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Noteworthy CFSAN Accomplishments in 2013

Dear Colleagues, FDA Foods Community:

The purpose of this letter is to highlight some noteworthy initiatives that we accomplished over the past year and to foreshadow some important initiatives that we will be working on in 2014.

First, I will highlight some significant internal initiatives. I am very pleased to report that we have established permanent leadership in the Office of the Center Director by filling both Deputy Director positions on a permanent basis. In April 2013, Dr. Steven Musser was appointed CFSAN Deputy Director for Scientific Operations. This is the position that was vacated by Janice Oliver nearly four years ago but with a new title to more accurately distinguish the responsibilities of this position from the responsibilities of the Deputy Director for Regulatory Affairs. Dr. Musser joined CFSAN in 1991 as a research chemist and became the Branch Chief of the Instrumentation and Biophysics Branch in 1998. In 2005 he was appointed Director of the Office of Scientific Analysis and Support, and following Center-wide reorganization, in 2007, he became the Director of the newly formed Office of Regulatory Science (ORS), his most recent position of record. As the ORS Director, Dr. Musser oversaw an extensive research portfolio supporting a number of priority food and cosmetic programs, including research on foodborne pathogens, chemical contaminants, natural toxins, and dietary supplements.

In July 2013, Roberta Wagner was appointed CFSAN Deputy Director for Regulatory Affairs. Ms. Wagner has worked for FDA for more than 28 years, 22 years in the Office of Regulatory Affairs (ORA) and almost seven years in CFSAN. Before re-joining CFSAN as the Director, Office of Compliance (OC) in February 2013, Ms. Wagner held the position of Assistant Commissioner for Operations in ORA for two years. In this capacity, she provided leadership to ORA's field force, principally investigators, compliance officers, and laboratory staff and the ORA headquarters components that supported/interfaced with the field organization. Ms. Wagner began her FDA career in ORA’s Baltimore District Office in 1987 where she worked for close to 20 years, first as an analytical chemist specializing in pesticide and industrial chemical analyses and applied research and then as a Supervisory Consumer Safety Officer in managerial positions in the District’s Investigations and Compliance Branches including serving as the Director of each of these Branches. Ms. Wagner joined CFSAN the first time in 2006 as the Director, Division of Communication and Education; she served in this capacity for two years prior to assuming leadership positions in the Center’s OC. Permanently filling the two Deputy Director positions will bring much needed stability and continuity in management and operations.

Last year we had another addition to the staff in the Office of the Center Director; in August 2013, Dr. Stephen Ostroff joined the Center as Senior Public Health Advisor and Chief Medical Officer. Although this position is organizationally located in CFSAN, Dr. Ostroff also serves as the Senior Public Health Advisor to the Deputy Commissioner for Foods and Veterinary Medicine and to senior leadership in the Center for Veterinary Medicine. Dr. Ostroff has more than 20 years of specialized experience coordinating infectious disease programs in the areas of bioterrorism, food safety, antimicrobial resistance, and healthcare-associated infections while working in the Public Health Service/National Health Services Corps, CDC, the HHS Office of Global Health Affairs, the World Bank, and most recently, the Pennsylvania Department of Health. Dr. Ostroff's broad public health background and expertise make him exceptionally qualified to serve as Senior Public Health Advisor and Chief Medical Officer. As announced by Dr. Hamburg on January 9, 2014, Dr. Ostroff has agreed to serve as the Agency’s Acting Chief Scientist following the departure of Dr. Jesse Goodman.

Over the past year we significantly advanced, or initiated, internal reviews in four program areas. These efforts will conclude in 2014 and I will share with you any program changes that will be made as a result of the reviews. The four program areas are as follows:

  1. Chemical safety review: Focuses on the scientific capacity, efficiency, and the management of the program’s multiple elements. This review will help us determine overall program needs and then determine not only how to meet the needs but also how to further improve our chemical safety program.
  2. Nutrition review: Focuses on current nutrition and related work in CFSAN. This review will help us to identify how we might better meet the challenges of nutrition in the U.S. over the coming decade.
  3. Organizational review of the Office of Food Safety: Focuses on the current structure and functions of the Office of Food Safety (OFS). This review will help us identify a sound structure and set of functions for OFS that will enable it to achieve and maintain highly efficient operations, especially in light of the need to implement the FDA Food Safety Modernization Act.
  4. Microbiology laboratory review: Focuses on the scientific capacity, efficiency, and management of microbiology work in CFSAN laboratories. This review will help us determine if microbiology research is meeting program needs; identify any unnecessary duplication; and ensure that microbiological research yields mission-relevant outcomes.

Attached you will find a brief summary of some additional noteworthy 2013 accomplishments. By no means is this a comprehensive list. On a daily basis we accomplish important work in our food safety, nutrition, and cosmetic programs and in our ongoing international, research, regulatory, enforcement, communications, education, and outreach activities.

Looking ahead, goals for 2014 include completion of the internal reviews identified above. Another goal for strengthening program operations in 2014 is recruitment of permanent SES or Title 42 leadership in the Office of Compliance (OC), the Office of Applied Research and Safety Assessment (OARSA), the Office of Nutrition, Labeling and Dietary Supplements (ONLDS), and the Office of Regulatory Science (ORS). I am very appreciative for the efforts of CFSAN managers that have been providing leadership to these offices during this interim period: Mr. Michael Roosevelt, William (Bill) Correll, and Ms. Charlotte Christin in OC; Dr. Kevin Gaido in OARSA; Mr. Philip Spiller in ONLDS; and Dr. Vincent (Kelly) Bunning in ORS.

Additional initiatives we plan to complete in 2014 are identified in “CFSAN’s 2013 – 2014 Plan for Program Priorities” I encourage you to review the Plan and monitor our progress. Although many of you are well aware of the challenges we face and the breadth of our mission, I think many of you will be astonished at the important initiatives we have on our plate over the next 12 months. This is a truly impressive list of initiatives; I believe that working together we will accomplish them for the benefit of American consumers.

/S/

Michael M. Landa
Director,
Center for Food Safety and Applied Nutrition


Attachment: Noteworthy CFSAN Accomplishments in 2013

FDA Food Safety Modernization Act

  • Proposed rule on produce safety standards
  • Proposed rule on preventive controls for human food
  • Proposed rule on accredited third party certification
  • Proposed rule on intentional contamination

Nutrition

  • Notice of tentative determination that partially hydrogenated oils are not generally recognized as safe
  • Proposed rule to add selenium to the list of required nutrients for infant formulas, and to establish both minimum and maximum levels of selenium in infant formulas

Initiatives to Reduce Risk of Illness or Injury

  • Final rule defining “gluten-free” and on using the term on food labels
  • Draft “action level” for arsenic in apple juice
  • Draft guidance to reduce acrylamide in foods
  • Guidance on purchasing reef fish species associated with the hazard of ciguatera fish poisoning
  • Working Group Report on and Food Advisory Committee meeting to discuss detecting signals for chemical hazards of concern in CFSAN-regulated products
  • Food additive regulations to increase the maximum dose of ionizing radiation permitted in the treatment of poultry products; provide for the safe use of a 4.5 kilogray maximum absorbed dose of ionizing radiation to treat certain meat products; and to provide for the safe use of sodium dodecylbenzenesulfonate as an antimicrobial agent for use in wash water for fruits and vegetables.

Risk and Safety Assessment

  • Assessment of the risk of Salmonellosis Associated With the Consumption of Tree Nuts
  • Draft Quantitative Risk Assessment of Inorganic Arsenic in Apple Juice
  • Draft Quantitative Risk Assessment of Listeria monocytogenes in Retail Delicatessens
  • Risk Profile on Pathogens and Filth in Spices
  • Data collection, analysis, and posting of analytical results of approximately 1,100 new samples for the presence of arsenic in rice and rice products

Guidance for Stakeholders

  • Draft guidance on cosmetic good manufacturing practices
  • Draft guidance on medical foods
  • Release of Food Code 2013
  • Draft guidance on the egg safety rule for farmers that provide their hens outdoor access
  • Distinguishing Liquid Dietary Supplements from Beverages
  • Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements

Regulatory Science and Research

  • Launched Genome Trakr pilot network
  • Published a method to identify Acacia-containing dietary supplements adulterated with an amine compound not found in the Acacia plant. [Acacia rigidula or its extracts are commonly listed as an ingredient in popular weight-loss supplements.] (Pawar, Grundel, Fardin-Kia and Rader, J. Pharm. Biomed. Anal. 2014 Jan 25;88:457-466).
    cardiotoxicity testing of dietary supplements
  • Developed a method to extract and detect Hepatitis A in spinach and tomatoes (Kulka and Papafragkou, Int J Food Microbiol. 2013 Feb 15;161(3):143-50).