TSCA Inventory Notification (Active-Inactive) Requirements

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The recent 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 proposing to require a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. EPA would also accept such notices for chemical substances that were processed. EPA would use these notifications to distinguish active substances from inactive substances. EPA would include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory. EPA is also proposing to establish 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 non-exempt commercial purposes is expected to resume. Upon receipt of a valid notice, EPA would change the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active. EPA is proposing 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:

Comments must be received on or before March 14, 2017.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0426, by one of the following methods.

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html . Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is 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 7401M), 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. Does this action apply to me?

You may be affected by this action if you domestically manufactured, imported, or processed chemical substances listed on the TSCA Chemical Substance Inventory for nonexempt commercial purposes during the ten-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 chemical substances listed on the TSCA Chemical Substance Inventory in the future. The following list of 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 III.A. describes in more detail which chemical substances would and would not be subject to reporting under this proposed action. You may also consult 40 CFR 710.3 and 710.4, as well as the proposed regulatory text in this document, for further information on the applicability of exemptions to this proposed rule. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

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

EPA is proposing this rule under TSCA section 8(b), 15 U.S.C. 2607(b). As described in more detail in Unit II.A., 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.

Note that TSCA's statutory definition of “manufacture” includes importing. Accordingly, the regulatory definition of “manufacture” for this rule includes importation. 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 notice will do so expressly.

C. What action is the Agency taking?

Pursuant to TSCA section 8(b)(4)(A), EPA is proposing procedural, retrospective notification requirements for persons who manufactured chemical substances on the TSCA Inventory as described in Unit III.A. Persons who manufactured these chemical substances for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, would be required to notify the Agency of certain information described in Unit III.C., including chemical identity and the date range when manufacture occurred in that ten-year time period. EPA would use the chemical identity information obtained from this retrospective reporting to designate as active those chemical substances on the TSCA Inventory for which notices were received. If no notice is received during this retrospective reporting for a chemical substance subject to designation on the TSCA Inventory, then that substance would be designated as inactive. EPA would require date range information in order to obtain confirmation that the chemical substance in question had indeed been manufactured or processed between June 21, 2006 and June 21, 2016.

Pursuant to TSCA section 8(b)(5)(B), EPA is also proposing procedural, forward-looking notification requirements for persons who intend to manufacture or process inactive chemical substances on the TSCA Inventory. After EPA's first publication of the TSCA Inventory that includes active and inactive designations determined by the retrospective reporting, persons who intend to manufacture or process for nonexempt commercial purposes those chemical substances designated as inactive on the TSCA Inventory would be required to notify the Agency of certain information described in Unit III.C. Such notification must occur before the actual date of manufacturing or processing. EPA is proposing that notification, which shall include chemical identity and the actual date of manufacturing or processing, occur no more than 30 days before the actual date of manufacturing or processing.

Included in this proposed rule are electronic reporting requirements described in Unit III.D. that are similar to those established in 2013 for reporting other kinds of information to EPA under TSCA sections 4, 5, 8(a), and 8(d). See 78 FR 72818, December 4, 2013 (FRL 9394-6). The Agency is proposing to require submitters to use EPA's Central Data Exchange (CDX), the Agency's electronic reporting portal, for reporting information under this proposed rule. The information would be submitted to the Agency under TSCA section 8(b), but the practical rationales for requiring submissions to proceed through CDX, cited in 2013, are also pertinent here by analogy.

Also included in this proposal are amendments to 40 CFR part 710, which conform the definitions applicable to these reporting requirements with those that apply to Chemical Data Reporting rule requirements (definitions found at 40 CFR 704.3 and 711.3) and the submission of Premanufacture Notifications (definitions found at 40 CFR 720.3). EPA believes that basing Section 8(b) reporting on definitions that are already familiar to the public from CDR and PMN reporting would reduce the potential for confusion and reduce the burden of rule familiarization. EPA is not proposing to modify the 40 CFR part 710 definitions in any manner that either is not conforming to Part 704, 710, or 720, or is a purely technical correction (e.g., eliminating references to the Canal Zone from the definition of “State”). Any other changes to the definitions in 40 CFR part 710 are beyond the scope of this proposal.

Included in this proposed rule are procedures for persons who co-manufacture or co-process a reportable chemical substance. These procedures would allow the submission of a single commercial activity notification in single instances of co-manufacturing or co-processing of a particular volume of a chemical substance. These proposed procedures are similar to Chemical Data Reporting rule requirements (40 CFR 711.22) when two or more persons are involved in a particular manufacture or import transaction. EPA believes that allowing a single notification for co-manufacturers and co-processors would serve to provide the Agency with the information necessary to designate a chemical substance as active on the TSCA Inventory while reducing duplicative reporting.

Also included in this proposed rule are requirements for filing a joint submission when specific chemical identity information is claimed confidential by a supplier. If an importer cannot provide the specific chemical identity of a reportable substance to EPA because the information is claimed confidential by a supplier, and therefore is unknown to the importer, the importer would be required to ask the supplier to provide the confidential chemical identity information directly to the Agency in a joint submission. If a domestic manufacturer or processor cannot provide the specific chemical identity of a reportable substance to EPA because the chemical identity of a reactant is claimed confidential by a supplier, and therefore is unknown to the domestic manufacturer or processor, the manufacturer or processor would be required to ask the supplier to provide the confidential chemical identity information directly to the Agency in a joint submission. EPA would only accept joint submissions that are submitted electronically using CDX. This requirement is similar to Chemical Data Reporting rule requirements (40 CFR 711.15) and would allow EPA to obtain the information necessary to identify the specific chemical identity of a reportable substance and designate it as active on the TSCA Inventory.

D. Why is the Agency taking this action?

TSCA section 8(b)(4)(A) requires EPA to issue a final retrospective reporting rule by June 22, 2017. These proposed reporting requirements would enable EPA to fulfill a statutory obligation to designate chemical substances on the TSCA Inventory as active or inactive in U.S. commerce. This proposed rule is not intended to indicate conclusions about the risks of chemical substances on the TSCA Inventory. Nonetheless, the designation of a chemical substance as active or inactive would be relevant to the Agency's prioritization of chemical substances in U.S. commerce under TSCA section 6(b).

Furthermore, TSCA section 8(b)(5) establishes a forward-looking notification requirement that goes into effect as soon as EPA designates inactive substances. EPA is proposing to establish the procedural framework whereby manufacturers and processors would discharge their notice obligations under this section of TSCA.

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

EPA has evaluated the potential costs of establishing the proposed reporting requirements for manufacturers and processors. This analysis, which is available in the docket, is discussed in Unit VI. and is briefly summarized here (Ref. 1).

During the retrospective (or “start-up”) period, between approximately June 2017 and June 2018, typical costs per firm are estimated at $1,346 per submission (with an estimated seven chemicals per submission), with possible additional costs at $40.22 per CDX registration in the event that the submitter is not currently registered in CDX. Among manufacturers, an estimated 6,169 firms would undertake rule familiarization with 4,692 completing compliance determination, form completion, and recordkeeping. For manufacturers, the total burden during start-up is estimated at 86,783 hours with an associated total cost of $6.68 million. For processors, the estimate of the universe of potentially affected firms is 161,550 who might initiate rule familiarization. For processors initiating rule familiarization, the cost would be 4 hours per firm (about $300 per firm). EPA believes that it is unlikely that 100% of processors will initiate rule familiarization and that the percentage will be less. EPA estimates that only 100 processors will complete compliance determination, form completion, and recordkeeping. For the 100 processors who complete a submission with one chemical, the burden during start-up is estimated at 692 hours with an associated cost of $0.05 million. Lastly, for 469 new CDX registrations (for individuals lacking previous experience with electronic reporting to EPA), burden during start-up is estimated at 249 hours with an associated cost of $0.02 million.

The rule has minimal burden and cost implications related to ongoing reporting 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 142 burden hours per year with an associated cost of $10,790 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 TSCA Inventory. Associated costs are estimated at $3.84 million during start-up, and $0.20 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 $7.22 million per year using a 3% discount rate, and at $8.77 million per year using a 7% discount rate.

F. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a CD-ROM or other electronic media that you mail to EPA, mark the outside of the media as CBI and then identify electronically within the media the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked would not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html .

II. Background

A. Overview of Applicable Authority

EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep current a list of chemical substances manufactured or processed in the United States. In 1977, EPA promulgated a rule under TSCA section 8(a), 15 U.S.C. 2607(a), to provide the information necessary for EPA to compile a list of chemical substances that had been in commerce since January of 1975 (Ref. 2). This list is known as the TSCA Chemical Substance Inventory (or simply the “TSCA Inventory”). Since compiling the initial TSCA Inventory, EPA regularly adds new chemical substances that have completed new chemical review requirements pursuant to TSCA section 5(a), 15 U.S.C. 2604(a), and that have been manufactured or processed for nonexempt commercial purposes. EPA maintains the TSCA Inventory as the authoritative list of all the chemical substances reported to the Agency for inclusion on the TSCA Inventory.

1. Retrospective reporting under TSCA section 8(b)(4)(A). TSCA section 8(b)(4)(A) requires EPA to promulgate a rule that requires manufacturers to notify the Agency, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the TSCA Inventory that was manufactured for nonexempt commercial purpose during the 10-year period ending on June 21, 2016. If EPA receives a valid notice for a chemical substance on the TSCA Inventory, EPA must designate that chemical substance as an active substance. If EPA receives no valid notice for a chemical substance on the TSCA Inventory (and that is subject to designation), EPA must designate that chemical substance as an inactive substance.

2. Forward-looking reporting under TSCA section 8(b)(5)(B). TSCA section 8(b)(5)(B) requires persons who intend to manufacture or process chemical substances for nonexempt commercial purposes in the future that are designated on the TSCA Inventory as inactive to notify EPA prior to the date that these chemicals are to be manufactured or processed. Upon receiving a valid notice, EPA must change the designation of the chemical substance from inactive to active.

3. Processors. TSCA section 8(b)(4)(A) indicates that the Administrator may require processors to report similarly to manufacturers under the rule. This proposed rule would not require processors to report during the retrospective reporting period. However, once EPA has designated a chemical substance as an inactive substance, the processing of that chemical substance for a non-exempt commercial purpose would be unlawful, unless the processor first submits a notice as required by TSCA section 8(b)(5)(B). Therefore, this proposed rule would allow processors to report during the retrospective reporting period, extended to not later than 360 days after the date on which the final rule is published in the Federal Register (which will be 180 days after EPA's publication of the first version of the TSCA Inventory with preliminary commercial activity designations). Processors could report any chemical substance that they had processed for a nonexempt commercial purpose during the 10-year period ending on June 21, 2016. The extended submission period for processors would allow processors time to evaluate whether they wish to voluntarily report chemical substances that have not been reported by manufacturers or importers and that are preliminarily designated as inactive on EPA's publication of the first version of the revised TSCA Inventory. (These designations would be merely preliminary so there would not yet be an obligation to report under TSCA Section 8(b)(5)(B).) If EPA receives no notice on a chemical substance that is subject to designation, EPA then must designate that preliminarily inactive substance as actually inactive. Hence, persons who processed a chemical substance between June 2006 and June 2016 may wish to report under TSCA section 8(b)(4)(A) in order to avoid a subsequent obligation to curtail processing on the day that EPA designates the substance as inactive, under TSCA section 8(b)(5)(B). Processing could resume as soon as the notice under TSCA section 8(b)(5)(B) is submitted, but processors may nonetheless find it less disruptive to ensure that the chemical substance is earlier reported as active under TSCA section 8(b)(5)(A).

4. General provisions. General provisions for TSCA section 8(b) rules appear in 40 CFR part 710. These provisions include definitions that apply to reporting under this proposed rule and also describe the scope of the Inventory. For example, 40 CFR 710.1 describes requirements for EPA to compile and keep current the TSCA Inventory of chemical substances manufactured or processed for commercial purposes, including the periodic updates to the Inventory to include new chemical substances reported under TSCA section 5(a) and commercialized for nonexempt purposes. In addition, the definitions in TSCA section 3 apply to this rulemaking.

5. Electronic reporting under the Government Paperwork Elimination Act (GPEA). GPEA, 44 U.S.C. 3504, provides that, when practicable, Federal organizations should use electronic forms, electronic filings, and electronic signatures to conduct official business with the public. EPA's Cross-Media Electronic Reporting Regulation (CROMERR) (40 CFR part 3), provides that any requirement in title 40 of the CFR to submit a notice directly to the Agency can be satisfied with an electronic submission that meets certain conditions once the Agency published a document in the Federal Register announcing that EPA is prepared to receive certain documents in electronic form (Ref. 3). For more information about CROMERR, go to http://www.epa.gov/cromerr .

III. Summary of Proposed Rule

EPA is proposing reporting and procedural requirements for manufacturers and processors of chemical substances pursuant to TSCA section 8(b).

A. What chemical substances would be reportable under this rule?

1. Reportable chemical substances. As a general matter, the retrospective reporting requirement of this proposed rule would apply to chemical substances listed on the TSCA Inventory that were manufactured for a nonexempt commercial purposes during the 10-year period ending on June 21, 2016. This lookback period is set by statute. TSCA also establishes forward-looking reporting requirements, at section 8(b)(5)(B), with respect to chemical substances listed on the TSCA Inventory that EPA designates as inactive. The TSCA Inventory is available at https://www.epa.gov/tsca-inventory .

2. Exemptions from reporting. i. Statutory background. This proposed rule provides exemptions from reporting based on sections 8(b)(4) and (5) and the general objectives that EPA can infer from that text. Unlike the reporting that informed the initial compilation of the TSCA Inventory (which arose under TSCA section 8(a)), the reporting requirements described in this proposed rule arise directly under TSCA section 8(b). EPA must finalize the retrospective reporting requirements by June 22, 2017, and all mandatory reporting under TSCA section 8(b)(4) must be completed by not later than 180 days thereafter. TSCA section 8(b)(4) and 8(b)(5) reporting requirements apply to “each chemical substance,” found on the TSCA Inventory, subject to the provision that reporting obligations shall only be triggered by manufacturing or processing for a “nonexempt commercial purpose.” The retrospective reporting requirements under TSCA section 8(b)(4) are expressed as being “subject to the limitations” of TSCA section 8(a)(5)(A). TSCA section 8(a)(5)(A), in turn, specifies that “to the extent feasible,” EPA shall: (1) Avoid requiring reporting that is “unnecessary or duplicative;” (2) “minimize the cost of compliance” to small manufacturers and processors; and (3) apply reporting obligations to the persons likely to have information relevant for effective implementation.

Furthermore, as EPA interprets its statutory authority, the reporting is intended to support two key objectives. First, to enable EPA to determine which reportable chemical substances are active in U.S. commerce. EPA will accomplish this based on notices received. Reportable chemical substances for which no notices are received would be considered inactive in U.S. commerce. See TSCA section 8(b)(4)(A)(iii). Second, with respect to chemical substances identified as being active in commerce that are listed on the confidential portion of the TSCA Inventory, to require that persons manufacturing or processing such chemical substances request that existing claims for protection against disclosure of the specific chemical identity be maintained. See TSCA sections 8(b)(4)(B)(ii), 8(b)(4)(C), 8(b)(5).

ii. Excluded chemical substances. If a chemical substance is not listed on the TSCA Inventory, then by the terms of TSCA sections 8(b)(4) and (5), it is not subject to reporting under this proposed rule. For example, chemical substances that are manufactured under a TSCA section 5(h) exemption are not added to the TSCA Inventory. Accordingly, this proposed rule would not require that reporting occur with respect to such substances. This is reflected in the proposed definitions at 40 CFR 710.23, which are drafted in such a manner that if a chemical substance was not on the TSCA Inventory as of June 22, 2016, it would not be subject to reporting.

Naturally occurring chemical substances also are proposed to be excluded from reporting under this proposed rule, so long as the manufacturing and processing of such substances meets the criteria set forth in 40 CFR 710.27(b). When EPA required manufacturers and processors to submit notices in support of the original compilation of the TSCA Inventory in 1977, EPA made clear that reporting on naturally occurring chemical substances would not be necessary, as these substances would automatically be included in the Inventory as a category: “Naturally Occurring Chemical Substances,” 42 FR 64578 (1977). EPA proposes to simply designate the whole category of Naturally Occurring Chemical Substances as active substances, by rule, without the need for reporting to differentiate among such substances.

Finally, this proposed rule would not require manufacturers to report chemical substances that are on both the non-confidential portion of the TSCA Inventory and the interim list of active substances described in TSCA section 8(b)(6). Such reporting would be unnecessary, since EPA already has reporting data to establish that the chemical substance was in active commerce at some time between June 21, 2006 and June 21, 2016. Furthermore, for such substances, there are no existing claims for protection against disclosure of the specific identity of the chemical substance for any party to elect to maintain or not maintain. With respect to chemical substances on the confidential portion of the TSCA Inventory, however, such reporting still serves a statutory function under TSCA sections 8(b)(4)(B)(ii) and 8(b)(4)(C), even where there is already adequate evidence, prior to reporting, that the substance was in active commerce during the lookback period.

Regarding the composition of the interim list of active substances, TSCA section 8(b)(6) requires EPA to compile an interim list of active substances reported under 40 CFR part 711 for the purposes of TSCA section 6(b), before promulgation of the rule. The definition of the interim list is somewhat ambiguous, since it refers to the “reporting period that most closely preceded June 22, 2016.” The term “reporting period” is not defined under 40 CFR part 711. In light of the definitional ambiguity of TSCA section 8(b)(6) and EPA's weighing of the statutory objectives noted previously, EPA has construed the “interim list of active substances” to include 2012 CDR data, which avoids delay of this proposed rule, but would allow for the 2016 CDR data to give rise to a reporting exemption as soon as they are publicly released in final form. Under the proposal, manufacturers and processors of chemical substances on the non-confidential portion of the Inventory would be exempt from reporting if the manufacture of that chemical substance was already reported (by any party) in response to 2012 or 2016 CDR.

iii. Manufacturing or processing for an exempt commercial purpose. TSCA section 8(b) directs EPA to limit reporting obligations to manufacturing and processing for “nonexempt commercial purpose.” This phrase had a commonly-accepted usage at the time that TSCA was amended, in 2016. See, for example, “Certain New Chemicals; Receipt and Status Information” (referencing TSCA section 5 requirements as applying to manufacture for “nonexempt commercial purpose”) (Ref. 4), and “2016 Chemical Data Reporting Frequent Questions” (associating “nonexempt commercial purpose” with exemptions codified at 40 CFR 720.30 and 40 CFR 711.10(a)) (Ref. 5). Since reporting under TSCA section 8(b) is a form of existing chemical reporting, EPA construes the phrase “nonexempt commercial purpose” consistent with the manner in which the 40 CFR 720.30 exemptions from pre-manufacture reporting requirements were adapted for use in the CDR at 40 CFR 711.10. Thus, for example, the manufacturing or processing of chemical substances solely in small quantities for research and development would not trigger reporting obligations under this proposed rule. Similarly, the manufacturing or processing of impurities, or byproducts that have no subsequent commercial purpose, would not trigger reporting obligations under this proposed rule. Finally, since the CDR integrates reporting exemptions for persons who import chemical substances solely as part of articles with reporting exemptions for nonexempt commercial purposes (see 40 CFR 711.10), EPA construes the TSCA 8(b) reference to “nonexempt commercial purpose” as also encompassing this article exemption. Further supporting this interpretation, EPA believes it would be incongruous to establish a more comprehensive reporting obligation for the import of inactive existing chemical substances under TSCA section 8(b)(5) (i.e., including import as part of an article), than would be applicable to the import of new chemical substances under TSCA section 5 (i.e., excluding import as part of an article).

3. Chemical substances added to the Inventory on or after June 22, 2016. In this proposed rule, chemical substances added to the Inventory on or after June 22, 2016 would be designated as active, without the need for any reporting to establish that the chemical substance is active and without the need for any statement by manufacturers or processors indicating whether such persons wish to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance. Reporting under TSCA section 8(b)(4) is based on manufacturing or processing, for non-exempt commercial purposes, that occurred between June 21, 2006 and June 21, 2016. TSCA section 8(b)(4)(A)(iii) directs EPA to classify a chemical substance as inactive if no notice of manufacturing or processing is received by EPA. A substance added to the Inventory on or after June 22, 2016, however, would be added so recently that it has no manufacturing or processing overlapping with the lookback period. It would be illogical to designate a very recent addition to the Inventory as inactive, on the grounds that the chemical substance was too recently added to the Inventory to be captured in the retrospective reporting of current manufacturing and processing. Furthermore, if a chemical substance was added to the Inventory on or after June 22, 2016, then any claim for the protection against disclosure of the specific chemical identity of such a substance would be a new claim rather than the maintenance of an existing claim for protection of the information. For the reasons presented previously, EPA construes TSCA section 8(b)(4) reporting requirements to be limited to chemical substances that were added to the Inventory prior to June 22, 2016.

B. When would reporting be required?

1. Retrospective reporting period for manufacturers. This proposed rule would require manufacturers to report to the Agency 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 would include the active and inactive designations, determined by the notices received, on the TSCA Inventory.

2. Retrospective reporting period for processors. This proposed rule would allow processors to report to the Agency not later than 360 days after the final rule is published in the Federal Register. The 360-day time period for this retrospective reporting for processors would allow processors to search EPA's publication of a first draft of the TSCA Inventory with active designations and draft inactive designations, based on retrospective reporting by manufacturers, and to report only those chemical substances not already reported. This first draft of the TSCA Inventory with active designations and draft inactive designations would not have the legal effect of actually designating any chemical substance as inactive. Processors would have the option to simply not report under TSCA section 8(b)(4) and continue processing until such time when EPA has actually designated a chemical substance as inactive. At such time, any further processing of the chemical substance, without prior notification to EPA, would be prohibited by section 8(b)(5). Prior notification would allow EPA to add the chemical substance to the TSCA Inventory as an active substance.

3. Forward-looking reporting. After EPA completes its review of the notices submitted under TSCA section 8(b)(4)(A), it must designate as inactive any chemical substance (subject to designation) for which no notice was received. TSCA section 8(b)(5)(B) provides that, once a chemical substance has been designated as inactive, any person who intends to manufacture or process that inactive substance for a nonexempt commercial purpose must first notify the Agency before the date on which the inactive substance is manufactured or processed. EPA proposes to furthermore limit the submission period for such notices, so that they may not be submitted more than 30 days before the actual date of manufacturing or processing.

The 30-day time period for forward-looking reporting is based on EPA's experience with Premanufacture Notices (PMNs). Although persons often form the intent to commercially manufacture or process chemical substances several months ahead of time, EPA's experience with processing PMNs is that business decisions, technical difficulties, and other unforeseen circumstances may delay a company's plans to commercialize. EPA believes that a commercial activity notice reflects a more tentative or provisional intent to manufacture or process if it is submitted more than 30 days prior to the actual date of manufacturing or processing of the chemical substance. As such, it is less reliable as evidence that placement as active Inventory is warranted. Reassigning chemical substances from inactive to active status, based on relatively unreliable indicia of intent to manufacture, could affect the reliability of the Inventory designations. Therefore, this proposed rule would require that forward-looking reporting of chemical substances designated as inactive on the TSCA Inventory occur not earlier than 30 days before companies intend to manufacturing or processing for nonexempt commercial purposes.

C. What information would be reported?

1. Retrospective reporting period for manufacturers. This proposed rule would require that manufacturers reporting for the retrospective reporting period provide certain information including chemical identity, type of commercial activity (i.e., whether it is domestic manufacture and/or import), date range of manufacture for nonexempt commercial purpose during the 10-year reporting period ending on June 21, 2016, and whether they seek to maintain an existing claim for protection against disclosure of a confidential chemical identity, if applicable.

2. Retrospective reporting period for processors. This proposed rule would allow processors to report for the retrospective reporting period, provided that the processor reports timely and consistent with the pertinent reporting requirements, including providing certain information such as chemical identity, date range of processing for nonexempt commercial purpose during the 10-year reporting period ending on June 21, 2016, and whether they seek to maintain an existing claim for protection against disclosure of a confidential chemical identity, if applicable.

3. Forward-looking reporting. TSCA section 8(b)(5) requires that manufacturers and processors of inactive substances notify EPA before the date on which they manufacture or process an inactive substance for non-exempt commercial purposes. This proposed rule stipulates that they would do so in the following manner: By reporting certain information including chemical identity, type of commercial activity (i.e., whether it is domestic manufacture, import, and/or processing), actual date of manufacturing or processing for nonexempt commercial purpose, and whether they seek to maintain an existing claim for protection against disclosure of a confidential chemical identity, if applicable.

4. Reporting forms. EPA developed two versions of a Notice of Activity (NOA) reporting form for submitting the information described in this proposed rule for the two reporting scenarios, retrospective and forward-looking (Ref. 6). NOA Form A (EPA Form No. TBD-1) would be used by manufacturers for the retrospective reporting period. It would also be used by processors who report for the retrospective reporting period. NOA Form B (EPA Form No. TBD-2) would be used by manufacturers and processors for forward-looking reporting. The new NOA forms are based on EPA's Notice of Commencement (NOC) form (Ref. 7), since much of the information submitted in an NOC form is the same or similar to the information proposed in the NOA.

Any person required to report under this proposed rule would provide the information identified in the relevant version of the NOA forms to the extent it is known to or reasonably ascertainable by them. Drafts of the two versions of the proposed NOA reporting forms are available in the docket for public review (Ref. 6).

As noted previously, these forms require very basic explanatory information about the type of commercial activity at issue (domestic manufacture, import, or processing) as well as the date range over which the activity occurred or the date when the activity is intended to resume. The collection of this explanatory information is intended to reduce the likelihood of receiving erroneous notices (e.g., notices regarding commercial activity outside the lookback period), to support EPA's capacity to inquire into the accuracy of activity notices, and thus to increase the reliability of commercial activity designations on the TSCA Inventory.

D. How would information be submitted to EPA?

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. 8). The final rule followed two previous rules requiring similar electronic reporting of information submitted to the Agency for TSCA Chemical Data Reporting and Pre-Manufacture Notifications. This proposed rule would require electronic reporting similar to the requirements established in 2013 for submitting certain other information under TSCA (see 711.35 and 720.40). This proposed rule would require submitters to 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 proposed rule in accordance with section 3.2000 of 40 CFR part 3 (CROMERR) (Ref. 3).

This proposed rule would require persons submitting notices of activity to EPA under TSCA section 8(b) to follow these same electronic reporting procedures used for other TSCA submissions, i.e., to register with EPA's CDX and use CISS to prepare a data file for submission. Registration in CDX 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 submissions would be able to add the “Submission for Chemical Safety and Pesticide Program” service to their current registration in CDX and use the CISS web-based reporting tool.

EPA developed the Chemical Information Submission System (CISS) for use in submitting data electronically under TSCA sections 4, 5, 8(a), and 8(d) to the Agency. The tool is available for use with Windows, Macs, Linux, and UNIX based computers and uses “Extensible Markup Language” (XML) specifications for efficient data transmission across the Internet. CISS works with CDX to secure online communication and provides user-friendly navigation. The NOA forms described in this proposed rule will be 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.

EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization and more easily save a copy for their records or future use. The resource and time requirements to review, process, store, and retrieve data by the Agency would also be reduced.

Any person submitting a reporting form could claim any part or all of the form as confidential. Except as otherwise provided in this proposed rule, any information that is claimed as confidential would be disclosed by EPA only to the extent and by the means of the procedures set forth in 40 CFR part 2.

E. How would CBI claims and requests be handled?

Notices pursuant to this rulemaking may contain two different types of CBI assertions: Claims for protection of information other than specific chemical identify, and requests to maintain existing claims for protection of specific chemical identify.

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, this proposed rule would require that all such claims be substantiated at the time of submission, except for claims for information exempted from substantiation under section 14(c)(2). In view of the rapid EPA review of claims required by section 14(g)(1), and in order to reduce the likelihood of unwarranted claims, EPA believes that a concurrent substantiation is required. EPA will review a representative subset of these claims as specified by section 14(g)(1).

2. Requests to maintain existing CBI claims for chemical identity. Requests to maintain existing CBI claims for specific chemical identity on Form A are governed in part by TSCA sections 8(b)(4)(C-E). TSCA section 8(b)(4)(C), in particular, requires EPA to issue a rule to establish a review plan for these requests. That review plan must specify a time when the Form A CBI requests for specific chemical identity are to be substantiated. EPA will be conducting a separate rulemaking to establish this review plan. Therefore, this proposal does not include mandatory substantiation requirements for Form A CBI requests for chemical identity. Mandatory substantiation requirements will be part of the review plan promulgated under section 8(b)(4)(C). However, the Agency proposes to allow companies to submit early substantiation at the same time that their 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 early substantiations would exempt the company from the requirement to submit additional substantiation for their Form A under the terms of the review plan. See section 8(b)(4)(D)(i). EPA will review requests to maintain CBI claims for specific chemical identity in accordance with the 8(b)(4)(D) review plan in the timeframe mandated by section 8(b)(4)(E).

Any manufacturer or processor submitting an active chemical notification 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 treated as confidential. EPA believes this is the correct interpretation of “a manufacturer or processor . . . that seeks to maintain an existing claim for protection of against disclosure” of specific chemical identity. A number of manufacturers and processors may legitimately benefit from the confidential status of a specific chemical identity, and the initial claimant may no longer exist. 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 no longer manufacture the chemical substances.

Pursuant to TSCA section 8(b)(4)(B)(iv), EPA would move an active chemical substance from the confidential portion of the Inventory to the non-confidential portion if no manufacturer or processor submitting an active chemical notification under TSCA section 8(b)(4)(A) requests to maintain the existing CBI claim for the specific identity of that chemical substance. See proposed 710.37(a).

Requests to maintain existing CBI claims for specific chemical identity on Form B are governed by TSCA section 8(b)(5)(B), which provides that the request to maintain the claim must be substantiated not later than 30 days after submitting Form B. See section 8(b)(5)(B)(ii)(II). Proposed substantiation requirements for Form B CBI claims for chemical identity are found in section 710.37(a)(1)(ii).

Although TSCA section 8(b)(5) provides that substantiation for requests to maintain existing CBI claims for specific chemical identity must be provided not later than 30 days after submitting a Form B, persons submitting a Form B may find it more efficient to simply provide the substantiation for a CBI claim for specific chemical identity at the time of filing. Section 8(b)(5)(iii)(II) provides that the Agency shall “promptly” review CBI claims for specific chemical identity in Form B. The Agency intends to review these claims within 90 days of receipt of the substantiation.

IV. Request for Comments

EPA is seeking public comment on all aspects of this proposed rule, including specific issues throughout this document, as well as other issues discussed in this Unit.

A. Considerations for the Agency's Economic Impact Analysis

EPA has evaluated the potential costs for manufacturers and processors of chemical substances reportable under this proposed rule (Ref. 1). EPA is specifically seeking additional information and data that the Agency could consider in developing the final economic analysis. In particular, EPA is seeking data that could facilitate the Agency's further evaluation of the potentially affected industry and firms, including data related to potential impacts for those small businesses that would be subject to reporting.

B. Electronic Reporting

Requiring electronic reporting under this proposed rule that is similar to those established in 2013 for other TSCA reporting, EPA expects to save time, improve data quality, and provide efficiencies for both submitters and the Agency. EPA is specifically interested in comments related to the adoption of the existing mechanisms and procedures for use in transmitting the notices proposed in this rule, including comments related to the extent to which potential reporting entities are already familiar with these mechanisms and procedures because of their existing use for other TSCA reporting. EPA is also interested in feedback on how electronic reporting affects potential reporting entities in terms of reporting time, reporting efficiency, and potential burden associated with training to use the electronic systems (i.e., CDX and CISS).

V. References

The following is a listing of the documents that are specifically referenced in this proposed rule. 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. 2016. EPA. Burden and Cost Report for the Proposed Rule: TSCA Inventory Notification Requirements (RIN 2070-AK24, December 21, 2016).

2. 1977. EPA. Inventory Reporting Requirements; Final Rule. Federal Register (42 FR 64572, December 23, 1977) (FRL 817-1).

3. 2005. EPA. Cross-Media Electronic Reporting Rule (CROMERR); Final Rule. Federal Register (70 FR 59848, October 13, 2005) (FRL 7977-1).

4. 2010. EPA. Certain New Chemicals; Receipt and Status Information; Notice. Federal Register (75 FR 71688, November 24, 2010) (FRL 8852-1).

5. 2016. EPA. 2016 Chemical Data Reporting Frequent Questions. https://www.epa.gov/chemical-data-reporting/2016-chemical-data-reporting-frequent-questions .

6. 2016. EPA. Notice of Activity Form A and Form B; Draft.

7. 2009. EPA. Notice of Commencement Form; Final.

8. 2013. EPA. Electronic Reporting Under the Toxic Substances Control Act; Final Rule. Federal Register (78 FR 72818, December 4, 2013) (FRL 9394-6).

9. 2016. EPA. Information Collection Request for the TSCA section 8(b) Proposed Reporting Requirements for TSCA Inventory Notification Active-Inactive (EPA ICR No. 2517.01).

10. 2016. EPA. Small Entity Analysis Report for the Proposed Rule: TSCA Inventory Notification Requirements (December 16, 2016).

VI. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/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 proposed rule have been submitted to OMB for review and approval under the PRA, 44 U.S.C. 3501 et seq. Specifically, EPA has prepared an Information Collection Request (ICR) to estimate the potential burden and costs associated with the proposed requirements (Ref. 9). The ICR, which is available in the docket, has been assigned the EPA ICR No. 2517.01 (OMB Control No. 2070-[new]). You can find a copy of the ICR in the docket for this proposed rule (Ref. 9), 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: 4,692.

Frequency of response: Once and on-occasion.

Estimated burden: 86,783 hours. The term “burden” is defined at 5 CFR 1320.3(b).

Estimated cost: $6.68 million.

Note that an additional number of respondents (i.e., processors), as high as 161,550, are each assumed to undergo four hours of rule familiarization (about $300 per firm), but would likely not be required to submit information. This is based on an assumption that 100 percent of processor firms would undertake rule familiarization. However, EPA believes that it is unlikely that 100% of processors would initiate rule familiarization and that the actual percentage would be lower. Although this count, and the associated burden and costs, are not included in the estimates, the estimated burden and costs account for the bulk of total start-up costs (88%). In addition, the estimated burden and costs includes 469 CDX registrations in addition to NOA submissions.

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: 142 hours.

Total estimated cost: $10,790.

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).

Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to OIRA_submission@omb.eop.gov, Attention: Desk Officer for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than February 13, 2017. EPA will respond to any ICR-related comments in the 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 small entities subject to the requirements of this action are manufacturers, and processors of chemical substances. As the most burdensome conditions are incurred during the start-up year for manufacturers, these reporters are the subject of the quantitative analysis with other reporters and other years assessed by inference. The detailed analysis is available in the docket (Ref. 10).

The quantitative analysis addresses the “most affected” subset of entities who are expected to incur the highest typical burden under the proposed rule as entities manufacturing (or importing) chemicals that must submit NOAs involving an average of seven chemicals per entity in the start-up year. These small entities most directly regulated by this rule are small businesses in NAICS 325: Chemical Manufacturing, and 324: Petroleum and Coal Products Manufacturing reporting during the start-up year. EPA has determined that all of the small entities (comprising about 96% of the total number of entities) within the scope of the quantitative analysis would experience an impact of less than 1% of revenues. This analysis follows EPA guidance on Regulatory Flexibility Act (RFA) and Small Business Regulatory Enforcement Fairness Act (SBREFA) analyses. Per this guidance document, the preferred measure of economic impacts is the “sales test:” Annualized compliance costs as a percentage of sales (or revenue or receipts when sales data are not readily available). This measure is termed “cost impact percentage” in the small entity analysis.

Additional groups of small entities may be affected by the rule and are expected to incur similar or lesser impacts, by inference. First, processors submitting NOAs during the start-up year are expected to incur a smaller unit burden with one chemical per NOA, and therefore experience similar or lesser impacts than manufacturers. Secondly, all reporters in future years, with lower counts and relatively smaller unit burdens, would therefore incur much lower impact than entities during the start-up year, Therefore, inferences drawn regarding small entity impacts on the most affected group may be extended to characterize the impacts on processors during the start-up year and all entities for future years.

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 because it would 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

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

This action does not have tribal implications 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, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000).

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

List of Subjects in 40 CFR Part 710

• Environmental protection
• Chemicals
• Reporting and Recordkeeping
• TSCA Inventory

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

PART 710—[AMENDED]

1. The authority citation for part 710 would continue to read as follows:

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

2. Redesignate §§ 710.1 through 710.4 as subpart A under the following subpart A heading:

PART 710—COMPILATION OF THE TSCA CHEMICAL SUBSTANCE INVENTORY

3. Revise § 710.1 paragraph (b) to read as follows:

Subpart A—General Provisions

4. Revise § 710.3 paragraph (d) to read as follows:

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

Subpart B—Commercial Activity Notification