January 18, 2013
New Food Safety Regulations Proposed for Fresh Produce Growers
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.
Biological Soil Amendments - At least a 9 month interval (270 days) would be required between application of raw animal manure to produce fields and harvesting if there is a possibility that the manure may contact the produce. Composted animal manures can be applied from 0 to 45 days before harvest depending on whether or not it can contact the crop. Growers, or commercial compost suppliers, must provide proof through laboratory testing that the composting process was adequate to make it safe to use. No human waste is allowed on fields except in the case of sewage sludge biosolids that are treated according to already existing regulations.
Domesticated Animals - Working animals, such as mules and horses, are allowed in produce fields as long as the grower can demonstrate that they have taken adequate measures to prevent contamination. If animals are allowed to graze in areas intended for produce growing, the waiting period specified for application of raw manure (270 days) would apply.
Wild Animals - FDA recognizes that it is impossible to keep all wild animals away from produce fields. If the situation is out of control and there is a reasonable probability that wild animals can contaminate produce, growers would be required to monitor their fields for signs of animals and take some kind of preventative measure to keep them out or discourage them from entering.
Equipment, Tools, and Buildings - Equipment and tools need to be kept reasonably clean. Sanitation standards for packing buildings requires good water drainage, control of dripping condensation, a pest control program, and regular clean-up of trash. Partially-enclosed packing buildings are acceptable if the grower or packer takes precautions to prevent birds and other pests from becoming established in the buildings.
Here are some important points that need to be made about the proposed rule.
- The proposed rule covers only fresh produce that is sold commercially. It does not apply to produce used for personal consumption, such as home gardens.
- The focus of the new regulation is on fruits, vegetable, nuts, herbs, mushrooms, and sprouts that are typically eaten raw, not commodities that are generally cooked or further processed. For example, potatoes, egg plant, winter squash, beets, and beans for drying are exempt.
- Not all farms that grow fresh produce are required to comply with the rule.
- Farms with gross food sales under $25,000 are exempt
- Farms with gross food sales over $500,000 are generally required to comply.
Those with total sales of between $25,000 and $500,000 may or may not receive exemptions, depending on what kind of marketing channels are used. For instance, if a farmer sells than more than half of his/her strawberry crop directly to consumers, such as at a farmers market, farm stand, as a CSA, or if he/she delivers it directly to a grocery store or restaurant, they are exempt from the regulation. However, to receive this exemption, these kinds of direct sales must be to buyers in the same state as the farm, or if out of state, no farther than 275 miles from the farm.
If a crop is mostly sold through wholesale outlets, such as through distributors, warehouses, or fresh-cut processors, the farm is not exempt and is covered under the rule.
Exemptions can be cancelled if FDA determines that a farm may be a source of contaminated produce.
And finally, keep in mind that growers of any size who sell at least some of their crop through wholesale marketing channels, even if technically not covered by the federal regulation, have been facing and will to continue to face standards at least as stringent as anything in the final FDA regulations.
Remember, this is a proposed rule. It is not a final regulation. This means that growers have an opportunity to comment on any part of the rule they do not understand or object to.
The draft ruling is available for viewing at http://www.fda.gov/Food/FoodSafety/FSMA/ucm304045.htm. The public will have the opportunity to submit comment on the draft rule until May 16, 2013. Before this date, FDA will be holding public meetings to explain the proposal and to provide additional opportunity for input.
There are two ways to send comments. You may submit comments through the internet at http://www.regulations.gov. Once you are on the site, follow the instructions for submitting comments.
For written comments, you may fax them to FDA at 301-827-6870 or mail them to:
Division of Dockets Management (HFA-305)
Food and Drug Administration,
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
All written submissions received must include the Docket No. (FDA-2011-N-0921)
Dr. Luke LaBorde, Department of Food Science, Penn State University
January 14, 2013
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
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/FoodSafety/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):
Training will be important. The rule requires that one or more qualified individuals prepare the food safety plan, validate controls, review records, and perform revalidation/reanalysis. A person becomes qualified through training and/or practice. It is also required that supervisors and sanitation people receive training.
“Personnel responsible for identifying sanitation failures or food contamination must have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors must receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices”
There is much more attention on allergen control, specifically preventing cross contact (that is the term used for allergens instead of cross contamination). This includes personnel as a source of cross contact.
Corrective actions will require a root cause analysis to determine and then eliminate the cause for a deviation.
“Proposed § 117.110(d) would specify that the mixing of a food containing defects at levels that render that food adulterated with another lot of food is not permitted and renders the final food adulterated, regardless of the defect level of the final food.:
“Containers and carriers of raw materials must be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.”
The current section of 21 CFR Part 110, the current CGMP regulation, will be revised with current terminology and moved to 21 CFR Part 117 along with hazard analysis and risk-based preventive controls.
There is a whole section defining ‘on-farm” and a “facility”, regarding who needs to comply.
January 7, 2013
On Friday, Jan. 4, 2013, the FDA rolled out proposed rules for food safety plans and for produce safety.
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
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.
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.
October 31, 2012
Food Safety following Hurricane Sandy
When a major disaster strikes, the safety of food becomes a major question. In some cases refrigeration is lost for several days, in other cases, food is exposed to contaminated water.
For consumers, careful evaluation is needed for those foods stored in a the refrigerator or freezer that has lost electrical power ( Penn State Extension ; FDA ) and what to do when returning to a home that has been in a hurricane or flood (FDA)
For businesses that handle food, FDA provides guidance for disasters.
Handling of food items exposed to flood waters (Get the fact sheet). It is important to note that jars with screw tops and bottles with crimp lids (beer and soda bottles) be destroyed. T(Get the FactSheet)he reason for this is that debris may become lodged in the space between the cap and jar.
April 25, 2012
BSE Cow Poses No Threat to US Food Supply
A cow in California was diagnosed with BSE, or Mad Cow. This is the fourth documented case of BSE in a cow in the US.
It poses no real risk to human health or the US food supply because the slaughtered animal did not enter the food supply. Further, this was a dairy cow and BSE is not transmitted through milk. The cow, more than 30 months of age, had died and was to be rendered. It was tested for BSE because it had died.
The US has an active monitoring system for all suspect animals and older animals as well as controls for the removal of SRMs (specific risk materials), including spinal and brain tissue, during slaughter.
For more information on the disease, see the EDEN BSE topic page.
February 24, 2012
Subject: Food Safety News - Norovirus Outbreaks in the News
The leading cause of foodborne disease is making its mark this winter. Just this February, Norovirus caused more than 200 attendees at a cheerleader camp in Washington State to become ill. In St. Maarten, a cruise ship returned to port as 31 became ill. In Virginia, an elementary school was closed because so many students were ill. And in New Jersey, more than 400 college students become ill at three universities located in the same county.
There are some important reasons that lead to so many people becoming ill from Norovirus. One is the virus’s low infectious dose. It is estimated that it may take only 10 viral particles to make someone ill. Then, there is the ability of the virus to survive for up to two weeks on dry surfaces and in water for months. The virus can be spread through a number of ways including through contaminated food or water, from contaminated surfaces, directly from a sick person, or from the intake of aerosolized droplets of vomitus.
The main symptom of Norovirus infection is another factor for its spread – acute-onset vomiting. This prevents people from becoming sick in a secure location. Rather, rapid onset can occur at a dinner table, on a carpet, or on the bus. People usually become ill within 24 hours of exposure, although longer incubation periods do occur. Once someone is sick, they can experience symptoms for 24 to 72 hours, and can remain contagious for up to 3 days.
Because of this short incubation time, low infectious dose, and ease of spread, one can see why it spreads through a school or a cruise ship so quickly. While rarely fatal, people who become ill need to watch so that they do not become dehydrated.
The most important key in preventing infection is frequent, but correct hand washing – scrubbing hands with soap and warm water. Additionally, it is important for people to stay home when ill, especially when they may have been exposed to someone who has had the illness. They should also stay home for at least 48 hours after systems have subsided. Contaminated surfaces must be cleaned using a strong chlorine bleach solution, 1 cup of bleach o one gallon of water. Cooking will destroy the organism.
CDC link for additional information
January 13, 2012
CDC has updated their Multistate Foodborne Outbreak listing for 2011 (http://www.cdc.gov/outbreaknet/outbreaks.html). This is a nice reference page for reviewing major food outbreaks that have occurred over the past 6 years. (An outbreak, as defined by CDC is "When two or more people get the same illness from the same contaminated food or drink”)
A few things to note:
This does not include recalled products – products recalled due to only the presence of pathogens (pathogens were detected in the product, but there were no illnesses reported). There have been many recalls that have occurred due to positive analysis for a pathogen, especially now with the Reportable Registry (http://www.fda.gov/food/foodsafety/foodsafetyprograms/rfr/default.htm). And so it follows, it does not include recalls for allergens – the major cause for companies to conduct recalls.
- This list does not include single state outbreaks – so this list is manly large companies that produce products. This does not mean that smaller establishments do not have issues.
- A few items were actually not food, but rather pets (frogs and chicks/ducklings in 2011, and water frogs and frozen rodents, which are used to feed slithering pets, in 2010). One item was dog food, which we will count as food .
- There appears to be an increase in the number of entries each year on this listing. I don’t suspect things are getting worse, but rather detection and reporting are getting better.
- Of the 41 entries over the 6 year period where a cause can be found (dropping the pet related entries and the laboratory entry), fresh ground meat had 6 entries, alfalfa sprouts had 5, leafy greens had 5, and cantaloupe had 3.
- Salmonella related outbreaks accounted for roughly 2/3 of the entries. This is due to the wide prevalence of Salmonella in the environment.
- FDA regulated product entries accounted for 25 entries, USDA for 11, and I suspect that two of the outbreaks were from facilities that had both USDA and FDA oversight.
- Roughly 27 are what one would consider ready to eat (no required consumer cooking step). 14 entries were products would be considered products that required cooking, that if done sufficiently by the consumer, would have prevented illness (reasons why vary - cookie dough traditionally eaten raw, pot pies – poor cooking instructions, raw meat – no thermometer use).