EPA's TSCAn New Chemical Reporting Rule

Under the TSCA Sun: EPA's New Chemical Reporting Rule

WASHINGTON D.C.– The U.S. Environmental Protection Agency is amending the Toxic Substances Control Act (TSCA) section 8(a) Inventory Update Reporting (IUR) rule, and changing its name to the Chemical Data Reporting (CDR) rule. EPA is promulgating several amendments to the IUR rule, taking into consideration comments received on the proposed rule. The amendments were proposed in the Federal Register issue of August 13, 2010.

Reactions from insiders to the new Chemical Data Reporting rule

“The new electronic reporting requirement and limits on confidentiality claims also will bring EPA’s data collection effort into the 21st Century and give the American people greater access to a wider range of information on chemicals to which their children and families are exposed every day,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. chemical reporting under tsca

Companies will be required to start following the new reporting requirements in the next data submission period, which will occur February 1, 2012 to June 30, 2012.

“Actio can assure its customers that their Environmental Management software is fortified to manage all recent shifts under TSCA,” said Russell McCann, president and CEO of Actio Corporation.

“Software for compliance with chemical legislation must constantly be updated to reflect changing policies and laws worldwide," said McCann. "This fact makes a secure, online compliance solution such as Actio's SaaS platform the perfect tool for the fluctuating regulatory changes made recently in the U.S. and abroad.”

The CDR chemical rule: who's affected

EPA proposed a rule that would require manufacturers, including importers, to submit chemical information electronically. Online chemical reporting software was made all but mandatory. The rule also limited the information that can be treated as confidential so the public can access it, and required more reporting from chemical manufacturers.

You may be potentially affected by this action if you manufacture (including manufacture as a byproduct) or import, for commercial purposes, chemical substances listed on the TSCA Inventory (under TSCA section 3, “import” is included in the definition of manufacture).

Potentially affected entities may include, but are not limited to:

chemical substance manufacturers and importers (NAICS codes 325 and 324110; e.g., chemical substance manufacturing and processing and petroleum refineries)
chemical substance users and processors who, in addition to manufacturers described, may manufacture a byproduct chemical substance (NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing)

The CDR chemical rule: key definitions

This final rule defines the term manufacture under the CDR to mean: to manufacture, produce, or import, for commercial purposes. Manufacture includes the extraction, for commercial purposes, of a component chemical substance from a previously existing chemical substance or a complex combination of substances. When a chemical substance, manufactured other than by import, is:

produced exclusively for another person who contracts for such production, and
that other person specifies the identity of the chemical substance and controls the total amount produced and the basic technology for the plant process, then that chemical substance is co-manufactured by the producing manufacturer and the person contracting for such production.

The final rule defines the term site under the CDR to mean: a contiguous property unit. Property divided only by a public right-of-way shall be considered one site. More than one plant may be located on a single site.

for chemical substances manufactured under contract, i.e., by a toll manufacturer, the site is the location where the chemical substance is physically manufactured
the site for an importer who imports a chemical substance described in 40 CFR 711.5 is the U.S. site of the operating unit within the person's organization that is directly responsible for importing the chemical substance. The import site, in some cases, may be the organization's headquarters in the United States. If there is no such operating unit or headquarters in the United States, the site address for the importer is the U.S. address of an agent acting on behalf of the importer who is authorized to accept service of process for the importer
for portable manufacturing units sent out to different locations from a single distribution center, the distribution center shall be considered the site

The CDR chemical rule: key amendments to the IUR effective August 2011

The primary amendments are as follows: chemical testing tsca

1. EPA is requiring electronic reporting of the CDR data, using a web-based reporting tool to submit CDR reports through the Internet to EPA’s Central Data Exchange (CDX)

2. EPA is adding a new definition section, revising the definition for manufacture and site; and making other needed definitional modifications and additions.

3. EPA is changing the reporting frequency from every 5 years to every 4 years.

4. EPA is modifying the method used to determine whether a manufacturer (including importer) is subject to CDR reporting. The method will be effective after the 2012 submission period. Subsequent to 2012, reporting is required if the production volume of a chemical substance met or exceeded the 25,000 pound (lb) threshold in any calendar year since the last principal reporting year (e.g., 2011).

5. EPA is replacing the 300,000 lb reporting threshold for processing and use information by phasing in a lower threshold:

for the 2012 submission period, the threshold for reporting processing and use information is 100,000 lb.
in subsequent submission periods, the reporting threshold will be 25,000 lb.

6. EPA is replacing the 25,000 lb threshold for specific chemical substances that are the subject of particular TSCA rules and/or orders. The new reporting threshold for these chemical substances is substantially lower: 2,500 lb. The lower threshold is effective for the 2016 submission period and subsequent submission periods.

7. EPA is amending 40 CFR 710.46 (which appears in the new 40 CFR part 711 as 40 CFR 711.6) to make chemical substances for which an enforceable consent agreement (ECA) to conduct testing has been made (under 40 CFR part 790) ineligible for exemptions, to provide a full exemption from CDR requirements for water, and to remove polymers, which are already fully exempt from the partially exempt list of chemical substances at 40 CFR 710.46(b)(2)(iv), which appears in the new 40 CFR part 711 as 40 CFR 711.6(b)(2)(iv).

8. EPA is modifying the reporting requirements for certain manufacturing data elements. Specifically, manufacturers (including importers) are required to report:

the name and address belonging to the parent company
the current Chemical Abstracts (CA) Index Name, as used to list the chemical substance on the TSCA Inventory, as part of the chemical identity
for the 2012 submission period only, the production volume for calendar year 2010
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)
the volume of a manufactured (including imported) chemical substance used at the reporting site (see definition)
whether an imported chemical substance is physically present at the reporting site
the volume directly exported and not domestically processed or used
when a manufactured chemical substance, such as a byproduct, is being recycled, remanufactured, reprocessed, or reused

9. EPA is replacing the “readily obtainable” reporting standard used for the reporting of processing and use information with the “known to or reasonably ascertainable by” reporting standard.

10. EPA is requiring upfront substantiation when processing and use information is claimed as CBI [confidential business information].

11. EPA will disallow confidentiality claims for processing and use data elements identified as not “known to or reasonably ascertainable by.”

12. EPA is revising the list of industrial function categories for the reporting of processing and use information. EPA is also replacing the 5-digit NAICS codes with 48 Industrial Sector (IS) codes.

13. EPA is revising the list of consumer and commercial product categories for the reporting of consumer and commercial use information. EPA is also requiring separate reporting for:

consumer or commercial categories
the number of commercial workers reasonably likely to be exposed to the subject chemical substance

14. EPA is eliminating the gaps in the ranges used to report concentration.

For more information on these and other regulatory updates, browse the Actio Blog, or try http://www.epa.gov/iur/pubs/Summary_of_CDR_Reporting_Requirements.pdf or www.epa.gov/iur.

For more detail about online software for handling chemical management and reporting to EPA, contact your Actio representative. For more information about the CDR Rule and reporting program, keep up with all the changes by subscribing to the Actio Newsletter.

About Actio chemical management and reporting solutions
Since 1996, Actio has been helping companies and their supply chain networks both upstream and downstream to cost-effectively manage the complexities surrounding environmental compliance and the exchange of information, substances and chemicals along the global manufacturing supply chain. Actio’s supply chain materials information management solutions are delivered as SaaS and encourage a lean or “best practices” approach for analyzing and managing component and chemical data in today’s complex regulatory environment. Actio solutions track raw material and part composition for compliance with global mandates under EPA's TSCA, REACH, RoHS, and WEEE. For more information about Actio Corporation, please visit http://www.actio.net.

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