Policy Concentrates SAFETY
White House updates biotech oversight plans First update in decades clarifies, but doesn’t change, genetic engineering regulations The Obama Administration’s update of a decades-old policy for reviewing U.S. biotechnology products is perhaps most notable for what it leaves out: a call for new regulations on or a mention of new
CRISPR gene editing could give the biotechnology industry an escape route from regulation. gene-editing technologies such as CRISPR. Released on Jan. 4, the revision for the first time sets down in a single document the roles of U.S. agencies involved in regulating products of biotechnology, says Robbie Barbero of the White House Office of Science & Technology Policy (OSTP). The Reagan Administration first addressed the stream of new genetically manipulated products through the Coordinated Framework for the Regulation of Biotechnology in 1986. Rather than calling for new statutes, the framework simply
specifies which existing laws authorize the Agriculture Department, FDA, and EPA to review such products. It was last updated in 1992. Barbero says the update to the framework “was really meant to be ground truth for how the system functions now.”Absent in the new document is mention of the popular CRISPR gene-editing technique. CRISPR-edited foods are already cropping up, including a mushroom that USDA said it would not regulate because it didn’t use plant pest parts—a formerly common genetic engineering method that serves as USDA’s hook for reviewing engineered crops. “In some instances, the agencies are hamstrung and unable to adapt to these rapidly changing technologies. And that can only get fixed by actually changing the regulation,” says Todd Kuiken of the Genetic Engineering & Society Center at North Carolina State University. “We will continue to see these problems emerge. It is CRISPR today, but tomorrow it will be something else.” Doug Gurian-Sherman of the Center for Food Safety, an environmental advocacy organization, says that without calling for new regulations, the revised framework “is really just kicking the can down the road.” The Biotechnology Innovation Organization, an industry group, says that it is reviewing the updated framework and that it supports efforts to modernize the regulatory system for biotechnology products.—RYAN CROSS
OVERHEARD
“I remain convinced that no country is better suited to confront the climate challenge and reap the economic benefits of a lowcarbon future than the United States.” —Outgoing U.S. President Barack Obama, in a Science article (DOI: 10.1126/science.aam6284)
12
C&EN | CEN.ACS.ORG | JANUARY 16, 2017
Beryllium exposure limit finalized Allowable worker exposure to beryllium will be reduced to onetenth of the current level, the Occupational Safety & Health Administration (OSHA) announced earlier this month. Beryllium is used in multiple applications in areas such as aerospace, electronics, energy, and medicine. Industrial workers who inhale beryllium-containing dust or mist while mining or processing the metal can develop lung disease. The current permissible exposure limit for airborne beryllium dates to the 1940s, when the now-defunct Atomic Energy Commission set the limit at 2.0 µg/m3, as averaged over an eight-hour period. OSHA first proposed lowering it in 1975. The Department of Energy lowered its exposure limit for nuclear weapons workers to 0.2 µg/m3 in 1999. In 2012, the United Steelworkers union and Materion, the only U.S. beryllium materials maker, together proposed to OSHA that the agency also lower its limit to 0.2 µg/m3. Employers have one year to implement most of the new standard’s provisions. Once the standard is fully implemented, OSHA estimates that it will prevent 46 new cases of chronic beryllium disease and save the lives of 94 workers annually. The effort to lower the exposure limit demonstrates that “industry and labor can collaborate to protect workers and protect jobs at the same time,” Materion chairman Richard J. Hipple has said in the past. “This rule will protect workers who are exposed to beryllium in general industry, construction, and shipyards and ensure that controls are put in place to prevent future occupational illness from developing,” says United Steelworkers president Leo W. Gerard.—JYLLIAN KEMSLEY
CREDIT: SHUTTERSTOCK
POLICY
