The U.S. Food and Drug Administration (FDA) has announced plans to phase out the use of certain antibiotics in food animals as part of its effort to reserve medically important drugs for the treatment of human infection. Noting that voluntary participation “is the fastest, most efficient way to make these changes,” the agency will partner with industry to discontinue the practice of adding these drugs to animal feed and drinking water as a growth promoter. To this end, FDA has issued final guidance that urges animal pharmaceutical companies “to voluntarily revise the FDA-approved conditions on the labels of these products to remove production indications,” in addition to proposing an updated veterinary feed directive (VFD) “to facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs.” “The plan also calls for changing the current over-the-counter (OTC) status to bring…
Category Archives U.S. Government and Regulatory Agencies
In response to a petition filed by the U.S. Pharmacopeial Convention, the U.S. Food and Drug Administration (FDA) has issued a final rule that amends select food-additive regulations referring to “food-grade specifications from prior editions of the Food Chemicals Codes (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition.” The rule took effect November 29, 2013, but objections and requests for hearing may be filed until December 30. See Federal Register, November 29, 2013.
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has reopened the comment period on a proposed rule concerning the description designation for needle- or blade-tenderized beef. First published in the June 10, 2013, Federal Register, the proposed rule would require “the descriptive designation ‘mechanically-tenderized’ on the labels of raw or partially-cooked needle- or blade tenderized beef products, including beef products injected with marinade or solution, unless these products are to be fully cooked at an official establishment.” Because the first comment period expired during the recent partial government shutdown, the agency will now accept feedback until December 24, 2013. Additional details about the proposed rule appear in Issue 486 of this Update. See Federal Register, December 3, 2013.
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has released its Salmonella Action Plan outlining steps theagency will take to address its “most pressing problem”—Salmonella in meat and poultry products. Key elements of the plan include modernizing an “outdated” poultry slaughter inspection system and shifting FSIS inspectors to more offline, food-safety duties, which the agency said will prevent at least an estimated 5,000 illnesses annually. The plan also calls for FSIS to (i) establish new performance standards; (ii) develop new strategies for “inspection and throughout the full farm-to-table continuum”; (iii) address all potential sources of Salmonella; and (iv) focus the agency’s “education and outreach tools on Salmonella.” Although lauded by many food-safety advocates, critics claim that it “completely ignores” one of the most crucial issues the meat industry faces— antibiotic-resistant Salmonella. “It is shocking for the agency to have stayed on the sidelines of this public health crisis, particularly in the…
Due to the recent government shutdown, the U.S. Food and Drug Administration (FDA) has extended the public comment period for several proposed rules related to the implementation of the Food Safety Modernization Act (FSMA). FDA has extended the deadline for comments on (i) “Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” until March 15, 2014; and (ii) “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” and “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,” until January 27.
The U.S. Food and Drug Administration (FDA) has issued the “Second BiennialReport to Congress on the Food Emergency Response Network (FERN)” as required under Section 202(b) of the Food Safety Modernization Act. Administered by FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), “FERN is an integrated, secure laboratory system for federal, state, and local government agencies engaged in food safety and food defense activities” responsible for detecting, identifying and responding to situations involving “biological, chemical, or radiological contamination of food.” Among other successes, FDA reports that FERN “has been vital in responding to major outbreaks of foodborne disease attributed to many products, including spinach, pet food, and peanut butter.” The network has also provided surge capacity for federal and state responses to both natural and industrial emergencies, in addition to handling large-scale, non-emergency projects, such as arsenic testing in fruit juices and rice products, and…
“A curious hurdle is threatening to complicate efforts by the United States to reach a major trade agreement with 11 Pacific nations by the end of the year: catfish,” reports New York Times writer Ron Nixon in a November 13, 2013, article describing how the U.S. Department of Agriculture’s (USDA’s) new catfish inspection program has angered Vietnam, a member of the TransPacific Partnership and a major exporter of a catfish known as pangasius. Vietnamese trade officials have apparently written to Secretary of State John Kerry, the White House and Congress, criticizing the new inspection program as a trade barrier in disguise. “And it’s not even a good disguise; it’s clearly a thinly veiled attempt designed to keep out fish from countries like Vietnam,” Le Chi Dzung, the chief economic officer of the Vietnamese Embassy in Washington, D.C., told the Times. Intended to replace the Food and Drug Administration’s (FDA’s) catfish…
In response to the U.S. Food and Drug Administration’s request for comments on its “Draft Guidance for Industry on Arsenic in Apple Juice: Action Level,” the Center for Food Safety (CFS) has asked the agency to “limit the public’s exposure to arsenic through a new regulatory strategy that recognizes the prevalence of arsenic in the food supply.” Stating that although individual foods containing arsenic may be safe to eat in moderation, CFS maintains that they are often consumed in combination, thereby presenting a risk of “cumulative arsenic exposure” that could reach dangerous levels. Calling FDA’s draft guidance “insufficient” to address these health hazards, CFS’s November 12, 2013, letter to FDA asks for the agency to regulate based on “cumulative arsenic exposure” rather than through product specific levels. According to CFS, FDA “must do more” to adequately protect public health. To that end, CFS suggests that, because arsenic is present in…
The U.S. Food and Drug Administration (FDA) has issued a request for comments on proposed revisions to its “Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds.” With the aim of helping sponsors design efficacy studies to support the submission of food additive petitions (FAPs) related to preventing Salmonella in food for animals, FDA noted that a revision is necessary because science, technology and FDA policy have changed since the guidance was last revised. Because current guidance addresses only chemical food additives intended to maintain feeds or feed ingredients as Salmonella-negative, the agency intends to expand the scope to address other categories of food additives beyond chemical food additives and to cover all food for animals, including pet food. Among other things, FDA seeks comment on the following questions: (i) what intended technical effects will the agency see in FAPs for anti-Salmonella use of…
The U.S. Department of Agriculture’s Food Safety and Inspection Services (FSIS) has issued a final rule amending the meat and poultry products inspection regulations “to expand the circumstances in which FSIS will generically approve the labels of meat and poultry products.” Effective January 6, 2014, the final rule will also consolidate the regulations governing meat and poultry product label approvals under a new Code of Federal Regulations part. Under the new regulations, FSIS will still require establishments to submit for evaluation certain types of labeling, “e.g., labels for temporary approval, labels for products produced under religious exemption, labels for products for export with labeling deviations, and labels with claims and special statements.” In particular, FSIS will continue to review the following special statements and claims: (i) “[c]laims relating a product’s nutrient content to a health or a disease condition”; (ii) “statements that identify a product as ‘organic’ or containing organic…
