FSMA Implementation Management Structure

How do you prepare more than 50 rules, guidance documents, reports and studies within strict timeframes? That is what FDA is charged with doing under the Food Safety Modernization Act that was signed into law on January 4, 2011.

To meet this challenge, the leadership of the FDA Foods Program has put in place a structured implementation process to ensure clearly defined roles and accountability for each FSMA deliverable, transparent prioritization of tasks based on public health impact, and streamlined decision making and clearances.

The implementation teams described here report directly to the senior leadership of the Foods Program, drawing fully upon all relevant expertise and capacity from across FDA but working through a streamlined matrix management system that is intended to expedite the work needed to implement FSMA.

A chart representation of the FSMA implementation structure is also available.

Implementation Executive Committee (IEC)

Accountability is key to performance. Therefore, an Implementation Executive Committee (IEC) has overall responsibility and accountability for the successful implementation of the FSMA.

The IEC is chaired by Mike Taylor, Deputy Commissioner for Foods, who acts on behalf of and is directly accountable to FDA Commissioner Margaret Hamburg. The other members of the IEC are Mike Landa, Acting Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, Director, Center for Veterinary Medicine; Steve Solomon, Deputy Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs; Ralph Tyler, FDA Chief Counsel; and David Dorsey, Deputy Commissioner for Policy, Planning and Budget.

This committee determines the implementation strategy and priorities, provides policy guidance, approves the implementation plans and their timing, assigns the required resources, and monitors the execution of those plans. This committee is supported by a chief implementation manager and a team of trained project managers.

Implementation Leadership Teams

To effectively implement the FSMA’s transformative and integrated approach to food safety reform, FDA is focusing on six major implementation areas, each headed by an Implementation Leadership Team. Reporting to these teams are task-specific working groups with hands-on responsibility for developing the regulations, reports, guidance and processes required by the legislation.

The six implementation teams are:

1. Prevention Standards
2. Inspection and Compliance
3. Imports
4. Federal/State Integration
5. Fees
6. Reports and Studies

Prevention Standards Team

Team Leader: Don Kraemer

The Prevention Standards Team is divided up into seven working groups assigned the following areas:

• Produce Safety Regulation
• Produce Safety Guidance
• Preventive Controls Regulation
• Preventive Controls Guidance
• Safe Food Transport
• Food Defense
• Contaminants

Among the tasks assigned to these working groups are:

• Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.
• Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, and animals in the growing area and water.
• Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.

Inspection and Compliance Team

Team Leader: Barbara Cassens

The Inspection and Compliance Team is divided into seven working groups assigned the following areas:

Mandatory Recall and Recall Communications

• Administrative Enforcement Tools
• Registration
• Frequency of Inspection
• Manner of Inspection/Food Safety Plan Review
• Tracing
• Reportable Food Registry Improvements

Among the tasks assigned to these working groups are:

• Mandated inspection frequency: The FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.
• Records access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.
• Mandatory recall: The FSMA provides FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA.
• Expanded administrative detention: The FSMA provides FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law (administrative detention is the procedure FDA uses to keep suspect food from being moved).
• Conduct pilot studies for product tracing.
• Suspension of registration: FDA can suspend registration of a facility if it determines that the food poses a reasonable probability of serious adverse health consequences or death. A facility that is under suspension is prohibited from distributing food.

Imports Team

Team Leader: Roberta Wagner

The Imports Team is divided up into seven working groups assigned the following areas:

• Importer Verification and Voluntary Qualified Importer Program
• Import Certification
• Accredited Third-Party Certification
• Lab Accreditation
• International Capacity Building
• Comparability
• Prior Notice and Smuggled Food

Among the tasks assigned to these working groups are:

• Foreign Supplier Verification Program: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe.
• Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports.
• Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.
• Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities.
• Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

Federal/State Integration

Team Leader: Joe Reardon

The Federal/State Integration Team is divided up into three working groups assigned the following areas:

• Operational Partnership
• Capacity Building
• Training

Among the tasks assigned to these working groups are:

• State and local capacity building: FDA must develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies. The FSMA provides FDA with a new multi-year grant mechanism to facilitate investment in State capacity to more efficiently achieve national food safety goals.
• Reliance on inspections by other agencies: FDA is explicitly authorized to rely on inspections of other Federal, State and local agencies to meet its increased inspection mandate for both domestic and foreign facilities. The FSMA also allows FDA to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.

Fees Team

Team Leaders: Roxanne Schweitzer & Bob Miller
The Fees Team has one working group for Inspection and Auditor Fees. This group is responsible for developing processes and guidance on registration and the assessment and collection of fees in the following areas:

• Inspection-Related Fees: This includes assessing and collecting fees for facility re-inspection (guidance), failure to comply with recall order (guidance), the voluntary qualified importer program (guidance), and importer re-inspection (guidance). In addition, the team will publish guidelines for adjustment of fees for re-inspection of small plants and will establish export certification fees for foods.
• Auditor Fees: This group will develop a regulation for a reimbursement program that requires auditors to reimburse FDA for work performed to establish and administer the accreditation system.

Reports and Studies Team

Team Leader: David Dorsey

The Reports and Studies Team is establishing working groups for each report and study required under the FSMA. The Team’s responsibilities include the following reports and studies:

• Report on capacity building for safety and supply chain security
• Plan to expand capacity of foreign governments
• Report on efforts to cooperate with other agencies
• Report on the basis for selecting countries with foreign offices
• Report on Food Emergency Response Network
• Report on pilot projects on tracing 
• Report on use of mandatory recall authority 
• Study and report on the food processing sector 
• Study and report on unique identification numbers

Strategic Communications and Outreach Team

Team Leader: Sharon Natanblut

Communication and outreach are key to transparency. A Strategic Communications and Outreach Team is planning events and other ways of keeping stakeholders informed and getting their timely input. For example, on March 29, FDA held a public meeting on the import provisions of the FSMA. In addition, FDA staff have spoken about FSMA at conferences around the country, answering questions along the way.

Communication specialists are embedded with the subject matter teams and working groups to keep up to date on team activities and facilitate communication with stakeholders that would be most interested in the work of specific teams. Other communication specialists are devoted to developing the FSMA web site and keeping it up to date, developing information materials for stakeholders, and conducting outreach with small businesses.

How to Ask Questions or Provide Input

In addition to having the opportunity to ask questions at public meetings, conferences and other events, FDA has posted “Frequently Asked Questions” on its web site. You may also send questions to fsma@fda.hhs.gov.