This year’s product safety controversies have affected manufacturers, regulators, consumers and laboratories alike. Manufacturers have increased product testing, while new regulatory efforts, by both governments and industry, have renewed calls for reform and scrutiny of the current system in multiple countries. Although it is too early to ascertain the exact effect of these efforts on instrument and laboratory product sales, instrument companies have not been shy in highlighting their capabilities for improving product safety. PerkinElmer has introduced the Melamine Analyzer, based on GC/MS, and the Polycyclic Aromatic Hydrocarbons (PAH) Analyzer, a UV-VIS/Fluorescent HPLC system for analysis of the organic pollutant. Thermo Fisher Scientific’s handheld NITON X-ray fluorescence system has been highlighted by US legislators and manufacturers as one tool for detecting high levels of lead in toys.

Earlier this month, the Bush Administration’s Interagency Working Group on Import Safety released its Import Safety Action Plan advocating an improved certification process for overseas producers, the adoption of best practices by importers, greater transparency, the exchange of import data among key agencies, a strengthening of overseas efforts through cooperative agreements and training, better standards and increased penalties. In addition, the Action Plan specifically calls for the development of new, rapid testing methods and the enhancement of field lab capacity. As part of the Plan’s proposals, the FDA’s Food Protection Plan recommends new preventive measures, increased intervention via inspection and sampling, and new methods for immediate responses. The FDA’s new powers would include the ability to ban imports if production records are insufficient and to mandate recalls of products because of safety concerns. Some of the proposals may be implemented by executive order while others will require legislative action. President Bush’s fiscal 2009 budget is expected to include funding for the proposals. Later this month, the European Commission will present its review of EU product safety mechanisms.

IBO spoke with two laboratories to understand how the recent crisis and the response to it has affected their businesses and about the many issues surrounding product safety testing. Based in Qingdao, China, Sino Analytica is joint venture with Hong Kong–based Pacific Andes, a vertically integrated food supplier. Founded in 1993, Sino Analytica provides a wide range of food testing services. “The initial objective was to establish a laboratory in China that would provide a contract testing service to the food industry of the same level as that from Western laboratories,” said Peter Leedham, Sino Analytica’s business manager. The company provides contaminants testing, food quality measurements and QA checks, as well as training, auditing and advisory services.

Mr. Leedham told IBO that Sino Analytica has experienced a marked rise in demand for its services due to recent events: “Our business has increased significantly because of the food safety controversies. More customers, particularly US importers and Chinese exporters to the US, approach us to help ensure products meet their requirements.” However, China’s reform efforts this year (see table) have not directly affected the business. As Mr. Leedham pointed out, “Chinese government activities have had only a minor effect on our business—most of our new activities are being driven by industry, not government. The Chinese Government does not allow nongovernment third-party laboratories to approve food for export, even though the standards and capabilities of those labs are more in line with foreign requirements.” However, the lab does serve some government clients. “We do gain some business from the various government bodies in China who use us to increase or complement their own range of testing services. Our major point of difference to most other laboratories in China (including government ones) is that we only operate to international, not Chinese, standards,” explained Mr. Leedham.

According to the US-China Business Council, China’s General Administration of Quality Supervision, Inspection and Quarantine’s network of approximately 17,000 “testing facilities” includes 3,900 “food testing labs.” The Chinese government cites 3,913 food testing labs that have been certified by the China National Accreditation Service for Conformity Assessment, including 48 “state-level quality inspection centers for foodstuffs,” “35 key food laboratories” and “163 inspection and quarantine laboratories.”

Although much of the recent coverage of product and food safety has focused on China, Mr. Leedham views the issue as a worldwide concern. “I do not believe the Chinese food industry is inherently any worse than that of other developing countries; in fact, if food safety recalls and issues in various countries are weighted in relation to the quantities imported to US, China is not at the top of the list,” he said. According to the Mr. Leedham, the major issues are the scale of China’s food production sector and the lack of understanding of China’s many small producers of quality requirements. He noted, “At the other extreme are many Chinese food companies who are among the best in the world. They are blamed along with everyone else when something goes wrong.“ Another issue is cost pressures. As he put it, “Finally, a part of the problem arises from the continuing expectation among many overseas buyers that Chinese products are cheap. This expectation is pushing down the quality of exports as production costs rise in China.”

A recent US Congressional report recommended the US adoption of a food safety scheme similar to that employed by Japan (see IBO 10/31/07) and Hong Kong, which mandates certification and registration of food producers by both the exporting and importing country. “For foods, the Japanese have the best system, “ said Mr. Leedham. “They are working towards a position where every contaminant has a maximum residue limit clearly defined. Europe and the US are not anywhere near this. The US standards in particular make our job very difficult because they are arbitrary, inconsistent and very poorly defined.”

However, Mr. Leedham thinks the situation in China is getting better. He cited improved testing, methods, training and standards. However, he ultimately believes market-based approaches are the answer. “All of these are positive moves, and we should not underestimate the amount of effort that is being put into these activities. The two problems with this approach relate first to the scale of the task and, secondly, to trust. Will trust be rebuilt between China and other governments?” He also advocates for the role of third-party testing labs. “One obstacle to this is the exclusion of input from third parties in the laboratory arena and in industry in helping. My home country, the UK, was in a similar position prior to BSE, foot and mouth, and other food scares; centralized government control did not work and the UK (and EU) policy now relies on self-policing by industry (of course, under strict controls and standards). I believe a similar approach is needed in China and the US.”

A market-based approach is also endorsed by Kurt Kneen, PhD, director of the Chemistry Laboratory at NSF International, a 63-year-old nonprofit organization based in Michigan, which specializes in standards development, certification, training and testing. Dr. Kneen believes a market-based approach also drives standards development. The toy and food industries, as well as the US Consumer Product Safety Commission and standards organizations, have increased their focus on standards in response to recent events. In September, the Toy Industry Association, a trade group representing US toy makers, announced a program to study and recommend improved testing and inspection procedures. The program includes working with the American National Standards Institute (ANSI) to standardize testing and verification procedures, such as the harmonization of test methods, and to certify testing labs. A report is scheduled to be released by year end. According to Dr. Kneen, new standards lead to increased testing. “I’ve heard people describe this time here in the United States as the era of the standard. Everybody wants to have standards for whatever their products are,” he explained. “As the demand for standards increases, then there is increased demand for testing.” NSF is an accredited ANSI standards developer.

Toy safety concerns have also boosted demand for NSF’s lead testing services, which includes tests for total lead, soluble lead and the bioavailability of lead. “We’ve had a number of clients who’ve called us up and they want us to test toys they currently have in stock and also test toys they recently purchased. They want to know how safe we think they are and whether or not they want to return them,” he said. He also noted that most of the business has been coming from retailers. Disney and Toys R Us increased the testing of their products prior to shipment and random testing of toys on store shelves. Mattel’s new efforts include the retesting of paint, including paint bought from certified suppliers; the testing of paint on finished-product samples from each production run by Mattel’s laboratories or labs certified by Mattel; and a greater number of random, unannounced inspections of vendors and subcontractors. In addition, six samples of each subcontractor’s components must be tested for lead paint.

Asked if the increased demand will slow, Dr. Kneen responded, “Yes, some of the testing does go down, but it doesn’t ever go back down to baseline, so to speak, because of the rewriting of [companies’] quality programs. Quite often these scares occur because there’s a weakness in a quality system and this highlights it for them so they beef up their quality program, which quite often means more testing or maybe more auditing.”