Top of Mind Regulatory Issues. Norm Robertson VP Regulatory Services IPPE, February 2019

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1 Top of Mind Regulatory Issues Norm Robertson VP Regulatory Services IPPE, February 2019

2 Hazard Analysis and Sodium Nitrite Sodium nitrite, in pure form, logically presents a chemical hazard Most sodium nitrite used in establishments is carried in Prague powder 6.25 and sometimes 12.5% sodium nitrite in salt formulation with pink colorant for easy ID If Prague powder is used, July 1998 Borchert and Cassens, et. al., provides support for why there is no likely to occur chemical hazard.

3 HACCP Categories HACCP Categories described differently in PHIS Raw Not Ground Steaks, Chops, mechanically tenderized steaks Raw Intact Steaks Raw Ground Ground Beef Raw Non-Intact Mechanically tenderized Steaks, Ground Beef Companies can call a HACCP plans anything, including what is in 317.2, PHIS, or another name. What is important is identifying and addressing the hazards

4 Steps of the Process, Hazard Analysis FSIS has posted AskFSIS Q&As that clarify what is a step of the process in relation to the hazard analysis A point or activity in an operation within the production process that is essential to the proper production of the finished product Multiple activities can be combined into one step Examples of activities that may not be a step not used to address a hazard in the hazard analysis Metal detection for customer specs only Application of a processing aid for customer specs

5 Downside to Calibration Target Allowing for a Range of Error Companies sometimes establish a tolerance related to calibration of process monitoring devices Typically establishes a ± 1 or 2 degree tolerance when verifying calibration, typically of thermometers If the device is found to be within the stated tolerance, the company determines the instrument is accurate Trouble begins when the company does not also adjust the critical limit to accommodate the possible variance If the plan allows ± 2 F when calibrating thermometers, and the critical limit is to keep product below 45 F, the critical limit should be adjusted down to 43 F to allow for the possible error in the instrument

6 New Public Health Regulation List A few new additions to the PHR list for FY 2019 Six of those return from the FY 2017 list Odd inclusion of when (a)(b)&(c) already on the list A few removals from FY 2018 list Mostly related to prescriptive slaughter regulations Tier 1 and 2 cut points increased for first time Still below 2017 cut points Paying attention to PHR noncompliance rates will serve to keep your company under the cut points, avoiding additional focus and resource allocation by the agency

7 Most Common Inappropriate PHR Citations on NRs seems broadly applicable, but page 10 of FSIS Directive limits use Systemic failures, repetitive, may result in adulteration of product, etc (d) broadly applicable language regarding protecting product, but page 23 of FSIS Directive limits use When product is not protected (i.e., exposed) and there is a condition present that can reasonably result in the adulteration of that product

8 Most Common Inappropriate PHR Citations on NRs a rather vague requirement to routinely reevaluate the effectiveness of the SSOP program. Per page 30 of FSIS Directive , the inspector would need to demonstrate there was a need for the company to reevaluate and update the program, but failed to do so. Could relate to repetitive failures without changes made to address the cause NOTE: Should not be automatically cited just because a failure has been repeatedly found, especially if the cause is supportably identified as an execution failure rather than a design of program issue Changes to the operation or equipment without necessary changes made to the SSOP to prevent product contamination

9 Most Common Inappropriate PHR citations on NRs 416.4(a) pertains to maintaining sanitary conditions of food contact surfaces. While it appears applicable to any findings of contamination on a food contact surface, FSIS has issued clarification that it should not be cited when a pre-op sanitation failure is documented Page 7 of FSIS Directive indicates should be cited but 416.4(a) should not also be cited

10 Documentation Following Use of Retain/Reject Tags Does the use of a USDA retain/reject tag require a NR be issued? No, but this AskFSIS response indicates if no NR is issued following the use of a retain/reject tag, a MOI is to be prepared to explain the basis for using the tag.

11 FSIS Subject to Company GMPs Do FSIS inspection personnel need to follow company GMP requirements (e.g., hair net policy, jewelry and wristwatch policies, etc.)? Yes, FSIS personnel are expected to follow company GMPs, per the AskFSIS Q&A below

12 Citing Appendix A Table as Critical Limit Can an establishment list appendix A table as the critical limit for a lethality CCP? Yes, provided initial validation was conducted on at least one of the time and temperature combinations listed in the table, per the AskFSIS response below.

13 Using E. coli O157:H7 Data When Non-O157 STECs are Found Can robust testing for E. coli O157:H7 be used to support microbiological independence between lots in the face of a non-o157 STEC positive? Yes, provided there is no indication of an event period or that process control was not lost Single, point source contamination versus an event period or loss of process control

14 Certificates of Free Sale Will FSIS issue or sign a Certificate of Free Sale? No, the agency does not issue or sign such certificates Per FSIS, Banks, the local Chamber of Commerce, and other organizations may provide this kind of statement.

15 Moving Work-In-Process Product Can an establishment ship meat or poultry products that are for further processing without fully labeling them? Yes, given adequate controls Moved on a company truck or under company or FSIS seal Shipped to a sister establishment, a warehouse owned by the establishment, or offsite warehouse to be maintained under company control (under company or FSIS seal) The mark of inspection may appear on the product, container, car, or truck to meet the requirement that the product be marked inspected and passed

16 Product Reconditioning Can product reconditioning, if included in the SSOP, be conducted without inspection coverage, as is the case with other SSOP procedures? No, primarily the cleaning procedures associated with pre-operational SSOP procedures can be done without inspection coverage, per FSIS Directive 12,600.2 Product reconditioning often requires trimming, cutting and packaging, all of which require inspection

17 Documenting Corrective Action on a Noncompliance Record Must SSOP and HACCP corrective actions in response to a documented noncompliance be documented on company records or just the NR itself? Technically, there is no regulatory requirement to respond to NRs in writing at all (but it s a good idea) Entering SSOP and HACCP corrective actions into the company record is required The response provided on the NR can be used to demonstrate compliance, but the NR then must become part of the SSOP or HACCP record and be maintained accordingly (i.e., per record retention requirements in the respective regulation)

18 List of Hazardous Chemicals Are Establishments required to provide a chemical list to assigned FSIS personnel, in addition to making SDS sheets available? Yes, per FSIS Directive , establishment management is to provide a list of chemicals to which IPP could be exposed, to the FLS or designee upon request If hazardous chemicals are acquired by the Agency and stored in the USDA office, the FLS or designee is to inform establishment management (e.g., formalin)

19 Less Than Daily Cleaning Operations and Cleaning for Specific Needs Does performance of sanitation interventions for specific purposes in a less-than-daily (LTD) cleaning operation support FSIS mandating daily pre-op inspection? No, provided the sanitation intervention is not a full pre-op like sanitation Cleaning for specific controls during operations (e.g., allergens, SRMs, etc.) does not impact the company s ability to support LTD status The NOTE in FSIS Directive regarding companies conducting daily cleaning still being subject to pre-operational sanitation inspection as they are scheduled, was not meant to address situations where cleaning for specific operational needs is conducted If written confirmation of this interpretation is needed, please me and I will forward the AskFSIS response I received

20 When Does Diced Beef Become Nonintact? Is diced beef considered a non-intact product? It depends at what size the product is diced. If ¾ inch or less in all three dimensions, then yes, the agency considers the product non-intact If one of the three dimensions is greater than ¾ inch, then no, the agency considers the product intact If written confirmation of this interpretation is needed, please me and I will forward the AskFSIS response I received

21 Zero Tolerance Defects Found After CCP Location and Final Rail Does the finding of a zero tolerance defect on a carcass after the agency and company CCP monitoring point of the process represent an unforeseen hazard? No, assuming the HACCP plan identifies zero tolerance defects as likely to occur and there is a CCP identified for zero tolerance, a finding after the normal monitoring point is a deviation from the established limit, not an unforeseen hazard If written confirmation of this interpretation is needed, please me and I will forward the AskFSIS response I received

22 Stunning Effectiveness Many NRs and enforcements have been based upon FSIS asserting signs of a possible return to consciousness equate to an ineffective stun FSIS has clarified (through appeal responses) that signs of a possible return to consciousness do not equate necessarily to consciousness Administering a security stun when an animal has not regained consciousness is not evidence of a regulatory failure to effectively stun on the first attempt For noncompliance to have occurred, FSIS must have determined the animal regained consciousness, not just that the animal was showing signs (i.e., rhythmic breathing, palpebral reflex, etc.)

23 Beef skulls as beef bones Can skulls from animals under 30 months of age be sold and labeled as beef bones? Yes, provided non-bone related parts of the skull have been removed Teeth, muscle, tendons, tonsils, etc., are not bone and would need to be removed If written confirmation of this interpretation is needed, please me and I will forward the AskFSIS response I received

24 Cutting to Facilitate Loading and Grading, Without Inspection Can establishment personnel make cuts to carcasses to facilitate loading and unloading without inspection being on duty (i.e., quartering carcasses, cutting low necks, etc.)? Yes, but only for the purpose of facilitating loading or grading (i.e., ribbing to expose muscle for grading) Gm0e~yLr9P8qTS75Mv~N~zj~PP8E

25 Product Dating Outside the mandatory pack date labeling on poultry products in 9 CFR , use by, sell by, and best by type dating are voluntary If a clear date is added to a label, it must be qualified (e.g., use by, sell by, etc.) Does not apply to codes that are not readily identifiable as a date No regulatory requirement for validation of such quality based dating If date is tied to food safety, then validation is necessary E.g., RTE product using an inhibitory compound to limit the growth of Listeria monocytogenes for a specified period of time reflected by the dating on the product Dating, including changing of dating, must be not be misleading

26 Donating Product Outside Date Labeling In an effort to reduce unnecessary food waste, FSIS issued guidance to clearly establish product exceeding the labeled use by, sell by, best if used by, etc., date, can be donated While quality may begin to deteriorate after the date, the product should still be wholesome, absent spoilage

27 Fat and Added Water in Cooked Sausage Finished Product may contain no more than 30% fat and 40% combined fat and added water FSIS asserts any verification of these levels is based on the finished cooked product, not ingoing levels in formulation This suggests higher levels of fat and water could be used in formulation, provided the process reduces the amounts below the 30/40 levels in provided in 9 CFR Only way I know of to verify would be lab analysis of finished product If documentation of the FSIS position on this is needed, e- mail me and I can forward the exchange I had with labeling

28 Managing OIEA (Compliance) Visits Cooperate, provide documents and programs requested by the officer for copying Access and examination provisions in the FMIA and PPIA supports their ability to take copies Only answer questions asked, don t elaborate or provide information not requested Don t feel compelled to sign or review statements prepared on your behalf by the officer Agreeing to review and confirm accuracy of content serves the same purpose as signing the statement The officer can document an affidavit attesting to the fact you reviewed and agreed it was accurate, serving the same purpose as you signing the document Best to explain company legal counsel prohibits signing or reviewing such documents without them first reviewing, but I defer to your company s counsel for guidance for your company

29 Disclaimer and Instructional Statements on Labels Voluntary, never mandatory, even if the raw beef being sold is untested or positive/presumptive positive for an adulterant pathogen (e.g., E. coli O157:H7) Many field inspectors misunderstand the policy to be something that is required by the agency when raw beef trim is sold untested Using such statements limits to whom the product can be sold, i.e., only Official Establishments that will apply lethality If the company wishes to add disclaimer or instructional statements, a sketch approval by FSIS is required See FSIS Directive 10,010.2, Chapter IV, for the above policy