December 8, 2011

Chris Bodendorfer
 Regulatory Requirement
◦ 9 CFR 417
◦ Notices (2)
 Options
◦ CCP
◦ SOP
 Recordkeeping
417.2 Hazard Analysis and HACCP Plan.
(a) Hazard analysis. (1) Every official establishment shall
conduct, or have conducted for it, a hazard analysis to
determine the food safety hazards reasonably likely to
occur in the production process and identify the preventive
measures the establishment can apply to control those
hazards. The hazard analysis shall include food safety
hazards that can occur before, during, and after entry into
the establishment. A food safety hazard that is reasonably
likely to occur is one for which a prudent establishment
would establish controls because it historically has
occurred, or because there is a reasonable possibility that
it will occur in the particular type of product being
processed, in the absence of those controls.
(i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Zoonotic diseases;
(vii) Decomposition;
(viii) Parasites;
(ix) Unapproved use of direct or indirect
food or color additives; and
(x) Physical hazards.
Every establishment shall reassess the adequacy of
the HACCP plan at least annually and whenever
any changes occur that could affect the hazard
analysis or alter the HACCP plan. Such changes
may include, but are not limited to, changes in:
raw materials or source of raw materials; product
formulation; slaughter or processing methods or
systems; production volume; personnel;
packaging; finished product distribution systems;
or, the intended use or consumers of the finished
product.
 FSIS NOTICE 35-11 7/7/11
◦ “This notice instructs inspection program
personnel (IPP) to make establishments aware of the
need for them to have appropriate process controls
for ingredients of public health concern, the need
for the ingredients to be properly labeled, and the
importance of taking steps to prevent the
production and shipment into commerce of
adulterated or misbranded meat, poultry, or egg
products. “
 FSIS NOTICE 54-11 9/28/11
◦ “It also instructs IPP at meat and poultry
establishments to verify the control procedures an
establishment uses for ingredients of public health
concern and to verify that the establishment has
addressed any chemical food safety hazard in its
hazard analysis. “
 Chemical Hazard
◦ Where address in the process?
◦ How address?
 CCP
 SOP
 Reasonably likely to occur
◦ CCP
 Not reasonably likely to occur because/why?
◦ Allergen control program
◦ Don’t have any allergens
 What is your critical limit?
 How do you measure it?
 Frequency of measuring?
 How perform verification?
 Stand Alone SOP – Allergen Control
Program/SOP
 Address the Big “8” Allergens and ingredients
of public health concern

• Most common allergens found in meat

plants are soy, milk, egg, wheat
proteins, & anchovy-containing
Worcestershire sauce
 Main objective is to protect the food-
allergic consumer by:
◦ Preventing cross-contamination between
allergenic ingredients or allergen-containing
products and ingredients or products that are not
suppose to contain allergens
◦ Insuring that the label accurately describes
ingredients in that product
◦ Insuring that documentation is accurate,
adequate & appropriate
 Secondary objective is to avoid regulatory
issues
 Labeling
◦ Approval (need completed allergen survey)
◦ Receipt
◦ Processing
◦ Finished goods
◦ Obsolete (label SOP)
 Specifications
◦ Highlight allergens
 Inventory/storage
◦ Allergens
◦ WIP
◦ Rework
◦ Clean up spills (GMP or other SOP)
 Cross Contact Prevention
◦ Scheduling
◦ Dedicated lines
◦ Wash matrix
 Rework (separate SOP)
◦ Usage Matrix
◦ Documentation
 Sanitation
◦ Operational
◦ Verification
 Training
◦ New hires
◦ Annual refresher
 Recordkeeping
 Allergen Questionnaire/survey
 Master Allergen List
 Vendor Ingredient Specifications
 Product Specifications
 Label Approvals
 Ingredient Inventory
 Formulation Sheet
 Work in process (wip)
 Rework generation & usage
 Change-over sanitation check lists
 Allergen-control Program Self Assessment
form
 Responsible Individual
◦ Could be multiple individuals
 Ingredient or formulation change prompts
dispatch of a new questionnaire
 Include allergens important to export markets
 List approved suppliers for each ingredient
 Develop a master list of products containing
Major Food Allergens & other allergens or
ingredients of interest
◦ Highlight “sister” codes to assist in rework control &
diversion of excess production
◦ Identify unique items, the production of which must
be isolated
 Rework Matrix
 Wash Matrix
 Ingredient listing: compare to ingredient label
 Information on extent of hydrolysis on
hydrolyzed protein-derived ingredients
 Written notification of any changes to
formulation of ingredient or sub-ingredient
 Reference label
 Master formula
 Sort by allergen
◦ “Sister codes”
 Highlight products containing allergens
◦ Color code
◦ Universal icon
◦ List allergen(s) in header
 Accurate listing of how much was used
(including ingredient supplier & lot
number), when, and in what product
 Formulator initials
 Check formula against specification
 Notification of allergen inclusion
◦ Different color paper
◦ Special Allergen entry
 When generated and from what code & batch
 How much used, when, and in what code &
batch
 Alerts to allergens present in rework
◦ Color code system
◦ Universal icon
 Document actions taken at change over
◦ Destroy product
◦ Blow out or push through; pounds &/or time
◦ Wash down & reinspection
◦ Swapping out or replacing equipment
◦ Oil treatment (e.g. filtration, dilution)
 Document program effectiveness with regular
reviews
 Break down allergen control program
◦ Allergen questionnaires
◦ Specification review process
◦ Receiving process
◦ Operational procedures
◦ Label control/accuracy
◦ Sanitation process
◦ Testing results
 Are forms filled out completely & properly?
◦ If not, determine reason
◦ Revise form as needed
◦ Educate/train personnel on proper recordkeeping &
form specifics
 Are records accurate?
 A recall (best case)

OR

 One or more deaths and a recall (worst case)