FDA Releases Final Rule on Food Defense - Preventing Intentional Contamination of Food - Summary

The rule, titled Mitigation Strategies To Protect Food Against Intentional Adulteration, applies to domestic and foreign food companies that are registered with the FDA to address hazards that may be introduced with the intention to cause wide scale public health harm. . Basically, if you are producing food for sale and have registered your facility with FDA, then you have to have a food defense plan. There are a few exemptions to who has to apply.

Commentary - this is very broad/open and care must taken when preparing this program  A concern would be claiming too many vulnerabilities and then having to correct too much (and the expense of that).

Below is a summary of the major sections of the document.

Requirements - "Each covered facility is required to prepare and implement a food defense plan. This written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented. " .

1.  You must prepare, or have prepared, and implement a written food defense plan.

This includes:

FDA Issues Draft Guidance on Qualified Facilities within the Preventive Controls Rule

As part of the Preventive Controls Rule, FDA establishes 'Qualified Facilities' as those facilities exempt from having to establish HACCP based systems (Preventive Controls), but only having to comply with GMPs. But in order to become 'Qualified', they must submit a form to FDA attesting to their status as 'Qualified". This guidance provides detail on how to submit the required form, Form FDA 3942.

‘Qualified Facility’’ as defined by FSMA:
• Business with average annual sales of <$500,000 and at least half the sales to consumers or local retailers or restaurants (within the same state or within 275 miles); or.
• Very small business, which the rule defines as a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).

You can access that document here.

Important Points in FSMA Final Rule on Sanitary Transportation of Human and Animal Food

Earlier this month, FDA issued the FSMA Final Rule on Sanitary Transportation of Human and Animal Food.  What are some interesting points you should know?

This rule defines transportation as “any movement of food in commerce by motor vehicle or rail vehicle” and establishes requirements for sanitary transportation practices applicable to shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in food transportation operations.  The rule address vehicles and transportation equipment; transportation operations; training; records; and waivers.

The goal is to ensure that practices are in place that prevents food from becoming adulterated during transport from such issues as failure to control temperatures or cross contamination or cross contact (allergens) from inadequate cleaning.  

The rule makes the shipper responsible for compliance to the rule.  The shipper is defined as the one who arranges for the transportation of food by the carrier. The shipper could be the manufacturer or a freight broker. By rule, the shipper  must develop and implement procedures for required parameters such as temperature control and cleanliness of the vehicle. The shipper can transfer some of this responsibility to the ‘loader’ or the ‘carrier’ based upon contractual agreement. They must have documentation to demonstrate this.

The rule is not prescriptive in that FDA does not establish mandatory procedures; rather it allows industry to use best practices to do this. So there are no regulatory requirements for continuous temperature monitoring, or the sharing of documentation for each load, or how a truck should be cleaned. Rather, it requires the shipper determine what is best in order for that food to be transported without becoming adulterated.

While there are some exemptions from the rule for food that is transported, such as farm activities, most other transport is covered including intra-company transport and food destined for food banks.

What about food that arrives and is out of temperature?  According to the rule "An inconsequential failure by a carrier to meet the shipper's temperature control specifications will not necessarily create a per se presumption that the affected food has become adulterated. However, if a person subject to this rule becomes aware of an indication of a possible material failure of temperature control or other conditions that may render the food unsafe during transportation, the person must take appropriate action to ensure that the food is not sold or otherwise distributed, unless a determination is made by a qualified individual that the temperature deviation or other condition did not render the food unsafe. Failure to take such action may render the food adulterated."

For Loaders, those who put product onto the trucks, they must check the vehicle for sanitary condition and ensure proper temperature control prior to loading.

For receivers, those who unload the product, they must ensure that the product was not temperature abused and intact. 

Carriers, those transporting product, must meet conditions established by the shipper – to include having the right equipment to meet sanitary and temperature requirements. The must also provide cleaning as required.

When carriers have responsibilities put on them by the shippers, their employees must be trained about potential food safety problems and basic sanitary practices. This must be documented.

Here is a link to the final rule.

FSMA Rule for Sanitary Transport of Food - Summary

FDA issued the final rule for the sanitary transport of food.  The final rule applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle.
It is important that companies evaluate their own shipping, and if using third party shippers, that those trucking companies are in compliance.  This will apply to USDA product.

Key Provisions:

1. The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe.
2. Measures taken during transportation to ensure food safety -
   Including adequate
• temperature controls,
• preventing contamination of ready to eat food from touching raw food,
• protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact (including the unintentional incorporation of a food allergen.)
3. Training of carrier personnel in sanitary transportation practices and documentation of the training when the carrier is responsible for sanitary conditions during transport.  (FDA plans to have an on-line training program).
4. Maintenance of records of written procedures, agreements and training (required of carriers). The required retention time for these records not exceed 12 months (depending on the type of record.

Key Exemptions:

• Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue
• Transportation activities performed by a farm
•  Transportation of food that is completely enclosed by a container except a food that requires temperature control for safety
• Food shipped through the US but not consumed in US.

Compliance - one year, for small companies, two years.

   

 

FDA - FSMA

Fact Sheet

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm

FSMA Final Rule on Sanitary Transportation of Human and Animal Food

 

Complete Rule in PDF

 https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-07330.pdf

    

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The earliest compliance dates for some firms begin one year after publication of the final rule in the Federal Register.

FSMA Food Safety Requirements for Transportation Coming Soon

The final rule for food safety requirements for transportation are coming on March 31st with implementation due in 2017.

While the transportation industry is probably doing much of what will be required, the requirements for documentation will be the biggest change.

The main focuses will be on:

• Written procedures
• Temperature control and its documentation, including pre-cooling of truck for refrigerated loads.
• Training - the final rule will state what will be required to meet the training requirement.
• Truck cleanliness
• Record transfer and maintenance

Fleet Owner
http://fleetowner.com/fleet-management/new-food-safety-rules-pose-impact-refrigerated-carriers
New food safety rules pose impact for refrigerated carriers
Final rule due March 31, with enforcement to begin in 2017.
Mar 14, 2016Sean Kilcarr | Fleet Owner

Refrigerated carriers face a bevy of new mandates governing not only the condition and operation of equipment used transport foodstuffs but the capture and preservation of shipment temperatures, along with driver training requirements, due to go into effect March 31.

FDA Developing New Micro Surveillance Sampling Approach

FDA published notice of its sampling program.  "Under the new sampling approach, the FDA is collecting a statistically determined number of samples of targeted foods over a shorter period of time—12 to18 months—to ensure a statistically valid amount of data is available for decision making."  FDA has  been sampling since 2014, but looks to increase this surveillance, especially for items considered higher risk.

Companies should have a plan in place for the event product is sampled, whether that is in the market, or during an inspection.  If FDA samples product or the environment during an facility inspection, consider:
- Holding product.
- Stopping production and conducting a complete sanitation.
- Pulling duplicate samples and having them tested.
One of the difficulties is the delay that can occur with FDA getting back to a facility with results.  The longer the period, the more exposure in terms of extent of product distribution.

A proactive approach is always best - developing and implementing a sampling program to understand and control potential risks.

FDA Website - Sampling

http://www.fda.gov/Food/ComplianceEnforcement/Sampling/ucm20041972.htm

Sampling to Protect the Food Supply

The FDA Food Safety Modernization Act is based on preventing problems before they happen, rather than solely responding to outbreaks of foodborne illness. But in order to develop prevention-based systems, you need data and other information to help identify hazards that need to be addressed and minimized.

That is why sampling is an important part of this preventive approach and why the FDA is developing a new microbiological surveillance sampling model designed to identify patterns that may help predict and prevent future contamination by disease-causing bacteria.

FDA Releases FSMA Rules on Produce, Foreign Suppliers, and Third Party Auditors

FDA released three new rules as past of the Food Safety Modernization Act. 

• The Produce Safety Final Rule focuses on requirements for farm activities associated with growing and harvesting produce.
• The Foreign Supplier Verification Program (FSVP) rules sets requirements for those importing food into the US to ensure that those suppliers are following the same requirements as US food manufacturers.
• Associated with FSVP, there is the Accredited Third Party Audit Certification Rule which sets up a program for certifying third party auditors who will evaluate foreign suppliers.

FDA Website

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm472505.htm

FDA Releases Groundbreaking Rules on Produce and Imported Foods to Modernize and Strengthen Food Safety System

Constituent Update

November 13, 2015

 

The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules that establish enforceable safety standards for produce farms, and make importers accountable for verifying that imported food meets U.S. safety standards. The agency also issued a rule establishing a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities.

 

Question - Are Transportation Companies Preparing for Food Safety Requirement per FSMA

Are your transportation companies preparing for upcoming FSMA regulations?  The FSMA Rule on Sanitary Transportation of Human and Animal Food was enacted to help maintain the safety of both human and animal food during transportation by establishing criteria, e.g., conditions and practices, training and record keeping, for the sanitary transportation of food.

According to the article in Bulk Transporter - probably not.  But they should begin.....getting an organization in the habit of executing food safety controls will take time.

A few highlights from the article:

• Carriers must develop and implement procedures that describe how they will comply with provisions for temperature control and how they will provide this information to shippers and receivers.
• Drivers will need to be trained on temperature management and reporting requirements, and temperature records for each shipment must be retained for one full year.
• Food shippers must specify in writing to carriers the sanitary requirements for transport vehicles and temperature control systems for all shipments of “Time/Temperature Control for Safety Food” (TCS food).
• Food receivers must carry out loading and unloading operations under conditions that will prevent TCS food from reaching unsafe temperatures.
• Condensation inside a refrigerated or tank trailer may get more attention.
• Carrier personnel must be trained.

So it would behoove you to ask the question of your logistical provider.

Bulk Transporter

http://bulktransporter.com/fleet-management/bulk-food-haulers-need-prepare-advance-fda-s-comprehensive-food-transport-requireme

Bulk food haulers need to prepare in advance for the FDA’s comprehensive food transport requirements

Oct 5, 2015 Charles Wilson | Bulk Transporter

 

NEW RULES covering food transportation and distribution will begin to take effect starting in June. However, there is growing concern that many food transporters still are not ready to deal with these new rules.

 

The lack of preparedness was a key point addressed during a panel discussion that took place during the 2015 Mid-America Trucking Show in Louisville, Kentucky.

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. 
 

The Blue Bell Situation and the Impact of FSMA

In his piece, Blue Bell and the Very Real Impact of the Food Safety Modernization Act,  FDA’s Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, discusses how FSMA will help prevent (not eliminate) foodborne outbreaks such as those associated with ice cream sold by Blue Bell.

The coming change with an implemented FSMA regulation that can be taken from this article is that companies will need 'real' controls in place for hazards that have been determined for their product and operation.  Real controls are ones that are well planned, implemented and verifiable.  This not only covers process-related controls, but those that had been considered as part of the prerequisite programs...sanitation for example.

In the Blue Bell case, Listeria monitoring was in place, but all their program was really able to do was show that Listeria was showing up, but beyond that, questions could be easily raised - was it in product, was it on food contact surfaces, what was the source and was anything done to eliminate that source.  In the FDA's 2008 draft guidance document,  Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance, recommendations for environmental and product sampling are made.  However, FSMA differs in that it will ask....'how do you know?'.  So instead of recommending testing, the question is 'how do you know you are controlling Listeria?'.  It is now on the that processor to be able to provide proof of control...which in this case, is most likely testing of the environment  as well as product.  Along with that, verification, documentation, and corrective action.

So in the build-up to FSMA, challenge the controls by asking 'how do you really know' whether the controls you have identified are working.  How do you know whether the corrective actions taken eliminated the hazard from occurring and prevented suspect product from reaching the consumer.
 

FDA Voice
 http://blogs.fda.gov/fdavoice/index.php/2015/05/blue-bell-and-the-very-real-impact-of-the-food-safety-modernization-act/
Blue Bell and the Very Real Impact of the Food Safety Modernization Act
Posted on May 20, 2015 by FDA Voice

By: Michael R. Taylor

Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries.

Above all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims – the 10 people who were hospitalized and the three who died.

Our mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. The FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse.

But more needs to be done, and more is being done. Congress passed the FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year.

FDA Proposes Exempting More Food Establishments from Required Food Safety Plans

FDA has proposed a rule change that will exempt more food establishments from registration requirements and thus the FSMA Preventive Controls rule.  This will primarily affect farms that sell food directly to the consumer.

 

A retail food establishment is currently defined as an establishment that sells food products directly to consumers as its primary function. .............The proposed rule would clarify that, in determining the primary function of an establishment, the sale of food directly to consumers from an on-farm establishment includes sales by the establishment at such direct sales platforms as roadside stands, farmers’ markets, and Community Supported Agriculture (CSA) programs.

 

HACCP based systems can be used by any sized business for better ensuring the safety of the food they make and sell.  While it would be good for FDA in having less establishments to visit, it means that there will probably be a few less companies taking that step to better understanding safe food processing.  Of course we know....small local businesses always make safe food and don't need no stinkin' new fangled food safety plans.


FDA News Release
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm440983.htm
FDA Proposes to Amend Regulation on Registration of Food Facilities; Changes to Definition of Retail Food Establishments Would Expand Exemption
Constituent Update

April 8, 2015

The U.S. Food and Drug Administration is issuing a proposed rule to amend and update its regulation on registration of food facilities. The proposed rule would provide for improvements to the food facility registration system, and would also implement certain provisions of the FDA Food Safety Modernization Act (FSMA), which adds new provisions to the requirements for food facility registration.

Under the current regulation, food facilities that manufacture/process, pack, or hold food for consumption in the United States must register with FDA. Notably, establishments that are “retail food establishments,” farms, restaurants, and certain other entities are exempt from the requirement to register. The proposed rule would amend the definition of a retail food establishment in a way that would expand the number of establishments that are considered retail food establishments, and that are therefore not required to register.

Applying the Drug Guidance "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection" to Food Operations

FDA recently issued a guidance for drug related companies titled "Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection". Some have suggested that this type of guidance may be extended to food processing facilities that fall under FDA jurisdiction.

It is stated in this guidance:

It is a prohibited act under sections 301(e) and 301(f) of the FD&C Act to refuse to permit entry or inspection or refuse to permit access to or copying of certain specified records.10 New section 501(j) of the FD&C Act, as added by FDASIA section 707, now deems a drug to be adulterated if "…it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection."

 Basically, if they can't see what they want, when they want, that product is adulterated.

The categories defined in the guidance include 1) Delay of inspection (pushing back an inspection, holding up during an inspection, delaying of getting records), 2) Denial of inspection, 3) Limiting an inspection (limiting access, limiting photography, limiting access to records or the copying of those records, and limiting or preventing the collection of samples, and 4) Refusal to permit entry.

It may be worth the time to gain an understanding of this guidance and what constitutes the definitions in preventing access.  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf

Trucking Industry Deploying Tracking Technology in Preparation of FSMA

 The trucking industry has begun to consider the impact of the Food Safety Modernization Act (FSMA) on their operations.  In order to comply, there will be greater need to track, monitor and record their loads, especially temperatures of refrigerated loads.

Trucking Info
http://www.truckinginfo.com/channel/fleet-management/article/story/2014/10/trailer-tracking-and-food-safety.aspx
Fleet Management
Trailer Tracking and Food Safety
New regulations will make tracking technology even more prevalent.
September 2014, TruckingInfo.com - Department
by Jim Beach, Technology Editor - Also by this author

Trailer tracking technology has been around a number of years, with a growing number of refrigerated and other food-related carriers deploying the technologies. But upcoming federal regulations will make it even more important.

“Trailer tracking was used as a ‘throw-in,’ but now if you aren’t tracking trailers, you are behind the curve,” says Chris MacDonald, vice president sales, StarTrak business for Orbcomm. MacDonald estimates that up to 80% of the top 100 fleets use trailer-tracking technologies. “The ROI comes from having the ability to effectively manage your trailer community in a more cost-effective way.”

For refrigerated carriers, industry estimates say that about a third of all refrigerated units on the road use some type of telematics, says Mark Fragnito, product manager, telematics, for Carrier Transicold. “The number of refrigerated fleets that use telematics systems has been steadily growing.”

Updated Proposal for FSMA Animal Feed Reg Relaxes Requirements for Food Companies Supplying Waste for Feed

The FDA announced some changes in the proposed rule for  Preventive Controls of Animal Food.

One of the biggest changes was reducing the requirements on food companies that provide their waste products for animal feed.  Basically, you would not need a HACCP based system, just controls to prevent chemical and physical contamination.

Human food processors already complying with FDA human food safety requirements, such as brewers, would not need to implement additional preventive controls or Current Good Manufacturing Practice regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed CGMPs to prevent physical and chemical contamination when holding and distributing the by-product (e.g., ensuring the by-product isn’t co-mingled with garbage).

They also are making the cGMP requirements more applicable to the type of feed being produced.  However, like the Human Foods updated proposal, they are looking at the possibility of adding language to affect product testing, environmental control, and supplier control.


FDA Website
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm
FSMA Proposed Rule for Preventive Controls for Animal Food
Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Based on FDA outreach efforts and public comments, the FDA is proposing a number of revisions to its proposed rule on preventive controls for animal food that are more flexible and less burdensome in key areas.

Changes to FSMA Rule on Preventive Controls - Product Testing, Environmental Monitoring, and Supplier Control

FDA rolled out its revised FSMA Rule for Preventive Controls for Human Foods and is allowing 75 days for comment. Part of the revisions focus on who has to comply and when (there is a broader exemption for farms is made as the defining of a small company), however probably the most important part of this is the inclusion of language on product testing environmental monitoring, and supplier control. While there is not an absolute requirement for all to have these programs in place, there is now language to say when it is required and what will be required.

 In general, if a facility says that they are controlling or verifying control of potential hazards by one of these programs, (programs traditionally termed as prerequisite programs), then that facility must have formalized programs. Below, I have clipped those sections from the proposed regulation for easier reference.

Product Testing and Environmental Monitoring - these are included in the Verification and Corrective Action sections. (117.165 and 117.150 below) Formalized programs will be needed when you are using these programs for verification of control. For example, if you have identified Listeria as a post process contaminate in an RTE food, then a program specific to that pathogen must be developed including written procedures, sampling locations within the facility, testing protocols, and identification of the laboratory conducting the testing.

Supplier Control (117.136) – The receiving company “must establish and implement a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient.” There is a list of requirements as to what must be done including the need for on-site audits.
It would be worth reviewing the sections below.


FDA.gov

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

FSMA Proposed Rule for Preventive Controls for Human Food Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

 Based on FDA’s outreach efforts and public comments, the FDA is proposing revisions to its proposed rule on preventive controls for human food that are more flexible and less burdensome in key areas.

Commenting

FDA is accepting comments for 75 days after the publication date. The FDA published the original proposed rule on January 16, 2013, and the comment period rule closed on November 22, 2013; no additional comments are being accepted on the originally proposed rule.

Maintenance of Records Finalized in FSMA Regulation

The Establishment and Maintenance Rule become final for those companies in the U.S. who manufacture, process, pack, transport, distribute, receive, hold, or import food for humans or animals, and foreign persons who transport food in the U.S.  Here is a simplified version of the FDA guidance to help you identify what you need to know about records needed for food operations.

Of course, this should already be in place, much having been required as part of the Bioterrorism Act of 2002.

What are the record availability requirements?

When FDA has a reasonable belief that an article of food, and any other article of food that FDA reasonably believes is likely to be adulterated and presents a threat of serious adverse health consequences or death to humans or animals, or when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, will cause serious adverse health consequences or death to humans or animals, any records or other information accessible to FDA must be made readily available for inspection and photocopying or other means of reproduction. These records must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice. 
The records may be kept in any format, paper or electronic, provided they contain all the required information.
The records requested may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such an article of food that are maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any location.

Food Producers Push Back on FSMA's Feed Rule

A number of food producers, impacted by FSMA Animal Feed Regulation, have commented to FDA about the impositions that the regulation will make.

Many of the waste products generated by food processing plants, including grains generated by distillers, will be subject to the feed regulation because these products are fed to animals.  The concern is that the producers will have to absorb additional costs to implement additional food safety controls over their waste streams.  And in reality, there have been really no issues to support the need for this level of control.

 

For many, it may come to the point where it is more cost effective to dump rather then use these items for feed.  From a sustainability standpoint, this is not the way to go.  The regulation needs to written that makes it easy, yet safe, for producers to continue to use their waste streams, when appropriate, as a source of animal feed.

Reaching Consumers with Product Safety Information - A Challenge for FSMA Regulation

On March 26th, FDA issued advanced notice of their proposed Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act(link). In summary, FDA is looking for a way to communicate food safety product notices (recalls) to consumers. The objectives are for companies to provide standardized information to FDA, FDA to develop a one-page recall notice regarding that food safety issue with a reportable food, and then that notice will then be distributed by the retail outlets, or grocery chains, to the consumers.

 

Sounds easy enough, however, there are many challenges in establishing a protocol that will work. Chiefly among them is the fact that consumers are not an easy group to reach with recall this type of information. So how do retailers do this to a point where it is not costly? And from a practical standpoint, will this mandated system have an impact compared to what currently happens today?

 

This has implications for the manufacturers, but more so for the grocery chains.

 

Here is a ‘quick’ summary, much taken directly from the seven page document published in the Federal Register.

FDA Shuts Down Delaware Cheese Plant

FDA shut down the Roos Foods cheese plant, that had recently recalled product linked to a Listeria outbreak, after FDA found a number of findings in their investigation.
From the FDA report, the findings included:

• the roof leaking so badly that water was raining down into the cheese processing room, including onto the cheese processing equipment and storage tanks;
• standing water on the floor throughout the cheese curd processing room in proximity to the cheese vats and in the storage rooms;
• metal roof/ceiling and metal supports exhibiting a rusted appearance with metal flaking precluding effective cleaning and sanitizing;
• food residues found on equipment after cleaning had been performed;
• openings to milk storage tanks and transfer piping were not capped to prevent contaminants from entering or contaminating food contact surfaces; and
• floors, wall, and equipment that were deteriorated and in bad repair, including processing equipment and storage vats with rust holes and floors with rough concrete deterioration.

 

The conditions found in the inspection were sure issues for Listeria contamination....leaks contributing to excessive moisture into the processing environment and being a source of contamination, poor cleaning practices that allow for growth of Listeria within that environment, poor operating equipment that allows access of that contamination to the product, and finally the facility was in bad condition which prevented that contamination from being removed.  The

 

In short, Listeria contamination had access into the facility and to the product, the conditions within the plant supported growth of the organism and bad facility conditions prevented good cleanup.

 

It is also important to note that this is the second time that FDA used its new powers granted by FSMA to remove a facilities registration and thus shut down that facility.  The first case was the peanut butter facility that had Salmonella contamination.  After about a number of months of working with FDA, that peanut butter facility ended up closing for good.  If this is an indication, this cheese facility will have a long road to get to the point of reopening, if they survive at all.
.

FDA News Release

FDA Investigates presence of Listeria in some Hispanic-style Cheeses

http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm386726.htm

Posted March 12, 2014 

Español1

 UPDATE

The FDA suspended the food facility registration of Roos Foods Inc.2 of Kenton Delaware on March 11, 2014 after the FDA determined there was a reasonable probability of food manufactured, processed, packed, or held by Roos Foods causing serious adverse health consequences or death to humans.

The FDA ordered the suspension after an investigation by the FDA, Centers for Disease Control and Prevention, and state and local partners linked a multi-state outbreak of listeriosis to cheeses found to be contaminated with Listeria monocytogenes and manufactured by the company. Food facility registration is required for any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States, and if the registration of a facility is suspended, no person shall introduce food from such facility into interstate or intrastate commerce in the United States. The FDA inspected the company’s facility from February 18 – March 4, 2014. During the inspection, FDA investigators found insanitary conditions including:

• the roof leaking so badly that water was raining down into the cheese processing room, including onto the cheese processing equipment and storage tanks;
• standing water on the floor throughout the cheese curd processing room in proximity to the cheese vats and in the storage rooms;
• metal roof/ceiling and metal supports exhibiting a rusted appearance with metal flaking precluding effective cleaning and sanitizing;
• food residues found on equipment after cleaning had been performed;
• openings to milk storage tanks and transfer piping were not capped to prevent contaminants from entering or contaminating food contact surfaces; and
• floors, wall, and equipment that were deteriorated and in bad repair, including processing equipment and storage vats with rust holes and floors with rough concrete deterioration.

Additionally, the FDA collected environmental samples from different areas of the facility, including the cheese processing room and various pieces of equipment. FDA's testing identified 12 swabs that tested positive for Listeria monocytogenes, and pulsed-field gel electrophoresis (PFGE) analysis showed that 11 of those swabs had the same Listeria monocytogenes "DNA-fingerprint" as the outbreak strain.

In response to evidence collected during the investigation by the FDA, CDC, and state officials, the state of Delaware’s Division of Public Health issued a Cease and Desist Production and Distribution order to the firm on February 28, 2014.

The FDA will vacate the suspension order and reinstate Roos Foods’ facility registration when the FDA determines that food manufactured, processed, packed, or held at the facility no longer has a reasonable probability of causing serious adverse health consequences or death to humans.

FDA has deadlines set for FSMA rules

We now have some deadlines set for FSMA final rules, with Preventive Controls for food in August of 2015 and Produce in October of 2015.   So it will follow, that the deadlines for companies to implement those rules will also be kicked down the road even further.

But this is no reason for companies not to begin the development and implementation of food safety systems based upon best practices. 

The Packer

FDA agrees to firm food safety law deadlines

 

02/26/2014 03:14:00 PM

Tom Karst

 

http://www.thepacker.com/fruit-vegetable-news/FDA-agrees-to-firm-food-safety-law-deadlines-247322601.html

  

The Food and Drug Administration has agreed to deadlines on final food safety rules mandated by the Food Safety Modernization Act.

 

The consent agreement (http://bit.ly/1o1bc8K), issued by the U.S. District Court in the Northern District of California, appears to be the final chapter on a legal action brought against the FDA by consumer activist groups. The Center for Food Safety and the Center for Environmental Health filed a lawsuit in August 2012 charging that the FDA illegally missed deadlines for food safety rules set by Congress in the 2011 Food Safety Modernization Act.