Wednesday, September 16, 2015

FSMA Preventive Controls Rule for Human Foods - A First Look

The FDA released the final rule for the Preventive Controls for Human Foods. For those who have been tasked with reviewing the PDF file of approximately 930 pages, it is easy to become overwhelmed. However, it is not as bad as it looks. The actual regulation, which starts around page 834, is then roughly only about 100 pages. Considering that the GMP regulation is included (formerly 21CFR part 110) and there are many pages dedicated to discussing on-farm exemptions, the meat of the regulation is rather brief In fact, this version has been skillfully streamlined compared to the last released supplemental version.

So this primer takes a look at new aspects as well as walks through the major sections of the regulation. 

Note - For companies with HACCP systems in place, especially those who undergo third party audits, complying with this regulation may not be more than modification of current paperwork. Along with that, there is plenty of time…for large companies…one year, small businesses, two years…and three years for very small companies.

First, what are some of the new aspects:

The final version is much less prescriptive (or as they say, adds flexibility) in terms of dealing with various preventive controls. There are less stringent requirements on certain components such as corrective actions for sanitation and allergen preventive controls in that it allows for corrections rather than the more formal corrective actions – thus there are less documentation requirements for deviations in those areas. Another component, validation, is not required for all controls.  

There is less interpretation of what a critical control point is. So there is no procedure for determining whether something is a CCP or just a control point, or CP. The definition of a CCP is still there, but not much more. And there is reference to the traditional 7 principles, a traditional mainstay for describing the HACCP development process. The principles themselves are all still in the regulation, but even with those principles, there is minimal writing. Perhaps it is that the principles have been well established. Or perhaps in the end, some things are better off simplified.  There will be guidance documents coming out that should provide more insight on this.

The regulations introduces the term ‘supply chain’ program to take the place of the term ‘supplier control’ program. The terminology change reflects that when working with incoming raw materials, there are often more than just one supplier, but rather a whole supply chain that supports the sourcing of raw materials in that it includes various components such as middlemen and brokers. 

There is lengthy discussion regarding on-farm operations. In this regulation, there are two types - primary farm operations and secondary farm operations. The list of exemptions focuses on what is considered low risk operations, giving operations the ability of falling outside of the preventive controls rule. At this point, it can be difficult for an on-farm operation to determine whether they are exempt or not. Even FDA acknowledges this and will provide a guidance document. For those operations who are trying to avoid inclusion in the rule, it may be better to ask whether – within their operation, do they have control of safety of the product or not. If they can control the safety of the product to some degree, then establishing preventive controls is the best way to go. In the end, it is not the regulators that get you, it is the lawyers after a foodborne outbreak.

What is a qualified individual - there are qualified individuals, preventive control qualified individuals, and qualified auditors (needed to review the company’s food safety plan.) Think of the term ‘qualified’ as ‘trained’. So anyone in an operation who has any responsibilities, they must be trained or qualified to perform the tasks they do. They must also have training in general food safety. For those assigned for writing or modifying HACCP plans, they must have training / credentials to do that in order to be identified as the ‘preventive control qualified individuals’, which was previously titled ‘HACCP Coordinator’. And now we have the need for a ‘qualified auditor’ to review the preventive control plan. These individual must be trained in that task and have the necessary technical capabilities.

Here is a summary of the major subparts, A through G, of the regulation and some of the items of note from those sections.

Subpart A – General Provisions

117.4 (pg 848) Qualifications for food workers – the regulation puts specific language to have workers and supervisors receive training for activities they perform and for general food hygiene and safety. Training must be documented. It also states that owners are responsible for having qualified individuals in place (think this may relate to the PCA case?).

117.5 - Exemptions from the rule including the lengthy discussion of on-farm operations.

Subpart B – Current Good Manufacturing Practices

This section provides a streamlined version of the Good Manufacturing Practices (GMPs).
117.10 Personnel (pg 862)
117.20 Plant and Grounds (pg 864)
117.35 Sanitary Operations (pg 868)
117.37 Sanitary Facilities - covers water, plumbing, toilets, and handwashing
117.40 Equipment and Utencils (pg 870)
117.89 Process and Controls (pg 871) – raw materials, manufacturing operations
117.93 Warehousing and Distribution (pg 876)
117.110 Defect Action Levels – You can’t take defective food and mix it with good food to achieve a dilution effect of the defect to make it all good.

Sub C – Preventive Controls
117.126 – Food Safety Plans – lists what needs to be part of a food safety plan – Hazard analysis, Preventive Controls, Supply Chain Program, Recall Plan, Monitoring, Corrective Action, Verification, Records.

117.130 – Hazard Analysis – those that are naturally occurring, unintentionally added, and those that are added in pursuit of economic gain.
 - Hazards are those that are known or reasonably foreseeable.
 - Must include environmental pathogens when RTE product is exposed.
 - Must take into account consumer use - both intended use and reasonable foreseeable use.

117.135 – Preventive Controls -
Controls include Process Controls that are CCPs as well as other process controls, Allergen controls (prevention of cross contact and labeling), Sanitation, Supply Chain

117.138 – Recall Plan

117.140 – Monitoring

117.150 – Corrective Actions - In this section, they introduce the term ‘corrections’ – which are used for allergen and sanitation. These require less paperwork than traditional corrective actions for CCPs

117.155 – Verification

117.160 – Validation – must be completed within 90 business days of starting a new process. Do not need to validate allergen, sanitation, supply chain and recall plan.

117.165 – Verification of implantation and effectiveness – This section includes discussion of Calibration, Product testing, and environmental monitoring that was introduced in the Supplement.

117.170 – Reanalysis of food safety plan - Every 3 years or with significant change to the process, new information, plan found to be ineffective at controlling a given hazard,

117.180 – Requirements for Preventive Controls Qualified Individual and Qualified Auditor???

Preventive Control Qualified individuals will prepare, validate, food safety plans and review (or oversee review) of paperwork. [For consideration - many companies have used outside consultants to prepare HACCP plans, but with this requirement, it would be easier to have that person on staff].

Qualified auditor – may be an employee of the company, but must be trained and have adequate technical expertise.

117.90 – Implementation of records

Subpart D – Modified Requirements – This subpart goes into lengthy detail on what a Qualified Facility must do to show it is a Qualified Facility. [While I have not seen the form, it may be just as easy to comply with the Preventive Controls Requirements.]

117.201 Qualified Facility - Must submit formalized attestation (qualification form) of being a qualified facility.

117.206 – Refrigerated packaged food – This section provides requirements for those facilities that are handling refrigerated foods with no product exposure (packaged food).

Sub F – Records – records must be maintained at least two years, may be longer for products such as canned items.

Sub G – Supply Chain Program

Must establish a risk based supply chain program which includes having approved suppliers, verification activities. There is a section on performing audits of suppliers. [We’ll do a summary of this section later.]

Stated in the 9/16/15 webinar, packaging, including food contact packaging, will not have to comply with FSMA, but should have HACCP based controls.

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