EPA and FDA Sharing Companies' Confidential Information Under Chemical Ingredients Data Sharing MOU
The US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA) recently announced that the two agencies are now sharing information with one another, including non-public information that may be exempt from public disclosure as confidential business information (CBI) or confidential commercial information (CCI). The new sharing arrangement could have direct impacts on companies that manufacture, process, distribute, or sell industrial chemicals or products that contain them, including companies with substances that have pesticidal and non-pesticidal applications.
To foster more efficient exchange of data, FDA and EPA have signed a Memorandum of Understanding (MOU) on Information Sharing.1 It allows FDA and EPA to exchange confidential data and information they obtain from companies which is related to substances that may be present in materials regulated by either agency, including in consumer and commercial use chemical substances, pesticides, human food, animal food and feed, drugs (including animal drugs), and cosmetics. Although this MOU is similar to other data sharing MOUs between FDA other regulatory agencies (including EPA),2 the decision to issue an MOU permitting the exchange of data related to industrial chemicals, including pesticides, may signal renewed regulatory interest in these products or future policy changes and guidance.
Overlapping EPA and FDA Jurisdiction Over Certain Ingredients and Processing Aids
Both EPA and FDA regulate substances that may be incorporated in consumer and commercial use chemical substances, pesticides, human food and dietary supplements, animal food and feed, drugs (including animal drugs), and cosmetics, many of which have an antimicrobial purpose. FDA primarily is responsible for regulating the safety of food, including animal food and feed, dietary supplements, drugs, medical devices, and cosmetics by enforcing the Federal Food, Drug, and Cosmetic Act (FFDCA) and related public health laws.
For example, the FFDCA prohibits the introduction, or delivery for introduction, into interstate commerce of any food that is "adulterated."3 Food is deemed adulterated, among other reasons, "if it is, or it bears or contains, any food additive which is unsafe within the meaning of § 409."4 Under § 409 of the FFDCA, a substance is deemed to be an unsafe food additive unless it is generally recognized as safe (GRAS) under the intended conditions of use, conforms to the terms of an exemption for investigational use, conforms to a food additive regulation, is exempted from regulation as a food additive, or, in the case of food-contact substances, there is a notification that is in effect. Food additive, and other food ingredient regulations provide the identity, specifications and conditions of safe use for a substance that results or reasonably may be expected to result directly or indirectly in its becoming a component or otherwise affecting the characteristics of any food as a result of its intended use.
EPA has jurisdiction over pesticides and chemical substances pursuant to its authorities under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA).
Pursuant to FFDCA and FIFRA, including amendments made by the Food Quality Protection Act (FQPA) of 1996 and the Antimicrobial Regulation Technical Corrections Act (ARTCA) of 1998 FDA and EPA have shared responsibilities with respect to pesticide chemical residues appearing in or on food, and for certain antimicrobial products when used in the context of food and on or in medical devices. Moreover a great many chemical substances that are used in the production of drugs and cosmetic products also have uses in commercial and consumer applications in products (e.g., soaps, oils, fragrances, detergents) that also are regulated under TSCA.
As a result, EPA and FDA continue to have complementary responsibilities which have prompted the agencies to agree to share certain confidential information obtained from companies in the context of these regulatory purposes, which would include enforcement.
Information Sharing Trend and Exchange of Confidential Business Information under the MOU
Although EPA and FDA currently have other MOUs relating to areas of overlapping jurisdiction,5 EPA and FDA's decision to share information related to industrial chemicals follows a growing trend that is apparent at the state and international levels. International markets, such as the European Union, rely on collaboration among member states for the shared review and mutual recognition of assessments of the safety of products that appear on common markets across national boundaries. Similarly, a number of state government agencies in the US have entered into data sharing arrangements-such as the Interstate Chemical Clearinghouse6-with the desire to facilitate the exchange of information regarding the presence of chemicals in consumer products for policy-making purposes. Unlike many of the state efforts, which enable only the sharing of publicly-available information, EPA and FDA's MOU allows them to exchange non-public information that companies have submitted to the government with the understanding that it would be treated as confidential.
In announcing the data sharing arrangement7, EPA and FDA emphasized their complementary roles and their respective regulatory authority over chemical substances, including those found in food, animal drugs, and cosmetics. One goal the agencies share for the data sharing MOU is to create efficiencies and encourage consistency where the mandates of the two agencies overlap. For example, manufacturers of antimicrobial food washes are regulated by both agencies: they must demonstrate to FDA that their products are safe and do not adulterate food, and they must provide data to EPA sufficient for that agency to determine the product (which would be labeled as an antimicrobial pesticide) will not cause unreasonable adverse effects on the environment. The agencies believe that by sharing information and opening channels of communication, they will be better able to serve their respective missions. Similarly, substances that are subject to the TSCA can be subject to EPA restrictions if the substance will present an unreasonable risk of injury to health or the environment.
The MOU describes certain safeguards for the exchange of confidential information. For example, the MOU explains that the agencies have not simply opened up their respective databases to each other. Instead, according to the MOU, if one agency wants information from the other, it must request it in writing, with specific reference to the MOU, and with a stated commitment not to further disclose the information. Responses to a written request must contain similar language. Confidential information is not to be transmitted electronically, but instead must be sent in hard copy, or downloaded to an encrypted disk for subsequent viewing by the other agency on a secure, "stand-alone" computer. In addition, EPA and FDA have agreed to adopt policies and procedures to ensure that information shared under the MOU will be exchanged and used consistent with the confidentiality provisions in other relevant federal statutes, including the FFDCA, FIFRA, TSCA, and FOIA. Only agency personnel specifically designated to have access to confidential business information may receive such information pursuant to the MOU. With respect to non-public information provided by EPA, the MOU provides that no state, county, or local official or FDA grantee or contractor will be permitted to have access to non-public information provided by EPA. Trade secret information held by FDA that previously was prohibited from being shared outside of the Department of Health and Human Services, however, now will be re-assessed by FDA to determine whether the information is in fact trade secret, and if so whether a masked or aggregated form of the information may be provided to EPA under the MOU.
Access to confidential data under the MOU began March 9, 2015.
It will be interesting to follow how the agencies ultimately make use of the MOU going forward. For example, it would be reasonable to expect the agencies will share test data and information concerning the health and environmental effects of substances over which they both may have jurisdiction-especially for use during periods of initial assessments and reassessments of a chemical substance, a pesticide or drug. Such data, including reports the agencies receive of unexpected adverse effects concerning a pesticide, chemical substance or drug might prove useful and will certainly provide enhancements to EPA's databases which inform its modeling tools and structure-activity relationship (SAR) analyses which rely on data received on analogous chemicals when data on a specific substance are not available. Whether persons with enforcement and compliance responsibility in the two agencies will find the ability to share confidential information helpful is an open question.
When companies submit information to either EPA or FDA in the future, they should be mindful to consider that the information is likely to be shared across these two agencies and assess accordingly whether additional protections may be needed in light of the new data sharing agreement.
For example, in 2011, FDA, EPA and USDA entered into a data sharing MOU that provides for the exchange of data involving genetically-engineered plants and foods derived from such plants. See MOU 225-11- 0001 available here.
See, e.g., MOU 225-04-4000 (collaborative research and development of emergency triage response efforts for FDA and EPA laboratories); MOU 225-73-8010 (describing FDA and EPA's shared jurisdiction over pesticides under the FFDCA and FIFRA); and MOU 225-93-4005 (describing FDA and EPA's jurisdiction over the registration and marketing of liquid chemical germicides).