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

Trader Joe's Recalls Frozen Chicken Dinner Due to Listeria

Trader Joe’s is recalling a frozen chicken product, Butter Chicken with Basmati Rice after routine testing found the product was contaminated with Listeria. 240 cases were shipped to 14 eastern US states and DC. The product was made in Canada.

 The product is a frozen product and would be considered heat and serve (although a final temperature of 165ºF is listed as a temperature that should be reached before serving. http://onefoodguy.blogspot.com/2009/08/triumphant-return-of-tuesdays-tastings.html). Freezing will prevent the organism from growing, so the risk then comes down to the level of contamination to start and to what degree can we expect the heating to reduce that initial contamination. Of course, if a consumer puts the frozen product in the refrigerator for a few days before cooking, those Listeria levels could rise once the product thaws. Overall, it may not be a high risk, but a risk that the consumer probably does not want, and should not have to expect. Since this product was pre-cooked, the facility should be controlling Listeria in the post-process environment (after cooking through packaging).

 This is the second recall to hit the media in the last few months. The last was the Sunland peanut butter that was contaminated with Salmonella and resulted in 41 becoming infected. Trader Joe’s is a company that sources its products from food manufacturers and therefore must ensure that those suppliers have good food safety programs. Having two recalls does raise concern about the company’s sourcing program.

 

Nearly 5,000 pounds of Trader Joe's chicken and rice recalled

 http://www.latimes.com/business/money/la-fi-mo-trader-joes-chicken-rice-recall-20121203,0,5193331.story

 By Tiffany Hsu
December 3, 2012, 8:19 a.m.

Trader Joe’s is facing yet another recall, this time affecting nearly 5,000 pounds of its store brand Butter Chicken with Basmati Rice, which may be contaminated with listeria bacteria.

The producer of the product, Canadian company Aliya’s Foods Limited, issued a voluntary recall of 4,865 pounds of the frozen food, according to the U.S. Department of Agriculture.

Martha Stewart, celebrity chef and author, contracts Salmonella

Martha Stewart contracted Salmonella over Thanksgiving from mishandling food in the form of raw turkey.  While we hate to see anyone become ill, having a celebrity chef come down with Salmonella can have a positive outcome.  Too often we see these celebrity chefs demonstrating poor practices, whether it is inadequate hand washing, cooking to the incorrect temperatures, or canning foods using the oven technique.  But my hope is that Martha will use this experience as motivator to endorse good safety practices.

Of course, in one of the news stories she has an idiot quote about a silver lining… “I lost some weight,”.  I can see it now, a bunch of kitchen debutantes licking raw chicken as a way to lose weight.  So much for my wishful thinking.

Salmonella: Martha Stewart Sickened Last Month After 'Handling So Many Turkeys'

Posted: 12/06/2012 11:06 am EST

http://www.huffingtonpost.com/2012/12/06/salmonella-martha-stewart-infection-salmonellosis-_n_2250353.html

Martha Stewart was confined to her bed for several days last month because of salmonella infection, the New York Post's Page Six reported.

“I never get sick, but I came down with salmonella. I think I caught it because I was handling so many turkeys around Thanksgiving," Stewart told Page Six. "I was on the 'Today' show, I did a number of other [Thanksgiving] appearances. It really hit me hard and I was in bed for days. It was terrible."

Veggie Burger Product Recalled Due to Potential for Listeria monocytogenes

Veggie Patch, a manufacturer of vegetable based food items, is recalling meatless burgers and falafel because their own internal testing program detected Listeria monocytogenes. What is the risk:

• The meatless burgers are soy-based products (Ingredient statement below), which are considered a TCS food in the FDA Food Code. That is, the product will support the growth of organisms such as Listeria.
• The product is considered fully cooked, so the instructions (attached below) are what would be considered heat-and-serve. These instructions would not be considered validated cooking instructions needed to destroy pathogens if present. (http://www.gmaonline.org/downloads/wygwam/121894_1.pdf is a guidance document for validating cooking instructions.)
• This is a frozen product, so while frozen, that will prevent the growth of Listeria. Of course, if the consumer thaws the product and then holds it for days before consuming, this will allow for growth.

Question is, to what degree does the company’s food safety program, including sanitation, limit this recall to the day in question.

 

FDA News Release

VEGGIE PATCH® Voluntarily Recalls Two Items- The Ultimate Meatless Burger and Falafel

- Due To Possible Risk Of Contamination By Listeria monocytogenes

http://www.fda.gov/Safety/Recalls/ucm330342.htm

 

FOR IMMEDIATE RELEASE – November 30, 2012 – VEGGIE PATCH® is voluntarily recalling two products --The Ultimate Meatless Burger and Falafel-- due to a risk of contamination with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy persons may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths in pregnant women.

 

The Ultimate Meatless Burger and Falafel, from VEGGIE PATCH, with the specific use-by dates and UPC codes listed below were distributed to a select number of retailers and distributors.

 9-ounce trays of refrigerated, fully cooked, VEGGIE PATCH, The Ultimate Meatless Burger with a Use-By date, Jan/12/2013; UPC code 6-10129-00211-5 (which can be found on back of package)

9-ounce trays of refrigerated, fully cooked, VEGGIE PATCH, Falafel with a Use-By date, Jan/15/2013; UPC code 6-10129-06619-3 (which can be found on back of package)

Fear the Grocery Carts?

Here is a study just released in Food Protection Trends. The study shows that grocery carts are a bit unsanitary as indicated by the presence of bacterial indicators (APC, coliforms, generic E. coli). While the study is a bit soft in the methodology (should have actually checked for pathogens, should have used better methods for testing), it does show that shopping carts are not the cleanest things in the world, and there is the possibility that carts can be a source of contamination, primarily children riding in those carts (putting their fingers on the cart seat and then sticking those same fingers in their mouth).  

But before we all go crazy worrying about grocery carts, it is important to point out this is just one of many risks that we all face each day. How about that grass where the kid is crawling….might that be a place where birds, dogs, or cats may have pooped? The refrigerator where juices from raw meats may have dripped…did it get on the apples?. That grocery store conveyor, where the packs of raw meat may have dripped…could those drops contaminated your other food packages?. How about those reusable grocery bags that never get washed after being used to carry raw meat? Where did you put your hands while eating lunch on a park bench where earlier, a group of the pigeons deposited their load as they flew by? Certainly it is important that we take precautionary measures such as washing our hands, cooking our food, and washing our grocery bags, but for each study that comes out that demonstrating the somewhat obvious, we cannot let the potential of contacting a contaminated surface become the bane of our lives. As they say, the key to a healthy immune system is a constant challenge.


Bacterial Contamination of Shopping Carts and Approaches to Control

Charles P. Gerba* and Sheri Maxwell
Dept. of Soil, Water and Environmental Science, University of Arizona, Tucson, AZ 85721, USA
Food Protection Trends, Vol. 32, No. 12, Pages 747–749

Summary

Placing children in grocery shopping carts has been implicated recently as a source of infection with Salmonella and Campylobacter in young children. This study was conducted to assess the occurrence total bacteria, coliform bacteria and Escherichia coli on grocery shopping cart handles and seats. A total of 85 shopping carts in parking lots of grocery stores were tested in five major metropolitan areas across the United States. The total numbers of heterotrophic bacteria were as great as 1.1 × 107 on the handle and seat. Coliforms were detected on 72% (62) of the carts. E. coli was identified on 18 of 35 carts (51%) on which coliform identifi­cation was conducted. The results of this study suggest the need for improved sanitation of shopping cards/baskets to reduce exposure to pathogens and potential transmission of microbial infections among shoppers.

Antibiotic-resistant pathogens in pork - reviewing the CR news release

Perhaps you have seen the latest food safety news to hit the mass media - antibiotic resistant bacterial pathogens in pork.

Is there need to worry - No.

1) Is pork that bad? No, all raw meat products - whether pork, beef, poultry, or fish - have the potential to carry bacterial pathogens such as Salmonella, or E. coli. Therefore, one just needs to properly cook (to eliminate those organisms) and properly hande (to prevent cross contamanation) raw meat products to prevent any potential for illness. Remember, use a thermometer.

2) What about the antibiotic resistance? Antibiotic resistenace adds no special ability for these organisms to resist heating and sanitizers, so these bacteria will be controlled the same as any other bacteria though proper cooking and cleaning. The biggest concern with these types of organsims are with high risk groups, so it is especially important to ensure the use of good practice when preparing food for these groups (including the elderly and young children).

 It is true that there is a link between the use of antibiotics in livestock and a higher level of antibiotic resistant organisms that can be found in that meat. And it is true that anitibiotics have been overused in livestock as well as for humans (have you been given antibiotics for a viral infection?). However, the epidemiolgical evidence is lacking in showing a tie between those organisms and increased human illness. To combat the concern, FDA recently released a guidance to promote the judicious use of medically important antibiotics in food-producing animals (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm299802.htm).

It is also important to note that one can find antibiotic resistant organsims in organically grown meat. So I do not agree with the assertion that is made that one should buy organically certified meat. If you feel that there are quality aspects related to organic meat, than that is one thing. But the fact that the meat is organic does not provide any real benefit regarding safety.

What’s in that pork?
 We found antibiotic-resistant bacteria and traces of a veterinary drug

Consumer Reports magazine: January 2013 http://www.consumerreports.org/cro/pork0113.htm

 Our analysis of pork-chop and ground-pork samples from around the U.S. found that yersinia enterocolitica, a bacterium that can cause fever, diarrhea, and abdominal pain, was widespread. Some samples harbored other potentially harmful bacteria, including salmonella. And there are more reasons to be concerned about “the other white meat.”
Some of the bacteria we found in 198 samples proved to be resistant to antibiotics commonly used to treat people. The frequent use of low-dose antibiotics in pork farming may be accelerating the growth of drug-resistant “superbugs” that threaten human health.

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