New GMPs Are Coming Our Way

I hope you were all paying attention when the new proposed rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Foods was released over a year ago. There has been so much discussion and fretting over the really new part (risk-based preventive controls) that most folks have glossed over the update to GMPs. The 21 CFR Part 110 is being deleted and a new 21 CFR 117 subpart B is replacing it. For at least the past 20 years I’ve heard rumors that the FDA is working on an update to GMPs. Since it is finally happening, I wondered if anything is really changing?

Let’s take a look at the history of the FDA GMPs. Even though the Pure Food and Drug Act was enacted in 1906, there was no such thing as GMPs until this was overhauled and revised into the Food, Drug, and Cosmetic Act (FD&C) of 1938. This was the basis for today’s GMPs. Two sections of the FD&C are directly related to conditions in a facility where food has been manufactured: Section 402 (a)(3) specifies that food is adulterated if “it has been manufactured under such conditions that it is unfit for consumption.” Section 402 (a)(4) considers that food may be adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.

However, this was too vague, so the GMP regulations for food processing facilities were finally proposed in 1968, finalized and published in 1969 as 21 CFR 128. In 1977, Part 128 was re-codified and published as 21 CFR Part 110. Guess what? These were very broad, not specifying exactly what a facility must do to comply and led to enforcement issues. They were again updated, and then finalized in 1986. At this time, GMPs also were included in the regulations for infant food, LACF, and Acidified Foods, and bottled water. They’ve been looked at and thought about and worked on a number of times since 1986, but no updates had been officially published. Until now —28 years later.

As an overview of the proposed changes:

• The old Part 110 had five sections of GMPs. (Sections D and F exist but are “reserved.”):

A. General Provisions, includes Personnel

B. Buildings and Facilities

C. Equipment

E. Production and Process Controls

G. Action Levels
 

• The proposed Part 117, subpart B has eight sections:

117.10 Personnel

117.20 Plant and Grounds

117.35 Sanitary Operations

117.37 Sanitary Facilities and Controls

117.40 Equipment and Utensils

117.80 Processes and Controls

117.93 Warehousing and Distribution

117.110 Defect Action Levels
 

We are food safety and quality geeks, so we are special in that we like to read the Federal Register—we think it’s entertaining and educational. I recommend that you read the proposed new rule. (The rule, along with FAQs and other supporting information is available at http://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm.) Although the initial, and extended, comment periods have closed, FDA announced that a need exists for significant changes in key provisions of this rule (and the Produce Safety rule) that affect farmers. So, FDA plans to propose revised rule language by early summer on these as well as other sections, at which time, it will open a new comment period. Although this means that there will be revisions coming out in a few months, then potential further refinements in the final rule, it is likely that much of the current proposed rule will stand to be enacted when this Preventive Controls rule is finalized.

To get back to the comparison between the proposed Preventive Controls rule and the old GMPs, Tables 8, 9, and 10 within the body of the proposed rule Q&A (pages 3714-3719 at http://www.gpo.gov/fdsys/pkg/FR-2013-01-16/pdf/2013-00125.pdf) are probably the best summary of the proposed changes, including:

1. Proposed deletions.
2. Proposed revisions for consistency of terms.
3. Proposed revisions regarding cross-contact.
    

So what is new and what is simply reorganization? My personal biggest take-away is “cross-contact,” which FDA now proposes to use to mean the unintentional incorporation of a food allergen into a food. In the FAQs on the proposed rule (http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM345224.pdf), FDA states:”In the past, inadvertent incorporation of an allergen into a food was referred to as ‘contamination’ or ‘cross contamination,’ and in many instances these terms are still used. More recently, the term ‘cross-contact’ (rather than ‘contamination’ or ‘cross contamination’) has been applied with respect to unintentional transfer of allergenic proteins from a food containing the proteins to one that does not, because an allergen is a normal component of food, and not itself a contaminant. Given this shift in the scientific literature distinguishing “cross-contact” from ‘contamination’ and ‘cross contamination,’ FDA tentatively concluded that it should begin using the term ‘cross-contact’ to describe inadvertent incorporation of an allergen into food, rather than the general term ‘contamination,’ for purposes of clarity.”

So, to me, “cross contact” now means “allergens.” Every time I see “cross contact,” I’m going to think about allergens and allergen potential. I recognize that allergens are the number one reason for food recalls by the FDA and this makes sense to me that FDA is putting additional emphasis on allergen control.

I trust you’re having just as much fun as I am reading all the proposed rules and decoding them into what it means for your operations. I’d enjoy hearing your thoughts when you read each of the proposed rules. Please don’t wait until the final rule is published to read it.