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By Eric Lindstrom, Keller and Heckman LLP | 01/03/2013
2013 will be a memorable year for food safety. Like last year, 2013 will be dominated by FDA's implementation of the Food Safety Modernization Act (FSMA). The relatively new law comprehensively changes the reactive U.S. food safety framework to a prevention-based system. USDA also will have its own food safety initiatives, however without the burden of implementing a new statutory framework.
FSMA was signed into law on January 4, 2011, and it granted FDA new authority, including a mandate to require science-based preventive controls throughout the food supply chain. It also gave the agency enhanced authority regarding inspection, compliance, outbreak response and recalls.
FSMA required FDA to implement many of its provisions by July 2012, but the agency has been unable to meet its deadlines. Nevertheless, we expect FDA to propose the delayed regulations in 2013 – if it hadn't already done so in the final days of 2012.
Among the regulations expected from FDA, those implementing the hazard analysis, risk-based preventative controls in Section 103 of FSMA will have the greatest impact. Under Section 103, each registered facility, with some exceptions, will be required to evaluate, identify and develop a written analysis of known or reasonably foreseeable hazards that could affect food manufactured, processed, packed or held at the facility. This includes hazards introduced unintentionally and intentionally, as well as those that occur naturally. The facility must subsequently apply preventive controls to minimize or prevent each identified hazard and to assure FDA that the food will not be adulterated or misbranded for failure to declare a major food allergen.
Although Section 103 technically became effective in July 2012, FDA will expect compliance with these new requirements in timeframes that will be described in the forthcoming final rules.
We also expect FDA to propose regulations in 2013 to protect against intentional adulteration of food for which there is a high risk of intentional contamination that could cause serious adverse health effects or death (FSMA Section 106); to implement sanitary food transportation practices to ensure that food is not transported under conditions that may render the food adulterated (Section 111); and to create a foreign supplier verification program requiring importers to perform risk-based assessments that verify that the food imported complies with the Food, Drug and Cosmetic Act (Section 301).
We anticipate FDA will increasingly use its new powers under FSMA. A recent example was provided by FDA's late-2012 response to Sunland Inc. Upon inspection of Sunland's peanut processing facilities, FDA found significant violations of Good Manufacturing Practices, the presence of salmonella and company records indicating that over the three years prior to the inspection, Sunland had introduced into interstate commerce peanut products contaminated with salmonella.
Prior to FSMA, FDA would have been required to seek an injunction in federal court to halt Sunland's operations. However, FDA used its new power under Section 102 of FSMA to suspend Sunland's food facility registration, halting the company's operations very quickly. Over the course of 2013, when appropriate circumstances arise, we expect to see FDA more frequently asserting its new authority, including mandatory recalls.
Another area of increasing FDA focus is the safety of energy drinks containing caffeine and other ingredients with potential stimulant properties. In late November, FDA responded to a letter from Senators Dick Durbin and Richard Blumenthal, stating that it plans to seek specialized outside expertise, most likely from the Institute of Medicine, to assess safety issues including the vulnerability of certain populations, such as young people. This could result in guidance or new regulatory requirements.
USDA's Food Safety Inspection Service (FSIS) does not have a new food safety statute to implement, but it generally shares the current food safety approach of FDA regarding the products it regulates; namely, meat, poultry, catfish and processed egg products. FSIS's primary goal is to keep the commercial supply of those products safe by, among other things, preventing foodborne illness outbreaks. The emphases are on salmonella, listeria monocytogenes and E. coli O157:H7, plus preventing intentional contamination and, when an outbreak does occur, responding quickly and effectively.
As an example of FSIS's plans for illness prevention, the agency is requiring establishments producing not-ready-to-eat ground or otherwise comminuted chicken and turkey products to reassess their Hazard Analysis and Critical Control Points (HACCP) plans to prevent the occurrence of circumstances that led to several recent salmonella outbreaks. FSIS will begin verifying that establishments have reassessed their HACCP plans in early 2013. The agency also will focus a significant majority of its investigations and enforcement actions on food safety-related violations.
To help prevent intentional contamination, FSIS will encourage regulated establishments to adopt a functional food defense plan. FSIS believes these voluntary plans should be written, should address inside, outside, personnel and incident response security and should be periodically tested and reviewed annually.
On November 30, two FDA final rules were published and became effective immediately, permitting the irradiation of unrefrigerated raw meat, to control pathogens. Previously, only refrigerated or frozen meats could be irradiated. It is unclear to what extent companies will utilize these new food safety options.
This article originally appeared in the January 2013 issue of Food Processing Magazine.