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FDA will make improvements in two areas (state partnerships on produce safety and import safety) with an increase of $25.3 million in new budget authority. This narrative provides context for this request by summarizing the resource impact of the FSMA mandate as well as the FSMA funding history, and accomplishments to date. The President’s Budget requests an additional $166.5 million in the form of user fees, which are subject to legislative authorization by Congress. To read more about how FDA will be investing funds to implement FSMA, visit www.fda.gov/fsma.
The Context and History of FSMA Funding
The President’s FY 2017 budget includes an increase of $25.3 million in new budget authority for investment in two specific areas of FSMA implementation: strengthening state capacity and collaboration with FDA on produce safety, and implementing FSMA’s new import safety system. This document provides context for the FY 2017 request by summarizing the resource impact of the FSMA mandate as well as the FSMA funding gap, funding history, and accomplishments to date. The FY 2017 request will build on the foundation laid when FSMA was enacted in 2011 to enable FDA, its state partners, and the food industry to move into the operational implementation phase.
FSMA’s Resource Impact
- FSMA mandates a sweeping modernization of FDA’s food safety program based on science- and risk-based prevention of food safety problems for both domestic and imported food. FSMA requires:
- comprehensive prevention-oriented food safety standards across the food system,
- mandated domestic inspection frequency, based on risk, to ensure high rates of compliance,
- a national integrated food safety system based on full partnership with states, and
- a new import safety system based on food safety accountability for importers, increased foreign presence, and more collaboration with foreign governments.
- In addition to the substantially increased levels of program activity mandated by FSMA, successful implementation requires a modernization of how FDA does its food safety work, including
- an increased focus on obtaining compliance with preventive control standards rather than finding and responding to legal violations after contamination or illness has occurred,
- substantially strengthening FDA technical expertise and capacity to support FDA investigators and industry in implementing the new prevention standards across our diverse and complex food system,
- furthering state partnerships and investing in state training and capacity to ensure efficient, high quality, and consistent oversight nationwide, and
- broadening interaction with foreign partners and increasing oversight of importers, who will have more responsibility for the safety of imported foods.
Highlights of Pre-FSMA Funding History
- Since the September 11 terrorist attack in 2001, funding and staffing for FDA’s food safety program have fluctuated, first rising to strengthen import oversight, then declining starting in 2004, before rising again in the 2008-2010 period in response to illness outbreaks and increasing concerns about the safety of imported food.
- When FSMA was enacted in 2011, FDA’s Center for Food Safety and Applied Nutrition (CFSAN), the unit with primary scientific and policy responsibility for implementing FSMA, had about 875 full-time-equivalent staff, fewer than 20 years earlier. This represents the net effect of budget fluctuations that occurred, despite significant new congressional mandates and sharp growth in the scale and complexity of its mission even prior to FSMA.
- For FDA’s field force, the 2008-2011 budget increases helped lay the foundation for FSMA implementation by sufficiently increasing the inspection staff to meet FSMA’s domestic inspection frequency mandate. These budget increases also permitted FDA to conduct more foreign inspections - from 350 in 2010 to more than 1,300 in 2015.
The FSMA Funding Gap Through FY 2016
- At the time of FSMA’s enactment in January 2011, the Congressional Budget Office (CBO) estimated that implementation would require an increase of $583 million in spending subject to appropriations by FY 2015.
- After increases totaling about $100 million in FY 2011 and 2012, HHS informed Congress in May 2013 that the remaining FSMA funding gap was $400-450 million.
- With a cumulative base increase of $138 million thru FY 2014, FDA estimated that the remaining FSMA funding gap was about $300 million.
- With the FY 2015 increase of $24 million, FDA revised the FSMA funding gap estimate to $276 million.
- Congressional enactment for FY 2016 of $104.5 million in new budget authority significantly reduced the remaining funding gap – to about $172 million – and enables FDA to maintain momentum toward successful implementation of FSMA.
- The FY 2017 request of $25.3 million in new budget authority helps close the FSMA funding gap by taking another step toward building state capacity to partner with FDA on produce safety and providing an additional increment of funding to implement the new FSMA import safety system. The President’s Budget also continues to propose the Food Facility Registration and Inspection Fee and the Food Import Fee.
Key FSMA Accomplishments for FY 2011-2015
The focus of FSMA implementation in the first years after enactment was on developing key regulations, stakeholder outreach and engagement, planning for implementation of the FSMA rules, investing in the states, and increasing inspection oversight for both domestic and foreign-produced food. By re‑deploying existing resources and applying the FSMA increases, FDA:
- Initiated work and made significant progress on 50 FSMA deliverables, including seven major framework regulations that required extensive data collection and risk and policy analysis;
- Developed a new strategy for implementing the FSMA rules in the field and initiated a detailed operational planning process that includes new inspection and compliance models and training approaches for FDA and state compliance staff;
- Conducted extensive stakeholder outreach and dialogue on all aspects of FSMA rulemaking and implementation, including hundreds of presentations, public and private meetings, and scores of farm and facility visits and listening sessions;
- Increased FDA technical staffing and established alliances with industry, academia, and state partners to support education, training, and technical assistance programs, especially for small and mid-size growers and processors;
- Established a strategic framework for the National Integrated Food Safety System, and strengthened state collaborative programs and partnerships in such areas as inspector training, laboratory enhancement, work planning, and data sharing;
- Increased FDA funding for state and local food safety programs from $32 million in FY 2010 to $74 million in FY 2015;
- Met the FSMA inspection frequency mandate for high risk domestic facilities two years early;
- Delivered initial training to FDA and state compliance staff in the new FSMA food safety “systems” and prevention framework;
- Increased investments in guidance development and educational materials to facilitate compliance with the final FSMA rules;
- Significantly improved oversight of imported food through the use of enhanced risk analytics and risk prioritization models that better targeted border activities, including sampling and product examinations, and foreign inspections; and
- Began building the new import safety system through:
- increased foreign inspections;
- expansion of foreign offices;
- increased collaboration with Mexico, Canada, the European Union, China, and other key trading partners; and
- establishment of a food safety system assessment and recognition program to enable appropriate reliance on foreign governments with well-developed food safety efforts.
FSMA Funding and Plans for FY 2016
In FY 2016, FDA will continue the increased levels of domestic inspection and import oversight mandated by FSMA that began in the 2011-2015 period.
- With the additional $104.5 million in FSMA funding that Congress provided for FY 2016, FDA is making investments in six areas:
- inspection modernization and training,
- the National Integrated Food Safety System,
- educational and technical assistance for industry,
- technical staffing and guidance development at FDA,
- implementation of the FSMA import safety program, and
- risk analytics and evaluation.
- Key FY 2016 investments include:
- Collaborating with industry, academia, and regulatory partners on the delivery of training and technical assistance to ensure consistent understanding and application of the FSMA rules.
- Training state and federal inspectors and compliance staff to ensure uniform application of the new FSMA standards.
- Building state capacity to foster and oversee compliance with the preventive controls and produce safety rules.
- Putting regulatory procedures and infrastructure in place to implement the new FSVP rule.
- Developing new tools for data analysis and evaluation.
FY 2017 Budget Request
The FY 2017 Budget for Food Safety is $1.5 billion, of which $1.3 billion is budget authority and $193 million is user fees, most of which would need to be authorized legislatively by Congress. The Budget includes an increase of $192 million for FSMA implementation within the food safety total, of which $25.3 million is in new budget authority.
FSMA rules are final for produce safety, preventive controls in food and feed facilities, and imports, with staggered compliance dates for industry that depend, in part, on the size of the business.
- This makes FY 2017 the crucial year for ramping up FSMA implementation investments in the two areas outlined in the President’s FY 2017 budget request:
- produce safety through the National Integrated Food Safety System, and
- implemention of the FSMA import safety program.
- The budget request also proposes legislative authorization of two new user fees.
- Food and Feed Import Fee to help modernize and streamline the entry process to facilitate entry of safe food.
- Food and Feed Facility Registration and Inspection Fee to make investments in inspection modernization, training, and state capacity building.
FDA’s Program Alignment Initiative
FDA’s total commitment to FSMA implementation is reflected in the internal transformation it is undergoing through the Program Alignment Initiative.
- This initiative includes specialization of FDA’s food and feed inspection and compliance workforce, and the vertical integration of the FDA technical experts and policymakers in headquarters with the field force that conducts inspections and most compliance activities.
- The vision of Program Alignment and FDA’s FSMA implementation strategy centers on enhanced food safety expertise and training and better tools for ensuring that FDA’s oversight is risk-based, efficient, and effective and results in consistent, public health decision making.
- The increase in base funding provided by FDA’s FY 2017 budget authority request will contribute to fulfilling this vision in 2017 and beyond.