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Does the FDA Bioterrorism Act apply to packaging materials?


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#1 Loren

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Posted 16 March 2016 - 09:56 PM

Hi Guys,

 

I kept receiving this request from our customers regarding our compliance with Bioterrorism act. Upon reading the act, it looked to me that it doesn't apply to us since we are only making packaging materials.

 

Am I right?

 

 

Regards,

Lorena



#2 Ehab Nassar

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Posted 17 March 2016 - 06:54 AM

Hi Lorens ,

 

It depends on the packaging you are producing , is it in direct contact with food the answer will be be yes , if it is it not in direct contact generally No , unless so some secondary packaging like a display box for sealed sachets it may be yes or no , some of customers require Tampering proof options .

 

I prefer to make vulnerability and risk assessment of each of your products ( linked with production line and the site ) according to it you can share with your customers that there is no risk and document this assessment .

 

this is the Bioterrorism Act of 2002 please review the below link 

 

http://www.fda.gov/RegulatoryInformation/Legislation/ucm148797.htm

 

Please also make sure that food defense plan is not required , because so of the customers required it as a mandatory requirement . 

 

Best regards,

Ehab



#3 Charles.C

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Posted 17 March 2016 - 08:26 AM

Hi Lorens ,

 

It depends on the packaging you are producing , is it in direct contact with food the answer will be be yes , if it is it not in direct contact generally No , unless so some secondary packaging like a display box for sealed sachets it may be yes or no , some of customers require Tampering proof options .

 

I prefer to make vulnerability and risk assessment of each of your products ( linked with production line and the site ) according to it you can share with your customers that there is no risk and document this assessment .

 

this is the Bioterrorism Act of 2002 please review the below link 

 

http://www.fda.gov/RegulatoryInformation/Legislation/ucm148797.htm

 

Please also make sure that food defense plan is not required , because so of the customers required it as a mandatory requirement . 

 

Best regards,

Ehab

 

Hi Ehab,

 

I'm only speculating but this quote seems to disagree  (or perhaps limit) yr  comment -

 

Certain other establishments are not required to be registered because they do not manufacture/process, pack, or hold "food" as defined in the registration regulation (21 CFR 1.227(b)(4)). This definition excludes food contact substances (including packaging materials), as defined in § 409(h)(6) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(h)(6)), and pesticides as defined in 7 U.S.C. 136(u). Thus, facilities that manufacture/process, pack, or hold only food contact substances or only pesticides are not required to be registered

 

.

http://www.fda.gov/F...e/ucm121288.htm

(revised 2006, claimed to be updated within 2015)

 

I'm not a packaging person so  welcome to be rebutted.

 

PS - I also saw this (2003) article -

 

https://www.khlaw.com/1090

 

PPS - one more -

 

16.10 Q: Are facilities that manufacture food packaging required to be registered as food facilities? 

A: No. The definition of "food" in 21 CFR 1.227(b)(4)(i)(A), for the purposes of food facility registration, excludes food contact substances as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)). Consequently, a facility that manufactures/processes, packs, or holds food contact substances, i.e., food packaging, is not required to be registered.

 

 

http://www.fda.gov/F...e/ucm331959.htm

(claimed to be last updated 2015 however the preamble notes that this is still a Guidance document)

 

Over to the Packaging People ?


Kind Regards,

 

Charles.C


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#4 Ehab Nassar

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Posted 17 March 2016 - 11:02 AM

Hi Ehab,

 

I'm only speculating but this quote seems to disagree  (or perhaps limit) yr  comment -

 

.

http://www.fda.gov/F...e/ucm121288.htm

(revised 2006, claimed to be updated within 2015)

 

I'm not a packaging person so  welcome to be rebutted.

 

PS - I also saw this (2003) article -

 

https://www.khlaw.com/1090

 

PPS - one more -

 

 

http://www.fda.gov/F...e/ucm331959.htm

(claimed to be last updated 2015 however the preamble notes that this is still a Guidance document)

 

Over to the Packaging People ?

 

thanks Charles for your comments ,

 

I under stand that the food contact is excluded ( as below in red ) , I'm right ! , this part is from  Q& A in the 'Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition) ' in the FDA website ( the link is below ) update November ,2014  ,Packaging is not to be registered  excluding food contact , 

16.10 Q: Are facilities that manufacture food packaging required to be registered as food facilities? 

A: No. The definition of "food" in 21 CFR 1.227(b)(4)(i)(A), for the purposes of food facility registration, excludes food contact substances as defined in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)). Consequently, a facility that manufactures/processes, packs, or holds food contact substances, i.e., food packaging, is not required to be registered. 

However , after reading this several times , It is not clear , even by exploring in the  food contact surface it is not directly related to packaging .

I think you are more to the right direction , as I do not have a sharp evidence except my interpretation for the red statement.

Best regards ,

Ehab  






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