Tag Archives: Preventive Controls

Patrick Embwaga, The Hershey Company
FST Soapbox

Open Letter to FDA on Adoption of Systems Approach to FSMA

By Patrick Embwaga
4 Comments
Patrick Embwaga, The Hershey Company

The new FSMA regulations are primarily intended to enhance the protection of public health through promotion of adopting a modern, preventive and risk-based approach to food safety regulation. The general consensus industry-wide is that the new regulations will increase the capacity of firms in the industry to develop effective food safety management system at facility levels that will be effective in preventing distribution of food-related hazards to the general public, which may result in foodborne illness.

There is widespread consensus that the development and implementation of a food safety system whose primary purpose is to prevent the distribution of hazardous product to the general public and hence prevent or reduce foodborne illness is a much more effective and practical approach towards this end. This is especially the case when compared to past approaches, among which many programs were quality control based and focused on end-product testing given the highly fluid and dynamic complexity in the food industry, which is being fueled by technological advancements that occur at the speed of light.

Having stated consumer safety as the primary stakeholder of a facility’s food safety system, there are other secondary stakeholders whose requirements are subservient to the consumer’s health requirements, but they play key roles in determining the architectural structure of the food safety system:

  • Regulatory requirements. Primarily serve the public and act on its behalf in ensuring that all food products distributed in the market are safe for consumption. However, the regulatory requirements have their own innate requirements (i.e., the uniformity of the structure of a food safety system) at the most basic level for the purposes of compliance, which enables a harmonized structure that conveniently lends itself to a uniform approach in the inspection of facilities by FDA agents.
  • Organizational requirements. There are existential risks to an organization should a facility ship out contaminated product, as can be seen from the recent cases widely reported by the media. These range from market share reductions to rattled shareholders, and to employees, it becomes a job security issue. In fact, this is one of the key points I always bring out during trainings: The consumer is the ultimate boss, and if the consumer complains, it’s bad for our jobs as food manufacturers. If they are outright sickened/angry/mad by our job performance, we should expect the pink slips (I’m sure a number of employees at the Blue Bell Creameries will support this opinion).

From a regulatory requirement perspective, uniformity is a key aspect of the requirements, as can be inferred from regulatory text on the preventive rules, which describe the fundamental elements that must be implemented by a facility in order for it to be compliant with FDA registration. The lifecycle of regulatory requirements are long term—the last time comprehensive changes were conducted on cGMPs was in the mid-1980s. And hence the analytical/reductionist approach of focusing on food safety at the facility level is complementary to its enforcement strategy (i.e., facility-based registration and inspection).

From the organizational perspective, given that the food safety system serves an existential purpose to the business, organizations are leveraging the best available resources to endure its proper design and implementation, including employing the use of the latest available technologies. From the organizational perspective, the organizational requirements are highly dynamic and often tied to consumer and market trends. And as such in most corporate organizations, the food safety system adopts a holistic approach, whereby plant facility food safety systems are often nested within larger hierarchical corporate food safety systems. One of the fundamental reasons for this holistic set up is to enhance efficiency of these programs, especially given their key functional roles in mitigating or preventing organizational risks that may be presented through distribution of contaminated product.

Pages: 1 2 3
Stephen Ostroff, FDA

FDA Commissioner Reflects on Food Safety Progress in 2015

By Food Safety Tech Staff
No Comments
Stephen Ostroff, FDA

Stephen Ostroff, M.D., acting commissioner for food and drugs at FDA, released his final blog on 2015 FDA achievements earlier this week, highlighting the strides made in food safety. As expected, Ostroff pointed to FSMA and how it will help industry take stronger steps in preventing contamination, improving safety in growing produce and holding importers accountable. He offered a few agency high points in food safety for 2015:

Imports

FSMA’s FSVP: Clearing the Confusion of Importing Rules

By Charles Breen
No Comments
Imports

On November 27, 2015, the Foreign Supplier Verification Programs for Food Importers (FSVP Rule) published in the Federal Register. The most significant new element is that importers are now responsible for assuring that the food they import complies with FDA requirements. Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

“Importer” is defined as: “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.” This differs from the importer of record as defined by Customs and Border Protection (CBP) as the person primarily responsible for paying any duties or an authorized agent acting on his behalf.

Under FSVP, an importer’s basic responsibilities are to:

  • Determine hazards reasonably likely to cause illness or injury
  • Evaluate the risk, using hazard analysis
  • Evaluate the foreign supplier’s performance
  • Perform supplier verification activities

Determining hazards and evaluating risk parallel the preventive control rules for human food (PCHF) and animal food (PCAF). Evaluation of a foreign supplier’s food safety performance and conducting verification activities are substantially aligned with supply-chain verification in 21 CFR 117 Subpart F (PCHF) and 21 CFR 507 Subpart E (PCAF). The importer is responsible for assuring compliance with FDA standards and requirements.

Deciding what parts of FSVP are applicable to each importer’s operation requires a comparison between what the importer does, and the exemptions, exceptions and modified requirements offered in the rule. These depend on what is imported, the food safety system in country of origin, the size of the importer, and the size of the foreign supplier. FDA delivered on its promise of flexibility, but deciding what applies requires some analysis.

If a food importer meets the definition of importer and does not fall into an exempted category or qualify for exceptions or modifications, then some or all of the FSVP rule applies to them. FDA estimates that about 55,000 importers will be covered by FSVP or some portion of it.

Who Is an Importer?

The U.S. owner or consignee of an article of food that is being offered for import into the United States is the importer. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the U.S. agent or representative of the foreign owner or consignee at the time of entry is the importer.

All importers must provide an identification number for each entry line of food that the importer brings into the country. FDA will be issuing more guidance on what it considers “an acceptable identification number.”  The agency is not mandating that each facility use a DUNS number, but is has ruled out other suggestions for the unique identification number that is required.

Exemptions to FSVP

FSVP does not apply to the following foods:

  • Fish and fishery products (in compliance seafood HACCP in 21 CRF 123)
  • Juice (in compliance with juice HACCP in 21 CFR 120)
  • Food for research or evaluation
  • Alcoholic beverages
  • Meat, poultry, and egg products regulated by USDA
  • Food imported for personal consumption,
  • Food that is transshipped through the United States
  • Food that is imported for processing and later export
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country (U.S. foods returned)

Partial exemption for import of low-acid canned foods (LACF). LACF are exempt from FSVP with respect to microbiological hazards for that food. To be exempt, the importer must verify and document that the food was produced in accordance with LACF requirements (21 CFR part 113). Other hazards not controlled by the LACF rule, if any, must be documented as controlled under FSVP.

Modified Requirements

Modified requirements for a receiving facility in compliance with the PCHF or PCAF rules that imports food:

  • If the process used controls the hazards of the imported food, the facility is considered in compliance with most of the FSVP rule.
  • If the food does not have any identified hazards requiring control, then the facility is considered in compliance with most of the FSVP rule.
  • If the facility has implemented a supply-chain program for the food in compliance with either PCHF or PCAF requirements, the facility is considered to be in compliance with most of the FSVP rule.

Receiving facilities must also accurately identify themselves to FDA for each entry line of food being imported.

Modified requirements for imported dietary supplements manufactured in compliance with CGMP requirements in 21 CFR part 111:

The importer must accurately identify itself to FDA for each entry line of dietary supplement or dietary ingredient being imported.

Modified requirements for very small importers:

Defined as less than $1 million in sales of human food a year, or less than $2.5 million in sales of animal food per year, very small importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance from those facilities.

Modified requirements for imports from small suppliers (i.e., qualified facilities under PCHF or PCAF, and some small farms not covered farms under the produce safety standards, and some small egg producers):

The importer must obtain written assurance before importing the food, and at least every two years after, that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations or the laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.

Modified requirements for food imported from a country with an officially recognized or equivalent food safety system:

Importers must determine that the supplier is in compliance with FDA requirements, or that the supplier is in compliance with food safety regulations or relevant laws in the country that FDA recognizes as equivalent.

At present, only New Zealand is officially recognized as comparable to the United States. FDA is in the process of auditing and evaluating audit results for mutual recognition with additional countries. The next countries to be recognized will most likely be Australia and Canada.

One final note: FSVP requires coverage of food contact surfaces, such as packaging. Manufacturers of food contact surfaces are not required to register with FDA. PCHF and PCAF rules are limited to those facilities required to register. The language requiring FSVP makes no exception for food contact surfaces.

SVP, Food Safety, United Fresh Product Association
FST Soapbox

GFSI and FDA’s Preventive Controls: Complementary or Redundant?

By Jennifer McEntire, Ph.D.
1 Comment
SVP, Food Safety, United Fresh Product Association

Accreditation, certification, certificates…the structure that supports the third-party audit system can be very confusing! Further, an audit company offers a menu of audits: An audit to their own private standard, audits to several GFSI benchmarked schemes, and perhaps in the future, an “FDA accredited” audit. How do you know which one you need? How do you know which best prepares you for FSMA?

Jennifer McEntire spoke during the session, “Staying Ahead of New USDA and FDA Mandates for Controlling Pathogens in Food Processing” at the Food Safety Consortium conference.  LEARN MOREUntil the compliance dates for the Preventive Controls rules pass, food manufacturers really only need to be compliant with good manufacturing practices (GMPs), from a regulatory standpoint. There are some specific audits that evaluate adherence to GMPs, but many companies wanted to take their food safety programs to the next level by demonstrating that they were implementing effective food safety management systems. Certification to a GFSI-benchmarked audit scheme (BRC, SQF, FSSC22000, IFS, etc.) was a primary means to show a commitment to food safety and the demonstration of exemplary programs. With the finalization of the Preventive Controls Rules, FDA is catching up. So how do the FDA requirements compare with the main elements of the GFSI Guidance Document?

Let’s evaluate the extent to which the scope of GFSI aligns with FSMA. In September, the Preventive Controls for Human Food rule was finalized, and the areas addressed within that rule constitute the bulk (although not all) of the topics covered by GFSI (GFSI covers additional areas for which FDA has not yet finalized rules, such as food defense and traceability). The question on everyone’s mind is, “If I’m certified to a GFSI-benchmarked audit scheme, am I compliant with the rule?” The answer is, “You’re probably in way better shape than someone who is not certified.” The reason is, regardless of which GFSI benchmarked audit scheme you choose, your facility will need to demonstrate, through fairly exhaustive documentation, the nature and validity of the programs that are in place, and the proof that those programs are followed day in and day out. FDA is looking for the same thing.

The Preventive Controls rules go beyond strict HACCP in that they require facilities to consider what has historically been termed the HACCP system. This includes programs that may not be critical control points (CCP) per se, but are critical to the safety of the food product. FDA identifies elements of sanitation and allergen control, as well as a supplier program, in this category. If you’re familiar with FSSC 22000, you might call these “operational prerequisite programs”.  FDA will want to see how each and every hazard is evaluated to determine if it needs a preventive control, whether that is a traditional CCP or another control. For the most part, this is aligned with the GFSI benchmarked schemes, although some of the language may differ.

When it comes to the implementation of a supplier program, facilities should be aware that FDA’s requirements of such a program are much more explicit than most of the GFSI-benchmarked schemes. Even if the result is the same at the end of the day, FDA inspectors may be looking for companies to follow a fairly structured approach compared to a GFSI auditor.

To further complicate matters, FDA will be finalizing a program for the accreditation of third-party auditors. If an effective private third-party audit system exists, why is FDA adding another layer with its own form of audits (separate from inspections)? The answer lies with Congress, not FDA, as it identified two specific circumstances in which a special regulatory audit would be necessary. One situation is when a facility (or their customer) wishes to participate in the forthcoming Voluntary Qualified Importer Program. The second is if FDA has determined that the food poses food safety risks such that a facility wishing to export that food needs a certification issued by an auditor under this program. In neither case will domestic facilities be audited under this program; this program only applies to foreign facilities and only in very limited instances.

Since the rule and accompanying guidance documents related to accreditation of third-party auditors hasn’t been issued by FDA, it is premature to comment on how these audits will compare to those in use by private industry today.

So with the implementation of new rules from FDA, is there still a market for audits? Absolutely. From a very practical standpoint, FDA won’t be inspecting most facilities on an annual basis, and many private audits are conducted on an annual schedule. Plus, industry typically pushes itself further than regulations, which lag behind. Regulations can be viewed as the floor for expectations, but not the ceiling. Moving forward, we expect audit standards and private audits to become even more stringent and aggressive in terms of promoting the very best food safety practices. But beware, as history has shown us, a certificate is not a guarantee or indication of the ongoing quality of a plant’s food safety system. This is why FDA will not blindly accept that a facility has a favorable audit; regardless of the audit certifications you hold, FDA will still inspect you. That said, depending on the audit, it can serve as a credible certification of a food safety system in a plant and demonstrate to your customers your level of food safety commitment.  And poor performance during an audit can find its way to FDA too, since in some instances the agency will have access to the conclusions of the audit and corrective actions taken in response to significant deficiencies identified during the audit. FDA initially proposed that serious issues uncovered during consultative audits conducted as part of the third-party accreditation of auditor program would be shared with FDA, and when audits are used as part of supplier programs, FDA will see how serious deficiencies in audits have been addressed. Be clear on why you are pursuing a particular audit, and take the program seriously. Audits should reflect your food safety culture, not serve as your motivation.

Robin Stombler, Auburn Health Strategies
In the Food Lab

Five Questions Food Facilities Should Ask About Testing

By Robin Stombler
No Comments
Robin Stombler, Auburn Health Strategies

The FDA issued the first of several final regulations aimed at modernizing the food safety system through the use of hazard analysis and risk-based preventive controls. Inherent in this system are a number of requirements that eligible food facilities must follow, such as developing a written food safety plan, monitoring, corrective actions and verification. Laboratory testing is an essential component as well.

Robin Stombler presented “Laboratory Oversight and FSMA: Why and When” at the Food Labs Conference in Atlanta, GA | March 7–8, 2016So, what should food facilities know about laboratory testing within the context of the preventive controls for human food final rule?  First and foremost, the final rule states, “facilities have a responsibility to choose testing laboratories that will produce reliable and accurate test results.”  While a future regulation is expected to address the need for accredited laboratories and model laboratory standards, the preventive controls rule adopts other requirements pertaining to testing. Here are five questions that food facilities should ask about testing and the preventive controls rule.

1. What is the difference between pathogens and microorganisms?

The final rule defines “pathogen” to mean a microorganism that is of public health significance. A microorganism is defined as “yeasts, molds, bacteria, viruses, protozoa and microscopic parasites, and includes species that are pathogens.” Microorganisms that are of public health significance and subject food to decomposition or indicate that the food is adulterated or is contaminated with filth are considered “undesirable.”

2. How must food facilities account for pathogens?

Food facilities must prepare and implement a written food safety plan. One component of the food safety plan must include a written hazard analysis. This analysis must identify known or reasonably foreseeable hazards. These hazards may be biological, which includes parasites, environmental pathogens and other pathogens.

In another example, the food safety plan must include written verification procedures. This is to demonstrate that the facility is verifying that its preventive controls are implemented consistently and are significantly minimizing or preventing the hazards. These verification procedures are intended to be appropriate to the particular food facility, the food in question, and the nature of the preventive control and its role within the facility’s food safety system. With this in mind, facilities must conduct activities such as product testing for a pathogen or an appropriate indicator organism or other hazard, and environmental monitoring.

3. Are there written procedures specific to product testing?

Yes. Procedures for product testing must be scientifically valid and must identify the test microorganisms or other analytes. The procedures for identifying samples, including their relationship to specific lots of products, must be written and implemented. The procedures for sampling, including the number of samples and the sampling frequency, must be outlined. The facility must recognize the laboratory conducting the testing as well as describe the tests that are performed and the analytical methods used. Corrective action steps must also be included.

4. What are the procedures for environmental monitoring?

Similar to product testing, these procedures must be scientifically valid, identify the test microorganisms, and be put in writing. For routine environmental monitoring, the location from which the samples are collected and the number of sites that are tested must be stated. The final rule indicates that the “number and location of sampling sites must be adequate to determine whether preventive controls are effective.”  Written procedures must also identify the timing and frequency for collecting and testing samples. Again, similar to product testing, the laboratory conducting the testing and the tests and analytical methods used must be divulged. Corrective action procedures must also be included.

5. How does the supply-chain program incorporate testing?

A receiving facility is required to document a written supply chain program in its records. A component of that program includes documentation of sampling and testing performed as a supplier verification activity. The documentation must include identification of the raw material or other ingredient (including, if appropriate, lot number) and the number of samples tested. It also means that the tests conducted and the analytical methods used must be identified. The date the test is conducted as well as the date of the test report must be provided, and the identity of the laboratory performing the testing must be revealed. Any corrective actions that were taken in response to a hazard detection must also be reported.

This Q&A provides a glimpse into how the preventive controls final rule for human food incorporates laboratory testing. For more details, access the final rule.

FSMA, Food Safety Tech, FDA

FSMA Rules for Preventive Controls Finalized

By Maria Fontanazza
No Comments
FSMA, Food Safety Tech, FDA

More than a week after being submitted to the Federal Register, the rules for preventive controls for human food and animal feed have been finalized.

The Current Good Manufacturing Practice Hazard Analysis and Risk Based Preventive Controls for Human Food final rule includes the following key requirements:

  • Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, and the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification).
  • The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm. Such farms that conduct produce activities will also have to comply with the Produce Safety Rule (to be finalized at the end of October).
  • A more flexible supply chain program, with separate compliance dates.
  • Update and clarification to CGMPs.

This year’s Food Safety Consortium conference will feature first-hand perspectives from FDA and USDA on FSMA implementation and enforcement. REGISTER NOWCompliance dates range between one and three years depending on the size and type of business. Several guidance documents will be created by FDA in an effort to further help companies with compliance, including on hazard analysis and preventive controls, environmental monitoring, food allergen controls, and the validation of process controls.

The Federal Register will publish the 930-page document on September 17. In the meantime, the pre-publication version can be viewed here.

The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals final rule includes the below key requirements:

  • CGMPs established for the production of animal food, taking into account the diverse types of animal food facilities.
  • Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification), and a recall plan.
  • A more flexible supply chain program, with separate compliance dates.
  • The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm.
  • Feed mills associated with farms (vertically integrated operations) are not covered.

As with the preventive controls for human food, FDA will be creating guidance documents that address CGMP requirements, hazard analysis and preventive controls, human food by-products for use as animal food, and a small-entity compliance guide.

The Federal Register will also publish this 666-page document on September 17. The pre-publication version can be viewed here.

At this year’s Food Safety Consortium Conference, the industry will have the opportunity to hear directly from FDA and USDA on what companies need to know to be FSMA compliant and how the agency will be enforcing the regulation. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA, will delivery the opening plenary presentation, which will be followed by an “Ask the FDA” Q&A town hall meeting.

First FSMA Deadline Here, Industry Awaits Final Preventive Controls Rule

By Food Safety Tech Staff
No Comments

According to an FDA alert, the agency has submitted the final preventive controls rules for human and animal food to the Federal Register. FDA notes it can take several days from the date of submission to final publication.

“The FDA is committed to sharing information about the final rules and how food facilities can comply as soon as we are able to do so.” The agency will be providing more information on the FSMA section of its website.

In the meantime, are you prepared for the Preventive Controls Rules for Human and Animal Food?

And if you’re in the animal feed industry, take these steps to prepare for success.

Is Your Company Prepared to Fight Food Fraud and Product Adulteration?

By Maria Fontanazza
No Comments

Having the ability to detect and identify contamination and adulteration in product is a top priority for companies, especially when working with foreign suppliers. In a discussion with Food Safety Tech, Craig S. Schwandt, Ph.D., director of industrial services at McCrone Associates, discusses how companies, especially those with limited resources, can use technologies to improve contamination detection to be ahead of the FSMA implementation curve.

Food Safety Tech: From your perspective, what key elements of FSMA will have a big impact on manufacturers and processors?

Craig Schwandt: For U.S. manufacturers, more and more of their ingredients are coming from foreign countries. [Companies] are responsible for reporting to FDA what measures they have taken to assure food safety in all aspects. Participating in the Foreign Supplier Verification Program will be critical to [their awareness of] whether their foreign suppliers are meeting those obligations. That critical element hasn’t been realized yet.

FST: Is navigating the foreign supplier relationship more of a challenge for smaller businesses versus larger companies?

Schwandt: Global companies have the resources to address contamination concerns and can monitor the processing that takes place in foreign countries. It’s the small companies that don’t have the financial resources to be present in foreign countries. There will be many more issues for them to address—are they really receiving product that they’re paying for? Is the testing that is being conducted in foreign countries really meeting the requirements.

FST: What steps can small companies take to ensure they have testing programs in place to meet requirements?

Schwandt: This ties in with the difference between testing and investigational analysis. Testing involves identification methods that are done to ascertain what is present—it might be an elemental concentration basis or an organic molecule basis—but they’re bulk analysis that determines whether the product is meeting the expected composition.

Then there might be components for which there are actionable levels, if the concentration exceeds actionable levels. But with bulk analysis testing methods, they only understand that they have a component in their product that exceeds an action level, and those methods don’t really specify where that component might be introduced into the product. This is where microscopy-based investigational analysis can assist smaller companies with understanding at what point the contaminant might have been introduced into the product. It can be isolated in individual particles, establishing a forensic pathway for stage of the process in which the contaminant might have been introduced.

FST: Can you expand on the technologies and methods that can be used to detect fraud or adulterated product?

Schwandt: In the case of intentional adulteration and fraud, current technologies include ultrahigh pressure liquid chromatography, liquid chromatography, and mass spectrometry, and the food industry is doing a great job of using them.

In the case of intentional adulteration or fraud, the level of adulteration has to be fairly high, otherwise there isn’t an economic incentive to adulterate it. A great example is with pomegranate juice—if you’re going to intentionally adulterate pomegranate juice with grape juice to cut it down, a fairly large percentage of the final juice will be grape juice in order to make that intentional adulteration process economically motivating. It’s not really so difficult to identify it with [current] technologies.

Where the technologies need to be improved is in instances in which there might be more unintentional adulteration or contamination at trace levels:

  • When there are solid phase particulate contaminants, use of microscopy-based methods (which isn’t new technology) where you isolate the contaminant particles of interest; they occur at trace level. Because we isolate them from the matrix, we can analyze them and [detect] if there were metal particles from processing machinery; we can identify them to the alloy level and give clients a way to trace back to what part in the process stream those particles may have originated.
  • Likewise, Liquid chromatography and mass spectrometry, especially for pesticide residue analysis, will be increasingly more valuable using the QuEChERS program FDA has outlined for quick, safe, reliable and easy analysis of trace contaminants in food products.

FST: What factors are contributing to under-use of microscopy-based methods?

Schwandt: I think the expensive–instrument vendors would like you believe it is as simple as pushing a button to receive your complete quantitative answer. In many cases, the instruments, even though they might be designed with the best intentions, actually do require expert chemists to use them for complete success. There’s a push on the part of instrument manufacturers to provide instrumentation that they sell as providing the complete answer. And there’s a willingness in the food industry to believe it would be as simple as putting a less-skilled person in front of the instrument to run the analysis, push the button, and get the answer, as opposed to hiring an analyst with a lot of expertise.

FST: What industry partnerships/collaborations are essential in testing and analysis?

Schwandt: The partnerships are productive in this area when they’re between production and quality assurance branches of companies and third-party laboratories that can offer niche solutions and third-party verification.

Bug Bytes

Tis the Season for Mosquitoes. Take Preventative Action to Protect Your Facility

By Maria Fontanazza
No Comments

With the heat of summer quickly upon us, food processors should take measures to keep their facilities free of pests that can both harm workers and lead to contamination.

Memorial Day is the unofficial start of summer, a time when we can look forward to more relaxing days sitting by the pool, just enjoying life. But the season also welcomes the unwelcome: more bugs and other little critters.  It is during this time of year that food processers should be extra vigilant about inspecting their facilities to ensure that pests do not become a problem.

While small in size, mosquitoes can be big in nuisance. Ron Harrison, Ph.D., director of technical services at Orkin, LLC, offers a few steps that companies should take to prepare for the season to both protect workers from potentially serious disease transmission such as West Nile Virus or chikungunya virus, and keep mosquitoes from contaminating a food processing facility.

1.    Inspection. Conduct a thorough survey of the perimeter or outside of your building. Have your pest control professional or entomologist look for the presence of natural breeding sites and how they can be eliminated. For example, if there is standing water, how can it be drained? Can it be moved as opposed to remain standing? Growth regulators can also be used to inhibit the developing larvae.

2.    Secure your building. Make sure all screens are in place and that your heating and air system is in proper working order. Check the pressure of your building. If you have positive air pressure with a door open, it pushes air out; if you have negative air pressure, it sucks air in, so a mosquito or any type of bug could be sitting on the outside and get sucked inside.

3.    Use residual products. Mosquitos can be blown in from long distances. Using good residual products on vegetation and shrubs on the outside of your building can help reduce the population. In addition, make sure any dense landscaping is pruned to reduce the harboring sites where mosquitoes might live.

Harrison adds that the prevalence of mosquitos tends to be worse based on the location of a facility. This is where making sure your building is tightly sealed, from the cracks to the positive air pressure in entranceways, is important. “The biggest reason we struggle is that the building or processing plant is built in a swampy area, which is a haven for bugs,” he says. Other factors, including the color of the building (light-colored buildings) and the presence of excessive lighting, can attract more insects.
 
Now is the time for food processing facility managers to take action and inspect their facility. “Mosquitos are just now starting. In another two or three weeks, it’s going to get serious,” says Harrison. “Preventative activity means that later on in the season when they are bad, your processing plant won’t have problems because you took proactive steps.”

Prepare Your Food Safety Plan for the Preventive Controls Rule

By Maria Fontanazza
No Comments

As FDA prepares to issue its next final FSMA rule, Preventive Controls for Human Food, companies should already be laying the groundwork for training staff.

With the August 31 deadline for the Preventive Controls for Human Food rule only months away, careful attention must be paid to training, metrics and collaboration between larger and smaller players to prepare for implementation.

Training surrounds all aspects of a food safety plan, from understanding validation and verification to proper recordkeeping. “Regardless of what happens, training is critical and imperative,” said Donna Garren, Ph.D., American Frozen Food Institute, at the Food Safety Summit last week in Baltimore. “FDA is measuring food safety culture in an operation, and training must be ongoing.”  Garren pointed to the FDA-funded Food Safety Preventive Control Alliance (FSPCA), which was established to develop standardized curriculum and help companies, especially those small and mid-sized, with training programs to meet requirements of the preventive controls regulation. The FSPCA curriculum is fairly broad and includes content that addresses an overview of food safety plans and GMPs, preventive controls related to allergens, sanitation, and suppliers, recall plans and record-keeping procedures. FSPCA has planned its pilot sessions for April, May and June of this year, with a train-the-trainer course planned for the fall.

Formed in January, the FSMA training workgroup has been working to develop training curriculum specifically for regulators on how to evaluate a facility against the preventive controls requirements. According to Priya Rathnam, supervisory consumer safety officer, Division of Enforcement/Office of Compliance at CFSAN/FDA, the agency plans to take a staggered approach to training based on deadlines, beginning with larger companies, as it is not practical to train all safety staff at once.

FDA’s Preventive Controls Phase 2 Workgroup is developing a metrics plan to measure progress (specifically measures that directly tie in with public health outcomes) and track trends, making adjustments as necessary. The agency plans to issue a guidance document to help industry and food and feed safety staff identify significant hazards and implement preventive control strategies. An internal technical assistance network is also planned to assist in consistent implementation in the field.

Start the journey now

While many in the industry may suffer from “FSMA fatigue”, discussing the implications of FSMA day in and day out, a lot of education and outreach still remains. Not everyone within an organization is aware of the intricacies of the regulation. “[We] need to make sure others have the same level of insight that we do,” said Tim Jackson, Ph.D., director of food safety at Nestlé North America.  In addition, the bigger industry players need to work with smaller suppliers and manufacturers that don’t have the resources.

When developing an implementation approach, a company should standardize an internal approach now, rather than wait until the rule comes out in August. This begins with establishing a FSMA team. Jackson advises that this specialized team perform a detailed review of the preventive controls rule requirements and conduct a face-to-face workshop to confirm a rollout strategy and action plan. “We’re looking at our own HACCP plan,” Jackson says of Nestle, adding that they are reviewing validation of control measures and the company’s documentation system, challenging whether it’s “good enough,” and enhancing its early warning system.