1 

### Njo, Heather

From: Schaeffer, John Sent: Wednesday, February 19, 2014 6:59 AM To: shaun.clancy@evonik.com Cc: Lewis, Paul; Mattheisen, Mike; Njo, Heather; Bernot a, Carolyn Subject: RE: Response to January 28, 2014 Test Rule letter

Dear Mr. Clancy,

This is in response to your email from Evonik Degus sa Corporation (Evonik) dated February 11, 2014, wi th the subject line “Response to January 28, 2014 Test Rule letter .” The email states that “Evonik believed it did no t have to take any

immediate action under the Test Rule because it con siders itself a Tier 2 person as described in Table 1 of the Test Rule. .... Specifically, persons who manufacture a Test Rul e substance solely for use "As a compo nent of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i))" are considere d Tier 2 persons.” (A Class 2 substance is defined in 40 CFR 720.45(a)(1)(i) as a “chemical substance that canno t be fully represented by a complete, specific chem ical structure diagram.”)

This statement in Evonik’s email is not accurate, h owever. Rather, the test rule states, in relevant p art, that Tier 2 includes “[p]ersons who manufacture ... a test rule s ubstance solely as ... a component of a Class 2 subst ance.” 76 FR 1067, Jan. 7, 2011. Thus, the chemical must be manu factured as a component of a Class 2 substance, not for use as a Class 2 substance. The distinction may be meaningfu l to your analysis.

Evonik’s reporting of CASRN 89-32-7 to the 2012 CD R indicates that Evonik is actually making CASRN 8 9-32-7, not a class 2 substance containing CASRN 89-32-7. However, should Evonik decide upon reconsideration that it still thinks it is not subject to the test rule, the proper response w ould be a letter signed by an authorized Evonik off icial stating, completely and with specificity, the reasons why Ev onik is not subject to the test rule.

As stated previously, Evonik is listed in the 2012 Chemical Data Reporting (CDR) database managed by t he U.S. Environmental Protection Agency (EPA) as an importe r or manufacturer (Tier 1) of 1H,3H-Benzo[1,2-c:4,5 -c']difuran1,3,5,7-tetrone (CASRN 89-32-7), which indicates th at Evonik is subject to the test rule and, to date, EPA has not

received either the letter-of-intent-to-test or the exemption application required by the test rule so me time ago. If Evonik believes that the 2012 CDR listing is an err or, it should amend its CDR filing. (Questions conc erning the CDR, should be directed to Ellie Clark at (202) 564-2962 or clark.ellie@epa.gov

.

If EPA does not receive a letter-of-intent-to-test, an exemption application, or a letter stating the reasons why Evonik is not subject to the test rule by March 31, 2014, EPA may take appropriate enforcement action.

Best regards,

John

John Schaeffer Senior Biologist USEPA/OPPT/CCD/CITB 1201 Constitution Ave, NW Washington, DC 20460 Mail Code: 7405M Phone: 202-564-8173

From: shaun.clancy@evonik.com [ mailto:shaun.clancy@evonik.com ]
Sent: Tuesday, February 11, 2014 10:26 AM2 To: Lewis, Paul
Cc: lee.braem@evonik.com ; Schaeffer, John Subject: Response to January 28, 2014 Test Rule letter

Dear Dr. Lewis,

Evonik received a letter from you dated January 28, 2014 pertaining to a potential failure to comply w ith a TSCA Section 4 test rule for a chemical referred to as P MDA (CAS RN 89-32-7). A copy of the letter is atta ched.

The letter notes that Evonik reported production of PMDA in 2011 in its 2012 submission under the Chem ical Data Reporting rule but is not participating in the PMDA HPV Consortium managed by the American Chemistry C ouncil. As stated below, we believe we are a Tier 2 person tha t qualifies for an automatic conditional exemption from the Test Rule.

Evonik believed it did not have to take any immedia te action under the Test Rule because it considers itself a Tier 2 person as described in Table 1 of the Test Rule. M anufacturers in Tier 2 do not have an immediate nee d to comply with the Rule. Specifically, persons who manufacture a Test Rule s ubstance solely for use "As a component of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i))" are considered Tier 2 persons. In Note 3 in Table 1, i t is stated that "Persons in Tier 2....are considered to have an aut omatic conditional exemption and you will be requir ed to comply only if directed to do so by EPA..." We saw nothin g else in the Rule that affirmatively required Evon ik or any Tier 2 person to submit an application for the exemption o r to notify EPA about use of the exemption. As the Rule says, the exemption for a Tier 2 person is "automatic". We a lso have not received any communications from EPA d irecting us to comply with the Test Rule at a Tier 2 level.

We will appreciate your concurrence with this reaso ning and written confirmation.

Thank you for your consideration of this explanatio n and we look forward to hearing from you.

Best regards,

Shaun

Shaun F. Clancy, Ph.D. Director and Regional Head Product Regulatory Services Phone +1 973 929 8047 Fax +1 973 929 8040 shaun.clancy@evonik.com

Evonik Corporation 299 Jefferson Road Parsippany, NJ 07054-2827, USA http://www.evonik.com http://www.evonik.com/northamerica

This message and any attachments are the property o f Evonik Industries and its subsidiaries, are confi dential, and may be privileged or otherwise protect ed from disclosure. This message is intended solely f or the use of the addressee. If you receive this e -mail in error, please telephone or e-mail the send er and delete this message and any attachments from your s ystem. If you are not the intended recipient you a re strictly prohibited from disclosing, copying, distributing or using any of this information.