Details of EPA Final Rule to Strengthen TSCA Inventory Reporting

(Note that EPA’s final rule renames the TSCA Inventory Update Reporting (IUR) rule as the Chemical Data Reporting (CDR) rule and moves it to 40 CFR Part 711. See ITT’s Online Archives or 08/16/10 news, 10081616, for BP summary of EPA’s proposed rule.)

Primary Changes Made by EPA’s Final Rule

According to EPA, the primary changes being made by the final rule include:

Beginning 2012, Reports Are due Every 4 Years

EPA is changing the reporting frequency from every 5 years to every 4 years. The next submission period is in 2012. For the 2012 CDR, all information reported to EPA in response to the CDR must be submitted between February 1, 2012 and June 30, 2012. Beginning in 2016, and for each subsequent submission period, the submission period will begin June 1 and end September 30.

(Note that EPA suspended the 2011 submission period (June-September 2011) to allow additional time to finalize its proposed modifications, and to provide sufficient time for companies to comply with the CDR reporting requirements. See ITT’s Online Archives or 05/12/11 news, 11051205, for BP summary.)

Data Must be Submitted Electronically Using CDX

EPA is requiring the mandatory use of EPA-provided, web-based reporting tool (e-CDRweb) and the EPA’s Central Data Exchange (CDX) to submit the required information on Form U (EPA Form 7740-8).

e-CDRweb. Electronic reporting for the 2012 CDR is not yet available. EPA states that it will make the CDR electronic reporting tool, e-CDRweb, available through the Agency's CDX. (e-CDRweb is a free, web-based reporting tool for completion of Form U for the 2012 CDR.)

Joint submissions by importer and foreign supplier. For purposes of CDR, submitters are allowed to report the CDR information jointly with the foreign supplier of a reportable chemical substance whose chemical identity is unknown to the importer. EPA will also require submitters to use CDX and e-CDRweb for preparation and submission of joint submissions. (Previously, joint submissions could not be made electronically.)

Manufacturers/Importers Need to Report More Information

EPA is modifying the reporting requirements to require manufacturers (including importers) to submit additional information, including:

1. The name and address belonging to the parent company (EPA notes that manufacturers, including importers, are required to report the company name and Dun & Bradstreet D-U-N-S (or D&B) number to identify the company associated with the plant site. If the company associated with the plant site or the plant site does not have a D&B number, the manufacturer (including importer) must obtain one for the company/site).
2. The current Chemical Abstracts (CA) Index Name, as used to list the chemical substance on the TSCA Inventory, as part of the chemical identity.
3. For the 2012 submission period only, the production volume for calendar year 2010.
4. The production volume for each of the years since the last principal reporting year. This requirement will be effective after the 2012 reporting cycle (i.e., for the 2016 submission period and subsequent submission periods).
5. The volume of a manufactured (including imported) chemical substance used at the reporting site.
6. Whether an imported chemical substance is physically present at the reporting site.
7. The volume directly exported and not domestically processed or used.
8. When a manufactured chemical substance, such as a byproduct, is being recycled, remanufactured, reprocessed, or reused.

Thresholds for CDR Reporting Revised

EPA states that it has made three changes related to CDR reporting thresholds:

Revised method for determining whether the 25,000 threshold is met. As amended by the final rule, 40 CFR 711.8(a) states that for the 2012 submission period, any person who manufactured (including imported) for commercial purposes 25,000 lb (11,340 kilogram (kg)) or more of a chemical substance described in 40 CFR 711.5 at any single site owned or controlled by that person during the principal reporting year (i.e., calendar year 2011) is subject to reporting.

For the submission periods subsequent to the 2012 submission period, any person who manufactured (including imported) for commercial purposes 25,000 lb (11,340 kg) or more of a chemical substance described in 40 CFR 711.5 at any single site owned or controlled by that person during any calendar year since the last principal reporting year (e.g., for the 2016 submission period, consider calendar years 2012, 2013, 2014, and 2015, given that 2011 was the last principal reporting year).

Reduction of 25,000 lb threshold for “high interest” chemicals. For the 2012 CDR, EPA is maintaining the 25,000 lb reporting threshold for chemical substances (i.e., those listed in 40CFR 711.8(b)) that are the subject of particular TSCA rules and/or orders¹. For future CDR collections, EPA is reducing the threshold for such chemical substances (including the threshold for the collection of processing and use information) to 2,500 lb. (EPA notes that these chemical substances are of demonstrated high interest to the EPA.)

(EPA had proposed to eliminate the threshold, which would have required manufacturers (including importers) of such chemical substances to report under the CDR rule, regardless of the production volume, but commenters objected. Instead, EPA decided to implement a de minimis threshold and to delay its implementation.)

Lower threshold for submitting more processing and use info. EPA is replacing the 300,000 lb threshold for submitting additional processing and use information by phasing in a lower reporting threshold. For the 2012 CDR, all submitters of non-excluded chemical substances are required to report processing and use information if they manufactured (including imported) 100,000 lb or more of a chemical substance in 2011. Subsequent to the 2012 submission period, the reporting threshold will be 25,000 lb (or 2,500 lb for chemical substances subject to particular TSCA rules and/or orders.¹

Stricter Standard of Reporting for Processing and Use Information

For information on the processing and use of chemical substances, EPA is replacing the standard of reporting from information that is “readily obtainable” to information that is “known to or reasonably ascertainable by” the submitter.

According to EPA, under this stricter standard, a submitter would prepare its report about the processing and use of a chemical substance it manufactures (including imports), without confining its inquiry solely to what is known to managerial and supervisory employees. The submitter would be expected to review information which the manufacturer (including importer) may have in their possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.

Adds/Removes Exemtions for Water, Polymers, ECAs

In its final rule, EPA makes changes to various exemptions from reporting under the CDR rule, including (i) fully exempting all (both naturally occurring and manufactured) water (Chemical Abstracts Service Registry Number 7732-18-5); (ii) removing from the partially exempt list of chemical substances three chemical substances which, as polymers, are fully exempt from reporting; and (iii) making chemical substances that are the subject of an enforceable consent agreement (ECA) ineligible for reporting exemptions.

Importer’s Site must be a U.S. Address, also Changes for Manufacture Definition

EPA is also revising the definition for site and manufacture and making other needed definitional modifications and additions.

Definition of site. EPA is amending the definition of site to: (i) clarify that the importer’s site must be a U.S. address; (ii) accommodate manufacturing under contract; and (iii) accommodate portable manufacturing units.

EPA notes that for importers, the U.S. address of an agent acting on behalf of the importer, and authorized to accept service of process for the importer, may also be reported as the importer’s site address if the operating unit that is directly responsible for importing the chemical substance and that controls the import transaction has no U.S. address.

Definition of “manufacture.”In order to improve the information submitted through the CDR rule, EPA is modifying the definition of manufacture by including elements from the 40 CFR 720.3 definition of manufacturer.

In addition to the change to the definition of manufacture, the EPA is adding a paragraph to 40 CFR 711.22 (Duplicative reporting) to clarify the reporting relationship between the contracting company and the toll manufacturer.

Certain Codes and Categories Revised or Replaced

EPA is revising or replacing various categories and codes as follows:

Industrial function categories. The list of industrial function categories for the reporting of processing and use information is being revised.

NAICS codes. The 5-digit North American Industrial Classification System (NAICS) codes are being replaced with 48 Industrial Sectors (IS).

Consumer and product category codes. The list of consumer and commercial product categories for the reporting of consumer and commercial use information is being revised. (EPA is requiring the separate reporting for consumer or commercial categories and reporting of the number of commercial workers reasonably likely to be exposed to the subject chemical substance.)

Certain Gaps in Ranges for Reporting Concentrations, Sites Eliminated

EPA is eliminating the gaps in the ranges used to report the maximum concentration of a chemical substance in 40 CFR 711.15(b)(3) and to report the number of sites in 40 CFR 711.15(b)(4). (See final rule for new ranges.)

Stricter Requirements for Confidential Business Information

EPA is requiring up-front substantiation when required processing and use information

is claimed as Confidential Business Information (CBI). EPA will prohibit confidentiality claims for processing and use data elements identified as not “known to or reasonably ascertainable by” manufacturers (including importers).

Additional EPA Guidance Available, EPA Plans Webinar on Revisions

EPA states that it has also developed guidance instructions, questions and answers, and case studies, and intends to conduct a webinar to help potential CDR submitters become familiar with the revised reporting form (Form U) and amended reporting requirements. Guidance documents and information on the webinar are available on the CDR Web site (http://www.epa.gov/iur).

September 23 webinar. On September 23, 2011, EPA will be hosting a webinar to demonstrate e-CDRweb. Those interested will be able to test the tool during the following week. The test version will not be usable for 2012 submissions.

Based on the proposed Inventory Update Reporting Modifications, EPA in November 2010 held a webinar to demonstrate the new reporting tool and the enhanced CDX registration process.

Details on EPA’s webinars, as well as it additional guidance documents, are available at www.epa.gov/iur.

¹A rule proposed or promulgated under TSCA section 5(a)(2), 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 5(e) or 5(f), or is the subject of relief that has been granted under a civil action under TSCA section 5 or 7.

EPA press release available here

EPA fact sheet available here

Federal Register notice (dated 09/06/11) providing technical corrections to the section numbers appearing throughout the regulatory text is available here.

EPA contact -- Chenise Farquharson (202) 564-7768; farquharson.chenise@epa.gov

(D/N 2009-0187, FR Pub 08/16/11)