Article: Regulations: Busy Regulatory Start to 2009 -- April 2009
Busy Regulatory Start to 2009
There has been much activity in early 2009 of interest to food processors.
Rep. John Dingell (D-Mich.) has reintroduced and added to his last-session legislative proposals as H.R. 759, “Food and Drug Administration Globalization Act of 2009.” (In the new Congress, Rep. Henry Waxman [D-Calif.] has taken Dingell’s position as chair of the House committee with FDA oversight.) The bill reintroduces the concepts of user fees and third-party certification. Third-party certification, as proposed, continues to contemplate a program in which foreign governments, food authorities and other third parties could be used to certify both domestic and foreign food production facilities. The certifier would serve as FDA’s access point for actions taken by inspected facilities in response to corrective actions recommended by a certifier in the course of one of its unannounced inspections or otherwise. As before, participation by facilities is optional, but advantageous, particularly to importers. Ramped-up records access, administrative detention standards and expanded “trace back” requirements are included in the bill.
Rep. Rosa DeLauro (D-Conn.) has introduced HR 875, the “Food Safety Modernization Act of 2009.” The bill contemplates creation of a Food Safety Administration (FSA), which would be the first step toward a consolidation of all food regulatory activities into one over-arching agency; but until one agency is formed, the FSA would not usurp the regulatory activities of the USDA.
COOL. On March 16, 2009, the final rule (74 Fed. Reg. 2658) on country of origin labeling becomes effective. Without limiting the effect of the final rule, U.S. Secretary of Agriculture Tom Vilsack, in the February 20 letter, “Dear Industry Representative,” expressed con-cern that the reach of the final rule be voluntarily expanded to identify more accurately the processing performed in each country of multi-country labeled products: for example, “Born in Country X and Raised and Slaughtered in Country Y;” that “processing” should be expanded to include curing, smoking, broiling, grilling or steaming; and shortening the time/inventory allowance for a ground meat product. The secretary’s letter requesting voluntary actions is guidance only.
Carbohydrate Claims. FDA has published the results of its “Experimental Study of Carbohydrate Claims of Food Packages,” a several-year review of the claims, and it is available at www.cfsan.fda.gov/~comm/crnutri8.html. There have been many changes in the use of carbohydrate claims since the research was begun, but the study does discuss the inferences that consumers might draw from “good, reduced, low and free” claims and would be of importance to any marketer interested in continuing or developing carbohydrate claims.
FDA has issued guidance on third-party certification pro-grams at www.fda.gov/oc/guidance/thirdpartycert.html. The guidance states that certifiers will have no reg-ulatory authority, partic-ipation by facilities is voluntary, and non-participating facilities will not be singled out for enhanced scrutiny. However, implemen-tation of such a program (with or without congressional man-date) is clearly the direction of choice at FDA, and participants may find that their imports will move more rapidly at the port of entry, their participation may be publicly acknowledged, and they may experience fewer regulatory inspections.
Mark Hostetler is an attorney at Husch Blackwell Sanders LLP. Experienced in advising consumer product companies and focusing primarily in the food industry, he has guided producers, advertisers and marketers through regulatory proceedings, product recalls, new product introductions, and new advertising and promotional campaigns. He can be reached at Mark.Hostetler@huschblackwell.com.
Regular readers of Prepared Foods’ E-dition, an electronic version of the magazine e-mailed to subscribers every two weeks, will note Mark Hostetler recently contributed an article highlighting and examining the new president’s hold on regulations. See the February 2 issue in the “E-dition Archives” on www.PreparedFoods.com. To subscribe to the E-dition, visit www.PreparedFoods.com/enews.
There has been much activity in early 2009 of interest to food processors.
Rep. John Dingell (D-Mich.) has reintroduced and added to his last-session legislative proposals as H.R. 759, “Food and Drug Administration Globalization Act of 2009.” (In the new Congress, Rep. Henry Waxman [D-Calif.] has taken Dingell’s position as chair of the House committee with FDA oversight.) The bill reintroduces the concepts of user fees and third-party certification. Third-party certification, as proposed, continues to contemplate a program in which foreign governments, food authorities and other third parties could be used to certify both domestic and foreign food production facilities. The certifier would serve as FDA’s access point for actions taken by inspected facilities in response to corrective actions recommended by a certifier in the course of one of its unannounced inspections or otherwise. As before, participation by facilities is optional, but advantageous, particularly to importers. Ramped-up records access, administrative detention standards and expanded “trace back” requirements are included in the bill.
Rep. Rosa DeLauro (D-Conn.) has introduced HR 875, the “Food Safety Modernization Act of 2009.” The bill contemplates creation of a Food Safety Administration (FSA), which would be the first step toward a consolidation of all food regulatory activities into one over-arching agency; but until one agency is formed, the FSA would not usurp the regulatory activities of the USDA.
COOL. On March 16, 2009, the final rule (74 Fed. Reg. 2658) on country of origin labeling becomes effective. Without limiting the effect of the final rule, U.S. Secretary of Agriculture Tom Vilsack, in the February 20 letter, “Dear Industry Representative,” expressed con-cern that the reach of the final rule be voluntarily expanded to identify more accurately the processing performed in each country of multi-country labeled products: for example, “Born in Country X and Raised and Slaughtered in Country Y;” that “processing” should be expanded to include curing, smoking, broiling, grilling or steaming; and shortening the time/inventory allowance for a ground meat product. The secretary’s letter requesting voluntary actions is guidance only.
Carbohydrate Claims. FDA has published the results of its “Experimental Study of Carbohydrate Claims of Food Packages,” a several-year review of the claims, and it is available at www.cfsan.fda.gov/~comm/crnutri8.html. There have been many changes in the use of carbohydrate claims since the research was begun, but the study does discuss the inferences that consumers might draw from “good, reduced, low and free” claims and would be of importance to any marketer interested in continuing or developing carbohydrate claims.
FDA has issued guidance on third-party certification pro-grams at www.fda.gov/oc/guidance/thirdpartycert.html. The guidance states that certifiers will have no reg-ulatory authority, partic-ipation by facilities is voluntary, and non-participating facilities will not be singled out for enhanced scrutiny. However, implemen-tation of such a program (with or without congressional man-date) is clearly the direction of choice at FDA, and participants may find that their imports will move more rapidly at the port of entry, their participation may be publicly acknowledged, and they may experience fewer regulatory inspections.
Mark Hostetler is an attorney at Husch Blackwell Sanders LLP. Experienced in advising consumer product companies and focusing primarily in the food industry, he has guided producers, advertisers and marketers through regulatory proceedings, product recalls, new product introductions, and new advertising and promotional campaigns. He can be reached at Mark.Hostetler@huschblackwell.com.
Regular readers of Prepared Foods’ E-dition, an electronic version of the magazine e-mailed to subscribers every two weeks, will note Mark Hostetler recently contributed an article highlighting and examining the new president’s hold on regulations. See the February 2 issue in the “E-dition Archives” on www.PreparedFoods.com. To subscribe to the E-dition, visit www.PreparedFoods.com/enews.
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