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Compliance References
Regulatory Procedures Manual 2008
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1-6 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)
     1-6-1 - Office Of Compliance (HFS-600)
     1-6-2 - Office Of Cosmetics And Colors (OCAC) (HFS-100)
     1-6-3 - Office Of Food Safety (HFS-300)
     1-6-4 - Office Of Nutritional, Labeling and Dietary Supplements (HFS-800)
     1-6-5 - Office of Regulatory Science (HFS-700)

1-6 - CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN)

1-6-1 - Office Of Compliance (HFS-600)

  1. Office of the Director
    1. Has primary responsibility within the Center for compliance and enforcement with respect to foods and cosmetics, including coordinating compliance and enforcement actions within the Center and with other FDA components.  Oversees the development of compliance and enforcement strategies for emerging compliance challenges.
    2. Provides expert advice to the Center Director, Deputy Center Directors, and other key Agency and government officials, and serves as principal liaison to industry, international, and other organizations on issues related to compliance and enforcement and to the Interstate Travel Program (ITP). 
    3. Serves as the primary contact between the Center and FDA's field organization, including the Field Food Committee.
    4. Has primary responsibility for management of compliance programs, field assignments, and work plans and maintains the center-wide compliance management and reference systems.
    5. Initiates or coordinates the planning, development, publication, and promotion of field guidance documents for CFSAN-regulated foods and cosmetics to implement sound public health practices, food safety/security interventions, compliance/enforcement strategies, and regulatory programs; provides information, training, and technical assistance to implement guidance and regulations.  
    6. Reviews proposed regulatory actions and recalls for adequacy of evidence and consistency across programs and with established program priorities, policy, and guidance.  
    7. Monitors information from internal and external sources to identify trends or emerging compliance and enforcement related issues that may influence the Center's area of regulatory responsibility.  Provides data and other information on field accomplishments to support the Center's evaluation of programs and assignments, development of new assignments, assessment of the industry, or any other relevant Agency purpose. 
    8. Oversees, monitors, and evaluates the food facility registration data base. 
    9. Provides leadership, oversight, and technical assistance for the Agency's Interstate Travel Program (ITP), including developing regulations, guidance, policy, programs, position papers, and advisory opinions, and recommending research priorities for matters within the scope of the ITP.

      There are two divisions within the Office of Compliance:
      1. Division of Enforcement
      2. Division of Field Programs and Guidance
  2. Division of Enforcement   (HFS-605)
    1. Has primary responsibility for managing reviews of regulatory actions recommended by Agency field offices and for guiding field offices' activities, when necessary, in developing scientifically and legally supportable actions.
    2. Reviews incoming investigational findings and recommendations to determine if a proposed enforcement action or alternative remedy is supported by the documented observations and other evidence, based on relevant statutes, regulations, policy, programs, precedents, and Agency and Center enforcement priorities; assesses the integrity and relevance of the evidence; and obtains necessary scientific verification from  appropriate subject matter experts. 
    3. Serves as the Center's point of contact for policy and inquiries related to enforcement, including recalls, from other Agency units, industry, and other parties. 
    4. Provides expert compliance and enforcement guidance for CFSAN officials, other FDA components, Federal and State officials, and industry; participates in Agency discussions, decisions, and fact finding on compliance and enforcement issues related to CFSAN-regulated products and industries.
    5. Works with other Center and FDA components to develop compliance and enforcement strategies to address cross-cutting regulatory issues or emerging compliance challenges.  Develops innovative enforcement solutions to novel, complex, and precedent-setting regulatory problems. 
    6. Evaluates recall recommendations, obtains scientific and technical support to document health risks associated with recalled products, and ensures that recall actions are consistent with Agency and Center policies. 
    7. Assists the Office of General Counsel and field units and the Department of Justice in developing legal documents including declarations, obtaining experts, responding to interrogatories, and providing trial or other requested assistance.  Represents the Center at enforcement negotiations.

      There are two teams and two branches within the Division of Enforcement:
      1. Recall Team
      2. Labeling Compliance Team
      3. Product Adulteration Branch
      4. Manufacturing and Storage Adulteration Branch
  3. Division of Field Programs and Guidance (HFS-615)
    1. Serves as the focal contact point within the Center for compliance programs, field assignments, and work plans; and plans and implements these activities working closely with the Agency field organization and Center offices to reflect a risk-based approach.
    2. Actively manages compliance programs and field assignments and provides information, based on its monitoring and data reporting activities, to other Center offices to support Center evaluation of programs and assignments.
    3. Provides Center leadership and coordination for Compliance Policy Guides and works closely with other Center offices and Agency headquarters and field offices in Compliance Policy Guide development and issuance.
    4. Provides expert guidance for CFSAN officials and other Agency components, Federal and State officials, and industry concerning field programs, guidance, the context of mined data, and regulatory requirements and their implementation for the Interstate Travel Program (ITP).
    5. Maintains the Center-wide compliance management and reference systems and works closely with Agency information technology offices and the field organization to provide effective compliance information management concerning foods and cosmetics. Implements and provides monitoring and evaluation of the food facility registration data base.
    6. Plans and develops approaches to administer regulatory responsibilities in the Interstate Travel Program and provides information, problem-solving, and technical assistance to Agency and external organizations within this program to maintain an effective and consistent regulatory program in the interstate travel industry.
    7. Reviews regulatory actions including information about proposed enforcement actions or alternative remedy to determine if ITP actions are supported by relevant science and established program priorities, policy, and guidance; determine, where policy or guidance do not exist, whether the Division can provide expert scientific testimony to defend the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions.
    8. Monitors and mines information from internal and external sources to identify trends or emerging compliance and enforcement related issues that may influence the Center's area of regulatory responsibility and brings the information to the attention of other Center offices for consideration and action when necessary.

      There are two branches within the Division of Field Programs and Guidance:
      1. Field Programs Branch
      2. Compliance Information Branch

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1-6-2 - Office Of Cosmetics And Colors (OCAC) (HFS-100)

  1. Office of the Director
    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for matters within the scope of the responsibility of the Office. 
    2. Provides expert advice to the Center Director, Deputy Center Directors, and other key Center, agency and government officials, and serves as principal liaison to industry, international, and other organizations on cosmetic products and ingredients and color additive certification. 
    3. As necessary, reviews regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within OCAC's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions. 
    4. Administers the Color Certification program including methodology research.
    5. Administers the Voluntary Cosmetic Registration Program. 
    6. Provides leadership and works closely with other Agency units in the area of nanotechnology.

      There is one staff and one division within the Office of Cosmetics and Colors:
      1. Cosmetics Staff
      2. Division of Color Certification and Technology
  2. Cosmetics Staff (HFS-125)
    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for cosmetics and color additives. 
    2. Provides expert guidance for CFSAN officials and other Agency components, Federal and State officials, and industry concerning regulatory requirements and their implementation for cosmetics and color additive certification.   
    3. Reviews regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within OCAC's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions. 
    4. Administers the Voluntary Cosmetic Registration Program.  
    5. Manages the Quality Assurance Program for the Color Certification Program.

      There is one team within the Cosmetics Staff.
      1. Industry Activities Team
  3. Division of Color Certification and Technology (HFS-105)
    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for color additives.
    2. Provides expert guidance for CFSAN officials and other Agency components, Federal and State officials, and industry concerning color additive methodology. 
    3. Reviews regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within OCAC's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions. 
    4. Administers the Agency Color Certification Program. 
    5. Identifies substances and issues of safety concern for certifiable color additives and their raw materials.

      There is one team and one branch within the Division of Color Certification and Technology:
      1. Color Technology Team
      2. Color Certification Branch

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1-6-3 - Office Of Food Safety (HFS-300)

(Note:  Replaces the Office of Plants and Dairy Foods and Office of Seafood both of which have been abolished.)

  1. Office of the Director
    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for issues related to food safety within the scope of the responsibility of the Office. 
    2. Conducts food safety research related to chemical or microbial contamination.
    3. Administers the federal portion of the Federal/State cooperative programs.
    4. Provides toxicological evaluations and quantitative risk assessments related to the presence of industrial chemicals, process-induced toxicants and toxic elements in food.
    5. Provides expert advice to the Center Director, Deputy Center Directors, and other Center, Agency, and government officials, as well industry, international and other organizations on food safety programs and policies.
    6. As necessary, reviews industry petitions and regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within OFS's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions. 
    7. Provides expertise in acidified and low acid food technologies, including the registration and evaluation of filed processes.

      There are two teams within the office of the Director, Office of Food Safety:
      1. Food Processing Evaluation Team
      2. Chemical Hazard Assessment Team

      There is one staff and four divisions within the Office of Food Safety:
      1. Retail Food & Cooperative Programs Coordination Staff
      2. Division of Food Processing Science and Technology
      3. Division of Seafood Science and Technology
      4. Division of Plant and Dairy Food Safety
      5. Division of Seafood Safety
  2. Retail Food & Cooperative Programs Coordination Staff (HFS-300)
    1. Supports interaction and collaboration among Federal and State partners in each of the three cooperative program areas.
    2. Maintains the Interstate Certified Shellfish Shippers List and the Interstate Milk Shippers List.
    3. Serves as Agency liaison with State partners in administering the federal portion of the federal/state cooperative retail food program. 
    4. Develops and promotes the adoption and implementation of the FDA Food Code, the National Retail Food Regulatory Program Standards, and related agency policy for sound public health practices.
    5. Provides technical support and outreach to FDA staff and other Federal, State and local officials on the Food Code and other agency guidance on retail food protection. 
  3. Division of Food Processing Science and Technology (HFS-450)
    1. Conducts food safety and defense research in food processing, food packaging and biotechnology; and quality assurance as it relates to food processing and handling principles.
    2. Participates, in conjunction with the Office of Food Defense, Communication and Emergency Response (OFDCER) and others, in educational and information programs on contemporary food safety and security issues.
    3. Evaluates and accredits Grade “A” Milk laboratories and certifies state laboratory evaluation officers.
    4. Conducts proficiency testing program for milk, shellfish, Food Emergency Response Network/Laboratory Response Network (FERN/LRN), and other food laboratories.
    5. Provides consultation to FDA, and outside organizations on laboratory equipment, apparatus, methods, and facilities problems associated with laboratory examination of foods.

      There are two branches and one team within the Division of Food Processing Science and Technology:
      1. Process Engineering Branch
      2. Food Technology Branch
      3. Laboratory Proficiency and Evaluation Team
  4. Division of Seafood Science & Technology (HFS-400)
    1. Identifies and characterizes health hazards in seafood, and recommends hazards management.
    2. Develops, optimizes, validates, and promotes surveillance/monitoring methods for detection of health hazards in seafood.
    3. Provides scientific information and technical support related to seafood safety. 
    4. Maintains scientific capability and currency with emerging technologies and the scientific community at-large.

      There are two branches within the Division of Seafood Science and Technology:
      1. Chemical Hazards Science Branch
      2. Microbiological Hazards Science Branch 
  5. Division of Plant and Dairy Food Safety (HFS-315)
    1. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for issues related to the safety, defense, composition, and quality of plant foods, dairy foods, eggs, game meats, and beverages.
    2. Provides expert advice to the Center Director, Deputy Center Directors, and other Center, FDA, and government officials, and serves as principal liaison to industry, international and other organizations on issues related to plant foods, dairy foods, eggs, game meats, and beverages.
    3. As necessary, reviews industry petitions and regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within the Division's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Division can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions.
    4. Reviews and accepts or rejects the sanitary design and construction standards for milk equipment.
    5. Standardizes, certifies, and evaluates FDA, State staff, and others relevant to standardizing and certifying the evaluation of state and international milk programs.
    6. Collaborates with other parts of the Agency to identify emerging needs, and to plan, develop, and coordinate compliance programs, field assignments, and work plans, as related to food safety.

      There are two branches within the Division of Plant and Dairy Food Safety:
      1. Dairy and Egg Branch
      2. Plant Products Branch
  6. Division of Seafood Safety (HFS-325) 
    1. Develops regulations, guidance, policy, programs, position papers and advisory opinions, and recommends research priorities for issues related to the safety of seafood.
    2. Examines and appraises the implementation of seafood regulations, domestic and foreign programs, and bilateral agreements.
    3. As necessary, reviews industry petitions and regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within the Division's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Division can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions.
    4. Provides expert advice to the Center Director, Deputy Center Directors, and other key Agency and government officials, and serves as principal liaison to industry, international and other organizations on issues related to seafood safety.
    5. Develops model regulations, and provides scientific/technical support, training, evaluation and certification for State and international shellfish programs.

      There are two branches within the Division of Seafood Safety:
      1. Shellfish and Aquaculture Policy Branch
      2. Seafood Processing and Technology Policy Branch

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1-6-4 - Office Of Nutritional, Labeling and Dietary Supplements (HFS-800)

  1. Office of the Director
    1. Has primary responsibility for policy development and management of food and nutrition labeling, dietary supplements, special nutritionals (including infant formula and medical foods) and, in conjunction with the Office of Food Defense, Communication and Emergency Response (OFDCER), associated educational initiatives.
    2. Develops regulations, guidance, policy, programs, position papers, and advisory opinions, and recommends research priorities for matters within the scope of the responsibility of the Office.
    3. Provides expert advice to the Center Director, Deputy Center Directors, and other key Agency and government officials on food and nutrition labeling, dietary supplements, and special nutritionals and serves as liaison for major Agency and Department nutrition and labeling initiatives.
    4. As necessary, reviews regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within ONLDS' purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions.

      There are three staffs and one division within the Office of Nutritional Labeling and Dietary Supplements.
      1. Food Labeling and Standards Staff
      2. Nutrition Programs Staff
      3. Infant Formula and Medical Foods Staff
      4. Division of Dietary Supplement Programs 
  2. Food Labeling and Standards Staff (HFS-820)
    1. Has primary responsibility for policy and regulatory development and management of the food labeling program (other than nutrition labeling).
    2. Conducts scientific and technical review of and responds to petitions and notifications related to all aspects of food labeling. 
    3. Provides expert guidance for CFSAN officials and other Agency components, Federal and State officials, and industry concerning regulatory requirements and their implementation for food labeling including infant formula, medical foods and nutrition-related labeling.
    4. Provides expert technical advice for participation in international forums.
    5. Reviews food product labeling (including infant formula, medical foods, and nutrition labels) for adherence to regulations and appropriateness of claims and manages the Small Business Nutrition Labeling Exemption Notification Program.

      There are two teams within the Food Labeling and Standards Staff:
      1. Product Evaluation and Labeling Team
      2. Labeling Regulations Implementation Team
  3. Nutrition Programs Staff (HFS-830)
    1. Manages and conducts scientific review and analysis of issues related to nutrition and nutrition labeling, and dietary guidance recommendations, and related nutrition science issues and provides expert advice and assistance on these issues to key CFSAN and Agency components as well as international bodies.
    2. Conducts scientific and regulatory review of health claim petitions, qualified health claim petitions, nutrient content claim petitions, and FDA Modernization Act notifications for health claims and nutrient content claims.
    3. Identifies program priorities for, provides content design input to, and analysis of large-scale databases of food consumption, food composition, food ingredients, sales of processed packaged food products, and product label information.  Develops methods for monitoring US populations and special subgroups relative to use and safety of conventional foods and dietary supplements.

      There are two teams within the Nutrition Programs Staff:
      1. Nutrition Assessment and Evaluation Team
      2. Nutrition Science Review Team
  4. Infant Formula and Medical Foods Staff (HFS-850)
    1. Manages and conducts scientific review and analysis of issues related to infant formula and medical foods including petitions and notifications, and provides expert advice and assistance on these issues to key CFSAN and Agency components as well as international bodies.
    2. Provides clinical and scientific expertise on the design and conduct of clinical trials, risk assessment, adverse event reports, and educational initiatives related to infant formula and medical foods.
  5. Division of Dietary Supplement Programs (HFS-810)
    1. Has primary responsibility for the development of regulations, guidance, policy, programs, position papers  and advisory opinions, and recommends research priorities for the management of the dietary supplement program, which includes safety assessments for the New Dietary Ingredient Notification Program, structure-function notifications,  Certificates of Export,  safety assessments for dietary supplement policy, responses to petitions and industry-related notifications, post-market adverse event evaluations, and  issues related to dietary supplement safety and nutrition.
    2. As necessary, reviews regulatory actions, including information about proposed enforcement actions that is provided by the Office of Compliance, to determine if those actions within the Division's purview are supported by relevant science and established program priorities, policy, and guidance; determines, where policy or guidance do not exist, whether the Office can provide expert scientific testimony to support the actions; and provides technical review of laboratory analyses supporting proposed enforcement actions. 
    3. Evaluates adverse event reports and other sources of signals related to the safety of dietary supplements.
    4. Provides clinical/scientific expertise in the evaluation of safety information provided in New Dietary Ingredient Notifications, and provides responses to citizen petitions.

      There are two teams and one staff within the Division of Dietary Supplement Programs:
      1. Clinical Evaluation Team
      2. Dietary Supplement Regulations Implementation Team
      3. NDI Review Staff

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1-6-5 - Office of Regulatory Science (HFS-700)

(Note:  This contains some functions from the Office of Plant and Dairy Foods which has been abolished).  

  1. Office of the Director
    1. ORS, in coordination with the Office of Applied Research and Safety Assessment (OARSA), establishes (with input from other Center components), manages, and conducts a cohesive, CFSAN mission-relevant research program to provide the science for the Center's regulatory, policy, and compliance and enforcement programs.  ORS' research focuses on: 1) regulatory methods development and validation – i.e., the recovery, detection, identification and quantification of microbial pathogens and chemical contaminants from foods, including dietary supplements, and for nutrition labeling requirements; 2) the transfer of the technology to appropriate testing laboratories; and 3) the toxicology of cosmetic ingredients and contaminants and of dietary supplement contaminants.
    2. In conjunction with OARSA, serves as one of the Center's research liaisons with other FDA Centers and other organizations outside the Agency.  In conjunction with other Center Offices, initiates and coordinates collaborative studies with Center stakeholders and coordinates development of collaborative research planning with other Center, Agency, academic, and research components to achieve food safety and food defense.
    3. In conjunction with OARSA, provides expert scientific direction, guidance, and support to the Center's regulatory and compliance programs and enforcement actions, and provides expertise in both food safety and food defense to ensure the safety of the U.S. food supply and the establishment of sound counterterrorism measures.
    4. Originates, plans, and conducts research in the areas of food processing and packaging, food chemistry, food toxicants, food microbiology and cosmetics.
    5. Reviews regulatory actions for adequacy of analytical and related evidence and accuracy of the science and technical procedures and findings.
    6. In coordination with OARSA, recommends and develops the Center's research program goals and priorities on food safety threat agents, safety and health hazards to foods, dietary supplements, chemical contaminants, natural toxicants and metabolites, and conducts related research.

      There are three divisions within the Office of Regulatory Science:
      1. Division of Analytical Chemistry
      2. Division of Bioanalytical Chemistry
      3. Division of Microbiology
  2. Division of Analytical Chemistry (HFS-705)
    1. Performs laboratory analysis of samples and provides technical support and expert advice in cooperation with other Center and Agency components to support research and policy development and to assess sample compliance with laws and regulations enforced by the Agency.
    2. Reviews regulatory actions for adequacy of analytical evidence in support of Agency compliance programs.
    3. Develops, extends, refines, and validates analytical chemistry based methods for food defense threat agents, food additives, pesticides, dietary supplements, seafood toxins, and industrial chemicals that may be present in or contaminate CFSAN-regulated food and cosmetic products;  recommends analytical methods for field use in monitoring and enforcement programs for these chemicals.
    4. Provides specialized infrared, nuclear magnetic resonance and electron spin resonance spectroscopy, and mass spectrometry support to Center and the Agency and conducts research to develop and refine the application of specialized instrumentation to Center and Agency problems.
    5. Originates, plans and documents research to ascertain the nature and magnitude of chemical contamination of CFSAN-regulated food and cosmetic products via environmental and other routes for risk assessment and policy development purposes.
    6. Develops analytical testing protocols for evaluating the migration of food packaging components to foods or food simulants in order to facilitate submission and safety evaluation of indirect food additive petitions and notifications.
    7. Supports food defense measures through special research projects and scientific support during threat situations.

      There are two branches within the Division of Analytical Chemistry:
      1. Methods Development Branch
      2. Spectroscopy and Mass Spectrometry Branch
  3. Division of Bioanalytical Chemistry (HFS-715)
    1. Conducts laboratory investigations in the broad areas of elemental analysis, natural toxins, nutrients in food, ingredients in dietary supplements, and ingredients in cosmetics.
    2. Develops analytical methods and provides technical support of regulations and related policy developments in areas of Division expertise.
    3. As necessary, reviews regulatory actions for adequacy of analytical evidence in support of CFSAN and Agency compliance programs.
    4. Serves as the focal point for expertise in the development and dissemination of methods of analysis for elements and radionuclides in foods, including dietary supplements.
    5. Identifies substances and issues of safety concern for cosmetic products and their raw materials and contaminants; and develops and evaluates methods to identify and quantify potentially harmful ingredients and contaminants.
    6. Provides expert scientific and technical advice and assistance to the Center Director, Deputy Center Directors and other Center components, as well as and other FDA officials on the conduct of international seafood activities, including the development and implementation of bilateral agreements; and develops technical content for and participates in programs designed to improve compliance by industry through problem prevention.
    7. Originates, plans, and conducts laboratory research related to the scope of responsibilities of the Office.  Develops appropriate methods for analysis of nutrients in food and ingredients in dietary supplements; reviews and evaluates chemistry information and data provided in New Dietary Ingredient Notifications and Infant Formula Notifications; maintains the Center's analytical capability for food labeling compliance.

      There are two branches within the Division of Bioanalytical Chemistry
      1. Chemical Contaminants Branch
      2. Bioanalytical Methods Branch 
  4. Division of Microbiology (HFS-710)
    1. Develops, optimizes and validates methods for recovery, detection, identification, and quantitation of pathogens and/or toxins from foods and cosmetics, and the processing environment.
    2. Provides technical support of regulations and related policy developments in areas of Division expertise.
    3. As necessary, reviews regulatory actions for adequacy of analytical evidence in support of CFSAN and Agency compliance programs.
    4. Accomplishes the standardization and general acceptance of FDA-developed methodology by field personnel in their use and application, and supports compliance where questions of microbial methodology arise.
    5. Maintains FDA's food-related gateway to the PulseNet System.  Develops and applies subtyping methods to further enhance data generated for PulseNet, strain identification, and molecular epidemiological investigations.
    6. Supports food security measures through special research projects and scientific support during threat situations.

      There are two branches within the Division of Microbiology.
      1. Microbial Methods Development Branch
      2. Molecular Methods and Subtyping Branch

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