Salmonella as an Adulterant in Raw Poultry

In October, Foster Farms poultry was linked to an outbreak of Salmonella but never recalled the product.   Many were outraged that Foster Farms did not recall the product, although Costco did recall cooked chicken product where the Foster Farm poultry was used.

Dr. Mel Kramer reviews (below) why Foster Farms did not recall product.  It hinges on the fact that Salmonella is not viewed (currently) as an adulterant.  This is because it naturally has the potential to be present on the raw poultry.

In another article, Dr. Nelson Cox discusses Zero Tolerance of Salmonella in Poultry.  Along the same lines, but viewed from an international trade standpoint.   There are those that argue that some European countries have gone a long way at reducing Salmonella in poultry, but as Dr. Cox points out, this may be difficult from an economic standpoint.  And even if we did reduce it, I believe we would still need to assume that there is still the risk that it is present.



Raw Poultry: Legal History, Public Policy, and Consumer Behavior
By Dr. Mel Kramer | February 14, 2014
http://www.foodsafetynews.com/2014/02/raw-poultry-the-legal-history-public-policy-and-consumer-behavior/#.Uv58_qMo59B

The U.S. Centers for Disease Control and Prevention (CDC) reported that, “as of January 15, 2014, a total of 430 persons infected with seven outbreak strains of Salmonella Heidelberg have been reported from 23 states and Puerto Rico.” In response to the news, the popular media, the technical and professional public health and consumer publications, including the blogosphere, have weighed in with opinions.

The question is whether or not the poultry producer should have voluntary recalled the raw chicken, which, based on epidemiologic, laboratory, and traceback investigations conducted by local, state, and federal officials, indicated that “consumption of Foster Farms brand chicken is the likely source of this outbreak of Salmonella Heidelberg infections.” This question is not only multi-faceted, but has a rich history from a public health, public policy and legal perspective dating back to the early 1970s.
I feel in a somewhat unique position to write this since my superior at the New Jersey State Department of Health, Oscar J. Sussman, DVM, JD, MPH, was involved. He influenced the American Public Health Association (APHA) to formally sue the U.S. Department of Agriculture (USDA) for failure to warn the public that up to 50.8 percent of federally inspected poultry was positive for Salmonella.(1) Sussman wanted USDA to put a very simplistic warning on every retail package of poultry stating, “Caution. Improper cooking of this product may be hazardous to your health.”

The warning was to counter the seal of inspection in which the USDA certifies that the poultry is “wholesome” because a pathogen such as Salmonella is not wholesome unless and until the poultry is properly thermalized to an internal temperature of 165 degrees F. This temperature will adequately kill all Salmonella and other pathogens present.

The lawsuit was filed and adjudicated in the U.S. District Court for the District of Columbia. The issue of the litigation went in a slightly different direction challenging the Wholesome Meat Act and the Wholesome Poultry Products Act as contained in 21 U.S.C.S. § 601, et seq. and 21 U.S.C.S. § 41 et seq., respectively.

In the initial case, which was ultimately appealed and decided on Dec. 19, 1974, by the U.S. Court of Appeals for the District of Columbia Circuit in the matter styled APHA v. Butz, the plaintiffs argued that the government’s official mark of inspection was misleading; therefore, the product was misbranded since USDA failed to warn against the dangers of Salmonella.(2)

Although USDA tried to settle the case in exchange for consumer education, which they ultimately did, the case went on to the appellate court, which affirmed the lower trial court’s decision in favor of the government.

What is relevant to the current debate with Foster Farms boils down to the definition of the term “adulterated,” which is defined in the statute as:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health.

USDA’s position, which was the prevailing position per the lawsuit decision, was articulated in a letter from USDA on Aug. 18, 1971, and cited in the appellate opinion, which stated:

“The ‘American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.’ In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in Salmonellosis.”

The court’s opinion that Salmonella in raw poultry is not an adulterant is the reason why Foster Farms did not conduct a voluntary recall nor was there a withdrawal of USDA from the plant, which would in effect close the processing facility. Furthermore, the plant must be operating within the numerous USDA regulations or else there would have been significant negative consequences up to and including the withdrawal of inspection.

In contrast to the poultry producer, Costco’s El Camino Real store in South San Francisco, CA, voluntarily recalled 9,043 units (approximately 39,755 lbs.) of rotisserie chicken products that may be contaminated with a strain of Salmonella Heidelberg, according to USDA’s Food Safety and Inspection Service (FSIS).

Costco recalled 8,730 “Kirkland Signature Foster Farms” rotisserie chickens and 313 total units of “Kirkland Farm” rotisserie chicken soup, rotisserie chicken leg quarters, and rotisserie chicken salad. The products were sold directly to consumers in a Costco located at 1600 El Camino Real, South San Francisco, CA, between Sept. 11 and Sept. 23, 2013.(9) The initial recall was initiated on Oct. 12, 2013, due to concerns about a group of Salmonella Heidelberg illnesses that may be associated with the consumption of rotisserie chicken products prepared in and purchased at the Costco El Camino Real store.

On Oct. 17, 2013, Costco’s El Camino Real store in San Francisco, CA, voluntarily recalled an additional 14,093 units of rotisserie chicken products that may be contaminated with a strain of Salmonella, USDA’s Food Safety and Inspection Service (FSIS) announced. This was in addition to the 9,043 units that were recalled on Oct. 12.

The products subject to recall were 13,455 “Kirkland Signature Foster Farms” rotisserie chickens and 638 total units of “Kirkland Farm” rotisserie chicken soup, rotisserie chicken leg quarters, and rotisserie chicken salad. The products were sold directly to consumers in a Costco located at 1600 El Camino Real, South San Francisco, CA, between Sept. 24 and Oct. 15, 2013.(10) These recalls were appropriate and in the best interest of public health since it was in a ready-to-eat product, which all consumers have a right to expect is pathogen-free.

Conversely, Tyson Foods Inc., a Sedalia, MO, establishment, voluntarily recalled approximately 33,840 pounds of mechanically separated (raw) chicken products that may be contaminated with a Salmonella Heidelberg strain, USDA’s Food Safety and Inspection Service (FSIS) announced today (Jan. 10, 2014).

The mechanically separated chicken products were produced on Oct. 11, 2013. The following products are subject to recall: 40-lb. cases, containing four, 10-lb. chubs of “TYSON MECHANICALLY SEPARATED CHICKEN.”(11) This product was not available to the consumer, and, in fact, was for institutional customers (this was from a correctional facility).

Salmonella’s status as a possible adulterant has been litigated, resulting in courts not considering salmonella an adulterant. From a public health law perspective, unless Congress passes specific legislation and it is signed into law by the president naming salmonella as an adulterant, raw poultry with salmonella will continue to not be considered adulterated and, therefore, will not be subject to involuntary or mandatory recall or plant shutdown.

I think the public policy facet of this debate is more interesting than the recalls themselves. As referenced earlier, USDA settled the legal case in exchange for consumer education in the early 1970s. At that time, and, to an extent, to this date, all USDA offered were public service spots on radio and television, particularly around holidays and other times with heavy public consumption of meat and poultry.

However, USDA’s FSIS (Food Safety and Inspection Service) also adopted mandatory Safe Handling Instructions (reproduced below), which are described in the Code of Federal Regulations, title 9, parts 317 and 381. In reality, I believe these mandatory Safe Handling Instructions gave credence to Dr. Sussman and the APHA’s position in the litigation. Furthermore, I believe consumer warnings would have potentially prevented untold illnesses and deaths from raw meat and poultry, if they had commenced decades earlier.

Safe Handling Instructions

This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.
Keep refrigerated or frozen. Thaw in refrigerator or microwave.
Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry.
Cook thoroughly.
Keep hot foods hot. Refrigerate leftovers immediately or discard.(12)

 
The historic problem, and the rationale for the Safe Handling Instructions, is that consumers lacked appropriate hand-washing practices and strategies to prevent cross-contamination between raw poultry and ready-to-eat foods as well as adequate and verifiable thermalization of poultry to ensure thermal kill of Salmonella and any other pathogens.

Therefore, the American consumer – whether in their kitchen or in a ready-to-eat processing plant, an institution such as a healthcare facility or university or retail food establishment – must pay acute attention to hand-washing, not cross-contaminating raw and ready-to-eat food products, and thermalization of poultry to 165 degrees F, verified with a calibrated thermometer.

Although it would be ideal to have a guarantee that no pathogens would be present on raw poultry, or for that matter raw beef, seafood, shellfish, fruits and vegetables, it is not a reality. Eradicating pathogens from raw food is likely not possible without getting into another thorny issue, which is irradiation of food.

If poultry were irradiated, there would be no Salmonella in raw poultry! However, until the government passes law otherwise, it is incumbent on consumers to be vigilant and take precautions to ensure pathogen prevention.

References:

(1) The exact statistic has varied in numerous studies as described in a June 30, 1966, article in the New England Journal of Medicine entitled, “Isolation of Salmonella from Poultry. “Arthur Wilder. Isolation of Salmonella from Poultry. The New England of Journal of Medicine. Volume 274, Number 26. June 30, 1966.

(2) American Public Health Asso. v. Butz. 511 F.2d 331 U.S. App. (1974).

(9) http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2013/recall-058-2013-release

(10) http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2013/recall-058-2013-expanded

(11) http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2014/recall-001-2014-release

(12) http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/teach-others/download-materials/image-libraries/safe-handling-label-text/ct_index

 

 World Poultry
Zero Salmonella tolerance on goal or trade protectionism?

http://www.worldpoultry.net/Special-Focus/Salmonella-special/Zero-Salmonella-tolerance-on-goal-or-trade-protectionism/
By Dr Nelson A Cox, USDA, Russell Research Center, Athens, GA, USA

No pathogen is as ‘popular’ among or misjudged by politicians and traders as Salmonella. Their zero-tolerance policy often form the basis of trade barriers or rejections of entire shipments. Are there scientific grounds to justify such a guiding principle?

The global trade of poultry meat is often hampered by non-tariff barriers, which are often thinly disguised mechanisms to limit the import of poultry for the benefit of the domestic industries in the importing countries. Probably one of the most widely used – and abused – of these non-tariff barriers is a zero-tolerance for Salmonella on raw poultry. In some cases, any finding of Salmonella on raw products can lead to the rejection of an entire shipment, or the de-listing of the plant of origin of the  suspect product. This raises the question that has long been asked by countries that export poultry:
Can an importing country justify on purely scientific grounds a zero-tolerance policy for Salmonella on raw poultry?
A widely occurring microorganism
We know that Salmonella occurs commonly in livestock and poultry, and can be frequently isolated from wild animals, including rodents, reptiles and birds. When poultry flocks become infected, most Salmonella are carried within the gut of the birds and subsequently contaminate the environment, including the bird’s feathers, feet, and skin. During postslaughter processing, Salmonella may also be transferred among carcasses by faecal or ingesta contamination, or may be spread by cross-contamination of carcasses in the rinse or chill cycles, or on equipment surfaces.

The industry, regulators and consumers all have a vested interest in interventions to mitigate Salmonella contamination of poultry throughout the food chain, and it is an important goal for all stakeholders to ensure that the final cooked product is safe for consumption. Although raw poultry meat is a frequent vehicle of foodborne Salmonella infections in humans, it is difficult to quantify the true proportion of all salmonellosis cases that are associated with poultry consumption.
Approaches used under scrutiny
Because of the trade ambiguities and regulatory confusion resulting from different Salmonella sampling and testing methodologies, an international group of 26 scientific experts from 16 countries convened in 2009 to discuss the scientific and technical issues that affect the setting of a microbiological criterion for Salmonella contamination of raw poultry. The result of these deliberations was the peer-reviewed publication of “Scientific and Technical Factors Affecting the Setting of Salmonella Criteria for Raw Poultry: A Global Perspective,” published in the Journal of Food Protection, 73(8):1566-1590, 2010.

Although Salmonella on raw poultry products is an important cause of human salmonellosis, it’s difficult to determine the extent to which it is responsible for foodborne human illness, whether directly or indirectly via cross-contamination. It is precisely this type of information, however, that is needed to understand the true risk to public health and to determine the effectiveness of intervention strategies. Ultimately, the efficacy of regulatory activities should be assessed on the basis of risk outcomes.

Zero tolerance often misunderstood
The use of HACCP in primary processing of poultry is widely advocated, and is mandatory in the United States and the European Union. In the US, the processing operation is the main focus for regulatory oversight and industry management of Salmonella, whereas in the EU processing is only one stage in the supply chain at which monitoring measures are required. Both approaches include a microbiological criterion for Salmonella, and both require regular testing of post-chill carcasses as part of the verification of the food safety management system. The US system also includes a zero-tolerance policy for visible faecal contamination on carcasses before they enter the chiller, as well as the requirement in the HACCP plan of a critical control point to help that faecal contamination is avoided. Otherwise, individual companies determine critical control points, and they may differ among establishments.

Applying quantitative risk-assessment practices in microbiological food safety exposes the reality that zero-risk is unattainable for all raw foods. Zero tolerance, which implies the complete absence of a hazard, may be regarded as the expression of a regulatory preference for the precautionary principle, but has little to do with food safety and human health. The term “zero tolerance” itself is commonly used but generally poorly defined or understood. This is troublesome, because it has different meanings for different audiences.
The “zero” concept is misleading
To some people, zero tolerance implies zero-risk associated with the food, or zero prevalence of a pathogen in the food. But without any way of consistently eliminating the pathogen from a raw product, the “zero” concept is misleading to consumers with unrealistic expectations of the effectiveness of regulation who may interpret such regulations as implying no risk. If a hazard exists, there is some probability it will cause an adverse effect, no matter how small.

Zero tolerance also implies that both minor and major deviations from a policy will be treated with the same severity. This is obviously not a sensible approach to identifying and resolving the source of contamination problems.

Internationally, there is no consistency in interpreting the zero-tolerance concept and how to deal with deviations. The purpose of a Salmonella monitoring policy for raw poultry should be to provide an alert that prompts a review of policies and procedures. It should also permit the finished product with minor deviation to be distributed into the marketplace, and should take into account cost and other practical considerations of withholding the product from sale.

Several other challenges exist to applying a “zero tolerance” policy for Salmonella on raw poultry meat: defining the accuracy, sampling intensity, sampling material, and sensitivity of the testing method. At which point is the assessment to be made, pre-harvest or post-harvest? Who bears the repercussions for enforcement? And who has and what is the enforcement capacity? How does one quantify cross-contamination of other foods or account for other transmission routes, such as person-to-person? The evidence suggests that currently there are no intervention treatments that can be applied in all countries to ensure the complete elimination of Salmonella from raw poultry products.
A mystery piece
Salmonella contamination is usually expressed in terms of prevalence, but evidence from microbiological risk assessment indicates that the levels (number of cells) of contamination can be even more important to public health, and that efforts at any stage of production or processing that reduce the Salmonella cell numbers on the raw product will reduce risk.

With the development of more sensitive methods for counting Salmonella and methods that are internationally acceptable, we should pay much greater attention to this aspect in the future, enabling more heavily contaminated items to be identified and suitable interventions developed.

Through the looking glass
Given the nature of the poultry industry, current interventions won’t guarantee the absence of Salmonella from raw poultry products. Approaches differ among countries in the emphasis placed on pre-harvest and post-harvest regulatory monitoring. However, the most effective strategy for Salmonella management would be one that covers all stages of the food chain. Therefore, this strategy should be followed wherever possible.
To establish international standards and achieve global compliance, governments and industries must be willing to work toward developing and adopting harmonized approaches for data collection and analysis.

The term “zero tolerance” for specific pathogens such as Salmonella in raw food products is interpreted differently in different countries and therefore has been confusing, misleading, and misapplied. Using terms such as “zero tolerance” or “absence of a bacterium” in relation to raw poultry should be avoided unless these terms are specifically defined and explained by international agreement.
New metrics, such as “performance objectives” that are linked to human health outcomes based on risk assessment, should be used throughout the food chain and will better define the resultant public health risk.
How far should you go?
Over the years, Sweden has developed and implemented a stringent and successful Salmonella management program for poultry. The present degree of Salmonella prevalence on raw poultry took several decades to achieve at considerable expense. For all countries, however, such measures are unlikely to be economically or technically feasible. Some lessons can be learned from the Swedes, especially about the need for Salmonella-free breeding stock and feed, as well as improved biosecurity.

Salmonella infection of broiler flocks and the contamination of processed carcasses differ widely among countries, largely reflecting the stringency of measures undertaken to eliminate Salmonella in poultry production and processing. Conditions in production and processing also differ widely, as do the strategies and methods used for sampling and testing for Salmonella. These sampling methods must be standardised, especially for raw product testing, in the interest of consumer safety and trade.