Resources for You
Information available related to Federal/State Integration under the FDA Food Safety Modernization Act (FSMA).
- Enhanced Partnerships Critical for Transformation of Food Safety System
- Frequently Asked Questions
- Sections of the Law Relating to Enhanced Partnerships
- Speeches and Statements
- Memorandum of Understanding Related to Federal/State Integration
- Assisting the Integrated Food Safety System's National Food/Feed Training Program
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. In doing so, the statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals.
Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done. Congress has established specific implementation dates in the legislation. The funding the Agency gets each year, which affects staffing and vital operations, will affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.
The following are examples of enhanced collaboration:
- 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.
- Foreign capacity building: The law directs FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries. One component of the plan is to address training of foreign governments and food producers on U.S. food safety requirements.
- 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 domestic 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.
Additional partnerships are required to develop and implement a national agriculture and food defense strategy, to establish an integrated consortium of laboratory networks, and to improve foodborne illness surveillance.
FS.1 Does FSMA change any of the authorities over food safety currently divided between FDA and USDA?
No. However, FSMA does provide for FDA and USDA and other federal and state/local food safety agencies to work together more closely.
FS.2 How will State, local, tribal and territorial agencies provide input into the sections of FSMA dedicated to enhanced partnerships?
Individuals from States, localities, tribes, and territories as well as affiliated organizations will have the opportunity to provide input through a series of project teams. One of the primary methods of input is through the Partnership for Food Protection (PFP). The PFP is a group of dedicated workers from Federal, State, and local governments with roles in protecting the food supply and public health. The PFP workgroups were formed following 50-state workshops in 2008 and 2010 and are working directly with members of FDA to improve food safety at all levels of government. View the Final Report from the 2012 50 State Workshop.
FS.3. How will FSMA support the vision of an Integrated Food Safety System (IFSS)?
FSMA calls for enhanced partnerships and integration with our Federal, State, local, tribal and territorial partners. The Partnership for Food Protection (PFP), of which FDA is a member, has been working to develop an integrated food safety system with strengthened inspection, laboratory, and response capacity. The Federal-State Integration team has been and will continue working closely with State, local, tribal, and territorial partners to develop and implement the IFSS. Examples of current ongoing activities include efforts to standardize training and expertise levels of inspectors. Another example of integration is the effort to develop national standards for federal, state, and local laboratories. These national standards, including laboratory accreditation, will increase the efficiency of the laboratories in responding to outbreaks and facilitate the rapid acceptance of lab analytical data for regulatory actions. The efforts of the PFP workgroups together with the agency’s implementation of provisions of FSMA that support enhanced partnerships will further develop the IFSS. To access the full vision document for the IFSS, go to Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity.
FS.4 With the current financial state of many State and local health agencies, how will State and local governments be able to assist FDA in implementing new provisions of FSMA, such as the increased inspection mandate?
FSMA is one of the top priorities in FDA at this time. The Federal-State Integration team is working to determine funding mechanisms and provide other types of support, such as training, to our State and local partners. FSMA created mechanisms for providing necessary funds to our regulatory partners to support enhanced food safety efforts, and FDA is diligently evaluating the implementation of those sections of the legislation to ensure that States and local governments are funded adequately to help implement FSMA.
FS.5 When I think of the Food Safety Modernization Act, I only think of food that people consume. What is the Federal-State Integration team doing about food for animals?
The Federal-State Integration team realizes the importance of improving animal food regulations and standards along with human food. The Federal-State Integration team has members from the Center of Veterinary Medicine at FDA and is partnering with organizations such as the Association of American Feed Control Officials to ensure that food for animals is safe.
FS.6 Considering the large task at hand, is the Federal-State Integration team going to partner with anyone else to help them implement FSMA?
The Federal-State Integration team has engaged various associations and State, local, territorial, and tribal agencies in its implementation efforts. The Federal-State Integration team is also partnering with other Federal agencies, including the Center for Disease Control (CDC), the Department of Agriculture (USDA), and the Department of Homeland Security (DHS) to improve foodborne illness outbreak response across the nation.
FS.7 Could you elaborate more on how you are looking to engage partners, particularly NGOs, within the regulated community to conduct compliance inspection and facilitate reporting to better leverage limited governmental resources and staff?
As part of the integrated food safety system and the formation of a national work plan, FDA/ORA has formed a work group to look at how to engage partners. FDA/ORA also has a field management directive (FMD) that outlines improvements in communications between FDA and state agencies.
The Association of Food & Drug Officials (AFDO), on behalf of the FDA and in support of FSMA Section 205(c)(2) is distributing a capacity survey to state, local, tribal and territorial food and feed safety agencies. The results will assist the FDA in working with its state and local partners to enhance food safety efforts. See AFDO's press release, Food and Feed Safety Agencies to be Surveyed in Support of FSMA , for additional information.
FS.8 What are some of FDA's funding mechanisms to support state and local governments in food safety activities?
FDA has recently issued two Requests for Applications (RFAs) related to emergency response/recall of foods and capacity building to undertake inspections. These RFAs were published in June 2012 and can be found at Department of Health and Human Services RFA Grant RFA-FD-12-026s and RFA-FD-12-027. These RFAs are cooperative agreements in support of FSMA Section 210(a), which authorizes FDA to provide grants to eligible entities -- State, Local, Tribal, and Territorial governments, and nonprofit food safety training entities that form partnerships with institutions of higher learning. FDA provides funding through contracts, grants, and cooperative agreements to state and local governments in several critical areas including food and feed inspections, as well as feed inspections to ensure compliance with the BSE rule, coordinating and accelerating responses to foodborne outbreaks, improving standardization of inspections, innovative food defense activities, increasing laboratory emergency response capabilities and to support food protection task force activities. In addition to funding these activities, FDA provided an additional $15 million to the states in 2011 to support continued growth and capacity building in these critical areas, and in FY12 FDA plans to provide up to $10 million to state and local partners to support manufactured and retail food program standards implementation, laboratory accreditation and increased participation in the Rapid Response Team project.
- SEC 110. Building domestic capacity
- SEC 209. Improving the training of State, local, territorial, and tribal food safety officials
- Improving Food Safety and Defense Capacity of State and Local Level, Review of State and Local Capacities
Request for Comments
On July 1, FDA and United States Department of Agriculture (USDA), National Institute of Food and Agriculture (NIFA), entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training, and other projects, as part of a Memorandum of Understanding with USDA’s Research, Education and Economics Agencies.
- On September 16, 2011, The Office of Acquisition and Grants (OAGs) issued grants at various funding levels to seven institutions for FDA/ORA Division of Human Resource Development. The primary focus of the awardees/FDA collaborative venture is to design, develop and disseminate food/feed safety training programs that are consistent with the Manufactured and Retail Food Standards, as well as 3rd party criteria for accreditation. More >