1. December 8, 2011 Chris Bodendorfer

2.  Regulatory Requirement ◦ 9 CFR 417 ◦ Notices (2)  Options ◦ CCP ◦ SOP  Recordkeeping

3. 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.

4. (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.

5. 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.

6.  FSIS NOTICE 35-117/7/11 ◦ “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. “

7.  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. “

8.  Chemical Hazard ◦ Where address in the process? ◦ How address?  CCP  SOP

9.  Reasonably likely to occur ◦ CCP  Not reasonably likely to occur because/why? ◦ Allergen control program ◦ Don’t have any allergens

10.  What is your critical limit?  How do you measure it?  Frequency of measuring?  How perform verification?

11.  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

12.  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

13.  Labeling ◦ Approval (need completed allergen survey) ◦ Receipt ◦ Processing ◦ Finished goods ◦ Obsolete (label SOP)  Specifications ◦ Highlight allergens

14.  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

15.  Sanitation ◦ Operational ◦ Verification  Training ◦ New hires ◦ Annual refresher  Recordkeeping

16.  Allergen Questionnaire/survey  Master Allergen List  Vendor Ingredient Specifications  Product Specifications  Label Approvals  Ingredient Inventory

17.  Formulation Sheet  Work in process (wip)  Rework generation & usage  Change-over sanitation check lists  Allergen-control Program Self Assessment form

18.  Responsible Individual ◦ Could be multiple individuals  Ingredient or formulation change prompts dispatch of a new questionnaire  Include allergens important to export markets

19.  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

20.  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

21.  Reference label  Master formula  Sort by allergen ◦ “Sister codes”  Highlight products containing allergens ◦ Color code ◦ Universal icon ◦ List allergen(s) in header

22.  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

23.  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

24.  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)

25.  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

26.  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?

27.  A recall (best case) OR  One or more deaths and a recall (worst case)