Questions and Exercises for Classroom Discussion
Consider the FSMA’s requirement to designate certain foods as high-risk. Food companies do not want their foods to qualify as high-risk. Review a food company and a food trade organization’s response to the FDA’s request for comments on Regulations.gov: http://www.regulations.gov/#!docketBrowser;rpp=25;po= 0;dct=PS;D=FDA-20i4-N-0053;refD=FDA-20i4-N-0053-0003. What methods does the food industry use to criticize the requirement? Do you agree? What do you think of the requirement in the first place?
What should the FDA’s GRAS rule permit in terms of a company’s ability to self- declare an ingredient to be GRAS? Should the FDA be required to undertake the formal GRAS rulemaking? Why or why not?
The Pink Slime case is one where an effort to address safety issues led to what might just be considered a disgusting product. When is something just unseemly and when is it unsafe? Do you trust the government to make that distinction? Would any other entity be better to make that determination?
What is the most pressing food safety issue today? Is the government addressing it appropriately? Why or why not? What have other countries done? Should other countries’ responses have an impact on how the United States responds to food safety concerns?
Section 105 of the Animal Drug User Fee Amendments of 2008 requires antimicrobial drug sponsors to report to the FDA the amount of antimicrobial drugs they sell or distribute for use in food-producing animals on an annual basis. (Note that these sales and distribution data do not directly correlate to actual use.) The FDA publishes yearly reports summarizing this data. The report for 2013, the year before the FDA implemented its judicial use strategy, shows increasing sales of antimicrobials, including those that are considered medically important.[1] Look up the report for the current year, compare it to years past, and analyze whether the FDA’s judicial use strategy is working. What could the FDA do to improve the outcome?
- [1] Food and Drug Administration. 2013 Summary Report on Antimicrobials Sold orDistributed for Use in Food-Producing Animals. April 2015. http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM440584.pdf
