EPA Finalizes TSCA Inventory "Reset" Rule

The 2016 Lautenberg 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 including imported for nonexempt commercial purposes during the 10-year 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.

Important. Reporting Due Dates. 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. (This date is likely very soon). The 180-day period for the retrospective reporting for manufacturers is the maximum time allowed under TSCA section 8(b)(4)(A).

Rule Summary

Companies may be affected by this rule if they domestically manufactured, imported, or processed a chemical substance listed on the TSCA Chemical Substance Inventory for nonexempt commercial purpose during the 10-year time ending on June 21, 2016. Companies may also be affected by the rule if they intend to domestically manufacture, import, or process in the future a chemical substance listed on the TSCA Chemical Substance Inventory.

TSCA's statutory definition of “manufacture” includes importing. Accordingly, the regulatory definition of “manufacture” for the rule includes importation. Since “manufacture” is itself defined (in the rule and in TSCA) to include “import,” importers are a subset of manufacturers. All references to manufacturing in the 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”), the rule will do so expressly.

On January 13, 2017,[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 (“Inventory”). EPA received numerous public comments on the proposed rule. The final rule is based on that proposal and the consideration of the public comments received.

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 period ending on June 21, 2016. EPA will accept notices for substances that were processed during the same ten-year time. EPA will use the chemical identity information obtained from the retrospective reporting to designate as active those substances on the Inventory for which notices were received. If no notice is received during the retrospective reporting for a substance subject to designation on the Inventory, then that substance will be designated as inactive.

The 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.

The 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 volume of a substance. These procedures are like TSCA Chemical Data Reporting (CDR) rule requirements[2] when two or more persons are involved in a manufacture or import transaction.

The 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. 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 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. The requirement is similar to CDR rule requirements[3] 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.

Final Rule Structure

The reporting requirements for manufacturers and processors of chemical substances are pursuant to TSCA section 8(b). EPA developed two versions of a Notice of Activity (NOA) reporting form for submitting the information described in the rule for the two reporting scenarios, retrospective and forward-looking. The Notice of Activity Form A will be used for retrospective reporting, and the Notice of Activity Form B will be used for forward-looking reporting.

Chemical Substances and Activities Reportable Under the Rule

Reportable chemical substances. The retrospective reporting requirements of the 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. The 10-year period, referred to 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.

Exemptions from reporting.

Excluded chemical substances. The scope of chemical substances covered under the rule is reflected in the definitions of “chemical substance subject to commercial activity designation,” and “reportable chemical substance,”[4] 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”[5] 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,[6] 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[7] 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.”

Naturally occurring chemical substances also are excluded from reporting under the rule, if the manufacturing and processing of such substances meet the criteria set forth in 40 CFR 710.27(b). Naturally occurring substances are automatically included on the Inventory as the category “Naturally Occurring Chemical Substances.”[8] EPA is designating the whole category of Naturally Occurring Chemical Substances as active substances by the rule, thereby excluding them from reporting under the rule.

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.[9] 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,[10] and therefore are already excluded from reporting under the 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.[11] For example, the manufacturing or processing of impurities or byproducts that have no subsequent commercial purpose will not trigger reporting obligations under the rule.[12] See. 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 the rule.[13] 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 the rule.[14] 

Important. 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 the rule, and they are exempted from retrospective notification requirements under the 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.[15] 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, the exemption now applies irrespective of whether the substance is on the confidential portion of the Inventory.[16]

 §  Second, chemical substances that were added to the Inventory during the ten-year 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 the rule They are exempted from retrospective notification requirements under the 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 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. The exemption applies irrespective of whether the substance is on the confidential portion of the Inventory.[17]

 §  Third, a manufacturer is exempt from the retrospective notification requirements under the rule, for a 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.[18] 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 the 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 the 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.

Important. 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.”[19] 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. 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, if such substance is designated active due, for instance, to EPA’s receipt of an equivalent notice[20]. Regarding 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 above, 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. [21]

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 the rule. Such substances are not subject to reporting under the rule. Furthermore, such substances are beyond the scope of the CBI claim maintenance provision under TSCA section 8(b)(4)(B)(ii). The CBI maintenance provision is intended to address “existing claim[s] for protection against disclosure of the specific chemical identity.” EPA interprets the to be a reference to CBI claims asserted prior to June 22, 2016.[22]

Important. Reporting Due Dates

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 period for the retrospective reporting for manufacturers is the maximum time allowed under TSCA section 8(b)(4)(A). Following the retrospective reporting for manufacturers, EPA will include the active designations, determined by the notices received, on a draft of the Inventory. EPA will publish the draft Inventory with the active designations as soon as is practicable following the close of the 180-day submission period for manufacturers. The draft Inventory with active designations will not have the legal effect of designating any chemical substance as inactive. EPA, therefore, does not construe the draft Inventory as the list with “designations of active substances and inactive substances”[23] from which forward-looking reporting commences.[24] 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.[25]

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.[26]

[1] 82 FR 4255, FRL-9956-28.

[2] 40 CFR 711.22.

[3] 40 CFR 711.15.

[4] 40 CFR 710.23.

[5] As provided in subsection 3(2)(B) of TSCA and in the definition of “chemical substance” in 40 CFR 710.3(d).

[6] 40 CFR 710.3(d).

[7] Such as, low releases and low exposures exemption, low volume exemption, polymer exemption, research and development exemption, test marketing exemption.

[8] 42 FR 64578.

[9] TSCA section 8(b)(4) or 8(b)(5).

[10] Due to similar exemptions under PMN regulations.

[11] Such as, due to another manufacturer’s actions.

[12] 40 CFR 710.27(a)(3).

[13] 40 CFR 710.27(a)(2).

[14] 40 CFR 710.27(a)(4) and (5).

[15] 82 FR 4259.

[16] 40 CFR 710.23.

[17] 40 CFR 710.23.

[18] 40 CFR 710.25(a).

[19] TSCA 8(b)(4)(B)(ii).

[20] Such as an NOC or CDR report.

[21] TSCA section 8(b)(4)(B)(iv) and 40 CFR 710.37(a).

[22] See 40 CFR 710.23 for revised definition of “active substance.”

[23] TSCA section 8(b)(5)(A).

[24] TSCA section 8(b)(5)(B).

[25] That is, a draft Inventory released between manufacturer and processor reporting.

[26] 40 CFR 710.30(a)(2).