Confidential Business Information

The Toxic Substances Control Act (TSCA) refers to "new chemicals" as those not on the TSCA Inventory of Chemical Substances which lists about 55,000 existing commercial chemicals. All new chemicals must enter EPA s premanufacture notification program (PMN) for review before manufacture. This program is the most complete record of development of new chemicals by U.S. industry over the past 2 1/2 years. To date over 1,000 notices have been submitted, many including confidential business information (CBI). Despite the CBI, it is possible to summarize EPA s experience with new chemical substances and to evaluate the PMN program and its impact on product innovation. That is essentially the aim of this paper. 

As you heard this morning from several speakers, the premanufacture notification provision of TSCA has been in effect since July 1, 1979 and since then EPA has received over 1,000 notices of intent to manufacture and introduce new chemicals into U.S. commerce. This is the only complete and accurate record of the development and commercialization of new chemicals ever compiled and, as such, is a repository of a wealth of information. A major portion of it is classified by EPA as confidential business information - CBI in our lingo - and is closely protected against inadvertent disclosure. 

In addition, the requirements and policies concerning the handling and treatment of confidential business information (CBI) are and will continue to be an important topic of "harmonization" discussions. In a number of ways, different approaches to CBI (between the EEC and the U.S.) will directly affect the CBI protections available within each country(ies). This is particularly true concerning the effects that the disclosure of proprietary information in one country will have upon industry s ability to protect CBI from disclosure in other nations. 

Section 14 - outlines the responsibility of the Agency to protect trade secret and confidential business information it gathers in the process of implementing the Act. 

Reluctance to share trade secrets or confidential business information. 

The current annual production of di-ra-octylphthalate is difficult to estimate because of confusion in nomenclature regarding the octylphthalate isomers and reported data describing only the entire group of dioctyl orthophthalates. A total of 122,384 metric tons of total dioctylphthalates were produced in 1992 (USITC 1994). The amount of di-w-octylphthalate included in this group was not reported because of the possible revelation of confidential business information. 

Production, Use, Release, and Disposal. Production methods for 1,2-diphenylhydrazine are well described in the literature (including he patent literature) there does not appear to be a need for further information in this area. Uses of 1,2-diphenylhydrazine are documented but no recent production figures or detailed descriptions of uses are available. This information is useful for estimating the potential for environmental releases from manufacturing and use industries as well as the potential environmental burden, but it is difficult to obtain in the detail desired since it is considered confidential business information for those industries that manufacture... 

According to the 1997 Directoiy of Chemical Producers (SRI 1997), only one eompany, Lomac, Ine. of Muskegon, Michigan, manufactures (that is, produees) 3,3 -dichlorobenzidine. By contrast, in 1986, there were approximately 10 suppliers of the chemical listed in the United States (NTP 1994). Current production volmnes of 3,3 -dichlorobenzidine for individual companies are considered confidential business information and cannot be reported. The United States International Trade Commission (USITC 1984a) reported a 1983 production volume of 3,3 -dichlorobenzidine-based dyes of over 18 million pounds in the United States. However, 3,3 -dichlorobenzidine is no longer used to manufacture dyes in the United States (CPMA 1998). Consimiption of 3,3 -dichlorobenzidine in the United States amoimted to 9.9 million pounds in 1987 (Hopmeier 1988). 

A classification and labeling inventory of dangerous substances will help promote agreement within industry on classification of a substance. For some substances of high concern there may be a Community-wide harmonization of classification by the authorities. Access to information rules combines a system of publicly available information over the Internet, the current system of requests for access to information, and REACH specific rules on the protection of confidential business information. 

The results of clinical trials conducted under an IND have traditionally been regarded as confidential business information that FDA was prohibited from releasing to the public under the Freedom of Information Act and that the publication of which was determined solely by the drug sponsor. The Food and Drug Administration Modernization Act of 1997 established a clinical trial data bank for drugs for serious or life-threatening disease and required the inclusion of information on all effectiveness trials for these drugs. As a result of widespread concern about the lack of public availability of information about all clinical trials and their results, individual companies and the Pharmaceutical Research and Manufacturers of America have... 

In another example, in 2004 a judge ordered the USDA to identify the Hawaiian locations of four companies operating open air test sites for bio-pharmaceutical crops. The order had been earlier denied as it was considered to contain confidential business information protected from disclosure under federal law. Public disclosure could result in the destruction of the fields by anti-GM extremists. Vandalism such as this does little to protect the health of the public or the environment. Rather, it causes the dispersal of transgenic crops into the environment, thus creating the very harm feared by these adversaries (Jaffe, 2004a). 

Data obtained from the site visits were analyzed and detailed trip reports were written and reviewed by each affected company to verify technical data and remove confidential business information. The data from the trip reports, along with data from the literature search and air pollution control agencies, were compiled, summarized, and analyzed. These data were used as the basis of this report. 

When it comes to Confidential Business Information (CBI), REACH (Tide XII) contains several provisions granting rights to companies, including protection of information regarding the full composition of preparations, the precise use and tonnage of substances and links between companies (Article 118).20 On the other hand, Article 119 explicitly lists information that shall be made publicly available by electronic means, for instance names and classifications of substances and safety-related data, unless the submitter can justify not doing so. Additional information from companies can also be made available upon request (see further in EDF 2007a). 

The REACH legal text includes several mechanisms to ensure that confidential business information and other proprietary data are not disclosed. 

Systems adopting the GHS should consider what provisions may be appropriate for the protection of confidential business information (CBI). Such provisions should not compromise the health and safety of workers or consumers, or the protection of the environment. As with other parts of the GHS, the rules of the importing country should apply with respect to CBI claims for imported substances and mixtures. 

Where a system chooses to provide for protection of confidential business information, competent authorities should establish appropriate mechanisms, in accordance with national law and practice, and consider ... 

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