Date: Jan 11, 2010
On December 23, 2009, the U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPR) aimed at greater disclosure of inert ingredient identities in pesticides, Public Availability of Identities of Inert Ingredients in Pesticides, 74 Fed. Reg. 68215 (Dec. 23, 2009). The purpose of the ANPR is to solicit comments on ways to achieve what appears to be a new EPA policy of increasing public availability of the identities of the inert ingredients. The proposal is being considered in response to petitions filed in 2006 from activist groups, including Beyond Pesticides and 21 other non-governmental organizations, and a group of 15 U.S. State Attorneys General. Comments are due by February 22, 2010, and we expect numerous comments from activist groups and individual consumers to provide reason for EPA to proceed with its proposal.
The adoption of this policy will lead to less accurate information being provided to consumers resulting in more confusion and anxiety among the public. Moreover, the policy conflicts with the historical recognition embodied in the U.S. Constitution that intellectual property should be protected because of the benefits to society that arise therefrom, and that there are other values to be balanced against a disclosure for the sake of disclosure. We believe the proposal should be vigorously opposed for a number of reasons.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), an active ingredient is defined as any ingredient "which will prevent, destroy, repel, or mitigate any pest" and an inert ingredient is an ingredient which is "not active." FIFRA section 10 prohibits EPA from disclosing, with limited exceptions, information which contains trade secrets or commercial or financial information. This provision implements long-standing policy in the U.S. that innovation and creativity should be encouraged through the protection of intellectual property, including trade secrets.
Currently, the exceptions focus on making safety and efficacy data available to the public, but there is an express limitation on disclosing the identity or percentage quantity of inert ingredients unless the Administrator has first determined that disclosure is necessary to protect against unreasonable risk of injury. In those cases, EPA must notify the owner of the confidential information before releasing the information, and, before disclosing confidential information to protect the health and safety of the public, must first show that the presence of the ingredient in the product poses an unreasonable risk on health or the environment.
Until now, EPA has required identification on labels of approximately 50 inert ingredients designated on "List 1", which are ingredients of "toxicological concern." EPA has also required registrants to remove these chemicals from their products under a policy and practice essentially prohibiting their use, and these ingredients are now rarely used.
EPA proposes that further disclosure of the identity of inert ingredients with the argument that the information will help consumers make more informed decisions when buying pesticides, which will lead to a decrease in usage of hazardous inert ingredients in pesticide formulations.
EPA has outlined two possible approaches to this proposed rule: to (1) require disclosure only if the inert ingredient is potentially hazardous; or (2) mandate disclosure the identity of all inert ingredients. If the first option is to be used, EPA is seeking comment on how hazardous ingredients should be identified.
We believe EPA's underlying premise is false. Currently, EPA evaluates the product as formulated and requires testing for acute toxicity for the purpose of classifying the products according to their hazards under the use conditions on the label. Identifying the inert ingredients by chemical identity will not change the precautionary information required on the labels nor will it change the overall hazard of the product as sold.
If EPA required the disclosure of all inert ingredients, or even of only the hazardous inert ingredients in a pesticide, it would produce a product that was misbranded under EPA's own definition and under any reasonable interpretation of current notions of commercial speech because it would convey the false impression that the product is not safe for its intended use. In fact, that is precisely the determination that FIFRA mandates the Administrator to make in registering a product.
The notion that one or more particular inert ingredients need to be identified on a label to enable purchasers to make more informed decisions about the hazards of a product has been previously discredited in the rulemaking of the Occupational Safety and Health Administration when it adopted the Hazard Communication Standard (HCS) in 1983. OSHA specifically concluded that ingredient disclosure is not needed and that disclosure of the hazardous effects of the product would be sufficient to protect of the user. It specifically provided for protection of trade secrets as part of the final rule, and requires the disclosure of the hazards but not the identity of hazardous ingredients to balance the competing interests at play.
If EPA wants to encourage the use of "safer" chemicals, it can do so through expansion of the proposed "green claims" initiative for pesticides. There is a lack of incentive to use green chemistries because EPA does not allow claims on products or for competitors to make comparative claims under its current misbranding regulations. EPA contends that claims that a product is safe for the environment or humans are per se misleading. While EPA is now considering allowing claims that a product is approved under its Design for the Environment program, this is extremely limited and does not follow current policy on environmental claims of the Federal Trade Commission. EPA should expand the program allowing such claims because the current policy against comparative and safety claims inhibits instead of promotes the flow of information to consumers.
To make a comparison of the safety of one end-use product to another, consumers and other pesticide users presently have limited access to information other than what is on the approved pesticide label. Making information on the identity of inert ingredients publicly available will do little to help this situation. The identity of inerts will be meaningful only to experts in chemistry, toxicology, and chemical risk assessment. But, on the down side, disclosure of inerts will provide vast new fertile ground to those who prey on the public by encouraging them to imagine that grave dangers are associated with even the safest pesticides. Allowing comparative safety claims would in contrast much more effectively favor the use of safer pesticides without the downside attendant to inerts disclosure.
The fallacy of EPA's position is in asserting that disclosure is necessary is that the hazards of an inert ingredient are already addressed by the precautionary labeling based on the testing of the product as a whole. It is well recognized by scientists and regulatory agencies that for purposes of assessing the hazard of a product, testing of the product as formulated is far more effective than relying on an assessment of the hazards of the individual ingredient. EPA now makes this determination on a case-by-case basis, based on data submitted by the registrant. This is precisely the process that has been adopted in Europe under the REACH initiative and which EPA is now promoting to be adopted in the US for non-pesticides as well.
EPA has specifically asked for public comment addressing more than 20 different issues, five of which are specific to the hazard-based proposal and two topics for the full ingredient disclosure proposal. There are 15 topics of information that address both approaches.
Registrants who have formulated products that have ingredients that are trade secrets are obviously affected, but so are companies who supply formulated products that are used to make pesticides and whose composition and chemical identity are proprietary to the supplier. It is important to note that inert ingredients that are identified on Material Safety Data Sheets (MSDS) or other technical documents cannot be claimed as confidential or trade secrets unless the access to those documents is controlled and they are labeled as confidential.
A concerted effort by both registrants and their inert ingredient suppliers is necessary to protect the assets that these formulations represent. EPA is seeking public comments until February 22, 2010.
For further information on this proposal, contact the Pesticide Practice Group at 202-434-4100 or email@example.com.