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United States Department of Agriculture
Washington, D.C. 20250-3700

Congressional Testimony

July 1, 1999

Statement of Margaret Glavin, Associate Administrator,
Food Safety and Inspection Service
United States Department of Agriculture
Before the Senate Committee on Governmental Affairs
Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia

July 1, 1999

Mr. Chairman and Members of the Subcommittee, I am Margaret Glavin, the associate administrator of the Food Safety and Inspection Service (FSIS). I am pleased to appear before you to discuss the egg products inspection program of the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service. I will also briefly describe the activities of other agencies within USDA that relate to the quality and safety of shell eggs and egg products. Because several USDA agencies play a role in egg safety and regulation, I am joined today by Mr. Michael Holbrook of the Agricultural Marketing Service (AMS), Dr. Jane Robens of the Agricultural Research Service (ARS), and Mr. Thomas Myers of the Animal and Plant Health Inspection Service (APHIS).

Because FSIS and the Food and Drug Administration (FDA) share jurisdiction for eggs, we have been working together for many years to prevent illness associated with SE in eggs. Our combined efforts have allowed us to accomplish many improvements in the area of egg safety. My testimony will specifically highlight USDA's responsibilities in this area and our joint accomplishments.

Let me begin by emphasizing USDA’s commitment to improving the safety of the foods it regulates—meat, poultry, and egg products. This commitment to a safer food supply is shared by the Food and Drug Administration (FDA), which has joint jurisdiction for eggs, and has resulted in a coordinated response to the problem of ensuring a safe food supply. Over the past several years, USDA has implemented a strategy for change that emphasizes the need to prevent food safety problems before they happen and the need to address food safety hazards all along the farm-to-table chain. This strategy also emphasizes the responsibility of industry to produce safe food and the responsibility of government to establish and monitor science-based food safety standards and to ensure that they are met.

We have made much progress in implementing this strategy for change, and data available show that our efforts are paying off. For example, results for the first year of large plant Salmonella testing for meat and poultry show that Salmonella prevalence in broilers, swine, ground beef, and ground turkey was lower after implementation of Hazard Analysis and Critical Control Points (HACCP) systems than in baseline studies completed before HACCP. Prevalence decreased between 25.3 percent and 45.5 percent, depending on the product. While HACCP does not currently apply to egg products, FSIS is in the process of developing such a proposal.

In addition, data from the Foodborne Diseases Active Surveillance Network (FoodNet) show a 13 percent decline in the rate of human Salmonella infections between 1996 and 1998 and a 44 percent drop in the rate of Salmonella Enteritidis (SE), which has been associated with shell egg contamination.

We have not won the war against foodborne illness by any means, and eggs still remain a major source of SE. But the steps we have taken are making a difference, and we at USDA are committed, along with our HHS colleagues, to further progress in reducing the incidence of foodborne illness.

USDA Reorganization Act of 1994

FSIS has a long history of inspecting meat and poultry products, but the Agency’s involvement in egg products inspection is relatively new. The USDA Reorganization Act of 1994 set the stage for FSIS involvement in egg products inspection by transferring this responsibility from AMS to FSIS.

Under the Egg Products Inspection Act (EPIA), FSIS is responsible for continuous Federal inspection in plants processing liquid, frozen, and dried egg products. The regulations governing the inspection of egg products specify minimum requirements for plant facilities, equipment, sanitation, processing procedures, and the testing of pasteurized products for Salmonella. The regulations also require continuous inspection of the packaging and labeling of egg products. During fiscal year 1998, 102 FSIS inspectors monitored operations at 73 egg products plants around the country. FSIS also had cooperative agreements with six States to provide inspection of egg products.

FSIS also oversees the importation of egg products into the United States. Two countries—Canada and the Netherlands—are approved to export egg products to the United States, but Canada is the only country now using that approval. FSIS also certifies egg products for export on request.

The current statutory framework for egg safety established by Congress presents a fragmented system of oversight, but the agencies are working well under this system and are trying to do better. I do want to make the point that USDA activities regarding shell eggs and egg products go beyond FSIS, and any effort to adjust the current statutory framework for egg safety should consider the broad range of activities carried out by USDA and HHS.

For example, the AMS administers a voluntary grading program for shell eggs, supported by user fees, that addresses egg quality as a service to shell egg processing plants. AMS also is responsible for the shell egg surveillance program, which enhances fair competition in the sale of consumer grade eggs. Under the program, eggs are graded to assure that product moving in commerce contains no more restricted eggs—often described as dirty, cracked, or leaking—than are permitted in the U.S. Consumer Grade B. AMS visits shell egg handlers and hatcheries four times each year to ensure conformance with these requirements. AMS also has developed a comprehensive voluntary grading and sanitation service for egg processors that participate in the shell egg grading program. This fee-for-service program allows processors to place a USDA shield on egg cartons verifying that the plant has complied with USDA’s sanitation and good manufacturing practices. In addition, AMS, on a voluntary, fee-for-service basis, conducts third-party monitoring for the United Egg Producers’ 5-Star quality assurance production program.

On April 27, 1998, AMS announced a prohibition on the repackaging of eggs packed under its voluntary grading program so the Agency could conduct further study on the issue. AMS is working on a proposed rule to address this matter more fully.

APHIS conducts activities related to animal health, and several of its activities have a public health impact by reducing the risk of diseases in layer flocks. APHIS administers the National Poultry Improvement Plan (NPIP), which certifies that poultry breeding stock and hatcheries are free from certain diseases. Breeders of egg-type chickens can use this program to monitor their flocks for Salmonella. Although it is a voluntary program, NPIP participation is necessary for those producers that ship interstate or internationally.

Under the Egg Products Inspection Act (EPIA), FSIS has responsibility for imported shell eggs for table use and for imported restricted eggs (dirty, cracked, leaking, etc.). Due to AMS' expertise in these areas, AMS carries out these tasks on behalf of FSIS. FSIS also has the responsibility for monitoring the importation of shell eggs from countries that are not free of certain poultry diseases. Due to APHIS' expertise in this area, APHIS carries out this program on behalf of FSIS.

APHIS' National Animal Health Monitoring System is currently conducting a nationwide survey of the egg industry. This study, entitled "Layers '99," will be used to estimate the national prevalence of SE in layer flocks. The study will also identify quality assurance programs. In cooperation with AMS, APHIS personnel will soon be available to conduct on-farm, third-party monitoring of industry quality assurance programs aimed at reducing the incidence of SE in shell eggs.

USDA also carries out food safety research through ARS and through the National Research Initiative Competitive Grants Program administered by USDA's Cooperative State Research, Education & Extension Service (CSREES). For example, Washington University in St. Louis, Missouri has received a three-year grant to study how Salmonella adheres to chicken cells, and Indiana’s Purdue University is in the midst of a project to develop an oral vaccine against SE.

Through ARS research, we have gained important knowledge, such as the fact that hens infected with SE can produce eggs that are contaminated internally, and that feed withdrawal may increase the transmission of SE infections in flocks. We have new methods for detecting strains of SE that are epidemiologically important, and we have helped to develop new products that competitively exclude Salmonella from chickens.

USDA also plays a role in educating consumers about the handling of eggs. FSIS has developed numerous publications on egg safety and uses a variety of networks to get this information to the grass roots level. For example, USDA cooperative extension agents work directly with consumers around the country to educate them about food safety.

Additionally, USDA plays a role in collecting processing data and distribution information for the economic analysis of the egg products industry through the National Agricultural Statistics Service (NASS).

Thus, USDA agencies carry out a variety of inspection, certification, research, education, and data collection activities that together help to improve the safety of shell eggs and egg products.

FSIS/FDA Cooperation

Of course, FSIS shares statutory authority for egg safety with the Food and Drug Administration (FDA). FSIS and FDA have worked closely together to develop a coordinated approach to the problem of SE in eggs and egg products. This cooperative approach is not new to the two agencies. Over the past several years, we have worked together on a number of food safety issues. For example, FSIS and FDA have worked closely on HACCP implementation for various foods. We have worked closely with HHS on foodborne disease surveillance and outbreak response. And we both are working to strengthen the Food Code and to encourage its adoption by States and local jurisdictions.

I would like to review our accomplishments on egg safety over the past several years, with an emphasis on this cooperation.

On November 22, 1996, FSIS and FDA published an Advance Notice of Proposed Rulemaking (ANPR) to seek input on approaches the two agencies should take to foster food safety improvements during the transportation and storage of potentially hazardous foods. The ANPR addressed all foods regulated by the two agencies, including eggs and egg products. Among the alternatives offered for consideration in the ANPR were temperature performance standards, mandatory HACCP systems, and voluntary guidelines.

On May 19, 1998, FSIS and FDA jointly published an ANPR to initiate a comprehensive and coordinated process of addressing the SE problem in shell eggs and to solicit input from the public on strategies.

On August 27, 1998, FSIS published a final rule to implement the requirements for the refrigeration and labeling of shell eggs that were mandated by the 1991 amendments to the EPIA. The rule requires that shell eggs packed for consumers be stored and transported under refrigeration at an ambient temperature not to exceed 45- degrees F, that all packed shell eggs be labeled to state that refrigeration is required, and that any shell eggs imported into the United States packed for consumer use include a certification that they have been stored and transported at an ambient temperature of no greater than 45-degrees F. The rule becomes effective on August 27th of this year, and yesterday, we issued a directive that details the procedures FSIS will follow to enforce these requirements. We believe that this refrigeration rule is a step in the right direction toward controlling SE during transportation.

Also in the summer of 1998, the final report on the joint USDA-FDA SE Risk Assessment was released. This was our first quantitative, microbial risk assessment, and it is the first in a series of risk assessments the two agencies are working on together.

We began the risk assessment in response to an increasing number of human illnesses attributed to the consumption of contaminated eggs. The risk assessment had several objectives. First, it was intended to characterize, using the data available, the adverse public health effects associated with consuming shell eggs and egg products contaminated with SE. A second goal was to identify data needs and prioritize future data collection efforts. Third, the risk assessment was designed to identify and evaluate potential risk reduction strategies, along the farm-to-table continuum.

The risk assessment extended from the production to consumption of shell eggs and egg products, reflecting our belief that to appropriately address the problem of SE, a comprehensive strategy with multiple interventions is needed.

From the risk assessment, we have a much better idea of the prevalence of illness attributable to SE in shell eggs and egg products. But even more importantly, we have a farm-to-table model—a computer program—we can use to determine the effects of specific interventions on the estimated likelihood of illness. In fact, it was through this model that we evaluated the 45-degree F. ambient temperature requirement mandated by Congress, in terms of the impact it would have on human illnesses.

Upcoming Initiatives

The risk assessment will enable us to better evaluate interventions in terms of public health impact as we further develop our food safety strategy for shell eggs and processed eggs. For example, the risk assessment is being used to develop a proposed rule that would address HACCP for egg products.

The risk assessment also will be helpful in the development of a strategic plan for shell eggs and processed egg products that is being carried out by the strategic planning taskforce of the President's Food Safety Council. It will parallel the broader strategic planning effort that already is underway by the Council. We want the strategic plan for shell eggs and egg products to run on a fast track in order to make immediate progress, and we are committed to completing it within 120 days. We expect the strategic plan to address the broad issue of controlling pathogens, including SE, in shell eggs and egg products, and to take a farm-to-table approach. We also expect it to address research needs and enhance additional Federal-State partnerships.

We are pleased with the progress made so far on the safety of shell eggs and egg products and with the emerging data that show reductions in foodborne illness attributed to SE. We look forward to continuing to work closely with FDA on a broad strategy for change. This concludes my testimony and I thank you for the opportunity to be here today. I, and those accompanying me from other mission areas within USDA, will be happy to answer any questions you or other Members of the Subcommittee may have.

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