With federal standards for gluten-free claims going into effect Aug. 5, an increase in food-plant audits to verify those claims is likely. How successful those audits are in ensuring the integrity of plant processes remains to be seen.
The FDA standard of fewer than 20 parts per million (ppm) of gluten in foods labeled gluten free is consistent with international standards, though most North American proprietary standards set the limit at 10 ppm. More than 80,000 products, the majority manufactured in the U.S., already carry gluten-free certifications from NSF International, the Gluten Intolerance Group’s GFCO program, Celiac Spruce Association, and Canada’s Gluten-Free Certification Program, which is endorsed by the National Foundation for Celiac Awareness. Product samples typically undergo chemical analysis to detect gluten levels, with on-site audits of cleaning and sanitation systems conducted annually or more frequently.
The audit protocol mirrors those in food safety and other certifications. Independent audits that yield a Good Housekeeping-type seal of approval are favored by food companies inundated by customer-specific audits. The strategy is proving effective in the area of animal welfare: instead of opening their packinghouses and slaughter facilities to all customers who want to verify practices, meat and poultry processors are submitting to a single animal-welfare audit to standards set by the American Meat Institute. Results of a plant’s audit then are sent to all customers receiving product from that facility. The standards are “robust enough to advance animal welfare, and the buyer and seller have said, ‘We agree,’” says Michael Simpson, executive director of the Professional Animal Auditor Certification Organization. PAACO certifies more than 500 auditors, many of whom are employed at the plants that they audit.
No such consensus exists for food-safety audits, and many retailers and restaurant chains still insist in conducting their own reviews. As a result of the Listeria contamination traced to Jensen Farms cantaloupes in 2011, those audits are likely to become more detailed and vigorous. As reported in the August edition of Food Processing, plaintiff’s attorney William Marler conservatively estimates he will win judgments in excess of $50 million against PrimusLabs, which was commissioned to audit Jensen Farms.
In court filings in eight states, Marler notes that FDA detected Listeria in swabs of whole cantaloupes and on food-contact surfaces. FDA’s Oct. 19, 2011, environmental assessment concluded there were deficiencies in Jensen’s equipment design and postharvest practices, in contrast to the auditor’s conclusion that they were in “total compliance.”
“You can’t put that on an auditor,” insists Jolyda Swaim, a principal attorney with the D.C. firm Olsson Frank Weeda (OFW Law). “The auditor is limited to the facts in hand. It’s still a company’s responsibility to understand what needs to be done.” However, Swaim also believes “a lot of companies miss the forest for the trees” by relying too heavily on audits to ensure food safety. “They have there place, but an audit is not the be all and end all,” she says.
Mathieu Labasse, vice president of AsiaInspection, agrees. His Hong Kong-based firm conducts both audits and inspections of food plants throughout Asia but primarily in China. International shipments of raw materials and finished goods has caused a huge increase in audits of China food plants; a 55 percent increase in 2014’s second quarter is indicative of the trend. “Manufacturers in North America and Europe can live with the proliferation of standards and initiatives, but for the Chinese factory just entering the international market, it’s confusing,” he says. “China is super big and super immature in terms of food safety, and it’s way behind in terms of education” of the workforce. Discoveries like the meat plant that recently was discovered to be supplying rotten hamburger patties to McDonald’s and KFC outlets in China are inevitable and not uncommon, he adds.
There are 500,000 food processing facilities in China, according to Labasse, and only a minute fraction have opened their doors for review by his firm under BRC, one of the food-safety standards endorsed by the Global Food Safety Initiative. For the others, dubious practices and outright fraud abound. Audits may yield a snapshot of a properly functioning operation, but on-site inspections and random sampling of finished goods are essential to get an accurate assessment of the operation. Unauthorized subcontracting of customer orders is rampant in China, he says, and inspectors compare actual throughput at a plant to the volume required to fill orders.
A large gulf exists between attitudes and education in China and those at North American and European food companies. Worker safety provides a telling statistic: industrial accidents claim about 70,000 lives a year in China, according to government statistics. By comparison, there were 4,628 industrial fatalities in the U.S. in 2012. “Industry in China is still immature,” allows Labasse. “It takes time to build a sustainable and safe industry. It is more a long-term educational issue and bringing them up to standards with repeated inspections and controls.”
Indifference, not ignorance, is the issue at U.S. food companies, suggests John Surak, a food safety consultant in Greenville, S.C. “Many companies just want a certificate to hang on the wall,” grouses Surak, who provides pre-audit assessments for plants but refrains from serving as a third-party auditor. “If that’s all they want, they’ll eventually go out of business.
“From an audit perspective, we have to change some of our thinking,” Surak continues. “It’s no longer a matter of what have you done in the last year and where are the records to support it. That’s a traditional audit, and we have to move to process audits.” An effective auditor is most interested in how a processor responded when there was a safety breach, he adds, but unless an upset can be identified, the auditor is unable to make an informed judgment.
OFW Law’s Swaim is another audit skeptic. A microbiologist and former QA technician with Sara Lee and other food companies, Swaim conducts food-safety inspections at plants facing regulatory audits by USDA and FDA. “Companies are relying too much on that piece of paper,” she says, referring to private-industry audit certificates. “Most of the audits are announced, so you’ve somewhat changed the operating parameters,” and auditors bring their own preconceptions of what is important, rather than zeroing in on the real vulnerabilities of a particular process.
QA and production managers are under tremendous pressure and seldom have time to step back and analyze what is actually going on in their plants; unfortunately, the outside experts they turn to may not capable of critically analyzing plant processes, either. “You have snake-oil salesmen with shingles saying they’re (food-safety) authorities, but they’re not,” complains Swaim. Lab technicians and microbiologists are presenting themselves on pathogen control, “but they don’t have that plant experience and don’t know what an old plant must do to meet today’s expectations.”
Most processors would welcome more rigorous audits if it meant fewer of them, though that is unlikely to happen. But reliance on audits to flag problems and raise the bar on food safety and other metrics isn’t the path forward. Inspections and critical analyses of processes are necessary.