EPA and FDA announce data sharing agreement for CBI.

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Today, EPA and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to share data on pesticides and toxic substances. According to a notice published last month in the Federal Register, in response to the FDA’s spring 2014 request, EPA will grant FDA access to information collected under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including information claimed by submitters as Confidential Business Information (CBI). This data-sharing initiative “is intended to maximize the utility of data collected under those statutes, and enhance the efficiency of the participants’ regulatory processes and facilitate better risk management activities.” The MOU applies specifically to EPA’s Office of Chemical Safety and Pollution Prevention and FDA’s Foods and Veterinary Medicine Program, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine.

FDA and EPA “have complementary roles” regulating substances incorporated into food (including animal feed), animal drugs, and cosmetics. Antimicrobial food wash products, for example, must meet different standards for safety and non-adulteration of food (FDA), and no adverse environmental effects (EPA).

The MOU covers the sharing of non-public information exempt from public disclosure, including CBI and “confidential commercial information” (CCI). Information will be shared “on a reciprocal and as-needed basis” for substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. The MOU provides that each agency will develop internal procedures and designate liaison officers for the information-sharing exchanges and to protect against unauthorized disclosure of CBI or CCI. Appendices to the MOU establish a framework process for information sharing, including specific language to be used in requesting information or responding to a request.

The MOU does not specify any limits as to programmatic uses for shared information. The disclosure of non-public information remains governed by applicable laws and regulations, and non-public information may not be disclosed further or shared with personnel at the other agency that have not been authorized to access non-public information. If EPA requests information from FDA identified as a trade secret, FDA will assess whether the information is in fact trade secret. TSCA/FIFRA-designated CBI requested by FDA will have to be returned to EPA or destroyed when no longer needed. Either agency may choose not to share requested information, or may choose to limit the scope of information provided in response to a request. The agencies may also protect information “in connection with research that has not been peer reviewed.”

Senate Bill Would Require Warning Labels for BPA on Food Containers.

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On July 10, 2013, Senator Dianne Feinstein (D-Calif.) introduced legislation (S. 1124) that would require manufacturers to include warning labels on consumer food packaging containing bisphenol A (BPA). The bill, titled the “BPA in Food Packaging Right to Know Act,” would require such packaging to state “this food packaging contains BPA, an endocrine-disrupting chemical.” It would also direct the Department of Health and Human Services (HHS) to conduct a safety assessment within 180 days from passage of the bill to determine the effect of long-term low-dose exposure and high-dose exposure.  Based on the results of this assessment, HHS is to then develop a safety standard for BPA and to use that standard to evaluate possible alternatives.

BPA, which is used in epoxy resins that are used to line some metal food and drink containers and in the manufacture of some clear plastics, exhibits hormone-like properties that have raised concerns about its safety. Feinstein said in a statement that more than 200 scientific studies that have linked BPA exposure to certain types of cancer, reproductive disorders, cardiac disease, diabetes, and other problems. She said that the growing scientific evidence about BPA’s health effects makes it “essential that consumers know what chemicals are in the products they purchase.”

The American Chemistry Council (ACC), who recently obtained a court order to remove BPA from California’s Proposition 65 list of potentially dangerous chemicals, called the bill “unnecessary” because government agencies worldwide support the safety of BPA in food contact materials. The U.S. Food and Drug Administration (FDA) considers BPA to be safe at the low levels that occur in some foods, although the agency said it had concern “about the potential effects of BPA on the brain, behavior and prostate gland in fetuses, infants and young children.” The FDA is currently conducting additional research with its National Center for Toxicological Research to further determine the safety of BPA as it is used in food packaging.

The new bill is Feinstein’s latest attempt at legislation aimed at limiting the use of BPA. She had previously introduced legislation in 2009 that would have banned BPA from reusable food containers. She also tried to amend the Food Safety Modernization Act in 2010 to ban BPA from baby bottles and sippy cups. The amendment failed, although the FDA later used its authority to implement the same ban in 2012. On July 12, 2013, in response to a petition introduced by Senator Edward Markey (D-Mass.), the FDA also abandoned the use of BPA in packaging for infant formula. In both cases, the FDA took action after determining that manufacturers in the industry had already phased out BPA for those uses.

Currently, thirteen states currently have pending legislation that would ban BPA from children’s products and food containers. Two other states, South Dakota and Connecticut, have legislation similar to the Feinstein bill, which would require BPA warning labels on food and drink packaging.

FDA Regulation of Nanotechnology

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Nanotechnology:

Readers interested in learning about FDA’s regulation of nanotechnology might want to download the free book available here:  FDA REGULATION OF NANOTECHNOLOGY .  Verdant attorney, Philip Moffat, and many others authored the book over the course of the past several years.  This book is a valuable resource to those wanting to learn about regulation in the United States of foods, cosmetics, drugs, medical devices and many other products that have been enhanced with nanotechnology.  Further information about FDA’s role in the regulation of nanotechnology may be found on the agency’s website, here.  Enjoy!