82 FR 6522 - Statutory Requirements for Substantiation of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA)
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 12 (January 19, 2017)
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6522-6525 | |
| FR Document | 2017-01235 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Notices] [Pages 6522-6525] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01235] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2017-0026; FRL-9958-34] Statutory Requirements for Substantiation of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In June 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act (TSCA). EPA is announcing an interpretation of TSCA section 14 concerning confidential business information (CBI) claims for information submitted to EPA. EPA interprets the revised TSCA section 14(c)(3) as requiring substantiation of non-exempt CBI claims at the time the information claimed as CBI is submitted to EPA. FOR FURTHER INFORMATION CONTACT: For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; email address: [email protected]. For technical information contact: Scott M. Sherlock, Attorney Advisor, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8257; email address: [email protected]. DATES: This action is effective on March 20, 2017. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? This announcement is directed to the public in general. It may, however, be of particular interest to you if you manufacture (defined by statute to include import) and/or process chemicals covered by TSCA (15 U.S.C. 2601 et seq.). This may include businesses identified by the North American Industrial Classification System (NAICS) codes 325 and 32411. Because this action is directed to the general public and other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. B. How can I get copies of this document and other related information? 1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2017-0026. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure. 2. Other related information. For information about EPA's programs to evaluate new and existing chemicals and their potential risks and the amended TSCA, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act. II. What action is the Agency taking? The amended TSCA provides new requirements relating to the assertion, substantiation and review of CBI claims. EPA is interpreting the revised TSCA section 14(c)(3) as requiring substantiation of all CBI claims at the time the information claimed as CBI is submitted to EPA, except for claims for information subject to TSCA section 14(c)(2). This action facilitates the Agency's implementation of TSCA section 14(g) to review all CBI claims for chemical identity, with limited exceptions, as well as to review a representative sample of at least 25% of other non-exempt claims. III. What is the Agency's authority for taking this action? EPA has determined that TSCA section 14(c)(3), 15 U.S.C. 2613(c)(3), requires an affected business to substantiate all TSCA CBI claims, except for information subject to TSCA section 14(c)(2), at the time the affected business submits the claimed information to EPA. TSCA section 14(c)(1)(a) requires an affected business to assert a claim for protection from disclosure concurrent with submission of the information in accordance with existing or future rules. TSCA section 14(c)(3) in turn requires an affected business submitting a claim to protect information from disclosure to substantiate the claim, also in accordance with existing or future rules. The language of TSCA section 14(c)(3) is as follows: ``(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 accordance with such rules as the Administrator has promulgated or may promulgate pursuant to this section.'' EPA interprets TSCA section 14(c)(3) to require substantiation for all TSCA CBI claims, except for information [[Page 6523]] within TSCA section 14(c)(2). That is the clear import of the language, ``a person asserting a claim to protect information from disclosure under this section shall substantiate the claim . . .'' While the final clause requires that submissions be in accordance with EPA rules, EPA interprets this provision as addressing the form and manner of a submission, not as making the substantiation requirement conditional upon a future EPA rulemaking. In the future, EPA may promulgate regulations governing the form and manner of substantiating CBI claims for those submissions addressed by this action. Nonetheless, EPA considers the statutory substantiation requirement to be in place as of the effective date of this action. EPA's interpretation is supported by legislative history for the recent amendments to TSCA. Both the Senate and House intended to require substantiation of CBI claims. See S. Rpt. 114-67 (observing, on page 5, that ``section 14 [of pre-amendment TSCA] and EPA's implementation of it has been criticized for failing to require . . . . up-front substantiation of confidentiality claims,'' and, on page 22, stating that, under the Senate bill, ``all new claims for protection of information not presumed to be protected from disclosure must be substantiated by the claimant''); H. Rpt. 114-176 at 29 (a confidentiality claim must ``include . . . . a justification for each claim of confidentiality''); Senate Environment and Public Works Committee summary: ``Reforming the Toxic Substances Control Act'' at 3 (http://www.epw.senate.gov/public/_cache/files/aa2ac4d1-15bb-4e71-9588-909d49bdcff2/tsca-reform-marketing-packet-5.19-final.pdf). (``The legislation promotes additional transparency by requiring up-front substantiation of claims to protect confidential commercial information. . . .'') EPA's interpretation also is supported by TSCA section 14(i)(2), which provides that, ``nothing in this chapter'' prevents EPA from requiring substantiation before the effective date of rules that may be promulgated after June 22, 2016, the date on which the amendments to TSCA were enacted. It might be maintained that TSCA section 14(c)(3) does not impose a substantiation requirement, but merely authorizes EPA to promulgate rules requiring substantiation. Alternatively, it might be maintained that the section does impose a substantiation requirement, but that the requirement must be effectuated through EPA rulemaking. The first reading does not effectuate the legislative intent to require substantiation. In addition, the provision is not worded as a mere grant of authority. Numerous other provisions of TSCA--both of the pre-amended statute and of the Lautenberg amendments--demonstrate that Congress used more straightforward language when it intended simply to grant EPA rulemaking or other authority (e.g., TSCA section 14(f)(1) (``The Administrator may require any person . . . to reassert and substantiate or re-substantiate'' an existing claim under certain circumstances); TSCA section 4(a)(2) (``The Administrator may, by rule, order, or consent agreement . . . . require the development of new information''). Finally, TSCA section 14(c)(1) already authorizes EPA to promulgate rules governing the assertion of CBI claims. This paragraph provides authority for EPA to promulgate rules requiring substantiation, and EPA in fact promulgated a number of rules requiring substantiation under similarly worded authority in pre-amendment TSCA section 14(c)(1). See, e.g., 40 CFR 711.30(b)(1), requiring up-front substantiation for chemical identity claims for Chemical Data Reporting under part 711. To interpret TSCA section 14(c)(3) as merely providing authority to require substantiation, where that authority already exists in TSCA section 14(c)(1), would arguably give TSCA section 14(c)(3) no effect at all. The second reading amounts to a revision of the legislative text. TSCA section 14(c)(3) does not require EPA to undertake rulemaking; it merely acknowledges that EPA ``may'' do so. Unless this ``may'' were read as ``shall'', EPA would be under no obligation to promulgate the rules required to carry out the objective of requiring substantiation. Here again, numerous other provisions of TSCA demonstrate that Congress used clear language--and included deadlines--when it intended to require EPA to promulgate regulations (e.g., TSCA section 6(b)(1)(A)(``Not later than 1 year after June 22, 2016, the Administrator shall establish, by rule, a risk-based screening process. . . .''). Having determined that TSCA section 14(c)(3) requires substantiation of all non-exempt TSCA CBI claims, EPA believes the provision is best interpreted as requiring substantiation concurrent with the submission. This is the natural reading of the requirement that ``a person asserting a claim . . . . shall substantiate the claim.'' By analogy, TSCA section 14(c)(5)--another requirement newly added by the Lautenberg amendments--provides that a claimant ``shall certify that the statement required to assert a [confidentiality] claim . . . . and any information required to substantiate a claim . . . . are true and correct.'' While this provision does not explicitly state that the certification must accompany the submission, it is reasonable to conclude that Congress intended that result. Moreover, a requirement to substantiate CBI claims at some unspecified time would not create any meaningful self-executing requirement, because there would be no point in time at which an affected business could be found not to have complied. Reading the law as requiring substantiation concurrent with the CBI claim also comports with the legislative history. In addition to the history cited earlier in this document, the Senate Report, on p. 5, noted stakeholder concerns that, under pre-amendment TSCA, the lack of a requirement for up-front substantiation resulted in ``an over- abundance of CBI claims, some of which may not be legitimate.'' Interpreting TSCA section 14(c)(3) as requiring substantiation of a CBI claim concurrent with the claim's submission best effectuates the expressed intent of Congress. This interpretation is consistent with the requirement in TSCA section 14(g)(1) that EPA review most confidentiality claims for chemical identity and at least 25% of claims for other types of non- exempt information within 90 days after the receipt of the claim. An approach under which substantiations were submitted at some point after assertion of CBI claims would significantly reduce (and has already significantly reduced) the short period for such CBI reviews. To date, for each review, the Agency must contact each affected business, request the submission of a substantiation, and allow a period of time for the affected business to submit the substantiation. Since timely substantiation provides critical information for completing CBI reviews, it is reasonable to conclude that Congress intended for claims to be substantiated at the time the CBI claim is asserted. When the amendments to TSCA became law on June 22, 2016, EPA published initial Questions and Answers (Q and A's) in an effort to respond to the inquiries and requests concerning EPA's views on the new law. EPA needed to issue guidance to the public as quickly as possible on a broad range of matters under the amendments, since the amendments became effective [[Page 6524]] upon signature. In the Q and A's on TSCA section 14, EPA stated that the Agency was using existing authorities to obtain CBI substantiations and that the Agency may revise CBI substantiation requirements for specific types of information submissions by subsequent rulemaking. Since the time the Q and A's were developed, EPA has heard the views of a number of stakeholders and has had the opportunity to more fully review the statute and legislative history and to evaluate the operational considerations associated with the interpretation of TSCA section 14(c)(3). Operationally, given the large volume of CBI claims, including those that the Agency has already received and those that the Agency expects to receive in the future, it is administratively efficient to interpret the statute as requiring up-front substantiation, which necessarily saves the Agency the time and resources that would otherwise be spent in attempting to contact the affected business. Up- front substantiation will also significantly enhance EPA's ability to meet the review deadlines in TSCA section 14(g). Further, requiring substantiation concurrent with submission will mitigate any need for an affected business to request an extension to substantiate a CBI claim. Additionally, requiring the affected business to provide justification at the time of submission may help limit unwarranted claims of CBI. Based on this further review, for the reasons stated above, EPA has concluded that the provision is best read as creating a requirement to substantiate non-exempt TSCA CBI claims concurrent with their submission. IV. Implementation Existing EPA confidentiality rules at 40 CFR part 2, section 2.204(e), provide substantiation questions that the Agency may specifically request answers to, pursuant to the procedures in those regulations. While those specific questions are not dictated by the self-executing substantiation requirement in TSCA section 14(c)(3), EPA suggests that companies look to those questions for guidance as to how to fulfill the TSCA section 14(c)(3) substantiation requirement for information that is not currently subject to an existing regulatory up- front substantiation requirement. The answers to those questions typically form the basis of EPA final confidentiality determinations, and substantiations that do not address those questions might not provide sufficient information to uphold a determination, pursuant to TSCA section 14(g)(1), that information claimed as CBI is eligible for confidential protection. For information that is currently subject to a regulatory up-front substantiation requirement (for example, chemical identity CBI claims in the Chemical Data Reporting rule, under 40 CFR 711.30), the terms of that requirement, including the substantiation questions required, will continue to govern the substantiation. EPA has revised its Web pages on CBI to assist compliance with this interpretation of TSCA section 14. The Web pages list the substantiation questions from 40 CFR 2.204(e) and provide information on substantiation exemptions and on how the substantiations should be directed to the Agency. Because EPA is providing this interpretation of TSCA section 14(c)(3) for the first time in this document, the Agency is setting different procedures for those who have submitted or will submit information claimed as CBI under TSCA before the effective date of this action, i.e., March 20, 2017, and those who submit information claimed as CBI afterwards. A. TSCA Submissions Filed on or After March 20, 2017 Those submissions containing information claimed as CBI filed on or after the effective-date of this action (i.e., March 20, 2017) must provide a substantiation for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA section 14(c)(2). Any non-exempt CBI claim that is submitted without a substantiation will be considered deficient, and EPA will send a notice of deficiency to the affected business. The notice will inform the affected business that it must submit its substantiation within 30 calendar days in order to remedy its deficient CBI claim. The notice letter will also inform the affected business that if a timely substantiation has not been received by EPA within 30 days of receipt of the letter, then any CBI claims not substantiated will be considered withdrawn, and the information may be made public with no further notice to the affected business. B. TSCA Submissions Filed Between June 22, 2016 and March 20, 2017 Those submissions containing information claimed as CBI filed between June 22, 2016 and March 20, 2017, must provide a substantiation for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA section 14(c)(2). The Agency is giving submitters until September 18, 2017 to provide substantiations and direct them to the Agency. If a substantiation has already been provided to EPA with the submission or in response to a substantiation request, no additional substantiation need be filed for the same information. Be aware, however, that if some non-exempt information claimed as confidential in a particular submission has already been substantiated and some has not, the unsubstantiated information claimed as CBI in the submission must still be substantiated by September 18, 2017. The CBI claims, and the substantiations, may then be reviewed consistent with the provisions of TSCA, its implementing regulations and in accordance with the Agency procedures set forth in 40 CFR part 2. Once September 18, 2017 has passed, if no substantiation has been received for a claim, then EPA will provide the affected business 30 days' notice and a final opportunity to substantiate. The notice will inform the affected business that any CBI claims not substantiated at the end of the 30 days will be considered withdrawn, and the information may be made public with no further notice to the affected business. EPA's electronic reporting systems for TSCA submissions have been modified to require substantiations for non-exempt CBI claims in submissions filed on or after March 20, 2017. Any new paper TSCA submissions that are directed to the Agency after that date must include substantiations for all non-exempt CBI claims at the time of submission. For electronic submissions made using EPA's Central Data Exchange (CDX) during the period from June 22, 2016 to March 20, 2017 that were not substantiated, affected businesses must provide substantiation for CBI claims using the amendment processes for the particular submission type. Information on electronic reporting, including how to make amendments, can be found at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/electronic-reporting-requirements-certain-information. For any paper TSCA submissions that were submitted to the Agency during the period from June 22, 2016 to March 20, 2017, the affected business must submit substantiations for any non-exempt CBI claims that have not yet been substantiated. Submit these substantiations to: TSCA Confidential Business Information Center (7407M), WJC East; Room 6428; Attn: TSCA CBI Substantiations. U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460-0001. [[Page 6525]] Courier Deliveries should be directed to: U.S. EPA, Office of Pollution Prevention and Toxics, Confidential Business Information Center (CBIC), Attn: TSCA CBI Substantiations. 1201 Constitution Avenue NW., WJC East; Room 6428 Washington, DC 20004- 3302, (202) 564-8930. More information on how to substantiate CBI claims for paper submissions can be found at https://www.epa.gov/tsca-cbi/. Authority: 15 U.S.C. 2601 et seq. Dated: January 13, 2017. James J. Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2017-01235 Filed 1-18-17; 8:45 am] BILLING CODE 6560-50-P
![6522 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices
regulatory requirements to nine states in For technical information contact: pass through a metal detector, and sign
multiple different circuits, and if denied Scott M. Sherlock, Attorney Advisor, the EPA visitor log. All visitor bags are
could impact the 13 states within the Environmental Assistance Division, processed through an X-ray machine
ozone transport region established in Office of Pollution Prevention and and subject to search. Visitors will be
CAA section 184. This proposed action Toxics, Environmental Protection provided an EPA/DC badge that must be
also discusses at length prior EPA action Agency, 1200 Pennsylvania Ave. NW., visible at all times in the building and
and analyses concerning the transport of Washington, DC 20460–0001; telephone returned upon departure.
pollutants between the different states number: (202) 564–8257; email address: 2. Other related information. For
under CAA section 110. For these sherlock.scott@epa.gov. information about EPA’s programs to
reasons, the Administrator determines DATES: This action is effective on March evaluate new and existing chemicals
that, when finalized, this action is of 20, 2017. and their potential risks and the
nationwide scope and effect for SUPPLEMENTARY INFORMATION: amended TSCA, go to https://
purposes of section 307(b)(1). Thus, www.epa.gov/assessing-and-managing-
pursuant to CAA section 307(b) any I. General Information chemicals-under-tsca/frank-r-
petitions for review of any final action A. Does this action apply to me? lautenberg-chemical-safety-21st-
regarding this document would be filed century-act.
This announcement is directed to the
in the Court of Appeals for the District public in general. It may, however, be of II. What action is the Agency taking?
of Columbia Circuit within 60 days from particular interest to you if you
the date any final action is published in The amended TSCA provides new
manufacture (defined by statute to requirements relating to the assertion,
the Federal Register. include import) and/or process substantiation and review of CBI claims.
VI. Statutory Authority chemicals covered by TSCA (15 U.S.C. EPA is interpreting the revised TSCA
2601 et seq.). This may include section 14(c)(3) as requiring
42 U.S.C. 7401 et seq.
businesses identified by the North substantiation of all CBI claims at the
Dated: January 11, 2017. American Industrial Classification time the information claimed as CBI is
Gina McCarthy, System (NAICS) codes 325 and 32411. submitted to EPA, except for claims for
Administrator. Because this action is directed to the information subject to TSCA section
[FR Doc. 2017–01097 Filed 1–18–17; 8:45 am] general public and other entities may 14(c)(2).
BILLING CODE 6560–50–P also be interested, the Agency has not This action facilitates the Agency’s
attempted to describe all the specific implementation of TSCA section 14(g)
entities that may be interested in this to review all CBI claims for chemical
ENVIRONMENTAL PROTECTION action. If you have any questions identity, with limited exceptions, as
AGENCY regarding the applicability of this action well as to review a representative
to a particular entity, consult the sample of at least 25% of other non-
[EPA–HQ–OPPT–2017–0026; FRL–9958–34] technical person listed under FOR exempt claims.
FURTHER INFORMATION CONTACT.
Statutory Requirements for III. What is the Agency’s authority for
B. How can I get copies of this document taking this action?
Substantiation of Confidential and other related information?
Business Information (CBI) Claims EPA has determined that TSCA
Under the Toxic Substances Control 1. Docket. EPA has established a section 14(c)(3), 15 U.S.C. 2613(c)(3),
Act (TSCA) docket for this action under docket requires an affected business to
identification (ID) number EPA–HQ– substantiate all TSCA CBI claims,
AGENCY: Environmental Protection OPPT–2017–0026. All documents in the except for information subject to TSCA
Agency (EPA). docket are listed in the docket index section 14(c)(2), at the time the affected
ACTION: Notice. available at http://www.regulations.gov. business submits the claimed
Although listed in the index, some information to EPA.
SUMMARY: In June 2016, the Frank R. information is not publicly available, TSCA section 14(c)(1)(a) requires an
Lautenberg Chemical Safety for the 21st e.g., CBI or other information whose affected business to assert a claim for
Century Act amended the Toxic disclosure is restricted by statute. protection from disclosure concurrent
Substances Control Act (TSCA). EPA is Certain other material, such as with submission of the information in
announcing an interpretation of TSCA copyrighted material, will be publicly accordance with existing or future rules.
section 14 concerning confidential available only in hard copy. Publicly TSCA section 14(c)(3) in turn requires
business information (CBI) claims for available docket materials are available an affected business submitting a claim
information submitted to EPA. EPA electronically at http:// to protect information from disclosure
interprets the revised TSCA section www.regulations.gov, or, if only to substantiate the claim, also in
14(c)(3) as requiring substantiation of available in hard copy, at the OPPT accordance with existing or future rules.
non-exempt CBI claims at the time the Docket. The OPPT Docket is located in The language of TSCA section 14(c)(3)
information claimed as CBI is submitted the EPA Docket Center (EPA/DC) at Rm. is as follows:
to EPA. 3334, EPA West Bldg., 1301
‘‘(3) Substantiation requirements. Except as
FOR FURTHER INFORMATION CONTACT: Constitution Ave. NW., Washington, provided in paragraph (2), a person asserting
For general information contact: DC. The EPA/DC Public Reading Room a claim to protect information from
Colby Lintner, Regulatory Coordinator, hours of operation are 8:30 a.m. to 4:30
mstockstill on DSK3G9T082PROD with NOTICES
disclosure under this section shall
Environmental Assistance Division p.m., Monday through Friday, excluding substantiate the claim, in accordance with
(7408M), Office of Pollution Prevention legal holidays. The telephone number of such rules as the Administrator has
and Toxics, Environmental Protection the EPA/DC Public Reading Room is promulgated or may promulgate pursuant to
Agency, 1200 Pennsylvania Ave. NW., (202) 566–1744, and the telephone this section.’’
Washington, DC 20460–0001; telephone number for the OPPT Docket is (202) EPA interprets TSCA section 14(c)(3)
number: (202) 554–1404; email address: 566–0280. Docket visitors are required to require substantiation for all TSCA
TSCA-Hotline@epa.gov. to show photographic identification, CBI claims, except for information
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![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6523
within TSCA section 14(c)(2). That is The first reading does not effectuate requirement newly added by the
the clear import of the language, ‘‘a the legislative intent to require Lautenberg amendments—provides that
person asserting a claim to protect substantiation. In addition, the a claimant ‘‘shall certify that the
information from disclosure under provision is not worded as a mere grant statement required to assert a
this section shall substantiate the of authority. Numerous other provisions [confidentiality] claim . . . . and any
claim . . .’’ While the final clause of TSCA—both of the pre-amended information required to substantiate a
requires that submissions be in statute and of the Lautenberg claim . . . . are true and correct.’’
accordance with EPA rules, EPA amendments—demonstrate that While this provision does not explicitly
interprets this provision as addressing Congress used more straightforward state that the certification must
the form and manner of a submission, language when it intended simply to accompany the submission, it is
not as making the substantiation grant EPA rulemaking or other authority reasonable to conclude that Congress
requirement conditional upon a future (e.g., TSCA section 14(f)(1) (‘‘The intended that result. Moreover, a
EPA rulemaking. In the future, EPA may Administrator may require any person requirement to substantiate CBI claims
promulgate regulations governing the . . . to reassert and substantiate or re- at some unspecified time would not
form and manner of substantiating CBI substantiate’’ an existing claim under create any meaningful self-executing
claims for those submissions addressed certain circumstances); TSCA section requirement, because there would be no
by this action. Nonetheless, EPA 4(a)(2) (‘‘The Administrator may, by point in time at which an affected
considers the statutory substantiation rule, order, or consent agreement . . . . business could be found not to have
requirement to be in place as of the require the development of new complied.
effective date of this action. information’’). Finally, TSCA section Reading the law as requiring
EPA’s interpretation is supported by 14(c)(1) already authorizes EPA to substantiation concurrent with the CBI
legislative history for the recent promulgate rules governing the claim also comports with the legislative
amendments to TSCA. Both the Senate assertion of CBI claims. This paragraph history. In addition to the history cited
and House intended to require provides authority for EPA to earlier in this document, the Senate
substantiation of CBI claims. See S. Rpt. promulgate rules requiring Report, on p. 5, noted stakeholder
114–67 (observing, on page 5, that substantiation, and EPA in fact concerns that, under pre-amendment
‘‘section 14 [of pre-amendment TSCA] promulgated a number of rules requiring TSCA, the lack of a requirement for up-
and EPA’s implementation of it has substantiation under similarly worded front substantiation resulted in ‘‘an
authority in pre-amendment TSCA over-abundance of CBI claims, some of
been criticized for failing to require
section 14(c)(1). See, e.g., 40 CFR which may not be legitimate.’’
. . . . up-front substantiation of
711.30(b)(1), requiring up-front Interpreting TSCA section 14(c)(3) as
confidentiality claims,’’ and, on page 22,
substantiation for chemical identity requiring substantiation of a CBI claim
stating that, under the Senate bill, ‘‘all
claims for Chemical Data Reporting concurrent with the claim’s submission
new claims for protection of information
under part 711. To interpret TSCA best effectuates the expressed intent of
not presumed to be protected from
section 14(c)(3) as merely providing Congress.
disclosure must be substantiated by the This interpretation is consistent with
authority to require substantiation,
claimant’’); H. Rpt. 114–176 at 29 (a the requirement in TSCA section
where that authority already exists in
confidentiality claim must ‘‘include 14(g)(1) that EPA review most
TSCA section 14(c)(1), would arguably
. . . . a justification for each claim of confidentiality claims for chemical
give TSCA section 14(c)(3) no effect at
confidentiality’’); Senate Environment identity and at least 25% of claims for
all.
and Public Works Committee summary: The second reading amounts to a other types of non-exempt information
‘‘Reforming the Toxic Substances revision of the legislative text. TSCA within 90 days after the receipt of the
Control Act’’ at 3 (http:// section 14(c)(3) does not require EPA to claim. An approach under which
www.epw.senate.gov/public/_cache/ undertake rulemaking; it merely substantiations were submitted at some
files/aa2ac4d1-15bb-4e71-9588- acknowledges that EPA ‘‘may’’ do so. point after assertion of CBI claims
909d49bdcff2/tsca-reform-marketing- Unless this ‘‘may’’ were read as ‘‘shall’’, would significantly reduce (and has
packet-5.19-final.pdf). (‘‘The legislation EPA would be under no obligation to already significantly reduced) the short
promotes additional transparency by promulgate the rules required to carry period for such CBI reviews. To date, for
requiring up-front substantiation of out the objective of requiring each review, the Agency must contact
claims to protect confidential substantiation. Here again, numerous each affected business, request the
commercial information. . . .’’) EPA’s other provisions of TSCA demonstrate submission of a substantiation, and
interpretation also is supported by that Congress used clear language—and allow a period of time for the affected
TSCA section 14(i)(2), which provides included deadlines—when it intended business to submit the substantiation.
that, ‘‘nothing in this chapter’’ prevents to require EPA to promulgate Since timely substantiation provides
EPA from requiring substantiation regulations (e.g., TSCA section critical information for completing CBI
before the effective date of rules that 6(b)(1)(A)(‘‘Not later than 1 year after reviews, it is reasonable to conclude
may be promulgated after June 22, 2016, June 22, 2016, the Administrator shall that Congress intended for claims to be
the date on which the amendments to establish, by rule, a risk-based screening substantiated at the time the CBI claim
TSCA were enacted. process. . . .’’). is asserted.
It might be maintained that TSCA Having determined that TSCA section When the amendments to TSCA
section 14(c)(3) does not impose a 14(c)(3) requires substantiation of all became law on June 22, 2016, EPA
substantiation requirement, but merely non-exempt TSCA CBI claims, EPA published initial Questions and
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authorizes EPA to promulgate rules believes the provision is best interpreted Answers (Q and A’s) in an effort to
requiring substantiation. Alternatively, as requiring substantiation concurrent respond to the inquiries and requests
it might be maintained that the section with the submission. This is the natural concerning EPA’s views on the new law.
does impose a substantiation reading of the requirement that ‘‘a EPA needed to issue guidance to the
requirement, but that the requirement person asserting a claim . . . . shall public as quickly as possible on a broad
must be effectuated through EPA substantiate the claim.’’ By analogy, range of matters under the amendments,
rulemaking. TSCA section 14(c)(5)—another since the amendments became effective
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![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6525
Courier Deliveries should be directed ADDRESSES: EPA has established a regulations on January 9, 2009.1 EPA
to: docket for this Notice of Decision under also granted a within-the-scope
U.S. EPA, Office of Pollution Docket ID EPA–HQ–OAR–2015–0224. authorization for amendments to the
Prevention and Toxics, Confidential All documents relied upon in making TRU regulations, adopted in 2010, on
Business Information Center (CBIC), this decision, including those submitted June 28, 2013.2 The TRU regulations
Attn: TSCA CBI Substantiations. 1201 to EPA by CARB, are contained in the establish in-use performance standards
Constitution Avenue NW., WJC East; public docket. Publicly available docket for diesel-fueled TRUs and TRU
Room 6428 Washington, DC 20004– materials are available either generator sets which operate in
3302, (202) 564–8930. electronically through California, and facilities where TRUs
More information on how to www.regulations.gov or in hard copy at operate. The TRU regulations are
substantiate CBI claims for paper the Air and Radiation Docket in the EPA contained in an Airborne Toxic Control
submissions can be found at https:// Headquarters Library, EPA West Measure (‘‘ATCM’’) adopted by CARB to
www.epa.gov/tsca-cbi/. Building, Room 3334, located at 1301 reduce the general public’s exposure to
Authority: 15 U.S.C. 2601 et seq. Constitution Avenue NW., Washington, diesel particulate matter (‘‘PM’’), other
DC. The Public Reading Room is open toxic airborne contaminants and air
Dated: January 13, 2017. from 8:30 a.m. to 4:30 p.m.; Monday pollutants generated by TRUs and
James J. Jones, through Friday, excluding legal reduce near source risk at facilities
Assistant Administrator, Office of Chemical holidays. The telephone number for the where TRUs congregate. TRUs are
Safety and Pollution Prevention. Reading Room is (202) 566–1744. The refrigeration systems powered by
[FR Doc. 2017–01235 Filed 1–18–17; 8:45 am] Air and Radiation Docket and internal combustion engines which
BILLING CODE 6560–50–P Information Center’s Web site is http:// control the environment of temperature-
www.epa.gov/oar/docket.html. The sensitive products that are transported
email address for the Air and Radiation in semi-trailer vans, truck vans, ‘‘reefer’’
ENVIRONMENTAL PROTECTION Docket is: a-and-r-Docket@epa.gov, the railcars or shipping containers. The
AGENCY telephone number is (202) 566–1742, engines in TRUs do not propel the
and the fax number is (202) 566–9744. vehicle, but are used strictly to power
[EPA–HQ–OAR–2013–0024; FRL–9958–64– An electronic version of the public the refrigeration system. These TRU
OAR] docket is available through the federal engines are nonroad engines and vary in
government’s electronic public docket horsepower (‘‘hp’’) generally from 7 hp
California State Nonroad Engine to 36 hp.
and comment system. You may access
Pollution Control Standards; In-Use By letter dated March 2, 2015, CARB
EPA dockets at http://
Diesel-Fueled Transport Refrigeration submitted a request to EPA for
www.regulations.gov. After opening the
Units (TRUs) and TRU Generator Sets authorization of amendments to its TRU
www.regulations.gov Web site, enter
and Facilities Where TRUs Operate; regulations 3 pursuant to section 209(e)
EPA–HQ–OAR–2015–0224 in the ‘‘Enter
Notice of Decision of the CAA.4 The 2011 TRU
Keyword or ID’’ fill-in box to view
documents in the record. Although a Amendments were adopted by CARB on
AGENCY: Environmental Protection
part of the official docket, the public October 21, 2011, and became operative
Agency (EPA).
docket does not include Confidential state law on October 15, 2012.5 The
ACTION: Notice of decision. 2011 TRU Amendments provide owners
Business Information (‘‘CBI’’) or other
of 2001 through 2003 model year (MY)
SUMMARY: The Environmental Protection information whose disclosure is
TRU engines that complied with
Agency (‘‘EPA’’) is granting the restricted by statute.
applicable Low-Emission TRU
California Air Resources Board EPA’s Office of Transportation and (‘‘LETRU’’) in-use performance
(‘‘CARB’’) request for authorization of Air Quality (‘‘OTAQ’’) maintains a Web standards by specified compliance
amendments to its Airborne Toxic page that contains general information deadlines a one- or two-year extension
Control Measure for In-Use Diesel- on its review of California waiver and from the more stringent Ultra-Low
Fueled Transport Refrigeration Units authorization requests. Included on that Emission (‘‘ULETRU’’) in-use
(‘‘TRU’’) and TRU Generator Sets and page are links to prior waiver Federal performance standards. The
Facilities Where TRUs Operate (together Register notices, some of which are amendments also clarify manual
‘‘2011 TRU Amendments’’). EPA’s cited in today’s notice; the page can be recordkeeping requirements for electric
decision also confirms that certain of accessed at http://www.epa.gov/otaq/ standby-equipped TRUs and ultimately
the 2011 TRU amendments are within cafr.htm. require automated electronic tracking
the scope of prior EPA authorizations. system requirements for such TRUs and
The 2011 TRU Amendments primarily FOR FURTHER INFORMATION CONTACT: establish requirements for businesses
provide owners of TRU engines with David Dickinson, Attorney-Advisor, that arrange, hire, contract, or dispatch
certain flexibilities; clarify Transportation and Climate Division, the transport of goods in TRU-equipped
recordkeeping requirements for certain Office of Transportation and Air trucks, trailers or containers. A more
types of TRU engines; establish Quality, U.S. Environmental Protection
requirements for businesses that Agency, 1200 Pennsylvania Ave. NW., 1 74 FR 3030 (January 16, 2009).
arrange, hire, contract, or dispatch the (6405J), Washington, DC 20460. 2 78 FR 38970 (June 28, 2013).
transport of goods in TRU-equipped Telephone: (202) 343–9256. Fax: (202) 3 13 California Code of Regulations (CCR),
trucks, trailers, or containers; and 343–2804. Email: dickinson.david@ sections 2111, 2112, Appendix A therein, 2139,
mstockstill on DSK3G9T082PROD with NOTICES
address other issues that arose during 2147, 2440, 2441, 2442, 2443.1, 2443.2, 2443.3,
epa.gov. 2444.1, 2444.2, 2445.1, 2445.2, 2447, 2474 and
the initial implementation of the 2448.
regulation. This decision is issued SUPPLEMENTARY INFORMATION: 4 ‘‘Clean Air Act § 209(e)(2) Authorization
under the authority of the Clean Air Act I. Background Support Document submitted by the California Air
(‘‘CAA’’ or ‘‘Act’’). Resources Board, March 2, 2015,’’ at EPA–HQ–
OAR–2015–0224–0002 (Authorization Support
DATES: Petitions for review must be filed EPA granted an authorization for Document).
by March 20, 2017. California’s initial set of TRU 5 Id., Attachment 13.
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Document Created: 2018-02-01 15:16:14
Document Modified: 2018-02-01 15:16:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This action is effective on March 20, 2017. | |
| Contact | For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: | |
| FR Citation | 82 FR 6522 |
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