EPA’s Chemical Data Reporting Rule

1. EPA’s Chemical Data Reporting Rule Bergeson & Campbell, P.C. Webinar September 15, 2011 Kathleen M. Roberts Susan Sharkey, EPA Charles M. Auer Lynn L. Bergeson

2. Agenda • Introductions • Overview of Chemical Data Reporting (CDR) Rule • EPA Perspective -- How CDR Information Fits within EPA’s Goals • Areas of Discussion • Reporting timeframe • Reporting for byproduct/reprocessed/recycled substances • Upfront substantiation for confidential business information (CBI) • “Readily ascertainable” reporting standard • Use of e-CDR • Outlook on Impact of Finalized Changes

3. Agenda (cont’d) • Comparing Current and Future Reporting with Past Inventory Update Reporting (IUR) • Questions & Answers

4. CDR -- Overview • Previously known as the IUR rulemaking • Amendments to IUR proposed in August 2010 • Rulemaking at the Office of Management and Budget from January to July 2011 • Final rulemaking published in Federal Register on August 16, 2011

5. CDR -- Who Is Required to Report? • Manufacturers and importers, that meet reporting threshold, to include: • Distribution centers that serve portable manufacturing units • Examples of “portable manufacturing units” are building or road projects that use tanks to produce calcium hydroxide slurry in construction and agricultural facilities that make ammonium hydroxide for land use • Contract or toll manufacturers must ensure their manufacturing data are reported under the CDR

6. CDR -- Reporting Thresholds • Threshold for determining CDR reporting obligation • In 2012 -- 25,000 pounds per site in 2011 • In 2016 -- 25,000 pounds per site in 2012, 2013, 2014, or 2015 • EXCEPTION STARTING IN 2016 -- 2,500 pounds per site threshold for chemicals subject to certain TSCA Rules/Orders (Sections 5, 6, 7) • Threshold for reporting process and use information (Form U, Part III) • In 2012 -- 100,000 pounds per site in 2011 • In 2016 -- 25,000 pounds per site in 2012, 2013, 2014, or 2015 • EXCEPTION STARTING IN 2016 -- 2,500 pounds per site threshold for chemicals subject to certain TSCA Rules/Orders (Sections 5, 6, 7)

7. CDR -- Manufacturing InformationForm U, Part II • In addition to past IUR manufacturing information elements, submitters must report: • Chemical Abstract Index Number (or TSCA Accession number if CBI) • Previous option of PMN number as chemical identification no longer allowed • Volume of chemical used at site • Whether imported chemical is physically at the reporting site • Volume of chemical directly exported • Whether manufactured chemical substance, such as a byproduct, is being recycled, remanufactured, reprocessed, or reused • To be reported for principal reporting year only (year preceding reporting year, e.g., 2011, 2015)

8. CDR -- Manufacturing InformationForm U, Part II (cont’d) • In addition to past IUR manufacturing information elements, submitters must report: • For 2012 • Production volume for 2010 (one year prior to principal reporting year of 2011) and 2011 • For 2016 • Production volumes for 2012, 2013, 2014, and 2015

9. CDR -- Process and Use InformationForm U, Part III • In addition to past IUR process and use information elements, submitters must: • Use revised lists of industrial function categories, Industrial Sectors (IS), and consumer and commercial codes • Report consumer and commercial product categories separately • Report number of commercial workers potentially exposed (ranges) • Provide upfront substantiation on any information element claimed confidential • Report information using the “known to or reasonably ascertainable by” reporting standard

10. EPA Perspective -- Susan Sharkey • How CDR information fits within EPA’s goals for chemical risk management

11. Areas of Discussion • Reporting Timeframe • Reporting for Byproduct/Reprocessed/Recycled Substances • Upfront Substantiation for CBI • “Reasonably Ascertainable” Reporting Standard • Use of e-CDR

12. Reporting Timeframe • Reduced reporting period for 2012 • Submission reporting period of February 1, 2012, to June 30, 2012 • Information to be reported on calendar year 2011 (January to December 2011) • One to six months to compile, review, analyze, correct, and submit information • In comparison, 2006 reporting allowed nine to twelve months after information collection period ended (which was extended an additional three months) • Likewise, 2016 reporting period will be a six to nine month period • Reporting cycle revised from five-year to four-year cycle

13. Byproduct/Reprocessed/Recycled Substances • Byproducts exempted from CDR reporting IF: • Burned as a fuel; • Disposed of as a waste, including in a landfill or for enriching soil; or • Used to extract component chemical substances from it for commercial purposes • To qualify for exemption, EPA states: • “‘[T]he component to be extracted must be already existing as a distinct chemical substance in the waste stream.’ When the chemical substance present in the byproduct and the chemical substance extracted from the byproduct are distinct chemical substances, neither the manufacture of the byproduct nor the manufacture of the extracted chemical substance qualify for the 40 CFR 720.30(g)(3) exemption.”

14. Byproduct/Reprocessed/Recycled Substances (cont’d) • Potential confusion as to when and what to report, particularly with inorganic chemical substances that are sent for recycling • Further confusion with materials that are processed for reuse within a facility (e.g., spent solvents)

15. Byproduct/Reprocessed/Recycled Substances (cont’d) • In the Federal Register notice, EPA noted: • “The Agency is committed to helping byproduct manufacturers report according to the CDR requirements and views the 2012 reporting cycle as an opportunity for the Agency and byproduct manufacturers to work together. Among other things, the Agency will use this opportunity to determine whether additional guidance tailored to these manufacturers is needed. In addition, EPA intends to provide training specific to byproduct reporting and to make available Agency personnel to answer questions on an individual basis.” • “EPA also intends to continue to work with industry and the interested public. EPA encourages recycling. The Agency intends to examine the collected information related to byproducts, recognizing the importance of recycling, to identify whether there are segments of byproduct manufacturing for which EPA can determine that there is no need for the CDR information for the 2016 or other future reporting cycles.”

16. Upfront Substantiation for CBI • Previously required for chemical identity and plant site identity • Now alsorequired for processing and use information

17. Upfront Substantiation for Process and Use Information Claimed CBI • Questions to Be Answered • Is the identified use of this chemical substance publicly known? For example, is information on the use available in advertisements or other marketing materials, professional journals or other similar materials, or in non-confidential mandatory or voluntary government filings or publications? Has your company ever provided use information on the chemical substance that was not claimed as confidential? • 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?

18. “Known to or Reasonably Ascertainable by” Reporting Standard • Means all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know • All CDR reporting elements to be reported under “reasonably ascertainable” standard • Previously applied only to Form U, Parts I and II • Now alsoapplies to process and use information (Form U, Part III)

19. “Known to or Reasonably Ascertainable by” Reporting Standard (cont’d) • Examples • Files maintained by the submitter, such as marketing studies, sales reports, or customer surveys • Information contained in standard references, such as Material Safety Data Sheets, that contain use information or concentrations of chemical substances in mixtures • Information from the Chemical Abstracts Service Registry Number (CASRN) and from Dun & Bradstreet number

20. e-CDR • All submissions must use e-CDRweb • e-CDRweb is a free, web-based reporting tool for completion of Form U for the 2012 CDR • Electronic reporting toolnot yet available • EPA will make e-CDRweb available through the Agency's CDX • EPA will host a webinar to demonstrate e-CDRweb on September 23, 2011, • Parties can test the tool during the week after the webinar • The test version will not be usable for 2012 submissions

21. Outlook on Impact of Finalized Changes • CBI Substantiation • e-CDRweb • Reporting Standard • Reporting Thresholds • Reporting Period and Frequency • Byproduct Reporting • Overall Impression

22. IUR/CDR Reporting Elements2006, 2012, and 2016

23. IUR/CDR Reporting Elements2006, 2012, and 2016 (cont’d)

24. IUR/CDR Reporting Elements2006, 2012, and 2016 (cont’d)

25. IUR/CDR Reporting Elements2006, 2012, and 2016 (cont’d)

26. Thank You THE ACTA GROUP, L.L.C. 2200 Pennsylvania Avenue, N.W. Suite 100W Washington, D.C. 20037 www.actagroup.com THE ACTA GROUP EU, LTD 23 New Mount Street Manchester M4 4DE United Kingdom www.actagroup.com BERGESON & CAMPBELL, P.C. 2200 Pennsylvania Avenue, N.W. Suite 100W Washington, D.C. 20037 lbergeson@lawbc.com www.lawbc.com B&C CONSORTIA MANAGEMENT, L.L.C. 2200 Pennsylvania Avenue, N.W. Suite 100W Washington, D.C. 20037 www.bc-cm.com