FDA Releases Supplemental Draft Guidance on Food Defense Regulation

FDA released a supplemental 'draft' guidance to support the IA Rule (Intentional Adulteration or Food Defense).  It is supplemental in that it adds content on elements not covered in the previous guidance issued last year (Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration March 2019).

This supplemental guidance covers the elements for managing mitigation strategies - specifically corrective action, verification, and reanalysis.  It provides more detail on what FDA would be looking for when evaluating the mitigation strategies the facility has chosen.

As you know, the facility conducts a vulnerability assessment to determine which points in the process are most vulnerable, the actionable process steps.  For the actionable process steps, the facility must determine and implement mitigation strategies to reduce the vulnerability.  These strategies must be monitored, documented, verified, have corrective action, and be reanalyzed.

In general, the guidance allows a more basic and flexible approach than Preventive Controls regarding corrective action and verification activities. For example, if a mitigation strategy is having a tank hatch locked with a monitoring activity stated as checking the lock. The corrective action if a tank is not locked would be to lock it and retrain the employee.  Verification is simply checking records to make sure the lock check was taking place, and the corrective action of retraining the employee took place.  And of course, conducting analysis of the plan every 3 years (unless there is a process change or other special conditions).


https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplemental-draft-guidance-industry-mitigation-strategies-protect-food-against-intentional
GUIDANCE DOCUMENT
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration 

FDA to Continue Leniency with Co-packers Supplier Control Where Brands Have Oversight

FDA announced that they will continue to provide 'enforcement discretion' with supply chain controls for co-packers where the brand companies they are packing for have oversight over those suppliers.  In these cases, the co-packer is packing under contract for the brand company, and that brand company has chosen and then manages the suppliers who provide raw materials to the co-packer.

Certainly if the brand companies want the control over the supply chain to the co-packer, then they should be responsible for the supply chain control components and should have the procedures and documentation to support that.  This FDA announcement does not go that far, outside of providing an out for the co-packer.

From the announcement, "under certain circumstances and on a temporary basis, we do not intend to take enforcement action against a receiving facility that is a co-manufacturer, and that is not in compliance with certain supply-chain program requirements for food manufactured for the brand owner."

From the previously published guidance establishing enforcement discretion:
"Supplier Approval
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner conducts supplier approval activities, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier approval activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when a brand owner (rather than the co-manufacturer) evaluates supplier performance as part of approving a supplier, the co-manufacturer’s food safety plan states that the brand owner will consider supplier performance before a supplier is approved, and the co-manufacturer conducts any other necessary supplier approval activities (e.g., hazard analysis of the food). The co-manufacturer is always responsible for following written procedures for receiving raw materials and other ingredients, and documenting use of the procedures (21 CFR §§ 117.420 and 507.120)."

"Supplier Verification
FDA does not intend to take enforcement action under the following circumstances: (1) a brand owner determines and/or conducts supplier verification activities for its co-manufacturer, (2) the co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer conducts any necessary supplier verification activities not conducted by the brand owner. For example, FDA does not intend to take enforcement action when an audit is determined to be the appropriate supplier verification activity but a co-manufacturer does not independently obtain a supplier audit or review the conclusions of a supplier audit obtained and reviewed by the brand owner, the co-manufacturer’s food safety plan states that the brand owner will obtain and review audits of the supplier, and the co-manufacturer conducts any other necessary supplier verification activities (e.g., sampling and testing of the raw material or other ingredient)."

FDA Constituent Update
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-supply-chain-program-requirements-and-co-manufacturer-supplier-approval-and
FDA Continues Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA
November 6, 2019

FDA to Start Inspections for Food Defense Plan Compliance in March of 2020

As part of the Food Safety Modernization Act, or FSMA, FDA's Rule Mitigation Strategies to Protect Food Against Intentional Adulteration, or IA Rule, requires facilities to write and implement a Food Defense Plan.  For facilities not considered small or very small,  the compliance date begins on July 2019.  Small facility compliance date will be the next year.  The list of exempted companies is listed below.

FDA announced this past week that it will begin to conduct compliance inspections in March of 2020.  The rule requires the facility "to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working".

In March of this year, FDA released an updated draft guidance titled Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.  A summary of that document is provided here.  Penn State will be conducting basic workshops on developing a Food Defense Plan.

FDA Food Safety Modernization Act (FSMA)
https://www.fda.gov/fsma
FDA Announces Intentional Adulteration Inspections to Begin March 2020
April 17, 2019

Developing A Food Defense Plan - Meeting Compliance Requirements in the FSMA Rule on Preventing Intentional Contamination

Penn State Extension
https://extension.psu.edu/developing-a-food-defense-plan

Developing a Food Defense Plan 

Meeting Compliance Requirements in the FSMA Rule on Preventing Intentional Contamination

The Food Safety Modernization Act, or FSMA, has 7 primary rules that have been enacted with a goal of improving food safety in the US.   The next FSMA rule with compliance dates on the horizon is the food defense rule which focuses on the prevention of intentional contamination.  This FDA rule, “Mitigation Strategies to Protect Against Intentional Adulteration”, or ‘IA’ rule, was finalized in May of 2016 with compliance is slated to begin next year.  The IA rule applies to food companies registered with the FDA who are involved in the production, transport, storage, or distribution of food for sale to the public.   Large companies, defined as having 500 or more employees, must comply by July 26th of 2019, while small companies’ compliance date is a year later, July of 2020.  Very small businesses, having less than $10,000,000 in annual sales, are exempt, but have to be able to demonstrate that they are classified as a very small company.

The goal of this rule is for companies to establish control measures to prevent or minimize the risk that a person or group intentionally contaminates food with the intent of public harm.    Intentional contamination includes 1) tampering, the intentional modification of a product in a way that would be harmful to the consumer, 2) terrorism, contamination by domestic or foreign aggressors for political or ideological reasons, and 3) contamination by disgruntled employees who may have a personal vendetta or have been bribed or manipulated by an outside source.

FDA Updates Preventive Controls Guidance With Chapter on Heat Processing PC

FDA updated their Preventive Controls Guidance document with a chapter on addressing the use of heat treatments as process controls.  To this point, the guidance provided somewhat similar information to that in the FSPCA manual, although the information is split differently among the chapters. However, the information covered in Chapter 6 goes into more detail, providing more information on heating, including examples for baking cookies, heating soup, and processing salsa.  This information covers how one would validate that information, and then implement and manage the process - monitoring, corrective actions, verification, and records.

Currently, the Guidance has 5 previous chapters, while Chapters 7 to 14 are yet to be released.

• Chapter 1 is an introduction
• Chapter 2 discusses how to conduct a hazard analysis.
• Chapter 3 provides additional information on hazards in foods. For example, it discusses pesticides, animal drugs, and mycotoxins as chemical hazards and when you may want to consider those hazards.  While it does not provide complete information on each of the hazards, it does provide some additional information.
• Chapter 4 overviews the preventive controls - Process, Sanitation, Allergen, and Supply Chain controls - highlighting primary types for each.  Under Process Controls, the chapter covers leathality treatments (heat, HPP, irradiation, fumigation), cold holding, formulation control, etc.  Again, not a complete listing of types, but give information on the major types.
• Chapter 5 is the application and management of preventive controls...provides some additional information to the preventive controls discussed in chapter 4.

Each of the coming chapters will expand upon the preventive controls as was done in Chapter 6 for heat processing.

This will become more of a companion reference document as examples of the process controls are expanded upon.  This guidance will give information on the types of things an FDA inspector will be looking for as they conduct inspections.  Certainly a document worth printing or bookmarking.  Be sure to watch for updated sections as they are released.

FDA Releases Food Defense Plan Guidance

FDA released a guidance document on developing and implementing a Food Defense Plan for mitigating against intentional contamination.  LINK.

The Food Defense Plan is required as part of FSMA.
The rule requires a written food defense plan for all covered facilities unless an exemption applies (21 CFR 121.5). The written plan must include (21 CFR 121.126):

1. 1. A vulnerability assessment to identify significant vulnerabilities and actionable process steps, and associated explanations
• Mitigation strategies and associated explanations
• Procedures for food defense monitoring
• Procedures for food defense corrective actions
• Procedures for food defense verification
2. The rule requires training for certain personnel. See “EDUCATION, TRAINING, AND QUALIFICATIONS” section (21 CFR 121.4)
3. The rule requires covered facilities to maintain the food defense plan as a record as well as records for training, food defense monitoring, food defense corrective actions, and food defense verification. (21 CFR 121.126(c), 121.140(c), 121.145(b), and 121.150(c))
4. The rule requires reanalysis of the food defense plan. (21 CFR 121.157)

For most companies, the compliance date is July of 2019. Smaller companies have more time.

FDA Releases Food Safety Plan Builder

FDA has provided a Food Safety Plan Builder which is an input driven tool that helps one to document and organize their company's Food Safety Plan.

While some may like having such a tool, I find it more difficult in some ways.  For one, you have to have all of your information ready as you input the data.  It is almost better to have your plan written before inputting for ease.  Second, it is hard to keep an overview of what you have written since with this, you are going step by step.  Lastly, it put the document into a format that is not as easy to change as if you used Word or Excel.

So this is not going to be something I recommend. I find it much easier to use open forms that are easy to add information, modify that information, or visual your plan when working on it.  I also prefer having my documentation in a format that will always be available, and for me, I prefer working in Excel for tables and Word for policies and procedures.

But take a look and let us know what you think.
Download the Food Safety Plan Builder Tool

Food Safety Plan Builder
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm539791.htm

FDA Delays Compliance Dates for Agricultural Water as Part of FSMA Produce Safety Rule

The FDA announced that it is planning to extend the deadline for compliance to agricultural water standards used in irrigation as part of the FSMA Produce Safety Rule .  Irrigation water can be a source of pathogens, but it is not an easy to control, especially when that water comes from surface waters.  Work done here at Penn State by Luke LaBorde etal (ref below) found that it was hard to make a connection between water standards and pathogen levels.  So testing water to see if it meets standards that may not mean much in terms of the pathogens present.  It is easy to see how environmental factors will constantly change...whether that be the occasional presence of animals, the amount of rainfall, the amount of sunshine, etc.

For more information on irrigation water, visit the Penn State Extension Website -http://extension.psu.edu/food/safety/farm/gaps/safe-uses-of-agricultural-water

Food Safety Modernization Act (FSMA) Updates
FDA Intends to Extend Compliance Dates for Agricultural Water Standards

Earlier this year, the U.S. Food and Drug Administration announced that it is exploring ways to simplify the agricultural water standards established by the Food Safety Modernization Act’s (FSMA) produce safety rule (PSR) after receiving feedback from stakeholders that some of the requirements are too complex to understand and implement.

Preparing for a FSMA Audit from FoodOnline

A recent article in FoodOnline (an informative online journal you should subscribe to if you haven't already) discusses how Kraft Heinz prepares for FDA FSMA inspections. A few key points brought up in this article are similar to what we have been hearing about from our industry friends about their recent audits.

A summary of what this company's regulatory affairs manager discussed about their company's experiences:

• 'Inspectors are calling these ‘routine FSMA inspections' and are not distinguishing between Preventive Controls and modernized GMP inspections' 
• These audits are generally more focused on high-risk products.
• Auditors had visited 7 of these audits - one full Preventive Controls inspection and six modernized GMP audits.
• Generally there are three inspectors.
• Audits have lasted 1 to 5 days, mostly 4 to 5 days.
• Four of the seven audits included swabathons (100 to 150 swabs), which included Zone 1 (30%), Zone 2 (20%) and Zone 3 (50%).  No zone 4.
• There is a focus on the company's environmental monitoring program including the records and corrective actions on positvie results.
• With regard to verification activities, they are focusing on records including corrective action logs, production schedules, sanitation records, and calibrating inspection equipment records.
• With regard to the Preventive Control plan, inspectors are reviewing the hazard analysis with questions on the justification behind each of the identified hazards.
• There is also a review of the written recall plan.
• Recently there is attention on the supply chain program.
• Review of handling of byproducts used for animal feed, consumer complaint handling, and FSPCA training looking for certificates of completion.

An interesting item in the article is that FDA will want to take photos in the facility, so a company needs to have a policy to address this.  The same goes with photocopying records.

Source: Food Online 
Inside Kraft Heinz's FSMA Inspection Readiness 
Link
By Sam Lewis, associate editor
Follow Me On Twitter @SamIAmOnFood

FDA Issues 3 Waivers to Sanitary Transport Rule, Including Shipments by Retail Outlets

With the Sanitary Transport Rule coming, FDA announced three waivers - 1) those permitted to ship milk, 2) those shipping food directly to consumers or as part of the operations of a foodservice / retail outlets, and 3) those approved to ship shellfish.

More specifically, from the FDA on item number two, this gives a waiver to grocery stores and food-service establishments.  It covers food sold directly to the consumer as well as food within the company or affiliate (a supermarket hub operation shipping to one of their stores).

• "Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments, as defined in 21 CFR 1.227), only when engaged in transportation operations as:
  • Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;
  • Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as:
    • delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or
    • delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s)."

FDA News Release

FDA Announces Three Waivers to Sanitary Transportation Rule

April 5, 2017

SoyNut Co-packer, Dixie Dew, Slammed in FDA Inspection, Now Suspended

FDA suspended the food facility registration of the co-manufacturing facility of the Soy Nut Butter which was recalled for E. coli contamination.

CDC now reports that there are 29 cases of E. coli infection with 9 people developing HUS.  The majority of cases (83%) affecting people under the age of 18.

FDA inspected the facility (3/3/17 to 3/15/17)  at the same time the initial recall.  FDA issued a 483 report detailing issues in facility.
Here are some of the highlight from the 8 page report.  (For ease, a copy of this document is pasted below, this was converted from the pdf file)

• The firm leaves product in the mix kettle overnight and over the weekend.
• The mixing equipment just shuts off during processing, 1 or 2 times per day, and has had this problem for 15 years.
• They do not calibrate their thermometer used for monitor the nut butter.  
• The chart recorder also does not work.
• During production of product, a clear liquid was observed dripping intermittently form a hole in the ceiling onto the floor and splashing on the equipment.  This was supposedly coming from a leaky pipe.
• Product build-up  on floors and walls, and walking platforms. Standing water on floor.
• Poor employee traffic flow as well as forklift flow, no restriction of movement from dirty areas /waste areas to processing areas.
• Cleaning supplies not properly maintained.
• Wooden pallets sitting in standing water.
• Product piping system not disassembled since 2015, smaller pipes and filling not routinely cleaned.
• Improper employee handwashing.
• Pest control issues.

While this is clearly a co-packer issue, somebody had to approve this company.  Did the IMHealthy folks visit the facility?  Did they recognize the risk, especially considering who would be eating this product - children.  To me, they are just as responsible.

As part of the movement to small, unique brands, more and  more of these small brand companies are turning to co-packers to package their product.  This includes store brands as well.  There are risks however if these co-packers are not properly vetted and managed.  One of the key elements of FSMA, supplier preventive controls, was put in place to prevent this type of travesty.  (This is why I stick to my big brands with lots of food scientists and well developed QA/QC systems protecting that product).

FDA Safety Alerts and Advisories
https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm549734.htm
FDA Suspends Food Facility Registration of Dixie Dew Products, Inc.
No food may leave the facility for sale or distribution
March 30, 2017

Shipping Food Products on Truck or Rail - Get Ready for Sanitary Transport Rule

FDA's Sanitary Transport Rule takes effect in April for the larger firms.  A nice article published in American Trucker outlines how various players (drivers, dispatchers, and planners) will be involved in implementing the rule.   A few things to know - this applies to product shipped from USDA facilities as well as FDA facilities, the shipper or the person arranging shipment has responsibility for that shipment, and smaller shippers have until next year to comply.

American Trucker
http://trucker.com/regulations/new-food-safety-rules-are-you-ready
New food safety rules: Are you ready?
FMSA begins to take effect in April
Mar 30, 2017 Cristina Commendatore

FDA Releases Draft Guidance to Assist Sprout Operations Comply with FSMA

FDA released a draft guidance to help sprout operations comply with FSMA regulations. 

The issue with sprouts is that the same conditions that allow the sprouts to grow from seeds also allows bacteria present on the seed to grow, and if these are pathogenic bacteria and the sprouts are eaten raw, then illnesses can occur.  One of the keys is sanitizing the beans before beginning the sprouting process to eliminate any pathogenic bacteria.

FDA Constituent Update
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm536958.htm
FDA Announces Draft Guidance to Help Sprout Operations Comply with Produce Safety Rule
Constituent Update
January 19, 2017

GAO Finds FDA Technical Assistance Network (TAN) Response Times Slow

The US Government Accountability Office (GAO) found that FDA's Technical Assistance Network (TAN), a system for answering questions regarding FSMA regulations including the produce rule, has been slow in responding to questions.

From the report:

"We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN."

While FDA is working on reducing the response times, there are questions that are not as easy to answer.  In some cases, the rule is still under development or the questions are more complex.

".....according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved."

These rules are new for many including the FDA, and many components of the rule have not yet been worked out for every permutation  So while delays in response times are completely understandable, I think that FDA officials and their surrogates need to acknowledge this when suggesting people go to the TAN for answers.  And considering that FDA technical support staff have a hard time answering these questions, this needs to be taken into account when inspectors are doing facility inspections.

GAO Release
http://www.gao.gov/products/GAO-17-98R
Food Safety:
FDA's Efforts to Evaluate and Respond to Business Concerns Regarding the Produce Rule
GAO-17-98R: Published: Nov 28, 2016. Publicly Released: Nov 28, 2016.

FSMA Draft Guidance for Notifying Customers of Hazards That Need to be Controlled

FDA issued a draft guidance that applies to food containing a hazard that must be controlled by a customer that is a further processor (not a consumer). This applies to the FSMA rules for Human Food, Animal Feed, Produce, and FSVP. The guidance titled "Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry " (Link) details how to make a disclosure in documents accompanying food that certain hazards have not been controlled by that entity.  

For example, if Company A is selling pepper to Company B, and that pepper had not been treated to eliminate Salmonella (which Company A has identified as a potential hazard), Company A would need to disclose on paperwork / documentation that "the pepper was not processed to adequately reduce the presence of microbial pathogens". 

So what are the documents of the trade? It has to be something the manager in charge of food safety is likely to read: "documents accompanying the food, in accordance with the practice of the trade." See 21 CFR 117.136(a)(2)(i), (a)(3)(i), and (a)(4)(i). This allows for the disclosure statement to be provided using a wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read."   " It is permissible, for the purposes of the requirements of the part 117 disclosure statement, to use labeling that includes a disclosure statement such as "not processed to control microbial pathogens" and then directs the recipient to a website for additional information about those microbial pathogens."

How does it need to state the hazards?  "For biological hazards, we will consider a manufacturing/processing facility that describes the "identified hazard" using a general term (e.g., "microbial pathogens," "microorganisms of public health significance") rather than a specific biological hazard (e.g., Salmonella or Listeria" 

For a chemical or physical hazard, the statement must be more specific.  "For chemical and physical hazards, a manufacturing/processing facility that chooses to not control chemical and physical hazards and to rely on its customers to do so, would be subject to the requirements of the part 117 disclosure statement. We expect such a facility to describe the identified chemical or physical hazard using a specific term (e.g., "mycotoxins," "aflatoxin," "stones") that adequately communicates the key safety information regarding the chemical or physical hazard that needs to be controlled."

Again, this is only needed when the supplier identifies a hazard and is relying on their customer (non-consumer) to control that hazard.
 

First Day of Preventive Controls Compliance - What Do You Need to Know

September 19, 2016 marks the compliance day when larger facilities making human food must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs) and larger animal food facilities must meet CGMPs.

So what should one expect?  FDA issued two letters today.  To summarize from the many words in those documents:

At this point, the FDA is still learning so "the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements." 

Does your Food Safety Plan have to be perfect at this point - "Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry."

 But FDA will still evaluate the facility in order to make safe products. "The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food."
 
"In addition, facilities should set up a thorough system for documenting what they do."

FDA is still learning as well.


FDA News Release
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm521171.htm
What to Expect Now that the First Big FSMA Compliance Dates Are Here
Questions and Answers with Joann Givens

FSMA Compliance Date Schedule - September 18th for General Compliance

FDA's FSMA compliance dates are nearing.  Take a few minutes to review to see if you are where you need to be.

Source - GMA website
http://www.gmaonline.org/file-manager/GMA%20Summary%20Reference%20Sheet%20for%20FSMA%20Compliance%20Dates.pdf

*Farms have an additional 2 years to comply with certain water-related requirements. Separate compliance date applicable to sprouts.

**PC Human: Supply Chain Program general compliance is (1) 3-17-17 (9-18-17 for small business) OR (2) six months after a supplier is required to comply with the applicable rule. PC Animal: Supply Chain Program general compliance is (1) 9-18-17 (9-17-18 for small business) OR (2) six months after a supplier is required to comply with the applicable rule.

†All importers must comply with FSVP requirements by 5-30-17 OR 6 months after their foreign suppliers’ reach their FSMA compliance deadlines, whichever is later. “Very small importers” and “importers of food from very small foreign suppliers” are subject to modified requirements.

‡ 3PAC’s provisions are effective immediately following the final rule, but can only be implemented after publication of Model Accreditation Standards, which are yet to be released by the FDA.

FDA Releases Draft Guidance on GMPs for Animal Feed

 FDA issued Draft Guidance for Industry #235 - Current Good Manufacturing Practice Requirements for Food for Animals "to help facilities that manufacture, process, pack or hold animal food for consumption in the United States comply with CGMP requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution. The guidance also includes information on training and related recordkeeping. The CGMPs required under the Preventive Controls for Animal Food rule are flexible to address the diversity of facilities and animal foods, the wide range of animal food activities, and the potential safety risks posed by some animal foods."

This guidance contains information to help these facilities determine whether they need to comply with the current good manufacturing practice (CGMP) requirements for animal food and provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping.

FDA Issues Draft Guidance for Facilities Sending By-Products for Use in Animal Feed

FDA issued a draft guidance for food processing facilities that send their by-products for animal feed. For example, a company sending peels or rinds after processing produce, or a company sending over baked cookies to a hog farmer.  The following is the important sections from this draft guidance.

FSMA - FDA Extends Deadline for Certain Provisions of Four Major Rules

As you know, the compliance dates are approaching for FSMA.  For Preventive Control for Human Foods, the compliance date for large firms in September 18th, 2016.  (This has not changed.)

But with this much of a major change in regulations, there will be areas where more guidance is needed from FDA for companies to figure out how to comply.  This is the case where these 6 issues resulted in the compliance dates being moved back, essentially 2 years from the proposed compliance date.

• certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. 
• for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. 
• for certain facilities that color RACs.  
• for facilities solely engaged in the ginning of cotton. 
• for importation of food contact substances. 
• for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.

The most impactful for those processing human and animal foods is the customer assurance requirement.  This provision requires the processor to make sure the downstream customer was going to take care of a hazard in the ingredient being sold.   Basically, if Company A is selling to Company B an ingredient containing a hazard, say for example Salmonella, where Company B said they were going to heat process that ingredient.  By Rule, Company A would need assurance that Company B was going to cook it sufficiently.   This, as written, may not be easy information to get.  (Specific sections of the posting below)

The other impactful section being delayed is for facilities holding or packing raw agricultural commodities that are not classified as a farm.  These facilities are more like a farm than a processor, but because of the way the rule was written, it classifies them more as a processor.  To help determine what these facilities need to do, FDA will write a specific guidance for these facilities. (Specific sections of the posting below)

Selected sections from:
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.
 https://www.federalregister.gov/articles/2016/08/24/2016-20176/the-food-and-drug-administration-food-safety-modernization-act-extension-and-clarification-of#t-1