Question:  In a turkey facility currently with NTIS, birds are presented in a 3 point configuration. A plant employee has presented a question concerning orientation of the bird to the inspector for the carcass inspector when a plant switches to NPIS. Does it matter if the bird is presented with the breasts or the back towards the inspector?

Response:  Yes it does.  The NPIS final rule, in 9 CFR 381.76(b)(6)(iii)(C), specifies that the back side of the carcass must be faced toward the inspector. 

Question:  The question and answer guide for poultry slaughter modernization states that turkey facilities’ line speeds will be able to be increased from 51 to 55 bpm. Does that line speed apply to all sizes of birds and opening type? Line speed is currently based on bird size and types of cuts for the opening and the number of FSIS inspectors per line.  Could you explain how and if any of that relates to NPIS?

Response: Yes, if a plant operates under NPIS, the line speed of 55 bpm applies to all sizes of turkeys and opening types.  If a plant continues under NTIS, it will follow the line speed under the NTIS regulations. 

Question: Will USDA FSIS be mandating the pre-chill sample location?

Response:  Pre-chill sampling means any location from re-hang to just prior to the chiller.  

Question: Will the sampling frequency/number be determined based on the number of evisceration lines, kill lines, or chillers maintained within an establishment?

Response:  No. Sampling frequency is based on annual production volume. 

Question: Will the establishments be required to collect and test a sample from both pre-chill as well as post chill?

Response:  Except for very small or very low volume establishments operating under traditional inspection, all poultry slaughter establishments (other than those that slaughter ratites) must collect and analyze a pair of samples, one at pre-chill and one at post-chill.  Very low volume and very small establishments operating under traditional inspection are required to test at post chill only.

Question: Will the establishments be required to collect and test samples at the same frequency prescribed within the generic E. coli criteria (1/22,000 birds)? 

Response:  Except for very low volume establishments, poultry slaughter establishments (other than those that slaughter ratites) must collect and test samples at the following frequency:  Chickens:  once per 22,000 carcasses, but at a minimum of once during each week of operation; Turkeys, ducks, geese, guineas, and squabs:  once per 3,000 carcasses but at a minimum of once during each week of operation.  If an establishment is very low volume (VLV), then the establishment must collect and analyze samples at least once during each week of operation starting June 1 of every year (381.65(g)(2)(ii)).

Question: What are the expectations and timelines for HIMP plants with respect to the modernization rule so that all current waivers are maintained?

Response:  As stated in the preamble to the final rule,  all young chicken and turkey slaughter establishments will initially have until February 23, 2015 to notify their District Office in writing of their intent to operate under the NPIS (79 FR 49566 and 49593). Establishments that do not notify their District office of their intent by February 23, 2015, will be deemed to have chosen the inspection system that they are currently operating under. Therefore, the 20 young chicken and 5 turkey establishments participating in the HIMP pilot should notify their District Office (DO) in writing of their intent to transition to NPIS, and when they would like to start NPIS before the end of the 6 month opt in period (i.e. February 23, 2015). If the HIMP establishments do not notify their DO that they do not intend to opt out, the Agency will assume that they intend to operate under NPIS. 

When the HIMP young chicken plants notify FSIS of their intent to transition to the NPIS, they should also submit a request to have their SIP letter revised to obtain a line speed waiver of 9 CFR 381.69(a) to run speeds of up to 175 bpm according to procedures in the SIP program (76 FR 41186, 7/13/11).  FSIS will update the SIP Letters documenting the waiver to also remove aspects of HIMP that are inconsistent with the NPIS.  Turkey HIMP establishments can continue to operate under their current SIP letter until they start operating under NPIS at which time the waiver is terminated.  

Question: Will current HIMP establishments have to amend their SIP waivers?  Is this something the establishment will need to do or something the Agency will address?  

Response: As stated in the previous response, all young chicken and turkey slaughter establishments will initially have until February 23, 2015 to notify their District Office in writing of their intent to operate under the NPIS (79 FR 49566 and 49593). Young chicken HIMP establishments should notify their District Office (DO) in writing of their intent, and when they will be ready to transition to NPIS by February 23, 2015.   At the same time, those establishments can request to have their SIP letter revised to obtain a line speed waiver of 9 CFR 381.69(a) to run speeds of up to 175 bpm. FSIS will update the SIP Letters documenting the waiver to also remove aspects of HIMP that are inconsistent with the NPIS in accordance with to procedures in the SIP program . Turkey establishments should also notify their DO of their decision to operate under NPIS and will continue to operate HIMP alternative procedures until they start operating under NPIS.

Question: Can the Agency please provide details on what is expected from large non-HIMP establishments on October 20th and November 19th?  And, if different, can the Agency please provide details on what must be completed by current HIMP establishments on October 20th and November 19th?

Response:  On October 20, 2014, the regulations that prescribe new requirements for online/offline reprocessing and chilling went into effect, and the generic E. coli regulations for all poultry except for ratites were rescinded. Therefore,  all waivers for online/offline reprocessing and alternative chilling procedures ended on October 20, 2014, and all plants that use these technologies, including HIMP plants, must now comply with the new regulatory requirements.  Under the new regulations, establishments’ chilling procedures or off-line reprocessing procedures have to be addressed in their HACCP plans, or sanitation SOPs, or other prerequisite program.

On November 19, 2014, all large establishments (whether HIMP or not) are required to meet the new regulations requiring that they maintain programs to prevent fecal and enteric pathogen contamination throughout the slaughter operations.  These programs need to include testing for microbial organisms. 

Question: Part 381-Poultry Products Inspection Regulations become effective on October 20, 2014 with the exception of 381.65-Operations and procedures, which becomes effective November 19, 2014.  Is my understanding correct?

Response: Yes.  But November 19th is only for large establishments. 

Question: Current HIMP establishments who want to maintain their 175 bpm line speed waiver are expected to express their interest in opting into NPIS in writing to their District Offices on or before February 23, 2015.  Is this correct?

Response: Yes. 

Question: Can current HIMP establishments opt into NPIS after February 23, 2015?

Response:  If a HIMP establishment does not notify its DO of its decision to operate under NPIS before February 23, 2015, FSIS will assume that the establishment will operate under NPIS. The DO will contact those HIMP establishments to confirm that the establishments will operate under NPIS.

Question: It is our understanding that SIP will still be in effect for HIMP plants including sampling frequencies and reporting responsibilities.  Is this correct?

Response: Until HIMP establishments are operating under NPIS, HIMP establishments will continue to operate under a SIP waiver and to collect and submit SIP data.

Once they are operating under NPIS, turkey establishments will not be under a HIMP waiver and will not need to collect and submit SIP data for that waiver.

Even once they are under NPIS, young chicken HIMP establishments that are granted a line speed waiver will continue to collect and submit SIP data.   

Establishments may use SIP microbial data as part of their sampling plan to monitor their process control as required by 9 CFR 381.65(g) and (h), provided minimum frequencies and locations for testing are met.

Question: For HIMP plants, does the safety attestation have to be included with the waiver request? When is that information required?

Response:  All establishments operating under NPIS must comply with the safety attestation requirement.  However, the revised SIP letter will indicate that the former HIMP establishment operating under NPIS with a line speed waiver will be subject to the safety attestation requirement.

Question: Is safety attestation required by establishments not opting into NPIS?  

Response: Safety attestation is not required by establishments that do not operate under NPIS. 

Question/Comment: The industry is concerned about the future of various waivers.  Regarding SIP, there are other waivers beyond time/temperature and OLR that the industry relies on.  We hope those waivers do not go away.  

Response:  OLR and chilling time temperature waivers are no longer necessary because the rule provides for flexibility to use alternative procedures. 

All FPS waivers will be terminated by operation of the final rule.  The purpose of the waivers was to gather the information on how non-food safety defects should be handled.  The Agency’s decision on this matter, to go the ready-to-cook standard in NPIS, was based on the information obtained under these waivers. Therefore, the reason for granting the waiver has been fulfilled. 

The effect of the termination of the waiver will depend on what an establishment elects to do on February 23, 2015 (the opt-in date). Establishments that are currently operating under FPS waivers and that would like to continue to use their alterative FPS procedures will need to convert to the NPIS. 

Establishments that notify FSIS of their intent to operate under NPIS, may continue to operate under the waiver from FPS requirements until they start operating under NPIS. If establishments choose to operate under SIS, NELS, or NTIS inspection systems (which require complying with FPS), their FPS waiver ends on February 23, 2015. FSIS will give 30 days written notice of the termination of that waiver. Otherwise, establishments will need to submit a request for a new waiver from FPS requirements under SIS, NELS or NTIS with information on how the waiver would provide new information that would facilitate definite improvements (9 CFR 381.3(b)). FSIS expects that it will be difficult for establishments to meet requirements necessary to obtain a waiver now that NPIS is available. FSIS will issue additional guidance on FPS waivers.

Question: Regarding pre-chill sampling, can the establishment determine the pre-chill location of its choosing or does the Agency have a suggested sampling location in mind?

Response: The establishment can determine the location that best supports its sampling plan.  Pre-chill means any location from rehang to before the chiller. 

Question: Who is answering questions submitted to askNPIS?

Response: We have a Triage group and other SMEs working on the copious questions coming into the askNPIS mailbox.

Question: If an establishment opts into NPIS and at some point determines the system is not working for it; can they convert back to the previous inspection system?

Response: Although we do not expect this situation to occur, an establishment would follow the same procedures that have been in place on switching from one system to another working with their DO.

Question: In determining the program we use to monitor and ensure RTC poultry is produced, will establishments be allowed to collect and monitor finished parts, past post-chill (accumulated to make a full carcass, i.e., breast, tenders, wings, thighs, drums)?

Response:  Under NPIS, establishments are required to maintain records to document that their products meet the RTC definition (9 CFR 381.76(b)(1)(iv).  Establishments have flexibility to develop the necessary process to meet these requirements.  As long as they support that their product is RTC, they can monitor finished parts. 

Question: Will the VI follow the plant’s frequency of monitoring for RTC poultry, or will they default to the current verification of 2x/line/shift?  

Response: FSIS intends for the VI to verify that establishments meet the ready to cook requirements by records review.  FSIS intends to routinely schedule this review in PHIS once in 30 working days. The PHV/IIC can schedule a directed RTC task and review the establishment’s program for monitoring its products to ensure they meet the RTC definition as needed.

Question: Regarding sampling frequency, is the one sample per 22,000 birds for total birds slaughtered in a plant or for each evisceration line?  If it is for total birds slaughtered at a plant, should the plant rotate through each evisceration line (provided they have more than one) for their pre-chill sample? 

Response: The sampling frequency of once per 22,000 refers to total birds slaughtered.  Note that establishments are required to collect a pair of samples, one at pre-chill and one at post-chill.  As noted in the preamble to the final rule, FSIS is prescribing “a minimum frequency with which establishments will be required to collect a pair of samples, one at pre-chill and one at post-chill, or, for very small and very low volume establishments that operate under Traditional Inspection, a single post-chill sample” (79 FR 49604).

Question: On page 49614 in the Federal Register, the table appears to be very specific that HIMP plants must meet the 1) new facility requirements 2) new carcass inspections stations for each evisceration line, and 3) underline trough for each evisceration line.  Does this mean that current HIMP plants will need to retrofit to meet these specifications?  Can establishments get waivers to operate in their current configuration?

Response: If HIMP establishments have questions about whether they comply with NPIS facilities requirements, they should contact the DO.

Question: For current HIMP plants, it is my understanding that until an establishment submits a letter to the District Office expressing interest in opting into NPIS, that establishment will continue to operate as a HIMP plant with a SIP waiver. This would include continuing to use HIMP Draft 8 as our tool for OCP compliance. Is this correct?

Response: Poultry HIMP establishments can continue to operate under their current SIP letter that includes following HIMP draft 8 for young chickens (HIMP draft 4 for turkeys) until the establishment starts operating under NPIS.  If the establishment has not notified their District Office of their intent to operate under NPIS by February 23, 2015, FSIS will assume they intend to operate under NPIS. The DO will contact those HIMP establishments to confirm whether the establishment will operate under NPIS. 

Question: If a USDA inspector observes contamination during the process, is the overall system still supposed to be evaluated?  Are there going to be any numeric values associated with this observation or is this strictly a subjective observation and action? 

Response:  FSIS is not setting numeric values associated with the observation of visible contamination. FSIS will verify that establishments meet the requirements throughout the process and according to the establishment’s plan. FSIS will verify the effectiveness of an establishment’s process control procedures in preventing carcasses from becoming contaminated with enteric pathogens and fecal material by reviewing the establishment’s monitoring records, including the establishment’s microbial testing results, observing an establishment implementing its  procedures, and inspecting carcasses and parts for visible fecal contamination when conducting both online carcass inspection and offline verification inspection procedures (77 FR 4427 and 79 FR 49601).

Question: When will CI’s begin writing fecal NRs in current HIMP plants and for plants opting into NPIS?

Response: CIs will begin issuing NRs for visible fecal contamination after an establishment converts to the NPIS. Thus, CIs in current HIMP establishments will begin issuing NRs for visible fecal after the plant converts to the NPIS.

Question: What is the earliest date FSIS anticipates granting the opportunity for NPIS changeovers?   

Response: FSIS is targeting the timeframe of summer 2015 as the earliest time that the Agency will be able to convert establishments to operating under NPIS.

Question: How much preliminary notice will the establishment receive in scheduling a firm changeover date?  Establishments will need to plan production accordingly and may have some downtime in order to make the necessary engineering changes.  As a result, a floating date or a date without sufficient notice will not work very well. 

Response: The Agency plans to notify establishments of their placement in the schedule well in advance of implementing NPIS.

Question:  How will an establishment’s need for a changeover on a certain date be worked in connection with the selection rubric the FSIS has designed for determining the order of changeovers?

Response: The Agency is using a computerized process (rubric) to ensure fairness in the roll out process and make sure there is no specific advantage inadvertently given to one corporation over any other establishment converting. Once the rubric is run, the Agency will use considerable effort in the assessment of resources, coverage, establishment’s readiness, and other factors that will impact the order from the rubric along the process.

Question:  In planning for the changeover to NPIS, will the Agency provide the establishment guidance as to what information will need to be prepared in advance for FSIS?  For example, will the Agency want to review blueprints for stand placement and acceptability of stand design?  Will the Agency require evidence of sorter training? 

Response: The agency is not seeking to review blueprints or other similar materials. The process will be as it is now when a plant changes systems, such as changing to NuOva or Meyn Maestro automated high speed evisceration equipment lines.

Question: The requirement for a large establishment to perform a complete changeover (all lines, both shifts), rather than a transitional changeover (1 line at a time) requires special and elaborate planning. To encourage participation, is there any flexibility by the Agency for reconsideration of the requirement for complete, all-at-once, changeover?

Response: As noted in the preamble to the final rule, FSIS has decided not to give establishments the option to stagger implementation by line and shift (79 FR 49594-49495).  It would be too difficult for FSIS to perform its inspection activities at establishments that are operating different lines or shifts under the NPIS and one of the other inspection systems at the same time.  For Agency planning and resource purposes, if an establishment wants to convert to the NPIS, all of the establishment’s lines and shifts will be required to switch to the NPIS during the transition. However, if an establishment wants to make changes to its operation to prepare for conversion to the NPIS, FSIS will try and accommodate those changes as long as they do not affect FSIS inspection activities or procedures.

Question: How does NPIS affect no objection letters and OLR limits?  We have establishments looking at increasing OLR targets compliant with 7120.1 (which allows up to 2000ppm) but they are getting push back saying new technology has only approved up to this level (220ppm).

Response: Antimicrobials listed in FSIS Directive 7120.1, “Safe and Suitable Ingredients Used in The Production of Meat, Poultry, and Egg Products” are not approved OLR or OFLR antimicrobial intervention systems.