Implementing Regulatory Controls Presented by a Panel of the First Cohort of IFPTI Fellows

Transcription

1 Implementing Regulatory Controls Presented by a Panel of the First Cohort of IFPTI Fellows Angela Montalbano NYS Dept. of Agriculture and Markets Natalie Adan Georgia Dept. of Agriculture Julie Henderson Virginia Department of Health June 5, 2012

2 Introduction As the US transitions to safeguard the food supply within and beyond our borders by implementing the newly enacted FDA FSMA requirements numerous states have been implementing preventative measures that address domestic and imported food concerns to improve public health.

3 Background IFPTI Research Projects parallel mandates in FDA s FSMA Preventative Measures using Regulatory Controls within state jurisdictions to prevent food safety problems.

4 Background Since the federal Bio-Terrorism Act of 2002 NYSDAM took a proactive approach by dedicating 6 Bio-Terrorism Food Inspectors to conduct imported food surveillance and investigations. Each of these inspectors are commissioned and credentialed with the FDA and have received specialized training on imported foods.

5 Targeted Enforcement Surveillance of Imported Foods in New York State Surveillance of particular imported foods, in specific locations at specific times of the year. The research revealed a higher percentage of food safety enforcement actions during these surveillance investigations. Food samples, food seizures, destruction, recalls, FDA Import Alerts, USDA Import Alerts

6 Research Conclusion In conclusion of the research it was determined there would be a higher percentage of imported food safety actions if all inspectors were trained to conduct imported food investigations as a routine protocol.

7 Follow Up NYS Food Inspection Staff are now fully trained in imported food concerns and issues. Currently ALL food inspectors conduct interagency imported food investigations resulting in a higher number of food safety actions including FDA Import Alerts!

8 FDA Import Alert 14 FDA Import Alerts were initiated by Bioterrorism Food Inspectors since inception of the program. 8 FDA Import Alerts were initiated by Food Safety Inspectors between August 2011 and February 2012.

9 Uneviscerated Processed Fish / Lead in Can Seams

10 Honey Standard of Identity and/or the presence of unapproved antibiotics (chloramphenicol / Sulfonamide)

11 MILK DRINKS USDA Permits Required Health Certificate from Country of Origin Foot and Mouth Disease

12 Deer Antlers / Tendons Ruminant Diseases

13 Meat Products Simmenthal / Bisto Beef products imported from Italy No English translation on label Prohibited in the US due to disease (BSE) status of Italy at the time of importation

14 Meat Products Smuggled Dumpling skins w/ pork from China

15 Smuggled Imported Poultry and Pork Products from China

16 The New York Model The New York Model: A Cooperative Federal- State Approach for Monitoring Imported Foods: (Joe Corby -AFDO, Bob Hart -FDA) could possibly serve as a model for other areas with high levels of imported food.

17 Training FDA and IFPTI have identified the need to develop a course on imported food. FDA has assigned the University of Tennessee to begin course development under one of its IFSS Training grants.

18 IMAGINE If ALL 50 states utilized integration of government resources providing a broad field of knowledge, jurisdiction and regulatory actionlevel -which is a strong component of an integrated food safety system. RESULT -a tremendous increase of Regulatory Food Safety Actions safeguarding the nation s food supply.

19 Questions

20 Finished Product and Finished Product Ingredient Testing as a Preventative Control Georgia Department of Agriculture is using the implementation of finished product and finished product ingredient testing to significantly minimize or prevent identified hazards from occurring.

21 Georgia Senate Bill 80 was created & passed during the 2009 legislative session in response to foodborne outbreaks. This Law requires GA manufacturing facilities to conduct finished product & finished product ingredient testing. The ability to detect contaminated or adulterated foods before they enter the market place can reduce foodborne illness outbreaks from occurring.

22 Additionally, the food processing plants are required to report positive test results within 24 hours to the GDA. This differs from the FDA s RFR in that reporting is required whether the product remains in the company s control or not. This reporting requirement allows for a comprehensive investigation to determine the reason for the positive result. Food processing plants in Georgia are also encouraged to have a Written Food Safety Plan, which consists of a prerequisite program, records, and other components.

23 Preventative Control Finished product testing is the cornerstone to preventative controls. These additional responsibilities have initiated more frequent communication between GDA and the food industry in GA resulting in a stronger relationship and more unified approach to food safety. Processing plants have used this opportunity to make positive improvements and change various business practices.

24 Each processing facility must identify any potential hazards associated with producing their product and verify that these hazards have been controlled. Food Processing plants cannot rely solely on testing of finished product results, but instead should use as one method of verification for the facility s overall food safety plan.

25 Conclusion The commitment the food processing plants have toward food safety and the progressive methods they are willing to use to achieve further prevention of foodborne illness reinforce the commitment of industry to making the necessary enhancements to improve food safety and reduce foodborne illness. If regulatory agencies & food industry can agree on the common goal of providing safe food, the efforts made to realize this goal will be easily met & beneficial for all parties involved, including the consumer.

26 Imagine Our hope is that these preventative controls will be implemented at a federal level to achieve a level playing field and build a consistency that will not impede commerce. The ability to detect contaminated or adulterated foods before the unsafe foods enter the market place can reduce foodborne illness outbreaks from occurring.

27 The Interstate Shellfish Sanitation Conference In 1984, the U. S. Food and Drug Administration entered into a Memorandum of Understanding with the ISSC recognizing the ISSC as the primary voluntary organization of State shellfish regulatory officials that provide guidance and counsel on matters for the sanitary control of shellfish. The purpose of the ISSC is to provide a formal structure for State regulatory authorities to participate in establishing updated regulatory guidelines and procedures for uniform state application of the Program. The NSSP Guide for the Control of MolluscanShellfish consists of a Model Ordinance, supporting FDA guidance documents and interpretations as well as recommended forms.

28 The Manufactured Food Regulatory Program Standards (MFRPS) establish a uniform foundation for the design and management of State programs responsible for the regulation of food plants. The elements of the program standards describe the best practices of a high-quality regulatory program. Achieving conformance with them will require comprehensive selfassessment on the part of a State program and will encourage continuous improvement and innovation. MFRPS Manual September 2010

29 What does performance management and continuous quality improvement mean? Accountability! Quality Assurance QA The systematic monitoring and evaluation of the performance of an organization or its programs to ensure that standards are being met. Are we doing things right? FDA evaluations Performance Measurement and Continuous Quality Improvement QI- Quality Improvement The use of a deliberate and defined improvement process, which is focused on activities that are responsive to stakeholder needs and improving public health. CQI- Continuous Quality Improvement and Performance Management - An organizational commitment to systems change to execute a continuous flow of improvements that meets or exceeds the expectations of the stakeholder and generally includes a link to the organization s strategic plan and goals. Are the right things being done? Strategic Planning - MFRPS

30 Outcomes of Performance Measurements? Transparency Improved planning, coordination and delivery of services. Identification of strengths and weaknesses. Performance measurement is not something done to you by someone else but something done together, in partnership, to improve our ability at every level local, state, regional, and national to achieve our common goals. former Assistant Secretary for Health, Philip R. Lee

31 Results of IFPTI Project Proposal No Internal Authority Self-Assessment Using a National Program Standards Manual Requirements of the Authority. Program Evaluation. The Authority shall conduct a selfassessment using the National Programs Standards Manual and report annually to the U.S. food and Drug Administration the results of the assessment. The NSSP Evaluation Criteria Committee has been charged with this proposal as adopted for the 2013 Interstate Shellfish Sanitation Conference.

32 The ISSC can play an active role in helping the state public health and regulatory agencies begin to transform the organizational culture from a typical reactive approach to a proactive one that includes continuous improvement. Long term leadership buy-in is essential. The state shellfish programs look to the ISSC and the FDA for not only a Model Ordinance but for guidance and direction. Should the ISSC continue to focus on quality assurance by depending on the FDA s program evaluations which mostly entail field inspections of shellfish plants and growing areas? What W. Edwards Deming called reliance on inspection to improve. Doesn t it make sense for the FDA to include shellfish in MFRPS to follow along with retail, manufactured foods and now feed and begin to break down those silos that we speak so much of?

33 Public Health agencies have intermittent public health crises. Virginia in 2011 had the second Vibrio vulnificus illnessattributed to shellfish harvested from a Virginia growing area. This resulted in significant changes in harvest and post harvest handling requirements to the shellfish industry. Emergency regulation amendments. Industry education HACCP plan changes, HACCP records, Inspection increases -Enforcement-Criminal action, Informal Fact Finding Conferences, Consent Orders etc. How could MFRPS and Strategic Planning have helped us? Using a performance management approach allows public health agencies to work more effectively by aligning performance measures, activities, and spending with public health priorities. Gives an increased ability to anticipate and manage change.

34 IMAGINE Forward thinking public health innovators working with other state regulators helping them to become leaders. States and the FDA in open frank discussions about training, compliance & resources. ISSC members sharing with other states lessons learned and goals achieved. What states experienced at the Inaugural MFRPS Training Course in Kansas City, MO in March, 2012 can happen for the ISSC!

35 Julie Henderson Plant Program Manager Virginia Department of Health Division of Shellfish Sanitation (804) Julie.