Category Archives Issue 422

The U.S. Environmental Protection Agency’s (EPA’s) Office of Inspector General (IG) has issued a report critical of how effectively the agency “is managing the human health and environmental risks of nanomaterials.” Noting that EPA has the statutory authority to regulate nanomaterials, the IG found that it “currently lacks the environmental and human health exposure and toxicological data to do so effectively.” The IG also found that lack of coordination between program offices, EPA’s failure to communicate with stakeholders on nanomaterial risk issues and limitations in existing statutes that regulate chemicals “present significant barriers to effective nanomaterial management when combined with existing resource challenges.” The agency has responded to the report by agreeing with the IG’s recommendation to “develop a process to assure effective dissemination and coordination of nanomaterial information across relevant program offices” and has established a corrective action plan with milestone dates.

The U.S. Food and Drug Administration (FDA) has issued a final rule prohibiting the extra-label use of cephalosporin antimicrobial drugs in livestock. Citing “evidence that certain extralabel uses… will likely cause an adverse event in humans,” the agency has specifically barred using cephalosporins (i) “at unapproved dose levels, frequencies, durations, or routes of administration”; (ii) “in cattle, swine, chickens, or turkeys that are not approved for use in that species (e.g., cephalosporin intended for humans or companion animals)”; and (iii) “for disease prevention.” The final rule, however, still permits the use of an older drug, cephapirin, while allowing veterinarians to oversee limited extra-label cephalosporin use “in cattle, swine, chicken, or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.” “We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account…

The House Energy and Commerce Committee’s report on the 2011 Listeria outbreak that was traced to cantaloupes grown and processed at Jensen Farms in Colorado has identified a number of problems that led to the “deadliest foodborne illness outbreak in over 25 years.” The bipartisan investigation found that a third-party auditing company (i) gave the farm high food-safety marks despite identifying major and minor deficiencies, (ii) did not hold the farm to anything other than baseline industry standards, and (iii) had no procedures in place to require corrective actions. One of the problems that led to the outbreak was the farm’s failure to use an anti-microbial solution in the cantaloupe wash water. Jensen Farms apparently stopped using the solution after consulting with the third-party auditing company in 2010 about ways to enhance its food-safety efforts. In 2011, the farm had adopted an alternative to the hydrocooler it previously used to process…

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