Judge orders FDA to release all FSMA regulations by June 2015
A federal judge in California has ruled that the US Food and Drug Administration must publish all the regulations required by the Food Safety Modernization Act by Jun 30, 2015, Food Safety News (FSN) reported yesterday.
In a Jun 21 ruling, Judge Phyllis Hamilton of US District Court of Northern California rejected the FDA's proposal for releasing the remaining rules in 2015 and 2016.
FSN said the ruling marked the latest and possibly last phase in a lawsuit the Center for Food Safety (CFS) brought against the FDA last August over the agency's failure to meet several deadlines for completing FSMA regulations.
Since then, the FDA has released three of the seven major rules, those dealing with produce safety, preventive controls across the food chain, and food facility registration. Three other rules are under review by the White House Office of Management.
Although Hamilton found the FDA's proposed timeline too "fluid," she acknowledged that the FDA's task is complex and rejected the CFS's proposed deadline of May 2014, the story said.
"This is a critical victory for consumers, farmers, and the public health," George Kimbrell, CFS senior attorney, said in a CFS press release. "The Court's decision will ensure FDA cannot unduly delay these life-saving measures any longer, while also ensuring all interested parties have a meaningful say in their outcome."
Jun 25 FSN story
Jun 21 CFS press release
Berry-linked hepatitis A outbreak grows to 122 cases
The US Centers for Disease Control and Prevention (CDC) reported today that two more cases of hepatitis A have been confirmed in an outbreak tied to an organic frozen fruit mix, raising the total to 122.
Eight states have had cases, with Wisconsin the only non-western state. The CDC said, though, that the Wisconsin case resulted from exposure to the product in California.
Patients range in age from 2 to 84 years, with 74 (61%) from 40 to 64 years old. Fifty-four of the patients (44%) have required hospitalization, and none have died.
Illness-onset dates have ranged from Mar 31 to Jun 15.
The cases have been linked to Townsend Farms Organic Anti-Oxidant Blend, a frozen berry and pomegranate mix that was distributed in 12 western states. It was sold at Costco and Harris Teeter stores, but all cases so far have been associated with Costco purchases.
Townsend Farms, of Fairview, Ore., has recalled certain lots of the berry mix.
Jun 26 CDC update