Remarks given by Linda Swacina, Deputy Administrator, Food Safety and Inspection Service, at the Mexico - U.S. Poultry Health and Trade Symposium, May 12, 2004, Mexico City, Mexico.

View or download slides to accompany this speech (PDF Only)

Introduction

(Slide 1) Good morning! It is a pleasure to be with you here in beautiful Mexico City with its rich history and cultural attractions.

On behalf of the Food Safety and Inspection Service, I want to thank the organizers of this symposium. This forum presents a wonderful opportunity to continue dialogue and learn from each other how we can further improve food safety across the common border between our two countries, and around the world.

A Brief Background

Before I get into the heart of my discussion, let me provide you some background about FSIS, as well as myself. I am the Deputy Administrator of the U.S. Department of Agriculture's Food Safety and Inspection Service, or FSIS as we call it.

(Slide 2) My role as Deputy Administrator of the Agency is to work with Acting Administrator, Dr. Barbara J. Masters, who is a veterinarian and our chief inspection official or central competent authority as the position is commonly referred to in international negotiations. We ensure that the programs and policies of the Agency are effectively carried out on a daily basis to protect public health.

My connection to FSIS is a unique one. My father is a veterinarian and worked for FSIS for 30 years, so I have a close and personal relationship to the Agency and to the issue of food safety and public health. I have witnessed many positive developments within FSIS, especially several recently which I will talk about shortly.

A Brief Background of the Agency

(Slide 3) FSIS is the U.S. Department of Agriculture's public health regulatory agency that protects consumers by ensuring that meat, poultry and egg products are safe, wholesome, and accurately labeled. (Slide 4) These products account for more than $120 billion in sales - or approximately 1.4 trillion Mexican pesos, or about one-third of all U.S. consumer spending on food.

(Slide 5) Looking at these products from another perspective, each year we inspect 39 million cattle, 97 million swine, 3.5 million sheep, and eight billion poultry before, and after, they are slaughtered. Our inspectors also are responsible for inspecting 3.2 billion pounds of liquid egg products, which eventually go into further processing facilities that produce mayonnaise, ice cream, salad dressings, etc. And finally, you will probably take particular attention to this point, we re-inspect 3.8 billion pounds, or approximately 1.7 million metric tons, of imported meat, poultry and processed egg products from 33 countries with inspection systems that are equivalent to our own.

Recent Successes

This enormous responsibility requires that we implement science-based policies to protect public health. Our policies have already yielded positive results for consumers. (Slide 6) Two weeks ago, the Centers for Disease Control and Prevention (CDC) issued a report on the incidence of infections from foodborne pathogens. The report noted significant declines from 1996, the beginning of HACCP, to 2003 in illnesses caused by E. coli O157:H7 (down 42%), Salmonella (down 17%), Campylobacter (down 28%) and Yersinia (down 49%). (Slide 7) The CDC report also noted that illnesses caused by Salmonella Typhimurium that are typically caused by meat and poultry fell by 38% during this same period. Most significantly, illnesses caused by E. coli 0157:H7 that are typically associated with ground beef dropped by 36% between 2002 and 2003.

(Slide 8) Our measures to prevent E. coli O157:H7 contamination in ground beef have also yielded an overall lower prevalence rate of this pathogen. After beef plants were instructed to reassess their HACCP plans to better address potential E. coli O157:H7 contamination, FSIS' scientifically trained personnel conducted the first-ever comprehensive audits of 1,550 beef establishments' HACCP plans. Sixty two percent of those plants made major improvements based on these reassessments, and sixty percent added E. coli O157:H7 as a pathogen likely to occur. As a result, we are seeing a significant drop in the number of E. coli O157:H7 positive samples in ground beef. In 2003, of the E. coli O157:H7 samples collected and analyzed, 0.30 percent tested positive, compared to 0.78 percent in 2002. That's a 60% reduction and a definite improvement! To see a significant drop in illnesses caused by this pathogen is also something both industry and government can be proud of, and consumers can reap the benefits of.

(Slide 9) For Salmonella, we issued new procedures to control this pathogen more quickly. Instead of waiting for three cycles of tests, the discovery of a second Salmonella positive set now triggers a review of an establishment's HACCP plan. Due to this process and other science-based initiatives, the rate of Salmonella found in our regulatory testing program for raw meat and poultry has dropped by 65% over the past six years and by 16% compared with last year.

(Slide 10) And for Listeria monocytogenes, we have seen similar decreases. Last June (2003), we issued a new rule for establishments producing ready-to-eat products where Listeria monocytogenes is a concern. Late last year, we released data that showed a 25 percent drop in the percentage of positive Listeria monocytogenes samples from the year before and a 70% decline compared with years prior to the implementation of HACCP.

Process for Evaluating Equivalence

These examples give you an idea of where we are headed with our food safety system since our actions directly impact other nations maintaining equivalency. (Slide 11) We (FSIS) are required by law to evaluate a foreign country's inspection system before that nation can export meat, poultry and egg products to the United States. Given this responsibility, I want to focus the rest of my discussion on the processes required for exporting to the United States.

Sanitary and Phytosanitary Measures Agreement

(Slide 12) The Sanitary and Phytosanitary Agreement (SPS) is an agreement that sets out the basic rules to ensure food safety, and animal and plant health standards for international trade. The agreement allows countries to set their own standards, but it also stipulates that any regulations must be based on science. Food safety equivalence judgments are based on the provisions of the SPS Agreement, and the United States is bound as a signatory.

(Slide 13) I want to highlight a very important point regarding equivalence that is summarized from Article 4.1 of the SPS Agreement. It states that:

"Members shall accept the sanitary…measures of other members as equivalent, even if these measures differ from their own…if the exporting member objectively demonstrates…that its measures achieve the importing member's appropriate level of sanitary…protection."

(Slide 14) This means that an exporting country has the burden to demonstrate equivalence. And an importing country has the right to decide if a foreign inspection system is either:

1. Equivalent;
2. Inadequate to achieve the appropriate level of protection; or
3. Unable to demonstrate equivalence adequately.

(Slide 15) Since the United States signed the SPS Agreement, FSIS has made several changes in its laws and regulations to comply. First, we amended our regulations to reflect the terminology "equivalent to" as the standard of eligibility. Second, our regulations now set forth the criteria for evaluating foreign systems. And finally, each criterion constitutes a sanitary measure as defined in the SPS Agreement.

(Slide 16) One of the most important terms cited within the SPS Agreement is "sanitary measure." Some examples of sanitary measures might include:

1. End product criteria;
2. A specific sampling procedure;
3. A testing, inspection or certification procedure; or
4. A packaging and labeling requirement directly related to food safety.

These sanitary measures must be based on scientific principles and applied in a non-arbitrary, non-discriminatory manner. In addition, they need to be based on an assessment of the risk from a food safety hazard.

(Slide 17) Another important term in the SPS Agreement is the "appropriate level of protection." This means the SPS Agreement affirms the right of each government to choose its own level of protection. Exporting countries may employ measures that differ from those used by importing countries, provided that they obtain the same level of protection established by the importing country.

(Slide 18) For example, we require generic E. coli testing as a sanitary measure to determine adequate process control during the slaughter of animals. A nation that exports to the United States might decide either to:

1. Adopt the U.S. requirements, or
2. Use another microorganism to determine whether the slaughter process is under control.

The SPS Agreement also directs FSIS in how to make equivalence decisions. The decision-making process requires a cooperative effort between both the importing and the exporting countries. For instance, the importing country, in this case the United States, must notify the 33 countries that export to the United States of any changes in U.S. regulations.

In another example, when the United States implemented HACCP and Salmonella testing requirements, we notified all countries (eligible to export to the United States) and asked them to provide us with documentation on the implementation of those requirements.

(Slide 19) On the other hand, the 33 countries that are eligible to export can ask FSIS to explain our appropriate level of protection and how the HACCP and Salmonella testing requirements are relevant. Once we provide an explanation, the exporting country can either implement those requirements or develop a case for implementing different requirements. If a country chooses to implement a different requirement, then FSIS will review the documentation from the exporting country and make a decision. (Slide 20) FSIS will then decide to do one of three things:

1. Determine whether the different sanitary measure is equivalent to the HACCP and Salmonella testing requirements;
2. Request more information; or
3. Reject the different sanitary measure.

How FSIS Determines Equivalence under the SPS Agreement

FSIS' Office of International Affairs

(Slide 21) Equivalence decisions under the SPS Agreement are handled by FSIS' Office of International Affairs (OIA). This office is headed by Ms. Karen Stuck, Assistant Administrator. Ms. Stuck has been with the Agency for more than 20 years and thus has extensive experience in food safety issues.

FSIS-OIA is the only government office in the U.S. federal government that makes these equivalence decisions each day. The decisions are made by a staff of analysts and scientists specially trained in food safety.

(Slide 22) FSIS-OIA makes two different kinds of equivalence determinations. The first is the initial equivalence determination. This process starts when a country wants to begin exporting to the United States. The second is the on-going equivalence determination. FSIS-OIA uses this process to decide whether a country continues to maintain an equivalent inspection program.

The Initial Equivalence Determination

First, let's look at how we make initial equivalence decisions. (Slide 23) We use a multi-step process to determine whether another country's food regulatory system is equivalent to our own. Any country can apply for eligibility to export meat, poultry or egg products to the United States. The process usually begins with a letter from a central competent authority within another country's government asking for approval to export its products for sale in the United States. We then respond with copies of our laws, FSIS regulations, and other documents that set forth meat, poultry and egg product regulatory policy, as well as questionnaires designed to collect detailed information about the country's food regulatory system.

Usually, it takes several months for countries to complete the application package we send, but we provide as much advice and guidance as possible to other governments concerning any portion of the process. (Slide 24) When we receive the completed application, we conduct an initial document analysis to compare that country's inspection system sanitary measures with the ones we apply in the United States. If there is any further information we need, then we work collaboratively with the country's food regulatory officials to get the necessary information to finish our initial evaluation.

(Slide 25) After reviewing the entire application, we decide whether that country's food regulatory system meets all U.S. import requirements in an equivalent manner to our own and if it provides the same level of public health protection attained domestically. If we determine that both of these objectives are met, then we send a multidisciplinary team of experts to that country to conduct an on-site audit of its entire meat, poultry or egg product regulatory system. We verify that the country has satisfactorily implemented all laws, regulations, and other inspection or certification requirements cited in the initial application.

(Slide 26) After the on-site audit has been successfully completed, we publish a proposed regulation in the Federal Register to add the country to our list of eligible importers. There is a period of time in which we must collect public comments to this proposed regulation to help us make a final decision on whether the country can be eligible to export to the United States.

(Slide 27) What I would like to point out here is that we do not conduct food inspections in another country, nor do we certify individual establishments for export to the United States. After we determine that a country has an equivalent food regulatory system, we rely on that system to meet our public health requirements.

Any establishment that desires to export to the United States must apply to their own central competent authority, and that country's chief inspection official must certify to FSIS a list of all establishments that meet our import requirements. This process is quite different from the one used by the U.S. Department of Health and Human Services' Food and Drug Administration, which looks at individual companies to determine whether they can export to the United States.

On-going Equivalence Determination

(Slide 28) Countries that are eligible to export to the United States must continuously demonstrate that they remain equivalent. FSIS-OIA utilizes three methods to make ongoing equivalence decisions.

(Slide 29) The first step in the on-going equivalence process is called the document analysis. We are especially concerned with government regulatory oversight, as well as verification and enforcement procedures. Therefore, we review documents that describe the country's fundamental laws, regulations, policies, food production requirements, regulatory oversight, verification and enforcement requirements.

(Slide 30) The second step is the system audit. This is where we send one or more of our auditors to the country to assess the inspection system in daily operation, particularly with respect to implementation of any new requirements we have put forth. We audit each country that exports to the United States at least once each year, and we focus on process control and government oversight.

After an audit plan is developed, an FSIS auditor will examine records pertaining to a country's oversight of establishments and laboratories. The auditor will also select a representative number of establishments for actual on-site review. After the audit is complete, the auditor holds an exit conference with inspection officials where the audit findings are discussed.

After an FSIS auditor returns to the United States, an audit report is prepared. We send a final draft audit report to a country for review. A nation has 60 days to comment on the findings, and these findings are then included as an addendum to the final audit report. FSIS-OIA often holds conference calls with the country's inspection officials and/or takes an enforcement action, if necessary. The final audit is then posted on FSIS' Web site.

(Slide 31) The third step of the on-going equivalence process is called port-of-entry reinspection. This involves reinspection of randomly selected samples at the port of entry. These samples are selected by an automated centralized computer database. Furthermore, the samples selected are performance-based, enabling compliance histories to be continuously updated based on test results. All shipments are checked for damage, accurate labeling, proper certification, and for general condition.

Meeting Export Requirements

(Slide 32) The thoroughness of our import inspection procedures is matched by our commitment to ensure that only the safest products are exported from the United States. Because of FSIS' centralized inspection program, we rely heavily on our inspection force to assure that plants are producing the safest possible products both domestically and for export. Our internal assurances come from a multi-tiered system which consists of our front line inspectors, an inspector-in-charge, and visits by circuit supervisors. In addition, the inspection force continually verifies the eligibility of exports from the United States by consulting with the FSIS Library of Export Requirements. The Library is on-line, on FSIS' Web site, and it provides current complete information for both exporters and FSIS inspectors for more than 100 countries.

Closing - The Global Farm-to-Table Chain

(Slide 33) With a global food supply, we are all interdependent on each other's actions. The farm-to-table chain that we historically visualized as being confined within one nation's borders is becoming more of a complex and integrated global network.

This is the reason why when we carry out our meat, poultry and egg products inspection, as well as other food safety activities, we work with all of our domestic and international partners. We need to make sure that we are seeking the highest levels of food safety standards possible - standards that are based on sound science.

(Slide 34) Hopefully, you have gained a better understanding of our food safety system and how we determine equivalence under the SPS Agreement. I want to reiterate the importance of government oversight and enforcement of food safety systems, as well as laboratory sampling. These are matters we take very seriously when we conduct audits of other nation's systems.

Mexico is a dear and close ally of ours, and we are working very closely together to ensure both food safety systems are based on science and protect all our consumers. Food safety is vital for free trade. We still have work to do - government to government…industry to industry. But when we focus on utilizing science as our common ally to improve food safety and public health, we will get it done.

Thank you for your attention, and I would be happy to answer any questions you might have.