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 

R E ~~iV E 0 

OPP lCBIC 

2012 FEB -1 AM 10 : 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 CFR 799.5089 

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 NO CEI~ ~ 
p. 2 

CONTAINS NO CONFIDENTIAL 

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 Consortium files 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. 

Greenchem Industries 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 NO CONFIDENTIAL 

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 OECD guidelines. 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 ASTM standards 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 from the 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, ASTM E 1218-04" references 11 other ASTM standards . 

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 NO CONFIDENTIAL 

BUSINESS INFORMATION 

U.S . Environmental Protection Agency 

January 31, 2012 

Page 4 

* 

The PCBTF Testing Consortium thanks 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 

Palm Beach 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 
FedEx Ship Manager API Label Page 

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JOHN V. MASSINGALE 

GREENWICH CHEMICAL CONSULTING, INC. 

3300 PGA BLVD 

SUITE 635 

PALM BEACH GARDENS, FL 33410 

® 

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