One of the toughest parts about FDA compliance from a manufacturing standpoint is that there’s always a tension between speed and quality control.
Columbia, MD (PRWEB) October 18, 2011
As this year’s China Seafood And Fisheries Expo approaches, industry leaders are preparing to tackle emerging food import issues and discuss how manufacturers and importers are bracing for the coming changes in FDA regulation. Benjamin England, a 17-year veteran of FDA and Founder and CEO of FDAImports.com and ExportToUsa.com.cn, predicts 3 major trends in regard to Chinese seafood exports as his firm gears up to exhibit at the expo and talk with thousands of manufacturers, distributers and brokers in Qingdao, China.
Speed Vs. Quality
“One of the toughest parts about FDA compliance from a manufacturing standpoint is that there’s always a tension between speed and quality control,” said Mr. England. “Chinese companies are having to produce larger shipments, faster than ever before to stay competitive. When you do that month after month there is a risk that quality control is diminished because the rules are getting more complicated and production outpaces your ability to stay on top of it.” Mr. England predicts that we will see more and more food shipments from China facing FDA detention and FDA import examination, especially as FDA begins implementing the new Food Safety Modernization Act requirements.
Complexity, Not Simplicity
“I’ve seen FDA law change over the years and I know how complex it can become,” said Mr. England. “The new regulations, FDA re-structuring and FDA’s compliance standards are becoming more complex instead of simpler. However complex they appear to American companies, simply double or triple the potential for confusion for foreign manufacturers and importers. Regulatory compliance is at a level now where you either have to be an expert, know an expert or have uncanny good luck.”
Increased Role of Private Third Parties
Mr. England also predicts an increased role for private third parties in the future. “Under the FSMA, FDA is directed to change its position with respect to private third parties, such as private laboratories and private inspection organizations, from one of critical reviewer to one of accreditor. But this is not an area where FDA has had much success in the recent past. FDA has even stated that the agency does not consider the Department of Commerce, Seafood Inspection Program to be an ‘appropriate third party.’” Mr. England further commented that getting United States government agencies to interact together was hard enough, let alone third parties and extra-government entities. “U.S. Congress had to force FDA, in the FSMA, to work with its sister agencies just to get the governmental parties together to work on inspections of foreign seafood processors,” he said. “Although Congress requires FDA to implement third party programs, I expect FDA will be reluctant to make much progress.”
As food imports increase and FDA demands more detailed disclosure and tracking, foreign seafood manufacturers and suppliers will undoubtedly feel the pressure in the coming months from both government agencies and U.S. importers … and they will have to pay for it both financially and from a labor perspective.
Benjamin L. England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Currently he is founder and CEO of FDAImports.com, LLC, a firm of consultants and affiliated attorneys practicing at the intersections of complex administrative law and regulations that impact international traders in highly regulated commodities.
For more information contact Benjamin L. England and the FDAImports.com team at http://www.fdaimports.com, call (410) 740-3403 or contact Jon Barnes at jrbarnes(at)fdaimports(dot)com.