1. TSCA Nanomaterial Reporting
Martha Marrapese
Partner

2. Introductions John Hilbert, NMA Executive Director
Purpose of NMA formed in significant part to address processor and user concerns with the EPA’s section 8(a) information collection rule for nanomaterials
NMA Members include:
Altana
American Coatings Association
Celluforce
CP Kelco
Georgia Pacific
Emulsion Polymers Council
Styrene Information and Research Center
Sabic
Trinseo

3. Plan for Today 11:00 – 11:15 11:15 – 11:30 11:30 – 12:15 12:15 – 1:00
Summary of final rule – what changed
11:15 – 11:30
Review EPA’s response to public comments
11:30 – 12:15
Discuss implementation issues
12:15 – 1:00
Present and discuss strategic options for responding to the rule

4. Final Rule – Who and When
Who must report: Manufacturers, importers and Processors
Exempt from reporting: Small manufacturers and processors whose total annual sales are less than $11 million.
When to Report: As of May 12, 2017
On or before May 12, 2018:
IF manufactured, imported, or processed reportable chemical substances and their discrete forms as defined in the rule in the three years prior to May 12, 2017.
Report 135 days before commencing manufacture, import, or processing of a reportable substance, or within 30 days after forming the intent to do so.

5. What - Reportable chemical
A solid at 25°C and standard atmospheric pressure
That is manufactured or processed in a form where any particles, including aggregates and agglomerates, are in the size range of nm in at least one dimension
That is manufactured or processed to exhibit unique and novel characteristics or properties because of its size and discrete forms of these substances.

6. Reportable chemical - baseline
“Unique and novel properties”
“any size-dependent properties that vary from those associated with other forms or sizes of the same chemical substance, and such properties are a reason that the chemical substance is manufactured or processed in that form or size.” (emphasis added)
Intent element explicit in new definition
Exemption for trace quantities
when chemical substance is manufactured or processed in a form where less than 1% (by weight) of any particles, including aggregates and agglomerates, are in the size in the range of nm.

7. Reportable chemical – discrete forms
Need ALL of the following:
Change in process effects a change in size;
And/or a change in:
zeta potential;
specific surface area;
dispersion stability;
surface reactivity.
Plus will need to have a variation in mean particle size
Plus the change in the listed properties or mean particle size must be greater than 7 times the standard deviation of the measured value (+/- 7)
OR Different morphology (examples provided)
OR Coated with a different chemical substance or mixture.
= 3 different ways, for a total of seven parameters

8. Information needs
Common name, trade name, specific chemical identity by Chemical Abstracts Index Name, Chemical Abstracts Service (CAS) Registry Number, and molecular structure.
Material characteristics including particle size, morphology, and surface modifications.
Physical and chemical properties.
Maximum weight percentage of impurities and byproducts resulting from manufacture, processing, use or disposal.
Annual production volume for prior three years and an estimate of the maximum 12-month production volume during the next two years. If a discrete form of the reportable chemical substance is first manufactured or processed after the effective date of the rule, EPA wants an estimate of the maximum 12-month production volume in the first three years of production.
Use information by category, function, and application, estimates of the amount manufactured and processed for each category of use, and an estimate of the percentage in the formulation for each use.

9. Information needs Detailed methods of manufacturing or processing.
Exposure information with estimates of the number of individuals exposed in their places of employment, descriptions and duration of occupational tasks, and descriptions and estimates of any general population or consumer exposures.
Release information with estimates of the amounts released, a description and the duration of the activities that cause the releases to occur, and whether the releases are directly to the environment or to control technology.
Risk management practices describing personal protective equipment (PPE), engineering controls, control technologies used, any hazard warning statement, label, safety data sheet, customer training, and other information provided to persons who are reasonably likely to be exposed to the substance regarding PPE, safe handling, transport, use or disposal.
Existing data concerning environmental and health effects.

10. Final Rule – What Information
Separate reports for each discrete form
EPA intends to issue guidance within six months on the “reasonably ascertainable” reporting standard, consolidating submissions, and generic chemical names.
Only report known or reasonably ascertainable information
Preamble language states no need to wait to commercialize after you file, but language of rule is inconsistent with this interpretation.

11. EPA Response to Public Comments
135 day Moratorium:
EPA did not intend to create de facto new chemical reporting for new discrete forms of nanoscale materials, because the 135-day period is not a formal review- period that prohibits manufacture before the end of the 135-day period. Rather, based on EPA’s experience with the Premanufacture Notice (PMN) program, EPA believes that in most cases companies have the requisite intent to manufacture or process at least 135 days before manufacturing or processing will begin, and the rule requires reporting based upon this presumed intent. However, if a company does not form the requisite intent 135 days ahead of time, the company must report within 30 days of the formation of such an intent. There is no obligation upon the company to wait 135 days after reporting to manufacture or process companies will not experience delay in market introduction and potential profit losses as a result of this rule.

12. EPA Response to Public Comments
Reports for Discrete Forms are Not Authorized:
TSCA section 8(a) authorizes EPA to promulgate rules for submission of such reports as the Agency ‘‘may reasonably require.’’
EPA believes that the information from this reporting will help EPA to determine whether chemical substances manufactured and processed at the nanoscale may exhibit behavior relevant to health and safety that is different from that of non-nanoscale forms of chemical substances.

13. EPA Response to Public Comments
Required Information is Beyond Section 8(a) Scope:
Section 8(a)(2) is best interpreted as listing examples of the kinds of information EPA can require reporting on under section 8(a)(1), not as limiting EPA’s authority.
Further, the information required under the rule is consistent with the examples of information discussed in section 8(a)(2). For example, requiring weight percent of impurities is analogous to byproducts, material characterization including particle size and morphology is analogous to molecular structure of chemical substances manufactured and processed at the nanoscale…
Some information collection elements were added specific to nanoscale materials that were not included in previous reporting requirements because those reporting requirements did not focus on information specific to nanoscale forms of chemical substances.

14. EPA Response to Public Comments
Duplicative Reporting by Processors:
The reporting required Does not duplicate reporting EPA would receive under other TSCA regulations.
If the information provided by the supplier indicates that reporting is required, the processor is required to report information that is known or reasonably ascertainable, which may include information obtained from the supplier.
Compliance Requires Testing:
Manufacturers and processors are not required to conduct testing or develop new information under this rule. However, they are required to report information that is known or reasonably ascertainable.
In the proposed rule, EPA supplied examples of testing guidelines that could be used for these types of properties should the company desire to do such testing.

15. EPA Response to Public Comments
Small Business Definition:
EPA’s change to this definition is consistent with both public comments and the feedback we received from SBA.
In the Federal Register of December 15, 2016 (81 FR 90840) (FRL ), EPA sought public comment on whether a revision of the current size standard definitions is warranted at this time; announced EPA’s initiation of the required consultation with the SBA, and provided its preliminary determination that revision to the currently codified size standards for TSCA Section 8(a) is indeed warranted.

16. Implementation issues
When to file?
Unique and novel criteria
Central to reporting obligation
Not subject to notice and comment
A logical extension of the rulemaking under the APA?
Ambiguous? Arbitrary?
As applied to polymers, other?
Seven standard deviations
Measurement baseline?
Morphology
= shape? structure? form?
How much change in size constitutes a change? 5 nm to 6 nm? 7 to 10 nm? 10 to 50 nm? Avg.? Mean? Single or evolving baseline?
What if nanomaterial is received and processed as part of a mixture rather than discrete form?
Language on guidance indicates consolidated submissions will be accepted, but this is not allowed by rule.
Dicta indicates you can commence after filing, rule states you must wait.
When is information reasonably ascertainable?

17. Implementation issues
Processor A forms intent on March 10, 2017 to process a nanomaterial.
If processed before May 12, 2017, file by May 2018.
What if Processor A cannot start processing until after May 12, 2017? File within 30 days? When can processing start?
Processor B forms intent on May 13, 2017 to start processing a nanomaterial in 3rd Q Must file 135 days before processing.
Processor C forms intent on May 13 to start processing in June. File within 30 days. Wait for 30 days to process?

18. Options assessment Congressional Review Act
Judicial challenge – deadline is March 27, 2017
Negotiation and development of guidance
Letter to Administrator Pruitt requesting reconsideration
Petition for rulemaking to rescind objectionable aspects of the rule
Prepare for Implementation

19. Congressional Review Act
The Congressional Review Act (CRA) is an oversight law that gives Congress the ability to overturn a final rule promulgated by a Federal Agency.
Congress has 60 legislative days (in session) to potentially overturn the regulation through a Joint Resolution of Disapproval.
The Nanomaterial Reporting Rule is subject to the CRA.
To pursue, NMA would draft a one-pager for Congress outlining EPA’s overreach on the rule and the need to overturn the rule.
NMA would also need to find a Republican Senator to champion this effort.

20. Chevron U.S.A. v. NRDC, 467 U.S. 837, 842-43 (1984)
Has Congress directly spoken to the precise question at issue?
If Congress has not directly addressed the precise question at issue, and the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute.
Is the agency interpretation arbitrary or capricious

21. Implementation issues
Section 8(a) on moratorium:
Directed to existing chemicals that are active in commerce.
Section 8(a) and on-going reporting:
Applies to companies that either manufacture, import or process - or propose to do so.
Section 8(a) on discrete form reporting:
Definition of chemical substance subject to report does not distinguish physical forms
Information requirements list is illustrative only
Reporting must be reasonable.

22. Implementation issues
Section 8(a) on conditions requiring processors to report
Reporting on mixtures can be imposed only if necessary for effective enforcement of Act.
EPA is not requiring this.
Simple “Reasonableness” hurdle for processors to report a discrete chemical
Even if received as part of a mixture?
Also cannot be unnecessary or duplicative.
House Report states: “For instance, where information respecting the chemical identity and molecular structure of chemicals comprising a mixture is obtained from the manufacturers of the chemical components, it would be duplicative for the Administrator to require similar reporting from the mixture manufacturer, and should if feasible be avoided.” H.R. Rep. No

23. Implementation issues
Section 8(a) on testing
Information insofar as known to the person making the report or insofar as reasonable ascertainable
House Committee Report:
“Information should be considered reasonably ascertainable if the manufacturer or processor required to obtain the information can do so without incurring unreasonable costs or burdens.”
House Conference Report: H.R. Conf. Rep. No
“The conferees intend that the “reasonably ascertainable” standard be an objective, rather than subjective one. Thus, the manufacturer or processor must provide information of which a reasonable person similarly situated might be expected to have knowledge”

24. Summary for Discussion
Where Congress has clearly spoken:
Duplicative reporting to be avoided if feasible for processors
Statute is silent or ambiguous
Moratorium
On-going reporting
Required information illustrative
Discrete form
Unique and novel criteria
Seven standard deviations criteria
Language of rule clearly wrong, not effectuating stated intent of agency
When manufacture, import, or processing can commence after 135 day/30 day report is filed.

25. Deadline and resources
Stages/Multi-year process:
Initial complaint by March 27
Research in anticipation of negotiations/briefing
Negotiations with agency
Briefing
Settlement negotiations
Oral argument and beyond
Coalition building
Come into existence upon commitment by at least 15 entities
Initial payment of at least $5,000 to Wiley Rein
First year budget: $75,000 to research and negotiate with EPA, with understanding that budget would increase $125,000 annually if litigation goes forward

26. Other Options Negotiation and development of guidance
Final rule indicated will be issued June 2017.
On-going reporting will be effective by then (May 12).
Request delay in implementation date until guidance is available?
Letter to Administrator Pruitt requesting reconsideration
Precedent, uncertain timeline and outcome, new AA not in place, need to comply in the meantime.
Petition for rulemaking to rescind objectionable aspects of the rule
EPA is under no deadline to respond and could respond to the same requests in the same way it has to-date, need to comply in the meantime.

27. Questions and discussion