seafood’haccp’update’session’fda 2011: fish and fisheries products hazards and control...

FDA 2011: Fish and Fisheries Products Hazards and Control Guidance

Seafood HACCP Update Session

Refrigerated Foods Associa7on October 26, 2011

Seafood HACCP Alliance


Seafood HACCP Alliance

Co-‐Sponsors:

•  Associa7on of Food & Drug Officials (AFDO) •  Interna7onal Food Protec7on & Training Ins7tute •  U.S. Food & Drug Administra7on/Division Seafood Safety •  USDA/ Na7onal Ins7tute of Food and Agriculture •  Sea Grant College Programs and Coopera7ve Extension Services in universi7es across the na7on


New 4th edi7on released April 2011

Previous 3rd edi7on was issued June 2001


General Changes and Clarifica6ons

Intent remains the same …

• Recommended guidance to assist processors of fish and fishery products

• Tool to be used by federal and state regulatory officials in HACCP Plan evalua7ons



Comple7ng a HACCP Plan ♦ Outlined in Chapter 2

Control Strategies consolidated ♦ Cri7cal Limit ♦ Monitoring ♦ Correc7ve Ac7on ♦ Verifica7on ♦ Record Keeping

Example Control Strategy Pages 83 -‐86

Format and Organiza7on:



Overarching changes for temperature controls to prevent various seafood hazards associated with –

-‐ Histamine forma7on -‐ Pathogen growth -‐ C. botulinum toxin forma7on


General Changes and Clarifica6ons Cri6cal Limits – During transit – Op7ons for Ice, gel-‐packs or refrigera7on

Cri6cal Limits – During Refrigerated Storage Cumula7ve 7me and temperature cri7cal limits during refrigerated storage are not recommended. Difficult to determine how long products are in unrefrigerated condi7ons.

Monitoring procedures •  Con7nuous 7me and temperature monitoring encouraged

•  To eliminate minor fluctua7ons in temp. measurements during refrigerated storage -‐ immerse sensor in liquid

•  No longer recommend high temperature alarms


Accuracy checks are usually done more frequently against one standard point •  e.g. immersing in ice slurry if the thermometer is to be used at cold temperatures

Frequency: •  before device is put in service •  daily checks at beginning of opera7ons or as recommended by manufacturer

•  check condi7on of the equipment Example: Page 227



Calibra6on of temperature-‐indica7ng devices are recommended annually

•  Two temperature points that reflect temperatures that the device is being used

•  Using a known reference device (NIST-‐traceable thermometer at least 1X/year or per manufacturer’s recommenda7ons

Example: Page 227



Chapter 3. Species and Process Related Hazards

Expect changes and some addi7ons to the list of poten7al hazards

Page 40


Chapter 5. Parasites

The Guide emphasizes original controls to destroy poten7al parasites with proper hea7ng or freezing

Control Strategies


Chapter 5. Parasites

If the consumer intends to cook the fish thoroughly before consump7on, this hazard is Not Significant.

In order to eliminate parasites as a significant hazard when you are unsure of the product’s intended use (could be served raw or par7ally cooked), processors should obtain documented assurance from the subsequent processor, restaurateur, or ins7tu7onal user that the fish will be processed in a way that will kill the parasites.

(addressed at bogom of Hazard Tables 3-‐2/page 61 and Chapter 5/page 93)

Significant Point


Chapter 7. Scombrotoxin (Histamine) Forma6on

Hazards of Concern: Scombrotoxins (elevated histamine levels) due to temperature abuse of certain fish species

Products of Concern include a variety of fish and fishery products that contain a natural level of his7dine that can be converted to toxic levels of histamine and related compounds if the products are temperature abused

Good background info page 113 -‐ 120


Chapter 7. Scombrotoxin (Histamine) Forma6on

CONTROL STRATEGY MAY APPLY TO

PRIMARY PROCESSOR

MAY APPLY TO SECONDARY PROCESSOR

1. Harvest Vessel Controls

2. Histamine Tes7ng

3. Transit Controls 4. Processing Controls 5. Storage Controls

Recommenda7ons regarding various controls is expanded and clarified


Three Components: •  Harvest Vessel Records

•  Sensory Examina7on •  Internal Temperature Measurements

Control Strategies for Primary Processors 1. Harvest Vessel Controls at Receiving

2. Histamine Tes7ng at Receiving


Control Strategy: 3. Transit Controls •  Transport monitoring records for all lots of fish to show ambient

or internal temperature of fish was 40°F or < throughout transit OR

•  Fish completely surrounded by ice at 7me of delivery OR

•  Fish delivered under ice (open–bed truck) with internal fish temperature on delivery ≤ 40°F OR

•  Fish delivered under chemical cooling media (gel packs) have adequate quan7ty of ‘frozen’ gel packs and internal fish temperature ≤ 40°F OR

•  If transit 7me is less than 4 hours, then internal fish temperature on delivery ≤ 40°F


The transit control recommenda7ons are similar to prior Guides, but with more emphasis -‐

-‐  Records for transit 7me

-‐  ‘Adequate’ or ‘sufficient’ ice or cooling media

-‐  Representa7ve number of containers checked, and number of containers in the lot

-‐  Representa7ve number of fish checked for internal temperatures (example, 12 fish minimum)

3. Transit Controls


Control Strategy : 4. Processing Controls

Much remains the same as in the previous Guide

Features control of 7me and temperature of the fish when handling outside refrigera7on, and preven7on of cross contamina7on through proper sanita7on control procedures

Use of gel packs for refrigerant during processing is discouraged


Cri6cal Limits can be based on ‘cumula7ve’ exposure 7me and temperature

When ambient air temperature (oF) of exposure is…

The maximum hours of exposure 7me for…

Fresh fish (not heat processed or previously frozen)

Heat processed or previously frozen

(exposed to possible recontamina7on)

> 70 oF at any 6me during processing ≤ 4 hours ≤ 12 hours

≤ 70oF during en6re exposure ≤ 8 hours ≤ 24 hours

4. Processing Controls

Page 119


Recommenda7ons for monitoring emphasize: •  Use of con7nuous temperature recording devices and visual checks at least once per day,

or •  When using ice, check and record results for a ‘representa7ve number of containers’ per approximate number of containers in the cooler

Control Strategy: 5. Storage Controls


Bad tuna sends seven Subway customers to the hospital in Vancouver

Posted: September 24th, 2011 -‐ 5:36am by Doug Powell

Seven customers at a Subway sandwich outlet in the interna7onal terminal of the Vancouver airport were taken to hospital on Friday a=ernoon suffering from an apparent bout of food poisoning.

Vancouver Coastal Health spokesman Jus7n Karasick said the suspected cause of their illness was some tuna that may not have been stored at the right temperature.

The customers are believed to have been stricken by a form of food poisoning known as scombroid, which occurs when there is a high level of histamine in raw or uncooked fish, said Mr. Karasick

FDA Hazards Guide 4th Edi7on Page 114: “The poten7al for histamine forma7on is increased when scombrotoxin forming fish muscle is in direct contact with enzyme forming bacteria. This direct contact occurs when fish are processed and can be par7cularly problema7c when the surface-‐to-‐volume ra7o is large such as minced tuna for salads. Even when such products are prepared from canned or pouch retorted fish, recontamina7on can occur during salad prepara7on, especially with the addi7on of raw ingredients. The mixing in of the bacteria throughout the product and the high surface-‐to-‐volume ra7o can result in substan7al histamine forma7on if 7me and temperature abuse occurs.”

Recall – Firm Press Release

Osamu Corp. Recalls Frozen Ground Tuna

For Immediate Release–October 12, 2011

Osamu Corp. of Gardena, CA is recalling up to 1,800 cases, Lot # 7013, of frozen ground tuna because the FDA found decomposi7on in several samples of the product and also found elevated histamine levels in samples taken from one retail loca7on.

The frozen ground tuna was shipped to three distributors from 08/18/11 to 9/08/11………(The three distributors are named. Two of the three have sushi franchises in grocery stores, one is a cash and carry establishment)……


More Background – Page 118 Scombrotoxin forming fish that have been heat processed

sufficiently to destroy bacteria and enzymes that are NOT subsequently handled in a manner in which there is an opportunity for recontamina6on

(E.G. NO CONTACT WITH Fresh Fish, Employees or Raw Ingredients) are at low risk for further histamine development.

If there is an opportunity for recontamina6on (Contact with Fresh Fish, Employees or Raw ingredients) then cumula6ve exposure 6me is:

12 Hours if any exposure 6me is > 70°F 24 Hours if no exposure 6me is > 70°F


Chapter 12. Pathogen Growth & Toxin Forma6on (other than C. botulinum) as a result of 6me and temperature abuse

Hazards of Concern: Bacterial Pathogens including: Salmonella, E. coli, Shigella, Listeria, S. aureus, Vibrio species, Bacillus cereus & C. perfringens

It is reasonable to assume certain poten7al pathogenic bacteria are associated with specific foods (page 209-‐210)


Chapter 12. Pathogen Growth & Toxin Forma6on (other than C. botulinum) as a result of 6me and temperature abuse

Products of Concern (RTE):

Raw ready-‐to-‐eat products like raw clams and oysters; sushi and sashimi; marinated products like ceviche; cold smoked fish

Cooked ready-‐to-‐eat products like cooked shrimp; cooked crab, lobster, and crayfish meat; surimi products; seafood salads and sandwiches; & hot smoked fish


Chapter 12. Pathogen Growth & Toxin Forma6on

Scien7fic Basis for Control Strategies (Appendix 4; p. 421):

For products that may not be cooked before they are eaten, pathogen growth must be prevented or minimized.

•  These pathogens do not grow below 40°F •  Growth is very slow between 40°F and 50°F •  Growth is somewhat faster between 50°F and 70°F •  Growth is fast above 70°F •  Growth stops and they are killed ≥ 135°F

Avoid or minimize product exposure in the temperature danger zone


Chapter 12. Pathogen Growth & Toxin Forma6on

Four Different Control Strategies May be Needed

Control Strategy May apply to primary

processor May apply to

secondary processor

1. Transit controls 2. Refrigerated Storage &

Refrigerated Processing

3. Cooling ader cooking 4. Unrefrigerated Processing


Product Types: Fully Cooked or Heat and Serve

•  This control strategy is only for those products where there is no significant handling and there is a need to control spore forming bacteria like Bacillus cereus or Clostridium perfringens.

•  These pathogens are not likely to be found in seafood, but controls may be needed in some cases (e.g. sushi made with rice).

Control Strategy: 3. Cooling Ader Cooking Controls


Cri6cal Limit Choices:

1. Product is cooled from 135°F to 70°F within 2 hours AND

Product is further cooled to 40°F within an addi7onal 4 hours

OR

2. The minimum or maximum values for the cri7cal factors that affect the rate of cooling as established by a cooling rate valida7on study.

3. Cooling Ader Cooking Controls


Control Strategy: 4. Unrefrigerated Processing of Raw Ready-‐to-‐Eat Seafood

Maximum exposure 7me for RAW READY-‐TO-‐EAT seafood products during Processing Steps

Aids in planning processing schedules

Text page 234 Table page 236


Control Strategy: 4. Unrefrigerated Processing of Cooked Ready-‐to-‐Eat

Maximum exposure 7me for COOKED READY-‐TO-‐ EAT seafood products during Processing Steps

Aids in planning a processing schedule

Text page 234-‐235 Table page 236


Chapter 13. C. botulinum Toxin Forma6on

Hazards of Concern: C. botulinum toxin has been associated with a limited number of temperature abused seafood products but it can be a very serious hazard that deserve careful controls

Products of Concern can involve all seafood depend on certain handling and package condi7ons that may favor the growth and toxin produc7on, i.e., reduced oxygen packaging (ROP)



Examples of Reduced Oxygen Packages (ROP):

•  Vacuum packed •  Modified atmosphere packed (e.g. CO, CO2, N2) •  Sealed containers (e.g. glass jars with sealed lids and heat sealed plas7c containers (e.g. pasteurized crab) •  Packed in oil •  Packed in deep containers (top opening is smaller than depth of container or product is densely packed)



Provides four example control strategies for C. botulinum

Control Strategy May apply to

primary processor May apply to

secondary processor

1. Smoking

2. Refrigerated with TTI’s

3. Frozen with Labeling

4. Pickling and Sal6ng


Control Strategy 1: Smoking

Recommended Cri7cal Control Points:

•  Brining or dry sal7ng and drying •  Cold smoking •  Hot smoking •  Refrigerated finished product storage •  Receipt of products by secondary processor


Control Strategy 2: Refrigera6on with TTI’s

New Guide recognizes use of TTI’s to monitor the temperature exposure for ROP packaged seafood;

Recommended Cri7cal Control Points:

•  Unac7vated TTI receipt •  Unac7vated TTI Storage •  Applica7on and Ac7va7on of TTI •  Refrigerated finished product storage •  Receipt of products by secondary processor


Control Strategy 3: Frozen Product with Labeling

If freezing is the sole barrier to prevent toxin forma7on in a reduced oxygen package (ROP), the product must be properly labeled:

Label Statement:

“ Important: Keep frozen un7l used, and thaw under refrigera7on immediately before use”


Control Strategy 4: Pickling and Salting

Recommended Cri7cal Control Points include:

•  Brining, pickling, sal7ng and formula7on •  Refrigerated finished product storage •  Receipt by secondary processor


Chapter 14. Pathogenic Bacterial Growth and Toxin Forma6on as a result of Inadequate Drying

Addi7onal Control Strategy if water ac7vity < 0.97 but > 0.85

“ Important: Keep refrigerated un7l used”


Chapter 15. Staphylococcus aureus Toxin Forma6on in Hydrated Bager Mixes

One Control Strategy Provided

Control strategy unchanged but clarifica7on provided on CCPs for different opera7ons

Possible CCPs: Hydrated bager mix storage; recircula7on; hand bagering

Control Strategy May apply to primary processor

May apply to secondary processor

Hydrated bager mix control


Chapter 16 Bacterial Survival through Cooking or Pasteuriza6on

Changes to 4th Edi6on

1.  Use of End Point Internal Product Temperature (EPIPT) monitoring

2.  Applica7on of cumula7ve lethality concept

3.  Specific lethality values unique to Dungeness crab pasteuriza7on

4.  Updated Listeria monocytogenes data based on FDA/USDA risk assessment


Chapter 19. Undeclared Major Food Allergens and Certain Food Intolerances …

Hazards of Concern: Natural allergens commonly associated with seafood, and/or certain food or color addi7ves used in processing seafood that can cause hypersensi7ve reac7ons or food intolerances seafood

Products of Concern •  Fish and crustaceans are included in the ‘eight’ most

common food allergens •  Certain seafood processing addi7ves have caused food

intolerances or sensi7ve reac7ons


Chapter 19. Undeclared Major Food Allergens & Certain Food Intolerances …

Control Strategies Page 366


One example Control Strategy: 8. Finished Product Labeling Controls

CCP is at finished product labeling with the following recommended:

Cri7cal limit – all finished product labeling must accurately list any major food allergens (and other addi7ves that cause food intolerances if applicable) included in product formula7on

Monitoring – visually compare label on representa7ve number of finished products from each lot with the product formula7on, including market name of finfish or crustacean species

– recommend at start of produc7on lot and every hour azerwards


TIPS •  Eight major allergens must be in ingredient statement or a

separate “Contains” statement. Includes milk, egg, wheat, soybeans, peanuts, tree nuts, finfish and crustacean shellfish

•  Specific type of finfish, crustacean shellfish and tree nuts must be listed (i.e., “salmon”, “shrimp”, “coconut”) -‐ use market name from FDA’s The Seafood List for finfish and crustacean shellfish

Market Names available at hgp://www.fda.gov/Food/GuidanceComplianceRegulatoryInforma7on/GuidanceDocuments/Seafood/ucm113260.htm

Chapter 19. Undeclared Major Food Allergens and Certain Food Intolerances …


Chapter 20. Metal Inclusion

Chapter 21. Glass Inclusion


FINAL COMMENTS

Alterna7ve Approaches

FDA will consider alterna7ve approaches as explained at the beginning of every chapter, but alterna7ve approaches must be based on science and prac7ce, and provide an equivalent level of control that sa7sfies the requirements of the applicable statues and regula7ons

TIP: Alterna7ve approaches should be well communicated with FDA before development or implementa7on to assure acceptance and compliance (Contact info on inside 7tle page)


How to submit ques6ons to the FDA


FINAL COMMENTS Access to the FDA’s Seafood Hazards Guide

• Websites FDA.gov AFDO.org UCDAVIS.com

• Purchase www.ifasbooks.com (HACCP seafood)