FDA exemption for facilities who solely store unexposed packaged food

We are a package in/package out warehouse/distribution center. With the exception of some produce (which I understand falls under a separate produce rule) we only handle "unexposed packaged food."

I have a question regarding an exemption listed in CFR that I came across this morning during my morning reading. That exemption at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=117.7   is as follows:

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 117 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

Subpart A--General Provisions Sec. 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food. 

(a) Applicability of subparts C and G. Subparts C and G of this part do not apply to a facility solely engaged in the storage of unexposed packaged food.

(b) Applicability of subpart D. A facility solely engaged in the storage of unexposed packaged food, including unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens is subject to the modified requirements in 117.206 for any unexposed packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens.

If I am reading this correctly,  subpart C (HARPC) and subpart G (supply chain program) would not apply to us, and we would instead fall under the modified requirements (subpart D).

Some additional info: We currently keep time/temp logs which are checked each morning by the facility manager. We train employees on GMP's and we enforce the GMP's that are applicable to us (an example of non-applicable gmp would be hair/beard nets, no jewelry. An example of applicable would be no eating/drinking in warehouse and washing of employee hands per FDA guidelines).

It seems pretty cut and dry to me, but I wanted to get some feedback on this exemption from people who may also be exempt.

It's funny, our "consultant" didn't want to touch this one in an email either. He would only talk to me on the phone about it. I couldn't tell if it was because he didn't want to be pinned down by saying something that could come back and bite him, or if he was ashamed he had been pushing PCQI and facility training sessions on us (that he of course provided and profited from) that we are (if I'm reading the CFR correctly) exempt from.

Hi Tim,

I think your assessment is correct and exactly why it's so important for manufacturers to read the dang regulations themselves and not just agree with consultants or inspectors. However, I think following the PCQI rules are in your best interest frankly, as your auditors are unlikely to share your knowledge of the regulation, and a quick thrown together justification of why you are a qualified individual, and as a qualified individual you made the assessment above that you are exempt, will go a long way to smoothing out your audits.

I'd also be careful that your produce handling doesn't fall under both the HARPC rule as well as the individual produce portions.

Thanks Fur for the reply. We actually already have 2 PCQI (they got certified because our consultant told them it was needed and was also before my time) who are under myself. I am going to get PCQI certified with our VP of purchasing in Feb (if he still wants to go, the exemption info might change his mind). I am just happy that the full hazard analysis and more importantly the supplier verification (we CONSTANTLY get new items and discontinue old, based on customer need day by day) are items we are exempt from.

We currently have a pretty robust HACCP plan for refrigerated and frozen items that we follow (covers us on time/temp document requirements that FSMA says we need to maintain). I also still plan on sitting down with the team and performing a full hazard analysis on produce (they are "exposed" as they are in boxes with breathable slits or sometimes without tops) and putting together a HACCP specifically for seafood (still looks like this is a requirement, I will know more after my seafood haccp class next month).

Hello Mr. Gross,

I would be interested to see what you came up with, as I am I currently trying to write a seafood HACCP plan for my cold storage. We usually handle prepackaged product as well as an occasional repackaging operation for Krill.

Thank you,