EU Court Orders Disclosure of Proprietary Information on Chemical Substance; May Impact Disclosure Laws Abroad

by K&L Gates LLP
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The General Court of the European Union (EU) recently delivered a judgment requiring the disclosure of proprietary information related to a pesticide ingredient. The Court’s decision may affect companies that have previously provided proprietary information on chemicals to EU regulators with the expectation it would be protected from public disclosure. [1] The judgment may signal an expanded interpretation of EU disclosure requirements and an erosion of laws protecting proprietary information, and has the potential to impact legislative and policy developments in the United States and in other jurisdictions.

EU Regulation 1049/2001 and “emissions into the environment”
EU Regulation 1049/2001 requires EU institutions and agencies to disclose documents held by them to any EU citizen, resident or company on request, subject to certain exceptions. [2] For example, a request must be refused if the disclosure would undermine the protection of the commercial interests of a person or company, including intellectual property. However, under EU Regulation 1367/2006, that exception does not apply where there is an overriding public interest in disclosure of the information; an overriding public interest is deemed to exist if the information requested relates to “emissions into the environment.” [3]

Greenpeace and the Pesticide Action Network requested information from the European Commission relating to the identity and quantity of impurities present in glyphosate (N-(phosphonomethyl) glycine, an active substance in widely-used, broad-spectrum pesticides); the analytical profile of the batches, in particular their composition; the “identity” and quantity of chemical substances added during the tests; the duration of those tests; and the actual effects on the active substance. That information had been provided to the Commission in the context of authorization of glyphosate as an active substance for pesticides under Directive 91/414 on plant protection products.

The judgment of the Court focuses on the single issue of whether the information requested related in a sufficiently direct manner to emissions into the environment, in which case disclosure is mandatory, notwithstanding the proprietary nature or commercial interest in nondisclosure.

The EU Commission initially concluded that the information requested by Greenpeace and the Pesticide Action Network was protected from public disclosure. The General Court disagreed. In its judgment annulling the Commission’s decision, the General Court ruled that since the active substance will be included in a pesticide that will ultimately be released into the air, principally by spraying, the following information related, in a sufficiently direct manner, to emissions into the environment:

  • the “identity” and the quantity of each impurity contained in the active substance;
  • the quantity of all the impurities present in the various lots and the minimum, median and maximum quantity of each of those impurities;
  • the exact quantities, per kilogramme or per litre, of the active substance and of adjuvants used in their manufacture.

In contrast, the Court found that the methods of analysis and validation of the data provided to establish the analytical profile of batches did not constitute information relating to emissions into the environment, since it did not appear to allow the determination, in a sufficiently direct manner, of the level of emission into the environment of the various components of the active substance.

This judgment is significant for companies that have submitted data to EU regulatory agencies with the expectation that the information would be protected against public disclosure in order to maintain the submitter’s commercial interests. Where such data relates in a sufficiently direct manner to emissions into the environment, the agency will have to disclose it on request. According to the Court, the phrase information relating to emissions into the environment is to be interpreted broadly, based on “an overriding public interest” in the disclosure of such information. [4]

U.S. implications
This judgment parallels emerging policies of the U.S. Environmental Protection Agency (U.S. EPA) favoring increased public disclosure of information and efforts to narrow the type of information considered “confidential business information” (CBI) and thereby protected from public disclosure.

Under the Toxic Substances Control Act (TSCA), companies are currently required to provide notice to the government if they obtain information “which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment.” [5] However, the identity of the chemical and other health and safety data included in such notifications have been historically treated as CBI and protected from public disclosure. In 2010, the U.S. EPA began tightening its policy on CBI assertions as part of its efforts to increase transparency. [6] As part of this ongoing effort, U.S. EPA has been scrutinizing CBI claims and encouraging companies to voluntarily declassify information it believes should now be publicly disclosed. [7]

In effect, U.S. EPA is seeking to change the balance between the benefits of protecting proprietary information (e.g., increased innovation, investment and certainty in commerce) and the benefits of greater public disclosure of that information (e.g., increased ability of consumers to make informed choices about product purchases, and to take voluntary precautions against exposure), in favor of the latter.

At the same time, Congress is actively considering a bipartisan measure to overhaul TSCA, including provisions addressing CBI protections. Congress and policymakers in the United States may take a cue from their European counterparts and further expand information disclosure requirements as they relate to substances that may affect the environment. In a statement of the Administration’s stance towards TSCA reform, the U.S. EPA recently stated that TSCA reform should include “stricter requirements for a manufacturer’s claim of [CBI].” [8] Significantly, it goes on to say that EPA “should be able to negotiate with other governments (local, state, and foreign) on appropriate sharing of CBI with the necessary protections, when necessary to protect public health and safety.” [9]

Additionally, the United States’ Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq., protects against public disclosure nearly all information the pesticide registrant designates as CBI (with a few exceptions). While these FIFRA CBI protections will remain in place in the United States for the foreseeable future, any similar claims for emissions-related information submitted by United States pesticide manufacturers to support their pesticide product registrations in the EU are now at risk. In other words, the Court’s decision is a potential back-door method to obtain historically-considered proprietary emissions-related information in the EU that is otherwise protected as CBI by the U.S. EPA under FIFRA. Where such data relates in a sufficiently direct manner to emissions into the environment, the European agency will have to disclose it on request.

Conclusion
The Greenpeace and Pesticide Action Network judgment raises new and significant questions. For example, the standards governing the protection of CBI in the EU and other jurisdictions may be different from the standards under which the CBI was or is initially submitted to the U.S. EPA. The judgment of the EU General Court suggests that any information held by an EU agency, regardless of its source or origin, will be subject to disclosure if it relates in a sufficiently direct manner to emissions into the environment, regardless of whether the same information is protected from disclosure in the U.S. or other jurisdictions.

As political pressure mounts to increase disclosure, companies manufacturing and distributing products that require the submission of proprietary, confidential information to U.S. or EU government agencies should pay close attention to developments in information disclosure laws and regulations around the globe, particularly given their potential to impact one another. In order to help protect or limit such disclosures of proprietary information by the Commission and other EU institutions and agencies (including the European Chemicals Agency) going forward, manufacturers and importers of pesticides and other EU-regulated substances and mixtures should consider steps to help group and classify emission-related data so that it is not commingled with other information that would be considered proprietary. This could help prevent inadvertent disclosure of such non-emissions-related proprietary information by the Commission pursuant to EU Regulation 1367/2006.

Notes:
[1] Case T-545/11 Stichting Greenpeace Nederland and Pesticide Action Network Europe v Commission.

[2] This regulation is similar in many ways to the United States’ disclosure requirements under the Freedom of Information Act (FOIA), 5 U.S.C. § 552.

[3] Regulation (EC) No. 1367/2006, Art. 6.1.

[4] Id.

[5] Such disclosures are required by TSCA Section 8(e), 15 U.S.C. § 2607(e).

[6] U.S. EPA, Increasing Transparency in TSCA, http://www.epa.gov/oppt/existingchemicals/pubs/transparency.html (last accessed Oct. 25, 2013).

[7] See U.S. EPA, TSCA CBI Declassification Challenge, available at http://www.epa.gov/oppt/existingchemicals/pubs/declassification-cbi.html (last accessed Oct. 25, 2013).

[8] U.S. EPA, Essential Principles for Reform of Chemicals Management Legislation, Principle No. 5 (last updated Dec. 20, 2012), available at http://www.epa.gov/opptintr/existingchemicals/pubs/principles.html (last accessed Oct. 20, 2013).

[9] Id.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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