Food Safety and Inspection Service
Ensuring that the Nation's Commercial Supply of Meat, Poultry, and Egg Products are Safe Domestically and Internationally
Melanie Abley, MS, PhD Senior Staff Officer Office of Policy and Program Development Food Safety and Inspection Service, USDA
Regional Occupational Health Conference: It’s a Small World: from Global to Local Threats John Hopkins University October 22, 2016
2 Food Safety and Inspection Service Overview
• Background on FSIS • Foodborne pathogens – threats domestically and internationally • Tips to avoid travelers diarrhea • FSIS international equivalency process • Food borne outbreak investigations • Food defense plans
3 Food Safety and Inspection Service: Mission in Action
We are the public health agency in the USDA responsible for ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled.
Our Authority • Federal Meat Inspection Act (FMIA), 1906 •Agricultural Marketing Act (AMA), 1946 Through a series of Acts, Congress empowers FSIS to inspect all meat, •Poultry Products Inspection Act (PPIA), 1957 poultry, and processed egg products •Humane Methods of Slaughter Act (HMSA), 1958 in interstate commerce. •Egg Products Inspection Act (EPIA), 1970
4 Food Safety and Inspection Service: One Team, One Purpose
We work together More than to accomplish our mission of 9,600 employees protecting strong public health.
5 Food Safety and Inspection Service: The Threat of Foodborne Illness
Each year, foodborne illness. . .
Sickens Results in Causes Costs consumers 1 in 6 128k 3,000 $6.9 Americans Hospitalizations deaths billion
Shiga toxin-producing E. coli pathogens Listeria monocytogenes most frequently affect Salmonella our regulated products. Campylobacter 6 Food Safety and Inspection Service Foodborne Pathogens ‐ Bacteria
Multipliers
Laboratory‐ Under‐ Under‐ Total, mean Travel‐ related, Pathogen confirmed repor ng† diagnosis‡ (90% CrI) % Bacteria Bacillus cereus, 85# 25.5 29.3 63,623 (15,770– <1 foodborne¶ 147,827)
Brucella spp. 120** 1.1 15.2 2,003 (1,302– 16 2,964) Campylobacter 43,696†† 1.0 30.3 1,322,137 20 spp. (530,126– 2,521,026) Clostridium 25** 1.1 2.0 56 (34–92) <1 botulinum, foodborne¶ Clostridium 1,295# 25.5 29.3 969,342 <1 perfringens, (192,977– foodborne¶ 2,492,003) 7 Food Safety and Inspection Service Foodborne Pathogens ‐ Bacteria
Multipliers
Laboratory‐ Total, mean (90% Pathogen confirmed Under‐repor ng† Under‐diagnosis‡ CrI) Travel‐ related, % Bacteria STEC O157 3,704†† 1.0 26.1 96,534 (26,982– 4 227,891)
STEC non–O157 1,579†† 1.0 106.8 168,698 18 (17,163– 428,522) ETEC, 53# 25.5 29.3 39,781 (53– 55 foodborne¶ 102,250)
Diarrheagenic E. 53 25.5 29.3 39,871 (53– <1 coli other than 102,378) STEC and ETEC Listeria 808†† 1.0 2.1 1,662 (582– 3 monocytogenes 3,302) 8 Food Safety and Inspection Service Foodborne Pathogens ‐ Bacteria
Multipliers
Laboratory‐ Total, mean (90% Pathogen confirmed Under‐repor ng† Under‐diagnosis‡ CrI) Travel‐ related, % Bacteria Mycobacterium 195†† 1.0 1.1 208 (177–241) 70 bovis
Salmonella spp., 41,930†† 1.0 29.3 1,229,007 11 nontyphoidal‡‡ (772,129– 2,008,076) S. enterica 433†† 1.0 13.3 5,752 (299– 67 serotype Typhi 17,357)
Shigella spp. 14,864†† 1.0 33.3 494,908 15 (93,877– 1,420,877) Staphylococcus 323‡# 25.5 29.3 241,994 <1 aureus, (72,584– 9 foodborne¶ 531,398) Food Safety and Inspection Service Foodborne Pathogens ‐ Bacteria
Multipliers
Laboratory‐ Total, mean (90% Pathogen confirmed Under‐repor ng† Under‐diagnosis‡ CrI) Travel‐ related, % Bacteria Streptococcus 15# 25.5 29.3 11,257 (15– <1 spp. group A, 78,104) foodborne¶ Vibrio cholerae, 8** 1.1 33.1 277 (94–630) 70 toxigenic V. vulnificus 111** 1.1 1.7 207 (138–287) 2
V. 287** 1.1 142.4 44,950 (23,706– 10 parahaemolytic 74,984) us Vibrio spp., 220** 1.1 142.7 34,585 (21,756– 11 other 51,535) Yersinia 950†† 1.0 122.8 116,716 7 enterocolitica (36,363– 10 204,898) Food Safety and Inspection Service Foodborne Pathogens ‐ Parasites
Multipliers
Laboratory‐ Total, mean (90% Pathogen confirmed Under‐repor ng† Under‐diagnosis‡ CrI) Travel‐ related, % Parasites Cryptosporidium 7,594†† 1.0 98.6 748,123 9 spp. (162,961– 2,135,110) Cyclospora 239†† 1.0 83.1 19,808 (239– 42 cayetanensis 65,135) Giardia 20,305** 1.3 46.3 1,221,564 8 intestinalis (892,393– 1,633,965) Toxoplasma 1.0 0 173,995 <1 gondii (134,593– 218,866) Trichinella spp. 13** 1.3 9.8 162 (44–355) 4
11 Food Safety and Inspection Service Foodborne Pathogens ‐ Viruses
Multipliers
Laboratory‐ Total, mean (90% Pathogen confirmed Under‐repor ng† Under‐diagnosis‡ CrI) Travel‐ related, % Viruses Astrovirus NA NA NA 3,090,384 0 (2,350,589– 3,833,232) Hepatitis A virus 3,576** 1.1 9.1 35,769 (21,505– 41 60,715) Norovirus NA NA NA 20,865,958 <1 (12,842,072– 30,743,963) Rotavirus NA NA NA 3,090,384 0 (2,350,589– 3,833,232) Sapovirus NA NA NA 3,090,384 0 (2,350,589– 3,833,232) 12
Food Safety and Inspection Service: FSIS ensuring safe meat, poultry and egg products internationally - What is Equivalence?
Equivalence is the process of determining whether a country’s food safety inspection system achieves an appropriate level of protection for public health as applied domestically in the US
14 Food Safety and Inspection Service: Why is This Important?
Importance Of Equivalence • World Trade Organization (WTO)/Sanitary and Phytosanitary (SPS) Measures • Protects public Agreement health • Ensures • Equivalence determinations of international an exporting country’s compliance with regulatory food safety food safety policies inspection system for meat, poultry, or egg products is a • Facilitates trade prerequisite for trade with the US 15 Food Safety and Inspection Service: Initial Equivalence
Initial equivalence is undertaken when a country wants to export meat, poultry, or egg products to the US for the first time
Initial Equivalence Process: 1. Country Submits Written Request to FSIS 2. Document Submission through Self‐Reporting Tool 3. Document Review 4. On‐Site Verification Audit 5. Public Notification‐Proposed Rule in Federal Register 6. Final Determination of Equivalence‐ Final Rule in Federal Register; FSIS sends the country a letter • Requesting a sample health certificate and list of eligible certified establishments approved by the CCA to export to the US; and • Instructions about exporting meat, poultry, or egg products to the US 16 Food Safety and Inspection Service: Ongoing Equivalence
Ongoing equivalence applies to countries currently eligible to export meat, poultry or egg products to the US
FSIS Verification of Ongoing Equivalence: • Routine audits of the country’s inspection system • Information to provide FSIS annually no later than May 18 • Updated SRT responses OR communicate to FSIS that the country has verified its SRT responses and the responses are accurate and complete • Up‐to‐date list of all certified establishments eligible to export to US • Updated government residue control program, including previous year’s test results and reactions to residue findings • Updated microbiological sampling and testing program, including previous year’s test results and reactions to findings • Reinspection of product at point‐of‐entry • Country’s response to US Point‐Of‐Entry (POE) violations 17 Food Safety and Inspection Service: An Example of an Equivalent Food Safety Procedure Different from FSIS
Using a Sanitary Dressing Program to Ensure Raw Beef Products Are Free of Shiga Toxin‐Producing Escherichia coli (STEC)
• FSIS has a food safety objective‐based criterion that the CCA ensures that raw beef products are free of STEC at the end of the production process.
• In the US, beef slaughter and processing establishments use a combination of antimicrobial treatments and sanitary dressing procedures to control STEC.
o Controls implemented focus on carcasses and other conditions (i.e. High Event Periods) and classes of raw beef products with increased likelihood of detecting STEC.
18 Food Safety and Inspection Service: An Example of an Individual Sanitary Measure Equivalence Determination
Using a Sanitary Dressing Program to Ensure Raw Beef Products Are Free of Shiga Toxin‐Producing Escherichia coli (STEC) • Other countries prohibit the use of antimicrobial treatments and have submitted requirements that raw beef establishments are to implement robust sanitary dressing procedures to prevent STEC . o The CCA has verification procedures (including rigorous microbial sampling) that demonstrate sanitary dressing procedures ensure that raw beef products are free of STEC at the end of the process. o The CCA’s controls include a focus on carcasses as well as other conditions (high event periods) and classes of raw products that collectively increase the likelihood of detecting STEC if present. o Based upon the evaluation of the CCA’s verification procedures, controls, and receipt and evaluation of ongoing microbial results from the CCA, FSIS has determined this approach to be equivalent because
the CCA demonstrates that it meets the food safety criterion. 19 Food Safety and Inspection Service: Food Borne Outbreak Investigation Essentials
• In collaboration with public health partners, FSIS collects and evaluates epidemiological,
Environmental microbiological, and traceback Health evidence • Epidemiology: Who, what, when, where, and how Laboratory • Laboratory: Food, environmental, and clinical Epidemiology samples • Environmental Health: Traceback in addition to assessments and inspection Source: http://www.cdc.gov/vitalsigns/foodsafety‐2015/infographic.html#infographic Food Safety and Inspection Service: Federal Effort
• Food safety policies • Disease surveillance • Inspection and enforcement • Outbreak Investigation • Product recall and traceback • Investigation of farm and production facilities Source assessment Problem identification Risk assessment Source implication Risk management Food Safety and InspectionPFGE Service: Comparisons PFGE Comparisons
USDA performs PFGE on Local, state, and federal agencies product isolates perform PFGE on human clinical and food isolates
VetNet Database PulseNet Database
Investigate potential outbreaks
Identify potential problems in regulated establishments
23 Food Safety and Inspection Service: FSIS Investigation Objectives
Epidemiologic and microbiologic analysis
Traceback and trace forward
Control actions
In‐plant assessments Food Safety and Inspection Service: Illness Reporting to FSIS
• Speed and accuracy are Federal essential in foodborne illness Partners investigations (CDC, FDA) • Identification of suspect
product quickly: FSIS/Office of Others in FSIS State Public Health (Microbial Partners Science/ Characterization • May prevent further illnesses Applied Branch Eastern (Public Health Epidemiology and Agriculture) Laboratory, • May prevent future outbreaks Staff OIEA CID, OFO) • Ensures the public’s confidence
in the food supply and public Other Surveillance health system Sources (Media tracking, • Minimize economic and public consumer complaints) health costs Food Safety and Inspection Service: Steps Leading to an Investigation
• Watch: An illness cluster with a likelihood of involvement of FSIS‐regulated product where additional exposures have not been ruled out • Case‐patients consumed ground beef, lettuce, unpasteurized milk, and visited petting zoo prior to illness onset
• Investigation: An illness cluster with a strong likelihood of involvement of FSIS‐regulated product that may necessitate additional Agency resources • 8/10 case‐patients consumed ground beef prior to illness onset • Purchase records are available for traceback Food Safety and Inspection Service: Environmental Assessment and Traceback/Trace forward
• FSIS works in coordination with federal, state, local, and territorial health, environmental health, and agriculture department personnel during traceback investigations • Objectives • Identify establishment where implicated product originated • Obtain information about the establishment’s suppliers • Identify distribution of implicated product • Locate or detain the product in commerce Food Safety and Inspection Service: Investigation Challenges
• Lack of epidemiologic or product information (case‐ patient lost to follow‐up, refused interview)
• Limited resources at state/local for laboratory analysis or interviews
• Insufficient or unavailable recordkeeping
• Inability to trace to the source (e.g., lack of grinding records) Food Safety and Inspection Service: Agency Action
• Agency action is not limited to recall of meat and poultry products • If human illness has been definitively linked to FSIS‐ regulated product, FSIS may take the following actions: • Issuance of a public health alert • Increased frequency of microbial sampling • Enhanced inspection • Comprehensive Food Safety Assessment (FSA) • Incident Investigation Team (IIT) • Notice of Intended Enforcement (NOIE) • Withholding action or suspension without prior notification Food Safety and Inspection Service: Food DefenseWhat – Ensuring is Food meat, Defense?poultry and egg products are safe from intentional threats domestically and internationally Food defense is the protection of food products from intentional adulteration where there is an intent to cause public health harm or economic disruption
30 Food SafetyWhy and InspectionWould Service: Someone Intentionally Why would someoneAdulterate intentionally Food? adulterate food? • Political or ideological motive: – Intelligence indicates terrorists have discussed attacking components of the food sector
An ISIS-backed hacking group has used an encrypted mobile app to call on supporters to carry out terror attacks with POISON. (The Sun, 8/23/16) Food FunctionalSafety and Inspection Service: Food Defense Plans Functional Food Defense Plans
• Voluntary adoption of a 1. Develop. A food defense plan includes information on security measures inside and functional food defense outside the establishment, personnel security, 1. Develop and incident response. It can also address plan can help to mitigation strategies, emergency contacts, prevent, protect, action plans, and supporting documents. 2. Implement Protective Measures. mitigate, respond to, Implementing protective measures includes 2. Implement adopting mitigation strategies, routine and recover from monitoring and surveillance, and training for employees. intentional adulteration 3. Test. Testing and validation of protective measures and mitigation strategies can occur and all hazards through analysis of ongoing monitoring and surveillance activities, after action assessments incidents 3. Test of real‐world events, or exercises (recommended annually).
• Developing a functional 4. Review & Maintain. It is recommended that, food defense plan can on an annual basis (or more frequently if 4. Review desired), review results from monitoring and surveillance; incorporate lessons learned from be achieved in four & Maintain exercises and real‐world events; and update plan to reflect changes in processes, simple steps procedures, employees, and new threats or information. August 2015 32 FoodThe Safety Relationship and Inspection Service: between Food Defense, Food The RelationshipSafety, and Between Food Security Food defense, Food Safety and Food Security
Food defense –protection of food products from adulteration intended to cause public health harm or economic disruption
Food safety –protection of food products from unintentional adulteration
Food security – when all people, at all times, have both physical, social, and economic access to sufficient, safe, and nutritious food to meet their dietary needs and food preferences for an active and healthy life (FAO, 2014) 33 Food Safety and Inspection Service: Farm‐to‐TableFarm Chain‐to‐Table Chain • Food supply is a soft target for terrorism – Attacks could be directed at any point from farm to table: • Crops, livestock • Processing, distribution, storage, transportation • Retail (restaurants or supermarkets) • Challenges – Traditional security measures may not be effective – Vast and open systems – Animal and plant pathogens and pests and possible adulterants readily available – Information on their use – available on the Internet Food SafetyBenefits and Inspection of Service: a Food Defense Plan Benefits to a Food Defense Plan
•Prevents Protects •productProtects from product from Prevents unauthorized unauthorized access by intentionalintentional contamination people,access orby entry people, of or entry contamination unapprovedof unapproved materials throughout the tomaterials the facility to the production process facility Outside Inside Security Security Measures Measures
Incident Personnel Response Security Security Measures Measures •RespondsResponds quickly to a • Ensures that only toproduct a product contamination authorizedEnsures that personnel only contaminationthreat for incident threat authorizedare in the facilitypersonnel at forresponse incident security response are inany the time facility at any security time Food Safety and Inspection Service: AdditionalBenefits Benefits of toFood a Food Defense Defense Plan • Supports safety and quality initiatives • Reduces cost of other security lapses (e.g., theft, vandalism, etc.) • May expose process or business inefficiencies • Reduces the risk of a devastating event • Reduces the impact of an event • Competitive advantage – More customers, especially multinational customers, are requiring a food defense plan – Head start when regulatory requirements arrive Food Safety and Inspection Service: PartneringPartnering with Industry for for Success Success
• Large establishments: 98% • Small establishments: 91% • Very small establishments: 77% 100% 2015 Target
90%
80% Functional
70% a
60% Plan with
50%
Defense 40%
30% Food Establishments 20% of
10%
Percent 0% 2006 2007 2008 2009 2010 2011 2012 2013 2014
August 2015 37 Preventing Foodborne Illness: Four Steps to Food Safety
www.foodsafety.gov 38 Preventing Foodborne Illness: FOODKEEPER: There’s an app for that…
Google Play & Apple Store 39 Food Safety and Inspection Service
Contact Information
Melanie Abley, MS, PhD Senior Staff Officer Office of Policy and Program Development Food Safety and Inspection Service, USDA
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