The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a press release on Wednesday, December 5, 2012, announcing that companies producing raw ground chicken and turkey and similar products will be required to reassess their sanitation procedures and pathogen control plans over the next few months. Specifically, over the next 90 days, producers of raw ground chicken and turkey must conduct a thorough examination of its current Hazard Analysis and Critical Control Points (HACCP) to confirm its ability to identify hazards and better prevent foodborne illness. After the 90 day period, FSIS inspection program personnel will begin verifying that establishments that manufacture raw ground turkey or chicken products have indeed reassessed their HACCP plans.
FSIS will be documenting whether establishments made any changes to their HACCP plans in response to the required reassessment and will later evaluate those changes. Later, the agency intends to publish guidance materials for the industry on best practices to reduce Salmonella in ground and comminuted (further processed by mechanical separation or deboning and chopped, flaked, minced or broken down) poultry.
In making this announcement, officials at FSIS are hoping to lower the prevalence of Salmonella contamination within these types of products. This attention to the ground poultry product industry with a focus on Salmonella comes as a response to recent outbreaks that have sickened hundreds across the country in the past few years. Just in the last two years there have been two major Salmonella outbreaks associated with ground poultry products that affected consumers nationwide.
In conducting these reassessments, FSIS is advising companies to look at, among other things, the following:
[E]stablishments should evaluate the adequacy of their sanitation procedures for processing equipment, including grinders, blenders, pipes, and other components and surfaces in contact with the product. Thus, Sanitation SOPs, other prerequisite programs, or HACCP plans should address procedures that ensure that all slaughter and further processing equipment, employee hands, tools, and clothing, and food contact surfaces are maintained in a sanitary manner to minimize the potential for cross contamination within and among lots of production. In addition, FSIS expects establishments to ensure that slaughter and dressing procedures are designed to prevent contamination to the maximum extent possible. Such procedures should, at a minimum, be designed to limit the exterior contamination of birds before exsanguination, as well as minimize digestive tract content spillage during dressing process.
Other FSIS recommendations include validating cooking instructions, examining lotting practices that minimize contact between lots, and requiring suppliers to show that they have used a Salmonella intervention step.
In FSIS’s notice, the agency also announced that it will be expanding the Salmonella verification sampling program to include other raw comminuted poultry products, in addition to ground product; it will be increasing the sample size for laboratory analysis from 25 grams to 325 grams to provide consistency as the Agency moves toward analyzing samples for Salmonella and Campylobacter; and it will be conducting sampling to determine the prevalence of Salmonella in raw comminuted poultry products.
Although these new procedures are intended for producers of ground or comminuted chicken and turkey products, FSIS is recommending that manufacturers of comminuted products derived from cattle, hogs, and sheep or comminuted poultry products derived from poultry other than chicken or turkeys also consider assessing whether their food safety systems present food safety vulnerabilities.
The Oregon Public Health Division’s (OPHD) Foodborne Illness Prevention Program announced that it is moving forward with the adoption of the 2009 Food and Drug Administration (FDA) Food Code. The new rules will take effect on September 4, 2012. Oddly, however, the agency noted that it would not be adopting the “No Bare Hand Contact” section of the Food Code.
In creating the “No Bare Hand Contact” rule for food handlers, the FDA pointed out that when hands are heavily contaminated, even effective handwashing practices may not be enough to prevent the transmission of pathogens from the hands to ready-to-eat (RTE) foods, such as sandwiches, salads, and other foods that are eaten without further washing or cooking. Accordingly, the rule requires the use of “suitable utensils such as scoops, spoons, forks, spatulas, tongs, deli tissue, single-use gloves, or dispensing equipment” when handling RTE food items to reduce foodborne illness.
Discussion of implementing the “No Bare Hand Contact” rule in Oregon was met with fierce opposition by restaurateurs who raised concerns over the cost of complying with the rule and whether it would actually increase food safety. In response, OPHD explained that over the next few months it will assemble a workgroup of interested parties (restaurateurs, government inspectors, consumers, etc.) to review and provide recommendations on addressing norovirus and fecal contamination of food, and to identify the best options to reduce illness.
Oregon’s process of adopting the 2009 FDA Food Code began in August 2010 when a Food Code Review Workgroup was established to work with the Oregon Department of Agriculture, food service and retail industry groups and regulators to develop recommendations regarding the new rules. Earlier this year, OPHD also provided training for regulators and industry on the 2009 Food Code in preparation for the September effective date.
The Association of Food and Drug Officials (AFDO), under contract to the FDA, has been gathering data on the progress of FDA Food Code adoptions by States, Territories, Local and Tribal Nation agencies. AFDO reported that 49 of the 50 States adopted codes patterned after the 1993, 1995, 1997, 1999, 2001, 2005, or 2009 versions of the Food Code, representing 96% of the U.S. population. Specifically:
- Four States adopted the 1993, 1995 or 1997 Food Code, representing 4% of the US population.
- Ten States adopted the 1999 Food Code, representing 13%of the US population.
- Eleven States adopted the 2001 Food Code, representing 38% of the US population.
- Twenty one States adopted the 2005 Food Code, representing 39%of the US population.
- Three States adopted the 2009 Food Code, representing2% of the US population.
In September, Oregon will join Mississippi, New Hampshire, and Delaware in adopting the 2009 version of the food code. Until the final rules take effect, food industry members can review the Fact Sheets provided by OPHD to ensure compliance and see what other changes may affect their business in the coming weeks.
President Obama signed into law today the Food Safety Modernization Act (FSMA).
Companies with facilities subject to FDA jurisdiction should take immediate steps to review and, where necessary, modify SOPs, policies and procedures.
For example, given the FDA's expanded access to business records, companies should set SOPs that anticipate (before a crisis occurs) what records they may have to turn over and what they may not. Food companies should take steps to protect confidential and proprietary information.
Companies also should anticipate now how they need to change their policies and approaches to mandatory recalls and whistleblower protections.
These parts of the legislation take effect today:
- Stronger records access authority by FDA (FSMA § 101)
- When FDA determines a "reasonable probability" of "serious adverse health consequences"
- FDA can access records of other food affected in a similar manner
- But FDA must show proper credentials and provide written notice
- Mandatory recall authority (FSMA § 206)
- FDA can order a recall if it finds a "reasonable probability" that
- food is adulterated or misbranded; and
- there may be serious adverse health consequences
- FDA has to provide an opportunity for a voluntary recall
- FDA will provide an informal hearing within two days of the order’s issuance
- FDA can order a recall if it finds a "reasonable probability" that
- Increased frequency of inspections (FSMA § 201)
- FDA will immediately increase the frequency of inspections
- FDA will apply a risk-based approach to determine priorities
- Whistleblower protection (FSMA § 402)
- Protects employees who:
- Provide information re violation of FDC Act ,
- Testify, assist or participate in a proceeding re a violation, and/or
- Object to "activity, policy, practice or assigned task" they "reasonably believe to be a violation"
- Protects employees who:
- Refused admission of imports if foreign facility refuses inspection (FSMA § 306)
- Foreign establishments must allow entry to U.S. inspectors within 24 hours of requesting entry
- Or imported food will be refused admission.
Future blog entries will discuss compliance with other provisions of the FSMA scheduled to be phased-in. If you are interested in a more detailed in-house discussion of the FSMA and its effect on your company, please let us know.
For what it's worth, this is the link to the FDA's own interpretation of what the new food safety bill means.
This entry has been corrected to reflect that some of the provisions in the Food Safety Modernization Act, most significantly the preventative controls section, will be phased in over time.
Today the House passed and sent to the President for his signature a bill to overhaul the current regulations on food safety, which were established over 70 years ago. Among other things, the bill will impose new record-keeping requirements on companies, require most FDA-regulating entities to maintain food safety plans, require the FDA to develop a traceability pilot project, and give the FDA broad authority to mandate recalls, regulate food and ingredients that are imported, conduct regular inspections of facilities that produce food and impose new fees on the industry.
Some of the provisions of the new law will be effective immediately. If you are an FDA-regulated food grower, processor or seller, compliance with the new law will be critical going forward. You should consult now with your food safety and food regulatory team to determine what your business needs to do to come in compliance.
On Friday, S. 510, the food safety bill, was declared dead. Last nite (Sunday), the Associated Press reported the bill may finally pass in the final hours of the 111th Congress. The New York Times report can be linked here. The text of what I understand will be headed to a final vote in the House on Tuesday and signed into law by the President can be linked here.
For years, a debate has raged on the merits of vesting the FDA with mandatory recall powers. Mandatory recall is part of the food safety legislation that may or may not pass in this Congress, so it’s worth discussing. At present, the FDA lacks any power to order a recall. Its only legal authority is administrative detention and seizure.
Many, including some regulators, have argued against mandatory recall because it will result in less and less timely recalls. The argument that mandatory recalls may result in less timely recalls goes as follows:
- Under the current system (where FDA lacks mandatory recall authority), the onus is on the food seller to initiate the recall. If it doesn't issue a recall in the face of an FDA request to issue a recall, the food seller faces the dire consequences of FDA's bully pulpit (press releases from FDA explaining why the food is unsafe) and possibly a seizure order. In the event of foodborne illnesses, ignoring an FDA request may also be grounds for punitive damages under the laws of some states;
- Because the onus under the current system is on the food seller (and not the FDA), the FDA frequently defers to the food seller's judgment when the facts surrounding a potential recall remain murky and uncertain. The FDA is not required to make a judgment about a recall and, for political reasons, often refrains from or delays making a decision as to whether to request a recall;
- Mandatory recall may reverse the dynamic and remove much of the onus from the food seller and put it on FDA. Mandatory recall may give the food seller cover if it chooses to delay or not issue a recall. If a food seller believes that its product is unlikely to be a threat to human or animal health, it might choose to wait until the FDA orders a recall. Under the current system, most food sellers will err on the side of caution when deciding whether or not to issue a recall. If the facts surrounding a recall are murky or uncertain, a mandatory recall regime may make it more prudent for a seller to wait for the FDA to decide. If the FDA is worried about being too trigger happy or quick to order recalls, a recall that may have been issued routinely under the current system may (ironically) never happen if FDA is vested with mandatory recall authority.
Mandatory recall authority, as its currently written in S. 510, may also change the threshold of when recalls are initiated. The threshold for a recall under sec. 206 of S.510 is described as when "there is a reasonable probability that an article of food . . . is adulterated . . . or misbranded . . . and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals."
The language of the statute closely follows what the FDA currently defines as a class I recall. But what about situations defined under the current scheme as class II or class III recalls? FDA's definition of a Class II recall is "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." A Class III recall is "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences." Query whether the statute lets foodd sellers off the hook for issuing recalls in Class II or Class III situations?
Note that FDA appears to retain some power even if there is not "reasonable probability" that the product will "cause serious adverse health consequences or death." S. 510 appears to lower the threshold for administrative detention by FDA by removing the condition that the food presents a risk of serious adverse health consequences. And, under S. 510, FDA would continue to have seizure power. The standard for seizure is simply if the food is adulterated or misbranded. One has to wonder whether FDA would use its limited resources on a seizure action in a class II or class III food recall where the chances of serious adverse health consequences are remote or not likely.