EPA’s Chemical Data Reporting Rule

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© 2011 Bergeson & Campbell, P.C., All Rights Reserved

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EPA’s Chemical Data Reporting Rule

Bergeson & Campbell, P.C. Webinar

September 15, 2011

Kathleen M. RobertsSusan Sharkey, EPACharles M. Auer Lynn L. Bergeson


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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


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Agenda (cont’d) Comparing Current and Future Reporting with

Past Inventory Update Reporting (IUR) Questions & Answers


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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


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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


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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)


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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)


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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


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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


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EPA Perspective -- Susan Sharkey How CDR information fits within EPA’s goals for

chemical risk management


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Areas of Discussion Reporting Timeframe

Reporting for Byproduct/Reprocessed/Recycled Substances

Upfront Substantiation for CBI

“Reasonably Ascertainable” Reporting Standard

Use of e-CDR


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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


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Byproduct/Reprocessed/Recycled Substances Byproducts exempted from CDR reporting IF:

1. Burned as a fuel;

2. Disposed of as a waste, including in a landfill or for enriching soil; or

3. 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.”


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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)


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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.”

Byproduct/Reprocessed/Recycled Substances (cont’d)


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Upfront Substantiation for CBI Previously required for chemical identity and

plant site identity

Now also required for processing and use information


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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?


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“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 also applies to process and use information (Form U, Part III)


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“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


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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 tool not 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


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Outlook on Impact of Finalized Changes CBI Substantiation

e-CDRweb

Reporting Standard

Reporting Thresholds

Reporting Period and Frequency

Byproduct Reporting

Overall Impression


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IUR/CDR Reporting Elements2006, 2012, and 2016

2006 2012 2016

Reporting threshold for production volume (Form U, Parts I and II)

25,000 lbs per site in 2005


25,000 lbs per site in 2012, 2013, 2014, or 2015

Reporting threshold for process and use (Form U, Part III)



25,000 lbs per site in 2012, 2013, 2014, or 2015

Reporting threshold for chemicals subject to certain TSCA rules/orders (Sections 5, 6, 7)

25,000 lbs per site

25,000 lbs per site

2,500 lbs per site


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

2006 2012 2016

Years of production and volume information to be reported

2005 2010 and 2011

2012, 2013, 2014, and 2015

Reporting period Original period 9/1/06 to 12/31/06; extended to 3/23/07

2/1/12 to

6/30/12

6/1/12 to

9/30/12

Report submission options Electronic submission urged but not required

e-CDR e-CDR


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2006 2012 2016

Upfront substantiation on CBI required

For chemical identity and plant site only

For chemical identity, plant site, and process and use information

For chemical identity, plant site, and process and use information

Reporting standard for processing and use information

Readily obtainable

Known to or reasonably ascertainable

Known to or reasonably ascertainable


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2006 2012 2016

Allowable chemical identifying number CAS, PMN, TSCA Accession numbers

Only CAS or TSCA Accession number

Only CAS or TSCA Accession number

Volume of substance used at site Not required

Required Required

Whether imported chemical is physically at the reporting site

Not required

Required Required

Volume of chemical directly exported Not required

Required Required

Whether substance is being recycled, remanufactured, reprocessed, or reused

Not required

Required Required

Reporting on number of commercial workers potentially exposed

Not required

Required Required


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Documents

EPA’s Chemical Data Reporting Rule