USP Proposes Standards for Microbial Food Cultures, Including Probiotics- January 11 2012
On January 3, 2012, the U.S. Pharmacopeial Convention (USP) proposed an appendix to the Food Chemicals Codex, which pertains to microbial food cultures (MFC), including probiotics. (A copy of the draft appendix is attached.) When finalized, Appendix XV to the Food Chemicals Codex will include standards that address the proper criteria for developing specifications -- such as identity, production, quantification, and safety -- for MFC intended for use in both fermentation and probiotic applications.
For more information, please contact Mark Itzkoff
FDA Announces Creation of Food Safety Preventive Controls Alliance- January 5, 2012
The Food and Drug Administration (FDA), in cooperation with the Illinois Institute of Technology's Institute for Food Safety and Health (IIT IFSH), has announced the creation of the Food Safety Preventive Controls Alliance (FSPCA) (see http://www.fda.gov/Food/FoodSafety/FSMA/ucm284406.htm).
The FSPCA will develop training courses and materials, as well as commodity-specific and industry sector-specific guidelines, to help the food industry comply with the Food Safety Modernization Act's (FSMA) requirement to conduct a hazard analysis and implement preventive controls. FDA is expected to issue two proposed rules on preventive controls, one for human food and one for animal feed, later this month.
For more information, please contact Bob Hahn
FDA Report on Good Guidance Practices- December 30, 2011
The Food and Drug Administration (FDA) has published a report, entitled "Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency" ("GGP Report"). The GGP Report is available at http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM285124.pdf.
FDA's announcement of its availability was published at 76 Fed. Reg. 82,311 (Dec. 30, 2011) (available at http://www.gpo.gov/fdsys/pkg/FR-2011-12-30/pdf/2011-33573.pdf). Comments on the GGP Report may be submitted to FDA by February 28, 2012.
The GGP Report derives from President Obama's Memorandum to Heads of Executive Departments and Agencies on Transparency and Open Government (Jan. 21, 2009) available at http://www.whitehouse.gov/the_press_office/TransparencyandOpenGovernment). In response to the Memorandum, FDA launched its Transparency Initiative in June 2009 (see generally http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm), and in January 2011 issued its Phase III Report, entitled "FDA Transparency Initiative: Improving Transparency to Regulated Industry" (available at http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm273856.htm).
For more information, please contact Michael O'Flaherty
Potential Changes to Nutrition Facts- December 29, 2011
The Food and Drug Administration (FDA) today published notice of its submission to the Office of Management and Budget (OMB) of a proposal for an online consumer survey that heralds potential changes in the information that prospectively may be required to be declared in Nutrition Facts. 76 Fed. Reg. 81,948 (Dec. 29, 2011 (available at http://www.gpo.gov/fdsys/pkg/FR-2011-12-29/pdf/2011-33303.pdf). Any written comments on the proposal must be submitted to OMB by facsimile or e-mail on or before January 30, 2012.
The consumer survey will incorporate study of potential revisions to the information presented in the Nutrition Facts.
For more information, please contact Michael O'Flaherty
FDA Guidance on Prevention of Salmonella Enteritidis in Shell Eggs- December 28, 2011
The Food and Drug Administration (FDA) has published a revised guidance document, entitled "Guidance for Industry: Prevention of Salmonella Enteritidis [SE] in Shell Eggs During Production, Storage, and Transportation" (Dec. 2011) (available at http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/UCM285137.pdf), to assist egg producers in complying with the agency's governing regulations, codified at 21 C.F.R. Part 118. Notice of the availability of this guidance document, modified pursuant to evaluation of comments submitted on the draft guidance document (see 75 Fed. Reg. 48,973 (Aug. 12, 2010)), was published at 76 Fed. Reg. 81,513 (Dec. 28, 2011) (available at http://www.gpo.gov/fdsys/pkg/FR-2011-12-28/pdf/2011-33292.pdf). Comments on the current guidance document may be submitted to FDA at any time.
For more information, please contact Michael O'Flaherty
Food Source Attribution - Notice of Public Meeting- December 27, 2011
The U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS), in collaboration with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), will host a public meeting on January 31, 2012, from 8:30 AM until 4 PM EST, at the USDA in Washington, DC, to:
• Discuss efforts to advance understanding of "food source attribution" (i.e., the attribution of foodborne illness to specific foods and/or settings);
• Develop harmonized food source attribution estimates (useful in establishing food safety strategies);
• Introduce the Interagency Food Safety Analytics Collaboration (IFSAC), formed to collaborate on analytic projects (see OFW Law's memorandum dated July 22, 2011); and
• Present the IFSAC's draft Strategic Plan for Attribution.
A notice of the public meeting is published at 76 Fed. Reg. 80,873 (Dec. 27, 2011) (available at http://www.gpo.gov/fdsys/pkg/FR-2011-12-27/pdf/2011-33018.pdf).
For more information, please contact Michael O'Flaherty
CDC/HHS/USDA Deliver Progress Report on the President's Food Safety Working Group- December 21, 2011
Yesterday, representatives from the Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (HHS), and the United States Department of Agriculture (USDA) held a media briefing highlighting the accomplishments and future priorities of President Obama's Food Safety Working Group (FSWG). A Progress Report on the FSWG's coordinated activities was also published.
For more information, please contact Michael O'Flaherty or Brett Schwemer
California Court Rejects Attempt to Overturn Proposition 65 Listing for Caramel Coloring Ingredient- December 15, 2011
A California court has denied a petition filed by a food industry coalition challenging California's listing of 4-methylimidazole (4-MEI) as a substance known to the state to cause cancer.1 4-MEI is a by-product of fermentation and is often found in soy sauce, roast coffee and certain caramel colorings used in food. 4-MEI was added to the list of Chemicals Known to the State of California to Cause Cancer or Reproductive Toxicity under The Safe Drinking Water and Toxic Enforcement Act of 1986 (the Proposition 65 List) on January 7, 2011.
FDA Considering Setting Guidance Level for Inorganic Arsenic in Apple Juice- December 06, 2011
The Food and Drug Administration (FDA) has stated that it is considering setting a guidance level for inorganic arsenic in apple juice. FDA already has a "level of concern" of 23 parts per billion (ppb) for inorganic arsenic in apple juice and pear juice. See FDA internal memoranda dated December 15, 2008 and April 8, 2008 (available at: http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Metals/ucm277681.htm and http://www.fda.gov/Food/FoodSafety/FoodContaminantsAdulteration/Metals/ucm277676.htm).
Although a level of concern is not a legal limit, FDA can and does take enforcement action against products that exceed the agency's level of concern under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (poisonous or deleterious substance which may render food injurious to health). While FDA may set legal limits (e.g., tolerances) for chemical contaminants like arsenic in food, it rarely does so, because setting a tolerance requires a lengthy formal rulemaking procedure and therefore tolerances, once set, are difficult to change if the agency's scientific understanding of the contaminant changes. Instead, FDA typically establishes guidance levels or levels of concern for chemical contaminants.
For more information, please contact Bob Hahn
FDA and USDA Agencies Enter Into a Memorandum of Understanding for Sharing of Food Safety Information on FDA-Regulated Foods Procured by USDA- December 02, 2011
The Food and Drug Administration (FDA) has entered into a memorandum of understanding (MOU) with the U.S. Department of Agriculture's (USDA) Agricultural Marketing Service (AMS), Food Nutrition Service (FNS), and Farm Service Agency (FSA) to share information regarding the safety of FDA-regulated "USDA Foods." 76 Fed. Reg. 74791 (Dec. 1, 2011) (copy attached). For purposes of this MOU, "USDA Foods" means commodities procured by USDA for use in domestic nutrition assistance programs. A list of such foods appears in Appendix A to the MOU. The MOU became effective on September 29, 2011.
For more information, please contact Bob Hahn
