Under Construction: Bolstering Food Import Safety
By Robert E. Brackett, Ph.D.
The food industry knows that U.S. consumers won’t buy what they don’t trust. This is why food safety is always the foundation of any food company’s brand value proposition. If a food product is not perceived as inherently safe, it won’t sell. Unfortunately, in recent months media surveys show a marked erosion of consumer confidence in the safety of foods, both domestically produced and imported, due to several highly publicized product safety failures involving a spectrum of food categories.
Certainly last year’s admission by two Chinese companies that wheat flour used in a feed ingredient supplied to U.S. pet food manufacturers was intentionally infused with the banned chemical melamine in order to boost the protein content of substandard wheat gluten served as a lightning rod on the issue of imported food safety like no other in recent memory. As the number of reported sickened dogs and cats continued to rise nationwide, the U.S. Food and Drug Administration’s (FDA) investigation revealed that melamine was also found in rice and corn gluten, cornmeal, soy protein, rice protein concentrate and rice bran ingredients imported from China and had been used in feeds for hogs and other livestock. American consumers began to wonder how many U.S.-made processed foods for human consumption contain potentially tainted imported ingredients—and what the government and U.S. food manufacturers are doing to assure that foreign suppliers meet the same standards of food safety and quality that the nation’s companies must meet.
In May 2007, the Bush Administration created the Interagency Working Group on Import Safety, charging taskforce members from a dozen federal consumer protection agencies to review the U.S. import system as a whole and to develop a comprehensive strategic plan that would pinpoint ways to improve the safety of all imports entering the U.S. The U.S. Import Safety Action Plan, released in November 2007, not only provides a blueprint containing both broad recommendations and specific action steps but gives critical insight into the complexities of the food protection challenges posed by imported foods. The most obvious of these is the increasing volume of imports entering the U.S. These recent statistics paint a clear picture:
• Approximately $2 trillion in goods from 825,000 importers arrives at 300 U.S. ports of entry each year. This makes designing a comprehensive inspection system that addresses all food safety contingencies a daunting, if not impossible, task. As President Bush stated when introducing the national Food Safety Import Plan in November 2007: “Physically inspecting every item would bring international trade to a standstill and divert limited resources from those items posing the greatest threat.”
• The volume of import activity is projected to triple by 2015, putting further pressure on food safety stakeholders to remodel the current U.S. import system.
• The value of agricultural imports increased from $45 billion in Fiscal Year (FY) 2003 to $64 billion in FY 2006. Agricultural imports from China alone nearly doubled in the same three-year period, from $1.2 billion to $2.1 billion. In September 2007, the U.S. Department of Agriculture’s Foreign Agricultural (USDA FAS) projected that U.S. agricultural imports will reach a record $75 billion in FY 2008, noting that while imports have been growing steadily for decades, “they have accelerated sharply since 2002, increasing by more than 10 percent a year—twice the historical rate of import growth.”
The USDA FAS also reports that since 2002 there has been a measurable increase in the percentage of total food imports represented by processed foods and beverages and/or agricultural products that do not compete with U.S. grown commodities. Both FAS and the USDA’s Economic Research Service (ERS) indicate that the increased volume of processed food imports, including apple juice, processed fruit, chocolate and confections, wine and beer, is likely due to the fact that these products are available in greater quantities, may offer greater quality attributes, and/or are produced at a lower cost overseas than on U.S. soil. The value of noncompetitive agricultural or raw materials, such as bananas, coffee, tea, spices, fish and shellfish and cocoa, rose from $3.5 billion in 1980 to $29.1 billion in 2006.
Currently, FDA estimates that between 10 and 12 million food import line items fall under its inspection purview each year, a testament to American consumers’ ever-growing, year-round and seemingly insatiable appetite for seasonal fresh and specialty products from around the world. Although FDA has been able to increase the number of inspections per inspector in the past few years, the agency has not received increased resources to bring the percentage or depth of inspections to adequate levels. Nor has federal inspectors’ increased use of computer screening technology to identify which imports warrant the most scrutiny helped to push the percentage up. While it might be true to say that this technology has improved the inspectors’ ability to see every single container as it passes through the screening device, it belies the fact that there are not enough FDA staff to actually take a close look at every item.
The fact is that looking for products that are not in compliance is a needle-in-the-haystack proposition, both from a regulatory inspector’s perspective and a food company’s standpoint. The U.S. food import safety system requires a remodel that shrinks the haystack, so to speak, by identifying ways that all stakeholders can minimize the chance of a food safety failure at any given point in the production, handling and distribution supply chain. This will require setting a preventive system in place, and the food industry has a critical part to play in constructing such a system to strengthen the national import infrastructure on a global scale and regain consumers’ trust.
Remodeling the Basic Foundation
Last fall, a Grocery Manufacturers Association (GMA) working group investigated imported food safety issues and developed a plan of action called the Commitment to Consumers: The Four Pillars of Imported Food Safety. Like the federal Import Safety Action Plan, the foundation of GMA’s four pillars is prevention but in this plan, the primary builders are companies in the food supply chain, the majority of which have stringent food safety programs in place. While some organizations have supported increased border inspections by FDA as the primary way to bar entry of adulterated foreign products into the U.S., the volume of imports and number of ports of entry makes it a practical impossibility to inspect all of the food that crosses our borders. Since we cannot effectively inspect our way to a safer food supply, the GMA working group developed the proposed action plan to take advantage of the food industry’s knowledge, expertise and practical experience to ensure products and ingredients sourced overseas comply with U.S. standards.
The GMA proposal focuses on four ways that food manufacturers can play an instrumental role in strengthening the entire food import system. Whether a food company is a multinational or mom-and-pop operation, every link in the food chain is a supplier to another link—and they get their materials from another supplier, and so on. At some point, each company is a customer of another in the supply chain. If every company, when in the upstream position, insists that their suppliers meet standards for food safety and quality best practices—and conversely, when in the downstream position, themselves implement the food safety best practices required by their customers—the entire supply chain system will be considerably stronger. This approach provides an improved framework for the food industry, rewarding responsible companies that invest in food safety best practices rather than those who may think that cutting corners on food safety will give them a competitive advantage over those who don’t.
In brief, GMA’s action plan to improve imported food safety will be effective if the following four pillars are part of the food industry’s remodeling of the system framework:
Pillar One. Every food company would be required to have a foreign supplier quality assurance program based on FDA guidance. Food companies and importers of record must ensure their suppliers meet FDA standards for food safety and quality.
USDA operates an inspection process in exporting countries for products that it regulates, and for this reason the first pillar specifies FDA as the oversight agency for a foreign supplier quality assurance program. Essentially, the proposed mandatory program requires importers of record to identify and document all programs they have put in place to meet FDA safety and quality requirements. This means that the importer would identify all food safety and quality assurance programs in place, and detailing or showing records that they are observing and adhering to those programs, including Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Point (HACCP) plans, or other preventive control systems. Importers would also need to show that they are applying due diligence in terms of auditing and verifying that food safety systems are working as intended. If the importer is supplying a product or ingredient that requires testing, either for the company’s own assurance or that of their U.S. customers, they will need to provide records as evidence that the testing is being conducted.
Pillar One also installs a “floor”, or common standard, in that all importers to the U.S. market must use FDA guidance as the baseline for compliance. At minimum, all importers must be able to show that they are in compliance with all applicable U.S. laws and regulations related to imports of foods and feed. As the next pillar indicates, if importers wish to go above and beyond that compliance baseline, that’s even better.
Pillar Two. In order to allow FDA to focus its limited resources on higher risk products or countries, the proposed action plan calls for food companies to institute a voluntary qualified importer food safety program. Under this proposal, food companies may voluntarily share proprietary information and testing results with the FDA on a confidential basis. In return, those products may qualify for expedited entry at the borders.
Essentially, this pillar proposing takes into account minimum standards of food safety and quality plus enhanced sharing of data to the agency that allows the product to be in a higher standing. Simply put, if a company is willing to upgrade its standards beyond minimum regulatory requirements and voluntarily develop a qualified importer food safety program, then that company should be rewarded with the proverbial “green lane” by FDA. For those importing entities that submit to extra testing or meet additional criteria, there should be less scrutiny and therefore less delay in terms of speed and/or processing at U.S. borders.
This approach is a win-win for both government and importers and serves a dual purpose. First, for those qualified food importers who opt to share data with FDA and provide documentation greater than the minimum required, the program offers a benefit in the form of preference for inspection at the border, which translates into time- and cost-savings. In other words, if you have the minimum food safety program and meet the regulatory compliance standards then you will be treated like any other business at the border; however, if you have enhanced food safety and quality control programs and you are willing to share certain data that the agency can use to assure itself that your company has a good food safety program in place and therefore warrants special consideration, you will in fact get credit via priority status during port of entry inspection procedures.
Second, the information provided by importers who opt to share data should also help FDA improve the quality of import inspections. With certain data, the agency will be able to better prioritize where they should place their resources and thus avoid expending resources inspecting responsible players and put more pressure and focus on those for which they have doubts.
Pillar Three. The food industry will work with the FDA and other federal government agencies to expand the capacity of foreign governments to prevent and detect threats to food safety by working with foreign countries and international organizations to expand FDA access to foreign facilities and to harmonize food safety standards globally.
Ensuring that foreign governments have the wherewithal in terms of food safety knowledge, training and resources is key to the success of the GMA action plan. Some foreign governments have very good infrastructures for food safety in place; others have little or very remedial food protection systems. GMA believes that it is incumbent upon our government to help bring those countries with inadequate infrastructures up to par with accepted food safety and quality standards. FDA, for example, recently indicated its intention to expand training and science outreach to overseas facilities to assist importers who supply or aim to supply the U.S. market. The goal is to educate foreign manufacturers about the agency’s expectations, with or without onsite FDA inspectors, to improve their ability to meet those standards.
Ultimately, building the food safety capacity of foreign governments will require more focus on the harmonization of international food safety standards. This is perhaps the most difficult aspect of Pillar Three because in many cases experts and countries differ philosophically in how best to achieve food safety objectives, and as mentioned, some nations do not have adequate infrastructures in place to meet agreed standards. However, we must take a holistic, global view of food safety, not just country by country; everyone in the food supply chain must be brought up to the same standard.
Pillar Four. The FDA needs more resources to adequately fulfill its food safety mission. The agency’s funding and resources have fallen precipitously in recent years. GMA is calling on Congress to double the FDA’s food safety budget over the next five years to help bolster the agency, more appropriately enforce our borders and improve the agency’s analytical testing and information technology.
Expanding FDA’s capabilities to assure the safety and quality of imported food products will require increased resources, not only in personnel but in terms of scientific expertise and information technology (IT) infrastructure. Through retirement and attrition, CFSAN’s scientific depth has been decimated over the last five years. With the institutional memory and broad expertise of the previous generation gone, it is imperative that the agency find talented new scientists and staff to take up the work of a new era. Further, FDA doesn’t just need more bodies out in the field; it needs a high quality inspection team comprised of individuals who have food expertise and who are placed in districts where food companies reside.
The advantage of an FDA having an experienced, trained, strong, happy agency is that it will increase consumer confidence in foods and that is good for the food industry. Ultimately, food safety rests on the industry, not the government; the government cannot make food safe, it has to be the producers who make the food. Nevertheless, having strong government oversight to make sure that industry is doing its job and that consumers are comfortable is an important component in truly assuring food safety.
A Structure for Successful Safety
GMA’s Commitment to Consumers: The Four Pillars of Imported Food Safety action plan provides a good architectural blueprint from which industry can play an effective and necessary role in building a better system to assure the safety of imported foods. Food companies must take a thorough and honest look at their operations and consider whether they are doing everything possible to ensure that the ingredients and food products they receive from foreign suppliers meet in-house standards and government regulations for food safety and quality. They need to provide a plan on how to address imported food safety within their own organizations and commit to adopting best practices that will help them effectively carry out that plan. In this new global economy, food companies will also need to be more vocal, becoming leaders in this effort rather than followers. If we are to continue to do business and maintain American consumers’ trust the products, we are going to have to do what it takes to build those assurances. It’s a cost of doing business that will reap great rewards.
Read the sidebar "Highlights of the U.S. Import Safety Action Plan."
Robert E. Brackett, Ph.D., serves as Senior Vice President and Chief Science and Regulatory Officer at the Grocery Manufacturers Association (GMA), which promotes sound public policy, champions initiatives that increase productivity and growth and helps to protect the safety and security of the food supply through scientific excellence. Dr. Brackett oversees all of the association’s scientific and regulatory activity, including the operation of its in-house food safety laboratory. Prior to coming to GMA, Dr. Brackett served in various positions within the U.S Food and Drug Administration’s Center for Food Safety and Applied Nutrition, eventually attaining the position of Center Director. As director, he provided executive leadership to the Center’s development and implementation of programs and policies relative to the composition, quality, safety, and labeling of foods, food and color additives, dietary supplements and cosmetics. Dr. Brackett has served elected leadership positions in several professional associations, and is a Fellow of the American Academy of Microbiology and the International Association for Food Protection.
He is also the recipient of numerous professional awards and serves on the Advisory Boards of the National Center for Food Protection and Defense, and the National Center for Food Safety and Technology. Dr. Brackett can be reached at email@example.com.
Categories: Supply Chain: Imports/Exports
Highlights of the U.S. Import Safety Action Plan
The Interagency Working Group on Import Safety’s Action Plan, which contains short- and long-term recommendations for continuing to improve the safety of imports entering the United States, is the product of extensive coordination among federal agencies, months of hands-on information-gathering, and feedback and suggestions from the private sector.
The Action Plan proposes a strategy focused on a risk-based prevention with verification model that allocates import safety resources based on risk. The Action Plan proposes steps to replace the current “snapshot” approach to import safety, in which inspections are made at the border, with a cost-effective, prevention-focused model that maximizes the impact of public and private safeguards by identifying and targeting critical points in the import life cycle where risk is greatest and focusing attention and resources on these areas.
Primary recommendations in the Import Safety Action Plan include:
1. Creating A Stronger Certification Process. Certification can be a powerful tool to foster compliance with U.S. safety standards while facilitating trade. For example, the FDA should have the authority to require that producers of certain high-risk foods in a particular country, under an agreement with that country, certify that their products meet FDA standards in order to export to the United States. This would help “shrink the haystack” and better target resources on the greatest threats. In addition, voluntary certification should be encouraged for foreign manufacturers of other products. Products certified as meeting U.S. safety standards could receive expedited entry.
2. Encouraging Good Importer Practices. The Action Plan recommends the adoption of best practices to improve import safety and benefit consumers by providing incentives to importers to maintain the highest safety practices for products that carry greater risks.
3. Increasing Transparency. The names of certified producers and importers of record that import products only from certified producers could be made public, so that consumers and distributors can make more informed decisions about product safety.
4. Exchanging Import Data. The importing community, U.S. Customs and Border Protection, and other federal agencies will exchange real-time product and compliance data on each import transaction to better inform decisions to clear or reject import shipments. The Action Plan also recommends that strategic information sharing agreements be concluded with key foreign governments, in order to facilitate the exchange of import and recall data.
5. Increasing U.S. Presence Overseas. Product safety should be a guiding principle of U.S. cooperative agreements with foreign governments. It will also be important to increase training for foreign inspection agencies to build the capacity of foreign governments to ensure the safety of products exported to the United States. In addition, increasing our physical presence abroad and working with foreign governments and manufacturers will help ensure compliance with U.S. safety standards.
6. Enhancing Standards. Congress should give import safety and inspection agencies the ability to strengthen their standards, where needed. These new authorities should take into consideration industry best practices in order to leverage the knowledge and experience of those who best understand how the products are made.
7. Strengthening Penalties. To hold both foreign and domestic entities accountable and discourage the sale of unsafe products, the Federal government will take steps to strengthen penalties against entities that violate U.S. laws, providing a significant incentive to comply with U.S. requirements.
More information on the Import Safety Working Group and the full text of the Import Safety Action Plan may be accessed at www.importsafety.gov.