Industry News

Final Guidance Is Issued on the Production, Storage, and Transportation of Shell Eggs

In August, the U.S Food and Drug Administration announced the availability of a final Guidance for Industry on the production, storage, and transportation of shell eggs under the Egg Safety Rule. The guidance is in response to questions the FDA received about the Egg Safety Rule, which published in July 2009 and is designed to prevent Salmonella Enteritidis (SE)  in shell eggs.

The guidance document addresses questions regarding the requirements under the rule, including how to determine whether and when producers must comply with the requirements, SE prevention measures, sampling and testing requirements, facility registration, and enforcement and compliance.

The agency also intends to publish draft guidance for producers who provide their laying hens with outdoor access. The guidance document and information on the Egg Safety Rule and Inspections are available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm313728.htm and http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/EggSafety.
 

Vilsack Highlights EPA Action to Increase Use of Biodiesel

In a tour of an Iowa biodiesel plant, Agriculture Secretary Tom Vilsack discussed how the increased use of biofuels is helping to reduce the nation’s reliance on foreign oil. Vilsack highlighted EPA’s recent action to establish the volume of biodiesel products required to be included in diesel fuel markets.

“President Obama’s all-of-the-above energy plan is working—today, we are importing less foreign oil than we have in nearly two decades, and we are creating jobs by producing more of our energy here at home,” Vilsack said. “Over the past three years, we have doubled generation from renewable energy and [the] announcement by EPA will ensure that we are continuing to utilize biodiesel to help meet our energy needs, create jobs, and strengthen the rural economy.”

The action by EPA sets the 2013 volume of biodiesel products required to be included in diesel fuel markets at 1.28 billion gallons under the Energy Independence and Security Act of 2007 (EISA) which established the second phase of the Renewable Fuel Standards program. EISA specifies a one-billion-gallon-minimum volume requirement for the biomass-based diesel category for 2012 and beyond. It also calls on EPA to increase the volume requirement after consideration of environmental, market, and energy-related factors.
 

FDA Set to Increase Category Requirements for Facility Registration

In August, the FDA issued draft guidance on the Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories, as provided by section 102 of the FDA Food Safety Modernization Act (FSMA). FSMA amended section 415 of the Federal Food, Drug and Cosmetic Act, which requires both domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA. Requiring the submission of food product category information as part of a facility’s registration is necessary to allow for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency, FDA said.

The draft guidance updates the previously issued Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities and proposes additional food categories to be included in the food facility registration form as mandatory fields, including food categories that are currently included on the food facility registration form as optional fields.

The draft guidance states that the FDA believes that information about a facility’s food categories is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected. For example, if FDA receives information indicating that soft drinks could be affected by a bioterrorist incident or other food related emergency, FDA is able to alert soft drink manufacturers/processors, packers, and holders about the incident.  

Additionally, the food categories, in conjunction with the prior notification requirements in 21 CFR Part 1, Subpart I aids FDA in verifying that imported products are correctly identified by where and by when they were produced. For example, if the registration information identifies a facility as producing only dairy products and FDA receives a prior notice for a shipment of nuts purporting to have been produced at that facility, FDA can inspect the shipment for verification based on the discrepancy. FDA finds that requiring food product category information as part of a facility’s registration is necessary for a quick, accurate, and focused response to an actual or potential bioterrorist incident or other food-related emergency.

FDA intends to issue three other updated food facility registration guidance documents to provide more information regarding FSMA amendments to the food facility registration requirements of section 415 of the Federal Food, Drug, and Cosmetic Act some time later this year. For more information, please visit http://www.fda.gov/Food/FoodSafety/FSMA/ucm314178.htm.