# 3q1*379

GREENWICH CHEMICAL CONSULTING, INC . 00 PGA BOULEVARD m SUITE 635 PALM BEACH GARDENS, FL 33410

TELEPHONE 561 .578 .8110 

# FACSIMILE 561 .578 .8120 

# January 31, 2012 p. 1

RE ~~iV E 0 OPPlCBIC 

# 2012 FEB -1 AM10: 44

CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION By Federal Express



# OPPT Document Control Office EPA East Building Room E6428 U.S . Environmental Protection Agency 1201 Constitution Ave., NW Washington, DC 20004

Re: 

# ~GNIIVYI~I~III~IIMMhIIIIIK41,lIMIBV

Attention: Docket ID Number : EPA-HQ-OPPT-2009-0112

40 CFR 799.5089 Request for Modification of Test Standards for Testing Conducted by the PCBTF Testing Consortium under the TSCA Section 4 Test Rule on the Testing of Certain High Production Volume Chemicals; Third Group Benzene, 1-chloro-4-(trifluoromethyl)- CAS RN 98-5G-G (para-Chlorobenzotrifluoride (PCBTF)) 

# Docket ID Number : EPA-HQ-OPPT-2009-0112 40 CFR799.5089

Dear Sir/Madam

: 

# Through this letter, the PCBTF Testing Consortium submits to the U.S . Environmental Protection Agency (EPA or the Agency) a request for the modification of test standards for studies conducted on the chemical substance, benzene, 1-chloro-4-(trifluoromethyl)- [CAS



# ~ CONTAINS NOCEI~

# p. 2 CONTAINS NOCONFIDENTIAL BUSINESS INFORMATION U.S. Environmental Protection Agency January 31, 2012 Page 2 

# RN 98-56-6] which is currently subject to a Toxic Substances Control Act (TSCA) Section 4 test rule.' For purposes of this letter, the chemical substance, benzene, 1-chloro-4- (trifluoromethyl)-, is herein referred to as, PCBTF. The PCBTF Testing Consortiumfiles this request in accordance with this test rule and the regulations set forth at 40 CFR 790.55. 1 . General Background Greenwich Chemical Consulting, Inc. (Greenwich Chemical Consulting) functions and operates as the panel manager for and authorized representative of the PCBTF Testing Consortium

. Therefore, Greenwich Chemical Consulting submits this letter on behalf of the PCBTF Testing Consortium's ten (10) member companies identified below :

.

.

. Brenntag North America, Inc. Chemsynergy, Inc. EMCO Chemical Distributors, Inc. GreenchemIndustries LLC Kowa American Corporation Makhteshim

Agan of North America, Inc. MC International, LLCZ Silver Fern Chemical, Inc. Special Materials Company Univar USA, Inc. This final test rule addresses 15 high production volume (HPV) chemicals that went unsponsored under the Agency's voluntary HPV Chemical Challenge Program . One of the 15 chemicals identified in the rule is PCBTF . The Agency has issued this test rule under its TSCA Section 4(a)(1)(B) authority based on its belief that HPV compounds, including PCBTF, are "produced in substantial quantities; there is or may be substantial human exposure to them

; existing data are insufficient to determine or predict their health and environmental effects ; and testing is necessary to develop such data ."' The final rule identifies the following two studies on PCBTF: " Ready Biodegradation4 " Aquatic Toxicity Testing: toxicity to plants (algae)) [ASTM E 1218-04"]

' 76 Fed. RePe. 65385; October 21, 2011 . 2 It is noted that NIC International, LLC operates the entity, Miami Chemical, Inc ., as a DBA . For purposes of U.S. Customs and TSCA, N1C International, LLC is the importer. 

# 3 76 Fed . Ree . at 65387. 4 The test rule identifies six ISO protocols and one AST:%1 standard for biodegradation testing. The protocol selection depends on the test substance's physical and chemical properties .

# p. 3 CONTAINS NOCONFIDENTIAL BUSINESS INFORMATION U.S. Environmental Protection Agency January 31, 2012 

# Page 3 II . Request for the Use of OECD Test Guidelines 

# The PCBTF Testing Consortium has selected CiToxLAB Hungary (CiToxLAB) to conduct these two tests, and the laboratory is able to conduct these studies at a single location. The biodegradation test identifies ISO and ASTM standards and the algae study calls for the use of an ASTM

standard. Because of the validation, widespread use, and broad acceptance of Organization for Economic Cooperation and Development ,OECD, test guidelines, as well as the near equivalency among the OECD, ASTM, ISO, and CFR protocols . the PCBTF Testing Consortium requests that EPA permit the PCBTF Testing Consortium's lab, CiToxLAB, to perform both studies under the corresponding OECDguidelines. Specifically, we request that the testing be performed under the OECD test guidelines listed below . " Ready Biodegradation [OECD 301D] " Aquatic Toxicity Testing: toxicity to plants (algae) [OECD 201]5 One significant benefit in permitting CiToxLAB to utilize the OECD protocols for this testing is that it will allow for more straightforward and expedient development of the data. Because it has significant experience and familiarity with the OECD test guidelines, CiToxLAB can begin testing immediately. Alternatively, the required use of the ASTM standards would delay the development of the test data .` In addition, CiToxLAB, along with a second lab contacted by the PCBTF Testing Consortium for cost estimates, was not familiar with the ASTM standards that EPA identifies in this and other recent TSCA Section 4 HPV rulemakings. Indeed, neither of these labs was familiar with or had experience with the ASTMstandards and both were surprised to learn that EPA was requiring their use in lieu of EPA's own Harmonized Test Guidelines or OECD guidelines .' Also, the use of familiar OECD protocols decreases the chances for errors due to inadvertent deviations fromthe guidelines. Presumably, the Agency intends to eventually submit these data as part of dossiers under the international OECD HPV SIDS Program . The development of data on PCBTF, under the internationally adopted and accepted OECD guidelines, would facilitate the Agency's efforts at the OECD level . It is also noted that the ASTM standard for the algae test internally references other ASTM standards which either must or should be observed. This adds to the complexity and duration of testing. Specifically, ASTME 1218-04" references 11 other ASTMstandards . Conversely, it is notable that this ASTM standard does not reference either the OECD guidelines or EPA's Harmonized Test Guidelines. 5 Harmonized with EPA's guidelines under OPPTS 850 .5400 and 40 CFR 797.1050 . 6 The labs contacted by the PCBTF Testing Consortium have advised that because of the additional time involved, the costs of performing tests under the ISO and ASTM standards is expected to be 20% to 30% higher. 7 See EPA's Harmonized Test Guidelines at : htrp :%%x1~TNv.cpa .govocspp/nubs'frs/liomc%gludclin .htm .

# p. 4 CONTAINS NOCONFIDENTIAL BUSINESS INFORMATION U.S. Environmental Protection Agency January 31, 2012 Page 4 * 

# The PCBTF Testing Consortiumthanks the Agency for its consideration in this matter . For all questions, comments, and determinations concerning this matter, please use the contact information given below . Mr . John V

. Massingale Greenwich Chemical Consulting, Inc. 3300 PGA Boulevard, Suite 635 PalmBeach Gardens, FL 33410 Telephone: (561) 578-8110 Facsimile: (561) 578-8120 E-mail : john c~grcci .com Sincerely, John V . Massingale Principal

cc: Dr . P. Campanella - EPA PCBTF Testing Consortium

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