Attachment A

2565.01_Attachment A_TSCA_2017-06-12.pdf

TSCA Section 8(b) Reporting Requirements for TSCA Inventory Notification (Active-Inactive) Requirements (Final Rule)

Attachment A

OMB: 2070-0201

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15 U.S.C. 2607 – Amended Section 8(b) of the Toxic Substances Control Act. Also available
online at the U.S. House of Representatives’ U.S. Code website.
§2607. Reporting and retention of information.
[…] (b) Inventory.  
(1) The Administrator shall compile, keep current, and publish a list of each chemical
substance which is manufactured or processed in the United States. Such list shall at least
include each chemical substance which any person reports, under section 2604 of this title or
subsection (a) of this section, is manufactured or processed in the United States. Such list may
not include any chemical substance which was not manufactured or processed in the United
States within three years before the effective date of the rules promulgated pursuant to the last
sentence of subsection (a)(1). In the case of a chemical substance for which a notice is
submitted in accordance with section 2604 of this title, such chemical substance shall be
included in such list as of the earliest date (as determined by the Administrator) on which such
substance was manufactured or processed in the United States. The Administrator shall first
publish such a list not later than 315 days after January 1, 1977. The Administrator shall not
include in such list any chemical substance which is manufactured or processed only in small
quantities (as defined by the Administrator by rule) 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.
(2) To the extent consistent with the purposes of this chapter, the Administrator may, in lieu of
listing, pursuant to paragraph (1), a chemical substance individually, list a category of chemical
substances in which such substance is included.
(3) Nomenclature.—
(A) In general.—In carrying out paragraph (1), the Administrator shall—
(i) maintain the use of Class 2 nomenclature in use on June 22, 2016;
(ii) maintain the use of the Soap and Detergent Association Nomenclature System,
published in March 1978 by the Administrator in section 1 of addendum III of the
document entitled "Candidate List of Chemical Substances", and further described in
the appendix A of volume I of the 1985 edition of the Toxic Substances Control Act
Substances Inventory (EPA Document No. EPA–560/7–85–002a); and
(iii) treat the individual members of the categories of chemical substances identified by
the Administrator as statutory mixtures, as defined in Inventory descriptions
established by the Administrator, as being included on the list established under
paragraph (1).
(B) Multiple nomenclature listings.—If a manufacturer or processor demonstrates to the
Administrator that a chemical substance appears multiple times on the list published
under paragraph (1) under different CAS numbers, the Administrator may recognize
the multiple listings as a single chemical substance.
(4) Chemical substances in commerce.—
(A) Rules.—
(i) In general.—Not later than 1 year after June 22, 2016, the Administrator, by rule,
shall require manufacturers, and may require processors, subject to the limitations
under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after
the date on which the final rule is published in the Federal Register, of each chemical
substance on the list published under paragraph (1) that the manufacturer or
processor, as applicable, has manufactured or processed for a nonexempt commercial
purpose during the 10-year period ending on the day before June 22, 2016.

(ii) Active substances.—The Administrator shall designate chemical substances for
which notices are received under clause (i) to be active substances on the list
published under paragraph (1).
(iii) Inactive substances.—The Administrator shall designate chemical substances for
which no notices are received under clause (i) to be inactive substances on the list
published under paragraph (1).
(iv) Limitation.—No chemical substance on the list published under paragraph (1) shall
be removed from such list by reason of the implementation of this subparagraph, or be
subject to section 2604(a)(1)(A)(i) of this title by reason of a change to active status
under paragraph (5)(B).
(B) Confidential chemical substances.—In promulgating a rule under subparagraph (A), the
Administrator shall—
(i) maintain the list under paragraph (1), which shall include a confidential portion and
a nonconfidential portion consistent with this section and section 2613 of this title;
(ii) require any manufacturer or processor of a chemical substance on the confidential
portion of the list published under paragraph (1) that seeks to maintain an existing
claim for protection against disclosure of the specific chemical identity of the chemical
substance as confidential pursuant to section 2613 of this title to submit a notice under
subparagraph (A) that includes such request;
(iii) require the substantiation of those claims pursuant to section 2613 of this title and
in accordance with the review plan described in subparagraph (C); and
(iv) move any active chemical substance for which no request was received to
maintain an existing claim for protection against disclosure of the specific chemical
identity of the chemical substance as confidential from the confidential portion of the
list published under paragraph (1) to the nonconfidential portion of that list.
(C) Review plan.—Not later than 1 year after the date on which the Administrator compiles
the initial list of active substances pursuant to subparagraph (A), the Administrator
shall promulgate a rule that establishes a plan to review all claims to protect the
specific chemical identities of chemical substances on the confidential portion of the
list published under paragraph (1) that are asserted pursuant to subparagraph (B).
(D) Requirements of review plan.—In establishing the review plan under subparagraph (C),
the Administrator shall—
(i) require, at a time specified by the Administrator, all manufacturers or processors
asserting claims under subparagraph (B) to substantiate the claim, in accordance
with section 2613 of this title, unless the manufacturer or processor has
substantiated the claim in a submission made to the Administrator during the 5year period ending on the last day of the of the time period specified by the
Administrator; and
(ii) in accordance with section 2613 of this title—
(I) review each substantiation—
(aa) submitted pursuant to clause (i) to determine if the claim qualifies for
protection from disclosure; and
(bb) submitted previously by a manufacturer or processor and relied on in lieu
of the substantiation required pursuant to clause (i), if the substantiation has
not been previously reviewed by the Administrator, to determine if the claim
warrants protection from disclosure;
(II) approve, approve in part and deny in part, or deny each claim; and
(III) except as provided in this section and section 2613 of this title, protect from
disclosure information for which the Administrator approves such a claim for a
period of 10 years, unless, prior to the expiration of the period—

(aa) the person notifies the Administrator that the person is withdrawing the
claim, in which case the Administrator shall not protect the information from
disclosure; or
(bb) the Administrator otherwise becomes aware that the information does
not qualify for protection from disclosure, in which case the Administrator shall
take the actions described in section 2613(g)(2) of this title.
(E) Timeline for completion of reviews.—
(i) In general.—The Administrator shall implement the review plan so as to complete
reviews of all claims specified in subparagraph (C) not later than 5 years after the date
on which the Administrator compiles the initial list of active substances pursuant to
subparagraph (A).
(ii) Considerations.—
(I) In general.—The Administrator may extend the deadline for completion of the
reviews for not more than 2 additional years, after an adequate public
justification, if the Administrator determines that the extension is necessary
based on the number of claims needing review and the available resources.
(II) Annual review goal and results.—At the beginning of each year, the
Administrator shall publish an annual goal for reviews and the number of
reviews completed in the prior year.
(5) Active and inactive substances.—
(A) In general.—The Administrator shall keep designations of active substances and
inactive substances on the list published under paragraph (1) current.
(B) Change to active status.—
(i) In general.—Any person that intends to manufacture or process for a nonexempt
commercial purpose a chemical substance that is designated as an inactive
substance shall notify the Administrator before the date on which the inactive
substance is manufactured or processed.
(ii) Confidential chemical identity.—If a person submitting a notice under clause (i) for
an inactive substance on the confidential portion of the list published under
paragraph (1) seeks to maintain an existing claim for protection against disclosure
of the specific chemical identity of the inactive substance as confidential, the
person shall, consistent with the requirements of section 2613 of this title—
(I) in the notice submitted under clause (i), assert the claim; and
(II) by not later than 30 days after providing the notice under clause (i), substantiate
the claim.
(iii) Active status.—On receiving a notification under clause (i), the Administrator
shall—
(I) designate the applicable chemical substance as an active substance;
(II) pursuant to section 2613 of this title, promptly review any claim and
associated substantiation submitted pursuant to clause (ii) for protection against
disclosure of the specific chemical identity of the chemical substance and
approve, approve in part and deny in part, or deny the claim;
(III) except as provided in this section and section 2613 of this title, protect from
disclosure the specific chemical identity of the chemical substance for which the
Administrator approves a claim under subclause (II) for a period of 10 years,
unless, prior to the expiration of the period—
(aa) the person notifies the Administrator that the person is withdrawing the
claim, in which case the Administrator shall not protect the information from
disclosure; or

(bb) the Administrator otherwise becomes aware that the information does
not qualify for protection from disclosure, in which case the Administrator shall
take the actions described in section 2613(g)(2) of this title; and
(IV) pursuant to section 2605(b) of this title, review the priority of the chemical
substance as the Administrator determines to be necessary.
(C) Category status.—The list of inactive substances shall not be considered to be a
category for purposes of section 2625(c) of this title.
(6) Interim list of active substances.—Prior to the promulgation of the rule required under
paragraph (4)(A), the Administrator shall designate the chemical substances reported under part
711 of title 40, Code of Federal Regulations (as in effect on June 22, 2016), during the reporting
period that most closely preceded June 22, 2016, as the interim list of active substances for the
purposes of section 2605(b) of this title.
(7) Public information.—Subject to this subsection and section 2613 of this title, the
Administrator shall make available to the public—
(A) each specific chemical identity on the nonconfidential portion of the list published under
paragraph (1) along with the Administrator's designation of the chemical substance as
an active or inactive substance;
(B) the unique identifier assigned under section 2613 of this title, accession number, generic
name, and, if applicable, premanufacture notice case number for each chemical
substance on the confidential portion of the list published under paragraph (1) for which
a claim of confidentiality was received; and
(C) the specific chemical identity of any active substance for which—
(i) a claim for protection against disclosure of the specific chemical identity of the active
substance was not asserted, as required under this subsection or section 2613 of
this title;
(ii) all claims for protection against disclosure of the specific chemical identity of the
active substance have been denied by the Administrator; or
(iii) the time period for protection against disclosure of the specific chemical identity of
the active substance has expired.
(8) Limitation.—No person may assert a new claim under this subsection or section 2613 of
this title for protection from disclosure of a specific chemical identity of any active or inactive
substance for which a notice is received under paragraph (4)(A)(i) or (5)(B)(i) that is not on the
confidential portion of the list published under paragraph (1).
(9) Certification.—Under the rules promulgated under this subsection, manufacturers and
processors, as applicable, shall be required—
(A) to certify that each notice or substantiation the manufacturer or processor submits
complies with the requirements of the rule, and that any confidentiality claims are true
and correct; and
(B) to retain a record documenting compliance with the rule and supporting confidentiality
claims for a period of 5 years beginning on the last day of the submission period.
(10) Mercury.—
(A) Definition of mercury.—In this paragraph, notwithstanding section 2602(2)(B) of this title,
the term "mercury" means—
(i) elemental mercury; and
(ii) a mercury compound.

(B) Publication.—Not later than April 1, 2017, and every 3 years thereafter, the Administrator
shall carry out and publish in the Federal Register an inventory of mercury supply, use,
and trade in the United States.
(C) Process.—In carrying out the inventory under subparagraph (B), the Administrator
shall—
(i) identify any manufacturing processes or products that intentionally add mercury; and
(ii) recommend actions, including proposed revisions of Federal law or regulations, to
achieve further reductions in mercury use.
(D) Reporting.—
(i) In general.—To assist in the preparation of the inventory under subparagraph (B),
any person who manufactures mercury or mercury-added products or otherwise
intentionally uses mercury in a manufacturing process shall make periodic reports to
the Administrator, at such time and including such information as the Administrator
shall determine by rule promulgated not later than 2 years after June 22, 2016.
(ii) Coordination.—To avoid duplication, the Administrator shall coordinate the reporting
under this subparagraph with the Interstate Mercury Education and Reduction
Clearinghouse.
(iii) Exemption.—Clause (i) shall not apply to a person engaged in the generation,
handling, or management of mercury-containing waste, unless that person
manufactures or recovers mercury in the management of that waste.

(c) Records
Any person who manufactures, processes, or distributes in commerce any chemical
substance or mixture shall maintain 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. Records of such 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. Any other record of such adverse reactions shall be
retained 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. Records required to be maintained
under this subsection shall include records of consumer allegations of personal injury or harm to
health, reports of occupational disease or injury, and reports or complaints of injury to the
environment submitted to the manufacturer, processor, or distributor in commerce from any
source. Upon request of any duly designated representative of the Administrator, each person
who is required to maintain records under this subsection shall permit the inspection of such
records and shall submit copies of such records.
 


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