# BEVERIDGE~

&DIAMONDpcT Karen M. Hansen 1350 IStreet, NW.

Suite 700 Washington, D.C. 20005-3311 Direct: (202) 789-6056 Fax: (202) 789-6190 khansen@bdlaw.com
July 20, 2009

Via Electronic and U.S. Mail Joan Harrigan Farrelly Director, Antimicrobials Division Office of Pesticide Programs U.S. Environmental Protection Agency Mail Code 7510P Washington, D.C. 20460
Mr. Philip J. Ross U.S. Environmental Protection Agency Office of General Counsel Pesticides and Toxic Substances Law Office Ariel Rios North 1200 Pennsylvania Ave., N.W Washington, D.C. 20460 Re: Nalco's Request for Confidential Business Information Contained in Ashland's June 30, 2009 Submittal to EPA

Washington, D.C. Maryland New York Massachusetts New Jersey Texas California Dear Ms. Harrigan-Farrelly and Mr. Ross: Ashland, Inc. (Ashland) hereby responds to Nalco, Inc. 's (Nalco's) July 17,2009 letter requesting an unredacted copy of Ashland's June 30, 2009 submission to EPA. As explained therein, Ashland's submission contains Confidential Business Information (CBI) consisting of a proprietary scientific analysis of urea-sodium hypochlorite chemistry. Ashland undertook this proprietary analysis solely and independently at its own expense for its own business purposes. Ashland voluntarily submitted this information to EPA to aid the Agency in its regulatory functions. As explained herein, this CBI is fully protected by law from disclosure to third parties, including Nalco and Buckman Laboratories, the other party in interest in the issues pending before EPA. As such, EPA is prohibited from disclosing Ashland's CBI material and therefore must deny Nalco's request. The CBI material contained in Ashland's June 30 submission represents Ashland's independent analysis of urea-sodium hypochlorite chemistry, including the biocidal properties and harmful byproducts of this chemical formulation. This scientific information is confidential and proprietary to Ashland, which has expended significant resources to date to develop this 

# BEVERIDGE~ &DIAMONDpcT Karen M. Hansen 1350 I Street. N.W. Suite 700 Washington, D.C. 20005-3311

Direct: (202) 789-6056 Fax: (202) 789-6190 khansen@bdlaw.com 

### July 20, 2009


### Via Electronic and U,S. Mail Joan Harrigan Farrelly 

### Director, Antimicrobials Division Office of Pesticide Programs 

### U.S. Environmental Protection Agency
Mail Code 751 OP 

### Washington, D.C. 20460 Mr. Philip 1. Ross U.S. Environmental Protection Agency 

### Office of General Counsel 

### Pesticides and Toxic Substances Law Office Ariel Rios North 1200 Pennsylvania Ave., N.W 

### Washington, D.C. 20460 Re: Na1co's Request for Confidential Business Information Contained in Ashland's 

### June 30, 2009 Submittal to EPA

Dear Ms. Harrigan-Farrelly and Mr. Ross: Ashland, Inc. (Ashland) hereby responds to Na1co, Inc.'s (Na1co's) July 17,2009 letter 

### requesting an unredacted copy of Ashland's June 30, 2009 submission to EPA. As explained therein, Ashland's submission contains Confidential Business Information (CBI) consisting of a 

### proprietary scientific analysis of urea-sodium hypochlorite chemistry. Ashland undertook this proprietary analysis solely and independently at its own expense for its own business purposes. 

### Ashland voluntarily submitted this information to EPA to aid the Agency in its regulatory 

### functions. As explained herein, this CBI is fully protected by law from disclosure to third parties, including Na1co and Buckman Laboratories, the other party in interest in the issues pending before EPA. As such, EPA is prohibited from disclosing Ashland's CBI material and 

### therefore must deny Na1co's request. 

### The CBI material contained in Ashland's June 30 submission represents Ashland's

independent analysis of 

### urea-sodium hypochlorite chemistry, including the biocidal properties 

### and harmful byproducts of this chemical formulation. This scientific information is confidential and proprietary to Ashland, which has expended significant resources to date to develop this

Washington, D.C. Maryland New York Massachusetts New Jersey Texas California

## BEVERIDGE&DIAMONDrc

CBI. Ashland has also filed a patent application for certain urea-sodium hypochlorite products based on this proprietary analysis. Ashland's CBI material falls well within the FOIA exemption for non-public information. See FOIA Exemption 4,5 U.S.C. § 552(b)(4) (protecting trade secrets and commercial or financial information obtained from a person and privileged or confidential). Any release of Ashland's CBI by EPA would "be likely to result in substantial harmful effects on [Ashland's] competitive position." 40 CFR § 2.204(e)(4)(viii). Thus, pursuant to FOIA, EPA is obligated to maintain the protections afforded CBI material and may not release Ashland's CBI material to any third party. In addition, EPA has a non-discretionary duty under FIFRA to protect from public disclosure information submitted by Ashland to EPA that contains or relates to Ashland's trade secrets or other proprietary commercial information. Specifically, FIFRA broadly prohibits EPA from disclosing information which "contains or relates to trade secrets or commercial or financial information obtained from a person and privileged or confidential." FIFRA § lOtb), 7 U.S.C. § 136h(b). In addition to this complete bar, FIFRA also protects Ashland's proprietary information in the event Ashland were to file this information with EPA in support of a new pesticide registration. FIFRA §lO(a-b), 7 U.S.c. §136h(a-b). Nalco's request is particularly ironic since Nalco has avoided registering its urea-based product or, apparently, even discussing it with EPA. Thus, Nalco's request to freely obtain Ashland's CBI from EPA merely highlights their outstanding regulatory obligations to provide information to the Agency. Nalco bears sole responsibility for identifying the chemistry of and demonstrating to EPA the safety of its urea-based product through the submission of, inter alia, "a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use," "the complete formula of the pesticide," and "a full description of the tests made and the results thereof upon which the claims are based ... ." FIFRA § 3(c)(1)(C), (D), (F). Nalco has no right to obtain this information from Ashland via EPA. Its request for this information in light of its own failure to provide basic information about its product to EPA is not only contrary to law, but also patently unreasonable.'

Page 2 EPA should not countenance any complaints from Nalco that it cannot respond toAshland's June 30 submission without the CBI. That is nonsense. IfNalco is marketing a ureahypochlorite product that it believes is not biocidal, it should prove that to EPA with its own independent analysis and data. Indeed, since Nalco is already marketing its urea-based product

!The complete bar on sharing Ashland's CBI material with Nalco is further dictated by FIFRA § 10(g)(1), which prohibits EPA's disclosure of information submitted under FIFRA to any employee or agent of any business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United States or in addition to the United States. Ashland's proprietary information is also protected by state law, and EPA is further prohibited from disclosing this information except as expressly authorized under FIFRA. See Uniroyal v. Drexel, 931 F. Supp. 132, 137-39 (D. Conn. 1996) (recognizing that data submitters retain state law property rights in the data they submit to EPA under FIFRA). 

### BEVERIDGE&DIAMONDpc

CBI. Ashland has also filed a patent application for certain urea-sodium hypochlorite products based on this proprietary analysis. Ashland's CBI material falls well within the FOIA exemption 

### for non-public information. See FOIA Exemption 4,5 U.S.C. § 552(b)(4) (protecting trade secrets and commercial or financial information obtained from a person and privileged or 

### confidential). Any release of Ashland's CBI by EPA would "be likely to result in substantial 

### harmful effects on (Ashland's) competitive position." 40 CFR § 2.204(e)(4)(viii). Thus, pursuant to FOIA, EPA is obligated to maintain the protections afforded CBI material and may not release Ashland's CBI material to any third party. 

### In addition, EPA has a non-discretionary duty under FIFRA to protect from public disclosure information submitted by Ashland to EPA that contains or relates to Ashland's trade 

### secrets or other proprietary commercial information. Specifically, FIFRA broadly prohibits EPA from disclosing information which "contains or relates to trade secrets or commercial or financial information obtained from a person and privileged or confidentiaL." FIFRA § 1 O(b), 7 

### U.S.C. § 136h(b). In addition to this complete bar, FIFRA also protects Ashland's proprietary information in the event Ashland were to file this information with EPA in support of a new
pesticide registration. FIFRA § 1 O(a-b), 7 U.S.c. § 136h(a-b). 

### Nalco's request is particularly ironic since Na1co has avoided registering its urea-based 

### product or, apparently, even discussing it with EPA. Thus, Nalco's request to freely obtain Ashland's CBI from EPA merely highlights their outstanding regulatory obligations to provide information to the Agency. Na1co bears sole responsibility for identifying the chemistry of and 

### demonstrating to EPA the safety of its urea-based product through the submission of, inter alia,

"a complete copy of the labeling of 

### the pesticide, a statement of all claims to be made for it, and 

### any directions for its use," "the complete formula of the pesticide," and "a full description of the

tests made and the results thereof 

### upon which the claims are based. . . ." FIFRA § 3(c)(l)(C), (D), (F). Nalco has no right to obtain this information from Ashland via EPA. Its request for this information in light of its own failure to provide basic information about its product to EPA is not only contrary to law, but also patently unreasonable.) 

### EPA should not countenance any complaints from Nalco that it cannot respond to

### Ashland's June 30 submission without the CBI. That is nonsense. IfNalco is marketing a ureahypochlorite product that it believes is not biocidal, it should prove that to EPA with its own independent analysis and data. Indeed, since Na1co is already marketing its urea-based product


### ) The complete bar on sharing Ashland's CBI material with Nalco is further dictated by

FIFRA § 10(g)(l), which prohibits EPA's disclosure of 

### information submitted under FIFRA to 

### any employee or agent of any business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United States or in addition to the United 

### States. Ashland's proprietary information is also protected by state law, and EPA is further prohibited from disclosing this information except as expressly authorized under FIFRA. See Uniroyal v. Drexel, 931 F. Supp. 132, 137-39 (D. Conn. 1996) (recognizing that data submitters 

### retain state law property rights in the data they submit to EPA under FIFRA).

Page 2

## BEVERIDGE&DIAMONDpc

without FIFRA registration, Nalco should currently have information demonstrating its evaluation of and conclusions regarding its product. IfNalco's urea-hypochlorite product is a biocide, as Ashland has asserted, then the CBI developed by Ashland represents a portion of the scientific work that Nalco itself would be required to conduct in order to support FIFRA registration of its product. In either scenario, any release of Ashland's information could be easily appropriated by Nalco, a direct competitor of Ashland, for its own commercial purposes. As described in Ashland's June 30 submission, Nalco is already enjoying significant economic benefits and commercial advantages in the market place from its noncompliant activities, including avoidance of the cost of rigorous scientific review required for FIFRA registration. EPA must require N alco to submit its own data in support of the registration or exemption of its products under FIFRA. IfNalco has a good scientific and factual understanding of its urea-based product, then it should be able to explain its position to EPA regardless of Ashland's proprietary analysis. I

# I.

For all of these reasons, EPA should deny N alco' s request for an umedacted version of Ashland's June 30 submission. Ashland's CBI materials are fully protected from disclosure by law, and in any event, have no bearing on Nalco's ability to respond to Ashland's submission. To the contrary, ifNalco had complied with rather than avoided altogether FIFRA's basic registration requirements, it would have already developed and provided EPA with information needed to assure the safe and effective use of its urea-based product. Ashland reserves all rights under FIFRA, FOIA, the Administrative Procedure Act (APA) and state law, under all of which authorities Ashland objects to EPA allowing any third party access to the information redacted as CBI from Ashland's June 30 submission. Ashland specifically reserves its rights to challenge any EPA intention to release Ashland's CBI material prior to such action being taken. As noted above, Nalco's request is without merit and EPA should simply reject it. Nevertheless, we understand that EPA will comply with its procedural obligations under 40 C.F.R. §§ 2.204(d), 2.205(£)(2), and 2.307(e)(3) if the Agency decides to consider Nalco's request. 

# Be?r:'M~

Karen M. Hansen Thank you and please contact me if you have any questions.

cc: Michael Boucher, Esq. Cynthia Taub, Esq. Kristina Woods, Esq.

Page 3 

## BEVERIGE&DIAMONDpc

without FIFRA registration, Na1co should currently have information demonstrating its 

### evaluation of and conclusions regarding its product. IfNalco's urea-hypochlorite product is a

biocide, as Ashland has asserted, then the CBI developed by Ashland represents a portion of 

### the

scientific work that Na1co itself 

### would be required to conduct in order to support FIFRA 

### registration of its product. In either scenario, any release of Ashland's information could be easily appropriated by Na1co, a direct competitor of Ashland, for its own commercial purposes. As described in Ashland's June 30 submission, Na1co is already enjoying significant economic 

### benefits and commercial advantages in the market place from its noncompliant activities, including avoidance of the cost of rigorous scientific review required for FIFRA registration. EP A must require N a1co to submit its own data in support of the registration or exemption of its 

### products under FIFRA. IfNa1co has a good scientific and factual understanding of its urea-based product, then it should be able to explain its position to EPA regardless of Ashland's proprietary 

### analysis. 

### F or all of these reasons, EPA should deny N a1co' s request for an unredacted version of Ashland's June 30 submission. Ashland's CBI materials are fully protected from disclosure by 

### law, and in any event, have no bearing on Nalco's ability to respond to Ashland's submission. 

### To the contrary, ifNa1co had complied with rather than avoided altogether FIFRA's basic registration requirements, it would have already developed and provided EPA with information needed to assure the safe and effective use of its urea-based product. Ashland reserves all rights under FIFRA, FOIA, the Administrative Procedure Act (APA)

and state law, under all of 

### which authorities Ashland objects to EPA allowing any third party 

### access to the information redacted as CBI from Ashland's June 30 submission. Ashland specifically reserves its rights to challenge any EPA intention to release Ashland's CBI material 

### prior to such action being taken. As noted above, Na1co's request is without merit and EPA 

### should simply reject it. Nevertheless, we understand that EPA wil comply with its procedural

obligations under 40 C.F.R. §§ 2.204(d), 2.205(£)(2), and 2.307(e)(3) if 

### the Agency decides to 

### consider Nalco's request. 

### Thank you and please contact me if you have any questions.



# Beir:'tUL

Karen M. Hansen

cc: Michael Boucher, Esq.

Cynthia Taub, Esq. 

### Kristina Woods, Esq.

Page 3