UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, 0 C 20460 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SEP 2 4 2013 

Mr. Michael S. Williams 

Chief Operation Officer 

Peach State Labs, Inc. 

P.O. Box 1087 

Rome, Georgia 30162 

Re: Test Requirements for 2-Butenedioic acid (2Eh di-C8-18-alkyl esters 

(CASRN 68610-90-2) 

Dear Mr. Williams: 

This responds to your letters both dated May 30, 2013, applying for an exemption 

from, and requesting that EPA revoke, the test requirements for 2-Butenedioic acid (2E)-, 

di-C8-18-alkyl esters (CASRN 6861 0-90-2) in a test rule that EPA issued under section 4 

of the Toxic Substances Control Act (TSCA) on October 21,2011 (76 FR 65385). As 

explained below, EPA is denying Peach State Labs' request to revoke the test 

requirements, but granting its request for an exemption, because another company has 

agreed to provide the test data. 

When EPA proposed the test rule on February 25, 2010, (75 FR 8575) and issued 

the test rule in October 201 1, it used the best information available at the time and found 

that 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters met the requirements for testing 

under TSCA section 4(a)(l)(B). TSCA section 4(a)(l)(B) requires EPA to show, among 

other things, that a chemical substance or mixture is produced or imported in substantial 

quantities and that it either enters the environment in substantial quantities or that there is 

substantial or significant human exposure. EPA's "B" policy for making § 4(a)(l)(B) 

findings (58 FR 28736; May 14, 1993) sets default values of substantial production as 

more than one million pounds per year and substantial human exposure as more than one 

thousand workers, or more than ten thousand consumers, or a general population of more 

than one hundred thousand people. EPA's substantial production finding was based on 

the 2006 Inventory Update Reporting (IUR) rule and its exposure finding on a TSCA 

section 8(a) Preliminary Assessment Information Rule (PAIR). EPA received no 

comments concerning its findings for this chemical from any chemical manufacturer 

during the sixty day public comment period provided by the proposed test rule. 

Internet Address (URL) · http //www epa gov 

Recycled/Recyclable • Pnnted w•th Vegetable 0•1 Based Inks on 100% Postconsumer Process Chlonne Free Recycled Paper 
Exemptions from test requirements in TSCA section 4 test rules are evaluated 

under the Procedures Governing Testing Consent Agreements and Test Rules (40 CPR 

part 790), which provide for exemptions from test rules ( 40 CFR part 790, subpart E) on 

the basis of data adequacy (i.e., data fulfilling the required testing endpoints is, or will 

become available, through testing under the test rule by another test sponsor). 40 CFR § 

790.87. 

The exemption application that Peach State Labs, Inc., submitted meets the 

exemption requirements in 40 CFR part 790. Specifically, BASF, Inc., has indicated that 

it will provide the required test data for this chemical and the exemption application that 

Peach State Labs, Inc. has submitted includes the required language regarding cost 

sharing (see, 40 CFR 790.99). 

Accordingly, EPA will not revoke the test requirements in the test rule, but will 

grant the exemption requested by Peach State Labs, Inc. The exemption is conditioned on 

EPA receiving acceptable test data from BASF (or elsewhere) that is adequate to fulfill 

the test requirements in the test rule. 

If you have any questions about this letter, please contact John Schaeffer of my 

staff (schae!Ier.jo1m@epa.gov; 202-564-8173). 

Cc: DocketEPA-HQ-OPPT-2009-0112 

Sincerely, 

Po<J~ Paul Lewis, Ph.D. 

Chief 

Chemical Information and 

Testing Branch (MC 7405M)