Thompson, Gavin, Ramboll Environ, TSCA Briefing, Compliance Challenges, 2016 CDR, and Getting Ready for Reform, MECC, 2016, Overland Park

1. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
TSCA BRIEFING:
COMPLIANCE CHALLENGES,
2016 CDR, AND
GETTING READY FOR REFORM
MIDWEST ENVIRONMENTAL COMPLIANCE
CONFERENCE
OVERLAND PARK, KANSAS
12 MAY 2016
GAVIN THOMPSON, PRINCIPAL
(WITH DAVID LIU AND BRIANNA SCHERFFIUS)
RAMBOLL ENVIRON

2. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
OVERVIEW
1. TSCA Compliance/Enforcement: 3 Case Studies
• Implications of CDR data mining by US EPA
• Changes in chemical identity management by US EPA
• The intersection of TSCA and FSMA
2. CDR: What’s New for 2016
3. TSCA Reform: Prepare Now!

3. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #1: CDR DATA MINING: EPA ACTIONS
• US EPA has conducted site visits and made inquiries based on desktop
reviews of and discrepancies identified in 2012 CDR data
• Discrepancies between quantities reported on Form Us in a toll manufacturing
relationship
• What might come out of US EPA’s review of this year’s submissions?
• Emphasis on down stream (customer) uses, exposures, and releases
• Scrutiny of tolling relationships, supply chain relationships, and
importer/distributors
• Critical review of joint submission Form U:
Downstream company may be manufacturing a substance and not
know what the substance is… because only the supplier knows the
identity of the upstream raw material

4. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #1: CDR DATA MINING: PENALTIES
EPA can assess penalties of up to $37,500 per day per violation,
including not reporting, or misreporting. Recent examples:
• Bethlehem Apparatus Co.: fined $103k for §8(a) 2006 IUR, §12(b) export
notification, and §13 import certification violations (2012)
• Chemtura Corp.: fined $56k for §8(a) 2006 IUR violations: 2 chemicals (2012)
• Haldor Topsoe, Inc.: fined $203k for §8(a) 2006 IUR violations: 13 chemicals
(2012)
• Kemira Water Solutions: fined $503k for §8(a) 2006 IUR violations: 27
chemicals (2013)
• Confidential: fined $327k for §8(a) 2012 CDR violations: 16 chemicals (2016)

5. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #1: CDR DATA MINING:
RECOMMENDED ACTIONS
• Prior to making submission of 2016 CDR, carefully
review any possible “dark areas” of supply chain.
• Carefully examine tolling arrangements and re-
confirm reporting obligations
• Do not assume that tolling arrangement/obligations
have been clearly communicated and that reporting
responsibilities are fulfilled.

6. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #2: CHEMICAL IDENTITY MANAGEMENT
• Example: Manufacturing C-6 to C-12 hydrocarbon referencing C-6 to C-
24 substance
• C-6 to C-12 substance is not on the TSCA Inventory
• US EPA is now examining companies’ practices of manufacturing short-
chained, medium-chained and long-chained hydrocarbons
C-4 C-8 C-12 C-16 C-20 C-24 C-28 C-32 C-36

7. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #2: CHEMICAL IDENTITY MANAGEMENT
Enforcement Cases:
• Dover Chemical paid $1.4 million in civil penalties (2012)
• TSCA PMNs for production of various chlorinated paraffins.
• Short-chain chlorinated paraffins – Dover Chemical ceased manufacturing –
US EPA argued these are PBTs.
• Medium-chain and long-chain chlorinated paraffins – Dover Chemical
required to submit PMNs.
• INEOS also manufacturing short-chained, medium-chained and long-
chained chlorinated paraffins without first submitting appropriate PMNs.
Source: https://www.epa.gov/enforcement/ineos-chlor-americas-settlement

8. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #2: CHEMICAL IDENTITY MANAGEMENT
Case in progress:
• Company is using same CASRN with wide C range (e.g., >C25) for multiple different
chemical products with narrower C ranges.
• Reviewing Company’s 2012 CDR report, US EPA questioned this practice.
• US EPA said such practice is not acceptable.
• As a result, a TSCA compliance audit is underway.
Implications:
• submissions of PMNs, potential fines.
• The Company is adhering to industry practice for these chemicals.
• Industry does not measure C ranges on a routine basis.
• Other companies to be impacted.

9. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #2: CHEMICAL IDENTITY
MANAGEMENT:
RECOMMENDED ACTIONS
•Evaluate basis for TSCA Inventory status for
your product
•Review chemical characterizations in similar
enforcement cases
•Confirm that the range represented by the
listed substance (e.g., C-6 to C-24) is present
in your product

10. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #3: INTERSECTION OF TSCA AND FSMA
• FDA is rolling out nine sets of regulations to implement
the Food Safety Modernization Act (FSMA)
• Many companies that supply chemical additives/ingredients are
subject to some portion of FSMA
• FDA has initially said that food-contact substances are not subject
to the Preventive Controls, but are subject to the Foreign Supplier
Verification Program (FSVP)
• There are 4,000-8,000 multi-channel chemicals, that is, chemicals
that have both industrial (TSCA) and food (FSMA) uses

11. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
CASE #3: INTERSECTION OF TSCA AND FSMA:
RECOMMENDED ACTIONS
• Earlier determination of product end-uses
• Import certification: TSCA positive or TSCA negative?
• Import for FD&C use(s): Additional paperwork
• More stringent segregation of chemical by end-use:
EPA’s “separate warehouse” advice
• Warehousing/handling:
FD&C ingredients/chemicals vs. TSCA industrial chemicals
• Know which substances are multi-channel substances and design
procedural and physical means of segregation.

12. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
2016 CDR: SCOPE AND SCHEDULE
• Production volumes and processing and use information regarding
certain chemicals manufactured in the US or imported into the US
from 2012–2015
• If the specified threshold was met during any of the calendar
years since the last reporting period (2012), then the
manufacturer or importer is required to report
• Submission period is June 1 – September 30, 2016

13. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
2016 CDR: COMPANIES AFFECTED
• Manufacturers and importers of organic and inorganic chemicals,
petroleum refiners, nonferrous smelters, steel mills, fertilizer
manufacturers and acid manufacturers, etc.
• Chemical substance users and processors, if they manufacture a
byproduct chemical substance – including utilities, paper
manufacturers, primary metal manufacturers, semiconductor and
other electronic component manufacturers (these are only a few
of the examples)

14. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
2016 CDR: MAJOR CHANGES
• Production volume annual review for 2012, 2013, 2014, and 2015: Chemical
manufacturers and importers must review production volume records for the past 4 years. If they
manufactured or imported at least 25,000 pounds of a chemical on the TSCA Chemical Substance
Inventory at a single site in 2012, 2013, 2014 or 2015, then the chemical must be reported
(unless otherwise exempt).
• New production volume thresholds: Reporting threshold of 2,500 pounds per year was
established for TSCA chemicals that are subject to certain TSCA actions (TSCA Sections 5, 6, and
7) as of June 1, 2016.
• Annual production volume reporting required: If production volume for any calendar year
2012-2015 exceeds the reporting threshold, companies must report production volumes for all
calendar years 2012-2015.
• Processing and Use information reporting required for all substances: If production
volume exceeds the relevant reporting threshold, companies must now report processing and use
information for all reported substances.
• Technical Contact information: Submitters must report a technical contact for each substance
rather than a single contact per facility.

15. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
TSCA REFORMS: NEW STATUTORY
AUTHORITY WILL INCREASE DATA DEMANDS
• Prepare for EPA to focus on high priority chemicals – EPA
Work Plan Chemicals – targeted based on risk assessments of the
uses:
https://www.epa.gov/assessing-and-managing-chemicals-under-
tsca/assessments-tsca-work-plan-chemicals
For example: antimony trioxide (ATO); 1-bromopropane (1-BP);
N-methylpyrrolidone (NMP)
• Prepare for EPA to “raise the bar” for PMN, LVE and SNUR
supporting data – starting with chemical identity specificity
• Prepare for more clashes over confidential business information
(CBI) vs. transparency

16. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
THANK YOU
FOR YOUR ATTENTION.
Questions and comments may be
addressed to
GAVIN THOMPSON, PHD, PRINCIPAL
RAMBOLL ENVIRON
2111 EAST HIGHLAND AVENUE, SUITE 402
PHOENIX, AZ 85016
PHONE: +1 602 734 7704
EMAIL: GTHOMPSON@RAMBOLL.COM

17. MAY 12, 2016
TSCA BRIEFING: COMPLIANCE CHALLENGES, 2016 CDR, AND GETTING
READY FOR REFORM
9 MITIGATING FACTORS IN
ASSESSING TSCA PENALTIES
• Systematic discovery of the violation through an environmental audit or a compliance
management system;
• Voluntary discovery;
• Prompt disclosure;
• Discovery and disclosure independent of government or third-party plaintiff;
• Correction and remediation;
• Prevent recurrence;
• No repeat violations;
• Other violations excluded; and
• Cooperation.