food safety and inspection service · food safety and inspection service ensuring that the...

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, PhDSenior Staff Officer

Office of Policy and Program DevelopmentFood Safety and Inspection Service, USDA

Regional Occupational Health Conference: It’s a Small World: from Global to Local ThreatsJohn Hopkins University

October 22, 2016

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Overview

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• 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

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.

• Federal Meat Inspection Act (FMIA), 1906•Agricultural Marketing Act (AMA), 1946•Poultry Products Inspection Act (PPIA), 1957•Humane Methods of Slaughter Act (HMSA), 1958•Egg Products Inspection Act (EPIA), 1970

Our AuthorityThrough a series of Acts, Congress empowers FSIS to inspect all meat, poultry, and processed egg products

in interstate commerce.

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More than

9,600employees

strong

Food Safety and Inspection Service:One Team, One Purpose

We work together

protectingto accomplish our mission of

public health.

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Food Safety and Inspection Service:The Threat of Foodborne Illness

Sickens

1 in 6Americans

Causes

3,000deaths

Results in

128kHospitalizations

Costs consumers

$6.9 billion

Each year, foodborne illness. . .

pathogensmost frequently affect our regulated products.

Shiga toxin-producing E. coliListeria monocytogenesSalmonellaCampylobacter

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Foodborne Pathogens ‐ Bacteria

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Pathogen Laboratory‐confirmed

Multipliers

Total, mean (90% CrI)

Travel‐ related, %

Under‐repor ng†

Under‐diagnosis‡

BacteriaBacillus cereus, foodborne¶

85# 25.5 29.3 63,623 (15,770–147,827)

<1

Brucella spp. 120** 1.1 15.2 2,003 (1,302–2,964)

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Campylobacter spp.

43,696†† 1.0 30.3 1,322,137 (530,126–2,521,026)

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Clostridium botulinum, foodborne¶

25** 1.1 2.0 56 (34–92) <1

Clostridium perfringens, foodborne¶

1,295# 25.5 29.3 969,342 (192,977–2,492,003)

<1



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Multipliers

Total, mean (90% CrI) Travel‐ related, %Under‐repor ng† Under‐diagnosis‡

Bacteria

STEC O157 3,704†† 1.0 26.1 96,534 (26,982–227,891)

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STEC non–O157 1,579†† 1.0 106.8 168,698 (17,163–428,522)

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ETEC, foodborne¶

53# 25.5 29.3 39,781 (53–102,250)

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Diarrheagenic E. coli other than STEC and ETEC

53 25.5 29.3 39,871 (53–102,378)

<1

Listeria monocytogenes

808†† 1.0 2.1 1,662 (582–3,302)

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Multipliers


Bacteria

Mycobacterium bovis

195†† 1.0 1.1 208 (177–241) 70

Salmonella spp., nontyphoidal‡‡

41,930†† 1.0 29.3 1,229,007 (772,129–2,008,076)

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S. enterica serotype Typhi

433†† 1.0 13.3 5,752 (299–17,357)

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Shigella spp. 14,864†† 1.0 33.3 494,908 (93,877–1,420,877)

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Staphylococcus aureus, foodborne¶

323‡# 25.5 29.3 241,994 (72,584–531,398)

<1



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Multipliers


Bacteria

Streptococcus spp. group A, foodborne¶

15# 25.5 29.3 11,257 (15–78,104)

<1

Vibrio cholerae, toxigenic

8** 1.1 33.1 277 (94–630) 70

V. vulnificus 111** 1.1 1.7 207 (138–287) 2

V. parahaemolyticus

287** 1.1 142.4 44,950 (23,706–74,984)

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Vibrio spp., other

220** 1.1 142.7 34,585 (21,756–51,535)

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Yersinia enterocolitica

950†† 1.0 122.8 116,716 (36,363–204,898)

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Foodborne Pathogens ‐ Parasites

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Multipliers


Parasites

Cryptosporidiumspp.

7,594†† 1.0 98.6 748,123 (162,961–2,135,110)

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Cyclospora cayetanensis

239†† 1.0 83.1 19,808 (239–65,135)

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Giardia intestinalis

20,305** 1.3 46.3 1,221,564 (892,393–1,633,965)

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Toxoplasma gondii

1.0 0 173,995 (134,593–218,866)

<1

Trichinella spp. 13** 1.3 9.8 162 (44–355) 4


Foodborne Pathogens ‐ Viruses

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Multipliers


Viruses

Astrovirus NA NA NA 3,090,384 (2,350,589–3,833,232)

0

Hepatitis A virus 3,576** 1.1 9.1 35,769 (21,505–60,715)

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Norovirus NA NA NA 20,865,958 (12,842,072–30,743,963)

<1

Rotavirus NA NA NA 3,090,384 (2,350,589–3,833,232)

0

Sapovirus NA NA NA 3,090,384 (2,350,589–3,833,232)

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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

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Food Safety and Inspection Service:Why is This Important?

• World Trade Organization (WTO)/Sanitary and Phytosanitary (SPS) Measures Agreement

• Equivalence determinations of an exporting country’s regulatory food safety inspection system for meat, poultry, or egg products is a prerequisite for trade with the US

Importance Of Equivalence

• Protects public health

• Ensures international compliance with food safety policies

• Facilitates trade

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Food Safety and Inspection Service:Initial Equivalence

Initial Equivalence Process:1. Country Submits Written Request to FSIS2. Document Submission through Self‐Reporting Tool3. Document Review 4. On‐Site Verification Audit5. Public Notification‐Proposed Rule in Federal Register6. 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

Initial equivalence is undertaken when a country wants to export meat, poultry, or egg products to the US for the first time

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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) violations17

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.

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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, microbiological, and traceback evidence• Epidemiology: Who, what,

when, where, and how• Laboratory: Food,

environmental, and clinical samples

• Environmental Health: Traceback in addition to assessments and inspection

Epidemiology

Laboratory

Environmental Health

Source: http://www.cdc.gov/vitalsigns/foodsafety‐2015/infographic.html#infographic


Federal Effort

• Disease surveillance• Outbreak Investigation

• Food safety policies• Inspection and enforcement• Product recall and traceback• Investigation of farm and

production facilities

Problem identification Source implication

Source assessmentRisk assessment Risk management

PFGE Comparisons

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VetNet Database PulseNetDatabase

Local, state, and federal agencies perform PFGE on human clinical and

food isolates

USDA performs PFGE on product isolates

Investigate potential outbreaks

Identify potential problems in regulated establishments


PFGE Comparisons


FSIS Investigation Objectives

Epidemiologic and microbiologic analysis

Traceback and trace forward

Control actions

In‐plant assessments


Illness Reporting to FSIS

• Speed and accuracy are essential in foodborne illness investigations

• Identification of suspect product quickly:• May prevent further illnesses• May prevent future outbreaks• Ensures the public’s confidence

in the food supply and public health system

• Minimize economic and public health costs

FSIS/Office of Public Health Science/ Applied

Epidemiology Staff

Federal Partners(CDC, FDA)

Others in FSISOthers in FSIS(Microbial

Characterization Branch Eastern Laboratory,

OIEA CID, OFO)

Other Surveillance Sources

(Media tracking, consumer complaints)

State Partners

(Public Health and Agriculture)


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


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


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)


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

What is Food Defense?

Food defense is the protection of food products from intentional adulteration where there is an intent to cause public health harm or economic disruption

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Food Defense – Ensuring meat, poultry and egg products are safe from intentional threats domestically and internationally

Why Would Someone Intentionally 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)


Why would someone intentionally adulterate food?

Functional Food Defense Plans

• Voluntary adoption of a functional food defense plan can help to prevent, protect, mitigate, respond to, and recover from intentional adulteration and all hazards incidents

• Developing a functional food defense plan can be achieved in four simple steps

August 2015 32

1. Develop

2. Implement

3. Test

4. Review & Maintain

1. Develop. A food defense plan includes information on security measures inside and outside the establishment, personnel security, and incident response. It can also address mitigation strategies, emergency contacts, action plans, and supporting documents.

2. Implement Protective Measures. Implementing protective measures includes adopting mitigation strategies, routine monitoring and surveillance, and training for employees.

3. Test. Testing and validation of protective measures and mitigation strategies can occur through analysis of ongoing monitoring and surveillance activities, after action assessments of real‐world events, or exercises (recommended annually).

4. Review & Maintain. It is recommended that, on an annual basis (or more frequently if desired), review results from monitoring and surveillance; incorporate lessons learned from exercises and real‐world events; and update plan to reflect changes in processes, procedures, employees, and new threats or information.


Functional Food Defense Plans

The Relationship between Food Defense, Food Safety, and Food Security

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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)


The Relationship Between Food defense, Food Safety and Food Security

Farm‐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


Farm‐to‐Table Chain

Benefits of a Food Defense Plan

• Ensures that only authorized personnel are in the facility at any time

•Responds quickly to a product contamination threat for incident response security

•Protects product from intentional contamination throughout the production process

• Prevents unauthorized access by people, or entry of unapproved materials to the facility

Outside Security Measures

Inside Security Measures

Personnel Security Measures

Incident Response Security Measures

Prevents unauthorized access by people, or entry of unapproved materials to the facility

Protects product from intentional contamination

Responds quickly to a product contamination threat for incident response security

Ensures that only authorized personnel

are in the facility at any time


Benefits to a Food Defense Plan

Benefits of Food Defense• 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


Additional Benefits to a Food Defense Plan

Partnering for Success

August 2015 37

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2006 2007 2008 2009 2010 2011 2012 2013 2014

Percen

t of E

stab

lishm

ents with

a Fun

ctiona

l Food

Defen

se Plan

2015 Target

• Large establishments: 98%• Small establishments: 91%• Very small establishments: 77%


Partnering with Industry for Success

Preventing Foodborne Illness:Four Steps to Food Safety

38www.foodsafety.gov

Preventing Foodborne Illness:FOODKEEPER: There’s an app for that…

39Google Play & Apple Store


Contact Information

Melanie Abley, MS, PhDSenior Staff Officer

Office of Policy and Program DevelopmentFood Safety and Inspection Service, USDA

[email protected]

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