Food Safety Magazine

FOOD SAFETY INSIDER | August/September 2010

The Food Safety Enhancement Act: How a Laboratory Information Management System (LIMS) Can Help

The Food Safety Enhancement Act: How a Laboratory Information Management System (LIMS) Can Help

In 2009, the Mexican tomato business was devastated because tomatoes were wrongly blamed for an outbreak of Salmonella that was actually caused by tainted jalapeño peppers. Without proper systems in place to provide traceability, there was no way to identify the contamination source. Several people died, many more became ill and a major business was damaged due to a lack of information. In cases like these, the price for food producers is not only lost revenue due to product recalls, but more importantly, they experience a loss of trust among the buying public and governments around the world. Unfortunately, in most food contamination occurrences, the grower or producer has inadequate methods in place to trace the original source of the contamination.

Current Food Safety Challenges
In the United States, the oversight of food has fallen under a fractured network of agencies responsible for different parts of the production process, from site inspections and safe processing methods, to the documentation of calorie counts and ingredient listings. Some grown and produced foods fall under the auspices of the U.S. Food and Drug Administration (FDA), while food groups that contain a combination of meat, dairy and produce have fallen under the oversight of the U.S. Department of Agriculture. Compound this regulatory environment with the fact that staffing for food inspections has been inadequate compared with the volume of inspection needed to manage safe production. This lack of manpower and the separation of responsibilities has exacerbated the ineffectiveness of the regulatory agencies and caused confusion among the consuming public. U.S. President Barack Obama has stated that the current regulatory framework “…is a hazard to public health.”

“[The Food Safety Enhancement Act] would indeed transform our nation’s approach to food safety from responding to outbreaks to preventing them. It would do so by requiring and then holding companies accountable for understanding the risks to the food supply under their control and then implementing effective measures to prevent contamination.”
–Margaret A. Hamburg, Commissioner, FDA (June 3, 2009)

The Proposed Legislation
The Food Safety Enhancement Act (FSEA)—as passed in the U.S. House of Representatives—updates food safety laws to improve the FDA’s supervision of the nation’s food supply. The legislation requires more frequent inspection of food facilities, improves inspector access to records and orders facilities to develop and implement safety plans to identify and protect against hazards. The FDA is to establish minimum standards for the safety plans. The bill compels all food plants to register with the FDA and pay an annual fee that, along with fees for food inspection and recall, will help pay for the expansions of oversight. Along with other measures that enhance the FDA’s ability to prevent the distribution of unsafe food, the FSEA authorizes the agency to order mandatory food recalls of products that may cause adverse health consequences or death. Finally, the bill makes food origin easier to trace, improves oversight of fresh produce and imported foods and boosts penalties for violations of food safety laws.

FSEA—Implications for Food Producers
For food producers that do not have automated systems for monitoring their processes or do not have methodologies in place to verify batch content or origin of raw materials, the FSEA may impose new strictures which would have an immediate impact on their business.

For example, if the law passes and is signed into law:

• All food producers will be required to register for mandatory inspections. Registration will identify every person involved in the production process so that a food tracing system can be established.

• All records will be required to be available on demand by the Secretary of Agriculture and/or delivered to the agency to verify that safety requirements and processes are being followed.

• Fees may be imposed on food producers, including annual inspection fees, as well as additional fees if a facility fails inspection and requires surveillance by the agency. Civil penalties may be imposed for those facilities involved in product recalls that include not only monetary fines, but also plant shut-downs and imprisonment.

• All foods and commodities will require regular testing and reporting of results that show compliance to new science-based standards. Penalties may be imposed on facilities that falsify records or submit falsified records for the purpose of non-compliance.

• Food importers will be required to produce certificates of compliance to the standards and ensure that accredited laboratories conduct proper testing, or else those food items will be refused entry into the United States.

Prospects for FSEA Passage
The House has passed its version of the FSEA, but the Senate has been stalled in its consideration. While the Senate committee of jurisdiction approved a version of the bill, the text awaits consideration on the Senate floor. In part, the legislation is delayed due to extended consideration of health care reform, as well as the inclusion of tangential issues related to food packaging. At the time of writing this article, the Senate’s current hope is to pass its bill before July 4th. Regardless of the timeframe, Thermo Fisher Scientific is available to help address new legal and regulatory requirements, no matter how and when new government rules are promulgated.

Employing a LIMS to Meet the Demanding FSEA Requirements
The most important, common thread throughout the FSEA is traceability. Laboratory Information Management Systems (LIMS) play a critical role in the traceability of quality in the production process from farm to fork, providing such capabilities as:

• Automated data collection from testing and delivery of the records of proof that are required for regulatory compliance;

• A secure environment for monitoring batch relationships between raw materials, processed materials and packaged goods;

• A centralized system that collects, stores, processes and reports all the data generated within food laboratories, allowing a complete overview of the quality of any product;

• Automated checks for out-of-specification results and identification of suspect products to prevent release pending investigation;

• Assurance that all (standard, fast turnaround and condition-sensitive) samples are handled and processed correctly.

Furthermore, a LIMS provides the producer with the knowledge that the quality of the product meets the standards set by the regulator, and it records that data for any subsequent inspection. Whenever required, auditors can review uniform compliance reports and the certificates of inspection stored within the LIMS to confirm consumer safety.

Ultimately, a LIMS plays a key role in the integration of the laboratory environment with critical enterprise systems to facilitate faster, more informed decisions. This makes laboratory data available to process control systems, giving managers immediate accessibility to results, as well as cascading any release data through to enterprise resource planning (ERP) systems.

LIMS-on-Demand—A New Alternative
For some food testing laboratories, commercial LIMS have been too costly for the businesses to absorb and support, forcing them to rely on inefficient manual and error-prone home-grown systems, spreadsheets or paper-based methods. Thermo Fisher Scientific has made the full functionality of LIMS available on-demand via the internet for a low, monthly subscription fee at LIMS-on-Demand is ideally suited for environments that require a robust solution for their laboratory data collection and reporting needs, but may not have the in-house resources traditionally associated with managing such a system. A top-tier hosting provider manages the system, relieving lab managers and information technology staff of software maintenance and configuration.

For companies with teams in multiple locations or those utilizing the services of external organizations, LIMS-on-Demand enables members to enter, view and share data and workflows, enhancing productivity and increasing opportunities for collaboration, requiring only a Web browser and internet connectivity to be able to access the system.
Traceability Solutions for Food Producers Worldwide
Molkerei Alois Müller produces more than a third of all yogurt eaten in the United Kingdom from the Market Drayton factory. The Müller UK labs focus mainly on production quality control. Every step in the process undergoes quality checks, which are managed and stored with the LIMS. Müller selected Thermo Scientific LIMS to manage their quality control (QC) data for raw materials, in-process and finished dairy desserts. The LIMS reduced the amount of error-prone manual paperwork processes and expedited testing, while providing the necessary reports and documentation for a complete audit trail during regulatory inspections. By using a LIMS, Müller is able to trend all data and make quality and safety decisions, as well as any necessary improvements, much faster and more reliably.

Sino Analytica in Qingdao City, China, is a world-class food analysis laboratory that provides contract analytical services to a wide range of food suppliers, trading companies and retailers from China and all over the world. Sino Analytica historically managed data manually in the laboratory with a monthly load of over 1,200 samples. The company chose Thermo Scientific LIMS to support its food safety contract laboratory and meet the internal quality standards and accreditation requirements. The LIMS has helped laboratory managers achieve faster assembly, collation and review of information and data relating to quality assurance and quality control (QA/QC) activities. The LIMS also demonstrates that the company meets the requirements of auditors and provides documentation for processing internal QC data.

Chr. Hansen in Hørsholm, Denmark, is one of the world’s top food ingredient companies. The company standardized on Thermo Scientific LIMS across all of its six culture production sites in Denmark, France, Germany and the U.S. to ensure optimum quality control in starter culture production. The LIMS implementation has delivered considerable benefits, including real-time, automated entry and processing of laboratory data and fast extraction of results, leading to increased laboratory productivity and accelerated sample turnaround. Chr. Hansen has also integrated the LIMS with its existing ERP system so that test results authorized in the LIMS by lab personnel can be immediately available for the processing facilities’ technicians and laboratory administrators. Contact us at for more information.