LexisNexis® CLE On-Demand features premium content from partners like American Law Institute Continuing Legal Education and Pozner & Dodd. Choose from a broad listing of topics suited for law firms, corporate legal departments, and government entities. Individual courses and subscriptions available.
USDA Assisting FDA with Environmental Assessment for Produce Safety Rule
USDA has been working with FDA to conduct an environmental impact statement (EIS) to evaluate the potential environmental effects of the proposed produce safety rule. FDA had announced its plans to conduct an EIS after acknowledging that regulatory changes under the rule may cause environmental repercussions. The department has been working with FDA to make sure the agency is aware of the activities in the field as well as the impact of the produce safety rule on all producers. Specifically, USDA’s staff has been standing by FDA regulators in the field to explain implementation. USDA is also interested in assessing the impact of the produce safety rule with regards to risk management and the estimated containing costs for producers. See: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm304045.htm#coordination
AMS Issues Final Rule on National List of Approved and Prohibited Substances
On October 3, USDA’s Agricultural Marketing Service (AMS) published a final rule that renewed several substances on the National List of Approved and Prohibited Substances for the National Organic Program, which is reviewed every five years. AMS renewed the following ingredients as non-synthetic, nonorganic substance allowed as ingredients in or on processed products labeled as “organic,” or “made with organic”: agar, animal enzymes, carrageenan, tartaric acid made from grape wine, calcium sulfate, and glucono delta-lactone. Four synthetic substances were also renewed for use in organic crop production: copper sulfate as an algicide in aquatic rice; copper sulfate for the use of tadpole shrimp control in aquatic rice; ozone gas as an irrigation system cleaner; and EPA List 3-Inerts of unknown toxicity, for use in passive pheromone dispensers. Finally, the following two synthetic, nonorganic substances were renewed as well: cellulose for use as anti-caking agent and a filtering aid, and tartaric acid made from malic acid. The final rule is effective as of November 3, 2013. See: 78 Fed. Reg. 61154 (October 3, 2013) at http://www.gpo.gov/fdsys/pkg/FR-2013-10-03/html/2013-24208.htm
Safe Food Coalition Urges USDA to Take Action on Salmonella Outbreak
On October 17, The Safe Food Coalition, a group of eight consumer groups, sent a letter to Agriculture Secretary Tom Vilsack regarding USDA’s Food Safety and Inspection Service (FSIS) response to the outbreak of Salmonella Heidelberg linked with Foster Farms establishments in California. The outbreak caused 317 illnesses in 20 states and Puerto Rico. In their letter, the Coalition said the department’s actions in response to the outbreak were “inadequate,” and questioned how quickly Foster Farms can implement the new procedures outlined in the Notices of Intended Enforcement Action issued by FSIS to three of the company’s plants in order to bring the systems in control. Therefore, the group recommended the following seven actions FSIS should take to facilitate a better response to future outbreaks: (1) declare four antibiotic-resistant strains of Salmonella as adulterants, at least in all poultry products, given the number of outbreaks and illnesses caused by those strains in recent years; (2) require poultry plants to reassess their HACCP plans for Salmonella; (3) unequivocally state that products linked to outbreaks are not adulterated; (4) seek authority from Congress to implement enforceable performance standards, mandatory recall authority and financial penalties; (5) develop a new performance standard for raw chicken parts; (6) conduct a baseline study and create a performance standard for incoming bacteria loads on poultry flocks; and (7) strengthen and clarify its policy on recalls and public health alerts and ensure consistent communication messages. See: http://www.consumerfed.org/news/713 and www.consumerfed.org/pdfs/SFC_letter_Foster_Farms_10-17-13.pdf
FDA Publishes Risk Profile for Pathogen and Filth in Spices
On October 30, FDA released a report titled, Risk Profile: Pathogen and Filth in Spices, which identifies the most commonly occurring microbial and filth hazards among imported spices. FDA had begun working on the project after several high-profile recalls involving spices, such as the 2009-2010 Salmonella outbreak linked to products with black and red pepper. The report focuses on Salmonella, which is the only pathogen linked to spices that has caused human illness, food recalls, and Reportable Food Registry reports in the U.S. The majority of data presented in the report is from FDA sampling of imports and retail surveillance data from other countries. FDA sampling data for shipments between fiscal year (FY) 2007 and 2009 showed an average shipment prevalence of 6.5% for Salmonella, with more than 80 different Salmonella serotypes isolated from spices in contaminated shipments during that time period, and 6.8% of isolates exhibited antimicrobial resistant properties. The data from FY2007-2010 revealed that a total 906 imported spice shipments were refused entry to the U.S. due to the presence or potential for presence of Salmonella and/or filth with 749 of those shipments refused due to Salmonella and 238 shipments refused due to filth. The report explains that failures identified in the farm-to-table food safety system potentially leading to adulteration of consumed spice generally arose from poor inconsistent application of appropriate preventive controls, including failing to limit animal access to the source plant during harvest and drying phases, failing to limit insect and rodent access to spices during storage, and failing to subject all spices to an effective pathogen reduction treatment or other lethality step. The report concludes with recommended actions for FDA and the industry to reduce the risk of illness from pathogen-contaminated spices, which include capacity building in spice exporting countries, outreach to the spice industry, improved storage practices for spices and preventive control training throughout the supply chain. See: http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/ucm367339.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Click to read Keller & Heckman LLP’s complete Food Regulatory Update.
For more information about LexisNexis products and solutions connect with us through our corporate site