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PCQI for Seafood Manufacture - FDA Guidance

seafood pcqi exempt fsma

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#1 TJW

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Posted 15 February 2018 - 08:12 PM

The guidance provided by FDA states the following:

 

4.  What additional training requirements apply to seafood processors under 21 CFR part 117?
In addition to the training requirements listed in 21 CFR 123.10, the management of an establishment must also ensure that their employees meet the training requirements listed in subpart A of part 117. The training requirements in subpart A replace the training recommendations previously listed in part 110. The workers who are engaged in manufacturing, processing, packing, or holding seafood (including temporary and seasonal personnel) must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties (“qualified individual”) and must receive training in the principles of food hygiene and food safety (21 CFR 117.4(b)). In addition, supervisory personnel must have the necessary education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe food (21 CFR 117.4©).
Seafood processors must maintain records of the training of those “qualified individuals” and their supervisors in the principles of food hygiene and food safety, including health and personal hygiene, as appropriate to the food, the facility, and their assigned duties (21 CFR 117.4(d)). The requirements of subpart F of part 117 apply to these training records.

 

I have seen previous threads on IFSQN state that if you are exempt you do not need to worry about PCQI training.  These threads were published prior to this guidance.  Can someone advise if a seafood manufacture would need to obtain this training?

 

Thank you! 



#2 FurFarmandFork

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Posted 15 February 2018 - 09:31 PM

Your product is only so relevant.

 

If you are familiar with the requirements of FSMA that do apply to you and you have been in the industry a while, you don't HAVE to take a PCQI course from FSPCA, you can rely on "the necessary education, training, or experience (or a combination thereof) necessary" to supervise these activities. They have to demonstrate that you don't have the knowledge. So take the course if you feel like you need it to help know your way around the rule, if not, document your personal education/experience and how it meets the requirement.

 

If it's 2018 and you're asking "what does FSVP mean?" Take the class. :) I have a feeling that since you have been keeping up on the guidance you don't necessarily need the course.


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#3 TJW

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Posted 15 February 2018 - 09:56 PM

Thank you FFF.  

 

The plant is preparing for their initial GFSI certification audit and are exempt from HARPC...the PCQI training requirement was confusing to me though.  Their audit is in 4 weeks and I'm certain they will not have time to complete the training.  They may need to go the route of experience at this point and follow-up with training.  Of course this is to meet the GFSI requirement that the facility is complying with legal requirements (FSMA).



#4 Charles.C

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Posted 16 February 2018 - 09:31 AM

I'm not in USA.

 

I thought Seafood was FSMA exempted. Period.

 

Apparently not.


Kind Regards,

 

Charles.C


#5 FurFarmandFork

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Posted 16 February 2018 - 04:02 PM

I'm not in USA.

 

I thought Seafood was FSMA exempted. Period.

 

Apparently not.

 

 

Exempt from the HARPC rule for food products that fall under the seafood haccp rule. Products are varied and ultimately it's up to each individual supplier to prove their exempt status, which arguably requires someone trained in them to discern the difference.

 

 

 

Not exempt from the new GMP's, FSVP, Food Defense, Sanitary Transport, Etc. rules.


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#6 Fishlady

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Posted 22 February 2018 - 06:06 PM

As long as you are in compliance with 21 CFR 123 (Seafood HACCP regulation), you are not required to comply with HARPC (FDA prefers to use the term "Preventive Controls for Human Food" or PCHF).  However, if you have the opportunity, I recommend taking the PCQI class.  It overlaps quite a bit with GFSI requirements, and I think that someday seafood will get pulled into it anyway.  FDA has also said that if a company is not found to comply with 21 CFR 123, then FDA may at its discretion require them to comply with PCHF.



#7 Charles.C

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Posted 22 February 2018 - 07:14 PM

Exempt from the HARPC rule for food products that fall under the seafood haccp rule. Products are varied and ultimately it's up to each individual supplier to prove their exempt status, which arguably requires someone trained in them to discern the difference.

 

 

 

Not exempt from the new GMP's, FSVP, Food Defense, Sanitary Transport, Etc. rules.

 

 

As long as you are in compliance with 21 CFR 123 (Seafood HACCP regulation), you are not required to comply with HARPC (FDA prefers to use the term "Preventive Controls for Human Food" or PCHF).  However, if you have the opportunity, I recommend taking the PCQI class.  It overlaps quite a bit with GFSI requirements, and I think that someday seafood will get pulled into it anyway.  FDA has also said that if a company is not found to comply with 21 CFR 123, then FDA may at its discretion require them to comply with PCHF.

 

 

Hi 3F / Fishlady,

 

Thks for above but unfortunately i found the content sort of incomprehensible.

I deduce the "simple"  English answer to my query is maybe/maybe not. Depending on "FSMA-speak".


Kind Regards,

 

Charles.C


#8 Fishlady

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Posted 22 February 2018 - 07:41 PM

Sorry if my reply was confusing.  My understanding is that if you are complying with Seafood HACCP (for the products that fall under that rule), you do not need to comply with the PCHF rule (or thus to have PCQI training).  You do still have to comply with the updated GMP's, the Sanitary Transportation Rule, and the Intentional Adulteration Rule. 

 

FDA also released guidance for the seafood industry where they stated that if FDA finds that enforcement actions under 21 CFR 123 are not sufficient to correct problems, the company may lose exemption from the PCHF rule.  See pages 5 and 6 of the document below.

https://www.fda.gov/...n/UCM569798.pdf



#9 Charles.C

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Posted 22 February 2018 - 07:59 PM

Sorry if my reply was confusing.  My understanding is that if you are complying with Seafood HACCP (for the products that fall under that rule), you do not need to comply with the PCHF rule (or thus to have PCQI training).  You do still have to comply with the updated GMP's, the Sanitary Transportation Rule, and the Intentional Adulteration Rule. 

 

FDA also released guidance for the seafood industry where they stated that if FDA finds that enforcement actions under 21 CFR 123 are not sufficient to correct problems, the company may lose exemption from the PCHF rule.  See pages 5 and 6 of the document below.

https://www.fda.gov/...n/UCM569798.pdf

 

Hi Fishlady,

 

Thks for clarification. Although IMO it’s essentially “back-covering” the text is indeed nicely written.

2.  What if the facility is not in compliance with 21 CFR part 123?

 

We expect that situations in which enforcement actions to ensure compliance with the

seafood HACCP regulation in 21 CFR part 123 are insufficient to correct problems and

lead to a facility losing its exemption from the requirements of subparts C and G of part

117 will be rare and will depend on very specific circumstances.  The extent of non-

compliance with part 123 that will result in the loss of exemption will be considered on a

case-by-case basis by FDA.  We do not expect loss of exemption to be commonplace;

however, FDA may use this regulatory tool when adequate control cannot be achieved

through the implementation of an effective HACCP program by a processor.

 

 

I haven’t gone back to the infamously long Part 123 to check but I found the “red” sentence below (a) rather hard to believe and (b) even more surprising if true  to have now emerged essentially unscathed -  

 

8.  Does 21 CFR part 117 require seafood processors to have written sanitation procedures?

 

No.  Subpart B of part 117 does not require written sanitation standard operating

procedures (SSOPs).  Seafood processors are exempt from subpart C of part 117 where

the requirement for written sanitation controls is found.  The seafood HACCP regulation

recommends, but does not require, written SSOPs for sanitation.  Seafood processors

continue to be required to implement sanitation monitoring procedures and to maintain

written sanitation monitoring and corrective action records as defined by 21 CFR 123.11.

 


Kind Regards,

 

Charles.C


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#10 Fishlady

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Posted 22 February 2018 - 08:02 PM

I renewed my FDA Seafood HACCP training in November 2017, and it is still true that SSOPs are not required to be written.  However, the instructor noted that if the regulation were written today, that would definitely be a requirement, and she strongly recommended that we have written SSOPs.  (Some of the states do require it.)



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#11 qualityfishgirl11

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Posted 28 February 2018 - 02:43 PM

where did you do your seafood haccp training? Is there one online? 



#12 Fishlady

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Posted 28 February 2018 - 04:08 PM

The US Department of Commerce/National Marine Fisheries Service/NOAA Seafood Inspection Program offers seafood HACCP training throughout the year. https://www.fisherie...-course-details

 

Cornell University also offers an online course.  The first part of the course is done online, but in order to get a certificate of completion, you must also attend a one-day in-person session, which is offered various times and places throughout the year. https://foodscience.....compressed.pdf

 

Both of these programs use the FDA curriculum and are designed to meet the FDA's requirements in 21 CFR 123.  Some universities also offer the course from time to time through the Sea Grant program.







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