TSCA Inventory Notification (Active-Inactive) Requirements, 37520-37544 [2017-15736]

Download as PDF asabaliauskas on DSKBBXCHB2PROD with RULES 37520 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations (b) Regulations: (1) In the RNAs under paragraph (a) of this section, the District Commander or respective COTP may issue orders to control vessel traffic for reasons which include but are not limited to: Channel obstructions, winter navigation, unusual weather conditions, or unusual water levels. Prior to issuing these orders, the District Commander or respective COTP will provide advance notice as reasonably practicable under the circumstances. The respective COTP may close and open these regulated navigation areas as ice conditions dictate. (2) Prior to the closing or opening of the regulated navigation areas, the COTP will give interested parties, including both shipping interests and island residents, not less than 72 hours notice of the action. This notice will be given through Broadcast Notice to Mariners, Local Notice to Mariners, and press releases to the media (radio, print and television), local COTP will ensure widest dissemination. No vessel may navigate in a regulated navigation area which has been closed by the COTP. The general regulations in 33 CFR 165.13 apply. The District Commander or respective COTP retains the discretion to authorize vessels to operate outside of issued orders. (c) The following are safety zones: (1) Lake Erie. The area known as the Lake Erie Islands which is defined as the U.S. waters of Lake Erie at the intersection of the International Border at 082°55′00″ W., following the International Border eastward to the intersection of the International Border at 082°35′00″ W., moving straight south to position 41°25′00″ N., 082°35′00″ W., continuing west to position 41°25′00″ N., 082°55′00″ W., and ending north at the International Border and 082°55′00″ W. (2) Lake Huron. The waters of Lake Huron known as Saginaw Bay, Michigan; bounded by a line from Port Austin Reef Light (LL–10275) at 44°04′55″ N., 082°58′57″ W.; to Tawas Light (LL–11240) at 44°15′13″ N., 083°26′58″ W.; to Saginaw Bay Range Front Light (LL–10550) at 43°38′54″ N., 083°51′06″ W.; then to the point of beginning. (d) Enforcement: (1) The District Commander or respective Captain of the Port (COTP) will enforce these safety zones as ice conditions dictate. Under normal seasonal conditions, only one closing each winter and one opening each spring are anticipated. (2) Prior to closing or opening these safety zones, the District Commander or respective COTP will give the public VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 advance notice, not less than 72 hours prior to the closure. This notice will be given through Broadcast Notice to Mariners, Local Notice to Mariners, and press releases to the media (radio, print and television), and the local COTP will ensure widest dissemination. The general regulations in 33 CFR 165.23 apply. The District Commander or respective COTP retains the discretion to permit vessels to enter/transit a closed safety zone under certain circumstances. Dated: June 12, 2017. J.E. Ryan, Commander, RADM, U.S. Coast Guard, Ninth Coast Guard District. [FR Doc. 2017–16997 Filed 8–10–17; 8:45 am] BILLING CODE 9110–04–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG–2017–0259] Safety Zone; Cleveland National Air Show, Cleveland, OH Coast Guard, DHS. Notice of enforcement of regulation. AGENCY: ACTION: The Coast Guard will enforce a safety zone for the Cleveland National Air Show, Lake Erie and the Cleveland Harbor, Cleveland, OH from 8:00 a.m. until 6:00 p.m. each day from August 31, 2017 through September 4, 2017. This action is necessary to provide for the safety of life and property on navigable waters during this event. During the enforcement period, no person or vessel may enter the respective safety zone without the permission of the Captain of the Port Buffalo. DATES: The regulation in 33 CFR 165.939(a)(35) will be enforced from 8:00 a.m. through 6:00 p.m., each day from August 31, 2017, through September 4, 2017. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice of enforcement, call or email LT Ryan Junod, Chief of Waterways Management, U.S. Coast Guard; telephone 216–937– 0124, email ryan.s.junod@uscg.mil. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety Zones; Annual Events in the Captain of the Port Buffalo Zone listed in 33 CFR 165.939(a)(35) for the Cleveland National Air Show, Cleveland, OH from 8:00 a.m. to 6:00 p.m. each day from SUMMARY: PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 August 31, 2017 through September 4, 2017. This action is being taken to provide for the safety of life and property on navigable waters during this event. Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within these safety zones during an enforcement period is prohibited unless authorized by the Captain of the Port Buffalo or his designated representative. Those seeking permission to enter one of these safety zones may request permission from the Captain of Port Buffalo via channel 16, VHF–FM. Vessels and persons granted permission to enter this safety zone shall obey the directions of the Captain of the Port Buffalo or his designated representative. While within the safety zone, all vessels shall operate at the minimum speed necessary to maintain a safe course. This notice of enforcement is issued under authority of 33 CFR 165.939 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of these enforcement periods via Broadcast Notice to Mariners and Local Notice to Mariners. If the Captain of the Port Buffalo determines that this safety zone need not be enforced for the full duration stated in this notice; he or she may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone. Dated: August 7, 2017. Joseph S. Dufresne, Captain, U. S. Coast Guard, Captain of the Port Buffalo. [FR Doc. 2017–16973 Filed 8–10–17; 8:45 am] BILLING CODE 9110–04–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 710 [EPA–HQ–OPPT–2016–0426; FRL–9964–22] RIN 2070–AK24 TSCA Inventory Notification (ActiveInactive) Requirements Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: The 2016 amendments to the Toxic Substances Control Act (TSCA) require EPA to designate chemical substances on the TSCA Chemical Substance Inventory as either ‘‘active’’ or ‘‘inactive’’ in U.S. commerce. To accomplish that, EPA is establishing a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured SUMMARY: E:\FR\FM\11AUR1.SGM 11AUR1 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations (including imported) for nonexempt commercial purposes during the 10-year time period ending on June 21, 2016, with provision to also allow notification by processors. EPA will use these notifications to distinguish active substances from inactive substances. EPA will include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory. EPA is also establishing procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for nonexempt commercial purposes is expected to resume. On receiving forward-looking notification, EPA will change the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active. EPA is establishing the procedures regarding the manner in which such retrospective and forwardlooking activity notifications must be submitted, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality. This final rule is effective on August 11, 2017. DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPPT–2016–0426, is available electronically at http:// www.regulations.gov or in person at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. ADDRESSES: For technical information contact: Myrta R. Christian, Chemistry, Economics, and Sustainable Strategies Division (Mailcode 7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (202) 564–8498; email address: christian.myrta@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– asabaliauskas on DSKBBXCHB2PROD with RULES FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. Executive Summary A. Who does this action apply to? You may be affected by this action if you domestically manufactured, imported, or processed a chemical substance listed on the TSCA Chemical Substance Inventory for nonexempt commercial purpose during the 10-year time period ending on June 21, 2016. You may also be affected by this action if you intend to domestically manufacture, import, or process in the future a chemical substance listed on the TSCA Chemical Substance Inventory. The following North American Industrial Classification System (NAICS) codes are not intended to be exhaustive, but rather provides a guide to help readers determine whether this action may apply to them: • Chemical manufacturing or processing (NAICS code 325). • Petroleum and Coal Products Manufacturing (NAICS code 324). In addition, the discussion in Unit II.A. describes in more detail which chemical substances will and will not be subject to reporting under this action. You may also consult the regulatory text in this document for further information on the applicability of exemptions to this rule. Note that TSCA’s statutory definition of ‘‘manufacture’’ includes importing. Accordingly, the regulatory definition of ‘‘manufacture’’ for this rule includes importation. Since ‘‘manufacture’’ is itself defined (in this rule and in TSCA) to include ‘‘import,’’ it is clear that importers are a subset of manufacturers. All references to manufacturing in this notice should be understood to also encompass importing. Where EPA’s intent is to specifically refer to domestic manufacturing or importing (both activities constitute ‘‘manufacture’’), this rule will do so expressly. B. What action is the Agency taking? On January 13, 2017 (82 FR 4255, FRL–9956–28) (Ref. 1), EPA proposed procedural reporting requirements for persons who manufactured (including imported) in the past or intend to manufacture in the future chemical substances on the TSCA Inventory (hereafter referred to as the ‘‘Inventory’’). EPA received numerous public comments on the proposed rule. This final rule is based on that proposal and the consideration of the public comments received. PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 37521 This TSCA section 8(b) rule requires electronic reporting of chemical identity from persons who manufactured a chemical substance for nonexempt commercial purpose during the 10-year time period ending on June 21, 2016. EPA will accept notices for substances that were processed during the same ten-year time period. EPA will use the chemical identity information obtained from this retrospective reporting to designate as active those substances on the Inventory for which notices were received. If no notice is received during this retrospective reporting for a substance subject to designation on the Inventory, then that substance will be designated as inactive. This rule also requires electronic reporting of certain information from persons who in the future intend to manufacture or process an inactive substance on the Inventory for nonexempt commercial purpose. The information to be reported includes chemical identity and the date when manufacturing or processing is anticipated to resume. Upon receipt of such notices, EPA will change the designation on the Inventory from inactive to active. This rule includes procedures for persons who co-manufacture or coprocess a reportable chemical substance. These procedures will allow the submission of a single commercial activity notice where there has been comanufacturing or co-processing of a particular volume of a substance. These procedures are similar to TSCA Chemical Data Reporting (CDR) rule requirements (40 CFR 711.22) when two or more persons are involved in a particular manufacture or import transaction. This rule also includes a simplified procedure for filing a submission, including when specific chemical identity information is claimed to be confidential business information (CBI) by a supplier, and finalizes the proposed procedure for filing a joint submission. See response to Comment 14 in Unit III. EPA expanded its electronic reporting system to include a pick list from which persons can select chemicals for reporting. The pick list will include only reportable chemical substances and will not include CBI. Substances that are on the confidential portion of the Inventory will be listed on the pick list by EPA accession numbers and generic names, as they appear on public versions of the Inventory. In cases where specific chemical identity is claimed CBI by a supplier, a submitter can provide a single notice to EPA for a CBI substance if it has in its possession the E:\FR\FM\11AUR1.SGM 11AUR1 37522 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations asabaliauskas on DSKBBXCHB2PROD with RULES corresponding non-CBI chemical identifiers (EPA accession number and generic name). If a manufacturer or processor cannot provide the specific chemical identity of a reportable chemical substance to EPA because the information is claimed CBI by a supplier, and therefore is unknown to the importer, the submitter will be required to ask the supplier to provide the CBI chemical identity information directly to the Agency in a joint submission. EPA will only accept joint submissions that are submitted electronically using CDX. This requirement is similar to CDR rule requirements (40 CFR 711.15) and will allow EPA to obtain the information necessary to identify the specific chemical identity of a reportable substance and designate it as active on the Inventory. This rule also finalizes proposed changes to 40 CFR 710.3 definitions. These changes were proposed to conform the definitions applicable to these reporting requirements with those that apply to CDR rule requirements (definitions found at 40 CFR 704.3 and 711.3) and the submission of Premanufacture Notices (PMNs) (definitions found at 40 CFR 720.3). Finally, this rule finalizes recordkeeping requirements as required by TSCA section 8(b)(9)(B). Records relevant to retrospective notification must be retained for a period of 5 years beginning on the last day of the submission period. Records relevant to forward-looking notification must be retained for a period of 5 years beginning on the day that the notice was submitted. C. Why is the Agency taking this action? TSCA section 8(b)(4)(A) requires EPA to issue a final rule for retrospective reporting by June 22, 2017. This rule will enable EPA to fulfill a statutory obligation to designate chemical substances on the Inventory as active or inactive in U.S. commerce. TSCA section 8(b)(5)(B) further establishes a forward-looking reporting requirement that goes into effect as soon as EPA designates inactive substances. This rule also establishes the procedural framework whereby manufacturers and processors will discharge their notice obligations under this section of TSCA. This rule and designations under the rule are not intended to indicate conclusions about the risks of chemical substances on the Inventory. Nonetheless, the designation of a substance as active or inactive will be relevant to the Agency’s prioritization of substances in U.S. commerce under TSCA section 6(b). VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 D. What is the Agency’s authority for taking this action? EPA is issuing this rule under TSCA section 8(b), 15 U.S.C. 2607(b). TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law 114–182. The Government Paperwork Elimination Act (GPEA), 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. Under section 553(d) of the Administrative Procedure Act, 5 U.S.C. 553(d), the Agency may make a rule immediately effective ‘‘for good cause found and published with the rule.’’ EPA finds that there is ‘‘good cause’’ to make this rule effective upon publication in the Federal Register because the deadline for manufacturers to submit retrospective reports under this rule is fixed by statute at ‘‘180 days after the date on which the final rule is published in the Federal Register.’’ TSCA section 8(b)(4)(A)(i). Because the submission deadline is tied by statute to the date of the rule’s publication, rather than the effective date of the rule, delaying the effective date of this rule would not afford any additional time for manufacturers to comply with reporting requirements. Rather, delaying the effective date of the rule would push back the start of the submission period for retrospective reporting, but not the end of the submission period (which remains fixed by statute), leaving manufacturers with a shorter period (less than 180 days) during which notices may be submitted. Thus, any impact on the regulated community of making the rule immediately effective is expected to be beneficial, given that an immediate effective date provides manufacturers with the greatest possible timing discretion regarding when to submit retrospective reports. E. What are the estimated incremental impacts of this action? EPA has reevaluated the potential costs of establishing the reporting requirements for manufacturers and processors in response to comments received. This analysis, which is available in the docket, is discussed in Unit V. and briefly summarized here (Ref. 2). During the retrospective (or ‘‘startup’’) period, between approximately June 2017 and June 2018, typical costs per firm are estimated at $1,188 per submission (with an estimated eighteen chemicals per submission), with possible additional costs at $41.55 per CDX registration in the event that the PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 submitter is not currently registered in CDX. Among manufacturers, an estimated 5,322 firms will undertake rule familiarization with 1,585 completing compliance determination, form completion, and recordkeeping. For manufacturers, the total burden during start-up is estimated at 38,613 hours with an associated total cost of $3.09 million. For processors, an estimated 283,993 firms will undertake rule familiarization, with 100 completing compliance determination, form completion, and recordkeeping. For processors completing rule familiarization only, the cost entails 3.30 hours on average per firm (under $300 per firm). For processors who complete a submission, typically involving one chemical, the burden for rule familiarization, compliance determination, form completion and recordkeeping during the start-up year is estimated at 500 hours with an associated cost of $0.04 million. Lastly, for 169 new CDX registrations (for individuals lacking previous experience with electronic reporting to EPA), burden during start-up is estimated at 90 hours with an associated cost of $0.007 million. The rule has minimal burden and cost implications related to ongoing reporting with the typical cost per firm estimated at $889 per submission after the start-up year. The forward-looking (or ‘‘ongoing’’) reporting after June 2018 involves compliance determination, form completion, and recordkeeping for twenty manufacturers and/or processors per year. Burden and cost are estimated to total 225 burden hours per year with an associated cost of $17,779 per year. Agency activities due to the rule include CDX and Chemical Information Submission System (CISS) capacity expansions, time to manage commercial activity notices, and increased costs incurred when making revisions to the Inventory. Associated costs are estimated at $3.62 million during startup, and $0.22 million annually thereafter. Combining Industry and Agency cost estimates, and annualizing over a 10year period, the total cost of the rule is estimated at $9.7 million per year using a 3% discount rate, and at $11.8 million per year using a 7% discount rate. II. Summary of the Final Rule EPA is describing in this unit the reporting requirements for manufacturers and processors of chemical substances pursuant to TSCA section 8(b). EPA developed two versions of a Notice of Activity (NOA) reporting form for submitting the information described in this rule for E:\FR\FM\11AUR1.SGM 11AUR1 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations asabaliauskas on DSKBBXCHB2PROD with RULES the two reporting scenarios, retrospective and forward-looking (Ref. 3). The Notice of Activity Form A (EPA Form No. TBD–1) will be used for retrospective reporting, and the Notice of Activity Form B (EPA Form No. TBD– 2) will be used for forward-looking reporting. EPA intends that the provisions of this rule be severable. In the event that any individual provision or part of the rule is invalidated, EPA intends that this would not render the entire rule invalid, and that any individual provisions that can continue to operate will be left in place. A. What chemical substances and activities are reportable under this rule? 1. Reportable chemical substances. The retrospective reporting requirements of this rule apply to chemical substances listed on the Inventory that were manufactured for nonexempt commercial purposes during the 10-year period ending on June 21, 2016. This 10-year period, referred to here as the ‘‘lookback period,’’ is set by statute. The forward-looking reporting requirements apply to substances listed as inactive on the Inventory that are to be reintroduced into U.S. commerce for nonexempt purposes. The Inventory is available at https://www.epa.gov/tscainventory. 2. Exemptions from reporting. i. Excluded chemical substances. The scope of chemical substances covered under this rule is reflected in the definitions of ‘‘chemical substance subject to commercial activity designation,’’ and ‘‘reportable chemical substance,’’ at 40 CFR 710.23, which exclude substances that are not chemical substances and substances that are not listed on the Inventory. For example, a substance that is not considered a ‘‘chemical substance’’ (as provided in subsection 3(2)(B) of TSCA and in the definition of ‘‘chemical substance’’ in 40 CFR 710.3(d)) is not a ‘‘chemical substance subject to commercial activity designation’’ or a ‘‘reportable chemical substance’’ and it thus cannot become an ‘‘active substance’’ or an ‘‘inactive substance.’’ A similar analysis applies with respect to a mixture (as defined in 40 CFR 710.3(d)), although individual Inventory-listed substances present in the mixture may be subject to reporting. Additionally, a substance that has not been added to the Inventory because it is manufactured solely under a TSCA section 5(h) exemption (e.g., low releases and low exposures exemption, low volume exemption, polymer exemption, research and development exemption, test marketing exemption) is VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 not a ‘‘chemical substance subject to commercial activity designation’’ or a ‘‘reportable chemical substance’’ and it cannot become an ‘‘active substance’’ or an ‘‘inactive substance.’’ See response to Comment 1 in Unit III. Naturally occurring chemical substances also are excluded from reporting under this rule, as long as the manufacturing and processing of such substances meet the criteria set forth in 40 CFR 710.27(b). Naturally occurring substances are considered to be automatically included on the Inventory as the category ‘‘Naturally Occurring Chemical Substances’’ (42 FR 64578). EPA is designating the whole category of Naturally Occurring Chemical Substances as active substances by this rule, thereby excluding them from reporting under this rule. ii. Manufacturing or processing for an exempt commercial purpose. Manufacturing or processing a chemical substance listed on the Inventory solely for an exempt commercial purpose is not subject to reporting requirements under TSCA section 8(b)(4) or 8(b)(5). The statute limits these notification obligations to manufacturing and processing for ‘‘nonexempt commercial purpose.’’ The scope of manufacturing or processing for an exempt commercial purpose is set forth in 40 CFR 710.27(a). While EPA expects that many chemical substances manufactured or processed for exempt commercial purposes will not be listed on the Inventory (due to similar exemptions under PMN regulations), and therefore are already excluded from reporting under this rule, the activity exemptions listed at 40 CFR 710.27(a) clarify circumstances under which a person is exempt from reporting requirements for the manufacturing or processing of a chemical substance that has been listed on the Inventory (e.g., due to another manufacturer’s actions). For example, the manufacturing or processing of impurities or byproducts that have no subsequent commercial purpose will not trigger reporting obligations under this rule. See 40 CFR 710.27(a)(3). Additionally, manufacturing or processing in small quantities solely for research and development is exempt as described in 40 CFR 710.3(d) and 40 CFR 710.27(a)(1). Furthermore, the import or processing of substances solely as part of articles is not subject to reporting under this rule. See 40 CFR 710.27(a)(2) and response to Comment 2 in Unit III. In response to comments, EPA revised the rule to clarify that manufacturing or processing a chemical substance solely for export from the United States or for test marketing purposes are also exempt commercial PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 37523 purposes not subject to reporting requirements under this rule. See 40 CFR 710.27(a)(4) and (5) and response to Comment 1 in Unit III. iii. Chemical substances for which EPA already has an equivalent notice. EPA is establishing an exemption from the retrospective reporting requirement for three different circumstances in which EPA has already received equivalent notice that a chemical substance was manufactured during the lookback period, and further requirement to submit a notice would therefore be inconsistent with TSCA section 8(a)(5)(B). First, chemical substances that are on the interim list of active substances described in TSCA section 8(b)(6) will be designated as active substances, by operation of this rule, and they are exempted from retrospective notification requirements under this rule. The interim list will be available on the TSCA Inventory Web page (see https://www.epa.gov/tsca-inventory), and is comprised of all chemical substances reported in 2012 or 2016 under the CDR rule, 40 CFR part 711. See 82 FR 4259. A CDR notice from 2012 or 2016 provides equivalent notice to EPA that the substance was manufactured during the lookback period. In response to comments, this exemption now applies irrespective of whether the substance is on the confidential portion of the Inventory. See 40 CFR 710.23 for revised definition of ‘‘interim active substance’’ and response to Comment 3 in Unit III. Second, chemical substances that were added to the Inventory during the ten-year time period ending on June 21, 2016, pursuant to a Notice of Commencement (NOC) under 40 CFR 720.102 received by the Agency between June 21, 2006 and June 21, 2016, will be designated as active substances, by operation of this rule, and they are exempted from retrospective notification requirements under this rule. An NOC is required to be submitted on or no later than 30 calendar days after the first day of manufacture for commercial purpose. Additionally, an NOC substance is considered to be added to the Inventory on the date the NOC is received by EPA, provided that the EPA determines the NOC to be valid during its review. Therefore, a processed NOC provides equivalent notice that the substance was manufactured or processed during the lookback period. This exemption applies irrespective of whether the substance is on the confidential portion of the Inventory. See 40 CFR 710.23 for revised definitions of ‘‘active substance,’’ ‘‘chemical substance subject E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37524 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations to commercial activity designation,’’ and response to Comment 4 in Unit III. Third, a manufacturer is exempt from the retrospective notification requirements under this rule, for a particular chemical substance, if the manufacturer has evidence in the form of a CDX receipt, documenting EPA’s receipt of an NOA Form A from another manufacturer. See 40 CFR 710.25(a) and response to Comment 6 in Unit III. Manufacturers should keep in mind, however, that they bear the risk of failing to submit a required forwardlooking notification (NOA Form B) notice if they rely on this Form A exemption, and the Form A notice (for which they have a CDX receipt) is later withdrawn, leading to the substance being designated as inactive. Furthermore, one manufacturer’s expectation that another manufacturer will later submit an NOA Form A is not an acceptable basis for relying on this exemption. Since it is only submitters who will be notified of errors, manufacturers relying on the exemption are responsible for assuring their substance is designated as commercially active. iv. Inapplicability of exemptions to persons seeking to maintain an existing CBI claim for specific chemical identity. Persons who manufactured or processed a chemical substance on the confidential portion of the Inventory, that was added to the Inventory prior to June 22, 2016, should recognize that they must submit an NOA Form A to EPA if they wish to indicate that they ‘‘seek to maintain an existing claim for protection against disclosure of the specific chemical identity of the substance as confidential.’’ See TSCA 8(b)(4)(B)(ii) and response to Comment 3 in Unit III. This includes persons that, during the lookback period, manufactured or processed a confidential substance on the Inventory for which EPA already has an equivalent notice (as described in paragraph A.2.iii. of this Unit). It may also potentially include persons that, during the lookback period, manufactured or processed a confidential substance on the Inventory for an exempt commercial purpose (as described in paragraph A.2.ii. of this Unit), if such substance is designated active due, for instance, to EPA’s receipt of an equivalent notice (such as an NOC or CDR report). In connection with extending manufacturers’ reporting exemptions to cover substances on the confidential portion of the Inventory, EPA has revised 40 CFR 710.25(b) to clarify manufacturers’ and processors’ discretion to report. If manufacturers elect not to submit a notice because they VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 are availing themselves of one of the exemptions described previously, then they are foregoing their opportunity to maintain an existing claim for protection against disclosure of the specific chemical identity of the substance as confidential. EPA is required, by statute, to move from the confidential to the public portion of the Inventory any active chemical substance for which no request is received to maintain an existing CBI claim for chemical identity. See TSCA section 8(b)(4)(B)(iv) and 40 CFR 710.37(a). 3. Chemical substances added to the Inventory on or after June 22, 2016. Chemical substances added to the Inventory on or after June 22, 2016 will be designated as active, by operation of this rule. Such substances are not subject to reporting under this rule. Furthermore, such substances are beyond the scope of the CBI claim maintenance provision under TSCA section 8(b)(4)(B)(ii). This CBI maintenance provision is intended to address ‘‘existing claim[s] for protection against disclosure of the specific chemical identity.’’ EPA interprets this to be a reference to CBI claims asserted prior to June 22, 2016. See 40 CFR 710.23 for revised definition of ‘‘active substance.’’ B. When will reporting be required? 1. Retrospective reporting period for manufacturers. Manufacturers must report to EPA not later than 180 days after the final rule is published in the Federal Register. The 180-day time period for this retrospective reporting for manufacturers is the maximum time allowed under TSCA section 8(b)(4)(A). Following this retrospective reporting for manufacturers, EPA will include the active designations, determined by the notices received, on a draft of the Inventory. EPA will publish this draft Inventory with the active designations as soon as is practicable following the close of the 180-day submission period for manufacturers. This draft Inventory with active designations will not have the legal effect of actually designating any chemical substance as inactive. EPA, therefore, does not construe this draft Inventory as the list with ‘‘designations of active substances and inactive substances’’ (TSCA section 8(b)(5)(A)) from which forward-looking reporting commences (TSCA section 8(b)(5)(B)). EPA concludes that the statute is referring in both sections to the completed product of the initial cycle of sorting between active and inactive substances, not the preliminary product of the initial cycle of such sorting (i.e., a draft Inventory released PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 between manufacturer and processor reporting). 2. Retrospective reporting period for processors. Processors may report to EPA not later than 420 days after the final rule is published in the Federal Register. EPA originally proposed that processors may report not later than 360 days after the final rule is published in the Federal Register. EPA’s rationale was that the additional 180-day time period for processors would allow processors to search EPA’s publication of the draft Inventory with active designations, based on the retrospective reporting by manufacturers, and to report only those chemical substances not already reported. In response to comments received that the additional 180-day submission period for processors should begin on the date on which the draft Inventory is published, which EPA anticipates will likely occur approximately 60 days after the 180-day submission period for manufacturers closes, and to a comment that the rule should specify a fixed date on which the processor submission period will end, EPA is finalizing the rule such that processors may report not later than 420 days, rather than 360 days, after the final rule is published in the Federal Register. See 40 CFR 710.30(a)(2) and response to Comment 7 in Unit III. Processors have the option to simply not report under TSCA section 8(b)(4) and continue processing until the effective date of EPA’s designation of a chemical substance as inactive on the Inventory. At such time, any further processing of the substance for a nonexempt commercial purpose, without prior notification to EPA, will be prohibited by TSCA section 8(b)(5). Earlier notification under TSCA section 8(b)(4) will allow EPA to add the substance to the Inventory as an active substance, so that processing can continue without the need for a later notification under TSCA section 8(b)(5). 3. Forward-looking reporting. The forward-looking reporting period begins on the effective date of EPA’s final active/inactive substance designations. Manufacturers and processors intending to reintroduce into U.S. commerce for a nonexempt commercial purpose a chemical substance designated as inactive on the Inventory must report to EPA not more than 90 days before the anticipated date of manufacturing or processing. EPA originally proposed that forward-looking notices would be required to be submitted not more than 30 days before the date of manufacturing or processing. EPA agrees with commenters that notices should be submitted based on the anticipated (not actual) date of E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations manufacturing or processing. EPA also finds that extending such submission period from 30 to 90 days prior to resuming manufacturing or processing will afford manufacturers and processors additional time to adjust to information and schedule changes and will not significantly impact the accuracy of notices submitted. See 40 CFR 710.29(c)(2), 40 CFR 710.30(b)(1), and response to Comment 8 in Unit III. 4. Transitional period reporting and effective date for inactive substance designations. The structure of the reporting requirements under TSCA sections 8(b)(4)(A) and 8(b)(5)(B) results in a transitional period beginning on June 22, 2016 (the day after the lookback period for retrospective reporting ends) and ending on the date that EPA designates chemical substances on the Inventory as active or inactive (the day that forward-looking reporting begins). It is possible that substances that were not manufactured or processed during the lookback period—and therefore cannot be designated as active through retrospective reporting—may be reintroduced into U.S. commerce during this transitional period. In response to comments expressing concern that persons who began manufacturing or processing such substances during the transitional period might be obliged to curtail manufacturing or processing on the date that EPA publishes an inactive substance designation, or else find themselves in violation of the forwardlooking notice requirement, EPA is establishing an effective date provision for the designation of a chemical substance as an inactive substance. As ‘‘inactive substance’’ is now defined, a substance is not designated as an ‘‘inactive substance’’ until 90 days after EPA has identified the substance for inactive designation. EPA will identify chemical substances for inactive designation in a signed action accompanying the first version of the Inventory with all finalized activeinactive listings. EPA expects to publish this first version of the Inventory with all listings identified as active or inactive as soon as practicable after compilation, in a posting on EPA’s TSCA Inventory Web page (see https:// www.epa.gov/tsca-inventory). See 40 CFR 710.23 for revised definition of ‘‘inactive substance’’ and response to Comment 9 in Unit III. Accordingly, the rule clarifies that the obligation to submit an NOA Form B does not arise until 90 days after EPA has identified chemical substances for the inactive designation. The rule also clarifies that manufacturers and processors will be permitted to submit an NOA Form B for a substance that VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 EPA has identified for inactive designation, even before the effective date of such designation has arrived, and thus before the substance has the legal status of being inactive. Thus, persons manufacturing or processing a substance for nonexempt commercial purpose during the transitional period are afforded time to react to an inactive substance identification and are permitted to file an NOA Form B prior to the effective date of the substance being designated as inactive. Similarly, persons that anticipate reintroducing a substance into U.S. commerce for nonexempt commercial purpose shortly after EPA identifies such substance as inactive are afforded time to react to an inactive substance identification and are permitted to file an NOA Form B prior to the effective date of the inactive designation, so long as such form is filed no more than 90 days before the anticipated date of manufacturing or processing. See 40 CFR 710.30(b)(2) and response to Comment 10 in Unit III. C. What information will be reported? 1. Information reported by manufacturers during retrospective reporting. This rule will require that manufacturers reporting for the retrospective reporting period provide chemical identity information and indicate whether they seek to maintain an existing claim for protection against disclosure of a CBI chemical identity, if applicable. In response to comments stating concern with burden associated with information required to be reported, EPA removed the proposed requirements to report commercial activity type and date range, as EPA determined these requirements are unnecessary to achieve the objective of designating substances as active or inactive on the Inventory. See 40 CFR 710.29(b) and response to Comment 11 in Unit III. In response to comments stating concern for availability of information required to be reported, EPA clarified that persons required to report under this rule will provide information to the extent it is known to or reasonably ascertainable by them. See 40 CFR 710.29(a) and response to Comment 12 in Unit III. In response to comments requesting that a manufacturer be able to correct or withdraw an NOA Form A in the event that it discovers errors in the notice, EPA is not establishing a formal corrections provision in the regulation, but will allow a manufacturer or processor to withdraw an NOA Form A, provided that the withdrawn notice is submitted prior to the end of the submission period for processors, i.e., not later than 420 days after the final PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 37525 rule is published in the Federal Register. See response to Comment 13 in Unit III. The manufacturer may effect a correction by filing a new NOA Form A following withdrawal, so long as the new Form A is filed within the time provided in the rule for the initial filing (i.e., no later than 180 days after the final rule is published in the Federal Register). 2. Information reported by processors during retrospective reporting. Processors that choose to report for the retrospective reporting period will be required to provide chemical identity information and whether they seek to maintain an existing claim for protection against disclosure of a CBI chemical identity, if applicable. In response to comments received, EPA removed the proposed requirements to report commercial activity type and date range as these requirements were deemed unnecessary to achieve the objective of designating substances as active or inactive on the Inventory. See 40 CFR 710.29(b) and response to Comment 11 in Unit III. EPA is not establishing a formal corrections provision in the regulation for an NOA Form A, but will allow a processer to withdraw an NOA Form A, provided that the withdrawn notice is submitted not later than 420 days after the final rule is published in the Federal Register. See 40 CFR 710.30(a)(3) and response to Comment 13 in Unit III. As with manufacturers, processors can effectuate a correction by filing a new Form A within the time provided in the rule for the initial filing (i.e., no later than 420 days after the final rule is published in the Federal Register). 3. Information reported during forward-looking reporting. This rule will require that persons that intend to manufacture or process an inactive substance for nonexempt commercial purpose provide chemical identity information, the anticipated date of manufacturing or processing for nonexempt commercial purpose, and whether they seek to maintain an existing claim for protection against disclosure of a CBI chemical identity, if applicable. In response to comments, EPA removed the proposed requirement to report commercial activity type as this requirement was deemed unnecessary to achieve the objective of re-designating inactive substances as active, and revised the date of manufacturing or processing for nonexempt commercial purpose from actual to anticipated date. See 40 CFR 710.29(c) and response to Comment 11 in Unit III. Persons that have already commenced manufacturing or processing for nonexempt commercial E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37526 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations purpose (e.g., during the transitional period prior to the effective date of a substance’s inactive designation) may provide the most recent date of manufacturing or processing in lieu of an anticipated future date, if the forward-looking notice is submitted prior to the effective date of the substance’s inactive designation. See 40 CFR 710.29(c). EPA’s proposed rule related the timing of the reporting to a future ‘‘actual date of manufacturing and processing.’’ See 82 FR 4267. In response to comments about the need for greater flexibility regarding the timing of a forward-looking notice, under the rule the validity of the notice does not depend on whether the intended manufacturing or processing actually occurs by the anticipated date. Therefore, manufacturers or processors need not supplement a forward-looking notice with confirmation of whether the intended manufacturing or processing of the chemical substance actually occurred by the anticipated date. By the same token, EPA will designate such substances as active, irrespective of subsequent changes in the intentions of the submitter of the forward-looking notice. Consistent with the regulatory definition of ‘‘active substance,’’ an inactive substance becomes an active substance ‘‘based on the receipt of a notice under this subpart,’’ 40 CFR 710.23, and the factual basis for the notice is the submitter’s intent, expressed at time of notification, to manufacture or process an inactive substance for a nonexempt commercial purpose within 90 days of notification. See 40 CFR 710.25(c) and 40 CFR 710.30(b)(2). This simplified approach reduces burdens for both submitters and EPA, is consistent with the statute, and furthers the orderly and efficient implementation of the Inventory. See TSCA section 8(b)(5)(B)(iii) (requiring EPA to take certain definite actions ‘‘on receiving’’ the notice). With respect to substances re-designated as active for which the intended manufacturing or processing has not been actualized after an extended period of time and not corrected, EPA may later adjust the status of such substances, through procedures that would be established by future rulemaking, to further implement TSCA section 8(b)(5)(A). Finally, in response to comment requesting that submitters be able to withdraw an NOA Form B if their intent to re-commence manufacture or process a chemical substance later changes, EPA is allowing a submitter to request to withdraw its NOA Form B, and EPA may do so, if EPA has not yet altered the Inventory status of the substance in VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 response to the original submission (i.e., EPA has neither re-designated the substance from inactive to active nor moved the substance from the confidential portion of the Inventory to the public portion Inventory as a result of a request in the original submission for a CBI claim to be withdrawn). Because another person may have commenced manufacturing or processing for non-exempt commercial purpose in reliance of a substance being re-designated as active, the rule does not allow for EPA to revert a substance redesignated as active back to inactive status based on a request to withdraw an NOA Form B, or for EPA to revert a nonCBI substance back to a CBI substance based on a request to withdraw a Form B. It would be burdensome and potentially impossible to implement such an approach. See 40 CFR 710.30(b)(3) and response to Comment 13 in Unit III. 4. Reporting forms. The NOA Form A will be used by manufacturers for the retrospective reporting period. It will also be used by processors who choose to report for the retrospective reporting period. The NOA Form B will be used by manufacturers and processors for forward-looking reporting, which includes reporting chemical substances reintroduced into U.S. commerce during the transitional period. For the sake of clarity, the final rule now defines the terms ‘Notice of Activity Form A’ and ‘Notice of Activity Form B’, consistent with the use of these terms in the proposal. The new NOA forms are based on EPA’s NOC form (Ref. 4), since the information required in an NOA form is the same or similar to the information in the NOC form. D. How will information be submitted to EPA? The rule requires electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see 40 CFR 704.20(e)) and in accordance with section 3.2000 of 40 CFR part 3 (CROMERR) (Ref. 5). Submitters will use EPA’s CDX, the Agency’s electronic reporting portal, and EPA’s Chemical Information Submission System (CISS), a web-based reporting tool, for all reporting under this rule. EPA expects that electronic reporting will minimize time requirements, support improved data quality, and provide efficiencies for both the submitters and the Agency. In 2013, EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under TSCA sections 4, 5, 8(a) and 8(d). (Ref. 6) The rule follows two previous rules requiring similar electronic PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 reporting of information submitted to EPA for CDR and PMNs. This rule will require persons submitting notices of activity to EPA under TSCA section 8(b) to follow the same electronic reporting procedures used for other TSCA submissions, i.e., to register with EPA’s CDX (if not already registered) and use CISS to prepare a data file for submission. Registration enables CDX to authenticate identity and verify authorization. To register, the CDX registrant (also referred to as ‘‘Electronic Signature Holder’’ or ‘‘Public/Private Key Holder’’) agrees to the Terms and Conditions, provides information about the submitter and organization, and selects a user name and password. Users who have previously registered with CDX for other TSCA submissions will be able to add the ‘‘Submission for Chemical Safety and Pesticide Program’’ (CSPP) service to their current registration in CDX and use the CISS web-based reporting tool. EPA developed the CISS for use in submitting data under TSCA sections 4, 5, 8(a), and 8(d) to the Agency electronically. The web reporting tool is available for use with Windows, iOS, Linux, and UNIX based computers and uses ‘‘Extensible Markup Language’’ (XML) specifications for the efficient transfer of data across the Internet when notices are submitted to EPA. CISS works with CDX to secure online communication, provides user-friendly navigation, creates a completed document in Portable Document Format (PDF) for review prior to submission, and enables information to be submitted easily in XML format or as PDF attachments. The NOA forms described in this rule are included in an e-NOA software module in CISS. Once a user completes entry of the relevant data fields and metadata information in the appropriate NOA form, the CISS reporting tool validates the submission by performing a basic error check. CISS also allows the user to choose ‘‘Preview,’’ ‘‘Save,’’ or ‘‘Submit.’’ When ‘‘Submit’’ is selected, the user is asked to provide the user name and password that was created during the CDX registration process. CISS then submits the data via CDX. Upon successful receipt of the submission by EPA, the status of the submissions will be flagged as ‘‘Submitted.’’ The user can also login to the application and download their Copy of Record. Any person submitting a reporting form can claim any part or all of the form as confidential. Except as otherwise provided in this rule, any information that is claimed as CBI will E:\FR\FM\11AUR1.SGM 11AUR1 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations asabaliauskas on DSKBBXCHB2PROD with RULES be disclosed by EPA only to the extent and by the means of the procedures set forth in 40 CFR part 2. E. How will CBI claims and requests be handled? Notices pursuant to this rule may contain two different types of CBI assertions: claims for protection of information other than specific chemical identity, and requests to maintain existing claims for protection of specific chemical identity. In response to comments received, EPA has extensively re-written the substantiation questions from the proposed rule in a manner intended to more succinctly secure responses for CBI assertions of discrete data elements as well as CBI concerns on the linkage of data elements. See 40 CFR 710.31 and response to Comment 17. 1. Information other than specific chemical identity. For all new claims for protection (i.e., for all CBI assertions under this rule other than requests to maintain existing claims for protection of specific chemical identity), TSCA section 14(c)(1)(B) and 14(c)(5) require that persons claiming CBI must provide a specific certification statement regarding the basis for the CBI claims. In addition, TSCA section 14(c)(3) and this rule require that all such claims be substantiated at the time of submission. EPA will review a representative subset of these claims as specified by TSCA section14(g)(1). 2. Requests to maintain existing CBI claims for chemical identity. Any manufacturer or processor submitting an NOA under TSCA section 8(b)(4)(A) may seek to maintain an existing CBI claim for specific chemical identity, regardless of whether that person asserted the original claim that caused the specific chemical identity to be listed on the confidential portion of the Inventory. EPA believes this is the correct interpretation of ‘‘a manufacturer or processor . . . that seeks to maintain an existing claim for protection against disclosure’’ of specific chemical identity in TSCA section 8(b)(4)(B)(ii). A number of manufacturers and processors may legitimately benefit from the confidential status of a specific chemical identity, even when such persons did not originally report that chemical identity to EPA and therefore were not in a position to assert a CBI claim for that chemical identity. Congress could not have intended that such companies would be forced to rely on another company to request to maintain the claim. For example, the initial claimant may no longer exist or may no longer manufacture or process VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 the chemical substance, or may simply fail to file the required NOA. EPA does not believe that Congress intended for specific confidential chemical identities to be disclosed without providing the opportunity for manufacturers and processors to make a request that the identities should remain confidential simply because the original claimants did not file under TSCA section 8(b)(4)(B)(ii). Pursuant to TSCA section 8(b)(4)(B)(iv), EPA will move an active substance from the confidential portion of the Inventory to the non-confidential portion if no manufacturer or processor submitting an NOA under TSCA section 8(b)(4)(A) requests to maintain the existing CBI claim for the specific chemical identity of that chemical substance. See 40 CFR 710.37(a). As a courtesy, EPA practice is to notify original claimants and/or the public when it has moved substances from the confidential portion of the Inventory to the public portion of the Inventory, e.g., through direct contact with the original claimant or publication of a Federal Register notice. A chemical substance for which EPA has received a request to maintain an existing CBI claim for specific chemical identity will remain on the confidential portion of the Inventory pending EPA’s review of the claim pursuant to a review plan to be promulgated at a later date in accordance with TSCA section 8(b)(4)(C)–(D). While this rule requires submitters to indicate whether they seek to maintain an existing CBI claim for specific chemical identity, this rule does not include mandatory substantiation requirements for CBI requests for specific chemical identity on an NOA Form A. TSCA section 8(b)(4)(B)(iii) stipulates that EPA shall ‘‘require the substantiation of those claims pursuant to section 14 and in accordance with the review plan described in subparagraph C.’’ EPA will be conducting a separate rulemaking to establish this review plan. The review plan will include mandatory requirements for substantiating a CBI request for specific chemical identity reported in an NOA Form A and specify when such substantiation is to be provided. If EPA receives an NOA Form A in which the submitter requests to maintain an existing CBI claim for specific chemical identity but chooses not to substantiate such at the time of filing, EPA will continue to list the chemical substance on the confidential portion of the Inventory pending the submission of any substantiation required under the review plan and EPA’s review of the claim pursuant to the review plan. PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 37527 However, in this rule the Agency is allowing companies to submit substantiation for the CBI claims for specific chemical identity at the same time that the NOA Form A is filed, if they so choose. As long as the period between the date these earlier substantiations are received and the due date to be established in the review plan (yet to be proposed) is not more than five years, these substantiations will exempt the company from the requirement to submit additional substantiation under the terms of the review plan. See TSCA section 8(b)(4)(D). EPA will review requests to maintain CBI claims for specific chemical identity in accordance with the TSCA section 8(b)(4)(D) review plan in the timeframe mandated by TSCA section 8(b)(4)(E). With respect to requests to maintain existing CBI claims that are submitted on an NOA Form B, TSCA section 8(b)(5)(B) stipulates that such requests must be substantiated not later than 30 days after submitting Form B. See TSCA section 8(b)(5)(B)(ii)(II). Substantiation requirements for NOA Form B CBI claims for specific chemical identity are found in 40 CFR 710.37(a)(2). The Agency will allow companies to submit substantiation at the same time that their NOA Form B is filed, if they so choose. Persons submitting an NOA Form B may find it more efficient to provide the substantiation for a CBI claim for specific chemical identity at the time of filing. III. Summary of Response to Comments Including Changes and Clarifications From the Proposed Rule This unit summarizes EPA’s responses to comments for several general areas from multiple stakeholders. EPA also discusses any changes to and clarifications from the proposed rule, and where responses are particularly relevant to the requirements of the final rule. A separate document that summarizes the comments relevant to the proposal and EPA’s responses to those comments has been prepared and is available in the docket for this rulemaking (Ref. 7). Comment 1: Several commenters indicated that EPA should clarify the activities for which notification is not required under the rule, and should confirm that all substances and activities that are exempt from premanufacture notification requirements are also exempt from reporting requirements under this rule. The commenters make reference to the following PMN exemptions: export-only exemption, low volume exemption, low releases/low exposures exemption, test E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37528 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations marketing exemption, and polymer exemption. One commenter elaborated that substances exempted from listing on the TSCA Inventory and other substances exempt from premanufacture notification are exempt from this rule but are ambiguously stated as such. Two commenters elaborated that substances listed on the Inventory but manufactured under a low volume exemption should be exempt from reporting under this rule by a person manufacturing the substance under the exemption. One commenter recommended that all categories of substances for which no reporting is required pursuant to the CDR rule should be exempt from reporting under this rule. Several commenters indicated that EPA should clarify or confirm that polymers are exempt from reporting under this action. One commenter requested that EPA clarify whether polymers manufactured under the pre1995 polymer exemption rule need to be reported, as technically such polymers are listed on the Inventory. A few commenters stated that polymers listed on the Inventory, including polymers with a ‘‘Y’’ designation, should be included on the interim list of active substances. One commenter elaborated that polymers on the Inventory are not subject to CDR, that many were placed on the Inventory before EPA promulgated the TSCA section 5 polymer exemption rule and would likely meet the current standard for the polymer exemption, and that such low risk polymers should be on the interim active Inventory. One commenter expressed concern that, without an explicit reporting exemption in the rule, a company manufacturing a chemical substance under a polymer, low volume, or test marketing exemption could inadvertently violate the reporting requirements if (without the company’s knowledge) another company manufacturing the same substance added that substance to the confidential portion of the Inventory, then ceased manufacturing, causing the substance to be designated inactive. Another commenter expressed concern that, in the absence of an explicit reporting exemption in the rule for all companies manufacturing chemical substances under a PMN exemption, the rule would appear to require such companies to submit an inquiry to EPA to ascertain whether the chemical substances in question had been added to the confidential portion of the Inventory by another manufacturer. Response: In response to the comment to clarify the reporting status under this VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 rule of a substance manufactured under a TSCA section 5 exemption and not listed on the Inventory, EPA confirms that such substance is not subject to reporting under this action. The scope of chemical substances covered under this rule excludes substances that are not listed on the Inventory. See definition of ‘‘reportable chemical substance’’ at 40 CFR 710.23. A substance that has not been added to the Inventory because it is manufactured solely under a PMN exemption is not a ‘‘reportable chemical substance’’ and, therefore, cannot become an ‘‘active substance’’ or an ‘‘inactive substance.’’ EPA recognizes that in certain cases, chemical substances manufactured by a company under a PMN exemption may nevertheless be added to the Inventory voluntarily, or may subsequently be added to the Inventory by another company. Accordingly, in the proposed rule, EPA listed reporting exemptions for the following activities, which EPA construed as exempt commercial purposes: The manufacture or processing of a substance as described in 720.30(g) or (h), the manufacture or processing of a substance solely in small quantities for research and development, and the import of a substance as part of an article. EPA finalized the rule to include these exemptions and, based on comments, revised the rule to include additional exemptions: the manufacture or processing of a substance solely for test marketing purposes, and the manufacture or processing of a substance solely for export from the United States, except where the Administrator has made a finding described in TSCA section 12(a)(2). See 40 CFR 710.27(a)(4) and (5). EPA believes that these two additional activities also qualify as exempt commercial purposes based on the limited nature of these commercial activities and the exemptions from PMN reporting under TSCA sections 5(h)(1) and 12(a)(1) for substances manufactured solely for these purposes. While TSCA section 12(a)(1) authorizes EPA to include substances manufactured or processed solely for export in TSCA section 8 reporting, EPA construes manufacturing or processing solely for export to be an exempt commercial purpose, given that section 12(a)(1) broadly exempts such activities from other TSCA provisions, including PMN requirements under section 5. EPA declined to add additional reporting exemptions in the final rule for activities that are exempt from PMN reporting based on rules promulgated under TSCA section 5(h)(4) (i.e., low volume, low releases/low exposures, PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 and polymer exemptions). EPA disagrees with comments that a substance manufactured under a TSCA section 5(h)(4) exemption but nevertheless listed on the Inventory should be exempt from reporting under this rule. EPA does not believe that manufacturing or processing under a low volume, low releases/low exposures, or polymer exemption (1984 or 1995 polymer exemption) qualify as exempt commercial purposes under TSCA section 8(b), despite the exemptions from reporting under TSCA section 5(h)(4) for such substances. This is because exemptions promulgated under section 5(h)(4) are predicated upon a risk determination, rather than the particular commercial purpose for which manufacturing is undertaken. Unlike the other activities that EPA has exempted from reporting requirements under this rule (e.g., research and development, test marketing, exportonly), the activities exempt from PMN reporting pursuant to rules promulgated under section 5(h)(4) need not be undertaken for any specific and limited commercial purpose. Because the commercial purpose for which a substance is manufactured is not integral to an exemption under section 5(h)(4), and in consideration of the statutory objective of TSCA section 8(b)(4)–(5) to enable EPA to determine which chemical substances on the Inventory are active in U.S. commerce, EPA does not construe activities undertaken pursuant to a section 5(h)(4) exemption to be exempt ‘‘commercial purposes’’ within the meaning of section 8(b)(4)(A)(i) and 8(b)(5)(B)(i). EPA emphasizes, however, that substances which (based on such PMN exemptions) have never been added to the Inventory are excluded from any reporting requirements under this rule. EPA also disagrees with comments that this rule should provide reporting exemptions for polymers and other categories of Inventory-listed substances that are exempt from CDR for reasons unrelated to the specific commercial purpose for which they are manufactured or processed. A statutory objective supported by reporting under this rule is to enable EPA to determine which chemical substances on the Inventory are active in U.S. commerce. This statutory objective under TSCA section 8(b) is distinct from the statutory objective for CDR under TSCA section 8(a). Whereas polymers and certain other categories of substances listed on the Inventory are exempt from reporting under CDR, these substances nevertheless require designation as active or inactive under TSCA section E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations 8(b), and are therefore subject to reporting under this rule if they were or are anticipated to be manufactured for nonexempt commercial purpose. Exempting polymers and other categories of substances under this TSCA section 8(b) rule for no other reason than that they are exempt from CDR under TSCA section 8(a) would not accomplish the statutory objective of designating substances on the Inventory manufactured for non-exempt commercial purposes as active or inactive. EPA does not believe Congress intended for an entire category of substances (such as polymers), that were listed on the Inventory as of June 22, 2016, to be designated inactive despite the fact that such substances were manufactured or processed for wideranging commercial purposes during the 10-year lookback period. EPA furthermore disagrees with comments that polymers should be included on the interim list of active substances. The interim list is defined by TSCA section 8(b)(6) to include only substances reported under CDR during the reporting period that most closely preceded the date of enactment of the TSCA amendments. Substances such as polymers that are exempt from reporting under CDR, therefore, are not eligible to be included on the interim list. Moreover, unless these substances were the subject of an NOC received during the lookback period, EPA has no equivalent notice that such substances were manufactured during the lookback period, and therefore no justification for designating the substances as active in this rule. Finally, in response to comments expressing concern that a person manufacturing under a PMN exemption may be unaware that another person subsequently added the same substance to the confidential portion of the Inventory, EPA notes that it revised 40 CFR 710.25(a) and (c) to clarify that reporting is not required where it is not ‘‘known to or reasonably ascertainable by’’ a company that it manufactured a chemical substance subject to commercial activity designation during the lookback period, or that it intends to manufacture or process an inactive substance on the confidential portion of the Inventory. EPA anticipates that the presence of a substance on the confidential portion of the Inventory may be information that is not ‘‘known to or reasonably ascertainable by’’ a person who is operating under a PMN exemption and who did not submit the confidentiality claim for the specific chemical identity of that substance. Changes to Activities that are Exempt from Reporting in the Final Rule: EPA VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 revised the rule to exempt additional commercial activities from reporting requirements: The manufacture or processing of a substance solely for test marketing purposes, and the manufacture or processing of a substance solely for export from the United States, except where the Administrator has made a finding described in TSCA section 12(a)(2). See 40 CFR 710.27(a)(4) and (5). Comment 2: One commenter stated that substances processed as part of an article should be exempt from reporting. One commenter indicated that substances contained within imported articles should be subject to reporting if and when they are released from the article during use and perform a separate end-use function. Response: The proposed rule included an exemption from reporting requirements for persons importing a chemical substance as part of an article. EPA agrees with commenter that the processing of a chemical substance as part of an article should likewise be exempt from reporting under this rule on the grounds that it is processing for an exempt commercial purpose, following the logic of the exemption for manufacture of a chemical as part of an article through import. Under TSCA, the import of a chemical substance as part of an article does not require new chemical reporting. Consequently, the Inventory does not list all chemical substances that are processed as part of articles since it does not include the processing of chemical substances as part of imported articles. More generally, the processing of a chemical as part of an article is not a basis to add a chemical substance to the Inventory. EPA believes it would be incongruous to identify a chemical substance as active solely based on the fact that it is processed as part of an article, when that would not be a basis to add the chemical substance to the Inventory in the first place if there were no manufacture reportable under TSCA section 5. In addition, EPA is concerned that an approach under which chemical substances are listed as active simply because they are components of articles that are processed in some fashion could undermine the purpose of meaningfully distinguishing active from inactive chemicals. It should be noted that the extraction of a chemical substance from an article would not be considered processing a chemical substance as part of an article and so would not be exempt from reporting under this provision. EPA therefore revised 40 CFR 710.27(a)(2) to exempt persons processing a chemical substance as part of an article from PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 37529 reporting requirements for that substance. Regarding the comment that substances contained within imported articles should be subject to reporting if and when they are released from the article during use and perform a separate end-use function, no regulatory change is necessary. The final rule at 40 CFR 710.27(a)(2) refers to ‘‘[t]he import or processing of a chemical substance as part of an article.’’ EPA’s longstanding interpretation of this phrase is that a chemical substance is only considered to be imported ‘‘as part of an article’’ if the substance is not intended to be removed from that article and it has no end use or commercial purpose separate from the article of which it is a part. See 42 FR 64583 (1977). Thus, for the kinds of articles from which a contained chemical substance would be released during use and perform a separate enduse function, the chemical substance would not be considered to be part of the article and would not qualify for exemption on that basis. In any event, as stated previously, even in the case where a chemical substance is part of an article, the extraction of a chemical substance from an article would not be considered processing a chemical substance ‘‘as part of an article’’ and so would not be exempt from reporting on this basis. See also TSCA Chemical Data Reporting Fact Sheet: Imported Articles, available at https://www.epa.gov/sites/ production/files/2015-12/documents/ cdr_fact_sheet_imported_articles_-_ final_dec2015.pdf. (Ref. 8) Changes to Activities that are Exempt from Reporting in the Final Rule: EPA amended the rule to reflect that both importing and processing a chemical substance as part of an article are exempt from reporting requirements under this rule. See 40 CFR 710.27(a)(2). Comment 3: Numerous commenters stated that CBI substances reported to the 2016 or 2012 CDR should be made active on the interim Inventory and should not be subject to retrospective reporting. Several commenters also stated that CBI substances reported to the 2016 CDR should also not be subject to further substantiation of CBI claims because the claims have already been substantiated. Response: EPA agrees in part with the comments involving CBI substances. EPA confirms that it had proposed that both CBI and non-CBI substances reported to the 2012 or 2016 CDR would be made active on the interim list. EPA finalized this aspect of the rule. Furthermore, EPA revised the rule to reflect that both CBI and non-CBI substances reported to the 2012 or 2016 CDR will be eligible for exemption from E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37530 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations retrospective notification requirements under this rule. See 40 CFR 710.23 and 710.25. However, a company that seeks to maintain an existing CBI claim for specific chemical identity cannot avail itself of this exemption, and must submit an NOA Form A that includes such request, because TSCA section 8(b)(4)(B)(ii) requires a specific request to maintain the CBI claim. Pursuant to TSCA section 8(b)(4)(B)(iv), EPA must move to the non-confidential portion of the Inventory any active substance for which no request is received to maintain an existing CBI claim for specific chemical identity. EPA recognizes in the final rule that there may be circumstances where a company, which had previously sought a CBI claim for a specific chemical identity, may no longer view the CBI status as necessary or currently defendable. In such circumstance, the company may take advantage of any retrospective reporting exemption for which it is eligible, and decline to submit a retrospective notice to EPA. Regarding substantiation, pursuant to TSCA section 8(b)(4)(D)(i), a previously submitted substantiation may satisfy the section 8(b)(4)(B)(iii) substantiation requirement if the prior substantiation was submitted to EPA within five years of a deadline to be established in the forthcoming review plan described in section 8(b)(4)(C)–(D). EPA does not expect that a 2012 CDR submission will satisfy the five-year substantiation requirement. Because the deadline for submitting substantiation in the review plan has not yet been set, EPA does not currently know whether substantiation submitted for a 2016 CDR submission will satisfy the TSCA section 8(b)(4)(B)(iii) five-year substantiation requirement. Note that a voluntary substantiation submitted with Form A might also not fall within the five-year period, depending upon the deadline that is set. Changes to Chemical Substances That Are Exempt from Retrospective Reporting in the Final Rule: EPA changed the exemptions from retrospective reporting requirements to reflect that both CBI and non-CBI chemical substances reported to the 2012 or 2016 CDR will be eligible. See 40 CFR 710.23 for revised definition of ‘‘interim active substance.’’ TSCA section 8(b)(4)(B)(ii) requires a notice to be submitted only by those manufacturers or processors that seek to maintain an existing CBI claim for the specific chemical identity of a reportable substance. Comment 4: Several commenters stated that non-CBI substances added to VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 the Inventory during the ten-year retrospective reporting period via an NOC should be exempt from notification. Response: EPA agrees with this comment. An NOC is required to be submitted to EPA on or no later than 30 calendar days after the first day of manufacture of a new chemical substance for commercial purpose and an NOC substance is considered to be added to the Inventory on the date the NOC is received by EPA, provided that the EPA determines the NOC to be valid during its review. Requiring retrospective reporting of substances for which an NOC was received during the lookback period would be duplicative because EPA already has an equivalent report (the NOC itself) indicating that the substance was manufactured or processed during the lookback period. EPA furthermore concludes (consistent with its response to comments about the availability of the interim list exemption for CBI substances) that the analogous reasoning applies with respect to CBI substances added to the Inventory during the lookback period. EPA revised the rule to reflect that both CBI and nonCBI substances reported in an NOC during the lookback period will be eligible for exemption from retrospective notification requirements under this rule. EPA was able to compile this list of substances and designate them as active substances by the deadline for publication of the rule. EPA’s June 2017 posting of the Inventory will include these NOC substances designated as active (see https://www.epa.gov/tsca-inventory). See 40 CFR 710.23 for revised definitions of ‘‘active substance’’ and ‘‘chemical substance subject to commercial activity designation.’’ However, a company that seeks to maintain an existing CBI claim for specific chemical identity cannot avail itself of this exemption because TSCA section 8(b)(4)(B)(ii) requires a specific request to maintain the CBI claim. See response to Comment 3 for additional discussion on CBI substances. Additionally, substantiation of a CBI claim for chemical identity submitted with an NOC may or may not satisfy the TSCA section 8(b)(4)(B)(iii) substantiation requirement. Pursuant to TSCA section 8(b)(4)(D)(i), a previously submitted substantiation may satisfy the section 8(b)(4)(B)(iii) substantiation requirement if the prior substantiation was submitted to EPA within 5 years of the deadline to be established in the forthcoming review plan described in section 8(b)(4)(C)–(D). NOCs submitted more recently may satisfy the 5-year substantiation requirement, while NOCs PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 submitted earlier in the 10-year lookback period for retrospective reporting may not satisfy the 5-year substantiation requirement. Note that a voluntary substantiation submitted with an NOA Form A might also not satisfy the 5-year substantiation requirement, depending upon the deadline that is set in the review plan. Changes to Chemical Substances That Are Exempt from Retrospective Reporting in the Final Rule: EPA added an exemption from retrospective reporting requirements for chemical substances added to the Inventory via an NOC during the ten-year retrospective reporting period. See 40 CFR 710.23 for revised definitions of ‘‘active substance’’ and ‘‘chemical substance subject to commercial activity designation.’’ Comment 5: Several commenters stated that EPA should update the interim list and/or publish submissions frequently or in real time in order for potential submitters to see what is being submitted and to avoid or reduce duplicative submissions during retrospective reporting. Response: EPA has determined that publishing submissions frequently or in real time is not feasible. In order to publish notices frequently or in real time, EPA would need to develop, test, and implement an electronic platform that would be able transfer non-CBI notices from the Agency’s confidential repository to a public system. EPA has not to date developed nor implemented such an electronic platform for TSCA purposes and does not believe that it could do so by the time it would be needed to support this action in a manner suggested by these comments. Additionally, because non-CBI notices suitable for publication would include those submitted with no CBI claims and those submitted with claims but for which CBI would be redacted, EPA would need to ensure that such an electronic platform would appropriately transfer only non-CBI notices to a public system. Furthermore, in order for published information to be accurate and reliable, EPA believes that notices would necessarily need to be fully processed and reviewed, which would not allow the Agency to publish notices in real time or even frequently, especially since the number of notices submitted may increase, possibly sharply, as the submission deadline approaches. Comment 6: Several commenters disagreed with the proposal that each manufacturer must report every nonexempt chemical manufactured during the retrospective lookback period. Commenters stated that, for E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations purposes of designating substances as active, EPA need only receive one notice for each reportable substance. Commenters elaborated that EPA should allow a ‘‘one-and-done’’ approach for retrospective reporting, i.e., once a notice is received by EPA for a particular substance, and either the notice is published and/or the interim list is updated and published, other manufacturers need not report the same substance. One commenter stated that EPA appropriately proposed to require that each company that has manufactured a chemical substance on the Inventory during the lookback period must notify EPA of such manufacture. The commenter elaborated that ‘‘one-and-done’’ reporting is legally impermissible. Response: EPA disagrees with the statement of one commenter that a ‘‘oneand-done’’ reporting exemption is impermissible under TSCA section 8(b)(4)(A)(i). Section 8(b)(4)(A)(i) states that the Administrator ‘‘shall require manufacturers . . . to notify the Administrator’’ of each chemical substance that the manufacturer has manufactured during the 10-year lookback period. The statute does not state that the Administrator shall require all manufacturers to submit such a notice. Had Congress intended to preclude the Administrator from implementing a ‘‘one-and-done’’ reporting process, Congress could have done so by specifying that the Administrator shall require all manufacturers to submit a notice for each chemical manufactured during the lookback period. Furthermore, EPA believes the commenter incorrectly discounts the significance of language in TSCA section 8(b)(4)(A)(i) admonishing EPA to issue the rule ‘‘subject to the limitations under subsection (a)(5)(A).’’ TSCA section 8(a)(5)(A) provides that ‘‘the Administrator shall, to the extent feasible . . . not require reporting which is unnecessary or duplicative.’’ EPA does not agree with the commenter’s assertion that subsection (a)(5)(A) is solely concerned with the manner of reporting, such that the scope of reporting would be unaffected. It is difficult to see how one could make a notification requirement less unnecessary or less duplicative except by tailoring the scope of persons who are required to submit the notification. EPA agrees in part with the other commenters that a ‘‘one-and-done’’ approach should be allowed for retrospective reporting. Accordingly, EPA has revised the rule to exempt a manufacturer from the retrospective notification requirements for a particular chemical substance, if the VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 manufacturer has evidence in the form of a CDX receipt, documenting EPA’s receipt of an NOA Form A from another manufacturer. As discussed further in Comment 5 in this Unit, it is infeasible for EPA to supply ‘‘real-time’’ reports to the public during the manufacturers’ submission period for retrospective reporting by listing the particular substances for which it has already received an NOA Form A. However, manufacturers who possess an NOA Form A CDX receipt for a substance (e.g., obtained through a consortium arrangement), documenting that an NOA Form A has already been received by EPA, may avail themselves of this exemption for that substance. Manufacturers should keep in mind, however, that they bear the risk of failing to submit a required forwardlooking notification (NOA Form B) notice if they rely on this Form A exemption, and the Form A notice (for which they have a CDX receipt) is later withdrawn, leading to the substance being designated as inactive. Furthermore, one manufacturer’s expectation that another manufacturer will later submit an NOA Form A is not an acceptable basis for relying on this exemption. If such an approach were allowed as a basis for exemption, then EPA would risk receiving no notification at all for an active substance, based on each manufacturer expecting that some other manufacturer would later submit an NOA Form A. Since it is only submitters who will be notified of errors, manufacturers relying on the exemption are responsible for assuring their substance is properly designated as commercially active. However, a company that seeks to maintain an existing CBI claim for specific chemical identity cannot avail itself of this exemption because TSCA section 8(b)(4)(B)(ii) requires a specific request to maintain the CBI claim. See response to Comment 3 for additional discussion on CBI substances. Changes to Chemical Substances That Are Exempt from Retrospective Reporting in the Final Rule: EPA added an exemption from retrospective reporting requirements in the rule for manufacturers that have evidence in the form of a copy of a CDX receipt documenting EPA’s receipt of an NOA Form A from another person for the same chemical substance. See 40 CFR 710.25(a). However, as noted in Unit II and in 40 CFR 710.25(a), any manufacturer relying on another person’s notice remains responsible for confirming that their substance becomes designated as active. Comment 7: Several commenters requested that processors be allowed to PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 37531 report for an additional 180 days that begins when the draft Inventory is published and not when the 180-day submission period for manufacturers closes. One commenter questioned whether EPA had legal authority to extend the submission period for processors beyond 180 days, but accepted EPA’s rationale for providing processors with additional reporting time after EPA’s publication of the draft Inventory, provided that the extra time for processor reporting remains a short (i.e., no more than 180 days) and fixed period, as proposed. Response: With respect to EPA’s legal authority to establish a voluntary retrospective submission period for processors beyond 180 days, EPA believes this is implicit in its authority to establish a mandatory reporting period for manufacturers during the first 180 days. EPA notes that TSCA does not require that the rule impose any retrospective reporting requirements at all on processors. Nor does TSCA section 8(b)(4) establish a deadline for the publication of the Inventory designating active and inactive substances. Furthermore, allowing processors additional time to report is consistent with the manner in which the original Inventory was assembled, it advances the statutory objective of efficiently dividing active substances from inactive substances, and it advances the statutory objective under TSCA section 8(a)(5) of avoiding (to the extent feasible) unnecessary reporting. Processors may be able to identify certain active substances that manufacturers would not, but requiring them to report during the same time period as manufacturers might lead them to duplicate the reports of manufacturers. EPA originally proposed that processors may report not later than 360 days after the final rule is published in the Federal Register. EPA’s rationale was that the additional 180-day submission period for processors, beyond the 180-day submission period for manufacturers, would allow processors to search EPA’s publication of the draft Inventory with active designations, based on the retrospective reporting by manufacturers, and to report only those substances not already reported. EPA agrees with comments that the purpose of affording the additional 180 days for processors is best served if that 180-day submission period begins on the date on which processors would actually be able to review the draft Inventory. EPA also agrees with the comment that the rule should specify a fixed date on which the processor submission period will end, E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37532 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations as originally proposed, but which would not be the case if the 180-day submission period were to begin on the unknown date of the publication of the draft Inventory. EPA intends to publish the draft Inventory with active designations as soon as is practicable following the close of the 180-day submission period for manufacturers, which is anticipated to be approximately 60 days after the 180-day submission period for manufacturers ends. Based on this anticipated timeframe for publishing the draft Inventory and in consideration of these comments, EPA is finalizing the rule to allow processors to report not later than 420 days after the publication of the rule in the Federal Register. See 40 CFR 710.30(a)(2). This revised submission period for processors provides a fixed date on which the processor submission period will end and is anticipated to provide an approximate 180-day period for processor reporting from the date by which EPA expects to publish the draft Inventory. Changes to Processor Submission Period for Retrospective Reporting: EPA changed the retrospective reporting submission period for processors to end not more than 420 days after the publication of the rule in the Federal Register. See 40 CFR 710.30(a)(2). Comment 8: Two commenters stated that an estimated date of recommercialization should be able to be provided rather than an actual date. Two commenters stated that there is no need to limit the submission period for forward-looking reporting (NOA Form B) to not more than 30 days prior to manufacturing or processing, as proposed by EPA, citing that the statute only requires notification to take place ‘‘before’’ commercialization resumes. One commenter suggests that persons be permitted to submit an NOA Form B up to 90 days before re-commercialization instead of 30 days. Another commenter suggested that the Agency require an NOA Form B to be submitted not less than 90 days prior to manufacturing or processing to allow sufficient time for the Agency to evaluate the chemical and determine whether a Significant New Use Rule (SNUR) is needed. Another commenter was supportive of the proposed 30-day requirement. Response: EPA agrees that the date that must be provided on an NOA Form B should be the anticipated date of reintroduction of a chemical substance in U.S. commerce, rather than the actual date. EPA recognizes that any reporting required in advance of actual commercialization is based on information and schedules that are subject to change, and providing an VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 actual date of commercialization in advance, therefore, is not always practical. EPA believes that providing an anticipated date of commercialization should lessen concerns expressed by commenters. See 40 CFR 710.29(c)(2). EPA has also decided to modify the date requirement from originally proposed, extending it to allow notice up to 90 days ahead of time, in addition to basing the date requirement on the anticipated date of manufacturing or processing rather than the actual date of manufacturing or processing. EPA decided to retain some limitation on the submission period because EPA’s experience with other reporting under TSCA (e.g., PMNs) is that the earlier a notice is submitted, the higher the likelihood is that the schedule for commercialization will change or that a chemical substance might not be commercialized at all. EPA believes that retaining a limitation on the submission period for future reporting will reduce the number of notices submitted for substances whose schedule for commercial re-introduction changes appreciably. EPA also believes that extending the submission period to begin from 90 days, rather than 30 days, prior to resuming manufacturing or processing will afford manufacturers and processers additional time to adjust to information and schedule changes and will not significantly impact the accuracy of notices submitted. See 40 CFR 710.30(b)(1). Regarding changing the deadline for submission of an NOA Form B to be at least 90 days prior to resuming manufacturing or processing for the purposes of Agency action (e.g., SNUR), EPA disagrees with the commenter’s interpretation that by requiring advance notification, Congress wanted to provide EPA an opportunity to take action to delay the resumption of manufacturing or processing if it had concerns about the subject chemical. To the contrary, the statute clearly reflects that the obligation to submit a section 8(b)(5)(B) notification was not intended as a tool to impede the resumption of manufacturing or processing. Specifically, the statute does not authorize EPA to structure the rule in such a manner that if a manufacturer or processor submits an NOA Form B, the manufacturer or processor could be obliged to wait longer than the next day to commence manufacturing and processing the chemical substance. See TSCA section 8(b)(5)(B)(i). EPA believes the most plausible explanations for why Congress imposed the advance notification requirement were: (1) To ensure that EPA actually receives the PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 notices (by making the lawful resumption of manufacturing or processing contingent on the notification) and; (2) to support EPA’s subsequent prioritization efforts under TSCA section 6(b). See TSCA section 8(b)(5)(B)(iii)(IV). Changes to the Date Requirement for Forward-looking Reporting: EPA changed the limitation on submitting an NOA Form B to be not more than 90 days prior to the anticipated date of manufacturing or processing. See 40 CFR 710.29(c)(2) and 40 CFR 710.30(b)(1). Comment 9: A few commenters asked EPA to clarify in the rule how it would implement the requirements of TSCA section 8(b)(7). For example, commenters requested that EPA confirm in the final rule when the draft and final lists of active and inactive substances will be published. One commenter indicated that EPA should identify all substances on the Inventory as active or inactive not later than 15 months after promulgation of this final rule. Another commenter indicated that EPA should publish an updated version of the Inventory, with all substances designated as active or inactive, not later than six months after the completion of the retrospective notification process. Commenters also stated that EPA should specify in the rule the date when substances will be designated as inactive. One commenter stated that EPA should publish a Federal Register notice every 90 days listing all substances that EPA has designated as active following receipt of an NOA Form B. Response: TSCA section 8(b)(7) requires EPA to make active and inactive designations available to the public, but it gives EPA discretion as to the manner and timing of doing so. EPA intends to publish a draft Inventory as soon as practicable after the close of the 180-day submission period for manufacturers, which will include only active designations (based on interim list designations, NOCs, and manufacturer reporting); chemicals that have no designation on this draft Inventory should not be assumed to be inactive. EPA intends to publish the first Inventory identifying both active and inactive substances as soon as practicable after the close of the retrospective submission period for processors, in a web posting of the Inventory on EPA’s Inventory Web page (see https://www.epa.gov/tscainventory). Given that the statute does not mandate a specific deadline for the publication of the first Inventory identifying both active and inactive substances, and given the challenges of E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations foreseeing precisely how much time will be necessary to review and compile the data it will receive from retrospective reporting, EPA has chosen not to impose a regulatory deadline on the publication of this first Inventory. The obligation to submit an NOA Form B under TSCA section 8(b)(5)(B)(i) does not arise until a chemical substance has been ‘‘designated as an inactive substance.’’ EPA is establishing an effective date provision for the designation of a substance as an inactive substance. EPA revised the rule so that an ‘‘inactive substance’’ designation becomes effective 90 days after the date that EPA identifies the substance for inactive designation. See 40 CFR 710.23 for revised definition of ‘‘inactive substance.’’ EPA will identify substances for inactive designation in a signed action accompanying the first version of the Inventory with all activeinactive listings following the close of the retrospective submission period for processors. EPA intends to publish this signed action together with the Inventory in a web posting on EPA’s Inventory Web page (see https:// www.epa.gov/tsca-inventory). With respect to Inventory updates based on forward-looking reporting, the statute does not specifically require that EPA inform the public of the reintroduction of chemical substances by issuing Federal Register notices every 90 days, indicating what substances (if any) have been reactivated. EPA intends to include substances submitted in forwardlooking notices and re-designated as active on the Inventory in its regular publications of the Inventory, which occur approximately every six months. Changes to the Final Rule to Establish the Date When a Chemical Substance Will Be Designated as Inactive: EPA revised the rule so that an inactive substance designation is not effective until 90 days after the date that EPA identifies a substance for inactive designation. See 40 CFR 710.23 for revised definition of ‘‘inactive substance.’’ Comment 10: A few commenters expressed concerns about the status of substances manufactured or processed in the period between June 22, 2016 and the date the first Inventory with active and inactive designations is finalized and published. These commenters requested that EPA clarify the status of such substances. Response: EPA clarified the status of these chemical substances in Unit II and the final rule. The structure of the reporting requirements under TSCA sections 8(b)(4)(A) and 8(b)(5)(B) results in a transitional period beginning on VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 June 22, 2016 (the day after the lookback period for retrospective reporting ends) and ending on the date the forwardlooking reporting period begins (i.e., the effective date that chemical substances are designated as inactive, which is 90 days after EPA publishes the first Inventory with listings identified as active or inactive). A person who did not manufacture or process a particular chemical substance during the lookback period (June 21, 2006 through June 21, 2016) is not subject to the retrospective reporting provisions of this rule with respect to that substance, and should not submit an NOA Form A for that substance regardless of whether the person manufactured or processed the substance on or after June 22, 2016. If that substance is ultimately designated by EPA as inactive, however, any person who intends to manufacture or process that substance after it is designated as inactive must submit an NOA Form B. To address concerns about substances reintroduced into U.S. commerce during the transitional period and potential interruptions in commercial activity that could arise upon EPA’s designation of such substances as inactive, EPA revised the rule to reflect that an inactive designation only becomes effective 90 days after EPA identifies the substance for such designation. EPA is clarifying that the obligation to submit an NOA Form B does not begin until the effective date of an inactive substance designation. Because EPA revised the rule so that an inactive substance designation is not effective until 90 days after the date that EPA identifies a substance for inactive designation, manufacturers and processors are afforded time to react to an inactive substance identification. Persons who are already manufacturing or processing a substance for nonexempt commercial purpose (e.g., during the transitional period), and wish to continue doing so without interruption after EPA’s designation of such substance as inactive, are permitted to submit an NOA Form B for such substance prior to the effective date of the inactive designation, which is the date that the substance attains the legal status of being inactive. Similarly, persons that anticipate reintroducing a substance into U.S. commerce for nonexempt commercial purpose shortly after EPA identifies the substance for inactive designation are also afforded time to react to the inactive substance identification and are permitted to file an NOA Form B prior to the effective date of the substance’s inactive designation, as long as such form is filed no more than 90 days before the PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 37533 anticipated date of manufacture or processing. Manufacturers should be aware that the timely filing of an NOA Form B does not remedy an earlier failure to comply with the retrospective reporting requirement; it merely ensures that the manufacturer will not also be in violation of the forward-looking reporting requirement. Changes to the Final Rule to Clarify the Status of Chemical Substances Manufactured or Processed in between the Retrospective and Forward-Looking Reporting Periods: EPA revised the rule to clarify that manufacturers and processors are permitted to submit an NOA Form B for a chemical substance that EPA has identified for inactive designation, even though the effective date of such designation has not yet arrived, and thus the substance does not yet have the legal status of being inactive. See 40 CFR 710.30(b)(2). Comment 11: Numerous commenters stated that certain data requirements should be eliminated or reduced. Two commenters stated that EPA should reduce the proposed requirement for a date range from retrospective notification by not requiring exact dates for the date range for retrospective notification, and instead suggested that the first and last dates of the range be reported by month and year. Numerous commenters stated that EPA should eliminate the proposed requirement for a date range from retrospective notification, indicating that such information would be burdensome to retrieve and evaluate and, in certain cases, may not be available due to record retention policies. Commenters further indicated that such information is not required to meet the statutory objective and that the certification statement should be sufficient to support data accuracy. Similarly, several commenters also stated that EPA should eliminate the proposed requirement for type of commercial activity from retrospective notification; one commenter indicated that the proposed requirement should also be eliminated from forward-looking notification. A few commenters suggested reducing the proposed requirement for type of commercial activity from retrospective notification by combining ‘‘Domestically manufactured’’ and ‘‘Imported’’ into one category for reporting. One commenter was supportive of requiring type of commercial activity. Response: EPA has decided not to require date range and activity type for retrospective notification. EPA had proposed such information to serve the objective of verifying and validating notices submitted. However, in response E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37534 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations to comments received, EPA has been persuaded that the collection of a date range of manufacture, as well as the collection of information to differentiate between domestic manufacture, import, and processing, is unnecessary to serve the underlying objective of reliably differentiating active and inactive substances. EPA is also mindful that TSCA section 8(b)(4)(A)(i) specially admonishes the Agency to avoid, to the extent feasible, the collection of unnecessary information in this rule. As an alternative to requiring date and information, EPA has revised the NOA Form A certification statement to require an affirmation that manufacturing or processing of the chemical substance occurred during the lookback period. If EPA needs to verify the basis for such a certification, it can obtain and evaluate the documentation that submitters are required to maintain under 40 CFR 710.35. EPA has similarly removed the activity type requirement for forwardlooking notification. This is consistent with the evidence of Congressional intent motivating the notification requirement. See S. Rep. 114–67 at 20 (purpose is to categorize the chemical substances on the Inventory as ‘‘active or inactive,’’ and ‘‘[m]anufacturers of an inactive substance may return the substance to the active inventory with a simple notification to EPA’’). In response to comments received, EPA has been persuaded that information on activity type is not necessary to accomplish the purpose of the rule regarding differentiating inactive substances from active substances. EPA has also revised the NOA Form B certification statement to require an affirmation that persons submitting an NOA Form B have forward-looking intent to manufacture or process for nonexempt commercial purpose. If EPA needs to verify the basis for such a certification, it can obtain and evaluate the documentation that submitters are required to maintain under 40 CFR 710.35. Changes to Required Reporting Elements in the Final Rule: EPA removed the date range and commercial activity type requirements from retrospective notification, and revised the certification statement on the NOA Form A to clarify that persons submitting the form are certifying that manufacturing or processing of the chemical substance occurred during the lookback period. EPA also removed the commercial activity type requirement from forward-looking notification, and revised the certification statement on the NOA Form B to clarify that persons submitting the form are certifying that VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 they have forward-looking intent to manufacture or process the substance. See 40 CFR 710.29(b) and 40 CFR 710.29(c). Comment 12: Numerous commenters stated that EPA should clarify the meaning of ‘‘known or reasonably ascertainable,’’ particularly in the context of scenarios involving mergers and acquisitions (e.g., corporate predecessors and successors) that occurred during or after the ten-year reporting period, and in such scenarios, who is responsible for reporting under the rule. Some commenters further elaborated that if a company no longer has a legal obligation to retain particular records, or if the records are no longer in the possession of the company (e.g., they are not available due to company document retention policies or are in the possession of an acquiring company), the information should be considered to be not ‘‘Known or Reasonably Available/Ascertainable’’ and reporting should not be required. One commenter suggested amending 40 CFR 710.25 to add a new paragraph (b) to address entities formed during the lookback period that may not have historical records in their possession or control. Another commenter stated that EPA’s proposal was still silent as to the level of diligence that must be used to determine which substances must be reported under NOA Form A and Form B, and suggested that EPA assign a ‘‘readily obtainable’’ standard to that level of diligence for the Form A’s. Response: CFR 40 part 704 defines ‘‘Known to or reasonably ascertainable by’’ as all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. In response to commenters’ request for clarification of possession or control as it relates to corporate mergers and acquisitions, EPA has added to 40 CFR 710.23 the definition of ‘‘Possession or Control’’ from 40 CFR 704.3. Consistent with its use in Part 704, ‘‘Possession or Control’’ is defined as meaning in the possession or control of any person, or of any subsidiary, partnership in which the person is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the person in the research, development, test marketing, or commercial marketing of the chemical substance in question. Information is in the possession or control of a person if it is: (1) In the person’s own files including files maintained by employees of the person PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 in the course of their employment, (2) in commercially available data bases to which the person has purchased access, or (3) maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question. EPA believes it is appropriate to construe what ‘‘a reasonable person similarly situated might be expected to possess, control, or know,’’ based on the totality of pertinent factors. Prior loss of records consistent with document retention policies and the other individual factors cited by the commenters could be pertinent in construing what information is known or reasonably ascertainable, but they are not replacements for the regulatory standard. In any event, if a person actually knows information, then it is known or reasonably ascertainable. In the context of the CDR rule, EPA has published extensive guidance on the application of the ‘‘known to or reasonably ascertainable by’’ standard and how to address retrospective reporting in the case of corporate succession. See, e.g., TSCA Chemical Data Reporting Fact Sheet: Reporting After Changes to Company Ownership or Legal Identity, available at https:// www.epa.gov/sites/production/files/ 2015-05/documents/cdr_fact_sheet_ company_changes.pdf (Ref. 9). See also 2016 Chemical Data Reporting Frequent Questions, available at https:// www.epa.gov/sites/production/files/ 2016-07/documents/cdr_fq_final_july_ 11_2016.pdf (Ref. 10). EPA finds that guidance issued on these topics in the context of the CDR rule is also instructive in the context of this rule. EPA agrees with one commenter that the level of diligence that must be used to determine which chemical substances must be reported using an NOA Form A should be clarified, but disagrees with the suggestion that manufacturers need not report their manufacture of substances during the lookback period if the knowledge that they conducted the prior manufacture is reasonably ascertainable by them but not ‘‘readily obtainable’’ by them. EPA revised 40 CFR 710.25(a) to clarify that if it is not ‘‘known to or reasonably ascertainable by’’ a manufacturer that the person manufactured a particular substance during the lookback period, then the person is not obligated to report that substance on an NOA Form A. EPA believes that the authority to limit retrospective reporting to information that is known or reasonably ascertainable at the time of the reporting obligation is implicit in the grant of E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations rulemaking authority under TSCA section 8(b)(4), consistent with TSCA section 8(a) and the overall statutory objectives of TSCA section 8(b), and consistent with past practice for retrospective reporting on the CDR rule. The commenter set forth little basis for adopting a ‘‘readily obtainable’’ standard and EPA continues to believe (see proposal at 82 FR 4256) that it is appropriate to base this rule on basic reporting concepts that the public is already familiar with from the CDR. It would be confusing to have one standard governing the need to submit an NOA Form A (‘‘readily obtainable’’) and another standard (‘‘known to or reasonably ascertainable by’’) governing the information elements that need to be reported on the NOA Form A. Finally, EPA has already significantly addressed commenters’ broader concern about the potential burden of conducting an information search by eliminating the requirement to report the specific start and end dates of manufacture. EPA also disagrees with one commenter that 40 CFR 710.25 should be amended to specifically address entities formed during the lookback period that do not have historical records in their possession. The revision to 40 CFR 710.23 to add the definition of ‘‘Possession or Control,’’ and the revision to 40 CFR 710.25(a) to clarify application of the ‘‘known to or reasonably ascertainable by’’ standard in the context of retrospective reporting, apply to all persons subject to reporting under 40 CFR 710.25(a). It is not necessary to separately address a specific type of entity, e.g., entities formed during the lookback period, in 40 CFR 710.25. With respect to the standard of diligence for determining whether a chemical substance is subject to forward-looking reporting on an NOA Form B, EPA revised 40 CFR 710.25(c) to clarify that if it is not ‘‘known to or reasonably ascertainable by’’ a person that the substance being manufactured or processed is listed on the confidential portion of the Inventory as an inactive substance, then the person is not obligated to report that substance on an NOA Form B. This may be the case, for instance, if one person manufactures a polymer under a PMN exemption, but another manufacturer subsequently adds the same polymer to the confidential portion of the Inventory and then ceases manufacturing before the lookback period, resulting in the confidential substance being designated inactive. EPA anticipates that only persons operating under PMN exemptions will be able to avail themselves of this revision, since other VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 persons will have no basis to manufacture an Inventory chemical without knowing the Inventory identity of the chemical. With respect to the information that must be reported on an NOA Form B, believes that the question of the information reporting standard and the standard of diligence has become moot, with the elimination of all information submission requirements other than those that EPA can reasonably expect the submitter to know. By direct operation of the statute and consistent with proposed procedural rules at 40 CFR 710.25, any person who intends to manufacture or process an inactive substance, except for a nonexempt commercial purpose, must submit an NOA Form B alerting EPA to ‘‘designate the applicable chemical substance as an active substance.’’ TSCA section 8(b)(5)(B). Thus, irrespective of any rulemaking, TSCA itself requires the identity of the substance to be placed on the active Inventory to be specified. The proposed requirement to report the type of intended commercial activity has been eliminated, along with the ‘‘actual date’’ by which the inactive substance is to be manufactured or processed. If a person does not know the date by which it anticipates that the inactive substance is to be manufactured or processed, then filing NOA Form B would be inconsistent with the timing requirements of 40 CFR 710.30. Finally, EPA can reasonably expect the submitter to know its own identity. Accordingly, EPA has removed, as moot, the proposed specification in 40 CFR 710.29(c) that a person required to submit information on an NOA Form B must report information to the extent that such information is known or reasonably ascertainable by that person. Changes to the Final Rule to Clarify ‘‘Known or Reasonably Ascertainable’’ and to Add a Definition for ‘‘Possession or Control:’’ EPA added a definition for ‘‘Possession or Control’’ in the rule to clarify the existing definition of ‘‘Known to or reasonably ascertainable by.’’ See 40 CFR 710.23. EPA also revised 40 CFR 710.25(a) to clarify that if it is not ‘‘known to or reasonably ascertainable by’’ a manufacturer that the person manufactured a particular chemical substance during the lookback period, then the person is not obligated to report that substance on an NOA Form A. EPA revised 40 CFR 710.25(c) to clarify that if it is not ‘‘known to or reasonably ascertainable by’’ a person that the substance being manufactured or processed is listed on the confidential portion of the Inventory as an inactive substance, then the person is not obligated to report that substance on an PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 37535 NOA Form B. EPA removed, as moot, the proposed specification in 40 CFR 710.29(c) that a person required to submit information on an NOA Form B must report information to the extent that such information is known to or reasonably ascertainable by that person. Comment 13: Numerous commenters stated that EPA should provide a reasonable opportunity or a formal process to amend or correct retrospective notices. Several commenters suggested a time frame for corrections, e.g., up until the date that the first Inventory with active and inactive designations is published; for manufacturers, during the additional 180-day submission period for processors; and for processors, 180 days from the date that the first Inventory is published. Two commenters stated that EPA should also allow forward-looking notices to be corrected or rescinded. Several commenters indicated that corrections should be non-punitive. Response: EPA agrees in part with these comments. The 180-day retrospective submission period for manufacturers is the maximum time provided for by the statute. While EPA is not providing a formal corrections process for retrospective reporting to the regulatory text, EPA will allow retrospective reporting notices submitted by manufacturers during the 180-day submission period for manufacturers to be withdrawn not later than 420 days after the publication of the final rule in the Federal Register. EPA will allow retrospective reporting notices submitted by processors during the 420-day submission period for processors to be withdrawn not later than October 5, 2018, should processors discover errors in their original notices. See 40 CFR 710.30(a)(3). With respect to forward-looking reporting, EPA is not providing a formal corrections process but has revised the regulatory text to allow forward-looking reporting notices submitted by manufacturers or processors to be withdrawn if EPA has not yet altered the Inventory status of the chemical substance in response to the original submission (i.e., EPA has neither redesignated the substance from inactive to active nor moved the substance from the confidential portion of the Inventory to the public portion of the Inventory as a result of a request in the original submission for a CBI claim to be withdrawn). See 40 CFR 710.30(b)(3). Because a forward-looking notice will be processed even if the intended manufacture and processing does not occur as originally anticipated, and because it would be burdensome and potentially impossible to implement E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37536 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations such an approach, the rule does not allow for EPA to revert a re-activated substance back to inactive status based on a request to withdraw a Form B, or for EPA to revert a non-CBI substance back to a CBI substance based on a request to withdraw a Form B. EPA appreciates that retrospective withdrawals should be non-punitive. However, after the period allowed for withdrawal, incorrect information would be considered a prohibited act under Section 15(1) and 15(3). Similarly, incorrect information in forward-looking notices would also be considered a prohibited act under Section 15(1) and 15(3), if not withdrawn prior to EPA altering the Inventory status of the chemical substance in the original notice. Persons making corrections after these retrospective and forward-looking timeframes and seeking future penalty mitigation considerations may disclose within 21 days after they have an objectively reasonable basis for believing that a violation has, or may have, occurred, pursuant to EPA’s SelfDisclosure policies. See: https:// www.epa.gov/compliance/epasedisclosure. Changes to the Final Rule to Allow Withdrawal of a Notice of Activity Form A or Form B: EPA revised the rule to allow retrospective notices to be withdrawn if done so not later than October 5, 2018. See 40 CFR 710.30(a)(3). EPA revised the rule to allow forward-looking notices to be withdrawn if EPA has not yet altered the Inventory status of the substance in response to the original submission. See 40 CFR 710.30(b)(3). Comment 14: A few commenters requested clarification on the proposed procedures for joint submissions. One commenter requested that EPA provide a different reporting option that avoids the need for a joint submission. Two commenters requested clarification on the reporting responsibilities of manufacturers, importers, and processors when a supplier fails to submit its information. Response: EPA proposed procedures for joint submissions that will enable a company to submit a commercial activity notice for a chemical substance on the confidential portion of the Inventory in situations where the submitter does not know the specific chemical identity of the substance because a portion of the specific chemical identity is held CBI by a supplier. This rule includes such joint submission procedures that allow the submitter to provide information on the specific chemical identity that it has in its possession, and the supplier to VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 separately provide information on the specific chemical identity that it has in its possession, in a manner that protects the supplier’s CBI from the submitter of the NOA. Additionally, since publication of the proposed rule, EPA expanded its electronic reporting system to include a pick list from which persons can select chemicals for reporting. The pick list will include only reportable substances and will not include CBI. Non-CBI substances will be listed by CASRNs and CA index names, as they appear on the Inventory, and CBI substances will be listed by EPA accession numbers and generic names, as they appear on public versions of the Inventory. Submitters can identify substances from the pick list and, therefore, do not have to manually enter chemical identity information. Because the chemical identity information selected from the pick list and transmitted on the NOA form will not be CBI, there is no need for submitters who use this pick list to supply CBI to EPA. In cases involving third party CBI, a submitter can provide a single notice to EPA for a CBI substance, provided they have in their possession the corresponding non-CBI chemical identifiers, EPA accession number and generic name, by selecting the non-CBI identifiers from the pick list, thereby avoiding the need for a joint submission. If a submitting company does not know the EPA accession number and generic name, they can use existing mechanisms (e.g., Inventory Correspondence) to request such information from EPA. A submitting company that does not know the CBI chemical identity of the substance that it is required to report because of third party CBI, therefore, has two options for reporting. Such submitter can utilize the joint submission functionality in the electronic reporting tool. Alternatively, such submitter can select from the pick list based on the corresponding non-CBI chemical identifiers, EPA accession number and generic name, provided they have this information. Changes to Reporting Options for Joint Submissions: EPA revised the final rule to add a description of the pick list that will be provided in the electronic reporting system and which can serve as an alternative to a joint submission, should submitters have in their possession non-CBI chemical identifiers (EPA accession number and generic name) for a reportable CBI substance. Comment 15: A few commenters stated that the estimated reporting burden and costs are too low or unrealistic, citing the following universe estimates as underestimated: Number of PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 chemicals that are not reported under CDR because of exemptions or reporting threshold (including ten percent basis for nonexempt low volume chemicals and polymers) and total burden for processors. One commenter recommended that EPA revise the number of processors or better explain the origins of EPA’s estimation of 161,000 affected processors. Additionally, a few commenters stated that unit burden estimates per activity and/or respondent are too low, including: Cost per industry submission, time needed for data gathering, time needed for due diligence, and rule familiarization (for processors). Response: EPA agrees in part with these comments. After considering these comments, EPA adjusted the universe estimates and certain unit burden estimates. Regarding the number of chemicals and associated firms, EPA adds a group of chemicals termed ‘‘XU Chemicals’’ that was not included in estimates for the proposed rule. XU chemicals are defined in 40 CFR 711.6 and largely consist of polymers. This group of chemicals is listed on the Inventory, but is exempt from the reporting requirements of the CDR rule. Given that the CDR database is the primary source from which this rule’s economic analysis draws measurements for counts of chemicals and firms, the XU Chemicals needed to be added. Regarding the number of processors, the origin for the proposed rule estimate of 161,550 processors was derived using the total chemical count for the initial reporting period combined with a model for ‘‘processors per chemical.’’ The model is based on a previous analysis for a different proposed rule (and cited in this proposed rule’s Burden and Cost Report.) For the final rule, the model is updated using the more current CDR 2016 data; detailed methodology is provided in Table 2 footnote (Ref. 2). Due to the increased value of the model coupled with the higher chemical counts (discussed previously), processors are estimated for the final rule at 283,993 firms Regarding unit burden estimates, EPA developed estimates for typical scenarios during start up and ongoing reporting to use as the representative average and then apply universe estimates to yield total burden estimates. Individual respondents may experience lower or higher levels of burden. The activities of ‘‘time for data gathering,’’ and ‘‘time needed for due diligence’’ are included in the unit burden estimate for compliance determination. Similarly, unit burden estimate for rule familiarization is based E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations on the activities expected: ‘‘. . . becoming familiar with the full requirements of the rule, which includes reading the rule, understanding the various reporting and administrative requirements, and determining the manner in which reporting requirements will be met for each chemical substance’’ (Ref. 2). EPA also developed a range of burden hours estimates for processors’ rule familiarization during start up at one to four hours, based on EPA judgment of how processors will familiarize themselves with the rule. Changes to the Burden and Cost Estimates in the Final Rule: EPA revised the universe estimates to add XU Chemicals, and to incorporate a revised, larger estimate for the number of processor firms. EPA also revised the unit burden for processors’ rule familiarization during start up. Comment 16: One commenter indicated that EPA should justify why certification is required for non-CBI notices. Another commenter suggested the following changes to the proposed regulatory text for certification: 40 CFR 710.37(b)(3) should be corrected to ‘‘[a]n authorized official of a person’’ instead of ‘‘person,’’ 40 CFR 710.29(d)(5) should be extended to substantiations as well as to claims and notices, and 40 CFR 710.37(b)(3) should be replicated in 40 CFR 710.37(a) so that it also applies to CBI claims for chemical identity in addition to other CBI claims. Response: Certification statements are required under TSCA section 8(b)(9)(A) and are essential whenever information is submitted to the EPA. Certification statements are routinely required for data submitted to the EPA under TSCA as well as other statutes for both CBI and non-CBI submissions. Such statements ensure that the data the EPA ultimately relies on are valid and accurate. It also puts the submitter on notice of the consequences of submitting false, inaccurate, or incomplete information to the Agency. EPA agrees in large part with the comment recommending specific corrections to 40 CFR 710.37(b)(3) and 710.29(d)(5), the proposed regulatory provisions for certifications. EPA has revised the certification provisions in the rule, which currently appear at 40 CFR 710.37(e) (applicable to CBI claims and associated substantiations) and 710.29(d)(5) (applicable to all information reported on NOA Forms A and B). The rule clarifies that an ‘‘authorized official’’ submitting or substantiating any new or existing CBI claim must provide a certification, consistent with the requirements of TSCA section 14(c)(5). VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 While EPA does not agree with the commenter’s implication that a request to maintain an existing CBI claim for specific chemical identity is subject to all of the same requirements and procedures that would apply to the assertion of a new claim under TSCA section 14(c), EPA finds it appropriate under the circumstances to require a certification statement for such requests that is consistent with TSCA section 14(c)(5), in addition to meeting the certification requirement of TSCA section 8(b)(9)(A). The earlier assertion of the CBI claim for specific chemical identity may have predated current provisions under TSCA subsections 14(c)(5) and (c)(1)(B) pertaining to the certification of a specific statement required for the assertion of a CBI claim. EPA does not believe that Congress intended the Agency to review existing CBI claims for chemical identity under TSCA section 8(b) without having the benefit of this certified statement. Changes to the Certification Statements in the Final Rule. EPA revised the certification statement applicable to CBI claims to substitute ‘‘authorized official’’ for ‘‘person,’’ and to address substantiation of claims, consistent with TSCA sections 8(b)(9)(A) and 14(c)(5). Comment 17: One commenter indicated that the CBI claims process should be better defined, particularly with regard to substantiation. Two commenters stated that the substantiation questions should be reduced in scope. Response: EPA has extensively rewritten the substantiation questions from the proposal in a manner intended to more succinctly secure answers for the basis of the CBI assertions for each data element as well as the CBI concerns on the linkage of data elements. Changes to Substantiation Questions in the Final Rule: EPA has rewritten the substantiation questions to more succinctly secure answers for the basis of the CBI assertions for each data elements as well as the CBI concerns on the linkage of data elements. IV. References The following is a listing of the documents that are specifically referenced in this document. The docket includes these references and other information considered by EPA. For assistance in locating these other documents, please consult the technical contact listed under FOR FURTHER INFORMATION CONTACT. 1. 2017. EPA. TSCA Inventory Notification (Active-Inactive) Requirements; Proposed Rule. Federal Register (82 FR 4255, January 13, 2017) (FRL 9956–28). PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 37537 2. 2017. EPA. Burden and Cost Report for the Final Rule: TSCA Inventory Notification Requirements (RIN 2070–AK24, June 19, 2017). 3. 2017. EPA. Notice of Activity Form A and Form B; Final. 4. 2009. EPA. Notice of Commencement Form; Final. 5. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final Rule. Federal Register (70 FR 59848, October 13, 2005) (FRL 7977–1). 6. 2013. EPA. Electronic Reporting Under the Toxic Substances Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 2013) (FRL 9394–6). 7. 2017. EPA. Response to Comments to the Proposed Rule, TSCA Inventory Notification (Active-Inactive) Requirements; RIN 2070–AK24. Docket # EPA–HQ–OPPT–2016–0426. 8. 2016. EPA. TSCA Chemical Data Reporting Fact Sheet: Imported Articles. https:// www.epa.gov/sites/production/files/ 2015-12/documents/cdr_fact_ sheet_imported_articles_-_ final_dec2015.pdf. 9. 2016. EPA. TSCA Chemical Data Reporting Fact Sheet: Reporting After Changes to Company Ownership or Legal Identity. https://www.epa.gov/sites/production/ files/2015-05/documents/cdr_fact_sheet_ company_changes.pdf. 10. 2016. EPA. Chemical Data Reporting Frequent Questions. https:// www.epa.gov/sites/production/files/ 2016-07/documents/cdr_fq_final_ july_11_2016.pdf. 11. 2017. EPA. Information Collection Request for the TSCA section 8(b) Reporting Requirements for TSCA Inventory Notifications (EPA ICR No. 2562.02). 12. 2017. EPA. Small Entity Analysis Report for the Final Rule: TSCA Inventory Notification Requirements (May 30, 2017). V. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/ lawsregulations/laws-and-executiveorders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is not a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). B. Paperwork Reduction Act (PRA) The information collection activities associated with this rule have been submitted to OMB for review and approval under the PRA, 44 U.S.C. 3501 et seq. Specifically, EPA has prepared E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37538 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations an Information Collection Request (ICR) (identified under EPA ICR No. 2565.01 (OMB Control No. 2070–0201), that estimates the potential burden and costs associated with the paperwork requirements contained in this rule (Ref. 11). You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. Start-up year burden/cost (Retrospective). Covers respondents/ affected entities, i.e., persons who manufacture chemical substances. Respondents’ obligation to respond: Mandatory. Estimated number of respondents: 1,685. Manufacturers: 5,322. Processors: 283,993. Frequency of response: Once and on occasion. Estimated burden: The term ‘‘burden’’ is defined at 5 CFR 1320.3(b). Manufacturers: 38,613 hours. Processors: 937,347 hours. Estimated cost: Manufacturers: $3.09 million. Processors: $75.8 million. Start-up year CDX Registrations burden/cost. Respondents’ obligation to respond: Mandatory. Estimated number of respondents: (169 registrations). Frequency of response: Once and on occasion. Estimated burden: 90 hours. Estimated cost: $7,022. Ongoing annual burden/cost (Forward-looking): Covers respondents/ affected entities, i.e., persons who manufacture or process chemical substances. Respondents’ obligation to respond: Mandatory. Estimated number of respondents: 20. Frequency of response: On-occasion. Total estimated burden: 225 hours. Total estimated cost: $17,779. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9 and included on any related collection instrument (e.g., the form). When OMB approves this ICR, the Agency will announce that approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities contained in this final rule. C. Regulatory Flexibility Act (RFA) EPA certifies under section 605(b) of the RFA, 5 U.S.C. 601 et seq., that this VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule would not have a significant economic impact on a substantial number of small entities if the rule has a very small level of impact on the small entities subject to the rule. The entities subject to the requirements of this action are manufacturers, and processors of chemical substances, i.e., small businesses in NAICS 325: Chemical Manufacturing, and 324: Petroleum and Coal Products Manufacturing. The most burdensome conditions are incurred during the start-up year, when all manufacturers are expected to report, and all processors are expected to become familiar with the requirements, but only a small number of the processors will likely also report. EPA has prepared a detailed analysis to evaluate the potential impacts quantitatively, a copy of which is available in the docket (Ref. 12). The quantitative analysis addresses the ‘‘most affected’’ subset of entities who are expected to incur the highest potential burden under the rule (18 hours and $1,188 per firm) are the small entities manufacturing (or importing) chemicals that must submit NOAs involving an average of eighteen chemicals per entity in the start-up year. Although all processors are assumed to experience burden from becoming familiar with the requirements, only a small subset are expected to experience the burdens associated with submitting the NOAs. D. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded mandate as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. The action is not expected to impose enforceable duty on any state, local or tribal governments, and the requirements imposed on the private sector are not expected to result in annual expenditures of $100 million or more for the private sector. As such, EPA has determined that the requirements of UMRA sections 202, 203, 204, or 205 do not apply to this action. E. Executive Order 13132: Federalism This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it does not have any PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it is not expected to have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5–501 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not a ‘‘significant energy action’’ as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use. I. National Technology Transfer and Advancement Act (NTTAA) Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that this action would not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This action does not affect E:\FR\FM\11AUR1.SGM 11AUR1 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations the level of protection provided to human health or the environment. K. Congressional Review Act (CRA) This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 710 Chemicals, Confidential Business Information, Environmental Protection, Hazardous Substances, Reporting and Recordkeeping Requirements. Dated: June 22, 2017. E. Scott Pruitt, Administrator. Therefore, 40 CFR Chapter I is amended as follows: PART 710—[AMENDED] 1. Revise the authority citation for part 710 to read as follows: ■ Authority: 15 U.S.C. 2607(a) and (b). 2. Designate §§ 710.1 through 710.4 as subpart A, and add a heading for subpart A to read as follows: ■ Subpart A—General Provisions * * * * * 3. In § 710.1, revise paragraph (b) to read as follows: ■ § 710.1 Scope and compliance. * * * * * (b) This part applies to the activities associated with the compilation of the TSCA Chemical Substance Inventory (Inventory) and the designation of chemical substances on the TSCA Inventory as active or inactive in U.S. commerce. * * * * * ■ 4. In § 710.3, revise paragraph (d) to read as follows: § 710.3 Definitions. asabaliauskas on DSKBBXCHB2PROD with RULES * * * * * (d) The following definitions also apply to this part: Act means the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq. Administrator means the Administrator of the U.S. Environmental Protection Agency, any employee or authorized representative of the Agency to whom the Administrator may either herein or by order delegate his/her authority to carry out his/her functions, or any other person who will by operation of law be authorized to carry out such functions. VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 Article means a manufactured item: (1) Which is formed to a specific shape or design during manufacture, (2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in § 710.4(d)(5); except that fluids and particles are not considered articles regardless of shape or design. Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s). CASRN means Chemical Abstracts Service Registry Number. Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical; except that ‘‘chemical substance’’ does not include: (1) Any mixture; (2) Any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide; (3) Tobacco or any tobacco product, but not including any derivative products; (4) Any source material, special nuclear material, or byproduct material; (5) Any pistol, firearm, revolver, shells, and cartridges; and (6) Any food, food additive, drug, cosmetic, or device, when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. Commerce means trade, traffic, transportation, or other commerce: (1) Between a place in a State and any place outside of such State or (2) Which affects trade, traffic, transportation, or commerce between a place in a State and any place outside of such State. Customs territory of the United States means the 50 States, Puerto Rico, and the District of Columbia. Distribute in commerce and distribution in commerce means to sell in commerce, to introduce or deliver for introduction into commerce, or to hold after its introduction into commerce. Domestic means within the geographical boundaries of the 50 United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 37539 the Northern Mariana Islands, and any other territory or possession of the United States. EPA means the U.S. Environmental Protection Agency. Importer means any person who imports any chemical substance, including a chemical substance as part of a mixture or article, into the customs territory of the United States. ‘‘Importer’’ includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his or her behalf. The term also includes, as appropriate, (1) The consignee, (2) The importer of record, (3) the actual owner if an actual owner’s declaration and superseding bond has been filed in accordance with 19 CFR 141.20, or (4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR 144. Impurity means a chemical substance which is unintentionally present with another chemical substance. Intermediate means any chemical substance that is consumed, in whole or in part, in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or that is intentionally present for the purpose of altering the rate(s) of such chemical reaction(s). Inventory means the TSCA Chemical Substance Inventory, which is EPA’s comprehensive list of confidential and non-confidential chemical substances manufactured or processed in the United States for nonexempt commercial purpose that EPA compiled and keeps current under section 8(b) of the Act. Manufacture means to manufacture, produce, or import, for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or complex combination of chemical substances. When a chemical substance, manufactured other than by import, is: (1) Produced exclusively for another person who contracts for such production, and (2) that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technology for the plant process, then that chemical substance is co-manufactured by the producing manufacturer and the person contracting for such production. Manufacture for commercial purposes means: (1) To manufacture, produce, or import with the purpose of obtaining an immediate or eventual commercial E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES 37540 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations advantage, and includes, among other things, the ‘‘manufacture’’ of any amount of a chemical substance or mixture (i) for commercial distribution, including for test marketing, or (ii) for use by the manufacturer, including use for product research and development or as an intermediate. (2) The term also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Byproducts and impurities without separate commercial value are nonetheless produced for the purpose of obtaining a commercial advantage, since they are part of the manufacture of a chemical substance for commercial purposes. Manufacturer means a person who manufactures a chemical substance. Mixture means any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction; except that ‘‘mixture’’ does include (1) any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined, and if all of the chemical substances comprising the combination are not new chemical substances, and (2) hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water, so long as the nonhydrated form is itself not a new chemical substance. New chemical substance means any chemical substance which is not included on the Inventory. Person includes any individual, firm, company, corporation, joint-venture, partnership, sole proprietorship, association, or any other business entity; any State or political subdivision thereof; any municipality; any interstate body; and any department, agency, or instrumentality of the Federal Government. Process means to process for commercial purposes. Process includes the preparation of a chemical substance or mixture, after its manufacture, (1) in the same form or physical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or (2) as part of a mixture or article containing the chemical substance or mixture. VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 Process for commercial purposes means the preparation of a chemical substance or mixture after its manufacture for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included in this definition. If a chemical substance or mixture containing impurities is processed for commercial purposes, then the impurities also are processed for commercial purposes. Processor means any person who processes a chemical substance or mixture. Site means a contiguous property unit. Property divided only by a public right-of-way will be considered one site. More than one manufacturing plant may be located on a single site. (1) For chemical substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured. (2) The site for an importer who imports a chemical substance described in § 710.25 is the U.S. site of the operating unit within the person’s organization that is directly responsible for importing the chemical substance. The import site, in some cases, may be the organization’s headquarters in the United States. If there is no such operating unit or headquarters in the United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of process for the importer. Small quantities solely for research and development (or ‘‘small quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product’’) means quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that are not greater than reasonably necessary for such purposes. State means any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States. Technically qualified individual means a person: (1) Who because of his/her education, training, or experience, or a combination of these factors, is capable PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 of appreciating the health and environmental risks associated with the chemical substance which is used under his/her supervision, (2) Who is responsible for enforcing appropriate methods of conducting scientific experimentation, analysis, or chemical research in order to minimize such risks, and (3) Who is responsible for the safety assessments and clearances related to the procurement, storage, use, and disposal of the chemical substance as may be appropriate or required within the scope of conducting the research and development activity. The responsibilities in this paragraph may be delegated to another individual, or other individuals, as long as each meets the criteria in paragraph (1) of this definition. Test marketing means the distribution in commerce of no more than a predetermined amount of a chemical substance, mixture, or article containing that chemical substance or mixture, by a manufacturer or processor to no more than a defined number of potential customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution of that chemical substance, mixture, or article in commerce. United States, when used in the geographic sense, means all of the States, territories, and possessions of the United States. ■ 5. Add a new subpart B to read as follows: SUBPART B—COMMERCIAL ACTIVITY NOTIFICATION Sec. 710.23 Definitions. 710.25 Persons subject to the notification requirement. 710.27 Activities for which notification is not required. 710.29 Information required in the notification. 710.30 When to submit notifications. 710.33 Co-manufacturers and co-processors. 710.35 Recordkeeping requirements. 710.37 Confidentiality claims. 710.39 Electronic filing. § 710.23 Definitions. The following definitions also apply to subpart B of this part. Active substance means any interim active substance, any naturally occurring chemical substance as defined by § 710.27(b), any chemical substance that was added to the Inventory on or after June 21, 2006 pursuant to a Notice of Commencement under § 720.102 received by the Agency on or after June 21, 2006, and any chemical substance E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations subject to commercial activity designation that the Administrator designates as active based on the receipt of a notice under this subpart. Central Data Exchange or CDX means EPA’s centralized electronic document reporting portal, or its successors. Chemical substance subject to commercial activity designation means a chemical substance that requires a designation as either an active or an inactive substance. A chemical substance is subject to commercial activity designation if it is not an interim active substance, it was added to the Inventory before June 21, 2006, it is not a naturally occurring chemical substance as defined by § 710.27(b), and it has not yet been designated by the Administrator as either an active or an inactive substance. Chemical Information Submission System or CISS means EPA’s web-based reporting tool for preparing and submitting a Notice of Activity. e-NOA means EPA’s software module within CISS for generating and completing Notice of Activity Forms A and B. Existing claim for protection of specific chemical identity against disclosure is a claim for protection of the specific chemical identity of a chemical substance that is listed on the confidential portion of the Inventory, asserted prior to June 22, 2016. Inactive substance means any chemical substance subject to commercial activity designation, that the Administrator designates as inactive based on the lack of receipt of a notice under this subpart, effective 90 days after the Administrator identifies the chemical substance for such designation. Interim active substance means any chemical substance that was reported, pursuant to 40 CFR part 711, as having been manufactured in and of the calendar years: 2010, 2011, 2012, 2013, 2014, or 2015. Known to or reasonably ascertainable by means all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know. Notice of Activity Form A means the form for supplying retrospective notification under TSCA section 8(b)(4), for which the submission obligation is described in § 710.25(a). Notice of Activity Form B means the form for supplying forward-looking reporting under TSCA section 8(b)(5), for which the submission obligation is described in § 710.25(c). VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 Lookback period means the period beginning on June 21, 2006 and ending on June 21, 2016. Possession or Control means in the possession or control of any person, or of any subsidiary, partnership in which the person is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the person in the research, development, test marketing, or commercial marketing of the chemical substance in question. Information is in the possession or control of a person if it is: (1) In the person’s own files including files maintained by employees of the person in the course of their employment. (2) In commercially available data bases to which the person has purchased access. (3) Maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question. Reportable chemical substance means a chemical substance that is listed on the Inventory and that is either: (1) A chemical substance subject to commercial activity designation for which notification is required or allowed under § 710.25(a) and § 710.25(b), (2) A chemical substance that was added to the confidential portion of the Inventory before June 22, 2016, or (3) an inactive substance for which notification is required under § 710.25(c). Submission period means the applicable period for submitting a Notice of Activity under § 710.25. § 710.25 Persons subject to the notification requirement. The following persons are subject to the requirements of this subpart. (a) Who must submit the Notice of Activity Form A? Any person who manufactured (including imported) a chemical substance subject to commercial activity designation at any time during the lookback period, except as provided in § 710.27, must submit a Notice of Activity Form A as specified under § 710.29 and § 710.30(a), unless such person has evidence in the form of a CDX receipt, documenting EPA’s receipt of a Notice of Activity Form A from another person, for the same chemical substance, or unless the prior manufacturing of such a substance is not known to or reasonably ascertainable by the person. Evidence in PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 37541 the form of a CDX receipt for a Notice of Activity Form A is not a basis for exemption from the requirements of § 710.25(c) if the chemical substance is ultimately designated as inactive due to withdrawal of the Notice of Activity Form A. (b) Who else may submit the Notice of Activity Form A? Any person not required to submit a Notice of Activity Form A under § 710.25(a), who manufactured (including imported) or processed a reportable chemical substance, at any time during the lookback period, may submit a Notice of Activity Form A as specified under § 710.29 and § 710.30(a). (c) Who must submit the Notice of Activity Form B? Any person who intends to manufacture (including import) or process an inactive substance, except as provided in § 710.27, after the effective date of the Administrator’s designation of such chemical substance as an inactive substance, must submit a Notice of Activity Form B as specified under § 710.29 and § 710.30(b), unless the presence of the inactive substance on the confidential portion of the Inventory is not known to or reasonably ascertainable by the person. § 710.27 Activities for which notification is not required. (a) In general. The following activities do not trigger notification requirements under this subpart: (1) The manufacturing or processing of a chemical substance in small quantities solely for research and development. (2) The import or processing of a chemical substance as part of an article. (3) The manufacturing or processing of a chemical substance as described in § 720.30(g) or (h). (4) The manufacturing or processing of a chemical substance solely for export from the United States as described in § 720.30(e) or § 721.3, except where the Administrator has made a finding described in TSCA section 12(a)(2). (5) The manufacturing or processing of a chemical substance solely for test marketing purposes. (b) Manufacturing or processing naturally occurring chemical substances. The following activities do not trigger notification requirements under this subpart: (1) The manufacture of a naturally occurring chemical substance, as described in § 710.4(b). Some chemical substances can be manufactured both as described in § 710.4(b) and by means other than those described in § 710.4(b). If a person manufactures a chemical substance by means other than those E:\FR\FM\11AUR1.SGM 11AUR1 37542 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations described in § 710.4(b), this exemption is inapplicable, regardless of whether the chemical substance also could have been produced as described in § 710.4(b). This exemption does not cover the manufacture of a chemical substance from a naturally occurring chemical substance. (2) The processing of a naturally occurring chemical substance only by manual, mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water. asabaliauskas on DSKBBXCHB2PROD with RULES § 710.29 Information required in the notification. (a) Reporting information to EPA. A person who reports information to EPA under this subpart must do so using the e-NOA software module, the CISS reporting tool, and the CDX electronic reporting portal provided by EPA at the addresses set forth in § 710.39. For notices of activity under § 710.25(a) and § 710.25(b), the submission must include all information described in paragraph (b) of this section. For a Notice of Activity under § 710.25(c), the submission must include all information described in paragraph (c) of this section. A person must submit a separate notice for each chemical substance that the person is required to report. Using e-NOA and CISS and registering in CDX are described in instructions available from EPA at the Web sites set forth in § 710.39. (b) Information to be reported on the Notice of Activity Form A. A person submitting a Notice of Activity Form A under § 710.25(a) or § 710.25(b) must submit the information specified in § 710.29(d) for each reportable chemical substance. A person submitting information under § 710.25(a) or § 710.25(b) must report information to the extent that such information is known to or reasonably ascertainable by that person. (c) Information to be reported on a Notice of Activity Form B. Any person submitting a Notice of Activity Form B under § 710.25(c) must provide the information described in this paragraph for each inactive substance intended to be manufactured or processed. (1) Information specified in § 710.29(d). (2) The anticipated date by which the inactive substance is to be manufactured or processed in the United States. If the Notice of Activity Form B is filed prior to the effective date of the chemical substance’s inactive designation, the most recent date of manufacturing or processing may be provided in lieu of an anticipated date. VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 (d) Information to be reported on either the Notice of Activity Form A or Form B. (1) Company. The name and address of the submitting company. (2) Authorized official. The name and address of the authorized official for the submitting company. (3) Technical contact. The name and telephone number of a person who will serve as technical contact for the submitting company and who will be able to answer questions about the information submitted by the company to EPA. (4) Chemical-specific information. The system described under § 710.29(a) will provide a list of reportable chemical substances from which a person can select his or her chemical. The list will include the correct CASRN and CA Index name used to list a nonconfidential chemical substance on the Inventory. For confidential substances on the Inventory, the list will include the TSCA Accession Number and generic name. (i) If an importer submitting a notice cannot provide the information specified in § 710.29(d)(4) because it is unknown to the importer and claimed as confidential by the supplier of the chemical substance or mixture, the importer must ask the supplier to provide the specific chemical identity information directly to EPA in a joint submission using the same e-NOA software module used for commercial activity reporting. Such request must refer the supplier to EPA’s instructions for submitting chemical identity information electronically, using eNOA, CISS, and CDX (see § 710.39), and for clearly referencing the importer’s submission. Contact information for the supplier, a trade name or other name for the chemical substance or mixture, and a copy of the request to the supplier must be included with the importer’s submission. (ii) If a manufacturer or processor submitting a notice cannot provide the information specified in § 710.29(d)(4) because the reportable chemical substance is manufactured or processed using a reactant having a specific chemical identity that is unknown to the manufacturer or processor and claimed as confidential by its supplier, the manufacturer or processor must ask the supplier of the confidential reactant to provide the specific chemical identity of the confidential reactant directly to EPA in a joint submission using the same e-NOA software module used for commercial activity reporting. Such request must refer the supplier to EPA’s instructions for submitting chemical identity information electronically using PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 e-NOA, CISS, and CDX (see § 710.39), and for clearly referencing the manufacturer’s or processor’s submission. Contact information for the supplier, a trade name or other name for the chemical substance, and a copy of the request to the supplier must be included with the manufacturer’s or processor’s submission with respect to the chemical substance. (iii) Joint submissions must be submitted electronically using e-NOA, CISS, and CDX (see § 710.39). (5) Certification statements. The authorized official must certify that the submitted information has been completed in compliance with the requirements of this part as described in this paragraph. (i) The certification must be signed and dated by the authorized official for the submitting company. (ii) The following is required certification language for an authorized official submitting a Notice of Activity Form A under § 710.25(a) or § 710.25(b): ‘‘I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge, is true, accurate, and complete. I also certify that I have manufactured, imported, or processed the above chemical between the dates of June 21, 2006 and June 21, 2016. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information, and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment.’’ (iii) The following is required certification language for an authorized official submitting a Notice of Activity Form B under § 710.25(c): ‘‘I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge, is true, accurate, and complete. I also certify that I have intent to manufacture, import, or process the above chemical within 90 days of submission. I am aware it is unlawful to knowingly submit incomplete, false and/or misleading information, and there are significant criminal penalties for such unlawful conduct, including the possibility of fine and imprisonment.’’ § 710.30 When to submit notifications. (a) When must a Notice of Activity Form A be submitted? The Notice of Activity Form A required to be submitted under § 710.25(a) must be submitted during the applicable submission period. E:\FR\FM\11AUR1.SGM 11AUR1 asabaliauskas on DSKBBXCHB2PROD with RULES Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations (1) Manufacturers. The submission period for manufacturers under § 710.25(a) and § 710.25(b) begins on August 11, 2017 and ends on February 7, 2018. (2) Processors. The submission period for processors under § 710.25(b) begins on August 11, 2017 and ends on October 5, 2018. (3) Withdrawal of a Notice of Activity Form A. A Notice of Activity Form A submitted under § 710.30(a)(1) or § 710.30(a)(2) may be withdrawn by the submitter no later than October 5, 2018. If EPA receives a timely request to withdraw a previously submitted Notice of Activity Form A for a chemical substance subject to commercial activity designation, and EPA has not received a Notice of Activity Form A from another submitter for the same chemical substance, EPA will not designate the chemical substance as active. A Form A withdrawn under this paragraph will not satisfy the obligation under this rule to submit a Form A. (b) When must a Notice of Activity Form B be submitted? (1) Manufacturers and processors. The Notice of Activity Form B required to be submitted under § 710.25(c) must be submitted before a person manufactures or processes the inactive substance, but not more than 90 days prior to the anticipated date of manufacturing or processing. (2) When else may a Notice of Activity Form B be submitted? A Notice of Activity Form B that will later be required to be submitted under § 710.25(c) may be submitted during the 90-day period between EPA’s identification of a chemical substance for inactive designation and the effective date for such designation, by a person who is currently manufacturing or processing such chemical substance or who anticipates manufacturing or processing such chemical substance within 90 days following submission. (3) When may EPA execute a request to withdraw a Notice of Activity Form B? If EPA receives a request to withdraw a previously submitted Notice of Activity Form B from the submitter of the Notice of Activity Form B and EPA has neither yet moved the subject chemical substance from the inactive to the active Inventory nor yet moved the subject chemical substance from the confidential portion of the Inventory to the public portion of the Inventory as a result of the original submission, then EPA may execute the request. § 710.33 Co-manufacturers and coprocessors. (a) Notice of Activity submitted by comanufacturers. When, in a single instance of manufacturing or importing VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 a particular volume of a chemical substance during the lookback period, two or more persons qualify as the manufacturer or importer of that volume, they may determine among themselves who should make the required submission under § 710.25(a). If no notice is submitted as required under this subpart, EPA will hold each such person liable for failure to submit a notice. (b) Notice of Activity by prospective co-manufacturers or co-processors. If two or more persons intend to manufacture, import, or process a particular volume of an inactive substance, such that multiple persons would qualify as the manufacturer, importer, or processor of that volume, they may determine among themselves who will submit the required notice under § 710.25(c). If no notice is submitted as required under this subpart, all of the persons remain subject to the reporting requirements, and EPA will hold each such person liable for a failure to submit a notice prior to the date of manufacturing, importing, or processing. § 710.35 Recordkeeping requirements. Each person who is subject to the notification requirements of this part must retain records that document any information reported to EPA. Records relevant to a Notice of Activity under § 710.25(a) and § 710.25(b) must be retained for a period of 5 years beginning on the last day of the submission period. Records relevant to a Notice of Activity under § 710.25(c) must be retained for a period of 5 years beginning on the day that the notice was submitted. § 710.37 Confidentiality claims. (a) Chemical identity. A person submitting information under this part may request to maintain an existing claim of confidentiality for the specific chemical identity of a reportable chemical substance, but may do so only if the identity of the chemical substance is listed on the confidential portion of the Inventory as of the time the notice is submitted for that chemical substance under this part. A request to maintain an existing claim of confidentiality must be made at the time the information is submitted. If no person submitting the information specified in § 710.29(d)(4) for a particular chemical substance requests that the claim be maintained, EPA will treat the specific chemical identity of that chemical substance as not subject to a confidentiality claim and will move the chemical substance to the public portion of the Inventory. Except as set forth in this subsection, PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 37543 information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2, subpart B. (1) Notice of Activity Form A. A person requesting to maintain an existing claim of confidentiality for specific chemical identity may submit with the notice answers to the questions in paragraphs (c)(1) and(c)(2) of this section, signed and dated by an authorized official. If these answers are submitted less than five years before the date on which substantiation is due pursuant to TSCA section 8(b)(4)(D)(i), the answers will be deemed to be substantiations made under TSCA section (8)(b)(4)(D)(i) and the person will be exempt from further substantiation requirements under TSCA section (8)(b)(4)(D)(i). Answers that do not include the answers to all applicable questions in paragraph (c) of this section will not be deemed to be substantiations made under the TSCA section (8)(b)(4)(D)(i) requirement. (2) Notice of Activity Form B. A person requesting to maintain an existing claim of confidentiality for specific chemical identity must submit answers to the questions in paragraphs (c)(1) and (c)(2) of this section within 30 days of submitting the notice, signed and dated by an authorized official. If this information is not submitted within 30 days of submitting the notice, EPA will consider the confidentiality claim as deficient, so that the specific chemical identity is not subject to a confidentiality claim, and may make the information public without further notice. (b) Information other than specific chemical identity. A person submitting information under this part may assert a claim of confidentiality for information other than specific chemical identity. Any such confidentiality claim must be made at the time the information is submitted. Except as set forth in this section, information claimed as confidential in accordance with this subsection will be treated and disclosed in accordance with 40 CFR part 2, subpart B. A person asserting a claim of confidentiality under this subsection must submit with the notice answers to the questions in paragraph (c)(1) of this section, signed and dated by an authorized official. If no claim is asserted at the time the information is submitted, or if the answers to the questions in paragraph (c)(1) of this section are not provided, EPA will consider the information as not subject to a confidentiality claim and may make the information public without further notice. E:\FR\FM\11AUR1.SGM 11AUR1 37544 Federal Register / Vol. 82, No. 154 / Friday, August 11, 2017 / Rules and Regulations asabaliauskas on DSKBBXCHB2PROD with RULES (c) Substantiation questions. Persons asserting that information is exempt from substantiation pursuant to TSCA section 14(c)(2) must answer only the question in paragraph (c)(1)(i) of this section. (1) Substantiation questions for any confidentiality claim. For any information with a confidentiality claim that you assert is exempt from substantiation pursuant to TSCA section 14(c)(2), answer only the question in paragraph (c)(1)(i) of this section. For all other information with a confidentiality claim, answer the questions in paragraphs (c)(1)(ii) through (vi) of this section. If more than one data element on Form A or Form B is claimed as confidential, you must answer the applicable questions individually for each data element. If the answer to a question applies for all confidentiality claims on the form, indicate this in your substantiation response. (i) Do you believe that the information is exempt from substantiation pursuant to TSCA section 14(c)(2)? If you answered yes, you must individually identify the specific information claimed as confidential and specify the applicable exemption(s). (ii) Will disclosure of the information likely result in substantial harm to your business’s competitive position? If you answered yes, describe with specificity the substantial harmful effects that would likely result to your competitive position if the information is made available to the public. (iii) To the extent your business has disclosed the information to others (both internally and externally), what precautions has your business taken? Identify the measures or internal controls your business has taken to protect the information claimed as confidential: Non-disclosure agreement required prior to access; access is limited to individuals with a need-toknow; information is physically secured; other internal control measure(s). If yes, explain. (iv) Does the information appear in any public documents, including (but not limited to) safety data sheets, advertising or promotional material, professional or trade publication, or any other media or publications available to VerDate Sep<11>2014 16:16 Aug 10, 2017 Jkt 241001 the general public? If you answered yes, explain why the information should be treated as confidential. (v) Is the claim of confidentiality intended to last less than 10 years? If so, indicate the number of years (between 1–10 years) or the specific date/ occurrence after which the claim is withdrawn. (vi) Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If you answered yes, explain the outcome of that determination and provide a copy of the previous confidentiality determination or any other information that will assist in identifying the prior determination. (2) Substantiation for confidentiality claims for chemical identity. Is the confidential chemical substance publicly known to have ever been offered for commercial distribution in the United States? If you answered yes, explain why the information should be treated as confidential. (d) Confidentiality of substantiation. If any of the information contained in the answers to the questions listed in paragraph (c)(1) or (c)(2) of this section is claimed as confidential business information, the submitter must clearly indicate such by marking the substantiation as confidential business information as provided in a Notice of Activity Form A or Form B. (e) Certification statement for claims. An authorized official of a person submitting or substantiating a claim of confidentiality or a request to maintain an existing claim of confidentiality for specific chemical identity must certify that the submission complies with the requirements of this part by signing and dating the following certification statement: ‘‘I certify that all claims for confidentiality made or sought to be maintained with this submission are true and correct, and all information submitted herein to substantiate such claims is true and correct. Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001.’’ I further certify that it is true and correct that: PO 00000 Frm 00034 Fmt 4700 Sfmt 9990 (1) My company has taken reasonable measures to protect the confidentiality of the information; (2) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (3) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and (4) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering. § 710.39 Electronic filing. (a) EPA will accept information submitted under this subpart only if submitted in accordance with this section. All information must be submitted electronically to EPA via CDX. Prior to submission to EPA via CDX, Notices of Activity and any associated information must be generated and completed using the eNOA software module. (b) Obtain instructions for registering in CDX as follows: (1) Web site. The CDX Registration User Guide is available at https:// www.epa.gov/sites/production/files/ documents/cdx_registration_guide_v0_ 02.pdf. To register in CDX, go to https:// cdx.epa.gov and follow the appropriate links. (2) Telephone. Contact the EPA CDX Help Desk at 1–888–890–1995. (3) Email. Email the EPA CDX Help Desk at HelpDesk@epacdx.net. (c) Obtain instructions for using CISS and the e-NOA software module as follows: (1) Web site. Go to the EPA New Chemicals under the Toxic Substances Control Act Web site at https:// www.epa.gov/reviewing-newchemicalsunder-toxic-substancescontrol-act-tsca/how-submit-e-pmn and follow the appropriate links. (2) Telephone. Contact the EPA TSCA Hotline at 1–202–554–1404. (3) Email. Email the EPA TSCA Hotline at TSCA-Hotline@epa.gov. [FR Doc. 2017–15736 Filed 8–10–17; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\11AUR1.SGM 11AUR1

Agencies

[Federal Register Volume 82, Number 154 (Friday, August 11, 2017)]
[Rules and Regulations]
[Pages 37520-37544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15736]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 710

[EPA-HQ-OPPT-2016-0426; FRL-9964-22]
RIN 2070-AK24


TSCA Inventory Notification (Active-Inactive) Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The 2016 amendments to the Toxic Substances Control Act (TSCA) 
require EPA to designate chemical substances on the TSCA Chemical 
Substance Inventory as either ``active'' or ``inactive'' in U.S. 
commerce. To accomplish that, EPA is establishing a retrospective 
electronic notification of chemical substances on the TSCA Inventory 
that were manufactured

[[Page 37521]]

(including imported) for nonexempt commercial purposes during the 10-
year time period ending on June 21, 2016, with provision to also allow 
notification by processors. EPA will use these notifications to 
distinguish active substances from inactive substances. EPA will 
include the active and inactive designations on the TSCA Inventory and 
as part of its regular publications of the Inventory. EPA is also 
establishing procedures for forward-looking electronic notification of 
chemical substances on the TSCA Inventory that are designated as 
inactive, if and when the manufacturing or processing of such chemical 
substances for nonexempt commercial purposes is expected to resume. On 
receiving forward-looking notification, EPA will change the designation 
of the pertinent chemical substance on the TSCA Inventory from inactive 
to active. EPA is establishing the procedures regarding the manner in 
which such retrospective and forward-looking activity notifications 
must be submitted, the details of the notification requirements, 
exemptions from such requirements, and procedures for handling claims 
of confidentiality.

DATES: This final rule is effective on August 11, 2017.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2016-0426, is available 
electronically at http://www.regulations.gov or in person at the Office 
of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental 
Protection Agency Docket Center (EPA/DC), West William Jefferson 
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. 
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Public Reading Room is (202) 566-1744, and the telephone number for the 
OPPT Docket is (202) 566-0280. Please review the visitor instructions 
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Myrta R. Christian, Chemistry, Economics, and Sustainable Strategies 
Division (Mailcode 7406M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8498; email 
address: christian.myrta@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Who does this action apply to?

    You may be affected by this action if you domestically 
manufactured, imported, or processed a chemical substance listed on the 
TSCA Chemical Substance Inventory for nonexempt commercial purpose 
during the 10-year time period ending on June 21, 2016. You may also be 
affected by this action if you intend to domestically manufacture, 
import, or process in the future a chemical substance listed on the 
TSCA Chemical Substance Inventory.
    The following North American Industrial Classification System 
(NAICS) codes are not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this action may apply to them:
     Chemical manufacturing or processing (NAICS code 325).
     Petroleum and Coal Products Manufacturing (NAICS code 
324).
    In addition, the discussion in Unit II.A. describes in more detail 
which chemical substances will and will not be subject to reporting 
under this action. You may also consult the regulatory text in this 
document for further information on the applicability of exemptions to 
this rule.
    Note that TSCA's statutory definition of ``manufacture'' includes 
importing. Accordingly, the regulatory definition of ``manufacture'' 
for this rule includes importation. Since ``manufacture'' is itself 
defined (in this rule and in TSCA) to include ``import,'' it is clear 
that importers are a subset of manufacturers. All references to 
manufacturing in this notice should be understood to also encompass 
importing. Where EPA's intent is to specifically refer to domestic 
manufacturing or importing (both activities constitute 
``manufacture''), this rule will do so expressly.

B. What action is the Agency taking?

    On January 13, 2017 (82 FR 4255, FRL-9956-28) (Ref. 1), EPA 
proposed procedural reporting requirements for persons who manufactured 
(including imported) in the past or intend to manufacture in the future 
chemical substances on the TSCA Inventory (hereafter referred to as the 
``Inventory''). EPA received numerous public comments on the proposed 
rule. This final rule is based on that proposal and the consideration 
of the public comments received.
    This TSCA section 8(b) rule requires electronic reporting of 
chemical identity from persons who manufactured a chemical substance 
for nonexempt commercial purpose during the 10-year time period ending 
on June 21, 2016. EPA will accept notices for substances that were 
processed during the same ten-year time period. EPA will use the 
chemical identity information obtained from this retrospective 
reporting to designate as active those substances on the Inventory for 
which notices were received. If no notice is received during this 
retrospective reporting for a substance subject to designation on the 
Inventory, then that substance will be designated as inactive.
    This rule also requires electronic reporting of certain information 
from persons who in the future intend to manufacture or process an 
inactive substance on the Inventory for nonexempt commercial purpose. 
The information to be reported includes chemical identity and the date 
when manufacturing or processing is anticipated to resume. Upon receipt 
of such notices, EPA will change the designation on the Inventory from 
inactive to active.
    This rule includes procedures for persons who co-manufacture or co-
process a reportable chemical substance. These procedures will allow 
the submission of a single commercial activity notice where there has 
been co-manufacturing or co-processing of a particular volume of a 
substance. These procedures are similar to TSCA Chemical Data Reporting 
(CDR) rule requirements (40 CFR 711.22) when two or more persons are 
involved in a particular manufacture or import transaction.
    This rule also includes a simplified procedure for filing a 
submission, including when specific chemical identity information is 
claimed to be confidential business information (CBI) by a supplier, 
and finalizes the proposed procedure for filing a joint submission. See 
response to Comment 14 in Unit III. EPA expanded its electronic 
reporting system to include a pick list from which persons can select 
chemicals for reporting. The pick list will include only reportable 
chemical substances and will not include CBI. Substances that are on 
the confidential portion of the Inventory will be listed on the pick 
list by EPA accession numbers and generic names, as they appear on 
public versions of the Inventory. In cases where specific chemical 
identity is claimed CBI by a supplier, a submitter can provide a single 
notice to EPA for a CBI substance if it has in its possession the

[[Page 37522]]

corresponding non-CBI chemical identifiers (EPA accession number and 
generic name).
    If a manufacturer or processor cannot provide the specific chemical 
identity of a reportable chemical substance to EPA because the 
information is claimed CBI by a supplier, and therefore is unknown to 
the importer, the submitter will be required to ask the supplier to 
provide the CBI chemical identity information directly to the Agency in 
a joint submission. EPA will only accept joint submissions that are 
submitted electronically using CDX. This requirement is similar to CDR 
rule requirements (40 CFR 711.15) and will allow EPA to obtain the 
information necessary to identify the specific chemical identity of a 
reportable substance and designate it as active on the Inventory.
    This rule also finalizes proposed changes to 40 CFR 710.3 
definitions. These changes were proposed to conform the definitions 
applicable to these reporting requirements with those that apply to CDR 
rule requirements (definitions found at 40 CFR 704.3 and 711.3) and the 
submission of Premanufacture Notices (PMNs) (definitions found at 40 
CFR 720.3). Finally, this rule finalizes recordkeeping requirements as 
required by TSCA section 8(b)(9)(B). Records relevant to retrospective 
notification must be retained for a period of 5 years beginning on the 
last day of the submission period. Records relevant to forward-looking 
notification must be retained for a period of 5 years beginning on the 
day that the notice was submitted.

C. Why is the Agency taking this action?

    TSCA section 8(b)(4)(A) requires EPA to issue a final rule for 
retrospective reporting by June 22, 2017. This rule will enable EPA to 
fulfill a statutory obligation to designate chemical substances on the 
Inventory as active or inactive in U.S. commerce. TSCA section 
8(b)(5)(B) further establishes a forward-looking reporting requirement 
that goes into effect as soon as EPA designates inactive substances. 
This rule also establishes the procedural framework whereby 
manufacturers and processors will discharge their notice obligations 
under this section of TSCA.
    This rule and designations under the rule are not intended to 
indicate conclusions about the risks of chemical substances on the 
Inventory. Nonetheless, the designation of a substance as active or 
inactive will be relevant to the Agency's prioritization of substances 
in U.S. commerce under TSCA section 6(b).

D. What is the Agency's authority for taking this action?

    EPA is issuing this rule under TSCA section 8(b), 15 U.S.C. 
2607(b). TSCA was amended by the Frank R. Lautenberg Chemical Safety 
for the 21st Century Act, Public Law 114-182. The Government Paperwork 
Elimination Act (GPEA), 44 U.S.C. 3504, provides that, when 
practicable, Federal organizations use electronic forms, electronic 
filings, and electronic signatures to conduct official business with 
the public.
    Under section 553(d) of the Administrative Procedure Act, 5 U.S.C. 
553(d), the Agency may make a rule immediately effective ``for good 
cause found and published with the rule.'' EPA finds that there is 
``good cause'' to make this rule effective upon publication in the 
Federal Register because the deadline for manufacturers to submit 
retrospective reports under this rule is fixed by statute at ``180 days 
after the date on which the final rule is published in the Federal 
Register.'' TSCA section 8(b)(4)(A)(i). Because the submission deadline 
is tied by statute to the date of the rule's publication, rather than 
the effective date of the rule, delaying the effective date of this 
rule would not afford any additional time for manufacturers to comply 
with reporting requirements. Rather, delaying the effective date of the 
rule would push back the start of the submission period for 
retrospective reporting, but not the end of the submission period 
(which remains fixed by statute), leaving manufacturers with a shorter 
period (less than 180 days) during which notices may be submitted. 
Thus, any impact on the regulated community of making the rule 
immediately effective is expected to be beneficial, given that an 
immediate effective date provides manufacturers with the greatest 
possible timing discretion regarding when to submit retrospective 
reports.

E. What are the estimated incremental impacts of this action?

    EPA has reevaluated the potential costs of establishing the 
reporting requirements for manufacturers and processors in response to 
comments received. This analysis, which is available in the docket, is 
discussed in Unit V. and briefly summarized here (Ref. 2).
    During the retrospective (or ``start-up'') period, between 
approximately June 2017 and June 2018, typical costs per firm are 
estimated at $1,188 per submission (with an estimated eighteen 
chemicals per submission), with possible additional costs at $41.55 per 
CDX registration in the event that the submitter is not currently 
registered in CDX. Among manufacturers, an estimated 5,322 firms will 
undertake rule familiarization with 1,585 completing compliance 
determination, form completion, and recordkeeping. For manufacturers, 
the total burden during start-up is estimated at 38,613 hours with an 
associated total cost of $3.09 million. For processors, an estimated 
283,993 firms will undertake rule familiarization, with 100 completing 
compliance determination, form completion, and recordkeeping.
    For processors completing rule familiarization only, the cost 
entails 3.30 hours on average per firm (under $300 per firm). For 
processors who complete a submission, typically involving one chemical, 
the burden for rule familiarization, compliance determination, form 
completion and recordkeeping during the start-up year is estimated at 
500 hours with an associated cost of $0.04 million. Lastly, for 169 new 
CDX registrations (for individuals lacking previous experience with 
electronic reporting to EPA), burden during start-up is estimated at 90 
hours with an associated cost of $0.007 million.
    The rule has minimal burden and cost implications related to 
ongoing reporting with the typical cost per firm estimated at $889 per 
submission after the start-up year. The forward-looking (or 
``ongoing'') reporting after June 2018 involves compliance 
determination, form completion, and recordkeeping for twenty 
manufacturers and/or processors per year. Burden and cost are estimated 
to total 225 burden hours per year with an associated cost of $17,779 
per year.
    Agency activities due to the rule include CDX and Chemical 
Information Submission System (CISS) capacity expansions, time to 
manage commercial activity notices, and increased costs incurred when 
making revisions to the Inventory. Associated costs are estimated at 
$3.62 million during start-up, and $0.22 million annually thereafter.
    Combining Industry and Agency cost estimates, and annualizing over 
a 10-year period, the total cost of the rule is estimated at $9.7 
million per year using a 3% discount rate, and at $11.8 million per 
year using a 7% discount rate.

II. Summary of the Final Rule

    EPA is describing in this unit the reporting requirements for 
manufacturers and processors of chemical substances pursuant to TSCA 
section 8(b). EPA developed two versions of a Notice of Activity (NOA) 
reporting form for submitting the information described in this rule 
for

[[Page 37523]]

the two reporting scenarios, retrospective and forward-looking (Ref. 
3). The Notice of Activity Form A (EPA Form No. TBD-1) will be used for 
retrospective reporting, and the Notice of Activity Form B (EPA Form 
No. TBD-2) will be used for forward-looking reporting.
    EPA intends that the provisions of this rule be severable. In the 
event that any individual provision or part of the rule is invalidated, 
EPA intends that this would not render the entire rule invalid, and 
that any individual provisions that can continue to operate will be 
left in place.

A. What chemical substances and activities are reportable under this 
rule?

    1. Reportable chemical substances. The retrospective reporting 
requirements of this rule apply to chemical substances listed on the 
Inventory that were manufactured for nonexempt commercial purposes 
during the 10-year period ending on June 21, 2016. This 10-year period, 
referred to here as the ``lookback period,'' is set by statute. The 
forward-looking reporting requirements apply to substances listed as 
inactive on the Inventory that are to be reintroduced into U.S. 
commerce for nonexempt purposes. The Inventory is available at https://www.epa.gov/tsca-inventory.
    2. Exemptions from reporting. i. Excluded chemical substances. The 
scope of chemical substances covered under this rule is reflected in 
the definitions of ``chemical substance subject to commercial activity 
designation,'' and ``reportable chemical substance,'' at 40 CFR 710.23, 
which exclude substances that are not chemical substances and 
substances that are not listed on the Inventory. For example, a 
substance that is not considered a ``chemical substance'' (as provided 
in subsection 3(2)(B) of TSCA and in the definition of ``chemical 
substance'' in 40 CFR 710.3(d)) is not a ``chemical substance subject 
to commercial activity designation'' or a ``reportable chemical 
substance'' and it thus cannot become an ``active substance'' or an 
``inactive substance.'' A similar analysis applies with respect to a 
mixture (as defined in 40 CFR 710.3(d)), although individual Inventory-
listed substances present in the mixture may be subject to reporting. 
Additionally, a substance that has not been added to the Inventory 
because it is manufactured solely under a TSCA section 5(h) exemption 
(e.g., low releases and low exposures exemption, low volume exemption, 
polymer exemption, research and development exemption, test marketing 
exemption) is not a ``chemical substance subject to commercial activity 
designation'' or a ``reportable chemical substance'' and it cannot 
become an ``active substance'' or an ``inactive substance.'' See 
response to Comment 1 in Unit III.
    Naturally occurring chemical substances also are excluded from 
reporting under this rule, as long as the manufacturing and processing 
of such substances meet the criteria set forth in 40 CFR 710.27(b). 
Naturally occurring substances are considered to be automatically 
included on the Inventory as the category ``Naturally Occurring 
Chemical Substances'' (42 FR 64578). EPA is designating the whole 
category of Naturally Occurring Chemical Substances as active 
substances by this rule, thereby excluding them from reporting under 
this rule.
    ii. Manufacturing or processing for an exempt commercial purpose. 
Manufacturing or processing a chemical substance listed on the 
Inventory solely for an exempt commercial purpose is not subject to 
reporting requirements under TSCA section 8(b)(4) or 8(b)(5). The 
statute limits these notification obligations to manufacturing and 
processing for ``nonexempt commercial purpose.'' The scope of 
manufacturing or processing for an exempt commercial purpose is set 
forth in 40 CFR 710.27(a). While EPA expects that many chemical 
substances manufactured or processed for exempt commercial purposes 
will not be listed on the Inventory (due to similar exemptions under 
PMN regulations), and therefore are already excluded from reporting 
under this rule, the activity exemptions listed at 40 CFR 710.27(a) 
clarify circumstances under which a person is exempt from reporting 
requirements for the manufacturing or processing of a chemical 
substance that has been listed on the Inventory (e.g., due to another 
manufacturer's actions). For example, the manufacturing or processing 
of impurities or byproducts that have no subsequent commercial purpose 
will not trigger reporting obligations under this rule. See 40 CFR 
710.27(a)(3). Additionally, manufacturing or processing in small 
quantities solely for research and development is exempt as described 
in 40 CFR 710.3(d) and 40 CFR 710.27(a)(1). Furthermore, the import or 
processing of substances solely as part of articles is not subject to 
reporting under this rule. See 40 CFR 710.27(a)(2) and response to 
Comment 2 in Unit III. In response to comments, EPA revised the rule to 
clarify that manufacturing or processing a chemical substance solely 
for export from the United States or for test marketing purposes are 
also exempt commercial purposes not subject to reporting requirements 
under this rule. See 40 CFR 710.27(a)(4) and (5) and response to 
Comment 1 in Unit III.
    iii. Chemical substances for which EPA already has an equivalent 
notice. EPA is establishing an exemption from the retrospective 
reporting requirement for three different circumstances in which EPA 
has already received equivalent notice that a chemical substance was 
manufactured during the lookback period, and further requirement to 
submit a notice would therefore be inconsistent with TSCA section 
8(a)(5)(B).
    First, chemical substances that are on the interim list of active 
substances described in TSCA section 8(b)(6) will be designated as 
active substances, by operation of this rule, and they are exempted 
from retrospective notification requirements under this rule. The 
interim list will be available on the TSCA Inventory Web page (see 
https://www.epa.gov/tsca-inventory), and is comprised of all chemical 
substances reported in 2012 or 2016 under the CDR rule, 40 CFR part 
711. See 82 FR 4259. A CDR notice from 2012 or 2016 provides equivalent 
notice to EPA that the substance was manufactured during the lookback 
period. In response to comments, this exemption now applies 
irrespective of whether the substance is on the confidential portion of 
the Inventory. See 40 CFR 710.23 for revised definition of ``interim 
active substance'' and response to Comment 3 in Unit III.
    Second, chemical substances that were added to the Inventory during 
the ten-year time period ending on June 21, 2016, pursuant to a Notice 
of Commencement (NOC) under 40 CFR 720.102 received by the Agency 
between June 21, 2006 and June 21, 2016, will be designated as active 
substances, by operation of this rule, and they are exempted from 
retrospective notification requirements under this rule. An NOC is 
required to be submitted on or no later than 30 calendar days after the 
first day of manufacture for commercial purpose. Additionally, an NOC 
substance is considered to be added to the Inventory on the date the 
NOC is received by EPA, provided that the EPA determines the NOC to be 
valid during its review. Therefore, a processed NOC provides equivalent 
notice that the substance was manufactured or processed during the 
lookback period. This exemption applies irrespective of whether the 
substance is on the confidential portion of the Inventory. See 40 CFR 
710.23 for revised definitions of ``active substance,'' ``chemical 
substance subject

[[Page 37524]]

to commercial activity designation,'' and response to Comment 4 in Unit 
III.
    Third, a manufacturer is exempt from the retrospective notification 
requirements under this rule, for a particular chemical substance, if 
the manufacturer has evidence in the form of a CDX receipt, documenting 
EPA's receipt of an NOA Form A from another manufacturer. See 40 CFR 
710.25(a) and response to Comment 6 in Unit III. Manufacturers should 
keep in mind, however, that they bear the risk of failing to submit a 
required forward-looking notification (NOA Form B) notice if they rely 
on this Form A exemption, and the Form A notice (for which they have a 
CDX receipt) is later withdrawn, leading to the substance being 
designated as inactive. Furthermore, one manufacturer's expectation 
that another manufacturer will later submit an NOA Form A is not an 
acceptable basis for relying on this exemption. Since it is only 
submitters who will be notified of errors, manufacturers relying on the 
exemption are responsible for assuring their substance is designated as 
commercially active.
    iv. Inapplicability of exemptions to persons seeking to maintain an 
existing CBI claim for specific chemical identity. Persons who 
manufactured or processed a chemical substance on the confidential 
portion of the Inventory, that was added to the Inventory prior to June 
22, 2016, should recognize that they must submit an NOA Form A to EPA 
if they wish to indicate that they ``seek to maintain an existing claim 
for protection against disclosure of the specific chemical identity of 
the substance as confidential.'' See TSCA 8(b)(4)(B)(ii) and response 
to Comment 3 in Unit III. This includes persons that, during the 
lookback period, manufactured or processed a confidential substance on 
the Inventory for which EPA already has an equivalent notice (as 
described in paragraph A.2.iii. of this Unit). It may also potentially 
include persons that, during the lookback period, manufactured or 
processed a confidential substance on the Inventory for an exempt 
commercial purpose (as described in paragraph A.2.ii. of this Unit), if 
such substance is designated active due, for instance, to EPA's receipt 
of an equivalent notice (such as an NOC or CDR report). In connection 
with extending manufacturers' reporting exemptions to cover substances 
on the confidential portion of the Inventory, EPA has revised 40 CFR 
710.25(b) to clarify manufacturers' and processors' discretion to 
report. If manufacturers elect not to submit a notice because they are 
availing themselves of one of the exemptions described previously, then 
they are foregoing their opportunity to maintain an existing claim for 
protection against disclosure of the specific chemical identity of the 
substance as confidential. EPA is required, by statute, to move from 
the confidential to the public portion of the Inventory any active 
chemical substance for which no request is received to maintain an 
existing CBI claim for chemical identity. See TSCA section 
8(b)(4)(B)(iv) and 40 CFR 710.37(a).
    3. Chemical substances added to the Inventory on or after June 22, 
2016. Chemical substances added to the Inventory on or after June 22, 
2016 will be designated as active, by operation of this rule. Such 
substances are not subject to reporting under this rule. Furthermore, 
such substances are beyond the scope of the CBI claim maintenance 
provision under TSCA section 8(b)(4)(B)(ii). This CBI maintenance 
provision is intended to address ``existing claim[s] for protection 
against disclosure of the specific chemical identity.'' EPA interprets 
this to be a reference to CBI claims asserted prior to June 22, 2016. 
See 40 CFR 710.23 for revised definition of ``active substance.''

B. When will reporting be required?

    1. Retrospective reporting period for manufacturers. Manufacturers 
must report to EPA not later than 180 days after the final rule is 
published in the Federal Register. The 180-day time period for this 
retrospective reporting for manufacturers is the maximum time allowed 
under TSCA section 8(b)(4)(A). Following this retrospective reporting 
for manufacturers, EPA will include the active designations, determined 
by the notices received, on a draft of the Inventory. EPA will publish 
this draft Inventory with the active designations as soon as is 
practicable following the close of the 180-day submission period for 
manufacturers. This draft Inventory with active designations will not 
have the legal effect of actually designating any chemical substance as 
inactive. EPA, therefore, does not construe this draft Inventory as the 
list with ``designations of active substances and inactive substances'' 
(TSCA section 8(b)(5)(A)) from which forward-looking reporting 
commences (TSCA section 8(b)(5)(B)). EPA concludes that the statute is 
referring in both sections to the completed product of the initial 
cycle of sorting between active and inactive substances, not the 
preliminary product of the initial cycle of such sorting (i.e., a draft 
Inventory released between manufacturer and processor reporting).
    2. Retrospective reporting period for processors. Processors may 
report to EPA not later than 420 days after the final rule is published 
in the Federal Register. EPA originally proposed that processors may 
report not later than 360 days after the final rule is published in the 
Federal Register. EPA's rationale was that the additional 180-day time 
period for processors would allow processors to search EPA's 
publication of the draft Inventory with active designations, based on 
the retrospective reporting by manufacturers, and to report only those 
chemical substances not already reported. In response to comments 
received that the additional 180-day submission period for processors 
should begin on the date on which the draft Inventory is published, 
which EPA anticipates will likely occur approximately 60 days after the 
180-day submission period for manufacturers closes, and to a comment 
that the rule should specify a fixed date on which the processor 
submission period will end, EPA is finalizing the rule such that 
processors may report not later than 420 days, rather than 360 days, 
after the final rule is published in the Federal Register. See 40 CFR 
710.30(a)(2) and response to Comment 7 in Unit III.
    Processors have the option to simply not report under TSCA section 
8(b)(4) and continue processing until the effective date of EPA's 
designation of a chemical substance as inactive on the Inventory. At 
such time, any further processing of the substance for a nonexempt 
commercial purpose, without prior notification to EPA, will be 
prohibited by TSCA section 8(b)(5). Earlier notification under TSCA 
section 8(b)(4) will allow EPA to add the substance to the Inventory as 
an active substance, so that processing can continue without the need 
for a later notification under TSCA section 8(b)(5).
    3. Forward-looking reporting. The forward-looking reporting period 
begins on the effective date of EPA's final active/inactive substance 
designations. Manufacturers and processors intending to reintroduce 
into U.S. commerce for a nonexempt commercial purpose a chemical 
substance designated as inactive on the Inventory must report to EPA 
not more than 90 days before the anticipated date of manufacturing or 
processing. EPA originally proposed that forward-looking notices would 
be required to be submitted not more than 30 days before the date of 
manufacturing or processing. EPA agrees with commenters that notices 
should be submitted based on the anticipated (not actual) date of

[[Page 37525]]

manufacturing or processing. EPA also finds that extending such 
submission period from 30 to 90 days prior to resuming manufacturing or 
processing will afford manufacturers and processors additional time to 
adjust to information and schedule changes and will not significantly 
impact the accuracy of notices submitted. See 40 CFR 710.29(c)(2), 40 
CFR 710.30(b)(1), and response to Comment 8 in Unit III.
    4. Transitional period reporting and effective date for inactive 
substance designations. The structure of the reporting requirements 
under TSCA sections 8(b)(4)(A) and 8(b)(5)(B) results in a transitional 
period beginning on June 22, 2016 (the day after the lookback period 
for retrospective reporting ends) and ending on the date that EPA 
designates chemical substances on the Inventory as active or inactive 
(the day that forward-looking reporting begins). It is possible that 
substances that were not manufactured or processed during the lookback 
period--and therefore cannot be designated as active through 
retrospective reporting--may be reintroduced into U.S. commerce during 
this transitional period. In response to comments expressing concern 
that persons who began manufacturing or processing such substances 
during the transitional period might be obliged to curtail 
manufacturing or processing on the date that EPA publishes an inactive 
substance designation, or else find themselves in violation of the 
forward-looking notice requirement, EPA is establishing an effective 
date provision for the designation of a chemical substance as an 
inactive substance. As ``inactive substance'' is now defined, a 
substance is not designated as an ``inactive substance'' until 90 days 
after EPA has identified the substance for inactive designation. EPA 
will identify chemical substances for inactive designation in a signed 
action accompanying the first version of the Inventory with all 
finalized active-inactive listings. EPA expects to publish this first 
version of the Inventory with all listings identified as active or 
inactive as soon as practicable after compilation, in a posting on 
EPA's TSCA Inventory Web page (see https://www.epa.gov/tsca-inventory). 
See 40 CFR 710.23 for revised definition of ``inactive substance'' and 
response to Comment 9 in Unit III.
    Accordingly, the rule clarifies that the obligation to submit an 
NOA Form B does not arise until 90 days after EPA has identified 
chemical substances for the inactive designation. The rule also 
clarifies that manufacturers and processors will be permitted to submit 
an NOA Form B for a substance that EPA has identified for inactive 
designation, even before the effective date of such designation has 
arrived, and thus before the substance has the legal status of being 
inactive. Thus, persons manufacturing or processing a substance for 
nonexempt commercial purpose during the transitional period are 
afforded time to react to an inactive substance identification and are 
permitted to file an NOA Form B prior to the effective date of the 
substance being designated as inactive. Similarly, persons that 
anticipate reintroducing a substance into U.S. commerce for nonexempt 
commercial purpose shortly after EPA identifies such substance as 
inactive are afforded time to react to an inactive substance 
identification and are permitted to file an NOA Form B prior to the 
effective date of the inactive designation, so long as such form is 
filed no more than 90 days before the anticipated date of manufacturing 
or processing. See 40 CFR 710.30(b)(2) and response to Comment 10 in 
Unit III.

C. What information will be reported?

    1. Information reported by manufacturers during retrospective 
reporting. This rule will require that manufacturers reporting for the 
retrospective reporting period provide chemical identity information 
and indicate whether they seek to maintain an existing claim for 
protection against disclosure of a CBI chemical identity, if 
applicable. In response to comments stating concern with burden 
associated with information required to be reported, EPA removed the 
proposed requirements to report commercial activity type and date 
range, as EPA determined these requirements are unnecessary to achieve 
the objective of designating substances as active or inactive on the 
Inventory. See 40 CFR 710.29(b) and response to Comment 11 in Unit III. 
In response to comments stating concern for availability of information 
required to be reported, EPA clarified that persons required to report 
under this rule will provide information to the extent it is known to 
or reasonably ascertainable by them. See 40 CFR 710.29(a) and response 
to Comment 12 in Unit III. In response to comments requesting that a 
manufacturer be able to correct or withdraw an NOA Form A in the event 
that it discovers errors in the notice, EPA is not establishing a 
formal corrections provision in the regulation, but will allow a 
manufacturer or processor to withdraw an NOA Form A, provided that the 
withdrawn notice is submitted prior to the end of the submission period 
for processors, i.e., not later than 420 days after the final rule is 
published in the Federal Register. See response to Comment 13 in Unit 
III. The manufacturer may effect a correction by filing a new NOA Form 
A following withdrawal, so long as the new Form A is filed within the 
time provided in the rule for the initial filing (i.e., no later than 
180 days after the final rule is published in the Federal Register).
    2. Information reported by processors during retrospective 
reporting. Processors that choose to report for the retrospective 
reporting period will be required to provide chemical identity 
information and whether they seek to maintain an existing claim for 
protection against disclosure of a CBI chemical identity, if 
applicable. In response to comments received, EPA removed the proposed 
requirements to report commercial activity type and date range as these 
requirements were deemed unnecessary to achieve the objective of 
designating substances as active or inactive on the Inventory. See 40 
CFR 710.29(b) and response to Comment 11 in Unit III. EPA is not 
establishing a formal corrections provision in the regulation for an 
NOA Form A, but will allow a processer to withdraw an NOA Form A, 
provided that the withdrawn notice is submitted not later than 420 days 
after the final rule is published in the Federal Register. See 40 CFR 
710.30(a)(3) and response to Comment 13 in Unit III. As with 
manufacturers, processors can effectuate a correction by filing a new 
Form A within the time provided in the rule for the initial filing 
(i.e., no later than 420 days after the final rule is published in the 
Federal Register).
    3. Information reported during forward-looking reporting. This rule 
will require that persons that intend to manufacture or process an 
inactive substance for nonexempt commercial purpose provide chemical 
identity information, the anticipated date of manufacturing or 
processing for nonexempt commercial purpose, and whether they seek to 
maintain an existing claim for protection against disclosure of a CBI 
chemical identity, if applicable. In response to comments, EPA removed 
the proposed requirement to report commercial activity type as this 
requirement was deemed unnecessary to achieve the objective of re-
designating inactive substances as active, and revised the date of 
manufacturing or processing for nonexempt commercial purpose from 
actual to anticipated date. See 40 CFR 710.29(c) and response to 
Comment 11 in Unit III. Persons that have already commenced 
manufacturing or processing for nonexempt commercial

[[Page 37526]]

purpose (e.g., during the transitional period prior to the effective 
date of a substance's inactive designation) may provide the most recent 
date of manufacturing or processing in lieu of an anticipated future 
date, if the forward-looking notice is submitted prior to the effective 
date of the substance's inactive designation. See 40 CFR 710.29(c).
    EPA's proposed rule related the timing of the reporting to a future 
``actual date of manufacturing and processing.'' See 82 FR 4267. In 
response to comments about the need for greater flexibility regarding 
the timing of a forward-looking notice, under the rule the validity of 
the notice does not depend on whether the intended manufacturing or 
processing actually occurs by the anticipated date. Therefore, 
manufacturers or processors need not supplement a forward-looking 
notice with confirmation of whether the intended manufacturing or 
processing of the chemical substance actually occurred by the 
anticipated date. By the same token, EPA will designate such substances 
as active, irrespective of subsequent changes in the intentions of the 
submitter of the forward-looking notice. Consistent with the regulatory 
definition of ``active substance,'' an inactive substance becomes an 
active substance ``based on the receipt of a notice under this 
subpart,'' 40 CFR 710.23, and the factual basis for the notice is the 
submitter's intent, expressed at time of notification, to manufacture 
or process an inactive substance for a nonexempt commercial purpose 
within 90 days of notification. See 40 CFR 710.25(c) and 40 CFR 
710.30(b)(2). This simplified approach reduces burdens for both 
submitters and EPA, is consistent with the statute, and furthers the 
orderly and efficient implementation of the Inventory. See TSCA section 
8(b)(5)(B)(iii) (requiring EPA to take certain definite actions ``on 
receiving'' the notice). With respect to substances re-designated as 
active for which the intended manufacturing or processing has not been 
actualized after an extended period of time and not corrected, EPA may 
later adjust the status of such substances, through procedures that 
would be established by future rulemaking, to further implement TSCA 
section 8(b)(5)(A).
    Finally, in response to comment requesting that submitters be able 
to withdraw an NOA Form B if their intent to re-commence manufacture or 
process a chemical substance later changes, EPA is allowing a submitter 
to request to withdraw its NOA Form B, and EPA may do so, if EPA has 
not yet altered the Inventory status of the substance in response to 
the original submission (i.e., EPA has neither re-designated the 
substance from inactive to active nor moved the substance from the 
confidential portion of the Inventory to the public portion Inventory 
as a result of a request in the original submission for a CBI claim to 
be withdrawn). Because another person may have commenced manufacturing 
or processing for non-exempt commercial purpose in reliance of a 
substance being re-designated as active, the rule does not allow for 
EPA to revert a substance re-designated as active back to inactive 
status based on a request to withdraw an NOA Form B, or for EPA to 
revert a non-CBI substance back to a CBI substance based on a request 
to withdraw a Form B. It would be burdensome and potentially impossible 
to implement such an approach. See 40 CFR 710.30(b)(3) and response to 
Comment 13 in Unit III.
    4. Reporting forms. The NOA Form A will be used by manufacturers 
for the retrospective reporting period. It will also be used by 
processors who choose to report for the retrospective reporting period. 
The NOA Form B will be used by manufacturers and processors for 
forward-looking reporting, which includes reporting chemical substances 
reintroduced into U.S. commerce during the transitional period. For the 
sake of clarity, the final rule now defines the terms `Notice of 
Activity Form A' and `Notice of Activity Form B', consistent with the 
use of these terms in the proposal. The new NOA forms are based on 
EPA's NOC form (Ref. 4), since the information required in an NOA form 
is the same or similar to the information in the NOC form.

D. How will information be submitted to EPA?

    The rule requires electronic reporting similar to the requirements 
established in 2013 for submitting other information under TSCA (see 40 
CFR 704.20(e)) and in accordance with section 3.2000 of 40 CFR part 3 
(CROMERR) (Ref. 5). Submitters will use EPA's CDX, the Agency's 
electronic reporting portal, and EPA's Chemical Information Submission 
System (CISS), a web-based reporting tool, for all reporting under this 
rule. EPA expects that electronic reporting will minimize time 
requirements, support improved data quality, and provide efficiencies 
for both the submitters and the Agency.
    In 2013, EPA finalized a rule to require electronic reporting of 
certain information submitted to the Agency under TSCA sections 4, 5, 
8(a) and 8(d). (Ref. 6) The rule follows two previous rules requiring 
similar electronic reporting of information submitted to EPA for CDR 
and PMNs.
    This rule will require persons submitting notices of activity to 
EPA under TSCA section 8(b) to follow the same electronic reporting 
procedures used for other TSCA submissions, i.e., to register with 
EPA's CDX (if not already registered) and use CISS to prepare a data 
file for submission. Registration enables CDX to authenticate identity 
and verify authorization. To register, the CDX registrant (also 
referred to as ``Electronic Signature Holder'' or ``Public/Private Key 
Holder'') agrees to the Terms and Conditions, provides information 
about the submitter and organization, and selects a user name and 
password. Users who have previously registered with CDX for other TSCA 
submissions will be able to add the ``Submission for Chemical Safety 
and Pesticide Program'' (CSPP) service to their current registration in 
CDX and use the CISS web-based reporting tool.
    EPA developed the CISS for use in submitting data under TSCA 
sections 4, 5, 8(a), and 8(d) to the Agency electronically. The web 
reporting tool is available for use with Windows, iOS, Linux, and UNIX 
based computers and uses ``Extensible Markup Language'' (XML) 
specifications for the efficient transfer of data across the Internet 
when notices are submitted to EPA. CISS works with CDX to secure online 
communication, provides user-friendly navigation, creates a completed 
document in Portable Document Format (PDF) for review prior to 
submission, and enables information to be submitted easily in XML 
format or as PDF attachments.
    The NOA forms described in this rule are included in an e-NOA 
software module in CISS. Once a user completes entry of the relevant 
data fields and metadata information in the appropriate NOA form, the 
CISS reporting tool validates the submission by performing a basic 
error check. CISS also allows the user to choose ``Preview,'' ``Save,'' 
or ``Submit.'' When ``Submit'' is selected, the user is asked to 
provide the user name and password that was created during the CDX 
registration process. CISS then submits the data via CDX. Upon 
successful receipt of the submission by EPA, the status of the 
submissions will be flagged as ``Submitted.'' The user can also login 
to the application and download their Copy of Record.
    Any person submitting a reporting form can claim any part or all of 
the form as confidential. Except as otherwise provided in this rule, 
any information that is claimed as CBI will

[[Page 37527]]

be disclosed by EPA only to the extent and by the means of the 
procedures set forth in 40 CFR part 2.

E. How will CBI claims and requests be handled?

    Notices pursuant to this rule may contain two different types of 
CBI assertions: claims for protection of information other than 
specific chemical identity, and requests to maintain existing claims 
for protection of specific chemical identity. In response to comments 
received, EPA has extensively re-written the substantiation questions 
from the proposed rule in a manner intended to more succinctly secure 
responses for CBI assertions of discrete data elements as well as CBI 
concerns on the linkage of data elements. See 40 CFR 710.31 and 
response to Comment 17.
    1. Information other than specific chemical identity. For all new 
claims for protection (i.e., for all CBI assertions under this rule 
other than requests to maintain existing claims for protection of 
specific chemical identity), TSCA section 14(c)(1)(B) and 14(c)(5) 
require that persons claiming CBI must provide a specific certification 
statement regarding the basis for the CBI claims. In addition, TSCA 
section 14(c)(3) and this rule require that all such claims be 
substantiated at the time of submission. EPA will review a 
representative subset of these claims as specified by TSCA 
section14(g)(1).
    2. Requests to maintain existing CBI claims for chemical identity. 
Any manufacturer or processor submitting an NOA under TSCA section 
8(b)(4)(A) may seek to maintain an existing CBI claim for specific 
chemical identity, regardless of whether that person asserted the 
original claim that caused the specific chemical identity to be listed 
on the confidential portion of the Inventory. EPA believes this is the 
correct interpretation of ``a manufacturer or processor . . . that 
seeks to maintain an existing claim for protection against disclosure'' 
of specific chemical identity in TSCA section 8(b)(4)(B)(ii). A number 
of manufacturers and processors may legitimately benefit from the 
confidential status of a specific chemical identity, even when such 
persons did not originally report that chemical identity to EPA and 
therefore were not in a position to assert a CBI claim for that 
chemical identity. Congress could not have intended that such companies 
would be forced to rely on another company to request to maintain the 
claim. For example, the initial claimant may no longer exist or may no 
longer manufacture or process the chemical substance, or may simply 
fail to file the required NOA. EPA does not believe that Congress 
intended for specific confidential chemical identities to be disclosed 
without providing the opportunity for manufacturers and processors to 
make a request that the identities should remain confidential simply 
because the original claimants did not file under TSCA section 
8(b)(4)(B)(ii).
    Pursuant to TSCA section 8(b)(4)(B)(iv), EPA will move an active 
substance from the confidential portion of the Inventory to the non-
confidential portion if no manufacturer or processor submitting an NOA 
under TSCA section 8(b)(4)(A) requests to maintain the existing CBI 
claim for the specific chemical identity of that chemical substance. 
See 40 CFR 710.37(a). As a courtesy, EPA practice is to notify original 
claimants and/or the public when it has moved substances from the 
confidential portion of the Inventory to the public portion of the 
Inventory, e.g., through direct contact with the original claimant or 
publication of a Federal Register notice. A chemical substance for 
which EPA has received a request to maintain an existing CBI claim for 
specific chemical identity will remain on the confidential portion of 
the Inventory pending EPA's review of the claim pursuant to a review 
plan to be promulgated at a later date in accordance with TSCA section 
8(b)(4)(C)-(D).
    While this rule requires submitters to indicate whether they seek 
to maintain an existing CBI claim for specific chemical identity, this 
rule does not include mandatory substantiation requirements for CBI 
requests for specific chemical identity on an NOA Form A. TSCA section 
8(b)(4)(B)(iii) stipulates that EPA shall ``require the substantiation 
of those claims pursuant to section 14 and in accordance with the 
review plan described in subparagraph C.'' EPA will be conducting a 
separate rulemaking to establish this review plan. The review plan will 
include mandatory requirements for substantiating a CBI request for 
specific chemical identity reported in an NOA Form A and specify when 
such substantiation is to be provided. If EPA receives an NOA Form A in 
which the submitter requests to maintain an existing CBI claim for 
specific chemical identity but chooses not to substantiate such at the 
time of filing, EPA will continue to list the chemical substance on the 
confidential portion of the Inventory pending the submission of any 
substantiation required under the review plan and EPA's review of the 
claim pursuant to the review plan.
    However, in this rule the Agency is allowing companies to submit 
substantiation for the CBI claims for specific chemical identity at the 
same time that the NOA Form A is filed, if they so choose. As long as 
the period between the date these earlier substantiations are received 
and the due date to be established in the review plan (yet to be 
proposed) is not more than five years, these substantiations will 
exempt the company from the requirement to submit additional 
substantiation under the terms of the review plan. See TSCA section 
8(b)(4)(D). EPA will review requests to maintain CBI claims for 
specific chemical identity in accordance with the TSCA section 
8(b)(4)(D) review plan in the timeframe mandated by TSCA section 
8(b)(4)(E).
    With respect to requests to maintain existing CBI claims that are 
submitted on an NOA Form B, TSCA section 8(b)(5)(B) stipulates that 
such requests must be substantiated not later than 30 days after 
submitting Form B. See TSCA section 8(b)(5)(B)(ii)(II). Substantiation 
requirements for NOA Form B CBI claims for specific chemical identity 
are found in 40 CFR 710.37(a)(2).
    The Agency will allow companies to submit substantiation at the 
same time that their NOA Form B is filed, if they so choose. Persons 
submitting an NOA Form B may find it more efficient to provide the 
substantiation for a CBI claim for specific chemical identity at the 
time of filing.

III. Summary of Response to Comments Including Changes and 
Clarifications From the Proposed Rule

    This unit summarizes EPA's responses to comments for several 
general areas from multiple stakeholders. EPA also discusses any 
changes to and clarifications from the proposed rule, and where 
responses are particularly relevant to the requirements of the final 
rule. A separate document that summarizes the comments relevant to the 
proposal and EPA's responses to those comments has been prepared and is 
available in the docket for this rulemaking (Ref. 7).
    Comment 1: Several commenters indicated that EPA should clarify the 
activities for which notification is not required under the rule, and 
should confirm that all substances and activities that are exempt from 
premanufacture notification requirements are also exempt from reporting 
requirements under this rule. The commenters make reference to the 
following PMN exemptions: export-only exemption, low volume exemption, 
low releases/low exposures exemption, test

[[Page 37528]]

marketing exemption, and polymer exemption. One commenter elaborated 
that substances exempted from listing on the TSCA Inventory and other 
substances exempt from premanufacture notification are exempt from this 
rule but are ambiguously stated as such. Two commenters elaborated that 
substances listed on the Inventory but manufactured under a low volume 
exemption should be exempt from reporting under this rule by a person 
manufacturing the substance under the exemption. One commenter 
recommended that all categories of substances for which no reporting is 
required pursuant to the CDR rule should be exempt from reporting under 
this rule.
    Several commenters indicated that EPA should clarify or confirm 
that polymers are exempt from reporting under this action. One 
commenter requested that EPA clarify whether polymers manufactured 
under the pre-1995 polymer exemption rule need to be reported, as 
technically such polymers are listed on the Inventory. A few commenters 
stated that polymers listed on the Inventory, including polymers with a 
``Y'' designation, should be included on the interim list of active 
substances. One commenter elaborated that polymers on the Inventory are 
not subject to CDR, that many were placed on the Inventory before EPA 
promulgated the TSCA section 5 polymer exemption rule and would likely 
meet the current standard for the polymer exemption, and that such low 
risk polymers should be on the interim active Inventory.
    One commenter expressed concern that, without an explicit reporting 
exemption in the rule, a company manufacturing a chemical substance 
under a polymer, low volume, or test marketing exemption could 
inadvertently violate the reporting requirements if (without the 
company's knowledge) another company manufacturing the same substance 
added that substance to the confidential portion of the Inventory, then 
ceased manufacturing, causing the substance to be designated inactive. 
Another commenter expressed concern that, in the absence of an explicit 
reporting exemption in the rule for all companies manufacturing 
chemical substances under a PMN exemption, the rule would appear to 
require such companies to submit an inquiry to EPA to ascertain whether 
the chemical substances in question had been added to the confidential 
portion of the Inventory by another manufacturer.
    Response: In response to the comment to clarify the reporting 
status under this rule of a substance manufactured under a TSCA section 
5 exemption and not listed on the Inventory, EPA confirms that such 
substance is not subject to reporting under this action. The scope of 
chemical substances covered under this rule excludes substances that 
are not listed on the Inventory. See definition of ``reportable 
chemical substance'' at 40 CFR 710.23. A substance that has not been 
added to the Inventory because it is manufactured solely under a PMN 
exemption is not a ``reportable chemical substance'' and, therefore, 
cannot become an ``active substance'' or an ``inactive substance.''
    EPA recognizes that in certain cases, chemical substances 
manufactured by a company under a PMN exemption may nevertheless be 
added to the Inventory voluntarily, or may subsequently be added to the 
Inventory by another company. Accordingly, in the proposed rule, EPA 
listed reporting exemptions for the following activities, which EPA 
construed as exempt commercial purposes: The manufacture or processing 
of a substance as described in 720.30(g) or (h), the manufacture or 
processing of a substance solely in small quantities for research and 
development, and the import of a substance as part of an article. EPA 
finalized the rule to include these exemptions and, based on comments, 
revised the rule to include additional exemptions: the manufacture or 
processing of a substance solely for test marketing purposes, and the 
manufacture or processing of a substance solely for export from the 
United States, except where the Administrator has made a finding 
described in TSCA section 12(a)(2). See 40 CFR 710.27(a)(4) and (5). 
EPA believes that these two additional activities also qualify as 
exempt commercial purposes based on the limited nature of these 
commercial activities and the exemptions from PMN reporting under TSCA 
sections 5(h)(1) and 12(a)(1) for substances manufactured solely for 
these purposes. While TSCA section 12(a)(1) authorizes EPA to include 
substances manufactured or processed solely for export in TSCA section 
8 reporting, EPA construes manufacturing or processing solely for 
export to be an exempt commercial purpose, given that section 12(a)(1) 
broadly exempts such activities from other TSCA provisions, including 
PMN requirements under section 5.
    EPA declined to add additional reporting exemptions in the final 
rule for activities that are exempt from PMN reporting based on rules 
promulgated under TSCA section 5(h)(4) (i.e., low volume, low releases/
low exposures, and polymer exemptions). EPA disagrees with comments 
that a substance manufactured under a TSCA section 5(h)(4) exemption 
but nevertheless listed on the Inventory should be exempt from 
reporting under this rule. EPA does not believe that manufacturing or 
processing under a low volume, low releases/low exposures, or polymer 
exemption (1984 or 1995 polymer exemption) qualify as exempt commercial 
purposes under TSCA section 8(b), despite the exemptions from reporting 
under TSCA section 5(h)(4) for such substances. This is because 
exemptions promulgated under section 5(h)(4) are predicated upon a risk 
determination, rather than the particular commercial purpose for which 
manufacturing is undertaken. Unlike the other activities that EPA has 
exempted from reporting requirements under this rule (e.g., research 
and development, test marketing, export-only), the activities exempt 
from PMN reporting pursuant to rules promulgated under section 5(h)(4) 
need not be undertaken for any specific and limited commercial purpose. 
Because the commercial purpose for which a substance is manufactured is 
not integral to an exemption under section 5(h)(4), and in 
consideration of the statutory objective of TSCA section 8(b)(4)-(5) to 
enable EPA to determine which chemical substances on the Inventory are 
active in U.S. commerce, EPA does not construe activities undertaken 
pursuant to a section 5(h)(4) exemption to be exempt ``commercial 
purposes'' within the meaning of section 8(b)(4)(A)(i) and 
8(b)(5)(B)(i). EPA emphasizes, however, that substances which (based on 
such PMN exemptions) have never been added to the Inventory are 
excluded from any reporting requirements under this rule.
    EPA also disagrees with comments that this rule should provide 
reporting exemptions for polymers and other categories of Inventory-
listed substances that are exempt from CDR for reasons unrelated to the 
specific commercial purpose for which they are manufactured or 
processed. A statutory objective supported by reporting under this rule 
is to enable EPA to determine which chemical substances on the 
Inventory are active in U.S. commerce. This statutory objective under 
TSCA section 8(b) is distinct from the statutory objective for CDR 
under TSCA section 8(a). Whereas polymers and certain other categories 
of substances listed on the Inventory are exempt from reporting under 
CDR, these substances nevertheless require designation as active or 
inactive under TSCA section

[[Page 37529]]

8(b), and are therefore subject to reporting under this rule if they 
were or are anticipated to be manufactured for nonexempt commercial 
purpose. Exempting polymers and other categories of substances under 
this TSCA section 8(b) rule for no other reason than that they are 
exempt from CDR under TSCA section 8(a) would not accomplish the 
statutory objective of designating substances on the Inventory 
manufactured for non-exempt commercial purposes as active or inactive. 
EPA does not believe Congress intended for an entire category of 
substances (such as polymers), that were listed on the Inventory as of 
June 22, 2016, to be designated inactive despite the fact that such 
substances were manufactured or processed for wide-ranging commercial 
purposes during the 10-year lookback period.
    EPA furthermore disagrees with comments that polymers should be 
included on the interim list of active substances. The interim list is 
defined by TSCA section 8(b)(6) to include only substances reported 
under CDR during the reporting period that most closely preceded the 
date of enactment of the TSCA amendments. Substances such as polymers 
that are exempt from reporting under CDR, therefore, are not eligible 
to be included on the interim list. Moreover, unless these substances 
were the subject of an NOC received during the lookback period, EPA has 
no equivalent notice that such substances were manufactured during the 
lookback period, and therefore no justification for designating the 
substances as active in this rule.
    Finally, in response to comments expressing concern that a person 
manufacturing under a PMN exemption may be unaware that another person 
subsequently added the same substance to the confidential portion of 
the Inventory, EPA notes that it revised 40 CFR 710.25(a) and (c) to 
clarify that reporting is not required where it is not ``known to or 
reasonably ascertainable by'' a company that it manufactured a chemical 
substance subject to commercial activity designation during the 
lookback period, or that it intends to manufacture or process an 
inactive substance on the confidential portion of the Inventory. EPA 
anticipates that the presence of a substance on the confidential 
portion of the Inventory may be information that is not ``known to or 
reasonably ascertainable by'' a person who is operating under a PMN 
exemption and who did not submit the confidentiality claim for the 
specific chemical identity of that substance.
    Changes to Activities that are Exempt from Reporting in the Final 
Rule: EPA revised the rule to exempt additional commercial activities 
from reporting requirements: The manufacture or processing of a 
substance solely for test marketing purposes, and the manufacture or 
processing of a substance solely for export from the United States, 
except where the Administrator has made a finding described in TSCA 
section 12(a)(2). See 40 CFR 710.27(a)(4) and (5).
    Comment 2: One commenter stated that substances processed as part 
of an article should be exempt from reporting. One commenter indicated 
that substances contained within imported articles should be subject to 
reporting if and when they are released from the article during use and 
perform a separate end-use function.
    Response: The proposed rule included an exemption from reporting 
requirements for persons importing a chemical substance as part of an 
article. EPA agrees with commenter that the processing of a chemical 
substance as part of an article should likewise be exempt from 
reporting under this rule on the grounds that it is processing for an 
exempt commercial purpose, following the logic of the exemption for 
manufacture of a chemical as part of an article through import. Under 
TSCA, the import of a chemical substance as part of an article does not 
require new chemical reporting. Consequently, the Inventory does not 
list all chemical substances that are processed as part of articles 
since it does not include the processing of chemical substances as part 
of imported articles. More generally, the processing of a chemical as 
part of an article is not a basis to add a chemical substance to the 
Inventory. EPA believes it would be incongruous to identify a chemical 
substance as active solely based on the fact that it is processed as 
part of an article, when that would not be a basis to add the chemical 
substance to the Inventory in the first place if there were no 
manufacture reportable under TSCA section 5. In addition, EPA is 
concerned that an approach under which chemical substances are listed 
as active simply because they are components of articles that are 
processed in some fashion could undermine the purpose of meaningfully 
distinguishing active from inactive chemicals. It should be noted that 
the extraction of a chemical substance from an article would not be 
considered processing a chemical substance as part of an article and so 
would not be exempt from reporting under this provision. EPA therefore 
revised 40 CFR 710.27(a)(2) to exempt persons processing a chemical 
substance as part of an article from reporting requirements for that 
substance.
    Regarding the comment that substances contained within imported 
articles should be subject to reporting if and when they are released 
from the article during use and perform a separate end-use function, no 
regulatory change is necessary. The final rule at 40 CFR 710.27(a)(2) 
refers to ``[t]he import or processing of a chemical substance as part 
of an article.'' EPA's longstanding interpretation of this phrase is 
that a chemical substance is only considered to be imported ``as part 
of an article'' if the substance is not intended to be removed from 
that article and it has no end use or commercial purpose separate from 
the article of which it is a part. See 42 FR 64583 (1977). Thus, for 
the kinds of articles from which a contained chemical substance would 
be released during use and perform a separate end-use function, the 
chemical substance would not be considered to be part of the article 
and would not qualify for exemption on that basis. In any event, as 
stated previously, even in the case where a chemical substance is part 
of an article, the extraction of a chemical substance from an article 
would not be considered processing a chemical substance ``as part of an 
article'' and so would not be exempt from reporting on this basis. See 
also TSCA Chemical Data Reporting Fact Sheet: Imported Articles, 
available at https://www.epa.gov/sites/production/files/2015-12/documents/cdr_fact_sheet_imported_articles_-_final_dec2015.pdf. (Ref. 
8)
    Changes to Activities that are Exempt from Reporting in the Final 
Rule: EPA amended the rule to reflect that both importing and 
processing a chemical substance as part of an article are exempt from 
reporting requirements under this rule. See 40 CFR 710.27(a)(2).
    Comment 3: Numerous commenters stated that CBI substances reported 
to the 2016 or 2012 CDR should be made active on the interim Inventory 
and should not be subject to retrospective reporting. Several 
commenters also stated that CBI substances reported to the 2016 CDR 
should also not be subject to further substantiation of CBI claims 
because the claims have already been substantiated.
    Response: EPA agrees in part with the comments involving CBI 
substances. EPA confirms that it had proposed that both CBI and non-CBI 
substances reported to the 2012 or 2016 CDR would be made active on the 
interim list. EPA finalized this aspect of the rule. Furthermore, EPA 
revised the rule to reflect that both CBI and non-CBI substances 
reported to the 2012 or 2016 CDR will be eligible for exemption from

[[Page 37530]]

retrospective notification requirements under this rule. See 40 CFR 
710.23 and 710.25.
    However, a company that seeks to maintain an existing CBI claim for 
specific chemical identity cannot avail itself of this exemption, and 
must submit an NOA Form A that includes such request, because TSCA 
section 8(b)(4)(B)(ii) requires a specific request to maintain the CBI 
claim. Pursuant to TSCA section 8(b)(4)(B)(iv), EPA must move to the 
non-confidential portion of the Inventory any active substance for 
which no request is received to maintain an existing CBI claim for 
specific chemical identity. EPA recognizes in the final rule that there 
may be circumstances where a company, which had previously sought a CBI 
claim for a specific chemical identity, may no longer view the CBI 
status as necessary or currently defendable. In such circumstance, the 
company may take advantage of any retrospective reporting exemption for 
which it is eligible, and decline to submit a retrospective notice to 
EPA.
    Regarding substantiation, pursuant to TSCA section 8(b)(4)(D)(i), a 
previously submitted substantiation may satisfy the section 
8(b)(4)(B)(iii) substantiation requirement if the prior substantiation 
was submitted to EPA within five years of a deadline to be established 
in the forthcoming review plan described in section 8(b)(4)(C)-(D). EPA 
does not expect that a 2012 CDR submission will satisfy the five-year 
substantiation requirement. Because the deadline for submitting 
substantiation in the review plan has not yet been set, EPA does not 
currently know whether substantiation submitted for a 2016 CDR 
submission will satisfy the TSCA section 8(b)(4)(B)(iii) five-year 
substantiation requirement. Note that a voluntary substantiation 
submitted with Form A might also not fall within the five-year period, 
depending upon the deadline that is set.
    Changes to Chemical Substances That Are Exempt from Retrospective 
Reporting in the Final Rule: EPA changed the exemptions from 
retrospective reporting requirements to reflect that both CBI and non-
CBI chemical substances reported to the 2012 or 2016 CDR will be 
eligible. See 40 CFR 710.23 for revised definition of ``interim active 
substance.'' TSCA section 8(b)(4)(B)(ii) requires a notice to be 
submitted only by those manufacturers or processors that seek to 
maintain an existing CBI claim for the specific chemical identity of a 
reportable substance.
    Comment 4: Several commenters stated that non-CBI substances added 
to the Inventory during the ten-year retrospective reporting period via 
an NOC should be exempt from notification.
    Response: EPA agrees with this comment. An NOC is required to be 
submitted to EPA on or no later than 30 calendar days after the first 
day of manufacture of a new chemical substance for commercial purpose 
and an NOC substance is considered to be added to the Inventory on the 
date the NOC is received by EPA, provided that the EPA determines the 
NOC to be valid during its review. Requiring retrospective reporting of 
substances for which an NOC was received during the lookback period 
would be duplicative because EPA already has an equivalent report (the 
NOC itself) indicating that the substance was manufactured or processed 
during the lookback period. EPA furthermore concludes (consistent with 
its response to comments about the availability of the interim list 
exemption for CBI substances) that the analogous reasoning applies with 
respect to CBI substances added to the Inventory during the lookback 
period. EPA revised the rule to reflect that both CBI and non-CBI 
substances reported in an NOC during the lookback period will be 
eligible for exemption from retrospective notification requirements 
under this rule. EPA was able to compile this list of substances and 
designate them as active substances by the deadline for publication of 
the rule. EPA's June 2017 posting of the Inventory will include these 
NOC substances designated as active (see https://www.epa.gov/tsca-inventory). See 40 CFR 710.23 for revised definitions of ``active 
substance'' and ``chemical substance subject to commercial activity 
designation.''
    However, a company that seeks to maintain an existing CBI claim for 
specific chemical identity cannot avail itself of this exemption 
because TSCA section 8(b)(4)(B)(ii) requires a specific request to 
maintain the CBI claim. See response to Comment 3 for additional 
discussion on CBI substances.
    Additionally, substantiation of a CBI claim for chemical identity 
submitted with an NOC may or may not satisfy the TSCA section 
8(b)(4)(B)(iii) substantiation requirement. Pursuant to TSCA section 
8(b)(4)(D)(i), a previously submitted substantiation may satisfy the 
section 8(b)(4)(B)(iii) substantiation requirement if the prior 
substantiation was submitted to EPA within 5 years of the deadline to 
be established in the forthcoming review plan described in section 
8(b)(4)(C)-(D). NOCs submitted more recently may satisfy the 5-year 
substantiation requirement, while NOCs submitted earlier in the 10-year 
lookback period for retrospective reporting may not satisfy the 5-year 
substantiation requirement. Note that a voluntary substantiation 
submitted with an NOA Form A might also not satisfy the 5-year 
substantiation requirement, depending upon the deadline that is set in 
the review plan.
    Changes to Chemical Substances That Are Exempt from Retrospective 
Reporting in the Final Rule: EPA added an exemption from retrospective 
reporting requirements for chemical substances added to the Inventory 
via an NOC during the ten-year retrospective reporting period. See 40 
CFR 710.23 for revised definitions of ``active substance'' and 
``chemical substance subject to commercial activity designation.''
    Comment 5: Several commenters stated that EPA should update the 
interim list and/or publish submissions frequently or in real time in 
order for potential submitters to see what is being submitted and to 
avoid or reduce duplicative submissions during retrospective reporting.
    Response: EPA has determined that publishing submissions frequently 
or in real time is not feasible. In order to publish notices frequently 
or in real time, EPA would need to develop, test, and implement an 
electronic platform that would be able transfer non-CBI notices from 
the Agency's confidential repository to a public system. EPA has not to 
date developed nor implemented such an electronic platform for TSCA 
purposes and does not believe that it could do so by the time it would 
be needed to support this action in a manner suggested by these 
comments. Additionally, because non-CBI notices suitable for 
publication would include those submitted with no CBI claims and those 
submitted with claims but for which CBI would be redacted, EPA would 
need to ensure that such an electronic platform would appropriately 
transfer only non-CBI notices to a public system. Furthermore, in order 
for published information to be accurate and reliable, EPA believes 
that notices would necessarily need to be fully processed and reviewed, 
which would not allow the Agency to publish notices in real time or 
even frequently, especially since the number of notices submitted may 
increase, possibly sharply, as the submission deadline approaches.
    Comment 6: Several commenters disagreed with the proposal that each 
manufacturer must report every nonexempt chemical manufactured during 
the retrospective lookback period. Commenters stated that, for

[[Page 37531]]

purposes of designating substances as active, EPA need only receive one 
notice for each reportable substance. Commenters elaborated that EPA 
should allow a ``one-and-done'' approach for retrospective reporting, 
i.e., once a notice is received by EPA for a particular substance, and 
either the notice is published and/or the interim list is updated and 
published, other manufacturers need not report the same substance. One 
commenter stated that EPA appropriately proposed to require that each 
company that has manufactured a chemical substance on the Inventory 
during the lookback period must notify EPA of such manufacture. The 
commenter elaborated that ``one-and-done'' reporting is legally 
impermissible.
    Response: EPA disagrees with the statement of one commenter that a 
``one-and-done'' reporting exemption is impermissible under TSCA 
section 8(b)(4)(A)(i). Section 8(b)(4)(A)(i) states that the 
Administrator ``shall require manufacturers . . . to notify the 
Administrator'' of each chemical substance that the manufacturer has 
manufactured during the 10-year lookback period. The statute does not 
state that the Administrator shall require all manufacturers to submit 
such a notice. Had Congress intended to preclude the Administrator from 
implementing a ``one-and-done'' reporting process, Congress could have 
done so by specifying that the Administrator shall require all 
manufacturers to submit a notice for each chemical manufactured during 
the lookback period. Furthermore, EPA believes the commenter 
incorrectly discounts the significance of language in TSCA section 
8(b)(4)(A)(i) admonishing EPA to issue the rule ``subject to the 
limitations under subsection (a)(5)(A).'' TSCA section 8(a)(5)(A) 
provides that ``the Administrator shall, to the extent feasible . . . 
not require reporting which is unnecessary or duplicative.'' EPA does 
not agree with the commenter's assertion that subsection (a)(5)(A) is 
solely concerned with the manner of reporting, such that the scope of 
reporting would be unaffected. It is difficult to see how one could 
make a notification requirement less unnecessary or less duplicative 
except by tailoring the scope of persons who are required to submit the 
notification.
    EPA agrees in part with the other commenters that a ``one-and-
done'' approach should be allowed for retrospective reporting. 
Accordingly, EPA has revised the rule to exempt a manufacturer from the 
retrospective notification requirements for a particular chemical 
substance, if the manufacturer has evidence in the form of a CDX 
receipt, documenting EPA's receipt of an NOA Form A from another 
manufacturer. As discussed further in Comment 5 in this Unit, it is 
infeasible for EPA to supply ``real-time'' reports to the public during 
the manufacturers' submission period for retrospective reporting by 
listing the particular substances for which it has already received an 
NOA Form A. However, manufacturers who possess an NOA Form A CDX 
receipt for a substance (e.g., obtained through a consortium 
arrangement), documenting that an NOA Form A has already been received 
by EPA, may avail themselves of this exemption for that substance. 
Manufacturers should keep in mind, however, that they bear the risk of 
failing to submit a required forward-looking notification (NOA Form B) 
notice if they rely on this Form A exemption, and the Form A notice 
(for which they have a CDX receipt) is later withdrawn, leading to the 
substance being designated as inactive. Furthermore, one manufacturer's 
expectation that another manufacturer will later submit an NOA Form A 
is not an acceptable basis for relying on this exemption. If such an 
approach were allowed as a basis for exemption, then EPA would risk 
receiving no notification at all for an active substance, based on each 
manufacturer expecting that some other manufacturer would later submit 
an NOA Form A. Since it is only submitters who will be notified of 
errors, manufacturers relying on the exemption are responsible for 
assuring their substance is properly designated as commercially active.
    However, a company that seeks to maintain an existing CBI claim for 
specific chemical identity cannot avail itself of this exemption 
because TSCA section 8(b)(4)(B)(ii) requires a specific request to 
maintain the CBI claim. See response to Comment 3 for additional 
discussion on CBI substances.
    Changes to Chemical Substances That Are Exempt from Retrospective 
Reporting in the Final Rule: EPA added an exemption from retrospective 
reporting requirements in the rule for manufacturers that have evidence 
in the form of a copy of a CDX receipt documenting EPA's receipt of an 
NOA Form A from another person for the same chemical substance. See 40 
CFR 710.25(a). However, as noted in Unit II and in 40 CFR 710.25(a), 
any manufacturer relying on another person's notice remains responsible 
for confirming that their substance becomes designated as active.
    Comment 7: Several commenters requested that processors be allowed 
to report for an additional 180 days that begins when the draft 
Inventory is published and not when the 180-day submission period for 
manufacturers closes. One commenter questioned whether EPA had legal 
authority to extend the submission period for processors beyond 180 
days, but accepted EPA's rationale for providing processors with 
additional reporting time after EPA's publication of the draft 
Inventory, provided that the extra time for processor reporting remains 
a short (i.e., no more than 180 days) and fixed period, as proposed.
    Response: With respect to EPA's legal authority to establish a 
voluntary retrospective submission period for processors beyond 180 
days, EPA believes this is implicit in its authority to establish a 
mandatory reporting period for manufacturers during the first 180 days. 
EPA notes that TSCA does not require that the rule impose any 
retrospective reporting requirements at all on processors. Nor does 
TSCA section 8(b)(4) establish a deadline for the publication of the 
Inventory designating active and inactive substances. Furthermore, 
allowing processors additional time to report is consistent with the 
manner in which the original Inventory was assembled, it advances the 
statutory objective of efficiently dividing active substances from 
inactive substances, and it advances the statutory objective under TSCA 
section 8(a)(5) of avoiding (to the extent feasible) unnecessary 
reporting. Processors may be able to identify certain active substances 
that manufacturers would not, but requiring them to report during the 
same time period as manufacturers might lead them to duplicate the 
reports of manufacturers.
    EPA originally proposed that processors may report not later than 
360 days after the final rule is published in the Federal Register. 
EPA's rationale was that the additional 180-day submission period for 
processors, beyond the 180-day submission period for manufacturers, 
would allow processors to search EPA's publication of the draft 
Inventory with active designations, based on the retrospective 
reporting by manufacturers, and to report only those substances not 
already reported. EPA agrees with comments that the purpose of 
affording the additional 180 days for processors is best served if that 
180-day submission period begins on the date on which processors would 
actually be able to review the draft Inventory. EPA also agrees with 
the comment that the rule should specify a fixed date on which the 
processor submission period will end,

[[Page 37532]]

as originally proposed, but which would not be the case if the 180-day 
submission period were to begin on the unknown date of the publication 
of the draft Inventory. EPA intends to publish the draft Inventory with 
active designations as soon as is practicable following the close of 
the 180-day submission period for manufacturers, which is anticipated 
to be approximately 60 days after the 180-day submission period for 
manufacturers ends. Based on this anticipated timeframe for publishing 
the draft Inventory and in consideration of these comments, EPA is 
finalizing the rule to allow processors to report not later than 420 
days after the publication of the rule in the Federal Register. See 40 
CFR 710.30(a)(2). This revised submission period for processors 
provides a fixed date on which the processor submission period will end 
and is anticipated to provide an approximate 180-day period for 
processor reporting from the date by which EPA expects to publish the 
draft Inventory.
    Changes to Processor Submission Period for Retrospective Reporting: 
EPA changed the retrospective reporting submission period for 
processors to end not more than 420 days after the publication of the 
rule in the Federal Register. See 40 CFR 710.30(a)(2).
    Comment 8: Two commenters stated that an estimated date of re-
commercialization should be able to be provided rather than an actual 
date. Two commenters stated that there is no need to limit the 
submission period for forward-looking reporting (NOA Form B) to not 
more than 30 days prior to manufacturing or processing, as proposed by 
EPA, citing that the statute only requires notification to take place 
``before'' commercialization resumes. One commenter suggests that 
persons be permitted to submit an NOA Form B up to 90 days before re-
commercialization instead of 30 days. Another commenter suggested that 
the Agency require an NOA Form B to be submitted not less than 90 days 
prior to manufacturing or processing to allow sufficient time for the 
Agency to evaluate the chemical and determine whether a Significant New 
Use Rule (SNUR) is needed. Another commenter was supportive of the 
proposed 30-day requirement.
    Response: EPA agrees that the date that must be provided on an NOA 
Form B should be the anticipated date of reintroduction of a chemical 
substance in U.S. commerce, rather than the actual date. EPA recognizes 
that any reporting required in advance of actual commercialization is 
based on information and schedules that are subject to change, and 
providing an actual date of commercialization in advance, therefore, is 
not always practical. EPA believes that providing an anticipated date 
of commercialization should lessen concerns expressed by commenters. 
See 40 CFR 710.29(c)(2).
    EPA has also decided to modify the date requirement from originally 
proposed, extending it to allow notice up to 90 days ahead of time, in 
addition to basing the date requirement on the anticipated date of 
manufacturing or processing rather than the actual date of 
manufacturing or processing. EPA decided to retain some limitation on 
the submission period because EPA's experience with other reporting 
under TSCA (e.g., PMNs) is that the earlier a notice is submitted, the 
higher the likelihood is that the schedule for commercialization will 
change or that a chemical substance might not be commercialized at all. 
EPA believes that retaining a limitation on the submission period for 
future reporting will reduce the number of notices submitted for 
substances whose schedule for commercial re-introduction changes 
appreciably. EPA also believes that extending the submission period to 
begin from 90 days, rather than 30 days, prior to resuming 
manufacturing or processing will afford manufacturers and processers 
additional time to adjust to information and schedule changes and will 
not significantly impact the accuracy of notices submitted. See 40 CFR 
710.30(b)(1).
    Regarding changing the deadline for submission of an NOA Form B to 
be at least 90 days prior to resuming manufacturing or processing for 
the purposes of Agency action (e.g., SNUR), EPA disagrees with the 
commenter's interpretation that by requiring advance notification, 
Congress wanted to provide EPA an opportunity to take action to delay 
the resumption of manufacturing or processing if it had concerns about 
the subject chemical. To the contrary, the statute clearly reflects 
that the obligation to submit a section 8(b)(5)(B) notification was not 
intended as a tool to impede the resumption of manufacturing or 
processing. Specifically, the statute does not authorize EPA to 
structure the rule in such a manner that if a manufacturer or processor 
submits an NOA Form B, the manufacturer or processor could be obliged 
to wait longer than the next day to commence manufacturing and 
processing the chemical substance. See TSCA section 8(b)(5)(B)(i). EPA 
believes the most plausible explanations for why Congress imposed the 
advance notification requirement were: (1) To ensure that EPA actually 
receives the notices (by making the lawful resumption of manufacturing 
or processing contingent on the notification) and; (2) to support EPA's 
subsequent prioritization efforts under TSCA section 6(b). See TSCA 
section 8(b)(5)(B)(iii)(IV).
    Changes to the Date Requirement for Forward-looking Reporting: EPA 
changed the limitation on submitting an NOA Form B to be not more than 
90 days prior to the anticipated date of manufacturing or processing. 
See 40 CFR 710.29(c)(2) and 40 CFR 710.30(b)(1).
    Comment 9: A few commenters asked EPA to clarify in the rule how it 
would implement the requirements of TSCA section 8(b)(7). For example, 
commenters requested that EPA confirm in the final rule when the draft 
and final lists of active and inactive substances will be published. 
One commenter indicated that EPA should identify all substances on the 
Inventory as active or inactive not later than 15 months after 
promulgation of this final rule. Another commenter indicated that EPA 
should publish an updated version of the Inventory, with all substances 
designated as active or inactive, not later than six months after the 
completion of the retrospective notification process. Commenters also 
stated that EPA should specify in the rule the date when substances 
will be designated as inactive. One commenter stated that EPA should 
publish a Federal Register notice every 90 days listing all substances 
that EPA has designated as active following receipt of an NOA Form B.
    Response: TSCA section 8(b)(7) requires EPA to make active and 
inactive designations available to the public, but it gives EPA 
discretion as to the manner and timing of doing so. EPA intends to 
publish a draft Inventory as soon as practicable after the close of the 
180-day submission period for manufacturers, which will include only 
active designations (based on interim list designations, NOCs, and 
manufacturer reporting); chemicals that have no designation on this 
draft Inventory should not be assumed to be inactive. EPA intends to 
publish the first Inventory identifying both active and inactive 
substances as soon as practicable after the close of the retrospective 
submission period for processors, in a web posting of the Inventory on 
EPA's Inventory Web page (see https://www.epa.gov/tsca-inventory). 
Given that the statute does not mandate a specific deadline for the 
publication of the first Inventory identifying both active and inactive 
substances, and given the challenges of

[[Page 37533]]

foreseeing precisely how much time will be necessary to review and 
compile the data it will receive from retrospective reporting, EPA has 
chosen not to impose a regulatory deadline on the publication of this 
first Inventory.
    The obligation to submit an NOA Form B under TSCA section 
8(b)(5)(B)(i) does not arise until a chemical substance has been 
``designated as an inactive substance.'' EPA is establishing an 
effective date provision for the designation of a substance as an 
inactive substance. EPA revised the rule so that an ``inactive 
substance'' designation becomes effective 90 days after the date that 
EPA identifies the substance for inactive designation. See 40 CFR 
710.23 for revised definition of ``inactive substance.'' EPA will 
identify substances for inactive designation in a signed action 
accompanying the first version of the Inventory with all active-
inactive listings following the close of the retrospective submission 
period for processors. EPA intends to publish this signed action 
together with the Inventory in a web posting on EPA's Inventory Web 
page (see https://www.epa.gov/tsca-inventory).
    With respect to Inventory updates based on forward-looking 
reporting, the statute does not specifically require that EPA inform 
the public of the reintroduction of chemical substances by issuing 
Federal Register notices every 90 days, indicating what substances (if 
any) have been reactivated. EPA intends to include substances submitted 
in forward-looking notices and re-designated as active on the Inventory 
in its regular publications of the Inventory, which occur approximately 
every six months.
    Changes to the Final Rule to Establish the Date When a Chemical 
Substance Will Be Designated as Inactive: EPA revised the rule so that 
an inactive substance designation is not effective until 90 days after 
the date that EPA identifies a substance for inactive designation. See 
40 CFR 710.23 for revised definition of ``inactive substance.''
    Comment 10: A few commenters expressed concerns about the status of 
substances manufactured or processed in the period between June 22, 
2016 and the date the first Inventory with active and inactive 
designations is finalized and published. These commenters requested 
that EPA clarify the status of such substances.
    Response: EPA clarified the status of these chemical substances in 
Unit II and the final rule. The structure of the reporting requirements 
under TSCA sections 8(b)(4)(A) and 8(b)(5)(B) results in a transitional 
period beginning on June 22, 2016 (the day after the lookback period 
for retrospective reporting ends) and ending on the date the forward-
looking reporting period begins (i.e., the effective date that chemical 
substances are designated as inactive, which is 90 days after EPA 
publishes the first Inventory with listings identified as active or 
inactive). A person who did not manufacture or process a particular 
chemical substance during the lookback period (June 21, 2006 through 
June 21, 2016) is not subject to the retrospective reporting provisions 
of this rule with respect to that substance, and should not submit an 
NOA Form A for that substance regardless of whether the person 
manufactured or processed the substance on or after June 22, 2016. If 
that substance is ultimately designated by EPA as inactive, however, 
any person who intends to manufacture or process that substance after 
it is designated as inactive must submit an NOA Form B.
    To address concerns about substances reintroduced into U.S. 
commerce during the transitional period and potential interruptions in 
commercial activity that could arise upon EPA's designation of such 
substances as inactive, EPA revised the rule to reflect that an 
inactive designation only becomes effective 90 days after EPA 
identifies the substance for such designation. EPA is clarifying that 
the obligation to submit an NOA Form B does not begin until the 
effective date of an inactive substance designation. Because EPA 
revised the rule so that an inactive substance designation is not 
effective until 90 days after the date that EPA identifies a substance 
for inactive designation, manufacturers and processors are afforded 
time to react to an inactive substance identification. Persons who are 
already manufacturing or processing a substance for nonexempt 
commercial purpose (e.g., during the transitional period), and wish to 
continue doing so without interruption after EPA's designation of such 
substance as inactive, are permitted to submit an NOA Form B for such 
substance prior to the effective date of the inactive designation, 
which is the date that the substance attains the legal status of being 
inactive. Similarly, persons that anticipate reintroducing a substance 
into U.S. commerce for nonexempt commercial purpose shortly after EPA 
identifies the substance for inactive designation are also afforded 
time to react to the inactive substance identification and are 
permitted to file an NOA Form B prior to the effective date of the 
substance's inactive designation, as long as such form is filed no more 
than 90 days before the anticipated date of manufacture or processing. 
Manufacturers should be aware that the timely filing of an NOA Form B 
does not remedy an earlier failure to comply with the retrospective 
reporting requirement; it merely ensures that the manufacturer will not 
also be in violation of the forward-looking reporting requirement.
    Changes to the Final Rule to Clarify the Status of Chemical 
Substances Manufactured or Processed in between the Retrospective and 
Forward-Looking Reporting Periods: EPA revised the rule to clarify that 
manufacturers and processors are permitted to submit an NOA Form B for 
a chemical substance that EPA has identified for inactive designation, 
even though the effective date of such designation has not yet arrived, 
and thus the substance does not yet have the legal status of being 
inactive. See 40 CFR 710.30(b)(2).
    Comment 11: Numerous commenters stated that certain data 
requirements should be eliminated or reduced. Two commenters stated 
that EPA should reduce the proposed requirement for a date range from 
retrospective notification by not requiring exact dates for the date 
range for retrospective notification, and instead suggested that the 
first and last dates of the range be reported by month and year. 
Numerous commenters stated that EPA should eliminate the proposed 
requirement for a date range from retrospective notification, 
indicating that such information would be burdensome to retrieve and 
evaluate and, in certain cases, may not be available due to record 
retention policies. Commenters further indicated that such information 
is not required to meet the statutory objective and that the 
certification statement should be sufficient to support data accuracy. 
Similarly, several commenters also stated that EPA should eliminate the 
proposed requirement for type of commercial activity from retrospective 
notification; one commenter indicated that the proposed requirement 
should also be eliminated from forward-looking notification. A few 
commenters suggested reducing the proposed requirement for type of 
commercial activity from retrospective notification by combining 
``Domestically manufactured'' and ``Imported'' into one category for 
reporting. One commenter was supportive of requiring type of commercial 
activity.
    Response: EPA has decided not to require date range and activity 
type for retrospective notification. EPA had proposed such information 
to serve the objective of verifying and validating notices submitted. 
However, in response

[[Page 37534]]

to comments received, EPA has been persuaded that the collection of a 
date range of manufacture, as well as the collection of information to 
differentiate between domestic manufacture, import, and processing, is 
unnecessary to serve the underlying objective of reliably 
differentiating active and inactive substances. EPA is also mindful 
that TSCA section 8(b)(4)(A)(i) specially admonishes the Agency to 
avoid, to the extent feasible, the collection of unnecessary 
information in this rule. As an alternative to requiring date and 
information, EPA has revised the NOA Form A certification statement to 
require an affirmation that manufacturing or processing of the chemical 
substance occurred during the lookback period. If EPA needs to verify 
the basis for such a certification, it can obtain and evaluate the 
documentation that submitters are required to maintain under 40 CFR 
710.35.
    EPA has similarly removed the activity type requirement for 
forward-looking notification. This is consistent with the evidence of 
Congressional intent motivating the notification requirement. See S. 
Rep. 114-67 at 20 (purpose is to categorize the chemical substances on 
the Inventory as ``active or inactive,'' and ``[m]anufacturers of an 
inactive substance may return the substance to the active inventory 
with a simple notification to EPA''). In response to comments received, 
EPA has been persuaded that information on activity type is not 
necessary to accomplish the purpose of the rule regarding 
differentiating inactive substances from active substances. EPA has 
also revised the NOA Form B certification statement to require an 
affirmation that persons submitting an NOA Form B have forward-looking 
intent to manufacture or process for nonexempt commercial purpose. If 
EPA needs to verify the basis for such a certification, it can obtain 
and evaluate the documentation that submitters are required to maintain 
under 40 CFR 710.35.
    Changes to Required Reporting Elements in the Final Rule: EPA 
removed the date range and commercial activity type requirements from 
retrospective notification, and revised the certification statement on 
the NOA Form A to clarify that persons submitting the form are 
certifying that manufacturing or processing of the chemical substance 
occurred during the lookback period. EPA also removed the commercial 
activity type requirement from forward-looking notification, and 
revised the certification statement on the NOA Form B to clarify that 
persons submitting the form are certifying that they have forward-
looking intent to manufacture or process the substance. See 40 CFR 
710.29(b) and 40 CFR 710.29(c).
    Comment 12: Numerous commenters stated that EPA should clarify the 
meaning of ``known or reasonably ascertainable,'' particularly in the 
context of scenarios involving mergers and acquisitions (e.g., 
corporate predecessors and successors) that occurred during or after 
the ten-year reporting period, and in such scenarios, who is 
responsible for reporting under the rule. Some commenters further 
elaborated that if a company no longer has a legal obligation to retain 
particular records, or if the records are no longer in the possession 
of the company (e.g., they are not available due to company document 
retention policies or are in the possession of an acquiring company), 
the information should be considered to be not ``Known or Reasonably 
Available/Ascertainable'' and reporting should not be required. One 
commenter suggested amending 40 CFR 710.25 to add a new paragraph (b) 
to address entities formed during the lookback period that may not have 
historical records in their possession or control. Another commenter 
stated that EPA's proposal was still silent as to the level of 
diligence that must be used to determine which substances must be 
reported under NOA Form A and Form B, and suggested that EPA assign a 
``readily obtainable'' standard to that level of diligence for the Form 
A's.
    Response: CFR 40 part 704 defines ``Known to or reasonably 
ascertainable by'' as all information in a person's possession or 
control, plus all information that a reasonable person similarly 
situated might be expected to possess, control, or know. In response to 
commenters' request for clarification of possession or control as it 
relates to corporate mergers and acquisitions, EPA has added to 40 CFR 
710.23 the definition of ``Possession or Control'' from 40 CFR 704.3. 
Consistent with its use in Part 704, ``Possession or Control'' is 
defined as meaning in the possession or control of any person, or of 
any subsidiary, partnership in which the person is a general partner, 
parent company, or any company or partnership which the parent company 
owns or controls, if the subsidiary, parent company, or other company 
or partnership is associated with the person in the research, 
development, test marketing, or commercial marketing of the chemical 
substance in question. Information is in the possession or control of a 
person if it is: (1) In the person's own files including files 
maintained by employees of the person in the course of their 
employment, (2) in commercially available data bases to which the 
person has purchased access, or (3) maintained in the files in the 
course of employment by other agents of the person who are associated 
with research, development, test marketing, or commercial marketing of 
the chemical substance in question.
    EPA believes it is appropriate to construe what ``a reasonable 
person similarly situated might be expected to possess, control, or 
know,'' based on the totality of pertinent factors. Prior loss of 
records consistent with document retention policies and the other 
individual factors cited by the commenters could be pertinent in 
construing what information is known or reasonably ascertainable, but 
they are not replacements for the regulatory standard. In any event, if 
a person actually knows information, then it is known or reasonably 
ascertainable.
    In the context of the CDR rule, EPA has published extensive 
guidance on the application of the ``known to or reasonably 
ascertainable by'' standard and how to address retrospective reporting 
in the case of corporate succession. See, e.g., TSCA Chemical Data 
Reporting Fact Sheet: Reporting After Changes to Company Ownership or 
Legal Identity, available at https://www.epa.gov/sites/production/files/2015-05/documents/cdr_fact_sheet_company_changes.pdf (Ref. 9). 
See also 2016 Chemical Data Reporting Frequent Questions, available at 
https://www.epa.gov/sites/production/files/2016-07/documents/cdr_fq_final_july_11_2016.pdf (Ref. 10). EPA finds that guidance issued 
on these topics in the context of the CDR rule is also instructive in 
the context of this rule.
    EPA agrees with one commenter that the level of diligence that must 
be used to determine which chemical substances must be reported using 
an NOA Form A should be clarified, but disagrees with the suggestion 
that manufacturers need not report their manufacture of substances 
during the lookback period if the knowledge that they conducted the 
prior manufacture is reasonably ascertainable by them but not ``readily 
obtainable'' by them. EPA revised 40 CFR 710.25(a) to clarify that if 
it is not ``known to or reasonably ascertainable by'' a manufacturer 
that the person manufactured a particular substance during the lookback 
period, then the person is not obligated to report that substance on an 
NOA Form A. EPA believes that the authority to limit retrospective 
reporting to information that is known or reasonably ascertainable at 
the time of the reporting obligation is implicit in the grant of

[[Page 37535]]

rulemaking authority under TSCA section 8(b)(4), consistent with TSCA 
section 8(a) and the overall statutory objectives of TSCA section 8(b), 
and consistent with past practice for retrospective reporting on the 
CDR rule. The commenter set forth little basis for adopting a ``readily 
obtainable'' standard and EPA continues to believe (see proposal at 82 
FR 4256) that it is appropriate to base this rule on basic reporting 
concepts that the public is already familiar with from the CDR. It 
would be confusing to have one standard governing the need to submit an 
NOA Form A (``readily obtainable'') and another standard (``known to or 
reasonably ascertainable by'') governing the information elements that 
need to be reported on the NOA Form A. Finally, EPA has already 
significantly addressed commenters' broader concern about the potential 
burden of conducting an information search by eliminating the 
requirement to report the specific start and end dates of manufacture.
    EPA also disagrees with one commenter that 40 CFR 710.25 should be 
amended to specifically address entities formed during the lookback 
period that do not have historical records in their possession. The 
revision to 40 CFR 710.23 to add the definition of ``Possession or 
Control,'' and the revision to 40 CFR 710.25(a) to clarify application 
of the ``known to or reasonably ascertainable by'' standard in the 
context of retrospective reporting, apply to all persons subject to 
reporting under 40 CFR 710.25(a). It is not necessary to separately 
address a specific type of entity, e.g., entities formed during the 
lookback period, in 40 CFR 710.25.
    With respect to the standard of diligence for determining whether a 
chemical substance is subject to forward-looking reporting on an NOA 
Form B, EPA revised 40 CFR 710.25(c) to clarify that if it is not 
``known to or reasonably ascertainable by'' a person that the substance 
being manufactured or processed is listed on the confidential portion 
of the Inventory as an inactive substance, then the person is not 
obligated to report that substance on an NOA Form B. This may be the 
case, for instance, if one person manufactures a polymer under a PMN 
exemption, but another manufacturer subsequently adds the same polymer 
to the confidential portion of the Inventory and then ceases 
manufacturing before the lookback period, resulting in the confidential 
substance being designated inactive. EPA anticipates that only persons 
operating under PMN exemptions will be able to avail themselves of this 
revision, since other persons will have no basis to manufacture an 
Inventory chemical without knowing the Inventory identity of the 
chemical.
    With respect to the information that must be reported on an NOA 
Form B, believes that the question of the information reporting 
standard and the standard of diligence has become moot, with the 
elimination of all information submission requirements other than those 
that EPA can reasonably expect the submitter to know. By direct 
operation of the statute and consistent with proposed procedural rules 
at 40 CFR 710.25, any person who intends to manufacture or process an 
inactive substance, except for a nonexempt commercial purpose, must 
submit an NOA Form B alerting EPA to ``designate the applicable 
chemical substance as an active substance.'' TSCA section 8(b)(5)(B). 
Thus, irrespective of any rulemaking, TSCA itself requires the identity 
of the substance to be placed on the active Inventory to be specified. 
The proposed requirement to report the type of intended commercial 
activity has been eliminated, along with the ``actual date'' by which 
the inactive substance is to be manufactured or processed. If a person 
does not know the date by which it anticipates that the inactive 
substance is to be manufactured or processed, then filing NOA Form B 
would be inconsistent with the timing requirements of 40 CFR 710.30. 
Finally, EPA can reasonably expect the submitter to know its own 
identity. Accordingly, EPA has removed, as moot, the proposed 
specification in 40 CFR 710.29(c) that a person required to submit 
information on an NOA Form B must report information to the extent that 
such information is known or reasonably ascertainable by that person.
    Changes to the Final Rule to Clarify ``Known or Reasonably 
Ascertainable'' and to Add a Definition for ``Possession or Control:'' 
EPA added a definition for ``Possession or Control'' in the rule to 
clarify the existing definition of ``Known to or reasonably 
ascertainable by.'' See 40 CFR 710.23. EPA also revised 40 CFR 
710.25(a) to clarify that if it is not ``known to or reasonably 
ascertainable by'' a manufacturer that the person manufactured a 
particular chemical substance during the lookback period, then the 
person is not obligated to report that substance on an NOA Form A. EPA 
revised 40 CFR 710.25(c) to clarify that if it is not ``known to or 
reasonably ascertainable by'' a person that the substance being 
manufactured or processed is listed on the confidential portion of the 
Inventory as an inactive substance, then the person is not obligated to 
report that substance on an NOA Form B. EPA removed, as moot, the 
proposed specification in 40 CFR 710.29(c) that a person required to 
submit information on an NOA Form B must report information to the 
extent that such information is known to or reasonably ascertainable by 
that person.
    Comment 13: Numerous commenters stated that EPA should provide a 
reasonable opportunity or a formal process to amend or correct 
retrospective notices. Several commenters suggested a time frame for 
corrections, e.g., up until the date that the first Inventory with 
active and inactive designations is published; for manufacturers, 
during the additional 180-day submission period for processors; and for 
processors, 180 days from the date that the first Inventory is 
published. Two commenters stated that EPA should also allow forward-
looking notices to be corrected or rescinded. Several commenters 
indicated that corrections should be non-punitive.
    Response: EPA agrees in part with these comments. The 180-day 
retrospective submission period for manufacturers is the maximum time 
provided for by the statute. While EPA is not providing a formal 
corrections process for retrospective reporting to the regulatory text, 
EPA will allow retrospective reporting notices submitted by 
manufacturers during the 180-day submission period for manufacturers to 
be withdrawn not later than 420 days after the publication of the final 
rule in the Federal Register. EPA will allow retrospective reporting 
notices submitted by processors during the 420-day submission period 
for processors to be withdrawn not later than October 5, 2018, should 
processors discover errors in their original notices. See 40 CFR 
710.30(a)(3).
    With respect to forward-looking reporting, EPA is not providing a 
formal corrections process but has revised the regulatory text to allow 
forward-looking reporting notices submitted by manufacturers or 
processors to be withdrawn if EPA has not yet altered the Inventory 
status of the chemical substance in response to the original submission 
(i.e., EPA has neither re-designated the substance from inactive to 
active nor moved the substance from the confidential portion of the 
Inventory to the public portion of the Inventory as a result of a 
request in the original submission for a CBI claim to be withdrawn). 
See 40 CFR 710.30(b)(3). Because a forward-looking notice will be 
processed even if the intended manufacture and processing does not 
occur as originally anticipated, and because it would be burdensome and 
potentially impossible to implement

[[Page 37536]]

such an approach, the rule does not allow for EPA to revert a re-
activated substance back to inactive status based on a request to 
withdraw a Form B, or for EPA to revert a non-CBI substance back to a 
CBI substance based on a request to withdraw a Form B.
    EPA appreciates that retrospective withdrawals should be non-
punitive. However, after the period allowed for withdrawal, incorrect 
information would be considered a prohibited act under Section 15(1) 
and 15(3). Similarly, incorrect information in forward-looking notices 
would also be considered a prohibited act under Section 15(1) and 
15(3), if not withdrawn prior to EPA altering the Inventory status of 
the chemical substance in the original notice. Persons making 
corrections after these retrospective and forward-looking timeframes 
and seeking future penalty mitigation considerations may disclose 
within 21 days after they have an objectively reasonable basis for 
believing that a violation has, or may have, occurred, pursuant to 
EPA's Self-Disclosure policies. See: https://www.epa.gov/compliance/epas-edisclosure.
    Changes to the Final Rule to Allow Withdrawal of a Notice of 
Activity Form A or Form B: EPA revised the rule to allow retrospective 
notices to be withdrawn if done so not later than October 5, 2018. See 
40 CFR 710.30(a)(3). EPA revised the rule to allow forward-looking 
notices to be withdrawn if EPA has not yet altered the Inventory status 
of the substance in response to the original submission. See 40 CFR 
710.30(b)(3).
    Comment 14: A few commenters requested clarification on the 
proposed procedures for joint submissions. One commenter requested that 
EPA provide a different reporting option that avoids the need for a 
joint submission. Two commenters requested clarification on the 
reporting responsibilities of manufacturers, importers, and processors 
when a supplier fails to submit its information.
    Response: EPA proposed procedures for joint submissions that will 
enable a company to submit a commercial activity notice for a chemical 
substance on the confidential portion of the Inventory in situations 
where the submitter does not know the specific chemical identity of the 
substance because a portion of the specific chemical identity is held 
CBI by a supplier. This rule includes such joint submission procedures 
that allow the submitter to provide information on the specific 
chemical identity that it has in its possession, and the supplier to 
separately provide information on the specific chemical identity that 
it has in its possession, in a manner that protects the supplier's CBI 
from the submitter of the NOA.
    Additionally, since publication of the proposed rule, EPA expanded 
its electronic reporting system to include a pick list from which 
persons can select chemicals for reporting. The pick list will include 
only reportable substances and will not include CBI. Non-CBI substances 
will be listed by CASRNs and CA index names, as they appear on the 
Inventory, and CBI substances will be listed by EPA accession numbers 
and generic names, as they appear on public versions of the Inventory. 
Submitters can identify substances from the pick list and, therefore, 
do not have to manually enter chemical identity information. Because 
the chemical identity information selected from the pick list and 
transmitted on the NOA form will not be CBI, there is no need for 
submitters who use this pick list to supply CBI to EPA. In cases 
involving third party CBI, a submitter can provide a single notice to 
EPA for a CBI substance, provided they have in their possession the 
corresponding non-CBI chemical identifiers, EPA accession number and 
generic name, by selecting the non-CBI identifiers from the pick list, 
thereby avoiding the need for a joint submission. If a submitting 
company does not know the EPA accession number and generic name, they 
can use existing mechanisms (e.g., Inventory Correspondence) to request 
such information from EPA.
    A submitting company that does not know the CBI chemical identity 
of the substance that it is required to report because of third party 
CBI, therefore, has two options for reporting. Such submitter can 
utilize the joint submission functionality in the electronic reporting 
tool. Alternatively, such submitter can select from the pick list based 
on the corresponding non-CBI chemical identifiers, EPA accession number 
and generic name, provided they have this information.
    Changes to Reporting Options for Joint Submissions: EPA revised the 
final rule to add a description of the pick list that will be provided 
in the electronic reporting system and which can serve as an 
alternative to a joint submission, should submitters have in their 
possession non-CBI chemical identifiers (EPA accession number and 
generic name) for a reportable CBI substance.
    Comment 15: A few commenters stated that the estimated reporting 
burden and costs are too low or unrealistic, citing the following 
universe estimates as underestimated: Number of chemicals that are not 
reported under CDR because of exemptions or reporting threshold 
(including ten percent basis for nonexempt low volume chemicals and 
polymers) and total burden for processors. One commenter recommended 
that EPA revise the number of processors or better explain the origins 
of EPA's estimation of 161,000 affected processors. Additionally, a few 
commenters stated that unit burden estimates per activity and/or 
respondent are too low, including: Cost per industry submission, time 
needed for data gathering, time needed for due diligence, and rule 
familiarization (for processors).
    Response: EPA agrees in part with these comments. After considering 
these comments, EPA adjusted the universe estimates and certain unit 
burden estimates. Regarding the number of chemicals and associated 
firms, EPA adds a group of chemicals termed ``XU Chemicals'' that was 
not included in estimates for the proposed rule. XU chemicals are 
defined in 40 CFR 711.6 and largely consist of polymers. This group of 
chemicals is listed on the Inventory, but is exempt from the reporting 
requirements of the CDR rule. Given that the CDR database is the 
primary source from which this rule's economic analysis draws 
measurements for counts of chemicals and firms, the XU Chemicals needed 
to be added. Regarding the number of processors, the origin for the 
proposed rule estimate of 161,550 processors was derived using the 
total chemical count for the initial reporting period combined with a 
model for ``processors per chemical.'' The model is based on a previous 
analysis for a different proposed rule (and cited in this proposed 
rule's Burden and Cost Report.) For the final rule, the model is 
updated using the more current CDR 2016 data; detailed methodology is 
provided in Table 2 footnote (Ref. 2). Due to the increased value of 
the model coupled with the higher chemical counts (discussed 
previously), processors are estimated for the final rule at 283,993 
firms
    Regarding unit burden estimates, EPA developed estimates for 
typical scenarios during start up and ongoing reporting to use as the 
representative average and then apply universe estimates to yield total 
burden estimates. Individual respondents may experience lower or higher 
levels of burden. The activities of ``time for data gathering,'' and 
``time needed for due diligence'' are included in the unit burden 
estimate for compliance determination. Similarly, unit burden estimate 
for rule familiarization is based

[[Page 37537]]

on the activities expected: ``. . . becoming familiar with the full 
requirements of the rule, which includes reading the rule, 
understanding the various reporting and administrative requirements, 
and determining the manner in which reporting requirements will be met 
for each chemical substance'' (Ref. 2). EPA also developed a range of 
burden hours estimates for processors' rule familiarization during 
start up at one to four hours, based on EPA judgment of how processors 
will familiarize themselves with the rule.
    Changes to the Burden and Cost Estimates in the Final Rule: EPA 
revised the universe estimates to add XU Chemicals, and to incorporate 
a revised, larger estimate for the number of processor firms. EPA also 
revised the unit burden for processors' rule familiarization during 
start up.
    Comment 16: One commenter indicated that EPA should justify why 
certification is required for non-CBI notices. Another commenter 
suggested the following changes to the proposed regulatory text for 
certification: 40 CFR 710.37(b)(3) should be corrected to ``[a]n 
authorized official of a person'' instead of ``person,'' 40 CFR 
710.29(d)(5) should be extended to substantiations as well as to claims 
and notices, and 40 CFR 710.37(b)(3) should be replicated in 40 CFR 
710.37(a) so that it also applies to CBI claims for chemical identity 
in addition to other CBI claims.
    Response: Certification statements are required under TSCA section 
8(b)(9)(A) and are essential whenever information is submitted to the 
EPA. Certification statements are routinely required for data submitted 
to the EPA under TSCA as well as other statutes for both CBI and non-
CBI submissions. Such statements ensure that the data the EPA 
ultimately relies on are valid and accurate. It also puts the submitter 
on notice of the consequences of submitting false, inaccurate, or 
incomplete information to the Agency.
    EPA agrees in large part with the comment recommending specific 
corrections to 40 CFR 710.37(b)(3) and 710.29(d)(5), the proposed 
regulatory provisions for certifications. EPA has revised the 
certification provisions in the rule, which currently appear at 40 CFR 
710.37(e) (applicable to CBI claims and associated substantiations) and 
710.29(d)(5) (applicable to all information reported on NOA Forms A and 
B). The rule clarifies that an ``authorized official'' submitting or 
substantiating any new or existing CBI claim must provide a 
certification, consistent with the requirements of TSCA section 
14(c)(5).
    While EPA does not agree with the commenter's implication that a 
request to maintain an existing CBI claim for specific chemical 
identity is subject to all of the same requirements and procedures that 
would apply to the assertion of a new claim under TSCA section 14(c), 
EPA finds it appropriate under the circumstances to require a 
certification statement for such requests that is consistent with TSCA 
section 14(c)(5), in addition to meeting the certification requirement 
of TSCA section 8(b)(9)(A). The earlier assertion of the CBI claim for 
specific chemical identity may have predated current provisions under 
TSCA subsections 14(c)(5) and (c)(1)(B) pertaining to the certification 
of a specific statement required for the assertion of a CBI claim. EPA 
does not believe that Congress intended the Agency to review existing 
CBI claims for chemical identity under TSCA section 8(b) without having 
the benefit of this certified statement.
    Changes to the Certification Statements in the Final Rule. EPA 
revised the certification statement applicable to CBI claims to 
substitute ``authorized official'' for ``person,'' and to address 
substantiation of claims, consistent with TSCA sections 8(b)(9)(A) and 
14(c)(5).
    Comment 17: One commenter indicated that the CBI claims process 
should be better defined, particularly with regard to substantiation. 
Two commenters stated that the substantiation questions should be 
reduced in scope.
    Response: EPA has extensively re-written the substantiation 
questions from the proposal in a manner intended to more succinctly 
secure answers for the basis of the CBI assertions for each data 
element as well as the CBI concerns on the linkage of data elements.
    Changes to Substantiation Questions in the Final Rule: EPA has 
rewritten the substantiation questions to more succinctly secure 
answers for the basis of the CBI assertions for each data elements as 
well as the CBI concerns on the linkage of data elements.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these references and 
other information considered by EPA. For assistance in locating these 
other documents, please consult the technical contact listed under FOR 
FURTHER INFORMATION CONTACT.

1. 2017. EPA. TSCA Inventory Notification (Active-Inactive) 
Requirements; Proposed Rule. Federal Register (82 FR 4255, January 
13, 2017) (FRL 9956-28).
2. 2017. EPA. Burden and Cost Report for the Final Rule: TSCA 
Inventory Notification Requirements (RIN 2070-AK24, June 19, 2017).
3. 2017. EPA. Notice of Activity Form A and Form B; Final.
4. 2009. EPA. Notice of Commencement Form; Final.
5. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final 
Rule. Federal Register (70 FR 59848, October 13, 2005) (FRL 7977-1).
6. 2013. EPA. Electronic Reporting Under the Toxic Substances 
Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 
2013) (FRL 9394-6).
7. 2017. EPA. Response to Comments to the Proposed Rule, TSCA 
Inventory Notification (Active-Inactive) Requirements; RIN 2070-
AK24. Docket # EPA-HQ-OPPT-2016-0426.
8. 2016. EPA. TSCA Chemical Data Reporting Fact Sheet: Imported 
Articles. https://www.epa.gov/sites/production/files/2015-12/documents/cdr_fact_sheet_imported_articles_-_final_dec2015.pdf.
9. 2016. EPA. TSCA Chemical Data Reporting Fact Sheet: Reporting 
After Changes to Company Ownership or Legal Identity. https://www.epa.gov/sites/production/files/2015-05/documents/cdr_fact_sheet_company_changes.pdf.
10. 2016. EPA. Chemical Data Reporting Frequent Questions. https://www.epa.gov/sites/production/files/2016-07/documents/cdr_fq_final_july_11_2016.pdf.
11. 2017. EPA. Information Collection Request for the TSCA section 
8(b) Reporting Requirements for TSCA Inventory Notifications (EPA 
ICR No. 2562.02).
12. 2017. EPA. Small Entity Analysis Report for the Final Rule: TSCA 
Inventory Notification Requirements (May 30, 2017).

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action that was 
submitted to the Office of Management and Budget (OMB) for review under 
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 
3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    The information collection activities associated with this rule 
have been submitted to OMB for review and approval under the PRA, 44 
U.S.C. 3501 et seq. Specifically, EPA has prepared

[[Page 37538]]

an Information Collection Request (ICR) (identified under EPA ICR No. 
2565.01 (OMB Control No. 2070-0201), that estimates the potential 
burden and costs associated with the paperwork requirements contained 
in this rule (Ref. 11). You can find a copy of the ICR in the docket 
for this rule, and it is briefly summarized here.
    Start-up year burden/cost (Retrospective). Covers respondents/
affected entities, i.e., persons who manufacture chemical substances.
    Respondents' obligation to respond: Mandatory.
    Estimated number of respondents: 1,685.
    Manufacturers: 5,322.
    Processors: 283,993.
    Frequency of response: Once and on occasion.
    Estimated burden: The term ``burden'' is defined at 5 CFR 
1320.3(b).
    Manufacturers: 38,613 hours.
    Processors: 937,347 hours.
    Estimated cost:
    Manufacturers: $3.09 million.
    Processors: $75.8 million.
    Start-up year CDX Registrations burden/cost.
    Respondents' obligation to respond: Mandatory.
    Estimated number of respondents: (169 registrations).
    Frequency of response: Once and on occasion.
    Estimated burden: 90 hours.
    Estimated cost: $7,022.
    Ongoing annual burden/cost (Forward-looking): Covers respondents/
affected entities, i.e., persons who manufacture or process chemical 
substances.
    Respondents' obligation to respond: Mandatory.
    Estimated number of respondents: 20.
    Frequency of response: On-occasion.
    Total estimated burden: 225 hours.
    Total estimated cost: $17,779.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9 and included on any 
related collection instrument (e.g., the form). When OMB approves this 
ICR, the Agency will announce that approval in the Federal Register and 
publish a technical amendment to 40 CFR part 9 to display the OMB 
control number for the approved information collection activities 
contained in this final rule.

C. Regulatory Flexibility Act (RFA)

    EPA certifies under section 605(b) of the RFA, 5 U.S.C. 601 et 
seq., that this action will not have a significant economic impact on a 
substantial number of small entities under the RFA. In making this 
determination, the impact of concern is any significant adverse 
economic impact on small entities. An agency may certify that a rule 
would not have a significant economic impact on a substantial number of 
small entities if the rule has a very small level of impact on the 
small entities subject to the rule.
    The entities subject to the requirements of this action are 
manufacturers, and processors of chemical substances, i.e., small 
businesses in NAICS 325: Chemical Manufacturing, and 324: Petroleum and 
Coal Products Manufacturing. The most burdensome conditions are 
incurred during the start-up year, when all manufacturers are expected 
to report, and all processors are expected to become familiar with the 
requirements, but only a small number of the processors will likely 
also report. EPA has prepared a detailed analysis to evaluate the 
potential impacts quantitatively, a copy of which is available in the 
docket (Ref. 12).
    The quantitative analysis addresses the ``most affected'' subset of 
entities who are expected to incur the highest potential burden under 
the rule (18 hours and $1,188 per firm) are the small entities 
manufacturing (or importing) chemicals that must submit NOAs involving 
an average of eighteen chemicals per entity in the start-up year. 
Although all processors are assumed to experience burden from becoming 
familiar with the requirements, only a small subset are expected to 
experience the burdens associated with submitting the NOAs.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate as described in 
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect 
small governments. The action is not expected to impose enforceable 
duty on any state, local or tribal governments, and the requirements 
imposed on the private sector are not expected to result in annual 
expenditures of $100 million or more for the private sector. As such, 
EPA has determined that the requirements of UMRA sections 202, 203, 
204, or 205 do not apply to this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it does 
not have any effect on the states, on the relationship between the 
national government and the states, or on the distribution of power and 
responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is 
not expected to have any effect on tribal governments, on the 
relationship between the Federal government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), 
as applying only to those regulatory actions that concern health or 
safety risks, such that the analysis required under section 5-501 of 
Executive Order 13045 has the potential to influence the regulation. 
This action is not subject to Executive Order 13045 because it does not 
establish an environmental standard intended to mitigate health or 
safety risks.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have a significant adverse effect on energy
    supply, distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA 
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994), because EPA has determined that this action 
would not have disproportionately high and adverse human health or 
environmental effects on minority or low-income populations. This 
action does not affect

[[Page 37539]]

the level of protection provided to human health or the environment.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA 
will submit a rule report to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States. This 
action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 710

    Chemicals, Confidential Business Information, Environmental 
Protection, Hazardous Substances, Reporting and Recordkeeping 
Requirements.


    Dated: June 22, 2017.
E. Scott Pruitt,
Administrator.

    Therefore, 40 CFR Chapter I is amended as follows:

PART 710--[AMENDED]

0
1. Revise the authority citation for part 710 to read as follows:

    Authority:  15 U.S.C. 2607(a) and (b).


0
2. Designate Sec. Sec.  710.1 through 710.4 as subpart A, and add a 
heading for subpart A to read as follows:

Subpart A--General Provisions

* * * * *

0
3. In Sec.  710.1, revise paragraph (b) to read as follows:


Sec.  710.1  Scope and compliance.

* * * * *
    (b) This part applies to the activities associated with the 
compilation of the TSCA Chemical Substance Inventory (Inventory) and 
the designation of chemical substances on the TSCA Inventory as active 
or inactive in U.S. commerce.
* * * * *

0
4. In Sec.  710.3, revise paragraph (d) to read as follows:


Sec.  710.3  Definitions.

* * * * *
    (d) The following definitions also apply to this part:
    Act means the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 
et seq.
    Administrator means the Administrator of the U.S. Environmental 
Protection Agency, any employee or authorized representative of the 
Agency to whom the Administrator may either herein or by order delegate 
his/her authority to carry out his/her functions, or any other person 
who will by operation of law be authorized to carry out such functions.
    Article means a manufactured item:
    (1) Which is formed to a specific shape or design during 
manufacture,
    (2) Which has end use function(s) dependent in whole or in part 
upon its shape or design during end use, and
    (3) Which has either no change of chemical composition during its 
end use or only those changes of composition which have no commercial 
purpose separate from that of the article and that may occur as 
described in Sec.  710.4(d)(5); except that fluids and particles are 
not considered articles regardless of shape or design.
    Byproduct means a chemical substance produced without a separate 
commercial intent during the manufacture, processing, use, or disposal 
of another chemical substance(s) or mixture(s).
    CASRN means Chemical Abstracts Service Registry Number.
    Chemical substance means any organic or inorganic substance of a 
particular molecular identity, including any combination of such 
substances occurring in whole or in part as a result of a chemical 
reaction or occurring in nature, and any chemical element or uncombined 
radical; except that ``chemical substance'' does not include:
    (1) Any mixture;
    (2) Any pesticide when manufactured, processed, or distributed in 
commerce for use as a pesticide;
    (3) Tobacco or any tobacco product, but not including any 
derivative products;
    (4) Any source material, special nuclear material, or byproduct 
material;
    (5) Any pistol, firearm, revolver, shells, and cartridges; and
    (6) Any food, food additive, drug, cosmetic, or device, when 
manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic, or device.
    Commerce means trade, traffic, transportation, or other commerce:
    (1) Between a place in a State and any place outside of such State 
or
    (2) Which affects trade, traffic, transportation, or commerce 
between a place in a State and any place outside of such State.
    Customs territory of the United States means the 50 States, Puerto 
Rico, and the District of Columbia.
    Distribute in commerce and distribution in commerce means to sell 
in commerce, to introduce or deliver for introduction into commerce, or 
to hold after its introduction into commerce.
    Domestic means within the geographical boundaries of the 50 United 
States, the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and 
any other territory or possession of the United States.
    EPA means the U.S. Environmental Protection Agency.
    Importer means any person who imports any chemical substance, 
including a chemical substance as part of a mixture or article, into 
the customs territory of the United States. ``Importer'' includes the 
person primarily liable for the payment of any duties on the 
merchandise or an authorized agent acting on his or her behalf. The 
term also includes, as appropriate,
    (1) The consignee,
    (2) The importer of record,
    (3) the actual owner if an actual owner's declaration and 
superseding bond has been filed in accordance with 19 CFR 141.20, or
    (4) The transferee, if the right to draw merchandise in a bonded 
warehouse has been transferred in accordance with subpart C of 19 CFR 
144.
    Impurity means a chemical substance which is unintentionally 
present with another chemical substance.
    Intermediate means any chemical substance that is consumed, in 
whole or in part, in chemical reaction(s) used for the intentional 
manufacture of other chemical substance(s) or mixture(s), or that is 
intentionally present for the purpose of altering the rate(s) of such 
chemical reaction(s).
    Inventory means the TSCA Chemical Substance Inventory, which is 
EPA's comprehensive list of confidential and non-confidential chemical 
substances manufactured or processed in the United States for nonexempt 
commercial purpose that EPA compiled and keeps current under section 
8(b) of the Act.
    Manufacture means to manufacture, produce, or import, for 
commercial purposes. Manufacture includes the extraction, for 
commercial purposes, of a component chemical substance from a 
previously existing chemical substance or complex combination of 
chemical substances. When a chemical substance, manufactured other than 
by import, is: (1) Produced exclusively for another person who 
contracts for such production, and (2) that other person specifies the 
identity of the chemical substance and controls the total amount 
produced and the basic technology for the plant process, then that 
chemical substance is co-manufactured by the producing manufacturer and 
the person contracting for such production.
    Manufacture for commercial purposes means: (1) To manufacture, 
produce, or import with the purpose of obtaining an immediate or 
eventual commercial

[[Page 37540]]

advantage, and includes, among other things, the ``manufacture'' of any 
amount of a chemical substance or mixture (i) for commercial 
distribution, including for test marketing, or (ii) for use by the 
manufacturer, including use for product research and development or as 
an intermediate. (2) The term also applies to substances that are 
produced coincidentally during the manufacture, processing, use, or 
disposal of another substance or mixture, including byproducts that are 
separated from that other substance or mixture and impurities that 
remain in that substance or mixture. Byproducts and impurities without 
separate commercial value are nonetheless produced for the purpose of 
obtaining a commercial advantage, since they are part of the 
manufacture of a chemical substance for commercial purposes.
    Manufacturer means a person who manufactures a chemical substance.
    Mixture means any combination of two or more chemical substances if 
the combination does not occur in nature and is not, in whole or in 
part, the result of a chemical reaction; except that ``mixture'' does 
include (1) any combination which occurs, in whole or in part, as a 
result of a chemical reaction if the combination could have been 
manufactured for commercial purposes without a chemical reaction at the 
time the chemical substances comprising the combination were combined, 
and if all of the chemical substances comprising the combination are 
not new chemical substances, and (2) hydrates of a chemical substance 
or hydrated ions formed by association of a chemical substance with 
water, so long as the nonhydrated form is itself not a new chemical 
substance.
    New chemical substance means any chemical substance which is not 
included on the Inventory.
    Person includes any individual, firm, company, corporation, joint-
venture, partnership, sole proprietorship, association, or any other 
business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal Government.
    Process means to process for commercial purposes. Process includes 
the preparation of a chemical substance or mixture, after its 
manufacture, (1) in the same form or physical state as, or in a 
different form or physical state from, that in which it was received by 
the person so preparing such substance or mixture, or (2) as part of a 
mixture or article containing the chemical substance or mixture.
    Process for commercial purposes means the preparation of a chemical 
substance or mixture after its manufacture for distribution in commerce 
with the purpose of obtaining an immediate or eventual commercial 
advantage for the processor. Processing of any amount of a chemical 
substance or mixture is included in this definition. If a chemical 
substance or mixture containing impurities is processed for commercial 
purposes, then the impurities also are processed for commercial 
purposes.
    Processor means any person who processes a chemical substance or 
mixture.
    Site means a contiguous property unit. Property divided only by a 
public right-of-way will be considered one site. More than one 
manufacturing plant may be located on a single site.
    (1) For chemical substances manufactured under contract, i.e., by a 
toll manufacturer, the site is the location where the chemical 
substance is physically manufactured.
    (2) The site for an importer who imports a chemical substance 
described in Sec.  710.25 is the U.S. site of the operating unit within 
the person's organization that is directly responsible for importing 
the chemical substance. The import site, in some cases, may be the 
organization's headquarters in the United States. If there is no such 
operating unit or headquarters in the United States, the site address 
for the importer is the U.S. address of an agent acting on behalf of 
the importer who is authorized to accept service of process for the 
importer.
    Small quantities solely for research and development (or ``small 
quantities solely for purposes of scientific experimentation or 
analysis or chemical research on, or analysis of, such substance or 
another substance, including such research or analysis for the 
development of a product'') means quantities of a chemical substance 
manufactured, imported, or processed or proposed to be manufactured, 
imported, or processed solely for research and development that are not 
greater than reasonably necessary for such purposes.
    State means any State of the United States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, 
American Samoa, the Northern Mariana Islands, or any other territory or 
possession of the United States.
    Technically qualified individual means a person:
    (1) Who because of his/her education, training, or experience, or a 
combination of these factors, is capable of appreciating the health and 
environmental risks associated with the chemical substance which is 
used under his/her supervision,
    (2) Who is responsible for enforcing appropriate methods of 
conducting scientific experimentation, analysis, or chemical research 
in order to minimize such risks, and
    (3) Who is responsible for the safety assessments and clearances 
related to the procurement, storage, use, and disposal of the chemical 
substance as may be appropriate or required within the scope of 
conducting the research and development activity. The responsibilities 
in this paragraph may be delegated to another individual, or other 
individuals, as long as each meets the criteria in paragraph (1) of 
this definition.
    Test marketing means the distribution in commerce of no more than a 
predetermined amount of a chemical substance, mixture, or article 
containing that chemical substance or mixture, by a manufacturer or 
processor to no more than a defined number of potential customers to 
explore market capability in a competitive situation during a 
predetermined testing period prior to the broader distribution of that 
chemical substance, mixture, or article in commerce.
    United States, when used in the geographic sense, means all of the 
States, territories, and possessions of the United States.

0
 5. Add a new subpart B to read as follows:

SUBPART B--COMMERCIAL ACTIVITY NOTIFICATION

Sec.
710.23 Definitions.
710.25 Persons subject to the notification requirement.
710.27 Activities for which notification is not required.
710.29 Information required in the notification.
710.30 When to submit notifications.
710.33 Co-manufacturers and co-processors.
710.35 Recordkeeping requirements.
710.37 Confidentiality claims.
710.39 Electronic filing.


Sec.  710.23  Definitions.

    The following definitions also apply to subpart B of this part.
    Active substance means any interim active substance, any naturally 
occurring chemical substance as defined by Sec.  710.27(b), any 
chemical substance that was added to the Inventory on or after June 21, 
2006 pursuant to a Notice of Commencement under Sec.  720.102 received 
by the Agency on or after June 21, 2006, and any chemical substance

[[Page 37541]]

subject to commercial activity designation that the Administrator 
designates as active based on the receipt of a notice under this 
subpart.
    Central Data Exchange or CDX means EPA's centralized electronic 
document reporting portal, or its successors.
    Chemical substance subject to commercial activity designation means 
a chemical substance that requires a designation as either an active or 
an inactive substance. A chemical substance is subject to commercial 
activity designation if it is not an interim active substance, it was 
added to the Inventory before June 21, 2006, it is not a naturally 
occurring chemical substance as defined by Sec.  710.27(b), and it has 
not yet been designated by the Administrator as either an active or an 
inactive substance.
    Chemical Information Submission System or CISS means EPA's web-
based reporting tool for preparing and submitting a Notice of Activity.
    e-NOA means EPA's software module within CISS for generating and 
completing Notice of Activity Forms A and B.
    Existing claim for protection of specific chemical identity against 
disclosure is a claim for protection of the specific chemical identity 
of a chemical substance that is listed on the confidential portion of 
the Inventory, asserted prior to June 22, 2016.
    Inactive substance means any chemical substance subject to 
commercial activity designation, that the Administrator designates as 
inactive based on the lack of receipt of a notice under this subpart, 
effective 90 days after the Administrator identifies the chemical 
substance for such designation.
    Interim active substance means any chemical substance that was 
reported, pursuant to 40 CFR part 711, as having been manufactured in 
and of the calendar years: 2010, 2011, 2012, 2013, 2014, or 2015.
    Known to or reasonably ascertainable by means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know.
    Notice of Activity Form A means the form for supplying 
retrospective notification under TSCA section 8(b)(4), for which the 
submission obligation is described in Sec.  710.25(a).
    Notice of Activity Form B means the form for supplying forward-
looking reporting under TSCA section 8(b)(5), for which the submission 
obligation is described in Sec.  710.25(c).
    Lookback period means the period beginning on June 21, 2006 and 
ending on June 21, 2016.
    Possession or Control means in the possession or control of any 
person, or of any subsidiary, partnership in which the person is a 
general partner, parent company, or any company or partnership which 
the parent company owns or controls, if the subsidiary, parent company, 
or other company or partnership is associated with the person in the 
research, development, test marketing, or commercial marketing of the 
chemical substance in question. Information is in the possession or 
control of a person if it is:
    (1) In the person's own files including files maintained by 
employees of the person in the course of their employment.
    (2) In commercially available data bases to which the person has 
purchased access.
    (3) Maintained in the files in the course of employment by other 
agents of the person who are associated with research, development, 
test marketing, or commercial marketing of the chemical substance in 
question.
    Reportable chemical substance means a chemical substance that is 
listed on the Inventory and that is either:
    (1) A chemical substance subject to commercial activity designation 
for which notification is required or allowed under Sec.  710.25(a) and 
Sec.  710.25(b),
    (2) A chemical substance that was added to the confidential portion 
of the Inventory before June 22, 2016, or (3) an inactive substance for 
which notification is required under Sec.  710.25(c).
    Submission period means the applicable period for submitting a 
Notice of Activity under Sec.  710.25.


Sec.  710.25  Persons subject to the notification requirement.

    The following persons are subject to the requirements of this 
subpart.
    (a) Who must submit the Notice of Activity Form A? Any person who 
manufactured (including imported) a chemical substance subject to 
commercial activity designation at any time during the lookback period, 
except as provided in Sec.  710.27, must submit a Notice of Activity 
Form A as specified under Sec.  710.29 and Sec.  710.30(a), unless such 
person has evidence in the form of a CDX receipt, documenting EPA's 
receipt of a Notice of Activity Form A from another person, for the 
same chemical substance, or unless the prior manufacturing of such a 
substance is not known to or reasonably ascertainable by the person. 
Evidence in the form of a CDX receipt for a Notice of Activity Form A 
is not a basis for exemption from the requirements of Sec.  710.25(c) 
if the chemical substance is ultimately designated as inactive due to 
withdrawal of the Notice of Activity Form A.
    (b) Who else may submit the Notice of Activity Form A? Any person 
not required to submit a Notice of Activity Form A under Sec.  
710.25(a), who manufactured (including imported) or processed a 
reportable chemical substance, at any time during the lookback period, 
may submit a Notice of Activity Form A as specified under Sec.  710.29 
and Sec.  710.30(a).
    (c) Who must submit the Notice of Activity Form B? Any person who 
intends to manufacture (including import) or process an inactive 
substance, except as provided in Sec.  710.27, after the effective date 
of the Administrator's designation of such chemical substance as an 
inactive substance, must submit a Notice of Activity Form B as 
specified under Sec.  710.29 and Sec.  710.30(b), unless the presence 
of the inactive substance on the confidential portion of the Inventory 
is not known to or reasonably ascertainable by the person.


Sec.  710.27  Activities for which notification is not required.

    (a) In general. The following activities do not trigger 
notification requirements under this subpart:
    (1) The manufacturing or processing of a chemical substance in 
small quantities solely for research and development.
    (2) The import or processing of a chemical substance as part of an 
article.
    (3) The manufacturing or processing of a chemical substance as 
described in Sec.  720.30(g) or (h).
    (4) The manufacturing or processing of a chemical substance solely 
for export from the United States as described in Sec.  720.30(e) or 
Sec.  721.3, except where the Administrator has made a finding 
described in TSCA section 12(a)(2).
    (5) The manufacturing or processing of a chemical substance solely 
for test marketing purposes.
    (b) Manufacturing or processing naturally occurring chemical 
substances. The following activities do not trigger notification 
requirements under this subpart:
    (1) The manufacture of a naturally occurring chemical substance, as 
described in Sec.  710.4(b). Some chemical substances can be 
manufactured both as described in Sec.  710.4(b) and by means other 
than those described in Sec.  710.4(b). If a person manufactures a 
chemical substance by means other than those

[[Page 37542]]

described in Sec.  710.4(b), this exemption is inapplicable, regardless 
of whether the chemical substance also could have been produced as 
described in Sec.  710.4(b). This exemption does not cover the 
manufacture of a chemical substance from a naturally occurring chemical 
substance.
    (2) The processing of a naturally occurring chemical substance only 
by manual, mechanical, or gravitational means; by dissolution in water; 
by flotation; or by heating solely to remove water.


Sec.  710.29  Information required in the notification.

    (a) Reporting information to EPA. A person who reports information 
to EPA under this subpart must do so using the e-NOA software module, 
the CISS reporting tool, and the CDX electronic reporting portal 
provided by EPA at the addresses set forth in Sec.  710.39. For notices 
of activity under Sec.  710.25(a) and Sec.  710.25(b), the submission 
must include all information described in paragraph (b) of this 
section. For a Notice of Activity under Sec.  710.25(c), the submission 
must include all information described in paragraph (c) of this 
section. A person must submit a separate notice for each chemical 
substance that the person is required to report. Using e-NOA and CISS 
and registering in CDX are described in instructions available from EPA 
at the Web sites set forth in Sec.  710.39.
    (b) Information to be reported on the Notice of Activity Form A. A 
person submitting a Notice of Activity Form A under Sec.  710.25(a) or 
Sec.  710.25(b) must submit the information specified in Sec.  
710.29(d) for each reportable chemical substance. A person submitting 
information under Sec.  710.25(a) or Sec.  710.25(b) must report 
information to the extent that such information is known to or 
reasonably ascertainable by that person.
    (c) Information to be reported on a Notice of Activity Form B. Any 
person submitting a Notice of Activity Form B under Sec.  710.25(c) 
must provide the information described in this paragraph for each 
inactive substance intended to be manufactured or processed.
    (1) Information specified in Sec.  710.29(d).
    (2) The anticipated date by which the inactive substance is to be 
manufactured or processed in the United States. If the Notice of 
Activity Form B is filed prior to the effective date of the chemical 
substance's inactive designation, the most recent date of manufacturing 
or processing may be provided in lieu of an anticipated date.
    (d) Information to be reported on either the Notice of Activity 
Form A or Form B.
    (1) Company. The name and address of the submitting company.
    (2) Authorized official. The name and address of the authorized 
official for the submitting company.
    (3) Technical contact. The name and telephone number of a person 
who will serve as technical contact for the submitting company and who 
will be able to answer questions about the information submitted by the 
company to EPA.
    (4) Chemical-specific information. The system described under Sec.  
710.29(a) will provide a list of reportable chemical substances from 
which a person can select his or her chemical. The list will include 
the correct CASRN and CA Index name used to list a non-confidential 
chemical substance on the Inventory. For confidential substances on the 
Inventory, the list will include the TSCA Accession Number and generic 
name.
    (i) If an importer submitting a notice cannot provide the 
information specified in Sec.  710.29(d)(4) because it is unknown to 
the importer and claimed as confidential by the supplier of the 
chemical substance or mixture, the importer must ask the supplier to 
provide the specific chemical identity information directly to EPA in a 
joint submission using the same e-NOA software module used for 
commercial activity reporting. Such request must refer the supplier to 
EPA's instructions for submitting chemical identity information 
electronically, using e-NOA, CISS, and CDX (see Sec.  710.39), and for 
clearly referencing the importer's submission. Contact information for 
the supplier, a trade name or other name for the chemical substance or 
mixture, and a copy of the request to the supplier must be included 
with the importer's submission.
    (ii) If a manufacturer or processor submitting a notice cannot 
provide the information specified in Sec.  710.29(d)(4) because the 
reportable chemical substance is manufactured or processed using a 
reactant having a specific chemical identity that is unknown to the 
manufacturer or processor and claimed as confidential by its supplier, 
the manufacturer or processor must ask the supplier of the confidential 
reactant to provide the specific chemical identity of the confidential 
reactant directly to EPA in a joint submission using the same e-NOA 
software module used for commercial activity reporting. Such request 
must refer the supplier to EPA's instructions for submitting chemical 
identity information electronically using e-NOA, CISS, and CDX (see 
Sec.  710.39), and for clearly referencing the manufacturer's or 
processor's submission. Contact information for the supplier, a trade 
name or other name for the chemical substance, and a copy of the 
request to the supplier must be included with the manufacturer's or 
processor's submission with respect to the chemical substance.
    (iii) Joint submissions must be submitted electronically using e-
NOA, CISS, and CDX (see Sec.  710.39).
    (5) Certification statements. The authorized official must certify 
that the submitted information has been completed in compliance with 
the requirements of this part as described in this paragraph.
    (i) The certification must be signed and dated by the authorized 
official for the submitting company.
    (ii) The following is required certification language for an 
authorized official submitting a Notice of Activity Form A under Sec.  
710.25(a) or Sec.  710.25(b): ``I certify under penalty of law that 
this document and all attachments were prepared under my direction or 
supervision and the information contained therein, to the best of my 
knowledge, is true, accurate, and complete. I also certify that I have 
manufactured, imported, or processed the above chemical between the 
dates of June 21, 2006 and June 21, 2016. I am aware it is unlawful to 
knowingly submit incomplete, false and/or misleading information, and 
there are significant criminal penalties for such unlawful conduct, 
including the possibility of fine and imprisonment.''
    (iii) The following is required certification language for an 
authorized official submitting a Notice of Activity Form B under Sec.  
710.25(c): ``I certify under penalty of law that this document and all 
attachments were prepared under my direction or supervision and the 
information contained therein, to the best of my knowledge, is true, 
accurate, and complete. I also certify that I have intent to 
manufacture, import, or process the above chemical within 90 days of 
submission. I am aware it is unlawful to knowingly submit incomplete, 
false and/or misleading information, and there are significant criminal 
penalties for such unlawful conduct, including the possibility of fine 
and imprisonment.''


Sec.  710.30  When to submit notifications.

    (a) When must a Notice of Activity Form A be submitted? The Notice 
of Activity Form A required to be submitted under Sec.  710.25(a) must 
be submitted during the applicable submission period.

[[Page 37543]]

    (1) Manufacturers. The submission period for manufacturers under 
Sec.  710.25(a) and Sec.  710.25(b) begins on August 11, 2017 and ends 
on February 7, 2018.
    (2) Processors. The submission period for processors under Sec.  
710.25(b) begins on August 11, 2017 and ends on October 5, 2018.
    (3) Withdrawal of a Notice of Activity Form A. A Notice of Activity 
Form A submitted under Sec.  710.30(a)(1) or Sec.  710.30(a)(2) may be 
withdrawn by the submitter no later than October 5, 2018. If EPA 
receives a timely request to withdraw a previously submitted Notice of 
Activity Form A for a chemical substance subject to commercial activity 
designation, and EPA has not received a Notice of Activity Form A from 
another submitter for the same chemical substance, EPA will not 
designate the chemical substance as active. A Form A withdrawn under 
this paragraph will not satisfy the obligation under this rule to 
submit a Form A.
    (b) When must a Notice of Activity Form B be submitted? (1) 
Manufacturers and processors. The Notice of Activity Form B required to 
be submitted under Sec.  710.25(c) must be submitted before a person 
manufactures or processes the inactive substance, but not more than 90 
days prior to the anticipated date of manufacturing or processing.
    (2) When else may a Notice of Activity Form B be submitted? A 
Notice of Activity Form B that will later be required to be submitted 
under Sec.  710.25(c) may be submitted during the 90-day period between 
EPA's identification of a chemical substance for inactive designation 
and the effective date for such designation, by a person who is 
currently manufacturing or processing such chemical substance or who 
anticipates manufacturing or processing such chemical substance within 
90 days following submission.
    (3) When may EPA execute a request to withdraw a Notice of Activity 
Form B? If EPA receives a request to withdraw a previously submitted 
Notice of Activity Form B from the submitter of the Notice of Activity 
Form B and EPA has neither yet moved the subject chemical substance 
from the inactive to the active Inventory nor yet moved the subject 
chemical substance from the confidential portion of the Inventory to 
the public portion of the Inventory as a result of the original 
submission, then EPA may execute the request.


Sec.  710.33  Co-manufacturers and co-processors.

    (a) Notice of Activity submitted by co-manufacturers. When, in a 
single instance of manufacturing or importing a particular volume of a 
chemical substance during the lookback period, two or more persons 
qualify as the manufacturer or importer of that volume, they may 
determine among themselves who should make the required submission 
under Sec.  710.25(a). If no notice is submitted as required under this 
subpart, EPA will hold each such person liable for failure to submit a 
notice.
    (b) Notice of Activity by prospective co-manufacturers or co-
processors. If two or more persons intend to manufacture, import, or 
process a particular volume of an inactive substance, such that 
multiple persons would qualify as the manufacturer, importer, or 
processor of that volume, they may determine among themselves who will 
submit the required notice under Sec.  710.25(c). If no notice is 
submitted as required under this subpart, all of the persons remain 
subject to the reporting requirements, and EPA will hold each such 
person liable for a failure to submit a notice prior to the date of 
manufacturing, importing, or processing.


Sec.  710.35  Recordkeeping requirements.

    Each person who is subject to the notification requirements of this 
part must retain records that document any information reported to EPA. 
Records relevant to a Notice of Activity under Sec.  710.25(a) and 
Sec.  710.25(b) must be retained for a period of 5 years beginning on 
the last day of the submission period. Records relevant to a Notice of 
Activity under Sec.  710.25(c) must be retained for a period of 5 years 
beginning on the day that the notice was submitted.


Sec.  710.37  Confidentiality claims.

    (a) Chemical identity. A person submitting information under this 
part may request to maintain an existing claim of confidentiality for 
the specific chemical identity of a reportable chemical substance, but 
may do so only if the identity of the chemical substance is listed on 
the confidential portion of the Inventory as of the time the notice is 
submitted for that chemical substance under this part. A request to 
maintain an existing claim of confidentiality must be made at the time 
the information is submitted. If no person submitting the information 
specified in Sec.  710.29(d)(4) for a particular chemical substance 
requests that the claim be maintained, EPA will treat the specific 
chemical identity of that chemical substance as not subject to a 
confidentiality claim and will move the chemical substance to the 
public portion of the Inventory. Except as set forth in this 
subsection, information claimed as confidential in accordance with this 
section will be treated and disclosed in accordance with the procedures 
in 40 CFR part 2, subpart B.
    (1) Notice of Activity Form A. A person requesting to maintain an 
existing claim of confidentiality for specific chemical identity may 
submit with the notice answers to the questions in paragraphs (c)(1) 
and(c)(2) of this section, signed and dated by an authorized official. 
If these answers are submitted less than five years before the date on 
which substantiation is due pursuant to TSCA section 8(b)(4)(D)(i), the 
answers will be deemed to be substantiations made under TSCA section 
(8)(b)(4)(D)(i) and the person will be exempt from further 
substantiation requirements under TSCA section (8)(b)(4)(D)(i). Answers 
that do not include the answers to all applicable questions in 
paragraph (c) of this section will not be deemed to be substantiations 
made under the TSCA section (8)(b)(4)(D)(i) requirement.
    (2) Notice of Activity Form B. A person requesting to maintain an 
existing claim of confidentiality for specific chemical identity must 
submit answers to the questions in paragraphs (c)(1) and (c)(2) of this 
section within 30 days of submitting the notice, signed and dated by an 
authorized official. If this information is not submitted within 30 
days of submitting the notice, EPA will consider the confidentiality 
claim as deficient, so that the specific chemical identity is not 
subject to a confidentiality claim, and may make the information public 
without further notice.
    (b) Information other than specific chemical identity. A person 
submitting information under this part may assert a claim of 
confidentiality for information other than specific chemical identity. 
Any such confidentiality claim must be made at the time the information 
is submitted. Except as set forth in this section, information claimed 
as confidential in accordance with this subsection will be treated and 
disclosed in accordance with 40 CFR part 2, subpart B. A person 
asserting a claim of confidentiality under this subsection must submit 
with the notice answers to the questions in paragraph (c)(1) of this 
section, signed and dated by an authorized official. If no claim is 
asserted at the time the information is submitted, or if the answers to 
the questions in paragraph (c)(1) of this section are not provided, EPA 
will consider the information as not subject to a confidentiality claim 
and may make the information public without further notice.

[[Page 37544]]

    (c) Substantiation questions. Persons asserting that information is 
exempt from substantiation pursuant to TSCA section 14(c)(2) must 
answer only the question in paragraph (c)(1)(i) of this section.
    (1) Substantiation questions for any confidentiality claim. For any 
information with a confidentiality claim that you assert is exempt from 
substantiation pursuant to TSCA section 14(c)(2), answer only the 
question in paragraph (c)(1)(i) of this section. For all other 
information with a confidentiality claim, answer the questions in 
paragraphs (c)(1)(ii) through (vi) of this section. If more than one 
data element on Form A or Form B is claimed as confidential, you must 
answer the applicable questions individually for each data element. If 
the answer to a question applies for all confidentiality claims on the 
form, indicate this in your substantiation response.
    (i) Do you believe that the information is exempt from 
substantiation pursuant to TSCA section 14(c)(2)? If you answered yes, 
you must individually identify the specific information claimed as 
confidential and specify the applicable exemption(s).
    (ii) Will disclosure of the information likely result in 
substantial harm to your business's competitive position? If you 
answered yes, describe with specificity the substantial harmful effects 
that would likely result to your competitive position if the 
information is made available to the public.
    (iii) To the extent your business has disclosed the information to 
others (both internally and externally), what precautions has your 
business taken? Identify the measures or internal controls your 
business has taken to protect the information claimed as confidential: 
Non-disclosure agreement required prior to access; access is limited to 
individuals with a need-to-know; information is physically secured; 
other internal control measure(s). If yes, explain.
    (iv) Does the information appear in any public documents, including 
(but not limited to) safety data sheets, advertising or promotional 
material, professional or trade publication, or any other media or 
publications available to the general public? If you answered yes, 
explain why the information should be treated as confidential.
    (v) Is the claim of confidentiality intended to last less than 10 
years? If so, indicate the number of years (between 1-10 years) or the 
specific date/occurrence after which the claim is withdrawn.
    (vi) Has EPA, another federal agency, or court made any 
confidentiality determination regarding information associated with 
this chemical substance? If you answered yes, explain the outcome of 
that determination and provide a copy of the previous confidentiality 
determination or any other information that will assist in identifying 
the prior determination.
    (2) Substantiation for confidentiality claims for chemical 
identity. Is the confidential chemical substance publicly known to have 
ever been offered for commercial distribution in the United States? If 
you answered yes, explain why the information should be treated as 
confidential.
    (d) Confidentiality of substantiation. If any of the information 
contained in the answers to the questions listed in paragraph (c)(1) or 
(c)(2) of this section is claimed as confidential business information, 
the submitter must clearly indicate such by marking the substantiation 
as confidential business information as provided in a Notice of 
Activity Form A or Form B.
    (e) Certification statement for claims. An authorized official of a 
person submitting or substantiating a claim of confidentiality or a 
request to maintain an existing claim of confidentiality for specific 
chemical identity must certify that the submission complies with the 
requirements of this part by signing and dating the following 
certification statement: ``I certify that all claims for 
confidentiality made or sought to be maintained with this submission 
are true and correct, and all information submitted herein to 
substantiate such claims is true and correct. Any knowing and willful 
misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 
1001.'' I further certify that it is true and correct that:
    (1) My company has taken reasonable measures to protect the 
confidentiality of the information;
    (2) I have determined that the information is not required to be 
disclosed or otherwise made available to the public under any other 
Federal law;
    (3) I have a reasonable basis to conclude that disclosure of the 
information is likely to cause substantial harm to the competitive 
position of my company; and
    (4) I have a reasonable basis to believe that the information is 
not readily discoverable through reverse engineering.


Sec.  710.39  Electronic filing.

    (a) EPA will accept information submitted under this subpart only 
if submitted in accordance with this section. All information must be 
submitted electronically to EPA via CDX. Prior to submission to EPA via 
CDX, Notices of Activity and any associated information must be 
generated and completed using the e-NOA software module.
    (b) Obtain instructions for registering in CDX as follows:
    (1) Web site. The CDX Registration User Guide is available at 
https://www.epa.gov/sites/production/files/documents/cdx_registration_guide_v0_02.pdf. To register in CDX, go to https://cdx.epa.gov and follow the appropriate links.
    (2) Telephone. Contact the EPA CDX Help Desk at 1-888-890-1995.
    (3) Email. Email the EPA CDX Help Desk at HelpDesk@epacdx.net.
    (c) Obtain instructions for using CISS and the e-NOA software 
module as follows:
    (1) Web site. Go to the EPA New Chemicals under the Toxic 
Substances Control Act Web site at https://www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/how-submit-e-pmn and 
follow the appropriate links.
    (2) Telephone. Contact the EPA TSCA Hotline at 1-202-554-1404.
    (3) Email. Email the EPA TSCA Hotline at TSCA-Hotline@epa.gov.

[FR Doc. 2017-15736 Filed 8-10-17; 8:45 am]
 BILLING CODE 6560-50-P