Food Safety Modernization Act-Center For Food Safety-Regulations-Provisions-Fsma

FDA and OMB Sued Over Delays in FSMA Implementation

By Ricardo Carvajal –The Center for Food Safety and the Center for Environmental Health filed suit in the Northern District of California to compel FDA and the Office of Management and Budget (“OMB”) to implement several major provisions of the Food Safety Modernization Act (“FSMA”). Those provisions require rulemaking to establish or provide for:

• Hazard analysis and risk-based preventive controls
• Clarification of activities that subject a farm to facility registration requirements
• Science-based minimum standards for the safe production and harvesting of fresh fruits and vegetables
• Protection against intentional adulteration
• Sanitary transportation of food
• Foreign supplier verification
• Standards for third-party audits

The suit contends that proposed rules to implement several of these provisions have been pending at OMB for 8-9 months – a period of review that exceeds the time allotted under Executive Order 12866 (that Order mandates review of regulations by OMB within specified timeframes, and with certain exceptions).  The suit also challenges FDA’s decision to exercise enforcement discretion for certain provisions that are self-executing (e.g., preventive controls), and characterizes that decision as “a complete failure to follow a Congressional mandate.”
Plaintiffs cite the numerous outbreaks that have occurred since the passage of FSMA in support of their allegation that “the agency’s unlawful delay is putting millions of lives at risk from contracting foodborne illness.”  They contend that FDA’s failure to issue the regulations and OMB’s failure to provide timely review “constitutes unlawfully withheld and unreasonably delayed agency action” within the meaning of the Administrative Procedure Act ("APA").  They also contend that FDA’s failure to enforce FSMA’s self-executing provisions constitutes an APA violation.  Plaintiffs ask the court to order FDA to issue the regulations “as soon as reasonably practicable” pursuant to a court-ordered timeline, and to order OMB to approve the regulations and “cease interfering with FDA’s promulgation” of those regulations.  Plaintiffs also ask the court to order FDA to “enforce all self-executing FSMA regulations immediately.”
The filing of this lawsuit comes as little surprise given the constituencies that backed passage of FSMA and the delays in the completion of OMB’s review.  APA litigation to compel agency action is typically protracted, so we expect to follow this case for months (if not years) to come. read more..

source:http://www.fdalawblog.net

Food Safety Modernization Act-Preventive Controls-Ricardo Carvajal-Provisions-Fsma

It’s Official – FDA States Intention to Exercise Enforcement Discretion for Key FSMA Provisions

By Ricardo Carvajal -In several letters issued to trade associations on June 18th (for an example, see here), FDA stated that it “will expect to enforce compliance” with the preventive controls provision in section 103 of the Food Safety Modernization Act ("FSMA") and the foreign supplier verification provision in FSMA section 301 “in timeframes that will be described in the final rules.”  Given that the proposed rules for those provisions have yet to publish, it is clear that industry will have substantial additional time to come into compliance with the requirements in those provisions.  However, that time will not be unlimited.  If the delay in publication of proposed and final rules proves too protracted, consumer advocates can be expected to put FDA’s feet to the fire. read more..

source:http://www.fdalawblog.net

Food Additive Petition-Neural Tube Defects-Corn Masa Flour-Hispanic Women-Ethnic Group

Food Additive Petition Seeks to Reduce Neural Tube Defects Among Hispanics

By Ricardo Carvajal –In a relatively rare example of a request for regulatory action intended to benefit a specific racial or ethnic group, a coalition of businesses and nonprofits submitted a food additive petition asking FDA to amend the food additive regulation for folic acid to permit its addition to corn masa flour – a staple among populations of Latin American descent.  Since the late 1990’s, standards of identity for several grain-based foods have required the addition of folic acid.  According to the petition, that requirement is credited with decreasing the prevalence of neural tube defects among Hispanics and non-Hispanics.  However, Hispanic women continue to have a higher rate of neural tube defects, and fewer of them consume folic acid from fortified foods.  The petition contends that “[f]ortification of corn masa flour presents a clear opportunity to improve intake in those who consume corn masa flour products as a significant portion of their diet,” and could potentially decrease neural tube defects among Hispanic women. The observation that diet-related risk factors for certain diseases may vary among racial and ethnic groups is not novel (see, e.g., CDC’s estimation of disparate rates of obesity for Whites, Blacks, and Hispanics).  Nonetheless, it is not clear that a systematic approach to these issues has emerged in relation to food, as it has for drugs.  A 1995 FDA guidance document geared to drug and biologics developers provides recommendations for the collection of race and ethnicity data in clinical trials, in recognition of the fact that numerous “[d]ifferences in response to medical products have already been observed in racially and ethnically distinct subgroups of the U.S. population.”  That same year, FDA approved the first drug to treat a disease in patients identified by race (BiDil, for heart failure in Black patients). Although perhaps difficult to estimate, the potential cost savings associated with dietary interventions that reduce the risk of disease could be significant, particularly in relation to the cost of the intervention.  The corn masa petition estimates that the addition of folic acid to corn masa could prevent 40 cases of neural tube defects annually, each of which could generate direct lifetime costs of a half-million dollars. read more..

source:http://www.fdalawblog.net