Modernization of Canada’s food safety system: Change is on the horizon

Canada’s food safety regulator, the Canadian Food Inspect Agency (CFIA), recently presented^[1] an integrated overview of its plan for modernizing Canada’s food safety system.  The plan is ambitious and will mean big changes for the food industry in Canada.

To strengthen Canada’s food safety system, the CFIA’s plan includes four key areas of enhancement: (1) stronger food safety rules; (2) more effective inspection; (3) a commitment to service; and (4) more information for consumers. For each enhancement area, the CFIA has identified actions it will take:^[2]

1. Stronger Food Safety Rules – Actions
• Develop and implement a single, horizontal regulation that will be outcome based.^[3]
• Design and provide better guidance for industry and inspectors.
• License importers of all products and require preventive controls as a license condition.
• Implement stronger rules for meat, including new testing requirements for E.Coil.
• Require meat establishments to maintain traceable distribution and production e-records.
2. More Effective Inspection – Actions
• Implement new 5-part inspection model (involving border control, field inspection, and centralized expertise) that requires preventive controls, adopts a single licensing regime, provide for risk-based oversight, is consistent across the food system, employs a single enforcement strategy, and includes a continual and systematic assessment of performance.^[4]
• Provide improved, consolidated, plain-language guidance to industry.
• Promote compliance through education, the use of model systems, and business support.
• Establish centres of expertise to ensure consistent and expert regulatory interpretation.
• Enhance scientific capacity by improving facilities and equipment, partnering with industry, and developing an integrated laboratory network.
3. Commitment to Service – Actions
• Change the regulatory culture by increasing transparency and accountability, establishing a new agenda, and implementing new complaint and appeals processes.
• Simplify, update and publically post user fees and service level commitments.
• Invest in a licensing management system that supports broader licensing, new functionality for business-regulator interaction, more e-business, and availability of online and electronic guidance documents and tools.
4. More Information for Consumers – Actions
• Improve transparency by providing consumers with more information about the CFIA, regulatory results, and regulatory plans.
• Modernize the food labelling and claims regime by reviewing enforcement of the CFIA requirements, considering inclusion of grade and composition standards, and considering improved enforcement of Health Canada labelling requirements.

To implement these enhancements, the CFIA is working to develop an entirely new, streamlined, modern regulatory regime by 2014 for implementation in 2015. The CFIA has indicated that these planned enhancements “focus on prevention and include [a] series of integrated actions to deliver [the] highest possible level of food safety for Canadians”.^[5] As the system evolves, CFIA is committed to consulting with, and tailoring its approaches to the needs of, small and medium sized enterprises and to providing ample time for businesses to transition to new licencing and preventative control requirements.^[6]

The next few years will likely bring tremendous change to the legal landscape of Canada’s food sector and, with significant change can come challenges – both for regulators (to ensure workable, efficient and appropriately funded regulations, systems and enforcement activities) and for industry (in terms of systems development and implementation of new processes). Canadian food manufacturers or food distributors will wish to consider participating in CFIA’s consultation processes for a modernized food safety system in Canada. 

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[1] Canadian Association of Importers and Exporters, 8th Annual Food Forum, Brampton, Ontario, Canada, March 26, 2013 (the IE Canada 2013 Food Forum).
[2] “Food Safety Modernization: CFIA’s Integrated Storyline”, presented by Colleen Barnes, Executive Director, CFIA, at the IE Canada 2013 Food Forum.
[3] “Update on Safe Food for Canadians Act and Implementation of New Food Program: Roadmap for Regulations and Regulatory Interpretation”, presented by Colleen Barnes, Executive Director, CFIA, at the IE Canada 2013 Food Forum.
[4] “Inspection Modernization: Optimizing Confidence in Food Safety – Consultation on the revised draft improved food inspection model”, presented by Pam MacDonald, Inspection Manager, North East Region, CFIA, at the IE Canada 2013 Food Forum.
[5] “Food Safety Modernization: CFIA’s Integrated Storyline”, presented by Colleen Barnes, Executive Director, CFIA, at the IE Canada 2013 Food Forum.
[6] “Food Safety Modernization: CFIA’s Integrated Storyline”, presented by Colleen Barnes, Executive Director, CFIA, at the IE Canada 2013 Food Forum.

Food safety in China - From a regulatory perspective

China’s food industry is rapidly changing, as consumers become increasingly knowledgeable and demanding with regard to the safety of their food. This presents opportunities for foreign investors, provided that they manage to successfully navigate China’s food safety regime.

This guide provides an overview of the legal framework for food safety in China. It introduces the main food safety laws and regulations and the Governmental authorities responsible for their implementation, the key licenses required for carrying out food related business activities in China and the different powers and procedures enabling the regulators to enforce the Food Safety Law. This guide also describes the penalties for breaching China’s food safety laws and regulations, with a few case studies illustrating how these rules have been applied so far to domestic and foreign food companies.

Read the full article here.

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Author: Jing Wang, Norton Rose LLP

FDA warning letter update

It is FDA’s practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency’s position is that it issues Warning Letters only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug and Cosmetic Act (the “FD&C Act”). Below is a synopsis of recent food-related Warning Letters.

• On March 26, 2013, the FDA issued a Warning Letter to Marvin O. Icu at Asociacion de Pequenos Agricultores Comalapenses de Productos No Tradicionales, a produce farm and packing house located in San Juan Comalapa, Chimaltenango, Guatemala. During an inspection, the agency observed significant objectionable conditions and practices that caused the company’s produce to be adulterated, in violation of section 402(a)(4) of the FD&C Act. All of the issues involved sewage pits located in close proximity to the company’s produce. The investigator issued an FDA-483 at the end of the inspection and the company promised to make corrections. FDA issued a Warning Letter because the company failed to provide the agency with any corrections. 

• On March 26, 2013, the FDA issued a Warning Letter to Saul D. Segura at Comercializadora Segura de Cartago S.S.R. S.A., a produce and packing house located in Oreamuno, Cartago, Costa Rica. During an inspection, the agency observed significant objectionable conditions and practices that caused the company’s carrots to be adulterated, in violation of section 402(a)(4) of the FD&C Act. Two of the issues involved the lack of improper bathroom and hand-washing facilities. Another issue involved the company’s lack of controls to prevent the transfer of microbes to carrots that the employees drag across the floor in plastic crates. Lastly, the company was using a pesticide for which there is no tolerance established in the United States. The investigator issued an FDA-483 at the end of the inspection and the company promised to make corrections. FDA issued a Warning Letter because the company failed to provide the agency with any corrections. 

• On March 27, 2013, the FDA issued a Warning Letter to Nicholas C. Mobilia at Mobilia Fruit Farms, Inc., a juice-processing facility in North East, Pennsylvania. The agency found serious violations of the Juice Hazard Analysis and Critical Control Point (HAACP) regulation, 21 C.F.R., Part 120. The company’s failure to have and implement a HAACP plan renders the juice products adulterated in violation of section 402(a)(4) of the FD&C Act. The agency also found significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for food manufacturers, 21 C.F.R., Part 110. Moreover, the agency determined that the product labels for the company’s 100% Pure Concord Grape Juice and 100% Pure Cherry Juice products deviated from the food labeling regulations, 21 C.F.R., Part 101, by failing to include required information on the labels, causing the products to be misbranded in violation of section 403 of the FD&C Act. The agency issued an FDA-483 and the company responded. FDA issued a Warning Letter because the agency determined that the company’s response was inadequate.

• On March 28, 2013, the FDA issued a Warning Letter to Cheryl A. Stewart, James D. Stewart and Ron T. Stewart at Stewart Brothers, Inc., a manufacturing facility located in Hood River, Oregon. The agency conducted an inspection and determined that the company’s Superberry Fruit Juice Drink Blend is adulterated in violation of section 402(a)(4) of the FD&C Act, because it contains Ginkgo biloba leaf extract, which is an unapproved food additive under section 409 of the FD&C Act. Additionally, the agency determined that the company’s Pomegranate Blueberry Cherry with Superfruits, Protein CoGo, Blueberry B’Mega, Strawberry Super C and Super C fruit juice drinks are misbranded within the meaning of section 403 of the FD&C Act. The labels of these products violated the FD&C Act in various ways including making invalid nutrient claims, making invalid health claims, failing to list all sub-components of ingredients, failing to declare the percent daily value of protein when the label includes a protein claim, misleading consumers with protein claims, and providing information on the company’s website that is inconsistent with the information contained on the label. 

The companies had fifteen days to respond to the agency in writing to explain the steps taken to correct the violations. FDA will evaluate the responses and can take regulatory action without further notice, such as seizure, injunction or the initiation of administrative enforcement procedures.

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Author: Cori Annapolen Goldberg (cgoldberg@fulbright.com / 202 662 0436 of Fulbright's Health Care practice.

FDA collaborates with Mexican officials on food-safety testing

On April 10, the FDA announced that it is working with Mexican public health officials to improve food safety testing in Mexico. FDA scientists met with Mexico’s National Service of Health, Food Safety and Agro-Alimentary Quality (SENASICA) officials last year and visited SENASICA laboratories in a joint effort to improve collaboration and learn more about lab operations, practices, methods and quality assurance, an FDA official said last week.

This effort is in response to Section 305 of the Food Safety Modernization Act (FSMA), which requires FDA to develop a comprehensive plan to expand technical, scientific and regulatory food safety capacity of foreign governments and their respective food industries in countries from which foods are exported to the United States.

Between 10% and 15% of all food consumed by U.S. households is imported from abroad. Food imports have grown by an average of 10% over the last seven years and estimates show that imports will continue to grow. The FDA admits that it does not have the resources to keep pace with this growth, so it has been prompted to develop a new strategy outlined in its “Pathway to Global Product Safety and Quality.” This strategy looks to move the agency’s focus from “a posture of intercepting harmful products to anticipating and preventing the arrival of such goods[.]”

“In Mexico, the key objectives of this FDA/SENASICA collaboration include improving communications and laboratory capacity, consulting with SENASICA on the development, validation and implementation of testing methods, and participation in proficiency programs[,]” wrote Carl Sciacchitano, a senior advisor for scientific international affairs in FDA’s Office of International Programs.

Sciacchitano also noted that FDA/SENASICA collaboration includes the creation of the Laboratory Capacity Collaboration Program (LCCP), which is aimed at enhancing the group’s collective ability to strengthen laboratory capacity and capabilities in effective and sustainable ways.

The LCCP includes experts from the FDA’s Office of International Programs in Mexico City, Office of Regulatory Affairs, and the Center for Food Safety and Applied Nutrition. These experts worked with representatives from the SENASICA National Laboratories to prioritize key leveraging opportunities to enhance public health through the LCCP.

The goal for both governments in 2013 will be to build on the progress from their work in 2012, continuing to share information on best laboratory practices, and moving forward with their collaborative efforts in method development and validation studies.

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Author: Brandon Crisp

FDA announces plan to boost international food safety capacity

Armed with a congressional mandate in the form of the 2011 Food Safety Modernization Act (FSMA), the Federal Food and Drug Administration (FDA) launched its International Food Safety Capacity-Building Plan (IFSCP or the Plan) in February. Given that the United States imports approximately 15% of its food supply—including 50 percent of fresh fruit and 80 percent of seafood—FDA has significant motivation to bolster the food safety capacity of foreign entities that export to the United States. The IFSCP is FDA’s road map to doing so.

Built around four broad goals, the Plan is part of an overall strategy to shift FDA from a domestically-focused agency to an international agency regulating products that “know no borders.” According to FDA, the goals are: (1) to “[e]nsure efficiency across the Food and Veterinary Medicine Program” (FVM); (2) to “[i]ncrease effectiveness through evidence-based decision making”; (3) to “[s]upport the exchange of information between FDA and other foreign government agencies or other entities”; and (4) to “[e]nhance technical assistance and capacity-building in food safety.” The FVM is FDA’s vehicle for implementing food safety standards.

In accomplishing these goals, the Plan aims, among other things, to improve collaboration and coordination across the various constituent parts of the FVM, which includes FDA’s many foreign offices. It aims to improve the international food safety intelligence network, in which FDA exchanges information on food risks with foreign governments and industries. It highlights the need to improve foreign technical food safety infrastructures, including both regulatory policies and information technology. It will leverage U.S. food safety efforts by emphasizing cooperation with countries that have already carried out some form of self-assessment of their food safety systems. And it will implement better training programs worldwide among what FDA calls “partners and stakeholders in food safety”—in other words, government and industry.

Even though the Plan does not delineate any concrete actions that FDA intends to take, it establishes a framework that will enable FDA to take action in the near future. And while FDA has previously participated in global food safety efforts­—through its involvement in the World Health Organization and other global bodies—the FSMA marks the first time Congress has granted FDA authority to complete a comprehensive overhaul of the international food safety system. FDA hopes that by improving food safety in exporting countries, the Plan will help decrease the risk of tainted food ever arriving at the U.S. border.

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Author: Daragh Hoey

Nutrition content claims and health claims

The Australia New Zealand Food Standards Code (the Code) sets out food Standards that are legislative instruments under the Legislative Instruments Act 2003. A new Standard to regulate nutrition content claims and health claims on food labels and in advertisements became law on 18 January 2013. The new Standard sets out conditions for making such claims.

Under the new Standard, health claims can only be made if they are based on food-health relationships that have been substantiated according to the Standard. There are more than 200 pre-approved food-health relationships set out in the Standard that can be used for general level health claims. Businesses may also self-substantiate a food-health relationship by notifying Food Standards Australia New Zealand (FSANZ) of the relationship before making the health claim. Businesses are not able to rely on a food-health relationship that has been self-substantiated by another business, they will still need to undertake their own review. There will be a public record of food businesses that have self-substantiated a food-health relationship.

Foods carrying health claims must also meet certain compositional requirements that are set out in the Standard, including the nutrient profiling scoring criterion (NPSC). This means that before making a health claim, food businesses will need to ensure that the food meets a certain nutrient profiling score.

From 18 January 2013, Australian and New Zealand food businesses have three years to meet the requirements of the new Standard 1.2.7 - Nutrition, Health and Related Claims. Review the new Standard.

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Author: Kate Sherburn, Norton Rose Australia

USDA to conduct increased “species testing” on imported beef from certain European countries

On April 1, 2013, the United States Department of Agriculture’s (“USDA”) Food Safety and Inspection Service (“FSIS”) issued Notice 25-13, which instructs import inspections personnel to conduct additional “species testing” on imported beef from certain targeted countries. The increased species testing applies to imported beef from the United Kingdom, Ireland, Northern Ireland, Iceland and Poland. The FSIS Notice 25-13 provides detailed instructions for the responsibilities of import inspections personnel and how these tests must be conducted.

The USDA has committed to this increased testing because Ireland and the other targeted countries are still investigating how some horsemeat has been passed off as beef in certain products. Earlier this year, the Food Safety Authority of Ireland (“FSAI”) announced that DNA testing showed that horsemeat had been passed off as more costly beef products. Since this issue was identified in Europe, officials have been using DNA testing to identify “beef” products that actually are horsemeat.

On March 25, 2013, the FSAI released the second set of results of DNA testing on beef products or beef ingredients for the presence of horsemeat. The results showed that 1,225 samples out of 1,228 were negative for the presence of horsemeat, and the remaining three samples, which came from two separate products, were positive for the presence of horsemeat. Review the FSAI Results. Officials removed from the marketplace the products that tested positive for horsemeat.

Although European officials have contained the horsemeat scandal to Europe, the FSIS is increasing its testing to ensure that a similar situation does not occur in the United States. The FSIS conducts species tests known as ELISA-TEK for cooked meat and DTEK Immunostick Meat Species Screening Kit for raw meat, which are two types of “immunological techniques.” Not only will the USDA conduct species testing on the imported beef products, but they will also test the meat for E. coli pathogens that can cause serious illness or death when ingested. Inspection personnel must follow the instructions in FSIS Notice 08-13, Control of Agency Tested Imported Products for Adulterants, when conducting these species tests.

The FSIS noted that none of the products that tested positive for horsemeat in Ireland or the other targeted countries were intended for exportation into the United States.

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Author: Megan Fanale Engel (mengel@fulbright.com / 202 662 4733 of Fulbright's Health Care practice.