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; Bernota, Carolyn

Subject: RE: Response to January 28, 2014 Test Rule letter

Dear Mr. Clancy, 

This is in response to your email from Evonik Degussa Corporation (Evonik) dated February 11, 2014, with the subject 

line “Response to January 28, 2014 Test Rule letter.” The email states that “Evonik believed it did not have to take any 

immediate action under the Test Rule because it considers itself a Tier 2 person as described in Table 1 of the Test Rule. 

.... Specifically, persons who manufacture a Test Rule substance 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.” (A Class 2 substance is defined in 40 CFR 

720.45(a)(1)(i) as a “chemical substance that cannot be fully represented by a complete, specific chemical structure 

diagram.”) 

This statement in Evonik’s email is not accurate, however. Rather, the test rule states, in relevant part, that Tier 2 

includes “[p]ersons who manufacture ... a test rule substance solely as ... a component of a Class 2 substance.” 76 FR 

1067, Jan. 7, 2011. Thus, the chemical must be manufactured as a component of a Class 2 substance, not for use as a 

Class 2 substance. The distinction may be meaningful to your analysis. 

Evonik’s reporting of CASRN 89-32-7 to the 2012 CDR indicates that Evonik is actually making CASRN 89-32-7, 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 would be a letter signed by an authorized Evonik official stating, 

completely and with specificity, the reasons why Evonik is not subject to the test rule. 

As stated previously, Evonik is listed in the 2012 Chemical Data Reporting (CDR) database managed by the U.S. 

Environmental Protection Agency (EPA) as an importer 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 that 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 some time ago. If 

Evonik believes that the 2012 CDR listing is an error, it should amend its CDR filing. (Questions concerning 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 AM 
2

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 with a TSCA 

Section 4 test rule for a chemical referred to as PMDA (CAS RN 89-32-7). A copy of the letter is attached. 

The letter notes that Evonik reported production of PMDA in 2011 in its 2012 submission under the Chemical Data 

Reporting rule but is not participating in the PMDA HPV Consortium managed by the American Chemistry Council. As 

stated below, we believe we are a Tier 2 person that qualifies for an automatic conditional exemption from the Test 

Rule. 

Evonik believed it did not have to take any immediate action under the Test Rule because it considers itself a Tier 2 

person as described in Table 1 of the Test Rule. Manufacturers in Tier 2 do not have an immediate need to comply 

with the Rule. Specifically, persons who manufacture a Test Rule substance 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, it is stated that 

"Persons in Tier 2....are considered to have an automatic conditional exemption and you will be required to comply 

only if directed to do so by EPA..." We saw nothing else in the Rule that affirmatively required Evonik or any Tier 2 

person to submit an application for the exemption or to notify EPA about use of the exemption. As the Rule says, the 

exemption for a Tier 2 person is "automatic". We also have not received any communications from EPA directing us to 

comply with the Test Rule at a Tier 2 level. 

We will appreciate your concurrence with this reasoning and written confirmation. 

Thank you for your consideration of this explanation 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 

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