies the
chemical substance for such designation.
Interim active substance means any chemical substance that was
reported, pursuant to 40 CFR part 711, as having been manufactured in
and of the calendar years: 2010, 2011, 2012, 2013, 2014, or 2015.
Known to or reasonably ascertainable by means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know.
Notice of Activity Form A means the form for supplying retrospective
notification under TSCA section 8(b)(4), for which the submission
obligation is described in Sec. 710.25(a).
Notice of Activity Form B means the form for supplying forward-
looking reporting under TSCA section 8(b)(5), for which the submission
obligation is described in Sec. 710.25(c).
Lookback period means the period beginning on June 21, 2006 and
ending on June 21, 2016.
Possession or Control means in the possession or control of any
person, or of any subsidiary, partnership in which the person is a
general partner, parent company, or any company or partnership which the
parent company owns or controls, if the subsidiary, parent company, or
other company or partnership is associated with the person in the
research, development, test marketing, or commercial marketing of the
chemical substance in question. Information is in the possession or
control of a person if it is:
(1) In the person's own files including files maintained by
employees of the person in the course of their employment.
(2) In commercially available data bases to which the person has
purchased access.
(3) Maintained in the files in the course of employment by other
agents of the person who are associated with research, development, test
marketing, or commercial marketing of the chemical substance in
question.
Reportable chemical substance means a chemical substance that is
listed on the Inventory and that is either:
(1) A chemical substance subject to commercial activity designation
for which notification is required or allowed under Sec. 710.25(a) and
Sec. 710.25(b),
(2) A chemical substance that was added to the confidential portion
of the Inventory before June 22, 2016, or (3) an inactive substance for
which notification is required under Sec. 710.25(c).
Submission period means the applicable period for submitting a
Notice of Activity under Sec. 710.25.
Sec. 710.25 Persons subject to the notification requirement.
The following persons are subject to the requirements of this
subpart.
(a) Who must submit the Notice of Activity Form A? Any person who
manufactured (including imported) a chemical substance subject to
commercial activity designation at any time during the lookback period,
except as provided in Sec. 710.27, must submit a Notice of Activity
Form A as specified under Sec. Sec. 710.29 and 710.30(a), unless such
person has evidence in the form of a CDX receipt, documenting EPA's
receipt of a Notice of Activity Form A from another person, for the same
chemical substance, or unless the prior manufacturing of such a
substance is not known to or reasonably ascertainable by the person.
Evidence in the form of a CDX receipt for a Notice of Activity Form A is
not a basis for exemption from the requirements of Sec. 710.25(c) if
the chemical substance is ultimately designated as inactive due to
withdrawal of the Notice of Activity Form A.
(b) Who else may submit the Notice of Activity Form A? Any person
not required to submit a Notice of Activity Form A under Sec.
710.25(a), who manufactured (including imported) or processed a
reportable chemical substance, at any time during the lookback period,
may submit a Notice of Activity Form A as specified under Sec. Sec.
710.29 and 710.30(a).
(c) Who must submit the Notice of Activity Form B? Any person who
intends to manufacture (including import) or process an inactive
substance, except as provided in Sec. 710.27, after the effective date
of the Administrator's designation of such chemical substance as an
inactive substance, must submit a
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Notice of Activity Form B as specified under Sec. Sec. 710.29 and
710.30(b), unless the presence of the inactive substance on the
confidential portion of the Inventory is not known to or reasonably
ascertainable by the person.
Sec. 710.27 Activities for which notification is not required.
(a) In general. The following activities do not trigger notification
requirements under this subpart:
(1) The manufacturing or processing of a chemical substance in small
quantities solely for research and development.
(2) The import or processing of a chemical substance as part of an
article.
(3) The manufacturing or processing of a chemical substance as
described in Sec. 720.30(g) or (h).
(4) The manufacturing or processing of a chemical substance solely
for export from the United States as described in Sec. 720.30(e) or
Sec. 721.3, except where the Administrator has made a finding described
in TSCA section 12(a)(2).
(5) The manufacturing or processing of a chemical substance solely
for test marketing purposes.
(b) Manufacturing or processing naturally occurring chemical
substances. The following activities do not trigger notification
requirements under this subpart:
(1) The manufacture of a naturally occurring chemical substance, as
described in Sec. 710.4(b). Some chemical substances can be
manufactured both as described in Sec. 710.4(b) and by means other than
those described in Sec. 710.4(b). If a person manufactures a chemical
substance by means other than those described in Sec. 710.4(b), this
exemption is inapplicable, regardless of whether the chemical substance
also could have been produced as described in Sec. 710.4(b). This
exemption does not cover the manufacture of a chemical substance from a
naturally occurring chemical substance.
(2) The processing of a naturally occurring chemical substance only
by manual, mechanical, or gravitational means; by dissolution in water;
by flotation; or by heating solely to remove water.
Sec. 710.29 Information required in the notification.
(a) Reporting information to EPA. A person who reports information
to EPA under this subpart must do so using the e-NOA software module,
the CISS reporting tool, and the CDX electronic reporting portal
provided by EPA at the addresses set forth in Sec. 710.39. For notices
of activity under Sec. Sec. 710.25(a) and 710.25(b), the submission
must include all information described in paragraph (b) of this section.
For a Notice of Activity under Sec. 710.25(c), the submission must
include all information described in paragraph (c) of this section. A
person must submit a separate notice for each chemical substance that
the person is required to report. Using e-NOA and CISS and registering
in CDX are described in instructions available from EPA at the Web sites
set forth in Sec. 710.39.
(b) Information to be reported on the Notice of Activity Form A. A
person submitting a Notice of Activity Form A under Sec. 710.25(a) or
Sec. 710.25(b) must submit the information specified in Sec. 710.29(d)
for each reportable chemical substance. A person submitting information
under Sec. 710.25(a) or Sec. 710.25(b) must report information to the
extent that such information is known to or reasonably ascertainable by
that person.
(c) Information to be reported on a Notice of Activity Form B. Any
person submitting a Notice of Activity Form B under Sec. 710.25(c) must
provide the information described in this paragraph for each inactive
substance intended to be manufactured or processed.
(1) Information specified in Sec. 710.29(d).
(2) The anticipated date by which the inactive substance is to be
manufactured or processed in the United States. If the Notice of
Activity Form B is filed prior to the effective date of the chemical
substance's inactive designation, the most recent date of manufacturing
or processing may be provided in lieu of an anticipated date.
(d) Information to be reported on either the Notice of Activity Form
A or Form B.
(1) Company. The name and address of the submitting company.
(2) Authorized official. The name and address of the authorized
official for the submitting company.
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(3) Technical contact. The name and telephone number of a person who
will serve as technical contact for the submitting company and who will
be able to answer questions about the information submitted by the
company to EPA.
(4) Chemical-specific information. The system described under Sec.
710.29(a) will provide a list of reportable chemical substances from
which a person can select his or her chemical. The list will include the
correct CASRN and CA Index name used to list a non-confidential chemical
substance on the Inventory. For confidential substances on the
Inventory, the list will include the TSCA Accession Number and generic
name.
(i) If an importer submitting a notice cannot provide the
information specified in Sec. 710.29(d)(4) because it is unknown to the
importer and claimed as confidential by the supplier of the chemical
substance or mixture, the importer must ask the supplier to provide the
specific chemical identity information directly to EPA in a joint
submission using the same e-NOA software module used for commercial
activity reporting. Such request must refer the supplier to EPA's
instructions for submitting chemical identity information
electronically, using e-NOA, CISS, and CDX (see Sec. 710.39), and for
clearly referencing the importer's submission. Contact information for
the supplier, a trade name or other name for the chemical substance or
mixture, and a copy of the request to the supplier must be included with
the importer's submission.
(ii) If a manufacturer or processor submitting a notice cannot
provide the information specified in Sec. 710.29(d)(4) because the
reportable chemical substance is manufactured or processed using a
reactant having a specific chemical identity that is unknown to the
manufacturer or processor and claimed as confidential by its supplier,
the manufacturer or processor must ask the supplier of the confidential
reactant to provide the specific chemical identity of the confidential
reactant directly to EPA in a joint submission using the same e-NOA
software module used for commercial activity reporting. Such request
must refer the supplier to EPA's instructions for submitting chemical
identity information electronically using e-NOA, CISS, and CDX (see
Sec. 710.39), and for clearly referencing the manufacturer's or
processor's submission. Contact information for the supplier, a trade
name or other name for the chemical substance, and a copy of the request
to the supplier must be included with the manufacturer's or processor's
submission with respect to the chemical substance.
(iii) Joint submissions must be submitted electronically using e-
NOA, CISS, and CDX (see Sec. 710.39).
(5) Certification statements. The authorized official must certify
that the submitted information has been completed in compliance with the
requirements of this part as described in this paragraph.
(i) The certification must be signed and dated by the authorized
official for the submitting company.
(ii) The following is required certification language for an
authorized official submitting a Notice of Activity Form A under Sec.
710.25(a) or Sec. 710.25(b): ``I certify under penalty of law that this
document and all attachments were prepared under my direction or
supervision and the information contained therein, to the best of my
knowledge, is true, accurate, and complete. I also certify that I have
manufactured, imported, or processed the above chemical between the
dates of June 21, 2006 and June 21, 2016. I am aware it is unlawful to
knowingly submit incomplete, false and/or misleading information, and
there are significant criminal penalties for such unlawful conduct,
including the possibility of fine and imprisonment.''
(iii) The following is required certification language for an
authorized official submitting a Notice of Activity Form B under Sec.
710.25(c): ``I certify under penalty of law that this document and all
attachments were prepared under my direction or supervision and the
information contained therein, to the best of my knowledge, is true,
accurate, and complete. I also certify that I have intent to
manufacture, import, or process the above chemical within 90 days of
submission. I am aware it is unlawful to knowingly
[[Page 114]]
submit incomplete, false and/or misleading information, and there are
significant criminal penalties for such unlawful conduct, including the
possibility of fine and imprisonment.''
Sec. 710.30 When to submit notifications.
(a) When must a Notice of Activity Form A be submitted? The Notice
of Activity Form A required to be submitted under Sec. 710.25(a) must
be submitted during the applicable submission period.
(1) Manufacturers. The submission period for manufacturers under
Sec. Sec. 710.25(a) and 710.25(b) begins on August 11, 2017 and ends on
February 7, 2018.
(2) Processors. The submission period for processors under Sec.
710.25(b) begins on August 11, 2017 and ends on October 5, 2018.
(3) Withdrawal of a Notice of Activity Form A. A Notice of Activity
Form A submitted under Sec. 710.30(a)(1) or Sec. 710.30(a)(2) may be
withdrawn by the submitter no later than October 5, 2018. If EPA
receives a timely request to withdraw a previously submitted Notice of
Activity Form A for a chemical substance subject to commercial activity
designation, and EPA has not received a Notice of Activity Form A from
another submitter for the same chemical substance, EPA will not
designate the chemical substance as active. A Form A withdrawn under
this paragraph will not satisfy the obligation under this rule to submit
a Form A.
(b) When must a Notice of Activity Form B be submitted?--(1)
Manufacturers and processors. The Notice of Activity Form B required to
be submitted under Sec. 710.25(c) must be submitted before a person
manufactures or processes the inactive substance, but not more than 90
days prior to the anticipated date of manufacturing or processing.
(2) When else may a Notice of Activity Form B be submitted? A Notice
of Activity Form B that will later be required to be submitted under
Sec. 710.25(c) may be submitted during the 90-day period between EPA's
identification of a chemical substance for inactive designation and the
effective date for such designation, by a person who is currently
manufacturing or processing such chemical substance or who anticipates
manufacturing or processing such chemical substance within 90 days
following submission.
(3) When may EPA execute a request to withdraw a Notice of Activity
Form B? If EPA receives a request to withdraw a previously submitted
Notice of Activity Form B from the submitter of the Notice of Activity
Form B and EPA has neither yet moved the subject chemical substance from
the inactive to the active Inventory nor yet moved the subject chemical
substance from the confidential portion of the Inventory to the public
portion of the Inventory as a result of the original submission, then
EPA may execute the request.
Sec. 710.33 Co-manufacturers and co-processors.
(a) Notice of Activity submitted by co-manufacturers. When, in a
single instance of manufacturing or importing a particular volume of a
chemical substance during the lookback period, two or more persons
qualify as the manufacturer or importer of that volume, they may
determine among themselves who should make the required submission under
Sec. 710.25(a). If no notice is submitted as required under this
subpart, EPA will hold each such person liable for failure to submit a
notice.
(b) Notice of Activity by prospective co-manufacturers or co-
processors. If two or more persons intend to manufacture, import, or
process a particular volume of an inactive substance, such that multiple
persons would qualify as the manufacturer, importer, or processor of
that volume, they may determine among themselves who will submit the
required notice under Sec. 710.25(c). If no notice is submitted as
required under this subpart, all of the persons remain subject to the
reporting requirements, and EPA will hold each such person liable for a
failure to submit a notice prior to the date of manufacturing,
importing, or processing.
Sec. 710.35 Recordkeeping requirements.
Each person who is subject to the notification requirements of this
part must retain records that document any information reported to EPA.
Records relevant to a Notice of Activity under
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Sec. Sec. 710.25(a) and 710.25(b) must be retained for a period of 5
years beginning on the last day of the submission period. Records
relevant to a Notice of Activity under Sec. 710.25(c) must be retained
for a period of 5 years beginning on the day that the notice was
submitted.
Sec. 710.37 Confidentiality claims.
(a) Chemical identity. A person submitting information under this
part may request to maintain an existing claim of confidentiality for
the specific chemical identity of a reportable chemical substance, but
may do so only if the identity of the chemical substance is listed on
the confidential portion of the Inventory as of the time the notice is
submitted for that chemical substance under this part. A request to
maintain an existing claim of confidentiality must be made at the time
the information is submitted. If no person submitting the information
specified in Sec. 710.29(d)(4) for a particular chemical substance
requests that the claim be maintained, EPA will treat the specific
chemical identity of that chemical substance as not subject to a
confidentiality claim and will move the chemical substance to the public
portion of the Inventory. Except as set forth in this subsection,
information claimed as confidential in accordance with this section will
be treated and disclosed in accordance with the procedures in 40 CFR
part 2, subpart B.
(1) Notice of Activity Form A. A person requesting to maintain an
existing claim of confidentiality for specific chemical identity may
submit with the notice answers to the questions in paragraphs (c)(1)
and(c)(2) of this section, signed and dated by an authorized official.
If these answers are submitted less than five years before the date on
which substantiation is due pursuant to TSCA section 8(b)(4)(D)(i), the
answers will be deemed to be substantiations made under TSCA section
(8)(b)(4)(D)(i) and the person will be exempt from further
substantiation requirements under TSCA section (8)(b)(4)(D)(i). Answers
that do not include the answers to all applicable questions in paragraph
(c) of this section will not be deemed to be substantiations made under
the TSCA section (8)(b)(4)(D)(i) requirement.
(2) Notice of Activity Form B. A person requesting to maintain an
existing claim of confidentiality for specific chemical identity must
submit answers to the questions in paragraphs (c)(1) and (c)(2) of this
section within 30 days of submitting the notice, signed and dated by an
authorized official. If this information is not submitted within 30 days
of submitting the notice, EPA will consider the confidentiality claim as
deficient, so that the specific chemical identity is not subject to a
confidentiality claim, and may make the information public without
further notice.
(i) Persons who submitted the information described in paragraph
(a)(2) of this section before May 5, 2020 must submit answers to the
questions in paragraphs (c)(2)(ii) and (iii) of this section not later
than June 4, 2020.
(ii) [Reserved]
(b) Information other than specific chemical identity. A person
submitting information under this part may assert a claim of
confidentiality for information other than specific chemical identity.
Any such confidentiality claim must be made at the time the information
is submitted. Except as set forth in this section, information claimed
as confidential in accordance with this subsection will be treated and
disclosed in accordance with 40 CFR part 2, subpart B. A person
asserting a claim of confidentiality under this subsection must submit
with the notice answers to the questions in paragraph (c)(1) of this
section, signed and dated by an authorized official. If no claim is
asserted at the time the information is submitted, or if the answers to
the questions in paragraph (c)(1) of this section are not provided, EPA
will consider the information as not subject to a confidentiality claim
and may make the information public without further notice.
(c) Substantiation questions. Persons asserting that information is
exempt from substantiation pursuant to TSCA section 14(c)(2) must answer
only the question in paragraph (c)(1)(i) of this section.
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(1) Substantiation questions for any confidentiality claim. For any
information with a confidentiality claim that you assert is exempt from
substantiation pursuant to TSCA section 14(c)(2), answer only the
question in paragraph (c)(1)(i) of this section. For all other
information with a confidentiality claim, answer the questions in
paragraphs (c)(1)(ii) through (vi) of this section. If more than one
data element on Form A or Form B is claimed as confidential, you must
answer the applicable questions individually for each data element. If
the answer to a question applies for all confidentiality claims on the
form, indicate this in your substantiation response.
(i) Do you believe that the information is exempt from
substantiation pursuant to TSCA section 14(c)(2)? If you answered yes,
you must individually identify the specific information claimed as
confidential and specify the applicable exemption(s).
(ii) Will disclosure of the information likely result in substantial
harm to your business's competitive position? If you answered yes,
describe with specificity the substantial harmful effects that would
likely result to your competitive position if the information is made
available to the public.
(iii) To the extent your business has disclosed the information to
others (both internally and externally), what precautions has your
business taken? Identify the measures or internal controls your business
has taken to protect the information claimed as confidential: Non-
disclosure agreement required prior to access; access is limited to
individuals with a need-to-know; information is physically secured;
other internal control measure(s). If yes, explain.
(iv) Does the information appear in any public documents, including
(but not limited to) safety data sheets, advertising or promotional
material, professional or trade publication, or any other media or
publications available to the general public? If you answered yes,
explain why the information should be treated as confidential.
(v) Is the claim of confidentiality intended to last less than 10
years? If so, indicate the number of years (between 1-10 years) or the
specific date/occurrence after which the claim is withdrawn.
(vi) Has EPA, another federal agency, or court made any
confidentiality determination regarding information associated with this
chemical substance? If you answered yes, explain the outcome of that
determination and provide a copy of the previous confidentiality
determination or any other information that will assist in identifying
the prior determination.
(2) Substantiation for confidentiality claims for specific chemical
identity. (i) Is the confidential chemical substance publicly known to
have ever been offered for commercial distribution in the United States?
If you answered yes, explain why the information should be treated as
confidential.
(ii) Does this particular chemical substance leave the site of
manufacture (including import) or processing in any form, e.g., as a
product, effluent, or emission? If yes, please explain what measures
have been taken, if any, to guard against the discovery of its identity.
(iii) If the chemical substance leaves the site in a form that is
available to the public or your competitors, can the chemical identity
be readily discovered by analysis of the substance (e.g., product,
effluent, or emission), in light of existing technologies and any costs,
difficulties, or limitations associated with such technologies? Please
explain why or why not.
(d) Confidentiality of substantiation. If any of the information
contained in the answers to the questions listed in paragraph (c)(1) or
(c)(2) of this section is claimed as confidential business information,
the submitter must clearly indicate such by marking the substantiation
as confidential business information as provided in a Notice of Activity
Form A or Form B.
(e) Certification statement for claims. An authorized official of a
person submitting or substantiating a claim of confidentiality or a
request to maintain an existing claim of confidentiality for specific
chemical identity must certify that the submission complies with the
requirements of this part by signing and dating the following
certification statement: ``I certify that all claims for confidentiality
made or
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sought to be maintained with this submission are true and correct, and
all information submitted herein to substantiate such claims is true and
correct. Any knowing and willful misrepresentation is subject to
criminal penalty pursuant to 18 U.S.C. 1001.'' I further certify that it
is true and correct that:
(1) My company has taken reasonable measures to protect the
confidentiality of the information;
(2) I have determined that the information is not required to be
disclosed or otherwise made available to the public under any other
Federal law;
(3) I have a reasonable basis to conclude that disclosure of the
information is likely to cause substantial harm to the competitive
position of my company; and
(4) I have a reasonable basis to believe that the information is not
readily discoverable through reverse engineering.
[82 FR 37540, Aug. 11, 2017, as amended at 85 FR 13067, Mar. 6, 2020]
Sec. 710.39 Electronic filing.
(a) EPA will accept information submitted under this subpart only if
submitted in accordance with this section. All information must be
submitted electronically to EPA via CDX. Prior to submission to EPA via
CDX, Notices of Activity and any associated information must be
generated and completed using the e-NOA software module.
(b) Obtain instructions for registering in CDX as follows:
(1) Web site. The CDX Registration User Guide is available at
https://www.epa.gov/ sites/production/files/documents/cdx_
_registration_ _guide__v0__02.pdf. To register in CDX, go to https://
cdx.epa.gov and follow the appropriate links.
(2) Telephone. Contact the EPA CDX Help Desk at 1-888-890-1995.
(3) Email. Email the EPA CDX Help Desk at [email protected].
(c) Obtain instructions for using CISS and the e-NOA software module
as follows:
(1) Web site. Go to the EPA New Chemicals under the Toxic Substances
Control Act Web site at https://www.epa.gov/ reviewing-new-
chemicalsunder-toxic-substances- control-act-tsca/how-submit-e-pmn and
follow the appropriate links.
(2) Telephone. Contact the EPA TSCA Hotline at 1-202-554-1404.
(3) Email. Email the EPA TSCA Hotline at [email protected].
Subpart C_Review Plan
Source: 85 FR 13068, Mar. 6, 2020, unless otherwise noted.
Sec. 710.41 Scope.
This subpart applies to the substantiation and review of claims of
confidentiality asserted in Notices of Activity Form A to protect the
specific chemical identities of chemical substances.
Sec. 710.43 Persons subject to substantiation requirement.
(a) Who must substantiate. Any person who filed a Notice of Activity
Form A requesting to maintain an existing confidentiality claim for a
specific chemical identity must substantiate that confidentiality claim
as specified in Sec. Sec. 710.45 and 710.47 unless eligible for an
exemption in paragraph (b) of this section.
(b) Exemptions. (1) Any person who completed the voluntary
substantiation process set forth in Sec. 710.37(a)(1) is exempt from
the substantiation requirement of this subpart pertaining to the
submission of answers to the questions in Sec. 710.45(b)(1) through
(6). All remaining requirements of Sec. 710.45 must be met in
accordance with the deadline specified in Sec. 710.47(a), including the
requirement to submit answers to the questions in Sec. 710.45(b)(7) and
(8), signed and dated by an authorized official, and to complete the
certification statement in Sec. 710.37(e).
(2) A person who has previously substantiated the confidentiality
claim for a specific chemical identity that the person requested to
maintain in a Notice of Activity Form A, by submitting information that
is responsive to all questions in Sec. 710.45, is exempt from the
substantiation requirement of this subpart if both of the following
conditions are met:
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(i) The previous substantiation was submitted to EPA on or after
November 1, 2015; and
(ii) The person reports to EPA the submission date, submission type,
and case number, transaction ID, or equivalent identifier for the
previous submission that contained the substantiation, not later than
the deadline specified in Sec. 710.47.
Sec. 710.45 Contents of substantiation.
(a) The submission. A person substantiating a confidentiality claim
for a specific chemical identity must submit written answers to the
questions in paragraph (b) of this section, signed and dated by an
authorized official, and complete the certification statement in Sec.
710.37(e). If any of the information contained in the answers to the
questions listed in paragraph (b) of this section is itself claimed as
confidential, the submitter must clearly indicate such by marking that
information as confidential business information.
(b) Substantiation questions. (1) Will disclosure of the information
claimed as confidential likely cause substantial harm to your business's
competitive position? If you answered yes, describe the substantial
harmful effects that would likely result to your competitive position if
the information is disclosed, including but not limited to how a
competitor could use such information and the causal relationship
between the disclosure and the harmful effects.
(2) To the extent your business has disclosed the information to
others (both internally and externally), has your business taken
precautions to protect the confidentiality of the disclosed information?
If yes, please explain and identify the specific measures, including but
not limited to internal controls, that your business has taken to
protect the information claimed as confidential.
(3)(i) Is any of the information claimed as confidential required to
be publicly disclosed under any other Federal law? If yes, please
explain.
(ii) Does any of the information claimed as confidential otherwise
appear in any public documents, including (but not limited to) safety
data sheets; advertising or promotional material; professional or trade
publications; state, local, or Federal agency files; or any other media
or publications available to the general public? If yes, please explain
why the information should be treated as confidential.
(iii) Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
(4) Is the claim of confidentiality intended to last less than 10
years? If yes, please indicate the number of years (between 1-10 years)
or the specific date/occurrence after which the claim is withdrawn.
(5) Has EPA, another Federal agency, or court made any
confidentiality determination regarding information associated with this
chemical substance? If yes, please provide the circumstances associated
with the prior determination, whether the information was found to be
entitled to confidential treatment, the entity that made the decision,
and the date of the determination.
(6) Is the confidential chemical substance publicly known (including
by your competitors) to have ever been offered for commercial
distribution in the United States? If yes, please explain why the
specific chemical identity should still be afforded confidential status
(e.g., the chemical substance is publicly known only as being
distributed in commerce for research and development purposes, but no
other information about the current commercial distribution of the
chemical substance in the United States is publicly available).
(7) Does this particular chemical substance leave the site of
manufacture (including import) or processing in any form, e.g., as a
product, effluent, or emission? If yes, please explain what measures
have been taken, if any, to guard against the discovery of its identity.
(8) If the chemical substance leaves the site in a form that is
available to the public or your competitors, can the chemical identity
be readily discovered by analysis of the substance (e.g., product,
effluent, or emission), in light of
[[Page 119]]
existing technologies and any costs, difficulties, or limitations
associated with such technologies? Please explain why or why not.
Sec. 710.47 When to submit substantiation or information on
previous substantiation.
(a) All persons required to substantiate a confidentiality claim
pursuant to Sec. 710.43(a) or (b)(1) must submit their substantiation
not later than November 1, 2020.
(b) All persons who seek an exemption under Sec. 710.43(b)(2) must
submit the information specified in Sec. 710.43(b)(2)(ii) not later
than November 1, 2020.
Sec. 710.49 Failure to report.
If neither the substantiation required under Sec. 710.43(a) or
(b)(1), nor the information specified in Sec. 710.43(b)(2)(ii), is
submitted to EPA in accordance with the provisions of this subpart, then
EPA will deny the confidentiality claim in accordance with the
procedures set forth in TSCA section 14(g)(2) and 40 CFR part 2, subpart
B.
Sec. 710.51 Electronic filing.
EPA will accept information submitted under this subpart only if
submitted in accordance with Sec. 710.39.
Sec. 710.53 Recordkeeping requirements.
Each person who is subject to this part must retain records that
document any information reported to EPA. Records must be retained for a
period of 5 years beginning on the last day of the submission period.
Sec. 710.55 Claim review, duration of protection, TSCA Inventory
maintenance, posting results, and extension.
(a) Review criteria and procedures. Except as set forth in this
subpart, confidentiality claims for specific chemical identities
asserted in Notices of Activity Form A will be reviewed and approved or
denied in accordance with the criteria and procedures in TSCA section 14
and 40 CFR part 2, subpart B.
(b) Duration of protection from disclosure. Except as provided in 40
CFR part 2, subpart B, and section 14 of TSCA, a specific chemical
identity that is the subject of an approved confidentiality claim under
this subpart will be protected from disclosure for a period of 10 years
from the date on which the confidentiality claim was first asserted by
any submitter after June 22, 2016, unless, prior to the expiration of
the period, the claimant notifies EPA that the person is withdrawing the
confidentiality claim, in which case EPA will not protect the
information from disclosure; or EPA otherwise becomes aware that the
information does not qualify for protection from disclosure, in which
case EPA will take the actions described in TSCA section 14(g)(2) to
notify the claimant of EPA's intent to disclose the information.
(c) Updating the TSCA Inventory. EPA will periodically update the
TSCA Inventory based on the results of the reviews of the
confidentiality claims asserted in Notices of Activity Form A.
(d) Posting of annual goals and numbers of reviews completed. At the
beginning of each calendar year until all reviews are completed, EPA
will publish an annual goal for reviews and the number of reviews
completed in the prior year on the Agency website. Determination of
annual review goals will take into consideration the number of claims
needing review, available resources, and a target completion date for
all reviews under this subpart not later than February 19, 2024.
(e) Extension. If EPA determines that the target completion date in
paragraph (d) of this section cannot be met based on the number of
claims needing review and the available resources, then EPA will publish
a document in the Federal Register announcing the extension of the
deadline to complete its review of all confidentiality claims under this
subpart for not more than two additional years, together with an
explanation of the reasons for the extension.
PART 711_TSCA CHEMICAL DATA REPORTING REQUIREMENTS--Table of Contents
Sec.
711.1 Scope, compliance, and enforcement.
711.3 Definitions.
711.5 Chemical substances for which information must be reported.
711.6 Chemical substances for which information is not required.
[[Page 120]]
711.8 Persons who must report.
711.9 Persons not subject to this part.
711.10 Activities for which reporting is not required.
711.15 Reporting information to EPA.
711.20 When to report.
711.22 Duplicative reporting.
711.25 Recordkeeping requirements.
711.30 Confidentiality claims.
711.35 Electronic filing.
Authority: 15 U.S.C. 2607(a).
Source: 76 FR 54933, Sept. 6, 2011, unless otherwise noted.
Sec. 711.1 Scope, compliance, and enforcement.
(a) This subpart specifies reporting and recordkeeping procedures
under section 8(a) of the Toxic Substances Control Act (TSCA) (15 U.S.C.
2607(a)) for certain manufacturers (including importers) of chemical
substances. TSCA section 8(a) authorizes the EPA Administrator to
require reporting of information necessary for the administration of
TSCA.
(b) This part applies to the activities associated with the periodic
update of information on a subset of the chemical substances included on
the TSCA Inventory.
(c) TSCA section 15(3) makes it unlawful for any person to fail or
refuse to submit information required under this part. In addition, TSCA
section 15(3) makes it unlawful for any person to fail to keep, and
permit access to, records required by this part. Section 16 of TSCA
provides that any person who violates a provision of TSCA section 15 is
liable to the United States for a civil penalty and may be criminally
prosecuted. Pursuant to TSCA section 17, the Federal Government may seek
judicial relief to compel submission of TSCA section 8(a) information
and to otherwise restrain any violation of TSCA section 15. (EPA does
not intend to concentrate its enforcement efforts on insignificant
clerical errors in reporting.) TSCA section 11 allows for inspections to
assure compliance, and the Administrator may by subpoena require the
attendance and testimony of witnesses and the production of reports,
papers, documents, answers to questions, and other information that the
Administrator deems necessary.
(d) Each person who reports under this part must maintain records
that document information reported under this part and, in accordance
with TSCA, permit access to, and the copying of, such records by EPA
officials.
[76 FR 54933, Sept. 6, 2011, as amended at 85 FR 20138, Apr. 9, 2020]
Sec. 711.3 Definitions.
The definitions in this section and the definitions in TSCA section
3 apply to this part. In addition, the definitions in 40 CFR 704.3 also
apply to this part, except the definitions manufacture and manufacturer
in 40 CFR 704.3.
CDX or Central Data Exchange means EPA's centralized electronic
document receiving system, or its successors.
Commercial use means the use of a chemical substance or a mixture
containing a chemical substance (including as part of an article) in a
commercial enterprise providing saleable goods or services.
Consumer use means the use of a chemical substance or a mixture
containing a chemical substance (including as part of an article) when
sold to or made available to consumers for their use.
e-CDRweb means the electronic, web-based tool provided by EPA for
the completion of Form U and submission of the CDR data.
Highest-level parent company means the highest-level company of the
site's ownership hierarchy as of the start of the submission period
during which data are being reported according to the following
instructions. The highest-level U.S. parent company is located within
the United States while the highest-level foreign parent company is
located outside the United States. The following rules govern how to
identify the highest-level U.S. parent company and highest-level foreign
parent company (if applicable):
(1) If the site is entirely owned by a single U.S. company that is
not owned by another company, that single company is the U.S. parent
company.
(2) If the site is entirely owned by a single U.S. company that is,
itself, owned by another U.S.-based company (e.g., it is a division or
subsidiary of a higher-level company), the highest-
[[Page 121]]
level domestic company in the ownership hierarchy is the United States
parent company. If there is a higher-level parent company that is
outside of the United States, the highest-level foreign company in the
ownership hierarchy is the foreign parent company.
(3) If the site is owned by more than one company (e.g., company A
owns 40 percent, company B owns 35 percent, and company C owns 25
percent), the company with the largest ownership interest in the site is
the parent company. If a higher-level company in the ownership hierarchy
owns more than one ownership company, then determine the entity with the
largest ownership by considering the lower-level ownerships in
combination (e.g., corporation x owns companies B and C, for a total
ownership of 60 percent for the site).
(i) If the parent company is a U.S. company owned by another U.S.
company, then the highest-level domestic company in the ownership
hierarchy is the U.S. parent company. If the U.S. parent company has a
higher-level foreign company in the ownership hierarchy, then the
highest-level foreign company in the ownership hierarchy is the foreign
parent company.
(ii) If the parent company is a foreign company, then the site is
its own U.S. parent company and the foreign parent company is the
highest-level foreign company in the ownership hierarchy.
(4) If the site is owned by a 50:50 joint venture or a cooperative,
the joint venture or cooperative is its own parent company. If the site
is owned by a U.S. joint venture or cooperative, the highest level of
the joint venture or cooperative is the U.S. parent company. If the site
is owned by a joint venture or cooperative outside the United States,
the highest level of the joint venture or cooperative outside the United
States is the foreign parent company.
(5) If the site is entirely owned by a foreign company (i.e.,
without a U.S.-based subsidiary within the site's ownership hierarchy),
the highest-level foreign company in the ownership hierarchy is the
site's foreign parent company.
(6) If the site is federally owned, the highest-level federal agency
or department is the U.S. parent company.
(7) If the site is owned by a non-federal public entity, that entity
(such as a municipality, State, or tribe) is the U.S. parent company.
Industrial function means the intended physical or chemical
characteristic for which a chemical substance or mixture is consumed as
a reactant; incorporated into a formulation, mixture, reaction product,
or article; repackaged; or used.
Industrial use means use at a site at which one or more chemical
substances or mixtures are manufactured (including imported) or
processed.
Intended for use by children means the chemical substance or mixture
is used in or on a product that is specifically intended for use by
children age 14 or younger. A chemical substance or mixture is intended
for use by children when the submitter answers ``yes'' to at least one
of the following questions for the product into which the submitter's
chemical substance or mixture is incorporated:
(1) Is the product commonly recognized (i.e., by a reasonable
person) as being intended for children age 14 or younger?
(2) Does the manufacturer of the product state through product
labeling or other written materials that the product is intended for or
will be used by children age 14 or younger?
(3) Is the advertising, promotion, or marketing of the product aimed
at children age 14 or younger?
Manufacture means to manufacture, produce, or import, for commercial
purposes. Manufacture includes the extraction, for commercial purposes,
of a component chemical substance from a previously existing chemical
substance or complex combination of chemical substances. A chemical
substance is co-manufactured by the person who physically performs the
manufacturing and the person contracting for such production when that
chemical substance, manufactured other than by import, is:
(1) Produced exclusively for another person who contracts for such
production, and
(2) That other person dictates the specific chemical identity of the
chemical substance and controls the total amount produced and the basic
technology for the manufacturing process.
[[Page 122]]
Manufacturer means a person who manufactures a chemical substance.
Master Inventory File means EPA's comprehensive list of chemical
substances which constitutes the TSCA Inventory compiled under TSCA
section 8(b). It includes chemical substances reported under 40 CFR part
710 and substances reported under 40 CFR part 720 for which a Notice of
Commencement of Manufacture or Import has been received under 40 CFR
720.120.
Principal reporting year means the latest complete calendar year
preceding the submission period.
Reasonably likely to be exposed means an exposure to a chemical
substance which, under foreseeable conditions of manufacture (including
import), processing, distribution in commerce, or use of the chemical
substance, is more likely to occur than not to occur. Such exposures
would normally include, but would not be limited to, activities such as
charging reactor vessels, drumming, bulk loading, cleaning equipment,
maintenance operations, materials handling and transfers, and analytical
operations. Covered exposures include exposures through any route of
entry (inhalation, ingestion, skin contact, absorption, etc.), but
excludes accidental or theoretical exposures.
Repackaging means the physical transfer of a chemical substance or
mixture, as is, from one container to another container or containers in
preparation for distribution of the chemical substance or mixture in
commerce.
Reportable chemical substance means a chemical substance described
in Sec. 711.5.
Site means a contiguous property unit. Property divided only by a
public right-of-way shall be considered one site. More than one
manufacturing plant may be located on a single site.
(1) For chemical substances manufactured under contract, i.e., by a
co-manufacturer, the site is the location where the chemical substance
is physically manufactured.
(2) The site for an importer who imports a chemical substance
described in Sec. 711.5 is the U.S. site of the operating unit within
the person's organization that is directly responsible for importing the
chemical substance. The import site, in some cases, may be the
organization's headquarters in the United States. If there is no such
operating unit or headquarters in the United States, the site address
for the importer is the U.S. address of an agent acting on behalf of the
importer who is authorized to accept service of process for the
importer.
(3) For portable manufacturing units sent to different locations
from a single distribution center, the distribution center shall be
considered the site.
Site-limited means a chemical substance is manufactured and
processed only within a site and is not distributed for commercial
purposes as a chemical substance or as part of a mixture or article
outside the site. Imported chemical substances are never site-limited.
Although a site-limited chemical substance is not distributed for
commercial purposes outside the site at which it is manufactured and
processed, the chemical substance is considered to have been
manufactured and processed for commercial purposes.
Submission period means the period in which the manufacturing,
processing, and use data are submitted to EPA.
Use means any utilization of a chemical substance or mixture that is
not otherwise covered by the terms manufacture or process. Relabeling or
redistributing a container holding a chemical substance or mixture where
no repackaging of the chemical substance or mixture occurs does not
constitute use or processing of the chemical substance or mixture.
[76 FR 54933, Sept. 6, 2011, as amended at 85 FR 20138, Apr. 9, 2020]
Sec. 711.5 Chemical substances for which information must be reported.
Any chemical substance that is in the Master Inventory File at the
beginning of a submission period described in Sec. 711.20, unless the
chemical substance is specifically excluded by Sec. 711.6.
Sec. 711.6 Chemical substances for which information is not required.
The following groups or categories of chemical substances are
exempted from some or all of the reporting requirements of this part,
with the following exception: A chemical substance described in
paragraph (a)(1),
[[Page 123]]
(2), or (4), or (b) of this section is not exempted from any of the
reporting requirements of this part if that chemical substance is the
subject of a rule proposed or promulgated under TSCA sections 4,
5(a)(2), 5(b)(4), or 6, or is the subject of an enforceable consent
agreement (ECA) developed under the procedures of 40 CFR part 790, or is
the subject of an order issued under TSCA sections 4, 5(e), or 5(f), or
is the subject of relief that has been granted under a civil action
under TSCA sections 5 or 7.
(a) Full exemptions. The following categories of chemical substances
are exempted from the reporting requirements of this part.
(1) Polymers. (i) Any chemical substance described with the word
fragments ``*polym,'' ``*alkyd,'' or ``*oxylated'' in the Chemical
Abstracts (CA) Index Name in the Master Inventory File, where the
asterisk (*) in the listed word fragments indicates that any sets of
characters may precede, or follow, the character string defined.
(ii) Any chemical substance that is identified in the Master
Inventory File as an enzyme, lignin, a polysaccharide (cellulose, gum,
starch), a protein (albumin, casein, gelatin, gluten, hemoglobin),
rubber, siloxane and silicone, or silsesquioxane.
(iii) This exclusion does not apply to a polymeric substance that
has been depolymerized, hydrolyzed, or otherwise chemically modified,
except in cases where the intended product of this reaction is totally
polymeric in structure.
(2) Microorganisms. Any combination of chemical substances that is a
living organism, and that meets the definition of microorganism at 40
CFR 725.3. Any chemical substance produced from a living microorganism
is reportable under this part unless otherwise excluded.
(3) Naturally occurring chemical substances. Any naturally occurring
chemical substance, as described in 40 CFR 710.4(b). The applicability
of this exclusion is determined in each case by the specific activities
of the person who manufactures the chemical substance in question. Some
chemical substances can be manufactured both as described in 40 CFR
710.4(b) and by means other than those described in 40 CFR 710.4(b). If
a person described in Sec. 711.8 manufactures a chemical substance by
means other than those described in 40 CFR 710.4(b), the person must
report regardless of whether the chemical substance also could have been
produced as described in 40 CFR 710.4(b). Any chemical substance that is
produced from such a naturally occurring chemical substance described in
40 CFR 710.4(b) is reportable unless otherwise excluded.
(4) Water and certain forms of natural gas. Chemical substances with
the following Chemical Abstracts Service Registry Number (CASRN): CASRN
7732-18-5, water; CASRN 8006-14-2, natural gas; CASRN 8006-61-9,
gasoline, natural; CASRN 64741-48-6, natural gas (petroleum), raw liq.
mix; CASRN 68410-63-9, natural gas, dried; CASRN 68425-31-0, gasoline
(natural gas), natural; and CASRN 68919-39-1, natural gas condensates.
(b) Partial exemptions. The following groups of chemical substances
are partially exempted from the reporting requirements of this part
(i.e., the information described in Sec. 711.15(b)(4) need not be
reported for these chemical substances). Such chemical substances are
not excluded from the other reporting requirements under this part.
(1) Petroleum process streams. EPA has designated the chemical
substances listed in Table 1 of this paragraph by CASRN, as partially
exempt from reporting under the CDR.
Table 1--CASRNs of Partially Exempt Chemical Substances Termed
``Petroleum Process Streams'' for Purposes of TSCA Chemical Data
Reporting
------------------------------------------------------------------------
CASRN Product
------------------------------------------------------------------------
8002-05-9......................... Petroleum.
8002-74-2......................... Paraffin waxes and hydrocarbon
waxes.
8006-20-0......................... Fuel gases, low and medium B.T.U.
8008-20-6......................... Kerosine (petroleum).
8009-03-8......................... Petrolatum.
8012-95-1......................... Paraffin oils.
[[Page 124]]
8030-30-6......................... Naphtha.
8032-32-4......................... Ligroine.
8042-47-5......................... White mineral oil (petroleum).
8052-41-3......................... Stoddard solvent.
8052-42-4......................... Asphalt.
61789-60-4........................ Pitch.
63231-60-7........................ Paraffin waxes and hydrocarbon
waxes, microcryst.
64741-41-9........................ Naphtha (petroleum), heavy straight-
run.
64741-42-0........................ Naphtha (petroleum), full-range
straight-run.
64741-43-1........................ Gas oils (petroleum), straight-run.
64741-44-2........................ Distillates (petroleum), straight-
run middle.
64741-45-3........................ Residues (petroleum), atm. tower.
64741-46-4........................ Naphtha (petroleum), light straight-
run.
64741-47-5........................ Natural gas condensates (petroleum).
64741-49-7........................ Condensates (petroleum), vacuum
tower.
64741-50-0........................ Distillates (petroleum), light
paraffinic.
64741-51-1........................ Distillates (petroleum), heavy
paraffinic.
64741-52-2........................ Distillates (petroleum), light
naphthenic.
64741-53-3........................ Distillates (petroleum), heavy
naphthenic.
64741-54-4........................ Naphtha (petroleum), heavy catalytic
cracked.
64741-55-5........................ Naphtha (petroleum), light catalytic
cracked.
64741-56-6........................ Residues (petroleum), vacuum.
64741-57-7........................ Gas oils (petroleum), heavy vacuum.
64741-58-8........................ Gas oils (petroleum), light vacuum.
64741-59-9........................ Distillates (petroleum), light
catalytic cracked.
64741-60-2........................ Distillates (petroleum),
intermediate catalytic cracked.
64741-61-3........................ Distillates (petroleum), heavy
catalytic cracked.
64741-62-4........................ Clarified oils (petroleum),
catalytic cracked.
64741-63-5........................ Naphtha (petroleum), light catalytic
reformed.
64741-64-6........................ Naphtha (petroleum), full-range
alkylate.
64741-65-7........................ Naphtha (petroleum), heavy alkylate.
64741-66-8........................ Naphtha (petroleum), light alkylate.
64741-67-9........................ Residues (petroleum), catalytic
reformer fractionator.
64741-68-0........................ Naphtha (petroleum), heavy catalytic
reformed.
64741-69-1........................ Naphtha (petroleum), light
hydrocracked.
64741-70-4........................ Naphtha (petroleum), isomerization.
64741-73-7........................ Distillates (petroleum), alkylate.
64741-74-8........................ Naphtha (petroleum), light thermal
cracked.
64741-75-9........................ Residues (petroleum), hydrocracked.
64741-76-0........................ Distillates (petroleum), heavy
hydrocracked.
64741-77-1........................ Distillates (petroleum), light
hydrocracked.
64741-78-2........................ Naphtha (petroleum), heavy
hydrocracked.
64741-79-3........................ Coke (petroleum).
64741-80-6........................ Residues (petroleum), thermal
cracked.
64741-81-7........................ Distillates (petroleum), heavy
thermal cracked.
64741-82-8........................ Distillates (petroleum), light
thermal cracked.
64741-83-9........................ Naphtha (petroleum), heavy thermal
cracked.
64741-84-0........................ Naphtha (petroleum), solvent-refined
light.
64741-85-1........................ Raffinates (petroleum), sorption
process.
64741-86-2........................ Distillates (petroleum), sweetened
middle.
64741-87-3........................ Naphtha (petroleum), sweetened.
64741-88-4........................ Distillates (petroleum), solvent-
refined heavy paraffinic.
64741-89-5........................ Distillates (petroleum), solvent-
refined light paraffinic.
64741-90-8........................ Gas oils (petroleum), solvent-
refined.
64741-91-9........................ Distillates (petroleum), solvent-
refined middle.
64741-92-0........................ Naphtha (petroleum), solvent-refined
heavy.
64741-95-3........................ Residual oils (petroleum), solvent
deasphalted.
64741-96-4........................ Distillates (petroleum), solvent-
refined heavy naphthenic.
64741-97-5........................ Distillates (petroleum), solvent-
refined light naphthenic.
64741-98-6........................ Extracts (petroleum), heavy naphtha
solvent.
64741-99-7........................ Extracts (petroleum), light naphtha
solvent.
64742-01-4........................ Residual oils (petroleum), solvent-
refined.
64742-03-6........................ Extracts (petroleum), light
naphthenic distillate solvent.
64742-04-7........................ Extracts (petroleum), heavy
paraffinic distillate solvent.
64742-05-8........................ Extracts (petroleum), light
paraffinic distillate solvent.
64742-06-9........................ Extracts (petroleum), middle
distillate solvent.
64742-07-0........................ Raffinates (petroleum), residual oil
decarbonization.
64742-08-1........................ Raffinates (petroleum), heavy
naphthenic distillate
decarbonization.
64742-09-2........................ Raffinates (petroleum), heavy
paraffinic distillate
decarbonization.
64742-10-5........................ Extracts (petroleum), residual oil
solvent.
64742-11-6........................ Extracts (petroleum), heavy
naphthenic distillate solvent.
[[Page 125]]
64742-12-7........................ Gas oils (petroleum), acid-treated.
64742-13-8........................ Distillates (petroleum), acid-
treated middle.
64742-14-9........................ Distillates (petroleum), acid-
treated light.
64742-15-0........................ Naphtha (petroleum), acid-treated.
64742-16-1........................ Petroleum resins.
64742-18-3........................ Distillates (petroleum), acid-
treated heavy naphthenic.
64742-19-4........................ Distillates (petroleum), acid-
treated light naphthenic.
64742-20-7........................ Distillates (petroleum), acid-
treated heavy paraffinic.
64742-21-8........................ Distillates (petroleum), acid-
treated light paraffinic.
64742-22-9........................ Naphtha (petroleum), chemically
neutralized heavy.
64742-23-0........................ Naphtha (petroleum), chemically
neutralized light.
64742-24-1........................ Sludges (petroleum), acid.
64742-25-2........................ Lubricating oils (petroleum), acid-
treated spent.
64742-26-3........................ Hydrocarbon waxes (petroleum), acid-
treated.
64742-27-4........................ Distillates (petroleum), chemically
neutralized heavy paraffinic.
64742-28-5........................ Distillates (petroleum), chemically
neutralized light paraffinic.
64742-29-6........................ Gas oils (petroleum), chemically
neutralized.
64742-30-9........................ Distillates (petroleum), chemically
neutralized middle.
64742-31-0........................ Distillates (petroleum), chemically
neutralized light.
64742-32-1........................ Lubricating oils (petroleum),
chemically neutralized spent.
64742-33-2........................ Hydrocarbon waxes (petroleum),
chemically neutralized.
64742-34-3........................ Distillates (petroleum), chemically
neutralized heavy naphthenic.
64742-35-4........................ Distillates (petroleum), chemically
neutralized light naphthenic.
64742-36-5........................ Distillates (petroleum), clay-
treated heavy paraffinic.
64742-37-6........................ Distillates (petroleum), clay-
treated light paraffinic.
64742-38-7........................ Distillates (petroleum), clay-
treated middle.
64742-39-8........................ Neutralizing agents (petroleum),
spent sodium carbonate.
64742-40-1........................ Neutralizing agents (petroleum),
spent sodium hydroxide.
64742-41-2........................ Residual oils (petroleum), clay-
treated.
64742-42-3........................ Hydrocarbon waxes (petroleum), clay-
treated microcryst.
64742-43-4........................ Paraffin waxes (petroleum), clay-
treated.
64742-44-5........................ Distillates (petroleum), clay-
treated heavy naphthenic.
64742-45-6........................ Distillates (petroleum), clay-
treated light naphthenic.
64742-46-7........................ Distillates (petroleum),
hydrotreated middle.
64742-47-8........................ Distillates (petroleum),
hydrotreated light.
64742-48-9........................ Naphtha (petroleum), hydrotreated
heavy.
64742-49-0........................ Naphtha (petroleum), hydrotreated
light.
64742-50-3........................ Lubricating oils (petroleum), clay-
treated spent.
64742-51-4........................ Paraffin waxes (petroleum),
hydrotreated.
64742-52-5........................ Distillates (petroleum),
hydrotreated heavy naphthenic.
64742-53-6........................ Distillates (petroleum),
hydrotreated light naphthenic.
64742-54-7........................ Distillates (petroleum),
hydrotreated heavy paraffinic.
64742-55-8........................ Distillates (petroleum),
hydrotreated light paraffinic.
64742-56-9........................ Distillates (petroleum), solvent-
dewaxed light paraffinic.
64742-57-0........................ Residual oils (petroleum),
hydrotreated.
64742-58-1........................ Lubricating oils (petroleum),
hydrotreated spent.
64742-59-2........................ Gas oils (petroleum), hydrotreated
vacuum.
64742-60-5........................ Hydrocarbon waxes (petroleum),
hydrotreated microcryst.
64742-61-6........................ Slack wax (petroleum).
64742-62-7........................ Residual oils (petroleum), solvent-
dewaxed.
64742-63-8........................ Distillates (petroleum), solvent-
dewaxed heavy naphthenic.
64742-64-9........................ Distillates (petroleum), solvent-
dewaxed light naphthenic.
64742-65-0........................ Distillates (petroleum), solvent-
dewaxed heavy paraffinic.
64742-67-2........................ Foots oil (petroleum).
64742-68-3........................ Naphthenic oils (petroleum),
catalytic dewaxed heavy.
64742-69-4........................ Naphthenic oils (petroleum),
catalytic dewaxed light.
64742-70-7........................ Paraffin oils (petroleum), catalytic
dewaxed heavy.
64742-71-8........................ Paraffin oils (petroleum), catalytic
dewaxed light.
64742-72-9........................ Distillates (petroleum), catalytic
dewaxed middle.
64742-73-0........................ Naphtha (petroleum),
hydrodesulfurized light.
64742-75-2........................ Naphthenic oils (petroleum), complex
dewaxed heavy.
64742-76-3........................ Naphthenic oils (petroleum), complex
dewaxed light.
64742-78-5........................ Residues (petroleum),
hydrodesulfurized atmospheric
tower.
64742-79-6........................ Gas oils (petroleum),
hydrodesulfurized.
64742-80-9........................ Distillates (petroleum),
hydrodesulfurized middle.
64742-81-0........................ Kerosine (petroleum),
hydrodesulfurized.
64742-82-1........................ Naphtha (petroleum),
hydrodesulfurized heavy.
64742-83-2........................ Naphtha (petroleum), light steam-
cracked.
64742-85-4........................ Residues (petroleum),
hydrodesulfurized vacuum.
64742-86-5........................ Gas oils (petroleum),
hydrodesulfurized heavy vacuum.
64742-87-6........................ Gas oils (petroleum),
hydrodesulfurized light vacuum.
[[Page 126]]
64742-88-7........................ Solvent naphtha (petroleum), medium
aliph.
64742-89-8........................ Solvent naphtha (petroleum), light
aliph.
64742-90-1........................ Residues (petroleum), steam-cracked.
64742-91-2........................ Distillates (petroleum), steam-
cracked.
64742-92-3........................ Petroleum resins, oxidized.
64742-93-4........................ Asphalt, oxidized.
64742-94-5........................ Solvent naphtha (petroleum), heavy
arom.
64742-95-6........................ Solvent naphtha (petroleum), light
arom.
64742-96-7........................ Solvent naphtha (petroleum), heavy
aliph.
64742-97-8........................ Distillates (petroleum), oxidized
heavy.
64742-98-9........................ Distillates (petroleum), oxidized
light.
64742-99-0........................ Residual oils (petroleum), oxidized.
64743-00-6........................ Hydrocarbon waxes (petroleum),
oxidized.
64743-01-7........................ Petrolatum (petroleum), oxidized.
64743-02-8........................ Alkenes, C10 .alpha.-.
64743-03-9........................ Phenols (petroleum).
64743-04-0........................ Coke (petroleum), recovery.
64743-05-1........................ Coke (petroleum), calcined.
64743-06-2........................ Extracts (petroleum), gas oil
solvent.
64743-07-3........................ Sludges (petroleum), chemically
neutralized.
64754-89-8........................ Naphthenic acids (petroleum), crude.
64771-71-7........................ Paraffins (petroleum), normal C10.
64771-72-8........................ Paraffins (petroleum), normal C5-20.
67254-74-4........................ Naphthenic oils.
67674-12-8........................ Residual oils (petroleum), oxidized,
compounds with triethanolamine.
67674-13-9........................ Petrolatum (petroleum), oxidized,
partially deacidified.
67674-15-1........................ Petrolatum (petroleum), oxidized, Me
ester.
67674-16-2........................ Hydrocarbon waxes (petroleum),
oxidized, partially deacidified.
67674-17-3........................ Distillates (petroleum), oxidized
light, compounds with
triethanolamine.
67674-18-4........................ Distillates (petroleum), oxidized
light, Bu esters.
67891-79-6........................ Distillates (petroleum), heavy arom.
67891-80-9........................ Distillates (petroleum), light arom.
67891-81-0........................ Distillates (petroleum), oxidized
light, potassium salts.
67891-82-1........................ Hydrocarbon waxes (petroleum),
oxidized, compounds with
ethanolamine.
67891-83-2........................ Hydrocarbon waxes (petroleum),
oxidized, compounds with
isopropanolamine.
67891-85-4........................ Hydrocarbon waxes (petroleum),
oxidized, compounds with
triisopropanolamine.
67891-86-5........................ Hydrocarbon waxes (petroleum),
oxidized, compds. with
diisopropanolamine.
68131-05-5........................ Hydrocarbon oils, process blends.
68131-49-7........................ Aromatic hydrocarbons, C6-10, acid-
treated, neutralized.
68131-75-9........................ Gases (petroleum), C3-4.
68153-22-0........................ Paraffin waxes and Hydrocarbon
waxes, oxidized.
68187-57-5........................ Pitch, coal tar-petroleum.
68187-58-6........................ Pitch, petroleum, arom.
68187-60-0........................ Hydrocarbons, C4, ethane-propane-
cracked.
68307-98-2........................ Tail gas (petroleum), catalytic
cracked distillate and catalytic
cracked naphtha fractionation
absorber.
68307-99-3........................ Tail gas (petroleum), catalytic
polymn. naphtha fractionation
stabilizer.
68308-00-9........................ Tail gas (petroleum), catalytic
reformed naphtha fractionation
stabilizer, hydrogen sulfide-free.
68308-01-0........................ Tail gas (petroleum), cracked
distillate hydrotreater stripper.
68308-02-1........................ Tail gas (petroleum), distn.,
hydrogen sulfide-free.
68308-03-2........................ Tail gas (petroleum), gas oil
catalytic cracking absorber.
68308-04-3........................ Tail gas (petroleum), gas recovery
plant.
68308-05-4........................ Tail gas (petroleum), gas recovery
plant deethanizer.
68308-06-5........................ Tail gas (petroleum),
hydrodesulfurized distillate and
hydrodesulfurized naphtha
fractionator, acid-free.
68308-07-6........................ Tail gas (petroleum),
hydrodesulfurized vacuum gas oil
stripper, hydrogen sulfide-free.
68308-08-7........................ Tail gas (petroleum), isomerized
naphtha fractionation stabilizer.
68308-09-8........................ Tail gas (petroleum), light straight-
run naphtha stabilizer, hydrogen
sulfide-free.
68308-10-1........................ Tail gas (petroleum), straight-run
distillate hydrodesulfurizer,
hydrogen sulfide-free.
68308-11-2........................ Tail gas (petroleum), propane-
propylene alkylation feed prep
deethanizer.
68308-12-3........................ Tail gas (petroleum), vacuum gas oil
hydrodesulfurizer, hydrogen sulfide-
free.
68308-27-0........................ Fuel gases, refinery.
68333-22-2........................ Residues (petroleum), atmospheric.
68333-23-3........................ Naphtha (petroleum), heavy coker.
68333-24-4........................ Hydrocarbon waxes (petroleum),
oxidized, compds. with
triethanolamine.
68333-25-5........................ Distillates (petroleum),
hydrodesulfurized light catalytic
cracked.
68333-26-6........................ Clarified oils (petroleum),
hydrodesulfurized catalytic
cracked.
68333-27-7........................ Distillates (petroleum),
hydrodesulfurized intermediate
catalytic cracked.
68333-28-8........................ Distillates (petroleum),
hydrodesulfurized heavy catalytic
cracked.
68333-29-9........................ Residues (petroleum), light naphtha
solvent extracts.
68333-30-2........................ Distillates (petroleum), oxidized
heavy thermal cracked.
[[Page 127]]
68333-81-3........................ Alkanes, C4-12.
68333-88-0........................ Aromatic hydrocarbons, C9-17.
68334-30-5........................ Fuels, diesel.
68409-99-4........................ Gases (petroleum), catalytic cracked
overheads.
68410-00-4........................ Distillates (petroleum), crude oil.
68410-05-9........................ Distillates (petroleum), straight-
run light.
68410-12-8........................ Distillates (petroleum), steam-
cracked, C5-10 fraction, high-
temperature stripping products with
light steam-cracked petroleum
naphtha C5 fraction polymers.
68410-71-9........................ Raffinates (petroleum), catalytic
reformer ethylene glycol-water
countercurrent exts.
68410-96-8........................ Distillates (petroleum),
hydrotreated middle, intermediate
boiling.
68410-97-9........................ Distillates (petroleum), light
distillate hydrotreating process,
low-boiling.
68410-98-0........................ Distillates (petroleum),
hydrotreated heavy naphtha,
deisohexanizer overheads.
68411-00-7........................ Alkenes, C8.
68425-29-6........................ Distillates (petroleum), naphtha-
raffinate pyrolyzate-derived,
gasoline-blending.
68425-33-2........................ Petrolatum (petroleum), oxidized,
barium salt.
68425-34-3........................ Petrolatum (petroleum), oxidized,
calcium salt.
68425-35-4........................ Raffinates (petroleum), reformer,
Lurgi unit-sepd.
68425-39-8........................ Alkenes, C10 .alpha.-,
oxidized.
68441-09-8........................ Hydrocarbon waxes (petroleum), clay-
treated microcryst., contg.
polyethylene, oxidized.
68459-78-9........................ Alkenes, C18-24 .alpha.-, dimers.
68475-57-0........................ Alkanes, C1-2.
68475-58-1........................ Alkanes, C2-3.
68475-59-2........................ Alkanes, C3-4.
68475-60-5........................ Alkanes, C4-5.
68475-61-6........................ Alkenes, C5, naphtha-raffinate
pyrolyzate-derived.
68475-70-7........................ Aromatic hydrocarbons, C6-8, naphtha-
raffinate pyrolyzate-derived.
68475-79-6........................ Distillates (petroleum), catalytic
reformed depentanizer.
68475-80-9........................ Distillates (petroleum), light steam-
cracked naphtha.
68476-26-6........................ Fuel gases.
68476-27-7........................ Fuel gases, amine system residues.
68476-28-8........................ Fuel gases, C6-8 catalytic reformer.
68476-29-9........................ Fuel gases, crude oil distillates.
68476-30-2........................ Fuel oil, no. 2.
68476-31-3........................ Fuel oil, no. 4.
68476-32-4........................ Fuel oil, residues-straight-run gas
oils, high-sulfur.
68476-33-5........................ Fuel oil, residual.
68476-34-6........................ Fuels, diesel, no. 2.
68476-39-1........................ Hydrocarbons, aliph.-arom.-C4-5-
olefinic.
68476-40-4........................ Hydrocarbons, C3-4.
68476-42-6........................ Hydrocarbons, C4-5.
68476-43-7........................ Hydrocarbons, C4-6, C5-rich.
68476-44-8........................ Hydrocarbons, C3.
68476-45-9........................ Hydrocarbons, C5-10 arom. conc.,
ethylene-manuf.-by-product.
68476-46-0........................ Hydrocarbons, C3-11, catalytic
cracker distillates.
68476-47-1........................ Hydrocarbons, C2-6, C6-8 catalytic
reformer.
68476-49-3........................ Hydrocarbons, C2-4, C3-rich.
68476-50-6........................ Hydrocarbons, C=5, C5-6-
rich.
68476-52-8........................ Hydrocarbons, C4, ethylene-manuf.-by-
product.
68476-53-9........................ Hydrocarbons, C=20,
petroleum wastes.
68476-54-0........................ Hydrocarbons, C3-5, polymn. unit
feed.
68476-55-1........................ Hydrocarbons, C5-rich.
68476-56-2........................ Hydrocarbons, cyclic C5 and C6.
68476-77-7........................ Lubricating oils, refined used.
68476-81-3........................ Paraffin waxes and Hydrocarbon
waxes, oxidized, calcium salts.
68476-84-6........................ Petroleum products, gases, inorg.
68476-85-7........................ Petroleum gases, liquefied.
68476-86-8........................ Petroleum gases, liquefied,
sweetened.
68477-25-8........................ Waste gases, vent gas, C1-6.
68477-26-9........................ Wastes, petroleum.
68477-29-2........................ Distillates (petroleum), catalytic
reformer fractionator residue, high-
boiling.
68477-30-5........................ Distillates (petroleum), catalytic
reformer fractionator residue,
intermediate-boiling.
68477-31-6........................ Distillates (petroleum), catalytic
reformer fractionator residue, low-
boiling.
68477-33-8........................ Gases (petroleum), C3-4, isobutane-
rich.
68477-34-9........................ Distillates (petroleum), C3-5, 2-
methyl-2-butene-rich.
68477-35-0........................ Distillates (petroleum), C3-6,
piperylene-rich.
68477-36-1........................ Distillates (petroleum), cracked
steam-cracked, C5-18 fraction.
68477-38-3........................ Distillates (petroleum), cracked
steam-cracked petroleum
distillates.
68477-39-4........................ Distillates (petroleum), cracked
stripped steam-cracked petroleum
distillates, C8-10 fraction.
68477-40-7........................ Distillates (petroleum), cracked
stripped steam-cracked petroleum
distillates, C10-12 fraction.
68477-41-8........................ Gases (petroleum), extractive, C3-5,
butadiene-butene-rich.
68477-42-9........................ Gases (petroleum), extractive, C3-5,
butene-isobutylene-rich.
[[Page 128]]
68477-44-1........................ Distillates (petroleum), heavy
naphthenic, mixed with steam-
cracked petroleum distillates C5-12
fraction.
68477-47-4........................ Distillates (petroleum), mixed heavy
olefin vacuum, heart-cut.
68477-48-5........................ Distillates (petroleum), mixed heavy
olefin vacuum, low-boiling.
68477-53-2........................ Distillates (petroleum), steam-
cracked, C5-12 fraction.
68477-54-3........................ Distillates (petroleum), steam-
cracked, C8-12 fraction.
68477-55-4........................ Distillates (petroleum), steam-
cracked, C5-10 fraction, mixed with
light steam-cracked petroleum
naphtha C5 fraction.
68477-58-7........................ Distillates (petroleum), steam-
cracked petroleum distillates, C5-
18 fraction.
68477-59-8........................ Distillates (petroleum), steam-
cracked petroleum distillates
cyclopentadiene conc.
68477-60-1........................ Extracts (petroleum), cold-acid.
68477-61-2........................ Extracts (petroleum), cold-acid, C4-
6.
68477-62-3........................ Extracts (petroleum), cold-acid, C3-
5, butene-rich.
68477-63-4........................ Extracts (petroleum), reformer
recycle.
68477-64-5........................ Gases (petroleum), acetylene manuf.
off.
68477-65-6........................ Gases (petroleum), amine system
feed.
68477-66-7........................ Gases (petroleum), benzene unit
hydrodesulfurizer off.
68477-67-8........................ Gases (petroleum), benzene unit
recycle, hydrogen-rich.
68477-68-9........................ Gases (petroleum), blend oil,
hydrogen-nitrogen-rich.
68477-69-0........................ Gases (petroleum), butane splitter
overheads.
68477-70-3........................ Gases (petroleum), C2-3.
68477-71-4........................ Gases (petroleum), catalytic-cracked
gas oil depropanizer bottoms, C4-
rich acid-free.
68477-72-5........................ Gases (petroleum), catalytic-cracked
naphtha debutanizer bottoms, C3-5-
rich.
68477-73-6........................ Gases (petroleum), catalytic cracked
naphtha depropanizer overhead, C3-
rich acid-free.
68477-74-7........................ Gases (petroleum), catalytic
cracker.
68477-75-8........................ Gases (petroleum), catalytic
cracker, C1-5-rich.
68477-76-9........................ Gases (petroleum), catalytic polymd.
naphtha stabilizer overhead, C2-4-
rich.
68477-77-0........................ Gases (petroleum), catalytic
reformed naphtha stripper
overheads.
68477-79-2........................ Gases (petroleum), catalytic
reformer, C1-4-rich.
68477-80-5........................ Gases (petroleum), C6-8 catalytic
reformer recycle.
68477-81-6........................ Gases (petroleum), C6-8 catalytic
reformer.
68477-82-.7....................... Gases (petroleum), C6-8 catalytic
reformer recycle, hydrogen-rich.
68477-83-8........................ Gases (petroleum), C3-5 olefinic-
paraffinic alkylation feed.
68477-84-9........................ Gases (petroleum), C2-return stream.
68477-85-0........................ Gases (petroleum), C4-rich.
68477-86-1........................ Gases (petroleum), deethanizer
overheads.
68477-87-2........................ Gases (petroleum), deisobutanizer
tower overheads.
68477-88-3........................ Gases (petroleum), deethanizer
overheads, C3-rich.
68477-89-4........................ Distillates (petroleum),
depentanizer overheads.
68477-90-7........................ Gases (petroleum), depropanizer dry,
propene-rich.
68477-91-8........................ Gases (petroleum), depropanizer
overheads.
68477-92-9........................ Gases (petroleum), dry sour, gas-
concentration concn.-unit-off.
68477-93-0........................ Gases (petroleum), gas concn.
reabsorber distn.
68477-94-1........................ Gases (petroleum), gas recovery
plant depropanizer overheads
68477-95-2........................ Gases (petroleum), Girbatol unit
feed.
68477-96-3........................ Gases (petroleum), hydrogen absorber
off.
68477-97-4........................ Gases (petroleum), hydrogen-rich.
68477-98-5........................ Gases (petroleum), hydrotreater
blend oil recycle, hydrogen-
nitrogen rich.
68477-99-6........................ Gases (petroleum), isomerized
naphtha fractionater, C4-rich,
hydrogen sulfide-free.
68478-00-2........................ Gases (petroleum), recycle, hydrogen-
rich.
68478-01-3........................ Gases (petroleum), reformer make-up,
hydrogen-rich.
68478-02-4........................ Gases (petroleum), reforming
hydrotreater.
68478-03-5........................ Gases (petroleum), reforming
hydrotreater, hydrogen-methane-
rich.
68478-04-6........................ Gases (petroleum), reforming
hydrotreater make-up, hydrogen-
rich.
68478-05-7........................ Gases (petroleum), thermal cracking
distn.
68478-08-0........................ Naphtha (petroleum), light steam-
cracked, C5-fraction, oligomer
conc.
68478-10-4........................ Naphtha (petroleum), light steam-
cracked, debenzenized, C8-16-
cycloalkadiene conc.
68478-12-6........................ Residues (petroleum), butane
splitter bottoms.
68478-13-7........................ Residues (petroleum), catalytic
reformer fractionator residue
distn.
68478-15-9........................ Residues (petroleum), C6-8 catalytic
reformer.
68478-16-0........................ Residual oils (petroleum),
deisobutanizer tower.
68478-17-1........................ Residues (petroleum), heavy coker
gas oil and vacuum gas oil.
68478-18-2........................ Residues (petroleum), heavy olefin
vacuum.
68478-19-3........................ Residual oils (petroleum), propene
purifn. splitter.
68478-20-6........................ Residues (petroleum), steam-cracked
petroleum distillates
cyclopentadiene conc., C4-
cyclopentadiene-free.
68478-22-8........................ Tail gas (petroleum), catalytic
cracked naphtha stabilization
absorber.
68478-24-0........................ Tail gas (petroleum), catalytic
cracker, catalytic reformer and
hydrodesulfurizer combined
fractionater.
68478-25-1........................ Tail gas (petroleum), catalytic
cracker refractionation absorber.
68478-26-2........................ Tail gas (petroleum), catalytic
reformed naphtha fractionation
stabilizer.
[[Page 129]]
68478-27-3........................ Tail gas (petroleum), catalytic
reformed naphtha separator.
68478-28-4........................ Tail gas (petroleum), catalytic
reformed naphtha stabilizer.
68478-29-5........................ Tail gas (petroleum), cracked
distillate hydrotreater separator.
68478-30-8........................ Tail gas (petroleum),
hydrodesulfurized straight-run
naphtha separator.
68478-31-9........................ Tail gas (petroleum), isomerized
naphtha fractionates, hydrogen
sulfide-free.
68478-32-0........................ Tail gas (petroleum), saturate gas
plant mixed stream, C4-rich.
68478-33-1........................ Tail gas (petroleum), saturate gas
recovery plant, C1-2-rich.
68478-34-2........................ Tail gas (petroleum), vacuum
residues thermal cracker.
68512-61-8........................ Residues (petroleum), heavy coker
and light vacuum.
68512-62-9........................ Residues (petroleum), light vacuum.
68512-78-7........................ Solvent naphtha (petroleum), light
arom., hydrotreated.
68512-91-4........................ Hydrocarbons, C3-4-rich, petroleum
distillates.
68513-02-0........................ Naphtha (petroleum), full-range
coker.
68513-03-1........................ Naphtha (petroleum), light catalytic
reformed, arom.-free.
68513-11-1........................ Fuel gases, hydrotreater
fractionation, scrubbed.
68513-12-2........................ Fuel gases, saturate gas unit
fractionater-absorber overheads.
68513-13-3........................ Fuel gases, thermal cracked
catalytic cracking residue.
68513-14-4........................ Gases (petroleum), catalytic
reformed straight-run naphtha
stabilizer overheads.
68513-15-5........................ Gases (petroleum), full-range
straight-run naphtha dehexanizer
off.
68513-16-6........................ Gases (petroleum), hydrocracking
depropanizer off, hydrocarbon-rich.
68513-17-7........................ Gases (petroleum), light straight-
run naphtha stabilizer off.
68513-18-8........................ Gases (petroleum), reformer effluent
high-pressure flash drum off.
68513-19-9........................ Gases (petroleum), reformer effluent
low-pressure flash drum off.
68513-62-2........................ Disulfides, C5-12-alkyl.
68513-63-3........................ Distillates (petroleum), catalytic
reformed straight-run naphtha
overheads.
68513-65-5........................ Butane, branched and linear.
68513-66-6........................ Residues (petroleum), alkylation
splitter, C4-rich.
68513-67-7........................ Residues (petroleum), cyclooctadiene
bottoms.
68513-68-8........................ Residues (petroleum), deethanizer
tower.
68513-69-9........................ Residues (petroleum), steam-cracked
light.
68513-74-6........................ Waste gases, ethylene oxide absorber-
reactor.
68514-15-8........................ Gasoline, vapor-recovery.
68514-29-4........................ Hydrocarbons, amylene feed
debutanizer overheads non-
extractable raffinates.
68514-31-8........................ Hydrocarbons, C1-4.
68514-32-9........................ Hydrocarbons, C10 and C12, olefin-
rich.
68514-33-0........................ Hydrocarbons, C12 and C14, olefin-
rich.
68514-34-1........................ Hydrocarbons, C9-14, ethylene-manuf.-
by-product.
68514-35-2........................ Hydrocarbons, C14-30, olefin-rich.
68514-36-3........................ Hydrocarbons, C1-4, sweetened.
68514-37-4........................ Hydrocarbons, C4-5-unsatd..
68514-38-5........................ Hydrocarbons, C4-10-unsatd..
68514-39-6........................ Naphtha (petroleum), light steam-
cracked, isoprene-rich.
68514-79-4........................ Petroleum products, hydrofiner-
powerformer reformates.
68515-25-3........................ Benzene, C1-9-alkyl derivs.
68515-26-4........................ Benzene, di-C12-14-alkyl derivs.
68515-27-5........................ Benzene, di-C10-14-alkyl derivs.,
fractionation overheads, heavy
ends.
68515-28-6........................ Benzene, di-C10-14-alkyl derivs.,
fractionation overheads, light
ends.
68515-29-7........................ Benzene, di-C10-14-alkyl derivs.,
fractionation overheads, middle
cut.
68515-30-0........................ Benzene, mono-C20-48-alkyl derivs.
68515-32-2........................ Benzene, mono-C12-14-alkyl derivs.,
fractionation bottoms.
68515-33-3........................ Benzene, mono-C10-12-alkyl derivs.,
fractionation bottoms, heavy ends.
68515-34-4........................ Benzene, mono-C12-14-alkyl derivs.,
fractionation bottoms, heavy ends.
68515-35-5........................ Benzene, mono-C10-12-alkyl derivs.,
fractionation bottoms, light ends.
68515-36-6........................ Benzene, mono-C12-14-alkyl derivs.,
fractionation bottoms, light ends.
68516-20-1........................ Naphtha (petroleum), steam-cracked
middle arom.
68526-52-3........................ Alkenes, C6.
68526-53-4........................ Alkenes, C6-8, C7-rich.
68526-54-5........................ Alkenes, C7-9, C8-rich.
68526-55-6........................ Alkenes, C8-10, C9-rich.
68526-56-7........................ Alkenes, C9-11, C10-rich.
68526-57-8........................ Alkenes, C10-12, C11-rich.
68526-58-9........................ Alkenes, C11-13, C12-rich.
68526-77-2........................ Aromatic hydrocarbons, ethane
cracking scrubber effluent and
flare drum.
68526-99-8........................ Alkenes, C6-9 .alpha.-.
68527-00-4........................ Alkenes, C8-9 .alpha.-.
68527-11-7........................ Alkenes, C5.
68527-13-9........................ Gases (petroleum), acid,
ethanolamine scrubber.
68527-14-0........................ Gases (petroleum), methane-rich off.
68527-15-1........................ Gases (petroleum), oil refinery gas
distn. off.
68527-16-2........................ Hydrocarbons, C1-3.
68527-18-4........................ Gas oils (petroleum), steam-cracked.
[[Page 130]]
68527-19-5........................ Hydrocarbons, C1-4, debutanizer
fraction.
68527-21-9........................ Naphtha (petroleum), clay-treated
full-range straight-run.
68527-22-0........................ Naphtha (petroleum), clay-treated
light straight-run.
68527-23-1........................ Naphtha (petroleum), light steam-
cracked arom.
68527-26-4........................ Naphtha (petroleum), light steam-
cracked, debenzenized.
68527-27-5........................ Naphtha (petroleum), full-range
alkylate, butane-contg.
68553-00-4........................ Fuel oil, no. 6.
68553-14-0........................ Hydrocarbons, C8-11.
68602-79-9........................ Distillates (petroleum), benzene
unit hydrotreater dipentanizer
overheads.
68602-81-3........................ Distillates, hydrocarbon resin
prodn. higher boiling.
68602-82-4........................ Gases (petroleum), benzene unit
hydrotreater depentenizer
overheads.
68602-83-5........................ Gases (petroleum), C1-5, wet.
68602-84-6........................ Gases (petroleum), secondary
absorber off, fluidized catalytic
cracker overheads fractionater.
68602-96-0........................ Distillates (petroleum), oxidized
light, strong acid components,
compds. with diethanolamine.
68602-97-1........................ Distillates (petroleum), oxidized
light, strong acid components,
sodium salts.
68602-98-2........................ Distillates (petroleum), oxidized
light, strong acid components.
68602-99-3........................ Distillates (petroleum), oxidized
light, strong acid-free.
68603-00-9........................ Distillates (petroleum), thermal
cracked naphtha and gas oil.
68603-01-0........................ Distillates (petroleum), thermal
cracked naphtha and gas oil, C5-
dimer-contg.
68603-02-1........................ Distillates (petroleum), thermal
cracked naphtha and gas oil,
dimerized.
68603-03-2........................ Distillates (petroleum), thermal
cracked naphtha and gas oil,
extractive.
68603-08-7........................ Naphtha (petroleum), arom.- contg.
68603-09-8........................ Hydrocarbon waxes (petroleum),
oxidized, calcium salts.
68603-10-1........................ Hydrocarbon waxes (petroleum),
oxidized, Me esters, barium salts.
68603-11-2........................ Hydrocarbon waxes (petroleum),
oxidized, Me esters, calcium salts.
68603-12-3........................ Hydrocarbon waxes (petroleum),
oxidized, Me esters, sodium salts.
68603-13-4........................ Petrolatum (petroleum), oxidized,
ester with sorbitol.
68603-14-5........................ Residual oils (petroleum), oxidized,
calcium salts.
68603-31-6........................ Alkenes, C10, tert-amylene
concentrator by-product.
68603-32-7........................ Alkenes, C15-20 .alpha.-,
isomerized.
68606-09-7........................ Fuel gases, expander off.
68606-10-0........................ Gasoline, pyrolysis, debutanizer
bottoms.
68606-11-1........................ Gasoline, straight-run, topping-
plant.
68606-24-6........................ Hydrocarbons, C4, butene
concentrator by-product.
68606-25-7........................ Hydrocarbons, C2-4.
68606-26-8........................ Hydrocarbons, C3.
68606-27-9........................ Gases (petroleum), alkylation feed.
68606-28-0........................ Hydrocarbons, C5 and C10-aliph. and
C6-8-arom.
68606-31-5........................ Hydrocarbons, C3-5, butadiene
purification (purifn.) by-product.
68606-34-8........................ Gases (petroleum), depropanizer
bottoms fractionation off.
68606-36-0........................ Hydrocarbons, C5-unsatd. rich,
isoprene purifn. by-product.
68607-11-4........................ Petroleum products, refinery gases.
68607-30-7........................ Residues (petroleum), topping plant,
low-sulfur.
68608-56-0........................ Waste gases, from carbon black
manuf.
68647-60-9........................ Hydrocarbons, C4.
68647-61-0........................ Hydrocarbons, C4-5, tert-amylene
concentrator by-product.
68647-62-1........................ Hydrocarbons, C4-5, butene
concentrator by-product, sour.
68650-36-2........................ Aromatic hydrocarbons, C8, o-xylene-
lean.
68650-37-3........................ Paraffin waxes (petroleum),
oxidized, sodium salts.
68782-97-8........................ Distillates (petroleum), hydrofined
lubricating-oil.
68782-98-9........................ Extracts (petroleum), clarified oil
solvent, condensed-ring-arom.-
contg.
68782-99-0........................ Extracts (petroleum), heavy
clarified oil solvent, condensed-
ring-arom.-contg.
68783-00-6........................ Extracts (petroleum), heavy
naphthenic distillate solvent,
arom. conc.
68783-01-7........................ Extracts (petroleum), heavy
naphthenic distillate solvent,
paraffinic conc.
68783-02-8........................ Extracts (petroleum), intermediate
clarified oil solvent, condensed-
ring-arom.-contg.
68783-04-0........................ Extracts (petroleum), solvent-
refined heavy paraffinic distillate
solvent.
68783-05-1........................ Gases (petroleum), ammonia-hydrogen
sulfide, water-satd.
68783-06-2........................ Gases (petroleum), hydrocracking low-
pressure separator.
68783-07-3........................ Gases (petroleum), refinery blend.
68783-08-4........................ Gas oils (petroleum), heavy
atmospheric.
68783-09-5........................ Naphtha (petroleum), catalytic
cracked light distd.
68783-12-0........................ Naphtha (petroleum), unsweetened.
68783-13-1........................ Residues (petroleum), coker
scrubber, condensed-ring-arom.-
contg.
68783-15-3........................ Alkenes, C6-7 .alpha.-.
68783-61-9........................ Fuel gases, refinery, sweetened.
68783-62-0........................ Fuel gases, refinery, unsweetened.
68783-64-2........................ Gases (petroleum), catalytic
cracking.
68783-65-3........................ Gases (petroleum), C2-4, sweetened.
68783-66-4........................ Naphtha (petroleum), light,
sweetened.
68814-47-1........................ Waste gases, refinery vent.
68814-67-5........................ Gases (petroleum), refinery.
[[Page 131]]
68814-87-9........................ Distillates (petroleum), full-range
straight-run middle.
68814-89-1........................ Extracts (petroleum), heavy
paraffinic distillates, solvent-
deasphalted.
68814-90-4........................ Gases (petroleum), platformer
products separator off.
68814-91-5........................ Alkenes, C5-9 .alpha.-.
68855-57-2........................ Alkenes, C6-12 .alpha.-.
68855-58-3........................ Alkenes, C10-16 .alpha.-.
68855-59-4........................ Alkenes, C14-18 .alpha.-.
68855-60-7........................ Alkenes, C14-20 .alpha.-.
68911-58-0........................ Gases (petroleum), hydrotreated sour
kerosine depentanizer stabilizer
off.
68911-59-1........................ Gases (petroleum), hydrotreated sour
kerosine flash drum.
68915-96-8........................ Distillates (petroleum), heavy
straight-run.
68915-97-9........................ Gas oils (petroleum), straight-run,
high-boiling.
68918-69-4........................ Petrolatum (petroleum), oxidized,
zinc salt.
68918-73-0........................ Residues (petroleum), clay-treating
filter wash.
68918-93-4........................ Paraffin waxes and Hydrocarbon
waxes, oxidized, alkali metal
salts.
68918-98-9........................ Fuel gases, refinery, hydrogen
sulfide-free.
68918-99-0........................ Gases (petroleum), crude oil
fractionation off.
68919-00-6........................ Gases (petroleum), dehexanizer off.
68919-01-7........................ Gases (petroleum), distillate
unifiner desulfurization stripper
off.
68919-02-8........................ Gases (petroleum), fluidized
catalytic cracker fractionation
off.
68919-03-9........................ Gases (petroleum), fluidized
catalytic cracker scrubbing
secondary absorber off.
68919-04-0........................ Gases (petroleum), heavy distillate
hydrotreater desulfurization
stripper off.
68919-05-1........................ Gases (petroleum), light straight
run gasoline fractionation
stabilizer off.
68919-06-2........................ Gases (petroleum), naphtha unifiner
desulfurization stripper off.
68919-07-3........................ Gases (petroleum), platformer
stabilizer off, light ends
fractionation.
68919-08-4........................ Gases (petroleum), preflash tower
off, crude distn.
68919-09-5........................ Gases (petroleum), straight-run
naphtha catalytic reforming off.
68919-10-8........................ Gases (petroleum), straight-run
stabilizer off.
68919-11-9........................ Gases (petroleum), tar stripper off.
68919-12-0........................ Gases (petroleum), unifiner stripper
off.
68919-15-3........................ Hydrocarbons, C6-12, benzene-
recovery.
68919-16-4........................ Hydrocarbons, catalytic alkylation,
by-products, C3-6.
68919-17-5........................ Hydrocarbons, C12-20, catalytic
alkylation by-products.
68919-19-7........................ Gases (petroleum), fluidized
catalytic cracker splitter
residues.
68919-20-0........................ Gases (petroleum), fluidized
catalytic cracker splitter
overheads.
68919-37-9........................ Naphtha (petroleum), full-range
reformed.
68920-06-9........................ Hydrocarbons, C7-9.
68920-07-0........................ Hydrocarbons, C<10-linear.
68920-64-9........................ Disulfides, di-C1-2-alkyl.
68921-07-3........................ Distillates (petroleum),
hydrotreated light catalytic
cracked.
68921-08-4........................ Distillates (petroleum), light
straight-run gasoline fractionation
stabilizer overheads.
68921-09-5........................ Distillates (petroleum), naphtha
unifiner stripper.
68921-67-5........................ Hydrocarbons, ethylene-manuf.-by-
product distn. residues.
68952-76-1........................ Gases (petroleum), catalytic cracked
naphtha debutanizer.
68952-77-2........................ Tail gas (petroleum), catalytic
cracked distillate and naphtha
stabilizer.
68952-78-3........................ Tail gas (petroleum), catalytic
hydrodesulfurized distillate
fractionation stabilizer, hydrogen
sulfide-free.
68952-79-4........................ Tail gas (petroleum), catalytic
hydrodesulfurized naphtha
separator.
68952-80-7........................ Tail gas (petroleum), straight-run
naphtha hydrodesulfurizer.
68952-81-8........................ Tail gas (petroleum), thermal-
cracked distillate, gas oil and
naphtha absorber.
68952-82-9........................ Tail gas (petroleum), thermal
cracked hydrocarbon fractionation
stabilizer, petroleum coking.
68953-80-0........................ Benzene, mixed with toluene,
dealkylation product.
68955-27-1........................ Distillates (petroleum), petroleum
residues vacuum.
68955-28-2........................ Gases (petroleum), light steam-
cracked, butadiene conc.
68955-31-7........................ Gases (petroleum), butadiene
process, inorg.
68955-32-8........................ Natural gas, substitute, steam-
reformed desulfurized naphtha.
68955-33-9........................ Gases (petroleum), sponge absorber
off, fluidized catalytic cracker
and gas oil desulfurizer overhead
fractionation.
68955-34-0........................ Gases (petroleum), straight-run
naphtha catalytic reformer
stabilizer overhead.
68955-35-1........................ Naphtha (petroleum), catalytic
reformed.
68955-36-2........................ Residues (petroleum), steam-cracked,
resinous.
68955-76-0........................ Aromatic hydrocarbons, C9-16,
biphenyl deriv.-rich.
68955-96-4........................ Disulfides, dialkyl and di-Ph,
naphtha sweetening.
68956-47-8........................ Fuel oil, isoprene reject
absorption.
68956-48-9........................ Fuel oil, residual, wastewater
skimmings.
68956-52-5........................ Hydrocarbons, C4-8.
68956-54-7........................ Hydrocarbons, C4-unsatd.
68956-55-8........................ Hydrocarbons, C5-unsatd.
68956-70-7........................ Petroleum products, C5-12,
reclaimed, wastewater treatment.
68988-79-4........................ Benzene, C10-12-alkyl derivs.,
distn. residues.
68988-99-8........................ Phenols, sodium salts, mixed with
sulfur compounds, gasoline alk.
scrubber residues.
[[Page 132]]
68989-88-8........................ Gases (petroleum), crude distn. and
catalytic cracking.
68990-35-2........................ Distillates (petroleum), arom.,
hydrotreated, dicyclopentadiene-
rich.
68991-49-1........................ Alkanes, C10-13, arom.-free
desulfurized.
68991-50-4........................ Alkanes, C14-17, arom.-free
desulfurized.
68991-51-5........................ Alkanes, C10-13, desulfurized.
68991-52-6........................ Alkenes, C10-16.
69013-21-4........................ Fuel oil, pyrolysis.
69029-75-0........................ Oils, reclaimed.
69430-33-7........................ Hydrocarbons, C6-30.
70024-88-3........................ Ethene, thermal cracking products.
70528-71-1........................ Distillates (petroleum), heavy
distillate solvent ext. heart-cut.
70528-72-2........................ Distillates (petroleum), heavy
distillate solvent ext. vacuum
overheads.
70528-73-3........................ Residues (petroleum), heavy
distillate solvent ext. vacuum.
70592-76-6........................ Distillates (petroleum),
intermediate vacuum.
70592-77-7........................ Distillates (petroleum), light
vacuum.
70592-78-8........................ Distillates (petroleum), vacuum.
70592-79-9........................ Residues (petroleum), atm. tower,
light.
70693-00-4........................ Hydrocarbon waxes (petroleum),
oxidized, sodium salts.
70693-06-0........................ Aromatic hydrocarbons, C9-11.
70913-85-8........................ Residues (petroleum), solvent-extd.
vacuum distilled atm. residuum.
70913-86-9........................ Alkanes, C18-70.
70955-08-7........................ Alkanes, C4-6.
70955-09-8........................ Alkenes, C13-14 .alpha.-.
70955-10-1........................ Alkenes, C15-18 .alpha.-.
70955-17-8........................ Aromatic hydrocarbons, C12-20.
71243-66-8........................ Hydrocarbon waxes (petroleum), clay-
treated, microcryst., oxidized,
potassium salts.
71302-82-4........................ Hydrocarbons, C5-8, houdry butadiene
manuf. by-product.
71329-37-8........................ Residues (petroleum), catalytic
cracking depropanizer, C4-rich.
71808-30-5........................ Tail gas (petroleum), thermal
cracking absorber.
72230-71-8........................ Distillates (petroleum), cracked
steam-cracked, C5-17 fraction.
72623-83-7........................ Lubricating oils (petroleum), C25, hydrotreated bright
stock-based.
72623-84-8........................ Lubricating oils (petroleum), C15-
30, hydrotreated neutral oil-based,
contg. solvent deasphalted residual
oil.
72623-85-9........................ Lubricating oils (petroleum), C20-
50, hydrotreated neutral oil-based,
high-viscosity.
72623-86-0........................ Lubricating oils (petroleum), C15-
30, hydrotreated neutral oil-based.
72623-87-1........................ Lubricating oils (petroleum), C20-
50, hydrotreated neutral oil-based.
73138-65-5........................ Hydrocarbon waxes (petroleum),
oxidized, magnesium salts.
92045-43-7........................ Lubricating oils (petroleum),
hydrocracked non-arom. solvent
deparaffined.
92045-58-4........................ Naphtha (petroleum), isomerization,
C6-fraction.
92062-09-4........................ Slack wax (petroleum), hydrotreated.
93762-80-2........................ Alkenes, C15-18.
98859-55-3........................ Distillates (petroleum), oxidized
heavy, compds. with diethanolamine.
98859-56-4........................ Distillates (petroleum), oxidized
heavy, sodium salts.
101316-73-8....................... Lubricating oils (petroleum), used,
non-catalytically refined.
164907-78-2....................... Extracts (petroleum), asphaltene-low
vacuum residue solvent.
164907-79-3....................... Residues (petroleum), vacuum,
asphaltene-low.
178603-63-9....................... Gas oils (petroleum), vacuum,
hydrocracked, hydroisomerized,
hydrogenated, C10-25.
178603-64-0....................... Gas oils (petroleum), vacuum,
hydrocracked, hydroisomerized,
hydrogenated, C15-30, branched and
cyclic.
178603-65-1....................... Gas oils (petroleum), vacuum,
hydrocracked, hydroisomerized,
hydrogenated, C20-40, branched and
cyclic.
178603-66-2....................... Gas oils (petroleum), vacuum,
hydrocracked, hydroisomerized,
hydrogenated, C25-55, branched and
cyclic.
212210-93-0....................... Solvent naphtha (petroleum), heavy
arom., distn. residues.
221120-39-4....................... Distillates (petroleum), cracked
steam-cracked, C5-12 fraction.
445411-73-4....................... Gas oils (petroleum), vacuum,
hydrocracked, hydroisomerized,
hydrogenated, C10-25, branched and
cyclic.
------------------------------------------------------------------------
(2) Specific exempted chemical substances--(i) Exemption. EPA has
determined that, at this time, the information in Sec. 711.15(b)(4)
associated with the chemical substances listed in paragraph (b)(2)(iv)
of this section is of low current interest.
(ii) Considerations. In making its determination of whether this
partial exemption should apply to a particular chemical substance, EPA
will consider the totality of information available for the chemical
substance in question, including but not limited to, one or more of the
following considerations:
[[Page 133]]
(A) Whether the chemical substance qualifies or has qualified in
past IUR or CDR collections for the reporting of the information
described in Sec. 711.15(b)(4).
(B) The chemical substance's chemical and physical properties or
potential for persistence, bioaccumulation, health effects, or
environmental effects (considered independently or together).
(C) The information needs of EPA, other Federal agencies, Tribes,
States, and local governments, as well as members of the public.
(D) The availability of other complementary risk screening
information.
(E) The availability of comparable processing and use information.
(F) Whether the potential risks of the chemical substance are
adequately managed.
(iii) Amendments. EPA may amend the chemical substance list in
paragraph (b)(2)(iv) of this section on its own initiative or in
response to a request from the public based on EPA's determination of
whether the information in Sec. 711.15(b)(4) is of low interest.
(A) Any person may request that EPA amend the chemical substance
list in Table 2 in paragraph (b)(2)(iv) of this section. Your request
must be in writing and must be submitted to the address provided in 40
CFR 700.17(a). Please label your request as follows: Attention: TSCA
Chemical Data Reporting--Partial Exemption Request. Requests must
identify the chemical substance in question, as well as its CASRN or
other chemical identification number as identified in Sec.
711.15(b)(3)(i), and must contain a written rationale for the request
that provides sufficient specific information, addressing the
considerations listed in Sec. 711.6(b)(2)(ii), including cites and
relevant documents, to demonstrate to EPA that the collection of the
information in Sec. 711.15(b)(4) for the chemical substance in question
either is or is not of low current interest. If a request related to a
particular chemical substance is resubmitted, any subsequent request
must clearly identify new information contained in the request. EPA may
request other information that it believes necessary to evaluate the
request. EPA will issue a written response to each request within 120
days of receipt of the request, and will maintain copies of these
responses in a docket that will be established for each reporting cycle.
(B) As needed, the Agency will initiate rulemaking to make revisions
to Table 2 in paragraph (b)(2)(iv) of this section.
(C) To assist EPA in reaching a decision regarding a particular
request prior to a given principal reporting year, requests must be
submitted to EPA no later than 12 months prior to the start of the next
principal reporting year.
(iv) List of chemical substances. EPA has designated the chemical
substances listed in Table 2 of this paragraph by CASRN, as partially
exempt from reporting under the CDR.
Table 2--CASRN of Partially Exempt Chemical Substances
------------------------------------------------------------------------
CASRN Chemical
------------------------------------------------------------------------
50-70-4........................... D-glucitol.
50-81-7........................... L-ascorbic acid.
50-99-7........................... D-glucose.
56-81-5........................... 1,2,3-Propanetriol.
56-87-1........................... L-lysine.
57-48-7........................... D-fructose.
57-50-1........................... .alpha.-D-Glucopyranoside, .beta.-D-
fructofuranosyl.
58-95-7........................... 2H-1-Benzopyran-6-ol, 3,4-dihydro-
2,5,7,8-tetramethyl-2-[(4R,8R)-
4,8,12- trimethyltridecyl]-,
acetate, (2R)-.
59-02-9........................... 2H-1-Benzopyran-6-ol, 3,4-dihydro-
2,5,7,8-tetramethyl-2-[(4R,8R)-
4,8,12- trimethyltridecyl]-, (2R)-.
59-51-8........................... Methionine.
68-04-2........................... 1,2,3-Propanetricarboxylic acid, 2-
hydroxy-, sodium salt (1:3).
69-65-8........................... D-mannitol.
77-92-9........................... 1,2,3-Propanetricarboxylic acid, 2-
hydroxy-.
87-79-6........................... L-sorbose.
87-99-0........................... Xylitol.
96-10-6........................... Aluminum, chlorodiethyl-.
97-93-8........................... Aluminum, triethyl-.
100-99-2.......................... Aluminum, tris(2-methylpropyl)-.
[[Page 134]]
123-94-4.......................... Octadecanoic acid, 2,3-
dihydroxypropyl ester.
124-38-9.......................... Carbon dioxide.
137-08-6.......................... .beta.-Alanine, N-[(2R)-2,4-
dihydroxy-3,3-dimethyl-1-oxobutyl]-
, calcium alt (2:1).
142-47-2.......................... L-glutamic acid, monosodium salt.
150-30-1.......................... Phenylalanine.
504-63-2.......................... 1,3-Propanediol.
563-43-9.......................... Aluminum, dichloroethyl-.
866-84-2.......................... 1,2,3-Propanetricarboxylic acid, 2-
hydroxy-, potassium salt (1:3).
1070-00-4......................... Aluminum, trioctyl-.
1116-70-7......................... Aluminum, tributyl-.
1116-73-0......................... Aluminum, trihexyl-.
1191-15-7......................... Aluminum, hydrobis(2-methylpropyl)-.
1317-65-3......................... Limestone.
1333-74-0......................... Hydrogen.
1592-23-0......................... Octadecanoic acid, calcium salt.
7440-37-1......................... Argon.
7440-44-0......................... Carbon.
7727-37-9......................... Nitrogen.
7782-42-5......................... Graphite.
7782-44-7......................... Oxygen.
8001-21-6......................... Sunflower oil.
8001-22-7......................... Soybean oil.
8001-23-8......................... Safflower oil.
8001-26-1......................... Linseed oil.
8001-29-4......................... Cottonseed oil.
8001-30-7......................... Corn oil.
8001-31-8......................... Coconut oil.
8001-78-3......................... Castor oil, hydrogenated.
8001-79-4......................... Castor oil.
8002-03-7......................... Peanut oil.
8002-13-9......................... Rape oil.
8002-43-5......................... Lecithins.
8002-75-3......................... Palm oil.
8006-54-0......................... Lanolin.
8013-07-8......................... Soybean oil, epoxidized.
8016-28-2......................... Lard, oil.
8016-70-4......................... Soybean oil, hydrogenated.
8021-99-6......................... Charcoal, bone.
8023-79-8......................... Oils, palm kernel.
8029-43-4......................... Syrups, hydrolyzed starch.
11103-57-4........................ Vitamin A.
12075-68-2........................ Aluminum, di-.mu.-
chlorochlorotriethyldi-.
12542-85-7........................ Aluminum, trichlorotrimethyldi-.
16291-96-6........................ Charcoal.
26836-47-5........................ D-glucitol, monooctadecanoate.
61788-61-2........................ Fatty acids, tallow, methyl esters.
61789-44-4........................ Fatty acids, castor-oil.
61789-97-7........................ Tallow.
61789-99-9........................ Lard.
64147-40-6........................ Castor oil, dehydrated.
64755-01-7........................ Fatty acids, tallow, calcium salts.
65996-63-6........................ Starch, acid-hydrolyzed.
65996-64-7........................ Starch, enzyme-hydrolyzed.
66071-94-1........................ Corn, steep liquor.
67701-01-3........................ Fatty acids, C12-18.
67762-26-9........................ Fatty acids, C14-18 and C16-18
unsaturated, methyl esters.
67762-38-3........................ Fatty acids, C16-18 and C-18
unsaturated, methyl esters.
67784-80-9........................ Soybean oil, methyl esters.
68002-85-7........................ Fatty acids, C14-22 and C16-22-
unsatd.
68131-37-3........................ Syrups, hydrolyzed starch,
dehydrated.
68188-81-8........................ Grease, poultry.
68308-36-1........................ Soybean meal.
68308-54-3........................ Glycerides, tallow mono-, di- and
tri-, hydrogenated.
68334-00-9........................ Cottonseed oil, hydrogenated.
68334-28-1........................ Fats and glyceridic oils, vegetable,
hydrogenated.
68409-76-7........................ Bone meal, steamed.
68424-45-3........................ Fatty acids, linseed-oil.
68424-61-3........................ Glycerides, C16-18 and C18-unsatd.
mono- and di-.
68425-17-2........................ Syrups, hydrolyzed starch,
hydrogenated
68439-86-1........................ Bone, ash.
68442-69-3........................ Benzene, mono-C10-14-alkyl derivs.
68476-78-8........................ Molasses.
[[Page 135]]
68514-27-2........................ Grease, catch basin.
68514-74-9........................ Palm oil, hydrogenated.
68525-87-1........................ Corn oil, hydrogenated.
68648-87-3........................ Benzene, C10-16-alkyl derivs.
68918-42-3........................ Soaps, stocks, soya.
68952-94-3........................ Soaps, stocks, vegetable-oil.
68956-68-3........................ Fats and glyceridic oils, vegetable.
68989-98-0........................ Fats and glyceridic oils, vegetable,
residues.
70131-50-9........................ Bentonite, acid-leached.
73138-67-7........................ Lard, hydrogenated.
120962-03-0....................... Canola oil.
129813-58-7....................... Benzene, mono-C10-13-alkyl derivs.
129813-59-8....................... Benzene, mono-C12-14-alkyl derivs.
129813-60-1....................... Benzene, mono-C14-16-alkyl derivs.
129828-16-6....................... Fatty acids, canola oil, methyl
esters.
515152-40-6....................... Fatty acids, corn oil, methyl
esters.
------------------------------------------------------------------------
[76 FR 54933, Sept. 6, 2011, as amended at 79 FR 35098, June 19, 2014;
79 FR 66658, Nov. 10, 2014; 81 FR 17395, Mar. 29, 2016; 85 FR 20138,
Apr. 9, 2020]
Sec. 711.8 Persons who must report.
Except as provided in Sec. Sec. 711.9 and 711.10, the following
persons are subject to the requirements of this part. Persons must
determine whether they must report under this section for each chemical
substance that they manufacture (including import) at an individual
site.
(a) Persons subject to recurring reporting. Any person who
manufactured (including imported) for commercial purposes 25,000 lb
(11,340 kg) or more of a chemical substance described in Sec. 711.5 at
any single site owned or controlled by that person during any calendar
year since the last principal reporting year.
(b) Exceptions. Any person who manufactured (including imported) for
commercial purposes any chemical substance that is the subject of a rule
proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6, or is
the subject of an order in effect under TSCA section 4, 5(e) or 5(f), or
is the subject of relief that has been granted under a civil action
under TSCA sections 5 or 7 is subject to reporting as described in Sec.
711.8(a), except that the applicable production volume threshold is
2,500 lb (1,134 kg).
[76 FR 54933, Sept. 6, 2011, as amended at 85 FR 20139, Apr. 9, 2020]
Sec. 711.9 Persons not subject to this part.
A person described in Sec. 711.8 is not subject to the requirements
of this part if that person qualifies as a small manufacturer or small
government as those terms are defined in 40 CFR 704.3. Notwithstanding
this exclusion, a person who qualifies as a small manufacturer or small
government is subject to this part with respect to any chemical
substance that is the subject of a rule proposed or promulgated under
TSCA section 4, 5(b)(4), or 6, or is the subject of an order in effect
under TSCA section 4 or 5(e), or is the subject of relief that has been
granted under a civil action under TSCA section 5 or 7.
[85 FR 20139, Apr. 9, 2020]
Sec. 711.10 Activities for which reporting is not required.
A person described in Sec. 711.8 is not subject to the requirements
of this part with respect to any chemical substance described in Sec.
711.5, when:
(a) The person manufactured or imported the chemical substance
solely in small quantities for research and development.
(b) The person imported the chemical substance as part of an
article.
(c) The person manufactured the chemical substance in a manner
described in 40 CFR 720.30(g) or (h).
[[Page 136]]
(d) The person manufactured the chemical substance in any of the
following manners:
(1) Byproduct substances listed in paragraph (i) of this section for
the following manufacturing processes, when recycled or otherwise used
within a site-limited, physically enclosed system that is part of the
same overall manufacturing process from which the byproduct substance
was generated, and when the site is reporting the byproduct or a
different chemical substance that was manufactured from the recycled
byproduct or manufactured in the same overall manufacturing process:
(i) List of processes and certain related byproduct substances. (A)
Portland Cement Manufacturing (i.e., CASRN 68475-76-3, Flue dust,
portland cement).
(B) Kraft Pulping Process (i.e., CASRN 66071-92-9, Sulfite liquors
and Cooking liquors, spent; CASRN 68514-09-0, Sulfite liquors and
Cooking liquors, spent, oxidized; and CASRN 471-34-1, Carbonic acid
calcium salt (1:1)).
(ii) Amendments. EPA may amend the exemptions list in paragraph
(d)(1)(i) of this section on its own initiative or in response to a
request from the public based on EPA's determination of whether the
byproduct substance and process described meet the criteria explained in
this paragraph (d)(1), based on the requirements and considerations
listed in paragraphs (d)(1)(ii)(B) and (C) of this section.
(A) Any person may request that EPA amend the chemical substance
list in paragraph (d)(1)(i) of this section. Your request must be in
writing and must be submitted to the address provided in 40 CFR
700.17(a). Please label your request as follows: Attention: TSCA
Chemical Data Reporting--Byproduct Exemption Request. Requests must
identify the manufacturing process and byproduct chemical substance in
question, as well as its CASRN or other chemical identification number
as identified in 40 CFR 711.15(b)(3)(i), and must contain a written
rationale for the request that provides sufficient specific information,
addressing the requirements and considerations listed in paragraphs
(d)(1)(ii)(B) and (C) of this section, including citations and relevant
documents, to demonstrate to EPA that the byproduct substance and
process in question either does or does not meet the criteria explained
in this paragraph (d)(1). If a request related to a particular byproduct
substance and process is resubmitted, any subsequent request must
clearly identify new information contained in the request. EPA may
request other information that it believes necessary to evaluate the
request. EPA will issue a written response to each request within 120
days of receipt of the request and will maintain copies of these
responses in a docket that will be established for each reporting cycle.
(B) In making its determination whether this exemption should apply
to a particular manufacturing process and related byproduct substance,
the following two requirements must be met:
(1) The byproduct substance is recycled or otherwise used to
manufacture another chemical substance within an enclosed system, within
the same overall manufacturing process, and on the same site as that
byproduct was originally manufactured.
(2) The site is reporting under CDR other chemical substances, in
particular a chemical substance other than the byproduct substance that
was manufactured from the byproduct or manufactured in the same overall
manufacturing process.
(C) In addition to the requirements in paragraph (d)(1)(ii)(B) of
this section, EPA will consider the totality of information available
for the process and related byproduct substance in question, including
but not limited to, one or both of the following considerations:
(1) Whether EPA has a current interest in the byproduct substance.
(2) Whether the byproduct substance must have already been reported
under CDR, or would be expected to be reported if not exempted by this
exemption.
(D) After granting a petition, the Agency will initiate rulemaking
to make revisions to the list of substances in paragraph (d)(1)(i) of
this section.
(E) To assist EPA in reaching a decision regarding a particular
request prior to a given principal reporting year, requests must be
submitted to EPA no later than 12 months prior to
[[Page 137]]
the start of the next principal reporting year.
(2) A quantity of the byproduct that is manufactured solely in the
following equipment when it is not integral to the chemical
manufacturing processes of the site:
(i) Pollution control equipment.
(ii) Boilers used to generate heat or electricity for that site.
[85 FR 20139, Apr. 9, 2020]
Sec. 711.15 Reporting information to EPA.
Any person who must report under this part, as described in Sec.
711.8, must submit the information described in this section for each
chemical substance described in Sec. 711.5 that the person manufactured
(including imported) for commercial purposes in an amount of 25,000 lb
(11,340 kg) or more (or in an amount of 2,500 lb (1,134 kg) or more for
chemical substances subject to the rules, orders, or actions described
in Sec. 711.8(b)) at any one site during any calendar year since the
last principal reporting year (e.g., for the 2020 submission period,
consider calendar years 2016, 2017, 2018, and 2019, because 2015 was the
last principal reporting year). The principal reporting year for each
submission period is the previous calendar year (e.g., the principal
reporting year for the 2020 submission period is calendar year 2019).
For all submission periods, a separate report must be submitted for each
chemical substance at each site for which the submitter is required to
report. A submitter of information under this part must report
information as described in this section to the extent that such
information is known to or reasonably ascertainable by that person.
(a) Reporting information to EPA. Any person who reports information
to EPA must complete a Form U using the e-CDRweb reporting tool provided
by EPA at the address set forth in Sec. 711.35. The submission must
include all information described in paragraph (b) of this section.
Persons must submit the chemical reports on a separate single Form U for
each site for which the person is required to report. The e-CDRweb
reporting tool is described in the instructions available from EPA at
the website set forth in Sec. 711.35.
(b) Information to be reported. The information described in
paragraphs (b)(1) through (4) of this section must be reported for each
chemical substance manufactured (including imported) in an amount of
25,000 lb (11,340 kg) or more (or in an amount of 2,500 lb (1,134 kg) or
more for chemical substances subject to the rules, orders, or actions
described in Sec. 711.8(b)) at any one site during any calendar year
since the last principal reporting year. The requirement to report
information described in paragraph (b)(4) of this section is subject to
exemption as described in Sec. 711.6.
(1) A certification statement signed and dated by an authorized
official of the submitter company. The authorized official must certify
that the submitted information has been completed in compliance with the
requirements of this part and that the confidentiality claims made on
the Form U are true and correct. The certification must be signed and
dated by the authorized official for the submitter company, and provide
that person's name, official title, and email address.
(2) Company and site information. The following currently correct
parent company and site information at the date of CDR submission must
be reported for each site at which a reportable chemical substance is
manufactured (including imported) above the applicable production volume
threshold, as described in this section (see Sec. 711.3 for the
``site'' for importers and special situations).
(i) The legal name, address, and Dun and Bradstreet D-U-N-S[supreg]
(D&B) number for the highest-level parent company located in the United
States and, if one exists, for the highest-level foreign-based parent
company. A submitter under this part must obtain a D&B number for the
parent company if none exists and must report using the standardized
conventions for the naming of a parent company as provided in the CDR
Instructions for Reporting identified in Sec. 711.35.
(ii) The name of a person who will serve as technical contact for
the submitter company who will be able to answer questions about the
information submitted by the company to EPA, and that technical contact
person's full
[[Page 138]]
mailing address, telephone number, and email address.
(iii) The legal name and full street address of each site. A
submitter under this part must include the appropriate D&B number for
each site reported, and the county or parish (or other jurisdictional
indicator) in which the site is located. A submitter under this part
must obtain a D&B number for the site reported if none exists. For a co-
manufacturing situation in which the contracting company initiates the
report, the contracting company must report both the site controlling
the contract and the producing company's site information.
(iv) The six-digit NAICS code for the site. A submitter under this
part must include the appropriate six-digit NAICS code for each site
reported.
(3) Chemical-specific information. The following chemical-specific
information must be reported for each reportable chemical substance
manufactured (including imported) above the applicable production volume
threshold, as described in paragraph (b) of this section:
(i) The specific, currently correct CA Index name as used to list
the chemical substance on the TSCA Inventory and the correct
corresponding CASRN for each reportable chemical substance at each site.
Submitters who wish to report chemical substances listed on the
confidential portion of the TSCA Inventory will need to report the
chemical substance using the corresponding TSCA Accession Number that is
listed on the public portion of the Inventory. In addition to reporting
the chemical identifying number itself, submitters must specify the type
of number they are reporting by selecting from among the codes in Table
1 to paragraph (b)(3)(i).
Table 1 to Paragraph (b)(3)(i)--Codes To Specify Type of Chemical
Identifying Number
------------------------------------------------------------------------
Code Number type
------------------------------------------------------------------------
A............................... TSCA Accession Number.
C............................... Chemical Abstracts Service Registry
Number (CASRN).
------------------------------------------------------------------------
(A) If an importer submitting a report cannot provide the
information specified in this paragraph (b)(3)(i) because it is unknown
to the importer and claimed as confidential by the supplier of the
chemical substance or mixture, the importer must use e-CDRweb to ask the
supplier to provide the correct chemical identity and, in the case of a
mixture, the percentage of formulation and chemical function information
directly to EPA in a joint submission. Such request must include
instructions for submitting chemical identity information
electronically, using e-CDRweb and CDX (see Sec. 711.35), and for
clearly referencing the importer's submission. Contact information for
the supplier, a trade name or other designation for the chemical
substance or mixture, and a copy of the request to the supplier must be
included with the importer's submission.
(B) If a manufacturer submitting a report cannot provide the
information specified in this paragraph (b)(3)(i) because the reportable
chemical substance is manufactured using a reactant having a specific
chemical identity that is unknown to the manufacturer and claimed as
confidential by its supplier, the manufacturer must use e-CDRweb to ask
the supplier of the confidential reactant to provide the correct
chemical identity of the confidential reactant directly to EPA in a
joint submission. Such request must include instructions for submitting
chemical identity information electronically using e-CDRweb and CDX (see
Sec. 711.35), and for clearly referencing the manufacturer's
submission. Contact information for the supplier, a trade name or other
designation for the chemical substance, and a copy of the request to the
supplier must be included with the importer's submission.
(C) EPA will accept only joint submissions that are submitted
electronically using e-CDRweb and CDX (see Sec. 711.35) and that
clearly reference the primary submission to which they refer.
(ii) For the principal reporting year only, a statement indicating,
for each reportable chemical substance at each site, whether the
chemical substance is manufactured in the United States, imported into
the United States, or both manufactured in the United States and
imported into the United States.
[[Page 139]]
(iii) For the principal reporting year only, the total annual volume
(in pounds) of each reportable chemical substance domestically
manufactured or imported at each site. The total annual domestically
manufactured volume (not including imported volume) and the total annual
imported volume must be separately reported. These amounts must be
reported to two significant figures of accuracy. In addition, the total
annual volume (domestically manufactured plus imported volumes in
pounds) of each reportable chemical substance at each site for each
complete calendar year since the last principal reporting year.
(iv) For the principal reporting year only, the volume used on site
and the volume directly exported of each reportable chemical substance
domestically manufactured or imported at each site. These amounts must
be reported to two significant figures of accuracy.
(v) For the principal reporting year only, a designation indicating,
for each imported reportable chemical substance at each site, whether
the imported chemical substance is physically present at the reporting
site.
(vi) For the principal reporting year only, a designation
indicating, for each reportable chemical substance at each site, whether
the chemical substance is being recycled or otherwise used for a
commercial purpose instead of being disposed of as a waste or included
in a waste stream.
(vii) For the principal reporting year only, the total number of
workers reasonably likely to be exposed to each reportable chemical
substance at each site. For each reportable chemical substance at each
site, the submitter must select from among the ranges of workers listed
in Table 2 to paragraph (b)(3)(vii) and report the corresponding code
(i.e., W1 through W8):
Table 2 to Paragraph (b)(3)(vii)--Codes for Reporting Number of Workers
Reasonably Likely To Be Exposed
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
W1.............................. Fewer than 10 workers.
W2.............................. At least 10 but fewer than 25 workers.
W3.............................. At least 25 but fewer than 50 workers.
W4.............................. At least 50 but fewer than 100
workers.
W5.............................. At least 100 but fewer than 500
workers.
W6.............................. At least 500 but fewer than 1,000
workers.
W7.............................. At least 1,000 but fewer than 10,000
workers.
W8.............................. At least 10,000 workers.
------------------------------------------------------------------------
(viii) For the principal reporting year only, the maximum
concentration, measured by percentage of weight, of each reportable
chemical substance at the time it is sent off-site from each site. If
the chemical substance is site-limited, you must report the maximum
concentration, measured by percentage of weight of the reportable
chemical substance at the time it is reacted on-site to produce a
different chemical substance. This information must be reported
regardless of the physical form(s) in which the chemical substance is
sent off-site/reacted on-site. For each chemical substance at each site,
select the maximum concentration of the chemical substance from among
the ranges listed in Table 3 to paragraph (b)(3)(viii) and report the
corresponding code (i.e., M1 through M5):
Table 3 to Paragraph (b)(3)(viii)--Codes for Reporting Maximum
Concentration of Chemical Substance
------------------------------------------------------------------------
Code Concentration range (percent weight)
------------------------------------------------------------------------
M1.............................. Less than 1 percent by weight.
M2.............................. At least 1 but less than 30 percent by
weight.
M3.............................. At least 30 but less than 60 percent
by weight.
M4.............................. At least 60 but less than 90 percent
by weight.
M5.............................. At least 90 percent by weight.
------------------------------------------------------------------------
(ix) For the principal reporting year only, the physical form(s) of
the reportable chemical substance as it is sent off-site from each site.
If the chemical substance is site-limited, you must report the physical
form(s) of the reportable chemical substance at the time it is reacted
on-site to produce a different chemical substance. For each chemical
substance at each site, the
[[Page 140]]
submitter must report as many physical forms as applicable from among
the physical forms listed in this Unit:
(A) Dry powder.
(B) Pellets or large crystals.
(C) Water- or solvent-wet solid.
(D) Other solid.
(E) Gas or vapor.
(F) Liquid.
(x) For the principal reporting year only, submitters must report
the percentage, rounded off to the closest 10 percent, of total
production volume of the reportable chemical substance, reported in
response to paragraph (b)(3)(iii) of this section, that is associated
with each physical form reported under paragraph (b)(3)(ix) of this
section.
(4) Chemical-specific information related to processing and use. The
following chemical-specific information must be reported for each
reportable chemical substance manufactured (including imported) above
the applicable production volume threshold, as described in this
section. Persons subject to paragraph (b)(4) of this section must report
the information described in paragraphs (b)(4)(i) and (ii) of this
section for each reportable chemical substance at sites under their
control and at sites that receive a reportable chemical substance from
the submitter directly or indirectly (including through a broker/
distributor, from a customer of the submitter, etc.). Information
reported in response to this paragraph must be reported for the
principal reporting year only and only to the extent that it is known to
or reasonably ascertainable by the submitter. Information required to be
reported under this paragraph is limited to domestic (i.e., within the
customs territory of the United States) processing and use activities.
If information responsive to a given data requirement under this
paragraph, including information in the form of an estimate, is not
known or reasonably ascertainable, the submitter is not required to
respond to the requirement.
(i) Industrial processing and use information. (A) A designation
indicating the type of industrial processing or use operation(s) at each
site that receives a reportable chemical substance from the submitter
site directly or indirectly (whether the recipient site(s) are
controlled by the submitter site or not). For each chemical substance,
report the letters which correspond to the appropriate processing or use
operation(s) listed in Table 4 to paragraph (b)(4)(i)(A). A particular
designation may need to be reported more than once, to the extent that a
submitter reports more than one sector (under paragraph (b)(4)(i)(B) of
this section) that applies to a given designation under this paragraph.
Table 4 to Paragraph (b)(4)(i)(A)--Codes for Reporting Type of
Industrial Processing or Use Operation
------------------------------------------------------------------------
Designation Operation
------------------------------------------------------------------------
PC........................................ Processing as a reactant.
PF........................................ Processing--incorporation
into formulation, mixture,
or reaction product.
PA........................................ Processing--incorporation
into article.
PK........................................ Processing--repackaging.
U......................................... Use--non-incorporative
activities.
------------------------------------------------------------------------
(B) A code indicating the sector(s) that best describe the
industrial activities associated with each industrial processing or use
operation reported under paragraph (b)(4)(i)(A) of this section. For
each chemical substance, report the code that corresponds to the
appropriate sector(s) listed in Table 5 to paragraph (b)(4)(i)(B). A
particular sector code may need to be reported more than once, to the
extent that a submitter reports more than one function code (under
paragraph (b)(4)(i)(C) of this section) that applies to a given sector
code under this paragraph.
Table 5 to Paragraph (b)(4)(i)(B)--Codes for Reporting Industrial
Sectors
------------------------------------------------------------------------
Code Sector description
------------------------------------------------------------------------
IS1....................................... Agriculture, forestry,
fishing, and hunting.
IS2....................................... Oil and gas drilling,
extraction, and support
activities.
IS3....................................... Mining (except oil and gas)
and support activities.
IS4....................................... Utilities.
IS5....................................... Construction.
IS6....................................... Food, beverage, and tobacco
product manufacturing.
IS7....................................... Textiles, apparel, and
leather manufacturing.
IS8....................................... Wood product manufacturing.
IS9....................................... Paper manufacturing.
IS10...................................... Printing and related support
activities.
[[Page 141]]
IS11...................................... Petroleum refineries.
IS12...................................... Asphalt paving, roofing, and
coating materials
manufacturing.
IS13...................................... Petroleum lubricating oil
and grease manufacturing.
IS14...................................... All other petroleum and coal
products manufacturing.
IS15...................................... Petrochemical manufacturing.
IS16...................................... Industrial gas
manufacturing.
IS17...................................... Synthetic dye and pigment
manufacturing.
IS18...................................... Carbon black manufacturing.
IS19...................................... All other basic inorganic
chemical manufacturing.
IS20...................................... Cyclic crude and
intermediate manufacturing.
IS21...................................... All other basic organic
chemical manufacturing.
IS22...................................... Plastics material and resin
manufacturing.
IS23...................................... Synthetic rubber
manufacturing.
IS24...................................... Organic fiber manufacturing.
IS25...................................... Pesticide, fertilizer, and
other agricultural chemical
manufacturing.
IS26...................................... Pharmaceutical and medicine
manufacturing.
IS27...................................... Paint and coating
manufacturing.
IS28...................................... Adhesive manufacturing.
IS29...................................... Soap, cleaning compound, and
toilet preparation
manufacturing.
IS30...................................... Printing ink manufacturing.
IS31...................................... Explosives manufacturing.
IS32...................................... Custom compounding of
purchased resins.
IS33...................................... Photographic film, paper,
plate, and chemical
manufacturing.
IS34...................................... All other chemical product
and preparation
manufacturing.
IS35...................................... Plastics product
manufacturing.
IS36...................................... Rubber product
manufacturing.
IS37...................................... Non-metallic mineral product
manufacturing (includes
cement, clay, concrete,
glass, gypsum, lime, and
other non-metallic mineral
product manufacturing).
IS38...................................... Primary metal manufacturing.
IS39...................................... Fabricated metal product
manufacturing.
IS40...................................... Machinery manufacturing.
IS41...................................... Computer and electronic
product manufacturing.
IS42...................................... Electrical equipment,
appliance, and component
manufacturing.
IS43...................................... Transportation equipment
manufacturing.
IS44...................................... Furniture and related
product manufacturing.
IS45...................................... Miscellaneous manufacturing.
IS46...................................... Wholesale and retail trade.
IS47...................................... Services.
IS48...................................... Other (requires additional
information).
------------------------------------------------------------------------
(C) For each sector reported under paragraph (b)(4)(i)(B) of this
section, the applicable code(s) from Table 6 to paragraph (b)(4)(i)(C)
must be selected to designate the function category(ies) that best
represents the specific manner in which the chemical substance is used.
For the 2020 submission period:
(1) Use column A in Table 6 to paragraph (b)(4)(i)(C) for chemical
substances designated in 2019 as high priority for risk evaluation
(those chemicals listed in Table 7 to paragraph (b)(4)(i)(C)); and
(2) Use either column A or B in Table 6 to paragraph (b)(4)(i)(C)
for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C).
For the 2024 and future submission periods, use only column A in Table 6
to paragraph (b)(4)(i)(C). A particular function category may need to be
reported more than once, to the extent that a submitter reports more
than one industrial processing or use operation/sector combination
(under paragraphs (b)(4)(i)(A) and (B) of this section) that applies to
a given function category under this paragraph. If more than 10 unique
combinations of industrial processing or use operations/sector/function
categories apply to a chemical substance, submitters need only report
the 10 unique combinations for the chemical substance that cumulatively
represent the largest percentage of the submitter's production volume
for that chemical substance, measured by weight. If none of the listed
function categories accurately describes a use of a chemical substance,
the category ``Other'' may be used, and must include a description of
the use.
Table 6 to Paragraph (b)(4)(i)(C)--Codes for Reporting Function
Categories
------------------------------------------------------------------------
Column A Column B
------------------------------------------------------------------------
Code Category Code Category
------------------------------------------------------------------------
F001........ Abrasives............ U001......... Abrasives.
F002........ Etching agent........
[[Page 142]]
F003........ Adhesion/cohesion U002......... Adhesives and
promoter. sealant chemicals.
F004........ Binder...............
F005........ Flux agent...........
F006........ Sealant (barrier)....
F007........ Absorbent............ U003......... Adsorbents and
absorbents.
F008........ Adsorbent............
F009........ Dehydrating agent
(desiccant).
F010........ Drier................
F011........ Humectant............
F012........ Soil amendments U004......... Agricultural
(fertilizers). chemicals (non-
pesticidal).
F013........ Anti-adhesive/ U005......... Anti-adhesive
cohesive. agents.
F014........ Dusting agent........
F015........ Bleaching agent...... U006......... Bleaching agents.
F016........ Brightener...........
F017........ Anti-scaling agent... U007......... Corrosion inhibitors
and anti-scaling
agents.
F018........ Corrosion inhibitor..
F019........ Dye.................. U008......... Dyes.
F020........ Fixing agent
(mordant).
F021........ Hardener............. U009......... Fillers.
F022........ Filler...............
F023........ Anti-static agent.... U010......... Finishing agents.
F024........ Softener and
conditioner.
F025........ Swelling agent.......
F026........ Tanning agents not
otherwise specified.
F027........ Waterproofing agent..
F028........ Wrinkle resisting
agent.
F029........ Flame retardant...... U011......... Flame retardants.
F030........ Fuel agents.......... U012......... Fuels and fuel
additives.
F031........ Fuel.................
F032........ Heat transferring U013......... Functional fluids
agent. (closed systems).
F033........ Hydraulic fluids.....
F034........ Insulators...........
F035........ Refrigerants.........
F036........ Anti-freeze agent.... U014......... Functional fluids
(open systems).
F037........ Intermediate......... U015......... Intermediates.
F038........ Monomers.............
F039........ Ion exchange agent... U016......... Ion exchange agents.
F040........ Anti-slip agent...... U017......... Lubricants and
lubricant
additives.
F041........ Lubricating agent....
F042........ Deodorizer........... U018......... Odor agents.
F043........ Fragrance............
F044........ Oxidizing agent...... U019......... Oxidizing/reducing
agents.
F045........ Reducing agent.......
F046........ Photosensitive agent. U020......... Photosensitive
chemicals.
F047........ Photosensitizers.....
F048........ Semiconductor and
photovoltaic agent.
F049........ UV stabilizer........
F050........ Opacifer............. U021......... Pigments.
F051........ Pigment..............
F052........ Plasticizer.......... U022......... Plasticizers.
F053........ Plating agent........ U023......... Plating agents and
surface treating
agents.
F054........ Catalyst............. U024......... Process regulators.
F055........ Chain transfer agent.
F056........ Chemical reaction
regulator.
F057........ Crystal growth
modifiers
(nucleating agents).
F058........ Polymerization
promoter.
F059........ Terminator/Blocker...
F060........ Processing aids, U025......... Processing aids,
specific to specific to
petroleum production. petroleum
production.
F061........ Antioxidant.......... U026......... Processing aids, not
otherwise listed.
F062........ Chelating agent......
F063........ Defoamer.............
F064........ pH regulating agent..
F065........ Processing aids not
otherwise specified.
F066........ Energy Releasers U027......... Propellants and
(explosives, motive blowing agents.
propellant).
F067........ Foamant..............
F068........ Propellants, non-
motive (blowing
agents).
F069........ Cloud-point U028......... Solids separation
depressant. agents.
F070........ Flocculating agent...
F071........ Flotation agent......
F072........ Solids separation
(precipitating)
agent, not otherwise
specified.
F073........ Cleaning agent....... U029......... Solvents (for
cleaning or
degreasing).
F074........ Diluent.............. U030......... Solvents (which
become part of
product formulation
or mixture).
F075........ Solvent..............
F076........ Surfactant (surface U031......... Surface active
active agent). agents.
F077........ Emulsifier...........
F078........ Thickening agent..... U032......... Viscosity adjustors.
F079........ Viscosity modifiers..
F080........ Laboratory chemicals. U033......... Laboratory
chemicals.
[[Page 143]]
F081........ Dispersing agent..... U034......... Paint additives and
coating additives
not described by
other categories.
F082........ Freeze-thaw additive.
F083........ Surface modifier.....
F084........ Wetting agent (non-
aqueous).
F085........ Aerating and U999......... Other (specify).
deaerating agents.
F086........ Explosion inhibitor..
F087........ Fire extinguishing
agent.
F088........ Flavoring and
nutrient.
F089........ Anti-redeposition
agent.
F090........ Anti-stain agent.....
F091........ Anti-streaking agent.
F092........ Conductive agent.....
F093........ Incandescent agent...
F094........ Magnetic element.....
F095........ Anti-condensation
agent.
F096........ Coalescing agent.....
F097........ Film former..........
F098........ Demulsifier..........
F099........ Stabilizing agent....
F100........ Alloys...............
F101........ Density modifier.....
F102........ Elasticizer..........
F103........ Flow promoter........
F104........ Sizing agent.........
F105........ Solubility enhancer..
F106........ Vapor pressure
modifiers.
F107........ Embalming agent......
F108........ Heat stabilizer......
F109........ Preservative.........
F110........ Anti-caking agent....
F111........ Deflocculant.........
F112........ Dust suppressant.....
F113........ Impregnation agent...
F114........ Leaching agent.......
F115........ Tracer...............
F116........ X-ray absorber.......
F999........ Other................
------------------------------------------------------------------------
For the 2020 submission period: (1) Use column A for chemical substances
designated in 2019 as high priority for risk evaluation (those
chemicals listed in Table 7 to paragraph(b)(4)(i)(C) and (2) use
either column A or B for chemical substances not listed in Table 7 to
paragraph (b)(4)(i)(C).
For the 2024 and future submission periods, use only column A.
Table 7 to Paragraph (b)(4)(i)(C)--CASRNs of Chemical Substances
Designated as High Priority for Risk Evaluation Under TSCA Section 6(b)
on December 30, 2019
------------------------------------------------------------------------
CASRN Chemical substance
------------------------------------------------------------------------
106-46-7.................................. p-Dichlorobenzene.
107-06-2.................................. 1,2-Dichloroethane.
156-60-5.................................. trans-1,2-Dichloroethylene.
95-50-1................................... o-Dichlorobenzene.
79-00-5................................... 1,1,2-Trichloroethane.
78-87-5................................... 1,2-Dichloropropane.
75-34-3................................... 1,1-Dichloroethane.
84-74-2................................... Dibutyl phthalate (DBP) (1,2-
Benzene-dicarboxylic acid,
1,2-dibutyl ester).
85-68-7................................... Butyl benzyl phthalate
(BBP)--1,2-Benzene-
dicarboxylic acid, 1-butyl
2(phenylmethyl) ester.
117-81-7.................................. Di-ethylhexyl phthalate
(DEHP)--(1,2-Benzene-
dicarboxylic acid, 1,2-
bis(2-ethylhexyl) ester).
84-69-5................................... Di-isobutyl phthalate
(DIBP)--(1,2-Benzene-
dicarboxylic acid, 1,2-bis-
(2methylpropyl) ester).
84-61-7................................... Dicyclohexyl phthalate.
79-94-7................................... 4,4'-(1-
Methylethylidene)bis[2,6-
dibromophenol] (TBBPA).
115-96-8.................................. Tris(2-chloroethyl)
phosphate (TCEP).
115-86-6.................................. Phosphoric acid, triphenyl
ester (TPP).
106-93-4.................................. Ethylene dibromide.
106-99-0.................................. 1,3-Butadiene.
1222-05-5................................. 1,3,4,6,7,8-Hexahydro-
4,6,6,7,8,8-
hexamethylcyclopental[g]-2-
benzopyran (HHCB).
50-00-0................................... Formaldehyde.
85-44-9................................... Phthalic anhydride.
------------------------------------------------------------------------
(D) The estimated percentage, rounded off to the closest 10 percent,
of total production volume of the reportable chemical substance
associated with each combination of industrial processing or use
operation, sector, and function category. Where a particular combination
of industrial processing or use operation, sector, and function category
accounts for less than 5 percent of the submitter's site's total
production volume of a reportable chemical substance, the percentage
must not be rounded off to 0 percent if the production volume
attributable to that industrial processing or use operation, sector, and
function category combination is 25,000 lb (11,340 kg) or more during
the reporting year. Instead, in such a case, submitters must report the
percentage, rounded off to the closest 1 percent, of the submitter's
site's total production volume of the reportable chemical substance
associated with the particular combination of industrial
[[Page 144]]
processing or use operation, sector, and function category.
(E) For each combination of industrial processing or use operation,
sector, and function category, the submitter must estimate the number of
sites at which each reportable chemical substance is processed or used.
For each combination associated with each chemical substance, the
submitter must select from among the ranges of sites listed in Table 8
to paragraph (b)(4)(i)(E) and report the corresponding code (i.e., S1
through S7):
Table 8 to Paragraph (b)(4)(i)(E)--Codes for Reporting Numbers of Sites
------------------------------------------------------------------------
Code Range
------------------------------------------------------------------------
S1........................................ Fewer than 10 sites.
S2........................................ At least 10 but fewer than
25 sites.
S3........................................ At least 25 but fewer than
100 sites.
S4........................................ At least 100 but fewer than
250 sites.
S5........................................ At least 250 but fewer than
1,000 sites.
S6........................................ At least 1,000 but fewer
than 10,000 sites.
S7........................................ At least 10,000 sites.
------------------------------------------------------------------------
(F) For each combination of industrial processing or use operation,
sector, and function category, the submitter must estimate the number of
workers reasonably likely to be exposed to each reportable chemical
substance. For each combination associated with each chemical substance,
the submitter must select from among the worker ranges listed in
paragraph (b)(3)(vii) of this section and report the corresponding code
(i.e., W1 though W8).
(ii) Consumer and commercial use information. (A) Using the
applicable codes listed in Table 9 to paragraph (b)(4)(ii)(A),
submitters must designate the consumer and commercial product
category(ies) that best describe the consumer and commercial products in
which each reportable chemical substance is used (whether the recipient
site(s) are controlled by the submitter site or not). For the 2020
submission period:
(1) Use column A in Table 9 to paragraph (b)(4)(ii)(A) for chemical
substances designated in 2019 as high priority for risk evaluation
(those chemicals listed in Table 7 to paragraph (b)(4)(i)(C); and
(2) Use either column A or B in Table 9 to paragraph (b)(4)(ii)(A)
for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C).
For the 2024 and future submission periods, use only column A in Table 9
to paragraph (b)(4)(ii)(A). If more than 10 codes apply to a chemical
substance, submitters need only report the 10 codes for the chemical
substance that cumulatively represent the largest percentage of the
submitter's production volume for that chemical, measured by weight. If
none of the listed consumer and commercial product categories accurately
describes the consumer and commercial products in which each reportable
chemical substance is used, the category ``Other'' may be used, and must
include a description of the use.
Table 9 to Paragraph (b)(4)(ii)(A)--Codes for Reporting Consumer and
Commercial Product Categories
------------------------------------------------------------------------
Column A Column B
------------------------------------------------------------------------
Code Category Code Category
------------------------------------------------------------------------
Chemical Substances in Furnishing, Cleaning, Treatment Care Products
------------------------------------------------------------------------
CC101....... Construction and C101......... Floor coverings.
building materials
covering large
surface areas
including stone,
plaster, cement,
glass and ceramic
articles; fabrics,
textiles, and
apparel.
CC102....... Furniture & C102......... Foam seating and
furnishings bedding products.
including plastic
articles (soft);
leather articles.
CC103....... Furniture & C103......... Furniture and
furnishings furnishings not
including stone, covered elsewhere.
plaster, cement,
glass and ceramic
articles; metal
articles; or rubber
articles.
CC104....... Leather conditioner.. C104......... Fabric, textile, and
leather products
not covered
elsewhere.
CC105....... Leather tanning, dye,
finishing,
impregnation and
care products.
[[Page 145]]
CC106....... Textile (fabric) dyes
CC107....... Textile finishing and
impregnating/surface
treatment products.
CC108....... All-purpose foam C105......... Cleaning and
spray cleaner. furnishing care
products.
CC109....... All-purpose liquid
cleaner/polish.
CC110....... All-purpose liquid
spray cleaner.
CC111....... All-purpose waxes and
polishes.
CC112....... Appliance cleaners...
CC113....... Drain and toilet
cleaners (liquid).
CC114....... Powder cleaners
(floors).
CC115....... Powder cleaners
(porcelain).
CC116....... Dishwashing detergent C106......... Laundry and
(liquid/gel). dishwashing
products.
CC117....... Dishwashing detergent
(unit dose/granule).
CC118....... Dishwashing detergent
liquid (hand-wash).
CC119....... Dry cleaning and
associated products.
CC120....... Fabric enhancers.....
CC121....... Laundry detergent
(unit-dose/granule).
CC122....... Laundry detergent
(liquid).
CC123....... Stain removers.......
CC124....... Ion exchangers....... C107......... Water treatment
products.
CC125....... Liquid water
treatment products.
CC126....... Solid/Powder water
treatment products.
CC127....... Liquid body soap..... C108......... Personal care
products.
CC128....... Liquid hand soap.....
CC129....... Solid bar soap.......
CC130....... Air fresheners for C109......... Air care products.
motor vehicles.
CC131....... Continuous action air
fresheners.
CC132....... Instant action air
fresheners.
CC133....... Anti-static spray.... C110......... Apparel and footwear
care products.
CC134....... Apparel finishing,
and impregnating/
surface treatment
products.
CC135....... Insect repellent
treatment.
CC136....... Pre-market waxes,
stains, and polishes
applied to footwear.
CC137....... Post-market waxes,
and polishes applied
to footwear (shoe
polish).
CC138....... Waterproofing and
water-resistant
sprays.
------------------------------------------------------------------------
Chemical Substances in Construction, Paint, Electrical, and Metal
Products
------------------------------------------------------------------------
CC201....... Fillers and putties.. C201......... Adhesives and
sealants.
CC202....... Hot-melt adhesives...
CC203....... One-component caulks.
CC204....... Solder...............
CC205....... Single-component
glues and adhesives.
CC206....... Two-component caulks.
CC207....... Two-component glues
and adhesives.
CC208....... Adhesive/Caulk C202......... Paints and coatings.
removers.
CC209....... Aerosol spray paints.
CC210....... Lacquers, stains,
varnishes and floor
finishes.
CC211....... Paint strippers/
removers.
CC212....... Powder coatings......
CC213....... Radiation curable
coatings.
CC214....... Solvent-based paint..
CC215....... Thinners.............
CC216....... Water-based paint....
CC217....... Construction and C203......... Building/
building materials construction
covering large materials--wood and
surface areas, engineered wood
including wood products.
articles.
CC218....... Construction and C204......... Building/
building materials construction
covering large materials not
surface areas, covered elsewhere.
including paper
articles; metal
articles; stone,
plaster, cement,
glass and ceramic
articles.
[[Page 146]]
CC219....... Machinery, mechanical C205......... Electrical and
appliances, electronic
electrical/ products.
electronic articles.
CC220....... Other machinery,
mechanical
appliances,
electronic/
electronic articles.
CC221....... Construction and C206......... Metal products not
building materials covered elsewhere.
covering large
surface areas,
including metal
articles.
CC222....... Electrical batteries C207......... Batteries.
and accumulators.
------------------------------------------------------------------------
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
CC990....... Non-TSCA use......... C301......... Food packaging.
CC301....... Packaging (excluding C302......... Paper products.
food packaging),
including paper
articles.
CC302....... Other articles with
routine direct
contact during
normal use,
including paper
articles.
CC303....... Packaging (excluding C303......... Plastic and rubber
food packaging), products not
including rubber covered elsewhere.
articles; plastic
articles (hard);
plastic articles
(soft).
CC304....... Other articles with
routine direct
contact during
normal use including
rubber articles;
plastic articles
(hard).
CC305....... Toys intended for C304......... Toys, playground,
children's use (and and sporting
child dedicated equipment.
articles), including
fabrics, textiles,
and apparel; or
plastic articles
(hard).
CC306....... Adhesives applied at C305......... Arts, crafts, and
elevated hobby materials.
temperatures.
CC307....... Cement/concrete......
CC308....... Crafting glue........
CC309....... Crafting paint
(applied to body).
CC310....... Crafting paint
(applied to craft).
CC311....... Fixatives and
finishing spray
coatings.
CC312....... Modelling clay.......
CC313....... Correction fluid/tape C306......... Ink, toner, and
colorant products.
CC314....... Inks in writing
equipment (liquid).
CC315....... Inks used for stamps.
CC316....... Toner/Printer
cartridge.
CC317....... Liquid photographic C307......... Photographic
processing solutions. supplies, film, and
photochemicals.
------------------------------------------------------------------------
Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
Products
------------------------------------------------------------------------
CC401....... Exterior car washes C401......... Automotive care
and soaps. products.
CC402....... Exterior car waxes,
polishes, and
coatings.
CC403....... Interior car care....
CC404....... Touch up auto paint..
CC405....... Degreasers........... C402......... Lubricants and
greases.
CC406....... Liquid lubricants and
greases.
CC407....... Paste lubricants and
greases.
CC408....... Spray lubricants and
greases.
CC409....... Anti-freeze liquids.. C403......... Anti-freeze and de-
icing products.
CC410....... De-icing liquids.....
CC411....... De-icing solids......
CC412....... Lock de-icers/
releasers.
CC413....... Cooking and heating C404......... Fuels and related
fuels. products.
CC414....... Fuel additives.......
CC415....... Vehicular or
appliance fuels.
CC416....... Explosive materials.. C405......... Explosive materials.
CC417....... Agricultural non- C406......... Agricultural
pesticidal products. products (non-
pesticidal).
CC418....... Lawn and garden care C407......... Lawn and garden care
products. products.
------------------------------------------------------------------------
Chemical Substances in Products not Described by Other Codes
------------------------------------------------------------------------
CC980....... Other (specify)...... C909......... Other (specify).
CC990....... Non-TSCA use......... C980......... Non-TSCA use.
------------------------------------------------------------------------
For the 2020 submission period: (1) Use column A for chemical substances
designated in 2019 as high priority for risk evaluation (those
chemicals listed in Table 7 to paragraph (b)(4)(i)(C) and (2) use
either column A or B for chemical substances not listed in Table 7 to
paragraph (b)(4)(i)(C).
[[Page 147]]
For the 2024 and future submission periods, use only column A.
(B) For each consumer and commercial product category reported under
paragraph (b)(4)(ii)(A) of this section, the applicable code(s)
described in paragraph (b)(4)(i)(C) of this section must be selected to
designate the function category(ies) that best represents the specific
manner in which the chemical substance is used. For the 2020 submission
period:
(1) Use column A in Table 6 to paragraph (b)(4)(i)(C) for chemical
substances designated in 2019 as high priority for risk evaluation
(those chemicals listed in Table 7 to paragraph (b)(4)(i)(C); and
(2) Use either column A or B in Table 6 to paragraph (b)(4)(i)(C)
for chemical substances not listed in Table 7 to paragraph (b)(4)(i)(C).
For the 2024 and future submission periods, use only column A in Table 6
to paragraph (b)(4)(i)(C). A particular function category may need to be
reported more than once, to the extent that a submitter reports more
than one consumer or commercial product category (under paragraph
(b)(4)(ii)(A) of this section) that applies to a given function category
under this paragraph. If none of the listed function categories
accurately describes a use of a chemical substance, the category
``Other'' may be used, and must include a description of the use.
(C) An indication, within each consumer and commercial product
category reported under paragraph (b)(4)(ii)(A) of this section, whether
the use is a consumer or a commercial use.
(D) Submitters must determine, within each consumer and commercial
product category reported under paragraph (b)(4)(ii)(A) of this section,
whether any amount of each reportable chemical substance manufactured
(including imported) by the submitter is present in (for example, a
plasticizer chemical substance used to make pacifiers) or on (for
example, as a component in the paint on a toy) any consumer products
intended for use by children age 14 or younger, regardless of the
concentration of the chemical substance remaining in or on the product.
Submitters must select from the following options: The chemical
substance is used in or on any consumer products intended for use by
children; the chemical substance is not used in or on any consumer
products intended for use by children; or information as to whether the
chemical substance is used in or on any consumer products intended for
use by children is not known to or reasonably ascertainable by the
submitter.
(E) The estimated percentage, rounded off to the closest 10 percent,
of the submitter's site's total production volume of the reportable
chemical substance associated with each consumer and commercial product
category. Where a particular consumer and commercial product category
accounts for less than 5 percent of the total production volume of a
reportable chemical substance, the percentage must not be rounded off to
0 percent if the production volume attributable to that commercial and
consumer product category is 25,000 lb (11,340 kg) or more during the
reporting year. Instead, in such a case, submitters must report the
percentage, rounded off to the closest 1 percent, of the submitter's
site's total production volume of the reportable chemical substance
associated with the particular consumer and commercial product category.
(F) Where the reportable chemical substance is used in consumer or
commercial products, the estimated typical maximum concentration,
measured by weight, of the chemical substance in each consumer and
commercial product category reported under paragraph (b)(4)(ii)(A) of
this section. For each chemical substance in each commercial and
consumer product category reported under paragraph (b)(4)(ii)(A) of this
section, submitters must select from among the ranges of concentrations
listed in Table 3 to paragraph (b)(3)(viii) of this section and report
the corresponding code (i.e., M1 through M5).
(G) Where the reportable chemical substance is used in a commercial
product, the submitter must estimate the number of commercial workers
reasonably likely to be exposed to each reportable chemical substance.
For each combination associated with each substance, the submitter must
select from among the worker ranges listed in
[[Page 148]]
Table 2 to paragraph (b)(3)(vii) of this section and report the
corresponding code (i.e., W1 though W8).
[85 FR 20139, Apr. 9, 2020]
Sec. 711.20 When to report.
All information reported to EPA in response to the requirements of
this part must be submitted during an applicable submission period. The
2020 CDR submission period is from June 1, 2020, to January 29, 2021.
Subsequent recurring submission periods are from June 1 to September 30
at 4-year intervals, beginning in 2024. In each submission period, any
person described in Sec. 711.8 must report as described in this part.
[85 FR 75238, Nov. 25, 2020]
Sec. 711.22 Duplicative reporting.
(a) With regard to TSCA section 8(a) rules. Any person subject to
the requirements of this part who previously has complied with reporting
requirements of a rule under TSCA section 8(a) by submitting the
information described in Sec. 711.15 for a chemical substance described
in Sec. 711.5 to EPA, and has done so within 1 year of the start of a
submission period described in Sec. 711.20, is not required to report
again on the manufacture of that chemical substance at that site during
that submission period.
(b) With regard to importers. This part requires that only one
report be submitted on each import transaction involving a chemical
substance described in Sec. 711.5. When two or more persons are
involved in a particular import transaction and each person meets the
Agency's definition of ``importer'' as set forth in 40 CFR 704.3, they
may determine among themselves who should submit the required report; if
no report is submitted as required under this part, EPA will hold each
such person liable for failure to report.
(c) Co-manufactured chemicals. This part requires that only one
report per site be submitted on each chemical substance described in
Sec. 711.5. However, both the contracting company and producing company
are liable if no report is made. When a company contracts with a
producing company to manufacture a chemical substance, and each party
meets the definition of ``manufacturer'' as set forth in Sec. 711.3,
reporting of the co-manufactured chemical can be performed by one of the
following methods:
(1) The contracting company initiates the required report for that
site as the primary submitter. The contracting company must indicate on
the report that this is a co-manufacturing situation, notify the
producing company, and record the production volume domestically co-
manufactured as set forth in Sec. 711.15(b)(3) and processing and use
information set forth in Sec. 711.15(b)(4). Upon notification by the
contracting company, the producing company must also record the
production volume domestically co-manufactured and complete the rest of
the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the
producing company, the producing company completes the full report for
the co-manufactured chemical. The contracting company supplies the
information not otherwise known to or reasonably ascertainable by the
producing company.
[76 FR 54933, Sept. 6, 2011, as amended at 85 FR 20148, Apr. 9, 2020]
Sec. 711.25 Recordkeeping requirements.
Each person who is subject to the reporting requirements of this
part must retain records that document any information reported to EPA.
Records relevant to reporting during a submission period must be
retained for a period of 5 years beginning on the last day of the
submission period. Submitters are encouraged to retain their records
longer than 5 years to ensure that past records are available as a
reference when new submissions are being generated.
Sec. 711.30 Confidentiality claims.
(a) Making confidentiality claims--(1) Generally. Any person
submitting information under this part may assert a confidentiality
claim for that information at the time it is submitted, except for
information described in paragraph (a)(2). Any such confidentiality
claims must be asserted at the time the information is submitted. These
claims will
[[Page 149]]
apply only to the information submitted with the claim. Instructions for
asserting confidentiality claims are provided in the document identified
in Sec. 711.35. Information claimed as confidential in accordance with
this section will be treated and disclosed in accordance with the
procedures in 40 CFR part 2 and section 14 of TSCA.
(2) Exceptions. Confidentiality claims cannot be asserted:
(i) For chemical identities listed on the public portion of the TSCA
Inventory;
(ii) For processing and use data elements required by Sec.
711.15(b)(4)(i)(A), (B), and (C) and Sec. 711.15(b)(4)(ii)(A), (B),
(C), and (D); or
(iii) When a response is left blank or designated as ``not known or
reasonably ascertainable.''
(3) Substantiations. All confidentiality claims must be
substantiated at time of submission, in accordance with the requirements
in paragraphs (b), (c), and (d)(1) of this section, and must be signed
and dated by an authorized official. Confidentiality claims for the
following data elements are exempt from this substantiation requirement:
(i) Production volume information required pursuant to Sec.
711.15(b)(3)(iii).
(ii) Joint submission information from the primary submitter,
consisting of trade name and supplier identification required pursuant
to Sec. 711.15(b)(3)(i)(A) and (B).
(iii) Joint submission information from the secondary submitter,
consisting of the percentage of formulation required pursuant to Sec.
711.15(b)(3)(i)(A) and (B).
(iv) Information that is supplied in a petition submitted under
Sec. 711.6(b)(2)(iii) or Sec. 711.10(d)(1)(ii) and that is described
in section 14(c)(2) of TSCA.
(4) Marking information claimed as confidential in confidentiality
substantiation documentation. If any of the information contained in the
answers to the questions listed in paragraphs (b) and (c) of this
section is asserted to contain information that itself is considered to
be confidential, you must clearly identify the information that is
claimed confidential.
(5) Certification statement for claims. An authorized official
representing a person asserting a claim of confidentiality must certify
that the submission complies with the requirements of this part by
signing and dating the following certification statement:
``I certify that all claims for confidentiality asserted with this
submission are true and correct, and all information submitted herein to
substantiate such claims is true and correct. Any knowing and willful
misrepresentation is subject to criminal penalty pursuant to 18 U.S.C.
1001. I further certify that: (1) I have taken reasonable measures to
protect the confidentiality of the information; (2) I have determined
that the information is not required to be disclosed or otherwise made
available to the public under any other Federal law; (3) I have a
reasonable basis to conclude that disclosure of the information is
likely to cause substantial harm to the competitive position of my
company; and (4) I have a reasonable basis to believe that the
information is not readily discoverable through reverse engineering.''
(6) Company, site, and technical contact identity information. A
submitter may assert a claim of confidentiality for a site, company, or
technical contact identity to protect the link between that information
and the reported chemical substance. Such claim may be asserted only
when the linkage of that information to a reportable chemical substance
is confidential and not publicly available.
(7) Processing and use information. A submitter may assert a claim
of confidentiality for each data element required by Sec.
711.15(b)(4)(i)(D), (E) and (F) and Sec. 711.15(b)(4)(ii)(E), (F), and
(G) to protect the link between that information and the reported
chemical substance. Such claim may be asserted only when the linkage of
that information to a reportable chemical substance is confidential and
not publicly available.
(b) All confidentiality claims requiring substantiation at time of
submission. For each data element (or information supplied in a petition
submitted under Sec. 711.6(b)(2)(iii)(A) or Sec. 711.10(d)(1)(ii)(A))
that is claimed as confidential, you must submit with your report
detailed written answers to the following questions:
(1) Will disclosure of the information claimed as confidential
likely cause substantial harm to your business's competitive position?
If you answered
[[Page 150]]
yes, describe the substantial harmful effects that would likely result
to your competitive position if the information is disclosed, including
but not limited to how a competitor could use such information, and the
causal relationship between the disclosure and the harmful effects.
(2) To the extent your business has disclosed the information to
others (both internally and externally), has your business taken
precautions to protect the confidentiality of the disclosed information?
If yes, please explain and identify the specific measures, including but
not limited to internal controls, that your business has taken to
protect the information claimed as confidential.
(3)(i) Is any of the information claimed as confidential required to
be publicly disclosed under any other Federal law? If yes, please
explain.
(ii) Does any of the information claimed as confidential otherwise
appear in any public documents, including (but not limited to) safety
data sheets; advertising or promotional material; professional or trade
publications; state, local, or Federal agency files; or any other media
or publications available to the general public? If yes, please explain
why the information should be treated as confidential.
(iii) Does any of the information claimed as confidential appear in
one or more patents or patent applications? If yes, please provide the
associated patent number or patent application number (or numbers) and
explain why the information should be treated as confidential.
(4) Does any of the information that you are claiming as
confidential constitute a trade secret? If yes, please explain how the
information you are claiming as confidential constitutes a trade secret.
(5) Is the claim of confidentiality intended to last less than 10
years (see TSCA section 14(e)(1)(B))? If yes, please indicate the number
of years (between 1-10 years) or the specific date after which the claim
is withdrawn.
(6) Has EPA, another federal agency, or court made any
confidentiality determination regarding information associated with this
chemical substance? If yes, please provide the circumstances associated
with the prior determination, whether the information was found to be
entitled to confidential treatment, the entity that made the decision,
and the date of the determination.
(c) Additional requirements for specific chemical identity. A person
may assert a claim of confidentiality for the specific chemical identity
of a chemical substance as described in Sec. 711.15(b)(3) of this part
only if the identity of that chemical substance is treated as
confidential in the Master Inventory File as of the time the report is
submitted for that chemical substance. Generic chemical identities and
accession numbers may not be claimed as confidential. To assert a claim
of confidentiality for the identity of a reportable chemical substance,
you must submit with the report detailed written answers to the
questions from paragraph (b) of this section and to the following
questions.
(1) Is this chemical substance publicly known (including by your
competitors) to be in U.S. commerce? If yes, please explain why the
specific chemical identity should still be afforded confidential status
(e.g., the chemical substance is publicly known only as being
distributed in commerce for research and development purposes, but no
other information about the current commercial distribution of the
chemical substance in the United States is publicly available). If no,
please complete the certification statement:
I certify that on the date referenced, I searched the internet for
the chemical substance identity (i.e., by both chemical substance name
and CASRN). I did not find a reference to this chemical substance that
would indicate that the chemical is being manufactured or imported by
anyone for a commercial purpose in the United States. [provide date].
(2) Does this particular chemical substance leave the site of
manufacture (including import) in any form, e.g., as a product,
effluent, emission? If yes, please explain what measures have been taken
to guard against the discovery of its identity.
(3) If the chemical substance leaves the site in a form that is
available to the public or your competitors, can the
[[Page 151]]
chemical identity be readily discovered by analysis of the substance
(e.g., product, effluent, emission), in light of existing technologies
and any costs, difficulties, or limitations associated with such
technologies? Please explain why or why not.
(4) Would disclosure of the specific chemical name release
confidential process information? If yes, please explain.
(d) Special situations--(1) Joint submissions. If a primary
submitter asks a secondary submitter to provide information directly to
EPA in a joint submission under Sec. 711.15(b)(3)(i)(A) and (B), only
the primary submitter may assert a confidentiality claim for the data
elements that it directly submits to EPA. The primary submitter must
substantiate those claims that are not exempt under paragraph (a)(3)(ii)
of this section. The secondary submitter is responsible for asserting
all confidentiality claims for the data elements that it submits
directly to EPA and for substantiating those claims that are not exempt
under paragraph (a)(3)(iii) of this section.
(2) Petitions. If a petition submitted under Sec.
711.6(b)(2)(iii)(A) or Sec. 711.10(d)(1)(ii)(A) includes any
information claimed as confidential, the petitioner must provide a
version of the petition that redacts the information claimed as
confidential.
(e) No claim of confidentiality. Information not claimed as
confidential in accordance with the requirements of this section may be
made public without further notice to the submitter.
[85 FR 20148, Apr. 9, 2020]
Sec. 711.35 Electronic filing.
(a) You must use e-CDRweb to complete and submit Form U (EPA Form
7740-8). Submissions may only be made as set forth in this section.
(b) Submissions must be sent electronically to EPA via CDX.
(c) Access e-CDRweb and instructions, as follows:
(1) By website. Go to the EPA Chemical Data Reporting internet
homepage at http://www.epa.gov/cdr and follow the appropriate links.
(2) By phone or e-mail. Contact the EPA TSCA Hotline at (202) 554-
1404 or [email protected] for a CD-ROM containing the instructions.
[76 FR 54933, Sept. 6, 2011, as amended at 85 FR 20149, Apr. 9, 2020]
PART 712_CHEMICAL INFORMATION RULES--Table of Contents
Subpart A_General Provisions
Sec.
712.1 Scope and compliance.
712.3 Definitions.
712.5 Method of identification of substances for reporting purposes.
712.7 Report of readily obtainable information for subparts B and C.
712.15 Confidentiality.
Subpart B_Manufacturers Reporting_Preliminary Assessment Information
712.20 Manufacturers and importers who must report.
712.25 Exempt manufacturers and importers.
712.28 Form and instructions.
712.30 Chemical lists and reporting periods.
Authority: 15 U.S.C. 2607(a).
Source: 47 FR 26998, June 22, 1982, unless otherwise noted.
Subpart A_General Provisions
Sec. 712.1 Scope and compliance.
(a) This part establishes procedures for chemical manufacturers and
processors to report production, use, and exposure-related information
on listed chemical substances. Subpart A establishes requirements that
apply to all reporting under this part. Subpart B covers manufacturers'
and processors' reporting.
(b) Chemical substances, mixtures, and categories of substances or
mixtures which have been recommended by the Interagency Testing
Committee for testing consideration by the Agency but not designated for
Agency response within 12 months, will be added to Sec. 712.30 using
the procedure specified in Sec. 712.30(c) only to the extent that the
total number of designated and recommended chemicals has not exceeded
[[Page 152]]
50 in any 1 year. Additional recommended but not designated chemicals
may be added after proposal, and consideration of public comment.
[47 FR 26998, June 22, 1982, as amended at 50 FR 34809, Aug. 28, 1985;
60 FR 31921, June 19, 1995]
Sec. 712.3 Definitions.
The definitions in section 3 of TSCA, 15 U.S.C. 2602, apply for this
part. In addition, the following definitions apply:
(a) Byproduct means any chemical substance or mixture produced
without a separate commercial intent during the manufacture, processing,
use, or disposal of another chemical substance or mixture.
(b) EPA means the U.S. Environmental Protection Agency.
(c) Import in bulk form means to import a chemical substance (other
than as part of a mixture or article) in any quantity, in cans, bottles,
drums, barrels, packages, tanks, bags, or other containers used for
purposes of transportation or containment, if the chemical substance has
an end use or commercial purpose separate from the container.
(d) Importer means anyone who imports a chemical substance,
including a chemical substance as part of a mixture or article, into the
customs territory of the U.S. and includes the person liable for the
payment of any duties on the merchandise, or an authorized agent on his
behalf. Importer also includes, as appropriate:
(1) The consignee.
(2) The importer of record.
(3) The actual owner if an actual owner's declaration and
superseding bond has been filed in accordance with 19 CFR 141.20.
(4) The transferee, if the right to withdraw merchandise in a bonded
warehouse has been transferred in accordance with subpart C of 19 CFR
part 144. For the purposes of this definition, the customs territory of
the U.S. consists of the 50 states, Puerto Rico, and the District of
Columbia.
(e) Impurity means a chemical substance unintentionally present with
another chemical substance or mixture.
(f) Intermediate means any chemical substance that is consumed, in
whole or in part, in chemical reactions used for the intentional
manufacture of other chemical substances or mixtures, or that is
intentionally present for the purpose of altering the rates of such
chemical reactions. (See also paragraph (j) of this section.)
(g) Known to or reasonably ascertainable by means all information in
a person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know, or could obtain without unreasonable burden.
(h) Manufacture for commercial purposes means to import, produce, or
manufacture with the purpose of obtaining an immediate or eventual
commercial advantage for the manufacturer and includes, among other
things, such ``manufacture'' of any amount of a chemical substance or
mixture:
(1) For commercial distribution, including for test marketing.
(2) For use by the manufacturer, including use for product research
and development, or as an intermediate. Manufacture for commercial
purposes also applies to substances that are produced coincidentally
during the manufacture, processing, use, or disposal of another
substance or mixture, including byproducts and coproducts that are
separated from that other substance or mixture, and impurities that
remain in that substance or mixture. Byproducts and impurities may not
in themselves have commercial value. They are nonetheless produced for
the purpose of obtaining a commercial advantage since they are part of
the manufacture of a chemical produced for a commercial purpose.
(i) Mixture means any combination of two or more chemical substances
if the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except that mixture does
include (1) any combination which occurs, in whole or in part, as a
result of a chemical reaction if the combination could have been
manufactured for commercial purposes without a chemical reaction at the
time the chemical substances comprising the combination were combined,
and if all
[[Page 153]]
of the chemical substances comprising the combination are included in
the EPA, TSCA Chemical Substance Inventory after the effective date of
the premanufacture notification requirement under 40 CFR part 720, and
(2) hydrates of a chemical substance or hydrated ions formed by
association of a chemical substance with water. The term mixture
includes alloys, inorganic glasses, ceramics, frits, and cements,
including Portland cement.
(j) Non-isolated intermediate means any intermediate that is not
intentionally removed from the equipment in which it is manufactured,
including the reaction vessel in which it is manufactured, equipment
which is ancillary to the reaction vessel, and any equipment through
which the substance passes during a continuous flow process, but not
including tanks or other vessels in which the substance is stored after
its manufacture. (See also paragraph (f) of this section.)
(k) Owned or controlled by the parent company means the parent owns
or controls 50 percent or more of the other company's voting stock or
other equity rights, or has the power to control the management and
policies of the other company.
(l) Person means any natural person, firm, company, corporation,
joint venture, partnership, sole proprietorship, association, or any
other business entity, any State or political subdivision thereof, any
municipality, any interstate body, and any department, agency, or
instrumentality of the Federal government.
(m) Process for commercial purposes means the preparation of a
chemical substance or mixture, after its manufacture, for distribution
in commerce with the purpose of obtaining an immediate or eventual
commercial advantage for the processor. Processing of any amount of a
chemical substance or mixture is included. If a chemical or mixture
containing impurities is processed for commercial purposes, then those
impurities are also processed for commercial purposes.
(n) Site means a contiguous property unit. Property divided only by
a public right-of-way shall be considered one site. There may be more
than one manufacturing plant on a single site.
(o) Test marketing means distributing in commerce a limited amount
of a chemical substance or mixture, or article containing such substance
or mixture, to a defined number of potential customers, during a
predetermined testing period, to explore market capability prior to
broader distribution in commerce.
(p) TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 et
seq.
(q) Central Data Exchange or CDX means EPA's centralized electronic
submission receiving system.
(r) Chemical Information Submission System or CISS means EPA's
electronic, web-based reporting tool for the completion and submission
of data, reports, and other information, or its successors.
[47 FR 26998, June 22, 1982, as amended at 78 FR 72825, Dec. 4, 2013]
Sec. 712.5 Method of identification of substances for reporting purposes.
(a) Report on TSCA-regulable quantities. Unless specifically
otherwise required, respondents must report only about quantities of a
chemical that is defined as a chemical substance under TSCA section
3(2).
(b) Chemicals from natural sources. A manufacturer of a chemical
substance which is extracted from an ore, from oil, or from any other
natural source must report only about the manufacturing steps for, and
the uses of, that chemical, not about production of the natural source
material or other crude precursors derived from the natural source
material.
For example, persons who manufacture a chemical substance such as
``sweetened naphtha, 64741-87-3,'' but do not refine the naphtha to
produce ``hexane, 110-54-3'' would not report on hexane. Only the
production of ``hexane'' as an isolated product must be reported--not
previous production of more crude, complex substances such as naphtha
from which hexane is extracted. Thus, persons who produce crude oil,
ores, and other crude natural materials, but do not carry them through
further manufacturing steps that produce a listed chemical have no
reporting responsibilities under this Part. Note, however, that any
method of extraction, refinement, or purification of a listed chemical
substance is considered to be manufacturing for the purposes of this
rule.
[[Page 154]]
(c) Chemical substances as marketed. This part requires reporting
about chemical substances as they are marketed or used in practice. The
following preparations of a chemical substance must be reported as the
substance itself, not as a mixture, since these preparations are
regarded as the substance in practice.
(1) The chemical substance in aqueous solution.
(2) The chemical substance containing an additive (such as a
stabilizer or other chemical) to maintain the integrity or physical form
of the substance.
(3) The chemical substance in any grade of purity.
Sec. 712.7 Report of readily obtainable information for subparts B and C.
TSCA section 8(a) authorizes EPA to require persons to report
information that is known to or reasonably ascertainable by them. For
purposes of subpart B, however, a lesser standard applies. Companies
must report information that is readily obtainable by management and
supervisory employees responsible for manufacturing, processing,
distributing, technical services, and marketing. Extensive file searches
are not required.
[47 FR 26998, June 22, 1982, as amended at 60 FR 31921, June 19, 1995]
Sec. 712.15 Confidentiality.
(a) Any person submitting information under this part may assert
business confidentiality claims for the information as described in the
pertinent reporting form and its instructions. Any information covered
by a claim will be disclosed by EPA only as provided in the procedures
set forth at 40 CFR part 2.
(b) Persons must certify to the validity of a claim of
confidentiality they make for information reported under this part, as
specified on the reporting form.
(c) If no claim accompanies the information at the time it is
submitted to EPA or if certification as to the claim is not made on the
reporting form, EPA may place the information in an open file available
to the public without further notice to the submitter.
Subpart B_Manufacturers Reporting_Preliminary Assessment Information
Sec. 712.20 Manufacturers and importers who must report.
Except as described in Sec. 712.25, at the time a chemical
substance is listed in Sec. 712.3, the following persons must submit
the ``Manufacturer's Report--Preliminary Assessment Information'' (as
described in Sec. 712.28) for each plant site at which they
manufactured or imported the chemical substance during the reporting
period specified in Sec. 712.30:
(a) Persons who manufactured one or more of the chemical substances
listed in Sec. 712.30 for commercial purposes.
(b) Persons who imported in bulk form one or more of the chemical
substances listed in Sec. 712.30 for commercial purposes.
Sec. 712.25 Exempt manufacturers and importers.
(a) Persons who manufactured or imported the chemical substance
during the reporting period, solely for purposes of scientific
experimentation, analysis, or research, including research or analysis
for product development, are not subject to reporting under Sec.
712.20.
(b) Persons who, during the reporting period, manufactured or
imported fewer than 500 kilograms (1100 pounds) of the chemical
substance at a single plant site are not subject to reporting for that
site under Sec. 712.20.
(c) Persons who qualify as small manufacturers (including importers)
in respect to a specific chemical substance listed in Sec. 712.30 are
exempt. However, the exemption in this paragraph (c) does not apply with
respect to any chemical in Sec. 712.30 designated by an asterisk. A
manufacturer is qualified as small and is exempt from submitting a
report under this subpart for a chemical substance manufactured at a
particular plant site if it meets the definition for small manufacturer
in Sec. 704.3 of this chapter.
(d) Persons are not subject to reporting under Sec. 712.20 if they
manufactured or imported the chemical substance during the reporting
period only in the following forms:
[[Page 155]]
(1) As a byproduct that was not used or sold or that was formed as
described in 40 CFR 710.4(d) (3) through (7).
(2) As a non-isolated intermediate.
(3) As an impurity.
[47 FR 26998, June 22, 1982; 47 FR 28382, June 30, 1982, as amended at
85 FR 31995, May 28, 2020]
Sec. 712.28 Form and instructions.
(a) Manufacturers and importers subject to this subpart must submit
a single EPA Form No. 7710-35, ``Manufacturer's Report--Preliminary
Assessment Information,'' for each plant site manufacturing or importing
a chemical substance listed in Sec. 712.30.
(b) Reporting companies may submit their reports through individual
plant sites or company headquarters as they choose. A separate form must
be submitted for each plant site manufacturing the chemical substance.
(c) Persons authorized to report information under this subpart must
include the following information on Form 7710-35, Manufacturer's
Report--Preliminary Assessment Information (Manufacturer's Report):
(1) A certification as to the truth and accuracy of the information
reported signed and dated by an authorized person located at the plant
site or corporate headquarters of the respondent company.
(2) A confidentiality statement signed and dated by an authorized
person located at the plant site or corporate headquarters of the
respondent company.
(3) The specific chemical name and Chemical Abstracts Service (CAS)
Registry Number listed in 40 CFR 712.30.
(4) The name, company, address, city, State, ZIP code, and telephone
number of a person who is submitting the form, which may be a person
located at a plant site or corporate headquarters that will serve as the
respondent, and will be able to answer questions about the information
submitted by the company to EPA. A respondent to this subpart must
include the appropriate Dun and Bradstreet Number for each plant site
reported.
(5) The plant site activities, such as the manufacturing of a
chemical substance, including the total quantity of the chemical
substance (in kilograms) imported in bulk during the reporting period.
(6) The total number of workers and total worker-hours in each
process category, which includes enclosed process, controlled release
process, and open process.
(7) The information related to chemical substance processing by
customers, including customers' use in industrial and consumer products,
the market names under which the chemical substance is manufactured or
imported, and the customer's process categories that are sold to
customers for further processing.
(d) Persons must use the CISS tool to complete and submit Form 7710-
35, Manufacturer's Report, and accompanying letters, via CDX. Submission
requires registration with CDX, and must be made only as set forth in
this section.
(e) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP /
PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links,
and for further instructions to go http://www.epa.gov/oppt/chemtest /
ereporting/index.html.
[47 FR 26998, June 22, 1982, as amended at 52 FR 20083, May 29, 1987; 53
FR 12523, Apr. 15, 1988; 60 FR 31921, June 19, 1995; 60 FR 34463, July
3, 1995; 71 FR 47126, Aug. 16, 2006; 78 FR 72825, Dec. 4, 2013]
Sec. 712.30 Chemical lists and reporting periods.
(a)(1) Persons subject to this subpart B must submit a Preliminary
Assessment Information Manufacturer's Report for each chemical substance
or mixture that is listed or designated in this section.
(2) Unless a respondent has already prepared a Manufacturer's Report
in conformity with conditions set forth in paragraph (a)(3) of this
section, the information in each Manufacturer's Report must cover the
respondent's latest complete corporate fiscal year as of the effective
date. The effective date will be 30 days after the Federal Register
publishes a rule amendment making the substance or mixture subject to
this subpart B.
(3) Persons subject to this subpart B need not comply with the
requirements of paragraph (a)(2) of this section if
[[Page 156]]
they meet either one of the following conditions:
(i)(A) The respondent has previously and voluntarily provided EPA
with a Manufacturer's Report on a chemical substance or mixture subject
to subpart B of this part, which contains data for a 1-year period
ending no more than 3 years prior to the effective date described in
paragraph (a)(2) of this section. Respondents meeting this condition
must notify EPA by letter of their desire to have the voluntary
submission used in lieu of a current data submission and must verify the
completeness and current accuracy of the voluntarily submitted data.
Such letters, sent in accordance with the method specified in Sec.
712.28(d) to EPA, must contain the following language:
I hereby certify that, to the best of my knowledge and belief, all
information entered on this form is complete and accurate. I agree to
permit access to, and the copying of records by, a duly authorized
representative of the EPA Administrator, in accordance with the Toxic
Substances Control Act, to document any information reported on the
form.
(B) Notification letters must be submitted in accordance with the
method specified in Sec. 712.28(d) prior to the reporting deadline.
(ii)(A) The respondent has previously submitted a Manufacturer's
Report on a chemical substance or mixture subject to subpart B of this
part to the Interagency Testing Committee, but not to EPA, and that
Manufacturer's Report contained data for a 1-year period ending less
than 3 years prior to the effective date described in paragraph (a)(2)
of this section. Respondents meeting this condition must submit a copy
of the Manufacture's Report, in accordance with the method specified in
Sec. 712.28(d) to EPA, and must submit an accompanying letter, also in
accordance with the methods specified in Sec. 712.28(d), notifying EPA
of the respondent's intent that the submission be used in lieu of a
current Manufacturer's Report. The notification letter must verify the
completeness and current accuracy of the voluntarily submitted data.
Such a letter must contain the following language:
I hereby certify that, to the best of my knowledge and belief, all
information entered on this form is complete and accurate. I agree to
permit access to, and the copying of records by, a duly authorized
representative of the EPA Administrator, in accordance with the Toxic
Substances Control Act, to document any information reported on the
form.
(B) The submission must be made prior to the reporting deadline.
(b) Except as provided in paragraph (c) of this section, chemical
substances and designated mixtures will be added after a notice of
proposed amendment of this subpart is published in the Federal Register.
There will be a 30 day public comment period on each notice; after
consideration of the comments, a final amendment will identify the
substances and mixtures added.
(c)(1) Chemical substances, mixtures, and categories of substances
or mixtures that have been added by the Interagency Testing Committee,
established under section 4(e) of TSCA, to the section 4(e) Priority
List, for testing consideration by the Agency, will be added to this
section 30 days after EPA issues for publication in the Federal Register
a rule amendment listing these chemical substances, mixtures and
categories. A Preliminary Assessment Information--Manufacturer's Report
must be submitted for each chemical substance and mixture within 60 days
after the effective date of the listing. At the discretion of the
Assistant Administrator for Chemical Safety and Pollution Prevention, a
listed substance, mixture or category may be withdrawn, for good cause,
from the rule's reporting requirements prior to the effective date. Any
information submitted showing why a substance, mixture or category
should be removed from the rule must be received by EPA within 14 days
after the date of publication of the notice under this paragraph. If a
substance, mixture or category is removed, a Federal Register notice
announcing this decision will be published no later than the effective
date of the amendment.
(2) You must submit the information using the method specified in
Sec. 712.28(d).
(d) Manufacturers and importers of the substances listed below must
submit a Preliminary Assessment Information Manufacturer's Report for
each
[[Page 157]]
site at which they manufacture or import each substance by the reporting
date shown in the table below. The substances are listed in Chemical
Abstracts Service Registry Number order. Typically EPA lists the trivial
or common name first, then, following the symbol ``- -'', EPA lists the
substance by its TSCA Chemical Substance Inventory name. Whenever EPA
lists a single name, the name may be either the TSCA Chemical Substance
Inventory name, a trivial name, or a common name. Generally, when a
single name is listed, it is the TSCA Chemical Substances Inventory
name.
------------------------------------------------------------------------
Effective Reporting
CAS No. Substance date date
------------------------------------------------------------------------
78-10-4 Ethyl silicate.......... 8/23/00 10/23/00
90-30-2 N-Phenyl-1-naphthylamine 9/30/91 11/27/91
100-40-3 4-Vinylcyclohexene...... 1/11/90 3/12/90
108-95-5 Thiophenol.............. 1/26/94 3/28/94
109-87-5 Methylal................ 8/23/00 10/23/00
118-79-6 2,4,6-tribromophenol.... 1/11/90 3/12/90
133-49-3 Pentachlorothiophenol... 8/27/01 10/24/01
136-35-6 1-Triazene, 1,3-diphenyl- 7/11/03 9/9/03
.
143-33-9 Sodium cyanide.......... 10/29/90 12/27/90
496-46-8 Glycoluril.............. 8/23/00 10/23/00
632-79-1 Tetrabromophthalic 1/11/90 3/12/90
anhydride.
637-92-3 Ethyl tert-butyl ether.. 12/28/94 2/27/95
994-05-8 Tert-amyl methyl ether.. 12/28/94 2/27/95
1163-19-5 Decabromodiphenyl ether. 1/11/90 3/12/90
1198-55-6 Tetrachloropyrocatechol. 8/27/01 10/24/01
1806-24-2 p-toluidine, 5-chloro- 8/27/01 10/24/01
.alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-
phenyl-.
3194-55-6 Hexabromocyclododecane.. 1/11/90 3/12/90
3278-89-5 Benzene, 1,3,5-tribromo- 7/11/03 9/9/03
2-(2-propenyloxy)-.
3296-90-0 Dibromoneopentyl glycol. 1/11/90 3/12/90
12185-10-3 White phosphorus........ 1/26/94 3/28/94
16691-43-3 3-Amino-5-mercapto-1,2,4- 8/23/00 10/23/00
triazole.
29091-20-1 Benzenamine, 3-chloro- 7/11/03 9/9/03
2,6-dinitro-N,N-
dipropyl-4-
(trifluoromethyl)-.
32534-81-9 Pentabromodiphenyl ether 1/11/90 3/12/90
32536-52-0 Octabromodiphenyl ether. 1/11/90 3/12/90
32588-76-4 Ethylene Bis- 1/11/90 3/12/90
(tetrabromophthalimide).
37853-59-1 1,2-Bis(tribromophenoxy) 1/11/90 3/12/90
ethane.
41291-34-3 Ethylene(5,6- 1/11/90 3/12/90
dibromonorbornane-2,3-
dicarboximide).
52907-07-0 Ethylene bis(5,6- 1/26/94 3/28/94
dibromonorbornane-2,3-
dicarboximide).
57137-10-7 Tribrominated 1/11/90 3/12/90
polystyrene.
61262-53-1 Ethylene 1/11/90 3/12/90
bis(pentabromophenoxide
).
68928-76-7 Stannane, dimethylbis[(1- 7/11/03 9/9/03
oxoneodecyl)oxy]-.
88185-22-2 Benzoic acid, 3-[2- 8/27/01 10/24/01
chloro-4-
(trifluoromethyl)phenox
y]-, 2-ethoxy-1-methyl-
2-oxoethyl ester.
------------------------------------------------------------------------
(e) Manufacturers and importers of the substances listed below by
category must submit a Preliminary Assessment Information Manufacturers
Report for each site at which they manufacture or import each substance
by the reporting date shown in the table below. The categories are
listed in alphabetic order with the chemical substances within each
category listed by ascending numerical CAS number.
------------------------------------------------------------------------
Effective Reporting
CAS No. Substance date date
------------------------------------------------------------------------
Aldehydes
------------------------------------------------------------------------
66-77-3 1-Naphthalenecarboxaldehyde... 9/30/91 11/27/91
75-07-0 Acetaldehyde.................. 9/30/91 11/27/91
75-87-6 Acetaldehyde, trichloro-...... 9/30/91 11/27/91
78-84-2 Propanal, 2-methyl-........... 9/30/91 11/27/91
78-85-3 2-Propenal, 2-methyl-......... 9/30/91 11/27/91
80-54-6 Benzenepropanal,4-(1,1- 9/30/91 11/27/91
dimethylethyl)-.alpha.-methyl-
.
84-83-3 Acetaldehyde, (1,3-dihydro-
1,3, 3-trimethyl-2H-indol-2-
ylidene).
89-98-5 Benzaldehyde, 2-chloro-....... 9/30/91 11/27/91
90-02-8 Benzaldehyde, 2-hydroxy-...... 9/30/91 11/27/91
93-02-7 Benzaldehyde, 2,5-dimethoxy-.. 9/30/91 11/27/91
93-53-8 Benzeneacetaldehyde, .alpha.- 9/30/91 11/27/91
methyl-.
95-01-2 Benzaldehyde, 2,4-dihydroxy-.. 9/30/91 11/27/91
[[Page 158]]
97-51-8 Benzaldehyde, 2-hydroxy-5- 9/30/91 11/27/91
nitro-.
98-01-1 2-Furancarboxaldehyde......... 9/30/91 11/27/91
98-03-3 2-Thiophenecarboxaldehyde..... 9/30/91 11/27/91
100-10-7 Benzaldehyde, 4- 9/30/91 11/27/91
(dimethylamino)-.
100-50-5 3-Cyclohexene-1-carboxaldehyde 9/30/91 11/27/91
100-52-7 Benzaldehyde.................. 9/30/91 11/27/91
101-39-3 2-Propenal, 2-methyl-3-phenyl- 9/30/91 11/27/91
101-86-0 Octanal, 2-(phenylmethylene)-. 9/30/91 11/27/91
103-95-7 Benzenepropanal, .alpha.- 9/30/91 11/27/91
methyl-4-(1-methylethyl)-.
104-09-6 Benzeneacetaldehyde, 4-methyl- 9/30/91 11/27/91
104-55-2 2-Propenal, 3-phenyl-......... 9/30/91 11/27/91
104-87-0 Benzaldehyde, 4-methyl-....... 9/30/91 11/27/91
104-88-1 Benzaldehyde, 4-chloro-....... 9/30/91 11/27/91
106-23-0 6-Octenal, 3,7-dimethyl-...... 9/30/91 11/27/91
106-26-3 2,6-Octadienal, 3,7-dimethyl-, 9/30/91 11/27/91
(Z)-.
106-72-9 5-Heptenal, 2,6-dimethyl-..... 9/30/91 11/27/91
107-02-8 2-Propenal.................... 9/30/91 11/27/91
107-20-0 Acetaldehyde, chloro-......... 9/30/91 11/27/91
107-22-2 Ethanedial.................... 9/30/91 11/27/91
107-75-5 Octanal, 7-hydroxy-3,7- 9/30/91 11/27/91
dimethyl-.
110-41-8 Undecanal, 2-methyl-.......... 9/30/91 11/27/91
110-62-3 Pentanal...................... 9/30/91 11/27/91
111-30-8 Pentanedial................... 9/30/91 11/27/91
111-71-7 Heptanal...................... 9/30/91 11/27/91
112-31-2 Decanal....................... 9/30/91 11/27/91
112-44-7 Undecanal..................... 9/30/91 11/27/91
112-45-8 10-Undecenal.................. 9/30/91 11/27/91
112-54-9 Dodecanal..................... 9/30/91 11/27/91
120-14-9 Benzaldehyde, 3,4-dimethoxy-.. 9/30/91 11/27/91
120-21-8 Benzaldehyde, 4-(diethylamino)- 9/30/91 11/27/91
.
120-57-0 1,3-Benzodioxole-5- 9/30/91 11/27/91
carboxaldehyde.
121-32-4 Benzaldehyde, 3-ethoxy-4- 9/30/91 11/27/91
hydroxy-.
121-33-5 Benzaldehyde, 4-hydroxy-3- 9/30/91 11/27/91
methoxy-.
122-40-7 Heptanal, 2-(phenylmethylene)- 9/30/91 11/27/91
122-78-1 Benzeneacetaldehyde........... 9/30/91 11/27/91
123-05-7 Hexanal, 2-ethyl-............. 9/30/91 11/27/91
123-08-0 Benzaldehyde, 4-hydroxy-...... 9/30/91 11/27/91
123-11-5 Benzaldehyde, 4-methoxy-...... 9/30/91 11/27/91
123-38-6 Propanal...................... 9/30/91 11/27/91
124-13-0 Octanal....................... 9/30/91 11/27/91
124-19-6 Nonanal....................... 9/30/91 11/27/91
126-15-8 4a(4H)- 9/30/91 11/27/91
Dibenzofurancarboxaldehyde,
1,5a,6,9,9a,9b-hexahydro-.
135-02-4 Benzaldehyde, 2-methoxy-...... 9/30/91 11/27/91
141-27-5 2,6-Octadienal, 3,7-dimethyl-, 9/30/91 11/27/91
(E)-.
143-14-6 9-Undecenal................... 9/30/91 11/27/91
455-19-6 Benzaldehyde, 4- 9/30/91 11/27/91
(trifluoromethyl)-.
505-57-7 02-Hexenal.................... 9/30/91 11/27/91
552-89-6 Benzaldehyde, 2-nitro-........ 9/30/91 11/27/91
590-86-3 Butanal, 3-methyl-............ 9/30/91 11/27/91
597-31-9 Propanal, 3-hydroxy-2,2- 9/30/91 11/27/91
dimethyl-.
939-97-9 Benzaldehyde, 4-(1,1- 9/30/91 11/27/91
dimethylethyl)-.
1121-60-4 2-Pyridinecarboxaldehyde...... 9/30/91 11/27/91
1200-14-2 Benzaldehyde, 4-butyl......... 9/30/91 11/27/91
1331-92-6 2-Propenal, 3-phenyl-, 9/30/91 11/27/91
monopentyl deriv..
1334-78-7 Benzaldehyde, methyl-......... 9/30/91 11/27/91
1423-46-7 3-Cyclohexene-1- 9/30/91 11/27/91
carboxaldehyde, 2,4,6-
trimethyl-.
1504-74-1 2-Propenal, 3-(2- 9/30/91 11/27/91
methoxyphenyl)-.
2591-86-8 1-Piperidinecarboxaldehyde.... 9/30/91 11/27/91
3132-99-8 Benzaldehyde, 3-bromo-........ 9/30/91 11/27/91
3268-49-3 Propanal, 3-(methylthio)-..... 9/30/91 11/27/91
3613-30-7 Octanal, 7-methoxy-3,7- 9/30/91 11/27/91
dimethyl-.
4501-58-0 3-Cyclopentene-1-acetaldehyde, 9/30/91 11/27/91
2,2,3-trimethyl-.
5435-64-3 Hexanal, 3,5,5-trimethyl-..... 9/30/91 11/27/91
5780-07-4 1,3-Benzodioxole-5- 9/30/91 11/27/91
carboxaldehyde, 7-methoxy-.
5949-05-3 6-Octenal, 3,7-dimethyl-, (S)- 9/30/91 11/27/91
5988-91-0 Octanal, 3,7-dimethyl-........ 9/30/91 11/27/91
10031-82-0 Benzaldehyde, 4-ethoxy-....... 9/30/91 11/27/91
13586-68-0 2-Propenal, 3- 4-(1,1- 9/30/91 11/27/91
dimethylethyl)phenyl-2-methyl-
.
17754-90-4 Benzaldehyde, 4-(diethylamino)- 9/30/91 11/27/91
2-hydroxy-.
26266-68-2 Hexenal, 2-ethyl-............. 9/30/91 11/27/91
27939-60-2 3-Cyclohexene-1- 9/30/91 11/27/91
carboxaldehyde, dimethyl-.
[[Page 159]]
28602-27-9 Benzaldehyde, (dimethylamino)- 9/30/91 11/27/91
31906-04-4 3-Cyclohexene-1- 9/30/91 11/27/91
carboxaldehyde, 4-(4-hydroxy-
4-methylpentyl)-.
37677-14-8 3-Cyclohexene-1- 9/30/91 11/27/91
carboxaldehyde, 4-(4-methyl-3-
pentenyl)-.
39515-51-0 Benzaldehyde, 3-phenoxy-...... 9/30/91 11/27/91
52475-86-2 3-Cyclohexene-1- 9/30/91 11/27/91
carboxaldehyde, 1-methyl-4-(4-
methyl-3-pentenyl)-.
66327-54-6 3-Cyclohexene-1- 9/30/91 11/27/91
carboxaldehyde, 1-methyl-4-(4-
methylpentyl)-.
------------------------------------------------------------------------
Alkyl-, Chloro-, and Hydroxymethyl Diaryl Ethers
------------------------------------------------------------------------
3061-36-7 1,4-Diphenoxybenzene.......... 04/12/93 06/10/93
3586-14-9 Benzene, 1-methyl-3-phenoxy-.. 04/12/93 06/10/93
13826-35-2 Benzenemethanol, 3-phenoxy-,.. 04/12/93 06/10/93
28299-41-4 Benzene, 1,1,'-oxybis[methyl-. 04/12/93 06/10/93
28984-89-6 1,1'-Biphenyl, phenoxy-....... 04/12/93 06/10/93
42874-96-4 2-Chloro-1-(3-methylphenoxy)-4- 04/12/93 06/10/93
(trifluoromethyl)benzene.
50594-77-9 Phenol, 3-[2-chloro-4- 04/12/93 06/10/93
(trifluoromethyl)phenoxy]-,
acetate.
50789-44-1 Benzenemethanol, 3-phenoxy-, 04/12/93 06/10/93
acetate.
51632-16-7 Benzene, 1-(bromomethyl)-3- 04/12/93 06/10/93
phenoxy-.
61702-88-3 Benzene, 1,1'-oxybis[(1,1,3,3- 04/12/93 06/10/93
tetramethylbutyl)-.
63734-62-3 Benzoic acid, 3-[2-chloro-4- 04/12/93 06/10/93
(trifluoromethyl)phenoxy]-,.
69834-19-1 Benzene, 1,1'-oxybis[dodecyl-. 04/12/93 06/10/93
72252-48-3 Benzoic acid, 3-[2-chloro-4- 04/12/93 06/10/93
(trifluoromethyl)phenoxy]-,
potassium salt.
------------------------------------------------------------------------
Alkylphenols, Alkylphenol ethoxylates, and Polyalkylphenols
------------------------------------------------------------------------
80-46-6 4-tert-Pentylphenol........... 3/29/96 5/29/96
88-18-6 2-tert-Butylphenol............ 3/29/96 5/29/96
94-06-4 4-(1-Methylbutyl)phenol....... 3/29/96 5/29/96
98-54-4 4-tert-Butylphenol............ 3/29/96 5/29/96
99-71-8 4-sec-Butylphenol............. 3/29/96 5/29/96
104-40-5 4-Nonylphenol................. 3/29/96 5/29/96
104-43-8 4-Dodecylphenol............... 3/29/96 5/29/96
136-81-2 Phenol, 2-pentyl-............. 8/4/00 10/3/00
140-66-9 Phenol, 4-(1,1,3,3- 8/4/00 10/3/00
tetramethylbutyl)-.
949-13-3 2-Octylphenol................. 3/29/96 5/29/96
1300-16-9 Nonylphenol (mixed isomers)... 3/29/96 5/29/96
1322-69-6 (1,1,3,3- 3/29/96 5/29/96
Tetramethylbutyl)phenol
(mixed isomers).
1331-57-3 Dodecylphenol (mixed isomers). 3/29/96 5/29/96
1638-22-8 4-n-Butylphenol............... 3/29/96 5/29/96
1806-26-4 4-Octylphenol................. 3/29/96 5/29/96
1987-50-4 Phenol, 4-heptyl-............. 8/4/00 10/3/00
2315-66-4 Decaethylene glycol 4- 3/29/96 5/29/96
isooctylphenyl ether.
2446-69-7 Phenol, 4-hexyl-.............. 8/4/00 10/3/00
2497-58-7 Hexaethylene glycol 4- 3/29/96 5/29/96
isooctylphenyl ether.
2589-78-8 Phenol, 4-hexadecyl-.......... 8/4/00 10/3/00
3180-09-4 2-Butylphenol................. 3/29/96 5/29/96
3279-27-4 Phenol, 2-(1,1-dimethylpropyl)- 8/4/00 10/3/00
.
3884-95-5 2-(1,1,3,3- 3/29/96 5/29/96
Tetramethylbutyl)phenol.
9002-93-1 Polyethylene glycol 4-(tert- 3/29/96 5/29/96
octyl)phenyl ether.
9004-87-9 Poly(oxy-1,2-ethanediyl), 8/4/00 10/3/00
[alpha]-(isooctylphenyl)-
[omega]-hydroxy-.
9014-92-0 Poly(oxy-1,2-ethanediyl), 8/4/00 10/3/00
[alpha]-(dodecylphenyl)-
[omega]-hydroxy-.
9036-19-5 Polyethylene glycol 3/29/96 5/29/96
mono(octyl)phenyl ether.
9063-89-2 Poly(oxy-1,2-ethanediyl), 8/4/00 10/3/00
[alpha]-(octylphenyl)-[omega]-
hydroxy-.
11066-49-2 Isononylphenol (mixed isomers) 3/29/96 5/29/96
14938-35-3 4-Pentylphenol................ 3/29/96 5/29/96
17404-66-9 4-(1-Methyloctyl)phenol....... 3/29/96 5/29/96
25154-52-3 Nonylphenol (mixed isomers)... 3/29/96 5/29/96
25401-86-9 Phenol, 2-hexadecyl-.......... 8/4/00 10/3/00
25735-67-5 Phenol, 4-sec-pentyl-......... 8/4/00 10/3/00
26401-47-8 Poly(oxy-1,2-ethanediyl), 8/4/00 10/3/00
[alpha]-(4-dodecylphenyl)-
[omega]-hydroxy-.
26401-74-1 Phenol, 2-sec-pentyl-......... 8/4/00 10/3/00
27157-66-0 Phenol, decyl-................ 8/4/00 10/3/00
27178-34-3 tert-Butylphenol (mixed 3/29/96 5/29/96
isomers).
27193-28-8 (1,1,3,3- 3/29/96 5/29/96
Tetramethylbutyl)phenol
(mixed isomers).
27193-86-8 Dodecylphenol (mixed isomers). 3/29/96 5/29/96
27985-70-2 (1-Methylheptyl)phenol (mixed 3/29/96 5/29/96
isomers).
29932-96-5 (1,1,3,3- 3/29/96 5/29/96
Tetramethylbutyl)phenol
(mixed isomers).
30105-54-5 (1,1,3,3- 3/29/96 5/29/96
Tetramethylbutyl)phenol
(mixed isomers).
31195-95-6 Isobutylphenol (mixed isomers) 3/29/96 5/29/96
54932-78-4 4-(2,2,3,3- 3/29/96 5/29/96
Tetramethylbutyl)phenol.
59911-95-4 Poly(oxy-1,2-ethanediyl), 8/4/00 10/3/00
[alpha]-(4-hexadecylphenyl)-
[omega]-hydroxy-.
61723-87-3 Poly(oxy-1,2-ethanediyl), 8/4/00 10/3/00
[alpha]-(tridecylphenyl)-
[omega]-hydroxy-.
[[Page 160]]
62744-41-6 (1,1,3,3- 3/29/96 5/29/96
Tetramethylbutyl)phenol
(mixed isomers).
68081-86-7 Phenol, nonyl derivs.......... 8/4/00 10/3/00
68784-24-7 Phenol, C18-30-alkyl derivs... 8/4/00 10/3/00
68891-67-8 Phenol, polypropene derivs.... 8/4/00 10/3/00
68908-55-4 Phenol, polybutene derivs..... 8/4/00 10/3/00
68954-70-1 Phenol, polyethyl derivs...... 8/4/00 10/3/00
68987-90-6 Poly(oxy-1,2-ethanediyl), 3/29/96 5/29/96
[alpha]-(octylphenyl)-[omega]-
hydroxy-, branched.
70682-80-3 Phenol, tetradecyl-........... 8/4/00 10/3/00
71902-25-5 Phenol, octenylated........... 8/4/00 10/3/00
72624-02-3 Phenol, heptyl derivs......... 8/4/00 10/3/00
74499-35-7 Phenol, (tetrapropenyl) 8/4/00 10/3/00
derivs..
84605-25-4 Phenol, 1-methylhexyl derivs.. 8/4/00 10/3/00
84852-15-3 Branched 4-nonylphenol (mixed 3/29/96 5/29/96
isomers).
91672-41-2 Phenol, 2-nonyl-, branched.... 8/4/00 10/3/00
112375-88-9 Phenol, polyisobutylene 8/4/00 10/3/00
derivs..
112375-89-0 Phenol, poly(2,4,4- 8/4/00 10/3/00
trimethylpentene) derivs.
------------------------------------------------------------------------
Alkyl phosphates
------------------------------------------------------------------------
78-40-0 Phosphoric acid, triethyl 10/29/90 12/27/90
ester.
78-42-2 Phosphoric acid, tris(2- 10/29/90 12/27/90
ethylhexyl)ester.
78-51-3 Ethanol, 2-butoxy-, phosphate 10/29/90 12/27/90
(3:1).
107-66-4 Phosphoric acid, dibutyl ester 10/29/90 12/27/90
126-71-6 Phosphoric acid, tris(2- 10/29/90 12/27/90
methylpropyl) ester.
126-73-8 Phosphoric acid tributyl ester 10/29/90 12/27/90
298-07-7 Phosphoric acid, bis(2- 10/29/90 12/27/90
ethylhexyl)ester.
812-00-0 Phosphoric acid, monomethyl 10/29/90 12/27/90
ester.
1070-03-7 Phosphoric acid, mono(2- 10/29/90 12/27/90
ethylhexyl)ester.
1498-51-7 Phosphorodichloridic acid, 10/29/90 12/27/90
ethylester.
1623-15-0 Phosphoric acid, monobutyl 10/29/90 12/27/90
ester.
1623-24-1 Phosphoric acid, mono(1- 10/29/90 12/27/90
methylethyl)ester.
2958-09-0 Phosphoric acid, monooctadecyl 10/29/90 12/27/90
ester.
3900-04-7 Phosphoric acid, monohexyl 10/29/90 12/27/90
ester.
3991-73-9 Phosphoric acid, monooctyl 10/29/90 12/27/90
ester.
7057-92-3 Phosphoric acid, didodecyl 10/29/90 12/27/90
ester.
7332-46-9 Ethanol, 2-(2-butoxyethoxy)-, 10/29/90 12/27/90
phosphate (3:1).
12645-31-7 Phosphoric acid, 2-ethylhexyl 10/29/90 12/27/90
ester.
12751-23-4 Phosphoric acid, dodecyl ester 10/29/90 12/27/90
27215-10-7 Phosphoric acid, diisooctyl 10/29/90 12/27/90
ester.
------------------------------------------------------------------------
Brominated flame retardants
------------------------------------------------------------------------
87-10-5 Benzamide, 3,5-dibromo-N-(4- 10/29/90 12/27/90
bromophenyl)-2-hydroxy-.
87-83-2 Benzene, pentabromomethyl-.... 10/29/90 12/27/90
87-84-3 Cyclohexane,1,2,3,4,5- 10/29/90 12/27/90
pentabromo-6-chloro-.
96-13-9 1-Propanol, 2,3-dibromo-...... 10/29/90 12/27/90
593-60-2 Ethene, bromo-................ 10/29/90 12/27/90
615-58-7 Phenol, 2,4-dibromo-.......... 10/29/90 12/27/90
4162-45-2 Ethanol,2,2'-((1- 10/29/90 12/27/90
methylethylidene)bis((2,6-
dibromo-4,1-
phenylene)oxy))bis-.
25327-89-3 Benzene, 1,1'-(1- 10/29/90 12/27/90
methylethylidene)bis(3,5-
dibromo-4-(2-propenyloxy)-.
30554-72-4 Cyclohexane, 10/29/90 12/27/90
tetrabromodichloro-.
30554-73-5 Cyclohexane, tribromotrichloro- 10/29/90 12/27/90
.
36483-57-5 1-Propanol, 2,2-dimethyl-, 10/29/90 12/27/90
tribromo deriv..
55205-38-4 2-Propenoic acid, (1- 10/29/90 12/27/90
methylethylidene)bis(2,6-
dibromo-4,1-phenylene) ester.
68955-41-9 Alkanes, C10-18, bromochloro-. 10/29/90 12/27/90
69882-11-7 Phenol, 2,4(or 2,6)-dibromo-, 10/29/90 12/27/90
homopolymer.
88497-56-7 Benzene, ethenyl-, 10/29/90 12/27/90
homopolymer, brominated.
------------------------------------------------------------------------
Chloralkyl phosphates
------------------------------------------------------------------------
34621-99-3 1,2-Ethanediyltetrakis(2- 6/14/93 8/12/93
chloro-1-methylethylene)
phosphate.
38051-10-4 2,2-Bis(chloromethyl)-1,3- 6/14/93 8/12/93
propanediyltetrakis(2-
chloroethyl) phosphate.
53461-82-8 Oxydi-2,1-ethanediyltetrakis(2- 6/14/93 8/12/93
chloroethyl) phosphate.
76649-15-5 2-Chloro-1-methylethylbis(2-
chloropropyl) phosphate.
------------------------------------------------------------------------
Cyanoacrylates
------------------------------------------------------------------------
137-05-3 2-Propenoic acid, 2-cyano-, 1/26/94 3/28/94
methyl ester.
1069-55-2 2-Propenoic acid, 2-cyano-, 1/26/94 3/28/94
isobutyl ester.
6197-30-4 2-Propenoic acid, 2-cyano-3,3- 1/26/94 3/28/94
diphenyl-, 2-ethylhexyl ester.
6606-65-1 2-Propenoic acid, 2-cyano-, 1/26/94 3/28/94
butyl ester.
7085-85-0 2-Propenoic acid, 2-cyano-, 1/26/94 3/28/94
ethyl ester.
[[Page 161]]
7324-02-9 2-Propenoic acid, 2-cyano-, 2- 1/26/94 3/28/94
propenyl ester.
10586-17-1 2-Propenoic acid, 2-cyano-, 1- 1/26/94 3/28/94
methylethyl ester.
21982-43-4 2-Propenoic acid, 2-cyano-, 1/26/94 3/28/94
ethoxyethyl ester.
23023-91-8 2-Propenoic acid, 2-cyano-, 1/26/94 3/28/94
2,2,2-trifluoromethyl ester.
27816-23-5 2-Propenoic acid, 2-cyano-, 2- 1/26/94 3/28/94
methoxyethyl ester.
64992-16-1 Ethanaminium, 2-[[2-cyano-3-[4- 1/26/94 3/28/94
(diethylamino)phenyl]-1-oxo-2-
propenyl]oxy]-N,N,N-trimethyl-
, chloride.
------------------------------------------------------------------------
Indium Chemicals
------------------------------------------------------------------------
923-34-2 Triethylindium................ 8/27/01 10/24/01
1303-11-3 Indium arsenide............... 8/27/01 10/24/01
1312-41-0 Indium antimonide............. 8/27/01 10/24/01
1312-43-2 Indium (III) oxide............ 8/27/01 10/24/01
1312-45-4 Indium (III) telluride........ 8/27/01 10/24/01
4194-69-8 Indium (III) citrate.......... 8/27/01 10/24/01
7440-74-6 Indium........................ 8/27/01 10/24/01
7783-52-0 Indium (III) fluoride......... 8/27/01 10/24/01
10025-82-8 Indium (III) chloride......... 8/27/01 10/24/01
12018-95-0 Copper indium diselenide...... 8/27/01 10/24/01
12030-14-7 Indium (II) sulfide........... 8/27/01 10/24/01
12030-24-9 Indium (III) sulfide.......... 8/27/01 10/24/01
12056-07-4 Indium selenide............... 8/27/01 10/24/01
12672-70-7 Indium chloride............... 8/27/01 10/24/01
12672-71-8 Indium oxide.................. 8/27/01 10/24/01
13464-82-9 Indium (III) sulfate.......... 8/27/01 10/24/01
13465-09-3 Indium (III) bromide.......... 8/27/01 10/24/01
13465-10-6 Indium (I) chloride........... 8/27/01 10/24/01
13510-35-5 Indium (III) iodide........... 8/27/01 10/24/01
13709-93-8 Indium (III) borate........... 8/27/01 10/24/01
13770-61-1 Indium (III) nitrate.......... 8/27/01 10/24/01
13966-94-4 Indium (I) iodide............. 8/27/01 10/24/01
14166-78-0 Indium (III) fluoride......... 8/27/01 10/24/01
14280-53-6 Indium (I) bromide............ 8/27/01 10/24/01
14405-45-9 Indium tris(acetylacetonate).. 8/27/01 10/24/01
20661-21-6 Indium (III) hydroxide........ 8/27/01 10/24/01
22398-80-7 Indium (I) phosphide.......... 8/27/01 10/24/01
25114-58-3 Indium (III) acetate.......... 8/27/01 10/24/01
25617-98-5 Indium nitride................ 8/27/01 10/24/01
27765-48-6 Indium (III) tetrafluoroborate 8/27/01 10/24/01
50926-11-9 Indium tin oxide.............. 8/27/01 10/24/01
55326-87-9 Indium hydroxide.............. 8/27/01 10/24/01
66027-93-8 Indium (III) sulfamate........ 8/27/01 10/24/01
66027-94-9 Hydroxybis(trifluoroacetato- 8/27/01 10/24/01
O)indium.
67816-06-2 Indium (III) 2-ethylhexanoate. 8/27/01 10/24/01
68310-35-0 Indium (III) neodecanoate..... 8/27/01 10/24/01
71243-84-0 Indium tin oxide 8/27/01 10/24/01
(In1.69Sn0.1502O2.85).
------------------------------------------------------------------------
IRIS Chemicals
------------------------------------------------------------------------
51-28-5 2,4 Dinitrophenol............. 9/30/91 11/27/91
95-65-8 3,4 Dinethylphenol............ 9/30/91 11/27/91
------------------------------------------------------------------------
Isocyanates
------------------------------------------------------------------------
91-97-4 1,1'-Biphenyl, 4,4'- 10/29/90 12/27/90
diisocyanato-3,3'-dimethyl-.
100-28-7 Benzene, 1-isocyanato-4-nitro- 10/29/90 12/27/90
101-68-8 Benzene, 1,1'-methylenebis(4- 10/29/90 12/27/90
isocyanato-.
102-36-3 Benzene, 1,2-dichloro-4- 10/29/90 12/27/90
isocyanato-.
103-71-9 Benzene, isocyanato-.......... 10/29/90 12/27/90
104-12-1 Benzene, 1-chloro-4-isocyanato- 10/29/90 12/27/90
.
104-49-4 Benzene, 1,4-diisocyanato-.... 10/29/90 12/27/90
109-90-0 Ethane, isocyanato-........... 10/29/90 12/27/90
110-78-1 Propane, 1-isocyanato-........ 10/29/90 12/27/90
111-36-4 Butane, 1-isocyanato-......... 10/29/90 12/27/90
112-96-9 Octadecane, 1-isocyanato-..... 10/29/90 12/27/90
123-61-5 Benzene, 1,3-diisocyanato-.... 10/29/90 12/27/90
329-01-1 Benzene, 1-isocyanato-3- 10/29/90 12/27/90
(trifluoromethyl)-.
614-68-6 Benzene, 1-isocyanato-2-methyl- 10/29/90 12/27/90
.
622-58-2 Benzene, 1-isocyanato-4-methyl- 10/29/90 12/27/90
.
624-83-9 Methane, isocyanato-.......... 10/29/90 12/27/90
1476-23-9 1-Propene, 3-isocyanato-...... 10/29/90 12/27/90
[[Page 162]]
2422-91-5 Benzene, 1,1',1''- 10/29/90 12/27/90
methylidynetris(4-isocyanato-.
2493-02-9 Benzene, 1-bromo-4-isocyanato- 10/29/90 12/27/90
2909-38-8 Benzene, 1-chloro-3-isocyanato- 10/29/90 12/27/90
.
2949-22-6 Acetic acid, isocyanato-, 10/29/90 12/27/90
ethyl ester.
3173-53-3 Cyclohexane, isocyanato-...... 10/29/90 12/27/90
4035-89-6 Imidodicarbonic diamide,N,N',2- 10/29/90 12/27/90
tris(6-isocyanatohexyl)-.
4098-71-9 Cyclohexane, 5-isocyanato-1- 10/29/90 12/27/90
(isocyanatomethyl)-1,3,3-
trimethyl-.
4151-51-3 Phenol, 4-isocyanato-, 10/29/90 12/27/90
phosphorothioate (3:1)
(ester).
5124-30-1 Cyclohexane, 1,1'- 10/29/90 12/27/90
methylenebis(4-isocyanato-.
5873-54-1 Benzene, 1-isocyanato-2-((4- 10/29/90 12/27/90
isocyanatophenyl)methyl)-.
10031-75-1 Benzene, 1,1'- 10/29/90 12/27/90
(diisocyanatomethylene)bis-.
15646-96-5 Hexane, 1,6-diisocyanato-2,4,4- 10/29/90 12/27/90
trimethyl-.
16938-22-0 Hexane, 1,6-diisocyanato-2,2,4- 10/29/90 12/27/90
trimethyl-.
25854-16-4 Benzene, bis(isocyanatomethyl)- 10/29/90 12/27/90
.
26447-40-5 Benzene, 1,1'- 10/29/90 12/27/90
methylenebis(isocyanato-.
26603-40-7 1,3,5,-Triazine-2,4,6(1H.3H,5H- 10/29/90 12/27/90
trione, 1,3,5-tris(3-
isocyanatomethylphenyl)-.
26747-90-0 1,3-Diazetidine-2,4-dione, 1,3- 10/29/90 12/27/90
bis(3-isocyanatomethylphenyl)-
.
28178-42-9 Benzene, 2-isocyanato-1,3- 10/29/90 12/27/90
bis(1-methylethyl)-.
28556-81-2 Benzene, 2-isocyanato-1,3- 10/29/90 12/27/90
dimethyl-.
30674-80-7 2-Propenoic acid, 2-methyl-,2- 10/29/90 12/27/90
isocyanatoethyl ester.
34893-92-0 Benzene, 1,3-dichloro-5- 10/29/90 12/27/90
isocyanato-.
68239-06-5 Cyclohexane, 2-heptyl-3,4- 10/29/90 12/27/90
bis(9-isocyanatononyl)-1-
pentyl-.
73597-26-9 2-Propenoic acid, 2-methyl-, 2- 10/29/90 12/27/90
(((((5-isocyanato-1,3,3-
trimethylcyclohexyl)
methyl)amino)carbonyl)oxy)eth
yl ester.
------------------------------------------------------------------------
Methyl ethylene glycol ethers and esters
------------------------------------------------------------------------
3121-61-7 Ethylene glycol monomethyl 1/26/94 3/28/94
ether acrylate.
23783-42-8 Tetraethylene glycol 1/26/94 3/28/94
monomethyl ether.
------------------------------------------------------------------------
Nonylphenol ethoxylates
------------------------------------------------------------------------
7311-27-5 Ethanol, 2-[2-[2-[2-(p- 2/10/00 4/10/00
nonylphenoxy)ethoxy]ethoxy]et
hoxy]-.
9016-45-9 Poly(oxy-1,2-ethanediyl), 2/10/00 4/10/00
alpha-(nonylphenyl)-omega-
hydroxy-.
20427-84-3 Ethanol, 2-[2-(p- 2/10/00 4/10/00
nonylphenoxy)ethoxy]-.
20636-48-0 3,6,9,12-Tetraoxatetradecan-1- 2/10/00 4/10/00
ol, 14-(4-nonylphenoxy)-.
26027-38-3 Poly(oxy-1,2-ethanediyl), 2/10/00 4/10/00
alpha-(4-nonylphenyl)-omega-
hydroxy-.
26264-02-8 3,6,9,12-Tetraoxatetradecan-1- 2/10/00 4/10/00
ol, 14-(nonylphenoxy)-.
26571-11-9 3,6,9,12,15,18,21,24- 2/10/00 4/10/00
Octaoxahexacosan-1-ol, 26-
(nonylphenoxy)-.
27176-93-8 Ethanol, 2-[2- 2/10/00 4/10/00
(nonylphenoxy)ethoxy]-.
27177-01-1 3,6,9,12,15-Pentaoxaheptadecan- 2/10/00 4/10/00
1-ol, 17-(nonylphenoxy)-.
27177-05-5 3,6,9,12,15,18,21- 2/10/00 4/10/00
Heptaoxatricosan-1-ol, 23-
(nonylphenoxy)-.
27177-08-8 3,6,9,12,15,18,21,24,27- 2/10/00 4/10/00
Nonaoxanonacosan-1-ol, 29-
(nonylphenoxy)-.
27986-36-3 Ethanol, 2-(nonylphenoxy)-.... 2/10/00 4/10/00
37205-87-1 Poly(oxy-1,2-ethanediyl), 2/10/00 4/10/00
alpha-(isononylphenyl)-omega-
hydroxy-.
51938-25-1 Poly(oxy-1,2-ethanediyl), 2/10/00 4/10/00
alpha-(2-nonylphenyl)-omega-
hydroxy-.
65455-72-3 3,6,9,12,15,18,21,24,27- 2/10/00 4/10/00
Nonaoxanonacosan-1-ol, 29-
(isononylphenoxy)-.
68412-54-4 Poly(oxy-1,2-ethanediyl), 2/10/00 4/10/00
alpha-(nonylphenyl)-omega-
hydroxy-, branched.
98113-10-1 NP9........................... 2/10/00 4/10/00
127087-87-0 Poly(oxy-1,2-ethanediyl), 2/10/00 4/10/00
alpha-(4-nonylphenyl)-omega-
hydroxy-, branched.
152143-22-1 Poly(oxy-1,2-ethanediyl), 2/10/00 4/10/00
alpha-(4-nonylphenyl)-omega-
hydroxy-, branched,
phosphates.
------------------------------------------------------------------------
OSHA Chemicals in Need of Dermal Absorption Testing
------------------------------------------------------------------------
60-29-7 Ethyl ether................... 1/26/94 3/28/94
61-82-5 Amitrole...................... 3/11/94 5/10/94
74-96-4 Ethyl bromide................. 3/11/94 5/10/94
75-05-8 Acetonitrile.................. 8/4/95 10/3/95
75-12-7 Formamide..................... 8/4/95 10/3/95
75-15-0 Carbon disulfide.............. 3/11/94 5/10/94
75-25-2 Bromoform..................... 3/11/94 5/10/94
75-34-3 1,1-Dichloroethane............ 3/11/94 5/10/94
75-35-4 Vinylidene chloride........... 8/4/95 10/3/95
75-65-0 tert-Butyl alcohol............ 1/26/94 3/28/94
76-22-2 Camphor....................... 1/26/94 3/28/94
77-73-6 Dicyclopentadiene............. 8/4/95 10/3/95
77-78-1 Dimethyl sulfate.............. 3/11/94 5/10/94
78-59-1 Isophorone.................... 8/4/95 10/3/95
78-87-5 Propylene dichloride.......... 8/4/95 10/3/95
78-92-2 sec-Butyl alcohol............. 1/26/94 3/28/94
79-20-9 Methyl acetate................ 1/26/94 3/28/94
[[Page 163]]
79-46-9 2-Nitropropane................ 3/11/94 5/10/94
88-72-2 o-Nitrotoluene................ 3/11/94 5/10/94
89-72-5 o-sec-Butylphenol............. 3/11/94 5/10/94
90-04-0 o-Anisidine................... 3/11/94 5/10/94
91-20-3 Naphthalene................... 8/4/95 10/3/95
92-52-4 Biphenyl...................... 8/4/95 10/3/95
95-13-6 Indene........................ 3/11/94 5/10/94
95-49-8 o-Chlorotoluene............... 3/11/94 5/10/94
95-50-1 o-Dichlorobenzene............. 8/4/95 10/3/95
96-18-4 1,2,3-Trichloropropane........ 8/4/95 10/3/95
97-77-8 Disulfiram.................... 1/26/94 3/28/94
98-29-3 t-Butylcatechol............... 8/4/95 10/3/95
99-08-1 m-Nitrotoluene................ 8/4/95 10/3/95
99-65-0 m-Dinitrobenzene.............. 3/11/94 5/10/94
99-99-0 p-Nitrotoluene................ 8/4/95 10/3/95
100-00-5 p-Nitrochlorobenzene.......... 3/11/94 5/10/94
100-01-6 p-Nitroaniline................ 3/11/94 5/10/94
100-44-7 Benzyl chloride............... 3/11/94 5/10/94
100-25-4 p-Dinitrobenzene.............. 1/26/94 3/28/94
100-63-0 Phenylhydrazine............... 3/11/94 5/10/94
105-46-4 sec-Butyl acetate............. 1/26/94 3/28/94
106-42-3 p-Xylene...................... 1/26/94 3/28/94
106-46-7 p-Dichlorobenzene............. 8/4/95 10/3/95
106-49-0 p-Toluidine................... 3/11/94 5/10/94
107-06-2 Ethylene dichloride........... 8/4/95 10/3/95
107-31-3 Methyl formate................ 1/26/94 3/28/94
107-66-4 Dibutyl phosphate............. 1/26/94 3/28/94
108-03-2 1-Nitropropane................ 1/26/94 3/28/94
108-44-1 m-Toluidine................... 3/11/94 5/10/94
108-87-2 Methylcyclohexane............. 1/26/94 3/28/94
108-90-7 Chlorobenzene................. 3/11/94 5/10/94
108-93-0 Cyclohexanol.................. 8/4/95 10/3/95
109-66-0 Pentane....................... 1/26/94 3/28/94
109-99-9 Tetrahydrofuran............... 3/11/94 5/10/94
110-12-3 Methyl isoamyl ketone......... 8/4/95 10/3/95
110-83-8 Cyclohexene................... 1/26/94 3/28/94
111-84-2 Nonane........................ 1/26/94 3/28/94
120-80-9 Catechol...................... 8/4/95 10/3/95
121-14-2 2,4-Dinitrotoluene............ 3/11/94 5/10/94
121-69-7 Dimethylaniline............... 8/4/95 10/3/95
122-39-4 Diphenylamine................. 3/11/94 5/10/94
123-42-2 Diacetone alcohol............. 8/4/95 10/3/95
123-92-2 Isoamyl acetate............... 1/26/94 3/28/94
126-99-8 beta-Chloroprene.............. 3/11/94 5/10/94
127-19-5 Dimethyl acetamide............ 8/4/95 10/3/95
142-82-5 Heptane (n-Heptane)........... 1/26/94 3/28/94
150-76-5 p-Methoxyphenol............... 3/11/94 5/10/94
287-92-3 Cyclopentane.................. 1/26/94 3/28/94
528-29-0 o-Dinitrobenzene.............. 3/11/94 5/10/94
532-27-4 a-Chloroacetophenone.......... 1/26/94 3/28/94
540-59-0 1,2-Dichloroethylene.......... 3/11/94 5/10/94
540-88-5 tert-Butyl acetate............ 1/26/94 3/28/94
542-92-7 Cyclopentadiene............... 8/4/95 10/3/95
626-17-5 m-Phthalodinitrile............ 3/11/94 5/10/94
628-63-7 n-Amyl acetate................ 1/26/94 3/28/94
768-52-5 N-Isopropylaniline............ 3/11/94 5/10/94
1300-73-8 Xylidine...................... 3/11/94 5/10/94
6423-43-4 Propylene glycol dinitrate.... 3/11/94 5/10/94
7631-90-5 Sodium bisulfite.............. 1/26/94 3/28/94
7681-57-4 Sodium metabisulfite.......... 1/26/94 3/28/94
25013-15-4 Vinyl toluene................. 3/11/94 5/10/94
34590-94-8 Dipropylene glycol methyl 8/4/95 10/3/95
ether.
------------------------------------------------------------------------
Propylene glycol ethers and esters
------------------------------------------------------------------------
108-65-6 Propylene glycol monomethyl 1/26/94 3/28/94
ether acetate.
110-98-5 Dipropylene glycol............ 1/26/94 3/28/94
770-35-4 1-Phenoxy-2-propanol.......... 1/26/94 3/28/94
20324-32-7 1-(2-Methoxy-1-methylethoxy)-2- 1/26/94 3/28/94
propanol.
20324-33-8 Tripropylene glycol methyl 1/26/94 3/28/94
ether.
28677-93-2 Methoxy-1-propanol............ 1/26/94 3/28/94
[[Page 164]]
29387-86-8 Propylene glycol monobutyl 1/26/94 3/28/94
ether.
29911-28-2 Dipropylene glycol butyl ether 1/26/94 3/28/94
42978-66-5 Tripropylene glycol diacrylate 1/26/94 3/28/94
57018-52-7 Propylene glycol mono-tert- 1/26/94 3/28/94
butyl ether.
88917-22-0 Dipropylene glycol monomethyl 1/26/94 3/28/94
ether acetate.
------------------------------------------------------------------------
Pyridinamines
------------------------------------------------------------------------
462-08-8 3-Pyridinamine................ 1/6/05 3/7/05
504-24-5 4-Pyridinamine................ 1/6/05 3/7/05
504-29-0 2-Pyridinamine................ 1/6/05 3/7/05
------------------------------------------------------------------------
Siloxanes
------------------------------------------------------------------------
107-46-0 Hexamethyldisiloxane.......... 10/12/93 2/28/94
107-50-6 Tetradecamethylcycloheptasilox 10/12/93 2/28/94
ane.
107-51-7 Octamethyltrisiloxane......... 10/12/93 2/28/94
107-52-8 Tetradecamethylhexasiloxane... 10/12/93 2/28/94
107-53-9 Tetracosamethylundecasiloxane. 10/12/93 2/28/94
141-62-8 Decamethyltetrasiloxane....... 10/12/93 2/28/94
141-63-9 Dodecamethylpentasiloxane..... 10/12/93 2/28/94
540-97-6 Dodecamethylcyclohexasiloxane. 10/12/93 2/28/94
541-01-5 Hexadecamethylheptasiloxane... 10/12/93 2/28/94
541-02-6 Decamethylcyclopentasiloxane.. 10/12/93 2/28/94
541-05-9 Hexamethylcyclotrisiloxane.... 10/12/93 2/28/94
546-56-5 Octaphenylcyclotetrasiloxane.. 10/12/93 2/28/94
556-67-2 Octamethylcyclotetrasiloxane.. 10/12/93 2/28/94
556-68-3 Hexadecamethylcyclooctasiloxan 10/12/93 2/28/94
e.
556-69-4 Octadecamethyloctasiloxane.... 10/12/93 2/28/94
556-70-7 Docosamethyldecasiloxane...... 10/12/93 2/28/94
556-71-8 Octadecamethylcyclononasiloxan 10/12/93 2/28/94
e.
999-97-3 Hexamethyldisilazane.......... 10/12/93 2/28/94
2370-88-9 Tetramethylcyclotetrasiloxane. 10/12/93 2/28/94
2374-14-3 Trifluoropropylmethylcyclotris 10/12/93 2/28/94
iloxane.
2471-08-1 Hexacosamethyldodecasiloxane.. 10/12/93 2/28/94
2471-09-2 Octacosamethyltridecasiloxane. 10/12/93 2/28/94
2471-10-5 Triacontamethyltetradecasiloxa 10/12/93 2/28/94
ne.
2471-11-6 Dotriacontamethylpentadecasilo 10/12/93 2/28/94
xane.
2554-06-5 Methylvinylcyclosiloxane...... 10/12/93 2/28/94
2627-95-4 Tetramethyldivinyldisiloxane.. 10/12/93 2/28/94
2652-13-3 Eicosamethylnonasiloxane...... 10/12/93 2/28/94
70131-67-8 Siloxanes and silicones, di- 10/12/93 2/28/94
Me, hydroxy-terminated.
9004-73-3 Methylpolysiloxane............ 10/12/93 2/28/94
18766-38-6 Docosamethylcycloundecasiloxan 10/12/93 2/28/94
e.
18772-36-6 Eicosamethylcyclodecasiloxane. 10/12/93 2/28/94
18844-04-7 Hexatriacontamethylheptadecasi 10/12/93 2/28/94
loxane.
18919-94-3 Tetracosamethylcyclododecasilo 10/12/93 2/28/94
xane.
23523-12-8 Hexatriacontamethylcyclooctade 10/12/93 2/28/94
casiloxane.
23523-14-0 Triacontamethylcyclopentadecas 10/12/93 2/28/94
iloxane.
23732-94-7 Hexacosamethylcyclotridecasilo 10/12/93 2/28/94
xane.
36938-50-8 Tetratriacontamethyl 10/12/93 2/28/94
hexadecasiloxane.
36938-52-0 Octatriacontamethyl 10/12/93 2/28/94
octadecasiloxane.
63148-62-9 Dimethyl silicones and 10/12/93 2/28/94
siloxanes.
67762-90-7 Dimethyl silicones and 10/12/93 2/28/94
siloxane, reaction products
with silica.
67762-94-1 Dimethylmethylvinylsiloxane... 10/12/93 2/28/94
68037-59-2 Dimethylhydropolylsiloxane.... 10/12/93 2/28/94
68037-74-1 Dimethylpolysiloxanes......... 10/12/93 2/28/94
68083-14-7 Dimethyldiphenylsiloxane...... 10/12/93 2/28/94
69430-24-6 Cyclopolydimethylsiloxane..... 10/12/93 2/28/94
115361-68-7 Dimethylmethyl 3,3,3- 10/12/93 2/28/94
trifluoropropyl siloxane.
149050-40-8 Octacosamethylcyclotetradecasi 10/12/93 2/28/94
loxane.
150026-95-2 Dotriacontamethylcyclohexadeca 10/12/93 2/28/94
siloxane.
150026-96-3 Tetratriacontamethylcyclohepta 10/12/93 2/28/94
decasiloxane.
150026-97-4 Octatriacontamethylcyclononade 10/12/93 2/28/94
casiloxane.
150026-98-5 Tetracontamethylcycloeicosasil 10/12/93 2/28/94
oxane.
150026-99-6 Tetracontamethylnonadecasiloxa 10/12/93 2/28/94
ne.
150027-00-2 Dotetracontamethyleicosasiloxa 10/12/93 2/28/94
ne.
not available Polymethyloctadecylsiloxane... 10/12/93 2/28/94
------------------------------------------------------------------------
Substantially produced chemicals in need of subchronic tests
------------------------------------------------------------------------
80-51-3 p,p'- 9/30/91 11/27/91
Oxybis(benzenesulfonylhydrazi
de).
[[Page 165]]
81-84-5 Naphthalenedicarboxylic 9/30/91 11/27/91
anhydride.
84-51-5 2-Ethylanthraquinone.......... 9/30/91 11/27/91
87-02-5 7-Amino-4-hydroxy-2- 9/30/91 11/27/91
naphthalenesulfonic acid.
90-15-3 1-Naphthol.................... 9/30/91 11/27/91
92-70-6 3-Hydroxy-2-naphthoic acid.... 9/30/91 11/27/91
94-28-0 Triethylene glycol bis(2- 9/30/91 11/27/91
ethylhexanoate).
95-32-9 2-(4-Morpholinyldithio)- 9/30/91 11/27/91
benzothiazole.
97-88-1 N-Butyl methacrylate.......... 9/30/91 11/27/91
98-48-6 1,3-Benzenedisulfonic Acid.... 9/30/91 11/27/91
99-54-7 3,4-Dichloronitrobenzene...... 9/30/91 11/27/91
99-63-8 Isophthaloyl chloride......... 9/30/91 11/27/91
100-20-9 Terephthaloyl chloride........ 9/30/91 11/27/91
100-29-8 4-Ethoxynitrobenzene.......... 9/30/91 11/27/91
102-01-2 Acetoacetanilide.............. 9/30/91 11/27/91
106-31-0 Butyric anhydride............. 9/30/91 11/27/91
106-63-8 Isobutyl acrylate............. 9/30/91 11/27/91
111-96-6 Diethylene glycol dimethyl 9/30/91 11/27/91
ether.
112-15-2 Ethanol, 2-(2-ethoxyethoxy)-, 9/30/91 11/27/91
acetate.
116-81-4 Bromamine acid................ 9/30/91 11/27/91
119-33-5 4-Methyl-2-nitro-phenol....... 9/30/91 11/27/91
121-60-8 4-(Acetylamino)benzenesulfonyl 9/30/91 11/27/91
chloride.
123-54-6 2,4-Pentanedione.............. 9/30/91 11/27/91
123-62-6 Propanoic anhydride........... 9/30/91 11/27/91
142-16-5 Bis(2-ethylhexyl)-2- 9/30/91 11/27/91
butenedioate.
311-89-7 Perfluorotributylamine........ 9/30/91 11/27/91
355-42-0 Perfluoro-N-hexane............ 9/30/91 11/27/91
594-42-3 Trichloromethanesulfenyl 9/30/91 11/27/91
chloride.
616-21-7 1,2-Dichlorobutane............ 9/30/91 11/27/91
626-17-5 1,3-Dicyanobenzene............ 9/30/91 11/27/91
760-23-6 3,4-Dichlorobutene............ 9/30/91 11/27/91
929-06-6 2-(2-Aminoethoxy)-ethanol..... 6/30/92 9/28/92
1047-16-1 Quinacridone.................. 9/30/91 11/27/91
1111-78-0 Ammonium carbamate............ 9/30/91 11/27/91
3089-11-0 Hexa(methoxymethyl) melamine.. 9/30/91 11/27/91
------------------------------------------------------------------------
Sulphones
------------------------------------------------------------------------
67-71-0 Dimethylsulfone............... 9/30/91 11/27/91
77-79-2 3-Sulfolene................... 9/30/91 11/27/91
80-07-9 Sulfonyl bis-(4-chlorobenzene) 9/30/91 11/27/91
80-08-0 4,4'-Diaminodiphenyl sulfone.. 9/30/91 11/27/91
80-09-1 Bisphenol S................... 9/30/91 11/27/91
98-30-6 2-Amino-4- 9/30/91 11/27/91
(methylsulfonyl)phenol.
126-33-0 Sulfolane..................... 9/30/91 11/27/91
127-63-9 Diphenylsulfone............... 9/30/91 11/27/91
2580-77-0 2,2'-Sulfonyl bis-ethanol..... 9/30/91 11/27/91
3278-22-6 1,1'-[Methylene 9/30/91 11/27/91
bis(sulfonyl)]bisethene.
5246-57-1 2-[(3- 9/30/91 11/27/91
Aminophenyl)sulfonyl]ethanol.
16588-67-3 3-[N-Ethyl-4-[[6- 9/30/91 11/27/91
(methylsulfonyl)-2-
benzothiazolyl] azo]-m-
toluidino]- propionitrile.
17557-67-4 6-(Methylsulfonyl)-2- 9/30/91 11/27/91
benzothiazolamine.
17601-96-6 2-Amino-4-[(2-hydroxyethyl) 9/30/91 11/27/91
sulfonyl]phenol.
17688-68-5 4-Phenylthiomorpholine, 1,1- 9/30/91 11/27/91
dioxide.
17741-62-7 4-[4-[(2,6-Dichloro-4- 9/30/91 11/27/91
nitrophenyl)
azo]phenyl]thiomorpholine,
1,1-dioxide-.
18760-44-6 3- 9/30/91 11/27/91
(Decyloxy)tetrahydrothiophene
1,1-dioxide.
20018-09-1 1-(Diiodomethyl) sulfonyl-4- 9/30/91 11/27/91
methyl benzene.
26750-50-5 1,1'- 9/30/91 11/27/91
[Oxybis(methylenesulfonyl)]
bisethene.
36724-43-3 2,2'- 9/30/91 11/27/91
[Oxybis(methylenesulfonyl)]bi
sethanol.
41123-59-5 1,1'- 9/30/91 11/27/91
[Methylenebis(sulfonyl)]bis-2-
chloroethane.
41123-69-7 2,2'- 9/30/91 11/27/91
[Methylenebis(sulfonyl)]biset
hanol.
41687-30-3 2-[(3- 9/30/91 11/27/91
Nitrophenyl)sulfonyl]ethanol.
52218-35-6 2-[(6-Amino-2- 9/30/91 11/27/91
naphthalenyl)sulfonyl]ethanol.
53061-10-2 1,1'- 9/30/91 11/27/91
[Oxybis(methylenesulfonyl)]bi
s-2-chloroethane.
63134-33-8 4-[[4- 9/30/91 11/27/91
(Phenylmethoxy)phenyl]sulfony
l]phenol.
------------------------------------------------------------------------
Tungsten compounds
------------------------------------------------------------------------
1314-35-8 Tungsten oxide (WO3).......... 1/6/05 3/7/05
7440-33-7 Tungsten...................... 1/6/05 3/7/05
7783-03-1 Tungstate (WO42-), dihydrogen, 1/6/05 3/7/05
(T-4)-.
7783-82-6 Tungsten fluoride (WF6), (OC-6- 1/6/05 3/7/05
11)-.
7790-60-5 Tungstate (WO42-), 1/6/05 3/7/05
dipotassium, (T-4)-.
[[Page 166]]
7790-85-4 Cadmium tungsten oxide (CdWO4) 1/6/05 3/7/05
10213-10-2 Tungstate (WO42-), disodium, 1/6/05 3/7/05
dihydrate, (T-4)-.
11105-11-6 Tungsten oxide (WO3), hydrate. 1/6/05 3/7/05
11120-01-7 Sodium tungsten oxide......... 1/6/05 3/7/05
11120-25-5 Tungstate (W12(OH)2O4010-), 1/6/05 3/7/05
decaammonium.
12027-38-2 Tungstate(4-),[.mu.12- 1/6/05 3/7/05
[orthosilicato(4-)-
.kappa.O:.kappa.O:.kappa.O:
.kappa.O'.kappa.O'.kappa.O'
.kappa.O':.kappa.O'
:.kappa.O'
:.kappa.O'':.kappa.O''
:.kappa.O'']]tetracosa- .mu.-
oxododecaoxododeca-,
tetrahydrogen.
12028-48-7 Tungstate (W12(OH)2O386-), 1/6/05 3/7/05
hexaammonium.
12036-22-5 Tungsten oxide (WO2).......... 1/6/05 3/7/05
12067-99-1 Tungsten hydroxide oxide 1/6/05 3/7/05
phosphate.
12138-09-9 Tungsten sulfide (WS2)........ 1/6/05 3/7/05
12141-67-2 Tungstate (W12(OH)2O386-), 1/6/05 3/7/05
hexasodium.
13283-01-7 Tungsten chloride (WCl6), (OC- 1/6/05 3/7/05
6-11)-.
13472-45-2 Tungstate (WO42-), disodium, 1/6/05 3/7/05
(T-4)-.
14040-11-0 Tungsten carbonyl (W(CO)6), 1/6/05 3/7/05
(OC-6-11)-.
23321-70-2 Tungsten oxide (WO3), 1/6/05 3/7/05
dihydrate.
------------------------------------------------------------------------
Vanadium compounds
------------------------------------------------------------------------
1314-34-7 Vanadium oxide (V2O3) 7/11/03 9/9/03
[Vanadium trioxide].
1314-62-1 Vanadium oxide (V2O5) 7/11/03 9/9/03
[Vanadium pentoxide].
1686-22-2 Vanadium, triethoxyoxo-, (T-4)- 7/11/03 9/9/03
[Triethyl orthovanadate].
3153-26-2 Vanadium, oxobis (2,4- 7/11/03 9/9/03
pentanedionato-
.kappa.O,.kappa.O')-, (SP-5-
21)-.
5588-84-1 Vanadium, oxotris(2- 7/11/03 9/9/03
propanolato)-, (T-4)-
[Vanadium triisopropoxide
oxide].
7440-62-2 Vanadium...................... 7/11/03 9/9/03
7632-51-1 Vanadium chloride (VCl4), (T- 7/11/03 9/9/03
4)- [Vanadium tetrachloride].
7718-98-1 Vanadium chloride (VCl3) 7/11/03 9/9/03
[Vanadium trichloride].
7727-18-6 Vanadium, trichlorooxo-, (T-4)- 7/11/03 9/9/03
[Vanadium oxytrichloride].
7803-55-6 Vanadate (VO31-), ammonium 7/11/03 9/9/03
[Ammonium metavanadate].
10049-16-8 Vanadium fluoride (VF4) 7/11/03 9/9/03
[Vanadium tetrafluoride].
10213-09-9 Vanadium, dichlorooxo- 7/11/03 9/9/03
[Vanadyl dichloride].
10580-52-6 Vanadium chloride (VCl2) 7/11/03 9/9/03
[Vanadium dichloride].
11099-11-9 Vanadium oxide [Polyvanadic 7/11/03 9/9/03
acid].
11115-67-6 Ammonium vanadium oxide....... 7/11/03 9/9/03
11130-21-5 Vanadium carbide.............. 7/11/03 9/9/03
12007-37-3 Vanadium boride (VB2)......... 7/11/03 9/9/03
12035-98-2 Vanadium oxide (VO)........... 7/11/03 9/9/03
12036-21-4 Vanadium oxide (VO2).......... 7/11/03 9/9/03
12070-10-9 Vanadium carbide (VC)......... 7/11/03 9/9/03
12083-48-6 Vanadium, dichlorobis (.eta.5- 7/11/03 9/9/03
2,4-cyclopentadien-1-yl)-.
12166-27-7 Vanadium sulfide (VS)......... 7/11/03 9/9/03
12439-96-2 Vanadium, oxo[sulfato(2-)- 7/11/03 9/9/03
.kappa.O]-, pentahydrate
[Vanadyl sulfate (VOSO4),
pentahydrate].
12604-58-9 Vanadium alloy, base, V,C,Fe 7/11/03 9/9/03
(Ferrovanadium).
13470-26-3 Vanadium bromide (VBr3)....... 7/11/03 9/9/03
13476-99-8 Vanadium, tris(2,4- 7/11/03 9/9/03
pentanedionato-
.kappa.O,.kappa.O')-, (OC-6-
11)- [Vanadium
tris(acetylacetonate)].
13497-94-4 Silver vanadium oxide (AgVO3). 7/11/03 9/9/03
13517-26-5 Sodium vanadium oxide 7/11/03 9/9/03
(Na4V2O7) [Sodium
pyrovanadate].
13718-26-8 Vanadate (VO31-), sodium 7/11/03 9/9/03
[Sodium metavanadate].
13721-39-6 Sodium vanadium oxide (Na3VO4) 7/11/03 9/9/03
[Sodium orthovanadate].
13769-43-2 Vanadate (VO31-), potassium 7/11/03 9/9/03
[Potassium metavanadate].
13930-88-6 Vanadium, oxo[29H,31H- 7/11/03 9/9/03
phthalocyaninato(2-)-
.kappa.N29,.kappa.N30,.kappa.
N31,.kappa.N32]-, (SP-5-12)-.
14059-33-7 Bismuth vanadium oxide (BiVO4) 7/11/03 9/9/03
19120-62-8 Vanadium, tris(2-methyl-1- 7/11/03 9/9/03
propanolato)oxo-, (T-4)-
[Isobutyl orthovanadate].
24646-85-3 Vanadium nitride (VN)......... 7/11/03 9/9/03
27774-13-6 Vanadium, oxo[sulfato(2-)- 7/11/03 9/9/03
.kappa.O]- [Vanadyl sulfate].
30486-37-4 Vanadium hydroxide oxide 7/11/03 9/9/03
(V(OH)2O).
39455-80-6 Ammonium sodium vanadium oxide 7/11/03 9/9/03
53801-77-7 Bismuth vanadium oxide........ 7/11/03 9/9/03
65232-89-5 Vanadium hydroxide oxide 7/11/03 9/9/03
phosphate.
68130-18-7 Vanadium hydroxide oxide 7/11/03 9/9/03
phosphate (V6(OH)3O3(PO4)7).
68815-09-8 Naphthenic acids, vanadium 7/11/03 9/9/03
salts.
68990-29-4 Balsams, copaiba, sulfurized, 7/11/03 9/9/03
vanadium salts.
------------------------------------------------------------------------
Voluntary HPV Challenge Program orphan (unsponsored) chemicals
------------------------------------------------------------------------
62-56-6 Thiourea...................... September November
29, 2006 28, 2006
[[Page 167]]
77-76-9 Propane, 2,2-dimethoxy-....... September November
29, 2006 28, 2006
81-07-2 1,2-Benzisothiazol-3(2H)-one, September November
1,1-dioxide. 29, 2006 28, 2006
81-16-3 1-Naphthalenesulfonic acid, 2- September November
amino-. 29, 2006 28, 2006
81-84-5 1H,3H-Naphtho[1,8-cd]pyran-1,3- September November
dione. 29, 2006 28, 2006
83-41-0 Benzene, 1,2-dimethyl-3-nitro- September November
29, 2006 28, 2006
84-69-5 1,2-Benzenedicarboxylic acid, September November
bis(2-methylpropyl) ester. 29, 2006 28, 2006
85-40-5 1H-Isoindole-1,3(2H)-dione, September November
3a,4,7,7a-tetrahydro-. 29, 2006 28, 2006
91-68-9 Phenol, 3-(diethylamino)-..... September November
29, 2006 28, 2006
94-96-2 1,3-Hexanediol, 2-ethyl-...... September November
29, 2006 28, 2006
96-22-0 3-Pentanone................... September November
29, 2006 28, 2006
97-00-7 Benzene, 1-chloro-2,4-dinitro- September November
29, 2006 28, 2006
98-09-9 Benzenesulfonyl chloride...... September November
29, 2006 28, 2006
98-16-8 Benzenamine, 3- September November
(trifluoromethyl)-. 29, 2006 28, 2006
98-56-6 Benzene, 1-chloro-4- September November
(trifluoromethyl)-. 29, 2006 28, 2006
101-34-8 9-Octadecenoic acid, 12- September November
(acetyloxy)-, 1,2,3- 29, 2006 28, 2006
propanetriyl ester,
(9Z,9'Z,9'',12R,12'R,12'')-.
104-66-5 Benzene, 1,1'-[1,2- September November
ethanediylbis(oxy)]bis-. 29, 2006 28, 2006
104-93-8 Benzene, 1-methoxy-4-methyl-.. September November
29, 2006 28, 2006
107-39-1 1-Pentene, 2,4,4-trimethyl-... September November
29, 2006 28, 2006
107-40-4 2-Pentene, 2,4,4-trimethyl-... September November
29, 2006 28, 2006
110-18-9 1,2-Ethanediamine, N,N,N',N'- September November
tetramethyl-. 29, 2006 28, 2006
110-33-8 Hexanedioic acid, dihexyl September November
ester. 29, 2006 28, 2006
111-44-4 Ethane, 1,1'-oxybis[2-chloro-. September November
29, 2006 28, 2006
111-85-3 Octane, 1-chloro-............. September November
29, 2006 28, 2006
111-91-1 Ethane, 1,1'- September November
[methylenebis(oxy)]bis[2- 29, 2006 28, 2006
chloro-.
118-90-1 Benzoic acid, 2-methyl-....... September November
29, 2006 28, 2006
119-33-5 Phenol, 4-methyl-2-nitro-..... September November
29, 2006 28, 2006
121-69-7 Benzenamine, N,N-dimethyl-.... September November
29, 2006 28, 2006
121-82-4 1,3,5-Triazine, hexahydro- September November
1,3,5-trinitro-. 29, 2006 28, 2006
124-63-0 Methanesulfonyl chloride...... September November
29, 2006 28, 2006
127-68-4 Benzenesulfonic acid, 3-nitro- September November
, sodium salt. 29, 2006 28, 2006
131-57-7 Methanone, (2-hydroxy-4- September November
methoxyphenyl)phenyl-. 29, 2006 28, 2006
137-20-2 Ethanesulfonic acid, 2- September November
[methyl[(9Z)-1-oxo-9- 29, 2006 28, 2006
octadecenyl]amino]-, sodium
salt.
138-25-0 1,3-Benzenedicarboxylic acid, September November
5-sulfo-, 1,3-dimethyl ester. 29, 2006 28, 2006
139-40-2 1,3,5-Triazine-2,4-diamine, 6- September November
chloro-N,N'-bis(1- 29, 2006 28, 2006
methylethyl)-.
140-93-2 Carbonodithioic acid, O-(1- September November
methylethyl) ester, sodium 29, 2006 28, 2006
salt.
[[Page 168]]
142-73-4 Glycine, N-(carboxymethyl)-... September November
29, 2006 28, 2006
330-54-1 Urea, N'-(3,4-dichlorophenyl)- September November
N,N-dimethyl-. 29, 2006 28, 2006
460-00-4 Benzene, 1-bromo-4-fluoro-.... September November
29, 2006 28, 2006
506-51-4 1-Tetracosanol................ September November
29, 2006 28, 2006
506-52-5 1-Hexacosanol................. September November
29, 2006 28, 2006
513-74-6 Carbamodithioic acid, September November
monoammonium salt. 29, 2006 28, 2006
515-40-2 Benzene, (2-chloro-1,1- September November
dimethylethyl)-. 29, 2006 28, 2006
529-33-9 1-Naphthalenol, 1,2,3,4- September November
tetrahydro-. 29, 2006 28, 2006
529-34-0 1(2H)-Naphthalenone, 3,4- September November
dihydro-. 29, 2006 28, 2006
542-92-7 1,3-Cyclopentadiene........... September November
29, 2006 28, 2006
557-61-9 1-Octacosanol................. September November
29, 2006 28, 2006
563-72-4 Ethanedioic acid, calcium salt September November
(1:1). 29, 2006 28, 2006
590-19-2 1,2-Butadiene................. September November
29, 2006 28, 2006
592-45-0 1,4-Hexadiene................. September November
29, 2006 28, 2006
598-72-1 Propanoic acid, 2-bromo-...... September November
29, 2006 28, 2006
617-94-7 Benzenemethanol, September November
.alpha.,.alpha.-dimethyl-. 29, 2006 28, 2006
628-13-7 Pyridine, hydrochloride....... September November
29, 2006 28, 2006
628-96-6 1,2-Ethanediol, dinitrate..... September November
29, 2006 28, 2006
645-62-5 2-Hexenal, 2-ethyl-........... September November
29, 2006 28, 2006
693-95-8 Thiazole, 4-methyl-........... September November
29, 2006 28, 2006
756-80-9 Phosphorodithioic acid, O,O- September November
dimethyl ester. 29, 2006 28, 2006
870-72-4 Methanesulfonic acid, hydroxy- September November
, monosodium salt. 29, 2006 28, 2006
928-72-3 Glycine, N-(carboxymethyl)-, September November
disodium salt. 29, 2006 28, 2006
939-97-9 Benzaldehyde, 4-(1,1- September November
dimethylethyl)-. 29, 2006 28, 2006
1000-82-4 Urea, (hydroxymethyl)-........ September November
29, 2006 28, 2006
1002-69-3 Decane, 1-chloro-............. September November
29, 2006 28, 2006
1111-78-0 Carbamic acid, monoammonium September November
salt. 29, 2006 28, 2006
1401-55-4 Tannins....................... September November
29, 2006 28, 2006
1445-45-0 Ethane, 1,1,1-trimethoxy-..... September November
29, 2006 28, 2006
1498-51-7 Phosphorodichloridic acid, September November
ethyl ester. 29, 2006 28, 2006
1738-25-6 Propanenitrile, 3- September November
(dimethylamino)-. 29, 2006 28, 2006
1912-24-9 1,3,5-Triazine-2,4-diamine, 6- September November
chloro-N-ethyl-N'-(1- 29, 2006 28, 2006
methylethyl)-.
2152-64-9 Benzenamine, N-phenyl-4-[[4- September November
(phenylamino)phenyl][4- 29, 2006 28, 2006
(phenylimino)-2,5-
cyclohexadien-1-
ylidene]methyl]-,
monohydrochloride.
2210-79-9 Oxirane, [(2- September November
methylphenoxy)methyl]-. 29, 2006 28, 2006
2372-45-4 1-Butanol, sodium salt........ September November
29, 2006 28, 2006
[[Page 169]]
2409-55-4 Phenol, 2-(1,1-dimethylethyl)- September November
4-methyl-. 29, 2006 28, 2006
2425-54-9 Tetradecane, 1-chloro-........ September November
29, 2006 28, 2006
2494-89-5 Ethanol, 2-[(4- September November
aminophenyl)sulfonyl]-, 29, 2006 28, 2006
hydrogen sulfate (ester).
2524-03-0 Phosphorochloridothioic acid, September November
O,O-dimethyl ester. 29, 2006 28, 2006
2691-41-0 1,3,5,7-Tetrazocine, octahydro- September November
1,3,5,7-tetranitro-. 29, 2006 28, 2006
2814-20-2 4(1H)-Pyrimidinone, 6-methyl-2- September November
(1-methylethyl)-. 29, 2006 28, 2006
2905-62-6 Benzoyl chloride, 3,5-dichloro- September November
. 29, 2006 28, 2006
2915-53-9 2-Butenedioic acid (2Z)-, September November
dioctyl ester. 29, 2006 28, 2006
3039-83-6 Ethenesulfonic acid, sodium September November
salt. 29, 2006 28, 2006
3132-99-8 Benzaldehyde, 3-bromo-........ September November
29, 2006 28, 2006
3386-33-2 Octadecane, 1-chloro-......... September November
29, 2006 28, 2006
3779-63-3 1,3,5-Triazine-2,4,6(1H,3H,5H)- September November
trione, 1,3,5-tris(6- 29, 2006 28, 2006
isocyanatohexyl)-.
3965-55-7 1,3-Benzenedicarboxylic acid, September November
5-sulfo-, 1,3-dimethyl ester, 29, 2006 28, 2006
sodium salt.
4035-89-6 Imidodicarbonic diamide, September November
N,N',2-tris(6- 29, 2006 28, 2006
isocyanatohexyl)-.
4170-30-3 2-Butenal..................... September November
29, 2006 28, 2006
4316-73-8 Glycine, N-methyl-, monosodium September November
salt. 29, 2006 28, 2006
4860-03-1 Hexadecane, 1-chloro-......... September November
29, 2006 28, 2006
5026-74-4 Oxiranemethanamine, N-[4- September November
(oxiranylmethoxy)phenyl]-N- 29, 2006 28, 2006
(oxiranylmethyl)-.
5216-25-1 Benzene, 1-chloro-4- September November
(trichloromethyl)-. 29, 2006 28, 2006
5460-09-3 2,7-Naphthalenedisulfonic September November
acid, 4-amino-5-hydroxy-, 29, 2006 28, 2006
monosodium salt.
5915-41-3 1,3,5-Triazine-2,4-diamine, 6- September November
chloro-N-(1,1-dimethylethyl)- 29, 2006 28, 2006
N'-ethyl-.
6473-13-8 2-Naphthalenesulfonic acid, 6- September November
[(2,4-diaminophenyl)azo]-3- 29, 2006 28, 2006
[[4-[[4-[[7-[(2,4-
diaminophenyl)azo]-1-hydroxy-
3-sulfo-2-
naphthalenyl]azo]phenyl]amino
]-3-sulfophenyl]azo]-4-
hydroxy-, trisodium salt.
7795-95-1 1-Octanesulfonyl chloride..... September November
29, 2006 28, 2006
8001-58-9 Creosote...................... September November
29, 2006 28, 2006
10265-69-7 Glycine, N-phenyl-, monosodium September November
salt. 29, 2006 28, 2006
13749-94-5 Ethanimidothioic acid, N- September November
hydroxy-, methyl ester. 29, 2006 28, 2006
13826-35-2 Benzenemethanol, 3-phenoxy-... September November
29, 2006 28, 2006
17103-31-0 Urea, sulfate (2:1)........... September November
29, 2006 28, 2006
17321-47-0 Phosphoramidothioic acid, O,O- September November
dimethyl ester. 29, 2006 28, 2006
17976-43-1 2,4,6,8,3,5,7- September November
Benzotetraoxatriplumbacycloun 29, 2006 28, 2006
decin-3,5,7-triylidene, 1,9-
dihydro-1,9-dioxo-.
19438-61-0 1,3-Isobenzofurandione, 5- September November
methyl-. 29, 2006 28, 2006
19525-59-8 Glycine, N-phenyl-, September November
monopotassium salt. 29, 2006 28, 2006
20068-02-4 2-Butenenitrile, 2-methyl-, September November
(2Z)-. 29, 2006 28, 2006
20227-53-6 Phosphorous acid, 2-(1,1- September November
dimethylethyl)-4-[1-[3-(1,1- 29, 2006 28, 2006
dimethylethyl)-4-
hydroxyphenyl]-1-
methylethyl]phenyl bis(4-
nonylphenyl) ester.
21351-39-3 Urea, sulfate (1:1)........... September November
29, 2006 28, 2006
[[Page 170]]
22527-63-5 Propanoic acid, 2-methyl-, 3- September November
(benzoyloxy)-2,2,4- 29, 2006 28, 2006
trimethylpentyl ester.
24615-84-7 2-Propenoic acid, 2- September November
carboxyethyl ester. 29, 2006 28, 2006
24794-58-9 Formic acid, compd. with September November
2,2',2[ethanol] (1:1). 29, 2006 28, 2006
25154-38-5 Piperazineethanol............. September November
29, 2006 28, 2006
25168-05-2 Benzene, chloromethyl-........ September November
29, 2006 28, 2006
25168-06-3 Phenol, (1-methylethyl)-...... September November
29, 2006 28, 2006
25321-41-9 Benzenesulfonic acid, dimethyl- September November
. 29, 2006 28, 2006
25383-99-7 Octadecanoic acid, 2-(1- September November
carboxyethoxy)-1-methyl-2- 29, 2006 28, 2006
oxoethyl ester, sodium salt.
25646-71-3 Methanesulfonamide, N-[2-[(4- September November
amino-3- 29, 2006 28, 2006
methylphenyl)ethylamino]ethyl
]-, sulfate (2:3).
26377-29-7 Phosphorodithioic acid, O,O- September November
dimethyl ester, sodium salt. 29, 2006 28, 2006
26401-27-4 Phosphorous acid, isooctyl September November
diphenyl ester. 29, 2006 28, 2006
26680-54-6 2,5-Furandione, dihydro-3- September November
(octenyl)-. 29, 2006 28, 2006
27193-28-8 Phenol, (1,1,3,3- September November
tetramethylbutyl)-. 29, 2006 28, 2006
28106-30-1 Benzene, ethenylethyl-........ September November
29, 2006 28, 2006
28188-24-1 Octadecanoic acid, 2- September November
(hydroxymethyl)-2-[[(1- 29, 2006 28, 2006
oxooctadecyl)oxy]methyl]-1,3-
propanediyl ester.
28908-00-1 Benzothiazole, 2- September November
[(chloromethyl)thio]-. 29, 2006 28, 2006
30574-97-1 2-Butenenitrile, 2-methyl-, September November
(2E)-. 29, 2006 28, 2006
34689-46-8 Phenol, methyl-, sodium salt.. September November
29, 2006 28, 2006
35203-06-6 Benzenamine, 2-ethyl-6-methyl- September November
N-methylene-. 29, 2006 28, 2006
35203-08-8 Benzenamine, 2,6-diethyl-N- September November
methylene-. 29, 2006 28, 2006
37734-45-5 Carbonochloridothioic acid, S- September November
(phenylmethyl) ester. 29, 2006 28, 2006
37764-25-3 Acetamide, 2,2-dichloro-N,N-di- September November
2-propenyl-. 29, 2006 28, 2006
38185-06-7 Benzenesulfonic acid, 4-chloro- September November
3,5-dinitro-, potassium salt. 29, 2006 28, 2006
38321-18-5 Ethanol, 2-(2-butoxyethoxy)-, September November
sodium salt. 29, 2006 28, 2006
39515-51-0 Benzaldehyde, 3-phenoxy-...... September November
29, 2006 28, 2006
40630-63-5 1-Octanesulfonyl fluoride..... September November
29, 2006 28, 2006
40876-98-0 Butanedioic acid, oxo-, September November
diethyl ester, ion(1-), 29, 2006 28, 2006
sodium.
51632-16-7 Benzene, 1-(bromomethyl)-3- September November
phenoxy-. 29, 2006 28, 2006
52184-19-7 Phenol, 2,4-bis(1,1- September November
dimethylpropyl)-6-[(2- 29, 2006 28, 2006
nitrophenyl)azo]-.
52556-42-0 1-Propanesulfonic acid, 2- September November
hydroxy-3-(2-propenyloxy)-, 29, 2006 28, 2006
monosodium salt.
52663-57-7 Ethanol, 2-butoxy-, sodium September November
salt. 29, 2006 28, 2006
56803-37-3 Phosphoric acid, (1,1- September November
dimethylethyl)phenyl diphenyl 29, 2006 28, 2006
ester.
57693-14-8 Chromate(3-), bis[3-(hydroxy- September November
.kappa.O)-4-[[2-(hydroxy- 29, 2006 28, 2006
.kappa.O)-1-naphthalenyl]azo-
.kappa.N1]-7-nitro-1-
naphthalenesulfonato(3-)]-,
trisodium.
61788-44-1 Phenol, styrenated............ September November
29, 2006 28, 2006
61788-76-9 Alkanes, chloro............... September November
29, 2006 28, 2006
[[Page 171]]
61789-85-3 Sulfonic acids, petroleum..... September November
29, 2006 28, 2006
63302-49-8 Phosphorochloridous acid, September November
bis(4-nonylphenyl) ester. 29, 2006 28, 2006
64743-02-8 Alkenes, C10 September November
.alpha.-. 29, 2006 28, 2006
64743-03-9 Phenols (petroleum)........... September November
29, 2006 28, 2006
65996-79-4 Solvent naphtha (coal)........ September November
29, 2006 28, 2006
65996-82-9 Tar oils, coal................ September November
29, 2006 28, 2006
65996-83-0 Extracts, coal tar oil alk.... September November
29, 2006 28, 2006
65996-86-3 Extract oils (coal), tar base. September November
29, 2006 28, 2006
65996-87-4 Extract residues (coal), tar September November
oil alk.. 29, 2006 28, 2006
65996-89-6 Tar, coal, high-temp.......... September November
29, 2006 28, 2006
65996-91-0 Distillates (coal tar), upper. September November
29, 2006 28, 2006
65996-92-1 Distillates (coal tar)........ September November
29, 2006 28, 2006
68081-86-7 Phenol, nonyl derivs.......... September November
29, 2006 28, 2006
68082-78-0 Lard, oil, Me esters.......... September November
29, 2006 28, 2006
68153-60-6 Fatty acids, tall-oil, September November
reaction products with 29, 2006 28, 2006
diethylenetriamine, acetates.
68187-41-7 Phosphorodithioic acid, O,O-di- September November
C1-14-alkyl esters. 29, 2006 28, 2006
68187-57-5 Pitch, coal tar-petroleum..... September November
29, 2006 28, 2006
68187-59-7 Coal, anthracite, calcined.... September November
29, 2006 28, 2006
68188-18-1 Paraffin oils, September November
chlorosulfonated, saponified. 29, 2006 28, 2006
68308-74-7 Amides, tall-oil fatty, N,N-di- September November
Me. 29, 2006 28, 2006
68309-16-0 Fatty acids, tall-oil, 2-(2- September November
hydroxyethoxy)ethyl esters. 29, 2006 28, 2006
68309-27-3 Fatty acids, tall-oil, September November
sulfonated, sodium salts. 29, 2006 28, 2006
68334-01-0 Disulfides, alkylaryl dialkyl September November
diaryl, petroleum refinery 29, 2006 28, 2006
spent caustic oxidn. products.
68441-66-7 Decanoic acid, mixed esters September November
with dipentaerythritol, 29, 2006 28, 2006
octanoic acid and valeric
acid.
68442-60-4 Acetaldehyde, reaction September November
products with formaldehyde, 29, 2006 28, 2006
by-products from.
68442-77-3 2-Butenediamide, (2E)-, N,N'- September November
bis[2-(4,5-dihydro-2-nortall- 29, 2006 28, 2006
oil alkyl-1H-imidazol-1-
yl)ethyl] derivs..
68457-74-9 Phenol, isobutylenated September November
methylstyrenated. 29, 2006 28, 2006
68513-62-2 Disulfides, C5-12-alkyl....... September November
29, 2006 28, 2006
68515-89-9 Barium, carbonate nonylphenol September November
complexes. 29, 2006 28, 2006
68527-22-0 Naphtha (petroleum), clay- September November
treated light straight-run. 29, 2006 28, 2006
68584-25-8 Benzenesulfonic acid, C10-16- September November
alkyl derivs., compds. with 29, 2006 28, 2006
triethanolamine.
68602-81-3 Distillates, hydrocarbon resin September November
prodn. higher boiling. 29, 2006 28, 2006
68608-59-3 Ethane, 1,2-dichloro-, manuf. September November
of, by-products from, distn. 29, 2006 28, 2006
lights.
68609-05-2 Cyclohexane, oxidized, non- September November
acidic by-products, distn. 29, 2006 28, 2006
lights.
68610-90-2 2-Butenedioic acid (2E)-, di- September November
C8-18-alkyl esters. 29, 2006 28, 2006
[[Page 172]]
68649-42-3 Phosphorodithioic acid, O,O-di- September November
C1-14-alkyl esters, zinc 29, 2006 28, 2006
salts.
68650-36-2 Aromatic hydrocarbons, C8, o- September November
xylene-lean. 29, 2006 28, 2006
68782-97-8 Distillates (petroleum), September November
hydrofined lubricating-oil. 29, 2006 28, 2006
68815-50-9 Octadecanoic acid, reaction September November
products with 2-[(2- 29, 2006 28, 2006
aminoethyl)amino]ethanol.
68909-77-3 Ethanol, 2,2'-oxybis-, September November
reaction products with 29, 2006 28, 2006
ammonia, morpholine derivs.
residues.
68915-05-9 Fatty acids, tall-oil, low- September November
boiling, reaction products 29, 2006 28, 2006
with ammonia-ethanolamine
reaction by-products.
68915-39-9 Cyclohexane, oxidized, aq. September November
ext., sodium salt. 29, 2006 28, 2006
68918-16-1 Tar, coal, dried and oxidized. September November
29, 2006 28, 2006
68919-17-5 Hydrocarbons, C12-20, September November
catalytic alkylation by- 29, 2006 28, 2006
products.
68937-29-1 1,6-Hexanediol, distn. September November
residues. 29, 2006 28, 2006
68937-70-2 Carboxylic acids, C6-18 and C8- September November
15-di-. 29, 2006 28, 2006
68937-72-4 Carboxylic acids, di-, C4-11.. September November
29, 2006 28, 2006
68953-80-0 Benzene, mixed with toluene, September November
dealkylation product. 29, 2006 28, 2006
68955-37-3 Acid chlorides, tallow, September November
hydrogenated. 29, 2006 28, 2006
68955-76-0 Aromatic hydrocarbons, C9-16, September November
biphenyl deriv.-rich. 29, 2006 28, 2006
68987-41-7 Benzene, ethylenated.......... September November
29, 2006 28, 2006
68987-66-6 Ethene, hydrated, by-products September November
from. 29, 2006 28, 2006
68988-22-7 1,4-Benzenedicarboxylic acid, September November
dimethyl ester, manuf. of, by- 29, 2006 28, 2006
products from.
68990-61-4 Tar, coal, high-temp., high- September November
solids. 29, 2006 28, 2006
68990-65-8 Fats and Glyceridic oils, September November
vegetable, reclaimed. 29, 2006 28, 2006
70084-98-9 Terpenes and Terpenoids, C10- September November
30, distn. residues. 29, 2006 28, 2006
70693-50-4 Phenol, 2,4-bis(1-methyl-1- September November
phenylethyl)-6-[(2- 29, 2006 28, 2006
nitrophenyl)azo]-.
70851-08-0 Amides, coco, N-[3- September November
(dimethylamino)propyl], 29, 2006 28, 2006
alkylation products with
sodium 3-chloro-2-
hydroxypropanesulfonate.
71077-05-9 Ethanol, 2,2'-oxybis-, September November
reaction products with 29, 2006 28, 2006
ammonia, morpholine product
tower residues.
72162-15-3 1-Decene, sulfurized.......... September November
29, 2006 28, 2006
72854-27-4 Tannins, reaction products September November
with sodium bisulfite, sodium 29, 2006 28, 2006
polysulfide and sodium
sulfite.
73665-18-6 Extract residues (coal), tar September November
oil alk., naphthalene distn. 29, 2006 28, 2006
residues.
83864-02-2 Nickel, bis[(cyano- September November
C)triphenylborato(1-)- 29, 2006 28, 2006
N]bis(hexanedinitrile-N,N')-.
84501-86-0 Hexanedioic acid, esters with September November
high-boiling C6-10-alkene 29, 2006 28, 2006
hydroformylation products.
90640-80-5 Anthracene oil................ September November
29, 2006 28, 2006
90640-86-1 Distillates (coal tar), heavy September November
oils. 29, 2006 28, 2006
119345-02-7 Benzene, 1,1'-oxybis-, September November
tetrapropylene derivs.. 29, 2006 28, 2006
125997-20-8 Phosphoric acid, mixed 3-bromo- September November
2,2-dimethylpropyl and 2- 29, 2006 28, 2006
bromoethyl and 2-chloroethyl
esters.
------------------------------------------------------------------------
(Secs 8(a) and 8(d), 90 Stat. 2027, 2029; 15 U.S.C. 2607 (a) and (d))
[47 FR 26998, June 22, 1982]
[[Page 173]]
Editorial Note: For Federal Register citations affecting Sec.
712.30, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and at www.govinfo.gov.
Effective Date Note: At 59 FR 14115, Mar. 25, 1994, in Sec. 712.30
paragraph (x), the chemical substances under the category ``propylene
glycol ethers esters'' and all related dates were stayed, effective Mar.
25, 1994. At 60 FR 31921, June 19, 1995, Sec. 712.30 was amended in
part by redesignating paragraph (x) as paragraph (e).
PART 713_REPORTING REQUIREMENTS FOR THE TSCA INVENTORY
OF MERCURY SUPPLY, USE, AND TRADE--Table of Contents
Sec.
713.1 Purpose, scope, and compliance.
713.5 Mercury for which information must be reported.
713.7 Persons who must report.
713.9 General requirements for which information must be reported.
713.11 Specific requirements for which information must be reported.
713.13 Contextual requirements for which information must be reported.
713.15 Reporting information to EPA.
713.17 When to report.
713.19 Recordkeeping requirements.
713.21 Electronic filing.
Authority: 15 U.S.C. 2607(b)(10)(D).
Source: 83 FR 30073, June 27, 2018, unless otherwise noted.
Sec. 713.1 Purpose, scope, and compliance.
(a) This part specifies reporting and recordkeeping procedures under
section 8(b)(10) of the Toxic Substances Control Act (TSCA) (15 U.S.C.
2607(b)(10)) for certain manufacturers (including importers) and
processers of mercury as defined in section 8(b)(10)(A) to include
elemental mercury and mercury compounds. Hereinafter ``mercury'' will
refer to both elemental mercury and mercury compounds collectively,
except where separately identified. Section 8(b)(10)(D) of TSCA
authorizes the EPA Administrator to require reporting from any person
who manufactures mercury or mercury-added products or otherwise
intentionally uses mercury in a manufacturing process to carry out and
publish in the Federal Register an inventory of mercury supply, use, and
trade in the United States. In administering this mercury inventory, EPA
is directed to identify any manufacturing processes or products that
intentionally add mercury and to recommend actions, including proposed
revisions of Federal law or regulations, to achieve further reductions
in mercury use. EPA intends to use the collected information to
implement TSCA and shape the Agency's efforts to recommend actions, both
voluntary and regulatory, to reduce the use of mercury in commerce. In
so doing, the Agency will conduct timely evaluation and refinement of
these reporting requirements so that they are efficient and non-
duplicative for reporters.
(b) This part applies to the activities associated with the periodic
publication of information on mercury supply, use, and trade in the
United States. Except as described at Sec. 713.7, the reporting
requirements for mercury supply, use, and trade apply to the following
activities:
(1) Activities undertaken with the purpose of obtaining an immediate
or eventual commercial advantage:
(i) Import of mercury;
(ii) Manufacture (other than import) of mercury;
(iii) Import of a mercury-added product;
(iv) Manufacture (other than import) of a mercury-added product; and
(v) Intentional use of mercury in a manufacturing process.
(2) Activities undertaken in relationship to those activities
described in paragraph (b)(1) of this section:
(i) Distribution in commerce, including domestic sale or transfer,
of mercury;
(ii) Distribution in commerce, including domestic sale or transfer,
of a mercury-added product;
(iii) Storage of mercury (including import);
(iv) Export of a mercury compound (unless specifically prohibited);
and
(v) Export of a mercury-added product.
(c) Section 15(3) of TSCA makes it unlawful for any person to fail
or
[[Page 174]]
refuse to submit information required under this part. In addition, TSCA
section 15(3) makes it unlawful for any person to fail to: Establish or
maintain records, or permit access to records required by this part.
Section 16 of TSCA provides that any person who violates a provision of
TSCA section 15 is liable to the United States for a civil penalty and
may be criminally prosecuted. Pursuant to TSCA section 17, the Federal
Government may seek judicial relief to compel submission of TSCA section
8 information and to otherwise restrain any violation of TSCA section
15.
(d) Each person who reports under this part must certify the
accuracy and maintain records of the information reported under this
part and, in accordance with TSCA, permit access to, and the copying of,
such records by EPA officials.
Sec. 713.5 Mercury for which information must be reported.
(a) Elemental mercury (Chemical Abstracts Service Registry Number
7439-97-6); or
(b) A mercury compound, including but not limited to the mercury
compounds listed in Table 1 of this part by Chemical Abstracts Service
Registry Number:
Table 1--Mercury Compounds
------------------------------------------------------------------------
Chemical Abstracts Service Registry No. Mercury compound
------------------------------------------------------------------------
10045-94-0.............................. Nitric acid, mercury(2+) salt
(2:1).
100-57-2................................ Mercury, hydroxyphenyl-.
10112-91-1.............................. Mercury chloride (Hg2Cl2).
10124-48-8.............................. Mercury amide chloride
(Hg(NH2)Cl).
103-27-5................................ Mercury, phenyl(propanoato-
.kappa.O)-.
10415-75-5.............................. Nitric acid, mercury(1+) salt
(1:1).
104-60-9................................ Mercury, (9-octadecenoato-
.kappa.O)phenyl-.
1191-80-6............................... 9-Octadecenoic acid (9Z)-,
mercury(2+) salt (2:1).
12068-90-5.............................. Mercury telluride (HgTe).
13170-76-8.............................. Hexanoic acid, 2-ethyl-,
mercury(2+) salt (2:1).
13302-00-6.............................. Mercury, (2-ethylhexanoato-
.kappa.O)phenyl-.
1335-31-5............................... Mercury cyanide oxide
(Hg2(CN)2O).
1344-48-5............................... Mercury sulfide (HgS).
1345-09-1............................... Cadmium mercury sulfide.
13876-85-2.............................. Mercurate(2-), tetraiodo-,
copper(1+) (1:2), (T-4)-.
138-85-2................................ Mercurate(1-), (4-
carboxylatophenyl)hydroxy-,
sodium (1:1).
141-51-5................................ Mercury, iodo(iodomethyl)-.
14783-59-6.............................. Mercury, bis[(2-
phenyldiazenecarbothioic acid-
.kappa.S) 2-phenylhydrazidato-
.kappa.N2]-, (T-4)-.
15385-58-7.............................. Mercury, dibromodi-, (Hg-Hg).
15785-93-0.............................. Mercury, chloro[4-[(2,4-
dinitrophenyl)amino]phenyl]-.
15829-53-5.............................. Mercury oxide (Hg2O).
1600-27-7............................... Acetic acid, mercury(2+) salt
(2:1).
1785-43-9............................... Mercury,
chloro(ethanethiolato)-.
19447-62-2.............................. Mercury, (acetato-.kappa.O)[4-
[2-[4-
(dimethylamino)phenyl]diazeny
l]phenyl]-.
20582-71-2.............................. Mercurate(2-), tetrachloro-,
potassium (1:2), (T-4)-.
20601-83-6.............................. Mercury selenide (HgSe).
21908-53-2.............................. Mercury oxide (HgO).
22450-90-4.............................. Mercury(1+), amminephenyl-,
acetate (1:1).
24579-90-6.............................. Mercury, chloro(2-hydroxy-5-
nitrophenyl)-.
24806-32-4.............................. Mercury, [.mu.-[2-
dodecylbutanedioato(2-
).kappa.O1:.kappa.O4]]dipheny
ldi-.
26545-49-3.............................. Mercury, (neodecanoato-
.kappa.O)phenyl-.
27685-51-4.............................. Cobaltate(2-),
tetrakis(thiocyanato-
.kappa.N)-, mercury(2+)
(1:1), (T-4)-.
29870-72-2.............................. Cadmium mercury telluride
((Cd,Hg)Te).
3294-57-3............................... Mercury,
phenyl(trichloromethyl)-.
33770-60-4.............................. Mercury, [3,6-dichloro-4,5-
di(hydroxy-.kappa.O)-
3,5cyclohexadiene-1,2-
dionato(2-)]-.
3570-80-7............................... Mercury, bis(acetato-
.kappa.O)[.mu.-(3',6'-
dihydroxy-
3oxospiro[isobenzofuran-
1(3H),9'-[9H]xanthene]-
2',7'diyl)]di-.
537-64-4................................ Mercury, bis(4-methylphenyl)-.
539-43-5................................ Mercury, chloro(4-
methylphenyl)-.
54-64-8................................. Mercurate(1-), ethyl[2-
(mercapto-.kappa.S)benzoato(2-
).kappa.O]-, sodium (1:1).
55-68-5................................. Mercury, (nitrato-
.kappa.O)phenyl-.
56724-82-4.............................. Mercury, phenyl[(2-
phenyldiazenecarbothioic
acid.kappa.S) 2-
phenylhydrazidato-.kappa.N2]-
.
587-85-9................................ Mercury, diphenyl-.
592-04-1................................ Mercury cyanide (Hg(CN)2).
592-85-8................................ Thiocyanic acid, mercury(2+)
salt (2:1).
593-74-8................................ Mercury, dimethyl-.
59-85-8................................. Mercurate(1-), (4-
carboxylatophenyl)chloro-,
hydrogen.
623-07-4................................ Mercury, chloro(4-
hydroxyphenyl)-.
[[Page 175]]
62-38-4................................. Mercury, (acetato-
.kappa.O)phenyl-.
62638-02-2.............................. Cyclohexanebutanoic acid,
mercury(2+) salt (2:1).
627-44-1................................ Mercury, diethyl-.
6283-24-5............................... Mercury, (acetato-.kappa.O)(4-
aminophenyl)-.
628-86-4................................ Mercury, bis(fulminato-
.kappa.C)-.
629-35-6................................ Mercury, dibutyl-.
63325-16-6.............................. Mercurate(2-), tetraiodo-, (T-
4)-, hydrogen, compd. with 5-
iodo-2-pyridinamine (1:2:2).
63468-53-1.............................. Mercury, (acetato-.kappa.O)(2-
hydroxy-5-nitrophenyl)-.
63549-47-3.............................. Mercury, bis(acetato-
.kappa.O)(benzenamine)-.
68201-97-8.............................. Mercury, (acetato-
.kappa.O)diamminephenyl-, (T-
4)-.
72379-35-2.............................. Mercurate(1-), triiodo-,
hydrogen, compd. with 3-
methyl2(3H)-benzothiazolimine
(1:1:1).
7439-97-6............................... Mercury.
7487-94-7............................... Mercury chloride (HgCl2).
7546-30-7............................... Mercury chloride (HgCl).
7616-83-3............................... Perchloric acid, mercury(2+)
salt (2:1).
7774-29-0............................... Mercury iodide (HgI2).
7783-33-7............................... Mercurate(2-), tetraiodo-,
potassium (1:2), (T-4)-.
7783-35-9............................... Sulfuric acid, mercury(2+)
salt (1:1).
7783-39-3............................... Mercury fluoride (HgF2).
7789-47-1............................... Mercury bromide (HgBr2).
90-03-9................................. Mercury, chloro(2-
hydroxyphenyl)-.
94070-93-6.............................. Mercury, [.mu.-[(oxydi-2,1-
ethanediyl
1,2benzenedicarboxylato-
.kappa.O2)(2-)]]diphenyldi-.
------------------------------------------------------------------------
Sec. 713.7 Persons who must report.
(a) Any person who manufactures (including imports) mercury, except:
(1) A person who does not manufacture (including import) mercury
with the purpose of obtaining an immediate or eventual commercial
advantage;
(2) A person who manufactures (including imports) mercury only as an
impurity; or
(3) A person engaged only in the generation, handling, or management
of mercury-containing waste, including recovered mercury that is
discarded or elemental mercury that is managed for long-term storage and
management under section 6939f(g)(2) of the Resource Conservation and
Recovery Act;
(b) Any person who manufactures (including imports) a mercury-added
product, except:
(1) A person who does not manufacture (including import) a mercury-
added product with the purpose of obtaining an immediate or eventual
commercial advantage; or
(2) A person engaged only in the manufacture (other than import) of
a product that contains a component that is a mercury-added product who
did not first manufacture (including import) the component that is a
mercury-added product; and
(c) Any person who otherwise intentionally uses mercury in a
manufacturing process, except a person who does not intentionally use
mercury in a manufacturing process with the purpose of obtaining an
immediate or eventual commercial advantage.
[83 FR 30073, June 27, 2018, as amended at 86 FR 61712, Nov. 8, 2021]
Sec. 713.9 General requirements for which information must be reported.
Except as described at Sec. 713.7:
(a) Persons who manufacture (including import) mercury in amounts
greater than or equal to 2,500 pounds (lbs.) for elemental mercury or
greater than or equal to 25,000 lbs. for mercury compounds for a
specific reporting year must report, as applicable:
(1) Amount of mercury stored (lbs.); and
(2) Amount of mercury distributed in commerce (lbs.).
(b) All other persons who manufacture (including import) mercury
must report, as applicable:
(1) Amount of mercury manufactured (other than imported) (lbs.);
(2) Amount of mercury imported (lbs.);
(3) Amount of mercury exported (lbs.), except mercury prohibited
from export at 15 U.S.C. 2611(c)(1) and (7);
(4) Amount of mercury stored (lbs.); and
[[Page 176]]
(5) Amount of mercury distributed in commerce (lbs.).
(c) Persons who report sales of mercury-added products to the
Interstate Mercury Education and Reduction Clearinghouse (IMERC) must
report, as applicable:
(1) Amount of mercury in manufactured (other than imported) products
(lbs.);
(2) Amount of mercury in imported products (lbs.); and
(3) Amount of mercury in exported products (lbs.).
(d) All other persons who manufacture (including import) mercury-
added products must report, as applicable:
(1) Amount of mercury in manufactured (other than imported) products
(lbs.);
(2) Amount of mercury in imported products (lbs.);
(3) Amount of mercury in exported products (lbs.); and
(4) Amount of mercury in products distributed in commerce (lbs.).
(e) Persons who otherwise intentionally use mercury in a
manufacturing process must report, as applicable:
(1) Amount of mercury otherwise intentionally used (lbs.) in a
manufacturing process; and
(2) Amount of mercury stored (lbs.).
Sec. 713.11 Specific requirements for which information must
be reported.
Except as described at Sec. 713.7:
(a) Any person who manufactures (including imports) mercury must
specify, as applicable, the specific mercury compound(s) from a pre-
selected list (as listed in Table 1 of this part).
(b) Any person who manufactures (including imports) a mercury-added
product must specify as applicable, the specific category(ies) and
subcategory(ies) from a pre-selected list, as listed in Table 2 of this
part:
Table 2--Categories and Subcategories of Mercury-Added Products
------------------------------------------------------------------------
Category Subcategory
------------------------------------------------------------------------
Batteries.............................. --Button cell, silver.
--Button cell, zinc-air.
--Button cell, alkaline.
--Stacked button cell
batteries.
--Manganese oxide.
--Silver oxide.
--Mercuric oxide, non-button
cell.
--Button cell, mercuric oxide.
--Button cell, zinc carbon.
--Other (specify).
Dental amalgam......................... [No subcategories].
Formulated products (includes uses in --Skin-lightening creams.
cosmetics, pesticides, and laboratory --Lotions.
chemicals). --Soaps and sanitizers.
--Bath oils and salts.
--Topical antiseptics.
--Preservatives (e.g., for use
in vaccines and eye-area
cosmetics when no preservative
alternatives are available).
--Pharmaceuticals (including
prescription and over-the-
counter drug products).
--Cleaning products (not
registered as pesticides under
the Federal Insecticide,
Fungicide, and Rodenticide
Act).
--Pesticides.
--Paints.
--Dyes.
--Reagents (e.g., catalysts,
buffers, fixatives).
--Other (specify).
Lighting, lamps, bulbs................. --Linear fluorescent.
--Compact fluorescent.
--U-tube and circular
fluorescent.
--Cold cathode fluorescent.
--External electrode
fluorescent.
--Mercury vapor.
--Metal halide.
--High pressure sodium.
--Mercury short arc.
--Neon.
--Other (specify).
[[Page 177]]
Measuring instruments.................. --Barometer.
--Fever thermometer.
--Flow meter.
--Hydrometer.
--Hygrometer/psychrometer.
--Manometer.
--Non-fever thermometer.
--Pyrometer.
--Sphygmomanometer.
--Other (specify).
Pump seals............................. [No subcategories].
Switches, relays, sensors, valves...... --Tilt switch.
--Vibration switch.
--Float switch.
--Pressure switch.
--Temperature switch.
--Displacement relay.
--Wetted reed relay.
--Contact relay.
--Flame sensor.
--Thermostat.
--Other (specify).
Miscellaneous/novelty mercury-added --Wheel weights.
products. --Wheel rotation balancers/
stabilizers.
--Firearm recoil suppressors.
--Carburetor synchronizers.
--Joint support/shock
absorption bands.
--Other (specify).
------------------------------------------------------------------------
(c) Any person who otherwise intentionally uses mercury in a
manufacturing process, other than the manufacture of a mercury compound
or a mercury-added product, must identify, as applicable:
(1) The specific manufacturing process for which mercury is
otherwise intentionally used from a pre-selected list, as listed in
Table 3 of this part:
Table 3--Manufacturing Process for Which Mercury Is Otherwise
Intentionally Used
------------------------------------------------------------------------
-------------------------------------------------------------------------
Chlorine production (e.g., mercury-cell chlor-alkali process).
Acetaldehyde production.
Sodium/potassium methylate/ethylate production.
Polyurethane/plastic production.
Other (specify).
------------------------------------------------------------------------
(2) The specific use of mercury in a manufacturing process from a
pre-selected list, as listed in Table 4 of this part:
Table 4--Specific Use of Mercury in a Manufacturing Process
------------------------------------------------------------------------
-------------------------------------------------------------------------
Catalyst.
Cathode.
Reactant.
Reagent.
Other (specify).
------------------------------------------------------------------------
Sec. 713.13 Contextual requirements for which information must be reported.
Except as described at Sec. 713.7:
(a) Persons who manufacture (including import) mercury in amounts
greater than or equal to 2,500 lbs. for elemental mercury or greater
than or equal to 25,000 lbs. for mercury compounds for a specific
reporting year must report, as applicable:
(1) Country(ies) of origin for imported mercury;
(2) Country(ies) of destination for exported mercury; and
(3) NAICS code(s) for mercury distributed in commerce.
(b) All other persons who manufacture (including import) mercury
must report, as applicable:
(1) Country(ies) of origin for imported mercury;
[[Page 178]]
(2) Country(ies) of destination for exported mercury; and
(3) NAICS code(s) for mercury distributed in commerce.
(c) Persons who report sales of mercury-added products to IMERC must
report, as applicable:
(1) Country(ies) of origin for imported products;
(2) Country(ies) of destination for exported products; and
(3) NAICS code(s) for products distributed in commerce.
(d) All other persons who manufacture (including import) mercury-
added products must report, as applicable:
(1) Country(ies) of origin for imported products;
(2) Country(ies) of destination for exported products; and
(3) NAICS code(s) for products distributed in commerce.
(e) Persons who otherwise intentionally use mercury in a
manufacturing process, other than the manufacture of a mercury compound
or a mercury-added product, must report, as applicable:
(1) Country(ies) of destination for exported final product(s); and
(2) NAICS code(s) for mercury in final product(s) distributed in
commerce.
Sec. 713.15 Reporting information to EPA.
Any person who must report under this part must report for the
submission period described at Sec. 713.17:
(a) Quantities of mercury in pounds per applicable activity listed
under the general requirements for which information must be reported
described at Sec. 713.9;
(b) Specific requirements for which information must be reported
described at Sec. 713.11;
(c) Contextual requirements for which information must be reported
described at Sec. 713.13; and
(d) According to the procedures described at Sec. 713.21.
Sec. 713.17 When to report.
(a) Any person who must report under this part must report for the
reporting year described as follows. A reporting year is the year during
which mercury activity, required to be reported by this rule, has
occurred. The 2018 reporting year is from January 1, 2018 to December
31, 2018. Subsequent reporting years are from January 1 to December 31
at 3-year intervals, beginning in 2021.
(b) All information reported for an applicable reporting year must
be submitted on or before the first day of July following the reporting
year. The submission deadline for the 2018 reporting year is July 1,
2019. Subsequent submission deadlines are on or before the first day of
July following the reporting year, in 3-year intervals, beginning in
2022.
(c) The data from the 2018 reporting year will be used for the 2020
mercury inventory, the data from the 2021 reporting year will be used
for the 2023 mercury inventory, and so forth at three-year intervals.
Sec. 713.19 Recordkeeping requirements.
Each person who is subject to the reporting requirements of this
part must retain records that document any information reported to EPA.
Records relevant to a reporting year must be retained for a period of 3
years beginning on the last day of the reporting year. Submitters are
encouraged to retain their records longer than 3 years to ensure that
past records are available as a reference when new submissions are being
generated.
Sec. 713.21 Electronic filing.
(a) You must use the Mercury Electronic Reporting (MER) application
to complete and submit required information as set forth in Sec.
713.17. Submissions may only be made as set forth in this section.
(b) Submissions must be sent electronically to EPA via CDX.
(c) Access MER and instructions, as follows:
(1) By website. Access MER via the CDX homepage at https://
cdx.epa.gov/ and follow the appropriate links.
(2) By phone or email. Contact the EPA TSCA Hotline at (202) 554-
1404 or [email protected].
[[Page 179]]
PART 716_HEALTH AND SAFETY DATA REPORTING--Table of Contents
Subpart A_General Provisions
Sec.
716.1 Scope and compliance.
716.3 Definitions.
716.5 Persons who must report.
716.10 Studies to be reported.
716.20 Studies not subject to the reporting requirements.
716.21 Chemical specific reporting requirements.
716.25 Adequate file search.
716.30 Submission of copies of studies.
716.35 Submission of lists of studies.
716.40 EPA requests for submission of further information.
716.45 How to report on substances and mixtures.
716.50 Reporting physical and chemical properties.
716.55 Confidentiality claims.
716.60 Reporting schedule.
716.65 Reporting period.
Subpart B_Specific Chemical Listings
716.105 Additions of substances and mixtures to which this subpart
applies.
716.120 Substances and listed mixtures to which this subpart applies.
Authority: 15 U.S.C. 2607(d).
Source: 51 FR 32726, Sept. 15, 1986, unless otherwise noted.
Subpart A_General Provisions
Sec. 716.1 Scope and compliance.
(a) This subpart sets forth requirements for the submission of lists
and copies of health and safety studies on chemical substances and
mixtures selected for priority consideration for testing rules under
section 4(a) of the Toxic Substances Control Act (TSCA) and on other
chemical substances and mixtures for which EPA requires health and
safety information in fulfilling the purposes of TSCA.
(b) Section 15(3) of TSCA makes it unlawful for any person to fail
or refuse to submit information required under this subpart. Section 16
provides that a violation of section 15 renders a person liable to the
United States for a civil penalty and possible criminal prosecution.
Under section 17, the district courts of the United States have
jurisdiction to restrain any violation of section 15.
Sec. 716.3 Definitions.
The definitions in section 3 of TSCA apply to this subpart. In
addition, the following definitions are provided for the purposes of
this subpart:
Byproduct means a chemical substance produced without a separate
commercial intent during the manufacture, processing, use, or disposal
of another chemical substance(s) or mixture(s).
Central Data Exchange or CDX means EPA's centralized electronic
submission receiving system.
Chemical Information Submission System or CISS means EPA's
electronic, web-based tool for the completion and submission of data,
reports, and other information, or its successors.
Co-product means a chemical substance produced for a commercial
purpose during the manufacture, processing, use, or disposal of another
chemical substance(s) or mixture(s).
Copy of study means the written presentation of the purpose and
methodology of a study and its results.
EPA means the United States Environmental Protection Agency.
Health and safety study or study means any study of any effect of a
chemical substance or mixture on health or the environment or on both,
including underlying data and epidemiological studies, studies of
occupational exposure to a chemical substance or mixture, toxicological,
clinical, and ecological or other studies of a chemical substance or
mixture, and any test performed under TSCA.
(1) It is intended that the term health and safety study be
interpreted broadly. Not only is information which arises as a result of
a formal, disciplined study included, but other information relating to
the effects of a chemical substance or mixture on health or the
environment is also included. Any data that bear on the effects of a
chemical substance on health or the environment would be included.
Chemical identity is part of, or underlying data to, a health and safety
study.
(2) Examples are:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological
[[Page 180]]
effects; mammalian absorption, distribution, metabolism, and excretion;
cumulative, additive, and synergistic effects; and acute, subchronic,
and chronic effects.
(ii) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including: Acute
toxicity tests, chronic toxicity tests, critical life-stage tests,
behavioral tests, algal growth tests, seed germination tests, plant
growth or damage tests, microbial function tests, bioconcentration or
bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular chemical substance or
mixture on the environment, including surveys, tests, and studies of:
Biological, photochemical, and chemical degradation; structure/activity
relationships; air, water, and soil transport; biomagnification and
bioconcentration; and chemical and physical properties, e.g., boiling
point, vapor pressure, evaporation rates from soil and water, octanol/
water partition coefficient, and water solubility.
(iv) Monitoring data, when they have been aggregated and analyzed to
measure the exposure of humans or the environment to a chemical
substance or mixture.
Import means to import for commercial purposes.
Import for commercial purposes means to import with the purpose of
obtaining an immediate or eventual commercial advantage for the
importer, and includes the importation of any amount of a chemical
substance or mixture. If a chemical substance or mixture containing
impurities is imported for commercial purposes, then those impurities
are also imported for commercial purposes.
Importer means any person who imports a chemical substance,
including a chemical substance as a part of a mixture or article, into
the customs territory of the United States and includes the person
primarily liable for the payment of any duties on the merchandise or an
authorized agent acting on his behalf (as defined in 19 CFR 1.11).
Importer also includes, as appropriate:
(1) The consignee.
(2) The importer of record.
(3) The actual owner, if an actual owner's declaration and
superseding bond has been filed in accordance with 19 CFR 141.20.
(4) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred in accordance with subpart C of 19 CFR
part 144. For the purpose of this definition, the customs territory of
the United States consists of the 50 States, Puerto Rico, and the
District of Columbia.
Impurity means a chemical substance which is unintentionally present
with another chemical substance.
Listed mixture means any mixture listed in Sec. 716.120.
Manufacture means to manufacture for commercial purposes.
Manufacture for commercial purposes means: (1) To produce, with the
purpose of obtaining an immediate or eventual commercial advantage for
the manufacturer, and includes among other things such ``manufacture''
of any amount of a chemical substance or mixture:
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research
and development, or as an intermediate.
(2) Manufacture for commercial purposes also applies to substances
that are produced coincidentally during the manufacture, processing,
use, or disposal of another substance or mixture, including byproducts
and impurities. Such byproducts and impurities may, or may not, in
themselves have commercial value. They are nonetheless produced for the
purpose of obtaining a commercial advantage since they are part of the
manufacture of a chemical product for a commercial purpose.
Manufacturer means a person who produces or manufactures a chemical
substance. A person who extracts a component chemical substance from a
previously existing chemical substance or a complex combination of
substances is a manufacturer of that component chemical substance.
Person includes any individual, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other
business entity,
[[Page 181]]
any State or political subdivision thereof, any municipality, any
interstate body, and any department, agency, or instrumentality of the
Federal government.
Process means to process for commercial purposes.
Process for commercial purposes means the preparation of a chemical
substance or mixture, after its manufacture, for distribution in
commerce with the purpose of obtaining an immediate or eventual
commercial advantage for the processor. Processing of any amount of a
chemical substance or mixture is included. If a chemical substance or
mixture containing impurities is processed for commercial purposes, then
those impurities are also processed for commercial purposes.
Propose to manufacture, import, or process means that a person has
made a management decision to commit financial resources toward the
manufacture, importation, or processing of a substance or mixture.
Substance means chemical substance as defined at section 3(2)(A) of
TSCA, 15 U.S.C. 2602(2)(A).
TSCA means the Toxic Substances Control Act (15 U.S.C. 2601 et
seq.).
[51 FR 32726, Sept. 15, 1986, as amended at 78 FR 72826, Dec. 4, 2013]
Sec. 716.5 Persons who must report.
(a) Except as provided in paragraphs (b) and (c) of this section,
only those persons described in this section are required to report
under this part. Persons who must report include manufacturers
(including importers) who fall within the North American Industry
Classification System (NAICS) (in effect as of January 1, 1997)
Subsector 325 (chemical manufacturing and allied products) or Industry
Group 32411 (petroleum refineries), who:
(1) In the 10 years preceding the effective date on which a
substance or mixture is added to Sec. 716.120, either had proposed to
manufacture (including import), or had manufactured (including imported)
the listed substance or listed mixture (including as a known byproduct),
are required to report during the reporting period specified in Sec.
716.65.
(2) As of the effective date on which a substance or mixture is
added to Sec. 716.120, and who propose to manufacture (including
import), or who are manufacturing (including importing) the listed
substance or listed mixture (including as a known byproduct), are
required to report during the reporting period specified in Sec.
716.65.
(3) After the effective date on which a substance or mixture is
added to Sec. 716.120, and who propose to manufacture (including
import) the listed substance or listed mixture (including as a known
byproduct), are required to report during the reporting period specified
in Sec. 716.65.
(b) A rule promulgated under the authority of 15 U.S.C. 2607(d) may
require that any person who does not fall within NAICS (in effect as of
January 1, 1997) Subsector 325 or Industry Group 32411, and who had
proposed to manufacture (including import) or process, had manufactured
(including imported) or processed, proposes to manufacture (including
import) or process, or is manufacturing (including importing) or
processing a substance or mixture listed in Sec. 716.120 must report
under this part.
(c) Processors and persons who propose to process a substance or
mixture otherwise subject to the reporting requirements imposed by this
part are not subject to this part unless EPA specifically states
otherwise in a particular notice or rule promulgated under the authority
of 15 U.S.C. 2607(d).
[63 FR 15773, Apr. 1, 1998]
Sec. 716.10 Studies to be reported.
(a) In general, health and safety studies, as defined in Sec.
716.3, on any substance or listed mixture listed in Sec. 716.120, that
are unpublished are reportable, i.e., must be submitted or listed.
However, this requirement has limitations according to the nature of the
material studied, so that:
(1) All studies of substances and listed mixtures are reportable.
However, in the case of physical and chemical properties, only those
studies listed in Sec. 716.50 must be submitted.
(2) Studies of mixtures known to contain substances or listed
mixtures listed in Sec. 716.120 are reportable except for studies of
physical and chemical properties and the studies exempted at Sec.
716.20(a)(6) (i) through (vi).
[[Page 182]]
(3) Studies of substances or listed mixtures that a person who is
reporting has manufactured, imported, or processed or proposed to
manufacture, import, or process only as impurities are not generally
reportable under Sec. 716.20(a)(9).
(4) Underlying data, such as medical or health records, individual
files, lab notebooks, and daily monitoring records supporting studies do
not have to be submitted initially. EPA may request underlying data
later under Sec. 716.40.
(b) [Reserved]
Sec. 716.20 Studies not subject to the reporting requirements.
(a) Excluding paragraph (a)(3) of this section, the following types
of studies are exempt from the copy and list submission requirements of
Sec. Sec. 716.30 and 716.35.
(1) Studies which have been published in the scientific literature.
(2) Studies previously submitted to the EPA Office of Pollution
Prevention and Toxics. These studies are limited to section 8(e)
submissions, studies submitted during section 4 proceedings, studies
submitted with premanufacture notices or significant new use notices,
and studies submitted ``for your information'' (FYI submissions) in
support of EPA's TSCA Existing Chemicals Program. Studies which have
been initiated pursuant to a TSCA section 4(a) test rule, for which the
person has submitted a letter of intent to conduct testing in accordance
with the provisions of Sec. 790.25 of part 790 of this chapter, are
exempt from the list submission requirements of Sec. 716.35.
(3) Except for those studies described in paragraph (a)(2) of this
section, studies previously submitted to any Federal agency with no
claims of confidentiality are exempt only from the copy submission
requirements of Sec. 716.30, and must be listed in accordance with the
provisions of Sec. 716.35.
(4) Studies conducted or initiated by or for another person who is
subject to, and who will report the studies under Sec. Sec. 716.30 and
716.35.
(5) Studies of chemical substances which are not on the TSCA
Chemical Substances Inventory. This exemption applies only to those
substances within categories listed under Sec. 716.120(c).
(6) The following types of studies when the subject of the study is
a mixture known to contain a substance or listed mixture listed under
Sec. 716.120.
(i) Acute oral toxicity studies.
(ii) Acute dermal toxicity studies.
(iii) Acute inhalation toxicity studies.
(iv) Primary eye irritation studies.
(v) Primary dermal irritation studies.
(vi) Dermal sensitization studies.
(vii) Physical and chemical properties.
If the substance or listed mixture is an impurity, no reporting is
required (see paragraph (a)(9) of this section).
(7) Analyzed aggregations of monitoring data based on monitoring
data acquired more than 5 years preceding the date the substance or
listed mixture was added to the list under Sec. 716.120.
(8) Analyzed aggregations of monitoring data on mixtures known to
contain one or more substances or listed mixtures listed in Sec.
716.120, when the monitoring data are not analyzed to determine the
exposure or concentration levels of the substances or listed mixture
listed under Sec. 716.120.
(9) Studies on a substance or listed mixture listed under Sec.
716.120 that the person who is reporting has manufactured, imported, or
processed or proposed to manufacture, import, or process only as an
impurity. When reporting of such studies is to be required, that
reporting will be separately proposed in the Federal Register.
(10) Studies of chemical substances or listed mixtures previously
submitted by trade associations in accordance with the provisions of
Sec. 716.30.
(b) The following types of studies on substances or listed mixtures
listed under Sec. 716.120 are exempt from the copy and list submission
requirements of Sec. Sec. 716.30 and 716.35.
(1) For the listed ureaformaldehyde resins (CAS Nos. 9011-05-6 and
68611-64-3), studies on agronomic plant growth or damage which
demonstrate only that the resins stimulate plant growth or cause plant
damage when applied as a fertilizer.
[[Page 183]]
(2) For the specified chemicals in Sec. 716.120(d) under the
category ``Siloxanes,'' acute oral, dermal, and inhalation toxicity
studies and primary eye and dermal irritation studies.
(3) For the listed chemicals under Sec. 716.120(d) in the category
``OSHA Chemicals in Need of Dermal Absorption Testing,'' studies on
ecological effects.
(4) For the chemicals listed at Sec. 716.120 with a special
exemption referencing this paragraph, studies on mixtures containing the
listed substance at levels below 1 percent of the mixture, except when a
purpose of the study includes the investigation of the effects of the
listed substance at levels below 1 percent.
(5) Rulemaking proceedings that add substances and mixtures to Sec.
716.120 will specify the types of health and/or environmental effects
studies that must be reported and will specify the chemical grade/purity
requirements that must be met or exceeded in individual studies.
Chemical grade/purity requirements will be specified on a per chemical
basis or for a category of chemicals for which reporting is required.
[51 FR 32726, Sept. 15, 1986, as amended at 58 FR 47649, Sept. 10, 1993;
58 FR 68315, Dec. 27, 1993; 60 FR 34884, July 5, 1995; 63 FR 15773, Apr.
1, 1998]
Sec. 716.21 Chemical specific reporting requirements.
(a) Health and safety studies reportable under part 716 for the
following chemical substances, mixtures, or categories of chemical
substances, as listed in Sec. 716.120, must be submitted or listed only
as specified in this section:
(1) For 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- and
imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro-, all unpublished
environmental effects studies and health effects studies on
pharmacokinetics, genotoxicity, subchronic toxicity, immunotoxicity,
carcinogenicity, reproductive effects, and developmental toxicity where
the purity of 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- or
imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione, tetrahydro- is greater than
or equal to 90% of the test substance by weight must be submitted.
(2) For benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-
(trifluoromethyl)-, all unpublished environmental effects studies
including bioconcentration, environmental fate studies on
biodegradation, and health effects studies on pharmacokinetics,
subchronic toxicity, mutagenicity, reproductive effects, and
developmental toxicity, and carcinogenicity where the purity of
benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- is
greater than or equal to 90% of the test substance by weight must be
submitted.
(3) For stannane, dimethylbis[(1-oxoneodecyl)oxy]-, all unpublished
environmental effects studies including bioconcentration, environmental
fate studies on hydrolysis and biodegradation and health effects studies
on pharmacokinetics, subchronic toxicity, mutagenicity, neurotoxicity,
reproductive effects, and developmental toxicity, and carcinogenicity
where the purity of stannane, dimethylbis[(1-oxoneodecyl)oxy]- is
greater than or equal to 90% of the test substance by weight must be
submitted.
(4) For benzene, 1,3,5-tribromo-2-(2-propenyloxy)-, all unpublished
environmental effects studies including bioconcentration, environmental
fate studies on biodegradation and health effects studies on
pharmacokinetics, subchronic toxicity, neurotoxicity, reproductive
effects, and developmental toxicity, and carcinogenicity where the
purity of benzene, 1,3,5-tribromo-2-(2-propenyloxy)- is greater than or
equal to 90% of the test substance by weight must be submitted.
(5) For 1-triazene, 1,3-diphenyl-, all unpublished health effects
studies on pharmacokinetics, genotoxicity, subchronic and chronic
toxicity, reproductive effects, and developmental toxicity where the
purity of 1-triazene, 1,3-diphenyl- is greater than or equal to 90% of
the test substance by weight must be submitted.
(6) For the 9 chemicals in the indium compound category, all
unpublished health effects studies on pharmacokinetics, genotoxicity,
subchronic and chronic toxicity, reproductive effects, and developmental
toxicity where the purity of the indium compound is greater than or
equal to 90% of the test
[[Page 184]]
substance by weight must be submitted.
(7) For all voluntary HPV Challenge Program orphan (unsponsored)
chemicals:
(i) All unpublished environmental fate studies, meeting the criteria
set forth in paragraph (a)(7)(iv) of this section, on water solubility;
adsorption/desorption on particulate surfaces, e.g., soil; vapor
pressure; octanol/water partition coefficient; density/relative density
(specific gravity); particle size distribution for insoluble solids;
dissociation constant; degradation by photochemical mechanisms--aquatic
and atmospheric; degradation by chemical mechanisms--hydrolytic,
reductive, and oxidative; degradation by biological mechanisms--aerobic
and anaerobic. Studies of physical and chemical properties meeting the
criteria set forth in paragraph (a)(7)(iv) of this section must be
reported if performed for the purpose of determining the environmental
or biological fate of a substance, and only if they investigated one or
more of the properties listed in this paragraph. In addition, all
unpublished studies meeting the criteria set forth in paragraph
(a)(7)(iv) of this section on melting point and boiling point must be
submitted.
(ii) All unpublished health effects studies meeting the criteria set
forth in paragraph (a)(7)(iv) of this section including
pharmacokinetics, genotoxicity, acute toxicity, subacute toxicity,
subchronic toxicity, chronic toxicity, reproductive toxicity,
developmental toxicity, immunotoxicity, neurotoxicity, and oncogenicity/
carcinogenicity.
(iii) All unpublished environmental effects studies meeting the
criteria set forth in paragraph (a)(7)(iv) of this section including
acute and chronic toxicity studies of aquatic and terrestrial
vertebrates and invertebrates and aquatic plants.
(iv) Only studies where the voluntary HPV Challenge Program orphan
(unsponsored) chemical is =90% of the test substance by
weight should be submitted. In addition, only studies that were
conducted using TSCA, Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), Organization for Economic Cooperation and Development
(OECD) or other internationally accepted test guidelines or voluntary
consensus standards should be submitted. Studies performed where the
voluntary HPV Challenge Program orphan (unsponsored) chemical is <90% of
the test substance by weight are not requested at this time.
(8)(i) Reporting requirements apply only to manufacturers (including
importers) of consumer products intended for use by children who also
manufacture (including import) lead or lead compounds. For the category
``lead and lead compounds,'' all unpublished health and safety studies
that:
(A) Relate to the lead content of consumer products that are
``intended for use by children'' as that term is defined at 40 CFR
710.43 (excluding children's metal jewelry), or
(B) Assess children's exposure to lead from such products (including
studies of bioavailability).
(ii) With regard to purity, studies showing any measurable lead
content in such products must be submitted.
(9) For 1,3-Butadiene (106-99-0), Butyl benzyl phthalate (BBP)--1,2-
Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (85-68-7),
Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl
ester) (84-74-2), o-Dichlorobenzene (95-50-1), p-Dichlorobenzene (106-
46-7), trans-1,2-Dichloroethylene (156-60-5), 1,2-Dichloropropane (78-
87-5), Dicyclohexyl phthalate (84-61-7), Di-ethylhexyl phthalate
(DEHP)--(1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)
(117-81-7), Di-isobutyl phthalate (DIBP)--(1,2-Benzene- dicarboxylic
acid, 1,2- bis-(2methylpropyl) ester) (84-69-5), Formaldehyde (50-00-0),
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran
(HHCB) (1222-05-5), Phthalic anhydride (85-44-9), 4,4'-(1-
Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (79-94-7), and 1,1,2-
Trichloroethane (79-00-5), all unpublished studies on health effects
(including toxicity studies (in vivo and in vitro) on carcinogenicity,
reproductive and developmental effects, genotoxicity, neurotoxicity,
immunotoxicity, endocrine effects, and other systemic toxicity);
[[Page 185]]
toxicokinetics (absorption, distribution, metabolism, or elimination),
including modelling studies, in humans or animals; environmental
effects; environmental fate; physical-chemical properties if performed
as described in 40 CFR 716.50; and occupational (both users and non-
users), general population, consumer, bystander, and environmental
exposure must be submitted. Studies showing any measurable content of
the High-Priority Substance in the tested substance (single substances
or mixture) must be reported. The composition and purity of test
substances must be reported if included as part of the study. Studies
previously submitted to EPA pursuant to a requirement under TSCA or of
the submitter's own accord and studies conducted or to be conducted
pursuant to a TSCA section 4 action are exempt from the submission of
lists of health and safety studies required under 40 CFR 716.35 and the
submission of studies required under this rule.
(10) For purposes of this paragraph, the term organohalogen flame
retardant includes any substances listed in paragraph(d) of this section
under the category ``Organohalogen flame retardants''. For any
organohalogen flame retardant, all unpublished studies on health effects
(including toxicity studies (in vivo and in vitro) on carcinogenicity,
reproductive and developmental effects, genotoxicity, neurotoxicity,
immunotoxicity, endocrine effects, and other systemic toxicity);
toxicokinetics (absorption, distribution, metabolism, or elimination),
including modelling studies, in humans or animals; environmental fate;
physical-chemical properties if performed as described in 40 CFR 716.50;
and occupational (both users and non-users), general population,
consumer, bystander, and environmental exposure must be submitted.
Studies showing any measurable content of the organohalogen flame
retardant in the tested substance (single substances or mixture) must be
reported. The composition and purity of test substances must be reported
if included as part of the study. Studies previously submitted to EPA
pursuant to a requirement under TSCA or of the submitter's own accord
and studies conducted or to be conducted pursuant to a TSCA section 4
action are exempt from the submission of lists of health and safety
studies requirements under 40 CFR 716.35 and the submission of studies
requirements under this rule.
(b) [Reserved]
[69 FR 24522, May 4, 2004, as amended at 71 FR 47135, Aug. 16, 2006; 73
FR 5115, Jan. 29, 2008; 86 FR 34152, June 29, 2021]
Sec. 716.25 Adequate file search.
The scope of a person's responsibility to search records is limited
to records in the location(s) where the required information is
typically kept, and to records kept by the person or the person's
individual employee(s) who is/are responsible for keeping such records
or advising the person on the health and environmental effects of
chemicals. Persons are not required to search for reportable information
dated before January 1, 1977, to comply with this subpart unless
specifically required to do so in a rule.
[63 FR 15773, Apr. 1, 1998]
Sec. 716.30 Submission of copies of studies.
(a)(1) Except as provided in Sec. Sec. 716.5, 716.20, and 716.50,
persons must send to EPA copies of any health and safety studies in
their possession for the substances or mixtures listed in Sec. 716.120.
Persons are responsible for submitting copies on only the substances or
listed mixtures which they: Have manufactured, imported, or processed or
proposed to manufacture, import, or process (including as known
byproducts) within the 10 years preceding the effective date for
reporting on the substances or listed mixtures; manufacture, import, or
process on the effective date for reporting on the substances or listed
mixtures; and propose to manufacture, import, or process following the
effective date for reporting on the substances or listed mixtures.
Persons who list studies as ongoing or initiated under Sec. 716.35(a)
(1) and (2) must submit them when they are completed.
(2) [Reserved]
(b) Submissions under paragraph (a) of this section must be
identified either on the face of the study or otherwise
[[Page 186]]
by the applicable chemical name and CAS number (if any) listed in Sec.
716.120(a) (1) and (2), and must be accompanied by a cover letter
containing the name, job title, address and telephone number of the
submitting official, and the name and address of the manufacturing or
processing establishment on whose behalf the submission is made. In the
cover letter, submitters must identify any impurity or additive known to
have been present in the substance or listed mixtures as studied unless
its presence is specifically noted in the study itself. The cover letter
accompanying a study submitted by a trade association must also state
that the submission is to satisfy reporting requirements under this
part.
(c) Persons must use the CISS tool to complete and submit all data,
reports, and other information required by 40 CFR part 716, via CDX.
Submission requires registration with CDX, and must be made only as set
forth in this section.
(d) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP /
PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and
for further instructions to go http://www.epa.gov/oppt/chemtest /
ereporting/index.html.
[51 FR 32726, Sept. 15, 1986, as amended at 52 FR 20084, May 29, 1987;
52 FR 44828, Nov. 20, 1987; 53 FR 12523, Apr. 15, 1988; 60 FR 34463,
July 3, 1995; 63 FR 15773, Apr. 1, 1998; 71 FR 47135, Aug. 16, 2006; 78
FR 72826, Dec. 4, 2013]
Sec. 716.35 Submission of lists of studies.
(a) Except as provided in Sec. Sec. 716.5, 716.20, and 716.50,
persons subject to this rule must send lists of studies to EPA for each
of the listed substances or listed mixtures (including as a known
byproduct) in Sec. 716.120 which they are manufacturing, importing, or
processing, or which they propose to manufacture (including import) or
process.
(1) Ongoing studies. As of the date a person becomes subject to this
part, a list of ongoing health and safety studies being conducted by or
initiated for them, noting for each entry: The beginning date of the
study, the purpose of the study, the types of data to be collected, the
anticipated date of completion, and the name and address of the
laboratory conducting the study.
(2) Initiated studies. After the date a person becomes subject to
this part, a list of studies initiated by or for them, noting for each
entry: The beginning date of the study, the purpose of the study, the
types of data to be collected, the anticipated date of completion, and
the name and address of the laboratory conducting the study.
(3) Studies which are known but without possession of copies. As of
the date a person becomes subject to this part, a list of unpublished
health and safety studies known to them of which they do not have
copies. The name and address of any person known to them to possess a
copy of the unpublished study must accompany each entry on the list. For
purposes of this section only, an unpublished study will be considered
to be ``known to'' a person, if the study can be discovered by a file
search in accordance with Sec. 716.25.
(4) Studies previously sent to Federal agencies without
confidentiality claims. A list of unpublished studies which have been
sent to a Federal Agency with no claims of confidentiality. The
submission must for each study: Identify the study by title, state the
name and address to whom the study was sent, and the month and year in
which the study was submitted. Any study identified will be treated as
if it were submitted under section 8(d) and will be available for public
disclosure under section 14(b) of TSCA. Persons subject to this
requirement may submit either a list of unpublished health and safety
studies previously submitted to any Federal agency without claims of
confidentiality in accordance with Sec. 716.35(a)(4), or copies of each
such study in accordance with Sec. 716.30.
(b) Submission under paragraph (a) of this section must be
identified either on the face of the study or otherwise by the
applicable chemical name and CAS number (if any) listed in Sec.
716.120(a) (1) and (2), and must be accompanied by a cover letter
containing the name, job title, address and telephone numbers of the
submitting official, and the name and address of the manufacturing or
processing establishment on whose behalf the submission is made.
[[Page 187]]
(c) Persons must use the CISS tool to complete and submit all data,
reports, and other information required by 40 CFR part 716, via CDX.
Submission requires registration with CDX, and must be made only as set
forth in this section.
(d) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP /
PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and
for further instructions to go http://www.epa.gov/oppt/chemtest /
ereporting/index.html.
[51 FR 32726, Sept. 15, 1986, as amended at 52 FR 20084, May 29, 1987;
52 FR 44828, Nov. 20, 1987; 53 FR 12523, Apr. 15, 1988; 53 FR 46746,
Nov. 18, 1988; 60 FR 34463, July 3, 1995; 63 FR 15774, Apr. 1, 1998; 71
FR 47135, Aug. 16, 2006; 78 FR 72826, Dec. 4, 2013]
Sec. 716.40 EPA requests for submission of further information.
EPA may, by letter, request a person to submit or make available for
review the following information after the initial reporting under
Sec. Sec. 716.30 and 716.35. If the requested submissions are not made,
EPA may subpoena them under section 11 of TSCA, 15 U.S.C. 2610.
(a) Submission of underlying data of the kind described in Sec.
716.10(a)(4) by persons who submit copies of studies under Sec. 716.30
or list studies under Sec. 716.35(a)(1) or Sec. 716.35(a)(2).
(b) Submission of preliminary reports of ongoing studies by persons
who list the studies under Sec. 716.35(a)(1) or Sec. 716.35(a)(2).
(c) Submission of copies of studies by persons listed under Sec.
716.35(a)(3) as possessing them.
Sec. 716.45 How to report on substances and mixtures.
Section 716.120 lists substances and mixtures, in order by Chemical
Abstract Service Registry Number and by alphabetical order. Studies of
listed substances and listed mixtures shall be reported as follows:
(a) When a substance is individually listed under Sec. 716.120(a),
studies of the substance and studies of mixtures known to contain the
substance must be reported as studies of that substance.
(b) When two or more substances are listed as a mixture under Sec.
716.120(b), studies of the listed mixture and studies of any mixture
known to contain the listed mixture must be reported as studies of the
listed mixture.
(c) Studies of the following preparations of a substance must be
reported as studies of the substance itself, not as studies of mixtures
known to contain the substance.
(1) The substance in aqueous solution.
(2) The substance containing a small amount of an additive, such as
a stabilizer, emulsifier, or other chemical added for purposes of
maintaining the integrity or physical form of the substance.
(3) The substance of the grade/purity specified in each rule
promulgated under 15 U.S.C. 2607(d).
[51 FR 32726, Sept. 15, 1986, as amended at 63 FR 15774, Apr. 1, 1998]
Sec. 716.50 Reporting physical and chemical properties.
Studies of physical and chemical properties must be reported under
this subpart if performed for the purpose of determining the
environmental or biological fate of a substance, and only if they
investigated one or more of the following properties:
(a) Water solubility.
(b) Adsorption/desorption on particulate surfaces, e.g., soil.
(c) Vapor pressure.
(d) Octanol/water partition coefficient.
(e) Density/relative density (specific gravity).
(f) Particle size distribution for insoluble solids.
(g) Dissociation constant.
(h) Degradation by photochemical mechanisms--aquatic and
atmospheric.
(i) Degradation by chemical mechanisms--hydrolytic, reductive, and
oxidative.
(j) Degradation by biological mechanisms--aerobic and anaerobic.
Sec. 716.55 Confidentiality claims.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
[88 FR 37172, June 7, 2023]
[[Page 188]]
Sec. 716.60 Reporting schedule.
(a) General requirements. Except as provided in Sec. 716.5 and
paragraphs (b) and (c) of this section, submissions under Sec. Sec.
716.30 and 716.35 must be submitted using the electronic method
specified in Sec. Sec. 716.30(c) and 716.35(c), on or before 60 days
after the effective date of the listing of a substance or mixture in
Sec. 716.120 or within 60 days of proposing to manufacture (including
import) or process a listed substance or listed mixture (including as a
known byproduct) if first done after the effective date of the substance
or mixture being listed in Sec. 716.120.
(b)(1) Submission of lists of initiated studies. Persons subject to
the listing requirements of Sec. 716.35(a)(2) must inform EPA of the
initiated study within 30 days of its initiation.
(2) Submission of copies of completed studies. Persons must submit
studies listed as ongoing or initiated under Sec. 716.35(a)(1) and (2)
within 30 days of completing the study, using the method specified in
Sec. Sec. 716.30(c) and 716.35(c).
(c) Requests for extensions of time. Respondents who cannot meet a
deadline under this section may apply for a reasonable extension of
time. Extension requests must be submitted on or before 40 days after
the effective date of the listing of a substance or mixture in Sec.
716.120, using the electronic method specified in Sec. Sec. 716.30(c)
and 716.35(c). The Director of EPA's Office of Pollution Prevention and
Toxics will grant or deny extension requests.
(d) Submission methods. Persons must use the CISS tool to complete
and submit all data, reports, and other information required by 40 CFR
part 716, via CDX. Submission requires registration with CDX, and must
be made only as set forth in this section.
(e) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP /
PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and
for further instructions to go http://www.epa.gov/oppt/chemtest /
ereporting/index.html.
[51 FR 32726, Sept. 15, 1986, as amended at 60 FR 34464, July 3, 1995;
63 FR 15774, Apr. 1, 1998; 71 FR 47135, Aug. 16, 2006; 78 FR 72826, Dec.
4, 2013]
Sec. 716.65 Reporting period.
Unless otherwise required in a rule promulgated under 15 U.S.C.
2607(d) relating to a listed chemical substance or listed mixture
[hereinafter ``rule''], the reporting period for a listed chemical
substance or listed mixture will terminate 60 days after the effective
date on which the listed chemical substance or listed mixture is added
to 40 CFR 716.120. EPA may require reporting for a listed chemical
substance or listed mixture beyond the 60 day period in a rule
promulgated under 15 U.S.C. 2607(d), however EPA will not extend any
reporting period later than 2 years after the effective date on which a
listed chemical substance or listed mixture is added to 40 CFR 716.120.
After the applicable reporting period terminates, any person subject to
the rule under 40 CFR 716.5 (a)(2) or (a)(3) and who has submitted to
EPA lists of ongoing or initiated studies under 40 CFR 716.35 (a)(1) or
(a)(2) must submit a copy of any such study within 30 days after its
completion, regardless of the study's completion date.
[63 FR 15774, Apr. 1, 1998]
Subpart B_Specific Chemical Listings
Sec. 716.105 Additions of substances and mixtures to which this subpart applies.
The requirements of this subpart will be extended periodically to
cover additional substances and mixtures. Two procedures will be used to
add substances and mixtures.
(a) Except as provided in paragraph (b) of this section, substances
and mixtures will be added to Sec. 716.120 after publication in the
Federal Register of a notice of proposed amendment to this subpart.
There will be at least a 30-day public comment period on the notice.
After consideration of the comments, EPA will amend Sec. 716.120 by
final rule to add the substances and listed mixtures.
(b) Except as provided in paragraph (c) of this section, chemical
substances, mixtures, and categories of chemical substances that have
been added to the TSCA section 4(e) Priority
[[Page 189]]
List by the Interagency Testing Committee, established under section 4
of TSCA, will be added to Sec. 716.120 but only to the extent that the
total number of designated and recommended substances, mixtures and
categories of chemical substances has not exceeded 50 in any 1 year. The
addition of such chemical substances, mixtures, and categories of
chemical substances to Sec. 716.120 will be effective 30 days after
publication of a notice to that effect in the Federal Register.
(c) Prior to the effective date of an amendment under paragraph (b)
of this section, the Assistant Administrator for Chemical Safety and
Pollution Prevention may for good cause withdraw a chemical substance,
mixture, or category of chemical substances from Sec. 716.120. Any
information submitted showing why a chemical substance, mixture, or
category of chemical substances should be withdrawn from the amendment
must be received by EPA within 14 days after the date of publication of
the notice under paragraph (b) of this section. If a chemical substance,
mixture, or category of chemical substances is withdrawn, a Federal
Register notice announcing this decision will be published no later than
the effective date of the amendment under paragraph (b) of this section.
(d) Persons who wish to submit information that shows why a
substance should be withdrawn must submit their comments by using the
CISS tool to complete and submit all data, reports, and other
information required by 40 CFR part 716, via CDX. Submission requires
registration with CDX, and must be made only as set forth in this
section.
(e) To access the CISS tool go to https://cdx.epa.gov/ssl/CSPP /
PrimaryAuthorizedOfficial/Home.aspx and follow the appropriate links and
for further instructions to go http://www.epa.gov/oppt/chemtest /
ereporting/index.html.
[51 FR 32726, Sept. 15, 1986, as amended at 60 FR 34464, July 3, 1995;
71 FR 47135, Aug. 16, 2006; 77 FR 46292, Aug. 3, 2012; 78 FR 72827, Dec.
4, 2013]
Sec. 716.120 Substances and listed mixtures to which this subpart applies.
Substances listed in this section appear in order by Chemical
Abstract Service Registry Number. Chemical mixtures and categories are
listed separately and by alphabetical order. Chemical substances listed
within a category are provided only as examples of the category, and are
not included on the list of substances. When a chemical substance in the
substance or category list had been listed previously by a trivial (or
common) name, it appears first, followed by the Chemical Abstract
Service (CAS) name appearing in the TSCA Chemical Substance Inventory.
(a) List of substances. The following chemical substances are
subject to all the provisions of part 716. Manufacturers, importers, and
processors of a listed substance are subject to the reporting
requirements of subpart A for that substance.
----------------------------------------------------------------------------------------------------------------
Effective Sunset
CAS No. Substance Special exemptions date date
----------------------------------------------------------------------------------------------------------------
62-74-8 Acetic acid, fluoro-, sodium salt........ ................................ 03/07/86 03/07/96
67-63-0 2-Propanol............................... ................................ 12/15/86 12/15/96
67-66-3 Methane, trichloro-...................... ................................ 06/01/87 06/01/97
67-72-1 Ethane, hexachloro-...................... ................................ 04/29/83 01/13/86
68-12-2 Dimethyl formamide-Formamide, N,N- ................................ 4/13/89 12/19/95
dimethyl-.
71-55-6 1,1,1-Trichloroethane--Ethane, 1,1,1- ................................ 10/04/82 10/04/92
trichloro-.
74-83-9 Methane, bromo-.......................... ................................ 06/01/87 06/01/97
74-87-3 Chloromethane--Methane, chloro-.......... ................................ 10/04/82 10/04/92
74-95-3 Methane, dibromo-........................ ................................ 6/1/87 12/19/95
74-97-5 Methane, bromochloro-.................... ................................ 6/1/87 12/19/95
75-00-3 Ethane, chloro-.......................... ................................ 06/01/87 06/01/97
75-02-5 Vinyl fluoride--Ethene, fluoro-.......... ................................ 10/04/82 10/04/92
75-04-7 Ethanamine............................... ................................ 6/1/87 12/19/95
75-05-8 Acetonitrile............................. ................................ 10/04/82 10/04/92
75-09-2 Methylene chloride--Methane, dichloro-... ................................ 10/04/82 10/04/92
75-12-7 Formamide................................ ................................ 04/29/83 04/29/93
75-21-8 Oxirane.................................. ................................ 10/04/82 10/04/92
75-25-2 Methane, tribromo-....................... ................................ 06/01/87 06/01/97
75-27-4 Methane, bromodichloro-.................. ................................ 6/1/87 12/19/95
75-29-6 Propane, 2-chloro-....................... ................................ 6/1/87 12/19/95
[[Page 190]]
75-34-3 Ethane, 1,1-dichloro-.................... ................................ 06/01/87 06/01/97
75-37-6 1,1-Difluoroethane-Ethane, 1,1-difluoro-. ................................ 4/13/89 12/19/95
75-38-7 Vinylidene fluoride--Ethene, 1,1-difluoro- ................................ 10/04/82 10/04/92
.
75-43-4 Dichloromonofluoromethane-Methane, ................................ 4/13/89 12/19/95
dichlorofluoro-.
75-45-6 Chlorodifluoromethane--Methane, ................................ 4/13/89 6/30/98
chlorodifluoro-.
75-52-5 Nitromethane-Methane, nitro-............. ................................ 4/13/89 12/19/95
75-56-9 Oxirane, methyl-......................... ................................ 10/04/82 10/04/92
75-68-3 1-Chloro-1,1-difluoroethane-Ethane, 1- ................................ 4/13/89 12/19/95
chloro-1,1-difluoro.
75-86-5 Propanenitrile, 2-hydroxy-2-methyl-...... ................................ 3/7/86 12/19/95
75-88-7 Ethane, 2-chloro- 1,1,1-trifluoro........ ................................ 10/15/90 11/09/93
76-13-1 1,1,2-Trichloro-1,2,2-trifluoroethane- ................................ 4/13/89 12/19/95
Ethane, 1,1,2-trichloro-1,2,2-trifluoro-
1.
77-47-4 Hexachlorocyclopentadiene--1,3- ................................ 10/04/82 10/04/92
Cyclopentadiene, 1,2,3,4,5,5-hexachloro-.
77-58-7 Dibutyltin dilaurate--Stannane, ................................ 01/03/83 01/03/93
dibutylbis[(1-oxododecyl)oxy]-.
78-59-1 Isophorone--2-Cyclohexen-1-one, 3,5,5- ................................ 10/04/82 10/04/92
trimethyl-.
78-83-1 1-Propanol, 2-methyl-.................... ................................ 03/07/86 03/07/96
78-87-5 1,2-Dichloropropane--Propane, 1,2- ................................ 10/04/82 10/04/92
dichloro-.
78-88-6 1-Propene, 2,3-dichloro-................. ................................ 6/1/87 12/19/95
78-93-3 Methyl ethyl ketone--2-Butanone.......... ................................ 10/04/82 10/04/92
78-97-7 Propanenitrile, 2-hydroxy-............... ................................ 6/1/87 12/19/95
78-99-9 Propane, 1,1-dichloro-................... ................................ 3/7/86 12/19/95
79-00-5 Ethane, 1,1,2-trichloro-................. ................................ 06/01/87 06/01/97
79-06-1 Acrylamide--2-Propenamide................ ................................ 10/04/82 10/04/92
79-24-3 Nitroethane-Ethane, nitro-............... ................................ 4/13/89 12/19/95
79-94-7 Tetrabromobisphenol A--Phenol, 4,4'- ................................ 06/20/85 06/20/95
(methylethylidene)bis[2,6-dibromo-.
80-05-7 Bisphenol A--Phenol, 4,4'-(1- ................................ 06/28/84 06/28/94
methylethylidene)bis-.
80-15-9 Hydroperoxide, 1-methyl-1-phenylethyl.... ................................ 3/7/86 12/19/95
80-62-6 Methyl methacrylate--2-Propenoic acid, 2- ................................ 4/13/89 6/30/98
methyl-, methyl ester.
84-65-1 Anthraquinone--9,10-Anthracenedione...... ................................ 12/28/84 11/09/93
85-22-3 Pentabromoethylbenzene--Benzene, ................................ 12/28/84 12/28/94
pentabromoethyl-.
85-68-7 Benzyl butyl phthalate--1,2- ................................ 04/29/83 04/29/93
Benzenedicarboxylic acid, butyl
phenylmethyl ester.
86-74-8 9H-Carbazole............................. ................................ 03/07/86 03/07/96
87-68-3 Hexachloro-1,3-butadiene--1,3-Butadiene, ................................ 10/04/82 10/04/92
1,1,2,3,4,4-hexachloro-.
88-04-0 p-Chloro-m-xylenol-Phenol, 4-chloro-3,5- ................................ l4/13/89 12/19/95
dimethyl-.
90-30-2 N-Phenyl-1-naphthylamine................. ................................ 9/30/91 12/19/95
90-42-6 [1,1'-Bicyclohexyl]-2-one................ ................................ 06/01/87 11/09/93
91-08-7 Benzene, 1,3-diisocyanato-2-methyl-...... ................................ 6/1/87 12/19/95
91-20-3 Naphthalene.............................. ................................ 06/01/87 06/01/97
91-58-7 Naphthalene, 2-chloro-................... ................................ 10/04/82 10/04/92
92-52-4 1,1'-Biphenyl............................ ................................ 04/29/83 04/29/93
92-69-3 [1,1'-Biphenyl]-4-ol..................... ................................ 6/1/87 12/19/95
92-84-2 10H-Phenothiazine........................ ................................ 06/01/87 06/01/97
92-87-5 [1,1'-Biphenyl]-4,4'-diamine............. ................................ 06/01/87 06/01/97
95-14-7 1,2,3-Benzotriazole-1H-Benzotriazole..... ................................ 4/13/89 12/19/95
95-47-6 o-Xylene--Benzene, 1,2-dimethyl-......... ................................ 10/04/82 10/04/92
95-48-7 o-Cresol--Phenol, 2-methyl-.............. ................................ 10/04/82 10/04/92
95-49-8 2/Chlorotoluene--Benzene, 1-chloro-2- ................................ 04/29/83 04/29/93
methyl-.
95-53-4 Benzenamine, 2-methyl-................... ................................ 3/7/86 12/19/95
95-63-6 1,2,4-Trimethylbenzene--Benzene, 1,2,4- ................................ 04/29/83 04/29/93
trimethyl-.
96-18-4 Propane, 1,2,3-trichloro-................ ................................ 06/01/87 06/01/97
96-29-7 2-Butanone, oxime........................ ................................ 12/15/86 12/19/95
96-37-7 Methylcyclopentane--Cyclopentane, methyl- ................................ 06/20/85 11/09/93
97-18-7 Phenol, 2,2'-thiobis[4,6-dichloro-....... ................................ 6/1/87 12/19/95
97-23-4 Phenol, 2,2'-methylenebis[4-chloro-...... ................................ 6/1/87 12/19/95
97-88-1 Butyl methacrylate-2-Propenoic acid, 2- ................................ 4/13/89 12/19/95
methyl-,butyl ester.
98-01-1 2-Furancarboxaldehyde.................... ................................ 06/01/87 06/01/97
98-06-6 Benzene, (1,1-dimethylethyl)-............ ................................ 6/1/87 12/19/95
98-09-9 Benzenesulfonyl chloride................. ................................ 3/7/86 12/19/95
98-51-1 p-tert-Butyltoluene--Benzene, 1-(1,1- ................................ 06/25/86 06/25/96
dimethylethyl)-4-methyl-.
98-56-6 4-Chlorobenzotrifluoride--Benzene, 1- ................................ 04/29/83 04/29/93
chloro-4-(trifluoromethyl)-.
98-73-7 p-tert-Butylbenzoic acid-Benzoic acid, 4- ................................ 6/25/86 12/19/95
(1,1-dimethylethyl)-.
98-82-8 Cumene--Benzene, (1-methylethyl)-........ ................................ 12/28/84 12/28/94
98-83-9 Benzene, (1-methylethenyl)-.............. ................................ 06/01/87 11/09/93
98-95-3 Nitrobenzene--Benzene, nitro-............ ................................ 10/04/82 10/04/92
100-02-7 p-Nitrophenol--Phenol, 4-nitro-.......... ................................ 4/13/89 6/30/98
100-40-3 4-Vinylcyclohexene....................... ................................ 1/11/90 11/09/93
100-41-4 Benzene, ethyl-.......................... ................................ 06/19/87 06/19/97
100-48-1 4-Pyridinecarbonitrile................... ................................ 06/01/87 06/01/87
100-54-9 3-Pyridinecarbonitrile................... ................................ 06/01/87 12/29/88
[[Page 191]]
100-70-9 2-Pyridinecarbonitrile................... ................................ 06/01/87 11/09/93
101-68-8 Benzene, 1,1'-methylenebis[4-isocyanato-. ................................ 06/01/87 06/01/97
101-77-9 Benzenamine, 4,4'-methylenebis-.......... ................................ 10/04/82 10/04/92
101-84-8 Diphenyl oxide--Benzene, 1,1'-oxybis-.... ................................ 4/13/89 6/30/98
102-71-6 Triethanolamine-Ethanol, 2,2',2''- ................................ 4/13/89 12/19/95
nitrilotris-.
104-49-4 Benzene, 1,4-diisocyanato-............... ................................ 06/01/87 11/09/93
104-51-8 Benzene, butyl-.......................... ................................ 6/1/87 12/19/95
104-76-7 1-Hexanol, 2-ethyl-...................... ................................ 6/1/87 12/19/95
105-60-2 2H-Azepin-2-one, hexahydro-.............. ................................ 06/01/87 06/01/97
106-42-3 p-Xylene--Benzene, 1,4-dimethyl-......... ................................ 10/04/82 10/04/92
106-43-4 Benzene, 1-chloro-4-methyl-.............. ................................ 6/1/87 12/19/95
106-44-5 p-Cresol--Phenol, 4-methyl-.............. ................................ 10/04/82 10/04/92
106-49-0 Benzenamine, 4-methyl-................... ................................ 03/07/86 03/07/96
106-50-3 p-Phenylenediamine--1,4-Benzenediamine... ................................ 10/04/82 10/04/92
106-51-4 Quinone--2,5-Cyclohexadiene-1,4-dione.... ................................ 10/04/82 10/04/92
106-88-7 Oxirane, ethyl-.......................... ................................ 10/04/82 10/04/92
106-89-8 Oxirane, (chloromethyl)-................. ................................ 10/04/82 10/04/92
107-06-2 Ethane, 1,2-dichloro-.................... ................................ 06/01/87 06/01/97
107-10-8 1-Propanamine............................ ................................ 3/7/86 12/19/95
107-19-7 2-Propyn-1-ol............................ ................................ 3/7/86 12/19/95
107-98-2 1-Methoxy-2-propanol--2-Propanol, 1- ................................ 4/13/89 6/30/98
methoxy-.
108-05-4 Vinyl acetate--Acetic acid ethenyl ester. ................................ 02/10/86 02/10/96
108-10-1 Methyl isobutyl ketone--2-Pentanone, 4- ................................ 10/04/82 10/04/92
methyl-.
108-31-6 Maleic anhydride--2,5-Furandione......... ................................ 09/10/84 09/10/94
108-38-3 m-Xylene--Benzene, 1,3-dimethyl-......... ................................ 10/04/82 10/04/92
108-39-4 m-Cresol--Phenol, 3-methyl-.............. ................................ 10/04/82 10/04/92
108-60-1 Propane, 2,2'-oxybis[1-chloro-........... ................................ 6/1/87 12/19/95
108-67-8 1,3,5-Trimethylbenezene--Benzene, 1,3,5- ................................ 02/13/84 02/13/94
trimethyl-.
108-86-1 Benzene, bromo-.......................... ................................ 6/1/87 12/19/95
108-88-3 Toluene--Benzene, methyl-................ ................................ 10/04/82 10/04/92
108-89-4 4-Methylpyridine--Pyridine, 4-methyl-.... ................................ 09/10/84 09/10/94
108-94-1 Cyclohexanone............................ ................................ 10/04/82 10/04/92
108-95-2 Phenol................................... ................................ 06/01/87 06/01/97
108-95-5 Thiophenol............................... ................................ 1/26/94 12/19/95
108-98-5 Benzenethiol............................. ................................ 03/07/86 03/07/96
108-99-6 3-Methylpyridine--Pyridine, 3-methyl-.... ................................ 09/10/84 09/10/94
109-06-8 2-Methylpyridine--Pyridine, 2-methyl-.... ................................ 09/10/84 09/10/94
109-77-3 Propanedinitrile......................... ................................ 3/7/86 12/19/95
109-87-5 Methane, Dimethoxy-...................... ................................ 6/1/87 12/19/95
109-89-7 Ethanamine, N-ethyl-..................... ................................ 06/01/87 06/01/97
110-75-8 Ethene, (2-chloroethoxy)-................ ................................ 3/7/86 12/19/95
110-82-7 Cyclohexane.............................. ................................ 12/19/85 12/19/95
110-86-1 Pyridine................................. ................................ 10/04/82 10/04/92
111-21-7 Ethylene bisoxyethylene diacetate-- ................................ 01/13/84 12/29/88
Ethanol, 2,2']-[1,2-
ethanediylbis(oxy)]bis-, diacetate.
111-40-0 Diethylenetriamine--1,2-Ethanediamine, N- ................................ 04/29/83 04/29/93
(2-aminoethyl)-.
111-42-2 Diethanolamine--Ethanol, 2,2'-iminobis-.. ................................ 4/13/89 6/30/98
111-69-3 Hexanedinitrile.......................... ................................ 6/1/87 12/19/95
111-76-2 2-Butoxyethanol--Ethanol, 2-butoxy-...... ................................ 4/13/89 6/30/98
111-77-3 Diethylene glycol monomethyl ether- ................................ 4/13/89 12/19/95
Ethanol, 2-(2-methoxyethoxy)-.
111-90-0 Diethylene glycol monoethyl ether- ................................ 4/13/89 12/19/95
Ethanol, 2-(2-ethoxyethoxy)-.
111-91-1 Ethane, 1,1'-[methylenebis(oxy)]bis[2- ................................ 3/7/86 12/19/95
chloro-.
111-92-2 1-Butanamine, N-butyl-................... ................................ 6/1/87 12/19/95
112-35-6 Triethyleneglycol monomethyl ether-- ................................ 06/20/85 06/20/95
Ethanol, 2-[2-(2-methoxyethoxy)ethoxy]-.
112-50-5 Triethyleneglycol monoethyl ether-- ................................ 06/20/85 06/20/95
Ethanol, 2-[2-(2-ethoxyethoxy)ethoxy]-.
112-90-3 Oleylamine--9-Octadecen-1-amine, (Z)-.... ................................ 01/13/84 01/13/94
115-28-6 Chlorendic acid--Bicyclo[2.2.1] hept-5- ................................ 04/29/83 01/13/86
ene-2,3-dicarboxylic acid, 1,4,5,6,7,7-
hexachloro-.
115-96-8 Ethanol, 2-chloro-, phosphate (3:1)...... ................................ 12/16/88 11/09/93
118-79-6 2,4,6-Tribromophenol..................... ................................ 1/11/90 6/30/98
120-20-7 Anthracene............................... ................................ 06/01/87 06/01/97
120-32-1 2-Benzyl-4-chlorophenol-Phenol, 4-chloro- ................................ 4/13/89 12/19/95
2-chlorophenol(phenyl methyl)-.
121-44-8 Ethanamine, N,N-diethyl-................. ................................ 01/13/84 01/13/94
121-47-1 Benzenesulfonic acid, 3-amino-........... ................................ 06/01/87 12/29/88
122-09-8 Benzeneethanamine, alpha,alpha-dimethyl-. ................................ 3/7/86 12/19/95
122-66-7 Hydrazine, 1,2-diphenyl-................. ................................ 06/01/87 06/01/97
122-99-6 2-Phenoxyethanol--Ethanol, 2-phenoxy-.... ................................ 07/01/83 07/01/93
123-31-9 Hydroquinone--1,4-Benzenediol............ ................................ 10/04/84 10/04/94
123-61-5 Benzene, 1,3-diisocyanato-............... ................................ 06/01/87 11/09/93
[[Page 192]]
123-72-8 Butanal.................................. ................................ 12/16/88 12/19/95
124-16-3 1-Butoxyethoxy-2-propanol-2-Propanol, 1- ................................ 4/13/89 12/19/95
(2-butoxyethoxy)-.
124-17-4 2-(2-Butoxyethoxy)ethyl acetate--Ethanol, ................................ 01/13/82 01/13/92
2-(2-butoxyethoxy)-, acetate.
124-48-1 Methane, dibromochloro-.................. ................................ 06/01/87 06/01/97
126-73-8 Phosphoric acid, tributyl ester.......... ................................ 06/18/86 06/18/96
126-99-8 Chloroprene--1,3-Butadiene, 2-chloro-.... ................................ 12/28/84 12/28/94
127-18-4 Ethene, tetrachloro-..................... ................................ 06/01/87 06/01/97
128-39-2 Phenol, 2,6-bis(1,1-dimethylethyl)-...... ................................ 12/19/85 11/09/93
128-86-9 2,6-Anthracenedisulfonic acid, 4,8- ................................ 12/21/87 11/09/93
diamino-9,10-dihydro-1,5-dihydroxy-9,10-
dioxo-.
129-00-0 Pyrene................................... ................................ 06/01/87 06/01/97
131-17-9 Diallyl phthalate-1,2-Benzenedicarboxylic ................................ 4/13/89 12/19/95
acid, di-2-propenyl ester.
135-98-8 Benzene, (1-methylpropyl)-............... ................................ 6/1/87 12/19/95
136-35-6 1-Triazene, 1,3-diphenyl-................ Sec. 716.21(a)(5) 6/3/04 8/2/04
137-20-2 Soldium N-methyl-N-oleoyltaurine-- ................................ 12/28/84 12/28/94
Ethanesulfonic acid, 2-[methyl (1-oxo-9-
octadecenyl)amino]-, sodium salt, (Z)-.
137-26-8 Thioperoxydicarbonic diamide, tetramethyl- ................................ 6/1/87 12/19/95
.
139-25-3 Benzene, 1,1 \1\-methylenebis[4- ................................ 06/01/87 11/09/93
isocyanato-3-methyl-.
140-08-9 Tris(2-chloroethyl)phosphite--Ethanol, 2- ................................ 04/29/83 01/13/86
chloro-, phosphite (3:1).
140-66-9 4-(1,1,3,3-Tetramethylbutyl) phenol-- ................................ 01/30/83 12/29/88
Phenol, 4-(1,1,3,3-tetramethylbutyl)-.
140-88-5 Ethyl acrylate--2-Propenoic acid, ethyl ................................ 4/13/89 6/30/98
ester.
141-79-7 Mesityl oxide--3-Penten-2-one, 4-methyl-. ................................ 10/04/82 10/04/92
142-28-9 Propane, 1,3,-dichloro-.................. ................................ 3/7/86 12/19/95
142-84-7 1-Propanamine, N-propyl-................. ................................ 03/07/86 12/5/90
143-22-6 Triethyleneglycol monobutyl ether-- ................................ 06/20/85 06/20/95
Ethanol, 2-[-2-(2-butoxyethoxy)ethoxy]-.
143-33-9 Sodium cyanide........................... ................................ 10/29/90 12/19/95
149-30-4 Mercaptobenzothiazole--2(3H- ................................ 12/28/84 12/28/94
Benzothiazolethione.
149-57-5 2-Ethylhexanoic acid--Hexanoic acid, 2- ................................ 06/28/84 06/28/94
ethyl-.
306-83-2 Ethane, 2,2-dichloro-1,1,1-trifluoro..... ................................ 10/15/90 11/09/93
328-84-7 3,4-Dichlorobenzotrifluoride--Benzene, ................................ 05/08/85 11/09/93
1,2-dichloro-4-(trifluoromethyl)-.
354-33-6 Ethane, pentafluoro...................... ................................ 10/15/90 11/09/93
357-57-3 Strychnidin-10-one, 2,3-dimethoxy-....... ................................ 3/7/86 12/19/95
428-59-1 Oxirane, trifluoro(trifluoromethyl)-..... ................................ 10/04/82 10/04/92
496-46-8 Imidazo[4,5-d]imidazole-2,5(1H,3H)-dione, Sec. 716.21(a)(1)............. 6/3/04 8/2/04
tetrahydro-.
472-41-3 Phenol, 4-(3,4-dihydro-2,2,4-trimethyl-2H- ................................ 06/01/87 12/29/88
1-benzopyran-4-yl)-.
506-96-7 Acetyl bromide........................... ................................ 6/1/87 12/19/95
526-73-8 1,2,3-Trimethylbenzene--Benzene, 1,2,3- ................................ 02/13/84 11/09/93
trimethyl-.
530-50-7 Hydrazine, 1,1-diphenyl-................. ................................ 6/1/87 12/19/95
534-07-6 2-Propanone, 1,3-dichloro-............... ................................ 6/1/87 12/19/95
540-54-5 Propane, 1-chloro-....................... ................................ 6/1/87 12/19/95
540-84-1 Pentane, 2,2,4-trimethyl-................ ................................ 6/1/87 12/19/95
542-75-6 1-Propene, 1,3-dichloro-................. ................................ 06/01/87 06/01/97
556-67-2 Octamethylcyclotetrasiloxane--Cyclotetras ................................ 12/28/84 12/28/94
iloxane, octamethyl-.
563-54-2 1-Propene, 1,2-dichloro-................. ................................ 03/07/86 12/29/88
563-58-6 1-Propene, 1,1-dichloro-................. ................................ 03/07/86 12/29/88
580-51-8 [1,1'-Biphenyl]-3-ol..................... ................................ 06/01/87 11/09/93
584-84-9 Benzene, 2,4-diisocyanato-1-methyl-...... ................................ 06/01/87 06/01/97
591-08-2 Acetamide, N-(aminothioxomethyl)-........ ................................ 3/7/86 12/19/95
594-20-7 Propane, 2,2-dichloro-................... ................................ 3/7/86 12/19/95
598-21-0 Acetyl bromide, bromo-................... ................................ 6/1/87 12/19/95
598-31-2 2-Propanone, 1-bromo-.................... ................................ 3/7/86 12/19/95
616-23-9 1-Propanol, 2,3-dichloro-................ ................................ 3/7/86 12/19/95
620-14-4 m-Ethyltoluene--Benzene, 1-ethyl-3-methyl- ................................ 04/29/83 04/29/93
.
622-96-8 p-Ethyltoluene--Benzene, 1-ethyl-4-methyl- ................................ 04/29/83 04/29/93
.
630-20-6 Ethane, 1,1,1,2-tetrachloro-............. ................................ 6/1/87 12/19/95
632-79-1 Tetrabromophthalic anhydride............. ................................ 1/11/90 12/19/95
637-92-3 Ethyl-tert-butyl ether Sec. 716.20(b)(3) applies 12/28/94 6/30/98
646-06-0 1,3-Dioxolane............................ ................................ 01/03/83 01/03/93
677-21-4 Trifluoromethylethene--1-Propene, 3,3,3- ................................ 04/29/83 01/13/86
trifluoro-.
685-91-6 Acetamide, N,N-diethyl-.................. ................................ 06/01/87 11/09/93
692-42-2 Arsine, diethyl-......................... ................................ 3/7/86 12/19/95
696-28-6 Arsonous dichloride, phenyl-............. ................................ 3/7/86 12/19/95
757-58-4 Tetraphosphoric acid, hexaethyl ester.... ................................ 3/7/86 12/19/95
811-97-2 Ethane, 1,1,2-tetrafluoro-............... ................................ 10/15/90 11/09/93
812-03-3 Propane, 1,1,1,2-tetrachloro-............ ................................ 6/1/87 12/19/95
822-06-0 Hexane, 1,6-diisocyanato-................ ................................ 6/1/87 12/19/95
828-00-2 1,3-Dioxan-4-ol, 2,6-dimethyl-, acetate.. ................................ 6/1/87 12/19/95
[[Page 193]]
930-22-3 Oxirane, ethenyl-........................ ................................ 10/04/82 10/04/92
939-97-9 p-tert-Butylbenzaldehyde--Benzaldehyde, 4- ................................ 06/25/86 11/09/93
(1,1-dimethylethyl)-.
994-05-8 Tert-amyl methyl ether Sec. 716.20(b)(3) applies 12/28/94 06/30/98
1000-82-4 Methylolurea--Urea, (hydroxymethyl)-..... ................................ 07/01/83 07/01/93
1070-78-6 Propane, 1,1,1,3-tetrachloro-............ ................................ 6/1/87 12/19/95
1163-19-5 Decabromodiphenyl ether.................. ................................ 1/11/90 06/30/98
1185-81-5 Dibutyltin bis(lauryl mercaptide)-- ................................ 01/03/83 01/03/93
Stannane, dibutylbis(dodecylthio).
1208-52-2 Benzenamine, 2-[(4-aminophenyl)methyl]-.. ................................ 06/01/87 11/09/93
1300-71-6 Phenol, dimethyl-........................ ................................ 6/1/87 12/19/95
1309-64-4 Antimony trioxide........................ ................................ 10/04/82 10/04/92
1321-38-6 Benzene, diisocyanatomethyl-(unspecified ................................ 06/01/87 11/09/93
isomer).
1321-64-8 Naphthalene, pentachloro-................ ................................ 10/04/82 10/04/92
1321-65-9 Naphthalene, trichloro-.................. ................................ 10/04/82 10/04/92
1331-47-1 [1,1'-Biphenyl]-4,4'-diamino, dichloro-.. ................................ 06/01/87 11/09/93
1333-41-1 Methyl pyridine--Pyridine, methyl-....... ................................ 09/10/84 12/29/88
1335-87-1 Naphthalene, hexachloro-................. ................................ 10/04/82 10/04/92
1335-88-2 Naphthalene, tetrachloro-................ ................................ 10/04/82 10/04/92
1345-04-6 Antimony trisulfide...................... ................................ 10/04/82 10/04/92
1464-53-5 2,2'-Bioxirane........................... ................................ 10/04/82 10/04/92
1634-04-4 Propane, 2-methoxy-2-methyl-............. ................................ 12/15/86 12/15/96
1649-08-7 Ethane, 1,2-dichloro-1,1-difluoro........ ................................ 10/15/90 12/19/95
1717-00-6 Ethane, 1,1-dichloro-1-fluoro-........... ................................ 10/15/90 11/09/93
1825-30-5 Naphthalene, 1,5-dichloro-............... ................................ 10/04/82 10/04/92
1825-31-6 Naphthalene, 1,4-dichloro-............... ................................ 10/04/82 10/04/92
1888-71-7 1-Propene, 1,1,2,3,3,3-hexachloro-....... ................................ 3/7/87 12/19/95
2050-69-3 Naphthalene, 1,2-dichloro-............... ................................ 10/04/82 10/04/92
2050-72-8 Naphthalene, 1,6-dichloro-............... ................................ 10/04/82 10/04/92
2050-73-9 Naphthalene, 1,7-dichloro-............... ................................ 10/04/82 10/04/92
2050-74-0 Naphthalene, 1,8-dichloro-............... ................................ 10/04/82 10/04/92
2050-75-1 Naphthalene, 2,3-dichloro-............... ................................ 10/04/82 10/04/92
2065-70-5 Naphthalene, 2,6-dichloro-............... ................................ 10/04/82 10/04/92
2198-75-6 Naphthalene, 1,3-dichloro-............... ................................ 10/04/82 10/04/92
2198-77-8 Naphthalene, 2,7-dichloro-............... ................................ 10/04/82 10/04/92
2234-13-1 Naphthalene, octachloro-................. ................................ 10/04/82 10/04/92
2536-05-2 Benzene, 1,1'-methylenebis[2-isocyanato-. ................................ 06/01/87 11/09/93
2556-36-7 Cyclohexane, 1,4-diisocyanato............ ................................ 06/01/87 11/09/93
2763-96-4 3(2H)-Isoxazolone, 5-(aminomethyl)-...... ................................ 3/7/86 2/19/95
2778-42-9 Benzene, 1,3-bis(1-isocyanato-1- ................................ 06/01/87 11/09/93
methylethyl-.
2861-02-1 2,6-Anthracenedisulfonic acid, 4,8- ................................ 12/21/87 12/19/95
diamino-9,10-dihydro-1,5-dihydroxy-9,10-
dioxo-, disodium salt
2873-89-0 Ethane, 2-chloro-1,1,1,2-tetrafluoro-.... ................................ 10/15/90 11/09/93
3083-25-8 Oxirane, (2,2,2-trichloroethyl)-......... ................................ 10/04/82 10/04/92
3173-72-6 Naphthalene, 1,5,-diisocyanato-.......... ................................ 6/1/87 12/19/95
3194-55-6 Hexabromocyclododecane................... ................................ 1/11/90 12/19/95
3278-89-5 Benzene, 1,3,5-tribromo-2-(2-propenyloxy)- Sec. 716.21(a)(4)............. 6/3/04 8/2/04
.
3288-58-2 Phosphorodithioic acid, O,O-diethyl-S- ................................ 3/7/86 12/19/95
methyl ester.
3296-90-0 1,3-Propanediol, 2,2-bis(bromomethyl)-... ................................ 6/1/87 12/19/95
3319-31-1 Tris(2-ethylhexyl) trimellitate--1,2,4- ................................ 01/03/83 01/03/93
Benzenetricarboxylic acid, tris(2-
ethylhexyl)ester.
3322-93-8 1,2-Dibromo-4-(1,2-dibromoethyl) ................................ 06/28/84 12/29/88
cyclohexane--Cyclohexane, 1,2-dibromo-4-
(1,2-dibromoethyl)-.
3389-71-7 1,2,3,4,7,7-Hexachloronorbornadiene-- ................................ 01/13/84 01/13/94
Bicyclo[2.2.1]hepta-2,5-diene,
1,2,3,4,7,7-hexachloro-.
3618-72-2 Acetamide, N-[5-[bis[2- ................................ 06/19/87 11/09/93
(acetyloxy)ethyl]amino]-2-[(2-bromo-4,6-
dinitrophenyl)azo]-4- methoxyphenyl]-.
3618-73-3 Acetamide, N-[5-[bis[2- ................................ 06/19/87 11/09/93
(acetyloxy)ethyl]amino]-2-[(2-chloro-4,6-
dinitrophenyl)azo]-4-methoxyphenyl]-.
3956-55-6 Acetamide, N-[5-[bis[2-(acetyloxy)ethyl]- ................................ 12/15/86 11/09/93
amino]-2-[(2-bromo-4,6-
dinitrophenyl)azo]-4-ethoxyphenyl.
4098-71-9 Cyclohexane, 5-isocyanato-1- ................................ 06/01/87 06/01/97
(isocyanatomethyl)-1,3,3-trimethyl-.
4170-30-3 2-Butenal................................ ................................ 3/7/86 12/19/95
5124-30-1 Cyclohexane, 1,1'-methylenebis[4- ................................ 06/01/87 06/01/97
isocyanato-.
5131-66-8 1-Butoxy-2-propanol-2-Propanol, 1-butoxy- ................................ 4/13/89 12/19/95
5344-82-1 Thiourea, (2-chlorophenyl)-.............. ................................ 3/7/86 12/19/95
5873-54-1 Benzene, 1-isocyanato-2-[4- ................................ 06/01/87 11/09/93
isocyanatophenyl)methyl]-.
6145-73-9 1-Propanol, 2-chloro-, phosphate (3:1)... ................................ 12/16/88 11/09/93
6247-34-3 2-Anthracenesulfonic acid, 4-[[4- ................................ 12/21/87 11/09/93
(acetylamino)phenyl]amino]-1-amino-9,10-
dihydro-9,10-dioxo-.
6422-86-2 Bis(2-ethylhexyl) terephthalate--1,4- ................................ 01/03/83 01/03/93
Benzenedicarboxylic acid, bis(2-
ethylhexyl) ester.
6424-85-7 2-Anthracenesulfonic acid, 4-[[4- ................................ 12/21/87 12/19/95
(acetylamino)phenyl]amino]- 1-amino-9,10-
dihydro-9,10-dioxo-, monosodium salt.
[[Page 194]]
7320-37-8 Oxirane, tetradecyl-..................... ................................ 10/04/82 10/04/92
7440-28-0 Thallium................................. ................................ 06/01/87 06/01/97
7440-36-0 Antimony................................. ................................ 10/04/82 10/04/92
7440-48-4 Cobalt................................... ................................ 06/01/87 06/01/97
7723-14-0 White phosphorus......................... ................................ 04/12/93 06/30/98
9011-05-6 Urea, polymer with formaldehyde.......... Sec. 716.20(b)(1) applies..... 06/03/85 06/03/95
9016-87-9 Isocyanic acid, ................................ 6/1/87 12/19/95
polymethylenepolyphenylene ester.
10347-54-3 Cyclohexane, 1,4-bis(isocyanatomethyl)-.. ................................ 06/01/87 06/01/87
10436-39-2 1-Propene, 1,1,2,3-tetrachloro-.......... ................................ 6/1/87 12/19/95
12001-85-3 Naphthenic acids, zinc salts............. ................................ 6/1/87 12/19/95
12185-10-3 White phosphorus......................... ................................ 01/26/94 06/30/98
12217-79-7 9,10-Anthracenedione, 1,5-diamino-chloro- ................................ 12/21/87 11/09/93
4,8-dihydroxy-.
13414-54-5 Methallyl 2-nitrophenyl ether--Benzene, 1- ................................ 02/13/84 11/09/93
[(2-methyl-2-propenyl)oxy]-2-nitro-.
13414-55-6 7-Nitro-2,2-dimethyl-2,3-dihydro- ................................ 02/13/84 02/13/94
benzofuran--Benzofuran, 2,3-dihydro-2,2-
dimethyl-7-nitro-.
13674-84-5 2-Propanol, 1-chloro-, phosphate (3:1)... ................................ 12/16/88 11/09/93
13674-87-8 2-Propanol, 1,3-dichloro-, phosphate ................................ 12/16/88 12/19/95
(3:1).
15646-96-5 Hexane, 1,6-diisocyanato-2,4,4-trimethyl- ................................ 06/01/87 11/09/93
16691-43-3 3H-1,2,4-Triazole-3-thione, 5-amino-1,2- Sec. 716.21(a)(1)............. 6/3/04 8/2/04
dihydro-.
16938-22-0 Hexane, 1,6-diisocyanato-2,2,4-trimethyl- ................................ 06/01/87 11/09/93
17418-58-5 9,10-Anthracenedione, 1-amino-4-hydroxy-2- ................................ 12/21/87 12/19/95
phenoxy-.
18495-30-2 Propane, 1,1,2,3-tetrachloro-............ ................................ 06/01/87 12/29/88
18633-25-5 Oxirane, tridecyl-....................... ................................ 10/04/82 10/04/92
19660-16-3 2-Propenoic acid, 2,3-dibromopropyl ester ................................ 06/01/87 12/29/88
21429-43-6 Acetamide, N-[5-[bis[2- ................................ 06/19/87 11/09/93
(acetyloxy)ethyl]amino]-2-[(2-chloro-4,6-
dinitrophenyl)azo]-4-methoxyphenyl]-.
25168-06-3 Isopropyl phenol--Phenol, (1-methylethyl)- ................................ 04/13/89 11/09/93
.
25168-21-2 Dibutyltin bis (isooctyl maleate)--2- ................................ 01/03/83 01/03/93
Butenoic acid, 4,4'-
[(dibutylstannylene)bis(oxy)]bis-[4-oxo-
, diisoctyl ester, (Z,Z)-.
25498-49-1 Tripropylene glycol monomethyl ether- ................................ 4/13/89 12/19/95
Propanol, [2-(2-methoxy
methylethoxy)methylethoxy]-.
25550-14-5 Benzene, ethylmethyl- (mixed isomers).... ................................ 04/29/83 04/29/93
25550-98-5 Phosphorous acid, diisodecyl phenyl ester ................................ 12/19/85 12/19/95
25551-13-7 Trimethylbenzene--Benzene, trimethyl- ................................ 02/13/84 02/13/94
(mixed isomers).
25640-78-2 Isopropyl biphenyl--1,1'-Biphenyl, (1- ................................ 06/28/84 11/09/93
methylethyl)-.
25852-70-4 Monobutyltin tris (isooctyl) mercapto- ................................ 01/03/83 01/03/93
acetate--Acetic acid, 2,2',2''-
[(butylstannylidyne)tris(thio)]tris-,
triisooctyl ester.
26447-40-5 Benzene, 1,1'-methylenebis[isocyanato-... ................................ 06/01/87 06/01/97
26471-62-5 Benzene, 1,3-diisocyanatomethyl-......... ................................ 06/01/87 06/01/97
26530-20-1 3(2H)-Isothiazolone, 2-octyl-............ ................................ 06/01/87 12/29/88
26952-23-8 1-Propene, dichloro-..................... ................................ 6/1/87 12/19/95
29091-20-1 Benzenamine, 3-chloro-2,6-dinitro-N,N- Sec. 716.21(a)(2)............. 6/3/04 8/2/04
dipropyl-4-(trifluoromethyl)-.
29385-43-1 Tolyl triazole-1H-Benzotriazole, methyl-. ................................ 4/13/89 12/19/95
32052-51-0 Isocyanic acid, trimethylcyclohexyl ester ................................ 06/01/87 11/09/93
32534-81-9 Pentabromodiphenyl ether................. ................................ 1/11/90 06/30/98
32536-52-0 Octabromodiphenyl ether.................. ................................ 1/11/90 06/30/98
32588-76-4 Ethylene Bis-(tetrabromophthalimide)..... ................................ 1/11/90 12/19/95
33125-86-9 Phosphoric acid, 1,2-ethanediyl tetrakis ................................ 12/16/88 11/09/93
(2-chloroethyl) ester.
34590-94-8 Dipropylene glycol monomethyl ether-- ................................ 4/13/89 6/30/98
Propanol, (2-methoxymethylethoxy)-.
37853-59-1 1,2-Bis(tribromophenoxy) ethane.......... ................................ 1/11/90 06/30/98
38661-72-2 Cyclohexane, 1,3-bis(isocyanatomethyl)-.. ................................ 06/01/87 11/09/93
41291-34-3 Ethylene(5,6-dibromonorbornane-2,3- ................................ 1/11/90 12/19/95
dicarboximide).
52907-07-0 Ethylene bis(5,6-dibromonorbornane-2,3- ................................ 1/26/94 12/19/95
dicarboximide.
57137-10-7 Tribrominated polystyrene................ ................................ 1/11/90 12/19/95
61262-53-1 Ethylene bis(pentabromophenoxide)........ ................................ 1/11/90 12/19/95
61788-33-8 Terphenyl, chlorinated................... ................................ 10/04/82 12/29/88
61789-36-4 Calcium naphthenate--Naphthenic acids, ................................ 07/01/83 07/01/93
calcium salts.
61789-51-3 Cobalt naphthenate--Naphthenic acids, ................................ 07/01/83 07/01/93
cobalt salts.
61790-14-5 Lead naphthenate--Naphthenic acids, lead ................................ 07/01/83 07/01/93
salts.
64742-95-6 Solvent naphtha (petroleum), light arom.. ................................ 2/13/84 2/13/94
68081-84-5 Oxirane, mono[(C10 16-alkyloxy) methyl] ................................ 10/04/82 10/04/92
derivatives.
68122-86-1 Imidazolium compounds, 4,5-dihydro-1- ................................ 6/20/88 12/19/95
methyl-2-nortallow alkyl-1-(2-tallow
amidoethyl), methyl sulfates.
68153-35-5 Ethanaminium, 2-amino-N-(2-aminoethyl-N- ................................ 06/20/88 11/09/93
(2-hydroxyethyl)-N-methyl-, N,N''-
ditallow acyl derivatives, methyl
sulfates (salts).
68298-46-4 7-Amino-2,2-dimethyl-2,3- ................................ 02/13/84 12/29/88
dihydrobenzofuran--7-Benzofuranamine,2,3-
dihydro-2,2-dimethyl-.
68389-88-8 Poly(oxy-1,2-ethanediyl), [alpha]-[2- ................................ 06/20/88 11/09/93
[bis(2-aminoethyl)methylammonio]ethyl]-
[omega]-hydroxy-, N,N''-dicoco acyl
derivatives, methyl sulfates (salts).
[[Page 195]]
68389-89-9 Poly(oxy-1,2-ethanediyl), [alpha]-[2- ................................ 06/20/88 11/09/93
[bis(2-aminoethyl)methylammonio]ethyl]-
[omega]-hydroxy-,N,N''-bis(hydrogenated
tallow acyl) derivatives, methyl
sulfates (salts).
68410-69-5 Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2- ................................ 6/20/88 12/19/95
aminoethyl) methylammonio]ethyl]-w-
hydroxy,- N,N'-ditallow acyl
derivatives, methyl sulfates (salts).
68413-04-7 Poly[oxy(methyl-1,2-ethanediyl)], [alpha]- ................................ 06/20/88 11/09/93
[2-[bis(2-aminoethyl)methylammonio]
methylethyl]-[omega]-hydroxy-, N,N''-
ditallow acyl derivatives, methyl
sulfates (salts).
68554-06-3 Poly(oxy-1,2-ethanediyl), [alpha]-[3- ................................ 06/20/88 11/09/93
[bis(2-aminoethyl)methylammonio]-2-
hydroxy-propyl]-[omega]-hydroxy-, N-coco
acyl derivatives, methyl sulfates
(salts).
68611-64-3 Urea, reaction products with formaldehyde Sec. 716.20(b)(1) applies..... 06/03/85 11/09/93
68928-76-7 Stannane, dimethylbis[(1-oxoneodecyl)oxy]- Sec. 716.21(a)(3)............. 6/3/04 8/2/04
.
69009-90-1 Diisopropyl biphenyl--1,1'-Biphenyl, ................................ 06/28/84 12/29/88
bis(1-methylethyl)-.
70914-09-9 Poly(oxy-1,2-ethanediyl), [alpha]-[2- ................................ 06/20/88 06/20/88
[bis(2-aminoethyl)methylammonio]ethyl]-
[omega]-hydroxy-, N,N''-di[C14 18 acyl]
derivatives, methyl sulfates (salts).
75790-84-0 Benzene, 2-isocyanato-4-[(4-isocyanato- ................................ 06/01/87 11/09/93
phenyl)methyl]-1-methyl-.
75790-87-3 Benzene, 1-isocyanato-2-[(4-isocyanato- ................................ 06/01/87 11/09/93
phenyl)thio]-.
----------------------------------------------------------------------------------------------------------------
(b) [Reserved]
(c) By category. The following categories are listed in alphabetical
order. Chemical substances listed within a category are provided only as
examples of the category. All chemical substances within a category are
subject to all the provisions of part 716 for the time period from the
effective date of the category until the sunset date. Manufacturers,
importers, and processors of any chemical substance within a category
are subject to the reporting requirements of subpart A for that
category, except when the sunset date for the particular substance
predates the sunset date for the category, or when the exemption of
Sec. 716.20(b) of this part applies.
----------------------------------------------------------------------------------------------------------------
CAS No.
Category (examples for Special Effective Sunset date
category) exemptions date
----------------------------------------------------------------------------------------------------------------
Alkyl epoxides--including all noncyclic aliphatic .............. ........... 10/4/82 12/29/88
hydrocarbons with one or more epoxy functional groups..
----------------------------------------------------------------------------------------------------------------
[[Page 196]]
----------------------------------------------------------------------------------------------------------------
CAS No.
Category (examples for Special Effective Sunset date
category) exemptions date
----------------------------------------------------------------------------------------------------------------
R 1 = R2 = R3 = R4 = H or alkyl. Groups R1-R4 may
contain one or more epoxide functions.
Oxirane, decyl-....................................... 2855-19-8 ........... 10/04/82 12/29/88
Oxirane, 2, 2 - dimethyl -............................ 558-30-5 ........... 10/04/82 12/29/88
Oxirane, 2, 3 - dimethyl -............................ 3266-23-7 ........... 10/04/82 12/29/88
Oxirane, dodecyl...................................... 3234-28-4 ........... 10/04/82 12/29/88
Oxirane, heptadecyl -................................. 67860-04-2 ........... 10/04/82 12/29/88
Oxirane, octyl-....................................... 2404-44-6 ........... 10/04/82,
12/29/88
Oxirane, pentadecyl -................................. 22092-38-2 ........... 10/04/82 12/29/88
Alkyl phthalates -- all alkyl esters of 1, 2- .............. ........... 10/04/82 10/04/92
benzenedicarboxylic acid (ortho -phthalic acid).......
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
CAS No.
Category (examples for Special Effective Sunset date
category) exemptions date
----------------------------------------------------------------------------------------------------------------
R1 = R2 = alkyl.
1,2-Benzenedicarboxylic acid, bis(2-ethylhexyl) ester. 117-81-7 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, bis(1-methylheptyl) 131-15-7 ........... 10/04/82 10/04/92
ester................................................
1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) 84-69-5 ........... 10/04/82 10/04/92
ester................................................
1,2-Benzenedicarboxylic acid, 2-butoxy-2-oxyethyl 85-70-1 ........... 10/04/82 01/13/86
butyl ester..........................................
1,2-Benzenedicarboxylic acid, butyl cyclohexyl ester.. 84-64-0 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, butyl 2-ethylhexyl ester 85-69-8 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, butyl octyl ester....... 84-78-6 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, decyl hexyl ester....... 25724-58-7 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, decyl octyl ester....... 119-07-3 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, dibutyl ester........... 84-74-2 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, dicyclohexyl ester...... 84-61-7 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, diethyl ester........... 84-66-2 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, dihexyl ester........... 84-75-3 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, diisodecyl ester........ 26761-40-0 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, diisononyl ester........ 28553-12-0 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, diisooctyl ester........ 27554-26-3 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, demethyl ester.......... 131-11-3 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, dinonyl ester........... 84-76-4 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, dioctyl ester........... 117-84-0 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, diundecyl ester......... 119-06-2 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, isodecyl tridecyl ester. 3648-20-2 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, 2-ethylhexyl-8- 89-13-4 ........... 10/04/82 10/04/92
methylnonyl ester....................................
1,2-Benzenedicarboxylic acid, hexyl isodecyl ester.... 61702-81-6 ........... 10/04/82 10/04/92
1,2-Benzenedicarboxylic acid, isodecyl tridecyl ester. 61886-60-0 ........... 10/04/82 10/04/92
Alkyltin compounds...................................... .............. ........... 01/03/83 12/29/88
Dibutyltin S,S'-bis(isooctyl mercaptoacetate)--Acetic 25168-24-5 ........... 01/03/83 12/29/88
acid, 2,2'-[(dibutylstannylene)bis(thio)]bis-,
diisooctyl ester.....................................
Dibutyltin S,S'-bis(isooctyl mercaptoacetate)--Acetic 26636-01-1 ........... 01/03/83 12/29/88
acid, 2,2'-[(dimethylstannylene)bis(thio)]bis-,
diisooctyl ester.....................................
Mono methyltin tris(isooctylmercaptoacetate) Acetic 54849-38-6 ........... 01/03/83 12/29/88
acid, 2,2',2''-[(methylstannylidyne)tris(thio)]tris-
triisoacetyl ester...................................
Aniline and chloro-, bromo-, and/or nitroanilines....... .............. ........... 10/04/82 10/04/92
[[Page 197]]
Benzenamine........................................... 62-53-3 ........... 10/04/82 10/04/92
Benzenamine, 4-bromo-................................. 106-40-1 ........... 10/04/82 10/04/92
Benzenamine, 2-bromo-6-chloro-4-nitro-................ 99-29-6 ........... 10/04/82 10/04/92
Benzenamine, 2-bromo-,4,6-dinitro-.................... 1817-73-8 ........... 10/04/82 10/04/92
Benzenamine, 2-chloro-................................ 95-51-2 ........... 10/04/82 10/04/92
Benzenamine, 3-chloro-................................ 108-42-9 ........... 10/04/82 10/04/92
Benzenamine, 4-chloro-................................ 106-47-8 ........... 10/04/82 10/04/92
Benzenamine, 2-chloro-4,6-dinitro-.................... 3531-19-9 ........... 10/04/82 10/04/92
Benzenamine, 4-chloro-2,6-dinitro-.................... 5388-62-5 ........... 10/04/82 10/04/92
Benzenamine, 3-chloro-, hydrochloride................. 141-85-5 ........... 10/04/82 10/04/92
Benzenamine, 2-chloro-4-nitro-........................ 121-87-9 ........... 10/04/82 10/04/92
Benzenamine, 2-chloro-5-nitro-........................ 6283-25-6 ........... 10/04/82 10/04/92
Benzenamine, 4-chloro-2-nitro-........................ 89-63-4 ........... 10/04/82 10/04/92
Benzenamine, 4-chloro-3-nitro-........................ 635-22-3 ........... 10/04/82 10/04/92
Benzenamine, 2,6-dibromo-4-nitro-..................... 827-94-1 ........... 10/04/82 10/04/92
Benzenamine, 2,3-dichloro-............................ 608-27-5 ........... 10/04/82 10/04/92
Benzenamine, 2,4-dichloro-............................ 554-00-7 ........... 10/04/82 10/04/92
Benzenamine, 2,5-dichloro-............................ 95-82-9 ........... 10/04/82 10/04/92
Benzenamine, 3,4-dichloro-............................ 95-76-1 ........... 10/04/82 10/04/92
Benzenamine, 3,5-dichloro-............................ 626-43-7 ........... 10/04/82 10/04/92
Benzenamine, 2,6-dichloro-4-nitro-.................... 99-30-9 ........... 10/04/82 10/04/92
Benzenamine, 2,4-dinitro-............................. 97-02-9 ........... 10/04/82 10/04/92
Benzenamine, 2-nitro-................................. 88-74-4 ........... 10/04/82 10/04/92
Benzenamine, 3-nitro-................................. 99-09-2 ........... 10/04/82 10/04/92
Benzenamine, 4-nitro-................................. 100-01-6 ........... 10/04/82 10/04/92
Benzenamine, 2,4,6-tribromo-.......................... 147-82-0 ........... 10/04/82 10/04/92
Benzenamine, 2,4,6-trichloro-......................... 634-93-5 ........... 10/04/82 10/04/92
Aryl phosphates--phosphate esters of phenol or of alkyl- .............. ........... 10/04/82 10/04/92
substituted phenols. Triaryl and mixed alkyl and aryl
esters are included but trialkyl esters are excluded...
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
CAS No.
Category (examples for Special Effective Sunset date
category) exemptions date
----------------------------------------------------------------------------------------------------------------
R1 = phenyl, either unsubstituted or substituted with
one or more alkyl or aralkyl groups R2 = R3 alkyl; or
phenyl, either unsubstituted or substituted with one or
more alkyl or aralkyl groups
Phenol, dimethyl-, phosphate (3:1).................... 25155-23-1 ........... 10/04/82 10/04/92
Phenol, 4-(1,1-dimethylethyl)-, phosphate (3:1)....... 78-33-1 ........... 10/04/82 10/04/92
Phosphoric acid, dibutyl phenyl ester................. 2528-36-1 ........... 10/04/82 10/04/92
Phosphoric acid, diisodecyl phenyl ester.............. 51363-64-5 ........... 10/04/82 10/04/92
Phosphoric acid, (1,1-dimethylethyl) phenyl diphenyl 56803-37-3 ........... 10/04/82 10/04/92
ester................................................
Phosphoric acid, 2-ethylhexyl diphenyl ester.......... 1241-94-7 ........... 10/04/82 10/04/92
Phosphoric acid, isodecyl diphenyl ester.............. 29761-21-5 ........... 10/04/82 10/04/92
Phosphoric acid, (1-methylethyl)phenyl diphenyl ester. 28108-99-8 ........... 10/04/82 10/04/92
Phosphoric acid, methylphenyl diphenyl ester.......... 25444-49-5 ........... 10/04/82 10/04/92
Phosphoric acid, (1-methyl-l-phenylethyl)phenyl 34364-42-6 ........... 10/04/82 10/04/92
diphenyl ester.......................................
Phosphoric acid, triphenyl ester...................... 115-86-6 ........... 10/04/82 10/04/92
Phosphoric acid, tris(methylphenyl) ester............. 1330-78-5 ........... 10/04/82 10/04/92
[[Page 198]]
Phosphoric acid, tris(2-methylphenyl) ester........... 78-30-8 ........... 10/04/82 10/04/92
Phosphoric acid, tris(3-methylphenyl) ester........... 563-04-2 ........... 10/04/82 10/04/92
Phosphoric acid, tris(4-methylphenyl) ester........... 78-32-0 ........... 10/04/82 10/04/92
Asbestos--asbestiform varieties of chrysolite .............. ........... 10/04/82 10/04/92
(serpentine); crocidolite (riebeckite); amosite
(cummingtonite--grunerite); anthophyllite; tremolite;
and actinolite.........................................
Asbestos.............................................. 1332-21-4 ........... 10/04/82 10/04/92
Asbestiform minerals.................................. 12001-29-5 ........... 10/04/82 10/04/92
Asbestiform minerals.................................. 17068-78-9 ........... 10/04/82 10/04/92
Asbestiform minerals.................................. 12172-73-5 ........... 10/04/82 10/04/92
Bisazobiphenyl dyes derived from benzidine and its .............. ........... 10/04/82 10/04/92
congeners, ortho-toluidine (dimethylbenzidine) and
dianisidine (dimethoxybenzidine).......................
Benoic acid, 2-[[2-amino-6-[[4'-[(-carboxy-4- 6739-62-4 ........... 10/04/82 10/04/92
hydroxphenyl) azo[-3,3'-dimethoxy[1,1'-biphenyl]-4-
yl]azo]-5-hydroxy-7-sulfo-1-naphthalenylazo]-5-nitro-
, trisodium salt.....................................
Benzoic acid, 5-[[4'-[2-amino-8-hydroxy-6-sulfo-1- 2429-84-7 ........... 10/04/82 10/04/92
naphthalenyl) azo] [1,1'-biphenyl]-4-yl]-azo]-2-
hydroxy-, disodium salt..............................
Benzoic acid, 5-[[4'-[7-amino-1-hydroxy-3-sulfo-2- 2429-82-5 ........... 10/04/82 10/04/92
naphthalenyl)azo] [1,1'-biphenyl]-4-yl]azo]-2-hydroxy-
, disodium salt......................................
Benzoic acid, 5-[[4'-[(1-amino-4-sulfo-2- 2429-79-0 ........... 10/04/82 10/04/92
naphthalenyl)azo] [1,1'-biphenyl]-4-yl]azo]-2-hydroxy-
, disodium salt......................................
Benzoic acid, 5-[[4'-[[2,6-diamino-3-[[8-hydroxy-3,6- 2429-81-4 ........... 10/04/82 10/04/92
disulfo-7-[(4-sulfo-1-naphthalenyl)azo]-2-
naphthalenyl]azo]-5-methylphenyl]azo] [1,1'-biphenyl]-
4-yl]azo]-2-hydroxy-, tetrasodium salt...............
Benzoic acid, 5-[[4'-[(2,6-diamino-3-methyl-5- 6637-88-3 ........... 10/04/82 10/04/92
sulfophenyl)azo]-3,3'-dimethyl[1,1'-biphenyl]-4-
yl]azo]-2-hydroxy-, disodium salt....................
Benzoic acid, 5-[[4'-[[2,6-diamino-3-methyl-5-[(4- 2586-58-5 ........... 10/04/82 10/04/92
sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-
2-hydroxy-, disodium salt............................
Benzoic acid, 5-[[4'-[[2,6-diamino-3-methyl-5-[(4- 6360-54-9 ........... 10/04/82 10/04/92
sulfophenyl)azo]phenyl]azo]1,1'-biphenyl]-4-yl]azo]-2-
hydroxy-3-methly-, disodium salt.....................
Benzoic acid, 5-[[4'-[[2,4-dihydroxy-3-[(4- 2893-80-3 ........... 10/04/82 10/04/92
sulfophenyl)azo]phenyl]azo] [1,1'-biphenyl]-4-yl]azo]-
2-hydroxy-, disodium salt............................
Benzoic acid, 3,3'-[(3,7-disulfo-1,5-naphthalene- 8014-91-3 ........... 10/04/82 10/04/92
diyl)bis[azo(6-hydroxy-3,1-phenylene)azo[6(or 7)-
sulfo-4,1-naphthalenediyl]azo[1,1'-biphenyl]-4,4'-
diylazo]]bis[6-hydroxy-, hexasodium salt.............
[1,1'-Biphenyl]-4,1'-bis diazonium), 3,3'-dimethoxy-.. 20282-70-6 ........... 10/04/82 10/04/92
Butanamide, N,N'-(3,3'-dimethyl [1,1'-biphenyl]-4,4'- 91-96-3 ........... 10/04/82 10/04/92
diyl)bis[3-oxo-......................................
C.I. Direct Blue 218.................................. 10401-50-0 ........... 10/04/82 10/04/92
Cuprate(2-), [5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy-5- 16071-86-6 ........... 10/04/82 10/04/92
sulfophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-
2-hydroxybenzoato(4-)]-, disodium....................
Cuprate(3-), [[mu]-[7-[[3,3'-dihydroxy-4'-[[1-hydroxy- 6656-03-7 ........... 10/04/82 10/04/92
6-(phenylamino)-3-sulfo-2-naphthalenyl]azo] [1,1'-
biphenyl]-4-yl]azo]-8-hydroxy-1,6-
naphthalenedisulfonato(7-)]]di-, trisodium...........
Cuprate(4-), [[mu]-[[6,6'-[3,3'-dihydroxy[1,1'- 16143-79-6 ........... 10/04/82 10/04/92
biphenyl]-4-4'-diyl)bis(azo)]bis[4-amino-5-hydroxy-
1,3-naphthalendisulfonato]](8-)]]di-, tetrasodium....
2-Naphthalenecarboxamide, N,N'-(3,3'-dimethoxy[1,1'- 91-92-9 ........... 10/04/82 10/04/92
biphenyl]-4,4'-diyl)bis[3-hydroxy-...................
1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6- 2586-57-4 ........... 10/04/82 10/04/92
[[4'-[(2hydroxy-1-naphthalenyl)azo]-3,3'-
dimethoxy[1,1'-biphenyl]-4-yl]azo]-, disodium salt...
1,3-Naphthalenedisulfonic acid, 6,6'-[(3,3'- 2610-05-1 ........... 10/04/82 10/04/92
dimethoxy[1,1'-biphenyl]-4,4'diyl)bis(azo)]bis[4-
amino-5-hydroxy-, tetrasodium salt...................
1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4- 3530-19-6- ........... 10/04/82 10/04/92
ethoxyphenyl)azo] [1,1'-biphenyl]-4-yl]azo]-7-hydroxy-
, disodium salt......................................
1,3-Naphthalenedisulfonic acid, 8-[[4'-[4- 6358-29-8 ........... 10/04/82 10/04/92
ethoxyphenyl)azo]-3,3'-dimethyl] [1,1'-biphenyl]-4-
yl]azo]-7-hydroxy-, disodium salt....................
[[Page 199]]
1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4'-[[4- 3567-65-5 ........... 10/04/82 10/04/92
[[(4-methylphenyl) sulfonyl]oxy]phenyl]-azo] [1,1'-
biphenyl]-4-yl]azo]-, disodium salt..................
2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'-(7- 2429-73-4 ........... 10/04/82 10/04/92
amino-1-hydroxy-3-sulfo-2-naphthalenyl)-azo] [1,1'-
biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt.......
2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4- 2429-83-6 ........... 10/04/82 10/04/92
diamino-5-methylphenyl)azo] [1,1'-biphenyl]-4-yl]azo]-
5-hydroxy-6-(phenylazo)-, disodium salt..............
2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2,4- 1937-37-7 ........... 10/04/82 10/04/92
diaminophenyl)azo] [1,1'-biphenyl]-4-yl]azo] 5-
hydroxy-6-(phenylazo)-, disodium salt................
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy- 4335-09-5 ........... 10/04/82 10/04/92
6[[4'-[(4-hydroxyphenyl)azo] [1,1'-biphenyl]-4-yl]-
azo]-3-[(4-nitrophenyl)azo]-, disodium salt..........
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3- 3626-28-6 ........... 10/04/82 10/04/92
[[4'-[(4-hydroxyphenyl)azo] [1,1'-biphenyl]-4-yl]azo)-
6-(phenylazo)-, disodium salt........................
2,7-Naphthalenedisulfonic acid, 3,3'-[[1,1'-biphenyl]- 2602-46-2 ........... 10/04/82 10/04/92
4,4'-diylbis(azo)]bis[5-amino-4-hydroxy-, tetrasodium
salt.................................................
2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'- 2429-74-5 ........... 10/04/82 10/04/92
dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-
amino-4-hydroxy-, tetrasodium salt...................
2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-dimethyl- 72-57-1 ........... 10/04/82 10/04/92
[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-
hydroxy-, tetrasodium salt...........................
2,7-Naphthalenedisulfonic acid, 3,3'-[(3,3'-dimethyl- 2150-54-1 ........... 10/04/82 10/04/92
[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis-[4,5-dihydroxy-
, tetrasodium salt...................................
1-Naphthalenesulfonic acid, 3-[[4'[(6-amino-1-hydroxy- 6449-35-0 ........... 10/04/82 10/04/92
3-sulfo-2-naphthalenyl)azo]-3,3'-dimethoxy[1,1'-
biphenyl]-4-yl]azo]-4-hydroxy-, disodium salt........
1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]-4,4'- 573-58-0 ........... 10/04/82 10/04/92
diyl-4,4'-diyl)bis(azo)]bis[(4-amino-,disodium salt..
1-Naphthalenesulfonic acid, 3,3'-[3,3'-dimethoxy-[1,1'- 2429-71-2 ........... 10/04/82 10/04/92
biphenyl]-4,4'-diyl)bis(azo)]bis[4-hydroxy-, disodium
salt.................................................
1-Naphthalenesulfonic acid, 3,3'-[(3,3'dimethyl[1,1'- 992-59-6 ........... 10/04/82 10/04/92
biphenyl]-4,4'-diyl)bis(azo)]bis[4-amino-,disodium
salt.................................................
Chlorinated benzenes, mono-, di-, tri-, tetra-, and .............. ........... 10/04/82 10/04/92
penta-.................................................
Benzene, chloro-...................................... 108-90-7 ........... 10/04/82 10/04/92
Benzene, 1,2-dichloro-................................ 95-50-1 ........... 10/04/82 10/04/92
Benzene, 1,3-dichloro-................................ 541-73-1 ........... 10/04/82 10/04/92
Benzene, 1,4-dichloro-................................ 106-46-7 ........... 10/04/82 10/04/92
Benzene, pentachloro-................................. 608-93-5 ........... 10/04/82 10/04/92
Benzene, 1,2,3,4-tetrachloro-......................... 634-66-2 ........... 10/04/82 10/04/92
Benzene, 1,2,3,5-tetrachloro-......................... 634-90-2 ........... 10/04/82 10/04/92
Benzene, 1,2,4,5-tetrachloro-......................... 95-94-3 ........... 10/04/82 10/04/92
Benzene, 1,2,3-trichloro-............................. 87-61-6 ........... 10/04/82 10/04/92
Benzene, 1,2,4-trichloro-............................. 120-82-1 ........... 10/04/82 10/04/92
Benzene, 1,3,5-trichloro-............................. 108-70-3 ........... 10/04/82 10/04/92
Chlorinated naphthalenes--chlorinated derivatives of .............. ........... 10/04/82 12/29/88
naphthalene (empirical formula) C10HxCly where x = y =
8......................................................
Naphthalene, chloro-.................................. 25586-43-0 ........... 10/04/82 12/29/88
Naphthalene, chloro derivatives....................... 70776-03-3 ........... 10/04/82 12/29/88
Naphthalene, 1-chloro-................................ 90-13-1 ........... 10/04/82 12/29/88
Naphthalene, heptachloro-............................. 32241-08-0 ........... 10/04/82 12/29/88
Chlorinated paraffins--chlorinated paraffin oils and .............. ........... 10/04/82 10/04/92
chlorinated paraffin waxes, with chlorine content of 35
percent through 70 percent by weight...................
Alkanes, chloro-...................................... 61788-76-9 ........... 10/04/82 10/04/92
Alkanes, C6 18, chloro-............................... 68920-70-7 ........... 10/04/82 10/04/92
Paraffin waxes and hydrocarbon waxes, chlorinated..... 63449-39-8 ........... 10/04/82 10/04/92
Ethyltoluenes--This category consists of ethyltoluene .............. ........... 04/29/83 12/29/88
(mixed isomers) and the ortho (1,2-), meta (1,3-) and
para (1,4-) isomers....................................
Benzene, 1-ethyl-2-methyl-............................ 611-14-3 ........... 04/29/83 12/29/88
Fluoroalkenes--This category is defined as fluroalkenes .............. ........... 04/29/83 04/29/93
of the general formula: CnH2n-xFx where n equals 2 to 3
and X equals 1 to 6....................................
Ethene, tetrafluoro-.................................. 116-14-3 ........... 04/29/83 04/29/93
Ethene, trifluoro-.................................... 359-11-5 ........... 04/29/83 01/13/86
1-Propene, 1,1,2,3,3,3-hexafluoro-.................... 116-15-4 ........... 04/29/83 04/29/93
Glycidol (oxiranemethanol) and its derivatives.......... .............. ........... 10/04/82 10/04/92
----------------------------------------------------------------------------------------------------------------
[[Page 200]]
----------------------------------------------------------------------------------------------------------------
CAS No.
Category (examples for Special Effective Sunset date
category) exemptions date
----------------------------------------------------------------------------------------------------------------
R = H; alkyl, alkenyl or alkynyl; aryl; acyl. where R =
alkyl, alkenyl, alkynyl, aryl, or acyl; any
substituents or functional groups may be present with
the alkyl, etc., groups
1,2-Cyclohexanedicarboxylic acid, bis(oxiranylmethyl) 5493-45-8 ........... 10/04/82 10/04/92
ester................................................
Disiloxane, 1,1,3,3-tetramethyl-1,3-bis[3- 126-80-7 ........... 10/04/82 10/04/92
oxiranylmethoxy)propyl]-.............................
2,4-Imidazolidinedione, 5,5-dimethyl-3-[2- 32568-89-1 ........... 10/04/82 10/04/92
(oxiranylmethoxy)propyl]-1-(oxiranylmethyl)-.........
2,4-Imidazolidenedione, 3,3'-[2-(oxiranylmethoxy)-1,3- 38304-52-8 ........... 10/04/82 10/04/92
propanediyl]bis[5,5-dimethyl-1-(oxiranyl-methyl)-....
Neodecanoic acid, oxiranylmethyl ester................ 26761-45-5 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[1,4-butanediylbis(oxymethylene)]bis.... 2425-79-8 ........... 10/04/82 10/04/92
Oxirane, (butoxymethyl)-.............................. 2426-08-6 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[1,4-cyclohexanedilbis 14228-73-0 ........... 10/04/82 10/04/92
(methyleneoxymethylene)]bis-.........................
Oxirane, [(2,4-dibromophenoxy)methyl]-................ 20217-01-0 ........... 10/04/82 10/04/92
Oxirane, [(1,2-dibromopropoxy)methyl]-................ 35243-89-1 ........... 10/04/82 10/04/92
Oxirane, [(1,1-dimethylethoxy)methyl]-................ 7665-72-7 ........... 10/04/82 10/04/92
Oxirane, [[4-(1,1-dimethylethyl)phenoxy]methyl]-...... 3101-60-8 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[(2,2-dimethyl-1,3- 17557-23-2 ........... 10/04/82 10/04/92
propanediyl)bis(oxymethylene)]bis-...................
Oxirane, [(dodecyloxy)methyl]-........................ 2461-18-9 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[1,2-ethanediylbis (oxymethylene)]bis-.. 2224-15-9 ........... 10/04/82 10/04/92
Oxirane, 2,2',2'',2'''-[1,2-ethanediylidenetetrakis- 7328-97-4 ........... 10/04/82 10/04/92
(4,1-phenyleneoxymethylene)]tetrakis-................
Oxirane, (ethoxymethyl)-.............................. 4016-11-9 ........... 10/04/82 10/04/92
Oxirane, [[(2-ethylhexyl)oxy]methyl]-................. 2461-15-6 ........... 10/04/82 10/04/92
Oxirane, [(hexadecyloxy)methyl]-...................... 15965-99-8 ........... 10/04/82 10/04/92
Oxirane, 2,2',2''-[1,2,6-hexanetriyltris- 68959-23-9 ........... 10/04/82 10/04/92
(oxymethylene)]tris-.................................
Oxirane, (methoxymethyl)-............................. 930-37-0 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[methylenebis(phenyleneoxymethylene)]bis- 39817-09-9 ........... 10/04/82 10/04/92
.....................................................
Oxirane, 2,2'-[methylenebis(2,1- 54208-63-8 ........... 10/04/82 10/04/92
phenyleneoxymethylene)]bis-..........................
Oxirane, [(1-methylethoxy)methyl]-.................... 4016-14-2 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[(1-methylethylidene)bis[4,1-phenyl- 71033-08-4 ........... 10/04/82 10/04/92
eneoxy[1-(butoxymethyl)-2,1-
ethanediyl]oxymethylene]]bis-........................
Oxirane, 2,2'-[1-methylethylidene) bis(4,1-phenyl- 1675-54-3 ........... 10/04/82 10/04/92
eneoxymethylene)]bis-................................
Oxirane, 2,2'-[(1-methylethylidene)bis(4,1-phenyl- 25085-99-8 ........... 10/04/82 10/04/92
eneoxymethylene)[bis-, homopolymer...................
Oxirane, 2,2'-[(1-methylethylidene)bis[4,1- 72319-24-5 ........... 10/04/82 10/04/92
phenyleneoxy-3,1-propanediyloxy-4,1-phenylene(1-
methylethylidene)-4,1-phenyleneoxymethylene]]bis-....
Oxirane, [(methylphenoxy)methyl]-..................... 26447-14-3 ........... 10/04/82 10/04/92
Oxirane, [(2-methylphenoxy)methyl]-................... 2210-79-9 ........... 10/04/82 10/04/92
Oxirane, [[4-(1-methyl-1-phenylethyl)phenoxy]-methyl]- 61578-04-9 ........... 10/04/82 10/04/92
Oxirane, mono[C6-C12-alkyloxy)methyl]derivatives...... 68987-80-4 ........... 10/04/82 10/04/92
Oxirane, mono[(C8-C12-alkyloxy)methyl]derivatives..... 68609-96-1 ........... 10/04/82 10/04/92
Oxirane, mono[C10-C16-alkyloxy)methyl]derivatives..... 68081-84-5 ........... 10/04/82 10/04/92
Oxirane, mono[(C10-C14-alkyloxy)methyl]derivatives.... 68609-97-2 ........... 10/04/82 10/04/92
Oxirane, [(4-nitrophenoxy)methyl]-.................... 5255-75-4 ........... 10/04/82 10/04/92
[[Page 201]]
Oxirane, [(4-nonylphenoxy)methyl]-.................... 6178-32-1 ........... 10/04/82 10/04/92
Oxirane, [(9-octadecenyloxy)methyl]-, (Z)-............ 60501-41-9 ........... 10/04/82 10/04/92
Oxirane, [(octadecyloxy)methyl]-...................... 16245-97-9 ........... 10/04/82 10/04/92
Oxirane, 2,2'-(oxiranylmethoxy)-1,3- 13561-08-5 ........... 10/04/82 10/04/92
phenylene]bis(methylene)]bis-........................
Oxirane, 2,2'-[[[2-oxiranylmethyoxy) 67786-03-2 ........... 10/04/82 10/04/92
phenyl]methylene]bis(4,1-phenyl-eneoxymethylene)]bis-
Oxirane, 2,2'-[oxybis(methylene)]bis-................. 2238-07-5 ........... 10/04/82 10/04/92
Oxirane, (phenoxymethyl)-............................. 122-60-1 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[1,3-phenylenebis (oxymethylene)]bis-... 2425-01-6 ........... 10/04/82 10/04/92
Oxirane, 2,2'-[1,4-phenylenebis (oxymethylene)]bis-... 101-90-6 ........... 10/04/82 10/04/92
Oxirane, 2,2',2\1/4\-[1,2,3-propanetriyl 13236-02-7 ........... 10/04/82 10/04/92
tris(oxymethylene)]tris-.............................
Oxirane, [(2-propenyloxy)methyl]-..................... 106-92-3 ........... 10/04/82 10/04/92
Oxirane, 2,2',2\1/4\-[propylidynetris (4,1- 68517-02-2 ........... 10/04/82 10/04/92
phenyleneoxymethylene)]tris-.........................
Oxirane, [(tetradecyloxy)methyl]-..................... 38954-75-5 ........... 10/04/82 10/04/92
Oxiranecarboxylic acid, 3-methyl-3-phenyl-, ethyl 77-83-8 ........... 10/04/82 10/04/92
ester................................................
Poly(oxy-1,2-ethanediyl),-[alpha]-[4- 69943-75-5 ........... 10/04/82 10/04/92
oxiranylmethyoxy)benzoyl]-[omega]-[[4-
oxiranylmethoxy)benzoyl]oxy]-........................
2-Propenoic acid, 2-methyl-, oxiranylmethyl ester..... 106-91-2 ........... 10/04/82 10/04/92
2-Propenoic acid, oxiranylmethyl ester................ 106-90-1 ........... 10/04/82 10/04/92
Silane, [(3-chloropropyl)(dimethoxy)[3- 71808-64-5 ........... 10/04/82 10/04/92
(oxiranylmethoxy)propyl]-............................
Silane, diethoxymethyl[3-(oxiranyl-methoxy)propyl]-... 2897-60-1 ........... 10/04/82 10/04/92
Silane, ethoxydimethyl[3-(oxiranyl-methoxy)propyl]-... 17963-04-1 ........... 10/04/82 10/04/92
Silane, trimethyoxy[3-(oxiranyl-methoxy)propyl]-...... 2530-83-8 ........... 10/04/82 10/04/92
Tetrasiloxane, 1,1,1,3,5,7,7,7-octamethyl-3,5-bis[3- 69155-42-6 ........... 10/04/82 10/04/92
(oxiranylmethoxy)propyl]-............................
Trisiloxane, 1,1,1,3,5,5,5-heptamethyl-3-[3-(oxiranyl- 7422-52-8 ........... 10/04/82 10/04/92
methoxy)propyl]-.....................................
Halogenated alkyl epoxides--halogenated noncyclic .............. ........... 10/04/82 12/29/88
aliphatic hydrocarbons with one or more epoxy
functional groups......................................
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
CAS No.
Category (examples for Special Effective Sunset date
category) exemptions date
----------------------------------------------------------------------------------------------------------------
R1 = X or CnH2n = 1-yXy(y = 1 to 1n = 1) .............. ........... ........... ............
R2 = H or X or CnH2n = 1-yXy(y = 0 to 2n = 1) .............. ........... ........... ............
R3 = H or X or CnH2n = 1-yXy(y = 0 to 2n = 1) .............. ........... ........... ............
R4 = H or X or CnH2n = 1-yXy(y = 0 to 2n = 1) .............. ........... ........... ............
X = halogen. Groups R1-R4 may contain one or more
expoxide functions.
Lead and lead compounds................................. .............. Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Lead.................................................. 7439-92-1 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Acetic acid, lead (2 + ) salt......................... 301-04-2 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
[[Page 202]]
Carbonic acid, lead (2 + ) salt (1:1)................. 598-63-0 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Lead chloride (PbCl 2 )............................... 7758-95-4 Sec. February April 28,
716.21 (a) 28, 2008 2008
(8)
Chromic acid (H 2 Cr0 4 ), lead (2 + ) salt (1:1).... 7758-97-6 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Lead oxide (PbO 2).................................... 1309-60-0 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Oxirane, (2,2,3,3,4,4,5,5,6,6,7,7,7- 38565-52-5 ........... 10/04/82 12/29/88
tridecafluoroheptyl)-................................
Borate (1-), tetrafluoro-, lead (2 + ) (2:1).......... 13814-96-5 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Phosphoric acid, lead (2 + ) salt (2:3)............... 7446-27-7 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Silicic acid, lead salt, basic........................ 53466-66-3 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Octadecanoic acid, lead salt (1:?).................... 7428-48-0 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Sulfuric acid, lead salt (1:?), basic................. 63653-42-9 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Oxirane, (bromomethyl)-............................... 3132-463-7 ........... 10/04/82 12/29/88
Oxirane, (2,2,3,3,4,4,5,5,6,6,7,7,7- 38565-52-5 ........... 10/04/82 12/29/88
tridecafluoroheptyl)-................................
Lead sulfide (PbS).................................... 1314-8 7-0 Sec. February April 28,
716.21 28, 2008 2008
(a)(8)
Phenylenediamines (Benzenediamines). This category is .............. ........... 04/29/83 04/29/93
defined as all nitrogen unsubstituted
phenylenediamines and their salts with zero to two
substitutents on the ring selected from the same of
different members of the group of halo, nitro,
hydroxy, hydroxy-lower alkoxy, lower-alkyl, and lower
alkoxy. For this purpose, the term ``lower'' is
defined as a group containing between one and four
carbons..............................................
1,2-Benzenediamine.................................... 95-54-5 ........... 4/29/83 4/29/93
1,3-Benzenediamine.................................... 108-45-2 ........... 4/29/83 4/29/93
1,2 - Benzenediamine, 4-butyl-........................ 3663-23-8 ........... 4/29/83 12/29/88
1,2 - Benzenediamine, 4-butyl-........................ 95-83-0 ........... 4/29/83 4/29/83
1,3-Benzenediamine, 4-chloro-......................... 5131-60-2 ........... 04/29/83 04/29/93
1,4-Benzenediamine, 2-chloro-, dihydrochloride........ 615-46-3 ........... 04/29/83 12/29/88
1,2-Benzenediamine, 5-chloro-3-nitro-................. 42389-30-0 ........... 04/29/83 12/29/88
1,2-Benzenediamine, 4-chloro-, sulfate (1:1).......... 68459-98-3 ........... 04/29/83 12/29/88
1,3-Benzenediamine, 4-chloro-, sulfate (1:1).......... 68239-80-5 ........... 04/29/83 12/29/88
1,4-Benzenediamine, 2-chloro-, sulfate................ 6219-71-2 ........... 04/29/83 12/29/88
1,4-Benzenediamine, 2,5-dichloro-..................... 20103-09-7 ........... 04/29/83 12/29/88
1,2-Benzenediamine, dihydrochloride................... 615-28-1 ........... 04/29/83 04/29/93
1,3-Benzenediamine, dihydrochloride................... 541-69-5 ........... 04/29/83 04/29/93
1,4-Benzenediamine, dihydrochloride................... 624-18-0 ........... 04/29/83 04/29/93
1,4-Benzenediamine, ethanedioate (1:1)................ 62654-17-5 ........... 04/29/83 04/29/93
1,2-Benzenediamine, 4-ethoxy-......................... 1197-37-1 ........... 04/29/83 12/29/88
1,3-Benzenediamine, 4-ethoxy-dihydrochloride.......... 67801-06-3 ........... 04/29/83 12/29/88
1,3-Benzenediamine, 4-ethoxy-, sulfate (1:1).......... 68015-98-5 ........... 04/29/83 12/29/88
1,3-Benzenediamine, ar-ethyl-ar-methyl-............... 68966-84-7 ........... 04/29/83 12/29/88
1,4-Benzenediamine, 2-methoxy......................... 5307-02-8 ........... 04/29/83 04/29/93
1,2-Benzenediamine, 4-methoxy-, dihydrochloride....... 614-94-8 ........... 04/29/83 12/29/88
1,3-Benzenediamine, 4-methoxy-, sulfate............... 6219-67-6 ........... 04/29/83 12/29/88
1,3-Benzenediamine, 4-methoxy-, sulfate (1:1)......... 39156-41-7 ........... 04/29/83 04/29/93
Benzenediamine, ar-methyl-............................ 25376-45-8 ........... 04/29/83 04/29/93
1,2-Benzenediamine, 3-methyl-......................... 2687-25-4 ........... 04/29/83 04/29/93
1,2-Benzenediamine, 4-methyl-......................... 496-72-0 ........... 04/29/83 04/29/93
1,3-Benzenediamine, 2-methyl-......................... 823-40-5 ........... 04/29/83 04/29/93
1,3-Benzenediamine, 4-methyl-......................... 95-80-7 ........... 04/29/83 04/29/93
1,3-Benzenediamine, 5-methyl-......................... 108-71-4 ........... 04/29/83 04/29/93
1,4-Benzenediamine, 2-methyl-......................... 95-70-5 ........... 04/29/83 04/29/93
1,4-Benzenediamine, 2-methyl-, dihydrochloride-....... 615-45-2 ........... 04/29/83 04/29/93
1,4-Benzenediamine, 2-methyl-, sulfate................ 6369-59-1 ........... 04/29/83 04/29/93
1,4-Benzenediamine, 2-methyl-, sulfate (1:1).......... 615-50-9 ........... 04/29/83 04/29/93
1,2-Benzenediamine, 4-nitro-.......................... 99-56-9 ........... 04/29/83 04/29/93
1,3-Benzenediamine, 4-nitro-,......................... 5131-58-8 ........... 04/29/83 12/29/88
1,3-Benzenediamine, 5-nitro-,......................... 5042-55-7 ........... 04/29/83 12/29/88
1,4-Benzenediamine, 2-nitro-,......................... 5307-14-2 ........... 04/29/83 04/29/93
1,2-Benzenediamine, 4-nitro-, dihydrochloride......... 6219-77-8 ........... 04/29/83 12/29/88
1,4-Benzenediamine, 2-nitro-, dihydrochloride......... 18266-52-9 ........... 04/29/83 12/29/88
1,2-Benzenediamine, 4-nitro-, sulfate (1:1)........... 68239-82-7 ........... 04/29/83 12/29/88
1,4-Benzenediamine, 2-nitro-, sulfate (1:1)........... 68239-83-8 ........... 04/29/83 12/29/88
1,3-Benzenediamine, sulfate (1:1)..................... 541-70-8 ........... 04/29/83 04/29/93
[[Page 203]]
1,4-Benzenediamine, sulfate (1:1)..................... 16245-77-5 ........... 04/29/83 04/29/93
Ethanol, 2-(2,4-diaminophenoxy)-, dihydrochloride..... 66422-95-5 ........... 04/29/83 12/29/88
Phenol, 2,4-diamino-, dihydrochloride................. 137-09-7 ........... 04/29/83 04/29/93
Phenol, 2,4-diamino-6-methyl-......................... 15872-73-8 ........... 04/29/83 12/29/88
Phenol, 2,4-diamino-6-methyl-, hydrochloride.......... 65879-44-9 ........... 04/29/83 12/29/88
----------------------------------------------------------------------------------------------------------------
(d) Listed members of categories. The following categories are
listed in alphabetical order with the chemical substances identified in
each category also listed alphabetically. Only those chemical substances
specifically listed within a category are subject to all provisions of
part 716 for the time period from the effective date of the rule until
the sunset date.
----------------------------------------------------------------------------------------------------------------
Category CAS No. Special Exemptions Effective Date Sunset Date
----------------------------------------------------------------------------------------------------------------
Aldehydes:......................
Acetaldehyde.................. 75-07-0........... .................. 9/30/91........... 6/30/98
Acetaldehyde, chloro-......... 107-20-0.......... .................. 9/30/91........... 6/30/98
Acetaldehyde, (1,3-dihydro- 84-83-3........... .................. 9/30/91........... 6/30/98
1,3,3-trimethyl-2H-indol-2-
ylidene).
Acetaldehyde, trichloro-...... 75-87-6........... .................. 9/30/91........... 6/30/98
Benzaldehyde.................. 100-52-7.......... .................. 9/30/91........... 6/30/98
Benzaldehyde, 3-bromo-........ 3132-99-8......... .................. 9/30/91........... 6/30/98
Benzaldehyde, 4-butyl-........ 1200-14-2......... .................. 9/30/91........... 12/19/95
Benzaldehyde, 2-chloro-....... 89-98-5........... .................. 9/30/91........... 6/30/98
Benzaldehyde, 4-chloro-....... 104-88-1.......... .................. 9/30/91........... 6/30/98
Benzaldehyde, 4-(diethylamino)- 120-21-8.......... .................. 9/30/91........... 6/30/98
.
Benzaldehyde, 4-(diethylamino)- 17754-90-4........ .................. 9/30/91........... 6/30/98
2-hydroxy-.
Benzaldehyde, 2,4-dihydroxy-.. 95-01-2........... .................. 9/30/91........... 12/19/95
Benzaldehyde, 2,5-dimethoxy-.. 93-02-7........... .................. 9/30/91........... 6/30/98
Benzaldehyde, 3,4-dimethoxy-.. 120-14-9.......... .................. 9/30/91........... 6/30/98
Benzaldehyde, (dimethylamino)- 28602-27-9........ .................. 9/30/91........... 12/19/95
Benzaldehyde, 4- 100-10-7.......... .................. 9/30/91........... 6/30/98
(dimethylamino)-.
Benzaldehyde, 4-ethoxy-....... 10031-82-0........ .................. l9/30/91.......... 12/19/95
Benzaldehyde, 3-ethoxy-4- 121-32-4.......... .................. 9/30/91........... 6/30/98
hydroxy-.
Benzaldehyde, 2-hydroxy-...... 90-02-8........... .................. 9/30/91........... 6/30/98
Benzaldehyde, 4-hydroxy-...... 123-08-0.......... .................. 9/30/91........... 12/19/95
Benzaldehyde, 4-hydroxy-3- 121-33-5.......... .................. 9/30/91........... 6/30/98
methoxy-.
Benzaldehyde, 2-hydroxy-5- 97-51-8........... .................. 9/30/91........... 12/19/95
nitro-.
Benzaldehyde, 2-methoxy-...... 135-02-4.......... .................. 9/30/91........... 12/19/95
Benzaldehyde, 4-methoxy-...... 123-11-5.......... .................. 9/30/91........... 6/30/98
Benzaldehyde, methyl-......... 1334-78-7......... .................. 9/30/91........... 12/19/95
Benzaldehyde, 4-methyl-....... 104-87-0.......... .................. 9/30/91........... 6/30/98
Benzaldehyde, 2-nitro-........ 552-89-6.......... .................. 9/30/91........... 12/19/95
Benzaldehyde, 3-phenoxy-...... 39515-51-0........ .................. 9/30/91........... 6/30/98
Benzaldehyde, 4- 455-19-6.......... .................. 9/30/91........... 12/19/95
(trifluoromethyl)-.
Benzeneacetaldehyde........... 122-78-1.......... .................. 9/30/91........... 6/30/98
Benzeneacetaldehyde, alpha- 93-53-8........... .................. 9/30/91........... 12/19/95
methyl-.
Benzeneacetaldehyde, 4-methyl- 104-09-6.......... .................. 9/30/91........... 12/19/95
Benzenepropanal, 4-(1,1- 80-54-6........... .................. 9/30/91........... 6/30/98
dimethylethyl)-.[alpha].-
methyl-.
Benzenepropanal, .[alpha].- 103-95-7.......... .................. 9/30/91........... 6/30/98
methyl-4-(1-methylethyl)-.
1,3-Benzodioxole-5- 120-57-0.......... .................. 9/30/91........... 6/30/98
carboxaldehyde.
1,3-Benzodioxole-5- 5780-07-4......... .................. 9/30/91........... 12/19/95
carboxaldehyde, 7-methoxy-.
Butanal, 3-methyl-............ 590-86-3.......... .................. 9/30/91........... 6/30/98
3-Cyclohexene-1-carboxaldehyde 100-50-5.......... .................. 9/30/91........... 6/30/98
3-Cyclohexene-1- 27939-60-2........ .................. 9/30/91........... 6/30/98
carboxaldehyde, dimethyl-.
3-Cyclohexene-1- 31906-04-4........ .................. 9/30/91........... 6/30/98
carboxaldehyde, 4-(4-hydroxy-
4-methylpentyl)-.
3-Cyclohexene-1- 52475-86-2........ .................. 9/30/91........... 6/30/98
carboxaldehyde, 1-methyl-4-(4-
methyl-3-pentenyl)-.
3-Cyclohexene-1- 66327-54-6........ .................. 9/30/91........... 6/30/98
carboxaldehyde, 1-methyl-4-(4-
methylpentyl)-.
3-Cyclohexene-1- 37677-14-8........ .................. 9/30/91........... 12/19/95
carboxaldehyde, 4-(4-methyl-3-
pentenyl)-.
[[Page 204]]
3-Cyclohexene-1- 1423-46-7......... .................. 9/30/91........... 12/19/95
carboxaldehyde, 2,4,6-
trimethyl-.
3-Cyclopentene-1-acetaldehyde, 4501-58-0......... .................. 9/30/91........... 6/30/98
2,2,3-trimethyl-.
Decanal....................... 112-31-2.......... .................. 9/30/91........... 6/30/98
4a(4H)- 126-15-8.......... .................. 9/30/91........... 6/30/98
Dibenzofurancarboxaldehyde,
1,5a,6,9,9a,9b-hexahydro-.
Dodecanal..................... 112-54-9.......... .................. 9/30/91........... 6/30/98
Ethanedial.................... 107-22-2.......... .................. 9/30/91........... 6/30/98
Heptanal...................... 111-71-7.......... .................. 9/30/91........... 6/30/98
Heptanal, 2-(phenylmethylene)- 122-40-7.......... .................. 9/30/91........... 6/30/98
5-Heptenal, 2,6-dimethyl-..... 106-72-9.......... .................. 9/30/91........... 12/19/95
Hexanal, 2-ethyl-............. 123-05-7.......... .................. 9/30/91........... 6/30/98
Hexanal, 3,5,5-trimethyl-..... 5435-64-3......... .................. 9/30/91........... 12/19/95
2-Hexenal..................... 505-57-7.......... .................. 9/30/91........... 12/19/95
Hexenal, 2-ethyl-............. 26266-68-2........ .................. 9/30/91........... 6/30/98
Indium Compounds:
Acetic acid, indium(3 + ) salt. 25114-58-3........ Sec. 6/3/04 8/2/04
716.21(a)(6)
Indium......................... 7440-74-6......... Sec. 6/3/04 8/2/04
716.21(a)(6)
Indium chloride (InCl3)........ 10025-82-8........ Sec. 6/3/04 8/2/04
716.21(a)(6)
Indium hydroxide (In(OH)3)..... 20661-21-6........ Sec. 6/3/04 8/2/04
716.21(a)(6)
Indium oxide (In2O3)........... 1312-43-2......... Sec. 6/3/04 8/2/04
716.21(a)(6)
Indium phosphide (InP)......... 22398-80-7........ Sec. 6/3/04 8/2/04
716.21(a)(6)
Indium tin oxide............... 50926-11-9........ Sec. 6/3/04 8/2/04
716.21(a)(6)
Sulfamic acid, indium(3 + ) 66027-93-8........ Sec. 6/3/04 8/2/04
salt. 716.21(a)(6)
Sulfuric acid, indium(3 + ) 13464-82-9........ Sec. 6/3/04 8/2/04
salt (3:2). 716.21(a)(6)
1-Naphthalene carboxaldehyde.. 66-77-3........... .................. 9/30/91........... 12/19/95
Nonanal....................... 124-19-6.......... .................. 9/30/91........... 6/30/98
2,6-Octadienal, 3,7-dimethyl-, 141-27-5.......... .................. 9/30/91........... 12/19/95
(E).
2,6-Octadienal, 3,7-dimethyl-, 106-26-3.......... .................. 9/30/91........... 12/19/95
(Z).
Octanal....................... 124-13-0.......... .................. 9/30/91........... 6/30/98
Octanal, 3,7-dimethyl-........ 5988-91-0......... .................. 9/30/91........... 12/19/95
Octanal, 7-hydroxy-3,7- 107-75-5.......... .................. 9/30/91........... 6/30/98
dimethyl-.
Octanal, 7-methoxy-3,7- 3613-30-7......... .................. 9/30/91........... 6/30/98
dimethyl-.
Octanal, 2-(phenylmethylene)-. 101-86-0.......... .................. 9/30/91........... 6/30/98
6-Octenal, 3,7-dimethyl-...... 106-23-0.......... .................. 9/30/91........... 6/30/98
6-Octenal, 3,7-dimethyl-, (S)- 5949-05-3......... .................. 9/30/91........... 12/19/95
Pentanal...................... 110-62-3.......... .................. 9/30/91........... 6/30/98
Pentanedial................... 111-30-8.......... .................. 9/30/91........... 6/30/98
1-Piperidinecarboxaldehyde.... 2591-86-8......... .................. 9/30/91........... 6/30/98
Propanal...................... 123-38-6.......... .................. 9/30/91........... 6/30/98
Propanal, 3-hydroxy-2,2- 597-31-9.......... .................. 9/30/91........... 6/30/98
dimethyl-.
2-Propenal, 2-methyl-......... 78-85-3........... .................. 9/30/91........... 12/19/95
Propanal, 3-(methylthio)-..... 3268-49-3......... .................. 9/30/91........... 6/30/98
2-Propenal.................... 107-02-8.......... .................. 9/30/91........... 6/30/98
2-Propenal, 3- 4-(1,1- 13586-68-0........ .................. 9/30/91........... 6/30/98
dimethylethyl)phenyl -2-
methyl-.
2-Propenal, 3-(2- 1504-74-1......... .................. 9/30/91........... 6/30/98
methoxyphenyl)-.
2-Propenal, 2-methyl-......... 78-85-3........... .................. 9/30/91........... 6/30/98
2-Propenal, 2-methyl-3-phenyl- 101-39-3.......... .................. 9/30/91........... 6/30/98
2-Propenal, 3-phenyl-......... 104-55-2.......... .................. 9/30/91........... 6/30/98
2-Propenal, 3-phenyl-, 1331-92-6......... .................. 9/30/91........... 6/30/98
monopentyl deriv..
2-Pyridinecarboxaldehyde...... 1121-60-4......... .................. 9/30/91........... 12/19/95
2-Thiophene carboxaldehyde.... 98-03-3........... .................. 9/30/91........... 12/19/95
Undecanal..................... 112-44-7.......... .................. 9/30/91........... 6/30/98
Undecanal, 2-methyl-.......... 110-41-8.......... .................. 9/30/91........... 6/30/98
9-Undecenal................... 143-14-6.......... .................. 9/30/91........... 12/19/95
10-Undecenal.................. 112-45-8.......... .................. 9/30/91........... 6/30/98
Alkyl-, Chloro-, and
Hydroxymethyl Diaryl Ethers:.
Benzene, 1-(bromomethyl)-3- 51632-16-7........ .................. 04/12/93.......... 06/30/98
phenoxy-.
Benzenemethanol, 3-phenoxy-,.. 13826-35-2........ .................. 04/12/93.......... 06/30/98
Benzenemethanol, 3-phenoxy-, 50789-44-1........ .................. 4/12/93........... 12/19/95
acetate.
Benzene, 1-methyl-3-phenoxy-.. 3586-14-9......... .................. 04/12/93.......... 06/30/98
Benzene, 1,1'-oxybis[dodecyl-. 69834-19-1........ .................. 4/12/93........... 12/19/95
Benzene, 1,1,'-oxybis[methyl-. 28299-41-4........ .................. 04/12/93.......... 06/30/98
Benzene, 1,1'-oxybis[(1,1,3,3- 61702-88-3........ .................. 4/12/93........... 12/19/95
tetramethylbutyl)-.
Benzoic acid, 3-[2-chloro-4- 63734-62-3........ .................. 04/12/93.......... 06/30/98
(trifluoromethyl)phenoxy]-,.
Benzoic acid, 3-[2-chloro-4- 72242-48-3........ .................. 04/12/93.......... 06/30/98
(trifluoromethyl)phenoxy],
potassium salt.
[[Page 205]]
1,1'-Biphenyl, phenoxy-....... 28984-89-6........ .................. 04/12/93.......... 06/30/98
2-Chloro-1-(3-methylphenoxy)-4- 42874-96-4........ .................. 04/12/93.......... 06/30/98
(trifluoromethyl)benzene.
1,4-Diphenoxybenzene.......... 3061-36-7......... .................. 4/12/93........... 12/19/95
Phenol, 3-[2-chloro-4- 50594-77-9........ .................. 04/12/93.......... 06/30/98
(trifluoromethyl)phenoxy]-,
acetate.
Alkyl Phosphates:...............
Ethanol, 2-butoxy-, phosphate 78-51-3........... .................. 10/29/90.......... 12/19/95
(3:1).
Ethanol, 2-(2-butoxyethoxy)-, 7332-46-9......... .................. 10/29/90.......... 11/09/93
phosphate (3:1).
Phosphoric acid, bis(2- 298-07-7.......... .................. 10/29/90.......... 12/19/95
ethylhexyl) ester.
Phosphoric acid, dibutyl ester 107-66-4.......... .................. 10/29/90.......... 06/30/98
Phosphoric acid, didodecyl 7057-92-3......... .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, diisooctyl 27215-10-7........ .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, dodecyl ester 12751-23-4........ .................. 10/29/90.......... 11/09/93
Phosphoric acid, 2-ethylhexyl 12645-31-7........ .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, monobutyl 1623-15-0......... .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, mono(2- 1070-03-7......... .................. 10/29/90.......... 11/09/93
ethylhexyl)ester.
Phosphoric acid, monohexyl 3900-04-7......... .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, monomethyl 812-00-0.......... .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, mono(1- 1623-24-1......... .................. 10/29/90.......... 11/09/93
methylethyl)ester.
Phosphoric acid, monooctyl 3991-73-9......... .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, monooctadecyl 2958-09-0......... .................. 10/29/90.......... 11/09/93
ester.
Phosphoric acid, triethyl 78-40-0........... .................. 10/29/90.......... 12/19/95
ester.
Phosphoric acid, tris(2- 78-42-2........... .................. 10/29/90.......... 12/19/95
ethylhexyl) ester.
Phosphoric acid, tris(2- 126-71-6.......... .................. 10/29/90.......... 11/09/93
methylpropyl) ester.
Phosphorodichloridic acid, 1498-51-7......... .................. 10/29/90.......... 11/09/93
ethyl ester.
Alkylphenols and Alkylphenol
Ethoxyates:.
tert-Butylphenol (mixed 27178-34-3........ Sec. 3/29/96........... 6/30/98
isomers). 716.20(b)(4)
applies.
2-Butylphenol................. 3180-09-4......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
2-tert-Butylphenol............ 88-18-6........... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-n-Butylphenol............... 1638-22-8......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-sec-Butylphenol............. 99-71-8........... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-tert-Butylphenol............ 98-54-4........... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Decaethylene glycol 4- 2315-66-4......... Sec. 3/29/96........... 6/30/98
isoctylphenyl ether. 716.20(b)(4)
applies.
4-Dodecylphenol............... 104-43-8.......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Dodecylphenol (mixed isomers). 1331-57-3......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Dedecylphenol (mixed isomers). 27193-86-8........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Hexaethylene glycol 4- 2497-58-7......... Sec. 3/29/96........... 6/30/98
isoctylphenyl ether. 716.20(b)(4)
applies.
Isobutylphenol (mixed isomers) 31195-95-6........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Isononylphenol (mixed isomers) 11066-49-2........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-(1-Methylbutyl)phenol....... 94-06-4........... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
(1-Methylheptyl)phenol (mixed 27985-70-2........ Sec. 3/29/96........... 6/30/98
isomers). 716.20(b)(4)
applies.
4-(1-Methyloctyl)phenol....... 17404-66-9........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Nonylphenol (mixed isomers)... 1300-16-9......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
25154-52-3........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-Nonylphenol................. 104-40-5.......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Branched 4-nonylphenol (mixed 84852-15-3........ Sec. 3/29/96........... 6/30/98
isomers). 716.20(b)(4)
applies.
2-Octylphenol................. 949-13-3.......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-Octylphenol................. 1806-26-4......... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-Pentylphenol................ 14938-35-3........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-tert-Pentylphenol........... 80-46-6........... Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
Polyethylene glycol 9036-19-5......... Sec. 3/29/96........... 6/30/98
mono(octyl)phenyl ether. 716.20(b)(4)
applies.
Polyethylene glycol 4-(tert- 9002-93-1......... Sec. 3/29/96........... 6/30/98
octyl)phenyl ether. 716.20(b)(4)
applies.
Poly(oxy-1,2-ethanediyl), 68987-90-6........ Sec. 3/29/96........... 6/30/98
[alpha]-(octylphenyl)-[omega]- 716.20(b)(4)
hydroxy-, branched. applies.
2-(1,1,3,3- 3884-95-5......... Sec. 3/29/96........... 6/30/98
Tetramethylbutyl)phenol. 716.20(b)(4)
applies.
(1,1,3,3- 1322-69-6......... Sec. 3/29/96........... 6/30/98
Tetramethylbutyl)phenol 716.20(b)(4)
(mixed isomers). applies.
27193-28-8........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
29932-96-5........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
30105-54-5........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
62744-41-6........ Sec. 3/29/96........... 6/30/98
716.20(b)(4)
applies.
4-(2,2,3,3- 54932-78-4........ Sec. 3/29/96........... 6/30/98
Tetramethylbutyl)phenol. 716.20(b)(4)
applies.
Brominated flame retardants:....
Alkanes, C10-18, bromochloro-. 68955-41-9........ .................. 10/29/90.......... 12/19/95
[[Page 206]]
Benzamide, 3,5-dibromo-N-(4- 87-10-5........... .................. 10/29/90.......... 12/19/95
bromophenyl)-2-hydroxy-.
Benzene, ethenyl-, 88497-56-7........ .................. 10/29/90.......... 11/09/93
homopolymer, brominated.
Benzene, 1,1'-(1- 25327-89-3........ .................. 10/29/90.......... 11/09/93
methylethylidene)bis (3,5-
dibromo-4-(2-propenyloxy)-.
Benzene, pentabromomethyl-.... 87-83-2........... .................. 10/29/90.......... 12/19/95
Cyclohexane, 1,2,3,4,5- 87-84-3........... .................. 10/29/90.......... 12/19/95
pentabromo-6-chloro-.
Cyclohexane, 30554-72-4........ .................. 10/29/90.......... 12/19/95
tetrabromodichloro-.
Cyclohexane, tribromotrichloro- 30554-73-5........ .................. 10/29/90.......... 12/19/95
.
Ethanol, 2,2'-((1- 4162-45-2......... .................. 10/29/90.......... 12/19/95
methylethylidene)bis ((2,6-
dibromo-4,1-phenylene)oxy))
bis-.
Ethene, bromo-................ 593-60-2.......... .................. 10/29/90.......... 06/30/98
Phenol, 2,4-dibromo-.......... 615-58-7.......... .................. 10/29/90.......... 12/19/95
Phenol, 2,4(or 2,6)-dibromo- 69882-11-7........ .................. 10/29/90.......... 12/19/95
,homopolymer.
1-Propanol, 2,3-dibromo-...... 96-13-9........... .................. 10/29/90.......... 12/19/95
1-Propanol, 2,2-dimethyl- 36483-57-5........ .................. 10/29/90.......... 12/19/95
,tribromo deriv.
2-Propenoic acid,(1- 55205-38-4........ .................. 10/29/90.......... 12/19/95
methylethylidene)bis (2,6-
dibromo-4,1-phenylene) ester.
Chloroalkyl phosphates:.........
2,2-Bis(chloromethyl)-1,3- 38051-10-4........ .................. 6/14/93........... 12/19/95
propanediyltetrakis(2-
chloroethyl) phosphate.
2-Chloro-1-methylethylbis(2- 76649-15-5........ .................. 6/14/93........... 12/19/95
chloropropyl) phosphate-.
1,2-Ethanediyl tetrakis(2- 34621-99-3........ .................. 6/14/93........... 12/19/95
chloro-1-methylethylene)
phosphate.
Oxydi-2,1-ethanediyltetrakis(2- 53461-82-8........ .................. 6/14/93........... 12/19/95
choloroethyl) phosphate.
Cyanoacrylates:.................
2-Propenoic acid, 2-cyano-, 137-05-3.......... .................. 1/26/94........... 12/19/95
methyl ester.
2-Propenoic acid, 2-cyano-, 1069-55-2......... .................. 1/26/94........... 12/19/95
isobutyl ester.
2-Propenoic acid, 2-cyano-3,3- 6197-30-4......... .................. 1/26/94........... 12/19/95
diphenyl-, 2-ethylhexyl ester.
2-Propenoic acid, 2-cyano-, 6606-65-1......... .................. 1/26/94........... 12/19/95
butyl ester.
2-Propenoic acid, 2-cyano-, 7085-85-0......... .................. 1/26/94........... 12/19/95
ethyl ester.
2-Propenoic acid, 2-cyano-, 2- 7324-02-9......... .................. 1/26/94........... 12/19/95
propenyl ester.
2-Propenoic acid, 2-cyano-, 1- 10586-17-1........ .................. 1/26/94........... 12/19/95
methylethyl ester.
2-Propenoic acid, 2-cyano-, 21982-43-4........ .................. 1/26/94........... 12/19/95
ethoxy ethyl ester.
2-Propenoic acid, 2-cyano-, 23023-91-8........ .................. 1/26/94........... 12/19/95
2,2,2-trifluoromethyl ester.
2-Propenoic acid, 2-cyano-, 2- 27816-23-5........ .................. 1/26/94........... 12/19/95
methoxyethyl ester.
Ethanaminium, 2-[[2-cyano-3-[4- 64992-16-1........ .................. 1/26/94........... 12/19/95
(diethylamino)phenyl]-1-oxo-2-
propenyl]oxy]-N,N,N-trimethyl-
, chloride.
High-Priority Substances:
1,3-Butadiene................. 106-99-0.......... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
Butyl benzyl phthalate (BBP)-- 85-68-7........... Sec. 7/29/21........... 12/01/21
1,2-Benzene-dicarboxylic 716.21(a)(9).
acid, 1-butyl 2(phenylmethyl)
ester.
Dibutyl phthalate (DBP) (1,2- 84-74-2........... Sec. 7/29/21........... 12/01/21
Benzene-dicarboxylic acid, 716.21(a)(9).
1,2-dibutyl ester).
o-Dichlorobenzene............. 95-50-1........... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
p-Dichlorobenzene............. 106-46-7.......... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
1,1-Dichloroethane............ 75-34-3........... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
1,2-Dichloroethane............ 107-06-2.......... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
Trans-1,2-Dichloroethylene.... 156-60-5.......... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
1,2-Dichloropropane........... 78-87-5........... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
Dicyclohexyl phthalate........ 84-61-7........... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
Di-ethylhexyl phthalate 117-81-7.......... Sec. 7/29/21........... 12/01/21
(DEHP)--(1,2-Benzene- 716.21(a)(9).
dicarboxylic acid, 1,2-bis(2-
ethylhexyl) ester).
[[Page 207]]
Di-isobutyl phthalate (DIBP)-- 84-69-5........... Sec. 7/29/21........... 12/01/21
(1,2-Benzene-dicarboxylic 716.21(a)(9).
acid, 1,2-bis-(2methylpropyl)
ester).
Ethylene dibromide............ 106-93-4.......... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
Formaldehyde.................. 50-00-0........... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
1,3,4,6,7,8-Hexahydro- 1222-05-5......... Sec. 7/29/21........... 12/01/21
4,6,6,7,8,8- 716.21(a)(9).
hexamethylcyclopenta [g]-2-
benzopyran (HHCB).
4,4'-(1- 79-94-7........... Sec. 7/29/21........... 12/01/21
Methylethylidene)bis[2,6- 716.21(a)(9).
dibromophenol] (TBBPA).
Phosphoric acid, triphenyl 115-86-6.......... Sec. 7/29/21........... 12/01/21
ester (TPP). 716.21(a)(9).
Phthalic anhydride............ 85-44-9........... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
1,1,2-Trichloroethane......... 79-00-5........... Sec. 7/29/21........... 12/01/21
716.21(a)(9).
Tris(2-chloroethyl) phosphate 115-96-8.......... Sec. 7/29/21........... 12/01/21
(TCEP). 716.21(a)(9).
Indium Compounds:
Acetic acid, indium(3 + ) salt 25114-58-3........ Sec. 6/3/04............ 8/2/04
716.21(a)(6).
Indium........................ 7440-74-6......... Sec. 6/3/04............ 8/2/04
716.21(a)(6).
Indium chloride (InCl3)....... 10025-82-8........ Sec. 6/3/04............ 8/2/04
716.21(a)(6).
Indium hydroxide (In(OH)3).... 20661-21-6........ Sec. 6/3/04............ 8/2/04
716.21(a)(6).
Indium oxide (In2O3).......... 1312-43-2......... Sec. 6/3/04............ 8/2/04
716.21(a)(6).
Indium phosphide (InP)........ 22398-80-7........ Sec. 6/3/04............ 8/2/04
716.21(a)(6).
Indium tin oxide.............. 50926-11-9........ Sec. 6/3/04............ 8/2/04
716.21(a)(6).
Sulfamic acid, indium(3 + ) 66027-93-8........ Sec. 6/3/04............ 8/2/04
salt. 716.21(a)(6).
Sulfuric acid, indium(3 + ) 13464-82-9........ Sec. 6/3/04............ 8/2/04
salt (3:2). 716.21(a)(6).
IRIS Chemicals:.................
3,4-Dimethylphenol............ 95-65-8........... .................. 9/30/91........... 12/19/95
2,4-Dinitrophenol............. 51-28-5........... .................. 9/30/91........... 12/19/95
Isocyanates:....................
Acetic acid, isocyanato-, 2949-22-6......... .................. 10/29/90.......... 11/09/93
ethyl ester.
Benzene, bis(isocyanatomethyl)- 25854-16-4........ .................. 10/29/90.......... 11/09/93
.
Benzene, 1-bromo-4-isocyanato- 2493-02-9......... .................. 10/29/90.......... 11/09/93
Benzene, 1-chloro-3-isocyanato- 2909-38-8......... .................. 10/29/90.......... 11/09/93
.
Benzene, 1-chloro-4-isocyanato- 104-12-1.......... .................. 10/29/90.......... 06/30/98
.
Benzene, 1,2-dichloro-4- 102-36-3.......... .................. 10/29/90.......... 06/30/98
isocyanato-.
Benzene, 1,3-dichloro-5- 34893-92-0........ .................. 10/29/90.......... 11/09/93
isocyanato-.
Benzene, 1,1'- 10031-75-1........ .................. 10/29/90.......... 11/09/93
(diisocyanatomethylene)bis-.
Benzene, isocyanato-.......... 103-71-9.......... .................. 10/29/90.......... 06/30/98
Benzene, 2-isocyanato-1,3- 28178-42-9........ .................. 10/29/90.......... 11/09/93
bis(1-methylethyl)-.
Benzene, 2-isocyanato-1,3- 28556-81-2........ .................. 10/29/90.......... 11/09/93
dimethyl-, ester.
Benzene, 1-isocyanato-2-methyl- 614-68-6.......... .................. 10/29/90.......... 11/09/93
.
Benzene, 1-isocyanato-4-methyl- 622-58-2.......... .................. 10/29/90.......... 11/09/93
.
Benzene, 1-isocyanato-4-nitro- 100-28-7.......... .................. 10/29/90.......... 11/09/93
Benzene, 1-isocyanato-3- 329-01-1.......... .................. 10/29/90.......... 06/30/98
(trifluoromethyl)-.
Benzene, 1,1',1''- 2422-91-5......... .................. 10/29/90.......... 11/09/93
methylidynetris(4-isocyanato-.
Butane, 1-isocyanato-......... 111-36-4.......... .................. 10/29/90.......... 06/30/98
Cyclohexane, 2-heptyl-3,4-bis 68239-06-5........ .................. 10/29/90.......... 11/09/93
(9-isocyanatononyl)-1-pentyl-.
Cyclohexane, isocyanato-...... 3173-53-3......... .................. 10/29/90.......... 11/09/93
1,3-Diazetidine-2,4-dione, 1,3- 26747-90-0........ .................. 10/29/90.......... 11/09/93
bis(3-isocyanato
methylphenyl)-.
Ethane, isocyanato-........... 109-90-0.......... .................. 10/29/90.......... 12/19/95
Imidodicarbonic diamide, N,N'- 4035-89-6......... .................. 10/29/90.......... 11/09/93
2-tris(6-isocyanatohexyl)-.
Methane, isocyanato-.......... 624-83-9.......... .................. 10/29/90.......... 12/19/95
Octadecane, 1-isocyanato-..... 112-96-9.......... .................. 10/29/90.......... 11/09/93
Phenol, 4-isocyanato-, 4151-51-3......... .................. 10/29/90.......... 11/09/93
phosphorothioate (3:1)
(ester).
Propane, 1-isocyanato-........ 110-78-1.......... .................. 10/29/90.......... 11/09/93
1-Propene, 3-isocyanato-...... 1476-23-9......... .................. 10/29/90.......... 11/09/93
2-Propenoic acid, 2-methyl-, 2- 30674-80-7........ .................. 10/29/90.......... 12/19/95
isocyanatoethyl ester.
2-Propenoic acid, 2-methyl-2- 73597-26-9........ .................. 10/29/90.......... 11/09/93
(((((5-isocyanato-1,3,3-
trimethylcyclohexyl)methyl)am
ino) carbonyl)oxy)ethyl ester.
1,3,5,-Triazine-2,4,6(1H.3H.5H- 26603-40-7........ .................. 10/29/90.......... 11/09/93
trione, 1,3,5-tris(3-
isocyanatomethylphenyl)-.
Methyl ethylene glycol ethers
and esters:.
Ethylene glycol monomethy 3121-61-7......... .................. 1/26/94........... 12/19/95
ether acrylate.
[[Page 208]]
Tetraethylene glycol 23783-42-8........ .................. 1/26/94........... 12/19/95
monomethyl ether.
Organohalogen flame retardants:
Bis(2-ethylhexyl) 26040-51-7........ Sec. 7/29/21........... 1/25/22
tetrabromophthalate. 716.21(a)(10).
Bis(hexachlorocyclopentadieno) 13560-89-9........ Sec. 7/29/21........... 1/25/22
cyclooctane. 716.21(a)(10).
1,2-Bis(2,4,6- 37853-59-1........ Sec. 7/29/21........... 1/25/22
tribromophenoxy)ethane. 716.21(a)(10).
1,1'-Ethane-1,2- 84852-53-9........ Sec. 7/29/21........... 1/25/22
diylbis(pentabromobenzene). 716.21(a)(10).
2-Ethylhexyl-2,3,4,5- 183658-27-7....... Sec. 7/29/21........... 1/25/22
tetrabromobenzoate. 716.21(a)(10).
2-(2-Hydroxyethoxy)ethyl 2- 20566-35-2........ Sec. 7/29/21........... 1/25/22
hydroxypropyl 3,4,5,6- 716.21(a)(10).
tetrabromophthalate.
2,2'-[(1- 3072-84-2......... Sec. 7/29/21........... 1/25/22
Methylethylidene)bis[(2,6- 716.21(a)(10).
dibromo-4,1-
phenylene)oxymethylene]]bis[o
xirane].
Mixture of chlorinated linear 85535-85-9........ Sec. 7/29/21........... 1/25/22
alkanes C14-17 with 45-52% 716.21(a)(10).
chlorine.
N,N-Ethylene- 32588-76-4........ Sec. 7/29/21........... 1/25/22
bis(tetrabromophthalimide). 716.21(a)(10).
Pentabromochlorocyclohexane... 87-84-3........... Sec. 7/29/21........... 1/25/22
716.21(a)(10).
(Pentabromophenyl)methyl 59447-55-1........ Sec. 7/29/21........... 1/25/22
acrylate. 716.21(a)(10).
Pentabromotoluene............. 87-83-2........... Sec. 7/29/21........... 1/25/22
716.21(a)(10).
Perbromo-1,4-diphenoxybenzene. 58965-66-5........ Sec. 7/29/21........... 1/25/22
716.21(a)(10).
Phosphonic acid, (2- 6294-34-4......... Sec. 7/29/21........... 1/25/22
chloroethyl)-, bis(2- 716.21(a)(10).
chloroethyl) ester.
Phosphoric acid, 2,2- 38051-10-4........ Sec. 7/29/21........... 1/25/22
bis(chloromethyl)-1,3- 716.21(a)(10).
propanediyl tetrakis(2-
chloroethyl) ester.
Propanoic acid, 2-bromo-, 5445-17-0......... Sec. 7/29/21........... 1/25/22
methyl ester. 716.21(a)(10).
Tetrabromobisphenol A-bis(2,3- 21850-44-2........ Sec. 7/29/21........... 1/25/22
dibromopropyl ether). 716.21(a)(10).
Tetrabromobisphenol A bis(2- 4162-45-2......... Sec. 7/29/21........... 1/25/22
hydroxyethyl) ether. 716.21(a)(10).
Tetrabromobisphenol A diallyl 25327-89-3........ Sec. 7/29/21........... 1/25/22
ether. 716.21(a)(10).
Tetrabromobisphenol A dimethyl 37853-61-5........ Sec. 7/29/21........... 1/25/22
ether. 716.21(a)(10).
2,4,6-Tribromoaniline......... 147-82-0.......... Sec. 7/29/21........... 1/25/22
716.21(a)(10).
1,3,5-Tribromo-2-(prop-2-en-1- 3278-89-5......... Sec. 7/29/21........... 1/25/22
yloxy)benzene. 716.21(a)(10).
Tris(2-chloroethyl)phosphite.. 140-08-9.......... Sec. 7/29/21........... 1/25/22
716.21(a)(10).
Tris(1-chloro-2- 13674-84-5........ Sec. 7/29/21........... 1/25/22
propyl)phosphate. 716.21(a)(10).
Tris(2-chloro-1- 6145-73-9......... Sec. 7/29/21........... 1/25/22
propyl)phosphate. 716.21(a)(10).
Tris(2,3- 126-72-7.......... Sec. 7/29/21........... 1/25/22
dibromopropyl)phosphate. 716.21(a)(10).
1,3,5-Tris(2,3-dibromopropyl)- 52434-90-9........ Sec. 7/29/21........... 1/25/22
1,3,5-triazine- 716.21(a)(10).
2,4,6(1H,3H,5H)-trione.
Tris(1,3-dichloro-2- 13674-87-8........ Sec. 7/29/21........... 1/25/22
propyl)phosphate. 716.21(a)(10).
Tris(tribromoneopentyl)phospha 19186-97-1........ Sec. 7/29/21........... 1/25/22
te. 716.21(a)(10).
2,4,6-Tris-(2,4,6- 25713-60-4........ Sec. 7/29/21........... 1/25/22
tribromophenoxy)-1,3,5- 716.21(a)(10).
triazine.
OSHA Chemicals in Need of Dermal
Absorption Testing:.
Amitrole...................... 61-82-5........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
n-Amyl acetate................ 628-63-7.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
o-Anisidine................... 90-04-0........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Benzyl chloride............... 100-44-7.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
sec-Butyl acetate............. 105-46-4.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
tert-Butyl acetate............ 540-88-5.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
sec-Butyl alcohol............. 78-92-2........... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
tert-Butyl alcohol............ 75-65-0........... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
t-Butylcatechol............... 98-29-3........... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
o-sec-butylphenol............. 89-72-5........... .................. 3/11/94........... 6/30/98
Camphor....................... 76-22-2........... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Carbon disulfide.............. 75-15-0........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Catechol...................... 120-80-9.......... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
a-Chloroacetophenone.......... 532-27-4.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Chlorobenzene................. 108-90-7.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
o-Chlorotoluene............... 95-49-8........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Cyclohexene................... 110-83-8.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Cyclohexanol.................. 108-93-0.......... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
Cyclopentadiene............... 542-92-7.......... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
[[Page 209]]
Cyclopentane.................. 287-92-3.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Diacetone alcohol............. 123-42-2.......... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
Dibutyl phosphate............. 107-66-4.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
1,2-Dichloroethylene.......... 540-59-0.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Dicylcopentadiene............. 77-73-6........... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
Dimethyl acetamide............ 127-19-5.......... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
Dimethylaniline............... 121-69-7.......... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
Dimethyl sulfate.............. 77-78-1........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
m-Dinitrobenzene.............. 99-65-0........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
o-Dinitrobenzene.............. 528-29-0.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
p-Dinitrobenzene.............. 100-25-4.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
2,4-Dinitrotoluene............ 121-14-2.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Diphenylamine................. 122-39-4.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Disulfiram.................... 97-77-8........... Sec. 1/26/94........... 1/26/94
716.20(b)(3)
applies.
Ethyl bromide................. 74-96-4........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Ethyl ether................... 60-29-7........... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Heptane (n-Heptane)........... 142-82-5.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Indene........................ 95-13-6........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Isoamyl acetate............... 123-92-2.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
N-Isopropylaniline............ 768-52-5.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
p-Methoxyphenol............... 150-76-5.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Methyl acetate................ 79-20-9........... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Methylcyclohexane............. 108-87-2.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Methyl formate................ 107-31-3.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Methyl isoamyl ketone......... 110-12-3.......... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
p-Nitroaniline................ 100-01-6.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
p-Nitrochlorobenzene.......... 100-00-5.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
1-Nitropropane................ 108-03-2.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
2-Nitropropane................ 79-46-9........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
m-Nitrotoluene................ 99-08-1........... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
o-Nitrotoluene................ 88-72-2........... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
p-Nitrotoluene................ 99-99-0........... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
Nonane........................ 111-84-2.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Pentane....................... 109-66-0.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Phenylhydrazine............... 100-63-0.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Propylene glycol dinitrate.... 6423-43-4......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Sodium bisulfite.............. 7631-90-5......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Sodium metabisulfite.......... 7681-57-4......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Tetrahydrofuran............... 109-99-9.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
m-Toluidine................... 108-44-1.......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Vinylidene chloride........... 75-35-4........... Sec. 8/4/95............ 6/30/98
716.20(b)(3) and
(b)(4) apply.
Vinyl toluene................. 25013-15-4........ Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
p-Xylene...................... 106-42-3.......... Sec. 1/26/94........... 6/30/98
716.20(b)(3)
applies.
Xylidine...................... 1300-73-8......... Sec. 3/11/94........... 6/30/98
716.20(b)(3)
applies.
Propylene glycol ethers and
esters:.
Dipropylene glycol............ 110-96-5.......... .................. 1/26/94........... 12/19/95
Dipropylene glycol butyl ether 29911-28-2........ .................. 1/26/94........... 12/19/95
Dipropylene glycol monomethyl 88917-22-0........ .................. 1/26/94........... 12/19/95
ether acetate.
1-(2-Methoxy-1-methylethoxy)-2- 20324-32-7........ .................. 1/26/94........... 12/19/95
propanol.
Methoxy-1-propanol............ 28677-93-2........ .................. 1/26/94........... 12/19/95
1-Phenoxy-2-propanol.......... 770-35-4.......... .................. 1/26/94........... 12/19/95
Propylene glycol monobutyl 29387-86-8........ .................. 1/26/94........... 12/19/95
ether.
Propylene glycol monomethyl 108-65-6.......... .................. 1/26/94........... 12/19/95
ether acetate.
Propylene glycol mono-tert- 57018-52-7........ .................. 1/26/94........... 12/19/95
butyl ether.
Tripropylene glycol diacrylate 42978-66-5........ .................. 1/26/94........... 12/19/95
Tripropylene glycol methyl 20324-33-8........ .................. 1/26/94........... 12/19/95
ether.
Siloxanes:......................
Cyclopolydimethylsiloxane..... 69430-24-6........ .................. 10/12/93.......... 06/30/98
Decamethylcyclopentasiloxane.. 541-02-6.......... .................. 10/12/93.......... 06/30/98
Decamethyltetrasiloxane....... 141-62-8.......... .................. 10/12/93.......... 06/30/98
Dimethyldiphenylsiloxane...... 68083-14-7........ .................. 10/12/93.......... 06/30/98
Dimethylhydropolylsiloxane.... 68037-59-2........ .................. 10/12/93.......... 06/30/98
Dimethylmethyl 3,3,3- 115361-68-7....... .................. 10/12/93.......... 06/30/98
trifluoropropyl siloxane.
[[Page 210]]
Dimethylmethylvinylsiloxane... 67762-94-1........ .................. 10/12/93.......... 06/30/98
Dimethylpolysiloxanes......... 68037-74-1........ Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Dimethyl silicones and 63148-62-9........ .................. 10/12/93.......... 06/30/98
siloxanes.
Dimethyl silicones and 67762-90-7........ Sec. 10/12/93.......... 06/30/98
siloxane, reaction products 716.20(b)(2)
with silica. applies.
Docosamethylcycloundecasiloxan 18766-38-6........ Sec. 10/12/93.......... 06/30/98
e. 716.20(b)(2)
applies.
Docosamethyldecasiloxane...... 556-70-7.......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Dodecamethylcyclohexasiloxane. 540-97-6.......... .................. 10/12/93.......... 06/30/98
Dodecamethylpentasiloxane..... 141-63-9.......... .................. 10/12/93.......... 06/30/98
Dotetracontamethyleicosasiloxa 150027-00-2....... Sec. 10/12/93.......... 06/30/98
ne. 716.20(b)(2)
applies.
Dotriacontamethylcyclohexadeca 150026-95-2....... Sec. 10/12/93.......... 06/30/98
siloxane. 716.20(b)(2)
applies.
Dotriacontamethylpentadecasilo 2471-11-6......... Sec. 10/12/93.......... 06/30/98
xane. 716.20(b)(2)
applies.
Eicosamethylcyclodecasiloxane. 18772-36-6........ Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Eicosamethylnonasiloxane...... 2652-13-3......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Hexacosamethylcyclotridecasilo 23732-94-7........ Sec. 10/12/93.......... 06/30/98
xane. 716.20(b)(2)
applies.
Hexacosamethyldodecasiloxane.. 2471-08-1......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Hexadecamethylcyclooctasiloxan 556-68-3.......... Sec. 10/12/93.......... 06/30/98
e. 716.20(b)(2)
applies.
Hexadecamethylheptasiloxane... 541-01-5.......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Hexamethylcyclotrisiloxane.... 541-05-9.......... .................. 10/12/93.......... 06/30/98
Hexamethyldisilazane.......... 999-97-3.......... .................. 10/12/93.......... 06/30/98
Hexamethyldisiloxane.......... 107-46-0.......... .................. 10/12/93.......... 06/30/98
Hexatriacontamethylcyclooctade 23523-12-8........ Sec. 10/12/93.......... 06/30/98
casiloxane. 716.20(b)(2)
applies.
Hexatriacontamethylheptadecasi 18844-04-7........ Sec. 10/12/93.......... 06/30/98
loxane. 716.20(b)(2)
applies.
Methylpolysiloxane............ 9004-73-3......... .................. 10/12/93.......... 06/30/98
Methylvinylcyclosiloxane...... 2554-06-5......... .................. 10/12/93.......... 06/30/98
Siloxanes and silicones, di- 70131-67-8........ Sec. 10/12/93.......... 06/30/98
Me, hydroxy-terminated. 716.20(b)(2)
applies.
Octacosamethylcyclotetradecasi 149050-40-8....... Sec. 10/12/93.......... 06/30/98
loxane. 716.20(b)(2)
applies.
Octacosamethyltridecasiloxane. 2471-09-2......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Octadecamethylcyclononasiloxan 556-71-8.......... Sec. 10/12/93.......... 06/30/98
e. 716.20(b)(2)
applies.
Octadecamethyloctasiloxane.... 556-69-4.......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Octamethyltrisiloxane......... 107-51-7.......... .................. 10/12/93.......... 06/30/98
Octaphenylcyclotetrasiloxane.. 546-56-5.......... .................. 10/12/93.......... 06/30/98
Octatriacontamethylcyclononade 150026-97-4....... Sec. 10/12/93.......... 06/30/98
casiloxane. 716.20(b)(2)
applies.
Octatriacontamethyloctadecasil 36938-52-0........ Sec. 10/12/93.......... 06/30/98
oxane. 716.20(b)(2)
applies.
Polymethyloctadecylsiloxane... not available..... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Tetracontamethylcycloeicosasil 150026-98-5....... Sec. 10/12/93.......... 06/30/98
oxane. 716.20(b)(2)
applies.
Tetracontamethylnonadecasiloxa 150026-99-6....... Sec. 10/12/93.......... 06/30/98
ne. 716.20(b)(2)
applies.
Tetracosamethylcyclododecasilo 18919-94-3........ Sec. 10/12/93.......... 06/30/98
xane. 716.20(b)(2)
applies.
Tetracosamethylundecasiloxane. 107-53-9.......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Tetradecamethylcycloheptasilox 107-50-6.......... Sec. 10/12/93.......... 06/30/98
ane. 716.20(b)(2)
applies.
Tetradecamethylhexasiloxane... 107-52-8.......... Sec. 10/12/93.......... 06/30/98
716.20(b)(2)
applies.
Tetramethylcyclotetrasiloxane. 2370-88-9......... .................. 10/12/93.......... 06/30/98
Tetramethyldivinyldisiloxane.. 2627-95-4......... .................. 10/12/93.......... 06/30/98
Tetratriacontamethylcyclohepta 150026-96-3....... .................. 10/12/93.......... 06/30/98
decasiloxane.
Tetratriacontamethylhexadecasi 36938-50-8........ Sec. 10/12/93.......... 06/30/98
loxane. 716.20(b)(2)
applies.
Triacontamethylcyclopentadecas 23523-14-0........ Sec. 10/12/93.......... 06/30/98
iloxane. 716.20(b)(2)
applies.
Triacontamethyltetradecasiloxa 2471-10-5......... Sec. 10/12/93.......... 06/30/98
ne. 716.20(b)(2)
applies.
Trifluoropropylmethylcyclotris 2374-14-3......... .................. 10/12/93.......... 06/30/98
iloxane.
Substantially produced chemicals
in need of subchronic tests:.
Acetoacetanilide.............. 102-01-2.......... .................. 9/30/91........... 12/19/95
4-(Acetylamino)benzenesulfonyl 121-60-8.......... .................. 9/30/91........... 6/30/98
chloride.
2-(2-Aminoethoxy)-ethanol..... 929-06-6.......... .................. 6/30/92........... 6/30/98
7-Amino-4-hydroxy-2- 87-02-5........... .................. 9/30/91........... 12/19/95
naphthalenesulfonic acid.
Ammonium carbamate............ 1111-78-0......... .................. 9/30/91........... 12/19/95
1,3-Benzenedisulfonic acid.... 98-48-6........... .................. 9/30/91........... 12/19/95
Bis(2-ethylhexyl)-2- 142-16-5.......... .................. 9/30/91........... 12/19/95
butenedioate.
Bromamine acid................ 116-81-4.......... .................. 9/30/91........... 12/19/95
Butyric anhydride............. 106-31-0.......... .................. 9/30/91........... 12/19/95
Ethanol, 2-(2-ethoxyethoxy)-, 112-15-2.......... .................. 9/30/91........... 6/30/98
acetate.
1,2-Dichlorobutane............ 616-21-7.......... .................. 9/30/91........... 12/19/95
3,4-Dichlorobutene............ 760-23-6.......... .................. 9/30/91........... 12/19/95
3,4-Dichloronitrobenzene...... 99-54-7........... .................. 9/30/91........... 6/30/98
1,3-Dicyanobenzene............ 626-17-5.......... .................. 9/30/91........... 6/30/98
Diethylene glycol dimethyl 111-96-6.......... .................. 9/30/91........... 6/30/98
ether.
4-Ethoxynitrobenzene.......... 100-29-8.......... .................. 9/30/91........... 6/30/98
[[Page 211]]
2-Ethylanthraquinone.......... 84-51-5........... .................. 9/30/91........... 12/19/95
Hexa(methoxymethyl) melamine.. 3089-11-0......... .................. 9/30/91........... 6/30/98
3-Hydroxy-2-naphthoic acid.... 92-70-6........... .................. 9/30/91........... 12/19/95
Isobutyl acrylate............. 106-63-8.......... .................. 9/30/91........... 12/19/95
Isophthaloyl chloride......... 9-63-8............ .................. 9/30/91........... 12/19/95
4-Methyl-2-nitro-phenol....... 119-33-5.......... .................. 9/30/91........... 6/30/98
2-(4-Morpholinyldithio)- 95-32-9........... .................. 9/30/91........... 12/19/95
benzothiazole.
Naphthalenedicarboxylic 81-84-5........... .................. 9/30/91........... 6/30/98
anhydride.
1-Naphthol.................... 90-15-3........... .................. 9/30/91........... 12/19/95
p,p'- 80-51-3........... .................. 9/30/91........... 6/30/98
Oxybis(benzenesulfonylhydrazi
de).
2,4-Pentanedione.............. 123-54-6.......... .................. 9/30/91........... 12/19/95
Perfluoro-N-hexane............ 355-42-0.......... .................. 9/30/91........... 12/19/95
Perfluorotributylamine........ 311-89-7.......... .................. 9/30/91........... 12/19/95
Propanoic anhydride........... 123-62-6.......... .................. 9/30/91........... 12/19/95
Quinacridone.................. 1047-16-1......... .................. 9/30/91........... 12/19/95
Terephthaloyl chloride........ 100-20-9.......... .................. 9/30/91........... ..................
Trichloromethanesulfenyl 594-42-3.......... .................. 9/30/91........... 6/30/98
chloride.
Triethylene glycol bis(2- 94-28-0........... .................. 9/30/91........... 12/19/95
ethylhexanoate).
Sulphones:......................
2-Amino-4-[(2-hydroxyethyl) 17601-96-6........ .................. 9/30/91........... 12/19/95
sulfonyl]phenol.
2-Amino-4- 98-30-6........... .................. 9/30/91........... 12/19/95
(methylsulfonyl)phenol.
2-[(6-Amino-2-naphthalenyl) 52218-35-6........ .................. 9/30/91........... 12/19/95
sulfonyl]ethanol.
2-[(3- 5246-57-1......... .................. 9/30/91........... 12/19/95
Aminophenyl)sulfonyl]ethanol.
Bisphenol S................... 80-09-1........... .................. 9/30/91........... 12/19/95
3- 18760-44-6........ .................. 9/30/91........... 12/19/95
(Decyloxy)tetrahydrothiophene
1,1-dioxide.
4,4'-Diaminodiphenyl sulfone.. 80-08-0........... .................. 9/30/91........... 12/19/95
4-[4-[(2,6-Dichloro-4- 17741-62-7........ .................. 9/30/91........... 12/19/95
nitrophenyl)azo]phenyl]
thiomorpholine, 11,1-dioxide.
1-(Diiodomethyl)sulfonyl-4- 20018-09-1........ .................. 9/30/91........... 12/19/95
methyl benzene.
Dimethylsulfone............... 67-71-0........... .................. 9/30/91........... 12/19/95
Diphenylsulfone............... 127-63-9.......... .................. 9/30/91........... 12/19/95
3-[N-Ethyl-4-[[6- 16588-67-3........ .................. 9/30/91........... 12/19/95
(methylsulfonyl)-2-
benzothiazolyl]azo]-m-
toluidino]propionitrile.
1,1'- 41123-59-5........ .................. 9/30/91........... 12/19/95
[Methylenebis(sulfonyl)]bis-2-
chloroethane.
2,2'- 41123-69-7........ .................. 9/30/91........... 12/19/95
[Methylenebis(sulfonyl)]biset
hanol.
1,1'- 3278-22-6......... .................. 9/30/91........... 12/19/95
[Methylenebis(sulfonyl)]biset
hene.
6-Methylsulfonyl)-2- 17557-67-4........ .................. 9/30/91........... 12/19/95
benzothiazolamine.
2-[(3- 41687-30-3........ .................. 9/30/91........... 12/19/95
Nitrophenyl)sulfonyl]ethanol.
1,1'- 53061-10-2........ .................. 9/30/91........... 12/19/95
[Oxybis(methylenesulfonyl)]bi
s-2-chloroethane.
2,2'- 36724-43-3........ .................. 9/30/91........... 12/19/95
[Oxybis(methylenesulfonyl)]
bisethanol.
1,1'- 26750-50-5........ .................. 9/30/91........... 12/19/95
[Oxybis(methylenesulfonyl)]
bisethene.
4-[[4- 63134-33-8........ .................. 9/30/91........... 12/19/95
(Phenylmethoxy)phenyl]sulfony
l] phenol.
4-Phenylthiomorpholine, 1,1- 17688-68-5........ .................. 9/30/91........... 12/19/95
dioxide.
Sulfolane..................... 126-33-0.......... .................. 9/30/91........... 12/19/95
3-Sulfolene................... 77-79-2........... .................. 9/30/91........... 12/19/95
Sulfonyl bis(4-chlorobenzene). 80-07-9........... .................. 9/30/91........... 12/19/95
2,2'-Sulfonyl bisethanol...... 2580-77-0 .................. 9/30/91........... 12/19/95
Voluntary HPV Challenge Program ..................
orphan (unsponsored) chemicals:
Acetaldehyde, reaction 68442-60-4........ Sec. September 29, 2006 November 28, 2006
products with formaldehyde, 716.21(a)(7)
by-products from.
Acetamide, 2,2-dichloro-N,N-di- 37764-25-3........ Sec. September 29, 2006 November 28, 2006
2-propenyl-. 716.21(a)(7)
Acid chlorides, tallow, 68955-37-3........ Sec. September 29, 2006 November 28, 2006
hydrogenated. 716.21(a)(7)
Alkanes, chloro............... 61788-76-9........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Alkenes, C10 64743-02-8........ Sec. September 29, 2006 November 28, 2006
.alpha.-. 716.21(a)(7)
Amides, coco, N-[3- 70851-08-0........ Sec. September 29, 2006 November 28, 2006
(dimethylamino)propyl], 716.21(a)(7)
alkylation products with
sodium 3-chloro-2-
hydroxypropanesulfonate.
[[Page 212]]
Amides, tall-oil fatty, N,N-di- 68308-74-7........ Sec. September 29, 2006 November 28, 2006
Me. 716.21(a)(7)
Anthracene oil................ 90640-80-5........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Aromatic hydrocarbons, C8, o- 68650-36-2........ Sec. September 29, 2006 November 28, 2006
xylene-lean. 716.21(a)(7)
Aromatic hydrocarbons, C9-16, 68955-76-0........ Sec. September 29, 2006 November 28, 2006
biphenyl deriv.-rich. 716.21(a)(7)
Barium, carbonate nonylphenol 68515-89-9........ Sec. September 29, 2006 November 28, 2006
complexes. 716.21(a)(7)
Benzaldehyde, 3-bromo-........ 3132-99-8......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzaldehyde, 3-phenoxy-...... 39515-51-0........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzaldehyde, 4-(1,1- 939-97-9.......... Sec. September 29, 2006 November 28, 2006
dimethylethyl)-. 716.21(a)(7)
Benzenamine, 2,6-diethyl-N- 35203-08-8........ Sec. September 29, 2006 November 28, 2006
methylene-. 716.21(a)(7)
Benzenamine, 2-ethyl-6-methyl- 35203-06-6........ Sec. September 29, 2006 November 28, 2006
N-methylene-. 716.21(a)(7)
Benzenamine, 3- 98-16-8........... Sec. September 29, 2006 November 28, 2006
(trifluoromethyl)-. 716.21(a)(7)
Benzenamine, N,N-dimethyl-.... 121-69-7.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzenamine, N-phenyl-4-[[4- 2152-64-9......... Sec. September 29, 2006 November 28, 2006
(phenylamino)phenyl][4- 716.21(a)(7)
(phenylimino)-2,5-
cyclohexadien-1-
ylidene]methyl]-,
monohydrochloride.
Benzene, (2-chloro-1,1- 515-40-2.......... Sec. September 29, 2006 November 28, 2006
dimethylethyl)-. 716.21(a)(7)
Benzene, 1-(bromomethyl)-3- 51632-16-7........ Sec. September 29, 2006 November 28, 2006
phenoxy-. 716.21(a)(7)
Benzene, 1,1'-[1,2- 104-66-5.......... Sec. September 29, 2006 November 28, 2006
ethanediylbis(oxy)]bis-. 716.21(a)(7)
Benzene, 1,1'-oxybis-, 119345-02-7....... Sec. September 29, 2006 November 28, 2006
tetrapropylene derivs.. 716.21(a)(7)
Benzene, 1,2-dimethyl-3-nitro- 83-41-0........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzene, 1-bromo-4-fluoro-.... 460-00-4.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzene, 1-chloro-2,4-dinitro- 97-00-7........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzene, 1-chloro-4- 5216-25-1......... Sec. September 29, 2006 November 28, 2006
(trichloromethyl)-. 716.21(a)(7)
Benzene, 1-chloro-4- 98-56-6........... Sec. September 29, 2006 November 28, 2006
(trifluoromethyl)-. 716.21(a)(7)
Benzene, 1-methoxy-4-methyl-.. 104-93-8.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzene, chloromethyl-........ 25168-05-2........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzene, ethenylethyl-........ 28106-30-1........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzene, ethylenated.......... 68987-41-7........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzene, mixed with toluene, 68953-80-0........ Sec. September 29, 2006 November 28, 2006
dealkylation product. 716.21(a)(7)
1,3-Benzenedicarboxylic acid, 138-25-0.......... Sec. September 29, 2006 November 28, 2006
5-sulfo-, 1,3-dimethyl ester. 716.21(a)(7)
1,3-Benzenedicarboxylic acid, 3965-55-7......... Sec. September 29, 2006 November 28, 2006
5-sulfo-, 1,3-dimethyl ester, 716.21(a)(7)
sodium salt.
1,2-Benzenedicarboxylic acid, 84-69-5........... Sec. September 29, 2006 November 28, 2006
bis(2-methylpropyl) ester. 716.21(a)(7)
1,4-Benzenedicarboxylic acid, 68988-22-7........ Sec. September 29, 2006 November 28, 2006
dimethyl ester, manuf. of, by- 716.21(a)(7)
products from.
Benzenemethanol, 617-94-7.......... Sec. September 29, 2006 November 28, 2006
.alpha.,.alpha.-dimethyl-. 716.21(a)(7)
Benzenemethanol, 3-phenoxy-... 13826-35-2........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Benzenesulfonic acid, 3-nitro- 127-68-4.......... Sec. September 29, 2006 November 28, 2006
, sodium salt. 716.21(a)(7)
Benzenesulfonic acid, 4-chloro- 38185-06-7........ Sec. September 29, 2006 November 28, 2006
3,5-dinitro-, potassium salt. 716.21(a)(7)
Benzenesulfonic acid, C10-16- 68584-25-8........ Sec. September 29, 2006 November 28, 2006
alkyl derivs., compds. with 716.21(a)(7)
triethanolamine.
[[Page 213]]
Benzenesulfonic acid, dimethyl- 25321-41-9........ Sec. September 29, 2006 November 28, 2006
. 716.21(a)(7)
Benzenesulfonyl chloride...... 98-09-9........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1,2-Benzisothiazol-3(2H)-one, 81-07-2........... Sec. September 29, 2006 November 28, 2006
1,1-dioxide. 716.21(a)(7)
Benzoic acid, 2-methyl-....... 118-90-1.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
2,4,6,8,3,5,7- 17976-43-1........ Sec. September 29, 2006 November 28, 2006
Benzotetraoxatriplumbacycloun 716.21(a)(7)
decin-3,5,7-triylidene, 1,9-
dihydro-1,9-dioxo-.
Benzothiazole, 2- 28908-00-1........ Sec. September 29, 2006 November 28, 2006
[(chloromethyl)thio]-. 716.21(a)(7)
Benzoyl chloride, 3,5-dichloro- 2905-62-6......... Sec. September 29, 2006 November 28, 2006
. 716.21(a)(7)
1,2-Butadiene................. 590-19-2.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Butanedioic acid, oxo-, 40876-98-0........ Sec. September 29, 2006 November 28, 2006
diethyl ester, ion(1-), 716.21(a)(7)
sodium.
1-Butanol, sodium salt........ 2372-45-4......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
2-Butenal..................... 4170-30-3......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
2-Butenediamide, (2E)-, N,N'- 68442-77-3........ Sec. September 29, 2006 November 28, 2006
bis[2-(4,5-dihydro-2-nortall- 716.21(a)(7)
oil alkyl-1H-imidazol-1-
yl)ethyl] derivs..
2-Butenedioic acid (2E)-, di- 68610-90-2........ Sec. September 29, 2006 November 28, 2006
C8-18-alkyl esters. 716.21(a)(7)
2-Butenedioic acid (2Z)-, 2915-53-9......... Sec. September 29, 2006 November 28, 2006
dioctyl ester. 716.21(a)(7)
2-Butenenitrile, 2-methyl-, 30574-97-1........ Sec. September 29, 2006 November 28, 2006
(2E)-. 716.21(a)(7)
2-Butenenitrile, 2-methyl-, 20068-02-4........ Sec. September 29, 2006 November 28, 2006
(2Z)-. 716.21(a)(7)
Carbamic acid, monoammonium 1111-78-0......... Sec. September 29, 2006 November 28, 2006
salt. 716.21(a)(7)
Carbamodithioic acid, 513-74-6.......... Sec. September 29, 2006 November 28, 2006
monoammonium salt. 716.21(a)(7)
Carbonochloridothioic acid, S- 37734-45-5........ Sec. September 29, 2006 November 28, 2006
(phenylmethyl) ester. 716.21(a)(7)
Carbonodithioic acid, O-(1- 140-93-2.......... Sec. September 29, 2006 November 28, 2006
methylethyl) ester, sodium 716.21(a)(7)
salt.
Carboxylic acids, di-, C4-11.. 68937-72-4........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Chromate(3-), bis[3-(hydroxy- 57693-14-8........ Sec. September 29, 2006 November 28, 2006
.kappa.O)-4-[[2-(hydroxy- 716.21(a)(7)
.kappa.O)-1-naphthalenyl]azo-
.kappa.N1]-7-nitro-1-
naphthalenesulfonato(3-)]-,
trisodium.
Coal, anthracite, calcined.... 68187-59-7........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Creosote...................... 8001-58-9......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Cyclohexane, oxidized, aq. 68915-39-9........ Sec. September 29, 2006 November 28, 2006
ext., sodium salt. 716.21(a)(7)
Cyclohexane, oxidized, non- 68609-05-2........ Sec. September 29, 2006 November 28, 2006
acidic by-products, distn. 716.21(a)(7)
lights.
1,3-Cyclopentadiene........... 542-92-7.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Decane, 1-chloro-............. 1002-69-3......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Decanoic acid, mixed esters 68441-66-7........ Sec. September 29, 2006 November 28, 2006
with dipentaerythritol, 716.21(a)(7)
octanoic acid and valeric
acid.
1-Decene, sulfurized.......... 72162-15-3........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Distillates (coal tar)........ 65996-92-1........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Distillates (coal tar), heavy 90640-86-1........ Sec. September 29, 2006 November 28, 2006
oils. 716.21(a)(7)
Distillates (coal tar), upper. 65996-91-0........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
[[Page 214]]
Distillates (petroleum), 68782-97-8........ Sec. September 29, 2006 November 28, 2006
hydrofined lubricating-oil. 716.21(a)(7)
Distillates, hydrocarbon resin 68602-81-3........ Sec. September 29, 2006 November 28, 2006
prodn. higher boiling. 716.21(a)(7)
Disulfides, alkylaryl dialkyl 68334-01-0........ Sec. September 29, 2006 November 28, 2006
diaryl, petroleum refinery 716.21(a)(7)
spent caustic oxidn. products.
Disulfides, C5-12-alkyl....... 68513-62-2........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Ethane, 1,1,1-trimethoxy-..... 1445-45-0......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Ethane, 1,1'- 111-91-1.......... Sec. September 29, 2006 November 28, 2006
[methylenebis(oxy)]bis[2- 716.21(a)(7)
chloro-.
Ethane, 1,1'-oxybis[2-chloro-. 111-44-4.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Ethane, 1,2-dichloro-, manuf. 68608-59-3........ Sec. September 29, 2006 November 28, 2006
of, by-products from, distn. 716.21(a)(7)
lights.
1,2-Ethanediamine, N,N,N',N'- 110-18-9.......... Sec. September 29, 2006 November 28, 2006
tetramethyl-. 716.21(a)(7)
Ethanedioic acid, calcium salt 563-72-4.......... Sec. September 29, 2006 November 28, 2006
(1:1). 716.21(a)(7)
1,2-Ethanediol, dinitrate..... 628-96-6.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Ethanesulfonic acid, 2- 137-20-2.......... Sec. September 29, 2006 November 28, 2006
[methyl[(9Z)-1-oxo-9- 716.21(a)(7)
octadecenyl]amino]-, sodium
salt.
Ethanimidothioic acid, N- 13749-94-5........ Sec. September 29, 2006 November 28, 2006
hydroxy-, methyl ester. 716.21(a)(7)
Ethanol, 2-(2-butoxyethoxy)-, 38321-18-5........ Sec. September 29, 2006 November 28, 2006
sodium salt. 716.21(a)(7)
Ethanol, 2,2'-oxybis-, 68909-77-3........ Sec. September 29, 2006 November 28, 2006
reaction products with 716.21(a)(7)
ammonia, morpholine derivs.
residues.
Ethanol, 2,2'-oxybis-, 71077-05-9........ Sec. September 29, 2006 November 28, 2006
reaction products with 716.21(a)(7)
ammonia, morpholine product
tower residues.
Ethanol, 2-[(4- 2494-89-5......... Sec. September 29, 2006 November 28, 2006
aminophenyl)sulfonyl]-, 716.21(a)(7)
hydrogen sulfate (ester).
Ethanol, 2-butoxy-, sodium 52663-57-7........ Sec. September 29, 2006 November 28, 2006
salt. 716.21(a)(7)
Ethene, hydrated, by-products 68987-66-6........ Sec. September 29, 2006 November 28, 2006
from. 716.21(a)(7)
Ethenesulfonic acid, sodium 3039-83-6......... Sec. September 29, 2006 November 28, 2006
salt. 716.21(a)(7)
Extract oils (coal), tar base. 65996-86-3........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Extract residues (coal), tar 65996-87-4........ Sec. September 29, 2006 November 28, 2006
oil alk.. 716.21(a)(7)
Extract residues (coal), tar 73665-18-6........ Sec. September 29, 2006 November 28, 2006
oil alk., naphthalene distn. 716.21(a)(7)
residues.
Extracts, coal tar oil alk.... 65996-83-0........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Fats and Glyceridic oils, 68990-65-8........ Sec. September 29, 2006 November 28, 2006
vegetable, reclaimed. 716.21(a)(7)
Fatty acids, tall-oil, 2-(2- 68309-16-0........ Sec. September 29, 2006 November 28, 2006
hydroxyethoxy)ethyl esters. 716.21(a)(7)
Fatty acids, tall-oil, low- 68915-05-9........ Sec. September 29, 2006 November 28, 2006
boiling, reaction products 716.21(a)(7)
with ammonia-ethanolamine
reaction by-products.
Fatty acids, tall-oil, 68153-60-6........ Sec. September 29, 2006 November 28, 2006
reaction products with 716.21(a)(7)
diethylenetriamine, acetates.
Fatty acids, tall-oil, 68309-27-3........ Sec. September 29, 2006 November 28, 2006
sulfonated, sodium salts. 716.21(a)(7)
Formic acid, compd. with 24794-58-9........ Sec. September 29, 2006 November 28, 2006
2,2',2[ethanol] (1:1). 716.21(a)(7)
2,5-Furandione, dihydro-3- 26680-54-6........ Sec. September 29, 2006 November 28, 2006
(octenyl)-. 716.21(a)(7)
Glycine, N-(carboxymethyl)-... 142-73-4.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Glycine, N-(carboxymethyl)-, 928-72-3.......... Sec. September 29, 2006 November 28, 2006
disodium salt. 716.21(a)(7)
Glycine, N-methyl-, monosodium 4316-73-8......... Sec. September 29, 2006 November 28, 2006
salt. 716.21(a)(7)
[[Page 215]]
Glycine, N-phenyl-, 19525-59-8........ Sec. September 29, 2006 November 28, 2006
monopotassium salt. 716.21(a)(7)
Glycine, N-phenyl-, monosodium 10265-69-7........ Sec. September 29, 2006 November 28, 2006
salt. 716.21(a)(7)
1-Hexacosanol................. 506-52-5.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Hexadecane, 1-chloro-......... 4860-03-1......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1,4-Hexadiene................. 592-45-0.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Hexanedioic acid, dihexyl 110-33-8.......... Sec. September 29, 2006 November 28, 2006
ester. 716.21(a)(7)
Hexanedioic acid, esters with 84501-86-0........ Sec. September 29, 2006 November 28, 2006
high-boiling C6-10-alkene 716.21(a)(7)
hydroformylation products.
1,3-Hexanediol, 2-ethyl-...... 94-96-2........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1,6-Hexanediol, distn. 68937-29-1........ Sec. September 29, 2006 November 28, 2006
residues. 716.21(a)(7)
2-Hexenal, 2-ethyl-........... 645-62-5.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1H-Isoindole-1,3(2H)-dione, 85-40-5........... Sec. September 29, 2006 November 28, 2006
3a,4,7,7a-tetrahydro-. 716.21(a)(7)
Hydrocarbons, C12-20, 68919-17-5........ Sec. September 29, 2006 November 28, 2006
catalytic alkylation by- 716.21(a)(7)
products.
Imidodicarbonic diamide, 4035-89-6......... Sec. September 29, 2006 November 28, 2006
N,N',2-tris(6- 716.21(a)(7)
isocyanatohexyl)-.
1,3-Isobenzofurandione, 5- 19438-61-0........ Sec. September 29, 2006 November 28, 2006
methyl-. 716.21(a)(7)
Lard, oil, Me esters.......... 68082-78-0........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Methanesulfonamide, N-[2-[(4- 25646-71-3........ Sec. September 29, 2006 November 28, 2006
amino-3- 716.21(a)(7)
methylphenyl)ethylamino]ethyl
]-, sulfate (2:3).
Methanesulfonic acid, hydroxy- 870-72-4.......... Sec. September 29, 2006 November 28, 2006
, monosodium salt. 716.21(a)(7)
Methanesulfonyl chloride...... 124-63-0.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Methanone, (2-hydroxy-4- 131-57-7.......... Sec. September 29, 2006 November 28, 2006
methoxyphenyl)phenyl-. 716.21(a)(7)
Naphtha (petroleum), clay- 68527-22-0........ Sec. September 29, 2006 November 28, 2006
treated light straight-run. 716.21(a)(7)
2,7-Naphthalenedisulfonic 5460-09-3......... Sec. September 29, 2006 November 28, 2006
acid, 4-amino-5-hydroxy-, 716.21(a)(7)
monosodium salt.
1-Naphthalenesulfonic acid, 2- 81-16-3........... Sec. September 29, 2006 November 28, 2006
amino-. 716.21(a)(7)
2-Naphthalenesulfonic acid, 6- 6473-13-8......... Sec. September 29, 2006 November 28, 2006
[(2,4-diaminophenyl)azo]-3- 716.21(a)(7)
[[4-[[4-[[7-[(2,4-
diaminophenyl)azo]-1-hydroxy-
3-sulfo-2-
naphthalenyl]azo]phenyl]amino
]-3-sulfophenyl]azo]-4-
hydroxy-, trisodium salt.
1-Naphthalenol, 1,2,3,4- 529-33-9.......... Sec. September 29, 2006 November 28, 2006
tetrahydro-. 716.21(a)(7)
1(2H)-Naphthalenone, 3,4- 529-34-0.......... Sec. September 29, 2006 November 28, 2006
dihydro-. 716.21(a)(7)
1H,3H-Naphtho[1,8-cd]pyran-1,3- 81-84-5........... Sec. September 29, 2006 November 28, 2006
dione. 716.21(a)(7)
Nickel, bis[(cyano- 83864-02-2........ Sec. September 29, 2006 November 28, 2006
C)triphenylborato(1-)- 716.21(a)(7)
N]bis(hexanedinitrile-N,N')-.
1-Octacosanol................. 557-61-9.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Octadecane, 1-chloro-......... 3386-33-2......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Octadecanoic acid, 2-(1- 25383-99-7........ Sec. September 29, 2006 November 28, 2006
carboxyethoxy)-1-methyl-2- 716.21(a)(7)
oxoethyl ester, sodium salt.
Octadecanoic acid, 2- 28188-24-1........ Sec. September 29, 2006 November 28, 2006
(hydroxymethyl)-2-[[(1- 716.21(a)(7)
oxooctadecyl)oxy]methyl]-1,3-
propanediyl ester.
Octadecanoic acid, reaction 68815-50-9........ Sec. September 29, 2006 November 28, 2006
products with 2-[(2- 716.21(a)(7)
aminoethyl)amino]ethanol.
[[Page 216]]
9-Octadecenoic acid, 12- 101-34-8.......... Sec. September 29, 2006 November 28, 2006
(acetyloxy)-, 1,2,3- 716.21(a)(7)
propanetriyl ester,
(9Z,9'Z,9'',12R,12'R,12'')-.
Octane, 1-chloro-............. 111-85-3.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1-Octanesulfonyl chloride..... 7795-95-1......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1-Octanesulfonyl fluoride..... 40630-63-5........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Oxirane, [(2- 2210-79-9......... Sec. September 29, 2006 November 28, 2006
methylphenoxy)methyl]-. 716.21(a)(7)
Oxiranemethanamine, N-[4- 5026-74-4......... Sec. September 29, 2006 November 28, 2006
(oxiranylmethoxy)phenyl]-N- 716.21(a)(7)
(oxiranylmethyl)-.
Paraffin oils, 68188-18-1........ Sec. September 29, 2006 November 28, 2006
chlorosulfonated, saponified. 716.21(a)(7)
3-Pentanone................... 96-22-0........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1-Pentene, 2,4,4-trimethyl-... 107-39-1.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
2-Pentene, 2,4,4-trimethyl-... 107-40-4.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phenol, (1,1,3,3- 27193-28-8........ Sec. September 29, 2006 November 28, 2006
tetramethylbutyl)-. 716.21(a)(7)
Phenol, (1-methylethyl)-...... 25168-06-3........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phenol, 2-(1,1-dimethylethyl)- 2409-55-4......... Sec. September 29, 2006 November 28, 2006
4-methyl-. 716.21(a)(7)
Phenol, 2,4-bis(1,1- 52184-19-7........ Sec. September 29, 2006 November 28, 2006
dimethylpropyl)-6-[(2- 716.21(a)(7)
nitrophenyl)azo]-.
Phenol, 2,4-bis(1-methyl-1- 70693-50-4........ Sec. September 29, 2006 November 28, 2006
phenylethyl)-6-[(2- 716.21(a)(7)
nitrophenyl)azo]-.
Phenol, 3-(diethylamino)-..... 91-68-9........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phenol, 4-methyl-2-nitro-..... 119-33-5.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phenol, isobutylenated 68457-74-9........ Sec. September 29, 2006 November 28, 2006
methylstyrenated. 716.21(a)(7)
Phenol, methyl-, sodium salt.. 34689-46-8........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phenol, nonyl derivs.......... 68081-86-7........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phenol, styrenated............ 61788-44-1........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phenols (petroleum)........... 64743-03-9........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Phosphoramidothioic acid, O,O- 17321-47-0........ Sec. September 29, 2006 November 28, 2006
dimethyl ester. 716.21(a)(7)
Phosphoric acid, (1,1- 56803-37-3........ Sec. September 29, 2006 November 28, 2006
dimethylethyl)phenyl diphenyl 716.21(a)(7)
ester.
Phosphoric acid, mixed 3-bromo- 125997-20-8....... Sec. September 29, 2006 November 28, 2006
2,2-dimethylpropyl and 2- 716.21(a)(7)
bromoethyl and 2-chloroethyl
esters.
Phosphorochloridothioic acid, 2524-03-0......... Sec. September 29, 2006 November 28, 2006
O,O-dimethyl ester. 716.21(a)(7)
Phosphorochloridous acid, 63302-49-8........ Sec. September 29, 2006 November 28, 2006
bis(4-nonylphenyl) ester. 716.21(a)(7)
Phosphorodichloridic acid, 1498-51-7......... Sec. September 29, 2006 November 28, 2006
ethyl ester. 716.21(a)(7)
Phosphorodithioic acid, O,O-di- 68187-41-7........ Sec. September 29, 2006 November 28, 2006
C1-14-alkyl esters. 716.21(a)(7)
Phosphorodithioic acid, O,O-di- 68649-42-3........ Sec. September 29, 2006 November 28, 2006
C1-14-alkyl esters, zinc 716.21(a)(7)
salts.
Phosphorodithioic acid, O,O- 756-80-9.......... Sec. September 29, 2006 November 28, 2006
dimethyl ester. 716.21(a)(7)
Phosphorodithioic acid, O,O- 26377-29-7........ Sec. September 29, 2006 November 28, 2006
dimethyl ester, sodium salt. 716.21(a)(7)
Phosphorous acid, 2-(1,1- 20227-53-6........ Sec. September 29, 2006 November 28, 2006
dimethylethyl)-4-[1-[3-(1,1- 716.21(a)(7)
dimethylethyl)-4-
hydroxyphenyl]-1-
methylethyl]phenyl bis(4-
nonylphenyl) ester.
Phosphorous acid, isooctyl 26401-27-4........ Sec. September 29, 2006 November 28, 2006
diphenyl ester. 716.21(a)(7)
[[Page 217]]
Piperazineethanol............. 25154-38-5........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Pitch, coal tar-petroleum..... 68187-57-5........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Propane, 2,2-dimethoxy-....... 77-76-9........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Propanenitrile, 3- 1738-25-6......... Sec. September 29, 2006 November 28, 2006
(dimethylamino)-. 716.21(a)(7)
1-Propanesulfonic acid, 2- 52556-42-0........ Sec. September 29, 2006 November 28, 2006
hydroxy-3-(2-propenyloxy)-, 716.21(a)(7)
monosodium salt.
Propanoic acid, 2-bromo-...... 598-72-1.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Propanoic acid, 2-methyl-, 3- 22527-63-5........ Sec. September 29, 2006 November 28, 2006
(benzoyloxy)-2,2,4- 716.21(a)(7)
trimethylpentyl ester.
2-Propenoic acid, 2- 24615-84-7........ Sec. September 29, 2006 November 28, 2006
carboxyethyl ester. 716.21(a)(7)
Pyridine, hydrochloride....... 628-13-7.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
4(1H)-Pyrimidinone, 6-methyl-2- 2814-20-2......... Sec. September 29, 2006 November 28, 2006
(1-methylethyl)-. 716.21(a)(7)
Solvent naphtha (coal)........ 65996-79-4........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Sulfonic acids, petroleum..... 61789-85-3........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Tannins....................... 1401-55-4......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Tannins, reaction products 72854-27-4........ Sec. September 29, 2006 November 28, 2006
with sodium bisulfite, sodium 716.21(a)(7)
polysulfide and sodium
sulfite.
Tar oils, coal................ 65996-82-9........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Tar, coal, dried and oxidized. 68918-16-1........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Tar, coal, high-temp.......... 65996-89-6........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Tar, coal, high-temp., high- 68990-61-4........ Sec. September 29, 2006 November 28, 2006
solids. 716.21(a)(7)
Terpenes and Terpenoids, C10- 70084-98-9........ Sec. September 29, 2006 November 28, 2006
30, distn. residues. 716.21(a)(7)
1-Tetracosanol................ 506-51-4.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Tetradecane, 1-chloro-........ 2425-54-9......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1,3,5,7-Tetrazocine, octahydro- 2691-41-0......... Sec. September 29, 2006 November 28, 2006
1,3,5,7-tetranitro-. 716.21(a)(7)
Thiazole, 4-methyl-........... 693-95-8.......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Thiourea...................... 62-56-6........... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
1,3,5-Triazine, hexahydro- 121-82-4.......... Sec. September 29, 2006 November 28, 2006
1,3,5-trinitro-. 716.21(a)(7)
1,3,5-Triazine-2,4,6(1H,3H,5H)- 3779-63-3......... Sec. September 29, 2006 November 28, 2006
trione, 1,3,5-tris(6- 716.21(a)(7)
isocyanatohexyl)-.
1,3,5-Triazine-2,4-diamine, 6- 5915-41-3......... Sec. September 29, 2006 November 28, 2006
chloro-N-(1,1-dimethylethyl)- 716.21(a)(7)
N'-ethyl-.
1,3,5-Triazine-2,4-diamine, 6- 139-40-2.......... Sec. September 29, 2006 November 28, 2006
chloro-N,N'-bis(1- 716.21(a)(7)
methylethyl)-.
1,3,5-Triazine-2,4-diamine, 6- 1912-24-9......... Sec. September 29, 2006 November 28, 2006
chloro-N-ethyl-N'-(1- 716.21(a)(7)
methylethyl)-.
Urea, (hydroxymethyl)-........ 1000-82-4......... Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Urea, N'-(3,4-dichlorophenyl)- 330-54-1.......... Sec. September 29, 2006 November 28, 2006
N,N-dimethyl-. 716.21(a)(7)
Urea, sulfate (1:1)........... 21351-39-3........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
Urea, sulfate (2:1)........... 17103-31-0........ Sec. September 29, 2006 November 28, 2006
716.21(a)(7)
----------------------------------------------------------------------------------------------------------------
[53 FR 38645, Sept. 30, 1988]
[[Page 218]]
Editorial Note: For Federal Register citations affecting Sec.
716.120, see the List of CFR Sections Affected, which appears in the
Finding Aids section of the printed volume and at www.govinfo.gov.
Effective Date Note: At 59 FR 14115, Mar. 25, 1994, in Sec. 716.120
paragraph (d), the chemical substances under the category ``propylene
glycol ethers and esters'' and all related dates, were stayed effective
Mar. 25, 1994.
PART 717_RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL
SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT
--Table of Contents
Subpart A_General Provisions
Sec.
717.1 Scope and compliance.
717.3 Definitions.
717.5 Persons subject to this part.
717.7 Persons not subject to this part.
717.10 Allegations subject to this part.
717.12 Significant adverse reactions that must be recorded.
717.15 Recordkeeping requirements.
717.17 Inspection and reporting requirements.
717.19 Confidentiality.
Authority: 15 U.S.C. 2607(c).
Source: 48 FR 38187, Aug. 22, 1983, unless otherwise noted.
Subpart A_General Provisions
Sec. 717.1 Scope and compliance.
Section 8 (c) of the Toxic Substances Control Act (TSCA) requires
manufacturers, processors, and distributors of chemical substances and
mixtures:
(a) To keep ``records of significant adverse reactions to health or
the environment, as determined by the Administrator by rule, alleged to
have been caused by the substance or mixture.''
(b) To ``permit inspection and submit copies of such records'', upon
request of any designated representative of the Administrator. This rule
implements section 8(c) of TSCA. It describes the records to be kept and
prescribes the conditions under which certain firms must submit or make
the records available to a duly designated representative of the
Administrator.
Sec. 717.3 Definitions.
The definitions set forth in section 3 of TSCA and the following
definitions apply to this part:
(a) Allegation means a statement, made without formal proof or
regard for evidence, that a chemical substance or mixture has caused a
significant adverse reaction to health or the environment.
(b) Firm or company means any person, that is subject to this part,
as defined in Sec. 717.5.
(c)(1) Known human effects means a commonly recognized human health
effect of a particular substance or mixture as described either in:
(i) Scientific articles or publications abstracted in standard
reference sources.
(ii) The firm's product labeling or material safety data sheets
(MSDS).
(2) However, an effect is not a ``known human effect'' if it:
(i) Was a significantly more severe toxic effect than previously
described.
(ii) Was a manifestation of a toxic effect after a significantly
shorter exposure period or lower exposure level than described.
(iii) Was a manifestation of a toxic effect by an exposure route
different from that described.
(d) Manufacture or process means to manufacture or process for
commercial purposes.
(e)(1) Manufacture for commercial purposes means to import, produce,
or manufacture with the purpose of obtaining an immediate or eventual
commercial advantage for the manufacturer, and includes, among other
things, such ``manufacture'' of any amount of a chemical substance or
mixture:
(i) For distribution in commerce, including for test marketing.
(ii) For use by the manufacturer, including use for product research
and development, or as an intermediate.
[[Page 219]]
(2) Manufacture for commercial purposes also applies to substances
that are produced coincidentally during the manufacture, processing,
use, or disposal of another substance or mixture, including both
byproducts that are separated from that other substances or mixture and
impurities that remain in that substance or mixture. Such byproducts and
impurities may, or may not, in themselves have commercial value. They
are nonetheless produced for the purpose of obtaining a commercial
advantage since they are part of the manufacture of a chemical product
for a commercial purpose.
(f) Person includes any individual, firm, company, corporation,
joint venture, partnership, sole proprietorship, association, or any
other business entity, any State or political subdivision thereof, and
any department, agency, or instrumentally of the Federal Government.
(g) Process for commercial purposes means the preparation of a
chemical substance or mixture, after its manufacture, for distribution
in commerce with the purpose of obtaining an immediate or eventual
commercial advantage for the processor. Processing of any amount of a
chemical substance or mixture is included. If a chemical substance or
mixture containing impurities is processed for commercial purposes, then
those impurities are also processed for commercial purposes.
(h) Retailer means a person who distributes in commerce a chemical
substance, mixture, or article to ultimate purchasers who are not
commercial entities.
(i) Significant adverse reactions are reactions that may indicate a
substantial impairment of normal activities, or long-lasting or
irreversible damage to health or the environment.
(j) Site means a contiguous property unit. Property divided only by
a public right-of-way is considered one site. There may be multiple
manufacturing, processing, or distribution activities occurring within a
single site.
(k) Substance means a chemical substance or mixture unless otherwise
indicated.
Sec. 717.5 Persons subject to this part.
(a) Manufacturers. (1) All manufacturers of chemical substances are
subject to this part except as provided in Sec. 717.7(a). If
manufacture of a chemcial substance occurs at any site owned or
controlled by a firm then that firm is subject to this part.
(2) A manufacturer must collect:
(i) Any allegation identifying a chemical substance it manufactures
and any allegation identifying the operations in the manufacture of any
chemical substance it manufactures.
(ii) Any allegation identifying any of its own processing or
distribution in commerce activities with respect to any chemical
substance it manufactures.
(iii) Any allegation identifying emissions, effluents, or other
discharges from activities described in this paragraph.
(iv) Any allegation identifying a substance produced coincidentally
during processing, use, storage or disposal of a chemical substance it
manufactures.
(3) For the purpose of this part, owned or controlled means
ownership of 50 percent or more of a firm's voting stock or other equity
rights, or the power to control the management and policies of that
firm.
(b) Processors. (1) A person who processes chemical substances, who
is not also a manufacturer of those chemical substances, is subject to
this part if (i) the person processes chemical substances to produce
mixtures, or (ii) the person repackages chemical substances or mixtures.
(2) As a processor subject to this part such person must collect:
(i) Any allegation identifying any mixture it produces and
distributes in commerce and any allegation identifying any chemical
substance or mixture it repackages and distributes in commerce.
(ii) Any allegation identifying any of its own further processing or
distribution in commerce activities of the products described in
paragraph (b)(2)(i) of this section.
(iii) Any allegation identifying emissions, effluents, or other
discharges from activities described in this paragraph.
[[Page 220]]
(iv) Any allegation identifying a substance produced coincidentally
during the processing, use, storage or disposal of the products
described in paragraph (b)(2)(i) of this section.
(c) SIC code. SIC codes applicable to this part are published in
Standard Industrial Classification Manual--1972 and the 1977 Supplement.
This manual and supplement may be obtained from the U.S. Government
Printing Office, Washington, D.C. 20402--stock number 4101-0006 and
stock number 003-005-0170-0 respectively. Where there is a conflict
between the SIC code use of a term and the definition of that term in
this part, the definition in this part applies.
[48 FR 38187, Aug. 22, 1983, as amended at 50 FR 46769, Nov. 13, 1985]
Sec. 717.7 Persons not subject to this part.
(a) Manufacturers. (1) Persons or site activities are exempt from
this part if the means by which they manufacture a chemical substance
solely involves mining or other solely extractive functions, e.g., those
companies or sites within a company whose sole function is to mine
mineral ores, extract petroleum or natural gas, quarry non-metallic
minerals (including extraction of salts from seawater or brines), mine
or otherwise extract coal, or separate gases from the atmosphere. This
exemption may include, but is not necessarily limited to, firms engaged
in activities as described in SIC Division B--Mining and SIC Code 2813--
Industrial Gases.
(2) A person is not subject to this part if the chemical substances
that person causes to be produced are limited to:
(i) Chemical substances that result from chemical reactions that
occur incidental to exposure of another chemical substance, mixture, or
article to environmental factors such as air, moisture, microbial
organisms, or sunlight.
(ii) Chemical substances that result from chemical reactions that
occur incidental to storage or disposal of other chemical substances,
mixtures, or articles.
(iii) Chemical substances that result from chemical reactions that
occur upon end use of other chemical substances, mixtures, or articles
such as adhesives, paints, miscellaneous cleaners or other housekeeping
products, fuel additives, water softening and treatment agents,
photographic films, batteries, matches, or safety flares, and that are
not themselves manufactured or imported for distribution in commerce for
use as chemical intermediates.
(iv) Chemical substances that result from chemical reactions that
occur upon use of curable plastic or rubber molding compounds, inks,
drying oils, metal finishing compounds, adhesives, or paints, or other
chemical substance formed during the manufacture of an article destined
for the marketplace without further chemical change of the chemical
substance.
(v) Chemical substances that result from chemical reactions that
occur when (A) a stabilizer, colorant, odorant, antioxidant, filler,
solvent, carrier, surfactant, plasticizer, corrosion inhibitor,
antifoamer or defoamer, dispersant, precipitation-inhibitor, binder,
emulsifier, deemulsifier, dewatering agent, agglomerating agent,
adhesion promoter, flow modifier, pH adjuster, sequestrant, coagulant,
flocculant, fire retardant, lubricant, chelating agent, or quality
control reagent functions as intended, or (B) a chemical substance,
which is intended solely to impart a specific physicochemical
characteristic, functions as intended.
(b) [Reserved]
(c) Sole distributors. A person solely engaged in the distribution
of chemical substances is exempt from this part, unless such person is
also a manufacturer or processor subject to this part. For example, a
``distributor'' who repackages chemical substances or mixtures is
considered to be a processor and, thus, is not a sole distributor. Sole
distributors may include, but are not limited to, those firms that
distribute chemical substances as described in the wholesale trade SIC
codes 5161--Chemicals and Allied Products, 5171--Petroleum Bulk Stations
and Terminals, and 5172--Petroleum and Petroleum Products Wholesalers,
Except Bulk Stations and Terminals.
(d) Retailers. A person who is a retailer is exempt from this part
unless
[[Page 221]]
such person is also a manufacturer or a processor subject to this part.
[48 FR 38187, Aug. 22, 1983, as amended at 50 FR 46770, Nov. 13, 1985]
Sec. 717.10 Allegations subject to this part.
(a) Allegations subject to this part are those allegations received
on or after November 21, 1983 by persons subject to this part.
(b) Allegations subject to this part are those that:
(1) Are submitted either in writing and are signed by the alleger,
or are submitted orally. In the case of an oral allegation, the firm
must transcribe the allegation into written form, or it must inform the
alleger that such allegation may be subject to this part and request
that the alleger submit such allegation to the firm in writing and
signed.
(2) Implicate a substance that caused the stated significant adverse
reaction by one of the following:
(i) Naming the specific substance.
(ii) Naming a mixture that contains a specific substance.
(iii) Naming an article that contains a specific substance.
(iv) Naming a company process or operation in which substances are
involved.
(v) Identifying an effluent, emission, or other discharge from a
site of manufacturing, processing or distribution of a substance.
(c) Allegations subject to this part may be made to a firm by any
person, such as an employee of the firm, individual consumer, a neighbor
of the firm's plant, another firm on behalf of its employees or an
organization on behalf of its members.
(d) EPA intends that firms should, to the maximum practical extent,
provide allegers with information regarding the ultimate disposition of
their allegations. For example, firms could provide a brief notice to
the alleger stating that a record was created under this part based upon
their allegation, or that a record was not created and briefly explain
the reasons why not.
Sec. 717.12 Significant adverse reactions that must be recorded.
(a) Except as provided in paragraph (b) of this section, significant
adverse reactions to human health that must be recorded include but are
not limited to:
(1) Long-lasting or irreversible damage, such as cancer or birth
defects.
(2) Partial or complete impairment of bodily functions, such as
reproductive disorders, neurological disorders or blood disorders.
(3) An impairment of normal activities experienced by all or most of
the persons exposed at one time.
(4) An impairment of normal activities which is experienced each
time an individual is exposed.
(b) Firms are not required to record significant adverse reactions
that are known human effects as defined in Sec. 717.3(c).
(c) Except as provided in paragraph (d) of this section, significant
adverse reactions to the environment that must be recorded, even if
restricted to the environs of a plant or disposal site, include but are
not limited to:
(1) Gradual or sudden changes in the composition of animal life or
plant life, including fungal or microbial organisms, in an area.
(2) Abnormal number of deaths of organisms (e.g., fish kills).
(3) Reduction of the reproductive success or the vigor of a species.
(4) Reduction in agricultural productivity, whether crops or
livestock.
(5) Alterations in the behavior or distribution of a species.
(6) Long lasting or irreversible contamination of components of the
physical environment, especially in the case of ground water, and
surface water and soil resources that have limited self-cleansing
capability.
(d) Firms are not required to record a significant adverse reaction
to the environment if the alleged cause of that significant adverse
reaction can be directly attributable to an accidental spill or other
accidental discharge, emission exceeding permitted limits, or other
incident of environmental contamination that has been reported to
[[Page 222]]
the Federal Government under any applicable authority.
[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58
FR 34204, June 23, 1993]
Sec. 717.15 Recordkeeping requirements.
(a) Establishment and location of records. A firm subject to this
part shall establish and maintain records of significant adverse
reactions alleged to have been caused by chemical substances or mixtures
manufactured or processed by the firm. Such records shall be kept at the
firm's headquarters or at any other appropriate location central to the
firm's chemical operations.
(b) Content of records. The record shall consist of the following:
(1) The original allegation as received.
(2) An abstract of the allegation and other pertinent information as
follows:
(i) The name and address of the plant site which received the
allegation.
(ii) The date the allegation was received at that site.
(iii) The implicated substance, mixture, article, company process or
operation, or site discharge.
(iv) A description of the alleger (e.g., ``company employee,''
``individual consumer,'' ``plant neighbor''). If the allegation involves
a health effect, the sex and year of birth of the individual should be
recorded, if ascertainable.
(v) A description of the alleged health effect(s). The description
must relate how the effect(s) became known and the route of exposure, if
explained in the allegation.
(vi) A description of the nature of the alleged environmental
effect(s), identifying the affected plant and/or animal species, or
contaminated portion of the physical environment.
(3) The results of any self-initiated investigation with respect to
an allegation. (EPA does not require persons subject to this part to
investigate allegations received, and no provision of this part shall be
construed to imply that EPA recommends, encourages or requires such
investigation.)
(4) Copies of any further required records or reports relating to
the allegation. For example, if an employee allegation results in a
requirement for the firm to record the case on Occupational Safety and
Health Form 101 or appropriate substitute (see 29 CFR part 1904 for
requirements under the Occupational Safety and Health Act of 1970), a
copy of that OSHA record must be included in the allegation record.
(c) File structure. Records must be retrievable by the alleged cause
of the significant adverse reaction, which cause may be one of the
following:
(1) A specific chemical identity.
(2) A mixture.
(3) An article.
(4) A company process or operation.
(5) A site emission, effluent or other discharge.
(d) Retention period. Records of significant adverse reactions to
the health of employees shall be retained for a period of 30 years from
the date such reactions were first reported to or known by the person
maintaining such records. This provision requires persons subject to
this part to retain for 30 years an employee health related allegation,
arising from any employment related exposure, whether or not such
allegation was submitted by or on the behalf of that recordkeeper's own
employee. Any other record of significant adverse reactions shall be
maintained for a period of five years from the date the information
contained in the record was first reported to or known by the person
maintaining the record.
(e) Transfer of records. (1) If a firm ceases to do business, the
successor must receive and keep all the records that must be kept under
this part.
(2) If a firm ceases to do business and there is no successor to
receive and keep the records for the prescribed period, these records
must be transmitted to EPA. See Sec. 717.17(c) for the address to which
such records must be sent.
[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58
FR 34204, June 23, 1993]
Sec. 717.17 Inspection and reporting requirements.
(a) Inspection. Firms must make records of allegations available for
inspection by any duly designated representative of the Administrator.
(b) Reporting. Each person who is required to keep records under
this part must submit copies of those records to
[[Page 223]]
the Agency as required by the EPA Administrator or appropriate designee.
EPA will notify those responsible for reporting by letter or will
announce any such requirements for submitting copies of records by a
notice in the Federal Register. Such letter or notice will be signed by
the Administrator or appropriate designee, and will specify which
records or portion of records must be submitted. The reporting period
will be specified by the letter or notice but in no case will such
reporting period be less than 45 days from the date of the letter or the
effective date of the notice.
(c) How to report. When required to report, firms must submit copies
of records via CDX https://cdx.epa.gov/ using the EPA provided
electronic reporting application.
[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 52
FR 20084, May 29, 1987; 53 FR 12523, Apr. 15, 1988; 58 FR 34204, June
23, 1993; 60 FR 34464, July 3, 1995; 71 FR 33641, June 12, 2006; 88 FR
37172, June 7, 2023]
Sec. 717.19 Confidentiality.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
[88 FR 37172, June 7, 2023]
PART 720_PREMANUFACTURE NOTIFICATION--Table of Contents
Subpart A_General Provisions
Sec.
720.1 Scope.
720.3 Definitions.
Subpart B_Applicability
720.22 Persons who must report.
720.25 Determining whether a chemical substance is on the Inventory.
720.30 Chemicals not subject to notification requirements.
720.36 Exemption for research and development.
720.38 Exemptions for test marketing.
Subpart C_Notice Form
720.40 General.
720.45 Information that must be included in the notice form.
720.50 Submission of test data and other data concerning the health and
environmental effects of a substance.
720.57 Imports.
Subpart D_Disposition of Notices
720.60 General.
720.62 Notice that notification is not required.
720.65 Acknowledgement of receipt of a notice; errors in the notice;
incomplete submissions; and false and misleading statements.
720.70 Notice in the Federal Register.
720.75 Notice review period.
720.78 Recordkeeping.
Subpart E_Confidentiality and Public Access to Information
720.80 General provisions.
720.87 Categories or proposed categories of uses of a new chemical
substance.
720.95 Public file.
Subpart F_Commencement of Manufacture or Import
720.102 Notice of commencement of manufacture.
Subpart G_Compliance and Inspections
720.120 Compliance.
720.122 Inspections.
Authority: 15 U.S.C. 2604, 2607, and 2613.
Source: 48 FR 21742, May 13, 1983, unless otherwise noted.
Subpart A_General Provisions
Sec. 720.1 Scope.
This part establishes procedures for the reporting of new chemical
substances by manufacturers under section 5 of the Toxic Substances
Control Act, 15 U.S.C. 2604. This part applies to microorganisms only to
the extent provided by part 725 of this chapter. The rule defines the
persons and chemical substances subject to the reporting requirements,
prescribes the contents of section 5 notices, and establishes procedures
for submitting notices. The rule also establishes EPA policy regarding
claims of confidentiality for, and public disclosure of, various
categories of information submitted in connection with section 5
notices.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 62
FR 17932, Apr. 11, 1997; 87 FR 39763, July 5, 2022]
Sec. 720.3 Definitions.
(a)(1) For the purposes of this part, the terms cosmetic, device,
drug, food,
[[Page 224]]
and food additive have the meanings contained in the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations issued
under it. In addition, the term ``food'' includes poultry and poultry
products, as defined in the Poultry Products Inspection Act, 21 U.S.C.
453 et seq.; meats and meat food products, as defined in the Federal
Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as
defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
(2) The term pesticide has the meaning contained in the Federal
Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and
the regulations issued under it.
(3) The terms byproduct material, source material, and special
nuclear material have the meanings contained in the Atomic Energy Act of
1954, 42 U.S.C 2014 et seq. and the regulations issued under it.
(b) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et
seq.
(c) Article means a manufactured item:
(1) Which is formed to a specific shape or design during
manufacture;
(2) Which has end use function(s) dependent in whole or in part upon
its shape or design during end use; and
(3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article and that may occur as
described in Sec. 720.30(h)(5), except that fluids and particles are
not considered articles regardless of shape or design.
(d) Byproduct means a chemical substance produced without a separate
commercial intent during the manufacture, processing, use, or disposal
of another chemical substance or mixture.
(e) Chemical substance means any organic or inorganic substance of a
particular molecular identity, including any combination of such
substances occurring in whole or in part as a result of a chemical
reaction or occurring in nature, and any chemical element or uncombined
radical, except that ``chemical substance'' does not include:
(1) Any mixture.
(2) Any pesticide when manufactured, processed, or distributed in
commerce for use as a pesticide.
(3) Tobacco or any tobacco product.
(4) Any source material, special nuclear material, or byproduct
material.
(5) Any pistol, firearm, revolver, shells, or cartridges.
(6) Any food, food additive, drug, cosmetic, or device, when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device.
(f) Commerce means trade, traffic, transportation, or other commerce
(1) between a place in a State and any place outside of such State, or
(2) which affects trade, traffic, transportation, or commerce between a
place in a State and any place outside of such State.
(g) Customs territory of the United States means the 50 States,
Puerto Rico, and the District of Columbia.
(h) Director means the Director of the EPA Office of Pollution
Prevention and Toxics.
(i) Distribute in commerce means to sell in commerce, to introduce
or deliver for introduction into commerce, or to hold after introduction
into commerce.
(j) EPA means the U.S. Environmental Protection Agency.
(k) Health and safety study or study means any study of any effect
of a chemical substance or mixture on health or the environment or on
both, including underlying data and epidemiological studies, studies of
occupational exposure to a chemical substance or mixture, toxicological,
clinical, and ecological, or other studies of a chemical substance or
mixture, and any test performed under the Act. Chemical identity is
always part of a health and safety study.
(1) Not only is information which arises as a result of a formal,
disciplined study included, but other information relating to the
effects of a chemical substance or mixture on health or the environment
is also included. Any data that bear on the effects of a chemical
substance on health or the environment would be included.
(2) Examples include:
(i) Long- and short-term tests of mutagenicity, carcinogenicity, or
[[Page 225]]
teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological effects; mammalian absorption, distribution, metabolism,
and excretion; cumulative, additive, and synergistic effects; acute,
subchronic, and chronic effects; and structure/activity analyses.
(ii) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including: Acute
toxicity tests, chronic toxicity tests, critical life stage tests,
behavioral tests, algal growth tests, seed germination tests, plant
growth or damage tests, microbial function tests, bioconcentration or
bioaccumulation tests, and model ecosystem (microcosm) studies.
(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular chemical substance or
mixture on the environment, including surveys, tests, and studies of:
Biological, photochemical, and chemical degradation; air, water, and
soil transport; biomagnification and bioconcentration; and chemical and
physical properties, e.g., boiling point, vapor pressure, evaporation
rates from soil and water, octanol/water partition coefficient, and
water solubility.
(iv) Monitoring data, when they have been aggregated and analyzed to
measure the exposure of humans or the environment to a chemical
substance or mixture.
(v) Any assessments of risk to health and the environment resulting
from the manufacture, processing, distribution in commerce, use, or
disposal of the chemical substance.
(l) Importer means any person who imports a chemical substance,
including a chemical substance as part of a mixture or article, into the
customs territory of the United States. ``Importer'' includes the person
primarily liable for the payment of any duties on the merchandise or an
authorized agent acting on his or her behalf. The term also includes, as
appropriate:
(1) The consignee.
(2) The importer of record.
(3) The actual owner if an actual owner's declaration and
superseding bond has been filed in accordance with 19 CFR 141.20; or
(4) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred in accordance with subpart C of 19 CFR
part 144. (See ``principal importer.'')
(m) Impurity means a chemical substance which is unintentionally
present with another chemical substance.
(n) Intermediate means any chemical substance that is consumed, in
whole or in part, in chemical reactions used for the intentional
manufacture of another chemical substance(s) or mixture(s), or that is
intentionally present for the purpose of altering the rates of such
chemical reactions.
(o) Inventory means the list of chemical substances manufactured or
processed in the United States that EPA compiled and keeps current under
section 8(b) of the Act.
(p) Known to or reasonably ascertainable by means all information in
a person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know.
(q) Manufacture means to produce or manufacture in the United States
or import into the customs territory of the United States.
(r) Manufacture for commercial purposes means:
(1) To manufacture with the purpose of obtaining an immediate or
eventual commercial advantage for the manufacturer, and includes, among
other things, ``manufacture'' of any amount of a chemical substance or
mixture:
(2) The term also applies to substances that are produced
coincidentally during the manufacture, processing, use, or disposal of
another substance or mixture, including byproducts that are separated
from that other substance or mixture and impurities that remain in that
substance or mixture. Byproducts and impurities without separate
commercial value are nonetheless produced for the purpose of obtaining a
commercial advantage, since they are part of the manufacture of a
chemical substance for commercial purposes.
(s) Manufacture solely for export means to manufacture for
commercial purposes a chemical substance solely for export from the
United States
[[Page 226]]
under the following restrictions on activities in the United States:
(1) Distribution in commerce is limited to purposes of export or
processing solely for export as defined in Sec. 721.3 of this chapter.
(2) The manufacturer and any person to whom the substance is
distributed for purposes of export or processing solely for export (as
defined in Sec. 721.3 of this chapter), may not use the substance
except in small quantities solely for research and development in
accordance with Sec. 720.36.
(t) Manufacturer means a person who imports, produces, or
manufactures a chemical substance. A person who extracts a component
chemical substance from a previously existing chemical substance or a
complex combination of substances is a manufacturer of that component
chemical substance. A person who contracts with a manufacturer to
manufacture or produce a chemical substance is also a manufacturer if
(1) the manufacturer manufactures or produces the substance exclusively
for that person, and (2) that person specifies the identity of the
substance and controls the total amount produced and the basic
technology for the plant process.
(u) Mixture means any combination of two or more chemical substances
if the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except ``mixture'' does include
(1) any combination which occurs, in whole or in part, as a result of a
chemical reaction if the combination could have been manufactured for
commercial purposes without a chemical reaction at the time the chemical
substances comprising the combination were combined, and if all of the
chemical substances comprising the combination are not new chemical
substances, and (2) hydrates of a chemical substance or hydrated ions
formed by association of a chemical substance with water, so long as the
nonhydrated form is itself not a new chemical substance.
(v) New chemical substance means any chemical substance which is not
included on the Inventory.
(w) Nonisolated intermediate means any intermediate that is not
intentionally removed from the equipment in which it is manufactured,
including the reaction vessel in which it is manufactured, equipment
which is ancillary to the reaction vessel, and any equipment through
which the chemical substance passes during a continuous flow process,
but not including tanks or other vessels in which the substance is
stored after its manufacture.
(x) Person means any natural person, firm, company, corporation,
joint-venture, partnership, sole proprietorship, association, or any
other business entity, any State or political subdivision thereof, any
municipality, any interstate body, and any department, agency or
instrumentality of the Federal Government.
(y) Possession or control means in possession or control of the
submitter, or of any subsidiary, partnership in which the submitter is a
general partner, parent company, or any company or partnership which the
parent company owns or controls, if the subsidiary, parent company, or
other company or partnership is associated with the submitter in the
research, development, test marketing, or commercial marketing of the
chemical substance in question. (A parent company owns or controls
another company if the parent owns or controls 50 percent or more of the
other company's voting stock. A parent company owns or controls any
partnership in which it is a general partner). Information is included
within this definition if it is:
(1) In files maintained by submitter's employees who are:
(i) Associated with research, development, test marketing, or
commercial marketing of the chemical substance in question.
(ii) Reasonably likely to have such data.
(2) Maintained in the files of other agents of the submitter who are
associated with research, development, test marketing, or commercial
marketing of the chemical substance in question in the course of their
employment as such agents.
(z) Principal importer means the first importer who, knowing that a
new chemical substance will be imported rather than manufactured
domestically, specifies the identity of the chemical substance and the
total
[[Page 227]]
amount to be imported. Only persons who are incorporated, licensed, or
doing business in the United States may be principal importers.
(aa) Process means the preparation of a chemical substance or
mixture, after its manufacture, for distribution in commerce (1) in the
same form or physical state as, or in a different form or physical state
from, that in which it was received by the person so preparing such
substance or mixture, or (2) as part of a mixture or article containing
the chemical substance or mixture.
(bb) Processor means any person who processes a chemical substance
or mixture.
(cc) Small quantities solely for research and development (or
``small quantities solely for purposes of scientific experimentation or
analysis or chemical research on, or analysis of, such substance or
another substance, including such research or analysis for the
development of a product'') means quantities of a chemical substance
manufactured or processed or proposed to be manufactured or processed
solely for research and development that are not greater than reasonably
necessary for such purposes.
(dd) State means any State of the United States and the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the
Canal Zone, American Samoa, the Northern Mariana Islands, and any other
territory or possession of the United States.
(ee) Technically qualified individual means a person or persons (1)
who, because of education, training, or experience, or a combination of
these factors, is capable of understanding the health and environmental
risks associated with the chemical substance which is used under his or
her supervision, (2) who is responsible for enforcing appropriate
methods of conducting scientific experimentation, analysis, or chemical
research to minimize such risks, and (3) who is responsible for the
safety assessments and clearances related to the procurement, storage,
use, and disposal of the chemical substance as may be appropriate or
required within the scope of conducting a research and development
activity.
(ff) Test data means data from a formal or informal test or
experiment, including information concerning the objectives,
experimental methods and materials, protocols, results, data analyses,
recorded observations, monitoring data, measurements, and conclusions
from a test or experiment.
(gg) Test marketing means the distribution in commerce of no more
than a predetermined amount of a chemical substance, mixture, or article
containing that chemical substance or mixture, by a manufacturer or
processor, to no more than a defined number of potential customers to
explore market capability in a competitive situation during a
predetermined testing period prior to the broader distribution of that
chemical substance, mixture, or article in commerce.
(hh) United States, when used in the geographic sense, means all of
the States.
(ii) Central Data Exchange or CDX means EPA's centralized electronic
document receiving system, or its successors.
(jj) e-PMN software means electronic-PMN software created by EPA for
use in preparing and submitting Premanufacture Notices (PMNs) and other
TSCA section 5 notices and support documents electronically to the
Agency.
(kk) Support documents means material and information submitted to
EPA in support of a TSCA section 5 notice, including but not limited to,
correspondence, amendments (if notices for these amendments were
submitted prior to January 19, 2016), and test data. The term ``support
documents'' does not include orders under TSCA section 5(e) (either
consent orders or orders imposed pursuant to TSCA section 5(e)(2)(B)).
[48 FR 21742, May 13, 1983, as amended at 51 FR 15101, Apr. 22, 1986; 75
FR 784, Jan. 6, 2010; 80 FR 42745, July 20, 2015; 87 FR 39763, July 5,
2022]
Subpart B_Applicability
Sec. 720.22 Persons who must report.
(a)(1) Any person who intends to manufacture a new chemical
substance in the United States for commercial
[[Page 228]]
purposes must submit a notice unless the substance is excluded under
Sec. 720.30.
(2) If a person contracts with a manufacturer to manufacture or
produce a new chemical substance, and (i) the manufacturer manufactures
or produces the substance exclusively for that person, and (ii) that
person specifies the identity of the substance, and controls the total
amount produced and the basic technology for the plant process, that
person must submit the notice. If it is unclear who must report, EPA
should be contacted to determine who must submit the notice.
(3) Only manufacturers that are incorporated, licensed, or doing
business in the United States may submit a notice.
(b)(1) Any person who intends to import a new chemical substance
into the United States for commercial purposes must submit a notice,
unless the substance is excluded under Sec. 720.30 or unless the
substance is imported as part of an article.
(2) When several persons are involved in an import transaction, the
notice must be submitted by the principal importer. If no one person
fits the principal importer definition in a particular transaction, the
importer should contact EPA to determine who must submit the notice for
that transaction.
Sec. 720.25 Determining whether a chemical substance is on the Inventory.
(a) A new chemical substance is any chemical substance that is not
currently listed on the Inventory.
(b)(1) A chemical substance is listed in the public portion of the
Inventory by a specific chemical name (either a Chemical Abstracts (CA)
Index Name or a CA Preferred Name) and a Chemical Abstracts Service
(CAS) Registry Number if its identity is not confidential. If its
identity is confidential, it is listed in the public portion of the
Inventory by a TSCA Accession Number and a generic chemical name that
masks the specific substance identity. The confidential substance is
listed by its specific chemical name only in the confidential portion of
the Inventory, which is not available to the public. A person who
intends to manufacture (including import) a chemical substance not
listed by specific chemical name in the public portion of the Inventory
may ask EPA whether the substance is included in the confidential
Inventory. EPA will answer such an inquiry only if EPA determines that
the person has a bona fide intent to manufacture (including import) the
chemical substance for commercial purposes.
(2) To establish a bona fide intent to manufacture (including
import) a chemical substance, the person who proposes to manufacture the
substance must submit the request to EPA via CDX. Prior to submission to
EPA via CDX, such bona fide intents to manufacture (including import)
must be generated and completed using e-PMN software. See Sec.
720.40(a)(2)(ii) for information on how to access the e-PMN software. A
bona fide intent to manufacture (including import) must contain:
(i) Except as provided in paragraphs (b)(3)(i) and (ii) of this
section, the specific chemical identity of the substance that the person
intends to manufacture (including import), using the currently correct
CA Index name for the substance and the other correct chemical identity
information in accordance with Sec. 720.45(a) (1), (2), and (3).
(ii) A signed statement that the person intends to manufacture
(including import) that chemical substance for commercial purposes.
(iii)(A) A brief description of the research and development
activities conducted to date related to the substance, including the
year in which the person first started to conduct research or
development activity on the substance, and the general types of research
and development activities conducted thus far (e.g., synthesis,
substance isolation/purification, formulating, product development,
process development, end-use application, toxicity testing, etc.). The
person must also indicate whether any pilot plant or production-scale
plant evaluations have been conducted involving the manufacture or
processing of the substance.
(B) If an importer is unable to provide the information requested in
paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer
or supplier,
[[Page 229]]
the following information shall be submitted:
(1) A brief statement indicating how long the substance has been in
commercial use outside of the United States.
(2) The name of a country in which it has been commercially used.
(3) Whether the importer believes that the substance has already
been used commercially, in any country, for the same purpose or
application that the importer is intending.
(iv) A specific description of the major intended application or use
of the substance.
(v) An infrared spectrum of the substance, or alternative spectra or
other data which identify the substance if infrared analysis is not
suitable for the substance or does not yield a reasonable amount of
structural information. When using alternative spectra or instrumental
analysis, the person must submit a spectrum or instrumental readout for
the substance.
(vi) The estimated date (month/year) in which the person intends to
submit a Premanufacture Notice (PMN) for this substance if EPA informs
the notice submitter that the substance is not on the Inventory.
(vii) The address of the facility under the control of the submitter
at which the manufacture or processing of the substance would most
likely occur. For an imported substance, the facility under the control
of the importer at which processing of the substance would likely occur,
if any.
(viii)(A) For substances intended to be manufactured in the United
States, a description of the most probable manufacturing process that
would be used by the submitter to produce the substance for non-exempt
commercial purposes.
(B) For substances intended to be imported, a brief description of
how the submitter is most likely to process or use the substance for a
commercial purpose. If the substance is not expected to be processed or
used at any facility under the importer's control, a statement to this
effect must be included along with a description of how the substance
will be processed or used at sites controlled by others, if this
information is known or reasonably ascertainable.
(3)(i) If an importer cannot provide the chemical identity
information required by paragraph (b)(2) (i) and (v) of this section
because it is claimed confidential by its foreign manufacturer or
supplier, the foreign manufacturer or supplier must supply the required
information directly to EPA in accordance with Sec. 720.45(a) (1), (2),
and (3) and reference the importer's notice. If the appropriate
supporting document from the foreign party is not received within 30
days after EPA receives the importer's notice, the notice will be
considered incomplete.
(ii) If a manufacturer cannot provide all of the required
information in accordance with Sec. 720.45(a) (1), (2), and (3) because
the new chemical substance is manufactured using a reactant that has a
specific chemical identity claimed as confidential by its supplier, the
notice must contain chemical identity information that is as complete as
known by the manufacturer. In addition, a letter of support for the
notice must then be sent to EPA by the chemical supplier of the
confidential reactant, providing the specific chemical identity of the
proprietary reactant. The letter of support must reference the
manufacturer's notice. If the appropriate supporting document from the
supplier is not received within 30 days after EPA receives the
manufacturer's notice, the notice will be considered incomplete.
(4) EPA will review the information submitted by the proposed
manufacturer (including importer) under this paragraph to determine
whether it has a bona fide intent to manufacture (including import) the
chemical substance. If necessary, EPA will compare this information to
the information requested for the confidential chemical substance under
Sec. 720.85(b)(3)(iii).
(5) If the proposed manufacturer (including importer) has shown a
bona fide intent to manufacture (including import) the substance, and
has provided sufficient unambiguous chemical identity information so EPA
can make a conclusive determination of the chemical substance's
Inventory status, EPA will search the confidential Inventory and inform
the proposed manufacturer
[[Page 230]]
(including importer) whether the chemical substance is on the
confidential Inventory.
(6) If the chemical substance is found on the confidential
Inventory, EPA will notify the person(s) who originally reported the
chemical substance that another person has demonstrated a bona fide
intent to manufacture (including import) the substance and therefore was
told that the chemical substance is on the Inventory.
(7) A disclosure of a confidential chemical identity to a person
with a bona fide intent to manufacture (including import) the particular
chemical substance will not be considered a public disclosure of
confidential business information under section 14 of the Act.
(8) EPA will answer an inquiry on whether a particular chemical
substance is on the confidential Inventory within 30 days after receipt
of a complete submission under paragraph (b)(2) of this section.
(9) If the required chemical identity information has not been
reported correctly or completely in the notice (except as provided under
paragraph (b)(3)(ii) of this section) or if any other required data or
information has been omitted or is incomplete, EPA will consider the
whole notice to be incomplete. As soon as an incomplete notice is
identified as such by EPA, the Agency will immediately return the notice
directly to the submitter. The submitter must then resubmit the whole,
completed bona fide notice to EPA in order to have the Agency perform
the desired Inventory search and respond to the notice.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60
FR 16309, Mar. 29, 1995; 80 FR 42745, July 20, 2015]
Sec. 720.30 Chemicals not subject to notification requirements.
The following substances are not subject to the notification
requirements of this part:
(a) Any substance which is not a ``chemical substance'' as defined
in Sec. 720.3(e).
(b) Any mixture as defined in Sec. 720.3(u). \1\
---------------------------------------------------------------------------
\1\ A new chemical substance that is manufactured as part of a
mixture is subject to the requirements of this part. This exclusion
applies only to a mixture as a whole and not to any chemical substances
which are part of the mixture.
---------------------------------------------------------------------------
(c) Any new chemical substance which will be manufactured in small
quantities solely for research and development under Sec. 720.36.
(d) Any new chemical substance which will be manufactured solely for
test-marketing purposes under an exemption granted under Sec. 720.38.
(e) Any new chemical substance manufactured solely for export if,
when the substance is distributed in commerce:
(1) The substance is labeled in accordance with section 12(a)(1)(B)
of the Act.
(2) The manufacturer knows that the person to whom the substance is
being distributed intends to export it or process it solely for export
as defined in Sec. 721.3 of this chapter.
(f) Any new chemical substance which is manufactured under the terms
of a rule promulgated under section 5(h)(4) of the Act.
(g) Any byproduct if its only commercial purpose is for use by
public or private organizations that (1) burn it as a fuel, (2) dispose
of it as a waste, including in a landfill or for enriching soil, or (3)
extract component chemical substances from it for commercial purposes.
(This exclusion only applies to the byproduct; it does not apply to the
component substances extracted from the byproduct.)
(h) The chemical substances described below: (Although they are
manufactured for commercial purposes under the Act, they are not
manufactured for distribution in commerce as chemical substances per se
and have no commercial purpose separate from the substance, mixture, or
article of which they are a part.)
(1) Any impurity.
(2) Any byproduct which is not used for commercial purposes.
(3) Any chemical substance which results from a chemical reaction
that occurs incidental to exposure of another chemical substance,
mixture, or article to environmental factors such as air,
[[Page 231]]
moisture, microbial organisms, or sunlight.
(4) Any chemical substance which results from a chemical reaction
that occurs incidental to storage or disposal of another chemical
substance, mixture, or article.
(5) Any chemical substance which results from a chemical reaction
that occurs upon end use of another chemical substance, mixture, or
article such as an adhesive, paint, miscellaneous cleanser or other
housekeeping product, fuel additive, water softening and treatment
agent, photographic film, battery, match, or safety flare, and which is
not itself manufactured for distribution in commerce or for use as an
intermediate.
(6) Any chemical substance which results from a chemical reaction
that occurs upon use of curable plastic or rubber molding compounds,
inks, drying oils, metal finishing compounds, adhesives, or paints, or
any other chemical substance formed during the manufacture of an article
destined for the marketplace without further chemical change of the
chemical substance except for those chemical changes that occur as
described elsewhere in this paragraph.
(7) Any chemical substance which results from a chemical reaction
that occurs when (i) a stabilizer, colorant, odorant, antioxidant,
filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor,
antifoamer or defoamer, dispersant, precipitation inhibitor, binder,
emulsifier, deemulsifier, dewater ing agent, agglomerating agent,
adhesion promoter, flow modifier, pH neutralizer, sequesterant,
coagulant, flocculant, fire retardant, lubricant, chelating agent, or
quality control reagent functions as intended, or (ii) a chemical
substance, which is intended solely to impart a specific physiochemical
characteristic, functions as intended.
(8) Any nonisolated intermediate.
(i) Any chemical substance which is manufactured solely for non-
commercial research and development purposes. Non-commercial research
and development purposes include scientific experimentation, research,
or analysis conducted by academic, government, or independent not-for-
profit research organizations (e.g., universities, colleges, teaching
hospitals, and research institutes), unless the activity is for eventual
commercial purposes.
[48 FR 21742, May 13, 1983, as amended at 51 FR 15101, Apr. 22, 1986; 87
FR 39763, July 5, 2022]
Sec. 720.36 Exemption for research and development.
(a) This part does not apply to a chemical substance if the
following conditions are met:
(1) The chemical substance is manufactured only in small quantities
solely for research and development.
(2) The manufacturer notifies all persons in its employ or to whom
it directly distributes the chemical substance, who are engaged in
experimentation, research, or analysis on the chemical substance,
including the manufacture, processing, use, transport, storage, and
disposal of the substance associated with research and development
activities, of any risk to health, identified under paragraph (b) of
this section, which may be associated with the substance. The
notification must be made in accordance with paragraph (c) of this
section.
(3) The chemical substance is used by, or directly under the
supervision of, a technically qualified individual.
(b)(1) To determine whether notification under paragraph (a)(2) of
this section is required, the manufacturer must review and evaluate the
following information to determine whether there is reason to believe
there is any potential risk to health which may be associated with the
chemical substance:
(i) Information in its possession or control concerning any
significant adverse reaction by persons exposed to the chemical
substance which may reasonably be associated with such exposure.
(ii) Information provided to the manufacturer by a supplier or any
other person concerning a health risk believed to be associated with the
substance.
(iii) Health and environmental effects data in its possession or
control concerning the substance.
(iv) Information on health effects which accompanies any EPA rule or
[[Page 232]]
order issued under sections 4, 5, or 6 of the Act that applies to the
substance and of which the manufacturer has knowledge.
(2) When the research and development activity is conducted solely
in a laboratory and exposure to the chemical substance is controlled
through the implementation of prudent laboratory practices for handling
chemical substances of unknown toxicity, and any distribution, except
for purposes of disposal, is to other such laboratories for further
research and development activity, the information specified in
paragraph (b)(1) of this section need not be reviewed and evaluated.
(For purposes of this paragraph, a laboratory is a contained research
facility where relatively small quantities of chemical substances are
used on a non-production basis, and where activities involve the use of
containers for reactions, transfers, and other handling of substances
designed to be easily manipulated by a single individual.)
(c)(1) The manufacturer must notify the persons identified in
paragraph (a)(2) of this section by means of a container labeling
system, conspicuous placement of notices in areas where exposure may
occur, written notification to each person potentially exposed, or any
other method of notification which adequately informs persons of health
risks which the manufacturer has reason to believe may be associated
with the substance, as determined under paragraph (b)(1) of this
section.
(2) If the manufacturer distributes a chemical substance
manufactured under this section to persons not in its employ, the
manufacturer must in written form:
(i) Notify those persons that the substance is to be used only for
research and development purposes.
(ii) Provide the notice of health risks specified in paragraph
(c)(1) of this section.
(3) The adequacy of any notification under this section is the
responsibility of the manufacturer.
(d) A chemical substance is not exempt from reporting under this
part if any amount of the substance, including as part of a mixture, is
processed, distributed in commerce, or used, for any commercial purpose
other than research and development, except where the chemical substance
is processed, distributed in commerce, or used only as an impurity or as
part of an article.
(e) Quantities of the chemical substance, or of mixtures or articles
containing the chemical substance, remaining after completion of
research and development activities may be:
(1) Disposed of as a waste in accordance with applicable Federal,
state, and local regulations, or
(2) Used for the following commercial purposes:
(i) Burning it as a fuel.
(ii) Reacting or otherwise processing it to form other chemical
substances for commercial purposes, including extracting component
chemical substances.
(f) Quantities of research and development substances existing
solely as impurities in a product or incorporated into an article, in
accordance with paragraph (d) of this section, and quantities of
research and development substances used solely for commercial purposes
listed in paragraph (e) of this section, are not subject to the
requirements of paragraphs (a), (b), and (c) of this section, once
research and development activities have been completed.
(g) A person who manufactures a chemical substance in small
quantities solely for research and development is not required to comply
with the requirements of this section if the person's exclusive
intention is to perform research and development activities solely for
the purpose of determining whether the substance can be used as a
pesticide.
[51 FR 15102, Apr. 22, 1986, as amended at 87 FR 39763, July 5, 2022]
Sec. 720.38 Exemptions for test marketing.
(a) Any person may apply for an exemption to manufacture a new
chemical substance for test marketing. EPA may grant the exemption if
the person demonstrates that the chemical substance will not present an
unreasonable risk to injury to health or the environment as a result of
the test marketing.
(b) Persons applying for a test-marketing exemption should provide
the following information:
[[Page 233]]
(1) All existing data regarding health and environmental effects of
the chemical substance, including physical/chemical properties or, in
the absence of such data, a discussion of toxicity based on structure-
activity relationships (SAR) and relevant data on chemical analogues.
(2) The maximum quantity of the chemical substance which the
applicant will manufacture for test marketing.
(3) The maximum number of persons who may be provided the chemical
substance during test marketing.
(4) The maximum number of persons who may be exposed to the chemical
substance as a result of test marketing, including information regarding
duration and route of such exposures.
(5) A description of the test-marketing activity, including its
length and how it can be distinguished from full-scale commercial
production and research and development.
(6) A fee payment identity number, as required in 40 CFR
700.45(g)(4).
(7) Any safety data sheet already developed for the chemical
substance, including draft safety data sheets.
(c) In accordance with section 5(h)(6) of the Act, after EPA
receives an application for exemption under this section, the Agency
will file with the Office of the Federal Register a notice containing a
summary of the information provided in the application, to the extent it
has not been claimed confidential.
(d) No later than 45 days after EPA receives an application, the
Agency will either approve or deny the application. Thereafter, EPA will
publish a notice in the Federal Register explaining the reasons for
approval or denial.
(e) In approving an application for exemption, EPA may impose any
restrictions necessary to ensure that the substance will not present an
unreasonable risk of injury to health and the environment as a result of
test marketing.
(f) When applying for a test marketing exemption, persons are
subject to fees in accordance with 40 CFR 700.45.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 83
FR 52719, Oct. 17, 2018; 87 FR 39763, July 5, 2022]
Subpart C_Notice Form
Sec. 720.40 General.
(a) Use of the notice form; electronic submissions. (1) Each person
who is required by subpart B of this part to submit a notice must
complete, sign, and submit a notice containing the information in the
form and manner specified in this paragraph. The information submitted
and all attachments (unless the attachment appears in the open
scientific literature) must be in English. All information submitted
must be true and correct.
(2) All notices must be submitted on EPA Form 7710-25. Notices, and
any support documents related to these notices, may only be submitted in
a manner set forth in this paragraph.
(i) Submission via CDX. TSCA section 5 notices and any related
support documents must be submitted electronically to EPA via CDX. Prior
to submission to EPA via CDX, such notices must be generated and
completed on EPA Form 7710-25 using e-PMN software.
(ii) You can access the e-PMN software as follows:
(A) Website. Go to EPA's TSCA New Chemicals Program website at
http://www.epa.gov/oppt/newchems and follow the appropriate links.
(B) Telephone. Call the EPA CDX Help Desk at 1-888-890-1995.
(C) E-mail. [email protected].
(b) When to submit a notice. Each person who is required to submit a
notice must submit the notice at least 90 calendar days before
manufacture of the new chemical substance for commercial purposes
begins.
(c) Where to submit a notice or support documents. For submitting
notices or support documents via CDX, use the e-PMN software.
(d) General notice requirements. (1) Each person who submits a
notice must provide the information described in Sec. 720.45 and
specified on the notice form, to the extent such information is known to
or reasonably ascertainable
[[Page 234]]
by the person. In accordance with Sec. 720.50, the notice must also
include any test data in the person's possession or control, and
descriptions of other data which are known to or reasonably
ascertainable by the person and which concern the health and
environmental effects of the new chemical substance.
(2) If information is claimed as confidential pursuant to Sec.
720.80, a person who submits a notice to EPA in the manner set forth in
Sec. 720.40(a)(2)(i), (ii), or (iii) must also provide EPA with a
sanitized copy.
(e) Agency or joint submissions. (1) A manufacturer (including
importer) may designate an agent to assist in submitting the notice. If
so, only the manufacturer (including importer), and not the agent, signs
the certification on the form.
(2) A manufacturer may authorize another person, (e.g., a supplier
or a toll manufacturer) to report some of the information required in
the notice to EPA on its behalf. The manufacturer should indicate in a
cover letter accompanying the notice which information will be supplied
by another person and must identify that other person as a joint
submitter where indicated on their notice form. The other person
supplying information (i.e., the joint submitter) may submit the
information to EPA using either the notice form or a Letter of Support,
except that if the joint submitter is not incorporated, licensed, or
doing business in the United States, the joint submitter must submit the
information to EPA in a Letter of Support only, not in a notice form.
The joint submitter must indicate in the notice or Letter of Support the
identity of the manufacturer. Any person who submits a notice form or
Letter of Support for a joint submission must sign and certify the
notice form or Letter of Support.
(3) Only the Authorized Official (AO) of a submitting company can
certify initial notices and submit all TSCA section 5 documents.
(i) An AO can authorize other persons to be non-certifying AOs who
may conduct all section 5 business on behalf of the submitting company
except for certifying and submitting initial notices to EPA via CDX.
(ii) An AO may grant access to a support registrant to edit section
5 documents.
(f) New information. During the notice review period, if the
submitter possesses, controls, or knows of new information that
materially adds to, changes, or otherwise makes significantly more
complete the information included in the notice, the submitter must that
information to the address listed on the notice form within ten days of
receiving the new information, but no later than five days before the
end of the notice review period. The new submission must clearly
identify the submitter and the notice to which the new information is
related. If the new information becomes available during the last five
days of the notice review period, the submitter must immediately inform
its EPA contract for that notice by telephone.
(g) Chemical substances subject to a section 4 test rule. (1) Except
as provided in paragraph (g)(3) of this section, if (i) A person intends
to manufacture a new chemical substance which is subject to the
notification requirements of this part, and (ii) The chemical substance
is subject to a test rule promulgated under section 4 of the Act before
the notice is submitted, section 5(b)(1) of the Act requires the person
to submit the test data required by the testing rule with the notice.
The person must submit the data in the form and manner specified in the
test rule and in accordance with Sec. 720.50. If the person does not
submit the test data, the submission is incomplete and EPA will follow
the procedures in Sec. 720.65.
(2) If EPA has granted the submitter an exemption under section 4(c)
of the Act from the requirement to conduct tests and submit data, the
submitter may not submit a notice until EPA receives the test data.
(3) If EPA has granted the submitter an exemption under section 4(c)
of the Act and if another person previously has submitted the test data
to EPA, the exempted person may either submit the test data or provide
the following information as part of the notice:
(i) The name, title, and address of the person who submitted the
test data to EPA.
[[Page 235]]
(ii) The date the test data were submitted to EPA.
(iii) A citation for the test rule.
(iv) A description of the exemption and a reference identifying it.
(h) Chemical substances subject to a section 5(b)(4) rule. (1) If a
person (i) intends to manufacture a new chemical substance which is
subject to the notification requirements of this part and which is
subject to a rule issued under section 5(b)(4) of the Act; and (ii) is
not required by a rule issued under section 4 of the Act to submit test
data for the substance before the submission of a notice, the person
must submit to EPA data described in paragraph (h)(2) of this section at
the time the notice is submitted.
(2) Data submitted under paragraph (h)(1) of this section must be
data which the person submitting the notice believes show that the
manufacture, processing, distribution in commerce, use and disposal of
the substance, or any combination of such activities, will not present
an unreasonable risk of injury to health or the environment.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60
FR 16309, Mar. 29, 1995; 75 FR 784, Jan. 6, 2010; 78 FR 72827, Dec. 4,
2013; 80 FR 42746, July 20, 2015; 87 FR 39763, July 5, 2022]
Sec. 720.45 Information that must be included in the notice form.
Each person who submits a notice must include the information
specified in the notice form to the extent it is known to or reasonably
ascertainable by the submitter. However, no person is required to
include information which relates solely to exposure of human or
ecological populations outside of the United States. The notice form
requires the following information relating to the manufacture,
processing, distribution in commerce, use, and disposal of the new
chemical substance:
(a)(1) The specific chemical identity of the substance that the
person intends to manufacture or import, which includes the following:
(i) The currently correct Chemical Abstracts (CA) name for the
substance, based on the Ninth Collective Index (9CI) of CA nomenclature
rules and conventions, and consistent with listings for similar
substances in the Inventory. For each substance having a chemical
composition that can be represented by a specific, complete chemical
structure diagram (a Class 1 substance), a CA Index Name must be
provided. For each chemical substance that cannot be fully represented
by a complete, specific chemical structure diagram (a Class 2
substance), or if the substance is a polymer, a CA Index Name or CA
Preferred Name must be provided (whichever is appropriate based on CA
9CI nomenclature rules and conventions). In addition, for a Class 2
substance, the notice must identify the immediate chemical precursors
and reactants by specific chemical name and Chemical Abstracts Service
Registry Number (CASRN), if the number is available. Tradenames or
generic names of chemical precursors or reactants are not acceptable as
substitutes for specific chemical names.
(ii) The currently correct CASRN for the substance if a CASRN
already exists for the substance.
(iii) For a Class 1 substance and for any Class 2 substance for
which a definite molecular formula is known or reasonably ascertainable,
the correct molecular formula.
(iv) For a Class 1 substance, a complete, correct chemical structure
diagram; for a Class 2 substance or polymer, a correct representative or
partial chemical structure diagram, as complete as can be known, if one
can be reasonably ascertained.
(2) For a polymer, the submitter must also report the following:
(i) The specific chemical name and CASRN, if the number is
available, of each monomer and other reactant used, at any weight
percent, to manufacture the polymer. Tradenames or generic names of
chemical reactants or monomers are not acceptable as substitutes for
specific chemical names.
(ii) The typical percent by weight of each monomer and other
reactant in the polymer (weight of the monomer or other reactant
expressed as a percentage of the weight of the polymeric chemical
substance manufactured), and the maximum residual amount of each monomer
present in the polymer.
(iii) For monomers and other reactants used at 2 weight percent or
[[Page 236]]
less (based on the dry weight of the polymer manufactured), indicate on
the PMN form any such monomers and other reactants that should be
included as part of the polymer description on the Inventory, where the
weight percent is based on either (A) the weight of monomer or other
reactant actually charged to the reaction vessel, or (B) the minimum
weight of monomer or other reactant required in theory to account for
the actual weight of monomer or other reactant molecules or fragments
chemically incorporated (chemically combined) in the polymeric substance
manufactured.
(iv) For a determination that 2 weight percent or less of a monomer
or other reactant is incorporated (chemically combined) in a polymeric
substance manufactured, as specified in paragraphs (a)(2)(iii)(B) of
this section, analytical data or appropriate theoretical calculations
(if it can be documented that analytical measurement is not feasible or
not necessary) to support this determination must be maintained at the
site of manufacture or import of the polymer.
(v) Measured or estimated values of the minimum number-average
molecular weight of the polymer and the amount of low molecular weight
species below 500 and below 1,000 molecular weight, with a description
of how the measured or estimated values were obtained.
(3) The person must use one of the following two methods to develop
or obtain the specified chemical identity information reported under
paragraphs (a) (1) and (2) of this section and must identify the method
used in the notice:
(i) Method 1. Obtain the correct chemical identity information
required by paragraphs (a) (1) and (2) of this section directly from the
Chemical Abstracts Service (CAS), specifically from the CAS Registry
Services Inventory Expert Service, prior to submitting a notice to EPA.
A copy of the chemical identification report obtained from CAS must be
submitted with the notice.
(ii) Method 2. Obtain the correct chemical identity information
required by paragraphs (a) (1) and (2) from any source. The notice will
be incomplete according to Sec. 720.65(c)(1)(vi) if the person uses
Method 2 and any chemical identity information is determined to be
incorrect by EPA.
(4) If an importer submitting the notice cannot provide all the
information specified in paragraphs (a) (1) and (2) of this section
because it is claimed as confidential by the foreign supplier of the
substance, the importer must have the foreign supplier follow the
procedures in paragraph (a)(3) of this section and provide the correct
chemical identity information specified in paragraphs (a) (1) and (2) of
this section directly to EPA in a joint submission or as a letter of
support to the notice, which clearly references the importer's notice
and PMN User Fee Identification Number. The statutory review process
will commence upon receipt of both the notice and the complete, correct
information.
(5) If a manufacturer cannot provide all the information specified
in paragraphs (a)(1) and (2) of this section because the new chemical
substance is manufactured using a reactant having a specific chemical
identity claimed as confidential by its supplier, the manufacturer must
submit a notice directly to EPA containing all the information known by
the manufacturer about the chemical identity of the reported substance
and its proprietary reactant. In addition, the manufacturer must ensure
that the supplier of the confidential reactant submit a letter of
support directly to EPA providing the specific chemical identity of the
confidential reactant, including the CAS number, if available, and the
appropriate PMN or exemption number, if applicable. The letter of
support must reference the manufacturer's name and PMN Fee
Identification Number. The statutory review period will commence upon
receipt of both the notice and the letter of support.
(b) The impurities anticipated to be present in the substance by
name, CAS Registry number, and weight percent of the total substance.
(c) Known synonyms or trade names of the new chemical substance.
(d) A description of the byproducts resulting from the manufacture,
processing, use, and disposal of the new chemical substance.
[[Page 237]]
(e) The estimated maximum amount to be manufactured during the first
year of production and the estimated maximum amount to be manufactured
during any 12-month period during the first three years of production.
(f) A description of intended categories of use by function and
application, the estimated percent of production volume devoted to each
category of use, and the percent of the new substance in the formulation
for each commercial or consumer use.
(g) For sites controlled by the submitter:
(1) The identity of sites where the new substance will be
manufactured, processed, or used.
(2) A process description of each manufacture, processing, and use
operation which includes a diagram of the major unit operations and
chemical conversions, the identity and entry point of all feedstocks,
and the points of release of the new chemical substance.
(3) Worker exposure information, including worker activities,
physical form of the new substance to which workers may be exposed, the
number of workers, and the duration of activities.
(4) Information on release of the new substance to the environment,
including the quantity and media of release and type of control
technology used.
(h) For sites not controlled by the submitter, a description of each
type of processing and use operation involving the new chemical
substance, including identification of the estimated number of
processing or use sites, situations in which worker exposure to and/or
environmental release of the new chemical substance will occur, the
number of workers exposed and the duration of exposure, and controls
which limit worker exposure and environmental release.
(i) Any safety data sheet already developed for the new chemical
substance, including draft safety data sheets.
[48 FR 21742, May 13, 1983, as amended at 60 FR 16310, Mar. 29, 1995; 83
FR 52719, Oct. 17, 2018; 87 FR 39763, July 5, 2022]
Sec. 720.50 Submission of test data and other data concerning
the health and environmental effects of a substance.
(a) Test data on the new chemical substance in the possession or
control of the submitter. (1) Except as provided in paragraph (d) of
this section, each notice must contain all test data in the submitter's
possession or control which are related to the effects on health or the
environment of any manufacture, processing, distribution in commerce,
use, or disposal of the new chemical substance or any mixture or article
containing the new chemical substance, or any combination of such
activities. This includes test data concerning the new chemical
substance in a pure, technical grade, or formulated form.
(2) A full report or standard literature citation must be submitted
for the following types of test data:
(i) Health effects data.
(ii) Ecological effects data.
(iii) Physical and chemical properties data.
(iv) Environmental fate characteristics.
(v) Monitoring data and other test data related to human exposure to
or environmental release of the chemical substance.
(3)(i) If the data do not appear in the open scientific literature,
the submitter must provide a full report. A full report includes the
experimental methods and materials, results, discussion and data
analysis, conclusions, references, and the name and address of the
laboratory that developed the data.
(ii) If the data appear in the open scientific literature, the
submitter need only provide a standard literature citation. A standard
literature citation includes author, title, periodical name, date of
publication, volume, and page numbers.
(4)(i) If a study, report, or test is incomplete when a person
submits a notice, the submitter must identify the nature and purpose of
the study; name and address of the laboratory developing the data;
progress to date; types of data collected; significant preliminary
results; and anticipated completion date.
[[Page 238]]
(ii) If a test or experiment is completed before the notice review
period ends, the person must submit the study, report, or test to the
address listed on the notice form, as specified in paragraph (a)(3)(i)
of this section, within ten days of receiving it, but no later than five
days before the end of the review period. If the test or experiment is
completed during the last five days of the review period, the submitter
must immediately inform its EPA contact for that notice by telephone.
(5) For test data in the submitter's possession or control which are
not listed in paragraph (a)(2) of this section, a person is not required
to submit a complete report. The person must submit a summary of the
data. If EPA so requests, the person must submit a full report within
ten days of the request, but no later than five days before the end of
the review period.
(6) All test data described by paragraph (a) are subject to these
requirements, regardless of their age, quality, or results.
(b) Other data concerning the health and environmental effects of
the new chemical substance that are known to or reasonably ascertainable
by the submitter. (1) Except as provided in paragraph (d) of this
section, any person who submits a notice must describe the following
data, including any data from a health and safety study, if the data are
related to the effects on health or the environment of any manufacture,
processing, distribution in commerce, use, or disposal of the new
chemical substance, of any mixture or article containing the new
chemical substance, or of any combination of such activities:
(i) Any data, other than test data, in the submitter's possession or
control.
(ii) Any data, including test data, which are not in the submitter's
possession or control, but which are known to or reasonably
ascertainable by the submitter. For the purposes of this section, data
are known to or reasonably ascertainable by the submitter if the data
are known to any of its employees or other agents who are associated
with the research and development, test marketing, or commercial
marketing of the substance.
(2) Data that must be described include data concerning the new
chemical substance in a pure, technical grade, or formulated form.
(3) The description of data reported under this paragraph must
include:
(i) If the data appear in the open scientific literature, a standard
literature citation, which includes the author, title, periodical name,
date of publication, volume, and pages.
(ii) If the data are not contained in the open scientific
literature, a description of the type of data and summary of the
results, if available, and the names and addresses of persons the
submitter believes may have possession or control of the data.
(4) All data described by this paragraph are subject to these
requirements, regardless of their age, quality, or results; and
regardless of whether they are complete at the time the notice is
submitted.
(c) [Reserved]
(d) Data that need not be submitted--(1) Data previously submitted
to EPA. (i) A person need not submit any data previously submitted to
EPA with no claims of confidentiality if the notice includes the office
or person to whom the data were submitted, the date of submission, and,
if appropriate, a standard literature citation as specified in paragraph
(a)(3)(ii) of this section.
(ii) For data previously submitted to EPA with a claim of
confidentiality, the person must resubmit the data with the notice and
any claim of confidentiality, under Sec. 720.80.
(2) Efficacy data. This part does not require submission of any data
related solely to product efficacy. This does not exempt a person from
submitting any of the data specified in paragraph (a), (b), or (c) of
this section.
(3) Non-U.S. exposure data. This part does not require submission of
any data which relates only to exposure of humans or the environment
outside the United States. This does not exclude nonexposure data such
as data on health effects (including epidemiological studies),
ecological effects, physical and chemical properties, or environmental
fate characteristics.
[48 FR 21742, May 13, 1983, as amended at 51 FR 15102, Apr. 22, 1986]
[[Page 239]]
Sec. 720.57 Imports.
(a) Except as otherwise provided in this section, the provisions of
this subpart C apply to each person who submits a notice for a new
chemical substance which he or she intends to import for a commercial
purpose. In addition, each importer must comply with this section.
(b) EPA will hold the principal importer, or the importer that EPA
determines must submit the notice when there is no principal importer
under Sec. 720.22(b)(2), liable for complying with this part, for
completing the notice form and for the completeness and truthfulness of
all information which it submits.
[48 FR 21742, May 13, 1983, as amended at 87 FR 39764, July 5, 2022]
Subpart D_Disposition of Notices
Sec. 720.60 General.
This subpart establishes procedures that EPA will follow in
reviewing notices.
Sec. 720.62 Notice that notification is not required.
When EPA receives a notice, EPA will review it to determine whether
the chemical substance is subject to the requirements of this part. If
EPA determines that the chemical substance is not subject to these
requirements, EPA will notify the submitter that section 5 of the Act
does not prevent the manufacture or import of the substance and that the
submission is not a notice under this part.
[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993]
Sec. 720.65 Acknowledgement of receipt of a notice; errors in the
notice; incomplete submissions; and false and misleading statements.
(a) Notification to the submitter. EPA will acknowledge receipt of
each notice by sending a letter via CDX or U.S. mail to the submitter
that identifies the premanufacture notice number assigned to the new
chemical substance and date on which the review period begins. The
review period will begin on the date the notice is received by the
Office of Pollution Prevention and Toxics Document Control Officer. The
acknowledgment does not constitute a finding by EPA that the notice, as
submitted, is in compliance with this part.
(b) Errors in the notice. (1) Within 30 days of receipt of the
notice, EPA may request that the submitter remedy errors in the notice.
The following are examples of such errors:
(i) Failure to date the notice form.
(ii) Typographical errors that cause data to be misleading or
answers to any questions to be unclear.
(iii) Contradictory information.
(iv) Ambiguous statements or information.
(2) In the request to correct the notice, EPA will explain the
action which the submitter must take to correct the notice.
(3) If the submitter fails to correct the notice within 15 days of
receipt of the request, EPA may extend the notice period under section
(5)(c) of the Act, in accordance with Sec. 720.75(c).
(c) Incomplete submissions. (1) A submission is not complete, and
the notification period does not begin, if:
(i) The wrong person submits the notice form.
(ii) The submitter does not sign the notice form.
(iii) Some or all of the information in the notice or the
attachments are not in English, except for published scientific
literature.
(iv) The submitter does not submit the notice in the manner set
forth in Sec. 720.40(a)(2).
(v) The submitter does not provide information that is required by
section 5(d)(1) (B) and (C) of the Act and Sec. 720.50.
(vi) The submitter does not provide information required on the
notice form and by Sec. 720.45 or indicate that it is not known to or
reasonably ascertainable by the submitter.
(vii) The submitter does not submit a second copy of the submission
with all confidential information deleted for the public file, as
required by Sec. 720.80(b)(2).
(viii) The submitter does not include any information required by
section 5(b)(1) of the Act and pursuant to a rule promulgated under
section 4 of the Act, as required by Sec. 720.40(g).
[[Page 240]]
(ix) The submitter does not submit data which the submitter believes
show that the chemical substance will not present an unreasonable risk
of injury to health or the environment, if EPA has listed the chemical
substance under section 5(b)(4) of the Act, as required in Sec.
720.40(h).
(x) The submitter does not include an identifying number and a
payment identity number as required by 40 CFR 700.45(e)(3).
(2)(i) If EPA receives an incomplete submission, the Director, or
his or her delegate, will notify the submitter within 30 days of receipt
that the submission is incomplete and that the notice review period will
not begin until EPA receives a complete notice.
(ii) If EPA obtains additional information during the notice review
period that indicates the original submission was incomplete, the
Director, or his or her delegate, may declare the submission incomplete
within 30 days after EPA obtains the additional information and so
notify the submitter.
(3) The notification that a submission is incomplete under paragraph
(c)(2) (i) or (ii) of this section will include:
(i) A statement of the basis of EPA's determination that the
submission is incomplete.
(ii) The requirements for correcting the incomplete submission.
(iii) Information on procedures under paragraph (c)(4) of this
section for filing objections to the determination or requesting
modification of the requirements for completing the submission.
(4) Within ten days after receipt of notification by EPA that a
submission is incomplete, the submitter may file written objections
requesting that EPA accept the submission as a complete notice or modify
the requirements necessary to complete the submission.
(5)(i) EPA will consider the objections filed by the submitter. The
Director, or his or her delegate, will determine whether the submission
was complete or incomplete, or whether to modify the requirements for
completing the submission. EPA will notify the submitter in writing of
EPA's response within ten days of receiving the objections.
(ii) If the Director, or his or her delegate, determines, in
response to the objection, that the submission was complete, the notice
review period will be deemed suspended on the date EPA declared the
notice incomplete, and will resume on the date that the notice is
declared complete. The submitter need not correct the notice as EPA
originally requested. If EPA can complete its review within 90 days from
the date of the original submission, the Director, or his or her
delegate, may inform the submitter that the running of the review period
will resume on the date EPA originally declared it incomplete.
(iii) If the Director, or his or her delegate, modifies the
requirements for completing the submission or concurs with EPA's
original determination, the notice review period will begin when EPA
receives a complete notice.
(d) Materially false or misleading statements. If EPA discovers at
any time that person submitted materially false or misleading statements
in the notice, EPA may find that the notice was incomplete from the date
it was submitted, and take any other appropriate action.
[48 FR 21742, May 13, 1983, as amended at 75 FR 785, Jan. 6, 2010]
Sec. 720.70 Notice in the Federal Register.
(a) Filing of Federal Register notice. In accordance with section
5(d)(2) of the Act, after EPA receives a notice, EPA will file with the
Office of the Federal Register a notice including the information
specified in paragraph (b) of this section.
(b) Contents of notice. (1) In the public interest, the specific
chemical identity listed in the notice will be published in the Federal
Register unless the submitter has claimed chemical identity
confidential. If the submitter claims confidentiality, a generic name
will be published in accordance with Sec. 720.85(a)(3).
(2) The categories of use of the new chemical substance will be
published as reported in the notice unless this information is claimed
confidential. If confidentiality is claimed, the generic information
which is submitted under Sec. 720.87(b) will be published.
(3) A list of data submitted in accordance with Sec. 720.50(a) will
be published.
[[Page 241]]
In addition, for test data submitted in accordance with Sec. 720.40(g),
a summary of the data will be published.
(4) The submitter's identity will be published, unless the submitter
has claimed it confidential.
Sec. 720.75 Notice review period.
(a) Length of notice review period. The notice review period
specified in section 5(a) of the Act runs for 90 days from the date the
Document Control Officer for the Office of Pollution Prevention and
Toxics receives a complete notice, or the date EPA determines the notice
is complete under Sec. 720.65(c), unless the Agency extends the period
under section 5(c) of TSCA and paragraph (c) of this section.
(b) Suspension of the running of the notice review period. (1) A
submitter may voluntarily suspend the running of the notice review
period if the Director or his or her delegate agrees. If the Director
does not agree, the review period will continue to run, and EPA will
notify the submitter. A submitter may request a suspension at any time
during the notice review period. The suspension must be for a specified
period of time.
(2)(i) Oral requests. A request for a suspension of 15 days or less
may be made orally, including by telephone, to the submitter's EPA
contact for that notice. Any request for a suspension exceeding 15 days
must be submitted in the manner set forth in paragraph (b)(2)(ii) of
this section. The running of the notice review period will be suspended
upon approval of the oral request by the Director or her or his
delegate.
(ii) Written requests. Requests for suspensions exceeding 15 days
must be submitted electronically to EPA via CDX using e-PMN software.
Requests for suspensions of 15 days or less may also be submitted
electronically to EPA via CDX using e-PMN software. See Sec.
720.40(a)(2)(ii) for information on how to access the e-PMN software.
The running of the notice review period will be suspended upon approval
of the written request by the Director or her or his delegate.
(c) Extension of notice review period. (1) At any time during the
notice review period, EPA may determine that good cause exists to extend
the notice review period specified in paragraph (a) of this section.
(2) If EPA makes such a determination, EPA will:
(i) Notify the submitter that EPA is extending the notice review
period for a specified length of time, and state the reasons for the
extension.
(ii) Issue a notice for publication in the Federal Register which
states that EPA is extending the notice review period and gives the
reasons for the extension.
(3) The initial extension may be for a period of up to 90 days. If
the initial extension is for less than 90 days, EPA may make additional
extensions. However, the total period of extensions may not exceed 90
days for any notice.
(4) The following are examples of situations in which EPA may find
that good cause exists for extending the notice review period:
(i) EPA has reviewed the notice and determined that there is a
significant possibility that the chemical substance will be regulated
under section 5(e) or section 5(f) of the Act, but EPA is unable to
initiate regulatory action within the initial 90-day period.
(ii) EPA has reviewed the submission and is seeking additional
information.
(iii) EPA has received significant additional information during the
notice review period.
(iv) The submitter has failed to correct a notice after receiving
EPA's request under Sec. 720.65(b).
(d) Notice of expiration of notice review period. EPA will notify
the submitter that the notice review period has expired or that EPA has
completed its review of the notice. Expiration of the review period does
not constitute EPA approval or certification of the new chemical
substance, and does not mean that EPA may not take regulatory action
against the substance in the future. After expiration of the statutory
notice review period, in the absence of regulatory action by EPA under
section 5(e), 5(f), or 6(a) of the Act, the submitter may manufacture or
import the chemical substance even if the submitter has not received
notice of expiration.
(e) Withdrawal of a notice by the submitter. (1)(i) A submitter may
withdraw
[[Page 242]]
a notice during the notice review period by submitting a statement of
withdrawal in a manner set forth in this paragraph. The withdrawal is
effective upon receipt by EPA of the CDX submission.
(ii) Submission of withdrawal notices. EPA will accept statements of
withdrawal only if submitted in accordance with this paragraph.
Statements of withdrawal must be generated, completed, and submitted to
EPA (via CDX) using e-PMN software. See Sec. 720.40(a)(2)(ii) for
information on how to obtain e-PMN software.
(2) If a manufacturer (including importer) which withdrew a notice
later resubmits a notice for the same chemical substance, a new notice
review period begins.
[48 FR 21742, May 13, 1983, as amended at 53 FR 12523, Apr. 15, 1988; 58
FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995; 71 FR 33641, June
12, 2006; 75 FR 786, Jan. 6, 2010; 78 FR 72827, Dec. 4, 2013; 80 FR
42746, July 20, 2015]
Sec. 720.78 Recordkeeping.
(a) Any person who submits a notice under this part must retain
documentation of information in the notice, including (1) other data, as
defined in Sec. 720.50(b), in the submitter's possession or control;
and (2) records of production volume for the first three years of
production or import, the date of commencement of manufacture or import,
and documentation of this information. This information must be retained
for five years from the date of commencement of manufacture of import.
(b)(1) Persons who manufacture a chemical substance under Sec.
720.36 must retain the following records:
(i) Copies of, or citations to, information reviewed and evaluated
under Sec. 720.36(b)(1) to determine the need to make any notification
of risk.
(ii) Documentation of the nature and method of notification under
Sec. 720.36(c)(1) including copies of any labels or written notices
used.
(iii) Documentation of prudent laboratory practices used instead of
notification and evaluation under Sec. 720.36(b)(2).
(iv) The names and addresses of any persons other than the
manufacturer or importer to whom the substance is distributed, the
identity of the substance to the extent known, the amount distributed,
and copies of the notifications required under Sec. 720.36(c)(2). These
records are not required when substances are distributed as impurities
or incorporated into an article, in accordance with paragraph (d) of
this section.
(2) A person who manufactures a chemical substance under Sec.
720.36 and who manufactures the substance in quantities greater than 100
kilograms per year must retain records of the identity of the substance
to the extent known, the production volume of the substance, and the
person's disposition of the substance. The person is not required to
maintain records of the disposition of products containing the substance
as an impurity or of articles incorporating the substances.
(3) Records under this paragraph must be retained for 5 years after
they are developed.
(c) Any person who obtains a test-marketing exemption under this
part must retain documentation of information in the application and
documentation of compliance with any restrictions imposed by EPA when it
granted the application. This information must be retained for five
years from the final date of manufacture under the exemption.
[48 FR 21742, May 13, 1983; 48 FR 33872, July 26, 1983, as amended at 51
FR 15102, Apr. 22, 1986; 58 FR 34204, June 23, 1993; 87 FR 39764, July
5, 2022]
Subpart E_Confidentiality and Public Access to Information
Sec. 720.80 General provisions.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
[88 FR 37172, June 7, 2023]
Sec. 720.87 Categories or proposed categories of uses of a new
chemical substance.
(a) A person who submits information to EPA under this part on the
categories or proposed categories of use of a new chemical substance may
assert a claim of confidentiality for this information.
[[Page 243]]
(b) A submitter that asserts such a claim must:
(1) Report the categories or proposed categories of use of the
chemical substance.
(2) Provide, in nonconfidential form, a description of the uses that
is only as generic as necessary to protect the confidential business
information. The generic use description will be included in the Federal
Register notice described in Sec. 720.70.
(c) The person must submit the information required by paragraph (b)
of this section in the manner specified in the notice form.
Sec. 720.95 Public file.
All information submitted with a notice, including any health and
safety study and other supporting documentation, will become part of the
public file for that notice, unless such materials are claimed
confidential in accordance with procedures in 40 CFR 703.5. In addition,
EPA may add materials to the public file, subject to subpart E of this
part. Publicly available materials are available at the docket addresses
in Sec. 700.17(b)(1) and (2) of this subchapter and on EPA's website.
[88 FR 37172, June 7, 2023]
Subpart F_Commencement of Manufacture or Import
Sec. 720.102 Notice of commencement of manufacture.
(a) Applicability. Any person who commences the manufacture of a new
chemical substance for a nonexempt commercial purpose for which that
person previously submitted a section 5(a) notice under this part must
submit a notice of commencement of manufacture.
(b) When to report. (1) If manufacture for commercial purposes
begins on or after the effective date of this rule, the submitter must
submit the notice to EPA on, or no later than 30 calendar days, after
the first day of such manufacture.
(2) If manufacture for commercial purposes began or will begin
before the effective date of this rule, the submitter must submit the
notice by the effective date of this rule.
(c) Information to be reported on form. (1) The notice must be
submitted on EPA Form 7710-56, which is available as part of EPA's e-PMN
software. See Sec. 720.40(a)(2)(iv) for information on how to obtain e-
PMN software. The form must be signed and dated by an Authorized
Official (AO). All information specified on the form must be provided.
The notice must contain the following information:
(i) The specific chemical identity of the PMN substance.
(ii) A generic chemical name (if the chemical identity is claimed as
confidential by the submitter).
(iii) The premanufacture notice (PMN) number assigned by EPA.
(iv) The date of commencement for the submitter's manufacture for a
non-exempt commercial purpose (indicating whether the substance was
initially manufactured in the United States or imported). The date of
commencement is the date of completion of non-exempt manufacture of the
first amount (batch, drum, etc.) of new chemical substance identified in
the submitter's PMN. For importers, the date of commencement is the date
the new chemical substance clears United States customs.
(v) The name and address of the submitter.
(vi) The name of the authorized official.
(vii) The name and telephone number of a technical contact in the
United States.
(viii) The address of the site where commencement of manufacture
occurred.
(ix) Clear indications of whether the chemical identity, submitter
identity, and/or other information are claimed as confidential by the
submitter.
(2) If the submitter claims any information on the form as
confidential, the claim must be asserted and substantiated in accordance
with the requirements described in 40 CFR part 703 and must be submitted
via EPA Form 7710-56. If the submitter wants the chemical identity to be
listed on the confidential portion of the TSCA Inventory, the chemical
identity must be claimed as confidential and the submitter must also
follow the certification, substantiation, and generic name requirements
[[Page 244]]
described 40 CFR part 703 and paragraphs (e) and (f) of this section.
Otherwise, EPA will list the specific chemical identity on the public
TSCA Inventory. Submitters who did not claim the chemical identity,
submitter identity, or other information to be confidential in the PMN
cannot claim this information as confidential in the notice of
commencement.
(d)(1) Where to submit. All notices of commencement must be
submitted to EPA on EPA Form 7710-56. Notices may only be submitted in a
manner set forth in this paragraph.
(2) Submission of notice of commencement. EPA will accept notices of
commencement only if submitted in accordance with this paragraph. All
notices of commencement must be submitted electronically to EPA via CDX.
Prior to submission to EPA via CDX, such notices of commencement must be
generated and completed using e-PMN software. See Sec. 720.40(a)(2)(ii)
for information on how to obtain e-PMN software.
(e) Confidentiality. (1) Any person who asserts a confidentiality
claim for chemical identity in a Notice of Commencement submitted under
this section must:
(i) Comply with generic name requirements described in 40 CFR part
703 and as specified in paragraph (f) of this section.
(ii) Agree that EPA may disclose to a person with a bona fide intent
to manufacture or import the chemical substance the fact that the
particular chemical substance is included on the confidential TSCA
Inventory for purposes of notification under section 5(a)(1)(A) of the
Act.
(iii) Have available for the particular chemical substance, and
agree to furnish to EPA upon request:
(A) An elemental analysis.
(B) Either an X-ray diffraction pattern (for inorganic substances),
a mass spectrum (for most other substances), or an infrared spectrum of
the particular chemical substance, or if such data do not resolve
uncertainties with respect to the identity of the chemical substance,
additional or alternative spectra or other data to identify the chemical
substance.
(2) Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703.
(f) Generic name. If a submitter asserts a claim of confidentiality
for chemical identity in a notice of commencement, they must provide a
structurally descriptive generic name.
(1) Generic names must:
(i) Be structurally descriptive (e.g., not a trade name);
(ii) Describe the chemical structure of the chemical substance as
specifically as practicable while protecting only those features of the
chemical structure that are claimed as confidential and disclosure of
which would likely cause substantial harm to the competitive position of
the person--the generic name should generally only obscure one
structural feature, but in any case, should conceal only the feature(s)
necessary to avoid a likelihood of substantial competitive harm to the
submitter; and
(iii) Be consistent with guidance on the determination of
structurally descriptive generic names, developed in accordance with
TSCA section 14(c)(4)(A) (e.g., Guidance for Creating Generic Names for
Confidential Chemical Substance Identity Reporting under TSCA; available
at https://www.epa.gov/tsca -inventory/guidance-creating-generic -names-
confidential-chemical -substance-identity-reporting).
(2) Generic names will be reviewed by EPA at the time of submission.
(i) If EPA concludes that a proposed generic name meets the criteria
in paragraph (f)(1) of this section, EPA will include that generic name
in the public TSCA Inventory listing for that substance.
(ii) If the proposed generic name does not meet the criteria in
paragraph (f)(1) of this section, EPA will notify the submitter
concerning the deficiency via CDX, as described in 40 CFR 703.5(f). EPA
will provide 10 business days to correct the deficiency and provide an
alternative generic name that would be acceptable to EPA. If the
alternative generic name proposed by EPA is acceptable to the submitter
(or if the submitter does not respond within the 10-day period), EPA
will place that alternative generic name on the
[[Page 245]]
public TSCA Inventory. If the alternative generic name proposed by EPA
is not acceptable to the submitter, the submitter must submit a revised
generic name that meets the criteria in paragraph (f)(1) of this section
and an explanation of how EPA's proposed generic name reveals
confidential information. If EPA concludes that the submitter's revised
generic name also does not meet the criteria in paragraph (f)(1) of this
section, EPA will hold the notice of commencement for a period of up to
10 business days. Reporting requirements will not be considered to have
been met and the substance will not be added to the TSCA Inventory
during this period. If the submission remains deficient after this 10-
day period, EPA will proceed with CBI review of the chemical identity
claim and will likely deny the claim.
[48 FR 21742, May 13, 1983, as amended at 48 FR 41140, Sept. 13, 1983;
51 FR 15103, Apr. 22, 1986; 53 FR 12523, Apr. 15, 1988; 60 FR 16311,
Mar. 29, 1995; 60 FR 34464, July 3, 1995; 65 FR 39304, June 26, 2000; 71
FR 33641, June 12, 2006; 75 FR 786, Jan. 6, 2010; 78 FR 72827, Dec. 4,
2013; 87 FR 39764, July 5, 2022; 88 FR 37172, June 7, 2023]
Subpart G_Compliance and Inspections
Sec. 720.120 Compliance.
(a) Failure to comply with any provision of this part is a violation
of section 15 of the Act (15 U.S.C 2614).
(b) A person who manufactures a new chemical substance before a
notice is submitted and the notice review period expires is in violation
of section 15 of the Act even if that person was not required to submit
the notice under Sec. 720.22.
(c) Using for commercial purposes a chemical substance or mixture
which a person knew or had reason to know was manufactured, processed,
or distributed in commerce in violation of section 5 of this rule is a
violation of section 15 of the Act (15 U.S.C. 2614).
(d) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by the Act, is a
violation of section 15 of the Act (15 U.S.C. 2614).
(e) Failure or refusal to permit entry or inspection as required by
section 11 is a violation of section 15 of the Act (15 U.S.C. 2614).
(f) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who
submit materially misleading or false information in connection with the
requirements of any provision of this rule may be subject to penalties
calculated as if they never filed their notices.
(g) EPA may seek to enjoin the manufacture or processing of a
chemical substance in violation of this rule or act to seize any
chemical substance manufactured or processed in violation of this rule
or take other actions under the authority of section 7 of this Act (15
U.S.C. 2606) or section 17 or this Act (15 U.S.C. 2616).
[48 FR 21742, May 13, 1983, as amended at 87 FR 39764, July 5, 2022]
Sec. 720.122 Inspections.
EPA will conduct inspections under section 11 of the Act to assure
compliance with section 5 of the Act and this rule, to verify that
information submitted to EPA under this rule is true and correct, and to
audit data submitted to EPA under this rule.