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Which Companies are part of FSMA regulations ?

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Microbiologist Scientist

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Posted 17 January 2019 - 07:43 AM

Hi again!!!!

 

One of the companies who work in the same facilities that we, sells Opuntia cacti (vegetable). I asked the owner if he had a food safety plan referring to FDA (Preventive Control for Humans). He had no idea that I was talking about.

FSMA came into effect in September 2018 (small companies).

 

They buy their product in California, but the product comes from Mexico. They remove the thorns from the product, then cut it into small pieces (with a machine or knife). They do not wash it because the product is like strawberry, if it is wash it will get damaged. They pack it in plastic bags. Their product contains a label which indicates among other things that the product has to be washed before consumption. Then they transport it to supermarkets (customers) for sale.
 
The owner of the business told me that the consumers of the supermarkets are Mexican people who recite in California and the  supermarkets owners do not ask for any type of GFSI Food Safety Plan standars. Of course, this does not mean that they do not have to abide by FDA regulations.
According to my understanding they need to abide by the FDA regulations since they are manufacturing food. I am almost sure that almost every company who works in the facilities where I work needs a food safety plan (Preventive Control for Humans). Other products that are produced there are salsas (sauce) and bakery products.
 
There are also some companies who cooks (for example: rice, meat, vegetables). They place food in containers and deliver to their customers, who are also their consumers. I'm not sure if these people needed to follow the  FDA regulation (Preventive Control for Humans).
 
​What do you think, does this companies are part of FSMA regulations or part of other regulations??????


kfromNE

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Posted 17 January 2019 - 02:39 PM

The companies that cook rice, meat, vegetables, etc and deliver them - they fall under California food safety laws/local inspection. https://www.fda.gov/...e/ucm122814.htm

 

As for the person who sells cacti - since they don't sell across state lines - I know the laws are different and it depends on their size as well. Attached is rules where you can be exempt - https://www.fda.gov/...A/UCM625684.pdf

 

" Or can it be justified that we can all wash in the sinks (3 sinks) since in the final stage the utensils will go to the machine that cleans and sanitizes our utensils ???" You should be okay to clean all items together because the utensils are cleaned and sanitized. My main concern would be allergen cross contact especially from the other employees of those other businesses.



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Microbiologist Scientist

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Posted 17 January 2019 - 11:55 PM

Thanks KfromIA,
I read the information you sent me. We are a small business. But I believe we still need to complaided with FSMA because we sell to Canada.
It's this right???



SQFconsultant

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Posted 18 January 2019 - 03:03 AM

I must have missed something along the way in reading your postings.  I did not realize your facility is in shared facility - this presents a a challenge in trying to get SQF certified, not that it can not be done, just that the entire facility must be compliant to everything you are compliant with for SQF.

 

The major issue in shared facilties is cross-contamination.

 

As a former SQF Auditor I was rated for the category that shared facilities would fall under, but I never did an audit on one of them.

 

As an SQF Consultant we started a project with a company in a shared facility but it became so daunting for the target company they decided to go into their own sealed facility and as it turned out they could not afford to do so, thus they never got SQF certified.

 

This is not meant to discourage you, it is a challenge to be sure - but you'll have to get the entire facility to cooperate on the program. 

 

Now, as the company that gave you a line about not washing, that is a stupid thing to say - strawberries coming off the field are flumed many times - they are "washed."  So, basically they take a dirty item and then with kives or a cutting machine drive what was on the outside of the item right into the interior of the item and then taking the dirty knives to the next batch they continue the practice - sheer luck they haven't killed somebody yet.


All the Best,

 

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http://www.GlennOster.com

 


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Posted 18 January 2019 - 06:44 AM

It is true what SQFconsultant says. They justify it with the label saying the consumer have to wash the nopales (Opuntia cacti) before eating them. But I believe if the product were be contaminated with some pathogen during the process of cutting it, washing them will not make much difference.

Do you think that if the consumers boil the product (100Celsius) it would be enough to justify their procedures? (the label doesn’t say anything about boiling)

The reality is that the nopales cannot be washed once cut, since the product emanates some kind of “slime” which greatly harms the self-live. Practically the quality of the product would be damaged. Maybe an alternative would be to wash the product and dry it slightly before cutting them. Or maybe selling them without cutting as most large supermarkets does.

 

I know they are registered with the FDA, but I think they do not have to follow the FDA (Preventive Control for Humans) regulations.

 

FDA says:

What is a qualified facility?

A qualified facility is either (1) a “very small business” or (2) a business (including any subsidiaries or affiliates) whose average annual monetary value of the food sold during the previous threeyear period was less than $500,000 (adjusted for inflation) and whose average annual monetary value of food manufactured, processed, packed or held and sold directly to consumers, retailers, and restaurants within the same state or the same Indian reservation or within 275 miles of the facility was more than the monetary value of food sold by the facility to other purchasers.  FDA anticipates that most “qualified facilities” will be ones that meet the definition of “very small business.”

 

What modified requirements apply to qualified facilities?

A qualified facility is required to submit Form FDA 3942a, attesting to its qualified facility status (meaning that the facility meets the financial requirements to be a qualify facility) and attesting that it is either:

1. Addressing identified hazards through preventive controls and monitoring the preventive controls; or

2. Complying with applicable non-federal food safety law (including state food safety laws), and notifying consumers of the name and complete business address of the facility where the food was manufactured or processed.

 

A qualified facility is also required to maintain the records they rely upon to support the attestations they make on Form FDA 3942a. In addition, qualified facilities are required to comply with the Current Good Manufacturing Practice requirements.

 





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