Avoiding The Pitfalls Of Recordkeeping and Sanitation Under FSMA

By Pamela Sweeten, Owner & Founder, P. Sweeten Consulting

Two cornerstones of FSMA’s final rule on Preventative Controls for Human Food are record keeping and sanitation. Food manufacturers and processors, along with companies importing goods into the U.S., are now being held to a much higher standard of sanitation, documentation, and compliance to better protect the health of the U.S. public.

Food Safety Records
It is not just that demand for record keeping has increased dramatically in scope, the FDA now has more legal authority to access and audit your records. This makes knowing and following the changes to Part 117 of the Current Good Manufacturing Practice (cGMP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food essential.

Record Requirements
There are general requirements for all records that must be followed. All records must:

• Be kept as original or electronic records or true copies
• Contain factual observations and values
• Be legible, permanent, and accurate
• Must be done in real time
• Include the detail required to create a history of performed work
• Standard details including identifying the facility or plant, date/time of the activity being documented, signatures and initials of the person who performed the activity, and when applicable the identity and lot code of the product

Record Retention Requirements

• You must store and retain your records for a minimum of two years
• Any documentation relating to supporting the status of a facility as being a qualified facility should be kept as long as necessary to support the status of the facility
• Records that have been discontinued (records related to changes) must be kept for a minimum of two years
• Records, other than the Food Safety Plan, must be able to be present at the facility within 24 hours of being requested by an official for review.
• The Food Safety Plan may only be transferred to another accessible location only if the facility is closed for an extended period. The document still must be able to be obtained and given to an official at the facility within 24 hours of an official review request

Food Safety Plan

• Must be kept on-site at the plant or facility
• Upon completion of the food safety plan, the owner, operator, or agent in charge of the plant or facility is required to sign and date the plan. Any changes to the plan must also be signed and dated by this person of authority.

Three Categories Of Records To Keep
There are three categories of records you may need to keep, depending on your hazard evaluation. The records needing to be kept reflect the entire supply chain process and potential hazards from prior to receiving at the facility through to the customer carrying the product.

First are hazards controlled by the supplier (prior to delivery to the receiving facility). Once the hazard evaluation has been completed, if it is determined that a hazard will be controlled by the supplier, then a written supply chain program (or Foreign Supplier Verification Program for facilities that are importers) is required.

Documentation in this program includes but is not limited to:

• Approval of the supplier
• Supplier verification
• Sampling and testing
• Suppliers food and safety records
• Procedure for receiving ingredients and raw materials
• Reanalysis documentation

Next come hazards controlled at the receiving facility. If the receiving facility will control the hazards, then the receiving facility will be required to develop, implement, and document preventative controls.

Documentation requirements include, but are not limited to:

• Preventative control monitoring and verification of monitoring
• Any corrective measures that were taken and verification of actions taken
• Environmental monitoring
• Product testing
• Training documentation
• Reanalysis documentation

Finally, there are hazards controlled by the customer. If the receiving facility relies on a customer or another first receiver to control a hazard, then there are some records that must be developed and kept.

Documentation requirements include but are not limited to:

• Written disclosure (included in the food’s shipping documents) that an identified hazard was not controlled by the facility
• A written assurance (submitted annually) that contains the established procedures the customer must follow to prevent (or drastically reduce) the identified hazard

Sanitation Controls
A large part of controlling hazards is creating sanitation regulations that will drastically reduce or prevent hazards before they can occur. The environment, equipment, and employees should all be part of the sanitation control solution. Sanitation controls should include:

• Food contact surfaces (including utensils, equipment, and food packaging)
• Food handling
• Cross contamination
• Food allergens

Sanitation can be costly, but you could lose so much more if your product quality or shelf life is affected by unsanitary facility conditions. The best sanitation departments audit their facility and then create a structure for consistency. When creating this structure, a facility should consider the type of soil that needs to be cleaned, what the chemical needs to do when used (dissolving, emulsification, wetting agents etc.), and the state of the plant’s water.

There are many products designed to properly manage each type of sanitation control. Depending on the type of food a facility is working with or the equipment utilized, the needs may be different. For example, facilities handling meat, poultry, or seafood should include in their sanitation controls antimicrobial treatments to maintain product quality and yield. And, depending on the type of conveyor a facility has, a wet or dry lubrication system is required to both lubricate and sanitize the conveyor.

Working with an experienced cleaning and sanitation company can ensure that a company’s unique needs are covered. Working with the sanitation department to identify the hazards, a sanitation company will implement a customized program and routinely test to ensure you are meeting food safety standards. These results should be kept in your records as evidence your facility has taken preventative measures and taken steps to control the environment.

FSMA: Sanitary Transportation of HUMAN & ANIMAL FOOD

Sanitary Transportation of Human and Animal Food, FSMA Rule going into effect March 31. Previously just guidelines set forth by the FDA, it’s now law for those involved in the transportation of perishable to meet requirements in sanitation, temperature control and record keeping. Full text of the FDAs guidelines and who is covered can be found here: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm

I spoke with three cold chain logistics professionals who have a focus on food safety in transportation to help you prepare facilities, written agreements and transportation operations.

Jim Fox has more than 30 years experience in shipping and warehousing operations and is the founder of Verispect Smart Inspections™, a cloud-based documentation program to track shipping processes and protocols for compliance.

Edgar Vargas is the founder of Food Safety Now! A 3rd party fresh produce sampling operation as well as KleenTrans, an equipment and container sanitizing service that also offers training and assessment programs to food transportation and logistics professionals.

Dr. John Ryan has extensive international manufacturing quality and operations experience and is the President of Sanitary Cold Chain and author of the book “Guide to Food Safety and Quality During Transportation”. He is also managing partner with Edgar Vargas in TransCert, providing the cold chain industry worldwide with guidance, certification and audit services.

What do you foresee the biggest challenges will be for food transport pros with FSMA rule #7?

Jim Fox: “There are a lot of little companies out there servicing this industry. They are the least prepared and most adverse to what will be going on within the year with FSMA. The record keeping in any small business is naturally – let’s say – limited. Large companies already have it boiled into a system, they are used to process and paper controls. The little guys – not so much.”

Edgar Vargas: “What I hope to see, and I know it’s going to be a challenge, is a standardized, uniform Food Safety in Transportation program much like what auditing

firms such as Primus, LGMA, Global GAP or Harmonised look for. There is no such thing right now. The importing and exporting of temperature controlled perishables during transport is a need all countries share in common. The health and safety of humans and animals is the goal for everyone and sanitary transportation has been a big black hole in food safety.”

How will it impact operations for raw material suppliers? distributors? transportation and logistics providers/transportation brokers?

Jim Fox: “Most importantly the onus is on each step of the supply chain knowing and having written proof (documentation) of compliance by the previous holder of the commodity. If it does not have that documentation and proof of it, the receiver is holding the bag if there is an issue.”

Edgar Vargas : “Everyone is going to need to change their mindset and start thinking of sanitation on the surfaces of shipping containers the same way they think of food contact surfaces in processing and shipping surfaces. Everyone has to do his part to make sure that this chain is safe and everyone is in compliance”

When it comes to data and records retention of sanitation and inspection of containers, what do food transportation operations need to do to comply?

Dr. John Ryan: “As an example, temperature records must be delivered by the carrier to the shipper and receiver. Generally that calls for updating contracts of carriage to show agreement between them. Rules formalize the requirements and will cause written agreements. All washing, storage and precooling of containers with perishables is required. Maintenance stations (wash and temperature monitoring systems) must have written procedures and be able to document what was done in detail for each container washed.”

Jim Fox: “They need to get rid of forms on paper! 20% of it gets misplaced, they are prone to error and falsification. I know a 3PL here that had a facility in Connecticut. They had to find an inspection form for a customer and could not find it. The customer pulled all their product out of the warehouse.”

What are the training requirements and who needs it?

Jim Fox: “There should be a certification for drivers and warehousemen that includes basic inspection rules and why they need to be followed. It is very basic and these people already are in the habit, or should be, of inspecting things like forklifts, trailers and trucks. It is the same process, just different things.”

Edgar Vargas: “Anyone loading containers with perishables needs to be trained to inspect containers for damage that may cause temperature fluctuations or cause food to become contaminated or spoiled. Drivers carrying perishables are supposed to have food safety training as well.”

Shippers and carriers already have strict mandates and standards set by some of their customers, how is FSMA Rule #7 different?

Dr. John Ryan: “It may not impact them if they are in compliance with details of the law. When rolled into the preventive control rules, their customers must now be able to prove the shippers and carriers are qualified and certified and have valid preventive control systems in place.”

Edgar Vargas: “Requirements in the communication between the shippers/brokers and carriers about pre-cooling of containers, prior cargoes, and their next destination being included on the Contract of Carriage makes everyone comply, not just those working with the big retailers.”

What, if any, are the different container sanitation requirements for each industry, Fresh Produce, Seafood, Raw Meat, Dairy?

Dr. John Ryan: “Many – it depends on the industry. Dairy and bulk carriers are impacted differently since they must have cleaning and temperature data for three previous loads. Other industries only need to show cleaning and temperature records for one previous load”

Jim Fox: “They all are based on HACCP in one way or another. It all has to do with process steps, time and temperature and sanitation. The biggest hurdles I believe are the cross contamination issues that can occur in a vehicle or a storage location in a warehouse – like raw chicken stored on top of lettuce.”

Edgar Vargas: “There is no one-size-fits-all answer but in all cases water source testing and certification needs to be done- non-potable or recycled water will not be acceptable in sanitation procedures.”

What training will need to happen for inspecting containers?

John Ryan: “More than container inspectors are expected to be trained and to comply.
We provide certification and other training for internal audit teams and external auditors. All training must be documented and matched to the person actually doing the job.

Edgar Vargas “They are going to need to know what to look for and smell for in containers. Pathogens and bacteria are not visible to the naked eye. Physical damage to doors and seals of containers can affect temperature. It’s important that there’s consistent implementation by anyone loading containers and that any corrective action is documented. An untrained substitute or stand-in on the dock checking off boxes is not going to be acceptable.”

Is this rule going to force the retirement of some food carrying containers? Old reefers? Pallets? Bins?

Dr. John Ryan: “Maybe. While not specifically stated, FDA is now hitting those as part of preventive control rules – not clean = not preventive = FDA audit fail.”

Edgar Vargas: “It should. No one should be shipping fresh produce in containers with wooden floors or interior damage where pathogens could potentially enter cracks or holes in walls.”

Jim Fox “It could. It is all about maintenance of equipment. There is no reason in my mind that a trailer, properly maintained, shouldn’t be ok. Pallets on the other hand, you don’t know if people were shipping arsenic on them before you put lettuce on them.”

If you’re on the shipping side your next steps should be updating your food safety plan to document your protocols around temperature and avoiding cross contamination through sanitation of containers, pallets and loading equipment. Be sure you have a process in place for communicating temperature tracking, violations and pre-cooling requirements with carriers. Also, hire competent loading staff who can ensure compliance to the regulations.

Next steps for carriers include; phase out any reefers with wood interiors, train all drivers on the use of refrigeration units and loading procedures for temperature sensitive loads and implement a system to communicate with shippers for pre-cooling requirements as well as temperature violations and issues.

Have We Lost Our Way With HACCP?

Source: Have We Lost Our Way With HACCP?

Source: Have We Lost Our Way With HACCP?

Have We Lost Our Way With HACCP?

Source: Have We Lost Our Way With HACCP?

Have We Lost Our Way With HACCP?

Source: Have We Lost Our Way With HACCP?

Have We Lost Our Way With HACCP?

HACCP Have We Lost Our Way With HACCP?

By Greg Scher, A Senior Food Protection Warrant Officer, U.S. Army

As food safety becomes an increasingly important issue, it might be a good idea to take a step back and reexamine your food safety plans. Asking a few key questions, such as “who are my customers?” and “how do my HACCP plans help them?” are a good place to start.

HACCP principles were pioneered by the Department of Defense as a way to assure things that can’t be tested are safe. When you look at things such as bombs and artillery shells, it is obvious that they can’t be tested. To test something like that is to destroy it and anything else in the area. I remember Bugs Bunny in the animated Looney Tunes cartoon Forward March Hare, released in 1953. At the end, Bugs is hitting each artillery shell as it came off an assembly line to see if it was a dud. It was the punchline because it’s a really bad idea to test ammunition that way. The thing with testing food is, much like artillery shells, when you test it, you destroy it.

Then we started putting people in space.

NASA could not have astronauts getting sick from the food they eat. To prevent illness from food in space, the agency asked Pillsbury and the U.S. Army Laboratories to find a way to ensure, to a very-high degree, that any hazards to food are removed during packaging and processing. This collaboration resulted in HACCP. A great timeline for the development of HACCP can be found here.

The USDA’s Food Safety and Inspection Service (FSIS) has made HACCP regulatory since 1996. Yet, we still have contamination and recalls with products the agency regulates. The agency will tell you exactly how your HACCP should be implemented and take no ownership if it fails to reduce a hazard to a safe level. You have to take your HACCP plan back; assume your customers are astronauts and you can’t allow a hazard to reach their food.

Having been in Food Safety and Defense for 25 years, I have seen HACCP go through many cycles; first by the requirement of regulators and then by third-party audit standards, such as GFSI. While most food safety professionals would argue this was a good thing, I would argue that, like most well-intended programs, it turned a producer-led process into a process being pulled by benchmarks and regulators to fit their ideas. I believe this stifles initiative, new ideas, and in many of the plants I have visited, seen it becomes a “check-the-box” mentality where there is no HACCP culture developed. There is a good “dog-and-pony” show for regulators and auditors, but when you peel back that first layer, you can often find that the programs are driven by the requirements of customers and regulators, and not specifically by the hazards.

Avoiding HACCP Pitfalls                                                                                             The most common snare to HACCP plans I see is companies not owning them. “Corporate wrote this plan not us.” If your corporation is so directive-based that you have no say in your facilities HACCP plan, then you need to take ownership and take a stand. Most of these types of violations can be found in prerequisite programs. An example would be a program that requires chlorine bleach spray used on a food contact surface to be tested to be at least 200ppm. When you look at the test strip it is obviously stronger than 200ppm. Federal rules state that if you go over 200ppm you are required to do a fresh water rinse of the surface. If you are just using paper that gets darker with the presence of chlorine why not back off to 150ppm? How can you assure that each time you mix the spray you have not exceeded 200ppm? More is not always better or more effective. By backing chorine to 150 you cut chlorine use by 25% and remove the hazard of going over the 200ppm threshold and avoiding violating 21CFR 178. Here is a link to a good paper on use of bleach.http://ucfoodsafety.ucdavis.edu/files/26437.pdf 

Another mistake I see is a lack of HACCP prerequisite programs that make sense. People are smart; when you want a program taken seriously, you need to make sure you are not wasting people’s time, money, or effort.

For instance, we are taught that “hair restraint” is a requirement and hairnets need to be worn. In comes the bald guy. Why is he made to wear a hairnet? Are you making people that are clean shaven wear a restraint for their beards? Programs have to make sense if you want them to be taken seriously and embraced by employees to create a great food safety culture.

I also see poor supervision and leadership. If your company’s supervisors are not knowledgeable and do not enforce the programs, it’s time to find new supervisors. If employees are “breaking” program rules there is a reason. Supervisors need to identify the reason and find the root cause. For example, a door to the back of the building is propped open because it is hot and is held open to cool the area. Supervisors should address the temperature in a way that does not violate food defense and won’t let pests in the building. Managers often tell me the employees set them up; I would argue there is poor supervision.

Make Audits A Two-Way Street                                                                                  If you do your homework and can convince a regulator or an auditor that what you do adequately addresses specific hazards, your HACCP plan will be seen effective in their eyes. You are in the plant every day and you know the ins and outs of your facility; most auditors and regulators are only interested in you putting out a safe product. Make audits and inspections two-way conversations where both parties are made the better.

About The Author Greg Scher is a CW4 in the U.S. Army Veterinary Corps with 25 years of food safety and defense experience. He has a B.S. in Management, and as a Senior Food Protection Warrant Officer, has audited over 500 food producers in 57 countries. He is a member of the Order of Military Medical Merit and has been awarded three Bronze Stars.

5 Eye-Opening Facts About Recordkeeping Under FSMA By Maile Gradison Hermida, Guest Columnist

Although food companies have lots of experience creating records, these records have never been subject to the type of scrutiny they soon will face by the Food FDA under FSMA. The FDA will not only assess whether companies adopt programs that are adequate, but also will inspect whether these programs are consistently implemented.

Records review will become a key component of the FDA’s FSMA inspections, so companies need to be sure that their records help, rather than hurt. Records must be thoughtfully prepared, complete, and accurate. Below are five facts about records under FSMA of which you may not be aware, emphasizing why companies need to include training on record creation as part of their FSMA preparations.

The FDA Can Review All Of The Records Related To Your Food Safety Plan — Without Cause
Currently, the FDA only has broad records access in emergency situations when it uses authority grantedby the Bioterrorism Act. However, FSMA gives the FDA this broad records access every day, for routine inspections and without cause. The FDA will review records to assess whether you have the systems in place to make safe food and whether you are always following these programs.

Records May Be Reviewed Out Of Context
The FDA’s records review will not occur only at your facility; you should expect that the FDA will want to make copies of records to take back for further agency review. This means that you may not have the opportunity to explain your records, so what they say on the page will be taken as gospel. For example, if your records show that you have a quality limit that was not met, but the record and your programs do not distinguish between what limits are necessary for food safety versus quality, the FDA could interpret this deviation as materially affecting the safety of your food. Records need to be able to stand on their own to keep this from happening.

You’re Only As Good As Your Records Say You Are
Deviations and gaps shown by your records will be scrutinized when assessing whether your process is under control. Even if you precisely follow your food safety plan, the FDA will not know this if your records do not demonstrate that is the case. Another way to understand this idea is to recognize that “if it isn’t documented, it didn’t happen.” Also, keep in mind that recordkeeping is a FSMA requirement. You not only need good records to show that you are taking the right actions for food safety, but also to comply with the regulations.

You Need To Do What Your Procedures Say You’ll Do
The FDA will expect you to execute your written programs and procedures, so you need to be sure that you’re actually following your programs as written. For example, if your program says you need to use acleaning solution at a specified concentration, but in practice you use a diluted solution, this will be viewed as a deviation. Regardless of whether you can justify the concentration you’re using, the FDA is going to take issue with the fact that you’re not doing what your procedure says you need to do.

Good Recordkeeping Practices Are Not Intuitive
The only way to become good at recordkeeping is through training and practice. Companies should implement training at all levels to ensure that employees understand how they can improve the records they are responsible for creating. It’s particularly effective to conduct this training using real, day-to-day examples with actual company records, and provide hands-on opportunities for employees to practice in a safe environment. Food companies also should consider conducting routine records audits, during which they should apply the same type of critical review that is expected from the FDA.

FSMA’s final rules are expected to provide companies with the flexibility to tailor programs as appropriate and necessary for food safety, but with this flexibility comes the responsibility to support your approach and then to execute your program. Both the support and execution need to be documented. Of course, once you master the art of good recordkeeping, you need to be sure you can actually find and produce on demand the records required for an FDA inspection!

About The Author

Maile Gradison Hermida is an Associate with the global law firm Hogan Lovells, practicing food and agriculture law. She represents food manufacturers, distributors, retailers, and their trade associations. Her practice has a particular focus on advising companies and trade associations on implementation of FSMA. For more information, visit www.hoganlovells.com.

FDA PUBLISHES FSMA PRODUCE, FSVP, AND 3RD PARTY ACCREDITATION RULES

Dr. Jim Gorny, PMA vice president of food safety & technology

NOVEMBER 23, 2015

On Nov. 13, the U.S. Food and Drug Administration (FDA) published three final rules as part of implementing the Food Safety Modernization Act (FSMA). Below you will find links to each rules’ fact sheet and more information from FDA.

• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Rule),
• Foreign Supplier Verification Program (FSVP), and
• Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (3rd-Party Accreditation).

FDA has done a commendable job in gathering stakeholder input and providing an opportunity for the food industry to express their concerns and provide comments on proposed FSMA rules.  As such, these three final rules reflect many, but not all, of the suggested amendments PMA and other leading food trade organizations have recommended in their comments to FDA over the last few years.

We are currently in the process of reading and assessing the hundreds of pages of text these rules encompass and will be developing educational outreach materials to assist PMA members in understanding and implementing these rules. Upon initial review, the following is a summary of key elements of the rules that we want to draw your attention to:

Produce Rule:

• This regulation affects both international and domestic produce growers, in that it establishes science-based standards focused on the growing, harvesting, packing and holding of produce on-farms.
• The key provision areas include agricultural-water quality standards and testing, standards for using raw manure and compost, training, control of domestic and wild animals, equipment, tools, buildings, sanitation as well as worker health and hygiene.
• This on-farm produce safety regulation is significant in that FDA will now put in place an enforceable implementing regulation that explicitly articulates on-farm standards of conduct for the safe growing, harvesting, packing and holding of fresh produce.

FSVP Rule:

• This regulation addresses import safety and is closely tied to the FSMA Preventive Controls for Human Foods Rule and Produce Rule requirements.
• Importers are required to verify that food imported into the U.S. has been produced to the same food safety standards that are required of U.S. producers.
• Food importers are required to develop Foreign Supplier Verification Programs (FSVP) that verify compliance with U.S. standards, including the FSMA Preventive Controls for Human Foods Rule and Produce Rule requirements.

3rd-Party Accreditation Rule:

• This regulation aims to establish a comprehensive, credible and reliable program of oversight based on third‐party audits and certification of foreign food facilities to help FDA make decisions regarding the admissibility of imported foods.
• This regulation does NOT set forth the exact criteria to which firms will be held accountable during audits. Those criteria will be specified in the FSMA Preventive Controls for Human Foods Rule and Produce Rule requirements.

Webinars help industry prepare 
The publication of these final rules by FDA is a major FSMA implementation milestone for this landmark legislation. These rules will have a significant impact on produce businesses, in that they will affect how businesses operate on a daily basis and set definitive regulatory compliance expectations for FDA regulated businesses.

To that end, PMA and United Fresh Produce Association, in partnership with regional produce trade organizations, are once again working in partnership to provide free webinars to help industry members understand the final rules and implications for their businesses. Each of these 90-minute webinars will provide you with opportunities to interact with FDA and ask questions. Registration is now available online.

• Produce Rule:  Friday, Dec. 11 at 1:30 p.m. EST/ 10:30 a.m. PST
• FVSP and 3rd-Party Accreditation Rules:  Monday, Dec. 14 at 12 p.m. EST / 9 a.m. PST

Looking ahead
As you likely know, FDA published the first of the final rules, the Preventive Controls for Human and Animal Food rules, in mid-September. Other final rules, such as the Mitigation of Intentional Adulteration Rule and Sanitary Transportation of Human and Animal Food Rule, are expected to be released in early 2016.

It’s also anticipated the agency will soon be issuing important companion guidance documents for all final FSMA rules that will provide more detailed information about coverage and compliance requirements. There will be an opportunity to provide comments on these upcoming draft guidance documents, so stay tuned.

In the meantime, PMA will continue to work closely with allied organizations, FDA and Congress to assure that FDA FSMA implementation is realistic and well-supported.

Thanksgiving Proclamation

Issued by President George Washington, at the request of Congress, on October 3, 1789

By the President of the United States of America, a Proclamation.

Whereas it is the duty of all nations to acknowledge the providence of Almighty God, to obey His will, to be grateful for His benefits, and humbly to implore His protection and favor; and—Whereas both Houses of Congress have, by their joint committee, requested me “to recommend to the people of the United States a day of public thanksgiving and prayer, to be observed by acknowledging with grateful hearts the many and signal favors of Almighty God, especially by affording them an opportunity peaceably to establish a form of government for their safety and happiness:”

Now, therefore, I do recommend and assign Thursday, the 26th day of November next, to be devoted by the people of these States to the service of that great and glorious Being who is the beneficent author of all the good that was, that is, or that will be; that we may then all unite in rendering unto Him our sincere and humble thanks for His kind care and protection of the people of this country previous to their becoming a nation; for the signal and manifold mercies and the favor, able interpositions of His providence in the course and conclusion of the late war; for the great degree of tranquility, union, and plenty which we have since enjoyed; for the peaceable and rational manner in which we have been enabled to establish constitutions of government for our safety and happiness, and particularly the national one now lately instituted; for the civil and religious liberty with which we are blessed, and the means we have of acquiring and diffusing useful knowledge; and, in general, for all the great and various favors which He has been pleased to confer upon us.

And also that we may then unite in most humbly offering our prayers and supplications to the great Lord and Ruler of Nations, and beseech Him to pardon our national and other transgressions; to enable us all, whether in public or private stations, to perform our several and relative duties properly and punctually; to render our National Government a blessing to all the people by constantly being a Government of wise, just, and constitutional laws, discreetly and faithfully executed and obeyed; to protect and guide all sovereigns and nations (especially such as have shown kindness to us), and to bless them with good governments, peace, and concord; to promote the knowledge and practice of true religion and virtue, and the increase of science among them and us; and, generally, to grant unto all mankind such a degree of temporal prosperity as He alone knows to be best.

FSMA, Traceability, And Electronic Record Keeping: What You Need To Know

The Food Safety Modernization Act will affect the entire supply chain, are you prepared for the safety, traceability, and record keeping challenges ahead?

FSMA affects producers, processors, and middlemen — such as storage facilities, transportation and hauling companies, and packaging producers of commodities — where the end product is for food consumption. For example, not only do nuts need to be tracked, but so do the almond hulls sold to a cattle operations for feed. Guidelines apply to different sectors and some sectors must adhere to more than one set of guidelines. Complete compliance will be mandatory in 2016. Until then, the FDA willcontinue to hold hearings to receive comments from affected parties in order to revise the law and make it practical for real-world application. Information on how FSMA applies to each type of business and open comment periods is available here.

The five elements of FSMA encompass preventative controls, inspection and compliance, imported food safety, response to occurrences of contamination, and enhanced partnerships with producers. The biggest change FSMA brings is the FDAs ability to enforce the law. Prior to FSMA, the FDA was not allowed to shut down producer facilities, even those with multiple health violations. The new regulation allows an FDA inspector to shut down a facility for a minimum of 30 days with only a suspicion of the possibility of a violation. If evidence of a violation is found, the FDA is able to shut down a facility for a longer period or even indefinitely.

Under FSMA, every handler taking possession of a product or produces an item touching that product, such as packaging, must have a record keeping system. When a food safety issue is identified, the record keeping system allows an auditor to evaluate the chain of tracking records to determine where the contamination took place. If the auditor finds a break in the chain of records during their audit, the last person with records is liable for the food safety issue, even if contamination occurred prior to them taking possession of the product. Since the U.S. does not have jurisdiction over foreign producers, the broker who brings foreign product into the country is liable for any issue that took place before a product reached the border.

Producers and handlers may choose to keep paper records, however, this is not cost effective. A FSMA audit for a domestic operation is $224 per hour and $300 per hour plus travel for a foreign auditor per auditor. Each audit will include a minimum of one local, two state, and two federal auditors. The FDA is currently in the process of hiring 6,000 newemployees as FSMA auditors for this purpose.

There are many software and digital reporting systems available for FSMA compliance. The main requirement for digital systems is that information is held off-site by a third party. Usually, the third party is the FDA. Full-chain traceability that is compliant with FSMA, the 2002 Bio-Terrorism Law / Food Defense, Country of Origin, BMP, GAP’s, SSOP, HACCP, USDA-FSIS, and EU traceback laws for all food handlers can be achieved in as little as 15 minutes per day with a digital reporting system.

With digital reporting systems, a consultant works with a business to set up its entire operation and provide training, ongoing education, and support. In the case of nut producers, each orchard is coded. Ideally, operations, such as any applications, water tests, and pest control measures, are entered into the system on the day that they happen. During harvest, a label is printed for the product that includes all information on that orchard and the product. These labels provide immediate scanning and retrieval of site-specific records in real time. There is also an option to provide workers with coded name badges to track product using GPS that is accurate within 10 feet. In the case of shippers and haulers or processing facilities, a record of vehicle or facility maintenance operations, such as sanitization of equipment and times of those operations, is recorded. The label will need to be scanned when possession of the product changes hands so that information may be entered into the records of each consecutive handler. This information follows a product throughout the process, from seed to consumer, and even enables this information to be linked to a QR code printed on the packaging of a final product for consumer benefit. In compliance with the law, it is impossible to change or edit a previous recorded entry, however, notes may be added to correct information in entries that are incomplete or contain errors.

While complete compliance is not mandatory until 2016, there is a cost benefit to producers, processors, and handlers who currently have a traceback and traceability record keeping system in place. In anticipation of the possibility of loan default and higher instance of insurance claims resulting from a shut-down due to violations, insurance companies and banks are more likely to respond favorably toward customers who are currently in compliance with FSMA. Using an electronic system which holds information off-site allows producers to avoid the costs of an on-site audit that could result from the use of paper records. Some companies are willing to pay a premium because they believe products with a complete recorded history have a built-in, value-added element. This is allowing these producers to gain reputations as forward-thinking and establish new relationships with buyers before the rest of the industry follows.

Furthermore, in this new age of easily-accessed information and the ultra-concerned consumer, processors who are taking advantage of the option to link information to final packaging are finding they are gaining an edge in the marketplace. Consumers who value certain production practices or local products appreciate having information at their fingertips at the point of sale. For those consumers who are not as concerned about the specifics of production, it simply provides the reassurance that their food was produced as safely as possible. Increased information on packaging also provides the consumer with the confidence of a safe reliable food supply.

About The Author
P. Sweeten consulting was founded by owner Pamela Sweeten to help growers and consumers track their food from farm to table.

Through the use of tracking and data storage technology, we are insuring the safety and integrity of your food. Everyone should know exactly where their food came from, where it ends up and where it has been along the way. With our products you can rest assured knowing that you can track your crop every step of the way.

Pamela focuses on helping growers, transporters, and manufacturers reduce and improve operating efficiency. Got a question, comment, or column idea? She can be reached at pamela@trackmycrop.com.