Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program. Final rule.

The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).

Optimal Food Safety Sampling Under a Budget Constraint.

Much of the literature regarding food safety sampling plans implicitly assumes that all lots entering commerce are tested. In practice, however, only a fraction of lots may be tested due to a budget constraint. In such a case, there is a tradeoff between the number of lots tested and the number of samples per lot. To illustrate this tradeoff, a simple model is presented in which the optimal number of samples per lot depends on the prevalence of sample units that do not conform to microbiological specifications and the relative costs of sampling a lot and of drawing and testing a sample unit from a lot. The assumed objective is to maximize the number of nonconforming lots that are rejected subject to a food safety sampling budget constraint. If the ratio of the cost per lot to the cost per sample unit is substantial, the optimal number of samples per lot increases as prevalence decreases. However, if the ratio of the cost per lot to the cost per sample unit is sufficiently small, the optimal number of samples per lot reduces to one (i.e., simple random sampling), regardless of prevalence. In practice, the cost per sample unit may be large relative to the cost per lot due to the expense of laboratory testing and other factors. Designing effective compliance assurance measures depends on economic, legal, and other factors in addition to microbiology and statistics.

Computer vision-based analysis of foods: a non-destructive colour measurement tool to monitor quality and safety.

Computer vision-based image analysis has been widely used in food industry to monitor food quality. It allows low-cost and non-contact measurements of colour to be performed. In this paper, two computer vision-based image analysis approaches are discussed to extract mean colour or featured colour information from the digital images of foods. These types of information may be of particular importance as colour indicates certain chemical changes or physical properties in foods. As exemplified here, the mean CIE a* value or browning ratio determined by means of computer vision-based image analysis algorithms can be correlated with acrylamide content of potato chips or cookies. Or, porosity index as an important physical property of breadcrumb can be calculated easily. In this respect, computer vision-based image analysis provides a useful tool for automatic inspection of food products in a manufacturing line, and it can be actively involved in the decision-making process where rapid quality/safety evaluation is needed.

State health agency workforce shortages and implications for public health: a case study of restaurant inspections in Louisiana.

The study described in this article evaluated the effects of public health workforce cuts on routine food safety inspections and the occurrence of critical violations. Routine inspection information was collected from two Louisiana databases for permanent food establishments categorized as risk category 3 or 4 in East Baton Rouge Parish, Louisiana, for the years 2005, 2007, and 2009. The length of time between routine inspections nearly quadrupled from 2005 to 2009. For risk category 4 establishments, a significant increase occurred in the proportion of inspections that resulted in a critical violation between the three years. The amount of time between routine inspections was significantly higher for inspections that resulted in a critical violation versus those that did not. Lastly, the amount of time between routine inspections, an establishment's risk category, and history of complaint were found to have significant predictive effects on the incidence of a critical violation during a routine inspection, although results varied by year. Study results indicate that decreased workforce capacity in Louisiana may negatively affect the outcomes of routine food safety inspections.

The impact of local environmental health capacity on foodborne illness morbidity in Maryland.

OBJECTIVES: We evaluated the relationship between local food protection capacity and service provision in Maryland's 24 local food protection programs (FPPs) and incidence of foodborne illness at the county level. METHODS: We conducted regression analyses to determine the relationship between foodborne illness and local FPP characteristics. We used the Centers for Disease Control and Prevention's FoodNet and Maryland Department of Health and Mental Hygiene outbreak data set, along with data on Maryland's local FPP capacity (workforce size and experience levels, budget) and service provision (food service facility inspections, public notification programs). RESULTS: Counties with higher capacity, such as larger workforce, higher budget, and greater employee experience, had fewer foodborne illnesses. Counties with better performance and county-level regulations, such as high food service facility inspection rates and requiring certified food manager programs, respectively, had lower rates of illness. CONCLUSIONS: Counties with strong local food protection capacity and services can protect the public from foodborne illness. Research on public health services can enhance our understanding of the food protection infrastructure, and the effectiveness of food protection programs in preventing foodborne illness.

Determination of melamine in milk powder, milk and fish feed by capillary electrophoresis: a good alternative to HPLC.

BACKGROUND: Since September 2008, an increased incidence of kidney stones and renal failure in infants, associated with the ingestion of infant formula contaminated with melamine has been reported in China. Furthermore, melamine was not only found in many protein-based food commodities, but also in the feeds for cattle and poultry. So it is necessary to develop a suitable method to determine melamine. RESULTS: A capillary zone electrophoresis (CZE) method for analysis of melamine was developed by use of running electrolyte containing 35 mmol L(-1) sodium dihydrogen phosphate at pH 3.5, with UV detection at 210 nm. Regression equation revealed linear relationships (r = 0.9999) between the peak-area and the content of melamine from 0.8 to 80 µg mL(-1). The detection limit was 0.08 µg mL(-1). The method was successfully applied to the determination of melamine in milk powder, milk and fish feed, with the recoveries from 94.5% to 103.7%. CONCLUSION: The performance of the CZE method evaluated in terms of precision, limits of detection, accuracy and quantification were comparable and in good agreement with those obtained by the HPLC method, with the advantage of shorter analysis time and lower cost.

Quantitative detection method for Roundup Ready soybean in food using duplex real-time PCR MGB chemistry.

BACKGROUND: Methodologies that enable the detection of genetically modified organisms (GMOs) (authorized and non-authorized) in food and feed strongly influence the potential for adequate updating and implementation of legislation together with labeling requirements. Quantitative polymerase chain reaction (qPCR) systems were designed to boost the sensitivity and specificity on the identification of GMOs in highly degraded DNA samples; however, such testing will become economically difficult to cope with due to increasing numbers of approved genetically modified (GM) lines. Multiplexing approaches are therefore in development to provide cost-efficient solution. RESULTS: Construct-specific primers and probe were developed for quantitative analysis of Roundup Ready soybean (RRS) event glyphosate-tolerant soybean (GTS) 40-3-2. The lectin gene (Le1) was used as a reference gene, and its specificity was verified. RRS- and Le1-specific quantitative real-time PCR (qRTPCR) were optimized in a duplex platform that has been validated with respect to limit of detection (LOD) and limit of quantification (LOQ), as well as accuracy. The analysis of model processed food samples showed that the degradation of DNA has no adverse or little effects on the performance of quantification assay. CONCLUSION: In this study, a duplex qRTPCR using TaqMan minor groove binder-non-fluorescent quencher (MGB-NFQ) chemistry was developed for specific detection and quantification of RRS event GTS 40-3-2 that can be used for practical monitoring in processed food products.

Creating an agricultural world order: regional plant protection problems and international phytopathology, 1878-1939.

Beginning in 1878 with the International Phylloxera Convention of Berne, international conventions have sought to relieve national agricultural industries from two specific burdens. First, by defining phytosanitary practices to be enforced by national plant protection services, these conventions attempted to prevent the introduction of plant diseases and pests into national territories from which they were previously absent. Second, by standardizing these practices - especially through the design of a unique certificate of inspection - the conventions attempted to eliminate barriers such as quarantines affection international agricultural trade. The succession of phytopathological conventions seemed to epitomize the coalescence of an international community against agricultural pests. What actually coalesced was bio-geopolitics wherein plant pathologists and economic entomologists from North America and the British Empire questioned the so-called internationality of the environmental and economic specificities of continental European agriculture, embodied in "international" conventions. Although an international phenomenon, the dissemination of agricultural pests provided opportunities for cooperation on a strictly regional albeit transnational basis that pitted bio-geopolitical spaces against each other. This article retraces the formation of these spaces by analyzing the deliberations of committees and congresses that gathered to define an international agricultural order based on the means to prevent the spread of plant diseases and pests.

Costs of Food Safety Investments in the Meat and Poultry Slaughter Industries.

To develop regulations efficiently, federal agencies need to know the costs of implementing various regulatory alternatives. As the regulatory agency responsible for the safety of meat and poultry products, the U.S. Dept. of Agriculture's Food Safety and Inspection Service is interested in the costs borne by meat and poultry establishments. This study estimated the costs of developing, validating, and reassessing hazard analysis and critical control points (HACCP), sanitary standard operating procedures (SSOP), and sampling plans; food safety training for new employees; antimicrobial equipment and solutions; sanitizing equipment; third-party audits; and microbial tests. Using results from an in-person expert consultation, web searches, and contacts with vendors, we estimated capital equipment, labor, materials, and other costs associated with these investments. Results are presented by establishment size (small and large) and species (beef, pork, chicken, and turkey), when applicable. For example, the cost of developing food safety plans, such as HACCP, SSOP, and sampling plans, can range from approximately $6000 to $87000, depending on the type of plan and establishment size. Food safety training costs from approximately $120 to $2500 per employee, depending on the course and type of employee. The costs of third-party audits range from approximately $13000 to $24000 per audit, and establishments are often subject to multiple audits per year. Knowing the cost of these investments will allow researchers and regulators to better assess the effects of food safety regulations and evaluate cost-effective alternatives.

Changes in the EU legislation on Trichinella inspection--new challenges in the epidemiology.

The European Union (EU) countries are searching for new ways to certify meat free of Trichinella; however, with the expansion of the EU, the acceptance of a unilateral method is complicated by the variability of pig and human trichinellosis among EU countries, where significantly higher prevalence rates have been observed in the newly added eastern countries. Several attempts have been made to define Trichinella-free areas, but certification of Trichinella-free pig production farms appears to be the only feasible approach. The increasing prevalence of the non-encapsulating species, Trichinella pseudospiralis, in game, domestic pigs and humans has eliminated the compression technique from the new EU legislation to be enacted in 2006. Also, the observation that several species of Trichinella tolerate freezing in horse meat for up to 4 weeks has forced a change in legislation as well where freezing is no longer an option for certifying horse meat. Because current serological detection methods are not suited for meat inspection, classical direct detection methods and inactivation by freezing remain the methods of choice for pork. It has been proposed, therefore, to automate direct inspection methods as a cost effective alternative to certify pig farms free of Trichinella.

The magnitude of the sulfa residue problem.

Expenditures and losses associated with the so-called sulfa residue problem have totaled about $5 million over the past 6 years. This amount was calculated by recording actual costs when available and by reasonable estimates where actual expenses or losses were not available. It is not conclusive whether the consumers, who are intended to be the benefactors of this program, have received protection commensurate with the expenditures. The losses to producers may be greater if the sulfa problem causes them to discontinue the use of medicated feeds. The problem is the unusually high occurrence of sulfonamide residues in livers of slaughtered swine. In an effort to reduce or eliminate these violative residues, there has been extensive testing of swine livers by the FSQS of the USDA, and inspection of farms from which the pigs were shipped, by the FDA, the Extension Service, and the APHIS. Producers whose pigs are found with violative levels of residue are prohibited from selling more pigs until it has been determined that swine from that farm do not contain violative residues. This restriction can result in serious financial losses to producers.

Economic feasibility analysis for an automated on-line poultry inspection technology.

On-line carcass inspection of chickens in the United States is currently done using visual (organoleptic) methods. Inspectors from the USDA Food Safety and Inspection Service (FSIS) inspect the viscera and carcass and, for older birds, the heads using a sequence of observations and palpations at a postmortem inspection station. The streamlined inspection system (SIS) and the new line speed inspection system (NELS) are the most prevalent visual inspection methods. The former has a line speed of 70 birds/min with two inspectors per line, and the latter has a line speed of 91 birds/min requiring three inspectors per line. Both inspection methods are labor intensive and prone to human error. In addition, the speed of the slaughter line is dictated by the number of birds per minute that can be inspected by FSIS inspectors. Ninety-one birds/min is currently the maximum visual inspection line speed allowed under current Federal regulations. This study evaluates the economic benefits of using automated inspection in place of visual inspection from the perspective of both the slaughter plant and FSIS. The results indicate that FSIS and slaughter plants would gain economic benefits by using automated inspection in place of visual inspection. The economic benefits to FSIS would accrue from labor savings, whereas the economic benefits to slaughter plants would accrue primarily from increased throughput from faster inspection line speeds.

Impact of ovine meat inspection systems on processing and production costs.

The efficiency and cost-effectiveness of government-regulated meat inspection systems are under review in a number of countries. A post mortem organoleptic meat inspection programme is the most costly component of an inspection system and the procedures applied to a particular class of livestock should be appropriate to the spectrum and prevalence of diseases and defects present in each geographical region. Awareness of the impact of specific inspection requirements on processing costs, the application of integrated quality management principles and the development of programmes that disseminate information on diseases and defects and reward the producer of high-quality carcases, are all features of an efficient and cost-effective inspection system.

[Integrated monitoring of the meat production chain and the interest of the stock-farmer]. / De IKB en de belangen van de veehouders.

The Commodity Board for Livestock and Meat should have a vested interest in an Integrated Surveillance System which includes the whole meat production sector from breeder to slaughterhouse. The feasibility, execution and financing of the surveillance system are described.

Epidemiologic and economic evaluation of risk-based meat inspection for bovine cysticercosis in Danish cattle.

Under the current EU meat inspection regulation, every single carcase from all bovines above 6 weeks of age has to be examined for bovine cysticercosis (BC). This is time-consuming, costly, and is of limited value in countries with low prevalence. The aim of this study was to develop a stochastic simulation model for analysis of tentative risk-based meat inspection systems for BC in Danish cattle with regard to system sensitivity (SSSe), specificity and potential monetary benefits compared to the current system, which has an estimated SSSe of 15%. The relevant risk factors used to construct three alternative scenario trees were identified from previous Danish risk factor studies (1) gender, (2) grazing and (3) access to risky water sources. Thus, females, animals that had been grazing or animals with access to risky water sources were considered high-risk and would be subjected to invasive inspection at meat inspection. All animals in the low-risk groups (i.e. males, non-grazing or no access to risky water sources, respectively) would be subjected to visual inspection only. It was assumed that half of the cattle were slaughtered in abattoirs that would be able to reorganise the work at the slaughterline, allowing them to do with one meat inspector less. All abattoirs would gain on the price of sold uncut beef from the masseter muscles from visually inspected cattle. Under these assumptions, using gender and grazing were preferable due to them having SSSe only slightly lower than the current system, and highest effectiveness ratios, but they had a lower net economic effect (NEE) than the scenario using risky water sources. Using gender to differentiate high and low-risk groups was judged preferable over grazing due to feasibility, because the information is readily available at the slaughter line. The exact total NEE for the cattle sector depends on how many and which of the abattoirs that would be able to reorganise the work at the slaughter line to save money on inspection of the head of carcases. Overall, the SSSe was low in all scenarios leading to undetected BC-positive cattle both in the current meat inspection and under the investigated risk-based meat inspection systems. Therefore, improving the sensitivity of the methods used for inspection of high-risk cattle would be beneficial.

Development of QuEChERS-based extraction and liquid chromatography-tandem mass spectrometry method for quantifying flumethasone residues in beef muscle.

A rapid, specific, and sensitive method based on liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) in the positive ion mode using multiple reaction monitoring (MRM) was developed and validated to quantify flumethasone residues in beef muscle. Methods were compared between the original as well as the EN quick, easy, cheap, effective, rugged, and safe (QuEChERS)-based extraction. Good linearity was achieved at concentration levels of 5-30 µg/kg. Estimated recovery rates at spiking levels of 5 and 10 µg/kg ranged from 72.1 to 84.6%, with relative standard deviations (RSDs)<7%. The results of the inter-day study, which was performed by fortifying beef muscle samples (n=18) on 3 separate days, showed an accuracy of 93.4-94.4%. The precision (expressed as relative standard deviation values) for the inter-day variation at two levels of fortification (10 and 20 µg/kg) was 1.9-5.2%. The limit of detection (LOD) and limit of quantitation (LOQ) were 1.7 and 5 µg/kg, at signal-to-noise ratios (S/Ns) of 3 and 10, respectively. The method was successfully applied to analyze real samples obtained from large markets throughout the Korean Peninsula. The method proved to be sensitive and reliable and, thus, rendered an appropriate means for residue analysis studies.

Development of a real-time PCR protocol for the species origin confirmation of isolated animal particles detected by NIRM.

At present, European legislation prohibits totally the use of processed animal proteins in feed for all farmed animals (Commission Regulation (EC) No. 1234/2003-extended feed ban). A softening of the feed ban for non-ruminants would nevertheless be considered if alternative methods could be used to gain more information concerning the species origin of processed animal proteins than that which can be provided by classical optical microscopy. This would allow control provisions such as the ban of feeding animals with proteins from the same species or intra-species recycling (Regulation (EC) No. 1774/2002). Two promising alternative methods, near-infrared microscopy (NIRM) and real-time polymerase chain reaction (PCR), were combined to authenticate, at the species level, the presence of animal particles. The paper describes the improvements of the real-time PCR method made to the DNA extraction protocol, allowing five PCR analyses to be performed with the DNA extracted from a single particle.