2 replies to this topic

[Emily_B]

Hi all,
My company is considering using a third-party warehouse for storing our food ingredients. This facility has historically only stored food packaging materials and has not been FDA registered. Now that we’re looking to store food products there, we would like them to register with the FDA to comply with the Bioterrorism Act.

 

However, the warehouse believes they are exempt, citing the following:

“Holding of food contact substances” is excluded. Additionally, if a facility only holds packaged food that is not exposed to the environment, and does not mix, repack, or relabel, it may not require registration. That’s how large retailers store packaged food without FDA registration.”

 

To add to the confusion, the warehouse is also pursuing SQF certification for storage and distribution. I mentioned that during an SQF audit, they could potentially be flagged if they are holding food but not FDA registered—since SQF requires compliance with applicable national and local regulations. They pushed back, saying they’re exempt, so FDA registration wouldn’t apply to them.

 

My understanding was that under the Bioterrorism Act, anyone “engaged in manufacturing, processing, packing, or holding food for consumption in the U.S.” is required to register.

 

I don’t want to push if they are truly exempt—but I also don’t want to risk non-compliance.

 

Has anyone run into something similar or have any insights into how this is usually handled for third-party storage of food ingredients?
Thanks in advance for your help!

Edited by Emily_B, Today, 02:09 AM.

[kingstudruler1]

You are correct, you need to register.    Whats the risk of registering?   Its free and easy.   

 

Retail stores dont register because retail facilites are exempt.   Thier distribution centers are not exempt  and are required to register.

 

What is the source of this?: "Additionally, if a facility only holds packaged food that is not exposed to the environment, and does not mix, repack, or relabel, it may not require registration"

 

https://www.fda.gov/...th-Edition).pdf

[jfrey123]

Yeah I dunno, this is one of the times where US Code is actually crystal clear to me.  I see the exemption specifically for retail and it has zero to do with any language about only holding food that is not exposed to the environment.  They point of the Bioterrorism Act is to protect food from terrorist actions, and somehow only holding it in a warehouse doesn't make it a potential target?

 

 

 

eCFR :: 21 CFR 1.225 -- Who must register under this subpart?

1.225 Who must register under this subpart?

 

(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States, unless your facility qualifies for one of the exemptions in § 1.226.

(b) If you are an owner, operator, or agent in charge of a domestic facility, you must register your facility whether or not the food from the facility enters interstate commerce.

© If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf.

 

 

 

eCFR :: 21 CFR 1.226 -- Who does not have to register under this subpart?

1.226 Who does not have to register under this subpart?

 

This subpart does not apply to the following facilities:

 

(a) A foreign facility, if food from such facility undergoes further manufacturing/processing (including packaging) by another facility outside the United States. A facility is not exempt under this provision if the further manufacturing/processing (including packaging) conducted by the subsequent facility consists of adding labeling or any similar activity of a de minimis nature;

(b) Farms;

© Retail food establishments;

(d) Restaurants;

(e) Nonprofit food establishments in which food is prepared for, or served directly to, the consumer;

(f) Fishing vessels, including those that not only harvest and transport fish but also engage in practices such as heading, eviscerating, or freezing intended solely to prepare fish for holding on board a harvest vessel. However, those fishing vessels otherwise engaged in processing fish are subject to this subpart. For the purposes of this section, “processing” means handling, storing, preparing, shucking, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, holding, or heading, eviscerating, or freezing other than solely to prepare fish for holding on board a harvest vessel;

(g) Facilities that are regulated exclusively, throughout the entire facility, by the U.S. Department of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);

Edited by jfrey123, Today, 02:13 PM.