IAEG Work Group 8 Toxic Substances Control Act

IAEG Work Group 8 Toxic Substances Control Act (TSCA) Inventory Notification Overview (INO) October 31, 2017 Disclaimer: This document is provided by IAEG for informational purposes only, and IAEG makes no representations or warranties about this document or its contents. Determination of whether and/or how to use all or any portion of this document is to be made in your sole and absolute discretion. No part of this document constitutes legal advice. Prior to using this document, you should review it, along with applicable laws and regulations, with your own legal counsel. Use of this document is voluntary. © 2017 IAEG® all rights reserved

Objective § IAEG has developed this overview of the TSCA Inventory Notification Rule in order to assist the Aerospace & Defense industry. The TSCA Inventory is an EPA list of ~85, 000 chemicals (public and confidential) that, at one time, were or are in commerce in the United States. The Inventory Notification Rule is intended to identify those chemicals on the Inventory that are “active” (i. e. , that are still in commerce in the United States). § This overview is intended to only address chemical substances already on the EPA TSCA Inventory (Section 8 b). Introduction of new chemicals is not within the scope of this overview. © 2017 IAEG® all rights reserved 2

Table of Contents Content Description I. Roles, Responsibilities & Reporting Requirements II. Reporting Exemptions III. USEPA Central Data Exchange Reporting Requirements IV. Confidential Business Information (CBI) Claims V. Potential Risks VI. Definitions © 2017 IAEG® all rights reserved Slide # 4 7 10 11 13 15 3

Roles, Responsibilities & Reporting Requirements Retrospective Reporting § Manufacturers/importers of chemical substances in US commerce between June 21, 2006 and June 21, 2016 must review the Interim List of Active Substances. § If chemical substances are on the Interim List of Active Substances or “otherwise exempt, ” no further action is required. § If chemical substances are not on the Interim List of Active Substances, manufacturers and importers must submit a Notice of Activity (NOA) Form A to EPA by February 7, 2018. § Within approximately 60 days after the manufacturer/importer reporting ends, EPA will publish a Draft Inventory (est. April 2018). § Processors of chemical substances in US commerce should review the Draft Inventory and may submit a NOA Form A by October 5, 2018 to report chemicals that are not listed as active. § Chemical substances that are not designated as active at the end of the processor reporting period will be identified as inactive by the EPA. § EPA will update to a Final Inventory (active and inactive chemical substances) “as soon as practicable” after the processor reporting deadline (est. December 2018). Forward Looking Reporting § After EPA issues the Final Inventory, manufacturers, importers, and processors are strongly encouraged to review the Final Inventory to verify status of chemical substances in US commerce. § Note: Once a chemical substance is on the Final Inventory, it cannot be removed. Its designation (active/inactive) can only be changed. Periodic Final Inventory reviews may be needed. § 90 days after publication of the Final Inventory, manufacturers, importers, and processors may no longer use chemical substances designated as inactive; however, those that intend to manufacture, import or process an inactive substance for nonexempt commercial purposes must submit a NOA Form B to EPA. This is required within 90 days of the anticipated date of commercial activity. Note: This U. S. regulation might require reporting by non-U. S. suppliers. © 2017 IAEG® all rights reserved 4

Reporting Sequence & Timeline Retrospective reporting NOA- Form A © 2017 IAEG® all rights reserved EPA Review EPA review Forward Looking reporting NOA- Form B 5

Roles, Responsibilities & Reporting Requirements (conclusion) § The NOA Form A and B information is to be included “to the extent that such information is known to or reasonably ascertainable by that person. ” The forms must be certified under penalty of law by an “Authorized Official”, a person who is in a position to sign the statement that appears in 40 CFR 710. 29 (d)(5). As applicable ( ), NOA Form A and/or B information shall include: Information NOA Form A NOA Form B Company Name Authorized Official Technical Contact Chemical Specific Information Certification Statement, under penalty of law, by the Authorized Official, as it appears in 40 CFR 710. 29(d)(5) Intent to maintain/claim chemical identity is confidential business information (CBI) Intended date of manufacture, import, or process for an inactive chemical substance © 2017 IAEG® all rights reserved 6

Exemptions Substances Not Subject to Retrospective Reporting § Chemical substances that are on the Interim List of Active Substances • Chemical substances reported in 2012 or 2016 under the CDR rule NOTE: Notification is necessary if chemical identity confidentiality is to be maintained. § Chemical substances added to the Inventory during the ten-year time period beginning June 21, 2006 and ending on June 21, 2016, for which a Notice of Commencement (NOC) was received by the Agency. § There is a manufacturer CDX receipt, documenting EPA's receipt of an NOA Form A, from another manufacturer. • Receipt does not contain any information identifying the chemical substance per EPA webinar on September 27, 2017 © 2017 IAEG® all rights reserved 7

Exemptions (continued) Activities Not Subject to Notification Requirements § Manufacturing or processing of a chemical substance in small quantities solely for research and development; § The import or processing of a chemical substance as part of an article; § The manufacturing or processing of a chemical substance as described in 40 CFR 720. 30 (g) and (h), presented in more detail on following slide; § The manufacturing or processing of a chemical substance solely for export from the United States as described in 40 CFR 720. 30(e) or 721. 3, except where the Administrator has made a finding described in TSCA section 12(a)(2); § The manufacturing or processing of a chemical substance solely for test marketing purposes; § The manufacture of a naturally occurring chemical substance, as described in 40 CFR 710. 4(b); and, § 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 Exempt activities as described in 40 CFR 710. 27 © 2017 IAEG® all rights reserved 8

Exemptions (conclusion) Substances Not Subject to Notification Requirements § Any impurity; § Any byproduct which is not used for commercial purposes; § Any chemical substance which results from a chemical reaction that occurs: § § § Incidental to exposure of another chemical substance, mixture, or article to environmental factors (i. e. air, moisture, microbial organisms, sunlight, etc. ); Incidental to storage or disposal of another chemical substance, mixture, or article; Upon end use of another chemical substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping product, fuel additive, water softening and treatment agent, photographic film, battery, match, or safety flare, and which is not itself manufactured or imported for distribution in commerce or for use as an intermediate; Upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or any other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance except for those chemical changes that occur as described elsewhere in this paragraph. When a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, binder, emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, p. H neutralizer, sequesterant, coagulant, flocculent, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or a chemical substance, which is intended solely to impart a specific physiochemical characteristic, functions as intended; § Any non-isolated intermediate; § Any byproduct if its only commercial purpose is for use by public or private organizations that burn it as a fuel, dispose of it as a waste (including in a landfill or for enriching soil), or extract component chemical substances from it for commercial purposes. Exemptions as outlined in 40 CFR 720. 30, specifically (g) and (h). © 2017 IAEG® all rights reserved 9

USEPA Central Data Exchange (CDX) Reporting Requirements § Rule requires electronic submission of NOA forms through EPA’s CDX and Chemical Information Submission System (CISS). • • User must register with CDX and use CISS to prepare a data file for submission NOA Forms are included in an e-NOA software module in CISS § Retrospective reporting via NOA Form A. • • Joint submissions allowed in circumstances where chemical identity is not known due to confidentiality. Importer must refer supplier to EPA’s instructions for submitting information and reference the importer’s submission. Supplier’s contact information, trade name or other name of substance, and copy of request made to supplier must be included with the importer’s submission. § Each chemical needs to be reported unless there is an exemption § Resources: • • The CDX Registration User Guide is available at: https: //www. epa. gov/sites/production/files/documents/cdx_registration_guide_v 0_02. pdf The e-NOA User Guide is available at: https: //www. regulations. gov/document? D=EPA-HQ-OPPT-2016 -0426 -0085 © 2017 IAEG® all rights reserved 10

CBI Claims § 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, must submit an NOA Form A to EPA if they wish to maintain an existing CBI claim for chemical identity. • • Claim must be asserted, but not substantiated, when Form A is submitted; however, substantiation when claim is asserted might enable submitter to avoid more rigorous substantiation requirements to be issued by EPA. A deadline for substantiating such chemical identity claims will be established in the future by EPA. § For CBI claims relating to matters other than chemical identity (new claims), the CBI claim must be both asserted and substantiated at the time of reporting. § For CBI claims associated with prospective reporting, substantiation must be provided to EPA no later than 30 days after the Form B is filed. © 2017 IAEG® all rights reserved 11

CBI Claims (conclusion) § If no person seeks to maintain an existing CBI claim for chemical identity for an active chemical substance, EPA moves the substance to the public portion of the Inventory. § Note: CBI claims do not need to be asserted for chemical substances added to the Inventory on or after June 22, 2016. § If a supplier does not provide 100% speciation of chemical substances on a Safety Data Sheet (SDS) there are two options available: • • § The submitter can provide a single notice to EPA for a CBI substance if it has the corresponding EPA accession number and generic name; or, The submitter must 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. Information required for reporting: • • • CAS number; Whether the submitter wishes to maintain the chemical identity as CBI; and, Technical contact © 2017 IAEG® all rights reserved

Potential Risks § Violation of TSCA is the primary risk associated with failure to submit notifications as required by this new regulation: • • Risk for manufacturers who continue to manufacture chemical substances that are not designated as active. Risk for companies that import into the U. S. chemical substances that are not designated as active Risk for suppliers who process chemical substances that are not designated as active Risk for companies such as those in the aerospace and defense industry that process inactive chemical substances as part of items/structures that they manufacture § Financial penalties for non-compliance: • • Criminal penalties: Up to one year in jail/$50, 000 penalty for knowing or willful violations Civil penalties: $37, 500 per violation per day © 2017 IAEG® all rights reserved 13

Potential Risks (conclusion) § There is a risk with using evidence in the form of a CDX receipt from another manufacturer § Manufacturers/Importers/Processors bear the risk of failing to submit a required forward-looking notification (NOA Form B) notice if they rely on this Form A exemption § The Form A notice (for which they have a CDX receipt) could be later withdrawn, leading to the substance being designated as inactive § Only submitters will be notified by EPA of errors § Manufacturers relying on this exemption are responsible for assuring their substance is designated as commercially active. § Companies processing a chemical that is listed on the TSCA Inventory and not designated as active would be in violation of TSCA. Although it is relatively easy to resolve the issue, there may be a disruption if a company needs to become compliant before resuming manufacturing, importing, or processing activities © 2017 IAEG® all rights reserved 14

Definitions § Active substance • • Any interim active substance Any naturally occurring chemical substance Any chemical substance that was added to the Inventory on or after June 21, 2006 Any chemical substance subject to commercial activity designation that the Administrator designates as active based on the receipt of a notice of activity § Article • • • A manufactured item Formed to a specific shape or design during manufacture, Has end use function(s) dependent in whole or in part upon its shape or design during end use, and 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) Fluids and particles are not considered articles regardless of shape or design © 2017 IAEG® all rights reserved 15

Definitions (continued) § Byproduct • A chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s) § Chemical substance • • Any organic or inorganic substance of a particular molecular identity, Includes any combination of such substances occurring in whole or in part • Result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical; Chemical substance does not include: any mixture; any pesticide when manufactured, processed, or distributed in commerce for use as a pesticide tobacco or any tobacco product, but not including any derivative products; any source material, special nuclear material, or byproduct material; any pistol, firearm, revolver, shells, and cartridges; and 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 © 2017 IAEG® all rights reserved 16

Definitions (continued) § Importer • • Any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the United States, and includes: The person primarily liable for the payment of any duties on the merchandise, or An authorized agent acting on his behalf Importer also includes, as appropriate: The consignee The importer of record The actual owner if an actual owner's declaration and superseding bond have been filed in accordance with 19 CFR 141. 20 The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144 For the purposes of this definition, the customs territory of the United States consists of the 50 States, Puerto Rico, and the District of Columbia. Note: An aerospace manufacturer might be a manufacture or importer of a reportable chemical substance, but is more likely to be a processor or user of a reportable chemical substance § Impurity • A chemical substance which is unintentionally present with another chemical substance © 2017 IAEG® all rights reserved 17

Definitions (continued) § Intermediate • 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) § Inactive substance • Any chemical substance subject to commercial activity designation that the Administrator designates as inactive Based on the lack of receipt of a notice of activity Designation effective 90 days after the Administrator identifies the chemical substance for such designation § Interim active substances • Any chemical substance that was reported, pursuant to 40 CFR part 711 (Chemical Data Reporting Rule), as having been manufactured in and of the calendar years: 2010, 2011, 2012, 2013, 2014, or 2015 § Known to or reasonably ascertainable by • All information in a person’s possession or control *(see definition of possession or control), plus all information that a reasonable person similarly situated might be expected to possess, control, or know © 2017 IAEG® all rights reserved 18

Definitions (continued) §Manufacture • • To manufacture, produce, or import chemicals, for commercial purposes Includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or complex combination of chemical substances § Manufacture for commercial purposes • To manufacture, produce, or import chemicals with the purpose of obtaining an immediate or eventual commercial advantage Includes, among other things, the “manufacture” of any amount of a chemical substance or mixture Ø For commercial distribution, including for test marketing, or Ø For use by the manufacturer, including use for product research and development or as an intermediate Applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture Ø Includes 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 © 2017 IAEG® all rights reserved 19

Definitions (continued) § Manufacturer • A person who manufactures a chemical substance Note: You may be a manufacturer if you create isolated intermediates (chemical reactions that create a new chemical during the manufacturing process) that are applied to your products. You need to report under the Manufacturer Reporting Period of February 2018. § Mixture • • • 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 Includes 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, Includes 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 § Possession or Control • 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 © 2017 IAEG® all rights reserved 20

Definitions (continued) § Process • To process chemicals for commercial purposes Includes the preparation of a chemical substance or mixture, after its manufacture Ø 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 Ø As part of a mixture or article containing the chemical substance or mixture § Process for commercial purposes • • • 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 • Any person who processes a chemical substance or mixture © 2017 IAEG® all rights reserved 21

Definitions (continued) § Reportable chemical substance • • • § Chemical substance listed on the Inventory and subject to commercial activity designation for which a Notice of Activity Form A is required or allowed Chemical substance that was added to the confidential portion of the Inventory before June 22, 2016, or An inactive substance for which a Notice of Activity Form B is required under § 710. 25(c) 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”) • Quantities of a chemical substance manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development are not greater than reasonably necessary for such purposes © 2017 IAEG® all rights reserved 22

Definitions (conclusion) § Test marketing • 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 § User • A person who uses a chemical substance or mixture but does not distribute it in commerce Note: This definition is derived from the definitions of “process”, “processor” and “process for commercial purposes”. Neither the statute nor the rules define “user” © 2017 IAEG® all rights reserved 23