FDA publishes Draft Approach for the Determination of High-Risk Foods

FDA released a draft of the approach it will take in determining which foods are considered high risk. This methodology is required under Sec. 204, Enhanced Tracking and Tracing of Food and Recordkeeping, has two major requirements. In this section, FDA must establish rules for recordkeeping requirements for high risk foods to help in tracing products. The requirement is designed to enable foods to be more rapidly and effectively tracked and traced during a foodborne illness outbreak or other event. Criterion for this determination are: outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or chemical contamination, potential for the food to support pathogen growth, food consumption patterns, the probability of contamination and steps taken during manufacturing to reduce contamination.

So what are the implications?  Basically if a company's food is designated high risk, they will need to follow mandated tracking procedures...whatever those turn out to be.


Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm380210.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA is required under section 204(d)(2) of FSMA to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order to rapidly and effectively track and trace such foods during a foodborne illness outbreak or other event. This is the first step towards meeting that requirement. FDA plans to publish a list of these high-risk foods either before or at the same time that it issues a proposed rule under section 204(d)(1) of FSMA to establish the recordkeeping requirements for the designated high-risk foods.

FDA Proposes Transportation Rule as Part of FSMA

 FDA released their proposed rule for Sanitary Transportation of Food as part of FSMA.  This rule applies, with a few exceptions, to any who transport food that will be consumed in the U.S.  Exemptions exist small companies (less than $500,000 in sales) and those who transport shelf-stable foods that are protected by a container (i.e. canned low-acid foods).

 As part of the rule, equipment will need to designed and maintained so it does not cause food contamination, measures are taken to prevent contamination of food during transport (i.e. temperature control, separation of food from non-food items), records to show temperature control and proper cleaning between loads, training of personnel engaged in the transportation of food, and maintenance of written procedures and records.

 

FDA News Release

Proposed Rule on Sanitary Transportation of Human and Animal Food

 

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm383900.htm

 

January 31, 2014

 

The U.S. Food and Drug Administration today proposed a rule that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. Part of the implementation of the Sanitary Food Transportation Act of 2005, the proposal marks the seventh and final major rule in the FDA Food Safety Modernization Act’s (FSMA) central framework aimed at systematically building preventive measures across the food system.

 

The proposed regulation would establish criteria for sanitary transportation practices, such as properly refrigerating food, adequately cleaning vehicles between loads, and properly protecting food during transportation.

FDA's Proposed Rule on Prevention of Intentional Contamination (Food Defense)

On December 20, 2013, FDA rolled out the proposed rule on food defense – Proposed Rule for Protecting Food against Intentional Adulteration. In this rule, facilities will need to develop and implement a food defense plan. In doing this, they will identify any actionable process steps and implement mitigation strategies that will protect food from intentional contamination.

 

Of the FSMA sections proposed thus far, this is one that should receive sufficient debate. Requiring facilities to have a written food defense plan is one thing, but the sticking points will be on enacting mitigation strategies for actionable steps is where there can be some controversy. Adulteration is a low risk event, so how much resources should a facility commit to putting in control measures. And there can be significant difference of opinions on which steps truly represent a risk, and then which control measures should be used for those steps.

 

For example, a facility may have a bulk mixing tank. People who work in the facility may not see any significant risk due to the fact that it is out in the open and only employees have access. But from the CARVER analysis, this process step was deemed the highest risk area within the facility. The facility management may not think that further mitigation is needed, outside of limiting visitors in the facility. But an inspector may want more control, like a cover (which would making cleaning difficulty), a gate to limit access (not practical if the batch operator has to constantly access the batch area), or hire an extra employee for two batch operators. Maybe all would be suggested.

 

In doing a Food Defense Plan, there are a number of factors that come into play in preventing adulteration in a facility. But a motivated assailant can pose a risk to even the most secure facilities. So in the case of the mix tank, what if a subversive terrorist was hired, what if they paid an employee millions of dollars, what if…..

 

So it is important that facility management and regulatory inspectors understand the true risks associated with intentional adulteration and that resources be judiciously applied. Otherwise, the ‘what ifs’ that can be posed the security of any operation or any process can get way out of hand and pose a significant financial burden to the facility, or create a bigger food safety risk.

 

 

Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

 

Link to the proposed regulation.

http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1425-0002

 

 The Link to the proposed rule website.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#summary

 

Here are a few sections from that summary page:

 

Summary

 

FDA’s proposed rule on food defense would require domestic and foreign facilities to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm. The proposed rule, which is required by the FDA Food Safety Modernization Act, would require the largest food businesses to have a written food defense plan that addresses significant vulnerabilities in a food operation.

 

The FDA is proposing that the requirements be effective 60 days after the final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, the FDA is proposing tiered compliance dates based on facility size. The proposed rule was published on December 24, 2013, and comments are due by March 31, 2014. The FDA will hold a public meeting on February 20, 2014, to explain the proposal and provide additional opportunity for input.

 

Safety of Imported Foods - Spices and FSMA

A NY Times article released today (below with link) details the high contamination Salmonella rate of spices and the challenges that exist in importing products. Primarily, these spices are produced in tropical zones in ‘rustic’ conditions. Because of this, these items have a high risk of becoming contaminated with Salmonella (from birds, animal manure, reptiles, etc) and then, that organism can survive in these dried spices for months or longer.

Spices have been processed this way it has been since the time of the spice trade, thousands of years ago. But as consumers, do we generally worry about the safety of spices? Generally not. Companies that have been involved in buying and selling spices have secured their supply chains and where needed, have added interventions such as irradiation to eliminate these bacterial hazards. So there is no risk to the consumer, when you look at the vast quantities of spice consumed each day in this country.

This is not to say there have not been issues, but primarily those issues were linked to food companies using less than reliable sources for their spices. In the small number of cases where there have been issues, importers of spice did not have adequate control measures in place.

So what is the point of the NY Times article? It is directed at the Foreign Supplier Verification Program (FSVP) component of FSMA. In this proposed regulation, emphasis is put on the companies who import food to ensure the safety of those foods. It defines the importer as the person in the US who has purchased the item, and in many cases, this can be the retailer or the distributor. 

The NY Times piece provides ammunition for those who feel that the federal government should have a heavier hand in determining the safety of those imported food items. This would necessitate a heavy testing program conducted by the government agencies at the border for incoming foods and having FDA inspectors inspect foreign companies.

With about 15% of the food consumed in this country being imported, it is not financially feasible to have FDA take on that responsibility. The concept proposed in FSVP is better…making companies responsible for the foods they import. We just have to look at companies like McCormick who have practiced the safe importation and processing of spices for more than a century.  

For those identified as importers, FSVP provides the elements of a supplier verification program that these companies will need to establish for each suppler, including verifying that he supplier has a HACCP type system in place and conducting verification, corrective action, and record keeping activities.

In the long run, FSVP will create a stronger food supply system. Companies who sell imported foods will either be forced out of selling if they are not willing or capable of implementing such an adequate supplier contol system, or will need to align with an importer who does have the necessary capabilities.


NY Times
Spices’ Link to Food Ills Prompts Changes in Farming
By GARDINER HARRIS
Published: August 27, 2013
http://www.nytimes.com/2013/08/28/world/asia/farmers-change-over-spices-link-to-food-ills.html?pagewanted=1&_r=0

IDUKKI, India — Spices grown in the mist-shrouded Western Ghats here have fueled wars, fortunes and even the discovery of continents, and for thousands of years farmers harvested them in the same traditional ways. Until now.

Science has revealed what ancient kings and sultans never knew: instead of improving health, spices sometimes make people very sick, so Indian government officials are quietly pushing some of the most far-reaching changes ever in the way farmers here pick, dry and thresh their rich bounty.

The United States Food and Drug Administration will soon release a comprehensive analysis that pinpoints imported spices, found in just about every kitchen in the Western world, as a surprisingly potent source of salmonella poisoning.

Local Farmers Worry About New Food Safety Guidelines

WPSU’s Emily Reddy talked with Dr. Luke LaBorde of Penn State and  Kim Tait, a small scale processor, on the FSMA bill and the impact on smaller farms and processors,   [Link to radio report]

FDA proposes fee structure for re-inspections and recalls as part of FSMA

As part of the provisions in FSMA, FDA is setting a fee schedule for re-inspections of a facility when that facility had non-compliance/food safety issues during the initial inspection and for conducting a recall when the company fails to comply with a recall order.

For 2014 (which begins Oct 1, 2013), the fee rate is $237 an hour ($302 when foreign travel is required).

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm257982.htm?source=govdelivery

So for an all day visit (8 hours - arriving at 8 am and leaving at 4 am, no lunch), a facility is looking at a roughly a $1900 bill from Uncle Sam. Their goal will be to determine that corrective action was aken to resolve the noncompliance issue. Hopefully they can be convinced actions in 30 minutes the the corrective action was successful.

Peanut butter facility reopens 8 months after Salmonella outreak

After being closed for 8 months due to a Salmonella outbreak in their peanut butter, the Sunland plant plans to reopen. The NM plant issued an extensive recall in September of 2012 ( http://pennstatefoodsafety.blogspot.com/2012/10/peanut-butter-recall-continues-to-expand.html) after 42 people in 20 states become ill (http://www.cdc.gov/salmonella/bredeney-09-12/index.html). The FDA prevented the plant from restarting after their investigation resulted in number of findings including 28 Salmonella-positive environmental samples (http://pennstatefoodsafety.blogspot.com/2012/11/fda-investigation-report-on-sunland.html). FDA kept the facility closed (http://pennstatefoodsafety.blogspot.com/2012/11/fda-prevents-sunland-foods-from.html) under new power granted by FSMA. In December, the facility and FDA reached a deal that provided conditions for the plant to reopen (http://news.yahoo.com/deal-reached-reopen-nm-peanut-butter-plant-214723148--finance.html) if the facility met the requirements of the consent decree with approval by the FDA.

So now 8 months later, the facility will begin making peanut butter for sale. I will stick with my brand that was not involved in an outbreak.



New Mexico plant shuttered for 8 months amid salmonella outbreak is making peanut butter againBy Associated Press,
http://www.washingtonpost.com/national/health-science/new-mexico-plant-shuttered-by-salmonella-outbreak-is-making-peanut-butter-again/2013/05/23/719863cc-c3c8-11e2-9642-a56177f1cdf7_story.html 

May 23, 2013 06:16 PM EDT

ALBUQUERQUE, N.M. — The eastern New Mexico peanut butter plant shuttered eight months ago after a salmonella outbreak is back in production, and company officials say their coveted natural and organic butters could be back on store shelves within a month.
Sunland Inc. Vice President Katalin Coburn says the company last week got the go-ahead from the Food and Drug Administration to restart peanut butter operations at its factory in Portales. It is currently in a test phase of production, she said.

“The restart of the plant is not as simple as turning on a switch,” Coburn said Thursday. “Hopefully we will be back in full production in the next few days.”

The Food and Drug Administration shut the plant in late September after its products were linked to 41 cases in 20 states. Most of those were linked to natural peanut butter the company made for Trader Joe’s.

New Food Safety Regulations Proposed for Fresh Produce Growers

Dr. LaBorde produced a very nice write-up on FSMA's proposed rule for produce safety.

 

New Food Safety Regulations Proposed for Fresh Produce Growers

 

Dr. Luke LaBorde, Department of Food Science, Penn State University 1/16/13

 

On January 4, 2013, the U.S. Food and Drug Administration (FDA) released a draft Produce Safety Rule as required under the Food Safety Modernization Act (FSMA) of 2011. This proposed regulation would establish mandatory practices that farmers must take to prevent microbial contamination of fresh produce. Below are highlights of requirements FDA would issue in the final regulation:

 

Worker Health and Hygiene - Farm and packing house workers who harvest or handle fresh produce, and their supervisors, must receive training on personnel hygiene and health conditions that can increase the risk for food contamination. Growers are required to show proof of training by keeping written records. Toilet facilities have to be readily accessible, kept reasonably clean, and supplied with toilet paper. Hand-washing stations must be close to toilet facilities and supplied with potable running water, hand soap, and clean single use towels.

 

Agricultural Water - Growers must be able to demonstrate that the water they use for irrigation, pesticide preparation, cooling and washing, etc. is safe for its intended use. Maximum average E. coli levels of 126 cells per 100 milliliters have been proposed for irrigation water that can contact the edible part of the crop. Water used for post harvest operations face more stringent standards; no detectable levels of E. coli are allowed.

 

FSMA Preventive Control Proposed Rule – Key Points for Food Processors

Official Title - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

 There has been a lot of press regarding the FDA’s proposed rule on preventive controls. It has been hailed by many as a needed step for a safer food supply. If anything, it certainly helps to bring most every processor up to the same level in terms of HACCP based preventive measures.

The rule requires that FDA registered firms have a written food safety plan which is based upon HACCP principles.

For the food processor who has a HACCP plan in place and has undergone third party audits, there is nothing overwhelming within this rule. The challenge will be for those companies that do not have a HACCP system in place yet, (or a good plan in place). All companies who have registered their facility with the FDA, including those that do not ship out of state, may be subject to the FSMA preventive control rule. However, there are exemptions from the requirements for a Food Safety Plan for firms based upon size and whether they can be considered ‘on-farm’.

For firms with an active, functioning HACCP plan, the biggest thing to revise will be in the hazard analysis and the need to identify preventive controls. Preventive controls, as defined, can be CCPs or certain prerequisite programs that are needed to control potential hazards. Also, in addition to biological, chemical and physical hazards, we now include radiological hazards.

In current HACCP, the focus is on hazards controlled within the process by CCPs. In this, we acknowledge that prerequisite programs as making certain ‘hazards not likely to occur’. In the FSMA rule, all potential hazards must be addressed, and then for any considered reasonably likely to occur, the preventive control must be identified that renders the product safe (non-adulterated), whether that be a CCP or other program. In doing the hazard analysis, it will be important to include an assessment the severity of the illness or injury associated with the hazards.

Similar to what is done with CCPs, all preventive controls must have documented procedures. There must be monitoring, verification, and record keeping. However, unlike a CCP, there may not be a measurable parameter (critical limit). Validation for the preventive controls may not be needed (for sanitation and allergen control).

For example, one would need to identify sanitation as a preventive control for Listeria with a RTE food item when there is exposure of that product to the environment before packaging. They would need procedures for cleaning, verification that cleaning was done, and documentation to show this.

Facilities are required to have a written Recall Plan. At this time, there are no requirements for an environmental monitoring program, finished product testing, or supplier verification, although there is this with regard to process control (Proposed § 117.80(a)(5) would require that chemical, microbial, or extraneous-material testing procedures be used where necessary to identify sanitation failures or possible cross-contact and food contamination). FDA does ask for comments regarding the need of these being addressed. 

Food defense / intentional contamination will not be addressed in this rule.

Overall, FDA takes a less prescriptive approach with regard to the preventive control rule. While this gives processors opportunity to use a number of different methods to meet standard, it can be an issue when being inspected when that inspector doesn’t agree with that method. (We see that now with USDA inspectors with regard to validation…..’how do you know that process works’).

It is important to remember that this is just the proposed rule. This is the comment period and this closes on May 16th. At that time FDA will review and then reissue the rule, which then becomes implemented 60 days after being issued. Large firms will have one year to implement, small firms will have 2 years, and very small firms will have 3 years.

For more detailed summaries (prepared by lawyers) see http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm or http://leavittpartners.com/wp-content/uploads/2013/01/Proposed-Rule-On-Preventive-Controls-Key-Provisions.pdf

Other points to note – (Items I found interesting):

FDA Proposed Rules for Food Safety Plans and Produce Food Safety

On Friday, Januray 4, 2013, the FDA rolled out two proposed rules.

 

1) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food 

• Preventive Controls – applies to facility that manufacture, process, pack or hold food that fall under FDA jurisdiction. This rule requires that facilities have food safety plans in place for the preventive control of potential hazards, both within the process (HACCP) and those associated with the prerequisite programs. The document is 680 pages.
• http://www.ofr.gov/OFRUpload/OFRData/2013-00125_PI.pdf

 

2) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

• Proposed Standards for Produce Safety – covers those fruits and vegetables that are likely to be consumed raw (spinach not potatoes). This document is 547 pages.
• http://www.ofr.gov/OFRUpload/OFRData/2013-00123_PI.pdf

 

Being proposed rules, there is a comment period before a final rule is issued. Then there will be a period of time from when the final rule is published until it is enacted

FDA Prevents Sunland Foods from Reopening

FDA flexed its new regulatory muscle as granted through FSMA and shut down Sunland Foods, the maker of contaminated Trader Joe's Peanut Butter.  Sunland was planning to reopen the processing facility this week, but FDA suspended the facility's registration due to a 'reasonable probability' that their product could cause serious health problems.  Numerous issues in the facility had been cited (http://pennstatefoodsafety.blogspot.com/2012/11/fda-investigation-report-on-sunland.html) including FDA's assertion that Sunland knowingly shipped contaminated product.  Sunland denies this claim.  

Now it is up to the company to prove its case in court in order to resume operations.

FDA's decision to shut a facility down begins a new chapter for food processors and their interaction with FDA under FSMA.  Most consumers would probably agree that this facility deserved to be closed.  But we don't know to what degree the facility had made steps to improve since the initial recall back in late September.  (http://pennstatefoodsafety.blogspot.com/2012/09/supplier-of-trader-joes-peanut-butter.html)  Was Sunland Foods unable to get up to standard in the last 2 months, or were there issues so numerous and/or bad that FDA still deemed the facility a risk to consumers?   What will be interesting moving forward is how FDA will use this new power.  Will it be used as a preventive tool, shutting plants down before the products they produce causes illness?  And if so, to what degree of risk will federal inspectors be willing to accept?  Listeria in a drain?  Salmonella in a product that is not fully cooked?  Or will it be used as a punitive action - a way to make a facility involved in an outbreak prove that it has made the necessary changes?

 

FDA halts company's peanut butter operations

The FDA suspended Sunland's registration over salmonella concerns.

http://www.usatoday.com/story/news/nation/2012/11/26/fda-peanut-butter-salmonella/1728017/?sf7473491=1

USAToday Health and Wellness  6:17PM EST November 26. 2012 -
WASHINGTON (AP) — The Food and Drug Administration halted operations of the country's largest organic peanut butter processor Monday, cracking down on salmonella poisoning for the first time with the new enforcement authority the agency gained in a 2011 food safety law.
FDA officials found salmonella all over Sunland Inc.'s New Mexico processing plant after 41 people in 20 states, most of them children, were sickened by peanut butter manufactured at the Sunland plant and sold at Trader Joe's grocery chain. The FDA suspended Sunland's registration Monday, preventing the company from producing or distributing any food.
The food safety law gave the FDA authority to suspend a company's registration when food manufactured or held there has a "reasonable probability" of causing serious health problems or death. Before the food safety law was enacted early last year, the FDA would have had to go to court to suspend a company's registration.
Sunland had planned to reopen its peanut processing facility on Tuesday and a spokeswoman said before the

Impact of FSMA on Recalls through Improved Prerequisite Programs

It is amazing to see the number of recalls that are issued each week. I put put together the listing of the recalls that occurred within the last week (Dec 6 to 12, 2012).  There are a range of items, most, if not all, related to prerequisite program issues (allergen control and labeling, supplier/ingredient control, environmental control).

In an article written by David Acheson, http://leavittpartnersblog.com/20113304/david-acheson/fda%E2%80%99s-views-on-preventive-control-requirements-beginning-to-emerge-time-to-go-beyond-haccp, he provides a view of FDA official comments, specifically that FSMA will go beyond HACCP. He suggests that FDA will put in more specific guidance to address key elements of food safety programs,  pointing out that environmental monitoring and training will be two highlighted areas.  Looking at the recalls we are seeing, it is hard to argue that prerequisite programs have become the primary issue with regard to outbreaks and recalls.  Companies should begin looking at all programs that are responsible for controlling hazards to ensure they address monitoring, corrective actions, and verification.

While some will bristle at additional requirements, the cost of conducting a recall due to lack of control is worth the effort for improving low risk hazards are controlled.