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BRC Clause 1.1.6 NC

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#1 Qualitelpcn


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Posted 04 November 2017 - 11:43 AM

Hello Everyone, 

I need your help please .

I completed my BRC audit last month and The auditor give us a NC for clause 1.1.6- this is what she wrote: 


-1.1.6 Even though site is kept aware of changes on regulation through subscription to website of CFIA, registered into My BRC participation, and kept update from their clients to comply with country-destination regulation, it was noted when interviewing the staff, that there was not objective evidence on how the site were kept aware of upcoming changes on FSMA regulation in USA, while USA was one country destination or about changes in labelling regulation in Canada to demonstrate if their site will be affected or not. FDA website was not included in the list in the regulation section in the quality manual version 2016.


My corrective action was: 

We included the web site of the FDA and the Canadian label regulations web site in the Quality Manuel, Regulation section 1.1.6 page 17

My root cause and preventive :

Quality Assurance was on the FDA web site to receive e-mail alerts. Although it was not documented in the Quality Manuel

Seafood are exempt from FSMA because we are under FDA HACCP regulations.


Preventive action: The company is subscribed on the FDA web site, to receive important FDA news and information as they become available. Will receive email notifications.

Quality Assurance is subscribed to e-mail notifications for Canadian labelling regulations.

and it seems like its not enough because she replied back saying this: 

For compliance with regulation, a) please clarify which is the plan to comply with FSMA and which are your deadlines according regulation, b) what about upcoming changes in Canada labelling regulations, how this will affect or not your site?, how the site will be prepared?

And know i`m not to sure what to answer her since to my understanding wsa that we are exempte from FSMA because we are Seafood facility we only do Lobster.
and as for canadian labeling when the changes come up we will make the changes then. 
any input would be very much appriciated since my dead line is today. 
Best Regards, 


#2 Ehab Nassar

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Posted 04 November 2017 - 03:34 PM

Hi Qualitepcn ,


Regarding 1.1.6 and your NC ,The auditor will look for evidence of systematic checking and the process for ensuring the information is transferred into action as necessary. Sites must understand and comply both with relevant food safety and labelling legislation in the country of manufacture and with any applicable legislation where the product can reasonably be expected to be sold.

Activities to achieve this may include: • membership of a trade association which provides this service • subscription to a service provider supplying legal updates • help from government officials or local enforcement offices • regular review of identified websites covering legislation and standards.


Back to the NC :

a) please clarify which is the plan to comply with FSMA and which are your deadlines according regulation,

You should attach a link or document from the FSMA that clearly stated that you are exempt , I think that the below link will help you ,you should make Before submit this to the auditor make sure that your facility is complied with it 


in the below link 



You can highlight the following for the auditor after verification as I'm not aware about your processes :


"Importantly, several of the regulations that FDA has issued under FSMA provide exemptions related to the seafood HACCP regulation.  This guidance addresses those exemptions, and also provides information about the seafood HACCP regulation in connection with the FSMA regulations."


Does the exemption from 21 CFR part 117 subpart B for establishments solely engaged in the holding of raw agricultural commodities apply to seafood processors?

Yes. A “raw agricultural commodity” is any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing (21 USC 321®). Examples of seafood products that are considered “raw agricultural commodities” are whole, raw uneviscerated fish, whole raw crabs or lobsters, and raw head-on shell-on shrimp.


however I think you should adhere to the other requirement in the guide. 


b) what about upcoming changes in Canada labeling regulations, how this will affect or not your site?, how the site will be prepared?

I'm not sure whether the site is sending updates to the registered members or not , but if they do not , you can state that someone is responsible to check the website for any updates on X frequency (e.g. weekly ,bi weekly,...) and update the QAM to update the labeling instruction ,procedure,policy ,or any related document you have , however I have an idea that the assigned person for reviewing updates can send QAM a X frequency brief about the latest information on the site e.g Weekly or monthly. Accordingly you can state in your internal document what is the next steps that grantee a proper action will be applied in a proper way.

e.g. the QAM study the new updates, then accordingly an assessment with production , NPD ,food safety mangers , a documented report is issued and signed off by the team showing the position of the facility regarding this updates with reference e.g. exempt or mandatory , action plan is documented how to comply with that.




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#3 Charles.C


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Posted 05 November 2017 - 03:31 AM

Hi Qualite,


If yr interpretation of the FDA/FSMA seafood involvement is correct, it seems that you have unfortunately encountered an auditor insufficiently knowledgeable regarding yr food category. And seemingly unwilling to be educated.


I guess you need to decide whether you prefer to initiate a complaint (see the BRC7 Standard for Procedural advice) or be prepared to proffer further detailed communications such as in previous Post.


IMEX of (rare) related dilemmas I directly "contacted" the auditor to attempt an understanding/reconciliation of the disagreement. This typically enabled avoidance of an official complaint.


From yr OP i guess you must have already decided.

Kind Regards,



#4 john.kukoly


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Posted 09 November 2017 - 11:39 AM

The only thing I would add - for all things FSMA I refer back to the FDA as the sole source for the final word on things. As to seafood being exempt - the real answer from the FDA seems to be "more or less". I would recommend having a look at this FDA guidance on the topic:




The other piece of advice for FSMA - all responsibility is put onto the US based importer of record - they are held liable by the FDA for the verifica4tion of supplier food safety programs, so do check with your importer of record to ensure what you are offering as evidence is what they require in their foreign supplier approval requirements.


John K

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