Environmental Health and Safety Blog | EHSWire

Paula Kaufmann, CIH


What are the basic criteria needed to support a confidentially claim on the 2012 CDR Submission? Any business with a trade secret or confidential chemical formula is definitely wondering about this very issue as they consider just how to file their 2012 CDR Form U.

The EPA has increased the requirements (as in, made it more challenging) for companies who want to justify a claim of Confidential Business Information (CBI) in their CDR submission. A summary of the CDR CBI criteria for 2012, along with the long list of questions that must be addressed to support this claim are as follows (from 40 CFR 2.208):

• The business must show that disclosure of the information is likely to cause substantial harm to the business's competitive position.


• The confidentiality claim must be valid at the date of submission.


• The business can demonstrate that it has and still does protect the confidentiality of the information.


• The information is not (and hasn’t been) obtainable by others without the business's consent.


• No statute specifically requires disclosure of the information.

What information can be claimed as Confidential Business Information (CBI) on the 2012 CDR Submission?

• Site
  
  
  
  • Identity of the manufacturing or importing site linked with a reportable chemical substance.  Site name, address, city, county, state, zip code, and Dun & Bradstreet number are protected.
  
  
  • The company name must also be claimed as confidential to protect the link between the chemical identity and the company name.
  
  
  
  

• Chemical Substance
  
  
  
  • Specific identity of a chemical substance (including Accession Number) -- only if EPA treats the identity of that chemical substance as confidential on the TSCA Inventory.
  
  
  
  

• Processing and Use Information
  
  
  
  • Data associated with the processing and use information -- if you think this information would reveal trade secrets or confidential commercial or financial information.
  
  
  
  

What needs to be substantiated for the confidentiality claim to be accepted (honored) by the EPA?

All claims need to be substantiated at the time of submission. A blank response or a response that is designated as “not known or reasonably ascertainable” may not be claimed as confidential.  There are specific questions for each type of claim as shown below -

Site

1. Has site information been linked with a chemical identity in any other Federal, State or local reporting scheme? For example, is the chemical identity linked to a facility in a filing under the Emergency Planning and Community Right-to-Know ACT (EPCRA) section 311, namely through a Material Safety Data Sheets (MSDS)? If so, identify all such schemes.  Was the linkage claimed as confidential in any of these instances?


2. What harmful effect, if any, to your competitive position or to your customer’s competitive position do you think would result from disclosure of the processing and use data and the chemical substance? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

Chemical Identity – the substantiation must be provided for each chemical substance claimed to be CBI

1. What harmful effects to your competitive position, if any, or to your supplier’s competitive position, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under the CDR? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?


2. For how long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?


3. Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented, and therefore disclosed through the patent, why should it be treated as confidential?


4. Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?


5. Is the fact that the chemical substance is being manufactured (including imported) for a commercial purpose available to the public, for example, in technical journals, libraries, or State, local, or Federal agency public files?


6. What measures have you taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured (including imported) for a commercial purpose?


7. To what extent has the fact that this chemical substance is manufactured (including imported) for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?


8. Does this particular chemical substance leave the site of manufacture (including import) in any form (e.g., as product, effluent, emission)? If so, what measures have been taken to guard against the discovery of its identity?


9. If the chemical substance leaves the site in a product that is available to the public or your competitors can the chemical substance be identified by analysis of the product?


10. For what purpose do you manufacture (including import) the chemical substance?


11. Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.

Processing and Use Information - the substantiation must be provided for each process and use claimed to be CBI for a specific chemical substance

1. Is the identified use of this chemical substance publicly known? Has your company ever provided use information on the chemical substance that was not claimed as confidential?


2. What harmful effect, if any, to your competitive position or to your customer’s competitive position do you think would result from disclosure of the processing and use data and the chemical substance? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?


3. Obviously, manufacturers and other businesses who filed a CBI in 2006 must revisit their eligibility for their 2012 filing. And, to continue their eligibility, consideration for the extra time and effort to prepare the required substantiation documentation. To put it in a nutshell, with the number and depth of the EPA’s questions that are involved, you better be prepared prior to making a CBI claim!

Did you file a CBI claim last year? Are you going to file a CBI claim for the same chemicals this year? If so, are you allowing for extra time (and budget!) to gather the substantiation information together? If not, why not?

Paula Kaufmann, CIH

The EPA hosted a 3-hour webinar on November 16, 2011 that reviewed the reporting process for the 2012 Chemical Data Reporting (CDR) Rule with a focus on joint reporting, considerations related to the reporting of byproducts, and updated information about registering for electronic reporting and for using the electronic reporting tool/  The EPA has posted the presentation slides online and expects to have a recording of the webinar available for viewing by December 1.

Webinar Take Aways – Still Many Questions

• The Agency has prepared a detailed instruction manual for the 2012 CDR that presents the reporting requirements using a decision logic diagram.


• Registration for the EPA Central Data Exchange (CDX) for CDR submission is scheduled to be opened on December 1.  The sign-up link will be posted on the IUR/CDR Home Page. (Emilcott will also post it on our TSCA Resource Web Page.)


• e-CDR web, the CDR reporting tool, is scheduled to be available in January.


• The TSCA Substance Registry Services (SRS) will be updated in January.


• Additional resources will continue to be posted at www.epa.gov/cdr.


• A few of the new requirements highlighted during the presentation brought in many questions during the subsequent 2-hour webinar Q&A – specifically concerning Contract Manufacturing, Joint Submission, and byproducts reporting.

Some of the questions not answered during the webinar that we found of particular interest are:

• What are the reporting responsibilities for toll manufacturers where the volume of a chemical made for one customer is less than 25,000 lbs but they manufacture for several customers putting the cumulative volume above the threshold?


• What does one do since the XML Schema that is currently posted does not function properly, and is stated to be the final version?


• Does starting material that is recycled (and reused) need to be reported since the material was not manufactured at the site?


• If off-specification material is reprocessed, does the material gained from the reprocessing get reported as a byproduct or is it included in the overall production volume?


• How does one account for non-isolated intermediates that are isolated and then reprocessed due to maintenance activities or upset conditions?


• What are the reporting responsibilities for an importer if the supplier does not agree to be a joint submitter?

As the reporting period nears we will be taking a careful look at the rationales and explanations provided in the Preamble to the Final Rule as the buck stops with the final rule as published.

If you need guidance for the EPA TSCA 2012 CDR Submission, Emilcott offers three helpful options

1. Contact Emilcott  directly with your questions about TSCA or other regulatory issues.


2. Subscribe to our free TSCA newsletter which delivers TSCA-related information just like this right to your mailbox.


3. Register for our free Dec 6 webinar:  Do You Understand TSCA 2012 CDR Requirements?