be presumed to no longer apply, subject to sub-
section (g)(1)(E) and subparagraphs (B) and (C) 
of this paragraph. 
‘‘(B) LIMITATIONS.— 
‘‘(i) CRITICAL USE.—In the case of a 
chemical substance or mixture for which a 
specific condition of use is subject to an ex-
emption pursuant to section 6(g), if the Ad-
ministrator establishes a ban or phase-out 
described in subparagraph (A) with respect 
to the chemical substance or mixture, the 
presumption against protection under such 
subparagraph shall only apply to informa-
tion that relates solely to any conditions of 
use of the chemical substance or mixture to 
which the exemption does not apply. 
‘‘(ii) EXPORT.—In the case of a chem-
ical substance or mixture for which there is 
manufacture, processing, or distribution in 
commerce that meets the conditions of sec-
tion 12(a)(1), if the Administrator estab-
lishes a ban or phase-out described in sub-
paragraph (A) with respect to the chemical 
substance or mixture, the presumption 
against protection under such subparagraph
shall only apply to information that relates 
solely to any other manufacture, processing, 
or distribution in commerce of the chemical 
substance or mixture for the conditions of 
use subject to the ban or phase-out, unless 
the Administrator makes the determination 
in section 12(a)(2). 
‘‘(iii) SPECIFIC CONDITIONS OF USE.— 
In the case of a chemical substance or mix-
ture for which the Administrator establishes 
a ban or phase-out described in subpara-
graph (A) with respect to a specific condi-
tion of use of the chemical substance or mix-
ture, the presumption against protection 
under such subparagraph shall only apply 
to information that relates solely to the con-
dition of use of the chemical substance or 
mixture for which the ban or phase-out is 
established. 
‘‘(C) REQUEST FOR NONDISCLOSURE.— 
‘‘(i) IN GENERAL.—A manufacturer or 
processor of a chemical substance or mixture 
subject to a ban or phase-out described in 
this paragraph may submit to the Adminis-
trator, within 30 days of receiving a notifi-
cation under subsection (g)(2)(A), a request, 
including documentation supporting such 
request, that some or all of the information 
to which the notice applies should not be 
disclosed or that its disclosure should be de-
layed, and the Administrator shall review 
the request under subsection (g)(1)(E). 
‘‘(ii) EFFECT OF NO REQUEST OR DE-
NIAL.—If no request for nondisclosure or 
delay is submitted to the Administrator 
under this subparagraph, or the Adminis-
trator denies such a request under sub-
section (g)(1)(A), the information shall not 
be protected from disclosure under this sec-
tion. 
‘‘(5) CERTAIN REQUESTS.—If a request is made 
to the Administrator under section 552(a) of title 5, 
United States Code, for information reported to or 
otherwise obtained by the Administrator under this 
Act that is not protected from disclosure under this 
subsection, the Administrator may not deny the re-
quest on the basis of section 552(b)(4) of title 5, 
United States Code. 
‘‘(c) 
REQUIREMENTS
FOR
CONFIDENTIALITY 
CLAIMS.—
‘‘(1) ASSERTION OF CLAIMS.— 
‘‘(A) IN
GENERAL.—A person seeking to 
protect from disclosure any information that 
person submits under this Act (including infor-
mation described in paragraph (2)) shall assert 
to the Administrator a claim for protection from 
disclosure concurrent with submission of the in-
formation, in accordance with such rules regard-
ing a claim for protection from disclosure as the 
Administrator has promulgated or may promul-
gate pursuant to this title. 
‘‘(B) INCLUSION.—An assertion of a claim 
under subparagraph (A) shall include a state-
ment that the person has— 
‘‘(i) taken reasonable measures to pro-
tect 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. 
‘‘(C) 
ADDITIONAL
REQUIREMENTS
FOR 
CLAIMS REGARDING CHEMICAL IDENTITY INFOR-
MATION.—In the case of a claim under subpara-
graph (A) for protection from disclosure of a spe-
cific chemical identity, the claim shall include a 
structurally descriptive generic name for the 
chemical substance that the Administrator may 
disclose to the public, subject to the condition 
that such generic name shall— 
‘‘(i) be consistent with guidance devel-
oped by the Administrator under paragraph 
(4)(A); and 
‘‘(ii) describe the chemical structure of 
the chemical substance as specifically as 
practicable while protecting those features of 
the chemical structure— 
‘‘(I) that are claimed as confiden-
tial; and 
‘‘(II) the disclosure of which 
would be likely to cause substantial 
harm to the competitive position of the 
person.
100 
number, and other information that would iden-
tify the specific chemical substance, if the specific 
chemical identity was claimed as confidential at 
the time it was submitted in a notice under sec-
tion 5. 
‘‘(3) SUBSTANTIATION REQUIREMENTS.—Except 
as provided in paragraph (2), a person asserting a 
claim to protect information from disclosure under 
this section shall substantiate the claim, in accord-
ance with such rules as the Administrator has pro-
mulgated or may promulgate pursuant to this section. 
‘‘(4) GUIDANCE.—The Administrator shall de-
velop guidance regarding— 
‘‘(A) the determination of structurally de-
scriptive generic names, in the case of claims for 
the protection from disclosure of specific chem-
ical identity; and 
‘‘(B) the content and form of the statements 
of need and agreements required under para-
graphs (4), (5), and (6) of subsection (d). 
‘‘(5) CERTIFICATION.—An authorized official of 
a person described in paragraph (1)(A) shall certify 
that the statement required to assert a claim sub-
mitted pursuant to paragraph (1)(B), and any infor-
101 
mation required to substantiate a claim submitted 
pursuant to paragraph (3), are true and correct. 
‘‘(d) EXCEPTIONS
TO PROTECTION FROM DISCLO-
SURE.—Information described in subsection (a)— 
‘‘(1) shall be disclosed to an officer or employee 
of the United States— 
‘‘(A) in connection with the official duties 
of that person under any Federal law for the 
protection of health or the environment; or 
‘‘(B) for a specific Federal law enforcement 
purpose; 
‘‘(2) shall be disclosed to a contractor of the 
United States and employees of that contractor— 
‘‘(A) if, in the opinion of the Administrator, 
the disclosure is necessary for the satisfactory 
performance by the contractor of a contract with 
the United States for the performance of work in 
connection with this Act; and 
‘‘(B) subject to such conditions as the Ad-
ministrator may specify; 
‘‘(3) shall be disclosed if the Administrator deter-
mines that disclosure is necessary to protect health or 
the environment against an unreasonable risk of in-
jury to health or the environment, without consider-
ation of costs or other nonrisk factors, including an
102 
unreasonable risk to a potentially exposed or suscep-
tible subpopulation identified as relevant by the Ad-
ministrator under the conditions of use; 
‘‘(4) shall be disclosed to a State, political sub-
division of a State, or tribal government, on written 
request, for the purpose of administration or enforce-
ment of a law, if such entity has 1 or more applicable 
agreements with the Administrator that are consistent 
with 
the 
guidance 
developed 
under 
subsection 
(c)(4)(B) and ensure that the entity will take appro-
priate measures, and has adequate authority, to 
maintain the confidentiality of the information in ac-
cordance with procedures comparable to the proce-
dures used by the Administrator to safeguard the in-
formation; 
‘‘(5) shall be disclosed to a health or environ-
mental professional employed by a Federal or State 
agency or tribal government or a treating physician 
or nurse in a nonemergency situation if such person 
provides a written statement of need and agrees to 
sign a written confidentiality agreement with the Ad-
ministrator, subject to the conditions that— 
‘‘(A) the statement of need and confiden-
tiality agreement are consistent with the guid-
ance developed under subsection (c)(4)(B);
103 
‘‘(B) the statement of need shall be a state-
ment that the person has a reasonable basis to 
suspect that— 
‘‘(i) the information is necessary for, 
or will assist in— 
‘‘(I) the diagnosis or treatment of 
1 or more individuals; or 
‘‘(II) responding to an environ-
mental release or exposure; and 
‘‘(ii) 1 or more individuals being diag-
nosed or treated have been exposed to the 
chemical substance or mixture concerned, or 
an environmental release of or exposure to 
the chemical substance or mixture concerned 
has occurred; and 
‘‘(C) the person will not use the information 
for any purpose other than the health or environ-
mental needs asserted in the statement of need, 
except as otherwise may be authorized by the 
terms of the agreement or by the person who has 
a claim under this section with respect to the in-
formation; 
‘‘(6) shall be disclosed in the event of an emer-
gency to a treating or responding physician, nurse, 
agent of a poison control center, public health or envi-
104 
ronmental official of a State, political subdivision of 
a State, or tribal government, or first responder (in-
cluding any individual duly authorized by a Federal 
agency, State, political subdivision of a State, or trib-
al government who is trained in urgent medical care 
or other emergency procedures, including a police offi-
cer, firefighter, or emergency medical technician) if 
such person requests the information, subject to the 
conditions that such person shall— 
‘‘(A) have a reasonable basis to suspect 
that— 
‘‘(i) a medical, public health, or envi-
ronmental emergency exists; 
‘‘(ii) the information is necessary for, 
or will assist in, emergency or first-aid di-
agnosis or treatment; or 
‘‘(iii) 1 or more individuals being di-
agnosed or treated have likely been exposed 
to the chemical substance or mixture con-
cerned, or a serious environmental release of 
or exposure to the chemical substance or 
mixture concerned has occurred; and 
‘‘(B) if requested by a person who has a 
claim with respect to the information under this 
section—
105 
‘‘(i) provide a written statement of 
need and agree to sign a confidentiality 
agreement, as described in paragraph (5); 
and 
‘‘(ii) submit to the Administrator such 
statement of need and confidentiality agree-
ment as soon as practicable, but not nec-
essarily before the information is disclosed; 
‘‘(7) may be disclosed if the Administrator deter-
mines that disclosure is relevant in a proceeding 
under this Act, subject to the condition that the disclo-
sure is made in such a manner as to preserve con-
fidentiality to the extent practicable without impair-
ing the proceeding; 
‘‘(8) shall be disclosed if the information is re-
quired to be made public under any other provision 
of Federal law; and 
‘‘(9) shall be disclosed as required pursuant to 
discovery, subpoena, other court order, or any other 
judicial process otherwise allowed under applicable 
Federal or State law. 
‘‘(e) DURATION
OF
PROTECTION
FROM
DISCLO-
SURE.— 
‘‘(1) IN
GENERAL.—Subject to paragraph (2), 
subsection (f)(3), and section 8(b), the Administrator
106 
shall protect from disclosure information described in 
subsection (a)— 
‘‘(A) in the case of information described in 
subsection (c)(2), until such time as— 
‘‘(i) the person that asserted the claim 
notifies the Administrator that the person is 
withdrawing the claim, in which case the 
information shall not be protected from dis-
closure under this section; or 
‘‘(ii) the Administrator becomes aware 
that the information does not qualify for 
protection from disclosure under this sec-
tion, in which case the Administrator shall 
take any actions required under subsections 
(f) and (g); and 
‘‘(B) in the case of information other than 
information described in subsection (c)(2)— 
‘‘(i) for a period of 10 years from the 
date on which the person asserts the claim 
with respect to the information submitted to 
the Administrator; or 
‘‘(ii) if applicable before the expiration 
of such 10-year period, until such time as— 
‘‘(I) the person that asserted the 
claim notifies the Administrator that
107 
the person is withdrawing the claim, 
in which case the information shall not 
be protected from disclosure under this 
section; or 
‘‘(II) the Administrator becomes 
aware that the information does not 
qualify for protection from disclosure 
under this section, in which case the 
Administrator shall take any actions 
required under subsections (f) and (g). 
‘‘(2) EXTENSIONS.— 
‘‘(A) IN GENERAL.—In the case of informa-
tion other than information described in sub-
section (c)(2), not later than the date that is 60 
days before the expiration of the period described 
in paragraph (1)(B)(i), the Administrator shall 
provide to the person that asserted the claim a 
notice of the impending expiration of the period. 
‘‘(B) REQUEST.— 
‘‘(i) IN GENERAL.—Not later than the 
date that is 30 days before the expiration of 
the period described in paragraph (1)(B)(i), 
a person reasserting the relevant claim shall 
submit to the Administrator a request for 
extension substantiating, in accordance
108 
with subsection (c)(3), the need to extend the 
period. 
‘‘(ii) ACTION BY ADMINISTRATOR.—Not 
later than the date of expiration of the pe-
riod described in paragraph (1)(B)(i), the 
Administrator shall, in accordance with 
subsection (g)(1)— 
‘‘(I) review the request submitted 
under clause (i); 
‘‘(II) make a determination re-
garding whether the claim for which 
the request was submitted continues to 
meet the relevant requirements of this 
section; and 
‘‘(III)(aa) grant an extension of 
10 years; or 
‘‘(bb) deny the request. 
‘‘(C) NO
LIMIT
ON
NUMBER
OF
EXTEN-
SIONS.—There shall be no limit on the number 
of extensions granted under this paragraph, if 
the Administrator determines that the relevant 
request under subparagraph (B)(i)— 
‘‘(i) establishes the need to extend the 
period; and
109 
‘‘(ii) meets the requirements established 
by the Administrator. 
‘‘(f) REVIEW AND RESUBSTANTIATION.— 
‘‘(1) DISCRETION OF ADMINISTRATOR.—The Ad-
ministrator may require any person that has claimed 
protection for information from disclosure under this 
section, whether before, on, or after the date of enact-
ment of the Frank R. Lautenberg Chemical Safety for 
the 21st Century Act, to reassert and substantiate or 
resubstantiate the claim in accordance with this sec-
tion— 
‘‘(A) after the chemical substance is des-
ignated as a high-priority substance under sec-
tion 6(b); 
‘‘(B) for any chemical substance designated 
as 
an 
active 
substance 
under 
section 
8(b)(5)(B)(iii); or 
‘‘(C) if the Administrator determines that 
disclosure of certain information currently pro-
tected from disclosure would be important to as-
sist the Administrator in conducting risk evalua-
tions or promulgating rules under section 6. 
‘‘(2) REVIEW
REQUIRED.—The Administrator 
shall review a claim for protection of information 
from disclosure under this section and require any
110 
person that has claimed protection for that informa-
tion, whether before, on, or after the date of enactment 
of the Frank R. Lautenberg Chemical Safety for the 
21st Century Act, to reassert and substantiate or re-
substantiate the claim in accordance with this sec-
tion— 
‘‘(A) as necessary to determine whether the 
information qualifies for an exemption from dis-
closure in connection with a request for informa-
tion received by the Administrator under section 
552 of title 5, United States Code; 
‘‘(B) if the Administrator has a reasonable 
basis to believe that the information does not 
qualify for protection from disclosure under this 
section; or 
‘‘(C) for any chemical substance the Admin-
istrator determines under section 6(b)(4)(A) pre-
sents an unreasonable risk of injury to health or 
the environment. 
‘‘(3) PERIOD OF PROTECTION.—If the Adminis-
trator requires a person to reassert and substantiate 
or resubstantiate a claim under this subsection, and 
determines that the claim continues to meet the rel-
evant requirements of this section, the Administrator 
shall protect the information subject to the claim from
111 
disclosure for a period of 10 years from the date of 
such determination, subject to any subsequent require-
ment by the Administrator under this subsection. 
‘‘(g) DUTIES OF ADMINISTRATOR.— 
‘‘(1) DETERMINATION.— 
‘‘(A) IN GENERAL.—Except for claims re-
garding information described in subsection 
(c)(2), the Administrator shall, subject to sub-
paragraph (C), not later than 90 days after the 
receipt of a claim under subsection (c), and not 
later than 30 days after the receipt of a request 
for extension of a claim under subsection (e) or 
a request under subsection (b)(4)(C), review and 
approve, approve in part and deny in part, or 
deny the claim or request. 
‘‘(B) REASONS FOR DENIAL.—If the Admin-
istrator denies or denies in part a claim or re-
quest under subparagraph (A) the Administrator 
shall provide to the person that asserted the 
claim or submitted the request a written state-
ment of the reasons for the denial or denial in 
part of the claim or request. 
‘‘(C) SUBSETS.—The Administrator shall— 
‘‘(i) except with respect to information 
described in subsection (c)(2)(G), review all
112 
claims or requests under this section for the 
protection from disclosure of the specific 
chemical identity of a chemical substance; 
and 
‘‘(ii) review a representative subset, 
comprising at least 25 percent, of all other 
claims or requests for protection from dis-
closure under this section. 
‘‘(D) EFFECT
OF
FAILURE
TO
ACT.—The 
failure of the Administrator to make a decision 
regarding a claim or request for protection from 
disclosure or extension under this section shall 
not have the effect of denying or eliminating a 
claim or request for protection from disclosure. 
‘‘(E) DETERMINATION OF REQUESTS UNDER 
SUBSECTION (b)(4)(C).—With respect to a request 
submitted under subsection (b)(4)(C), the Admin-
istrator shall, with the objective of ensuring that 
information relevant to the protection of health 
and the environment is disclosed to the extent 
practicable, determine whether the documenta-
tion provided by the person rebuts what shall be 
the presumption of the Administrator that the 
public interest in the disclosure of the informa-
tion outweighs the public or proprietary interest
113 
in maintaining the protection for all or a por-
tion of the information that the person has re-
quested not be disclosed or for which disclosure 
be delayed. 
‘‘(2) NOTIFICATION.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B) and subsections (b), (d), and 
(e), if the Administrator denies or denies in part 
a claim or request under paragraph (1), con-
cludes, in accordance with this section, that the 
information does not qualify for protection from 
disclosure, intends to disclose information pursu-
ant to subsection (d), or promulgates a rule 
under section 6(a) establishing a ban or phase- 
out with respect to a chemical substance or mix-
ture, the Administrator shall notify, in writing, 
the person that asserted the claim or submitted 
the request of the intent of the Administrator to 
disclose the information or not protect the infor-
mation from disclosure under this section. The 
notice shall be furnished by certified mail (re-
turn receipt requested), by personal delivery, or 
by other means that allows verification of the 
fact and date of receipt.
114 
‘‘(B) DISCLOSURE OF INFORMATION.—Ex-
cept as provided in subparagraph (C), the Ad-
ministrator shall not disclose information under 
this subsection until the date that is 30 days 
after the date on which the person that asserted 
the claim or submitted the request receives notifi-
cation under subparagraph (A). 
‘‘(C) EXCEPTIONS.— 
‘‘(i) FIFTEEN DAY NOTIFICATION.—For 
information the Administrator intends to 
disclose under subsections (d)(3), (d)(4), 
(d)(5), and (j), the Administrator shall not 
disclose the information until the date that 
is 15 days after the date on which the per-
son that asserted the claim or submitted the 
request receives notification under subpara-
graph (A), except that, with respect to infor-
mation to be disclosed under subsection 
(d)(3), if the Administrator determines that 
disclosure of the information is necessary to 
protect against an imminent and substan-
tial harm to health or the environment, no 
prior notification shall be necessary. 
‘‘(ii) NOTIFICATION AS SOON AS PRAC-
TICABLE.—For information the Adminis-
115 
trator intends to disclose under paragraph 
(6) of subsection (d), the Administrator 
shall notify the person that submitted the 
information that the information has been 
disclosed as soon as practicable after disclo-
sure of the information. 
‘‘(iii) NO NOTIFICATION REQUIRED.— 
Notification shall not be required— 
‘‘(I) for the disclosure of informa-
tion under paragraphs (1), (2), (7), or 
(8) of subsection (d); or 
‘‘(II) for the disclosure of informa-
tion for which— 
‘‘(aa) the Administrator has 
provided to the person that as-
serted the claim a notice under 
subsection (e)(2)(A); and 
‘‘(bb) such person does not 
submit to the Administrator a re-
quest under subsection (e)(2)(B) 
on or before the deadline estab-
lished in subsection (e)(2)(B)(i). 
‘‘(D) APPEALS.— 
‘‘(i) ACTION
TO
RESTRAIN
DISCLO-
SURE.—If a person receives a notification
116 
under this paragraph and believes the infor-
mation is protected from disclosure under 
this section, before the date on which the in-
formation is to be disclosed pursuant to sub-
paragraph (B) or (C) the person may bring 
an action to restrain disclosure of the infor-
mation in— 
‘‘(I) the United States district 
court of the district in which the com-
plainant resides or has the principal 
place of business; or 
‘‘(II) the United States District 
Court for the District of Columbia. 
‘‘(ii) NO DISCLOSURE.— 
‘‘(I) IN
GENERAL.—Subject to 
subsection (d), the Administrator shall 
not disclose information that is the 
subject of an appeal under this para-
graph before the date on which the ap-
plicable court rules on an action under 
clause (i). 
‘‘(II) EXCEPTION.—Subclause (I) 
shall not apply to disclosure of infor-
mation described under subsections 
(d)(4) and (j).
117 
‘‘(3) REQUEST AND NOTIFICATION SYSTEM.—The 
Administrator, in consultation with the Director of 
the Centers for Disease Control and Prevention, shall 
develop a request and notification system that, in a 
format and language that is readily accessible and 
understandable, allows for expedient and swift access 
to information disclosed pursuant to paragraphs (5) 
and (6) of subsection (d). 
‘‘(4) UNIQUE
IDENTIFIER.—The Administrator 
shall— 
‘‘(A)(i) develop a system to assign a unique 
identifier to each specific chemical identity for 
which the Administrator approves a request for 
protection from disclosure, which shall not be ei-
ther the specific chemical identity or a struc-
turally descriptive generic term; and 
‘‘(ii) apply that identifier consistently to all 
information relevant to the applicable chemical 
substance; 
‘‘(B) annually publish and update a list of 
chemical substances, referred to by their unique 
identifiers, for which claims to protect the spe-
cific chemical identity from disclosure have been 
approved, including the expiration date for each 
such claim;
118 
‘‘(C) ensure that any nonconfidential infor-
mation received by the Administrator with re-
spect to a chemical substance included on the list 
published under subparagraph (B) while the spe-
cific chemical identity of the chemical substance 
is protected from disclosure under this section 
identifies the chemical substance using the 
unique identifier; and 
‘‘(D) for each claim for protection of a spe-
cific chemical identity that has been denied by 
the Administrator or expired, or that has been 
withdrawn by the person who asserted the claim, 
and for which the Administrator has used a 
unique identifier assigned under this paragraph 
to protect the specific chemical identity in infor-
mation that the Administrator has made public, 
clearly link the specific chemical identity to the 
unique identifier in such information to the ex-
tent practicable. 
‘‘(h) CRIMINAL PENALTY
FOR WRONGFUL DISCLO-
SURE.— 
‘‘(1) INDIVIDUALS SUBJECT TO PENALTY.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (C) and paragraph (2), an individual de-
scribed in subparagraph (B) shall be fined under
119 
title 18, United States Code, or imprisoned for 
not more than 1 year, or both. 
‘‘(B) DESCRIPTION.—An individual referred 
to in subparagraph (A) is an individual who— 
‘‘(i) pursuant to this section, obtained 
possession of, or has access to, information 
protected from disclosure under this section; 
and 
‘‘(ii) knowing that the information is 
protected from disclosure under this section, 
willfully discloses the information in any 
manner to any person not entitled to receive 
that information. 
‘‘(C) EXCEPTION.—This paragraph shall 
not apply to any medical professional (including 
an emergency medical technician or other first 
responder) who discloses any information ob-
tained under paragraph (5) or (6) of subsection 
(d) to a patient treated by the medical profes-
sional, or to a person authorized to make med-
ical or health care decisions on behalf of such a 
patient, as needed for the diagnosis or treatment 
of the patient. 
‘‘(2) OTHER LAWS.—Section 1905 of title 18, 
United States Code, shall not apply with respect to
120 
the publishing, divulging, disclosure, or making 
known of, or making available, information reported 
to or otherwise obtained by the Administrator under 
this Act. 
‘‘(i) APPLICABILITY.— 
‘‘(1) IN GENERAL.—Except as otherwise provided 
in this section, section 8, or any other applicable Fed-
eral law, the Administrator shall have no authority— 
‘‘(A) to require the substantiation or re-
substantiation of a claim for the protection from 
disclosure of information reported to or otherwise 
obtained by the Administrator under this Act 
prior to the date of enactment of the Frank R. 
Lautenberg Chemical Safety for the 21st Century 
Act; or 
‘‘(B) to impose substantiation or resubstan-
tiation requirements, with respect to the protec-
tion of information described in subsection (a), 
under this Act that are more extensive than those 
required under this section. 
‘‘(2) ACTIONS
PRIOR
TO
PROMULGATION
OF 
RULES.—Nothing in this Act prevents the Adminis-
trator from reviewing, requiring substantiation or re-
substantiation of, or approving, approving in part, or 
denying any claim for the protection from disclosure
121 
of information before the effective date of such rules 
applicable to those claims as the Administrator may 
promulgate after the date of enactment of the Frank 
R. Lautenberg Chemical Safety for the 21st Century 
Act. 
‘‘(j) ACCESS
BY CONGRESS.—Notwithstanding any 
limitation contained in this section or any other provision 
of law, all information reported to or otherwise obtained 
by the Administrator (or any representative of the Adminis-
trator) under this Act shall be made available, upon written 
request of any duly authorized committee of the Congress, 
to such committee.’’. 
SEC. 12. PENALTIES. 
Section 16 of the Toxic Substances Control Act (15 
U.S.C. 2615) is amended— 
(1) in subsection (a)(1), by striking ‘‘$25,000’’ 
and inserting ‘‘$37,500’’; and 
(2) in subsection (b)— 
(A) by striking ‘‘Any person’’ and inserting 
the following: 
‘‘(1) IN GENERAL.—Any person’’; 
(B) by striking ‘‘$25,000’’ and inserting 
‘‘$50,000’’; and 
(C) by adding at the end the following:
122 
‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS 
BODILY INJURY.— 
‘‘(A) IN GENERAL.—Any person who know-
ingly and willfully violates any provision of sec-
tion 15 or 409, and who knows at the time of the 
violation that the violation places an individual 
in imminent danger of death or serious bodily 
injury, shall be subject on conviction to a fine of 
not more than $250,000, or imprisonment for 
not more than 15 years, or both. 
‘‘(B) 
ORGANIZATIONS.—Notwithstanding 
the penalties described in subparagraph (A), an 
organization that commits a knowing violation 
described in subparagraph (A) shall be subject on 
conviction to a fine of not more than $1,000,000 
for each violation. 
‘‘(C) INCORPORATION
OF
CORRESPONDING 
PROVISIONS.—Subparagraphs (B) through (F) of 
section 113(c)(5) of the Clean Air Act (42 U.S.C. 
7413(c)(5)(B)–(F)) shall apply to the prosecu-
tion of a violation under this paragraph.’’. 
SEC. 13. STATE-FEDERAL RELATIONSHIP. 
Section 18 of the Toxic Substances Control Act (15 
U.S.C. 2617) is amended—
123 
(1) by amending subsection (a) to read as fol-
lows: 
‘‘(a) IN GENERAL.— 
‘‘(1) ESTABLISHMENT OR ENFORCEMENT.—Ex-
cept as otherwise provided in subsections (c), (d), (e), 
(f), and (g), and subject to paragraph (2), no State 
or political subdivision of a State may establish or 
continue to enforce any of the following: 
‘‘(A) DEVELOPMENT OF INFORMATION.—A 
statute or administrative action to require the 
development of information about a chemical 
substance or category of chemical substances that 
is reasonably likely to produce the same informa-
tion required under section 4, 5, or 6 in— 
‘‘(i) a rule promulgated by the Admin-
istrator; 
‘‘(ii) a consent agreement entered into 
by the Administrator; or 
‘‘(iii) an order issued by the Adminis-
trator. 
‘‘(B) CHEMICAL
SUBSTANCES
FOUND
NOT 
TO PRESENT AN UNREASONABLE RISK OR RE-
STRICTED.—A statute, criminal penalty, or ad-
ministrative action to prohibit or otherwise re-
strict the manufacture, processing, or distribu-
124 
tion in commerce or use of a chemical sub-
stance— 
‘‘(i) for which the determination de-
scribed in section 6(i)(1) is made, consistent 
with the scope of the risk evaluation under 
section (6)(b)(4)(D); or 
‘‘(ii) for which a final rule is promul-
gated under section 6(a), after the effective 
date of the rule issued under section 6(a) for 
the chemical substance, consistent with the 
scope of the risk evaluation under section 
(6)(b)(4)(D). 
‘‘(C) SIGNIFICANT NEW USE.—A statute or 
administrative action requiring the notification 
of a use of a chemical substance that the Admin-
istrator has specified as a significant new use 
and for which the Administrator has required 
notification pursuant to a rule promulgated 
under section 5. 
‘‘(2) EFFECTIVE DATE OF PREEMPTION.—Under 
this subsection, Federal preemption of statutes and 
administrative actions applicable to specific chemical 
substances shall not occur until the effective date of 
the applicable action described in paragraph (1) 
taken by the Administrator.’’;
125 
(2) by amending subsection (b) to read as fol-
lows: 
‘‘(b) NEW STATUTES, CRIMINAL PENALTIES, OR AD-
MINISTRATIVE
ACTIONS
CREATING
PROHIBITIONS
OR 
OTHER RESTRICTIONS.— 
‘‘(1) IN GENERAL.—Except as provided in sub-
sections (c), (d), (e), (f), and (g), beginning on the 
date on which the Administrator defines the scope of 
a risk evaluation for a chemical substance under sec-
tion 6(b)(4)(D) and ending on the date on which the 
deadline established pursuant to section 6(b)(4)(G) for 
completion of the risk evaluation expires, or on the 
date on which the Administrator publishes the risk 
evaluation under section 6(b)(4)(C), whichever is ear-
lier, no State or political subdivision of a State may 
establish a statute, criminal penalty, or administra-
tive action prohibiting or otherwise restricting the 
manufacture, processing, distribution in commerce, or 
use of such chemical substance that is a high-priority 
substance designated under section 6(b)(1)(B)(i). 
‘‘(2) EFFECT OF SUBSECTION.—This subsection 
does not restrict the authority of a State or political 
subdivision of a State to continue to enforce any stat-
ute enacted, criminal penalty assessed, or administra-
tive action taken, prior to the date on which the Ad-
126 
ministrator defines and publishes the scope of a risk 
evaluation under section 6(b)(4)(D).’’; and 
(3) by adding at the end the following: 
‘‘(c) SCOPE
OF PREEMPTION.—Federal preemption 
under subsections (a) and (b) of statutes, criminal pen-
alties, and administrative actions applicable to specific 
chemical substances shall apply only to— 
‘‘(1) with respect to subsection (a)(1)(A), the 
chemical substances or category of chemical substances 
subject to a rule, order, or consent agreement under 
section 4, 5, or 6; 
‘‘(2) with respect to subsection (b), the hazards, 
exposures, risks, and uses or conditions of use of such 
chemical substances included in the scope of the risk 
evaluation pursuant to section 6(b)(4)(D); 
‘‘(3) with respect to subsection (a)(1)(B), the 
hazards, exposures, risks, and uses or conditions of 
use of such chemical substances included in any final 
action the Administrator takes pursuant to section 
6(a) or 6(i)(1); or 
‘‘(4) with respect to subsection (a)(1)(C), the uses 
of such chemical substances that the Administrator 
has specified as significant new uses and for which 
the Administrator has required notification pursuant 
to a rule promulgated under section 5.
127 
‘‘(d) EXCEPTIONS.— 
‘‘(1) NO PREEMPTION OF STATUTES AND ADMIN-
ISTRATIVE ACTIONS.— 
‘‘(A) IN
GENERAL.—Nothing in this Act, 
nor any amendment made by the Frank R. Lau-
tenberg Chemical Safety for the 21st Century 
Act, nor any rule, standard of performance, risk 
evaluation, or scientific assessment implemented 
pursuant to this Act, shall affect the right of a 
State or a political subdivision of a State to 
adopt or enforce any rule, standard of perform-
ance, risk evaluation, scientific assessment, or 
any other protection for public health or the en-
vironment that— 
‘‘(i) is adopted or authorized under the 
authority of any other Federal law or 
adopted to satisfy or obtain authorization 
or approval under any other Federal law; 
‘‘(ii) implements a reporting, moni-
toring, or other information obligation for 
the chemical substance not otherwise re-
quired by the Administrator under this Act 
or required under any other Federal law; 
‘‘(iii) is adopted pursuant to authority 
under a law of the State or political sub-
128 
division of the State related to water qual-
ity, air quality, or waste treatment or dis-
posal, except to the extent that the action— 
‘‘(I) imposes a restriction on the 
manufacture, processing, distribution 
in commerce, or use of a chemical sub-
stance; and 
‘‘(II)(aa) addresses the same haz-
ards and exposures, with respect to the 
same conditions of use as are included 
in the scope of the risk evaluation pub-
lished pursuant to section 6(b)(4)(D), 
but is inconsistent with the action of 
the Administrator; or 
‘‘(bb) would cause a violation of 
the applicable action by the Adminis-
trator under section 5 or 6; or 
‘‘(iv) subject to subparagraph (B), is 
identical to a requirement prescribed by the 
Administrator. 
‘‘(B) IDENTICAL REQUIREMENTS.— 
‘‘(i) IN GENERAL.—The penalties and 
other sanctions applicable under a law of a 
State or political subdivision of a State in 
the event of noncompliance with the iden-
129 
tical requirement shall be no more stringent 
than the penalties and other sanctions 
available to the Administrator under section 
16 of this Act. 
‘‘(ii) PENALTIES.—In the case of an 
identical requirement— 
‘‘(I) a State or political subdivi-
sion of a State may not assess a pen-
alty for a specific violation for which 
the Administrator has assessed an ade-
quate penalty under section 16; and 
‘‘(II) if a State or political sub-
division of a State has assessed a pen-
alty for a specific violation, the Ad-
ministrator may not assess a penalty 
for that violation in an amount that 
would cause the total of the penalties 
assessed for the violation by the State 
or political subdivision of a State and 
the Administrator combined to exceed 
the maximum amount that may be as-
sessed for that violation by the Admin-
istrator under section 16. 
‘‘(2) APPLICABILITY TO CERTAIN RULES OR OR-
DERS.—
130 
‘‘(A) PRIOR RULES AND ORDERS.—Nothing 
in this section shall be construed as modifying 
the preemptive effect under this section, as in ef-
fect on the day before the effective date of the 
Frank R. Lautenberg Chemical Safety for the 
21st Century Act, of any rule or order promul-
gated or issued under this Act prior to that effec-
tive date. 
‘‘(B) CERTAIN CHEMICAL SUBSTANCES AND 
MIXTURES.—With respect to a chemical sub-
stance or mixture for which any rule or order 
was promulgated or issued under section 6 prior 
to the effective date of the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act with 
respect to manufacturing, processing, distribu-
tion in commerce, use, or disposal of the chem-
ical substance or mixture, nothing in this section 
shall be construed as modifying the preemptive 
effect of this section as in effect prior to the en-
actment of the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act of any rule or 
order that is promulgated or issued with respect 
to such chemical substance or mixture under sec-
tion 6 after that effective date, unless the latter 
rule or order is with respect to a chemical sub-
131 
stance or mixture containing a chemical sub-
stance and follows a designation of that chemical 
substance as a high-priority substance under sec-
tion 6(b)(1)(B)(i), the identification of that 
chemical substance under section 6(b)(2)(A), or 
the selection of that chemical substance for risk 
evaluation under section 6(b)(4)(E)(iv)(II). 
‘‘(e) PRESERVATION OF CERTAIN LAWS.— 
‘‘(1) IN GENERAL.—Nothing in this Act, subject 
to subsection (g) of this section, shall— 
‘‘(A) be construed to preempt or otherwise 
affect the authority of a State or political sub-
division of a State to continue to enforce any ac-
tion taken or requirement imposed or require-
ment enacted relating to a specific chemical sub-
stance before April 22, 2016, under the authority 
of a law of the State or political subdivision of 
the State that prohibits or otherwise restricts 
manufacturing, processing, distribution in com-
merce, use, or disposal of a chemical substance; 
or 
‘‘(B) be construed to preempt or otherwise 
affect any action taken pursuant to a State law 
that was in effect on August 31, 2003.
132 
‘‘(2) EFFECT OF SUBSECTION.—This subsection 
does not affect, modify, or alter the relationship be-
tween Federal law and laws of a State or political 
subdivision of a State pursuant to any other Federal 
law. 
‘‘(f) WAIVERS.— 
‘‘(1) DISCRETIONARY
EXEMPTIONS.—Upon ap-
plication of a State or political subdivision of a 
State, the Administrator may, by rule, exempt from 
subsection (a), under such conditions as may be pre-
scribed in the rule, a statute, criminal penalty, or ad-
ministrative action of that State or political subdivi-
sion of the State that relates to the effects of exposure 
to a chemical substance under the conditions of use if 
the Administrator determines that— 
‘‘(A) compelling conditions warrant grant-
ing the waiver to protect health or the environ-
ment; 
‘‘(B) compliance with the proposed require-
ment of the State or political subdivision of the 
State would not unduly burden interstate com-
merce in the manufacture, processing, distribu-
tion in commerce, or use of a chemical substance; 
‘‘(C) compliance with the proposed require-
ment of the State or political subdivision of the
133 
State would not cause a violation of any appli-
cable Federal law, rule, or order; and 
‘‘(D) in the judgment of the Administrator, 
the proposed requirement of the State or political 
subdivision of the State is designed to address a 
risk of a chemical substance, under the condi-
tions of use, that was identified— 
‘‘(i) consistent with the best available 
science; 
‘‘(ii) using supporting studies con-
ducted in accordance with sound and objec-
tive scientific practices; and 
‘‘(iii) based on the weight of the sci-
entific evidence. 
‘‘(2) REQUIRED
EXEMPTIONS.—Upon applica-
tion of a State or political subdivision of a State, the 
Administrator shall exempt from subsection (b) a 
statute or administrative action of a State or polit-
ical subdivision of a State that relates to the effects 
of exposure to a chemical substance under the condi-
tions of use if the Administrator determines that— 
‘‘(A)(i) compliance with the proposed re-
quirement of the State or political subdivision of 
the State would not unduly burden interstate 
commerce in the manufacture, processing, dis-
134 
tribution in commerce, or use of a chemical sub-
stance; 
‘‘(ii) compliance with the proposed require-
ment of the State or political subdivision of the 
State would not cause a violation of any appli-
cable Federal law, rule, or order; and 
‘‘(iii) the State or political subdivision of 
the State has a concern about the chemical sub-
stance or use of the chemical substance based in 
peer-reviewed science; or 
‘‘(B) no later than the date that is 18 
months after the date on which the Adminis-
trator has initiated the prioritization process for 
a chemical substance under the rule promulgated 
pursuant to section 6(b)(1)(A), or the date on 
which the Administrator publishes the scope of 
the risk evaluation for a chemical substance 
under section 6(b)(4)(D), whichever is sooner, the 
State or political subdivision of the State has en-
acted a statute or proposed or finalized an ad-
ministrative action intended to prohibit or other-
wise restrict the manufacture, processing, dis-
tribution in commerce, or use of the chemical 
substance.
135 
‘‘(3) DETERMINATION OF A WAIVER REQUEST.— 
The duty of the Administrator to grant or deny a 
waiver application shall be nondelegable and shall be 
exercised— 
‘‘(A) not later than 180 days after the date 
on which an application under paragraph (1) is 
submitted; and 
‘‘(B) not later than 110 days after the date 
on which an application under paragraph (2) is 
submitted. 
‘‘(4) FAILURE TO MAKE A DETERMINATION.—If 
the Administrator fails to make a determination 
under paragraph (3)(B) during the 110-day period 
beginning on the date on which an application under 
paragraph (2) is submitted, the statute or adminis-
trative action of the State or political subdivision of 
the State that was the subject of the application shall 
not be considered to be an existing statute or admin-
istrative action for purposes of subsection (b) by rea-
son of the failure of the Administrator to make a de-
termination. 
‘‘(5) NOTICE AND COMMENT.—Except in the case 
of an application approved under paragraph (9), the 
application of a State or political subdivision of a
136 
State under this subsection shall be subject to public 
notice and comment. 
‘‘(6) FINAL AGENCY ACTION.—The decision of the 
Administrator on the application of a State or polit-
ical subdivision of a State shall be— 
‘‘(A) considered to be a final agency action; 
and 
‘‘(B) subject to judicial review. 
‘‘(7) DURATION OF WAIVERS.—A waiver granted 
under paragraph (2) or approved under paragraph 
(9) shall remain in effect until such time as the Ad-
ministrator publishes the risk evaluation under sec-
tion 6(b). 
‘‘(8) JUDICIAL REVIEW OF WAIVERS.—Not later 
than 60 days after the date on which the Adminis-
trator makes a determination on an application of a 
State or political subdivision of a State under para-
graph (1) or (2), any person may file a petition for 
judicial review in the United States Court of Appeals 
for the District of Columbia Circuit, which shall have 
exclusive jurisdiction over the determination. 
‘‘(9) APPROVAL.— 
‘‘(A) AUTOMATIC APPROVAL.—If the Admin-
istrator fails to meet the deadline established 
under paragraph (3)(B), the application of a
137 
State or political subdivision of a State under 
paragraph (2) shall be automatically approved, 
effective on the date that is 10 days after the 
deadline. 
‘‘(B) 
REQUIREMENTS.—Notwithstanding 
paragraph (6), approval of a waiver application 
under subparagraph (A) for failure to meet the 
deadline under paragraph (3)(B) shall not be 
considered final agency action or be subject to ju-
dicial review or public notice and comment. 
‘‘(g) SAVINGS.— 
‘‘(1) NO PREEMPTION OF COMMON LAW OR STAT-
UTORY
CAUSES
OF
ACTION
FOR
CIVIL
RELIEF
OR 
CRIMINAL CONDUCT.— 
‘‘(A) IN
GENERAL.—Nothing in this Act, 
nor any amendment made by the Frank R. Lau-
tenberg Chemical Safety for the 21st Century 
Act, nor any standard, rule, requirement, stand-
ard of performance, risk evaluation, or scientific 
assessment implemented pursuant to this Act, 
shall be construed to preempt, displace, or sup-
plant any State or Federal common law rights 
or any State or Federal statute creating a rem-
edy for civil relief, including those for civil dam-
age, or a penalty for a criminal conduct.
138 
‘‘(B) CLARIFICATION OF NO PREEMPTION.— 
Notwithstanding any other provision of this Act, 
nothing in this Act, nor any amendments made 
by the Frank R. Lautenberg Chemical Safety for 
the 21st Century Act, shall preempt or preclude 
any cause of action for personal injury, wrongful 
death, property damage, or other injury based on 
negligence, strict liability, products liability, 
failure to warn, or any other legal theory of li-
ability under any State law, maritime law, or 
Federal common law or statutory theory. 
‘‘(2) NO EFFECT ON PRIVATE REMEDIES.— 
‘‘(A) IN
GENERAL.—Nothing in this Act, 
nor any amendments made by the Frank R. 
Lautenberg Chemical Safety for the 21st Century 
Act, nor any rules, regulations, requirements, 
risk evaluations, scientific assessments, or orders 
issued pursuant to this Act shall be interpreted 
as, in either the plaintiff’s or defendant’s favor, 
dispositive in any civil action. 
‘‘(B) AUTHORITY
OF
COURTS.—This Act 
does not affect the authority of any court to 
make a determination in an adjudicatory pro-
ceeding under applicable State or Federal law 
with respect to the admission into evidence or
139 
any other use of this Act or rules, regulations, re-
quirements, standards of performance, risk eval-
uations, scientific assessments, or orders issued 
pursuant to this Act.’’. 
SEC. 14. JUDICIAL REVIEW. 
Section 19(a) of the Toxic Substances Control Act (15 
U.S.C. 2618(a)) is amended— 
(1) in paragraph (1), by adding at the end the 
following: 
‘‘(C)(i) Not later than 60 days after the publica-
tion of a designation under section 6(b)(1)(B)(ii), 
any person may commence a civil action to challenge 
the designation. 
‘‘(ii) The United States Court of Appeals for the 
District of Columbia Circuit shall have exclusive ju-
risdiction over a civil action filed under this subpara-
graph.’’; and 
(2) by striking paragraph (3). 
SEC. 15. CITIZENS’ CIVIL ACTIONS. 
Section 20(b) of the Toxic Substances Control Act (15 
U.S.C. 2619(b)) is amended— 
(1) in paragraph (1)(B), by striking ‘‘or’’ at the 
end; and 
(2) in paragraph (2), by striking the period at 
the end and inserting the following: ‘‘, except that no
140 
prior notification shall be required in the case of a 
civil action brought to compel a decision by the Ad-
ministrator pursuant to section 18(f)(3)(B); or 
‘‘(3) in the case of a civil action brought to com-
pel a decision by the Administrator pursuant to sec-
tion 18(f)(3)(B), after the date that is 60 days after 
the deadline specified in section 18(f)(3)(B).’’. 
SEC. 16. STUDIES. 
Section 25 of the Toxic Substances Control Act (15 
U.S.C. 2624) is repealed. 
SEC. 17. ADMINISTRATION OF THE ACT. 
Section 26 of the Toxic Substances Control Act (15 
U.S.C. 2625) is amended— 
(1) in subsection (b)(1)— 
(A) by striking ‘‘of a reasonable fee’’; 
(B) by striking ‘‘data under section 4 or 5 
to defray the cost of administering this Act’’ and 
inserting ‘‘information under section 4 or a no-
tice or other information to be reviewed by the 
Administrator under section 5, or who manufac-
tures or processes a chemical substance that is 
the subject of a risk evaluation under section 
6(b), of a fee that is sufficient and not more than 
reasonably necessary to defray the cost related to 
such chemical substance of administering sec-
141 
tions 4, 5, and 6, and collecting, processing, re-
viewing, and providing access to and protecting 
from disclosure as appropriate under section 14 
information on chemical substances under this 
title, including contractor costs incurred by the 
Administrator’’; 
(C) by striking ‘‘Such rules shall not pro-
vide for any fee in excess of $2,500 or, in the 
case of a small business concern, any fee in ex-
cess of $100.’’; and 
(D) by striking ‘‘submit the data and the 
cost to the Administrator of reviewing such 
data’’ and inserting ‘‘pay such fee and the cost 
to the Administrator of carrying out the activi-
ties described in this paragraph’’; 
(2) in subsection (b)— 
(A) in paragraph (2), by striking ‘‘para-
graph (1)’’ and inserting ‘‘paragraph (4)’’; and 
(B) by adding at the end the following: 
‘‘(3) FUND.— 
‘‘(A) ESTABLISHMENT.—There is established in 
the Treasury of the United States a fund, to be known 
as the TSCA Service Fee Fund (in this paragraph re-
ferred to as the ‘Fund’), consisting of such amounts 
as are deposited in the Fund under this paragraph.
142 
‘‘(B) COLLECTION AND DEPOSIT OF FEES.—Sub-
ject to the conditions of subparagraph (C), the Ad-
ministrator shall collect the fees described in this sub-
section and deposit those fees in the Fund. 
‘‘(C) USE OF FUNDS BY ADMINISTRATOR.—Fees 
authorized under this section shall be collected and 
available for obligation only to the extent and in the 
amount provided in advance in appropriations Acts, 
and shall be available without fiscal year limitation 
for use in defraying the costs of the activities de-
scribed in paragraph (1). 
‘‘(D) ACCOUNTING AND AUDITING.— 
‘‘(i) ACCOUNTING.—The Administrator shall 
biennially prepare and submit to the Committee 
on Environment and Public Works of the Senate 
and the Committee on Energy and Commerce of 
the House of Representatives a report that in-
cludes an accounting of the fees paid to the Ad-
ministrator under this paragraph and amounts 
disbursed from the Fund for the period covered 
by the report, as reflected by financial statements 
provided in accordance with sections 3515 and 
3521 of title 31, United States Code. 
‘‘(ii) AUDITING.—
143 
‘‘(I) IN GENERAL.—For the purpose of 
section 3515(c) of title 31, United States 
Code, the Fund shall be considered a compo-
nent of a covered executive agency. 
‘‘(II) COMPONENTS
OF
AUDIT.—The 
annual audit required in accordance with 
sections 3515 and 3521 of title 31, United 
States Code, of the financial statements of 
activities carried out using amounts from 
the Fund shall include an analysis of— 
‘‘(aa) 
the 
fees 
collected 
and 
amounts disbursed under this sub-
section; 
‘‘(bb) the reasonableness of the fees 
in place as of the date of the audit to 
meet current and projected costs of ad-
ministering the provisions of this title 
for which the fees may be used; and 
‘‘(cc) the number of requests for a 
risk evaluation made by manufacturers 
under section 6(b)(4)(C)(ii). 
‘‘(III) FEDERAL
RESPONSIBILITY.— 
The Inspector General of the Environmental 
Protection Agency shall conduct the annual 
audit described in subclause (II) and sub-
144 
mit to the Administrator a report that de-
scribes the findings and any recommenda-
tions of the Inspector General resulting from 
the audit. 
‘‘(4) AMOUNT
AND
ADJUSTMENT
OF
FEES; RE-
FUNDS.—In setting fees under this section, the Adminis-
trator shall— 
‘‘(A) prescribe lower fees for small business con-
cerns, after consultation with the Administrator of the 
Small Business Administration; 
‘‘(B) set the fees established under paragraph (1) 
at levels such that the fees will, in aggregate, provide 
a sustainable source of funds to annually defray— 
‘‘(i) the lower of— 
‘‘(I) 25 percent of the costs to the Ad-
ministrator of carrying out sections 4, 5, 
and 6, and of collecting, processing, review-
ing, and providing access to and protecting 
from disclosure as appropriate under sec-
tion 14 information on chemical substances 
under this title, other than the costs to con-
duct and complete risk evaluations under 
section 6(b); or 
‘‘(II) $25,000,000 (subject to adjust-
ment pursuant to subparagraph (F)); and
145 
‘‘(ii) the costs of risk evaluations specified 
in subparagraph (D); 
‘‘(C) reflect an appropriate balance in the assess-
ment of fees between manufacturers and processors, 
and allow the payment of fees by consortia of manu-
facturers or processors; 
‘‘(D) notwithstanding subparagraph (B)— 
‘‘(i) except as provided in clause (ii), for 
chemical substances for which the Administrator 
has granted a request from a manufacturer pur-
suant to section 6(b)(4)(C)(ii), establish the fee 
at a level sufficient to defray the full costs to the 
Administrator of conducting the risk evaluation 
under section 6(b); 
‘‘(ii) for chemical substances for which the 
Administrator has granted a request from a 
manufacturer pursuant to section 6(b)(4)(C)(ii), 
and which are included in the 2014 update of 
the TSCA Work Plan for Chemical Assessments, 
establish the fee at a level sufficient to defray 50 
percent of the costs to the Administrator of con-
ducting the risk evaluation under section 6(b); 
and
146 
‘‘(iii) apply fees collected pursuant to 
clauses (i) and (ii) only to defray the costs de-
scribed in those clauses; 
‘‘(E) prior to the establishment or amendment of 
any fees under paragraph (1), consult and meet with 
parties potentially subject to the fees or their rep-
resentatives, subject to the condition that no obliga-
tion under the Federal Advisory Committee Act (5 
U.S.C. App.) or subchapter II of chapter 5 of title 5, 
United States Code, is applicable with respect to such 
meetings; 
‘‘(F) beginning with the fiscal year that is 3 
years after the date of enactment of the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act, 
and every 3 years thereafter, after consultation with 
parties potentially subject to the fees and their rep-
resentatives pursuant to subparagraph (E), increase 
or decrease the fees established under paragraph (1) 
as necessary to adjust for inflation and to ensure that 
funds deposited in the Fund are sufficient to defray— 
‘‘(i) approximately but not more than 25 
percent of the costs to the Administrator of car-
rying out sections 4, 5, and 6, and of collecting, 
processing, reviewing, and providing access to 
and protecting from disclosure as appropriate
147 
under section 14 information on chemical sub-
stances under this title, other than the costs to 
conduct and complete risk evaluations requested 
under section 6(b)(4)(C)(ii); and 
‘‘(ii) the costs of risk evaluations specified 
in subparagraph (D); and 
‘‘(G) if a notice submitted under section 5 is not 
reviewed or such a notice is withdrawn, refund the fee 
or a portion of the fee if no substantial work was per-
formed on the notice. 
‘‘(5) MINIMUM AMOUNT OF APPROPRIATIONS.—Fees 
may not be assessed for a fiscal year under this section un-
less the amount of appropriations for the Chemical Risk 
Review and Reduction program project of the Environ-
mental Protection Agency for the fiscal year (excluding the 
amount of any fees appropriated for the fiscal year) are 
equal to or greater than the amount of appropriations for 
that program project for fiscal year 2014. 
‘‘(6) TERMINATION.—The authority provided by this 
subsection shall terminate at the conclusion of the fiscal 
year that is 10 years after the date of enactment of the 
Frank R. Lautenberg Chemical Safety for the 21st Century 
Act unless otherwise reauthorized or modified by Congress.’’; 
and 
(3) by adding at the end the following:
148 
‘‘(h) SCIENTIFIC STANDARDS.—In carrying out sec-
tions 4, 5, and 6, to the extent that the Administrator makes 
a decision based on science, the Administrator shall use sci-
entific information, technical procedures, measures, meth-
ods, protocols, methodologies, or models, employed in a 
manner consistent with the best available science, and shall 
consider as applicable— 
‘‘(1) the extent to which the scientific informa-
tion, technical procedures, measures, methods, proto-
cols, 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 rel-
evant for the Administrator’s use in making a deci-
sion about a chemical substance or mixture; 
‘‘(3) the degree of clarity and completeness with 
which the data, assumptions, methods, quality assur-
ance, and analyses employed to generate the informa-
tion are documented; 
‘‘(4) the extent to which the variability and un-
certainty in the information, or in the procedures, 
measures, methods, protocols, methodologies, or mod-
els, are evaluated and characterized; and 
‘‘(5) the extent of independent verification or 
peer review of the information or of the procedures,
149 
measures, methods, protocols, methodologies, or mod-
els. 
‘‘(i) WEIGHT OF SCIENTIFIC EVIDENCE.—The Admin-
istrator shall make decisions under sections 4, 5, and 6 
based on the weight of the scientific evidence. 
‘‘(j) AVAILABILITY OF INFORMATION.—Subject to sec-
tion 14, the Administrator shall make available to the pub-
lic— 
‘‘(1) all notices, determinations, findings, rules, 
consent agreements, and orders of the Administrator 
under this title; 
‘‘(2) any information required to be provided to 
the Administrator under section 4; 
‘‘(3) a nontechnical summary of each risk eval-
uation conducted under section 6(b); 
‘‘(4) a list of the studies considered by the Ad-
ministrator in carrying out each such risk evaluation, 
along with the results of those studies; and 
‘‘(5) each designation of a chemical substance 
under section 6(b), along with an identification of the 
information, analysis, and basis used to make the des-
ignations. 
‘‘(k) REASONABLY AVAILABLE INFORMATION.—In car-
rying out sections 4, 5, and 6, the Administrator shall take 
into consideration information relating to a chemical sub-
150 
stance or mixture, including hazard and exposure informa-
tion, under the conditions of use, that is reasonably avail-
able to the Administrator. 
‘‘(l) POLICIES, PROCEDURES, AND GUIDANCE.— 
‘‘(1) DEVELOPMENT.—Not later than 2 years 
after the date of enactment of the Frank R. Lauten-
berg Chemical Safety for the 21st Century Act, the 
Administrator shall develop any policies, procedures, 
and guidance the Administrator determines are nec-
essary to carry out the amendments to this Act made 
by the Frank R. Lautenberg Chemical Safety for the 
21st Century Act. 
‘‘(2) REVIEW.—Not later than 5 years after the 
date of enactment of the Frank R. Lautenberg Chem-
ical Safety for the 21st Century Act, and not less fre-
quently than once every 5 years thereafter, the Ad-
ministrator shall— 
‘‘(A) review the adequacy of the policies, 
procedures, and guidance developed under para-
graph (1), including with respect to animal, 
nonanimal, and epidemiological test methods 
and procedures for assessing and determining 
risk under this title; and 
‘‘(B) revise such policies, procedures, and 
guidance as the Administrator determines nec-
151 
essary to reflect new scientific developments or 
understandings. 
‘‘(3) TESTING OF CHEMICAL SUBSTANCES AND 
MIXTURES.—The policies, procedures, and guidance 
developed under paragraph (1) applicable to testing 
chemical substances and mixtures shall— 
‘‘(A) address how and when the exposure 
level or exposure potential of a chemical sub-
stance or mixture would factor into decisions to 
require new testing, subject to the condition that 
the Administrator shall not interpret the lack of 
exposure information as a lack of exposure or ex-
posure potential; and 
‘‘(B) describe the manner in which the Ad-
ministrator will determine that additional infor-
mation is necessary to carry out this title, in-
cluding information relating to potentially ex-
posed or susceptible populations. 
‘‘(4) CHEMICAL SUBSTANCES WITH COMPLETED 
RISK ASSESSMENTS.—With respect to a chemical sub-
stance listed in the 2014 update to the TSCA Work 
Plan for Chemical Assessments for which the Admin-
istrator has published a completed risk assessment 
prior to the date of enactment of the Frank R. Lau-
tenberg Chemical Safety for the 21st Century Act, the
152 
Administrator may publish proposed and final rules 
under section 6(a) that are consistent with the scope 
of the completed risk assessment for the chemical sub-
stance and consistent with other applicable require-
ments of section 6. 
‘‘(5) GUIDANCE.—Not later than 1 year after the 
date of enactment of the Frank R. Lautenberg Chem-
ical Safety for the 21st Century Act, the Adminis-
trator shall develop guidance to assist interested per-
sons in developing and submitting draft risk evalua-
tions which shall be considered by the Administrator. 
The guidance shall, at a minimum, address the qual-
ity of the information submitted and the process to be 
followed in developing draft risk evaluations for con-
sideration by the Administrator. 
‘‘(m) REPORT TO CONGRESS.— 
‘‘(1) INITIAL REPORT.—Not later than 6 months 
after the date of enactment of the Frank R. Lauten-
berg Chemical Safety for the 21st Century Act, the 
Administrator shall submit to the Committees on En-
ergy and Commerce and Appropriations of the House 
of Representatives and the Committees on Environ-
ment and Public Works and Appropriations of the 
Senate a report containing an estimation of—
153 
‘‘(A) the capacity of the Environmental 
Protection Agency to conduct and publish risk 
evaluations under section 6(b)(4)(C)(i), and the 
resources necessary to conduct the minimum 
number of risk evaluations required under sec-
tion 6(b)(2); 
‘‘(B) the capacity of the Environmental 
Protection Agency to conduct and publish risk 
evaluations under section 6(b)(4)(C)(ii), the like-
ly demand for such risk evaluations, and the an-
ticipated schedule for accommodating that de-
mand; 
‘‘(C) the capacity of the Environmental 
Protection Agency to promulgate rules under sec-
tion 6(a) as required based on risk evaluations 
conducted and published under section 6(b); and 
‘‘(D) the actual and anticipated efforts of 
the Environmental Protection Agency to increase 
the Agency’s capacity to conduct and publish 
risk evaluations under section 6(b). 
‘‘(2) SUBSEQUENT
REPORTS.—The Adminis-
trator shall update and resubmit the report described 
in paragraph (1) not less frequently than once every 
5 years. 
‘‘(n) ANNUAL PLAN.—
154 
‘‘(1) IN GENERAL.—The Administrator shall in-
form the public regarding the schedule and the re-
sources necessary for the completion of each risk eval-
uation as soon as practicable after initiating the risk 
evaluation. 
‘‘(2) PUBLICATION OF PLAN.—At the beginning 
of each calendar year, the Administrator shall publish 
an annual plan that— 
‘‘(A) identifies the chemical substances for 
which risk evaluations are expected to be initi-
ated or completed that year and the resources 
necessary for their completion; 
‘‘(B) describes the status of each risk evalua-
tion that has been initiated but not yet com-
pleted; and 
‘‘(C) if the schedule for completion of a risk 
evaluation has changed, includes an updated 
schedule for that risk evaluation. 
‘‘(o) CONSULTATION WITH SCIENCE ADVISORY COM-
MITTEE ON CHEMICALS.— 
‘‘(1) ESTABLISHMENT.—Not later than 1 year 
after the date of enactment of the Frank R. Lauten-
berg Chemical Safety for the 21st Century Act, the 
Administrator shall establish an advisory committee, 
to be known as the Science Advisory Committee on
155 
Chemicals (referred to in this subsection as the ‘Com-
mittee’). 
‘‘(2) PURPOSE.—The purpose of the Committee 
shall be to provide independent advice and expert 
consultation, at the request of the Administrator, with 
respect to the scientific and technical aspects of issues 
relating to the implementation of this title. 
‘‘(3) COMPOSITION.—The Committee shall be 
composed of representatives of such science, govern-
ment, labor, public health, public interest, animal 
protection, industry, and other groups as the Admin-
istrator determines to be advisable, including rep-
resentatives that have specific scientific expertise in 
the relationship of chemical exposures to women, chil-
dren, and other potentially exposed or susceptible sub-
populations. 
‘‘(4) SCHEDULE.—The Administrator shall con-
vene the Committee in accordance with such schedule 
as the Administrator determines to be appropriate, 
but not less frequently than once every 2 years. 
‘‘(p) PRIOR ACTIONS.— 
‘‘(1) RULES, ORDERS, AND EXEMPTIONS.—Noth-
ing in the Frank R. Lautenberg Chemical Safety for 
the 21st Century Act eliminates, modifies, or with-
draws any rule promulgated, order issued, or exemp-
156 
tion established pursuant to this Act before the date 
of enactment of the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act. 
‘‘(2) PRIOR-INITIATED
EVALUATIONS.—Nothing 
in this Act prevents the Administrator from initi-
ating a risk evaluation regarding a chemical sub-
stance, or from continuing or completing such risk 
evaluation, prior to the effective date of the policies, 
procedures, and guidance required to be developed by 
the Administrator pursuant to the amendments made 
by the Frank R. Lautenberg Chemical Safety for the 
21st Century Act. 
‘‘(3) ACTIONS COMPLETED PRIOR TO COMPLE-
TION OF POLICIES, PROCEDURES, AND GUIDANCE.— 
Nothing in this Act requires the Administrator to re-
vise or withdraw a completed risk evaluation, deter-
mination, or rule under this Act solely because the ac-
tion was completed prior to the development of a pol-
icy, procedure, or guidance pursuant to the amend-
ments made by the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act.’’. 
SEC. 18. STATE PROGRAMS. 
Section 28 of the Toxic Substances Control Act (15 
U.S.C. 2627) is amended by striking subsections (c) and 
(d).
157 
SEC. 19. CONFORMING AMENDMENTS. 
(a) TABLE OF CONTENTS.—The table of contents in 
section 1 of the Toxic Substances Control Act is amended— 
(1) by striking the item relating to section 6 and 
inserting the following: 
‘‘Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances 
and mixtures.’’; 
(2) by striking the item relating to section 10 
and inserting the following: 
‘‘Sec. 10. Research, development, collection, dissemination, and utilization of in-
formation.’’; 
(3) by striking the item relating to section 14 
and inserting the following: 
‘‘Sec. 14. Confidential information.’’; 
and 
(4) by striking the item relating to section 25. 
(b) SECTION 2.—Section 2(b)(1) of the Toxic Sub-
stances Control Act (15 U.S.C. 2601(b)(1)) is amended by 
striking ‘‘data’’ both places it appears and inserting ‘‘infor-
mation’’. 
(c) SECTION 3.—Section 3 of the Toxic Substances 
Control Act (15 U.S.C. 2602) is amended— 
(1) in paragraph (8) (as redesignated by section 
3 of this Act), by striking ‘‘data’’ and inserting ‘‘in-
formation’’; and 
(2) in paragraph (15) (as redesignated by sec-
tion 3 of this Act)—
158 
(A) by striking ‘‘standards’’ and inserting 
‘‘protocols and methodologies’’; 
(B) by striking ‘‘test data’’ both places it 
appears and inserting ‘‘information’’; and 
(C) by striking ‘‘data’’ each place it ap-
pears and inserting ‘‘information’’. 
(d) SECTION 4.—Section 4 of the Toxic Substances 
Control Act (15 U.S.C. 2603) is amended— 
(1) in subsection (b)— 
(A) in paragraph (1)— 
(i) in the paragraph heading, by add-
ing ‘‘, ORDER, OR CONSENT AGREEMENT’’ at 
the end; and 
(ii) by striking ‘‘rule’’ each place it ap-
pears and inserting ‘‘rule, order, or consent 
agreement’’; 
(B) in paragraph (2)(B), by striking 
‘‘rules’’ and inserting ‘‘rules, orders, and consent 
agreements’’; 
(C) in paragraph (3)(A), by striking ‘‘rule’’ 
and inserting ‘‘rule or order’’; and 
(D) in paragraph (4)— 
(i) by striking ‘‘rule under subsection 
(a)’’ each place it appears and inserting
159 
‘‘rule, order, or consent agreement under 
subsection (a)’’; 
(ii) by striking ‘‘repeals the rule’’ each 
place it appears and inserting ‘‘repeals the 
rule or order or modifies the consent agree-
ment to terminate the requirement’’; and 
(iii) by striking ‘‘repeals the applica-
tion of the rule’’ and inserting ‘‘repeals or 
modifies the application of the rule, order, 
or consent agreement’’; 
(2) in subsection (c)— 
(A) in paragraph (1), by striking ‘‘rule’’ 
and inserting ‘‘rule or order’’; 
(B) in paragraph (2)— 
(i) in subparagraph (A), by striking 
‘‘a rule under subsection (a) or for which 
data is being developed pursuant to such a 
rule’’ and inserting ‘‘a rule, order, or con-
sent agreement under subsection (a) or for 
which information is being developed pursu-
ant to such a rule, order, or consent agree-
ment’’; 
(ii) in subparagraph (B), by striking 
‘‘such rule or which is being developed pur-
suant to such rule’’ and inserting ‘‘such
160 
rule, order, or consent agreement or which 
is being developed pursuant to such rule, 
order, or consent agreement’’; and 
(iii) in the matter following subpara-
graph (B), by striking ‘‘the rule’’ and in-
serting ‘‘the rule or order’’; 
(C) in paragraph (3)(B)(i), by striking 
‘‘rule promulgated’’ and inserting ‘‘rule, order, 
or consent agreement’’; and 
(D) in paragraph (4)— 
(i) by striking ‘‘rule promulgated’’ 
each place it appears and inserting ‘‘rule, 
order, or consent agreement’’; 
(ii) by striking ‘‘such rule’’ each place 
it appears and inserting ‘‘such rule, order, 
or consent agreement’’; and 
(iii) in subparagraph (B), by striking 
‘‘the rule’’ and inserting ‘‘the rule or order’’; 
(3) in subsection (d), by striking ‘‘rule’’ and in-
serting ‘‘rule, order, or consent agreement’’; and 
(4) in subsection (g), by striking ‘‘rule’’ and in-
serting ‘‘rule, order, or consent agreement’’. 
(e) SECTION 5.—Section 5 of the Toxic Substances 
Control Act (15 U.S.C. 2604) is amended— 
(1) in subsection (b)—
161 
(A) in paragraph (1)(A)— 
(i) by striking ‘‘rule promulgated’’ and 
inserting ‘‘rule, order, or consent agree-
ment’’; and 
(ii) by striking ‘‘such rule’’ and insert-
ing ‘‘such rule, order, or consent agree-
ment’’; 
(B) in paragraph (1)(B), by striking ‘‘rule 
promulgated’’ and inserting ‘‘rule or order’’; and 
(C) in paragraph (2)(A)(ii), by striking 
‘‘rule promulgated’’ and inserting ‘‘rule, order, 
or consent agreement’’; and 
(2) in subsection (d)(2)(C), by striking ‘‘rule’’ 
and inserting ‘‘rule, order, or consent agreement’’. 
(f) SECTION 7.—Section 7(a) of the Toxic Substances 
Control Act (15 U.S.C. 2606(a)) is amended— 
(1) in paragraph (1), in the matter following 
subparagraph (C), by striking ‘‘a rule under section 
4, 5, 6, or title IV or an order under section 5 or title 
IV’’ and inserting ‘‘a determination under section 5 
or 6, a rule under section 4, 5, or 6 or title IV, an 
order under section 4, 5, or 6 or title IV, or a consent 
agreement under section 4’’; and 
(2) in paragraph (2), by striking ‘‘subsection 
6(d)(2)(A)(i)’’ and inserting ‘‘section 6(d)(3)(A)(i)’’.
162 
(g) SECTION 8.—Section 8(a) of the Toxic Substances 
Control Act (15 U.S.C. 2607(a)) is amended— 
(1) in paragraph (2)(E), by striking ‘‘data’’ and 
inserting ‘‘information’’; and 
(2) in paragraph (3)(A)(ii)(I), by striking ‘‘or 
an order in effect under section 5(e)’’ and inserting 
‘‘, an order in effect under section 4 or 5(e), or a con-
sent agreement under section 4’’. 
(h) SECTION 9.—Section 9 of the Toxic Substances 
Control Act (15 U.S.C. 2608) is amended— 
(1) in subsection (a), by striking ‘‘section 6’’ 
each place it appears and inserting ‘‘section 6(a)’’; 
and 
(2) in subsection (d), by striking ‘‘Health, Edu-
cation, and Welfare’’ and inserting ‘‘Health and 
Human Services’’. 
(i) SECTION 10.—Section 10 of the Toxic Substances 
Control Act (15 U.S.C. 2609) is amended— 
(1) in the section heading, by striking ‘‘DATA’’ 
and inserting ‘‘INFORMATION’’; 
(2) by striking ‘‘Health, Education, and Wel-
fare’’ each place it appears and inserting ‘‘Health 
and Human Services’’; 
(3) in subsection (b)—
163 
(A) in the subsection heading, by striking 
‘‘DATA’’ and inserting ‘‘INFORMATION’’; 
(B) by striking ‘‘data’’ and inserting ‘‘in-
formation’’ in paragraph (1); 
(C) by striking ‘‘data’’ and inserting ‘‘infor-
mation’’ in paragraph (2)(A); and 
(D) by striking ‘‘a data’’ and inserting ‘‘an 
information’’ in paragraph (2)(B); and 
(4) in subsection (g), by striking ‘‘data’’ and in-
serting ‘‘information’’. 
(j) SECTION 11.—Section 11(b)(2) of the Toxic Sub-
stances Control Act (15 U.S.C. 2610(b)(2)) is amended— 
(1) by striking ‘‘data’’ each place it appears and 
inserting ‘‘information’’; and 
(2) in subparagraph (E), by striking ‘‘rule pro-
mulgated’’ and inserting ‘‘rule promulgated, order 
issued, or consent agreement entered into’’. 
(k) SECTION 12.—Section 12(b)(1) of the Toxic Sub-
stances Control Act (15 U.S.C. 2611(b)(1)) is amended by 
striking ‘‘data’’ both places it appears and inserting ‘‘infor-
mation’’. 
(l) SECTION 15.—Section 15(1) of the Toxic Sub-
stances Control Act (15 U.S.C. 2614(1)) is amended by 
striking ‘‘(A) any rule’’ and all that follows through ‘‘or 
(D)’’ and inserting ‘‘any requirement of this title or any
164 
rule promulgated, order issued, or consent agreement en-
tered into under this title, or’’. 
(m) SECTION 19.—Section 19 of the Toxic Substances 
Control Act (15 U.S.C. 2618) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)(A)— 
(i) by striking ‘‘Not later than 60 days 
after the date of the promulgation of a rule 
under section 4(a), 5(a)(2), 5(b)(4), 6(a), 
6(e), or 8, or under title II or IV’’ and in-
serting ‘‘Except as otherwise provided in 
this title, not later than 60 days after the 
date on which a rule is promulgated under 
this title, title II, or title IV, or the date on 
which an order is issued under section 4, 
5(e), 5(f), or 6(i)(1),’’; 
(ii) by striking ‘‘such rule’’ and insert-
ing ‘‘such rule or order’’; and 
(iii) by striking ‘‘such a rule’’ and in-
serting ‘‘such a rule or order’’; 
(B) in paragraph (1)(B)— 
(i) by striking ‘‘Courts’’ and inserting 
‘‘Except as otherwise provided in this title, 
courts’’; and
165 
(ii) by striking ‘‘subparagraph (A) or 
(B) of section 6(b)(1)’’ and inserting ‘‘this 
title, other than an order under section 4, 
5(e), 5(f), or 6(i)(1),’’; and 
(C) in paragraph (2)— 
(i) by striking ‘‘rulemaking record’’ 
and inserting ‘‘record’’; and 
(ii) by striking ‘‘based the rule’’ and 
inserting ‘‘based the rule or order’’; 
(2) in subsection (b)— 
(A) by striking ‘‘review a rule’’ and insert-
ing ‘‘review a rule, or an order under section 4, 
5(e), 5(f), or 6(i)(1),’’; 
(B) by striking ‘‘such rule’’ and inserting 
‘‘such rule or order’’; 
(C) by striking ‘‘the rule’’ and inserting 
‘‘the rule or order’’; 
(D) by striking ‘‘new rule’’ each place it ap-
pears and inserting ‘‘new rule or order’’; and 
(E) by striking ‘‘modified rule’’ and insert-
ing ‘‘modified rule or order’’; and 
(3) in subsection (c)— 
(A) in paragraph (1)— 
(i) in subparagraph (A)—
166 
(I) by striking ‘‘a rule’’ and in-
serting ‘‘a rule or order’’; and 
(II) by striking ‘‘such rule’’ and 
inserting ‘‘such rule or order’’; 
(ii) in subparagraph (B)— 
(I) in the matter preceding clause 
(i), by striking ‘‘a rule’’ and inserting 
‘‘a rule or order’’; 
(II) by amending clause (i) to 
read as follows: 
‘‘(i) in the case of review of— 
‘‘(I) a rule under section 4(a), 5(b)(4), 6(a) 
(including review of the associated determination 
under section 6(b)(4)(A)), or 6(e), the standard 
for review prescribed by paragraph (2)(E) of 
such section 706 shall not apply and the court 
shall hold unlawful and set aside such rule if the 
court finds that the rule is not supported by sub-
stantial evidence in the rulemaking record taken 
as a whole; and 
‘‘(II) an order under section 4, 5(e), 5(f), or 
6(i)(1), the standard for review prescribed by 
paragraph (2)(E) of such section 706 shall not 
apply and the court shall hold unlawful and set 
aside such order if the court finds that the order
167 
is not supported by substantial evidence in the 
record taken as a whole; and’’; and 
(III) by striking clauses (ii) and 
(iii) and the matter after clause (iii) 
and inserting the following: 
‘‘(ii) the court may not review the contents and 
adequacy of any statement of basis and purpose re-
quired by section 553(c) of title 5, United States 
Code, to be incorporated in the rule or order, except 
as part of the record, taken as a whole.’’; and 
(iii) by striking subparagraph (C); 
and 
(B) in paragraph (2), by striking ‘‘any 
rule’’ and inserting ‘‘any rule or order’’. 
(n) SECTION 20.—Section 20(a)(1) of the Toxic Sub-
stances Control Act (15 U.S.C. 2619(a)(1)) is amended by 
striking ‘‘order issued under section 5’’ and inserting ‘‘order 
issued under section 4 or 5’’. 
(o) SECTION 21.—Section 21 of the Toxic Substances 
Control Act (15 U.S.C. 2620) is amended— 
(1) in subsection (a), by striking ‘‘order under 
section 5(e) or (6)(b)(2)’’ and inserting ‘‘order under 
section 4 or 5(e) or (f)’’; and 
(2) in subsection (b)—
168 
(A) in paragraph (1), by striking ‘‘order 
under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)’’ 
and inserting ‘‘order under section 4 or 5(e) or 
(f)’’; and 
(B) in paragraph (4)(B)— 
(i) in the matter preceding clause (i), 
by striking ‘‘order under section 5(e) or 
6(b)(2)’’ and inserting ‘‘order under section 
4 or 5(e) or (f)’’; 
(ii) in clause (i), by striking ‘‘order 
under section 5(e)’’ and inserting ‘‘order 
under section 4 or 5(e)’’; and 
(iii) in clause (ii), by striking ‘‘section 
6 or 8 or an order under section 6(b)(2), 
there is a reasonable basis to conclude that 
the issuance of such a rule or order is nec-
essary to protect health or the environment 
against an unreasonable risk of injury to 
health or the environment’’ and inserting 
‘‘section 6(a) or 8 or an order under section 
5(f), the chemical substance or mixture to be 
subject to such rule or order presents an un-
reasonable risk of injury to health or the en-
vironment, without consideration of costs or 
other nonrisk factors, including an unrea-
169 
sonable risk to a potentially exposed or sus-
ceptible subpopulation, under the conditions 
of use’’. 
(p) SECTION 24.—Section 24(b)(2)(B) of the Toxic 
Substances Control Act (15 U.S.C. 2623(b)(2)(B)) is 
amended— 
(1) by inserting ‘‘and’’ at the end of clause (i); 
(2) by striking clause (ii); and 
(3) by redesignating clause (iii) as clause (ii). 
(q) SECTION 26.—Section 26 of the Toxic Substances 
Control Act (15 U.S.C. 2625) is amended— 
(1) in subsection (e), by striking ‘‘Health, Edu-
cation, and Welfare’’ each place it appears and in-
serting ‘‘Health and Human Services’’; and 
(2) in subsection (g)(1), by striking ‘‘data’’ and 
inserting ‘‘information’’. 
(r) SECTION 27.—Section 27(a) of the Toxic Sub-
stances Control Act (15 U.S.C. 2626(a)) is amended— 
(1) by striking ‘‘Health, Education, and Wel-
fare’’ and inserting ‘‘Health and Human Services’’; 
(2) by striking ‘‘test data’’ both places it appears 
and inserting ‘‘information’’; 
(3) by striking ‘‘rules promulgated’’ and insert-
ing ‘‘rules, orders, or consent agreements’’; and
170 
(4) by striking ‘‘standards’’ and inserting ‘‘pro-
tocols and methodologies’’. 
(s) SECTION 30.—Section 30(2) of the Toxic Sub-
stances Control Act (15 U.S.C. 2629(2)) is amended by 
striking ‘‘rule’’ and inserting ‘‘rule, order, or consent agree-
ment’’. 
SEC. 20. NO RETROACTIVITY. 
Nothing in sections 1 through 19, or the amendments 
made by sections 1 through 19, shall be interpreted to apply 
retroactively to any State, Federal, or maritime legal action 
filed before the date of enactment of this Act. 
SEC. 21. TREVOR’S LAW. 
(a) PURPOSES.—The purposes of this section are— 
(1) to provide the appropriate Federal agencies 
with the authority to help conduct investigations into 
potential cancer clusters; 
(2) to ensure that Federal agencies have the au-
thority to undertake actions to help address cancer 
clusters and factors that may contribute to the cre-
ation of potential cancer clusters; and 
(3) to enable Federal agencies to coordinate with 
other Federal, State, and local agencies, institutes of 
higher education, and the public in investigating and 
addressing cancer clusters.
171 
(b) DESIGNATION AND INVESTIGATION OF POTENTIAL 
CANCER CLUSTERS.—Part P of title III of the Public 
Health Service Act (42 U.S.C. 280g et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 399V–6. DESIGNATION AND INVESTIGATION OF PO-
TENTIAL CANCER CLUSTERS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) CANCER CLUSTER.—The term ‘cancer clus-
ter’ means the incidence of a particular cancer within 
a population group, a geographical area, and a pe-
riod of time that is greater than expected for such 
group, area, and period. 
‘‘(2) PARTICULAR
CANCER.—The term ‘par-
ticular cancer’ means one specific type of cancer or 
a type of cancers scientifically proven to have the 
same cause. 
‘‘(3) POPULATION GROUP.—The term ‘population 
group’ means a group, for purposes of calculating 
cancer rates, defined by factors such as race, eth-
nicity, age, or gender. 
‘‘(b) CRITERIA FOR DESIGNATION OF POTENTIAL CAN-
CER CLUSTERS.— 
‘‘(1) DEVELOPMENT
OF
CRITERIA.—The Sec-
retary shall develop criteria for the designation of po-
tential cancer clusters.
172 
‘‘(2) REQUIREMENTS.—The criteria developed 
under paragraph (1) shall consider, as appropriate— 
‘‘(A) a standard for cancer cluster identi-
fication and reporting protocols used to deter-
mine when cancer incidence is greater than 
would be typically observed; 
‘‘(B) scientific screening standards that en-
sure that a cluster of a particular cancer in-
volves the same type of cancer, or types of can-
cers; 
‘‘(C) the population in which the cluster of 
a particular cancer occurs by factors such as 
race, ethnicity, age, and gender, for purposes of 
calculating cancer rates; 
‘‘(D) the boundaries of a geographic area in 
which a cluster of a particular cancer occurs so 
as not to create or obscure a potential cluster by 
selection of a specific area; and 
‘‘(E) the time period over which the number 
of cases of a particular cancer, or the calculation 
of an expected number of cases, occurs. 
‘‘(c) GUIDELINES FOR INVESTIGATION OF POTENTIAL 
CANCER CLUSTERS.—The Secretary, in consultation with 
the Council of State and Territorial Epidemiologists and 
representatives of State and local health departments, shall
173 
develop, publish, and periodically update guidelines for in-
vestigating potential cancer clusters. The guidelines shall— 
‘‘(1) recommend that investigations of cancer 
clusters— 
‘‘(A) use the criteria developed under sub-
section (b); 
‘‘(B) use the best available science; and 
‘‘(C) rely on a weight of the scientific evi-
dence; 
‘‘(2) provide standardized methods of reviewing 
and categorizing data, including from health surveil-
lance systems and reports of potential cancer clusters; 
and 
‘‘(3) provide guidance for using appropriate epi-
demiological and other approaches for investigations. 
‘‘(d) INVESTIGATION OF CANCER CLUSTERS.— 
‘‘(1) SECRETARY DISCRETION.—The Secretary— 
‘‘(A) in consultation with representatives of 
the relevant State and local health departments, 
shall consider whether it is appropriate to con-
duct an investigation of a potential cancer clus-
ter; and 
‘‘(B) in conducting investigations shall have 
the discretion to prioritize certain potential can-
174 
cer clusters, based on the availability of re-
sources. 
‘‘(2) COORDINATION.—In investigating potential 
cancer clusters, the Secretary shall coordinate with 
agencies within the Department of Health and 
Human Services and other Federal agencies, such as 
the Environmental Protection Agency. 
‘‘(3) BIOMONITORING.—In investigating poten-
tial cancer clusters, the Secretary shall rely on all ap-
propriate biomonitoring information collected under 
other Federal programs, such as the National Health 
and Nutrition Examination Survey. The Secretary 
may provide technical assistance for relevant biomon-
itoring studies of other Federal agencies. 
‘‘(e) DUTIES.—The Secretary shall— 
‘‘(1) ensure that appropriate staff of agencies 
within the Department of Health and Human Serv-
ices are prepared to provide timely assistance, to the 
extent practicable, upon receiving a request to inves-
tigate a potential cancer cluster from a State or local 
health authority; 
‘‘(2) maintain staff expertise in epidemiology, 
toxicology, data analysis, environmental health and 
cancer surveillance, exposure assessment, pediatric 
health, pollution control, community outreach, health
175 
education, laboratory sampling and analysis, spatial 
mapping, and informatics; 
‘‘(3) consult with community members as inves-
tigations into potential cancer clusters are conducted, 
as the Secretary determines appropriate; 
‘‘(4) collect, store, and disseminate reports on in-
vestigations of potential cancer clusters, the possible 
causes of such clusters, and the actions taken to ad-
dress such clusters; and 
‘‘(5) provide technical assistance for inves-
tigating cancer clusters to State and local health de-
partments through existing programs, such as the 
Epi-Aids program of the Centers for Disease Control 
and Prevention and the Assessments of Chemical Ex-
posures Program of the Agency for Toxic Substances 
and Disease Registry.’’. 
TITLE II—RURAL HEALTHCARE 
CONNECTIVITY 
SEC. 201. SHORT TITLE. 
This title may be cited as the ‘‘Rural Healthcare 
Connectivity Act of 2016’’.
176 
SEC. 202. TELECOMMUNICATIONS SERVICES FOR SKILLED 
NURSING FACILITIES. 
(a) IN GENERAL.—Section 254(h)(7)(B) of the Com-
munications Act of 1934 (47 U.S.C. 254(h)(7)(B)) is 
amended— 
(1) in clause (vi), by striking ‘‘and’’ at the end; 
(2) by redesignating clause (vii) as clause (viii); 
(3) by inserting after clause (vi) the following: 
‘‘(vii) skilled nursing facilities (as de-
fined in section 1819(a) of the Social Secu-
rity Act (42 U.S.C. 1395i–3(a))); and’’; and 
(4) in clause (viii), as redesignated, by striking 
‘‘clauses (i) through (vi)’’ and inserting ‘‘clauses (i) 
through (vii)’’. 
(b) SAVINGS CLAUSE.—Nothing in subsection (a) shall 
be construed to affect the aggregate annual cap on Federal 
universal service support for health care providers under 
section 54.675 of title 47, Code of Federal Regulations, or 
any successor regulation.
177 
(c) EFFECTIVE DATE.—The amendments made by sub-
section (a) shall apply beginning on the date that is 180 
days after the date of the enactment of this Act. 
Attest: 
Clerk.
114TH CONGRESS 
2D SESSION 
H.R. 2576 
HOUSE AMENDMENT TO 
SENATE AMENDMENT