Daily Rules, Proposed Rules, and Notices of the Federal Government
In addition, FSIS is expanding its
Finally, this notice announces that FSIS will apply its Category 1 performance measure based on current performance standards for ground chicken and turkey product to comminuted poultry to mark the level of process control that all establishments producing such products should maintain. No sooner than 90 days after publication of this notice, the Agency will begin sampling to determine the prevalence of
FSIS invites comments on this notice.
FSIS administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
Section 417.2(a)(1) of the HACCP regulations states that a food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish control measures because the hazard historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls. Whenever a hazard analysis reveals that one or more hazards are reasonably likely to occur in the production process, the regulations require that the establishment develop and implement a written HACCP plan that includes specific control measures for each hazard identified (9 CFR 417.2(b)(1) and (c)).
Section 417.4(a)(3) of the regulations requires that every establishment reassess the adequacy of its HACCP plan at least annually and whenever any
In February 2011, the Wisconsin Department of Health and Family Services (WDHFS) notified FSIS of a case-patient hospitalized with a confirmed
In response to the events, the Agency conducted a Food Safety Assessment (FSA) at the establishment in April-May 2011. An FSA is performed to assess the design and validity of food safety systems in an establishment. FSAs are conducted routinely and periodically and also “for cause” when prompted by a positive sample result, production and shipment of adulterated product, or any other high priority food safety related incident. FSIS issued a Notice of Intended Enforcement Action (NOIE) to this establishment in early May due to lack of validated cooking instructions, among other findings. Specifically, the cooking instructions prescribed a certain number of minutes for cooking per patty side, but the establishment's validation cooking study did not demonstrate that the cook time and cooking methods prescribed in these instructions ensured that a safe internal temperature is reached. In response to the NOIE, the establishment decreased its patty thickness, revalidated cooking instructions, and changed its consumer package instructions to recommend cooking to 165 degrees Fahrenheit. The establishment also implemented antimicrobial treatments in product manufacture and made other changes in response to the NOIE. FSIS verified that the establishment was implementing effective
The establishment associated with this outbreak is not a slaughter establishment and receives raw product for grinding and ground product for blending from other establishments in its corporate structure. The recalled product was produced at this establishment by blending turkey ground at slaughter establishments within its corporate structure.
Through review of records, FSIS found that at the time of the outbreak, this further processing establishment had not, as cited above, provided validated cooking instructions for the recalled product, did not use interventions other than temperature control on raw parts for grinding, and did not prevent lots from contaminating each other by cleaning and sanitizing blending and grinding equipment between lots. FSIS also found that in the months leading up to the outbreak, the establishment that manufactured the product associated with the outbreak may not have had adequate controls to prevent or reduce
In May 2011, FSIS became aware of a cluster of 29
The establishment responded with modifications to its food safety system to improve its interventions designed to control
FSIS initiated an FSA and scheduled an Incident Investigation Team (IIT) review at the establishment. An IIT review is convened to investigate and provide information regarding a non-routine incident involving the adulteration of FSIS-regulated product
Establishment data indicated, furthermore, that the use of mechanically deboned and separated product increased the likelihood of
Based on information from the FSA and IIT, FSIS issued an NOIE on the same NRTE ground processes previously suspended to provide the establishment the opportunity to demonstrate compliance as directed by 9 CFR 500.4(a). This resulted in a new suspension of inspection for the specified NRTE ground processes until the establishment was able to demonstrate effective controls. On September 11, the producing establishment voluntarily recalled 185,000 pounds of ground turkey. Information on this recall can be found on the FSIS Web page (
Because the recent outbreaks discussed above have been directly associated with illness in many unrelated individuals in multiple states, these outbreaks, in the Agency's view, represent evidence of a material change in the effectiveness of what heretofore had been regarded as necessary and appropriate sanitary conditions required to manufacture safe and wholesome product. As such, the occurrence of these outbreaks is a change that could affect the hazard analysis or alter the HACCP plans for such products and like products. Therefore, establishments that produce NRTE comminuted turkey or chicken poultry products (including ground, mechanically separated, or hand- or mechanically-deboned poultry that is further chopped, flaked, minced, or otherwise processed to reduce particle size but not battered or breaded) in final form or as an intermediary product must evaluate the information discussed above to determine whether their HACCP plans for these products adequately address biological hazards, particularly
The investigations conducted at establishments associated with the outbreaks showed that sanitation procedures are particularly important in the production of ground and comminuted poultry products. When conducting a reassessment that takes these outbreaks into account to determine whether HACCP plans for NRTE comminuted poultry products adequately address biological hazards,
Establishments producing NRTE comminuted poultry products should ensure that cooking instructions are validated, especially if the instructions explain how to cook the product to attain an end-point temperature of 165 degrees Fahrenheit (e.g., when grilling patties, cook from the unfrozen state on each side for “X” minutes for a patty of “Y” thickness; bake uncovered in an oven at “Z” degrees for “A” minutes).
Establishments producing NRTE comminuted poultry products should also consider lotting practices (distinguishing one portion of production from another such that they are microbiologically independent) and ability to prevent lots from contaminating each other, including not carrying over production; cleaning and sanitizing between lots; and being able to trace back product to originating slaughter establishments (if applicable), grow-out houses, hatcheries, and breeding flocks. Such process control procedures may be instrumental in reducing the impact of potential future product recalls.
Establishments producing NRTE comminuted poultry products should evaluate the adequacy of any
If they have not already done so, establishments producing NRTE ground and comminuted poultry products should consider implementing purchase specifications that require raw materials used to produce such products to have been treated with an intervention shown to reduce
Establishments producing comminuted poultry should also consider serotype information, focusing on presence and trends in the serotypes of human health concern identified by the Centers for Disease Control and Prevention (CDC) in the CDC top 30 serotypes list (available at
Finally, establishments producing NRTE comminuted poultry products should consider pre-harvest factors and interventions that may influence
Although comminuted livestock products (e.g., beef and pork) are similarly produced, this notice is specific to poultry. Historically, ground chicken products have the highest
FSIS will instruct inspection program personnel to ensure that all establishments producing non-breaded, non-battered NRTE comminuted chicken or turkey, including small and very small establishments that may not belong to a trade association, are aware that the Agency has issued this notice.
No sooner than 90 days following publication of this notice in the
FSIS will subsequently evaluate establishments that produce NRTE comminuted poultry products to collect in-depth information on changes made. FSIS will evaluate information gathered in the survey and may conduct FSAs of establishments producing NRTE comminuted poultry products. The Agency will decide on the conditions under which it will conduct any other evaluations for establishments producing NRTE comminuted poultry products. Consistent with current Agency practices, FSIS may conduct a “for cause” FSA in response to production and shipment of adulterated product. In response to the survey results discussed above, FSIS may consider conducting a “for cause” FSA, if FSIS has any concerns regarding that establishment's food safety system.
Once FSIS has evaluated such establishments, it intends to publish guidance for industry on best practices to reduce
FSIS recommends that manufacturers of comminuted products derived from cattle, hogs, and sheep or comminuted poultry products derived from poultry other than chicken or turkeys also take note of the factors contributing to the recent comminuted turkey product outbreaks. These manufacturers should consider the instructions in this notice with regard to assessing whether their food safety systems present similar vulnerabilities.
When NRTE poultry or meat products are associated with an illness outbreak and contain pathogens that are not considered adulterants, FSIS likely will consider the product linked to the illness outbreak to be adulterated under 21 U.S.C. 453(g)(3) or 21 U.S.C. 601(m)(3) because the product is “* * * unsound, unhealthful, unwholesome, or otherwise unfit for human food.” In such cases, the Agency would request that the establishment recall the product if it is still in commerce.
FSIS will also evaluate whether the particular product associated with the illness outbreak may also be adulterated because it was “* * *prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health” (21 U.S.C. 453(g)(4) or 21 U.S.C. 601(m)(4)). FSIS would likely find that such product is adulterated because it was produced under insanitary conditions where the establishment produced the product of concern under conditions that did not adequately address control of the pathogen in the product associated with the illness.
The Agency would also likely determine the insanitary conditions to be continuing in the establishment until the establishment demonstrates that it has regained control of its production processes and re-established sanitary conditions under which the product is produced so that the establishment is able to produce unadulterated product.
FSIS would also have to evaluate whether the type of product produced at other establishments, when demonstrably linked to product associated with the outbreak, is adulterated because it was produced under substantially similar processes and insanitary conditions. For example, associated product at another establishment produced from birds that came from the same grow-out house as the birds that were the source of the product associated with the illness outbreak, and that were subject to substantially similar processing conditions, may also be determined to be adulterated by the Agency.
FSIS would not be likely, however, to consider product of the same type adulterated though it is found to have the pathogen associated with the illness outbreak, provided it was produced in other establishments that have no relationship to product involved in the illness outbreak. A determination of
The Agency is expanding its
As explained above, “NRTE comminuted poultry” products to be sampled include any non-breaded, non-battered raw or otherwise NRTE product that has been ground, mechanically separated, or hand- or mechanically-deboned and further chopped, flaked, minced, or otherwise processed to reduce particle size. The Agency will also include in its sampling non-breaded, non-battered NRTE comminuted poultry product after other ingredients such as spices have been added, since the Agency expects establishments to control pathogens in final product regardless of the source of the pathogens. Consistent with FSIS's current
A sampling change will be initiated to allow for a more accurate measurement of the incidence of
Meanwhile, based on analysis of data from three consecutive years, Fiscal Year (FY) 2009 to FY2011, FSIS is considering reducing the number of samples in a set from 53 to 26 samples. FY2009-2011 data analysis showed that reducing samples from 53 to 26 will not compromise the ability to detect non-compliant establishments. With this change, based on current standards, FSIS is considering accepting a maximum of 15 positive samples in a 26-sample ground turkey set to meet the performance standard and a maximum of seven positive samples for such a set to count toward Category 1 status. For ground chicken, based on current standards, FSIS is considering accepting a maximum of 13 positive samples in a 26-sample set to meet the performance standard and a maximum of six positive samples for such a set to count toward Category 1 status. Because a reduction in sample set size could increase the number of sets that can be performed in a given period of time, the possibility exists that this modification may result in a greater number of non-compliant establishments detected in that time period, providing a better reflection of current production practices and increasing the efficiency of FSIS resource utilization.
FSIS intends to conduct a risk assessment based on at least three months of these new sampling and testing results and issue a new performance standard for these products for
Except for category 3 establishments, FSIS will discontinue the concept of set testing for ground and comminuted chicken or turkey at least until it establishes new performance standards for these products. For samples that are not collected as part of sets, FSIS field service laboratories will perform qualitative testing for the presence or absence of
FSIS has reviewed the paperwork and recordkeeping requirements in this notice in accordance with the Paperwork Reduction Act and has determined that the paperwork requirements for this notice, which informs establishments that produce not ready-to-eat comminuted poultry products that they need to reassess their HACCP Plans, have already been accounted for in the Pathogen Reduction/HACCP Systems information collection approved by the Office of Management and Budget (OMB). The OMB approval number for the Pathogen Reduction/HACCP Systems information collection is 0583-0103.
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FSIS will announce this document online through the FSIS Web page located at
FSIS will also make copies of this