Top of Mind Regulatory Issues. Norm Robertson January, 2018, IPPE

Transcription

1 Top of Mind Regulatory Issues Norm Robertson January, 2018, IPPE

2 HACCP Reassessment Failure to adequately document reassessment becoming more common basis for NRs 9 CFR 417.4(a)(3)(ii) requires documentation of reasons why changes were made or not made Required for all reassessments except for annual reassessment with no changes as the outcome

3 HACCP Reassessment 9 CFR 417.4(a)(3)(i) requires reassessment whenever changes occur that could affect the hazard analysis or alter the HACCP plan Includes, but not limited to changes in: Raw materials or source or raw materials Product formulation Slaughter or processing methods or systems Production volume Personnel Packaging Finished product distribution systems Intended use or consumers of finished product

4 HACCP Reassessment The need to reassess is not dependent upon the change actually impacting the hazard analysis or HACCP plan, only that it could Appeal basis needs to show the change could not Coupled with other HACCP system failures, lack of documented reassessments responsive to triggers identified in the regulation can be painted easily as an inadequate system HACCP system inadequacy determination supports issuance of Notice of Intended Enforcement (NOIE)

5 Public Health Risk Evaluation (PHRE) FSIS Directive outlines the PHRE process Office of Data Integration and Food Protection (ODIFP) provides districts with prioritized list of establishments for food safety assessments (FSA) Based on public health risk triggers or determinants Production of adulterated product or associated with outbreak Exceeding public health regulation (PHR) tier 1 or 2 cut points See table 1 in directive for full list in priority order:

6 Public Health Risk Evaluation EIAOs at the district level conduct PHRE process Recommend FSA, enforcement or no action District can add establishments to prioritized list NOTE for RTE producers: lack of any positive sample results in post lethality exposed RTE establishments can be a flag to schedule a risk based FSA as opposed to a for cause FSA Essentially all post-lethality exposed RTE establishments are slated for an FSA at some point

7 Public Health Regulations (PHR) Updated list went into effect October 1, 2017: No big surprises in changes from FY 2017 list Added (a) poisonous or deleterious packaging material?? SRM regulations listed removed (e)(1), general written procedures, added (e)(2) and (c), covering appropriate corrective actions and disposal of SRMs Removes some duplicative citations e.g., removed and left individual listings of (a) and (b)

8 Public Health Regulations (PHR) Tier 1 and 2 cut points have tightened for FY 2018 * Tier 1 is the higher threshold at which FSIS will consider the establishment for a Public Health Risk Evaluation. Tier 2 is the lower threshold at which FSIS inspection personnel will be notified via a PHIS Alert that an establishment is at an elevated level. FY 17 Operation Type Tier 1* Tier 2* Processing Combination 4.81% 3.16% 9.46% 5.82% FY 18 Operation Type Tier 1* Tier 2* Processing Combination 4.22% 2.82% 8.73% 5.38%

9 Recall lessons learned Adulterated or misbranded product shipped out of company control should not always result in recall be proactive before an issue arises! Can it be demonstrated there is no product in commerce? If out of physical control, can all product be accounted for with documentation showing product is on hold? If some or all product has been sold to consumers, is the product well beyond labeled shelf life?

10 Recall lessons learned Can it be demonstrated there is no product in commerce? Can it be demonstrated that the product was all sold to end use consumers for consumption on site, i.e., restaurants Knowing and having documentation showing how products are sold and used down stream can be critical In relation to adulterant pathogens found, can it be demonstrated adequate lethality was reached downstream?

11 Recall lessons learned Voluntary recalls should not be wielded as a punitive tool by the agency Sometimes reminding them is necessary Purpose should be to protect public health or otherwise protect consumers If conducting a voluntary recall will have no public health impact, why should it be done? Burden is on the company to explain why a recall is unnecessary when the agency is pushing

12 Recall lessons learned Inadequate labeling of donated product resulted in a recall Product was shipped from producing establishment with inadequate labeling No ingredient statement or mark of inspection Donated product can be technically misbranded, however, not when it comes to food safety (i.e., not declaring allergen) Product then repacked and relabeled by donation recipient and resold, further complicating the situation

13 Recall lessons learned Donating misbranded product, FSIS Directive : Economically adulterated product can be donated without temporary label approval or not for sale labeling Provided no missing declaration of allergens If undeclared allergens, temp approval and not for sale labeling required Bill of lading must include: Quantity of donated product Description of donated product Reason product diverted for donation (e.g., incorrect net weight) Statement that product is not for sale

14 Agency Notification, 9 CFR Continues to be a source of confusion Uniformity at District level increasing, but still some outliers Below District level, variability in interpretation increases noticeably Know the policy and appeal NRs documented in appropriately!

15 Agency Notification, 9 CFR Current written policy: AskFSIS Q&A currently posted defines adulterated or misbranded product shipped in commerce, as: Pre-shipment review signed and dated Out of the producing establishment s direct control If not out of the establishment s direct control, notification under is not required» Direct control can be demonstrated at third party locations (i.e., third party cold storage)»

16 Agency Notification, 9 CFR Current written policy FSIS Directive , July 3, form can be used by in-plant inspection to document receipt of adulterated or misbranded product If form is used, no additional notification under is required If company elects to notify the district under 418.2, form should not be used

17 Agency Notification, 9 CFR Important note in FSIS Directive : NOTE: When FSIS personnel at the supplying establishment receive notification of the product that has been shipped through the DO, the supplying establishment is not required to provide any additional notification under 9 CFR

18 Foreign Material FSIS continuing to focus on foreign material contamination issues Beyond base requirements of Industry Best Practice guidance document is in final development stages. NAMI worked with member companies, NCC, and NTF, with input from SMA and AAMP, to develop the guidance Awaiting a second look by FSIS Intended to be widely distributed and available across the industry when completed

19 Foreign Material Incidents of FSIS focusing on pre-op inspection related to possible foreign material, increasing Incidents in multiple districts during the past year Inspection looking closely at equipment during pre-op for missing materials Plastic scrapers/paddles missing material (e.g., v-mag) Exposed product conveyor bets missing material Metal to metal contact areas with grooves, evidently caused by rubbing

20 Foreign Material Evidence of missing material at pre-op, cont. FSIS inspectors pointing out missing material Comparing with company records to see If damaged equipment was identified previously If missing material was accounted for If no record or accounting found, FSIS has questioned whether the previous day s production may be contaminated with the missing material

21 Foreign Material Practical measures to address the issue Inspect contact surfaces prone to shedding material after production each day If missing material identified, take corrective actions before next day s pre-op by FSIS Be sure equipment is adjusted, repaired, or replaced, as necessary, before room is released to FSIS for pre-op If equipment must be used with obvious missing material, be sure it has been documented as being in that condition previously and that action was taken when first identified If metal detection is used, consider detectable plastic parts available from some manufacturers

22 Evidence Collection When FSIS Alleges Noncompliance Ideally, take a photograph of contaminant on food contact surface, or other alleged noncompliance Add in a sanitized ruler or other known size object to establish size of finding Ideally, collect the evidence, photographic or otherwise, while inspector is present

23 Evidence Collection When FSIS Alleges Noncompliance Collect the physical evidence when appropriate Alleged zero tolerance defects (color and texture?) Alleged rodent droppings (droppings or peppercorns?) Can be utilized for feedback and training of personnel Evidence can be used to support appeal, when appropriate Don t forget video evidence if available

24 FSIS Notice 1-18 Poultry specific notice, could be expanded to include red meat products down the road FSIS will conduct 16 sample follow up sample sets when companies fail to meet the performance standard (i.e., category 3) Will start 30 days after notified of failure to allow for time to implement corrective action Will serve to demonstrate effectiveness of any changes Although not stated in the notice, or not completes the above If not, an FSA would logically be scheduled to identify any inadequacies within the food safety system

25 Natural Sources of Curing Agents FSIS reissued appendix B (stabilization) guidance along with a compliance guide in June, Acknowledges that nitrite and ascorbate from natural sources can be used as a validated antimicrobial agent Page 15, provides that at least 100ppm nitrite from purified or natural source, with at least 250ppm ascorbate, support the use of option 3 Option to 80 F in 5 hours or less and 80 to 45 F in 10 hours or less

26 Natural Sources of Curing Agents Latest version of FSIS Directive , issued Dec. 27, 2017, lists two options for use with natural sourced curing agents as antimicrobial Option ppm nitrite and 250 ppm ascorbate Option 2-75 ppm nitrite and 500 ppm ascorbate Although the language on page 26 of reads, by weight of the finished food product, FSIS confirmed through askfsis that calculation to determine nitrite and ascorbate levels should be done based on ingoing formulation levels FSIS will update language in to reflect the above

27 Natural Sources of Curing Agents Although revised appendix B guidance does not explicitly include option 2 from directive , FSIS confirmed this option would qualify products for the slow cooling option Need to have a copy of the King study referenced in appendix B guideline as support for use of option 2 from , because the compliance guide does not include this option NOTE: Labeling policy required by 9 CFR and still applies to products produced with natural sources of curing agents even if used supportably as antimicrobial agents FSIS position is that these products are not cured

28 Fourth Cooling Option, Appendix B Resurrected the old slow cool option from rescinded FSIS Directive For products cured with nitrite or salt 120 to 40 F in 20 hours, provided: Process causes a continuous drop in product temp, or Controls temperature so product does not stay between 120 and 80 F for more than 2 hours

29 Fourth Cooling Option, Appendix B All ready to eat products formulated with 40 ppm sodium nitrite or equivalent AND brine concentration of 6% or more, OR With or without nitrite, with a maximum water activity of 0.92 This option no longer includes option from to use with products containing 120 ppm sodium nitrite and brine concentration of 3.5% or more Agency cites current pathogen modeling predicting > 2.0 log growth of C. perfringens using those parameters, as reason to consider this option NOT validated.

30 Appendix B 2.0 log C. perfringens option The document provides options to establish validated processes allowing no more than 2.0 log growth of C. perfringens For (a)(2), (b)(3)(ii)(c), and (a)(2) products subject to performance standard of 1 log growth of C. perfringens require a regulatory waiver Ready-to-eat(RTE) and heat treated but non-rte products not subject to these standards can utilize the process without a waiver, with adequate validation

31 Appendix B 2.0 log C. perfringens option Support for use of 2.0 log C. perfringens option Baseline study to show formulated raw product contains 100 cfu/g C. perfringens spore levels Formulated product, not just the meat component N=500 samples in baseline, assuming 10% of samples detect C. perfringens spores, if < 10% rate of positive, more sampling needed in baseline

32 Appendix B 2.0 log C. perfringens option Support for use of 2.0 log C. perfringens option Ongoing verification testing expected on weekly basis after baseline completed At least as many samples as taken during baseline should be collected per year as part of ongoing verification If N=500 in baseline, 10 samples per week for ongoing verification OR Alternative to baseline study is to employ a validated intervention to reduce C. perfringens spores

33 Appendix B 2.0 log C. perfringens option Once validated, two stabilization options are provided #1 130 to 80 in 2.5 hours, and 80 to 40 in 6.5 hours for a total of 9 hours #2 120 to 80 in 2.5 hours, and 80 to 55 in 3.5 hours for a total of 6 hours, provided the cooling is continuous down to 40 or less thereafter

34 Questions